IFS PACsecure

Standard for auditing quality and

safety of packaging materials

Version 1
October 2012
IFS publishes information, opinions and bulletins to its best knowledge, but cannot take
any responsibility for any mistakes, omissions or possibly misleading information in its
publications, especially in this document.
The Standard owner of the present document is:
IFS Management GmbH
Am Weidendamm 1A
10117 Berlin
Germany
Managing Director: Stephan Tromp
AG Charlottenburg HRB 136333 B
VAT-N°: DE278799213
Bank: Berliner Sparkasse
Bank code number: 100 500 00
Account number: 190 029 765
IBAN number: DE96 1005 0000 0190 02 97 65
BIC-/Swift-Code: BE LA DE BE
All rights reserved. All publications are protected under international copyright laws. With-
out the expressed written consent of the IFS Standard owner any kind of unauthorised use
is prohibited and subject to legal action.This also applies to the reproduction with a photo-
copier, the inclusion into an electronic database/software, or the reproduction on CD-Rom.
No translation may be made without official permission by the IFS Standard owner.
The IFS PACsecure is available online via:
www.ifs-certification.com
Or by Mail, Fax and E-mail:
IFS Management GmbH
Am Weidendamm 1A
10117 Berlin
Germany
Phone: +49-(0) 30-72 62 50-74
Fax: +49-(0) 30-72 62 50-79
E-mail: [email protected]
IFS PACsecure

Standard for auditing quality and

safety of packaging materials

Version 1
October 2012
 International Featured Standards · IFS PACsecure · Version 1 3

ACKNOWLEDGEMENTS

IFS is pleased to acknowledge the essential support provided by the following

experts:
James D Downham President & CEO of PAC,The Packaging Association of Canada
Larry Dworkin PAC, The Packaging Association of Canada
Larry Shortt L & G Shortt Solutions Limited, Canada
Thomas Maiwald real,- SB-Warenhaus GmbH, Germany
Dr. Andrea Niemann-
Haberhausen Det Norske Veritas, Germany

IFS likes to thank all all companies who contributed in the development
of the PACsecure Standard, which is the basis for the IFS PACsecure Standard:
Acorn Packaging GayLea Foods Parmalat Canada
Agriculture and Agrifood Canada General Mills Canada Peel Plastics Products
Agropur Division Natrel Graham Packaging Plasticap
Alcan Packaging Graphic Packaging Polytainers
Alte-Rego Guelph FoodTechnology Centre Primex Packaging Services
Atlantic Packaging Health Canada R.A. Miller & Co.
Ball Packaging Products High Liner Foods Reinhart Foods
Bericap Ian Britt and Associates Richards Packaging
Bothwell Cheese JM Smucker Robinhood Multifoods
Brewers Association of Canada Jones Packaging Ropak
Bright Cheese House,The Kraft Canada Sandler Consulting
Cadbury Adams Canada Kraft Foods Global Saputo Bakery Division
Canadian Corrugated Case Association Labelad Saxco Canada
Canadian Council of Grocery Distributors Langen Packaging Scott Paper Limited
Canadian Food Inspection Agency Loblaw Brands Silgan Plastics
Canadian General Standards Board Maple Leaf Consumer Foods Smucker Foods of Canada
Canadian Plastics Industry Association Maple Lodge Farms Smurfit MBI
CanAmera Foods McCain Foods Sobeys
Canbra Foods Limited MultiPak Sonoco
Central Graphics Minute Maid Company Canada,The Specialty Paper
Chantler Packaging Nestle Canada Tetra Pak Canada
Ciom/Novacote Norampac The Packaging Group
Coca-Cola Owens-Illinois Glass Containers TWDTechnologies
Cousins Currie Old Dutch Foods W.G. Pro Manufacturing
Crown Packaging Ontario Ministry of Agriculture and WC Parchment
Dainty Foods Food WG Corporate
Dare Foods Ellis Packaging Packaging Association of Canada WinPakTechnologies
FoodCon Packall

© IFS, October 2012

4 International Featured Standards · IFS PACsecure · Version 1

IFS is grateful to the members of the IFS International Technical Com-

mittee and the associated national working groups in France, Germany,
Italy and United States. The IFS PACsecure Standard is the result of the
international partnership between IFS and the Packaging Association of
Canada.

Members of the IFS International Technical Committee

Andrea Artoni CONAD, on behalf of ANCD (Associazone Nazionale Coopera-
tive tra Dettaglianti), Italy
Sabrina Bianchini Det Norske Veritas, Italy
Yvan Chamielec EMC Distribution – Groupe Casino, France
Fayçal Bellatif Eurofins certification, France
Roberta Denatale/
Eleonora Pistochini Auchan, on behalf of Federdistribuzione, Italy
Gerald Erbach METRO AG, Germany
Jean-François Feillet Meralliance, France
Cécile Gillard-Kaplan Groupe Carrefour, France
Almudena Hernandez AENOR, Spain
Luc Horemans Scamark – Groupement Leclerc, France
Dr. Horst Lang Globus SB-Warenhaus Holding GmbH & Co. KG, Germany
Joachim Mehnert DQS, Germany
Patricia Menendez/
Maria López de
Montenegro Dia Group, Spain
Dr. Angela Moritz REWE Group; REWE-Zentral-AG, Germany
Alberto Peiró Mercadona, Spain
Bizhan Pourkomailian Mc Donalds Europe, United Kingdom
Horst Roeser COOP, Switzerland
Nuria Sanz Levia El Corte Ingles, Spain
Sergio Stagni COOP, on behalf of ANCC (Associazone Nazionale Cooperative
Consumatori), Italy
Stephen Thome Dawn Food Products, USA
Dr. Bert Urlings Vion Food, The Netherlands
Karin Voß EDEKA Zentrale AG & Co. KG, Germany
Roman Wißner HARIBO GmbH & Co. KG, Germany
Stefano Zardetto Voltan, Italy

IFS Team
George Gansner Marketing/Business Development Director
Dr. Helga Hippe Quality Assurance Management Director
Seon Kim Shop Manager
Christin Kluge Quality Assurance Project Manager
Nina Lehmann Project Manager Academy/Marketing/Communications
Stéphanie Lemaitre Technical Director
Lucie Leroy Project Manager
Clemens Mahnecke Technical Project Manager
Marek Marzec Business Consultant Central/Eastern Europe
Caroline Nowak Representative, South America
Ksenia Otto Office Manager
Sabine Podewski Project Manager Auditor Approval/Examination
Maria Thalmann Project Manager
Serena Venturi Project Manager
Stephan Tromp Managing Director

© IFS, October 2012

 International Featured Standards · IFS PACsecure · Version 1 5

Table of contents
Part 1: Audit Protocol

1 The history of International Featured Standards and

IFS PACsecure Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11

2 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12
2.1 Purpose and contents of the audit protocol . . . . . . . . . . . . . . . 12
2.2 Extraordinary information to the certification body
by the certified company . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13
2.3 General requirements for the quality and product safety
management system . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13

3 Types of audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.1 Initial audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.2 Follow-up audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14
3.3 Renewal audit (for recertification) . . . . . . . . . . . . . . . . . . . . . . . . 14
3.4 Extension audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15

4 Scope of the audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16

5 The certification process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18

5.1 Preparation of an audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18
5.2 Certification body selection – contractual arrangements . . 18
5.3 Duration of an audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19
5.4 Drawing up an audit time schedule . . . . . . . . . . . . . . . . . . . . . . 20
5.5 Evaluation of requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21
5.5.1 Scoring a requirement as a deviation . . . . . . . . . . . . . . . . . . . . 21
5.5.2 Scoring a requirement as a non-conformity . . . . . . . . . . . . . . 22
5.5.2.1 Major . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 22
5.5.2.2 KO (Knock out) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23
5.5.3 Scoring a requirement with N/A (not applicable) . . . . . . . . . 24
5.6 Determination of the audit frequency . . . . . . . . . . . . . . . . . . . . 24
5.7 Audit report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.7.1 Structure of the audit report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24
5.7.2 The different steps for the audit report . . . . . . . . . . . . . . . . . . . 25
5.7.2.1 Drawing up the pre-report of the audit and the outline
of the action plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25
5.7.2.2 Company’s completion of the corrective action plan . . . . . . 26
5.7.2.3 Auditor validation of the action plan . . . . . . . . . . . . . . . . . . . . . 27
5.7.3 Further rules about the audit report . . . . . . . . . . . . . . . . . . . . . . 27

© IFS, October 2012

6 International Featured Standards · IFS PACsecure · Version 1

5.7.3.1 Link between two consecutive audit reports (initial and

renewal audits) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 27
5.8 Scoring and conditions for issuing audit report
and certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 28
5.8.1 Specific management of the audit process in case one
or several KO’s has/have been scored with D during
the audit . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 29
5.8.2 Specific management of the audit process in case one or
several Major non-conformity(ies) has/have been issued . 29
5.8.3 Specific management of the audit process in case
the final score is < 75 % . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31
5.8.4 Specific management of the audit process in case
of multi-site companies . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6 Awarding the certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 31

6.1 Deadlines for awarding certificate . . . . . . . . . . . . . . . . . . . . . . . . 32
6.2 Certification cycle . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32
6.3 Information about conditions of withdrawal of certificate . 33

7 Distribution and storage of the audit report . . . . . . . . . . . . . . 34

8 Supplementary action . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34

9 Appeal and complaints procedure . . . . . . . . . . . . . . . . . . . . . . . 34

10 Ownership and usage of the IFS PACsecure logo . . . . . . . . . 35

11 Review of the Standard . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

12 IFS Integrity Program . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37

12.1 Preventive quality assurance actions . . . . . . . . . . . . . . . . . . . . . 37
12.2 Quality assurance actions after complaint notification . . . . 38
12.3 Sanctions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38

ANNEX 1
Clarification for the scope application of the different
IFS Standards . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40

ANNEX 2
Certification process . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42

ANNEX 3
Product scopes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43

ANNEX 4
Flow chart for management of KO scored with D and Major
non-conformities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44

© IFS, October 2012

 International Featured Standards · IFS PACsecure · Version 1 7

Part 2: List of audit requirements

1 Senior Management Responsibility . . . . . . . . . . . . . . . . . . . . . . 46

1.1 Corporate policy/Corporate principles . . . . . . . . . . . . . . . . . . . 46
1.2 Corporate structure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47
1.3 Customer focus . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49
1.4 Management review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50

2 Quality and Packaging Material Safety Management System 52

2.1 Quality management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
2.1.1 Documentation requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . 52
2.1.2 Record keeping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53
2.2 Packaging Material Safety Management . . . . . . . . . . . . . . . . . 55
2.2.1 Hazard analysis and risk assessment system . . . . . . . . . . . . . 55
2.2.2 Hazard analysis and/or risk assessment team . . . . . . . . . . . . 56
2.2.3 Hazard analysis and risk assessment . . . . . . . . . . . . . . . . . . . . 57
3 Resource Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60
3.1 Human resources management . . . . . . . . . . . . . . . . . . . . . . . . . . 60
3.2 Human resources . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
3.2.1 Personnel hygiene . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61
3.2.2 Working conditions and protective clothing for personnel,
contractors and visitors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62
3.2.3 Procedures applicable to infectious diseases . . . . . . . . . . . . . 64
3.3 Training and instruction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64
3.4 Sanitary facilities, equipment for personnel hygiene and
staff facilities . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65
4 Planning and Production Process . . . . . . . . . . . . . . . . . . . . . . . . 67
4.1 Contract agreement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 67
4.2 Specifications and formulas/configurations . . . . . . . . . . . . . . 68
4.2.1 Specifications and other legally required documentation . 68
4.2.2 Formula/configuration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
4.3 Product development/Product modification/Modification
of production processes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 69
4.4 Purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4.4.1 General purchasing . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 71
4.4.2 Trade of packaging materials . . . . . . . . . . . . . . . . . . . . . . . . . . . . 73
4.5 Product wrapping . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 74
4.6 Factory location . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
4.7 Factory Exterior . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 75
4.8 Plant layout and process flows . . . . . . . . . . . . . . . . . . . . . . . . . . . 76
4.9 Constructional requirements for production and storage
areas . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
4.9.1 Constructional requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
4.9.2 Walls . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77

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8 International Featured Standards · IFS PACsecure · Version 1

4.9.3 Floors . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 77
4.9.4 Ceilings/Overheads . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.9.5 Windows and other openings . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78
4.9.6 Doors and gates . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4.9.7 Lighting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 79
4.9.8 Air conditioning/Ventilation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.9.9 Water supply . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 80
4.9.10 Compressed air . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
4.10 Cleaning and disinfection . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81
4.11 Waste disposal . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 84
4.12 Risk of foreign material, metal, broken glass and wood . . . 85
4.13 Pest monitoring/Pest control . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87
4.14 Receipt of goods and storage . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89
4.15 Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91
4.16 Maintenance and repair . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92
4.17 Equipment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93
4.18 Traceability (including GMOs and allergens) . . . . . . . . . . . . . . 94
4.19 Allergens and specific conditions of production . . . . . . . . . . 96
5 Measurements, Analysis, Improvements . . . . . . . . . . . . . . . . . 96
5.1 Internal audits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96
5.2 Site factory inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
5.3 Process validation and control . . . . . . . . . . . . . . . . . . . . . . . . . . . 98
5.4 Calibration, adjustment and checking of measuring
and monitoring devices . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 99
5.5 Control of quantity/filling quantity . . . . . . . . . . . . . . . . . . . . . . . 100
5.6 Product analysis . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 101
5.7 Product quarantine (blocking/hold) and product release . . 103
5.8 Management of complaints from authorities and customers 103
5.9 Management of incidents, product withdrawal, product
recall . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 104
5.10 Management of non-conformities and non conforming
products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105
5.11 Corrective actions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 106
6 Packaging material defense/Food defense and external
inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
6.1 Defense assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 107
6.2 Site Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
6.3 Personnel & Visitor Security . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 109
6.4 External Inspections . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111

ANNEX 1
GLOSSARY/DEFINITIONS LIST . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 112

© IFS, October 2012

 International Featured Standards · IFS PACsecure · Version 1 9

Part 3: Requirements for Accreditation Bodies,

Certification Bodies and Auditors
IFS accreditation and certification process

0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119

1 Requirements for the Accreditation Bodies . . . . . . . . . . . . . . 119

1.1 General requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
1.2 The training of the accreditation committee
(or competent person) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 119
1.3 Competences of the assessor of the accreditation body . . 120
1.4 Frequency of the assessments of certification bodies . . . . . 120
1.5 Accreditation of an internationally-active certification body 121
1.6 Conditions for recovering accreditation after withdrawal
or suspension . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 121
1.7 Transfer of certification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 122

2 Requirements for the Certification Bodies . . . . . . . . . . . . . . . . 122

2.1 ISO/IEC 17065 IFS accreditation process . . . . . . . . . . . . . . . . . . 122
2.2 Signing of contract with the proprietor of IFS . . . . . . . . . . . . . 122
2.3 Certification decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
2.4 Certification bodies’ responsibilities for IFS PACsecure
trainers and the IFS PACsecure auditors (including
freelancers) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 123
2.5 Specific requirements for IFS PACsecure trainers . . . . . . . . . 125

3 Requirements for IFS PACsecure auditors . . . . . . . . . . . . . . . . 126

3.1 Conversion of auditors to get the IFS PACsecure version 1
auditor approval . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
3.2 Requirements for new IFS PACsecure auditors . . . . . . . . . . . 126
3.2.1 Requirements before applying for the IFS PACsecure
examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 126
3.2.2 General requirements for auditors when applying for
IFS PACsecure examinations . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 127
3.3 IFS examination process (for new auditors, as specified
in chapter 3.2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 128
3.4 Maintenance of auditors’ qualification (for both types of
auditors, as specified in chapters 3.1 and 3.2) . . . . . . . . . . . . 129
3.5 Scope extension for IFS-approved auditors . . . . . . . . . . . . . . . 130
3.6 Audit team . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
3.6.1 General rules . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 130
3.6.2 Specific rules for audit team and auditing 3 consecutive
times . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 131
ANNEX 1
Product scopes . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 132

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10 International Featured Standards · IFS PACsecure · Version 1

Part 4: Reporting and IFS Audit Portal

0 Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133

1 Reporting . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
1.1 Audit overview (Annex 1) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 133
1.2 Audit report (Annex 2) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
1.3 Action plan (Annex 3) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135
1.4 Minimum requirements for IFS PACsecure certificate
(Annex 4) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 135

2 The IFS Audit Portal and the IFS Database

(www.ifs-certification.com) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 136

ANNEX 1
Final Audit Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 139

ANNEX 2
Detailed Audit Report . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 143

ANNEX 3
Action plan . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 145

ANNEX 4
Certificate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 146

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 International Featured Standards · IFS PACsecure · Version 1 Part 1 11

Part 1: Audit Protocol

1 The history of International Featured

Standards and IFS PACsecure Standard

Supplier audits have been a permanent feature of retailer’s systems and

procedures for many years. Until 2003 they were performed by the
quality assurance departments of the individual retailers, wholesalers
and food services. The ever-rising demands of consumers, the increas-
ing liabilities of retailers, wholesalers and food services, the increasing
of legal requirements and the globalisation of product supply, all made
it essential to develop a uniform quality assurance and food safety
Standard. Also, a solution had to be found to reduce the time associ-
ated with a multitude of audits for involved stakeholders.

The associated members of the German retail federation – Handelsver-

band Deutschland (HDE) – and of its French counterpart – Fédération
des Entreprises du Commerce et de la Distribution (FCD) – drew up a
quality and food safety standard for retailer branded food products
named the IFS Food, the first Standard of the IFS family, which is
intended to allow the assessment of suppliers’ food safety and quality
systems in accordance with a uniform approach. This Standard is now
managed by IFS Management GmbH, a company owned by FCD and
HDE, and applies to all the post-farm gate stages of food processing.
IFS Food Standard has been benchmarked with GFSI Guidance Docu-
ment and is recognised by GFSI (Global Food Safety Initiative).

The first version implemented (version 3) of the IFS Standard was

developed by the HDE and launched in 2003. In January 2004, an
updated version, version 4, was designed and introduced in collabora-
tion with the FCD. Within 2005/2006, the Italian retail associations also
joined the International Food Standard and the development of version
5 was a collaboration of retail federations from France, Germany and
Italy as well as retailers from Switzerland and Austria.

For IFS Food version 6, the International Technical Committee and the
French, German and Italian working groups have been actively involved,
in addition to retailers, stakeholders and representatives of industry,
food services and certification bodies. During the development of IFS
Food version 6, IFS gained input from a recently formed IFS North
American working group and retailers from Spain, Asia and South
America.

Based on this experience, the IFS PACsecure Standard is a new one in

the IFS (International Featured Standards) family covering another part
of the supply chain.

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12 Part 1 International Featured Standards · IFS PACsecure · Version 1

The fundamental objectives of IFS PACsecure, as well as for other IFS

Standards, are:
– to establish a common standard with a uniform evaluation sys-
tem,
– to work with accredited certification bodies and qualified IFS
approved auditors,
– to ensure comparability and transparency throughout the entire
supply chain,
– to reduce costs and time for both suppliers and retailers,
– to meet GFSI requirements.

As announced on February 15th 2012, IFS Management GmbH, owner of

the GFSI benchmarked IFS Food Standard, IFS Logistics and other sup-
ply chain Standards, together with The Packaging Association of Can-
ada (PAC), have joined to bring the world’s foremost packaging stand-
ard for primary and secondary packaging to the industry.

PACsecure was created by PAC to provide packaging manufacturers

and converters the ability to certify primary and secondary packaging
materials for the food industry. However, the IFS PACsecure Standard is
applicable to all kinds of packaging materials. Developed by a technical
working group made up of some of North America’s largest global
packaging and food manufacturers, the Standard is now managed by a
joint effort of the PAC through their technical expertise and know-how
in the packaging industry and IFS and its global network of food safety
and quality standards infrastructure.

2 Introduction

2.1 Purpose and contents of the audit protocol

This audit protocol describes the specific requirements made on the

organisations involved in IFS PACsecure audits.

The purpose of the protocol is to define the criteria to be followed by a

certification body performing audits against the IFS requirements, and
in accordance with the accreditation norm ISO/IEC 17065.

It also details the procedures to be observed by the companies being

audited, and clarifies the rationale of auditing them. Only accredited
certification bodies to ISO/IEC 17065 for the scope of IFS PACsecure,
and which have signed an agreement with the scheme owner can per-
form audits against the IFS PACsecure Standard and can issue IFS PAC-
secure certificates. The IFS requirements for certification bodies are
clearly described in Part 3 of this document.

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 International Featured Standards · IFS PACsecure · Version 1 Part 1 13

2.2 Extraordinary information to the certification body

by the certified company
In accordance with ISO/IEC Guide 65, the company shall inform its cer-
tification body about any change or information indicating that the
products may no longer comply with the requirements of the certifica-
tion system (e.g. recall, alert on products, etc.). For IFS, this information
shall be made within 3 working days.

2.3 General requirements for the quality and product

safety management system
In general, when auditing in accordance with IFS, the auditor assesses
if the various elements of a company’s quality and product safety man-
agement system are documented, implemented, maintained, and con-
tinuously improved. The auditor shall examine the following elements:
– organisational structure in relation to responsibility, authority,
qualification and job description,
– documented procedures and the instructions concerning their
implementation,
– inspection and testing: specified requirements and defined
acceptance/tolerance criteria,
– actions to be taken in case of non-conformities,
– investigation of the causes of non-conformities and the imple-
mentation of corrective actions,
– conformity analysis of safety and quality data and review of
implementation in practice,
– handling, storage and retrieval of quality and packaging mate-
rial safety records, such as traceability data, document control.

All processes and procedures shall be clear, concise and unambiguous

and the personnel responsible shall understand the principles of the
quality and product safety management system.

The quality and product safety management system is based on the

following methodology:
– to identify the processes needed for the quality and product
safety management system,
– to determine the sequence and interaction of these processes,
– to determine the criteria and methods required to ensure the
effective operation and control of these processes,
– to ensure the availability of information necessary to support
the operation and monitoring of these processes,

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14 Part 1 International Featured Standards · IFS PACsecure · Version 1

– to measure, monitor and analyse these processes, and imple-

ment the necessary action to achieve planned results and con-
tinuous improvement.

3 Types of audit

3.1 Initial audit

An initial audit is a company’s first audit to IFS PACsecure. It is per-
formed at a time and date agreed between the company and the selected
certification body. During this audit the entire company is assessed,
both in relation to its documentation and the processes themselves.
During the audit, all criteria of the IFS requirements shall be assessed
by the auditor. In the case of a pre-audit, the auditor who performs this
audit shall be different from the auditor who performs the initial audit.

3.2 Follow-up audit

A follow-up audit is required in a specific situation when the results of
the audit (an initial audit or a renewal audit) have been insufficient to
allow the award of the certificate (see chart N° 6). During the follow-up
audit, the auditor focuses on the implementation of the actions taken to
correct the Major non-conformity determined during the previous audit.
The follow-up audit shall be performed within a six months period from
the date of the previous audit. In general, the auditor who performed
the audit where a Major non-conformity has been identified shall per-
form the follow up audit.
If the Major non-conformity is related to production failure(s), the fol-
low up audit shall be performed at least 6 weeks after the previous audit
and no later than 6 months after the previous audit. For other kinds of
failures (e.g. documentation), the certification body is responsible for
the determination of the date of the follow-up audit.
If there is no follow-up audit performed after 6 months from the date of
the previous audit, then a complete new audit is necessary.
In the event that the follow-up audit establishes that requirements
remain inadequate, a complete new audit is necessary. The elimination
of Major non-conformities shall always be established by an on-site
visit by the auditor.

3.3 Renewal audit (for recertification)

Renewal audits are those which are performed after the initial audit.
The period in which a renewal audit shall be performed is shown on the
certificate. A renewal audit involves a full and thorough audit of a com-

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 International Featured Standards · IFS PACsecure · Version 1 Part 1 15

pany resulting in the issue of a new certificate. During the audit, all cri-
teria of the IFS requirements shall be assessed by the auditor. Particular
attention is paid to the deviations and non-conformities identified dur-
ing the previous audit, as well as to the effectiveness and implementa-
tion of corrective actions and preventive measures laid down in the
company’s corrective action plan.

Note: corrective action plans from the previous audit shall always be
assessed by the auditor, even if the previous audit has been performed
more than one year ago. Therefore, audited companies shall always
inform their certification body if they have already been IFS certified in
the past.

The date of the renewal audit shall be calculated from the date of the
initial audit and not from the date of issue of the certificate. Further-
more, the renewal audit can be scheduled at earliest 8 weeks before and
at latest 2 weeks after the renewal audit due date (see also section 6.2).
Companies are responsible for maintaining their certification. The certi-
fication bodies shall contact companies in advance in order to set a date
for a new audit.

In general, the expected date of each audit shall be uploaded in the IFS
Audit Portal, in the diary function and at latest 2 weeks (14 calendar
days) before the audit due date (it is possible to change the date short
term).

3.4 Extension audit

In specific situations, such as new products and/or processes to be

included in the audit scope or each time the audit scope would need to
be updated on the certificate, then, for an IFS PACsecure certified com-
pany, it is not necessary to perform a complete new audit, but to organ-
ise an on-site extension audit during the validity period of the existing
certificate. The certification body is responsible for determining relevant
requirements to be audited and relevant audit duration. The extension
audit shall be performed by the auditor who performed the “normal”
audit. The report of this extension audit shall be represented as an
annex adjoined with the current audit report. Conditions for passing the
extension audit (relative score ≥ 75 %) are the same as normal one, but
only focused on specific requirements which have been audited; the
original audit score does not change.

If the extension audit demonstrates compliance, the certificate shall be

updated with the new scope and uploaded in the Audit Portal.

The updated certificate shall keep the same due date of end of validity
as the current certificate.

If, during the extension audit, a Major non-conformity or a KO (Knock

Out non-conformity) has been identified, the full audit is failed and the
current certificate shall be suspended as described in 5.8.1 and 5.8.2.

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16 Part 1 International Featured Standards · IFS PACsecure · Version 1

4 Scope of the audit

IFS PACsecure is a Standard for auditing primary and secondary pack-
aging material manufacturers and converters.

Although initially developed for food contact packaging material manu-

facturers (e.g. plastic foils for vegetables, cans for beverages, paper
wrapping for flour, etc.) IFS PACsecure is also applicable to non-food
contact packaging materials, such as:
– packaging materials for products intended to be used on the
skin (e.g. cosmetic products),
– packaging materials for products not intended to be used on
the skin (e.g. household products, consumer goods, hardware,
etc.).
The Standard can only be used when packaging material is “processed”,
converted or printed and applies both to B to B and B to C businesses.
As a result, IFS PACsecure shall not apply to the following activities:
– importation (offices, e.g. typical broker companies)
– transport, storage and distribution.
For clarification of the scope determination between IFS PACsecure and
other IFS Standards (Food, Broker, Logistics, Cash & Carry/Wholesale
and HPC) please see Annex 1.

If the company trades packaging materials as finished products and if it

wants to include them in the audit scope, the suppliers of these prod-
ucts shall themselves be IFS PACsecure certified (if the trade products
are under the same product scope) or certified under a comparable
scheme (if the trade products are under a different product scope) and
the specific requirements in the audit check-list (Part 2) related to trade
of packaging materials (4.4.2.1 to 4.4.2.3) shall be fulfiled. If this is not
the case, those products shall be excluded from the certificate and the
certificate shall mention: “trade activity is not included”.

If the above mentioned requirements are fulfiled, those traded packag-

ing materials shall clearly be specified on the certificate, detailing the
product scope(s), and specified in the report, both in the audit scope
and in the company profile.

The scope of the audit shall be defined and agreed between the com-
pany and the certification body before the audit takes place. The scope
shall be clearly and unambiguously stated in the contract between the
company and the certification body, in the audit report and on the cer-
tificate.

The audit shall be performed at a time to ensure the full scope of prod-
ucts and processes, as mentioned in the report and on the certificate,
can be effectively assessed.

If, between two certification audits, new processes or products different

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 International Featured Standards · IFS PACsecure · Version 1 Part 1 17

from those included in the scope of the current IFS PACsecure audit are
implemented, the certified company shall immediately inform its certi-
fication body, who shall perform a risk assessment to decide whether
an extension audit should be performed or not (see also 3.4). The results
of this risk assessment, based on hygiene and safety risks, shall be
documented.

The audit shall be specific to the site where all the processing of the
products is undertaken. Where decentralised structures exist and the
audit of a certain location is insufficient for gaining a complete view of
the company’s processes, then all other relevant facilities shall also be
included in the audit. Full details shall be documented within the com-
pany profile in the audit report.

The audit scope shall include the complete activity of the company (i.e.
the same kind of production on several lines for products under indus-
try brands and retailer/wholesaler brands). The scope shall be reviewed
and agreed at the beginning of the audit after an initial risk assessment.
Furthermore, the scope can be modified after the risk assessment (for
instance, if a further activity interferes with the one concerned by the
audit scope).

The audit scope shall make reference to the audited product scope(s)
corresponding to the type of packaging materials being processed/con-
verted during the audit (see Annex 3).

If, under exceptional circumstances, the company decides to exclude

specific product ranges (product lines) from the scope of the audit, then
this shall be clearly noted and included in the audit report and on the
IFS PACsecure certificate.

Auditing of multi-location companies with central management

If defined processes are centrally organised in a company with several
production sites (e.g. purchasing, personnel management, complaint
management), the central managing site – headquarter – shall also be
audited and relevant audited requirements outcome shall be consid-
ered in the audit reports of each production site.

Note: Each production site shall be audited separately in a period of

maximum 12 months after the central managing site and shall have its
own audit report and certificate. Each site shall be mentioned in the
relevant contract. If the central managing site does not have any pro-
duction activity, this site cannot be IFS certified as an independent com-
pany. The time for auditing the central managing site shall be described
in the company profile of the report.

The audit of the managing site shall always take place before the audit
of each production site in order to have a preliminary overview.

Note: If it is not possible to perform an audit at the managing site, then

it shall be ensured that, during the audit of the production site, all nec-
essary information from the managing site is available (e.g. a repre-
sentative of the managing site should attend at the audit(s) of the pro-
duction site(s)).

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5 The certification process

5.1 Preparation of an audit

Before being audited, the company shall review all requirements of the
IFS PACsecure Standard in detail. On the day of the audit, the current
version of the Standard shall be available at the site being audited. The
company is responsible for acquiring the current version of the Stand-
ard. In order to prepare for an initial audit, a company may carry out a
pre-audit, which is only intended to be used in-house. The pre-audit
cannot include any recommendations.

If the audit is not an initial audit, the company shall also inform the
certification body so that the auditor can check the corrective action
plan from the previous audit.

The expected date for the initial or renewal audit shall be communi-
cated to the IFS offices via the IFS Audit Portal. This shall be the respon-
sibility of the certification body.

5.2 Certification body selection – contractual

arrangements
In order to undertake the IFS PACsecure audit, the company shall
appoint a certification body which is approved to perform such audits.
It is the responsibility of the company to verify that the certification
body is accredited for IFS PACsecure certification.

Only those IFS approved certification bodies – which shall be accredited

to ISO/IEC 17065 for IFS PACsecure and shall have signed a contract
with IFS (see Part 3) – can carry out IFS PACsecure audits and issue
certificates. The list of all IFS international approved certification bod-
ies, by country, is available on the website www.ifs-certification.com.

Certification bodies can have auditors qualified for one or several prod-
uct scopes. Confirmation of the product scopes for which the certifica-
tion body can perform audits shall be obtained from the individual cer-
tification body.

IFS PACsecure audits can be carried out by an audit team only if all
members of the audit team are IFS approved auditors. Additional
requirements for audit teams are described in detail in Part 3 of the
Standard, chapter 3.6.

An auditor is not allowed to perform more than 3 consecutives audits of

the same company’s site (whatever the time between audits); rules in
case of audit team are also detailed in Part 3, chapter 3.6.

A contract shall exist between the company and the certification body
detailing the scope of the audit, the duration and reporting require-

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 International Featured Standards · IFS PACsecure · Version 1 Part 1 19

ments. The contract shall have a reference to Integrity Program (see

chapter 12), in relation to the possibility of on-site audits organized by
Quality Assurance Management of the IFS offices.

The audit shall take place when products of the audit scope are being
processed/converted.

The audit shall preferably be carried out in the language of the company
being audited and the certification body shall make every attempt to
appoint an auditor whose native language or main working language is
the language of the company. If this is not possible, the audit should be
carried out in English language. Furthermore, languages used by the
auditor for leading an audit – others than native language – shall be
approved by IFS offices prior to undertaking audits (see also Part 3).
Nevertheless, and in all cases, the audit report, certificate and action
plan shall be written in English language.

5.3 Duration of an audit

The certification bodies have an appropriate system for estimating the
minimum time needed for an audit.

A number of factors, which are detailed in the contract between the

certification body and the company, play a role in determining the time
required for a comprehensive audit. They include:
– the size of the site
– the type of production/conversion process
– the scope of the audit
– the number of production lines involved
– the number of personnel employed at the site
– the number of non-conformities found in the previous audit.

Experience shows that the minimum audit duration on site shall be

2 working days. Exceptions to this requirement, including decreasing
linked to multi-site companies, shall be precisely explained by the certi-
fication body/the auditor on the first page of the report, in the “com-
pany profile” field.

The audit duration might be extended, depending on the above factors.

If the auditor estimates that additional time is necessary, the audit dura-
tion shall be extended.

The above-mentioned requirements shall apply equally to renewal

audits, which shall be considered as completely new audits.

A normal audit day duration is 8 hours.

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20 Part 1 International Featured Standards · IFS PACsecure · Version 1

Independently from audit duration, besides on-site audit, preparation of

the audit shall be at least 2 hours.

1/3 of the audit duration shall be spent, as a minimum, in the produc-

tion/converting area of the site.

Additionally, time for generation of the audit report is typically 0,5 days.

Note 1: For multi-location companies, audit duration could be decreased

by a maximum of 0,5 days, if requirements have already been audited
at the central managing site.

Note 2: For an audit team, the minimum audit duration shall be 1 day.
In addition to the calculated audit time, minimum 2 hours shall be
added. This additional time shall be allocated to the team and not to an
individual auditor for common tasks (e.g. opening and closing meeting,
discussion about audit findings, etc.).

See also Part 3, chapter 3.6 about audit team.

5.4 Drawing up an audit time schedule

The certification body shall provide the audit time schedule. The audit
time schedule includes appropriate details concerning the scope cov-
ered and the complexity of the audit. The audit time schedule shall be
sufficiently flexible to respond to any unexpected events which may
arise during the site inspection activity within the certification audit.
The audit time schedule takes into consideration a review of the audit
report and action plan relating to the previous audit, whatever the date
when the previous audit has been performed. It also specifies which of
the company’s products or product ranges are to be audited. The com-
pany can only be audited at a time when it is actually producing/con-
verting the products specified in the scope of the audit. The audit time
schedule shall be sent to the auditee before the audit, to ensure availa-
bility of responsible persons at the day of the audit.

In case of an audit team, the audit time schedule shall clearly indicate
which auditor performs which part of the audit.

If the IFS PACsecure audit is performed in combination with another

standard/norm, the audit time schedule shall clearly indicate when each
standard or part of it has been audited.

The audit shall be scheduled based on the following steps:

– the opening meeting
– the evaluation of existing quality and product safety systems;
achieved by checking documentation (HACCP/risk assessment,
quality management documentation)

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 International Featured Standards · IFS PACsecure · Version 1 Part 1 21

– the on-site inspection and interviewing of the personnel

– the final conclusions drawn from the audit
– the closing meeting.
The company will assist and co-operate with the auditor during the
audit. As part of the audit, personnel from different levels of manage-
ment are interviewed. It is advisable that the company’s senior manag-
ers are present at the opening and closing meetings so that any devia-
tions and non-conformities can be discussed.

The auditor(s) who conduct(s) the audit will assess all the requirements
of IFS PACsecure which are relevant to the company’s structure and
function.

During the closing meeting, the auditor (or lead auditor in the case of an
audit team) shall present all findings and discuss all deviations and
non-conformities which have been identified. As specified by ISO/IEC
17065, the auditor may only issue a provisional assessment of compa-
ny’s status during the closing meeting. The certification body shall issue
a provisional audit report and outline an action plan to the company,
which shall be used as a basis for drawing up corrective actions for the
determined deviations and non-conformities.

The certification body is responsible for making the certification deci-

sion and the preparation of the formal audit report after the receipt of
the completed action plan. The issue of the certificate is dependent on
the audit results and on agreement on an appropriate action plan.

5.5 Evaluation of requirements

The auditor assesses the nature and significance of any deviation or
non-conformity. In order to determine whether compliance with a
requirement of IFS PACsecure has been met, the auditor has to evaluate
every requirement in the Standard. There are different levels to rank the
findings.

5.5.1 Scoring a requirement as a deviation

In IFS PACsecure there are 4 scoring possibilities. Scoring with:

A: Full compliance with the requirement specified in the Standard

B: Almost full compliance with the requirement specified in the Stand-
ard, but a small deviation was found
C: Only a small part of the requirement has been implemented
D: The requirement in the Standard has not been implemented

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22 Part 1 International Featured Standards · IFS PACsecure · Version 1

Points are awarded for each requirement according to the following

chart:

Chart N° 1: Scoring

Result Explanation Points

A Full compliance 20 points
B (deviation) Almost full compliance 15 points
C (deviation) Small part of the requirement has been imple- 5 points
mented
D (deviation) Requirement has not been implemented –20 points

The auditor shall explain all scorings with B, C and D in the audit report.

In addition to this scoring, the auditor can decide to give the company a
“KO” or a “Major” non-conformity that will subtract points from the
total amount. These possibilities are explained within the next chapters.

5.5.2 Scoring a requirement as a non-conformity

In IFS, there are two (2) kinds of non-conformities which are Major and
KO. Both will lead to a subtraction of points from the total amount. If the
company gets at least one of these non-conformities, the certificate
cannot be awarded.

5.5.2.1 Major

A Major is defined as follows:

A Major non-conformity can be given to any requirement which is not
defined as KO requirement.

When there is a substantial failure to meet the requirements of the

Standard, which includes product safety and/or the legal requirements
of the production and destination countries. A Major can also be given
when the identified non-conformity can lead to a serious health hazard.

A Major will subtract 15 % of the possible total amount of points.

Chart N° 2: Evaluation of a Major

Evaluation Scoring Result

Major 15 % of possible total amount is No certificate awarding is
subtracted possible

See also section 5.8 for the general management of audit process in
case of Major non-conformity(ies).

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 International Featured Standards · IFS PACsecure · Version 1 Part 1 23

5.5.2.2 KO (Knock out)

In IFS, there are specific requirements which are designated as KO

requirements (KO – Knock Out).

If during the audit the auditor establishes that these requirements are
not fulfiled by the company, this results in non-certification.

In IFS PACsecure the following 9 requirements are defined as KO

requirements:

1.2.4 Responsibility of the senior management

3.2.1.2 Personnel hygiene
4.2.1.2 Raw material specifications
4.2.2.1 Product formula compliance
4.12.1 Foreign material management
4.18.1 Traceability system
5.1.1 Internal audits
5.9.2 Procedure for withdrawal and recall
5.11.2 Corrective actions

KO requirements shall be evaluated according to the following scoring

rules:

Chart N° 3: Scoring for a KO requirement

Result Explanation Awarded scores

A Full compliance 20 points
B (deviation) Almost full compliance 15 points
C (deviation) Small part of the requirement No “C” scoring is possible
is implemented
KO (= D) The requirement is not 50 % of the possible total amount
implemented of points is subtracted => No
certificate awarding is possible

Important note
A “C” scoring is not possible for KO requirements. In this respect, the
auditor can only use A, B or D (= KO).

When a KO requirement has been scored as “D”, 50 % of the possible

total amount of points will be subtracted automatically meaning that
the company is “not approved” for IFS PACsecure certification.

A KO cannot be scored with N/A, except KO 4.2.2.1.

See also section 5.8 for the general management of audit report in case
of one or several KO requirements.

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5.5.3 Scoring a requirement with N/A (not applicable)

When the auditor decides that a requirement is not applicable for a

company, the auditor has to use as scoring:

N/A: Not applicable and provide a short explanation in the audit report.

N/A scoring is possible for any requirements of the IFS PACsecure audit
checklist, except for KO requirements (exception for KO 4.2.2.1).

N/A requirements shall not be included in the outline action plan, but
they shall be listed in a separate table in the audit report.

If there are a significant number of requirements which are deemed as

not applicable, using a total points score for the audit may be mislead-
ing; however, the scoring system for IFS PACsecure is based on a per-
centage of the total available score and it is this which is used to decide
the status of the site i.e. foundation or higher level.

5.6 Determination of the audit frequency

For all products and for all certification levels, the audit frequency for
IFS PACsecure audits is 12 months, starting from the date of the audit
and not the date of issue the certificate. Further regulations are described
in 6.2 (certification cycle).

5.7 Audit report

Following each audit, a full written report shall be prepared in the agreed
format (see Part 4).

5.7.1 Structure of the audit report

The audit report shall provide transparency and confidence to the reader
and will be completed by the auditor. The audit report is subdivided into
different sections.
– General information about the company with compulsory fields
(see Part 4)
– General audit result with detailed description of the scope
– General summary in a tabular format for all chapters. The result
of the audit will specify the level and percentage
– General summary of all chapters and comments about follow
up of corrective actions implemented from the previous audit
– Observations on KO requirements and Major non-conformities

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– Summary of all established deviations and non-conformities

for each chapter (1 to 6)
– Separate list (including explanations) of all requirements evalu-
ated with N/A (not applicable)

All deviations (B, C, D) and KO requirements scored with a B, non-con-

formities (Major, KO requirement scored with a D) identified during the
audit, are presented in a separate action plan. Following the allocation
of a grade, non-conformities and deviations, the company has to pro-
duce a corrective action plan. In this way, the reader of the report can
see the non-conformities and deviations, and also the corrective actions
that the company is initiating.

5.7.2 The different steps for the audit report

5.7.2.1 Drawing up the pre-report of the audit and the outline of the
action plan

The auditor shall explain all non-conformities (KO requirements scored

with a D and Majors), all deviations (B, C, D) and KO requirements
scored with a B, and all requirements that are found N/A.

The action plan shall include all the requirements which are not evalu-
ated with A or N/A. The outline action plan shall conform to the outline
action plan as specified in Part 4, Annex 3. It shall include the elements
of the chart N° 4.

The auditor shall complete all of field A in chart N° 4 explaining and

justifying the deviations and non-conformities finding before sending
the company the outline action plan and the pre-report of the audit.

The certification body or the auditor shall send the company both the
pre-report of the audit and the outline action plan within two weeks of
the audit date.

Note: If the auditor identified deviations during the audit and the
audited company has already planned corrective actions, the deviations
shall be noted in the audit report and a comment shall be added indicat-
ing the company has already planned corrective actions.

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Chart N° 4: Outline action plan

Number IFS requirement Evalua- Explanation Corrective Responsibility Release by

of the tion (by the action Date and the auditor
require- auditor) (by the status of
ment company) implementation
(by the
company)
Field A Field B Field C Field D
1.2.1 An organisation B
chart …
1.2.2 Competences and C
responsibilities …
1.2.3 Job descriptions D
with clearly …
1.2.4 KO The senior manage- KO/D
ment shall ensure …
1.2.5 Employees with Major
influence …

5.7.2.2 Company’s completion of the corrective action plan

The company shall enter proposed corrective actions (field B of chart

N° 4) for all deviations (B, C, D) and KO requirements scored with a B
and non-conformities (Major, KO requirements scored with a D) listed
by the auditor.

For all evaluated deviations with score C and D, as well as non-conform-

ities, Major or KO requirements scored with a B and/or a D, the com-
pany shall clearly state the responsibilities and implementation dead-
lines for corrective action (chart N° 4, field C). The company shall forward
the corrective action plan to the certification body within 2 weeks of
having received the pre-report of the audit and the action plan layout. If
this deadline is not respected, the company has to undergo a complete
initial or renewal audit.

An IFS PACsecure certificate shall not be awarded unless the corrective

actions for requirements scored with a C or D, and KO requirements
scored with B, specify responsibilities and implementation dates in the
action plan.

The final decision of awarding the IFS PACsecure certificate is depend-

ent both on final scoring and on relevance of corrective action plan
communicated by the company to the certification body.

The company shall always submit a written corrective action plan before
receiving the final report and the certificate. The intention of the correc-
tive action plan is for the company to strive for continuous improve-
ments.

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5.7.2.3 Auditor validation of the action plan

The auditor or a representative of the certification body shall validate

the relevance of the corrective actions in the last column of the action
plan before preparing the final audit report (Field D of the chart N° 4). If
the corrective actions are not valid or are inadequate, the certification
body shall return the action plan to the company for completion in due
time.

5.7.3 Further rules about the audit report

5.7.3.1 Link between two consecutive audit reports (initial and

renewal audits)

When the auditor scores a requirement with C or D, corrective actions

shall be implemented before the renewal audit. This means the certifi-
cation body shall read the audit report and the action plan of the previ-
ous audit, even if the report was issued by another certification body.

If C and/or D scorings remain the same from one audit to the next, or if
scorings are getting worse, the auditor shall assess in accordance with
the IFS chapter related to “Corrective actions” (chapter 5.11 of the audit
check-list, Part 2). This link between two consecutive audits ensures a
continuous improvement process.

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5.8 Scoring and conditions for issuing audit report and

certificate
Chart N° 5: Scoring and awarding of certificates

Audit result Status Action company Report form Certificate

At least 1 KO Not approved Actions and new Report gives No
scored with D initial audit to be status
agreed upon
> 1 Major Not approved Actions and new Report gives No
and/or < 75 % initial audit to be status
of the agreed upon
requirements
are fulfilled
Max 1 Major Not approved Send completed Report Certificate at
and ≥ 75 % of unless further action plan including foundation
the require- actions taken within 2 weeks action plan level, if the
ments are and validated of receiving the gives status Major non-
fulfilled after follow- preliminarily conformity is
up audit report. Follow-up finally solved
audit max. as controlled
6 months after during the
the audit date follow-up
audit
Total score is Approved at Send completed Report Yes, certifi-
≥ 75 % and foundation action plan including cate at
< 95 % IFS PACsecure within 2 weeks action plan foundation
level after of receiving the gives status level,
receipt of the preliminarily 12 months
action plan report. validity
Total score is Approved at Send completed Report Yes, certifi-
≥ 95 % higher action plan including cate at higher
IFS PACsecure within 2 weeks action plan level,
level after of receiving the gives status 12 months
receipt of the preliminarily validity
action plan report.

Note: the total score is calculated as follows:

Total number of points

= (total number of IFS requirements – requirements scored with N/A) × 20

Final score (in %)

= number of points awarded/total number of points.

The certificate shall always be issued in English language. If requested

by the customer, it can additionally be issued in a different language.

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5.8.1 Specific management of the audit process (report,

certificate, uploading) in case one or several KO’s
has/have been scored with D during the audit
(see also Annex 4)

In case one or several KO is/are scored with D during the audit, the cur-
rent IFS PACsecure certificate shall be suspended in the IFS Audit Portal
by the certification body as soon as possible and a maximum 2 working
days after the audit date.

In the database, explanation about reasons for suspending the current

certificate shall be given in English language. Clear explanations about
the identified non-conformity(ies) shall be provided by giving the num-
ber of involved KO requirement(s). These explanations shall be detailed
and be the same as those described in the action plan.

Note: All users having access to the IFS Audit Portal and having men-
tioned the respective company in their favourites list will get an e-mail
notice from the IFS Audit Portal that the current certificate has been
suspended.

In each case, the audit shall be completed and all requirements shall be
evaluated in order to give the company a complete overview about its
situation.

Furthermore, it is recommended to complete the action plan for

improvement purposes.

The audit report where one or several KO requirement(s) have been

scored with D shall always be uploaded into the IFS Audit Portal (only
for administrative purpose, but will not be visible).

In these situations, a complete new audit shall be performed. The new

audit shall be scheduled no earlier than 6 weeks after the audit where a
KO requirement was scored with D.

5.8.2 Specific management of the audit process (report,

certificate, uploading) in case one or several Major non-
conformity(ies) has/have been issued (see also Annex 4)

In case one or several Major non-conformity(ies) is/are issued during

the audit, the current IFS PACsecure certificate shall be suspended in
the IFS Audit Portal by the certification body as soon as possible and a
maximum 2 working days after the audit date.

In the database, explanation about reasons for suspending the current

certificate shall be given in English language. Clear explanations about
the identified non-conformity(ies) shall be provided by giving the num-
ber of involved requirement(s). These explanations shall be detailed
and be the same as those described in the action plan.

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In cases where more than one Major non-conformity have been identi-
fied, a complete new audit shall be performed. The new audit shall be
scheduled no earlier than 6 weeks after the audit where Major non-
conformities were issued.

If the Major non-conformity is related to production failure(s), the fol-

low up audit shall be performed at least 6 weeks after the previous audit
and no later than 6 months after the previous audit. For other kinds of
failures (e.g. documentation), the certification body is responsible for
the determination of the date of the follow-up audit.

The audit report where one or several Major non-conformity(ies)

has/have been identified shall always be uploaded into the IFS Audit
Portal after receiving the action plan (only for administrative purpose,
but will not be visible).

Specific situation in case of follow-up audit:

If a Major non-conformity has been identified with a total score of 75 %
or above and then resolved, and if the audit result is deemed positive:

The certification body shall mention on the updated audit report:

– in the “date” section: specify the date of the follow up audit in
addition to the date of audit when the Major non-conformity
was identified,
– in the “final result of audit” section: specify that a follow up
audit has taken place and that the Major non-conformity has
been solved,
– in the “observations regarding KO non-conformities and
Majors” section explain on which requirement the Major non-
conformity has been solved.
· The company cannot be certified with higher level even if the
final total score is equal or more than 95 %.
· The same valid date of the certificate remains in the certifica-
tion cycle as described in 6.2.
· It shall be defined on the certificate the date of initial audit
and date of follow up audit.
· If it was during an initial audit, the longest certificate valid
due date is calculated using initial audit date, plus one year
and 8 weeks.

Example:
Initial audit date 1: 01. October, 2012
Date of issue of certificate: 26. November, 2012
Certificate valid until: 25. November, 2013
Renewal date
(audit where Major has been issued) 2: 25. September, 2013
Follow up audit: 03. December, 2013
Latest date of validity of the certificate: 25. November, 2014.

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The report (first of the audit with the estimated Major, then updated
with results of follow up audit) shall be uploaded into the IFS Audit
Portal after performing the follow up audit with the proviso that the
Major non-conformity is finally solved.

5.8.3 Specific management of the audit process in case the

final score is < 75 %

In these situations, the certification is failed and a complete new audit

shall be performed. The new audit shall be scheduled no earlier than 6
weeks after the audit where the final score was <75 %.

5.8.4 Specific management of the audit process in case of

multi-site companies

All KO requirements shall be audited at all sites even if some of them

are partly managed at the central managing site.

In the audit report of each site, only the audit date of the respective site
shall be mentioned; the audit date of managing site is not additionally
necessary.

In case that a Major non-conformity or a KO scored with D has been

issued during the audit of the central managing site, all audited produc-
tion sites are also affected and the certificates of these sites shall be
suspended (according the procedure described above).

After a successful audit of the central managing site (or after positive
follow-up after a Major was issued in the central managing site), the
certificates of the production sites can be reinstated. Depending upon
which non-conformity has been issued in the central managing site, a
new audit of the production sites may also be necessary.

6 Awarding the certificate

A certificate shall be issued to one specific site.

Detailed minimum mandatory information to be published on the IFS

PACsecure certificate is determined in Part 4.

Note: the final audit score, in percentage, can also be published on the
certificate, if required by customer and/or audited company.

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6.1 Deadlines for awarding certificate

The certification body is responsible for the decision to award or not

award the IFS PACsecure certificate. The decision is made by person(s)
other than those who have carried out the audit. The certification shall
be valid effectively from the date of issue stated on the certificate itself
and shall end after 12 months. The date for the renewal audit shall be
calculated from the date of the initial audit, not from the date of issue
the certificate. If the audit is not performed in due time, the retailers or
other users will be informed via the Audit Portal.

The time between the date of the audit and the awarding of certificate is
determined as follows:
– 2 weeks to draw up the pre-report of the audit
– 2 weeks for the company to respond to the deviations and non-
conformities (i.e. draw up the action plan)
– 2 weeks for the auditor to check the proposed corrective actions,
for the certification procedure and upload of the audit report,
the action plan and the certificate to the Audit Portal.

In total: 6 weeks between the date of audit and uploading the audit
report to the Audit Portal and awarding the certificate:
– Target time: 6 weeks,
– Maximum time: 8 weeks.

6.2 Certification cycle

Even if the renewal audit due date changes every year and does not
completely correspond to the anniversary date, the certificate validity
date shall remain the same each year. Due date of the certificate is
determined as follows: initial audit date + 8 weeks.

This allows to avoid gaps between two (2) consecutive certificates and
to avoid that a company scheduling the audit earlier loses some months
of certificate validity.

Example:
Initial audit date: 01. October, 2012
Date of issue of certificate: 26. November, 2012
Certificate valid until: 25. November, 2013

Renewal audit date: 25. September, 2013

Certificate valid until: 25. November, 2014 (independently from
the renewal audit date).

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Chart N° 6: Certification cycle

Oct. Nov. D J F M A M J J A Sept. O Nov. D J F M A M J J A S Oct. Nov. D J F M A M J J A S

2012 2013 2014

< 12 months > 12 months

IA: RA: RA:
01. 10. 2012 25. 09. 2013 05. 10. 2014

C: = 12 months C: = 12 months C:
25. 11. 2013 25. 11. 2014 25. 11. 2015
IA: Initial audit
RA: Renewal audit
C: Issue a certificate valid until

Note: the certificate shall always be edited on the basis of a certification

decision and after the several steps of certification decision according
to ISO/IEC 17065.

Ideally, the renewal audit shall be performed within eight (8) weeks of
the date of expiry of certificate to have enough time for the several
steps of the certification process.

The renewal audit shall be scheduled at earliest eight (8) weeks before
and at latest two (2) weeks after the audit due date (due date is anniver-
sary date of the initial audit). If this is not the case, or if the several steps
of the certification process were not completed in time, the certificate
cannot be renewed with the “due date” but with the actual new date;
this will lead to a break in the certification.

In the example above, this means that the audit shall never be sched-
uled before 06. August and after 15. October.

The previous audit report remains a further eight (8) weeks (after audit
due date) on the Audit Portal, but if the renewal audit takes place later
than described above, the report will be automatically inactivated from
the IFS Audit Portal.

6.3 Information about conditions of withdrawal of

certificate
Withdrawal of certificate by the certification body is only permitted in
case of any information indicating that the product may no longer com-
ply with the requirements of the certification system (ISO/IEC 17065).

The only exception of this rule may be related to the non-payment of

the current audit by the certified company.

The contract between certification body and audited company shall be

harmonized with the certification cycle (see above chart N° 6).

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7 Distribution and storage of the audit

report

Audit reports shall remain the property of the company and shall not be
released, in whole or part, to a third party without the company’s prior
consent (except where required by law). This consent for distribution of
the audit report must be in writing and can be granted by the company
vis-à-vis the certification body and/or vis-à-vis the relevant user. The
certification body shall keep a copy of the audit report. The audit report
shall be stored safely and securely for a period of five years.

Access conditions to information about audit reports are fully detailed

in Part 4.

8 Supplementary action
The decision on the level of supplementary actions required on the
basis of the certificate shall be made at the discretion of the individual
buying organisation.

9 Appeal and complaints procedure

The certification body shall have documented procedures for the con-
sideration and resolution of appeals against the results of an audit.
These procedures shall be independent of the individual auditor and
will be considered by senior management of the certification body.
Appeals will be finalised within 20 working days of receiving informa-
tion from the auditee.

The certification body shall have documented general procedures for

handling complaints received from the companies and/or other relevant
parties. An initial response will be given within ten (10) working days of
receiving the complaint. A letter confirming receipt of the complaint will
be issued within a maximum of five (5) working days. A full written
response will be given after the completion of a full and thorough inves-
tigation into a complaint.

For the handling of complaints received by the IFS offices, the basis for
the complaint management is described in the IFS framework agree-
ment with certification bodies:
– If the complaint relates to the quality of the content of IFS PAC-
secure audits or IFS PACsecure audit reports, IFS offices require
the certification body to provide a statement on the cause and
the measures introduced to rectify the problem within 2 weeks.

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– If the complaint relates to administrative errors, e.g. in IFS PAC-

secure audit reports, IFS PACsecure certificates or in the IFS
database, IFS offices ask the certification body to provide a
statement and rectify the problem within one (1) week. The
statement shall be issued in writing by e-mail or post.

10 Ownership and usage of the

IFS PACsecure logo

The copyright of IFS PACsecure and the registered trademark is fully

owned by the IFS Management GmbH. The IFS PACsecure logo can be
downloaded via the secured section of the IFS Audit Portal.

Furthermore, the below terms and conditions shall be checked by the

auditor during the audit and results of this check shall be described in
the company profile of the audit report as a compulsory field (see Part 4,
section 1.1). If the auditor identifies during an audit that the company
does not fulfil the conditions of logo usage, the auditor shall note it in
the company profile of the audit report and shall inform the IFS offices
accordingly.

Terms and conditions for using the IFS PACsecure logo and communi-
cation about the IFS PACsecure certification

Application
These terms and conditions apply for both IFS PACsecure and all IFS
logos in general.

Form, design and colour of the IFS PACsecure logo

When used, the IFS PACsecure logo must comply with the form and
colour of the scale drawing. If it is used in documents, black and white
print is also permitted.

The IFS PACsecure logo can be used in print, physical and electronic
form, and in films, providing the forms and formats are respected. The
same conditions apply to the use of the logo as a stamp.

Restriction of comment and interpretations

When an IFS PACsecure certified company, an IFS PACsecure support-
ing company or an IFS PACsecure certification body publishes docu-
ments bearing the IFS logo, comment and interpretations referring to
the IFS shall be clearly identifiable as such.

Use of the IFS PACsecure logo in promotional material

An IFS PACsecure certified company, an IFS PACsecure supporting
company (broker, food manufacturer, retailer, logistics provider or
wholesaler) which accepts IFS PACsecure certificates from their suppli-
ers or service providers, or an IFS certification body may use the IFS

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logo for promotional reasons and publish information about IFS certifi-
cation provided that it is not visible on final product packaging which
are available to the end-consumer (B to C business).

Companies which provide products and/or services to IFS certified or

supporting companies, but which are not themselves IFS certified (e.g.
manufacturers of devices, clothing, cleaning materials or service pro-
viders which would like to promote that their products and/or services
help to fulfil the IFS requirements) must ask for express written permis-
sion to IFS Management GmbH to use the IFS PACsecure logo and/or
any other IFS logo(s).

The IFS PACsecure logo and information about the certification may be
used in correspondence with relevant IFS users. Presentations mention-
ing IFS on the internet are only permitted if they are in a direct link with
product safety (e.g. within information about the safety/quality man-
agement system).

The IFS PACsecure logo may be displayed on any kind of general com-
munication (e.g. exhibitions for business contacts, brochures, generic
articles about packaging, product safety and quality management in
general, vehicles). The IFS PACsecure Standard was developed in order
to assure the product safety and quality.

It must be ensured that all information concerning certifications refers

clearly to IFS. The IFS logo may not be used in presentations having no
clear connection to IFS.

Further restriction on the use of the IFS PACsecure logo

The IFS PACsecure logo shall not be used in a way that could show
intent that the IFS owner is responsible for the certification decision.
Furthermore, the same applies for opinions and interpretations which
could be deriven from it. In the event of suspension or withdrawal of the
IFS PACsecure certification, the certified company has to immediately
stop the inclusion of the IFS logo on its documents or other associated
material and cease all communications regarding IFS. The audited com-
pany must demonstrate that they have complied with these require-
ments.

Communication of the IFS PACsecure certification

All the above mentioned rules apply to any communication regarding
IFS PACsecure. This also means that using the wordmarks “IFS”, “Inter-
national Featured Standards”, or “IFS PACsecure” or similar is not
allowed when communicating on finished products, which are available
to the end-consumer.

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11 Review of the Standard

The Review Committee needs to demonstrate control of the quality and
content of the Standard and will review annually the Standard and the
Protocol to ensure that they are still in compliance with their require-
ments. The Review Committee shall be formed with all participants
involved in the audit process: the representatives of retailers, repre-
sentatives of the industry, of (non) food services and of certification
bodies. The objective of the Review Committee is to share experiences,
discuss and decide about the changes to the Standard, the requirements
of the audit report and training.

12 IFS Integrity Program

The IFS Integrity Program launched in early 2010 includes different
measures to assure the quality of the IFS certification scheme, with a
focus on the review of audits conducted by the IFS certification bodies
and their auditors.

There are two cornerstones of this program:

12.1 Preventive quality assurance actions

Quality assurance activities monitor the entire IFS system. Surveillance

audits at the certification body offices and on-site supplier audits are
carried out on a regular basis in order to assess the IFS system. These
audits are undertaken regardless of whether or not a complaint has
been made. The sampling for these surveillance audits is based on a
random selection process and by use of objective criteria. These criteria
are both economic criteria (e.g. number of issued certificates) and qual-
ity criteria (e.g. the review and analyses of IFS certification processes
and corresponding reports).

A surveillance office audit of a certification body (CB) takes place at the

accredited certification body’s premises to verify the correct application
of the IFS regulations at the certification body offices and to promote
continuous improvement.

Additionally, surveillance on-site supplier audits at certified companies

may be undertaken. In general, surveillance on-site supplier audits are
announced 48 hours before the audit date. In these audits the documen-
tation reviewed in the office audit of the certification body, or in the IFS
database, is compared with the real situation found at the company.

Witness audits can also be performed. In this case, Integrity auditors

assess an IFS PACsecure auditor during a real IFS PACsecure audit.

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12.2 Quality assurance actions after complaint

notification
A detailed complaint management process analyzes all necessary infor-
mation. Retailers or any other interested parties have the right to for-
ward any possible non-conformity to IFS for investigation as part of the
Integrity Program.

The IFS Offices collect complaints concerning IFS PACsecure audits,

reports, certificates or other circumstances in which the integrity of
the IFS brand is in question. Retailers, certification bodies, employees
of IFS-certified companies or any person can use the complaint form
on the IFS website www.ifs-certification.com or can send an e-mail to
[email protected] to inform IFS about a cer-
tain issue. In addition to any complaints received, IFS also analyses the
IFS database using analytical tools in order to identify any deficiencies.
If IFS Quality Assurance Management is informed of significant discrep-
ancies between the results of an IFS PACsecure audit and a subsequent
retailer audit, this will be investigated within the complaint manage-
ment process as described below.

The IFS Offices will gather all necessary information in order to investi-
gate the cause of the complaint and to establish if there are deficiencies
by certified companies, accredited certification bodies or IFS-approved
auditors in meeting IFS requirements. Appropriate steps are taken to
fully investigate a complaint, which may include a request to a certifica-
tion body to carry out internal investigations and provide a statement
on the outcome of their investigations to IFS.

In the event that a complaint cannot be successfully resolved by the

investigation undertaken by the certification body, an on-site investiga-
tion audit will be undertaken at the certified company(s). In general,
investigation audits are announced 48 hours before the audit date,
however in special cases unannounced audits are undertaken.

Witness audits can also be performed. In this case, Integrity auditors

assess an IFS PACsecure auditor during a real IFS PACsecure audit.

Audits carried out as part of the Integrity Program are conducted by

auditors employed by IFS and completely independent of the auditees.

12.3 Sanctions

If, following a complaint or preventive quality assurance actions, the

cause of a deficiency has been found to be the fault of a certification
body and/or an auditor, IFS will forward all necessary information
anonymously to an independent Sanction Committee. The Sanction
Committee, which is made up of a lawyer and participants from indus-
try, retailers and certification bodies, shall make a decision on whether
a breach exists and on its severity.

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 International Featured Standards · IFS PACsecure · Version 1 Part 1 39

Sanctions will be issued to the certification body and/or its auditors if

the Sanction Committee concludes that a breach has been committed.
The type of sanction depends on the number of breaches previously
committed by the auditor and/or the certification body as well as the
level of severity of such breaches. IFS Management informs the appro-
priate accreditation body if a breach for a certification body and/or for
an auditor has been established.

All these procedures are laid down in the contract between IFS and
each certification body and all stakeholders of the IFS system are
informed of the process. The IFS Integrity Program strengthens the reli-
ability of the IFS scheme by checking the implementation of the IFS
Standard in practice.

Chart N° 7: Summary of IFS Integrity Program activities

Integrity Program

Complaint Preventive QA
management measures

Investigation Surveillance
audits audits

On-site On-site
Witness CB office Witness CB office
supplier supplier
audit audit audit audit
audit audit

IFS quality
management
sufficient evidence
at hand/breach
likely

Sanction committee

Chairman Participant Participant from Participant from CBs

lawyer from retailers the industry without right to vote

© IFS, October 2012

40 Part 1 International Featured Standards · IFS PACsecure · Version 1

ANNEX 1: Clarification for the scope application

of the different IFS Standards

IFS PACsecure is a Standard for auditing food and non-food packaging

material manufacturers and converters and only concerns packaging
processing and/or converting companies.

IFS Food is a Standard for auditing food product suppliers/manufactur-

ers and only concerns food processing companies or companies that
pack loose food products. IFS Food shall be used when a product is
“processed” or when there is a hazard for product contamination dur-
ing the primary packing.

IFS Logistics is a Standard for auditing companies whose activities are

logistics oriented for food and non-food products, as well as packaging
materials, such as transport, storage, distribution, loading/unloading,
etc. It applies to all types of activities: delivery by road, rail or ship; fro-
zen/refrigerated products or ambient stable products.

Clarifications/examples of scope application between IFS PACsecure

and IFS Logistics:
– IFS Logistics only concerns logistics activities where compa-
nies have a physical contact with already processed/converted
packaging materials (transport, storage and/or distribution,
transport and storage of pallets). When the processing com-
pany has its own logistics and/or transport department/activi-
ties (storage and distribution), it is included in the IFS PACse-
cure under the specific sub-chapter about transport or storage.

Note: If the logistics operation owned by the processing com-

pany is situated in the same location as the company, and if the
company or the customer wishes to get this operation IFS
Logistics certified, an IFS Logistics audit can be performed.

In this case, the following requirements shall be fulfiled:

· the logistics operation is only used for already packed pack-
aging materials,
· in case of two (2) certificates (IFS PACsecure and Logistics),
the respective scopes of each audit and certificate shall be
clearly defined,
· the requirements of IFS PACsecure concerning transport and
storage shall be anyway evaluated during the IFS PACsecure
audit,
· an IFS PACsecure audit of the processing company shall be
performed; IFS Logistics is an additional audit,
· all relevant documents shall be located at the platform.
– If logistics and/or transport activities are outsourced by the pro-
cessing company, the requirements specified in the appropri-

© IFS, October 2012

 International Featured Standards · IFS PACsecure · Version 1 Part 1 41

ate chapter of IFS PACsecure about storage and transport shall

be clearly defined in the respective contract, or IFS Logistics
applies.

IFS Broker is a Standard for auditing companies such as trade agencies,

brokers or any other companies that do not take physical possession of
the products or material (e.g. which do not have warehouses, packing
stations or truck fleet, but are legal entities with mailboxes, offices etc.).
The Standard applies to food, packaging and household and personal
care products.

Matrix for the determination of the right IFS Standard

N° Main activity of the company International Featured Standards

IFS IFS IFS IFS IFS IFS
Food HPC Log. 2 Broker C & C/ PAC
W. secure
1 Food processing
(when products are processed or as soon as X
there is a hazard for product contamination)
2 HPC processing
(when products are processed or as soon as X
there is a hazard for product contamination)
3 Food, Non-Food, HPC, packaging materials
logistics activities
Logistics activities only as service, no trading
activities
(when companies have a physical contact X
with already primary packed products or
only for specific unpacked goods, such as
meat carcasses or bulk/tanker transport
(glucose syrup, milk, grain, etc.)
4 Food, HPC, packaging trading without
product contact
(when no physical possession of products, X
only purchase – sale from an office, no
logistics activities)
5 Cash & Carry/Wholesale
(when distribution of products, small amount
X
of processing activities can be included,
under specific requirements)
6 Packaging materials processing/converting
(when packaging products are processed/ X
converted)
Combined certification
7 Food/HPC/packaging material trading and
Food/HPC/packaging material logistics
X X
Combined audit for trading AND logistics
activities, with a specific combined check-list

© IFS, October 2012

42 Part 1 International Featured Standards · IFS PACsecure · Version 1

ANNEX 2: Certification process

1. Decision by the company to get certified against
the IFS Standard

2. Reading of the respective copy of IFS Standard

3. Evaluation of the current status by the company

4. Selection by the company of the IFS certification body Together with

(accredited and approved). certification body:
Quotation, decision and signature of contract · Determination of
the audit date
Voluntary: Pre-Audit
· Determination of
5. Audit planning and preparation audit times
Realisation of the audit on-site at the determined date, · Definition of the
by an auditor competent in the relevant scopes audit scope

Opening meeting – Evaluation of the documentation –

Site assessment and interviews of employees – Creation of the audit conclusions

Determination of 6. Closing meeting Determination of

1 Major and particu- Information about the determined non-conformities Majors, KO – Audit
lar circumstances – not approved
Not approved before
7. Preparation of a preliminary audit report and
further actions Suspension
preparation of action plan by the auditor (2 weeks)
of the
current
Suspension 8. Completion of the action plan and determination certificate
of the of corrective actions by the audited company (2 weeks)
current
certificate Action plan and
9. Return of the fulfilled action plan preliminary audit
to the certification body/auditor (2 weeks) report sent to
Action plan and
audited company
preliminary audit
report sent to 10. Proofreading of the completed action plan by the
audited company certification body/auditor
Voluntary comple-
Checking the complete audit report and action plan
tion of the action
(with mandatory review) by the certification body
plan and return to
Corrective actions of
the certification body
the non-conformities
which have led to 11. Certification decision, determination
the Major within of the certificate validity by the certification body
Finalisation of the
6 months
action plan and
12. Awarding of certificate and sending of the final report report – upload into
to the audited company the IFS Audit portal
Validation of the
No certificate
corrective actions
by the certification 13. Uploading of the audit data’s into the IFS Audit portal
body (audit details, report, action plan and certificate)
by the certification body

14. Three months before the audit expires, a reminder

will be sent to the company by the IFS Audit portal for
scheduling a new audit with the certification body.
The audit shall be scheduled no later than the renewal
audit date scheduled in the certificate.

© IFS, October 2012

 International Featured Standards · IFS PACsecure · Version 1 Part 1 43

ANNEX 3: Product scopes

In IFS PACsecure version 1, all activities of the company are related to
product scopes as follows:

Table 1: Product scopes

1. Flexible packaging
2. Rigid plastic
3. Paper
4. Metal
5. Glass
6. Other natural materials

Multi component packaging materials (e.g. Tetra Pak) have to be

assigned based on the material which is the main component of the
material. The main component of multi component packaging materi-
als shall be mentioned in the scope of the audit on the report.

Materials to be considered as “other natural materials” are, for exam-

ple wood, clay, cork, jute, textiles, banana leaves, etc.

© IFS, October 2012

44 Part 1 International Featured Standards · IFS PACsecure · Version 1

ANNEX 4: Flow chart for management of KO

scored with D and Major non-
conformities
IFS PACsecure audit

Audit
result

1 Major and ≥ 75 % of the require- > 1 Major and/or < 75 % or

ments are fulfilled =>15 % of the total More than one Major or
possible amount is subtracted One or several KO’s scored with D

Not approved unless further actions Not approved

are taken and validated after follow-
up audit Suspension of the current certificate,
max. two (2) working days after audit
Suspension of the current certificate, date
max. two (2) working days after audit Inserting the explanations in English
date about non-conformity(ies) in IFS portal
Inserting the explanations in English
about non conformity in IFS portal Send preliminary report and action
plan template to the audited company
Send preliminary report and action
plan template to the audited company Recommended: completion of the
action plan by the audited company
Mandatory: completion of the action and return to the certification body
plan by the audited company and within two (2) weeks
return to the certification body within
two (2) weeks Uploading report in IFS portal
(not visible)
Uploading report in IFS portal
(not visible) Time
period to the
Time next audit
period to the
next audit
Full new audit, scheduled not earlier
than six (6) weeks after the audit
Initial audit, if > 6 months Follow-up audit, if < 6 months where non-conformity(ies) was/were
between audit where Major between audit where Major identified
was issued and next audit was issued and next audit
(earliest after six (6) weeks
in case of failure concerning Positive audit
production activities) result

Uploading final IFS report in portal

Positive audit (visible)
result

Uploading final IFS report in portal (visible):

In case of follow up audit:
– Define in the “date” section date of initial audit and date of
follow up audit
– Define in the “final result of audit” section that a follow audit
has taken place and that the Major has been solved
– In the “observations regarding KO and Majors”, explain on
which requirement Major has been solved
The company can not be certified with higher level, even if the
final score is ≥ 95 %
Date of end of validity of certificate based on date of initial audit
© IFS, October 2012
 International Featured Standards · IFS PACsecure · Version 1 Part 2 45

Part 2: List of audit requirements

The following list contains the IFS PACsecure auditing requirements.

The below chart demonstrates the connection between IFS PACsecure

and PACsecure Prerequisite Program requirements. Additionally, there
are examples given on questions auditors should ask (5th column) and
examples for KO or Major scoring (6th column).

The PACsecure Packaging Material Manufacturer & Converter Generic

Food Safety Prerequisite Program (PP) contains foundation require-
ments on documentation, management and food safety program main-
tenance, and considers current packaging industry practices. The IFS
PACsecure was developed taking into account this Program.

PACsecure documents, workbooks and plans (Packaging Material

Manufacturer & Converter Generic Food Safety Prerequisite Program,
HACCP Workbooks and HACCP Plans) can be obtained from the Packag-
ing Association of Canada. These documents can assist, for example, in
implementing HACCP for a specific packaging material manufacturer,
like e.g. manufacturers of flexible packaging and may be used as indus-
try guidelines as mentioned in requirement 2.2.1.1

© IFS, October 2012

 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
46

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
1 Senior Management Responsibility 5.0

1.1 Corporate policy/Corporate

principles

1.1.1 The senior management shall draw 5.0 Management commit- – How and where is corporate policy
up and implement a corporate policy. ment to the food safety documented?
This shall consider as a minimum: system is required. This – What are the contents of the corporate
– customer focus may be demonstrated policy?
– environmental responsibility by the development – How was corporate policy communicated
– sustainability and approval of a food to all employees?
– ethics and personnel responsibility safety policy or other – <corporate policy>, <posters> <docu-
– product requirements (includes: statements of commit- mented evidence of corporate policy
product safety, quality, legality, ment to the food safety communication>
process and specification). system. Environmental responsibility and sustain-
The corporate policy shall be ability are included in the IFS PACsecure
communicated to all employees. Standard, even if it is a packaging material
safety and quality standard, in order to
initiate/develop in companies processes of
awareness for both topics.

1.1.2 The corporate policy shall have – What short, medium and long term
objectives specifying responsibilities quality objectives are addressed?
and timelines appropriate for the size – How are the objectives attained?
and complexity of the organization. – What is the time frame to attain the
objectives?
– Who is responsible for objectives attain-
ment?
– What actions are taken by specific
departments, e.g. purchase, to attain the
objectives?
– <written review meeting minutes>,
<list of attendees at review meeting>,
<quality objectives>
International Featured Standards · IFS PACsecure · Version 1

© IFS, October 2012

 1.1.3 From the corporate policy, the – What quality objectives are defined?
quality and packaging material – Are these objectives known by concerned
safety objectives shall be communi- employees?
cated to the employees in the respec- – What tools are used to measure that the
tive departments and shall be objectives have been attained?

© IFS, October 2012

effectively implemented. – <list of attendees at review meeting>,
<mailing list of review meeting minutes>,
<posters showing the different depart-
ment objectives>
1.1.4 The senior management shall ensure – When is objective achievement There is basically no
that the achievement of all objectives reviewed? review/other rating of
is regularly reviewed, as a minimum – How often is this review performed? objectives available.
at least once a year. – <review>, <review minutes>,
<internal audit report>
1.1.5 All relevant information related to – How is relevant information transmitted A packaging material
packaging material safety and to concerned persons? safety and/or legality
quality shall be communicated – <posters>, <distribution of meeting issue occurs due to
effectively and in a timely manner to minutes> missing communica-
the relevant personnel. tion within the
company.
1.2 Corporate structure
1.2.1 An organisation chart shall be – Is an organisation chart available?
available showing the structure of – How is the organisation structured?
the company. – <organisation chart>
1.2.2 Competences and responsibilities, – For which positions do written job When a packaging
including deputation of responsibil- descriptions exist? material Safety and
International Featured Standards · IFS PACsecure · Version 1

ity shall be clearly laid down. – What is regulated in the job descriptions? Legality issue occurs
– Who, for example substitutes QA man- due to failure to
ager during his absence? define responsibilities
– <responsibility description for important for existing company
key staff “dedicated to a specific person”, regulations.
e.g. QA Manager, Production Manager,
Shift Leader …>
1.2.3 Job descriptions with clearly defined 5.0 For each prerequisite – What is the content of the job descrip-
responsibilities shall exist and shall program and HACCP tions?
be applicable for employees whose Plan the responsibility – For which positions do job descriptions
work has an effect on product for complying with the exist?
Part 2

requirements. requirements of this

standard is assigned to
47

a competent employee.
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
48

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
1.2.4 KO N° 1: The senior management 5.0 The authority to – How is it ensured that employees know When senior man-
KO shall ensure that employees are develop, implement their responsibilities? agement does
aware of their responsibilities and maintain the – How does senior management ensure nothing to ensure
related to packaging material safety prerequisite programs that employees know their responsibili- that employees know
and quality and that mechanisms will be established by ties? their responsibilities.
are in place to monitor the effective- management. – Who is responsible for packaging mate- When during the
ness of their operation. Such rial safety? audit the Auditor has
mechanisms shall be clearly identi- evidence that key
fied and documented. employees are not
aware of their
responsibilities and
this leads to a
packaging material
safety and/or legality
issue.
1.2.5 Employees with influence on product 5.0 Key personnel and – <interview of at least: QSMD, person Key employees are
requirements shall be aware of their responsibilities will be responsible for labeling/printing, person not aware of their
responsibilities, and shall be able to identified in the written responsible for product development, responsibilities.
demonstrate their understanding of program. person responsible for production,
their responsibilities. person responsible for monitoring CP’s >
1.2.6 The company shall have an IFS – Who is the IFS PACsecure representative? No IFS PACsecure
PACsecure representative nominated – What are the responsibilities of the IFS representative exists.
by senior management. PACsecure representative?
– Is the function of the IFS PACsecure
representative clearly laid down?
– <job description>, <organization chart>
1.2.7 The senior management shall – How were the necessary resources When senior man-
provide sufficient and relevant defined? agement doesn’t
resources to meet the product – <budget plan> provide enough
requirements. resources and this
leads to a packaging
material safety and/or
legality issue.
International Featured Standards · IFS PACsecure · Version 1

© IFS, October 2012

 1.2.8 The department responsible for – Who is the QS manager?
quality and packaging material – To whom does the QS manager report?
safety management shall have a – <job description>, <organization chart>
direct reporting relationship to the
senior management.

© IFS, October 2012

1.2.9 The company shall ensure that all – What criteria are used to ensure process When key personnel
processes (documented and undocu- control? have no process
mented) are known by the relevant – What is done to ensure that processes knowledge and this
personnel and are applied consist- are known to relevant personnel (incl. leads to a packaging
ently. permanent staff and temporary/seasonal material safety and/or
workers)? Processes can be understood legality issue.
as ISO processes (see also chapter 2.3,
Part 1 of the standard)
1.2.10 The company shall have a system in – How does management ensure that all When absence of
place to ensure that it is kept relevant packaging safety laws are in legal knowledge and
informed of all relevant legislation place and known? information on
on packaging material safety and – How does management ensure that relevant laws lead to
quality issues, scientific and techni- purchased products comply with all a packaging material
cal developments and industry codes relevant legislation? safety and/or legality
of practice. – How does management ensure that issue.
manufactured products comply with all
relevant legislation?
– <packaging material laws subscription>,
<training>
1.2.11 The company shall inform its custom- For example, if regulatory bodies come to
ers, as soon as possible, of any issue the company and identify that something is
related to product specifications or wrong (related to legality/quality/safety) on
International Featured Standards · IFS PACsecure · Version 1

other legally required documentation a private label product, the company shall
in particular of all non-conformity(ies) inform the relevant customer accordingly. If
identified by competent authorities this product is also manufactured for other
related to products which could have, customers and if the identified deviation/
has or has had a defined impact on non-conformity also has an impact on the
safety and/or legality of respective other private labels, the company shall also
products. This could include, but are inform these other relevant customers.
not limited to cautionary issues.
1.3 Customer focus
1.3.1 A documented procedure shall be in – How are customer needs and expecta-
place to identify fundamental needs tions identified?
Part 2

and expectations of customers. – How often are these identified?

<questionnaire/survey regarding cus-
49

tomer needs and expectations>

 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
50

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
1.3.2 The results of this procedure shall be – What were the results of the last cus-
evaluated and considered to deter- tomer survey?
mine quality and packaging material <analysis of customer surveys>
safety objectives. – How these results were evaluated
regarding quality objectives?
<quality objectives>
– Have identified needs influence on the
production process?
<survey analyses>
1.4 Management review
1.4.1 Senior management shall ensure 6.1 Management will – When is the quality and safety manage- When the quality
that the quality and packaging 6.6 determine the internal ment system reviewed and evaluated? management system
material safety management sys- activities required to – How often was the system reviewed last is not reviewed
tems are reviewed at least annually ensure the requirements year? regularly and there is
or more frequently if changes occur. of this standard are met. – What was the result of the review? no assurance that it
Such reviews shall contain, at least, <review report> works properly.
results of audits, customer feed- The food safety pro- – Does the management review take into
backs, process compliance and gram shall be reviewed consideration, as a minimum, the assess-
product conformity, status of at least once per year to ment of the following:
preventive and corrective actions, assess if it is: · documents from the previous manage-
follow up actions from previous – Current. That is, it ment review,
management reviews, changes that reflects factors · results from internal and external audits,
could affect the packaging material including, but not as well as inspections,
safety and quality management limited to: · performance indicators for customers,
systems and recommendations for · Applicable stand- complaints and withdrawals/recalls,
improvement. ards. · incidents, corrective actions, results out
· Operational/Process/ of specifications and non-conforming
Material changes. materials,
· Organization · process performance and product
changes. compliance,
· Scientific develop- · review of hazard analysis/risk assessment
ments. system and changes which may affect qua-
– Implemented. lity and packaging material safety system,
– Maintained. · evolutions of scientific information
International Featured Standards · IFS PACsecure · Version 1

related to products,

© IFS, October 2012

Results of the re-assess- · improvement of quality system efficiency
ment are used to and production process,
update, maintain or · improvement of product, related to
improve the food safety customer requirements,
system. · needs in resources (including investments)?
 1.4.2 This review shall include the evalua- 6.1 The frequencies of Based on the review result, have any
tion of measures for the control of completing activities actions for improvement been taken?
the quality and packaging material will be established and <improvement actions>
safety management system and for will ensure the effective
the continuous improvement implementation and

© IFS, October 2012

process. maintenance of the
packaging material
safety system.
1.4.3 The company shall identify and – When is infrastructure (building, machin- When infrastructure
review regularly (e.g. by internal ery, transport) evaluated? is not evaluated and
audits or on-site inspection) the – What was the result of infrastructure therefore a risk for
infrastructure needed to achieve evaluation? <audit report> legality, safety and
conformity to product requirements. – Who evaluated infrastructure? quality of products
This shall include, as a minimum, the – What were the results of the infra- occurs.
following: structure assessment?
– buildings <corrective actions> <investment plan>
– supply systems – Were the results used for further infra-
– machines and equipment structure planning? <investment plan>
– transport. – What risks were identified according to
The results of the review shall be the results of infrastructure assessment?
considered, with due consideration <hazard analysis>
to risk, for investment planning. – What are infrastructure related investments
for the near future? <investment plan>
1.4.4 The company shall identify and – When is the work environment (staff facili- When work environ-
review regularly (e.g. by internal ties, environmental conditions, safety and ment is not evaluated
audits or on-site inspection) the work security at work, hygienic conditions, and therefore a risk
environment needed to achieve workplace design etc.) evaluated? for legality, safety
International Featured Standards · IFS PACsecure · Version 1

conformity to product requirements. – What was the result of work environment and quality of
This shall include, as a minimum the evaluation? <audit report> products occurs.
following: – Who evaluated work environment?
– staff facilities – What were the results of the work
– environmental conditions environment assessment?
– hygienic conditions <corrective actions> <investment plan>
– workplace design – Were the results used for further work
– external influences (e.g. noise, environment planning?
vibration). <investment plan>
The results of the review shall be – What risks were identified according to
considered, with due consideration the results of the work environment
to risk for investment planning. assessment? <hazard analysis>
Part 2

– What are work environment related

investments for the near future?
51

<investment plan>
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
52

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
2 Quality and Packaging Material
Safety Management System
2.1 Quality management
2.1.1 Documentation requirements 4.1 Control of Documents
Documents are created
and maintained to en-
sure the effective devel-
opment, implementa-
tion, maintenance and
improvement of the
food safety system.
A document control
procedure is established
that will define how
documents are:
– Approved.
– Reviewed, revised
and updated.
– Remain legible and
easily identifiable.
– Identified, including
current status (e.g.
revision level).
– Maintained so current
versions are available
for use and unintend-
ed use is prevented.
Each prerequisite pro-
gram requires proper
documentation of the pro-
gram elements and sup-
porting information in-
cluding, but not limited to:
– Standard operating
International Featured Standards · IFS PACsecure · Version 1

procedures.
– Forms.

© IFS, October 2012

– Checklists.
– Corrective Action
Reports.
– Food Safety Program
Reassessment.
 2.1.1.1 The system of packaging material 4.1 – Where is documentation concerning the When there is no
safety and quality management shall quality system for quality assurance and quality system for
be documented and implemented, packaging material safety retained? quality assurance and
and shall be retained in one location <procedure for document control> packaging material
(packaging material safety and safety in place.

© IFS, October 2012

quality manual or electronic docu-
mented system).
2.1.1.2 A documented procedure shall exist 4.1 – What rules exist regarding document When documents do
for the control of documents and control? not state clearly
their amendments. – Do the documents have an identification which exist, are in
code? use and valid.
– How is the identification code structured?
– How can a revision be identified?
– Who is responsible for changes
<procedure for documents>
2.1.1.3 All documents shall be clearly 4.1 – Are all documents legible? When documents are
legible, unambiguous and compre- – Are the documents unambiguous? unavailable and this
hensive. They shall be available to – Are the documents available at the right endangers legality,
relevant personnel at all times. places? Also after office hours? safety or quality of
– How do relevant employees have access the product.
to documents?
– How are document changes communi-
cated to relevant employees?
– Are there any distribution lists for
documents? <examples>, <procedure>,
<distribution lists>
2.1.1.4 All documents which are necessary 4.1 – How is document validity identified? When void/obsolete
International Featured Standards · IFS PACsecure · Version 1

for compliance with the product – How is it ensured that only valid docu- or out-of date docu-
requirements shall be available in ments are in circulation? ments are not identi-
their latest version. fied as such and thus
endanger legality,
safety or quality.
2.1.1.5 The reason for any amendments to 4.1 – Are the reasons for any amendments to
documents critical for the product documents, critical for the product
requirements shall be recorded. requirements recorded?
<examples>
2.1.2 Record keeping
Part 2

2.1.2.1 All relevant records necessary for the 4.2 Records are established – What records exist? When insufficient or
product requirements shall be to provide objective evi- – Are the records complete? no records are made
53

complete, detailed and maintained dence of conformity to – Are the records available? and thus endanger
and shall be available on request. the requirements of the legality, safety or
food safety program. quality.
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
54

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
2.1.2.2 Records shall be legible and genu- 4.2 A procedure is estab- – Are records plausible? When records are
ine. They shall be maintained in a lished that will define – Are records legible? illegible and therefore
way that subsequent manipulation of how food safety related – What kind of assurance is given that no evidence exists for
records is prohibited. records are maintained records cannot be subsequently manipu- legally required
so that they are: lated? checks/inspections.
– Legible. – Are the records reviewed by a supervi-
– Readily identifiable sor?
and retrievable.
– Auditable.
– Protected and stored
to prevent damage or
deterioration.
– Stored for an appro-
priate retention
period.
– Properly disposed.
Records include, but
are not limited to,
completed:
– Forms.
– Checklists.
– Service Agreements
and Contracts.
– Corrective Action
Reports.
– Food Safety Program
Reassessment.
2.1.2.3 All records shall be kept in accord- 4.2 – Where are records stored? When records are not
ance with legal requirements and for – Who stores records? stored in accordance
a minimum of one year after the – How long are records kept? to legal requirements.
recommended converting time. For On what basis were record storage times
products which have no recom- defined?
mended converting time, the – For products with a short recommended
duration of record keeping shall be converting time, was record storage time
justified and this justification shall be definition based on hazard analysis?
International Featured Standards · IFS PACsecure · Version 1

documented. If a recommended converting time is

© IFS, October 2012

defined, corresponding records shall be
available at least until that date. <proce-
dure documents>, <hazard analysis>
 2.1.2.4 Any amendments to records shall 4.1 – How are amendments to records carried When a general
only be carried out by authorized out? problem exists
persons. – Who is authorized to make amendments? regarding record
– How are amendments authorized? changes/amend-
ments in the com-

© IFS, October 2012

pany.
2.1.2.5 Records shall be securely stored and – What is the process in place to make
easily accessible. documents and data available and
readable?
<backup system>, <storage condition>
2.2 Packaging Material Safety Manage-
ment
2.2.1 Hazard analysis and risk assessment See
system generic
HACCP
models
PACsecure
2.2.1.1 The basis of the company’s packag- – The company’s hazard analysis/risk If there is no hazard
ing material safety control system assessment plan is based on what analysis/risk assess-
shall be a fully implemented, principles? ment plan.
systematic and comprehensive – Has every site/plant a separate hazard If legal requirements
hazard analysis and/or risk assess- analysis/risk assessment plan? are not included in
ment system, based upon the Codex – Which specific regulations are taken care hazard analysis/risk
Alimentarius principles or on of in hazard analysis/risk assessment assessment plan
industry guidelines. It shall take into plan? If there is no hazard
account any legal requirements of < hazard analysis plan> analysis/risk assess-
International Featured Standards · IFS PACsecure · Version 1

the production and destination – are the legal requirements of the destina- ment plan for each
countries which may go beyond tion country are known, especially the individual site/plant.
such principles. The hazard analysis labeling regulation?
and/or risk assessment system shall
be implemented at each production
site.
2.2.1.2 The hazard analysis and/or risk – Does hazard analysis/risk assessment When the hazard
assessment system shall cover all plan cover all product groups and analysis/risk assess-
raw materials, products or product processes incl. product development and ment plan does not
groups as well as every process from product wrapping material? cover all product
goods into dispatch, including – Which processes are performed? groups and pro-
Part 2

product development and product <product group overview>, <flow chart> cesses.
packaging.
55
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
56

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
2.2.1.3 The company shall ensure that the – Is the hazard analysis/risk assessment plan When hazard analy-
hazard analysis and/or risk assess- based upon scientific literature or techni- sis/risk assessment
ment system is based upon scientific cally verified specifications or other legally plan is not based on
literature, or technical verified required documentations relating to the scientific literature or
specifications or other legally manufactured products and procedures? technically verified
required documentations relating to – How are new technical developments data about products
the manufactured products and taken care of? and processes and
procedures. This shall be maintained <references of used literature, etc.> therefore causes a
in line with new technical process – Does the hazard analysis/risk assessment packaging material
development. system meet all applicable regulatory safety or legality risk.
requirements of the country in which it is
established, including the required and
applicable risk assessments and support-
ing documentation?
(Where applicable, such regulatory require-
ments will supercede requirements of the
standard. Related to Canadian and US law,
certain forms and formats are required.)
2.2.1.4 The hazard analysis and/or risk How are product development/product
assessment system shall be reviewed modification and hazard analysis intercon-
and necessary changes shall be made nected?
when any modification is made in the
product, process or any step.
2.2.2 Hazard analysis and/or risk assess-
ment team
2.2.2.1 Assemble hazard analysis and/or – Who is member of the hazard analysis/ Although there is a
risk assessment team risk assessment team? lack of product
The hazard analysis and/or risk – Which departments/functions are included knowledge no
assessment team shall be multidisci- in the hazard analysis/risk assessment external expert has
plinary and include operational staff. team? been consulted and
Personnel appointed as hazard analy- – How was qualification for hazard analy- this results in packag-
sis and/or risk assessment team sis/risk assessment team membership ing material safety
members shall have specific knowl- verified? <evidences for education, and legality risk.
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edge of hazard analysis and/or risk advanced training>

assessment, product and process – What hazards are connected to the

© IFS, October 2012

knowledge and the associated product?
hazards. Where competent knowl- – Does a contract exist with an external
edge is not available, external expert expert? <service contract>
advice shall be obtained.
 2.2.2.2 Those responsible for the develop- – What is the content of a hazard analy-
ment and maintenance of the hazard sis/risk assessment training course?
analysis and/or risk assessment <hazard analysis training proofs>
system shall have an internal team – When was the last hazard analysis/risk
leader and shall have received assessment training course held?

© IFS, October 2012

adequate training in the application <training evidences>
of the hazard analysis and/or risk – Who participated in the hazard analy-
assessment principles. sis/risk assessment training course?
<training evidences>
2.2.2.3 The hazard analysis and/or risk – Who is member of the hazard analy- When no hazard
assessment team shall have strong sis/risk assessment team? analysis/risk assess-
senior management support and – Is the team well known across the ment team exists or
shall be well known and established company? How was it announced? no person has been
across the whole facility. <job descriptions>, <team matrix>, appointed hazard
<blackboard notice>, <presence of analysis team leader.
management in any hazard analysis
brief>, <result of hazard analysis rewiew
include in Management review>,
<attribution of resources>
2.2.3 Hazard analysis and risk assessment See gene-
ric HACCP
models
PACsecure
2.2.3.1 Describe product Form 1 – Does a complete product description When there are no
The assessment shall make refer- exist for each product? product descriptions
ence to the full description of the – What is included in the product descrip- for each product.
product including all applicable tion? When product
International Featured Standards · IFS PACsecure · Version 1

relevant information on product <product description> descriptions do not

safety such as: <product specification> provide essential
– composition (raw materials, product data. When
rework, reprocessing, recycled essential information
waste etc.), does not match
– physical, chemical and microbio- legislation (e.g.
logical parameters, migration test
– methods of treatment, values).
– wrapping, labeling,
– durability (shelf life),
– conditions for storage and method
of transport.
57Part 2
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
58

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
2.2.3.2 Identify intended use Form 1 – What is the intended use of the product When there is a
The intended use of the product shall by customer? packaging material
be described in relation to the – What is the intended use of the product safety risk for con-
expected use of the product by the by final consumer? sumers due to lack of
consumer, taking into account – Are there any restrictions for usage? definition for usage.
vulnerable groups of consumers. <product description>
2.2.3.3 Construct flow diagram Form 3 – Are flow charts available for all products? Flow charts are
A process flow diagram shall be – Are the flow charts dated? unavailable for any of
evaluated against each product, or <flow charts for all products> the products, charts
product group, and for all variations or are not conform to
of the processes and sub-processes. the specifications or
other legally required
documentation.
2.2.3.4 On-site confirmation of the flow Form 3 – Was the flow chart confirmed during When flow charts are
diagram a hazard analysis/risk assessment not validated.
The risk assessment team shall meeting?
review the processes at all operation <meeting minutes>
stages against the flow diagram.
Where appropriate, amendments of
the diagram will be made.
2.2.3.5 Conduct a hazard analysis and risk Form 3, 5, – Does a hazard analysis/risk assessment When a hazard
assessment for each step 6, 7 exist for each step? analysis/risk assess-
An assessment shall be available of <hazard analysis> ment was not
all physical, chemical and biological – Does it include every hazard? performed for each
hazards that may reasonably be – Which biological, physical and chemical step.
expected. hazards can be expected? When hazards were
<hazard analysis> not properly assessed
or not all significant
hazards were taken
into account and a
safety issue exists.
2.2.3.5.1 The hazard analysis shall demon- – Does a hazard analysis for all product When, due to lack of
strate the motivation if a hazard is groups including harm and likelihood a hazard analysis, a
International Featured Standards · IFS PACsecure · Version 1

a risk, taking into account the exist? safety risk exists.

© IFS, October 2012

likelihood of harm to the consumer <hazard analysis>
and the potential severity of damage
(effect, potential consequences).
 2.2.3.5.2 All risks that need specific monitor- 4.1 Each prerequisite – Which CPs were defined? When there are no
ing and/or preventive actions shall 6.5 program requires – How many CPs exist clear limits for each
be identified as Control Points (CP). Form 3, 5, proper documentation – Is a clear limit defined for each CP? CP or they are
Clear limits and registration of the 6, 7, 8 of the program ele- – What clear limits are defined? insufficient and this
risk identification shall be available. ments and supporting – How were the critical limits determined? causes a safety risk.

© IFS, October 2012

information including, <hazard analysis>
but not limited to: <flow chart>
– Standard operating <decision tree>
procedures.
– Forms.
– Checklists.
– Corrective Action
Reports.
– Food Safety Program
Reassessment.
Changes to the prereq-
uisite programs will be
reviewed and approved
by authorized personnel.
2.2.3.5.3 For all risks that are identified as Form 3, 5, – How are CPs monitored? When CPs were not
Control Points (CP) to manage the 6, 7, 8 – Are the CPs under control? identified as such
identified risk, the company shall – How is the monitoring of each CP and/or they are not
implement, maintain and document documented? under permanent
specific preventive measures and – Who documents? control so that a
monitoring procedures. Records of – Are date, time, responsible employee and safety risk exists.
monitoring shall be maintained for a result/reading documented?
relevant period. – How long will records be stored?
– Where are records stored?
International Featured Standards · IFS PACsecure · Version 1

– Which prerequisite measures are docu-

mented?
– How are the measures documented?
<hazard analysis> <flow chart>,
<decision tree>, <prerequisite measures>
2.2.3.6 Establish corrective actions Form 10 – What corrective actions exist for each CP? When there are no
For each CP corrective actions shall – When was a corrective action carried out? corrective actions
be established. In case the monitor- – Where are corrective actions docu- defined or no correc-
ing indicates that a particular CP is mented? tive actions are taken.
not under control, adequate correc- – Who documents the taken corrective When corrective
tive actions shall be taken and actions? actions are not
Part 2

documented. Such corrective actions <CP records> <corrective actions> documented.

shall also take into account any
59

non-conforming products.
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
60

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number

2.2.3.7 Establish verification procedures 6.2 Verification activities – How often is the hazard analysis/risk When no verification
Procedures of verification shall be Form 10 are completed for each assessment plan verified? was carried out and
established to confirm that the risk prerequisite program to – What was the date of the last verification? this leads to a safety
management system is effective. confirm that the – What was the result of the last verifica- risk.
Verification of the risk management programs are: tion?
system shall be performed at least – Properly imple- – Does the hazard analysis/risk assessment
once a year. Examples of mented. plan reflect the results of the verification?
verification activities include: – Adequately main- – What was the last date when the hazard
– internal audits, tained. analysis/risk assessment plan was
– analysis, – Suitable to the changed?
– sampling, operations of that <audit reports or other reports for
– evaluations, establishment in validation>
– complaints by authorities and controlling identified
customers. food safety hazards.
The results of this verification shall Verification activities
be incorporated into the risk man- may include, but are
agement system. not limited to:
– Internal Inspections.
– Document review.
– Internal Audits.
– External Audits,
Assessments,
Inspections.
– End product testing.

2.2.3.8 Establish documentation 4.1 Documents are created – What hazard analysis/risk assessment When hazard analy-
Documentation shall be available, and maintained to plan related documents exist? sis/risk assessment
covering all processes, procedures, ensure the effective – Do these documents include processes, plan is not sufficiently
measures and records. Documenta- development, imple- procedures and results? documented and this
tion and record keeping shall be mentation, mainte- <inspection plans>, <records>, leads to a legality
appropriate to the nature and size of nance and improve- <product descriptions>, issue.
the company. ment of the food safety <hazard analysis>, <risk assessment>
system.

3 Resource Management
International Featured Standards · IFS PACsecure · Version 1

3.1 Human resources management

© IFS, October 2012

 3.1.1 All personnel performing work that D 1.1.1 1 – How is it assured that new employees When, due to lack of
affects product safety, legality and have the right capabilities for the job? education, experience
quality shall have the required or training the
competence by education, work legality or safety of
experience and/or training, commen- the product is

© IFS, October 2012

surate with their role, based on jeopardized.
hazard analysis and assessment of
associated risks.
3.2 Human resources
3.2.1 Personnel hygiene
3.2.1.1 There shall be documented require- D 1.1.1 2, 3, 4 – What is the policy regarding personal When insufficient
ments relating to personnel hygiene. hygiene? rules for personal
These include, as a minimum, the <hygiene rules for employees> hygiene cause a
following fields: – The rules regarding personnel hygiene safety risk.
– protective clothing D 2.1.1/2 include hand cleaning, food, beverages When no correspond-
– hand washing and disinfection and other material, smoking, handling of ing hazard analysis
– eating and drinking injuries, finger nails and jewelry, hair and exists.
– smoking beards?
– actions to be taken in case of cuts – Are the rules based on a hazard analysis?
or skin abrasions <hazard analysis>
– fingernails, jewelry and personal – Where is it allowed to smoke?
belongings – How should lesions be treated/covered?
– hair and beards. – What kinds of hair restraints are needed
The requirements shall be based on in which areas?
hazard analysis and assessment of Example of result from the hazard analysis
associated risks in relation to and assessment of associated risks: if
product and process. gloves are used, then hand disinfection is
International Featured Standards · IFS PACsecure · Version 1

not required for low risk production.

3.2.1.2 KO N° 2: The requirements for – How is the hygiene policy communicated? When, during the
KO personnel hygiene shall be in place <hygiene rules for employees> audit major violations
and applied by all relevant person- – Are personnel hygiene rules also follow- of the rules are
nel, contractors and visitors. ed by external service providers/workmen identified that lead to
and visitors? <hygiene rules for visitors> a safety risk.
– How is it assured that external persons
know the relevant hygiene rules?
<hygiene rules for visitors>
3.2.1.3 Compliance with personnel hygiene – How are employees monitored during
Part 2

requirements shall be checked work? <hand swab tests, etc.>

regularly. – Is employee compliance to hygiene rules
checked on a regular basis?
61

<minutes site inspection>,

<list of identified failures>, etc.
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62

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
3.2.1.4 Visible jewelry (incl. piercing) and D 1.1.1 2,3 – Is it allowed to use jewelry and watches When wearing
watches shall not be worn. Any D 2.1.1 1 in production areas? <personnel hygiene jewelry or a watch
exceptions shall have been compre- D 1.2.1 3 rules> causes a packaging
hensively evaluated by hazard – Is allowance based on risk hazard material or employee
analysis and assessment of associ- analysis? safety risk.
ated risks in relation to product and <hazard analysis>
process. This shall be effectively
managed.
3.2.1.5 Cuts and skin abrasions shall be D 2.2.1–3 1,2,3 – What color is plaster and where is it When hand injuries
covered by a colored plaster/band- used? ensue a product
age (different from the product – Does the plaster contain a metal strip? safety risk (e.g. an
color)—containing a metal strip, – What is an employee required to observe uncovered purulent
where appropriate—and in case of in case of hand injury? wound that comes
hand injuries, in addition to a <personnel hygiene rules> into contact with the
plaster/bandage, a single use glove product).
shall be worn.
3.2.2 Working conditions and protective
clothing for personnel, contractors
and visitors
3.2.2.1 Company procedures shall exist to D 2.1.1–2 1,2 – What are the rules regarding protective When the lack of
ensure that all personnel, contractors clothing? protective clothing
and visitors are aware of the rules <personnel hygiene rules> ensues a product
regarding the management of – Are the protective clothing rules based on safety risk.
wearing and changing of protective hazard analysis?
clothing in specified areas in accord- <hazard analysis>
ance with product requirements. – When must protective clothing be
changed?
<personnel hygiene rules>
– examples of areas: catering, changing
rooms, smoking area, toilets, etc.
3.2.2.2 In work areas where wearing D 2.1.2 1 – In which production areas is wearing of When incorrect
headgear and/or beard snood (cover- protective headgear and/or beard snood wearing or absence
ings) is required, the hair shall be mandatory? of headgear and/or
International Featured Standards · IFS PACsecure · Version 1

covered completely, so that product – What kind of headgear is used? bear snood ensues a

© IFS, October 2012

contamination is prevented. – How shall headgear be used? product safety risk.
<personnel hygiene rules>
 3.2.2.3 Clearly defined usage rules shall D 2.1.2 – In which production areas is wearing of When missing or
exist for work areas/activities where gloves mandatory? unclean gloves ensue
it is required to wear gloves (colored <personnel hygiene rules> a product safety risk.
differently from the product color). – What kinds of gloves are used?
Compliance with these rules shall be When must gloves be changed?

© IFS, October 2012

checked on a regular basis. – How is the compliance with these rules
checked?
<on site inspections>

3.2.2.4 Suitable protective clothing shall be – How many protective suits/uniforms are When employees do
available in sufficient quantity for at the disposal of each employee? not have protective
each employee, when required. – How often is an employee supposed to clothing and therefore
change his/her protective suit/uniform? a product contamina-
tion risk exists.

3.2.2.5 When required, all protective – How is protective clothing laundered? When insufficient
clothing shall be thoroughly and <personnel hygiene rules> laundering ensues a
regularly laundered. Hazard analysis – Are there any employees who launder product contamina-
and assessment of associated risks, their protective clothing at home? tion risk.
together with consideration given to – Is protective clothes laundering based on
the processes and products of the a hazard analysis?
company shall determine if clothing <hazard analysis>
shall be washed by a contract
laundry, on site laundry or by the
employee.

3.2.2.6 Guidelines shall exist for laundering – How is the laundering procedure checked
of protective clothing and a proce- for effectiveness?
dure shall be in place for checking its <protective clothes swab test results>
cleanliness, when required. – What guidelines exist regarding protec-
International Featured Standards · IFS PACsecure · Version 1

tive clothes laundering?

<personnel hygiene rules>

3.2.2.7 Senior management shall ensure How the good working condition of
hazardous working conditions that personnel is followed?
could cause injuries to personnel are How are personnel informed?
identified and preventive measures
are managed.

3.2.2.8 The company shall review that Does an inspection plan exist?
preventive measures to ensure <report of inspection>
personnel safety related to hazard-
Part 2

ous working conditions are effective,

in line with applicable legislation or
63

recognized conventions.
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64

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
3.2.3 Procedures applicable to infectious
diseases
3.2.3.1 There shall be written and communi- D 2.1.1–2 1, 2 – How shall personnel and visitors behave When due to an
cated measures for personnel, D 2.2.1–3 1, 2, 3, 4, 5 in case or suspicion of an infectious employee’s infectious
contractors and visitors to declare disease? disease a product
any infectious disease which may – How is it ensured that personnel and safety risk is given
have an impact on packaging visitors know the guidelines? and no preventive
material safety. In case of declaration <personnel hygiene rules> <visitors steps are taken by the
of infectious disease, actions shall be hygiene rules> company.
taken in order to minimize risk of
contamination of products.
3.3 Training and instruction
3.3.1 The company shall implement D 1.2.1–4 1, 2, 3 – Who is responsible for training? When due to lack or
documented training and/or instruc- 7.0 <training evidences> insufficient training a
tion programs with respect to the D 1/D 2 1, 2, 3, 4, 5 – What are the evidences for the trainer’s product safety or
product requirements and the D 1.1.1 qualification? legality risk exists.
training needs of the employees – What was the content of the last training When legally
based on their job and shall include: session? required packaging
– training contents <training program> material safety
– training frequency – How are foreign employees trained/ instructions are not
– employee’s task instructed? undertaken.
– languages – Who participates in the training sessions?
– qualified trainer/tutor – How are the instruction necessities for
– evaluation methodology. each employee determined?
– How often are training sessions held?
<training schedule>
3.3.2 The documented training and/or D 1.2.1–4 1, 2, 3, 7 – Are prospective employees (incl. sea-
instruction shall apply to all person- sonal and temporary workers)
nel, including seasonal and tempo- trained/instructed upon employment?
rary workers and employees from – Which employees are trained/instructed
external companies, employed in the upon employment? What is the content
respective work area. Upon employ- of these instructions?
ment, and before commencing work, <training evidences>
International Featured Standards · IFS PACsecure · Version 1

they shall be trained in accordance

© IFS, October 2012

with the documented train-
ing/instruction programs.
 3.3.3 Records shall be available of all D 1.2.1–4 5, 7 – Which training courses are undertaken? No training proofs
training/instruction events, stating: – Are there any special training courses? exist to confirm that
– list of participants (this shall – Are training courses documented? employees were
include their signature) – What has been documented? trained/instructed.
– date – Have participants signed the training

© IFS, October 2012

– duration proofs?
– contents of training – How often are hygiene training sessions
– name of trainer/tutor. held?
There shall be a procedure or – What was the content of the last hygiene
program in place to prove the training session?
effectiveness of the training and/or <training evidences>
instruction programs.
3.3.4 The contents of training and/or D 1.2.1–4 4, 5 – How are training contents reviewed? During the on-site
instruction shall be reviewed and <review test> audit evidence was
updated regularly and take into – When are training contents reviewed? given that employees
account company’s specific issues, – When was the latest training content did not act according
packaging material safety, packaging update done? to knowledge trans-
material related legal requirements – What was the content of the latest mitted in the training
and product/process modifications. update? sessions and this lead
<audit results> to a product safety
– specific issues: non-conformitites, failure, risk.
complaints, etc
3.4 Sanitary facilities, equipment for
personnel hygiene and staff facilities
3.4.1 The company shall provide staff A 3.1.2 4 – How many employees are there? When social facilities
facilities, which shall be proportional 7.0 – Do they have access to a cafeteria? are underequipped or
in size, equipped for the number of A3 1, 2, 3 – Are there locker-rooms? are out of proportion
International Featured Standards · IFS PACsecure · Version 1

personnel and designed and oper- A 3.1.1 1, 2, 3, 4, 5, 6, 7, 8, 9 – Where are the restrooms? to the number of
ated so as to minimize packaging A 3.1.2 – Are there bathing facilities? employees so that a
material safety risks. Such facilities <plant lay-out> safety issue arises.
shall be kept in clean and good – Staff facilities = e.g. changing room,
condition. smoking area, dining room, etc.
3.4.2 The risk of product contamination by – May employees bring food and other
foreign material from staff facilities material from home?
shall be evaluated and minimized. <personnel hygiene rules>
Consideration shall also be given to – May employees take medicine along to
food and other material brought to their work place?
work by personnel and personal <personnel hygiene rules>
Part 2

belongings. – Does a hazard analysis exist regarding

foreign material from social facilities?
65

<hazard analysis>
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66

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
3.4.3 There shall be in place rules and
facilities to ensure the correct
management for personnel belong-
ings and for food and other material
brought to work by personnel, food
coming from dining room and from
vending machines. The food and
other material shall only be stored
and/or used in designated areas.
3.4.4 The company shall provide suitable A 3.1.2 7,8 – Are there locker-rooms for employees
changing rooms for personnel, and visitors with separation for outdoor
contractors and visitors. Where and protective clothing?
necessary, outdoor clothing and
protective clothing shall be stored
separately.
3.4.5 Toilets shall not have direct access to A 3.1.2 6 – Do toilets open directly into production When toilet exhaus-
an area where packaging material A 3.1.1 3 areas? tion poses a contami-
products are handled. The toilets nation risk.
shall be equipped with adequate
hand washing facilities. Sanitary
facilities shall have adequate natural
or mechanical ventilation. Mechani-
cal airflow from a contaminated area
to a clean area shall be avoided.
3.4.6 Adequate hand hygiene facilities shall A 3.1.1 1,2 – Are there enough hand washing facilities When a contamina-
be provided at access points to and available at the entrance to processing tion problem occurs
within production areas, as well as at areas and in social areas? due to lack of hand
staff facilities. Based on hazard ana- washing facilities.
lysis and assessment of associated
risks, further areas (e.g. wrapping
area) shall be similarly equipped.
3.4.7 Hand washing facilities shall provide A 3.1.1 1 – Are all hand washing facilities provided
as a minimum: with appropriate equipment for hand
International Featured Standards · IFS PACsecure · Version 1

– running potable water at an drying and liquid soap?

© IFS, October 2012

appropriate temperature – Are all hand washing facilities provided
– liquid soap with running potable water at an appro-
– appropriate equipment for hand priate temperature?
drying.
 3.4.8 If necessary, following additional A 2.1.1 1, 2, 3, 4, 5 – Are all areas where due to risk assess- When a contamina-
requirements regarding hand ment extended hygiene requirements are tion problem occurs
hygiene shall also be provided: necessary equipped with hand washing due to lack of appro-
– hand contact-free fittings facilities with hand contact-free fittings, priate hand washing
– hand disinfection hand disinfection devices and signs or facilities.

© IFS, October 2012

– adequate hygiene equipments pictograms?
– signage highlighting hand hygiene <signs/pictograms>
requirements
– waste container with hand contact-
free opening.
3.4.9 Based on hazard analysis and A 3.1.1 2
assessment of associated risks, there
shall be a program to control
effectiveness of hand hygiene.
3.4.10 Changing rooms shall be separated A 3.1.2 6 – Do locker-rooms give direct access to When a contamina-
from production area and shall be processing areas? tion occurs due to
situated so that they allow direct – How is protective clothing handled locker-room location
access to the areas where packaging during breaks/intervals? which leads to
material products are handled. <personnel hygiene rules> packaging material
Based on hazard analysis and – Does a hazard analysis exist for locker- product safety
assessment of associated risks, rooms with no direct access to process- problem.
exceptions shall be justified and ing areas? <hazard analysis>
managed.
3.4.11 Where the hazard analysis and – Are there cleaning facilities for boots and
assessment of associated risks show protective aprons?
the necessity, cleaning facilities shall
be available and used for boots,
International Featured Standards · IFS PACsecure · Version 1

shoes and further protective clothing.

4 Planning and Production Process
4.1 Contract agreement
4.1.1 The requirements which are defined – What assurances are given that customer When there are no
between the contract partners shall requirements and own specifications or approved specifica-
be established, agreed upon and other legally required documentations are tions or other legally
reviewed concerning their accept- in accordance with each other? required documenta-
ability before a supply agreement is – Do written supply agreements with tions and no clarity
concluded. All clauses related to customers exist? exists if required
quality and packaging material – Do specific customer requirements for product can be
Part 2

safety shall be known and communi- purchased products exist? delivered.

cated to each relevant department. – Who checks and approves specifications
or other legally required documentations?
67

– Who ensures that the proper raw materi-

als are available whenever needed?
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
68

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.1.2 Changes of existing contractual – How is it ensured that customers are
agreements shall be documented informed about product changes?
and communicated between the – Who checks and approves specifications
contract partners. or other legally required documentations?
4.2 Specifications and formulas/configu-
rations
4.2.1 Specifications and other legally
required documentation
4.2.1.1 Specifications or other legally – How are specifications or other legally When not all specifi-
required documentation shall be required documentations compiled, cations for final
available and in place for all finished checked and approved? products are up to
products. They shall be up to date, – Are there specifications or other legal date and in conform-
unambiguous and be in compliance required documentations for all final ance with legal
with legal and customer require- products? requirements.
ments. – How are up to date specifications or other
legally required documentations recog-
nizable?
<specifications or other legal required
documentation>
4.2.1.2 KO N° 3: Specifications or other Form 2 – Are specifications or other legal required When not all raw
KO legal required documentation shall documentation available for all raw materials, additives,
be available and in place for all raw materials, additives, inks, adhesives, inks, adhesives,
materials (raw materials, additives, solvents, wrapping material and rework? solvents, wrapping
inks, adhesives, solvents, wrapping – What assurance is given that specifica- materials and rework
materials, rework). Specifications tions and other legally required docu- have specifications or
shall be up to date, unambiguous mentation are followed? other legal required
and be in compliance with legal <evidence of specification compliance, documentation.
requirements and, if existing, with e.g. lab results> When specifications
customer requirements. – What assurance is given that specifica- do not comply with
tions are in conformance with legal legal requirements.
requirements?
– Who writes, checks and approves
specifications?
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4.2.1.3 Where required by customers,

© IFS, October 2012

product specifications shall be
formally agreed.
 4.2.1.4 Specifications or other legally – Who has access to specifications or other When key employees
required documentation and/or their legally required documentation? do not have access to
contents shall be provided in the specifications or
relevant location and accessible to other legally required
all relevant personnel. documentation and a

© IFS, October 2012

product safety and/or
legal requirement
issue ensues.
4.2.1.5 There shall be a procedure for the – Who writes, amends, checks and When specifications
creation, the modification and approves specifications or other legally or other legally
approval of specifications or other required documentation? required documenta-
legally required documentation for tion are used but
all parts of the process, which shall have not been
include the preliminary acceptance properly approved
of the customer, if specifications or and it is not clear if
other legally required documentation they can be complied
have been agreed with customers. with.
4.2.1.6 The specification/other legally
required documentation control
procedure shall include the update of
finished product specification in case
of any modification:
– of raw material
– of formula/configuration
– of process with influence on the
final products
– of wrapping material with influ-
ence on the final products.
International Featured Standards · IFS PACsecure · Version 1

4.2.2 Formula/configuration
4.2.2.1 KO N° 4: Where there are customer – What assurance is given that specified When there is evi-
agreements in relation to the configuration is followed? dence that configura-
product formula/configuration and – How is configuration compliance tion and finished
technological requirements, these checked? product specifications
shall be complied with. – If no specific technological requirements do not fit together.
and/or formulas are agreed between the When during a trace-
contract partners, the formula of the ability test there is
supplier is the basis. In this case the evidence that agreed
requirement shall be rated with N/A. upon configuration is
Part 2

not complied with.

4.3 Product development/Product The requirements for product development
69

modification/Modification of have to be checked even if there are only

production processes product modifications (new ingredient
used, changes in packaging) or modifica-
tions of production processes.
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
70

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.3.1 A procedure for product develop- – How are the processing procedures for When no processing
ment shall be in place which incor- product development built up? procedures were
porates the hazard analysis princi- – Do processing procedures for product established for
ples, in accordance with the HACCP development also contain a hazard product development
and/or risk assessment system. analysis? and a packaging
<hazard analysis> material safety and/or
legal issue ensues.
4.3.2 Product formulation/configuration, – What do product development proce- When new process-
manufacturing processes, process dures look like? ing procedures,
parameters and the fulfilment of <product development procedures> configurations and
product requirements shall be – What tests are made while a product is product requirements
established and shall have been developed? are not ensured by
assured by factory trials and product <test results> tests and trial runs
testing. – Is developed product submitted to trial and enter directly into
runs? production and this
<trial run documentation> entails a packaging
material safety and/or
legality issue which
cannot be corrected.
4.3.3 Recommendation for use-tests or – How is recommended converting time When no proof for
adequate processes shall be carried determined? defined converting
out and consideration given to <converting tests> time exists and a
product formulation/configuration, – Are products submitted to converting safety issue can
wrapping material, manufacturing time tests? occur.
and declared conditions. <converting time test results>
4.3.4 Product development shall consider – How often are organoleptic tests made?
the results of organoleptic assess- – Who participates in organoleptic tests?
ments. – Are organoleptic tests documented?
– How are the results from organoleptic
tests taken into consideration during
product development?
<organoleptic test results evaluation>
4.3.5 A process shall be in place to ensure What kind of process is implemented for
International Featured Standards · IFS PACsecure · Version 1

that the finished product complies legislation approval? Process of informa-

© IFS, October 2012

with current legislation of destina- tion gathering approval process e.g. with
tion country and customer require- customer.
ments. – Export goes to which countries? Which
countries have special requirements?
 4.3.6 Recommendations for handling – Who issues the cliches/printing block Product and labeling
and/or use of the packaging materi- approval? are not in conformity
als shall be established. Where – Who issues the labels? with each other, thus
appropriate, customer requirements – Who approves labels? creating a legality
shall be included. – How is conformity of the product and problem.

© IFS, October 2012

label reviewed?
4.3.7 The progress and results of product – How are converting recommendations When a safety issue
development shall be properly and/or product use information estab- occurs due to not
recorded. lished? taking customer
– How are converting requirements taken requirements into
into consideration during product account.
development?
<example>
4.3.8 The company shall ensure that in the
event of changes to product formula-
tion/configuration, including rework
and wrapping material, process
characteristics are reviewed in order
to assure that product requirements
are complied with.
4.4 Purchasing
4.4.1 General purchasing
4.4.1.1 The company shall control purchas- – How is it ensured that purchased prod- When purchased
ing processes to ensure that all ucts and services conform to specifica- products do not
externally sourced materials and tions or other legally required documen- conform to specifica-
services, which have an impact on tation or other legal required tions or other legally
packaging material safety and documentation? required documenta-
International Featured Standards · IFS PACsecure · Version 1

quality, conform to requirements. tion and thus entail a

Where a company chooses to safety or legality
outsource any process that may problem.
have an impact on packaging
material safety and quality, the
company shall ensure control over
such processes. Control of such
outsourced processes shall be
identified and documented within
the packaging material safety and
quality management system.
71Part 2
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72

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.4.1.2 There shall be a procedure for – Does an approval procedure exist for new When there are no
approval and monitoring of suppliers suppliers and co-producer? approval procedures
(internal and external), outsourced <supplier procedures> for suppliers and this
production or part of it. – How are supplies monitored? causes a safety risk.
– Are suppliers graded?
<supplier grading systems>
– Have suppliers been barred?
– How is a barred supplier identified?
– How is the qualification of suppliers
ensured?
<product entry monitoring>
<supplier audits>
<lab tests>
– Are there any co-producers?
<co-packers list>
– How are co-producers monitored?
– Are co-producers IFS PACsecure certified?
<certificate>

4.4.1.3 The approval and monitoring – How often are external audits made? No hazard analysis
procedure shall contain clear <external audit plan> was made.
assessment criteria such as: audits, – Which criteria are consulted for supplier
certificates of analysis, supplier assessment?
reliability and complaints, as well as – Which supplier has analysis certificates?
required performance standards. <analysis certificates>
– How was the hazard analysis for supplier
approval performed?
<hazard analysis>

4.4.1.4 The results of suppliers’ assess- – Who reviews the results of supplier When the results for
ments shall be reviewed regularly assessments? supplier assessment
and this review shall be based on – How often are the results of supplier are not taken into
hazard analysis and assessment of assessments reviewed? account and this
associated risks. There shall be – What actions are taken after review of the causes a safety or
records of the reviews and of the results for supplier assessments? legality issue.
actions taken as a consequence of <audit results>
International Featured Standards · IFS PACsecure · Version 1

assessment.

© IFS, October 2012

 4.4.1.5 The purchased products shall be – How are purchased products and their When purchased
checked in accordance with the specifications reviewed? products are never
existing specifications or other <incoming product check-list> checked on compli-
legally required documentation. The <lab tests> ance with specifica-
schedule of these checks shall, as a – Does a test schedule exist? tions or other legally

© IFS, October 2012

minimum, take into account the <test schedule> required documenta-
following criteria; product require- tions.
ments, supplier status (according to
its assessment) and impact of the
purchased products on the finished
product. If mentioned in the specifi-
cations or other legally required
documentation additional required
topics shall be checked.
4.4.1.6 The purchased services shall be
checked in accordance with the
existing specifications or other
legally required documentation. The
schedule of these checks shall at
least take into account the following
items: service requirements, supplier
status (according to its assessment)
and impact of the service on the
finished product.
4.4.2 Trade of packaging materials Mean purchased products, which have been
already processed and which are bought
and stored on-site of the audited company.
International Featured Standards · IFS PACsecure · Version 1

4.4.2.1 In case a company trades packaging If the company trades packaging materials
materials, it shall be ensured that a as finished products and if it wants to
process for approving and monitor- include them in the audit scope, the
ing suppliers exists and is imple- suppliers of these products shall them-
mented. selves be IFS PACsecure certified (if the
trade products are under the same product
scope) or certified under a comparable
scheme (if the trade products are under a
different product scope).
Compulsory field in the company profile:
specify if the company has trade products.
73Part 2
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
74

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.4.2.2 In case of traded packaging materials,
the process for approving and
monitoring suppliers shall contain
clear assessment criteria such as:
audits, certificates of analysis,
supplier reliability, complaints as well
as required performance standards.
4.4.2.3 In case of packaging materials for
private labels, a supplier approval
system in accordance with customer
requirements shall exist for pre-sup-
pliers of finished or semi-finished
products.
4.5 Product wrapping
4.5.1 Based on hazard analysis, assessment – Does a risk assessment also exist for
of associated risks and intended use, wrapping material not in direct packaging
the company shall determine the key material contact, to prove the evidence of
parameters for the wrapping material. direct negative influence on the product?
4.5.2 Detailed specifications shall exist for – How is it ensured that wrapping material Wrapping material
all wrapping materials which comply complies with current relevant legislation? that does not comply
with the current relevant legislation. – Who develops, reviews new wrapping with legislation. Not
material? all wrapping materi-
– Are specifications or other legally required als have specifica-
documentation available for all wrapping tions.
materials used?
<wrapping material specifications>
4.5.3 For all wrapping material which could
have an influence on products, certi-
ficates of conformity shall exist which
comply with current legal require-
ments. In the event that no specific
legal requirements are applicable,
evidence shall be available to demon-
International Featured Standards · IFS PACsecure · Version 1

strate that wrapping material is suit-

© IFS, October 2012

able for use. This applies for wrap-
ping material which could have an
influence on raw materials, semi-
processed and finished products.
 4.5.4 Based on hazard analysis and – How is it ensured that wrapping materials No hazard analysis
assessment of associated risks, the have no negative effects on the product? was made.
company shall verify the suitability – Has a hazard analysis been performed in
of the wrapping material for each relation to suitability of wrapping mate-
relevant product (e.g. organoleptic rial?

© IFS, October 2012

tests, storage tests, chemical analy- <hazard analysis>
sis, migration tests).
4.5.5 The company shall ensure that the Which system has the company imple-
wrapping used corresponds to the mented to ensure that wrapping material is
product being wrapped. The use of suitable and traceable?
correct wrapping shall be regularly
checked.
4.5.6 Printing and labeling information
shall be legible, indelible and shall
comply with agreed customer
product specifications or other
legally required documentations.
This shall be regularly checked and
checks shall be documented.
4.6 Factory location
4.6.1. The company shall investigate to A 1.1.1 1, 4 – Does a location investigation exist? Can When company
what extent the factory environment location have a negative influence on surroundings have a
(e.g. ground, air) may have an product quality? negative influence on
adverse impact on product safety <location analysis> product (e.g. water
and product quality. If product safety – What protective measures have been treatment) and no
and quality could be compromised, established if potentially damaging protective measures
International Featured Standards · IFS PACsecure · Version 1

appropriate measures shall be materials/substances are nearby? have been established

established. The effectiveness of the <protective measures> and therefore a safety
established measures shall be <corrective actions> problem exists.
periodically reviewed (examples: – Is efficiency of protective measures When established
extremely dusty air, strong smells). regularly reviewed? protective measures
– Who reviews the efficiency of the estab- are unclear or with
lished protective measures? questionable effi-
– How is efficiency of established protec- ciency and therefore a
tive measures reviewed? safety problem exists.
4.7 Factory Exterior 7.0 A 1
4.7.1 The factory exterior shall be main- A 1.1.1 2 – Are factory exteriors tidy?
Part 2

tained to be clean and tidy. – Are factory exteriors reviewed through

internal audits?
75

<audit results>
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76

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.7.2 All external areas of the factory shall A 1.1.1-2 3,6,7,8 – Are grounds within the factory premises
be maintained in good condition. in good condition?
Where natural drainage is inad- – Is natural drainage sufficient?
equate, a suitable drainage system – If natural drainage is insufficient, has a
shall be installed. suitable drainage system been installed?
4.7.3 Outdoor storage shall be kept to a A 1.1.1 5 – Are goods stored outdoors? No hazard analysis
minimum. Where goods are stored – What is stored outdoors? exists for outdoor
outside, hazard analysis and assess- – What rules exist for outdoor storage? storage.
ment of associated risks shall be – Is outdoor storage based on hazard Goods under outdoor
undertaken in order to ensure that analysis? <hazard analysis> storage are influ-
there is no risk of contamination or enced in a way that a
adverse effect on quality and safety risk is given
packaging material safety. (e.g. unprotected
primary packaging
material is kept
outdoors, becomes
moldy and is not
barred from use).
4.8 Plant layout and process flows
4.8.1 Plans clearly describing internal A 2.1.8 1, 2, 3 – How is it ensured that cross-contamina- When there are no
flows of finished products, packag- Form 4 tion is avoided? flow plans and
ing materials, raw materials, waste, <waste elimination plan> internal flows do not
personnel, water, etc. shall be in <personnel flow plan> respect the segrega-
place. A site map covering all <materials flow plan> tion of product
buildings of the facility shall be <process flow plan> processes (e.g.
available. <hydraulic plan> separation of “dirty”
from “clean” pro-
cessing areas but
personnel cross
boundaries without
according protective
clothing).
4.8.2 The process flow, from receipt of 7.0 – How is cross-contamination avoided The process flow
International Featured Standards · IFS PACsecure · Version 1

goods to dispatch, shall be in place A2 4, 6 within factory premises? allows for a cross-
so that contamination of raw materi- A 2.1.8 <process flow diagram> contamination be-

© IFS, October 2012

als, packaging, semi-processed and tween raw materials,
finished products is avoided. The risk packaging material,
of cross-contamination shall be mini- half-finished products
mized through effective measures. and finished products.
 4.8.3 In case of sensitive production areas, – Are there sensitive areas? When ventilation is
these shall be operated and moni- – Are sensitive areas ventilated? missing in sensitive
tored to ensure product safety is not – What additional measures are taken? areas and a safety
compromised. problem is given.

© IFS, October 2012

4.8.4 Laboratory facilities and in-process – Is there a laboratory on site? When product safety
controls shall not affect the product – Has the lab a direct contact with produc- is endangered
safety. tion premises? through the labora-
– Can lab waste (e.g. lab waste water) dirty tory (e.g. waste
the production premises? water, air circulation,
<plant lay-out> waste disposal).
<waste water drainage system>
4.9 Constructional requirements for
production and storage areas
4.9.1 Constructional requirements
4.9.1.1 Rooms where packaging material A 2.1.5–7 1, 2 – Are there “dirty” and “clean” areas? No separation of
products are prepared, treated, A 1.1.1–2 10 – Are there appropriate storage rooms? “dirty” and “clean”
processed and stored shall be areas even though
designed and constructed so that legally prescribed.
packaging material safety is ensured. When there is no
compliance with legal
requirements.
4.9.2 Walls
4.9.2.1 Walls shall be designed and con- A 2.1.5–7 3 – Are walls mouldy? Extreme mold
structed to prevent the accumulation A 2.1.2 1 build-up which
of dirt, to reduce condensation and ensues a contamina-
International Featured Standards · IFS PACsecure · Version 1

mould growth, and to facilitate tion risk.

cleaning.
4.9.2.2 The surfaces of walls shall be in a A 2.1.5–7 – How often are walls cleaned?
good condition and easy to clean; <cleaning schedule>
they shall be impervious and <cleaning evidence>
wear-resistant.
4.9.2.3 The junctions between walls, floors A 2.1.5–7 2 – Are wall-floor junctions and corners
and ceilings shall be designed to A 2.1.2 rounded?
facilitate cleaning.
4.9.3 Floors
Part 2

4.9.3.1 Floor covering shall be designed to A 2.1.5–7 – Are floors cleanable?

meet production requirements and – How often are floors cleaned?
77

shall be in good condition and easy <cleaning schedule>

to clean. Surfaces shall be impervi- <cleaning evidence>
ous and wear-resistant.
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
78

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.9.3.2 The hygienic disposal of waste water A 2.1.5–7 – How is waste water disposal ensured?
shall be ensured. Drainage systems – How often are gullies cleaned?
shall be easy to clean and designed <cleaning evidence>
to minimize the risk of product <drainage schedule>
contamination (e.g. ingress of pests,
etc.).
4.9.3.3 Water or other liquids shall reach A 2.1.5–7 – Are there water or other liquid puddles
drainage without difficulties, using A 2.1.4 1 on the floors of production areas?
appropriate measures. Puddles shall
be avoided.
4.9.3.4 In packaging material handling A 2.1.5–7 – Where is machinery which produces a
areas, machinery and piping shall be large amount of waste water located?
arranged so that waste water, if <machinery lay-out>
possible, goes directly into a drain.
4.9.4 Ceilings/Overheads
4.9.4.1 Ceilings (or, where no ceilings exist, A 2.1.5–7 3 – How often are ceilings cleaned? Ceilings are very dirty
the inside of roofs) and overhead A 1.1.1 11 <cleaning evidence> and dirt can fall on
fixtures (incl. piping, cableway, <cleaning evidence> product.
lamps etc.) shall be constructed to
minimize the accumulation of dirt
and shall not pose any risk of
physical and/or microbiological
contamination.
4.9.4.2 Where false ceilings are used, an A 2.1.5–7 – How often are false ceilings cleaned?
access to the void shall be provided <cleaning evidence>
in order to facilitate cleaning, <cleaning evidence>
maintenance and inspections for
pest control.
4.9.5 Windows and other openings
4.9.5.1 Windows and other openings shall A 2.1.5–7 4 – Can dirt accumulate on window sills?
be designed and constructed to
International Featured Standards · IFS PACsecure · Version 1

avoid the accumulation of dirt and

© IFS, October 2012

shall be maintained in good condi-
tion.
 4.9.5.2 Where there is risk of contamination, A 2.1.5–7 6 – Are windows kept open? Windows are open and
windows and roof glazing shall no insect gratings are
remain closed and fixed during in place so that pests
production. can enter production
areas and a contami-

© IFS, October 2012

nation risk exists.
Pests are visible.
4.9.5.3 Where windows and roof glazing are A 2.1.5–7 5 – Are windows sealed with insect gratings? Windows are open
designed to be opened for ventila- A 1.1.1 12 <pest control schedule> and no insect gratings
tion purposes, they shall be fitted – Is integrity of gratings regularly are in place so that
with easily removable, good condi- reviewed? pests can enter produc-
tion pest screens or other measures <monitoring schedule> tion areas and a
in order to avoid any contamination. contamination risk
exists.
4.9.5.4 In areas where unpackaged product A 2.1.5–7 7, 8 – How are windows protected against Windows with no
is handled, windows shall be breakage? breakage protection
protected against breakage. are in production areas
where uncovered and
broken and unpack-
aged products are
handled which ensues
a contamination risk.
4.9.6 Doors and gates
4.9.6.1 Doors and gates shall be in good A 2.1.5.7 3 – Are doors damaged? Doors are open or
condition (e.g. no splintering parts, damaged so that pests
flaking paints or corrosion) and easy can enter production
to clean. areas and a contami-
International Featured Standards · IFS PACsecure · Version 1

nation risk exists.

Pests are visible.
4.9.6.2 Based on hazard analysis and A 2.1.5.7 4 – Do external doors prevent pest entrance
assessment of associated risks into production areas?
external doors and gates shall be
constructed to prevent the ingress of
pests; if possible, they shall be
self-closing.
4.9.7 Lighting
4.9.7.1 All working areas shall have ade- A 2.2.1 1 – What is the assurance that all working
Part 2

quate lighting. areas are adequately illuminated?

79

4.9.7.2 All lighting equipment shall be A 2.2.2 1, 2 – Where are fly killing units mandatory? When fly traps and
protected by shatter proof covers <fly trap plan> lighting devices
and installed to minimise the risk of – Are all fly killing units and lamps pro- constitute a contami-
breakage. tected by splinter shields? nation risk.
<lighting protectors>
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80

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.9.8 Air conditioning/Ventilation
4.9.8.1 Adequate natural and/or artificial A 2.3.1 1, 2, 3, 4 – How is ventilation reviewed?
ventilation shall exist in all areas. A 2.3.3 1, 2, 3, 4, 5, 6, 7, 8
4.9.8.2 If ventilation equipments are in- A 2.3.1 2, 3 – How are air filters maintained and cleaned? Filters which are not
stalled, filters and other components A 1.1.1 14 <maintenance schedule> cleaned as programmed
which require cleaning or replace- A 2.3.3 7 <maintenance documentation> constitute a product
ment shall be easily accessible. <cleaning protocols> contamination risk.
4.9.8.3 Air conditioning equipment and A 2.3.1 1 – Is the use of air during production based When air supply causes
artificially generated airflow shall not on hazard analysis? <hazard analysis> a contamination which
lead to any product safety or quality – Are there production areas with under- or ensue a packaging
risks. over-pressurization? material safety risk.
4.9.8.4 Dust extraction equipment shall be A 2.3.3 1 – Are there areas where large amounts of
installed in areas where considerable dust are formed?
amounts of dust are generated. – Do dust extraction devices exist in these
areas?
4.9.9 Water supply
4.9.9.1 Water which is used as ingredient in 7.0 A 4 – Where does water supply come from?
the production process, or for clean- A 4.1.1 1, 2 (City supply, well water, tanker)?
ing, shall comply with legal require- A 4.1.1 5 – Is water demand always covered?
ments and shall be supplied in A 4.1.2 1, 2, 3, 4, 5, 6, 7
sufficient quantity; this also applies
to steam and ice used within the
production area. A supply of such
water shall be available at all times.
4.9.9.2 Recycled water which is used in the A 4.1.3–6 1, 2, 3, 4, 5 – For what purpose is water used in the There is evidence that
process shall not pose a contamina- company (social facilities, cleaning water does not com-
tion risk. The water shall comply procedures, product ingredient, for ply with legal stand-
with applicable legal requirements washing fruits and vegetables)? ards and is used for
for potable water; records of compli- – Is water treated on site (water hardness cleaning procedures
ance testing shall be available. correction, chlorination, sterilization, of surfaces in direct
filtration …)? contact with packag-
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– Are local legal requirements on hand? ing material or as in-

© IFS, October 2012

– Is water analysed according to legal gredient, or company
requirements (own water supply, outside cannot show that
supply). Do results comply with stand- water complies with
ards? <several analysis results> required standards.
 The checking interval
for relevant water
safety issues has been
clearly overdrawn.

© IFS, October 2012

The company has no
water analysis plan
even though it is
mandatory and water
is used for cleaning
procedures or as an
ingredient.
4.9.9.3 The quality of water, whatever the 7.0 A 4 – Is water, steam or ice used – is a station When contaminated
condition of aggregation, shall be A 3.1.2 4, 5, 6 monitoring in place? water reaches the
monitored following a risk based A 4.1.1 3, 4 <maintenance> <analysis results> product due to bad
sampling plan. – What kind of piping system exists? conditions of piping
Ring-pipes, water-tanks) or improper piping
– What is piping made from? material.
– Is analysis and sampling plan based on
hazard analysis?
4.9.9.4 Non-potable water shall be trans- A 4.1.3–6 3, 4 – Is drinking water system completely All existing water
ported in separate, properly marked A 2.4.1 1, 2 separated from non-potable water systems are intercon-
piping. Such piping shall not be piping? nected, no reflux
connected to the drinking water <hydraulic system lay-out> avoidance equip-
system, or allow the possibility of – What other systems are there? ments exist, therefor
reflux to contaminate potable water (e.g. used water, cooling water, water a contamination
sources or the factory environment. used for firefighting). hazard is given.
– Are water systems properly marked and
International Featured Standards · IFS PACsecure · Version 1

where they are?

– Are reflux avoidance equipments
installed wherever necessary?
4.9.10 Compressed air
4.9.10.1 The quality of compressed air that A 2.3.3 4
comes in direct contact with packag-
ing material or wrapping material
shall be monitored based on hazard
analysis and assessment of associ-
ated risks.
Part 2

4.9.10.2 Compressed air shall not pose a risk A 2.3.3 4

of contamination.
81

4.10 Cleaning and disinfection

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82

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.10.1 Based on hazard analysis and 7.0 E 1 – Who is in charge of cleaning and disinfec- When a contamina-
assessment of associated risks, E 1.1.1–3 1, 2, 3, 4, 5, 11 tion? <cleaning schedule> tion of packaging
cleaning and disinfection schedules – What kind cleaning products and disin- material products or
shall be available and implemented. fectants are used? tools exists due to the
These shall specify: <up to date cleaning products and use of inefficient or
– objectives disinfectant list> wrong kind of
– responsibilities – What must be observed when using chemicals or ineffi-
– the products used and their different cleaning products and disinfect- cient cleaning
instructions for use ants? <product instructions> procedures.
– the areas to be cleaned and/or – What areas are cleaned and disinfected?
disinfected <cleaning schedule>
– cleaning frequency – How often are areas cleaned and disin-
– documentation requirements fected?
– hazard symbols (if necessary). – Where are cleaning and disinfection
procedures documented?
<cleaning procedures documentation>
– Do hazard symbols exist?
– Does a contract exist for external service
provider? <external services contract>
– Cleaning schedules can include SSOP‘s.
4.10.2 Cleaning and disinfection schedules 7.0 E 1
shall be implemented and documented. E 1.1.1–3 4, 5, 12, 16
4.10.3 Only qualified personnel shall be E 1.1.1–3 6 – Are cleaning personnel qualified? When a product or
allowed to undertake cleaning and <training proof> tools contamination
disinfection. The personnel shall be – How often are they trained? occurs due to untrain-
trained and retrained to carry out the – Who trains them? ed cleaning person-
cleaning schedules. – Are these trainings documented? nel or wrong use of
cleaning products or
when cleaning
process is inefficient.
4.10.4 The effectiveness and safety of the 7.0 E 1 – How are cleaning and disinfection When cleaning is
cleaning and disinfection measures, E 1.1.1–3 7, 13 controls performed? <cleaning controls> unsuccessful and this
based on hazard analysis and assess- – Who performs these controls? error is not corrected.
International Featured Standards · IFS PACsecure · Version 1

ment of associated risks, shall be <cleaning controls>

verified and documented according – How often are cleaning and disinfection

© IFS, October 2012

to a sampling schedule by using controls performed? <cleaning controls>
appropriate procedures. Resulting – Where are cleaning and disinfection
corrective actions shall be docu- controls documented?
mented.
 – When are corrective actions executed?
<corrective actions>
– Who executes corrective actions?
– Who reviews effectiveness of corrective
actions?

© IFS, October 2012

– Where are corrective actions docu-
mented?
4.10.5 Cleaning and disinfection schedules E 1.1.1–3 8, 14 – When are cleaning and disinfection When circumstances
shall be reviewed and modified, if procedures validated? have been changed
necessary, in the event of a change – Who adapts cleaning and disinfection but no adaptations
to product, process or cleaning procedures? were made for
equipment. – How often are cleaning and disinfection cleaning and disinfec-
schedules changed? tion procedures and a
contamination risk
ensues.
4.10.6 The intended use of cleaning utensils
shall be clearly identified. Cleaning
utensils shall be used in a way to
avoid contamination.
4.10.7 Current material safety data sheets B 2.2.1–4 13 – Are material safety data sheets available When a safety risk
(MSDS) and instructions for use shall for all cleaning chemicals? occurs due to defi-
be available for chemicals and – Are these no older than two years? cient material safety
cleaning agents. Personnel responsi- – Are cleaning chemicals instructions up to data sheets.
ble for cleaning shall be able to date?
demonstrate their knowledge of such – How are instructions transmitted to
instructions, which shall be always personnel in charge of cleaning proce-
available on site. dures?
International Featured Standards · IFS PACsecure · Version 1

– Where and when can the instructions be

inspected?
4.10.8 Cleaning chemicals shall be clearly A 3.2.2 1, 2, 3 – How are cleaning utensils and chemicals When cleaning
labeled, used and stored appropri- B 2.2.1–4 8, 9, 10, 12, 14 recognizable? utensils can be mixed
ately, to avoid contamination. E 1.1.1–3 1, 9 <chemicals list> up with other utensils
– Where are cleaning utensils and chemi- and packaging
cals stored? material contamina-
<chemicals storage list> tion ensues.
When improper
storage can lead to
packaging material
Part 2

and other utensils

contamination.
83
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84

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.10.9 Cleaning activities shall be carried A 3.2.1 1, 2, 3, 4, 5, 6 – Where are containers cleaned? The tool cleaning
out in periods of non-production. If E 1.1.1–3 9, 15 – When and where are tools cleaned? process is a product
this is not possible, these operations <cleaning evidence> contamination
shall be controlled as to not affect problem; e.g. wet
the product. cleaning of contain-
ers and pallets during
production and near
unprotected packag-
ing material.
4.10.10 Where a company hires a third-party
service provider for cleaning and
disinfection activities, all require-
ments specified within section 4.10
shall be clearly defined in the
respective contract.
4.11 Waste disposal
4.11.1 A waste management procedure A 2.4.1 1, 2, 3, 4, 5, 6
shall exist and shall be implemented A 2.4.2 1, 2, 3, 4, 5, 6, 7, 8
to avoid cross contamination.
4.11.2 All current legal requirements for – How is it ensured that current legal waste When legal require-
waste disposal shall be met. disposal requirements are met? ments regarding
– How is waste material disposed of? waste disposal are
not met.
4.11.3 Packaging material waste and other – How often are packaging material waste When wastes accu-
waste shall be removed as quickly as and other wastes removed from packag- mulate in packaging
possible from areas where packag- ing material handling areas? material handling
ing material is handled. The accumu- – Who is responsible for waste removal? areas which ensues a
lation of waste shall be avoided. packaging material
contamination risk.
4.11.4 Waste collection containers shall be A 2.4.2 1, 4, 5, 6 – What kind of waste exists? What wastes When waste contain-
clearly marked, suitably designed, in are collected in separate containers? How ers can be mixed up
good state of repair, easy to clean, are waste containers marked? Can waste with packaging
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and where necessary disinfected. containers easily be cleaned? material containers

© IFS, October 2012

– How often are waste containers cleaned? which ensues a
<cleaning protocol> packaging material
contamination risk.
 4.11.5 Waste collection rooms and contain- A 2.4.2 7 – Are waste collection rooms kept clean? When waste collec-
ers (incl. compactors) shall be A 1.1.1 9 – Are waste collection rooms protected tion rooms are not
designed to be kept clean to mini- from pests? protected from pest
mize pest attraction. <integrated pest control> invasions and there is
a contamination risk.

© IFS, October 2012

4.11.6 Waste shall be collected in separate A 2.4.2 5 – What kinds of waste disposal records When wastes are
containers in accordance with the exist? removed by unau-
intended means of disposal. Such – Who is responsible for waste disposal? thorized persons.
waste shall be disposed by author- <waste disposal register>
ised third parties only. Records of
waste disposal shall be kept by the
company.
4.12 Risk of foreign material, metal,
broken glass and wood
4.12.1 KO N° 5: Based on hazard analysis – What kinds of foreign material may be When a foreign
KO and assessment of associated risks, found? material contamina-
procedures shall be in place to avoid – Where foreign material sources identified tion occurs due to
contamination with foreign material. through hazard analysis? lack of hazard
Contaminated products shall be <hazard analysis> analysis or when
treated as non-conforming products. – Are staples used? foreign material
– How are contaminated products handled? sources are insuffi-
<segregation records> ciently considered.
– What is done in case of glass breakage?
<glass breakage prevention procedures>
– What shall be considered when glass
fixtures are replaced?
<glass handling procedures>
International Featured Standards · IFS PACsecure · Version 1

4.12.2 In all areas, e.g. handling of raw – Under what circumstances is the use of When wood gets in
materials, converting, wrapping and wood allowed? <hazard analysis> contact with open
storage, where hazard analysis and Is the wooden tool in use in good and clean product.
assessment of associated risks have conditions? When wood poses a
identified the potential for product – Who inspects and how often is the contamination risk for
contamination, the use of wood shall wooden tool condition inspected? packaging material
be excluded. Where the use of wood <plant inspections> product. When wooden
cannot be avoided, the risk shall be tool condition is not
controlled and the wood shall be in inspected and a conta-
good order and clean. mination risk ensues.
Part 2

4.12.3 Where metal- and/or other foreign – Where are the foreign material detectors When foreign
material detectors are required, they installed? material detectors are
85

shall be installed to ensure maximum <equipment lay-out> installed but later on

efficiency of detection, in order to a foreign material risk
avoid subsequent contamination. still persists which
Detectors shall be subjected to regu- has not been taken
lar maintenance to avoid malfunction. into account.
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secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.12.4 Potentially contaminated products – Are contaminated products automatically When segregation
shall be isolated. Access and actions isolated? does not work.
for further handling or checking for – Who may handle/has access to isolated When isolated
these isolated products shall be products? products re-enter
carried out only by authorized – How are isolated products handled? production line
personnel according to defined <non-conforming products list> without previous
procedures. After this check, con- <isolation protocol> inspection.
taminated products shall be treated
as non-conforming products.
4.12.5 The appropriate accuracy of detec- – How often are detector accuracies checked? When proper opera-
tors shall be specified. Checks of – Who checks detector accuracy? tion or measuring
proper function of detectors shall be <metal detector check-list> accuracy is not
carried out regularly. In case of – What corrective actions exist when a checked and a foreign
malfunction or failure of a metal detector is defective? material risk occurs.
and/or foreign material detector, – Are corrective actions verified?
corrective actions shall be defined, – Are operational defects documented?
implemented and documented. <defect/failure protocols>
4.12.6 In cases where special equipment or – Are filters and sieves or other technical or When damage to
methods are used to detect foreign mechanical systems like strainers, sieves or filters
material, these shall be properly magnets, vacuum cleaner etc. being used? passes without
validated and maintained. – How often are working conditions of noticed and this leads
filters or other technical or mechanical to a foreign material
systems and sieves inspected? contamination risk.
– Who inspects/maintains filters and sieves
or other technical or mechanical systems?
– What is the concern of inspection?
<maintenance schedule>
<monitoring system>
4.12.7 In all areas, e.g. handling of raw – Does a hazard analysis exist concerning When no hazard
materials, converting, wrapping and contamination through glass? analysis has been
storage, where hazard analysis and <hazard analysis> conducted.
assessment of associated risks have – Where is glass used in the plant? When there exists a
identified a potential product con- – How is glass protected from breakage? contamination risk
International Featured Standards · IFS PACsecure · Version 1

tamination, the presence of glass and <glass register> due to glass usage.
brittle material shall be excluded. When glass is

© IFS, October 2012

Where the presence of glass or brittle unprotected and
plastic cannot be avoided, appropri- there is a contamina-
ate measures shall be in place to tion risk.
protect against breakage.
 4.12.8 All stationary objects made of or – Is there a glass fixtures register including When glass breakage
incorporating glass or brittle material location? happens unnoticed
present in areas of handling of raw <glass register> and a contamination
materials, converting, wrapping and – How often and who inspects glass fixture risk ensues.
storage shall be listed in a specific conditions?

© IFS, October 2012

register, including details of their – How often is glass fixtures register up
exact location. An assessment of the dated?
condition of objects on the register <inspection results>
shall be performed on a regular <glass register>
basis and recorded. Frequency of
this check shall be justified by
documents.
4.12.9 Breakages of glass and brittle – Is every glass breakage documented? When no hazard
material shall be recorded. Excep- <glass breakage registry> analysis has been
tions shall be justified and docu- – Where is glass breakage documented? made.
mented. <glass register>
– Are there exceptions to documentation?
Are exceptions based on hazard analysis?
<hazard analysis>
4.12.10 Procedures shall be in place describ- – What is done in case of glass breakage? When a contamina-
ing the measures to be taken in case – What should be taken into account? tion risk exists due to
of breakage of glass and/or brittle – Who cleans the production environment? glass breakage and
material. Such measures shall – Who permits production continual? because involved
include identifying the scope of <glass breakage prevention procedures> product has not been
goods to be isolated, specifying <glass breakage documentation> inspected.
authorized personnel, cleaning the
production environment and release
of production line for continued
International Featured Standards · IFS PACsecure · Version 1

production.
4.12.11 Based on hazard analysis and – Has a hazard analysis been performed? When no hazard ana-
assessment of associated risks, <hazard analysis> lysis has been made.
preventive measures shall be in – What preventive measures are in place? When there exists a
place for handling of all kinds of <preventive measures> contamination risk
containers in the production process due to missing
(turn over, blow, rinse, etc.). preventive measures.
4.12.12 Where visual inspection is used to
detect foreign material, the employ-
ees shall be trained and operative
Part 2

change shall be performed at an

appropriate frequency to maximize
87

effectiveness of process.
4.13 Pest monitoring/Pest control
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secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.13.1 The company shall have a pest con- 7.0 E 2 – How is pest control organized? When no pest control
trol system in place which is in com- E 2.1.1 1, 2, 3, 4, 6 <pest control procedures> is made.
pliance with local legal requirements, – Which pests are controlled? When a product
taking into account, as a minimum: – Which kinds of baits are used? contamination can
– the factory environment (potential <pest control chemicals list> occur due to
pests) – Is product contamination through baits unmapped baits.
– site plan with area for application being prevented? When a product
(bait map) <bait map> safety occurs due to
– identification of the baits on site – Who is responsible for pest control? incorrect use of pest
– responsibilities, in-house/external – What is inspection schedule? control chemicals or
– used products/agents and their wrongly laid out
instructions for use and safety baits.
– the frequency of inspections.
The pest control system shall be
based on hazard analysis and assess-
ment of associated risks.
4.13.2 The company shall have qualified E 2.1.1 4, 5 – Is pest control executed by own staff When a product
and trained in-house staff and/or A 1.1.1-2 15 members? contamination occurs
employ the services of a qualified – Who is responsible for pest control? due to incorrect
external provider. Where an external – What kind of training has the responsible handling of bait
provider is used, the activities person? <training evidence> material.
required on site shall be specified in – Is pest control executed by external
a written contract. services provider?
– Does a written contract exist between
services provider and company?
<written contract>
– What is the content of the contract?
– What kind of training has the external
services provider? <training evidence>
4.13.3 Pest control inspections and result- E2.1.1 7,11,12 – Where are inspections and resulting When inspections are
ing actions shall be documented. corrective actions documented? not documented.
Implementation of actions shall be <inspection results>
monitored and recorded. – Are documents signed and dated by both
parties?
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– Which corrective actions were executed

© IFS, October 2012

lately?
 4.13.4 Baits, traps and insect exterminators E 2.1.1 8, 9, 10 – Where are electrical fly killers installed? When fly killers are
shall be functioning, shall be in <fly killer map> positioned in such a
sufficient numbers and shall be – Are all fly killers correctly working and way that flies can fall
placed in an appropriate position. connected? directly on packaging
They shall be constructed and material products.

© IFS, October 2012

positioned as not to cause any
contamination risk.
4.13.5 Incoming deliveries shall be checked – Are incoming goods inspected for pest When incoming
on arrival for the presence of pests. contamination? goods are not
Any infestation shall be documented – Where is this documented? inspected for pest
and control measures taken. <incoming goods inspection> presence and an
– Is pest presence documented? uncontrolled invasion
<incoming goods inspection> ensues.
– What control measures are taken when
pests are found?
<corrective actions>
– Where are these control measures
documented?
<corrective actions>
4.13.6 The effectiveness of the pest control E 2.1.1 12
shall be monitored with the help of
regular trend analyses.
4.14 Receipt of goods and storage 7.0 B 2
4.14.1 All incoming goods, including 7.0 B 2 – What goods (incl. semi-processed When no receipt
wrapping materials, shall be checked B 2.1.1–2 1, 2 products) are inspected when received? checks are made.
for conformity against specifica- <receipt checks> When checks do not
International Featured Standards · IFS PACsecure · Version 1

tions/other legally required docu- – What is checked when received? guarantee legally
mentation and to a determined – Is receipt documented? requirements.
inspection plan. The inspection plan – Who checks? When receipt checks
shall be risk based. Test results shall do not take into
be documented. account specifica-
tions or other legally
required documenta-
tion requirements
which prevent that
products fulfil their
given specifications
or other legally
Part 2

required documenta-
tion.
89
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90

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.14.2 The storage conditions of raw 7.0 B 2 – Where are raw materials, half finished When goods are
materials, semi-processed and B 2.1.1–2 3, 19 products and packaging materials stored? improperly stored
finished products as well as wrap- B 1.1.1–3 1–19 <storage plan> and a contamination
ping shall in each case correspond to B 1.2.2 1 – How is cross-contamination avoided? risk ensues.
product requirements (e.g. protective B 2.3.1–2 1–12 <product flow plan>
covers) and shall not be detrimental
to other products.
4.14.3 Raw materials, packaging, semi- B 2.1.1–2 – Where and how are packaging materials A product contamina-
processed and finished products and equipments stored? tion risk is given due
shall be stored so as to minimize the <materials flow-diagram> to storage of packag-
risk of cross contamination. – How is cross-contamination through ing materials and
packaging materials avoided? equipments (e.g.
<materials flow-diagram> unprotected external
– How is return of packaging materials to storage of packaging
the storeroom regulated? material) When
– What kind of storage regulations exist? storage facilities are
– Are pests taken into account during not inspected for pest
storage? Are pallets located approxi- presence.
mately 1 m from walls?
<plant inspection protocol>
– Are there baits laid out in storage rooms?
<pest control schedule>
– Are there sensitive products stored?
– What kinds of preventive measures are in
place for these goods?
<preventive measures>
4.14.4 Appropriate storage facilities shall be B 2.2.1–4 1–15 – How are chemicals stored? When a packaging
available for the management and – Who uses chemicals and takes them out material or utensils
storage of working materials, of storage? contamination occurs
process aids, and additives. The <responsibility list> due to inappropriate
personnel responsible for the – Are the chemicals users trained? storage conditions.
management of storage facilities – Is training documented? When a packaging
shall be trained. <training documentation> material or utensils
contamination occurs
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due to insufficient

© IFS, October 2012

knowledge.
 4.14.5 All products shall be clearly identi- 7.0 B 2 – How is “FIFO” or “FEFO” ensured? When goods are
fied. Use of products shall be B 2.1.1–2 18 taken out of storage
undertaken in accordance with the B 2.3.1–2 7 without control and a
principles of First In/First Out and/or product safety risk
First Expired/First Out. ensues.

© IFS, October 2012

4.14.6 Where a company hires a third-party B 2.1.1–2 1 – Is storage leased to storage service
storage service provider, the service provider?
provider shall be subject to IFS – Does a contract exist?
Logistics requirements. If the third <service provider contract>
party service provider is not certified – What is specified in the contract?
to IFS Logistics, all relevant require- – Has storage service provider an
ments equivalent to the company’s IFS Logistics certification?
own warehousing practices shall be <certificate copy>
fulfiled and this shall be clearly
defined in the respective contract.
4.15 Transport
4.15.1 Before loading transport vehicles, B 1.1.1–3 1, 2, 3 – What is checked before loading?
their condition (e.g. absence of B 1.2.2 1 <expedition inspection>
strange smells, high dust load, – Where is inspection documented?
adverse humidity, pests, mould) – What corrective actions are taken?
shall be checked and action taken, if
necessary.
4.15.2 Procedures to prevent contamination 7.0 B 1 – May goods be transported alongside with When a contamina-
during transport shall be imple- B 1.1.1–3 non packaging material products? tion can occur during
mented (packaging material/non- – How is cross-contamination prevented? transport.
packaging material/different catego-
International Featured Standards · IFS PACsecure · Version 1

ries of goods).
4.15.3 Where goods must be transported at – Are products which require a certain When there are
certain conditions, before loading, conditions (e.g. humidity during paper certain conditions
the condition inside the vehicle shall transportation) being loaded? specifications for
be checked and documented. – Are vehicle conditions checked and outgoing product but
documented before loading? they are not checked
<expedition inspection> before loading and a
– What are the procedures when vehicle health issue occurs.
condition is not according to specifica-
tions or other legally required documen-
tation? <expedition inspection>
Part 2

– How the company ensure the compliance

of conditions during transport?
91
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92

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.15.4 Where goods must be transported at – Are vehicles equipped with registering When there are
certain conditions maintaining these devices? condition specifica-
conditions during transport shall be <registering devices> tions or other legally
ensured and documented. – How is it ensured that products reach required documenta-
destination under good conditions? tions for the product
and condition control
is not ensured during
transport so that a
health issue may
occur.
4.15.5 Adequate hygienic requirements for B 1.1.1–3 1, 2, 3 – Are transport vehicles cleaned? When absence of
all transport vehicles and equipment – Where are cleaning procedures docu- cleaning procedures
used for loading/unloading (e.g. mented? ensue a product
hoses of silo installations) shall exist. <cleaning protocol> contamination
There shall be records of the meas- problem.
ures taken.
4.15.6 Loading and unloading areas shall B 1.1.1–3 17 – How is goods reception organized?
have equipment in place to protect – How is loading organized?
transported products from external External influences: e.g. pollen, climate, etc.
influences.
4.15.7 Where a company hires a third-party – Are there internal or external transporta-
transport service provider, all the tion regulations?
requirements specified within – Does a contract exist with a transporta-
section 4.15 shall be clearly defined tion services provider?
in the respective contract or the <service provider contract>
service provider shall be subject to – Has storage service provider an IFS
IFS Logistics requirements. Logistics certification?
<certificate copy>
4.15.8 Security of transport vehicles shall B 1.1.1–3 19 Are loading areas shuttered?
be appropriately maintained. Are the transports sealed?
4.16 Maintenance and repair
4.16.1 An adequate system of maintenance C 1.1.1–3 1–13 – How is maintenance organized? No maintenance
International Featured Standards · IFS PACsecure · Version 1

shall be in place, maintained and <maintenance plan> system exists.

documented, covering all critical – Where are maintenance procedures

© IFS, October 2012

equipment (incl. transport) for documented?
compliance with product require- – Which equipments are subject to external
ments. This applies both for internal maintenance?
and external maintenance activities.
 4.16.2 Product requirements and preven- 7.0 C – How is it ensured that maintenance and When a contamina-
tion of contamination shall be C 1.1.1–3 repair works do not affect product safety? tion risk for the
ensured during and after mainte- C 1.2.1–2 1–13 – How are lighting fixtures repaired? product occurs due to
nance and repair work. Records of – Where are repair works documented? maintenance and
maintenance and repair work and of – Are corrective actions necessary after product is not

© IFS, October 2012

corrective actions taken shall be repair works? segregated.
kept. – What rules are in place for re-activating
equipment when maintenance is com-
pleted?
<examples for repair works and mainte-
nance>
4.16.3 All materials used for maintenance B 2.2.1–4 4, 6 – How is it ensured that materials used in When materials used
and repair shall be fit for the C 1.2.1 1, 2, 4, 5 maintenance or repair work are fit for in maintenance or
intended use. intended use? repair works are not
– What kinds of greases are used? food grade and a
<grease list> safety risk for the
consumer ensues.
4.16.4 Failures of plant and equipment (incl. C 1.2.1–2 1, 2, 4, 5 – Are processing interruptions docu-
transport) covered by the mainte- mented?
nance system shall be documented <processing interruptions>
and reviewed with a view to adapt- – Are processing interruptions considered
ing the maintenance system. in maintenance planning?
4.16.5 Temporary repairs shall be carried C 1.2.1–2 1, 2, 4, 5 – Are temporary repairs allowed?
out so that product requirements are – Where are these documented?
not affected. Such work shall be – How fast must temporary repairs be
documented and a short-term definitely mended?
deadline set for eliminating the fault. – Who verifies this?
International Featured Standards · IFS PACsecure · Version 1

4.16.6 Where a company hires a third-party C 1.2.1–2 1, 2, 4, 5

maintenance and repair service
provider, all the company specified
requirements regarding material and
equipment shall be clearly defined,
documented and maintained.
4.17 Equipment
4.17.1 Equipment shall be suitably 7.0 C – Are equipments suitably designed and When equipment
designed and specified for the C 1.1.1–3 1.2.3 were they checked before start up? construction can lead
intended use. Before commissioning, A 2.1.3 1 <start up protocol> to a packaging
Part 2

it shall be verified that the product material contamina-

requirements are complied with. tion.
93
 IFS PAC IFS PACsecure requirement Connec- Text/Number of What to check? Example for
94

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.17.2 For all equipment and tools with C 1.1.1–3 5 – Are conformity certificates or other Wrappings and
direct packaging material contact, certificates available for all wrapping wrapping materials
certificates of conformity shall exist materials which come into direct contact which come into
which confirm compliance with with packaging material products? direct contact with
current legal requirements. In case <conformity certificates> packaging material
no specific legal requirements are – Are conformity certificates available for are not suitable for
applicable, evidence shall be avail- wrapping materials which come into intended use and
able to demonstrate that all equip- direct contact with raw materials, half- therefore a safety risk
ment and tools are suitable for use. finished or finished products? exists.
This applies for all equipment and <conformity certificates>
tools in direct contact with raw – Are conformity certificates available for
materials, semi-processed and containers and conveyor belts?
finished products. <conformity certificates>
4.17.3 Equipment shall be designed and C 1.1.1–3 3 – Are equipments suitably designed and When equipment is
located so that cleaning and mainte- A 2.1.8 5 were they checked before start up? installed in a way that
nance operations can be effectively <start up protocol> cleaning procedures
performed. – What rules exist for start up of new are hindered and thus
equipments? constitute a contami-
– Were new equipments immediately nation source.
considered in maintenance plan?
– Does an equipment installation plan
exist?
<machinery installation plan>
4.17.4 The company shall ensure that all 7.0 C
product equipment is in good
condition without any negative
influence on packaging material
safety.
4.17.5 The company shall ensure that in the C 1.1.1–3 4 – What happens in case of equipment When equipment
event of changes to processing failures? stops lead to a
methods and equipment, process <equipment stops> product safety issue
characteristics are reviewed in order and these are not
to assure that product requirements segregated.
International Featured Standards · IFS PACsecure · Version 1

are complied with.

© IFS, October 2012

4.18 Traceability (including GMOs and 7.0 F 1
allergens)
 4.18.1 KO N° 6: A traceability system shall 7.0 F1 – How is traceability ensured? When no traceability
KO be in place which enables the F 1.2.1–2 1, 2, 3, 4, 5, 6, 7, 8 <traceability procedures> system exists and the
identification of product lots and What products come from which supplier? system does not
their relation to batches of raw – Is there a list available with all current include raw and
materials and wrapping materials suppliers? wrapping materials.

© IFS, October 2012

intended or expected to be in direct <supplier list> When traceability is
contact with produced products. The not complete up to
traceability system shall incorporate the supplier.
all relevant receiving, converting and
distribution records. Traceability
shall be ensured and documented
until delivery to the customer.
4.18.2 Downstream traceability records F 1.2.1–2 2, 3
(from production sites to the custom-
ers) shall be available. The time-
frame for producing these records
for review shall be compliant with
customer’s requirements.
4.18.3 Traceability shall be in place to iden- F 1.2.1–2 2, 3
tify the relationship between batches
of final products and their labels.
4.18.4 The traceability system shall be F 1.1.1–2 10 – When was the last traceability test in both When traceability
tested on a periodic basis - at least directions done? system is not tested in
annually and each time traceability <traceability test results> both directions so that
system changes. The test shall verify – What percentage of total amount was no assurance is given
upstream and downstream traceabil- traced? as to its effectiveness.
ity (from delivered products to raw – How big is a lot? When test results are
International Featured Standards · IFS PACsecure · Version 1

materials, and vice versa), including negative and no

quantity checking. Test results shall corrective actions are
be recorded. taken.
4.18.5 Traceability shall be ensured at all F 1.2.1–2 4,5 – Can rework be completely traced? When rework trace-
stages, including work in progress, <results from rework traceability test> ability is not ensured.
post treatment and rework. – How is rework documented/
4.18.6 Labeling of semi-finished or finished F 1.2.1–2 4,5 – When is lot labeling done? When lot labeling is
product lots shall be made at the time – What is the lot labeling code? done at a step where
when the goods are directly packed/ <lot labeling example> mix ups occur which
wrapped to ensure a clear traceability – When are labels applied to product units? unable correct
Part 2

of goods. Where goods are labeled at – How is recommended converting time traceability.
a later time, the temporarily stored calculated?
95

goods shall have been provided with a <converting time example>

specific lot labeling. The recom-
mended converting time of the labeled
goods shall be calculated from the
original production batch.
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96

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
4.18.7 If required by customer, identified F 1.2.1–2 7 – Is a sample bank implemented?
samples representative for the manu-
facturing lot shall be stored appropri-
ately and kept until expiration of the
recommended converting time of the
finished product and if necessary for
a determined period beyond this date.
4.19 Allergens and specific conditions of
production
4.19.1 When specified by the customer, the B 2.2.1–4 15 – Are allergens identified in specifications? Allergens are not
company shall maintain a continu- – Does a list exist that covers allergens in identified and a
ously up to date listing of all raw use? customer safety issue
materials containing allergens used <allergen list> ensues.
at its premises (e.g. starch as a glue),
which also identifies all blends and
formulas/configurations to which
such raw materials containing
allergens are added.
4.19.2 The manufacturing of products – Is a procedure in place to avoid contami-
which contain allergens requiring nation of allergen free products?
declaration shall be carried out as to – How often is effectiveness of these
ensure cross contamination is procedures reviewed?
minimized as far as possible. – Where are these proofs documented?
<examples>
4.19.3 Where customers specifically require – Has allergen status been documented in Allergens are not
that products are “free from” certain specifications? declared and a safety
substances or ingredients (e.g. <finished product specifications> risk for the consumer
starch), or that certain methods of occurs.
treatment or production are
excluded, verifiable procedures shall
be in place.
5 Measurements, Analysis,
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Improvements

© IFS, October 2012

5.1 Internal audits
 5.1.1 KO N° 7: Effective internal audits – Does an up to date internal audit plan No internal audits are
KO shall be conducted according to a exist? performed.
defined agreed audit program and <audit plan>
shall cover at least all requirements – Is audit plan based on hazard analysis?
of the IFS PACsecure Standard. <hazard analysis>

© IFS, October 2012

Scope and frequency of internal
audits shall be determined by hazard
analysis and assessment of associ-
ated risks. This is also applicable for
off site storage locations owned or
rented by the company.
5.1.2 Internal audits of activities which are – How often are internal audits performed?
critical to packaging material safety <audit plan>
and product specifications or other – The following issues can be taken into
legally required documentations consideration for internal audits:
shall be carried out at least once a · all production steps (packaging area,
year. labeling, GMP’s, GHP’s, CP’s)
· traceability,
· control plan (analysis, calibration)
· documentation management (updates)
· management of non-conformities
(complaints, internal non-conformities,
withdrawal, recall)
5.1.3 The auditors shall be competent and – Who are the auditors? <auditors list>
independent from the audited – How are auditors qualified for this job?
department. <continued education evidence>
– Have auditors any connection with audit
International Featured Standards · IFS PACsecure · Version 1

area?
5.1.4 Audit results shall be communicated – How are audit results communicated to No documented audit
to the senior management and to the persons in charge? results.
responsible persons of concerned <audit report distribution>
department. Necessary corrective – Is the communication immediate and in
actions and a schedule for imple- time to take measures?
mentation shall be determined and – Are corrective actions documented?
documented and communicated to <audit report>
every relevant person. – Is a time schedule in place for corrective
actions? <audit report>
– From which audits were corrective actions
Part 2

derived?
<audit report containing corrective actions>
97

– How are audit results forwarded to senior

management?
<audit report distribution>
– How are audit results evaluated?
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98

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
Part 2

ment
number
5.1.5 It shall be documented how and – How corrective action verification No corrective actions
when the corrective actions resulting regulated? taken although
from the internal audits shall be <verification evidence> necessary.
verified. – Who verifies and when?
5.2 Site factory inspections
5.2.1 Factory inspections shall be planned 7.0 A 1 – How often and who performs site No site inspections
and carried out (e.g. product control, A 3.1.2 9 inspections? are performed.
hygiene, foreign material hazards, <site inspections protocol>
personnel hygiene and housekeep- – What is reviewed during site inspections?
ing). The frequency of inspections in – For which areas do site inspections exist?
every area (including outdoor areas)
and every single activity shall be
based on hazard analysis and assess-
ment of associated risks and on the
history of previous experience.
5.3 Process validation and control
5.3.1 The criteria for process validation 6.5 A mechanism of
and control shall be clearly defined. change control will be
established to ensure
changes to the packag-
ing material safety
system are communi-
cated and imple-
mented.
5.3.2 In circumstances where the control – How are temperatures monitored? In case a legality
of process and working environment – Where are temperatures recorded? issue occurs due to
parameters (temperature, time, <printed measurement data> missing records.
pressure, chemical properties etc.) is 4.12.4.
essential to ensure the product
requirements, such parameters shall
be monitored and recorded continu-
ously and/or at appropriate intervals.
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© IFS, October 2012

 5.3.3 All rework operations shall be – How is it assured that reworks comply to
validated, monitored and docu- specifications or other legally required
mented. These operations shall not documentations?
affect the product requirements. – Where is rework documented?
<model documentation for rework>

© IFS, October 2012

– Who reviews rework results?
– Who decides rework liberation?
– How is it ensured that rework fulfils
legally requirements?
5.3.4 There shall be appropriate proce- – What happens when a failure occurs? In case failures are
dures for prompt notification, record- – What happens when cold chain is not noticed and result
ing and monitoring of equipment interrupted? in a safety or legal
malfunction and process deviations. <machinery stand still protocol> problem.
5.3.5 Process validation shall be per- 6.4 Prerequisite program
formed using the collected data that validation will be
is relevant for product safety and the planned and imple-
processes. If substantial modifica- mented.
tions occur, a revalidation shall be
carried out.
5.4 Calibration, adjustment and check-
ing of measuring and monitoring
devices
5.4.1 The company shall identify the C 1.2.1–2 1–13 – What kinds of monitoring devices exist? The company has no
measuring and monitoring devices <monitoring devices list> measuring and
required to ensure compliance with – What is demanded of monitoring devices? monitoring devices.
product requirements. These devices – What monitoring device is adequate for
International Featured Standards · IFS PACsecure · Version 1

shall be recorded on a document and which kind of measurement?

clearly identified. – How are monitoring devices identified?
<identification stickers on monitoring
devices>
– Do calibrated devices exist?
<monitoring devices list>
5.4.2 All measuring devices shall be C 1.2.1–2 1–13 – How is measuring devices check organ- No calibration is
checked, adjusted and calibrated, ized? <calibration procedures> performed.
under a monitoring system, at – Are measuring devices regularly cali-
specified intervals and in accordance brated? <calibration protocol>
with defined recognized stand- – Who is responsible for calibration?
Part 2

ard/methods. The results of the – How is calibration done? Where is it

checks, adjustments and calibrations documented? <calibration records>
99

shall be documented. Where neces- – What corrective actions are taken when a
sary, corrective actions on devices tolerance deviation is found?
and, if necessary, on process and <corrective actions> <calibration protocol>
products shall be carried out. – Is calibration up to date?
<calibration certificate>
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100

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
ment
Part 2

number
5.4.3 All measuring devices shall be used C 1.2.1–2 1–13 – What actions are taken when measure- When defective
exclusively for their defined purpose. ment results are uncertain? measuring devices
Where the results of measurements – How are embargoed measuring devices are not exchanged
indicate a malfunction, the device in identified? and a safety issue
question shall be immediately <identification stickers> ensues. (e.g. defec-
repaired or replaced. tive migration
measurement device
e.g. gas chromato-
graph for migration
tests).
5.4.4 The calibration status of the measur- C 1.2.1–2 1–13 – How is calibration status of measuring
ing devices shall be clearly identified device identified?
(labeled at the machine or on a list of <measuring devices list>
test devices).
5.5 Control of quantity/filling quantity
5.5.1 The frequency and methodology of – How is it ensured that legal requirements Legal requirements
control of quantity shall be deter- for amount control are met? are not met due to
mined so that the legally require- lack of or insufficient
ments and customer specifications amount measure-
or other legally required documenta- ments being made.
tion, or if appropriate, guidelines for
nominal quantity are met.
5.5.2 A procedure shall exist to define
criteria for compliance checking. This
procedure shall also, among others,
take into consideration the tare, the
density and other critical attributes.
5.5.3 Checks shall be implemented and
recorded, according to a sampling
plan which ensures a proper repre-
sentation of the manufacturing lot.
5.5.4 Results of these checks shall be
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compliant with defined criteria for all

© IFS, October 2012

products ready to be delivered.
 5.5.5 For purchased, already pre-packed – How is it ensured that purchased, No evidence exists
products from third parties, there pre-packed products from third parties that purchased
shall be evidence about the compli- contain the correct product amount products comply with
ance with the legal requirements. (applicable for retail branded products legal requirements.
and other labels)?

© IFS, October 2012

<inspection plan> <dealer evidence>
5.5.6 If applicable, all equipment used for – Are measuring devices in use regularly
final checking shall be approved. calibrated?
– Where is calibration recorded?
<calibration protocol>
– Are there calibrated measuring devices ?
<calibration certificate>
5.6 Product analysis
5.6.1 There shall be procedures ensuring – Which chemical, physical or microbio- No results of analy-
that all specified product require- logical analyses are made or subcon- ses are available.
ments are met, including legal tracted?
requirements and specifications. <analysis results>
Chemical, physical and microbiologi-
cal analysis required for that purpose
shall be performed internally and/or
subcontracted.
5.6.2 Analyses, which are relevant for – Is there an analytical laboratory on site?
packaging material safety, shall Is it accredited under ISO 17025?
preferably be performed by laborato- <accreditation evidence>
ries having appropriate accredited – Are internal lab results verified by an
programs/methods (ISO 17025). If accredited lab?
International Featured Standards · IFS PACsecure · Version 1

the analyses are performed by a – Which external laboratories are used?

factory internal or a laboratory not Are these accredited under ISO 17025?
having appropriate accredited <accreditation evidence>
programs/methods, the results shall
be verified on a regular basis by
laboratories accredited on these
programs/methods (ISO 17025).
5.6.3 Procedures shall exist which ensure – How is it ensured that internal analytical
the reliability of the internal analysis methods are appropriate?
results on the basis of official – Are ring tests performed?
recognized analysis methods. This <ring test performance evidence>
Part 2

shall be demonstrated by ring tests

or other proficiency tests.
101
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102

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
ment
Part 2

number
5.6.4 A test plan shall be drawn up for – Does an inspection plan exist? No inspection plan
internal and external analysis, based <inspection plan> exists.
on hazard analysis and assessment – Who organizes inspection plan?
of associated risks, which covers raw Which products are encompassed by
materials, semi-processed and inspection plan? (raw materials, half-
finished products as well as process- finished and finished products, wrapping
ing equipments and packaging materials, environmental tests?)
materials, and where necessary <inspection plan>
environmental tests. The test results – Is inspection plan based on hazard
shall be documented. analysis?
<hazard analysis>
– Where are test results documented?
<test results>
5.6.5 Results of analysis shall be evaluated – Who reviews analytical results? When test results
promptly. Appropriate corrective – How are analytical results verified? exist that do not
measures shall be introduced for any – Are trends investigated? comply with legal
unsatisfactory results. The analytical – Are corrective actions introduced when requirements and no
results shall be reviewed regularly in results are unsatisfactory? corrective actions
order to identify trends. Trends indi- <corrective actions> were taken.
cating potential unsatisfactory results
shall be taken into consideration.
5.6.6 Where internal analysis is under- – Which tests are performed internally?
taken, qualified and trained person- – What qualifications do lab technicians have?
nel shall be in place, as well as <qualification evidence>
appropriate equipment and prem- – Is an internal lab available?
ises. – How is product contamination by internal
lab prevented?
5.6.7 For verification of finished product – When and how are organoleptic tests
quality, internal organoleptic tests performed?
shall be carried out regularly when <inspection plan>
specified by the customer. These <documentation of organoleptic test
tests shall be in accordance with results>
specifications or other legally requir-
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ed documentation and related to the

impact on respective parameters of

© IFS, October 2012

product characteristic. The results of
these tests shall be documented.
 5.6.8 Based on any internal or external For example, if an alert system informs that
information on product risks which a raw material sourced from a specific
may have an impact on packaging country regularly has specific rate of
material safety, the company shall dangerous substance, and if the company
update its control plan and/or take is used to buying this specific raw material,

© IFS, October 2012

any appropriate measure to control the company shall increase the frequency
impact on finished products. of analysis of this raw material, to improve
monitoring.
On the other hand, if results of analysis
always show good results, and if the raw
material is considered as a low risk one, the
company can decide to decrease the
frequency of analysis.
5.7 Product quarantine (blocking/hold)
and product release
5.7.1 A procedure shall be in place, based 7.0 B 2 In response to devia- – Who quarantines or releases products? When no procedures
on hazard analysis and assessment 6.3 tions from the prerequi- <job description> exist for product
of associated risks, for the quaran- site programs correc- – How are quarantined products identified? quarantine or release.
tine (blocking/hold) and release of all tive actions will be When quarantined
raw materials, semi-processed and determined. products go
finished products and wrapping Corrective actions may unchecked into
materials. The procedure shall include, but are not further use and a
ensure that only products and limited to: safety issue occurs.
materials conforming to product – Product hold, assess-
requirements are converted and ment and disposition.
dispatched. – Ensuring the correc-
tive action is com-
International Featured Standards · IFS PACsecure · Version 1

pleted.
– Root cause identifica-
tion.
– Preventive actions.
5.8 Management of complaints from
authorities and customers
5.8.1 A system shall be in place for the – How are complaints handled? If there is no proce-
management of product complaints. <complaint handling procedure> dure for complaint
handling.
5.8.2 All complaints shall be assessed by – Who ponders about complaint signifi-
Part 2

competent staff. Where it is justified cance?

appropriate actions shall be taken – Who defines the actions to be taken?
103

immediately, if necessary. – Within what time frame must actions be

taken?
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104

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
ment
Part 2

number
5.8.3 Complaints shall be analyzed with a – Who manages complaint statistics? No corrective actions
view to implementing preventive <complaint statistics> were taken although
actions which avoid the recurrence – How often are complaint statistics a failure comes up
of the non-conformity. compiled? more frequently or is
– What actions are taken to avoid recur- considered as
rence? serious.

5.8.4 The results of complaint data – To whom are complaint statistics data
analysis shall be made available to presented?
the relevant responsible persons and <retailer complaint statistics data>
to the senior management.

5.9 Management of incidents, product

withdrawal, product recall

5.9.1 A documented procedure shall be 7.0 F 1 – Who belongs to incident management If there is no incident
defined for management of incidents F 1.1.1–2 1–10 staff? management system
and of potential emergency situa- <phone list> implemented.
tions that impact packaging material – Who is informed when an incident
safety, legality and quality. This occurs?
procedure shall be implemented and – How are incidents managed?
maintained. This includes as a <crisis management procedures>
minimum: the nomination and – What is an incident?
training of a crisis team, an alert <incident management procedures>
contact list, sources of legal advice – communication plan: definition of the
(if necessary), contacts availability, internal and external communication
customer information, and a com- (in the case of incidents, product with-
munication plan, including informa- drawal, product recall),
tion to consumers. Who is allowed to report what to whom?

5.9.2 KO N° 8: There shall be an effective 7.0 F 1 – How much is distribution involved with If there is no proce-
procedure for the withdrawal/recall F 1.1.1–2 1–10 incident management? dure for recall/with-
of all products, which ensures that – When and who informs customer? drawal in place.
involved customers are informed, as <alarm plan>
soon as possible. This procedure <phone list>
shall include a clear assignment of A withdrawal/recall management proce-
International Featured Standards · IFS PACsecure · Version 1

responsibilities. dure is not enough to define an incident

management procedure.

© IFS, October 2012

 5.9.3 Updated emergency contact details F 1.1.1–2 5 – What kind of incident management is No incident manage-
(such as names and phone numbers implemented? ment is available in
of suppliers, customers and compe- – Who is responsible for communication with the company.
tent authorities) shall be available. customers, press/media and authorities?
A person of the company, who has – Is a list of important telephone numbers

© IFS, October 2012

the authority to initiate the incident available? <phone list>, <emergency plan>
management process, shall be – Who is informed when a crisis occurs?
permanently available. <alarm plan> <phone list>
– When are media involved?
<incident management procedures>
5.9.4 The feasibility, effectiveness and F 1.1.1–2 10 – How is effectiveness of withdrawal When withdrawal
timeliness of implementation of the tested? procedures are not
withdrawal procedure shall be – How often is effectiveness of withdrawal tested or when test
subject to regular internal testing, tested? results have shown
based on hazard analysis and assess- <withdrawal test results> that the procedures
ment of associated risks but carried are ineffective but no
out at least once a year. This shall be corrective actions
carried out in a manner to ensure the were implemented.
effective implementation and
operation of the procedure.
5.10 Management of non-conformities
and non conforming products
5.10.1 A procedure shall exist for the B 2.3.1–2 8 – What procedures exist for non-conform- When no procedures
management of all non-conforming ing products management? exist for non-con-
raw materials, semi-finished and – How are non-conforming products forming products
finished products, converting equip- identified? management.
ment and wrapping materials. This – What rules exist for product quarantine
International Featured Standards · IFS PACsecure · Version 1

shall include, as a minimum: procedures?

– isolation/quarantine procedures <quarantine tickets>
– hazard analysis and assessment of
associated risks
– identification (e.g. labeling)
– decision about the further use (e.g.
release, rework/post treatment, block-
ing, quarantine, rejection/disposal).
5.10.2 The responsibilities for the manage- – Who is responsible for putting non-con- When employees do
ment of non-conforming products forming products into quarantine? not know who is
Part 2

shall be clearly identified. The <quarantine tickets> authorized to release

procedure for the management of – Who may release quarantined products? quarantined products
non-conforming products shall be <quarantine tickets> or when the products
105

understood by all relevant employ- – How is it ensured that only authorized are in conditions to
ees. persons release quarantined products? be released or when
<quarantine tickets> products are quaran-
tined and a safety
issue occurs.
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106

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
ment
Part 2

number
5.10.3 Where non-conformities are present, B 2.3.1–2 8, 9, 10 – What procedures are implemented with
immediate corrections shall be taken non-conforming products?
to ensure that product requirements <quarantine tickets>
are complied with. – Who decides about non-conforming
products?
<quarantine tickets>
5.10.4 Out of specification finished goods B 2.3.1–2 11, 12 For example, evidences can be provided to
or finished goods that do not meet show that products have not been placed
other legal requirements are not on the market (e.g. contracts with external
allowed to be put on the market. The waste destroying service providers).
material has to be destroyed appro- Exceptions can be checked with examples
priately. Exceptions shall be agreed (situations which already occurred), by
in writing with the contract partners. checking the content of the contract.
5.11 Corrective actions – In case of a renewal audit: were the
corrective actions of the previous IFS
audit applied?
5.11.1 A procedure shall be in place for the – What are corrective actions procedures? No corrective actions
recording and analysis of the <corrective actions procedures> procedures exist.
non-conformities with the objective
to avoid recurrences by preventive
actions and/or corrective actions.
5.11.2 KO N° 9: Corrective actions shall be 6, 3 In response to devia- – Which corrective actions were imple- No corrective actions
KO clearly formulated, documented and tions from the prerequi- mented? are taken.
undertaken, as soon as possible to site programs correc- <model corrective action procedures> Corrective actions are
avoid further occurrence of non- tive actions will be – Where are corrective actions docu- not implemented
conformity. The responsibilities and determined. mented? within a short time
the timescales for corrective action Corrective actions may <model corrective action procedures > span.
shall be clearly defined. The docu- include, but are not – Who is responsible for corrective actions? Corrective actions are
mentation shall be securely stored, limited to: <model corrective action procedures > not documented
and easily accessible. – Product hold, assess- – How long may it take to implement No responsibilities
ment and disposition. corrective actions? are assigned to
– Ensuring the correc- <model corrective action procedures > implement corrective
tive action is com- actions.
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pleted.

© IFS, October 2012

– Root cause identifica-
tion.
– Preventive actions.
 5.11.3 The performance of the implemented – Where are corrective actions documented? Corrective actions are
corrective actions shall be docu- <model corrective action procedures> not documented
mented and the effectiveness shall – How are corrective actions verified? and/r verified.
be checked. <model with verified corrective action
procedures>

© IFS, October 2012

6 Packaging material defense/Food
defense and external inspections
6.1 Defense assessment
6.1.1 Responsibilities for packaging – Who has the accountability for the
material defense shall be clearly packaging material defense program?
defined. Those responsible shall be – What are the competence and qualifica-
key staff or shall have access to the tions demonstrated for the person(s)
top management team. Sufficient responsible for the packaging material
knowledge in this area shall be defense program?
demonstrated. – What is the position of the person(s)
responsible for the packaging material
defense program with respect to the
management team?
– How do management teams support the
person(s) responsible for the packaging
material defense program?
– Where are the responsibilities clearly
defined?
– Was this communicated to the members
of the company? How?
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secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
ment
Part 2

number
6.1.2 A packaging material defense hazard – What are the legal/customer packaging
analysis and assessment of associ- material defense requirements applicable
ated risks shall have been performed to the company?
and documented. Based on this – How can the company demonstrate
assessment, and based on the legal compliance with such requirements?
requirements, areas critical to – What is the process/procedure used to
security shall be identified. perform the hazard analyisis and assess-
Packaging material defense hazard ment of associated risks?
analysis and assessment of associ- – Is the hazard analysis in line with legal
ated risks shall be conducted and/or customer needs and/or expecta-
annually or upon changes that affect tions?
packaging material integrity. – How do the systems assist the company
An appropriate alert system shall be to identify critical or high risk areas?
defined and periodically tested for – How often is a review of the packaging
effectiveness. material defense program performed?
– What criteria does the company consider
in order to determine the frequency to
perform the hazard analysis, if is not
done annually?
– How is the company alerted of any
packaging material defense breach?
– How does the company evaluate the
effectiveness of the packaging material
defense program?
6.1.3 If legislation makes registration or – What are the legal/customer packaging
on-site inspections necessary, material defense requirements applicable
evidence shall be provided. to the company?
– Based on legal requirements in the
country where the plant is located or by
the country where the product is con-
sumed, is it required to apply for formal
registration?
– If registration is required, who has this
information? Could the company demon-
strate compliance?
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– Is there any requirement for periodic

© IFS, October 2012

inspection? If yes, then:
– Who performs it?
– Against what standard?
 – When was the last inspection?
– What was the result of the inspection?
– Is it required to provide evidence that
deviations have been solved? (corrective
actions)

© IFS, October 2012

– What are the implications if a major
breach is identified?
6.2 Site Security
6.2.1 Based on a hazard analysis and – Based on the hazard analysis and assess- Unauthorized per-
assessment of associated risks, ment of associated risks, what areas have sons freely enter
identified areas critical to security been identified as critical? production or storage
shall be adequately protected to – What control measures are in place in areas so that a safety
prevent unauthorized access. order to control the entrance to those risk occurs.
Access points shall be controlled. areas?
– How does the company maintain control
over who enters to the premises and
critical areas?
– What are the access controls applicable
to the following people?
– Temporary employees
– Contractors
– Visitors
– Employees
– Carrier drivers
6.2.2 Procedures shall be in place to – Does the company define procedures to
prevent tampering and/or allow identify tampering of raw materials,
identification of signs of tampering. Works in Process (WIP) and final goods?
International Featured Standards · IFS PACsecure · Version 1

– Are there means to verify if products

have been tampered?
– Are employees trained in the identifica-
tion of tampered products?
– Does the design of packaging material
include the identification of tamper
evident measures? Is it required by law in
the country of origin or destination?
– Are there tests to verify that measures
against tampering are properly applied
and working properly?
Part 2

6.3 Personnel & Visitor Security

109
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110

secure tion with connected PACsecure What should be asked? KO/Major

number PACsecure PP (Prerequisite
PP require- Program) requirement
ment
Part 2

number
6.3.1 Visitor policy shall contain aspects of – Do visitor/contractor access policies in-
packaging material defense plan. clude controls to avoid that no members
Delivery and loading staff in contact of the company are able to move freely
with the product shall be identified without escorts inside the premises?
and shall respect the access rules of – Are visitors and contractors informed of
the company. Visitors and external the packaging material defense rules and
service providers shall be identified their scope while inside company prem-
in areas with product storage and ises?
shall be registered at the time of – Does the company have defined means to
access. They should be informed ensure that contractors who will spend a
about the site policies and their long time inside the plants are properly
access controlled accordingly. identified, supervised and escorted inside
critical areas?
– Are there controls to ensure that the
access for truck drivers who load or
unload products/materials is restricted to
defined areas inside and outside the build-
ing and company premises? Are there
means to watch the movements of
non-employees once they enter company
premises? (E.g. cameras or guards at
defined areas? Other procedures?)
– If contractors and visitors are provided
with access keys, are those keys pro-
grammed to limit the access to specified
and selected areas?
– If escorts are required to guide visitors and
contractors at all times, are there arrange-
ments to have defined guides at all shifts?
– Are security/guards aware of how to deal
in cases where there are no escorts
available at any particular moment?
6.3.2 All employees shall be trained in – Does the annual training program include
packaging material defense on an packaging material defense?
annual basis or when significant – How is packaging material defense and
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program changes occur. The training associated controls explained to new

© IFS, October 2012

sessions shall be documented. employees?
Employee hiring and employment – Are there records that demonstrate that
termination practices shall consider employees received packaging material
security aspects as permitted by law. defense training?
 – Is training updated according to changes
in the packaging material defense
program?
– How are employees informed of major
changes in the packaging material

© IFS, October 2012

defense program?
– Does the system evaluate training
effectiveness?
– Does training include controls of knowl-
edge acquired from the last version of the
packaging material defense training?
– What controls are implemented at the
time of hire/termination of an employee
or creation/termination of a service by a
contractor?
– Are access controls updated at the time
of termination of an employee or when
the work is finished on the part of a
contractor?
6.4 External Inspections
6.4.1 A documented procedure shall exist – Is there a documented procedure that
for managing external inspections defines the criteria to follow in case an
and regulatory visits (if applicable). external organization requires access to
Relevant personnel shall be trained the company’s premises?
to execute the procedure. – Are there clearly defined levels of
authority to provide access to external
organizations at all times?
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– Does the procedure define the means to

proceed if or when a regulatory body
requests access to the premises?
– Are relevant functions aware of their
responsibilities under such conditions?
– Are levels of authority defined with
respect to the kind of information that is
allowed to be provided?
– Are there means to ensure a complete
record of activities done and details of
the visit?
Part 2
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112 Part 2 International Featured Standards · IFS PACsecure · Version 1

ANNEX 1: GLOSSARY/DEFINITIONS LIST

Definitions which are not mentioned within the glossary can be found
in relevant regulations and directives. In relation to the terms used
within this document and PACsecure documents, the following defini-
tions apply and shall be respected.

Term Explanation
Additive Materials such as plasticizers, preservatives, slip agents, antistatic
agents, processing aids, and others, added to a base material in order to achieve a
specific result.
Adhesive An adhesive substance (as glue or cement, or starch in paper industry).
Allergen (EU) Food causing an adverse reaction that is mediated by an immunological response.
Defined allergens are:
– Cereals containing gluten (i.e. wheat, rye, barley, oats, spelt, kamut or their
hybridised strains) and products thereof
– Crustaceans and products thereof
– Eggs and products thereof
– Fish and products thereof
– Peanuts and products thereof
– Soybeans and products thereof
– Milk and products thereof (including lactose)
– Nuts i.e. Almond (Amygdalus communis L.), Hazelnut (Corylus avellana), Walnut
(Juglans regia), Cashew (Anacardium occidentale), Pecan nut (Carya illinoiesis
(Wangenh.) K. Koch), Brazil nut (Bertholletia excelsa), Pistachio nut (Pistacia vera),
Macadamia nut and Queensland nut (Macadamia ternifolia) and products thereof
– Celery and products thereof
– Lupin and products thereof
– Molluscs and products thereof
– Mustard and products thereof
– Sesame seeds and products thereof
– Sulphur dioxide and sulphites at concentrations of more than 10 mg/kg or
10 mg/litre expressed as SO2.
(Commission Directive 2007/68 EC of 27 November 2007 amending Annex III a to
Directive 2000/13/EC of the European Parliament and of the Council as regards
certain food ingredients.)
Allergen (US) There are 8 major allergens recognized in the United States according to the
2009 U.S. Food and Drug Administration (FDA) Model Food Code, Definitions
section, page 12.
(1) “Major food allergen“ means:
(a) Milk, egg, fish (such as bass, flounder, cod, and including crustacean shell-
fish such as crab, lobster, or shrimp), tree nuts (such as almonds, pecans, or
walnuts), wheat, peanuts, and soybeans
(b) A Food ingredient that contains protein derived from a food, as specified in
Subparagraph (1)(a) of this definition.
(2) “Major food allergen” does not include:
a) Any highly refined oil derived from a food specified in Subparagraph (1)(a) of
this definition and any ingredient derived from such highly refined oil; or
b) Any ingredient that is exempt under the petition or notification process
specified in the Food Allergen Labelling and Consumer Protection Act of
2004 (Public Law 108-282).
Aseptic technique Precautionary measures taken to prevent contamination.
Assessor (for Person assigned by an accreditation body to perform, alone or as part of an assess-
accreditation bodies) ment team, an assessment of a Conformity Assessment Body.
Audit Systematic, independent and documented process for obtaining audit evidence
and evaluating it objectively to determine the extent to which the audit criteria are
fulfiled.

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Auditor An individual who is qualified to provide audits, such as certified auditor.

Note: An employee who is qualified and independent of the audited function
typically conducts first-party/internal audit within the organization. A totally
independent certified auditor who is not involved in the customer-supplier relation-
ship conducts third-party audits.
Biological hazards Parasites, bacteria, moulds, or viruses that have the ability to cause illness or death.

Buyer/filler A company who buys packaging materials from packaging material manufacturer
and converter and fill the package with the product.
Calibration Set of operations that establish, under specified conditions, the relationship
between values of quantities indicated by a measuring instrument or measuring
system, or values represented by a material measure or a reference material and
the corresponding values realised by standards.
Carrier An operator of a conveyance such as a truck, railcar, vessel, or aircraft used to
transport goods.
CCP – Critical Control A step at which control can be applied and is essential to prevent or eliminate a
Point food safety hazard or reduce it to an acceptable level.

Chemical hazards Chemical products (e.g. agricultural chemicals, cleaning agents, food and packag-
ing additives, waxes and coatings, heavy metals, inks, solvents, etc.) that have the
potential to cause illness or death especially when used in excess of regulatory
limits.
Cleaning The removal of soil, residue, dirt, grease or other objectionable matter.

Company General organisation (whereas the site is a unit of the company).

Competent employee An employee who is familiar with and capable of assessing the operation of a piece
of equipment or process.
Contact surfaces Surfaces that contact packaging product. This also includes any surface that might
drip or drain onto a surface that contacts packaging product during the normal
course of operations. Contact surfaces include equipment such as containers, tables
and conveyor belts used in packaging operations. It does not include forklifts, hand
trucks, or pallets that are used for handling wrapped packaging products.
Contamination Introduction or occurrence of a contaminant in packaging material or environment.
Contamination does include: physical, chemical, biological contamination. Contami-
nation can also mean correlation of packages among themselves.
Control measure (Food safety) action or activity that can be used to prevent or eliminate a food
safety hazard or reduce it to an acceptable level. Acceptable levels may be derived
from; regulatory requirements; industry standards; scientific information; customer
requirements; risk assessments.
Converter A manufacturer that takes raw materials and converts them into a usable package
or package component.
Converting time The period in which a product may be processed/converted before being consid-
ered unsuitable for the purpose.
Corporate Company.

Correction Action to eliminate a detected non-conformity or deviation.

Corrective action Action to eliminate the cause of a detected non-conformity or other undesirable
situation.
CP – Control point Identified by the hazard analysis as essential in order to control the likelihood of
introducing or proliferation of food safety hazard in the product and/or the environ-
ment.
A CP can be considered as an OPRP (Operational Prerequisite Program), as defined
in ISO 22000.
Customer A customer is a business company or person to whom products are sold either as
finished product or as a semi-finished part of the finished product.

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Deviation Non-compliance with a requirement but there is no impact on food safety related to
products and processes. In the IFS, deviations are requirements scored with a B, C
or D and KO requirements scored with a B.
Establishment Any building or surrounding area in which packaging material and/or product is
handled manufactured, or converted, and is under the control of the same manage-
ment.
Extrusion The process of forming a thermoplastic film, container, or profile by forcing the
polymer melts through a shaped orifice. The extruded plastic is immediately chilled.
Facility Buildings and other physical structures used for or in connection with the manufac-
turing and converting of packaging material and product.
Factory inspection Factory inspection covers specific subjects and can be carried out by any appropri-
(versus Internal audits) ate person. That means regular visits in any areas, for any purposes, to check the
conformity (hygiene, pest control, product control, fabrication, foreign material
hazards, surrounding control etc.).
FIFO “First In—First Out”: an inventory system of product rotation, where the oldest
product is shipped first.
Flow diagram A systematic representation of the sequence of steps or operations used in the
production or manufacture of a particular packaging material item.
Food safety Assurance that food will not cause harm to the consumer when it is prepared
and/or eaten according to its intended use.
Formula Exhaustive description of quantity and quality of raw materials to be used to
process the products, as required in customer specifications.
Formula can also include technological parameters and specific “know-how” on the
process.
FSEP Food Safety Enhancement Program. The FSEP is the Canadian Food Inspection
Agency’s (CFIA) approach to encourage and support the development, implementa-
tion and maintenance of Hazard Analysis Critical Control Point (HACCP) systems in
all federally registered establishments of the meat, dairy, honey, maple syrup,
processed fruit and vegetable, shell egg, processed egg and poultry hatchery
sectors. Government and food industry developed FSEP jointly in 1991 in consulta-
tion with consumer groups.
(http://www.inspection.gc.ca/english/fssa/polstrat/haccp/haccpe.shtml)
Glue Any of various strong adhesive substances; especially: a hard protein chiefly
gelatinous substance that absorbs water to form a viscous solution with strong
adhesive.
GMO An organism, with the exception of human beings, in which the genetic material
has been modified otherwise than natural multiplication or natural recombination.
GMP – Good Manufac- The practices that prevent and minimize the biological, chemical and physical
turing Practices contamination of packaging material and product during receiving, manufacturing,
converting, storage and transportation, to ensure food safety.
GMP regulation EU: (EC) No 2023/2006 of 22 December 2006 on good manufacturing practices for
(EU/US) materials and articles intended to come into contact with food.
US: 21 CFR 174 - 21 CFR 190.
HACCP (risk assess- A system which identifies evaluates and controls hazards which are significant for
ment) packaging material safety.
Hazard A biological, chemical or physical agent in, or condition of, packaging material with
the potential to cause an adverse health effect.
Hazard analysis The process of collecting and evaluating information on hazards and conditions
leading to their presence to decide which are significant for packaging material
safety and therefore should be addressed in the HACCP plan.
Head office assessment Assessment of the Conformity Assessment Body Head Office.
(for accreditation
bodies)

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 International Featured Standards · IFS PACsecure · Version 1 Part 2 115

Hygiene Conditions and measures that are required to ensure that packaging material and
product is safe.
Inert Material without active chemical properties.

Integrity Program Program implemented by IFS in order to:

– Monitor, as preventive actions performance of auditors and certification bodies as
well as audited companies,
– Manage, as corrective actions, any complaints addressed to IFS.
Internal audit General process of audit, for all the activity of the company. Conducted by or on
behalf of the company for internal purposes.
Internal auditing is an independent, objective assurance and consulting activity
designed to add value and improve an organization‘s operations. It helps an
organization accomplish its objectives by bringing a systematic, disciplined
approach to evaluate and improve the effectiveness of risk management, control,
and governance processes.
Lamination A process of plying layers of stock to a given thickness.

Lot The packaging product manufactured during a period of time or according to a

specific code.
Leak test A testing process designed to find unintended holes or voids that allow air or fluid
to pass through packaging materials. For labeled products, leak test is conducted
prior to labeling in order to avoid concealing any leaks.
Microorganisms Organisms too small to be seen by the naked eye that include yeasts, moulds,
bacteria, and viruses.
Monitoring The act of conducting a planned sequence of observations or measurements of
control parameters to assess whether a CP is under control.
See also Codex Alimentarius, General principles of Food hygiene, Guidelines for
the application of the HACCP system, section 9.
MSDS – Material Safety The safety data sheet information is principally intended for use by professional
Data Sheet users and must enable them to take the necessary measures as regards the protec-
tion of health, safety and the environment at the place of work. The safety data
sheet may be supplied on paper or electronically, provided that the addressee has
the necessary means of receiving it.
Non-conformity Non-fulfilment of a specified requirement. Non-conformity can be given in non-
respect of legislation, law, packaging material safety, internal dysfunctions and
customer issues. In the IFS, defined non-conformities are Majors and KO’s scored
with a D.
Packaging material Food Defense is the collective term used by the US Food and Drug Administration
defense/Food defense (FDA), United States Department of Agriculture (USDA), Department of Homeland
(US) Security (DHS), etc. to encompass activities associated with protecting the nation’s
food supply from deliberate or intentional acts of contamination or tampering. This
term encompasses other similar verbiage (i.e., bioterrorism (BT), counter-terrorism
(CT), etc.),
The USDA Food Safety and Inspection Service define Food Defense as “the protec-
tion of food products from intentional adulteration by biological, chemical, physical
or radiological agents.”
The definition also applies on packaging materials.
Pest Any animal or insect such as birds, rodents, cockroaches, flies, and larvae that may
carry pathogens and can contaminate packaging material and product.
Physical hazards Physical components (e.g. wood or glass chip, metal piece, etc.) and foreign matter
that can cause illness or injury. This includes pests and their components.
Potable air Air containing less than 1,000 viable colony-forming units of total micro-organisms
per cubic meter of air. Air containing less than 200 viable colony-forming units of
bacteria and 200 viable colony-forming units of fungi in a cubic meter of air. Users
should check with authority having local jurisdiction for limits pertaining to chemi-
cal and other contaminants.

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Potable water (CA) Water that meets Health Canada’s Canadian Drinking Water Guidelines.
(http://www.hc-sc.gc.ca/ewh-semt/pubs/water-eau/doc_sup-appui/index_e.html)
Potable water Water suitable for human consumption without endangering health. It is immacu-
late concerning smell, taste and nature.
Primary packaging Packaging coming into contact with the packed goods such as PET bottles, cups,
plastic closures of packages.
Procedure Specified way to carry out an activity or process. Procedures shall be implemented
and the elaboration of procedures shall be done by documents or process descrip-
tion (e.g. flowchart).
Product Result of a process or activities transforming inputs into outputs. Products include
services. In the context of this Standard a product is to be considered a packaging
material.
Product development The creation of products with new or different characteristics that offer new or
additional benefits to the customer. Product development may involve modification
of an existing product or its presentation, or formulation of an entirely new product
that satisfies a newly defined customer who wants a market niche. In the IFS
PACsecure Standard, the requirements for chapter product development apply even
if there is just a product modification, use of new wrapping materials or modifica-
tions of production processes.
Product recall Any measure aimed at achieving the return of a dangerous product that has already
been supplied or made available to consumers by the producer or distributor.
Product requirements Product requirements includes: product safety, product quality, product legality,
process and specification.
Product withdrawal Any measure aimed at preventing the distribution, display and offer of a product
dangerous to the consumer.
Qualified employee An employee who is qualified (such as certified auditor) and independent of the
audited function conducts first-party/internal audit within the organization.
Raw material One of the parts of a mixture
Raw material specifica- A document describing detailed product features, attributes and processing factors
tion (RMS) that enable the user or the document (i.e. supplier) to produce or supply material
that will fulfil its intended use.
Reviewer Person of the certification body in charge of assessing the IFS PACsecure audits
reports before a certification decision is made.
The tasks of the reviewer are, at least:
– To check the overall consistency of the audit reports.
– To check if the audit reports are properly completed
– To check if the findings are well described and if the justifications are relevant.
– To check if the corrective actions proposed by the audited company have been
validated by the auditor (or by a representative of the certification body) and are
relevant.
The review shall be documented.
Risk A function of the probability of an adverse health effect and the severity of that
effect consequential to (a) hazard(s) in packaging material.
Secondary packaging Packaging, e.g. films that have no contact with the food.
Senior management Executive management.
Services See definition of product.
Site A unit of the company.
Supplier Quality A program designed to ensure raw materials/other material suppliers are in
Assurance (SQA) compliance with product specifications and safety or quality requirements. The
Program program often includes elements such as a supplier selection and approval process;
supplier auditing and product testing.

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System Set of interrelated or interacting elements. System is a planned, sustainable

structured course of action. Depending on the complexity, documentation is
recommended. System includes: documentation, procedure description, con-
trol/monitoring, corrective action, site plan.
Tertiary packaging Packaging/wrapping that is used to group secondary packaging together to aid
handling and transportation and prevent damage to the products, for example, the
pallet and shrink wrap used to transport a number of cardboard outer containing
boxes filled with packaging material.
Traceability Ability to trace and follow a material intended to be, or expected to be incorporated
into a packaging material, through all stages of production, converting and distribu-
tion.
Validation Confirmation through the provision of objective evidences that the requirements for
the specific intended use or application have been fulfiled.
Verification Confirmation through the provision of objective evidences that specified require-
ments have been fulfiled.
Witness assessment Assessment of the Conformity Assessment Body when it is carrying out conformity
(by accreditation assessment services within its scope of accreditation.
bodies)
Witness audit before The auditor who is witnessed shall be accompanied by an observer from the
applying to IFS exami- certification body during a complete audit in order to evaluate his/her competence.
nations The observer shall not be part of the audit (as a team member).
The observer shall fulfil the same requirements as for trainers or shall be an IFS
PACsecure auditor, IFS Food auditor or IFS HPC auditor.
This witness audit shall be a product safety audit and/or an audit under ISO/IEC
17065.
On the application file of the auditor (sent afterwards to the IFS offices), the certifi-
cation body shall specify the name of the company, audit date and name of the
person who observed the auditor. On request, the certification body shall be able to
provide minutes of the witness audit.
Witness audit, The auditor who is witnessed shall be accompanied by an observer from the
to be performed certification body during a complete IFS PACsecure, IFS Food, IFS HPC, or another
every 2 years, GFSI recognized packaging material safety scheme audit, in order to evaluate
for IFS PACsecure his/her competence. The observer shall not be part of the audit (as a team mem-
approved auditors ber).
The observer shall fulfil the same requirements as for trainers or shall be an IFS
PACsecure, IFS Food or IFS HPC auditor. For the observer, relevant product scope(s)
approval, in relation to the products/processes of the audit, is not mandatory.
The certification body shall specify the name of the observer in the participants’ list
of the IFS PACsecure audit report and shall be able to provide, on request, minutes
of this witness audit.
Wrapping See tertiary packaging.

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 International Featured Standards · IFS PACsecure · Version 1 Part 3 119

Part 3: Requirements for Accreditation

Bodies, Certification Bodies and
Auditors
IFS accreditation and certification
process

0 Introduction
IFS PACsecure certification is a product and process certification. All
bodies involved shall comply with the international rules and IFS-spe-
cific requirements described in this document. Part 3 of the IFS PACse-
cure Standard deals mainly with accreditation bodies, certification bod-
ies and auditors.

1 Requirements for the Accreditation Bodies

1.1 General requirements

The accreditation bodies shall fulfil the requirements of the ISO/IEC

17011 norm “Conformity assessment – General requirements for Accre-
ditation Bodies accrediting conformity assessment bodies”, and shall
have signed the MLA (Multilateral Agreement) for Product Certification
of the EA or IAF.
As soon as it will come into force, the accreditation bodies shall also
fulfil the GFSI Requirements for the Application of ISO/IEC 17011:2004,
which is complementary of the below requirements.
In order to ensure interactive communication, the accreditation body
shall appoint an IFS contact person within their organisation.

1.2 The training of the accreditation committee

(or competent person)
In general, all accreditation body personnel engaged in IFS PACsecure
accreditation activity shall have sufficient knowledge of the IFS PACse-
cure scheme, related normative documents and food or packaging
industry.

Decisions on accreditation can only be made following a recommenda-

tion of a competent person or accreditation committee. The person in
charge, or at least one member of the accreditation committee, shall

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have taken part in an IFS PACsecure training course organised by IFS or

shall be able to demonstrate equivalent knowledge level as confirmed
by IFS. In case of a committee, the trained person provides the other
members of the accreditation committee with the necessary informa-
tion. This information is based on the main points of the IFS PACsecure
training course with the main emphasis on Part 1 (IFS PACsecure audit
protocol), Part 3 (requirements for accreditation bodies, certification
bodies and auditors), Part 4 (audit report, certificate) and the auditors’
approval process for IFS.

1.3 Competences of the assessor of the accreditation

body
The assessor(s) of the accreditation bodies is responsible for the follow-
ing:
– accompanying IFS PACsecure auditors during registered IFS
PACsecure audits (witness assessment),
– assessing the head office of the certification body (head office
assessment) according to the ISO/IEC 17065 rules and IFS-spe-
cific requirements.
In general, the assessor(s) shall meet ISO/IEC 17065 and IFS require-
ments.

Witness assessors shall, at a minimum:

– Have taken part in the IFS PACsecure training course, or shall
be able to demonstrate an equivalent knowledge level as con-
firmed by IFS,
– Have taken part in a HACCP course or other course related to
hazard analysis and assessment of associated risks,
– Have a minimum of two (2) years of experience in the packag-
ing material industry sector.

Head office assessors shall, at a minimum:

– Have specific knowledge in the IFS PACsecure scheme,
– Have specific knowledge of the related normative documents.

1.4 Frequency of the assessments of certification bodies

For initial assessment, a head office assessment (with review of at least

one full certification process) and at least one witness assessment shall
be performed.

The certification body is allowed to perform maximum 5 audits before

getting accreditation. In this case, at least one of the audits shall be

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assessed by the accreditation body (witness assessment) and all audits

(including at least one full certification process) shall be reviewed by the
accreditation body during the initial headquarter assessment.

For renewal assessment, a head office assessment (with review of at

least one full certification process) and at least one witness assessment
shall be performed.

During the surveillance of the accreditation cycle:

– A minimum of one head office assessment a year,
– A minimum of one witness assessment every two (2) years
shall take place.

Remark: a flexibility of three (3) months at the maximum can be allowed

for the interval between two (2) assessments, according to the accredi-
tation body rules.

During head office assessments, the following documentation shall be

sampled and assessed, as a minimum:
– At least 10 % or two (2) IFS PACsecure auditor files, whichever
is greater,
– At least two (2) site files or 2 % of delivered audits, whichever is
greater.
For consecutive witness assessments, the accreditation body shall,
wherever possible, select two different certification body’s IFS PACse-
cure auditors with different scopes.

1.5 Accreditation of an internationally-active

certification body
The witness assessments shall cover the typical activities (including
international activities and critical locations) of the certification body. If
the accreditation body subcontracts an assessment, the subcontracted
accreditation body shall be a signatory to the IAF MLA for Product Cer-
tification. IAF GD 3 Cross Frontier Policy shall apply.

1.6 Conditions for recovering accreditation after

withdrawal or suspension
In case the accreditation body decides to withdraw or suspend accredi-
tation, certification bodies shall stop performing IFS PACsecure audits
and issuing IFS PACsecure certificates. To recover accreditation after
withdrawal, the same conditions as for initial assessment apply. In case
of accreditation suspension, IFS and accreditation body will jointly
determine requirements to remove suspension.

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1.7 Transfer of certification

In case one certification body decides to transfer its certification activi-

ties to another one, the new certification body shall verify all current IFS
PACsecure certificates, in order to decide if further actions (e.g. with-
drawal of recent certificates or additional IFS renewal audit) will be nec-
essary.

2 Requirements for the Certification Bodies

Certification bodies intending to perform IFS PACsecure audits shall
comply with the following rules. The prescribed tender procedure for
certification bodies is supplied by IFS.

2.1 ISO/IEC 17065 IFS accreditation process

The certification body shall be accredited according to ISO/IEC 17065
for the scope of IFS PACsecure by an IAF or EA recognised accreditation
body (see section 1). Certification bodies in the process of IFS accredita-
tion to ISO/IEC 17065 may organise the witness assessment(s) before
having achieved accreditation status. They shall demonstrate that they
are actively applying for ISO/IEC 17065 accreditation.

Note: In case of withdrawal or suspension of the ISO/IEC 17065 accred-

itation of the scope of IFS PACsecure for the certification body, the
whole certification process is stopped and the certification body is no
longer allowed to issue any IFS PACsecure certificates. In particular, the
certification body cannot issue IFS PACsecure certificates from the date
of withdrawal or suspension, even for the audits which have been
already performed but which are still in the certification process (review
of the report, certification decision, etc.).

2.2 Signing of contract with the proprietor of IFS

After having applied and then gained IFS accreditation to ISO/IEC 17065,
in order to be allowed to perform IFS PACsecure audits, the certification
body shall sign a contract with IFS in which it commits to meet all IFS
requirements. The certification body is not authorised to perform IFS
PACsecure audits (except the first witness assessment(s) during the
accreditation process) before having signed this contract.

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2.3 Certification decision

The person in charge of assessing the audit reports (reviewer) shall be

either an approved IFS PACsecure auditor, an IFS PACsecure trainer or
shall fulfil the following rules:
– To have a food or packaging university degree and two (2) years
professional experience in the food safety/packaging material
safety and quality related professions
– To have attended (as auditor or observer) at ten (10) complete
audits (related to other packaging material safety schemes) in
the last five (5) years
– To have participated in a hygiene training course
– To have participated in IFS PACsecureTrain-the-trainer course
– To be different of the person who performed the audit.

The review shall be documented.

The decision concerning the certification can only be made following

the recommendation of a competent person or a certification commit-
tee. Furthermore, decision can only be made by a person different from
the person who performed the audit.The competent person for the cer-
tification decision or at least one of the members of the certification
committee shall be an IFS PACsecure auditor, an IFS PACsecure trainer
or an IFS PACsecure reviewer.

According to ISO/IEC 17065, the final certification decision shall be

made by the certification body and shall not be subcontracted.

2.4 Certification bodies’ responsibilities for

IFS PACsecure trainers and the IFS PACsecure
auditors (including freelancers)
Certification bodies have the following responsibilities:
– To facilitate witness audits (by accreditation bodies and/or by
Integrity Program).
– To ensure that at least one member of their staff is an IFS PAC-
secure trainer who has taken part in an IFS PACsecure Train-
the-trainer course. The trainer is responsible for the in-house
training of all auditors, intending to become IFS PACsecure
auditors or who already are IFS PACsecure auditors. Persons
intending to become IFS PACsecure trainers shall meet the
requirements mentioned in 2.5.
Note: for a certification body which is starting IFS activities,
this in-house training can be organised by IFS, on request.

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– To ensure that the auditor is competent for the scope of the

audit and its execution and is able to access and to apply rele-
vant laws and regulations, based on IFS and internal certifica-
tion body’s requirements; the certification body shall maintain
these competences (continuous supervision by the certification
body) and shall monitor audit execution by on-site witness
audit. Every auditor shall be monitored by an IFS PACsecure (or
IFS Food, IFS HPC or other GFSI recognized packaging material
safety) on-site witness audit at least once every two (2) years,
and the results of this witness audit shall be documented. The
observer shall be an IFS PACsecure, IFS Food or IFS HPC
approved auditor or shall follow the same rules as for trainers
(see section 2.5).

– To maintain records of auditor competences.

– To ensure that no auditor has either acted against IFS rules, for
example acting as a consultant, or has been active in and/or on
behalf of the company being audited during the previous two
(2) years. That is to say, during the certification process, no
other commercial and/or personal relationships are permitted
between the auditee and the auditor.

– To ensure that no auditor shall perform more than three (3) con-
secutive IFS PACsecure audits of the same production site (only
applies for complete audits, whatever the time between them;
follow up and extension audits are not concerned by this rule).

– To ensure that an auditor is employed by only one IFS certifica-

tion body for performing IFS PACsecure audits and this for a
period of not less than 12 months. In special cases, IFS offices
shall be contacted and may allow exceptions.

– To sign an audit order for each audit, this includes a statement

accepting all the above-mentioned requirements.

– To organise a 2-day training session for IFS PACsecure auditors

once a year for the purposes of sharing experience, calibration
and updating knowledge of relevant legal requirements, etc.
The IFS PACsecure trainer shall lead a part of the training
course.

– To perform an on-site witness audit of an auditor during a prod-

uct safety audit and/or an audit under ISO/IEC 17065 accredita-
tion to ensure the auditor’s competence (see glossary) before
he/she has applied for the IFS examinations. The certification
body shall state the date, the name of the audited company
where the on-site witness audit took place, and the name of the
observer in the IFS examination application file.The minutes of
the on-site witness audit shall be provided on request to the IFS
in English, French or German. The observer for the on-site wit-
ness audit of an auditor applying for IFS examination shall
comply with the same requirements as the trainers (see section
2.5) or shall be an IFS PACsecure, IFS Food or IFS HPC auditor.

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– To include the name of the observer in the Audit Portal when

uploading the audit data, when it has scheduled specific on-
site IFS witness audit(s) according to ISO/IEC 17065 on internal
audits.

The certification body is responsible for choosing an auditor with the

corresponding scope(s), language, competence(s), etc. for each IFS
PACsecure audit.

2.5 Specific requirements for IFS PACsecure trainers

IFS PACsecure trainers shall have the following profile:

– Fulfil requirements for IFS PACsecure auditors as described in
section 3.2 a), b), c) and d),
– Have audit experience to GFSI standards or other packaging
material safety schemes,
– Have knowledge of packaging legislation,
– Have taken part in a IFS PACsecure Train-the-trainer course
organised by IFS,
– Be fluent in writing and speaking the languages they will use
during participating in training and leading training; they shall
inform the IFS offices about the languages they are able to use
when teaching.

The IFS PACsecureTrain-the-Trainer course is organised by IFS.

In order to keep his/her knowledge of IFS PACsecure up to date, each

IFS PACsecure trainer shall take part in a 2-day IFS PACsecure training
course every two (2) years. These seminars are organised by IFS and
shall be the basis for in-house training to all auditors.

IFS PACsecure trainers have the responsibility to:

– Train new IFS PACsecure auditors before applying to IFS PAC-
secure exams,
– Lead (a part or the whole) 2-day training session for IFS PACse-
cure auditors once a year, for the purposes of sharing experi-
ence, calibration and updating knowledge of relevant legal
requirements, etc.
When a new version of the Standard is published, the certification
body’s trainer shall take part in the new IFS PACsecure course organised
by IFS and carry out in-house training of all the already IFS PACsecure
approved auditors, before performing audits based on new version.The
duration of this in-house training shall be at least one day.

In case of publication of new doctrines, the trainer shall train all IFS
PACsecure auditors before the doctrine comes into force.

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3 Requirements for IFS PACsecure auditors

In general, the auditors shall meet the requirements of chapters 7.2 and
7.3.1 of ISO 19011.
During an IFS PACsecure audit, auditors shall, according to IFS good
auditing practices, use relevant samples of products, in order to inves-
tigate on-site the auditee’s production processes and documentation
and to check the fulfilment of IFS requirements. In particular, auditors
shall perform, during the audit, a traceability test in the company.
IFS publishes guidelines which can provide further information on topics
to be checked and/or requested to the audited company during the audit.

3.1 Conversion of auditors to get the IFS PACsecure

version 1 auditor approval
Auditors being already qualified for PACsecure or other IFS schemes
are allowed to audit against the IFS PACsecure version 1, without going
through the full qualification process as mentioned in 3.2 and 3.3 if they
fulfil the following requirements:
– If they are PACsecure auditors: they shall have experience in
product/process certification (or attend a training on product/
process certification organised by IFS, including verification of
acquired knowledge) and additionally attend an IFS PACsecure
training organised by IFS.
– If they are IFS HPC auditors approved for scope 3 (Housekeep-
ing properties): they shall additionally attend an IFS PACsecure
training organised by IFS.
– If they are IFS Food approved auditors, also qualified for a pack-
aging standard related to safety and quality, like GMP FEFCO,
ISO 22000 scope M or BRC IoP: they shall additionally attend an
IFS PACsecure training organised by IFS.
– If they are qualified for a packaging standard related to safety
and quality (e.g. BRC IoP, ISO 22000 scope M, etc.): they shall
attend an IFS PACsecure training organised by IFS and, if rele-
vant, additional training on product/process certification,
organised by IFS.

3.2 Requirements for new IFS PACsecure auditors

3.2.1 Requirements before applying for the IFS PACsecure

examinations

Before applying for IFS examinations, auditors shall have met the fol-
lowing requirements:
– They shall have signed a contract with the certification body
(see ISO/IEC 17065 norm).

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– They confirm to the certification body that, for a period of at

least 12 months, they will perform IFS PACsecure audits only
for the respective certification body. They may, however, work
for several certification bodies on other standards. In special
cases, IFS should be contacted and may allow exceptions.

– They shall have participated at the IFS PACsecure in-house

course organised by the certification body.
– They shall have submitted all the relevant information about
their competence to the certification body.
– The certification body shall have observed and confirmed the
professional qualification and competence of the auditors.

3.2.2 General requirements for auditors when applying for

IFS PACsecure examinations

Candidates applying for qualification as IFS PACsecure auditors shall

meet the following requirements and provide evidence with the appli-
cation documents. An outline CV is available from IFS.
a) Education in the food and packaging material sector
1) A food or packaging-related university degree (bachelor’s and/or
master’s degree equivalents) and two (2) years professional expe-
rience in the packaging material industry in relation to packaging
material production activities (quality, production, R & D, …).
or
2) If the candidate started directly as an auditor after completing
his/her food or packaging related university degree then the can-
didate shall have five (5) years professional audit experience in
the packaging related industry.
or
3) If the candidate has a university degree but not a food or packag-
ing-related one, (bachelor’s and/or master’s degree equivalents)
then the candidate shall have five (5) years professional experi-
ence in the packaging material industry—in relation to packaging
material production activities (quality, production, R & D, …).
or
4) Professional education in food or packaging processing (high
degree) and five (5) years professional experience in the packag-
ing material industry—in relation to packaging material produc-
tion activities (quality, production, R & D, …).
b) General audit experience
A minimum of ten (10) complete audits shall be performed by the
auditor in the packaging material processing industry during the pre-
vious two years. The audits shall have been carried out in different
companies.
c) Food/Packaging hygiene (including HACCP/risk assessment) training
Qualified training on the basis of the Codex General Principles for
Food Hygiene.

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d) Training in auditing techniques based on Quality Management Sys-

tem or Packaging Material Safety Management System
Duration: one week/40 hours or equivalent.

e) Specific and practical knowledge for product scopes auditors apply

for (see Annex 1 for product scopes)
At least two (2) years professional experience in the packaging mate-
rial industry in relation to packaging activities, for each applied prod-
uct scope.
or
At least ten (10) packaging safety audits and/or second party audits
including quality and packaging material safety investigations with
traceable origin and confirmed by the retailer or by the industry, per
product scope. Ten (10) witness audits during IFS PACsecure audits,
as observer, are also accepted to qualify the observer on the product
scope. Audits shall have been carried out in different companies.

f) Language
Auditors must be fluent in English.

g) IFS PACsecure in-house training

IFS PACsecure in-house training materials shall be based on the
materials provided by IFS. The auditor shall have taken part in the
in-house training (covering IFS, packaging-related legislation, gen-
eral hygiene requirements, GMP) undertaken by an authorised IFS
PACsecure trainer and organised by the certification body. The mini-
mum duration shall be two (2) days.
IFS is responsible for the technical validation of the auditors’ applica-
tion files before they take part in IFS examinations. If the auditor’s CV
does not meet the above-mentioned requirements, IFS may reject the
auditor’s examination application. If the auditor does not show suffi-
cient evidence for the product scopes he/she is applying for, IFS may
reject the applications for the product scopes concerned.
All CV’s content shall be confirmed by a person from the accredited
certification body who shall put his/her name and position on the bot-
tom of the CV.
Note: IFS offices have the possibility to withdraw an IFS PACsecure
auditor approval or not to accept him/her at the examination, if the
information provided in the CV is false. This kind of breach will be also
forwarded to the IFS Integrity Program.

3.3 IFS examination process (for new auditors,

as specified in chapter 3.2)
Auditors who comply with the requirements mentioned in chapter 3.2
can take part in an IFS PACsecure written examination. If successful, the
auditor is officially authorised to perform IFS PACsecure audits. The
auditor is registered and a personal IFS PACsecure auditor certificate is
issued. Starting from the day of passing the written examination, the
auditor is allowed to perform IFS PACsecure audits for the product

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scopes he/she was authorized for by IFS offices until the end of the
second calendar year. The IFS PACsecure auditor certificate mentions
the duration of validity, the name of the certification body and the audi-
tors’ product scope(s).

3.4 Maintenance of auditors’ qualification (for both types

of auditors, as specified in chapters 3.1 and 3.2)
The auditor cannot perform IFS PACsecure audits anymore when his/her
IFS PACsecure auditor certificate expires. The certification body is
responsible to maintain auditor’s IFS approval so that there are no gaps
during the auditor approval.
Auditors’ approval shall be re-assessed before end of validity of the
auditor certificates. For maintaining their approval, auditors shall fulfil
the following requirements:
– have performed a minimum number of ten (10) IFS PACsecure
audits (5 audits per year),
– have been trained internally by the certification body on pack-
aging-related legislation, Standard requirements, audit prac-
tices, etc. (2 days per year),
– be monitored by an IFS on-site witness audit (once every two
years).This audit can be performed at any time during the year
of end of validity of auditor’s certificate. Witness assessments
performed by accreditation bodies during IFS PACsecure audits
are accepted as witness audits,
– have taken part in an IFS PACsecure calibration training course
(subsequent to passing the initial examination, the first manda-
tory calibration training shall be successfully completed in the
second calendar year following the date on which the initial
examination was successfully completed.Then, the re-approval
shall be managed every two (2) calendar years, based on the
same rule).
Documented evidences shall be provided to IFS offices.
Example:
Date of initial written examination: 25th of October 2012
Date of end of validity for IFS PACsecure auditor certificate (initial
approval): 31st of December 2014
Auditor is authorised to perform IFS PACsecure audits between 25th Octo-
ber 2012 and 31st December 2014.
In 2014, if the auditor has performed 10 IFS PACsecure audits (5 per
year), if he/she has been trained internally, through a yearly 2 days
course, has been witnessed, and has taken part in the IFS PACsecure
calibration training, the new end validity date of IFS PACsecure auditor
certificate (re-approval) is: 31st December 2016.

If any of these three rules are not fulfiled, the auditor shall participate
again in the IFS PACsecure initial written examination.

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3.5 Scope extension for IFS-approved auditors

Auditors may, during the validity of their IFS PACsecure auditor certifi-
cate, extend their product scopes. Scope extension may not be requested
in the first 12 months after the initial IFS PACsecure auditor approval.

For extension of product scope(s), they shall provide the same evidence
as for the initial approval, based on new experience (new from the ini-
tial application). At least ten (10) IFS PACsecure audits in the scope, as a
trainee, can also be accepted as evidence. The auditor shall have par-
ticipated in all steps of the audit (on-site audit, assessment and decision
processes).

The auditors can only perform IFS PACsecure audits according to the
scopes stated by IFS.

3.6 Audit team

3.6.1 General rules

In general, all members of the audit team shall be IFS approved audi-
tors.

In case of auditing with teams, the following general regulations apply:

– An IFS PACsecure audit team consists of IFS PACsecure
approved auditors whose product scopes comply with the
activities of the audited site.
– A lead auditor shall always be appointed.
– Co-auditor(s) shall always be approved for at least one product
scope of the audit scope.Two (2) hours of the audit duration are
not shareable; this additional time shall be allocated to the
team, not to an individual auditor, for common tasks (e.g. open-
ing and closing meeting, discussion about audit findings, etc.)
– The remaining time can be split as long as the auditor compe-
tencies for product scopes are not disconnected during the
audit. No “crossing over” is allowed.This means that, if the lead
or co-auditor(s) do not have, individually, all product scopes
which are necessary for the audit, they have to audit all parts of
the audit related to product scope knowledge together.

It shall be clearly indicated in the audit time schedule which auditor did
which part of the audit. Auditors without necessary scopes can only
take part as trainees.

The minimum audit duration shall anyway be respected.

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3.6.2 Specific rules for audit team and auditing 3 consecutive

times

For audit teams an additional rule applies as regulation for consecutive

audits. As an exceptional case, (if the certification body has no other
possibility to combine an audit team in year 4–6, due to missing approval
for product scope of their auditors) the following sequence of auditor
planning is possible:

Year 1–3: Lead auditor A + co-auditor B

Year 4–6: Lead auditor B + co-auditor C
Year 7: Lead auditor A or C + co-auditor A or C.

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ANNEX 1: Product scopes

1. Flexible packaging
2. Rigid plastic
3. Paper
4. Metal
5. Glass
6. Other natural materials

Multi component packaging materials (e.g.Tetra Pak) have to be assigned

based on the material which is the main component of the material.The
main component of multi component packaging materials shall be
mentioned in the scope of the audit on the report.

Materials to be considered as “other natural materials” are, for example

wood, clay, cork, jute, textiles, banana leaves, etc.

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Part 4: Reporting and IFS Audit Portal

0 Introduction
After an IFS PACsecure audit has been performed, a detailed and well-
structured audit report shall be completed. The language of the report
shall be English. The IFS PACsecure audit report shall be prepared
according to the following format.

1 Reporting

1.1 Audit overview (Annex 1)

The first part of the audit report shall contain the following general
information:

Audit details
The cover page of the audit report shall include:
– name and address of the certification body
– the logo of the certification body
– the certification body’s accreditation details
– name of the audited company or site
– date of the audit.

These first pages shall give a summary of the most important audit
report items and shall include:
– name and address of the audited site
– name and address of the company (if headquarters)
– EAN. UCC Global Location Number, if available
– COID, as defined in the IFS Portal
– audit date (in case of a follow up audit the date of the follow up
audit shall additionally be defined)
– time of the audit
– previous audit date
– the name of the certification body and the auditor who per-
formed the previous audit
– details of the version of the Standard

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– audit scope (mandatory detailed descriptions of processes/

products)
– numbers of product scopes
– list of key personnel present at audit
– name of the lead auditor
– if applicable, additional name of the co-auditor
– if applicable, name of the auditor trainee
– result of the audit (in case of a follow up audit, to specify that a
follow up audit has taken place and that the Major non-con-
formity has been solved)
– company profile: some compulsory general information about
the company shall be provided, as follows:
· The year of construction of the plant
· The registration numbers of the company by authorities if
available and/or existing (and GS1 number, if available)
· The COID (IFS identification code number), in case of renewal
audit
· When the last investment was made in production, product
oriented investments concerning quality and safety (con-
struction changes, machines). Specify the kind of investment
made in production area
· The name and contact data (phone/fax/e-mail) of the contact
person in case of emergency (e.g. withdrawal/recall)
· Product groups and products per group produced in the
company
· Complete view of the company’s processes
· If the audited company also has trade products (already pro-
cessed), specify the kinds products
· How many employees are there, listed according to full-time
and part-time workers (own employees, external compa-
nies), shift work
· The number and names of the sub-companies (sites) of the
company (where are they situated, if they are IFS certified),
precision about names and kinds of sub-contracted part(s) of
the process
· The site area of the plant in square meters
· State if the company fulfils the requirements about use of
IFS logo, as defined in IFS PACsecure audit protocol (Part 1)
· If the certification body has decided to decrease audit dura-
tion (see rules in chapter 5.3 of audit protocol), explanations
about the reasons for decreasing
· If the site is certified according to other schemes, specify the
schemes’ names

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· If there are seasonal breaks in production process, please

specify time frame
– further explanations regarding scoring and frequency
– below the company profile: name of the person in charge of
assessing the report (reviewer).

1.2 Audit report (Annex 2)

The audit report itself is structured as follows:

– the result of the audit with level and percentage
– observations on KO’s and Majors (in case of a follow up audit,
additional explanation on which requirement the Major has
been solved)
– general summary table for all chapters
– an overall summary of the audit (of all chapters)
– a list of all established deviations and non-conformities for
each chapter (1 to 6)
– a description of follow up of corrective actions from the previ-
ous audit
– a separate list (including explanations) of all requirements
evaluated with N/A (not applicable)
– a detailed audit report.

1.3 Action plan (Annex 3)

The certification body/the auditor describes and explains all established

deviations and non-conformities (KO’s, Majors) in each chapter in the
action plan, which has a specified format shown in the annex.

1.4 Minimum requirements for IFS PACsecure certificate

(Annex 4)
After successful completion of the IFS PACsecure process, the certifica-
tion body shall issue a certificate in English language. For the purposes
of international recognition, and so as to be understandable, IFS PACse-
cure certificates awarded by the certification body shall include the fol-
lowing information at a minimum:
– the name and address of the certification body, including its
logo

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– the logo of the accreditation body or its name and registration

number (requirement mentioned in the ISO/IEC Guide 65,
G.12.7.); the logo of accreditation body shall be used in con-
formity with accreditation body’s rules
– the name and address of the audited company
– the COID, as defined in the IFS Portal
– if the company is a subsidiary, the name of the company’s
headquarters
– audit scope (with mandatory detailed descriptions of pro-
cesses/products and including for instance trade products if
applicable). If the list of the products is too long to be specified
on the one page certificate, the list shall be specified in an annex
and the IFS certificate shall make a reference to that annex.
– name and number of product scope(s)
– level achieved
– audit score in percentage, if required by the customer or by the
audited company
– date of audit (last day of audit)
– date of follow up audit if relevant
– next audit to be performed within the time period (renewal
audit)
– certificate issue date
– certificate expiry date, i.e. 12 months after the date of issue the
certificate (the certificate validity date shall remain the same
each year as described in the audit protocol, Part 1)
– place and date of signature
– name and signature of the certification body’s person(s) respon-
sible for the certification decision as described in Part 3 of the
Standard
– IFS PACsecure logo
– PACsecure logo.

2 The IFS Audit Portal and the IFS Database

(www.ifs-certification.com)
Every IFS PACsecure audit shall be uploaded to the IFS Audit Portal by
the certification body (uploading of report, action plan and certificate).

There are 3 user groups which have access to the IFS Database:

– Certification bodies
– Certified companies
– Retailers and other users.

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 International Featured Standards · IFS PACsecure · Version 1 Part 4 137

The different groups’ access rights are as follows:

Certification bodies:
– manage their certified companies and upload audit reports,
action plans and certificates
– may suspend certificates in specific situations
– can manage all IFS PACsecure audit dates via the diary func-
tion, enabling retailers and companies to have a good overview
of the scheduled audits. It is mandatory to upload in the diary
function of the Audit Portal all audits dates, at latest 2 weeks
before the audit.
– manage their accounts
– have the possibility to compare two consecutive audit reports
and action plans, for internal auditor training and calibration
purposes
– download the IFS logo(s).

Certified companies/suppliers:
– have access to their own audit data
– have the possibility to unlock retailers and other users for their
achieved percentage, detailed audit report and action plan
– have the possibility to compare two consecutive audit reports
and action plans, for improvement purposes
– download the IFS Logo(s)
– manage their certification bodies
– manage company personnel access (create sub-accounts) to
the audit data
– search for other certified companies
– manage their suppliers using a “favourites” option.

Access for the headquarters of certified companies

A “headquarter” access for certified companies can be set up which
allows a company headquarter to administer all of their certified sites
through a single access point.

Retailers and other users:

– search for certified companies
– manage their certified companies via a “favourites” option
– get information via e-mail in case of a certificate suspension of
their favourite companies.

The user manuals for the IFS Audit Portal are available on the respective
secured area for each user group.

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138 Part 4 International Featured Standards · IFS PACsecure · Version 1

Security of the Database

The security system used for the database is based on international
recognised and mostly used security systems. The retailer and certified
companies access provide general information about all certified com-
panies. If no further authorisation is granted by the certified companies
both user groups will be able to see the following information only:
– the company’s name and address
– the certification body’s name and address
– the auditor’s name (including auditor scopes)
– the scope of the audit
– the date and duration of the audit
– the level achieved at the audit
– the IFS PACsecure certificate’s date of issue and its validity.

By using their secure log-in access‚ the certified companies themselves

can give the authorisation for access to the following detailed informa-
tion:

– audit report and action plan.

The retailers and other users/certified companies automatically receive

access to the unlocked data by the certified company after the data has
been unlocked. Communication to retailers and other users is via a
secure Web process which guarantees that only authorised retailers
and other users/certified companies can view specific data of the certi-
fied companies/suppliers.

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 International Featured Standards · IFS PACsecure · Version 1 Part 4 139

ANNEX 1

Cover page of the audit report

Logo of the certification body

IFS PACsecure
Version 1

Final Audit Report

Audited company: “Paper and Plastic Ltd”

Date of audit: 02. 12./03. 12. 2012

Name and address of certification body

Accreditation number of the certification body

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140 Part 4 International Featured Standards · IFS PACsecure · Version 1

Explanations regarding the audit report

Evaluation of requirements

Result Explanation Points

A Full compliance 20 points
B (deviation) Almost full compliance 15 points
KO requirement Almost full compliance 15 points
scored with a B
C (deviation) Small part of the requirement has been 5 points
implemented
D (deviation) Requirement has not been implemented –20 points

Major When there is a substantial failure to 15 % of the

meet the requirements of the Standard, possible total
which includes product safety and/or the amount of points
legal requirements of the production and is subtracted
destination countries. A major can also
be given when the identified non-con-
formity can lead to a serious health
hazard. A major can be given to any
requirement which is not defined as KO.
KO requirement The KO requirement has not been 50 % of the
scored with a D implemented possible total
amount of points
is subtracted

N/A Not applicable N/A requirements

Requirement not applicable for will be excluded
a company from the final
scoring

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 International Featured Standards · IFS PACsecure · Version 1 Part 4 141

Scoring and awarding of certificates

Audit result Status Action company Report form Certificate

At least 1 KO Not approved Actions and new Report gives No
scored with D initial audit to be status
agreed upon
> 1 Major Not approved Actions and new Report gives No
and/or < 75 % initial audit to be status
of the agreed upon
requirements
are fulfilled
Max 1 Major Not approved Send completed Report includ- Certificate at
and ≥ 75 % of unless further action plan ing action foundation
the require- actions taken within 2 weeks plan gives level, if the
ments are and validated of receiving the status Major non-
fulfilled after follow- preliminarily conformity is
up audit report. Follow-up finally solved
audit max. as controlled
6 months after during the
the audit date follow-up
audit
Total score is Approved at Send completed Report includ- Yes, certifi-
≥ 75 % and foundation IFS action plan ing action cate at
< 95 % PACsecure within 2 weeks plan gives foundation
level after of receiving the status level,
receipt of the preliminarily 12 months
action plan report. validity
Total score is Approved at Send completed Report includ- Yes, certifi-
≥ 95 % higher IFS action plan ing action cate at higher
PACsecure within 2 weeks plan gives level,
level after of receiving the status 12 months
receipt of the preliminarily validity
action plan report.

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142 Part 4 International Featured Standards · IFS PACsecure · Version 1

First pages of the audit report

IFS PACsecure
Version 1, October 2012
Audit Overview
Audit details
Lead auditor: Date/time of current audit: Date/time of previous audit:
Mr. Müller 02. 12. 2012 07. 12. 2011 (09:00–18:00)
Co-auditor:
(09:00–18:00) 08. 12. 2011 (08:30–17:30)
Ms. Lehmann CB and auditor of previous audit:
03. 12. 2012
Trainee: (08:30–17:30) TEST GmbH/FrankTest
Mr. Schubert
Name and address of the company (or headquarter) Name and address of the audited site
Perfect Packaging Paper and Plastic Ltd
Example street Musterstraße
12345 Witzenhausen 12346 Berlin
Germany Germany
EAN Code/UCC Global Location Number
COID
Phone: Fax: Phone: Fax:
0 12 34 56 01 23 45 67 89 0 12 34 57 01 23 45 67 88
Scope of audit

Production of paper and PE foil

Product scope(s): 1, 3
Audit participants
Name: Position: Opening Documentation Site assess- Closing
meeting review ment (Audit): meeting

Mr. Quality Quality X X X X

Manager
Mr. Manager General X X
Manager
Mr.Transport Transport X X X
Manager
Final Result of Audit

As a result of the audit performed on 02. 12. and 03. 12. 2012, “xyz” found Next audit in
that the processing activities of Paper and Plastic Ltd for the above- 12 months
mentioned scope of production comply with the requirements set out in
the IFS PACsecure, Version 1, at Foundation Level, with a score of XX %.
Company profile

Compulsory information
In case of reduction of audit duration, explanations of the reasons:
Reviewer:

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 International Featured Standards · IFS PACsecure · Version 1 Part 4 143

ANNEX 2

IFS PACsecure
Version 1, October 2012
Audit Report

Result:
The processing activities of company “Paper and Plastic Ltd” met the
requirements of the IFS PACsecure, version 1.

The company passed with a score of XX % at:

Foundation (Higher) level

…%

Date of renewal audit: between the XX/XX and the XX/XX.

Summary:

Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6

Senior Quality and Resource Planning and Measure- Packaging
management packaging management production ments, material
responsibility material safety process analysis, defense/
management improvements Food defense
system and external
inspections
KO 0 0 0 0 0 0
Majors 0 0 0 0 0 0

A 0 0 0 0 0 0

B 0 0 0 0 0 0

C 0 0 0 0 0 0

D 0 0 0 0 0 0

N/A 0 0 0 0 0 0

Observations regarding KO’s and Majors:

General summary table for all chapters:

100%
90%
80%
70%
60%
50%
40%
30%
20%
10%
0%
Chapter 1 Chapter 2 Chapter 3 Chapter 4 Chapter 5 Chapter 6 Total

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144 Part 4 International Featured Standards · IFS PACsecure · Version 1

Overall summary of the audit:

Description of follow up of corrective actions from the previous

audit:

Chapter 1: Senior management responsibility

Summary of all Chapter 1 deviations and non-conformities found:

N° Reference IFS requirements Evaluation Explanation

1. 1.1.1
2. 1.1.2

Report of the N/A evaluations

N° Reference IFS requirements Evaluation Explanation
1.

Detailed audit report

N° Reference IFS requirements Evaluation Explanation
1.
2.

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 International Featured Standards · IFS PACsecure · Version 1 Part 4 145

ANNEX 3

Action plan

Name and address of the audited company

The Corrective Action Plan must be returned to the certification body

before: ___________________________________________________________

Requirement IFS Evaluation Explanation Corrective Responsibility/ Release

number PACsecure (by the action Date/Status of by the
requirement auditor) (by the implementation auditor
company) (by the
company)

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146 Part 4 International Featured Standards · IFS PACsecure · Version 1

ANNEX 4

CERTIFICATE
Herewith the certification body

Name of the certification body

being an ISO/IEC 17065 accredited certification body for IFS certification
and having signed an agreement with the IFS owner,
confirms that the processing activities of

Name of the audited company

Address

COID
(Headquarter)
for the audit scope:
(detailed descriptions of processes/products plus, if relevant, trade products)

Name and number of the product scope(s)

meet the requirements set out in the

IFS PACsecure
Version 1, October 2012

at Foundation level/Higher Level

with a score of XX % (if required)

Certificate – register number: ________________________________________________

Audit date: ________________________________________________
(If relevant: date of follow up audit)

Date of issue of certificate: ________________________________________________

Certificate valid until: ________________________________________________
Next audit to be performed within the time period: ______________________________
(specify soonest and latest audit date, according to requirements of audit protocol, Part 1)

Date and place

Name and signature of
the responsible person
at the certification body
Address of the
certification body

Logo of the accreditation

body or its name and
registration number

© IFS, October 2012

CONTACT DETAILS OF THE IFS OFFICES

GERMANY | BERLIN BRAZIL | DOURADOS

IFS Management GmbH Repesentante IFS Brasil
Am Weidendamm 1A Caroline Nowak
D-10117 Berlin BR-79824 Dourados, MS
Phone: +49 (0) 30 72 62 50 74 Phone: +55 (67) 81 51 45 60
Fax: +49 (0) 30 72 62 50 79 E-mail: [email protected]
E-mail: [email protected]
CHINA | HEFEI
FRANCE | PARIS StarFarm
IFS Office Paris Room 2301, C building,
FCD Fortune Plaza No. 278 Suixi Road, 230041,
12, rue Euler Hefei, Anhui, China
F-75008 Paris Phone: +86 (0) 55 15 66 60 69
Phone: +33 (0) 1 44 43 99 16 Fax: +86 (0) 55 15 68 13 76
Fax: +33 (0) 1 47 20 53 53 E-mail: [email protected]
E-mail: [email protected] [email protected]

ITALY | MILAN USA | ST. LOUIS

IFS Office Milan IFS Americas
Federdistribuzione 1610 Des Peres Road, Suite 150
Via Albricci 8 St. Louis, MO 63131
I-20122 Milano USA
Phone: +39 (0) 2 89 07 51 50 Phone: +1 31 46 86 46 10
Fax: +39 (0) 26 55 11 69 Fax: +1 31 46 86 46 02
E-mail: [email protected] E-mail: [email protected]

POLAND | WARSAW
IFS Office Central & Eastern Europe
ul. Serwituty 25
PL-02-233 Warsaw
Phone: +4 86 01 95 77 01
E-mail: [email protected]

CONTACT DETAILS OF THE PACKAGING ASSOCIATION OF CANADA (PAC)

THE PACKAGING ASSOCIATION | CANADA

1 Concorde Gate, Suite 607
Toronto ON
M3C 3N6
Canada
Phone: +1 41 64 90 78 60
E-mail: [email protected]
© IFS, October 2012