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FSSC V.6 Internal Audit Checklist

The document is a self-assessment/audit checklist for FSSC 22000 Version 6, focusing on food manufacturing and compliance with ISO 22000:2018 standards. It outlines various clauses related to the context of the organization, leadership, planning, support, operation, and hazard control, detailing requirements and responsibilities for ensuring food safety management systems are effectively implemented. The checklist categorizes findings as minor, major, or critical, and emphasizes the importance of documented information and communication within the organization.

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Vin M Muindi
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100% found this document useful (1 vote)
879 views26 pages

FSSC V.6 Internal Audit Checklist

The document is a self-assessment/audit checklist for FSSC 22000 Version 6, focusing on food manufacturing and compliance with ISO 22000:2018 standards. It outlines various clauses related to the context of the organization, leadership, planning, support, operation, and hazard control, detailing requirements and responsibilities for ensuring food safety management systems are effectively implemented. The checklist categorizes findings as minor, major, or critical, and emphasizes the importance of documented information and communication within the organization.

Uploaded by

Vin M Muindi
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as XLSX, PDF, TXT or read online on Scribd
You are on page 1/ 26

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 *If no – details NC
Yes No MI*, MA*, CR* reference *Justify “not
applicable” clauses

4 CONTEXT OF THE ORGANIZATION


Understanding the organization and its context
The organisation has determined external and internal issues that are
4.1 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.
Understanding the needs and expectations of interested parties.

The organization can consistently provide products and service that meet
4.2 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.

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
4.3 specify the products and services processes and production sites that are
addressed by the 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.

Food safety management system


The organization had established implemented, maintained, updated, and
4.4 continually improve a food safety management system including the
processes needed and their interactions, in accordance with the
requirements of document.
5 LEADERSHIP
Leadership and commitment
Top management has demonstrated leadership and commitment with
5.1 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.
Policy
Top management have established, implemented, and maintained a food
5.2 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.
Communicating the food safety policy
5.2.2 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.
Organizational roles, responsibilities

5.3
Top management has ensured that the responsibilities and authorities for
relevant roles are assigned, communicated, and understood within the
5.3 organization. Top management shall the responsibility and authority for
ensuring 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
Actions to address risks and opportunities.
There are actions to address these risks and opportunities How to
6.1 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.
Objectives of the food safety management system and planning to
achieve them
The organization has established objectives of the food safety
6.2 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

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
6.3 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
Resources

The organization had provided the resources needed for the


7.1 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.

People

The organization has ensured that persons necessary to operate and


maintain an effective food safety management system are competent.
7.1.2
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.

Infrastructure

The organization has provided the resources for the determination,


establishment and maintenance of the infrastructure necessary to achieve
7.1.3 conformity with the requirements of the food safety management system.
7.1.3

Infrastructure can include land, vessels, buildings and associated utilities,


equipment, including hardware and software, transportation, information
and communication technology.
Work environment
The organization has determined, provided and maintained the resources
for the establishment, management and maintenance of the work
7.1.4 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.

Externally developed elements of the food safety management system

The organisation makes use of externally developed elements for the


7.1.5 implemented food safety management system and ensured that the
external 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.

Control of externally provided processes, products or services


7.1.6 The organization has established and applied criteria for the evaluation, 1.
selection, monitoring of performance and re-evaluation of external
providers of processes, products and/or services used.
Competence
There’s necessary competence of person(s) including external providers
doing work under its control that affects its food safety performance and
7.2 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.
Awareness
The organization had ensured that all persons doing work under the
organization control shall be aware of the food safety policy, the
7.3 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.
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
7.4 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.

External communication
The organization has ensured that sufficient information is
communicated externally and is available for interested parties of the
food chain.

7.4.2
The organization has effective communications with external providers
7.4.2 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.
Internal communication

The organization has an effective system for communicating issues


7.4.3 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.

Documented information
The organization food safety management had included documented
information required by this document, document information
7.5 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.
Creating and updating
7.5.2 The organization has the appropriate identification and description,
format and review and approval processes for suitability and adequacy of
documents.
Control of documented information
All documented information is available and suitable for its use, is
7.5.3 adequately protected, distributed, and retrieved as needed, stored and
preserved adequately, controlled with regards to changes/ updates,
retained and correctly disposed of when required.
8 OPERATION
Operation planning and control
8.1 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.
Prerequisite programs (PRPs)
There’s establishment of the hazard control plan, the organization shall
8.2 update the following information, if necessary, characteristics of raw 1.
materials, ingredients, and product – contact materials, characteristics of
end product intended use and flow diagrams and description of processes
and process environment.
Traceability system
The traceability system can uniquely identify any component of any
8.3 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.
Emergency preparedness and response
Top management has prepared and planned to identify preventive actions
8.4 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.
Handling of emergencies and incidents

8.4.2
The organisation can respond to actual emergency situations and take
8.4.2 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 incident, emergency situation or tests.

Hazard control
The hazard analysis preliminary information had been collected, updated,
8.5 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.
Preliminary steps to enable hazard analysis

The organization has carried out the hazard analysis, preliminary


8.5.1 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.

Characteristics of raw materials, ingredients and product contact


materials

The organization has ensured that all applicable statutory and regulatory
8.5.1.2 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.

Characteristics of end products


The organization ensured that all applicable statutory and regulatory food
8.5.1.3 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.
Intended use
The intended use, including reasonably expected handling of the end
8.5.1.4 product and any unintended use but reasonably expected mishandling
and misuse of the end product, is considered and shall be maintained as
documented information to the extent needed to conduct the hazard
analysis.
Flow diagrams and description of processes

8.5.1.5 The food safety team has established, updated flow diagrams as 1.
documented information for the products or product categories and the
processes covered by the food safety management system.

Preparation of the flow diagrams


8.5.1.5.1 Flow diagrams are clear, accurate and sufficiently detailed to the extent
needed to conduct the hazard analysis.
On-site confirmation of flow diagrams
8.5.1.5.2 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.
Description of processes and process environment

8.5.1.5.3
The food safety team shall describe, to the extent needed to conduct the
hazard analysis, the layout of premises, including food and non-food
8.5.1.5.3 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.
Hazard analysis
8.5.2 The food safety team has conducted a hazard analysis, based on the
preliminary information and determined the hazards that needs to be
controlled.
Hazard identification and determination of acceptable levels
8.5.2.2 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 and process environment.
Hazard assessment
8.5.2.3 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.
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
8.5.2.4 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.
Validation of control measure(s) and combinations of control
measures

The food safety team has validated that the selected control measures can
8.5.3 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.

Hazard control plan (HACCP/OPRP plan)


The hazard control plan includes the following information for each
control measure at each CCP or OPR:
8.5.4 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.
Determination of critical limits and action criteria
Critical limits at CCPs and action criteria for OPRPs are specified. The
8.5.4.2 rationale for their determination is documented.
Critical limits at CCPs are measurable and action criteria for OPRPs are
measurable or observable.
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
8.5.4.3
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.
Actions when critical limits or action criteria are not met

8.5.4.4
The organization has specified corrections and corrective actions to be
8.5.4.4 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.
Implementation of the hazard control plan
8.5.4.5 The organization has implemented and maintained the hazard control
plan and retain evidence of the implementation as documented
information.
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
8.6 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.
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 measuring activities related to the PRP(s) and the hazard
control plan.

The monitoring and measuring the equipment used shall be calibrate or


8.7 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
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:
8.8.1 · 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.
Analysis of results of verification activities
8.8.2 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.
Verification related to PRPs and the hazard control plan

8.9 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.

Corrections

8.9.2
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.
8.9.2
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.
Corrective action
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.
8.9.3 1.
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
Evaluation for release
8.9.4.2 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.
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
8.9.4.3 · 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.
Withdrawal/ Recall
The organization can ensure the timely withdrawal/ recall of lots of end
8.9.5 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
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
9.1 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.
Analysis and evaluation
The organization has analysed and evaluated appropriate data and
9.1.2 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.
Internal audit
The organization had planned, established, implemented, and maintained
and audit programme(s) including the frequency, methods,
9.2 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
Management review
9.3.1 Top management had reviewed the organization’s food safety
management system, at planned intervals, to ensure its continuing
suitability, adequacy, and effectiveness.
Management review input
The management review shall consider the following:
a. The status of actions from previous management reviews.
b. Changes in external and internal issues that are relevant to the food
safety management system.
c. Information on the performance and the effectiveness of the food
safety management system.
d. The adequacy of resources.
9.3.2 1.
e. Any emergency situation, incident or withdrawal/recall that occurred.

f. Relevant information obtained through external (see 7.4.2) and internal


(see 7.4.3) communication,
including requests and complaints from interested parties;
g. Opportunities for continual improvement.
The data shall be presented in a manner that enables top management to
relate the information to stated objectives of the food safety management
system.
Management review output
The outputs of the management review shall include the following:
9.3.3 · Decisions and actions related to continual improvement
opportunities.
· Any need for updates and changes to the food safety management
system.
10 IMPROVEMENT
Nonconformity and corrective action
10.1 The organization shall retain documented information as evidence of the
nature nonconformities and any subsequent action taken.
Continual improvement
Top management shall ensure that FSMS is continually updated. To
achieve this, the food safety team shall evaluate the food safety
10.2 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.
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


10.3 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 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


Finding
Conform? Remark
Category

Clause Requirement *If no – details NC


MI*, MA*, reference *Justify
Yes No
CR* “not applicable”
clauses

4 CONSTRUCTION AND LAYOUT OF BUILDINGS


General requirements

Buildings shall be designed, constructed and maintained in a manner


appropriate to the nature of the processing operations to be carried out,
4.1 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.
Environment
Consideration given to potential sources of contamination from the
environment.
4.2 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.
Locations of establishments
Site boundaries clearly identified. Access to site is controlled. Site must
4.3 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
General requirements
Internal layouts are maintained to facilitate good hygiene and
manufacturing practices.
5.1
The movement patterns of materials, products, people and the layout of
equipment is designed to protect against potential contamination.

Internal design, layout and traffic patterns


5.2
5.2 The building has adequate space, with a logical flow of materials,
products and personnel. Also physical separation of raw and processed
areas.
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.
5.3 · 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.
· External opening windows, roof vents or fan, where present, are
insect screened.

· External opening doors are closed or screened when not in use.

Location of equipment
5.4 Equipment to be designed and located to facilitate good hygiene
practices and monitoring. Equipment is located to permit operation,
cleaning and maintenance.
Laboratory facilities
In-line and on-line test facilities are controlled to minimise the risk of
product contamination.
5.5
Microbiological laboratories are designed, located and operated to
prevent contamination of people, plant and products. They shall not open
directly to production areas.
Temporary or mobile premises and vending machines
Designed, located and constructed to prevent pest harbourage and
5.6 potential contamination of products.
Additional hazards associated with temporary structures and vending
machines to be controlled.
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.
5.7
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
General requirements

6.1
The provisions and distribution routes for utilities to and around
6.1 processing and storage areas are designed to minimise the risk of product
contamination. Utilities’ quality to be monitored to minimise product
contamination risk.
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.
6.2 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 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.

Boiler chemicals
Boiler chemicals, if used, are either:
· approved food additives which meet relevant additive
specifications.
6.3
· 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.
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
6.4 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.
Exterior air intake ports shall be examined periodically for physical
integrity.
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.
6.5
6.5
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.

Lighting
The lighting provided (natural or artificial) will allow personnel to
operate in a hygienic manner. The intensity of the lighting is appropriate
6.6
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
General requirements
7.1 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.
Containers for waste and inedible or hazardous substances
Containers for waste and inedible or hazardous substances shall be
7.2 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 in immediate use and locked where the waste
may pose a risk to the product.
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.


7.3
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.
Drains and drainage
Drains are designed, constructed and located so that the risk of
contamination of materials or products is avoided. Drains shall have
7.4 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
General requirements
Food contact equipment is designed and constructed to facilitate
cleaning, disinfection and maintenance. Contact surfaces are not affected
8.1
by the intended product or cleaning system.
Food contact equipment shall be constructed of durable materials able to
resist repeated cleaning.
Hygienic design

Equipment can meet established principles of hygienic design, including


smooth, accessible, cleanable surfaces, self-draining in wet process areas,
framework not penetrated by holes or nuts and bolts.
8.2
Piping and ductwork are cleanable, drainable, and with no dead ends.
8.2

Equipment is designed to minimize contact between the operator's hands


and the products.
Product contact surfaces
8.3 Product contact surfaces are constructed from materials designed for
food use. They shall be impermeable and rust or corrosion free.
Temperature control and monitoring equipment

Equipment used for thermal processes is able to meet the temperature


8.4
gradient and holding conditions given in relevant product specifications.

Equipment supports the monitoring and control of the temperature.


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.
8.5
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.

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.
8.6 Lubricants and heat transfer fluids are food grade where there is a risk of
direct 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
General requirements
Purchasing of materials which impact food safety are controlled to ensure
9.1 that the suppliers used have the capability to meet the specified
requirements. The conformance of incoming materials to specified
purchase requirements shall be verified.
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
9.2 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.
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
9.3 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.
10 MEASURES FOR PREVENTION OF CROSS-CONTAMINATION
General requirements
10.1 Programmes must in place to prevent, control and detect contamination.
Measures to prevent physical, allergen and microbiological
contamination are included.
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


10.2 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.
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.
10.3
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.
Physical contamination
Where brittle materials are used, periodic inspection requirements and
defined procedures in case of breakage is in place.
10.4
Glass breakage records are maintained.
Measures are in place to prevent, control or detect potential
contamination.
11 CLEANING AND SANITIZING
General requirements
Cleaning and sanitizing programmes are established to ensure that the
11.1 food-processing equipment and environment are maintained in a
hygienic condition. Programmes are monitored for continuing suitability
and effectiveness.
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
11.2 manufacturer's instructions.

Tools and equipment are of hygienic design and maintained in a


condition which does not present a potential source of contamination.

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:


11.3 · Areas, items of equipment and utensils to be cleaned and/or
sanitized.
11.3

· responsibility for the tasks specified.


· cleaning/sanitizing method and frequency.
· monitoring and verification arrangements.
· post-clean inspections.
· pre-start-up inspections.
Cleaning in place (CIP) systems
CIP systems are separated from active product lines.
11.4
Parameters for CIP systems are defined and monitored (type,
concentration, contact time and temperature of any chemicals used).

Monitoring sanitation effectiveness


11.5 Cleaning and sanitation programmes are monitored at frequencies
specified by the organization to ensure their continuing suitability and
effectiveness.
12 PEST CONTROL
General requirements
12.1 Hygiene, cleaning, incoming materials inspection and monitoring
procedures are implemented to avoid creating an environment conducive
to pest activity.
Pest control programmes
The establishment has a nominated person to manage pest control
activities and/or deal with appointed expert contractors.
12.2 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 areas of the establishment.
Preventing access
Holes, drains and other potential pest access points are sealed.
12.3
External doors, windows or ventilation openings are designed to
minimize the potential for entry of pests.
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
12.4
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.
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,
12.5 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.
Eradication

12.6 1.
Eradication measures are initiated immediately after evidence of
infestation is reported.
12.6 Pesticide use and application is restricted to trained operatives and are 1.
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


General requirements
Personal hygiene and behaviour procedures related to the hazard posed to
13.1 the process area or product are established and documented. All
personnel, visitors and contractors are required to comply with the
documented requirements.
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.
13.2
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.
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
13.3
is minimized.
Storage, cooking and holding temperatures, and time limitations, shall be
specified.
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
13.4 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.
Health status
Employees undergo a medical examination prior to employment in food
contact operations (including site catering) unless documented hazard or
13.5 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.
Illness and injuries
Employees are required to report to management for possible exclusion
13.6 from food-handling areas when their illness pose a significant risk to the
food being handled/ processed. These reports are documented and
recorded.
Personal cleanliness
13.7 Monitoring measures in place to record any deviations from personal
cleanliness.
Personal behaviour
13.8 A documented policy that describes the behaviours required of personnel
in processing, packing and storage areas.
14 REWORK
General requirements
14.1 Rework is stored, handled and used in such a way that product safety,
quality, traceability and regulatory compliance are maintained.

Storage, identification, and traceability

Segregation requirements for rework (e.g. allergen) shall be documented.


14.2 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).
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-
14.3 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 matter.
15 PRODUCT RECALL PROCEDURES
General requirements
15.1 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.
Product recall requirements
A list of key contacts in the event of a recall is maintained.
15.2 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
General requirements
16.1 Materials and products are stored in clean, dry, well-ventilated spaces
protected from dust, condensation, fumes, odours or other sources of
contamination.
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?
16.2
Waste materials and chemicals are stored separately.
All non-conforming materials are segregated and easily identified.
Specified stock rotation systems in place (FIFO).
Gasoline- or diesel-powered fork-lift trucks are not used in food
ingredient or product storage areas.
Vehicles, conveyances, and containers
Vehicles, conveyances, and containers are maintained in a state of repair
and cleanliness. Also provide protection against damage or
16.3 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
Consumers are made aware of the product and its importance so that they
can make informed decisions regarding the product.
17
Information relayed in the form of labels, advertisements or company
websites.
18 FOOD DEFENCE, BIOVIGILANCE AND BIOTERRORISM
General requirements
18.1 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.
Access controls
Potentially sensitive areas are access controlled.
18.2
Access should be physically restricted by use of locks, electronic card
key or alternative systems.
Summary:

PART 3: FSSC 22000 V6 Additional Requirements


Finding
Conform? Remark
Category

Clause Requirement *If no – details NC


MA*, MI*, reference *Justify
Yes No
CR* “not applicable”
clauses

2.5.1 MANAGEMENT OF SERVICES AND PURCHASED MATERIALS


Management of Services
Laboratory analysis services used for the verification and/or validation of
2.5.1(a) 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.
Emergency Procurement (C, D, I, FII, G, and K)
2.5.1(b) 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.
Product specifications review procedure (C0, CI, CIII, and CIV)

2.5.1(c) 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.

Raw Material and Finished product Specification (C, D, I, FII, G,


and K)

2.5.1(d)
2.5.1(d) 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.
Recycled Packaging (I)
The organisation shall establish criteria related to the use of recycled
2.5.1(e) 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
The organisation has ensured that finished products are labelled
according to all applicable statutory and regulatory requirements in the
2.5.2(a)
country of intended sale, including allergen and customer specific
requirements.
Where the product is unlabelled, all relevant product information shall be
2.5.2(b) made available to ensure the safe use of food by the customer or
consumer.

Where a claim (e.g., allergen, nutritional, method of production, chain of


custody, raw material status, etc) is made on the product label or
2.5.3(c) 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.

Food Chain category I, artwork management and print control procedures


shall be established and implemented to ensure the printed material
meets applicable 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
2.5.3(d) n/a
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
Threat Assessment
The organisation has:

a) Conducted and documented the food threat assessment, based on a


2.5.3.1 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.
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.
2.5.3.2
c) The plan complies with applicable legislation, cover the process and
products within the scope of the organisation and be kept up to date.

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
Vulnerability Assessment
The organisation has:
a) Conducted and documented the food fraud vulnerability assessment,
2.5.4.1 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.
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.
2.5.4.2
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
The FSSC 22000 logo can only be used for marketing activities such as
2.5.5 the organization's printed matter and / or website and another
promotional material.
2.5.6 MANAGEMENT OF ALLERGENS (ALL)
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
2.5.6 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 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)
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:
2.5.7
- 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
produced by the organisation.
2.5.8 FOOD SAFETY AND QAULITY CULTURE (ALL)
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:

2.5.8(a) · Communication
· Training
· Employee feedback and engagement

· Performance measurement of defined activities covering all


sections of the organisation impacting on the food safety and quality.

The objective(s) shall be supported by a document food safety and


quality culture plan, with targets and timelines and included in the
2.4.8(b)
management review and continuous improvements process of the
management system.
2.5.9 QUALITY CONTROL (ALL)
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.
2.5.9 (a)
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 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.
Quality control procedures, including for unit, weight, and volume, shall
be established, and implemented to ensure product meets the applicable
2.5.9(b) customer and legal requirements. This shall include a program for
calibration and verification of equipment used for quality and quantity
control.

Line start-up and change over procedures shall be established and


implemented to ensure products including packaging and labelling, meet
2.5.9 (c) 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)
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:
2.5.10
- Organisation that uses tankers for transportation of their final
product 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.
HAZARD CONTROL AND MEASURES TO PREVENT CROSS CONTAMINATION (ALL
2.5.11
EXLUDING FII)
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)

2.5.11
b) Food category D, the following requirements applies in addition to
ISO/T 22000-1:2009 clause 10.1: The organisation shall have specified
2.5.11
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.

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
required justification shall be maintained as documented information
2.5.11 (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)
The organisation has established, implemented, and maintained routine
site inspections/prp checks to verify that site (internal and external),
2.5.12 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)
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
2.5.13 and existing product and processes,
c) Resources and training needs,
d) Equipment and maintenance requirement,
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)
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
2.5.14
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)
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.
2.5.15.
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.

2.5.16 FOOD LOSS AND WASTE (ALL EXCLUDING I)


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
2.5.16 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)
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
2.5.17 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
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.
*MI = Minor finding, MA* = Major Finding, CR*=Critical Finding

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