P-ROP-01 Rules For Operators V8
P-ROP-01 Rules For Operators V8
RULES FOR
OPERATORS
VERSION 8
2017-10-02
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
TABLE OF CONTENTS
1. Scope ..................................................................................................... 4
2. Application for certification .................................................................... 4
2.1. Evaluation procedure of the application ..................................................................................................... 5
4. Assessment of Operators........................................................................ 6
4.1. Auditing Time Calculation ............................................................................................................................ 7
4.1.1. Initial Auditing Time Calculation .......................................................................................................... 7
4.1.2. Auditing Time Calculation for Surveillance audit and Re-Certification................................................ 7
7. Special Audits....................................................................................... 10
7.1. Extension to the scope ............................................................................................................................... 10
7.2. Short Notice Audits .................................................................................................................................... 10
7.3. Unannounced Audits.................................................................................................................................. 11
7.3.1. Topics covered during an unannounced audit for production activity.............................................. 11
7.3.1. Topics covered during an unannounced audit for trading activity .................................................... 11
FAMI-QS asbl
2
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
FAMI-QS asbl
3
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
1. Scope
FAMI-QS certification is based on the FAMI-QS Code of Practice. The only valid version of the Code is the English
version, published on the FAMI-QS Asbl website (http://www.fami-qs.org/code).
The aim of this European Code of Practice is to ensure safety of Specialty Feed Ingredients by:
minimizing the risk, that adulterated Specialty Feed Ingredients enter the feed chain;
enabling an Operator to implement the objectives of the feed hygiene regulation and
providing measures to ensure that other applicable feed safety regulatory requirements are met.
Feed is considered unsafe for its intended use if it has adverse effect on human or animal health.
This Code shall apply to Operators at all stages from the first placing on the market, including imports. FAMI-QS Code
covers the following activities: Production and Trade.
Feed Safety and Quality Management System certification against FAMI-QS Code does attest that the production
process is taking place under hygiene conditions in order to minimize and possibly eliminate the risks pertaining to the
Feed/Food Chain.
FAMI-QS requires an operator to meet all applicable feed-safety-related statutory and regulatory requirements
through its management system both in the country of production and in the country of destination. In case that in
the country of or production and/ or destination there are no applicable feed-safety related statutory and regulatory
requirements, the EU Feed Safety requirements shall be applied.
Certification of a Feed Safety and Quality Management System according to FAMI-QS Code is a management system
certification, not a product certification.
For the current scope of FAMI-QS certification, please consult the FAMI-QS Code of Practice, Chapter 2 (available on
http://www.fami-qs.org/code.html).
The ten (10) steps outlining the certification process are detailed below:
STEP 1 The Operator should download a free copy of the FAMI-QS Code and the Rules of Operators and read the
documents carefully.
STEP 2 The Operator should evaluate their readiness and perform an internal audit.
STEP 3 The Operator should identify its product(s) and fill in all the sections of the application form (e-form or word
format available on http://www.fami-qs.org/apply) in order to register for FAMI-QS Certification.
STEP 4 FAMI-QS will evaluate the application and will return an email stating if the application can be accepted or not.
FAMI-QS asbl
4
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
Once it has been approved, FAMI-QS will issue an invoice for membership fee. The membership fee is paid on a yearly
basis. Once it is paid, a letter of acceptance (Approval Letter) is sent to the Operator. A payment receipt is sent by
email, upon request. The approval letter needs to be provided to the auditor.
STEP 5 The Operator should select a Certification Body (CB) from the FAMI-QS website list (http://www.fami-
qs.org/certificationbodies) and contact them for the audit. The approval letter will be required for the communication
with the CB.
STEP 7 Outcomes of the audit and possible action plan for the non-conformities.
Assessment of the action plan and its implementation by the Certification Body.
The CB submits the audit documentation to FAMI-QS.
STEP 8 Revision of the audit documentation and its findings by the Certification Body, followed by the certification
decision. The CB delivers the certificate to your company.
STEP 9 FAMI-QS reviews the audit documentation and membership payment and gives its validation for registration.
After verification of the audit documentation, the Operator will be registered and listed on the FAMI-QS website
(http://www.fami-qs.org/certifiedcompanies) as a certified Operator.
Step 10 After the initial certification, an annual surveillance audit will apply. The certification is valid for 3 years. After
the cycle of 3 years, a recertification audit will take place.
If there are no changes in the scope, company name or address, there is no need to request a new approval letter. The
previous one remains valid.
Specialty feed ingredients shall be defined and labelled with clear application instructions according to the applicable
animal feed legislation of the intended market. The regulatory status of the products will be under the responsibility
of the Operator. The products shall be legally produced in the country of origin and shall meet the regulatory
requirements of the country of destination.
To get an application’s approval, the product shall comply with the definition of Specialty Feed Ingredient. Any other
result will lead to the rejection of the application.
FAMI-QS asbl
5
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
A fee is applied for each registered site within the FAMI-QS system.
The amount of the membership fee will be announced on the website.
An invoice will be issued each calendar year following the application.
In the event that a FAMI-QS certified Operator refuses to pay the membership fee, the company will be
removed from the FAMI-QS website.
In addition, an administrative fee will be applied to process changes linked with the updates of the Approval letter,
such as scope extension or other amendments. Only in case of new sites registration, no administrative fee will be
applied.
4. Assessment of Operators
Operators shall contact one of the FAMI-QS authorised Certification Bodies listed in the FAMI-QS website
(http://www.fami-qs.org/certificationbodies).
For the application, the following information must be sent by the Operator to the Certification Body before the
certification audit takes place:
The CB shall not exclude activities, processes, products or services from the scope of the audit when those
activities/processes/products/services can have an impact on the feed safety. These considerations shall be taken into
account in the audit programme and audit plan.
The Certification Body assesses the Operators’ compliance with FAMI-QS, on the basis of initial, surveillance and re-
certification audits.
In case of any unresolved disagreement between an Operator and an authorised Certification Body, circumstances
should be reported in writing by the Operator to FAMI-QS Asbl for consideration by the FAMI-QS Board.
FAMI-QS asbl
6
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
A B C D E F
Basic audit time for Number Number of Purchases under Gatekeeper Number of audit For each additional
the total of of audit days in approach dates per number of site under the same
activities additional the absence employees Feed Safety and
(production and/or days for of a relevant Quality Management
trade) and one additional certified This column will be System, operating a
process process system applied in case of similar
absence of a relevant manufacturing
certified system. process.
1.5 0.5 0.25 01-05 ingredients 0.25 1 to 19 = 0 50% of the minimum
20 to 49 = 0.5 on site audit time.
06-10 Ingredients 0.5 50 to 79 = 1.0
80 to 199 = 1.5
11-15 ingredients 0.75 200 to 499 = 2.0
A: Basic audit time. The basic audit includes one process and one activity (Production or Trade). In case of trading the basic audit
time covers only one process from which the final product(s) are derived.
C: In order to avoid duplication where another relevant management system (ISO 9001, GMP+, FSSC 22000, ISO 22000) is in place
and certified by the same certification body, column C is not applicable.
D: Additional auditing time dedicated to the auditing of the files for those feed ingredients entering the production process and/or
trading which are coming from non-assured sources.
E: Additional auditing time in absence of relevant certified system (ISO 9001, GMP+, FSSC 22000, ISO 22000, FSSC 22000) according
to the number of employees.
F: For each additional site operating under centrally controlled and administrative FAMI-QS System, 50% of the minimum on-site
audit time shall be considered.
Surveillance Audit: the total minimum surveillance audit time should be one-third of the initial certification audit time,
with a minimum of eight hours.
Re-Certification Audit: the total minimum time should be two-thirds of the initial certification audit time, with a
minimum of eight hours.
FAMI-QS asbl
7
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
5. Audit planning
According to the requirements of ISO/IEC 17021-1:2015 and ISO/TS 22003, the FAMI-QS initial certification audit shall
be conducted in two stages, stage 1 and stage 2.
Before the stage 1 audit for initial certification, the Operator shall provide the Certification Body (in written, electronic
form or during a meeting between the Operator and the auditor) the documentation described in the previous chapter
“Assessment of Operators”.
Traders that place on the market products under their own label, are considered producers. In case the subcontractor
is not certified against one of the standards with which the FAMI-QS maintains mutual recognition arrangements (see
document P-MS-003), the CB shall consider to audit the contracted manufacturer at least once within the certification
cycle.
5.1.1. Stage 1
Planning shall ensure that the objectives of stage 1 can be met and the client shall be informed of any “on site”
activities during stage 1. Stage 1 does not require a formal audit plan.
The objective of the stage 1 audit is to provide a focus for planning the stage 2 audit. This shall be achieved by gaining
an understanding of the Feed Safety and Quality Management System, in the context of the Operator’s feed safety
hazard identification, analysis, HACCP plan and PRPs, policy and objectives, and in particular according to the
Operator’s level of preparation for the audit by reviewing the extent to which:
a) The Feed Safety and Quality Management System is aligned with the requirements in the FAMI-QS Code.
b) The Operator has identified PRPs that are appropriate to the business.
c) Evaluating the audit report on audits carried out at the supplier premises (if applicable).
d) Evaluating the audit report on audits carried out at the subcontractors’ facilities (if applicable).
e) The Feed Safety and Quality Management System includes adequate processes and methods for the
identification and assessment of the Operator’s feed safety hazards as well as the subsequent selection and
categorization of control measures according to the FAMI-QS code.
f) The Operator complies with the relevant feed legislation.
g) The Operator’s System collects the relevant statutory and regulatory requirements, related to the production
in the country of origin and the placing of the specialty feed ingredients in the country of destination.
h) The Feed Safety and Quality Management System is designed to achieve the Operator’s feed safety policy.
i) The Feed Safety and Quality Management System implementation programme allows to proceed to stage 2
of the audit.
j) The validation, verification and improvement programmes are conformed to the requirements of the FAMI-
QS Code
k) The Feed Safety and Quality Management System documentation is in place and its requirements are
internally and externally communicated (relevant suppliers, customers, other interested parties, etc.).
l) Additional documentation needs to be reviewed /or which knowledge needs to be obtained in advance.
In exceptional circumstances, a part of stage 1 can take place off-site and shall be fully justified. The evidence
demonstrating that stage 1 objectives are fully achieved shall be provided. Exceptional circumstances can include very
remote location.
FAMI-QS asbl
8
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
The findings in Stage 1 shall be documented and communicated to the client. The findings of Stage 1 do not include
Non Conformities.
The interval between stage 1 and stage 2 shall not be longer than 6 months. Stage 1 shall be repeated if a longer
interval is needed.
A stage 1 audit might apply for the re-certification audit when major changes in the Operator’s Feed Safety and Quality
Management System have occurred.
5.1.1. Stage 2
A stage 2 audit takes place at the location of an applicant who seeks certification against the FAMI-QS Code. All sections
of the FAMI-QS code shall be verified.
The stage 2 audit takes place at the Operator’s site. The purpose of the stage 2 audit is:
a) To confirm the implementation, including the effectiveness of the Operator’s Feed Safety and Quality
Management System to the requirements of the FAMI-QS Code.
b) To verify that the information and evidence of conformity is achieved, for all of the FAMI-QS Code’s
requirements.
c) To assess the capability of the Feed Safety and Quality Management System to perform key activities, such as
production methods, controls, PRPs, HACCP plans and procedures, as well as the competency of the personnel
involved in the feed/food safety functions, in conformity with the ISO standards.
d) To assess the Operator’s Feed Safety and Quality Management System, in compliance with EU and local
statutory, regulatory and contractual requirements.
e) To confirm that the Operator’s Feed Safety and Quality Management System is effective in achieving the
stated feed safety policies and objectives.
The selection of the executive and other personnel to be interviewed shall adequately cover every relevant functional
area. If shift-work is performed, an interview can be planned outside normal working hours.
Any part of the Feed Safety and Quality Management System that is audited during the stage 1 audit and determined
to be fully implemented, effective and in conformity with requirements, may not need to be re-audited during the
stage 2 audit. However, the certification body shall ensure that the already audited parts of the Feed Safety and Quality
Management System continue to conform to the certification requirements. In this case, the audit report shall include
these findings and shall clearly state that conformity has been established during the stage 1 audit.
5.2. Subcontractor
The Operator’s subcontractor(s) (toll manufacturer(s), supplier(s)…) is subject to the same approval criteria as any
other supplier of FAMI-QS certified Operator.
If the subcontractor is not FAMI-QS certified or is not certified by any other mutual recognized standard, the Operator
shall evaluate the risk connected to the Operator’s service and, if relevant, perform a full audit, in order to ensure that
FAMI-QS asbl
9
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
the subcontractor meets the FAMI-QS requirements. Thus, the Operator shall audit the establishment of the
subcontractor against FAMI-QS requirements. A report shall be made available.
During the Operator’s certification and surveillance audits, the auditor shall check the audit report of the
subcontractor.
The Certification Body may also audit the subcontractor based on the evidence presented in the subcontractor audit
report. On successful completion of the audit, a certificate will be granted to the Operator only.
If the subcontractor is certified according to FAMI-QS or to a mutually recognized standard, no additional FAMI-QS
audit by the Operator is required as long as the applicable product falls under the scope of that certification.
6. Maintaining certification
6.1. Surveillance Audits
Frequency of the surveillance audits:
a) 1st Surveillance Audit: within 12 months after the Initial Certification Audit.
b) 2nd Surveillance Audit: approximately 24 months after the Initial Certification Audit.
CB shall report to FAMI-QS Secretariat the annual surveillance activities (Company name, site, Auditor(s), audit dates.
If a re-certification is conducted after the expiry of a certificate, a Stage 1 and Stage 2 Audit shall be carried out.
7. Special Audits
7.1. Extension to the scope
In response to an application for the extension of the scope of a certification that has already been granted, the
Certification Body shall undertake a review of the application and determine any audit activities that may be deemed
necessary to decide whether or not the extension may be granted. This may be conducted in conjunction with a
surveillance or re-certification audit.
investigate a complaint, or
FAMI-QS asbl
10
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
In such cases:
a) The Certification Body shall inform the certified Operator(s) in advance and describe the conditions under
which this/these short notice visit(s) will be conducted.
b) The Certification Body shall notify FAMI-QS about the result of the audit.
In case of an incident the P-CM-001 Feed Incident Management Procedure for Operators and Certification Bodies
current version shall be applied.
The conditions for the provision of the unannounced audits shall be agreed on between the Certification Body and the
FAMI-QS certified Operator and shall be part of the contract. The contract needs to ensure that one unannounced
audit is undertaken after the initial certification audit and within each 3-year period thereafter.
The FAMI-QS certified Operator can voluntary choose to replace one of the surveillance audits by an unannounced
surveillance audit or to get one additional unannounced audit.
The topics that shall be covered during an unannounced audit for production activity are the following:
Monitoring of CCP
Validation of the flowchart
Validation of the list of products covered under the FAMI-QS certificate
Inspection of the premises (internal – external)
Observation if the employees perform their tasks according to the written procedure
FAMI-QS Code Version 6 (Chapter 7. Good Manufacturing Practices)
Crisis Management
The topics that shall be covered during an unannounced audit for trading activity are the following:
FAMI-QS asbl
11
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
In the event that the certified Operator refuses to participate in the unannounced audit, as defined in the contract
between the CB and the FAM-QS Operator, the certificate shall be suspended immediately, and the CB shall withdraw
the certificate, if the unannounced audit is not conducted within a six-month timeframe.
if there is a significant documented evidence that there is no effective process control in place, or that products
or services do not meet the specified requirements;
a number of minor nonconformities associated with the same requirement or issues could demonstrate a
systematic failure and thus constitute a major nonconformity.
More than 2 or 3 minor non-conformities under the same clause shall be considered as major.
FAMI-QS asbl
12
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
The auditor shall confirm that he has reviewed, accepted and verified the effectiveness of corrective actions.
Note on the “experienced employees”: An experienced employee is the employee that can demonstrate
competences related to the following aspects:
Knowing the importance of the quality of the raw material for the production process.
Understanding the principles of a Feed Safety and Quality Management System.
Knowing auditing techniques
Have been for at least three years within the Operator.
It is the FAMI-QS external auditor's responsibility to check that the requirements set according to the FAMI-QS Code
are met.
FAMI-QS asbl
13
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
Together with the Operator, the Certification Body in turn shall take appropriate action steps to assess the situation
and any implications that there may be for the Operator’s certificate. The Certification Body shall inform FAMI-QS of
the result from this assessment and its further progress.
The Operator and the Certification Body shall follow the “Feed Safety Incident and Crisis Management Procedure for
Operators and CBs” (P-CM-01).
11. Certificate
11.1. Text of the certificate
Operator’s Name
has implemented and maintains a Feed Safety and Quality Management System including Good Manufacturing Practice (GMP)
in compliance with:
FAMI-QS Code (Version x, yyyy-mm-dd)
on the following site/s(1) XXX
for Activity(2) of Specialty Feed Ingredients
From Production Process (3)
This certificate is valid until: yyyy-mm-dd
Signature of the Certification Body: Place, Date yyyy-mm-dd
(1)
For Operators running multiple manufacturing processes at different sites, it is sufficient to issue one certificate listing all the
sites.
(2)
Activity means: Production and/ or Trading. The term placing on the market may also be used but the activity production or
trade shall be specified, e.g. placing on the market (trade, production). Any other term like design and development, warehousing,
transportation is not allowed.
(3)
Production Process: The certification body shall identify and clearly state the process from which the ingredients are resulting
from: Bioprocess – Chemical – Mixing – Formulating – Mining – Extraction.
Certified companies holding valid certificates are listed on the above mentioned FAMI-QS website.
FAMI-QS asbl
14
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
A note of a withdrawn certificate will be e-mailed to all of the FAMI-QS certified companies and also uploaded on our
section news of FAMI-QS website.
The CB shall make FAMI-QS immediately aware about the suspension of a certificate. The name of the Operator will
be removed from the section certified companies on the FAMI-QS website during the period of the suspension.
A list of suspended FAMI-QS certificates will be maintained on line. Suspension cannot exceed three months. Following
that period, a FAMI-QS certified company will be removed from our website. Initial audit shall be applied if the feed
business operator wishes to restore its FAMI-QS certificate.
All the traceability and recall procedures are under the responsibility of the invoicing address.
The CB which will be responsible for the transfer shall contact FAMI-QS Secretariat prior to the transfer for pre-
approval of the transfer. FAMI-QS Secretariat will communicate any open issues if related to the transfer of the
certificate.
FAMI-QS asbl
15
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
12. Transparency
FAMI-QS is eligible to answer any questions concerning the products covered under the certificate.
In the surveillance programme process, a representative of FAMI-QS monitors the activities of the Certification Bodies
and its associated auditor(s) on the occasion of an assessment of a specific feed business Operator on site and / or at
the Certification Body’s premises. The surveillance process is compulsory for all of the authorized Certification Bodies.
Part 1: Office Audit - FAMI-QS conducts an assessment, at the Certification Body premises, to verify the
implementation of the FAMI-QS rules.
Part 2: FAMI-QS conducts an assessment of a Certification Body’s performance, during its on-site audit, with prior
agreement of the Operator.
The CBs shall include in the contracts with their clients a relevant reference, for the on-site audit with the participation
of the FAMI-QS auditor. A FAMI-QS certified Operator shall be aware that it might be selected for the FAMI-QS
Surveillance Programme.
FAMI-QS may also initiate the Surveillance Programme in case of an Operator’s complaint.
A copy of the Surveillance Programme audit report will also be made available to the Certification Body’s local
accreditation body.
Any exchange of information related to the purpose of the surveillance activities will be kept strictly confidential and
shall only be communicated between the parties involved (FAMI-QS, Certification Body)
A National Accreditation Body could have access to the Surveillance Programme report after a request.
The information obtained during the surveillance of the Certification Body, which is recorded in the report, will be
handled in a strictly confidential manner by FAMI-QS. FAMI-QS will not use it for purposes apart from those established
in the frame of the surveillance process.
FAMI-QS asbl
16
www.fami-qs.org
RULES FOR OPERATORS
VERSION 8 / 2017-10-02
For changes regarding a, b, c, d, the FAMI-QS certified Operator needs to use the FAMI-QS Changes Notification form
(D-ROP-01-03).
Certified Operators may display the FAMI-QS logo for the period of validity of their certificate. Use or display of the
FAMI-QS logo does not constitute proof that the Operator is certified.
The FAMI-QS logo is available upon request made to FAMI-QS Asbl and/or to the relevant Certification Body. It may
be used only in its original colours and proportions.
The FAMI-QS name and logo shall not be used on products, packaging, labels, means of transport, but may be used on
certificates, advertisements and brochures.
Certification Body will verify during the on-site audit the appropriate use of the logo.
FAMI-QS asbl
17
www.fami-qs.org