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FSSC 22000 VERSION 6 FOR FOOD MANUFACTURING SELF ASSESSMENT / AUDIT CHECKLIST
*MI = Minor finding, MA* = Major Finding, CR*=Critical Finding

PART 1: ISO 22000: 2018

Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
4 CONTEXT OF THE ORGANIZATION
4.1 Understanding the organization and its context
The organisation has determined external and internal issues that are relevant to
its purpose and that can affect its ability to achieve the intended results of
FSMS. The organisation has identified, reviewed, and updated external and
internal issues.

4.2 Understanding the needs and expectations of interested parties.

The organization can consistently provide products and service that meet
applicable statutory/regulatory and customer requirements with regard of food
safety, the organization shall determine and the interested parties that are
relevant to the food safety management system.

4.3 Determining the scope of the food safety management system

The organization had determined the boundaries and applicability of the food
safety management system to establish its scope the scope shall specify the
products and services processes and production sites that are addressed by the

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Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
food management systems and shall include the activities, processes product or
service that can have an influence on the food safety of the end products.

4.4 Food safety management system

The organization had established implemented, maintained, updated, and
continually improve a food safety management system including the processes
needed and their interactions, in accordance with the requirements of document.

5 LEADERSHIP

5.1 Leadership and commitment

Top management has demonstrated leadership and commitment with respect
the food safety management system by ensuring that the integration of food
safety management system requirements into the organization’s business
process and the resource needed for the food safety management system are
available etc.

5.2 Policy
Top management have established, implemented, and maintained a food safety
policy that Is appropriate to the purpose and context of organization and
provides a framework for setting and reviewing the objectives of food safety
management system.

5.2.2 Communicating the food safety policy

Top management has communicated the policy, made sure every employee
understood the food safety policy and applied the policy at all levels within the
organization.

5.3 Organizational roles, responsibilities

Top management has ensured that the responsibilities and authorities for
relevant roles are assigned, communicated, and understood within the
organization. Top management shall the responsibility and authority for ensuring

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Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
that the food safety management system conforms to the requirements of this
document and reporting on the performance of the food safety management
system to top management including appointing the food safety team and the
food safety team leaders.

6 PLANNING

6.1 Actions to address risks and opportunities.

There are actions to address these risks and opportunities How to integrate and
implement the actions into its food safety management system processes,
evaluate the effectiveness of these actions taken by the organization to address
risks and opportunities shall be proportionate and the potential impact on food
safety requirements.

6.2 Objectives of the food safety management system and planning to achieve
them
The organization has established objectives of the food safety management
system at relevant functions and levels.
The objectives of the food safety management shall be consistent with food
safety policy; authorization of results and it is measurable.

6.3 Planning of changes

The organization has determined the need for change to the food safety
management system, including personnel changes, the changes shall be carried
out and communicated in planned manner. The organization shall consider the
purpose of the changes and their potential consequence for supply and
maintenance of safe food production, the integrity of the food safety
management system, and the availability resources to effectively implement the
change including the allocation or re-allocation of responsibilities and authorities.

7 SUPPORT

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Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
7.1 Resources
The organization had provided the resources needed for the establishment,
implementation, maintenance, updating and continual improvement of the food
safety management system. The capability of and any constraints on existing
internal resources and Resources required from external source are considered.

7.1.2 People
The organization has ensured that persons necessary to operate and maintain
an effective food safety management system are competent.
Where the assistance of external experts is used, evidence of agreement or
contracts defining the competency, responsibility and authority of external
experts has been retained as documented information.

7.1.3 Infrastructure
The organization has provided the resources for the determination,
establishment and maintenance of the infrastructure necessary to achieve
conformity with the requirements of the food safety management system.
Infrastructure can include land, vessels, buildings and associated utilities,
equipment, including hardware and software, transportation, information and
communication technology.

7.1.4 Work environment

The organization has determined, provided and maintained the resources for the
establishment, management and maintenance of the work environment
necessary to achieve conformity with the requirements of the food safety
management system.
A suitable environment can be a combination of human and physical factors.

7.1.5 Externally developed elements of the food safety management system

The organisation makes use of externally developed elements for the
implemented food safety management system and ensured that the external
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Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
elements are developed in conformance with requirements, is applicable to the
site(s), specifically adapted to the processes and products of the organization, is
implemented, maintained and updated as required and retained as documented
information.

7.1.6 Control of externally provided processes, products or services 1.

The organization has established and applied criteria for the evaluation,
selection, monitoring of performance and re-evaluation of external providers of
processes, products and/or services used.

7.2 Competence
There’s necessary competence of person(s) including external providers doing
work under its control that affects its food safety performance and effectiveness
of food safety management system, ensure that these persons, including the
food safety and those responsible for operation of the hazards control plan, are
competent based on appropriate education, training, or experience.

7.3 Awareness
The organization had ensured that all persons doing work under the organization
control shall be aware of the food safety policy, the objective of the food safety
management system relevant to their task(s) and the individual contribution to
the effectiveness of the food safety management system, including the benefits
of improved food safety performance.

7.4 Communication
The organisation had established sufficient information is communicated
externally and is available for interested parties of the food chain. the
organization shall establish implement and maintain effective communications
with: External providers and contractors, customers and/or consumers in relation
to, product information to enable the safe handling display, storage,
preparations, distribution and use of product within the food chain or by the
consumer and Identified foods safety hazards that need to be controlled by the
other organizations in the food chain, and/or consumers.

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Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
7.4.2 External communication
The organization has ensured that sufficient information is communicated
externally and is available for interested parties of the food chain.
The organization has effective communications with external providers and
contractors, customers and/or consumers, statutory and regulatory authorities
and other organizations that have an impact on, or will be affected by, the
effectiveness or updating of the food safety management system.
Evidence of external communication is retained as documented information.

7.4.3 Internal communication

The organization has an effective system for communicating issues having an
impact on food safety. Ensuring that the food safety team is informed in a timely
manner of any changes to any process or procedure.

7.5 Documented information

The organization food safety management had included documented information
required by this document, document information determined by the organization
as being necessary for the effectiveness of the food safety management system
and documented information and food safety requirements required by
statutory/regulatory authorities and customer.

7.5.2 Creating and updating

The organization has the appropriate identification and description, format and
review and approval processes for suitability and adequacy of documents.

7.5.3 Control of documented information

All documented information is available and suitable for its use, is adequately
protected, distributed, and retrieved as needed, stored and preserved
adequately, controlled with regards to changes/ updates, retained and correctly

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Category
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MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
disposed of when required.

8 OPERATION

8.1 Operation planning and control

The organization has met the requirements for the realization of safe products
and implemented control and record keeping for the established criteria of the
processes.

8.2 Prerequisite programs (PRPs) 1.

There’s establishment of the hazard control plan, the organization shall update
the following information, if necessary, characteristics of raw materials,
ingredients, and product – contact materials, characteristics of end product
intended use and flow diagrams and description of processes and process
environment.

8.3 Traceability system

The traceability system can uniquely identify any component of any process
from incoming material from the suppliers to the first stage of the distribution
route of the end product. This included rework of materials/ products.

8.4 Emergency preparedness and response

Top management has prepared and planned to identify preventive actions that
deal with potential emergency situation and incidents that may impact on food
safety and which are relevant to the role of the organization in the food chain.

8.4.2 Handling of emergencies and incidents

The organisation can respond to actual emergency situations and take action to
reduce the consequences of the emergency situation, including the impact on
food safety during an emergency. Able to periodically test procedures where
practical and update the documented information after the occurrence of any

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Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
incident, emergency situation or tests.

8.5 Hazard control

The hazard analysis preliminary information had been collected, updated, and
maintained by the food safety team. This shall include but not be limited to the
organization products, processes, customers’ requirements, equipment, and
food safety hazards relevant to the food safety management system.

8.5.1 Preliminary steps to enable hazard analysis

The organization has carried out the hazard analysis, preliminary documented
information has been collected, maintained and updated by the food safety
team. This includes applicable statutory, regulatory and customer requirements,
the organization’s products, processes and equipment and relevant food safety
hazards.

8.5.1.2 Characteristics of raw materials, ingredients and product contact materials

The organization has ensured that all applicable statutory and regulatory food
safety requirements are identified for all raw materials, ingredients and product
contact materials. Has maintained documented information concerning all raw
materials, ingredients and product contact materials to the extent needed to
conduct the hazard analysis.

8.5.1.3 Characteristics of end products

The organization ensured that all applicable statutory and regulatory food safety
requirements are identified for all the end products intended to be produced.
Also maintain documented information concerning the characteristics of end
products to the extent needed to conduct the hazard analysis.

8.5.1.4 Intended use

The intended use, including reasonably expected handling of the end product
and any unintended use but reasonably expected mishandling and misuse of the
end product, is considered and shall be maintained as documented information

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Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
to the extent needed to conduct the hazard analysis.

8.5.1.5 Flow diagrams and description of processes 1.

The food safety team has established, updated flow diagrams as documented
information for the products or product categories and the processes covered by
the food safety management system.

8.5.1.5.1 Preparation of the flow diagrams

Flow diagrams are clear, accurate and sufficiently detailed to the extent needed
to conduct the hazard analysis.

8.5.1.5.2 On-site confirmation of flow diagrams

The food safety team has confirmed on-site the accuracy of the flow diagrams,
update the flow diagrams where appropriate and retained the documented
information.

8.5.1.5.3 Description of processes and process environment

The food safety team shall describe, to the extent needed to conduct the hazard
analysis, the layout of premises, including food and non-food handling areas,
processing equipment and contact materials, existing PRPs, external
requirements that can impact the choice and the strictness of the control
measures and variations resulting from expected seasonal changes or shift
patterns.

8.5.2 Hazard analysis

The food safety team has conducted a hazard analysis, based on the
preliminary information and determined the hazards that needs to be controlled.

8.5.2.2 Hazard identification and determination of acceptable levels

The organization has identified and documented all food safety hazards that are
reasonably expected to occur in relation to the type of product, type of process

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Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
and process environment.

8.5.2.3 Hazard assessment

The organization has conducted, for each identified food safety hazard, a hazard
assessment to determine whether its prevention or reduction to an acceptable
level is essential.

8.5.2.4 Selection and categorization of control measure(s)

Based on the hazard assessment, the organization has selected appropriate
control measures or combination of control measures that will be capable of
preventing or reducing the identified significant food safety hazards to defined
acceptable levels.
The organization has categorized the selected identified control measures to be
managed as OPRP(s) or at CCPs. The categorization is carried out using a
systematic approach.

8.5.3 Validation of control measure(s) and combinations of control measures

The food safety team has validated that the selected control measures can
achieve the intended control of the significant food safety hazard(s).
The validation was done prior to implementation of control measure(s) to be
included in the hazard control plan and after any change therein.

8.5.4 Hazard control plan (HACCP/OPRP plan)

The hazard control plan includes the following information for each control
measure at each CCP or OPR:
Food safety hazards to be controlled at the CCP or by the OPRP, critical limit(s)
at CCP or action criteria for OPRP, monitoring procedures, corrections to be
made, records of monitoring, responsibilities and authorities.

8.5.4.2 Determination of critical limits and action criteria

Critical limits at CCPs and action criteria for OPRPs are specified. The rationale
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Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
for their determination is documented.
Critical limits at CCPs are measurable and action criteria for OPRPs are
measurable or observable.

8.5.4.3 Monitoring systems at CCPs and for OPRPs

At each CCP, a monitoring system is established for each control measures to
detect any failure to remain within the critical limits. The system includes all
scheduled measurements relative to the critical limits.
For each OPRP, a monitoring system is established for the control measures to
detect failure to meet the action criterion.

8.5.4.4 Actions when critical limits or action criteria are not met
The organization has specified corrections and corrective actions to be taken
when critical limits or action criterion are not met. Actions include potentially
unsafe products are not released; the cause of nonconformity is identified, and
recurrence is prevented.

8.5.4.5 Implementation of the hazard control plan

The organization has implemented and maintained the hazard control plan and
retain evidence of the implementation as documented information.

8.6 Updating the information specifying the PRPs and the hazard control plan
There’s establishment of the hazard control plan, the organization shall update
the following information, if necessary, characteristics of raw materials,
ingredients, and product – contact materials, characteristics of product intended
use and flow diagrams and description of processes and process environment.
When required, the hazard control plan and/or the PRP(s) shall be updated.

8.7 Control of monitoring and measuring

The organization had provided evidence that the specified monitoring and
measuring methods and equipment is in use is adequate for the monitoring and
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Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
measuring activities related to the PRP(s) and the hazard control plan.
The monitoring and measuring the equipment used shall be calibrate or verified
at specified intervals prior to use, adjusted or re-adjusted as necessary, identify
to enable the calibration status to be determined.
Safeguard from adjustments that would invalidate the measurement result; and
protect from damage and deterioration.
The results of calibration and verification shall be retained as documented
information. The calibration of equipment shall be traceable to international
measurements standards.

8.8 Verification related to PRPs and the hazard control plan

8.8.1 Verification
The organization shall establish, implement and maintain verification activities.
The verification planning shall define purpose, methods, frequencies and
responsibilities for the verification activities. The verification activities shall
confirm that:
 the PRP(s) are implemented and effective;
 the hazard control plan is implemented and effective;
 hazard levels are within identified acceptable levels;
 input to the hazard analysis is updated;
 other actions determined by the organization are implemented and
effective.

8.8.2 Analysis of results of verification activities

The food safety team has conducted an analysis of the results of verification that
shall be used as an input to the performance evaluation of the food management
system.

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Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
8.9 Verification related to PRPs and the hazard control plan
The organization had ensured that data derived from monitoring of OPRPs and
CCPs are evaluated by designated persons with sufficient competence and
authority to initiate corrective actions and corrections.

8.9.2 Corrections
The organization had ensured that when critical limits at CCPs and/or action
criteria for OPRPs are not met, the products affected are identified and
controlled about their use and release.
The organization has established, maintained and updated documented
information that includes methods of identification assessment, correction for
affected products to ensure their proper handling: and arrangements for review
of corrections carried out.

8.9.3 Corrective action 1.

The need for corrective action shall be evaluated when critical limits at CCPs
and/or action criteria for OPRPs are not met.
The organization shall establish and maintain document information that specify
appropriate action to identify and eliminate the cause of detected
nonconformities, to prevent recurrence, and to return the process to control after
a nonconformity is identified.
This action shall include reviewing nonconformities identified by customers
and/or consumer complaints/regulatory inspection reports, reviewing trends in
monitoring results that may indicate loss of control and determining the cause (s)
of nonconformities, documenting the results of corrective action taken; and
reviewing corrective action taken to ensure that they are effective.
Document information on all corrective actions shall be retained.

8.9.4 Handling of potentially unsafe products

8.9.4.2 Evaluation for release

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MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
Each lot of products affected by the nonconformity shall be evaluated. Products
affected by failure to remain within critical limits at CCPs shall not be released.

8.9.4.3 Disposition of nonconforming products

Products that are not acceptable for release shall be:
 reprocessed or further processed within or outside the organization to
ensure that the food safety hazard is reduced to acceptable levels
 redirected for other use as long as food safety in the food chain is not
affected.
 destroyed and/or disposed as waste.
Documented information on the disposition of nonconforming products, including
the identification of the persons with approving authority shall be retained.

8.9.5 Withdrawal/ Recall

The organization can ensure the timely withdrawal/ recall of lots of end products
that have been identified as potentially unsafe, by appointing competent
persons, having the authority to initiate and carry out the withdrawal/recall. The
organization shall establish and maintain documented information of the entire
recall process.

9 PERFORMANCE EVALUATION

9.1 Monitoring, measuring, analysis and evaluation.

The organization had determined what need to be monitored and measured, the
method for monitoring the measurements, analysis, and evaluation, as
applicable, to ensure valid results, when the monitoring shall be performed.
The organization had retained appropriate documented information as
evidence of the results. The organization had evaluated performance and the
effectiveness of the food safety management system.

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Finding
Conform? Remark
Category
Clause Requirement
MI*, MA*, *If no – details NC reference *Justify “not
Yes No
CR* applicable” clauses
9.1.2 Analysis and evaluation
The organization has analysed and evaluated appropriate data and information
arising from monitoring and measurement, including the results of verification
activities related to PRPs and the hazard control plan, the internal and external
audits.

9.2 Internal audit

The organization had planned, established, implemented, and maintained and
audit programme(s) including the frequency, methods, responsibilities, planning
requirements and reporting, which shall take into consideration the importance
of the process concerned changes in the food safety management system, and
a results of monitoring measurements and previous audits

9.3 Management review

Top management had reviewed the organization’s food safety management
system, at planned intervals, to ensure its continuing suitability, adequacy, and
effectiveness.

The Management review input 1.

The management review shall consider the following:
 The status of actions from previous management reviews.
 Changes in external and internal issues that are relevant to the food
safety management system.
 Information on the performance and the effectiveness of the food safety
management system.
 The adequacy of resources.
 Any emergency situation, incident or withdrawal/recall that occurred.
 Opportunities for continual improvement.
The data shall be presented in a manner that enables top management to relate

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Yes No
CR* applicable” clauses
the information to stated objectives of the food safety management system.

9.3.3 Management review output

The outputs of the management review shall include the following:
 Decisions and actions related to continual improvement opportunities.
 Any need for updates and changes to the food safety management
system.

10 IMPROVEMENT

10.1 Nonconformity and corrective action

The organization shall retain documented information as evidence of the nature
nonconformities and any subsequent action taken.

10.2 Continual improvement

Top management shall ensure that FSMS is continually updated. To achieve
this, the food safety team shall evaluate the food safety management system at
planned intervals. The team shall then consider whether it necessary to review
the hazard analysis (see8.5.2), the establish hazard control plan (see 8.5.4). the
establish PRPs (see 8.2). the updating activities shall be based on input form
communication external as well as internal.

10.3 Update of the food safety management system

The organizational had continually improved the suitability, adequacy, and
effectiveness of the food safety management system to enhance the operation
of the organization.
Top management shall ensure that the organization continually improve the
effectiveness of the food safety management system through the use of
communication (see 7.4), management system through the use of
communication (see9.3), and internal audit (see 9.2), analysis of result of
verification activities, validation of control measure(s) and combination (s) of
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Yes No
CR* applicable” clauses
control measure(s) (, corrective actions (see 8.9.2) and food safety management
system updating (see 10.2).

Summary:

PART 2: ISO/TS 22002:1-2009 for Food Manufacturing

Clause Requirement Conform? Finding Remark
Category

Yes No MI*, MA*, *If no – details NC reference *Justify “not

CR* applicable” clauses

4 CONSTRUCTION AND LAYOUT OF BUILDINGS

4.1 General requirements

Buildings shall be designed, constructed and maintained in a manner
appropriate to the nature of the processing operations to be carried out, the food
safety hazards associated with the operations and the potential sources of
contamination from the environment.
Buildings is of durable construction which presents no hazard to the product.

4.2 Environment
Consideration given to potential sources of contamination from the environment.
Food production should not be carried out in areas where potentially harmful
substances could enter the product.
Effective measurements taken to protect against potential contaminants are
periodically reviewed.

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Category

Yes No MI*, MA*, *If no – details NC reference *Justify “not

CR* applicable” clauses

4.3 Locations of establishments

Site boundaries clearly identified. Access to site is controlled. Site must be
maintained in very good order. Vegetation to be removed/ tended to. Roads,
yards and parking areas properly drained to prevent standing water.

5 LAYOUT OF PREMISES AND WORKSPACE

5.1 General requirements

Internal layouts are maintained to facilitate good hygiene and manufacturing
practices.
The movement patterns of materials, products, people and the layout of
equipment is designed to protect against potential contamination.

5.2 Internal design, layout and traffic patterns

The building has adequate space, with a logical flow of materials, products and
personnel. Also physical separation of raw and processed areas.

5.3 Internal structures and fittings

Process are walls and floors are washable/ cleanable, as appropriate for the
process or product hazard. Materials of construction is resistant to the cleaning
system applied.
 Wall floor junctions and corners are rounded in processing areas to
facilitate cleaning.
 Floors to be designed to avoid standing water.
 In wet process areas, floors are sealed and drained, the drains are
trapped and covered.
 Ceilings and overhead fixtures are designed to minimise build-up of dirt
and condensation.
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CR* applicable” clauses

 External opening windows, roof vents or fan, where present, are insect
screened.
 External opening doors are closed or screened when not in use.

5.4 Location of equipment

Equipment to be designed and located to facilitate good hygiene practices and
monitoring. Equipment is located to permit operation, cleaning and maintenance.

5.5 Laboratory facilities

In-line and on-line test facilities are controlled to minimise the risk of product
contamination.
Microbiological laboratories are designed, located and operated to prevent
contamination of people, plant and products. They shall not open directly to
production areas.

5.6 Temporary or mobile premises and vending machines

Designed, located and constructed to prevent pest harbourage and potential
contamination of products.
Additional hazards associated with temporary structures and vending machines
to be controlled.

5.7 Storage of food, packaging materials, ingredients and non-food chemicals

Facilities used to store ingredients, packaging and products provide protection
against dust, condensation, drains, waste and other sources of contamination.
Stage areas are dry and well ventilated. Monitoring and control of temperature
and humidity are applied where specified.
Storage areas designed or arranged to allow segregation of raw materials, work
in progress and finished products.

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CR* applicable” clauses

All materials and products to be stored off the floor and with sufficient space
between materials and the walls to allow inspection and pest control activities to
be carried out.
The storage area designed to allow maintenance and cleaning, prevent
contamination and minimise deterioration.
A separate, secure storage area provided for cleaning materials, chemicals and
other hazardous substances.
Exceptions for bulk or agricultural crop materials to be documented in the food
safety management system.

6 UTILITIES – AIR, WATER, ENERGY

6.1 General requirements

The provisions and distribution routes for utilities to and around processing and
storage areas are designed to minimise the risk of product contamination.
Utilities’ quality to be monitored to minimise product contamination risk.

6.2 Water supply

The supply of potable water must be sufficient to meet the needs of the
production processes. Facilities for storage, distribution and where needed,
temperature control of the water is designed to meet specified water quality
requirements.
Water used as product ingredient, including ice or steam (including culinary
steam), or in contact with products or product surfaces, must meet specified
quality and microbiological requirements relevant to the product.
Water for cleaning or applications where there is a risk of indirect product
contact must meet specified quality and microbiological requirements to the
application.
Where water supplies are chlorinated, checks are done to ensure the residual
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chlorine levels at the point of use remains withing the limits given in relevant
specifications.
Non-potable water must have a separate supply system that is labelled and not
connected to the potable water system. Take measures to prevent the non-
potable water refluxing into the potable system.

6.3 Boiler chemicals

Boiler chemicals, if used, are either:
 approved food additives which meet relevant additive specifications.
 additives which have been approved by the relevant regulatory authority
as safe for use in water intended for human consumption.
Boiler chemicals are stored in a separate, secure (locked or otherwise access-
controlled) area when not in immediate use.

6.4 Air quality and ventilation

The organization has established requirements for filtration, humidity (RH%) and
microbiology of air used as an ingredient or for direct product contact Where
temperature and/or humidity are deemed critical by the organization, a control
system is put in place and monitored.
Ventilation (natural or mechanical) is provided to remove excess or unwanted
steam, dust and odours, and to facilitate drying after wet cleaning.
Room air supply quality is controlled to minimise risk from airborne
microbiological contamination.
Ventilation systems are designed and constructed such that air does not flow
from contaminated or raw areas to clean areas. Specified air pressure
differentials shall be maintained. Systems shall be accessible for cleaning, filter
changing and maintenance.

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Exterior air intake ports shall be examined periodically for physical integrity.

6.5 Compressed air and other gases

Compressed air, carbon dioxide, nitrogen and other gas systems used in
manufacturing and/or filling shall be constructed and maintained to prevent
contamination.
Gases intended for direct or incidental product contact is from a source
approved for food contact use, filtered to remove dust, oil and water.
Where oil is used for compressors, the oil used must be food grade.

6.6 Lighting
The lighting provided (natural or artificial) will allow personnel to operate in a
hygienic manner. The intensity of the lighting is appropriate to the nature of
operations.
Light fixtures are protected to ensure that materials, product or equipment are
not contaminated in the case of breakages.

7 WASTE DISPOSAL

7.1 General requirements

Systems are in place to ensure that waste materials are identified, collected,
removed and disposed of in a manner which prevents contamination of products
or production areas.

7.2 Containers for waste and inedible or hazardous substances

Containers for waste and inedible or hazardous substances shall be clearly
identified for their intended purpose, located in a designated area, constructed of
impervious material which can be readily cleaned and sanitized, closed when not

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in immediate use and locked where the waste may pose a risk to the product.

7.3 Waste management and removal

Provision is made for the segregation, storage and removal of waste.
Accumulation of waste is not allowed in food-handling or storage areas.
Labelled materials, products or printed packaging designated as waste shall be
disfigured or destroyed to ensure that trademarks cannot be reused.
Removal and destruction are carried out by approved disposal contractors. The
organization shall retain records of destruction.

7.4 Drains and drainage

Drains are designed, constructed and located so that the risk of contamination of
materials or products is avoided. Drains shall have capacity sufficient to remove
expected flow loads. Drains shall not pass over processing lines.
Drainage direction shall not flow from a contaminated area to a clean area

8 EQUIPMENT SUITABILITY, CLEANING, AND MAINTENANCE

8.1 General requirements

Food contact equipment is designed and constructed to facilitate cleaning,
disinfection and maintenance. Contact surfaces are not affected by the intended
product or cleaning system.
Food contact equipment shall be constructed of durable materials able to resist
repeated cleaning.

8.2 Hygienic design

Equipment can meet established principles of hygienic design, including smooth,
accessible, cleanable surfaces, self-draining in wet process areas, framework
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not penetrated by holes or nuts and bolts.

Piping and ductwork are cleanable, drainable, and with no dead ends.
Equipment is designed to minimize contact between the operator's hands and
the products.

8.3 Product contact surfaces

Product contact surfaces are constructed from materials designed for food use.
They shall be impermeable and rust or corrosion free.

8.4 Temperature control and monitoring equipment

Equipment used for thermal processes is able to meet the temperature gradient
and holding conditions given in relevant product specifications.
Equipment supports the monitoring and control of the temperature.

8.5 Cleaning plant, utensils and equipment

Wet and dry-cleaning programmes are documented to ensure that all plant,
utensils and equipment are cleaned at defined frequencies.
The programmes do specify what is to be cleaned (including drains), the
responsibility, the method of cleaning (e.g., CIP, COP), the use of dedicated
cleaning tools, removal or disassembly requirements and methods for verifying
the effectiveness of the cleaning.

8.6 Preventive and corrective maintenance

The preventive maintenance programme includes all devices used to monitor
and/or control food safety hazards.
Corrective maintenance shall be carried out in such a way that production on
adjoining lines or equipment is not at risk of contamination.
Lubricants and heat transfer fluids are food grade where there is a risk of direct
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or indirect contact with the product.

The procedure for releasing maintained equipment back to production includes
clean up, sanitizing, where specified in process sanitation procedures, and pre-
use inspection.
Maintenance personnel shall be trained in the product hazards associated with
their activities.

9 MANAGEMENT OF PURCHASED MATERIALS

9.1 General requirements

Purchasing of materials which impact food safety are controlled to ensure that
the suppliers used have the capability to meet the specified requirements. The
conformance of incoming materials to specified purchase requirements shall be
verified.

9.2 Selection and management of suppliers

There is a defined process for the selection, approval and monitoring of
suppliers. The process used is justified by hazard assessment, including the
potential risk to the final product, and includes assessment of the supplier's
ability to meet quality and food safety expectations, requirements and
specifications and description of how suppliers are assessed.

9.3 Incoming material requirements (raw/ingredients/packaging)

Delivery vehicles are checked prior to, and during, unloading to verify that the
quality and safety of the material has been maintained during transit.
Materials are inspected, tested or covered by COA to verify conformity with
specified requirements prior to acceptance or use. The method of verification is
documented.

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10 MEASURES FOR PREVENTION OF CROSS-CONTAMINATION

10.1 General requirements

Programmes must in place to prevent, control and detect contamination.
Measures to prevent physical, allergen and microbiological contamination are
included.

10.2 Microbiological cross-contamination

Areas where potential microbiological cross-contamination exists, the hazard is
identified and segregated. Control measures are in place, suitable for each area
of processing as follows:
Separation of raw from finished or ready to eat products. This can be structural
segregation - physical barriers, walls or separate buildings.
Access controls with requirements to change into required workwear.
Traffic patterns or equipment segregation.
Air pressure differentials.

10.3 Allergen management

Allergens present in the product, either by design or by potential manufacturing
cross-contact, is declared. The declaration is on the label for consumer products,
and on the label or the accompanying documentation for products intended for
further processing.
Products are protected from unintended allergen cross-contact by cleaning and
line change-over practices and/or product sequencing.
Rework containing allergens are used only in products which contain the same
allergen(s) or through a process which is demonstrated to remove or destroy the
allergenic material.

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10.4 Physical contamination

Where brittle materials are used, periodic inspection requirements and defined
procedures in case of breakage is in place.
Glass breakage records are maintained.
Measures are in place to prevent, control or detect potential contamination.

11 CLEANING AND SANITIZING

11.1 General requirements

Cleaning and sanitizing programmes are established to ensure that the food-
processing equipment and environment are maintained in a hygienic condition.
Programmes are monitored for continuing suitability and effectiveness.

11.2 Cleaning and sanitizing agents and tools

Cleaning and sanitizing agents and chemicals are clearly identified, food grade,
stored separately and used only in accordance with the manufacturer's
instructions.
Tools and equipment are of hygienic design and maintained in a condition which
does not present a potential source of contamination.

11.3 Cleaning and sanitizing programmes

Established and validated by the organization to ensure that all parts of the
establishment and equipment are cleaned and/or sanitized to a defined
schedule, including the cleaning of cleaning equipment.
Cleaning and/or sanitizing programmes must specify:
 Areas, items of equipment and utensils to be cleaned and/or sanitized.
 responsibility for the tasks specified.

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 cleaning/sanitizing method and frequency.

 monitoring and verification arrangements.
 post-clean inspections.
 pre-start-up inspections.

11.4 Cleaning in place (CIP) systems

CIP systems are separated from active product lines.
Parameters for CIP systems are defined and monitored (type, concentration,
contact time and temperature of any chemicals used).

11.5 Monitoring sanitation effectiveness

Cleaning and sanitation programmes are monitored at frequencies specified by
the organization to ensure their continuing suitability and effectiveness.

12 PEST CONTROL

12.1 General requirements

Hygiene, cleaning, incoming materials inspection and monitoring procedures are
implemented to avoid creating an environment conducive to pest activity.

12.2 Pest control programmes

The establishment has a nominated person to manage pest control activities
and/or deal with appointed expert contractors.
Pest management programmes are documented and shall identify target pests,
and address plans, methods, schedules, control procedures and, where
necessary, training requirements.
Programmes include a list of chemicals which are approved for use in specified

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areas of the establishment.

12.3 Preventing access

Holes, drains and other potential pest access points are sealed.
External doors, windows or ventilation openings are designed to minimize the
potential for entry of pests.

12.4 Harbourage and infestations

Storage practices minimize the availability of food and water to pests.
Material found to be infested are handled in to prevent contamination of other
materials, products or the establishment.
Potential pest harbourage (e.g. burrows) are removed.
Where outside space is used for storage, stored items shall be protected from
weather or pest damage.

12.5 Monitoring and detection

Pest-monitoring programmes include the placing of detectors and traps in key
locations to identify pest activity.
A map of detectors and traps are maintained. Detectors and traps are designed
and located to prevent potential contamination of materials, products or facilities.
Detectors and traps are of robust, tamper-resistant construction. They are
appropriate for the target pest.
The detectors and traps are inspected at a frequency intended to identify new
pest activity. The results of inspections are analysed to identify trends.

12.6 Eradication 1.
Eradication measures are initiated immediately after evidence of infestation is

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reported.
Pesticide use and application is restricted to trained operatives and are
controlled to avoid product safety hazards.
Records of pesticide use are maintained to show the type, quantity and
concentrations used; where, when and how applied, and the target pest.

13 PERSONAL HYGIENE AND EMPLOYEE FACILITIES

13.1 General requirements

Personal hygiene and behaviour procedures related to the hazard posed to the
process area or product are established and documented. All personnel, visitors
and contractors are required to comply with the documented requirements.

13.2 Personnel hygiene facilities and toilets

Clearly designated personnel hygiene facilities are made available to ensure that
the degree of personal hygiene required by the organization can be maintained.
The establishment has adequate resources for proper handwashing practices,
sinks solely designated for handwashing, a sufficient number of toilets, ensures
the hygiene facilities do not open into production areas and have adequate
changing facilities.

13.3 Staff canteens and designated eating areas

Staff canteens and designated areas for food storage and consumption is
situated so that the potential for cross-contamination of production areas is
minimized.
Storage, cooking and holding temperatures, and time limitations, shall be
specified.

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13.4 Workwear and protective clothing

Personnel who work in, or enter into, areas where exposed products and/or
materials are handled wear work clothing.
Workwear must not have buttons or outside pockets above waist level.
Zips or press stud fastenings are acceptable.
Workwear is laundered to standards and at intervals suitable for the intended
use of the garments.
Workwear provides adequate coverage to ensure that hair, perspiration, etc.
cannot contaminate the product, unless hazard analysis indicates otherwise.
Where gloves are used for product contact, they are clean and in good condition.
Use of latex gloves should be avoided.
Shoes for use in processing areas fully enclose the foot and is made from non-
absorbent materials.

13.5 Health status

Employees undergo a medical examination prior to employment in food contact
operations (including site catering) unless documented hazard or medical
assessment indicates otherwise. (subject to legal restrictions in the country of
operation)
Additional medical examinations, where permitted, are carried out at intervals
defined by the organization.

13.6 Illness and injuries

Employees are required to report to management for possible exclusion from
food-handling areas when their illness pose a significant risk to the food being
handled/ processed. These reports are documented and recorded.

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13.7 Personal cleanliness

Monitoring measures in place to record any deviations from personal
cleanliness.

13.8 Personal behaviour

A documented policy that describes the behaviours required of personnel in
processing, packing and storage areas.

14 REWORK

14.1 General requirements

Rework is stored, handled and used in such a way that product safety, quality,
traceability and regulatory compliance are maintained.

14.2 Storage, identification, and traceability

Segregation requirements for rework (e.g. allergen) shall be documented.
Reworked products are clearly identified and/or labelled to allow traceability.
The reason for rework designation is recorded (e.g. product name, production
date, shift, line of origin, shelf-life).

14.3 Rework usage

Where rework is incorporated into a product as an "in-process" step, the
acceptable quantity, type and conditions of rework use is specified. The process
step and method of addition, including any necessary pre-processing stages, is
defined.
Where rework activities involve removing a product from filled or wrapped
packages, controls are put in place to ensure the removal and segregation of
packaging materials and to avoid contamination of the product with extraneous

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matter.

15 PRODUCT RECALL PROCEDURES

15.1 General requirements

Systems are in place to ensure that products failing to meet required food safety
standards can be identified, located and removed from all necessary points of
the supply chain.

15.2 Product recall requirements

A list of key contacts in the event of a recall is maintained.
Where products are withdrawn due to immediate health hazards, the safety of
other products produced under the same conditions is evaluated. The need for
public warnings shall be considered.

16 WAREHOUSING

16.1 General requirements

Materials and products are stored in clean, dry, well-ventilated spaces protected
from dust, condensation, fumes, odours or other sources of contamination.

16.2 Warehousing requirements

Effective control of warehousing temperature, humidity and other environmental
conditions is provided where required by product or storage specifications.
Where products are stacked, are the lower levels protected?
Waste materials and chemicals are stored separately.
All non-conforming materials are segregated and easily identified.

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Specified stock rotation systems in place (FIFO).

Gasoline- or diesel-powered fork-lift trucks are not used in food ingredient or
product storage areas.

16.3 Vehicles, conveyances, and containers

Vehicles, conveyances, and containers are maintained in a state of repair and
cleanliness. Also provide protection against damage or contamination of the
product.
Cleaning to be carried out between loads and records are kept of cleaning
activities.
Bulk containers are dedicated to food use only.

17 PRODUCT INFORMATION / CONSUMER AWARENESS

17 Consumers are made aware of the product and its importance so that they can
make informed decisions regarding the product.
Information relayed in the form of labels, advertisements or company websites.

18 FOOD DEFENCE, BIOVIGILANCE AND BIOTERRORISM

18.1 General requirements

The establishment has assessed the hazards to products posed by potential
acts of sabotage, vandalism or terrorism and has put in place proportional
protective measures.

18.2 Access controls

Potentially sensitive areas are access controlled.

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Access should be physically restricted by use of locks, electronic card key or

alternative systems.

Summary:

PART 3: FSSC 22000 V6 Additional Requirements

Clause Requirement Conform? Finding Remark
Category

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CR* applicable” clauses

2.5.1 MANAGEMENT OF SERVICES AND PURCHASED MATERIALS

2.5.1(a) Management of Services

Laboratory analysis services used for the verification and/or validation of food
safety, are competent laboratory (external and internal) that have a capability to
produce precise and repeatable test results using validated test methods and
best practices.

2.5.1(b) Emergency Procurement (C, D, I, FII, G, and K)

The organisation has a documented procedure for procurement for emergency
situations to ensure that products still conform to specified requirements and the
supplier has been evaluated.

2.5.1(c) Product specifications review procedure (C0, CI, CIII, and CIV)

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The organisation has a policy for the procurement of animals, fish, and seafoods
that are subject to control of prohibited substances (e.g., Pharmaceuticals,
Veterinary, medicines, heavy metals, and pesticides.

2.5.1(d) Raw Material and Finished product Specification (C, D, I, FII, G, and K)
The organisation shall establish, implement, and maintain a review process for
raw material and finished product specifications to ensure continued compliance
with food safety, quality, legal and customer requirements.

2.5.1(e) Recycled Packaging (I)

The organisation shall establish criteria related to the use of recycled packaging
as a raw material input into the production of finished packaging material and
ensure that relevant legal and customer requirements are met.

2.5.2 PRODUCT LABELLING

2.5.2(a) The organisation has ensured that finished products are labelled according to all
applicable statutory and regulatory requirements in the country of intended sale,
including allergen and customer specific requirements.

2.5.2(b) Where the product is unlabelled, all relevant product information shall be made
available to ensure the safe use of food by the customer or consumer.

2.5.3(c) Where a claim (e.g., allergen, nutritional, method of production, chain of custody,
raw material status, etc) is made on the product label or packaging, the
organisation shall maintain evidence of validation to support the claim and shall
have verification systems in place, including traceability and mass balance, to
ensure product integrity is maintained.

2.5.3(d) Food Chain category I, artwork management and print control procedures shall n/a
be established and implemented to ensure the printed material meets applicable

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customer and legal requirements. The procedures must include the following
information:
1. Approval of artwork standard or masterpiece.
2. Process to manage changes to artwork and print specifications and to
manage obsolete artwork and printing materials.
3. Approval of each print run against the agreed standard or master
sample.
4. Process to ensure effective segregation of differing print variation.
5. Process to account for any unused printed material.

2.5.3 FOOD DEFENSE

2.5.3.1 Threat Assessment

The organisation has:
a) Conducted and documented the food threat assessment, based on a
defined methodology, to identify and evaluate potential threats linked to
the process and products within the scope of the organisation: and
b) Developed and implemented appropriate mitigation measures for
significant threats.

2.5.3.2 Plan
a) The organization has a documented food defence plan specifying the
mitigation measures and verification procedures.
b) The food defence plan shall be implemented ad supported by the
organisations FSMS.
c) The plan complies with applicable legislation, cover the process and
products within the scope of the organisation and be kept up to date.

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d) For food category FII, in addition to above, the organisation ensured that
their suppliers have a food defence plan in place.

2.5.4 FOOD FRAUD MITIGATION

2.5.4.1 Vulnerability Assessment

The organisation has:
a) Conducted and documented the food fraud vulnerability assessment,
based on a defined methodology. To identify and assess potential
vulnerability; and
b) Developed and implemented appropriate mitigation measures for
significant vulnerabilities. The assessment shall cover the process and
products within the scope of the organisation.

2.5.4.2 Plan
a) The organisation has a documented food defence plan, based on the
threats assessment, specifying the mitigation measures and verification
procedures.
b) The food defence plan is implemented and supported by the
organisations FSMS.
c) The plan shall comply with applicable legislation, cover the process and
products within the scope of the organisation and be kept up to date.
d) For food chain category FII, in addition to the above, the organisation
shall ensure that the suppliers have a food defence plan in place.

2.5.5 LOGO USE

2.5.5 The FSSC 22000 logo can only be used for marketing activities such as the
organization's printed matter and / or website and another promotional material.
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2.5.6 MANAGEMENT OF ALLERGENS (ALL)

2.5.6 The organization has a documented allergen management plan that includes: 
a) A list of all the allergens handled on site, including in raw material and
finished products.
b) Risk assessment covering all potential sources of allergens cross-
contamination.
c) Identification and implementation of control measures to reduce or
eliminate the risk of cross-contamination, based on outcome of the risk
assessment; and
d) Validation and verification of these control measures shall be
implemented and maintained as documented information. Where more
than one product is produced in the same production area that has
different allergen profiles, verification testing shall be conducted at a
frequency based on risk e.g., surface testing, air sampling, and/or
product testing.
e) Precautionary or warning labels shall only be used where the outcome of
the risk assessment identifies allergen cross contamination as a risk to
the customer, even though all the necessary control measures have
been effectively implemented. Applying warning labels does not exempt
the organisation from implementation the necessary allergen control
measures or undertaking verification testing.
f) All personnel shall receive training in allergen awareness and specific
training on allergen control measures associated with their area of work.
g) The allergen management plan shall be reviewed at least annually, and
following any significant change that impacts food safety, a public recall
or a product withdrawal by the organisation as a result of an allergen/s,
or when trends in the industry show contamination or similar products
relating to allergens. The review shall include an evaluation of the

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effectiveness of existing control measures and the need for additional

measures verification data shall be trended and used as input for the
review.
h) For food chain Category D: Where there is no allergen-related legislation
for the country of the sale pertaining to animal feed, this section of the
scheme requirements may be indicated as Not Applicable, unless a
claim relating to an allergen status has been made on the animal feed.

2.5.7 ENVIRONMENTAL MONITORING (C, I AND K)

2.5.7 The organization has in place:

a) Risk-based environmental monitoring program.
b) Documented procedure for the evaluation of the effectiveness of all
controls on preventing contamination from the manufacturing
environment and this shall include, at a minimum, the evaluation of
microbiological and allergen controls present.
c) Data of the monitoring activities including regular trend analysis.
d) The program must be reviewed at least annually and more frequently if
required including when the following triggers occurs:
- Significant changes related to product, processes or legislation.
- When no positive testing results have been obtained over an extended
period:
- Trend in out of specification microbial results, related to both
intermediate and finished products, linked to environmental monitoring.
- A repeated detection of pathogens during routine environmental
monitoring; and
- When there are alerts, recalls, or withdrawals relating to product/s

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produced by the organisation.

2.5.8 FOOD SAFETY AND QAULITY CULTURE (ALL)

2.5.8(a) As part of the organisations commitment to cultivating a positive food safety and
quality culture, senior management shall establish, implement and maintain a
food safety and quality culture objective(s) as part of the management system:
The following shall be addressed at minimum:
 Communication
 Training
 Employee feedback and engagement
 Performance measurement of defined activities covering all sections of
the organisation impacting on the food safety and quality.

2.4.8(b) The objective(s) shall be supported by a document food safety and quality
culture plan, with targets and timelines and included in the management review
and continuous improvements process of the management system.

2.5.9 QUALITY CONTROL (ALL)

2.5.9 (a) The organisation has:

I. Establish, implement, and maintain policy and quality objectives.
II. Establish implement and maintain quality parameters in line with
finished product specifications, for all products and/or product
groups within the scope of certification including product release
that addresses quality control and testing.
III. In addition to and aligned with clauses 9.1 and 9.3 od ISO
22000:2018 undertake analysis and evaluation of the results of

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the quality control parameters as defined 2.5.9(a)(ii) above and

include it as input in management review.
IV. In addition to and aligned with clause 9.2 ISO 22000:2018
include quality elements as defined in this clause within the
scope of internal audit.

2.5.9(b) Quality control procedures, including for unit, weight, and volume, shall be
established, and implemented to ensure product meets the applicable customer
and legal requirements. This shall include a program for calibration and
verification of equipment used for quality and quantity control.

2.5.9 (c) Line start-up and change over procedures shall be established and implemented
to ensure products including packaging and labelling, meet applicable customer
and legal requirements. This shall include having controls in place to ensure
labelling and packaging from the previous run have been removed from the line.

2.5.10 TRANSPORTATION, STORAGE AND WAREHOUSING (ALL)

2.5.10 a) The organization established, implemented and maintain a procedure

and specified stock rotation system that includes FEFO principles in
conjunction with the FIFO requirements.
b) The organization has specified requirements in place that define post-
slaughter time and temperature in relation with chilling or freezing of the
products.
c) For food chain category FI, in addition to BSI/PAS 221:2-13 clause, the
organisation shall ensure that the product is transported and delivered
under conditions which minimize the potential for contamination.
d) Where transport tanker is used, the following shall apply in addition to
clause 8.2.4 of ISO 22000:2018:
- Organisation that uses tankers for transportation of their final product

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CR* applicable” clauses

shall have a documented risk-based plan to address transportation tank

cleaning. It shall consider potential sources of cross contamination, and
appropriate control measures including cleaning and ventilation.
Measures shall be in place to assess cleanliness of the tanker at the
point of reception of the empty tanker, prior to loading.
- For organisations receiving raw material in tankers, the following shall
be included in the supplier agreement as minimum to ensure product
safety to prevent cross-contamination: tanker cleaning validation,
restrictions linked to prior use and applicable control measures relevant
to the product being transported.

2.5.11 HAZARD CONTROL AND MEASURES TO PREVENT CROSS CONTAMINATION (ALL EXLUDING FII)

2.5.11 a) Food category BII, C, AND I the following additional requirements

applies to ISO 2200:2018 clause 8.5.1.3: The organisation has specific
requirements in place where packaging is used to impact or provide a
functional effect on food (e.g., shelf-life extension)
b) Food category D, the following requirements applies in addition to ISO/T
22000-1:2009 clause 10.1: The organisation shall have specified
requirements for an inspection process at lairage and/or at evisceration
to ensure animals are fit for human consumption.
c) For food chain category D, the following requirements applies in addition
ISO/TS 22002-6:2016 clause 4.7: The organisation shall have in place
procedures to manage the use of ingredients/additives that contain
components that can have adverse animal health impact.

2.5.11 d) For all food categories, excluding FII the following requirements relating
to foreign matter management apply, in addition to clause 8.2.4 (h) of
ISO 22000:2018:
- The organisation shall have a risk assessment in place to determine the
need and type of foreign body detection equipment required. Where
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required justification shall be maintained as documented information

(Magnets, metal detectors, x-ray equipment) filters and sieves)
- A documented procedure shall be in place for foreign matter
management and use of selected equipment.
- The organisation shall have controls in place for foreign matter
management including procedures for the management of all breakages
linked to potential physical contamination.

2.5.12 PRP VERIFICATION PROCESS (C, D, G, I & K)

2.5.12 The organisation has established, implemented, and maintained routine site
inspections/prp checks to verify that site (internal and external), production
environment and processing equipment are maintained in a suitable condition to
ensure food safety. (Frequency shall be based on risk and PRP)

2.5.13 PRODUCT DESIGN AND DEVELOPMENT (BIII, C, D, E, F, I & K)

2.5.13 A product design and development procedure is established, implemented and

maintained for new products and changes to product or manufacturing
processes to ensure safe and legal products are produced.
This shall include:
a) Evaluation of the impact of the change on the FSMS taking into account
any new food safety hazards (incl, allergens) introduced and update
hazard analysis accordingly.
b) Consideration of the impact on the process flow for the new product and
existing product and processes,
c) Resources and training needs,
d) Equipment and maintenance requirement,

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e) The need to conduct production and shelf-life trails validate product

formulation and process can produce a safe production and meet
customer requirements. A process for on-going shelf-life certification
shall be in place, at a frequency based on risk.
f) Where a ready to cook product is produced, the cooking instructions
provided on the product label or packaging shall be validated to ensure
food safety is maintained.

2.5.14 HEALTH STATUS (D)

2.5.14 In addition to ISO/TS 22000-6 clause 4.10.1, The organization has a procedure
to ensure that the health of personnel does not have an adverse effect on the
feed production operations. Subject to legal restrictions in the country of
operation, employee shall undergo medical examinations, where permitted, shall
be conducted at intervals determined by organisation.

2.5.15 EQUIPMENT MANAGEMENT (ALL EXCLUDING FII)

2.5.15. The organisation has:

a) Have documented purchase specification in place, which addresses
hygienic design, applicable legal and customer requirements and
intended use of the equipment, including product handled. The supplier
shall provide evidence of meeting the purchase specification prior to
installation.
b) Establish and implement a risk-based change management process for
new equipment and/or any changes to existing equipment, which shall
be adequately documented including evidence of successful
commissioning. Possible effects on existing systems shall be assessed
and adequate control measures determined and implemented.

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CR* applicable” clauses

2.5.16 FOOD LOSS AND WASTE (ALL EXCLUDING I)

2.5.16 The organisation has:

a) Have a documented policy and objective detailing the organisations
strategy to reduce food loss and waste within their organisation and
related supply chain,
b) Have controls in place to manage products donated to non-profit
organisations, employees and other organisations and ensure that these
products are safe to consume.
c) Manage surplus products or by-products intended as animal feed/food to
prevent contamination of these products.
d) These processes shall comply with the applicable legislation, be kept up
to date, and not have a negative impact on food safety.

2.5.17 COMMUNICATION REQUIREMENTS (ALL)

2.5.17 The organisation shall inform certification body within 3 working days of the
commencement of events or situation below and implement suitable measures
as part of their emergency preparedness and response process:
a) Serious events that impact the FSMS, legality and/or the integrity of the
certification including situations that pose a threat food safety, or
certification integrity as a result of a force majeure, natural or man-made
disaster,
b) Serious situation where the integrity of the certification is at risk and/or
where the foundation can be brought into disrepute. These include, but
not limited to:
- Public safety events
- Actions imposed by regulatory authority as a result of food safety

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issue(s). where addition monitoring or forces shutdown of production is

required
- Legal proceedings, prosecution, malpractice and negligence and
- Fraudulent activities and corruption.

2.5.18 INTERNAL AUDIT REQUIREMENTS

The organization shall adhere to the following requirement relating to internal

audit:
a) An internal audit procedure and program shall be established by central
function covering management system, central function all sites. Internal
auditors must be independent from the areas and allocated by central
function.
b) The management system, centralised systems function and all sites
shall be audited at least annually or more frequently based on risk
assessment, and the effectiveness of corrective action shall be
demonstrated.
c) Internal auditors shall be competent:
- 2 years full-time work experience in food industry and at least a year in
organisation
- Completed higher education or have at least 5 years work experience in
food industry.
- Relevant training in FSSC.
d) Internal audit reports shall be subject to technical review by central
function.
e) Internal auditors and technical reviewers shall be subject to annual
performance monitoring and calibration.

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