V6.002-FSSC-22000-V6-Part-2-Presentation.pdf

FSSC 22000 VERSION 6
TRAINING COURSE
SCHEME PART 2: REQUIREMENTS
FOR ORGANIZATIONS TO BE
AUDITED
SESSION 1
V1.0 - July 2023

General Requirements
01.
Scheme Interpretation Articles
02.
FSSC 22000 Additional
Requirements
03.
TOPICS

SCHEME PART 2, SECTION 2.1
General
➢ Organizations shall develop, implement, and maintain all the
requirements outlined below and shall be audited by a licensed
Certification Body in order to receive a valid FSSC 22000 certificate.
➢ The audit requirements for FSSC 22000 certification consist of:
1) ISO 22000:2018 Food Safety Management System
requirements;
2) Sector-specific prerequisite program (PRPs) requirements
(ISO/TS 22002-x series or other specified PRP standard) and;
3) FSSC 22000 Additional requirements.

6
2. SCHEME INTERPRETATION ARTICLES

SCHEME PART 2, SECTION 2.2
Scheme Changes and Interpretations
➢ Scheme interpretation articles have been included in the
Scheme.
➢ These articles are available to CBs in MyFSSC.
➢ They include further clarification on requirements and are
mandatory.

8
3. FSSC 22000 ADDITIONAL REQUIREMENTS

ADDITIONAL REQUIREMENTS
1) Management of services and purchased materials (All Food Chain Categories)
2) Product labelling and printed materials (All Food Chain Categories)
3) Food defense (All Food Chain Categories)
4) Food fraud mitigation (All Food Chain Categories)
5) Logo use (All Food Chain Categories)
6) Management of allergens (All Food Chain Categories)
7) Environmental monitoring (Food chain categories BIII, C, I & K)
8) Food safety and quality culture (All Food Chain Categories)
9) Quality control (All Food Chain Categories)
10) Transport, storage and warehousing (All Food Chain Categories)
11) Hazard Control and Measures for Preventing Cross-Contamination (All Food Chain Categories, Excl. FII)
12) PRP Verification (Food chain categories BIII, C, D, G, I & K)
13) Product Design and Development (Food chain categories BIII, C, D, E, F, I & K)
14) Health Status (Food chain category D)
15) Equipment Management (All Food Chain Categories, Excl. FII)
16) Food Loss and Waste (All Food Chain Categories, Excl. I)
17) Communication Requirements (All Food Chain Categories)
18) Requirements for Organization with Multi-site certification (Food chain categories E, F & G)

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SECTION 2.5.1
MANAGEMENT OF SERVICES AND PURCHASED
MATERIALS

REQUIREMENT 2.5.1 a)
In addition to clause 7.1.6 of ISO 22000:2018, the organization shall ensure that
where laboratory analysis services are used for the verification and/or validation of
food safety, these shall be conducted by a competent laboratory (including both
internal and external laboratories as applicable) that has the capability to produce
precise and repeatable test results using validated test methods and best practices
(e.g., successful participation in proficiency testing programs, regulatory approved
programs or accreditation to international standards such as ISO 17025).
Guidance
➢ Evaluate whether the organization can demonstrable competence of external
and internal laboratories to produce reliable and accurate results that will be
used in the process of decision-making within the FSMS;
➢ Review evidence such as results of proficiency testing or regulatory approved
programs or a valid ISO 17025 accreditation certificate.

REQUIREMENT 2.5.1 b)
For food chain categories C, D, I, FII, G, and K, the following additional requirement
applies to ISO 22000:2018 clause 7.1.6: The organization shall have a documented
procedure for procurement in emergency situations to ensure that products still
conform to specified requirements and the supplier has been evaluated.
Guidance
➢ Assess whether the organization has established a procedure describing the
process to be followed in the case of procurement under emergency situations to
ensure that products still conform to specified requirements and that the
supplier has been evaluated prior to buying any products.
➢ Assess whether any emergency procurements have occurred and sample
documented evidence thereof.

REQUIREMENT 2.5.1 c)
For food chain categories C0, CI, CIII, and CIV: In addition to ISO/TS 22002-1:2009
clause 9.2, the organization shall have a policy for the procurement of animals, fish,
and seafood that are subject to the control of prohibited substances (e.g.,
pharmaceuticals, veterinary medicines, heavy metals, and pesticides);
Guidance
➢ Evaluate whether the organization has considered the control of any prohibited
substances relating to the procurement of animals, fish, and seafood.
➢ Look at how the organization has included this in their supplier approval process
and the controls and verification activities established (monitoring system).

REQUIREMENT 2.5.1 d)
For food chain categories C, D, I, FII, G, and K, the following additional requirement
applies: The organization 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.
Guidance
➢ Evaluate the review process for raw material and finished product specifications.
Raw materials include packaging materials.
➢ Sample raw material and finished product specifications, including whether the
review frequency has been met.

REQUIREMENT 2.5.1 e)
For food chain category I, in addition to clause 7.1.6 of ISO 22000:2018, the
organization 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 being met.
Guidance
➢ Establish whether the organization uses recycled packaging as a raw material
input.
➢ If so, review the criteria established by the organization and determine whether
the criteria established is appropriate and in accordance with legal and customer
requirements.
➢ Sample evidence of the criteria being met.

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SECTION 2.5.2
PRODUCT LABELING AND PRINTED MATERIALS

REQUIREMENT 2.5.2 a)
In addition to clause 8.5.1.3 of ISO 22000:2018, the organization shall ensure that
finished products are labeled according to all applicable statutory and regulatory
requirements in the country of intended sale, including allergen and customer-
specific requirements.
Guidance
➢ Evaluate whether the organization has established the necessary processes.
➢ Sample finished product labels/packaging material and evaluate it in accordance
with legal and customer requirements. Specific attention must be given to
allergens.

REQUIREMENT 2.5.2 b)
Where a product is unlabeled, all relevant product
information shall be made available to ensure the
customer or consumer's safe use of the food.
Guidance
➢ Bulk or unlabeled product: evaluate whether
the labeling process or method of
communication for the product has been
defined.
➢ E.g., via a website or accompanying
documentation.

REQUIREMENT 2.5.2 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 organization
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.
Guidance
➢ Claims include allergen-free claims, nutritional content claims, method of
production claims, chain of custody claims, and raw material status claims.
➢ Look out for claims when sampling product labels and packaging material.
➢ Sample evidence of the validation and verification activities for claims made.

REQUIREMENT 2.5.2 d)
For 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 procedure shall address the following as a
minimum:
i. Approval of artwork standard or master sample;
ii. Process to manage changes to artwork and print specifications and to manage
obsolete artwork and printing materials;
iii. Approval of each print run against the agreed standard or master sample;
iv. Process to detect and identify printing errors during the run;
v. Process to ensure effective segregation of differing print variants; and
vi. Process to account for any unused printed product.

REQUIREMENT 2.5.3.1
Threat assessment
The organization shall:
a) Conduct and document the food defense threat assessment, based on a defined
methodology, to identify and evaluate potential threats linked to the processes
and products within the scope of the organization; and
b) Develop and implement appropriate mitigation measures for significant threats.
Guidance
➢ Evaluate whether the organization has a methodology for conducting the Food
Defense Threat Assessment documented.
➢ Assess whether potential threats identified have been assessed by the
organization for their significance (e.g., Likelihood of occurrence x
Impact/Consequence). Determine whether other factors, such as accessibility, the
likelihood of detection, and recognizability, have been considered?
➢ Evaluate the mitigation measures implemented.

REQUIREMENT 2.5.3.2
Plan
a) The organization shall have a documented food defense plan based on the
threat assessment, specifying the mitigation measures and verification
procedures.
b) The food defense plan shall be implemented and supported by the
organization’s FSMS.
c) The plan shall comply with applicable legislation, cover the processes and
products within the scope of the organization, and be kept up to date.
d) For food chain category FII, in addition to the above, the organization shall
ensure that its suppliers have a food defense plan in place.

REQUIREMENT 2.5.3.2
Guidance
➢ Evaluate whether the plan is supported by the organization’s Food Safety
Management System for all its products meaning that it should contain elements
such as control measures, verification activities, corrections and corrective
actions, responsibilities, record keeping, and continuous improvement. Assess
whether the plan has been kept up-to-date.
➢ For category FII organizations, assess whether the organization has evidence
relating to their suppliers having a food defense plan in place, e.g., do they have a
supplier questionnaire confirming the plan is in place, including a copy of the
supplier's plan or evidence of the supplier having GFSI certification?
An updated guidance document will be freely available on our website during 2023.

TRAINING COURSE
AUDITED
SESSION 2
V1.0 – July 2023

26
SECTION 2.5.4
FOOD FRAUD MITIGATION

REQUIREMENT 2.5.4.1
Vulnerability assessment
The organization shall:
a) Conduct and document the food fraud
vulnerability assessment, based on a defined
methodology, to identify and assess potential
vulnerabilities; and
b) Develop and implement appropriate mitigation
measures for significant vulnerabilities. The
assessment shall cover the processes and
products within the scope of the organization.

REQUIREMENT 2.5.4.1
Guidance
➢ Evaluate whether the organization has a methodology for conducting the Food
Fraud Vulnerability Assessment documented.
➢ Assess whether potential vulnerabilities identified have been assessed by the
organization for their significance (e.g., Likelihood of occurrence x
Impact/Consequence). Profitability is an important factor in the likelihood of
occurrence.
➢ Evaluate the mitigation measures implemented

REQUIREMENT 2.5.4.2
Plan
a) The organization shall have a documented food fraud mitigation plan based on
the output of the vulnerability assessment, specifying the mitigation measures
and verification procedures.
b) The food fraud mitigation plan shall be implemented and supported by the
organization’s FSMS.
c) The plan shall comply with the applicable legislation, cover the processes and
products within the scope of the organization, and be kept up to date.
d) For food chain category FII, in addition to the above, the organization shall
ensure that its suppliers have a food fraud mitigation plan in place.

REQUIREMENT 2.5.4.2
Guidance
➢ Evaluate whether the plan is supported by the organization’s Food Safety
Management System for all its products meaning that it should contain elements
such as control measures, verification activities, corrections and corrective
actions, responsibilities, record keeping, and continuous improvement. Assess
whether the plan has been kept up-to-date.
➢ For category FII organizations, assess whether the organization has evidence
relating to their suppliers having a food fraud mitigation plan in place, e.g., do
they have a supplier questionnaire confirming the plan is in place, including a
copy of the supplier's plan or evidence of the supplier having GFSI certification?
An updated guidance document will be freely available on our website during 2023.

LOGO USE
Requirement 2.5.5
a) Certified organization shall use the FSSC 22000 logo only for marketing activities
such as the organization’s printed matter, website, and other promotional
material.
b) In case of using the logo, the certified organization shall request a copy of the
latest FSSC logo from their Certification Body and comply with the following
specifications:
Use of the logo in black and white is permitted when all other text and images are in
black and white.

REQUIREMENT 2.5.5
c) The certified organization is not allowed to use the FSSC 22000 logo, any
statement, or refer to its certified status on:
i. a product;
ii. its labeling;
iii. its packaging (primary, secondary, or any other form);
iv. certificates of analysis or certificates of conformance (CoA’s or CoC’s);
v. in any other manner that implies FSSC 22000 approves a product, process,
or service and
vi. where exclusions to the scope of certification apply.
Guidance
➢ Auditor to assess whether the logo is used and, if so, whether it meets the
requirements of 2.5.5.

MANAGEMENT OF ALLERGENS
Requirement 2.5.6
The organization shall have a documented allergen management plan that includes:
a) A list of all the allergens handled on site, including in raw materials and finished
products;
b) Risk assessment covering all potential sources of allergen cross-contamination;
c) Identification and implementation of control measures to reduce or eliminate
the risk of cross-contamination based on the risk assessment outcome.
Guidance
➢ Review the list of allergens handled by the site and verify it during the site
inspection.
➢ Evaluate the risk assessment and whether it considers all the potential sources of
allergen cross-contamination and whether the control measures are
implemented accordingly.

Requirement 2.5.6
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;
Guidance
➢ Review the validation undertaken by the site.
➢ Evaluate verification testing results and whether they are conducted at a
frequency based on risk.

Requirement 2.5.6
e) Precautionary or warning labels shall only be used where the risk assessment
outcome identifies allergen cross-contamination as a risk to the consumer, even
though all the necessary control measures have been effectively implemented.
Applying warning labels does not exempt the organization from implementing
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;
Guidance
➢ Assess whether the organization has precautionary or warning statements
relating to allergens on their product labeling or packaging.
➢ Sample evidence of training undertaken.

Requirement 2.5.6
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 organization as a result of an allergen/s, or when trends in the
industry show contamination of 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.
Guidance
➢ Confirm when the last review was undertaken and whether any triggers occurred.
Assess the output of the review.
➢ Evaluate the trending results and the output thereof.

Requirement 2.5.6
The organization shall have a documented
allergen management plan that includes:
h) For Food Chain Category D: Where there is
no allergen-related legislation for the
country of 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.
MANAGEMENT OF
ALLERGENS

ENVIRONMENTAL MONITORING
Requirement 2.5.7
The organization shall have in place:
a) A risk-based environmental monitoring program for the relevant pathogens,
spoilage, and indicator organisms;
Guidance
➢ Assess whether the environmental monitoring program has been developed,
documented, and implemented to reduce the potential of environmental
contamination of food and support the FSMS and safe product production.
➢ Assess whether relevant microorganisms have been considered and whether the
program complies with legal and customer requirements.

Requirement 2.5.7
b) A 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 controls present;
and shall comply with legal and customer requirements.
Guidance
➢ Evaluate the organizations sampling protocol; identification of sample locations;
frequency of tests; target organism(s) (e.g., pathogens, spoilage organisms and/or
indicator organisms); test methods (e.g., settle plates, rapid testing, and swabs);
recording and evaluation of results including how nonconforming results are
handled.

Requirement 2.5.7
c) Data of the environmental monitoring activities, including regular trend analysis; and
d) The environmental monitoring program shall be reviewed for continued effectiveness
and suitability, at least annually and more often if required, including when the
following triggers occur:
i. Significant changes related to products, processes, or legislation;
ii. When no positive testing results have been obtained over an extended period of
time;
iii. Trend in out-of-specification microbiological results, related to both intermediate
and finished products, linked to environmental monitoring;
iv. A repeat detection of pathogens during routine environmental monitoring; and
v. When there are alerts, recalls, or withdrawals relating to product/s produced by
the organization.

Guidance
➢ Evaluate the trending results and the output
thereof.
➢ Confirm when the last review was undertaken
and whether any triggers occurred. Assess the
output of the review.
➢ IMPORTANT: This is not a section on cleaning.
ENVIRONMENTAL
MONITORING

FOOD SAFETY & QUALITY CULTURE
NEW: Requirement 2.5.8
a) In accordance with and in addition to clause 5.1 of ISO 22000:2018, as part of the
organizations’ 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 elements shall be addressed as a minimum:
• Communication,
• Training,
• Employee feedback and engagement, and
• Performance measurement of defined activities covering all sections of the
organization impacting on food safety and quality.
b) The objective(s) shall be supported by a documented food safety and quality
culture plan, with targets and timelines and included in the management review
and continuous improvement processes of the management system.

Guidance
➢ Assess whether the organization has food
safety and quality culture objectives in place
➢ Evaluate the food safety and quality culture
plan and confirm it includes targets and
timelines
➢ Assess the management review and evaluate
whether it addresses food safety and quality
culture.
➢ Refer to the updated guidance document
once published for further guidance.
FOOD SAFETY &
QUALITY CULTURE

QUALITY CONTROL
a) The organization shall:
i. In addition to and aligned with clauses 5.2 and 6.2 of ISO 22000:2018,
establish, implement, and maintain a quality policy and 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 of ISO 22000:2018,
undertake analysis and evaluation of the results of the quality control
parameters, as defined under 2.5.9 (a)(ii) above, and include it as an input
for the management review; and
iv. In addition to, and aligned with, clause 9.2 of ISO 22000:2018, include
quality elements as defined in this clause within the scope of the internal
audit.

QUALITY CONTROL
Examples of quality control parameters:
Audits are of a sampling nature, and therefore quality
parameters will be verified as part of the audit sample.
Product group Possible quality control parameters
Jams and sauces Acidity, brix, viscosity, fill height, weight, etc.
Fish fillets Firmness, no scales, weight, etc.

QUALITY CONTROL
NEW: Requirement 2.5.9 (continued)
b) Quantity control procedures, including unit, weight, and volume, shall be
established and implemented to ensure products meet the applicable customer
and legal requirements. This shall include a program for calibration and
verification of equipment used for quality and quantity control.
c) Line start-up and change-over procedures shall be established and implemented
to ensure products, including packaging and labeling, meet applicable customer
and legal requirements. This shall include having controls in place to ensure
labeling and packaging from the previous run have been removed from the line.

QUALITY CONTROL
Guidance
➢ Assess the quality policy and quality objectives.
➢ Evaluate the quality control parameters established by the organization within
the specifications. Sample-related records, including results of quality control
checks.
➢ Evaluate trends and the output of these trends.
➢ Review the internal audit program and assess whether the quality is included in
the scope of the audit program.
➢ Assess the quantity control procedures and equipment calibration/verification
program, including sampling related records.
➢ Assess the line start-up and change-over procedures, including sampling related
records.

TRAINING COURSE
AUDITED
SESSION 3
V1.0 – July 2023

TRANSPORT, STORAGE & WAREHOUSING
Requirement 2.5.10
a) The organization shall establish, implement, and maintain a procedure and
specified stock rotation system that includes FEFO principles in conjunction with
the FIFO requirements.
b) For food chain category C0, in addition to ISO/TS 22002-1:2009 clause 16.2, the
organization shall have specified requirements in place that define post-
slaughter time and temperature in relation to the chilling or freezing of the
products.
c) For food chain category FI, in addition to BSI/PAS 221:2013 clause 9.3, the
organization shall ensure that the product is transported and delivered under
conditions that minimize the potential for contamination.
Guidance:
➢ Assess the organization’s procedure for stock rotation.

TRANSPORT, STORAGE & WAREHOUSING
Requirement 2.5.10
d) Where transport tankers are used, the following shall apply in addition to clause
8.2.4 of ISO 22000:2018:
i. Organizations that use tankers for the transportation of their final product
shall have a documented risk-based plan to address transport tank
cleaning. It shall consider potential sources of cross-contamination, and
appropriate control measures, including cleaning validation. Measures
shall be in place to assess the cleanliness of the tanker at the point of
reception of the empty tanker prior to loading.
ii. For organizations receiving raw material in tankers, the following shall be
included in the supplier agreement as a minimum to ensure product safety
and prevent cross-contamination: tanker cleaning validation, restrictions
linked to prior use, and applicable control measures relevant to the
product being transported.

HAZARD CONTROL & MEASURES FOR PREVENTING
CROSS-CONTAMINATION
Requirement 2.5.11
a) For food chain categories BIII, C, and I, the following additional requirement
applies to ISO 22000:2018 clause 8.5.1.3: The organization shall have specific
requirements in place where packaging is used to impart or provide a functional
effect on food (e.g., shelf-life extension).
b) For food chain category C0, the following requirement applies in addition to
ISO/TS 22002-1:2009 clause 10.1: The organization 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 requirement applies in addition to
ISO/TS 22002-6:2016 clause 4.7: The organization shall have in place procedures
to manage the use of ingredients/additives that contain components that can
have an adverse animal health impact.

HAZARD CONTROL & MEASURES FOR PREVENTING
CROSS-CONTAMINATION
d) For all food chain categories, excluding FII, the following requirements relating to
foreign matter management apply, in addition to clause 8.2.4 (h) of ISO
22000:2018:
i. The organization shall have a risk assessment in place to determine the
need and type of foreign body detection equipment required. Where the
organization deems no foreign body detection equipment is necessary,
justification shall be maintained as documented information. Foreign body
detection equipment includes equipment such as magnets, metal
detectors, X-ray equipment, filters, and sieves.
ii. A documented procedure shall be in place for the management and use of
the equipment selected.
iii. The organization shall have controls in place for foreign matter
management, including procedures for the management of all breakages
linked to potential physical contamination (e.g., metal, ceramic, hard
plastic).

PRP VERIFICATION
Requirement 2.5.12
The following additional requirement applies to ISO 22000:2018 clause 8.8.1:
➢ The organization shall establish, implement, and maintain routine (e.g., monthly) site
inspections/PRP checks to verify that the site (internal and external), production
environment, and processing equipment are maintained in a suitable condition to
ensure food safety. The frequency and content of the site inspections/PRP checks shall
be based on risk with defined sampling criteria and linked to the relevant technical
specification.
Guidance
➢ Assess whether the routine site inspections/PRP checks included verification of the
internal and external site, production environment, and processing equipment; and
whether the criteria covered the relevant PRP specification(s), e.g., ISO/TS 22002-1.
➢ Confirm if the frequency was adequate and based on risk.

PRODUCT DESIGN & DEVELOPMENT
Requirement 2.5.13
A product design and development procedure shall be 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 the
following:
a) Evaluation of the impact of the change on the FSMS, taking into account any new
food safety hazards (incl. allergens) introduced and updating the hazard analysis
accordingly,
b) Consideration of the impact on the process flow for the new product and
existing products and processes,
c) Resource and training needs,
d) Equipment and maintenance requirements.

Guidance
➢ Determine whether product development is applicable, and if so, whether a
procedure on the process to incorporate new products and changes into the
product or manufacturing processes is in place and implemented.
➢ Evaluate whether it addresses any potential hazards introduced (update to
hazard analysis), impact on the process, equipment, and maintenance, and any
shelf-life and production trials conducted.
➢ Confirm when a new product or process was last implemented and evaluate
documented evidence to confirm the procedure is implemented accordingly.

Requirement 2.5.13
e) The need to conduct production and shelf-life trials to validate product
formulation and processes are capable of producing a safe product and meeting
customer requirements. A process for ongoing shelf-life verification 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.
Guidance
➢ Sample production trial and shelf-life testing results; confirm that the results
align with the shelf life given to the product.
➢ For ready-to-cook products that have cooking instructions on the
label/packaging, assess the validation results.

HEALTH STATUS
Requirement 2.5.14
In addition to ISO/TS 22002-6 clause 4.10.1, the organization shall have 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,
employees shall undergo medical screening prior to employment in feed contact
operations unless documented hazards or medical assessment indicates otherwise.
Additional medical examinations, where permitted, shall be carried out as required
and at intervals defined by the organization.
Guidance
➢ Evaluate the procedure and confirm whether employees have undergone
medical screening/assessments (prior to employment and at intervals defined by
the organization).

EQUIPMENT MANAGEMENT
In addition to clause 8.2.4 of ISO 22000:2018, the organization shall:
a) Have a documented purchase specification in place, which addresses the
hygienic design, applicable legal and customer requirements, and the intended
use of the equipment, including the 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.

Guidance
➢ If new (incl. second-hand) equipment has
been purchased, assess the related purchase
specification and evidence of the supplier
meeting this specification.
➢ Review the change management process
established and whether it is risk-based.
➢ Sample evidence of successful
commissioning and the effect on existing
systems.
EQUIPMENT
MANAGEMENT

FOOD LOSS AND WASTE
In addition to clause 8 of ISO 22000:2018, the organization shall:
a) Have a documented policy and objectives detailing the organization’s strategy to
reduce food loss and waste within their organization and the related supply
chain.
b) Have controls in place to manage products donated to not-for-profit
organizations, employees, and other organizations, 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.

Example of an objective on a strategy
to reduce food loss and waste:
FOOD LOSS AND
WASTE
REDUCE FOOD WASTAGE BY
10% YEAR ON YEAR;
WITH AN OVERALL REDUCTION OF
50% OVER 5 YEARS

FOOD LOSS AND WASTE
Guidance
➢ Evaluate the policy and objectives established by the organization.
➢ Assess whether the organization has met these objectives and actions taken to meet
the objectives.
➢ Determine whether the organization:
• Donates products and, if so, assesses the controls in place, including the safety of
these donated products.
• Produces surplus products or by-products intended as animal feed/food, and if so,
assesses the controls in place to prevent contamination of these products.
➢ Assess whether the processes in place meet legal requirements and do not
compromise on food safety.

COMMUNICATION REQUIREMENTS
In addition to clause 8.4.2 of ISO 22000:2018, the organization shall inform the
certification body within 3 working days of the commencement of the events or
situations 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 to food safety or certification
integrity as a result of a Force majeure, natural or man-made disasters (e.g., war,
strike, terrorism, crime, flood, earthquake, malicious computer hacking, etc.);

b) Serious situations where the integrity of the certification is at risk and/or where
the Foundation can be brought into disrepute. These include, but are not limited
to:
• Public food safety events (e.g., public recalls, withdrawals, calamities, food
safety outbreaks, etc.);
• Actions imposed by regulatory authorities as a result of a food safety issue(s),
where additional monitoring or forced shutdown of production is required;
• Legal proceedings, prosecutions, malpractice, and negligence; and
• Fraudulent activities and corruption.

Guidance
➢ Establish whether any serious events or situations have occurred since the
previous audit. If so:
• Determine whether the organization notified the CB within 3 working days,
e.g., contacting your CB office and confirming if they have a notification on
record. Recommend to do this prior to the audit, when preparing for the audit.
• Evaluate the measures taken by the organization in response to the event or
situation, as part of their emergency preparedness and response process.

68
SECTION 2.5.18
REQUIREMENTS FOR MULTI-SITES

REQUIREMENTS FOR MULTI-SITES
➢ Only applicable to multi-site organizations where the
conditions for multisite certification are being met;
➢ Refer to Part 3 of the Scheme, Section 5.3;
➢ Only allowed for Food Chain Categories: E, F (FI and FII), and G;
➢ Does not apply to organizations with multiple functions across
more than one site as set out in Part 3 of the Scheme, Section
5.2 (Head office functions).

CENTRAL FUNCTION
Requirement 2.5.18.1
a) The management of the central function shall ensure that sufficient resources
are available, and that roles, responsibilities, and requirements are clearly
defined for:
• Management,
• Internal auditors,
• Technical personnel reviewing internal audits and
• Other key personnel involved in the FSMS.
Guidance
➢ Evaluate whether sufficient resources have been made available by the Central
function.
➢ Assess whether the roles and responsibilities of key personnel have been
defined, including the above-mentioned roles.

INTERNAL AUDIT REQUIREMENTS
Requirement 2.5.18.2
In addition to clause 9.2 of ISO 22000:2018, the organization shall adhere to the
following requirements relating to internal audits:
a) An internal audit procedure and program shall be established by the central
function covering the management system, central function, and all sites.
Internal auditors shall be independent of the areas they audit and be assigned
by the central function to ensure impartiality at the site level.
b) The management system, centralized function, and all sites shall be audited at
least annually or more frequently based on a risk assessment, and the
effectiveness of corrective action shall be demonstrated.

c) Internal auditors shall meet at least the following requirements, and this shall be
assessed by the CB annually as part of the audit:
• Work experience: 2 years’ full-time work experience in the food industry
including at least 1 year in the organization.
• Education: completion of a higher education course or in the absence of a
formal course, have at least 5 years work experience in the food production or
manufacturing, transport, and storage, retailing, inspection, or enforcement
areas.

Training
i. For FSSC 22000 internal audits, the lead auditor shall have successfully
completed an FSMS, QMS, or FSSC 22000 Lead Auditor Course of 40
hours.
ii. Other auditors in the internal audit team shall have successfully
completed an internal auditor course of 16 hours covering audit
principles, practices, and techniques. The training may be provided by
the qualified internal Lead Auditor or through an external training
provider.
iii. FSSC Scheme training covering at least ISO 22000, the relevant
prerequisite programs based on the technical specification for the
sector (e.g., ISO/TS 22002-x; PAS-xyz), and the FSSC additional
requirements – minimum 8 hours.

d) Internal audit reports shall be subject to a technical review by the central
function, including addressing the non-conformities resulting from the internal
audit. Technical reviewers shall be impartial, have the ability to interpret and
apply the FSSC normative documents (at least ISO 22000, the relevant ISO/TS
22002-x; PAS-xyz and the FSSC additional requirements) and have knowledge of
the organization’s processes and systems.
e) Internal auditors and technical reviewers shall be subject to annual performance
monitoring and calibration. Any follow-up actions identified shall be suitably
actioned in a timely and appropriate manner by the Central function.

THANK
YOU
THANK
YOU
@FoundationFSSC
Foundation FSSC +31 (0) 183 64 50 28
info@fssc.com

V6.002-FSSC-22000-V6-Part-2-Presentation.pdf

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