FSNS Certification & Audit FSSC 22000 Checklist

FSSC 22000 Self-Assessment Checklist
Version 5.1
This checklist helps organizations assess their compliance with FSSC 22000 certification criteria.
Use it to help uncover gaps that must be addressed prior to your FSSC 22000 certification audit or
to ascertain your readiness to achieve FSSC 22000 certification.
It is intended for organizations in the following food chain categories:
Food Manufacturing (Category C)

▪ Processing of perishable animal products. Production of animal products, including fish
and seafood, meat, eggs, dairy and fish products.
▪ Processing of perishable plant products. Production of plant products, including fresh
fruits and fresh juices, vegetables, grains, nut, and pluses, and frozen water-based
products (e.g., ice).
▪ Processing of perishable animal and plant products. Production of mixed animal and
plant products including pizza, lasagna, sandwich, dumpling and ready-to-eat meals.
▪ Processing of ambient stable products. Production of food products from any source
that is stored and sold at ambient temperature, including canned foods, biscuits, bread,
snacks, oil, drinking water, beverages, pasta, flour, sugar and food-grade salt.
Production Of Biochemicals (Category K)

▪ Food chain category K involves the production of Bio-Chemicals and applies to the
production of food and feed additives, vitamins, minerals, bio-cultures, flavorings, enzymes,
and processing aids but excludes pesticides, drugs, fertilizers and cleaning agents.
If you have questions or want to schedule an FSSC 22000 audit, our Certification & Audit Specialists
are happy to help.
Contact an FSNS Certification & Audit Specialist

ISO 22000:2018 - Audit Report
4 Context of the Organization
4.1 The organization shall determine external and internal issues that are relevant
Understanding the to its purpose and that affect its ability to achieve the intended result(s) of its
organization and FSMS.
its context The organization shall identify, review and update information related to these
external and internal issues.
NOTE 1: Issues can include positive and negative factors or conditions for
consideration.
NOTE 2: Understanding the context can be facilitated by considering external
and internal issues, including, but not limited to, legal, technological,
competitive, market, cultural, social and economic environments, cybersecurity
and food fraud, food defence and intentional contamination, knowledge and
performance of the organization, whether international, national, regional or
local.
Auditor Response
4.2 To ensure that the organization has the ability to consistently provide products
Understanding the and services that meet applicable statutory, regulatory and customer
needs and requirements with regard to food safety, the organization shall determine:
expectations of a) the interested parties that are relevant to the FSMS;
interested parties b) the relevant requirements of the interested parties of the FSMS.
The organization shall identify, review and update information related to the
interested parties and their requirements.
Auditor Response
4.3 The organization shall determine the boundaries and applicability of the FSMS
Determining the to establish its scope. The scope shall specify the products and services,
scope of the food processes and production site(s) that are included in the FSMS. The scope shall
safety include the activities, processes, products, or services that can have an
management influence on the food safety of its end products.
system When determining this scope, the organization shall consider:
a) the external and internal issues referred to in 4.1;
b) the requirements referred to in 4.2.
The scope shall be available and maintained as documented information.
Auditor Response
4.4 The organization shall establish, implement, maintain, update, and continually
Food Safety improve a FSMS, including the processes needed and their interactions, in
Management accordance with the requirements of this document.
System
Auditor Response
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5 Leadership
5.1 Top management shall demonstrate leadership and commitment with respect
Leadership and to the FSMS by:
Commitment a) ensuring that the food safety policy and the objectives of the FSMS are
established and are compatible with the strategic direction of the organization;
b) ensuring the integration of the FSMS requirements into the organization’s
business processes;
c) ensuring that the resources needed for the FSMS are available;
d) communicating the importance of effective food safety management and
conforming to the FSMS requirements, applicable statutory and regulatory
requirements, and mutually agreed customer requirements related to food
safety;
e) ensuring that the FSMS is evaluated and maintained to achieve its intended
result(s) (see 4.1);
f) directing and supporting persons to contribute to the effectiveness of the
FSMS;
g) promoting continual improvement;
h) supporting other relevant management roles to demonstrate their
leadership as it applies to their areas of responsibility.
Auditor Response
5.2.1 Top management shall establish, implement and maintain a food safety policy
Establishing the that:
food safety policy a) is appropriate to the purpose and context of the organization;
b) provides a framework for setting and reviewing the objectives of the FSMS;
c) includes a commitment to satisfy applicable food safety requirements,
including statutory and regulatory requirements and mutually agreed customer
requirements related to food safety;
d) addresses internal and external communication;
e) includes a commitment to continual improvement of the FSMS;
f) addresses the need to ensure competencies related to food safety.
Auditor Response
5.2.2 The food safety policy shall:

Communicating a) be available and maintained as documented information;
the food safety b) be communicated, understood, and applied at all levels within the
policy organization;.
c) be available to relevant interested parties, as appropriate.
Auditor Response

5.3.1 Top management shall ensure that the responsibilities and authorities for
Organizational relevant roles are assigned, communicated and understood within the
roles, organization.
responsibilities, Top management shall assign the responsibility and authority for:
and authorities a) ensuring that the FSMS conforms to the requirements of this document;
b) reporting on the performance of the FSMS to top management;
c) appointing the food safety team and the food safety team leader;
d) designating persons with defined responsibility and authority to initiate and
document action(s).
Auditor Response
5.3.2 The food safety team leader shall be responsible for:

Organizational a) ensuring the FSMS is established, implemented, maintained, and updated;
roles, b) managing and organizing the work of the food safety team;
responsibilities, c) ensuring relevant training and competencies for the food safety team (see
and authorities 7.2);
d) reporting to top management on the effectiveness and suitability of the
FSMS
Auditor Response
5.3.3 All persons shall have the responsibility to report problem(s) with regards to
Organizational the FSMS to identified person(s).
roles,
responsibilities,
and authorities
Auditor Response
6 Planning
6.1.1 When planning for the FSMS, the organization shall consider the issues referred
Actions to address to in 4.1 and the requirements referred to in 4.2 and 4.3 and determine the
risks and risks and opportunities that need to be addressed to:
opportunities a) give assurance that the FSMS can achieve its intended result(s);
b) enhance desirable effects;
c) prevent, or reduce, undesired effects;
d) achieve continual improvement.
Auditor Response
6.1.2 The organization shall plan:

Actions to address a) actions to address these risks and opportunities;
risks and b) how to:
opportunities 1) integrate and implement the actions into its FSMS processes;
2) evaluate the effectiveness of these actions
Auditor Response

6.1.3 The actions taken by the organization to address risks and opportunities shall
Actions to address be proportionate to:
risks and a) the impact on food safety requirements;
opportunities b) the conformity of food products and services to customers;
c) requirements of interested parties in the food chain.
NOTE 1: Actions to address risks and opportunities can include: avoiding risk,
taking risk in order to pursue an opportunity, eliminating the risk source,
changing the likelihood or consequences, sharing the risk, or accepting the
presence of risk by informed decision.
NOTE 2: Opportunities can lead to the adoption of new practices (modification
of products or processes), using new technology and other desirable and viable
possibilities to address the food safety needs of the organization or its
customers.
Auditor Response
6.2.1 The organization shall establish objectives for the FSMS at relevant functions
Objectives of the and levels.
food safety The objectives of the FSMS shall:
management a) be consistent with the food safety policy;
system and b) be measurable (if practicable);
planning to c) take into account applicable food safety requirements, including statutory,
achieve them regulatory and customer requirements;
d) be monitored and verified;
e) be communicated;
f) be maintained and updated as appropriate.
The organization shall retain documented information on the objectives for the
FSMS.
Auditor Response
6.2.2 When planning how to achieve its objectives for the FSMS, the organization
Objectives of the shall determine:
food safety a) what will be done;
management b) what resources will be required;
system and c) who will be responsible;
planning to d) when it will be completed;
achieve them e) how the results will be evaluated.
Auditor Response

6.3.1 When the organization determines the need for changes to the FSMS, including
Planning of personnel changes, the changes shall be carried out and communicated in a
Changes planned manner.
The organization shall consider:
a) the purpose of the changes and their potential consequences;
b) the continued integrity of the FSMS;
c) the availability of resources to effectively implement the changes;
d) the allocation or re-allocation of responsibilities and authorities.
Auditor Response
7 Support
7.1.1 The organization shall determine and provide the resources needed for the
Resources establishment, implementation, maintenance, update, and continual
improvement of the FSMS.
The organization shall consider:
a) the capability of, and any constraints on, existing internal resources;
b) the need for external resources.
Auditor Response
7.1.2 The organization shall ensure that persons necessary to operate and maintain
People an effective FSMS are competent (see 7.2).
Where the assistance of external experts is used for the development,
implementation, operation, or assessment of the FSMS, evidence of agreement
or contracts defining the competency, responsibility and authority of external
experts shall be retained as documented information.
Auditor Response
7.1.3 The organization shall provide the resources for the determination,
Infrastructure establishment, and maintenance of the infrastructure necessary to achieve
conformity with the requirements of the FSMS.
NOTE: Infrastructure can include:
a) land, vessels, buildings and associated utilities;
b) equipment, including hardware and software;
c) transportation;
d) information and communication technology.
Auditor Response

7.1.4 The organization shall determine, provide and maintain the resources for the
Work Environment establishment, management and maintenance of the work environment
necessary to achieve conformity with the requirements of the FSMS.
NOTE: A suitable environment can be a combination of human and physical
factors such as:
a) social (e.g. non-discriminatory, calm, non-confrontational);
b) psychological (e.g. stress-reducing, burnout prevention, emotionally
protective);
c) physical (e.g. temperature, heat, humidity, light, air flow, hygiene, noise).
These factors can differ substantially depending on the products and services
provided.
Auditor Response
7.1.5 When an organization establishes, maintains, updates and continually improves

Externally its FSMS by using externally developed elements of a FSMS, including PRPs, the
developed hazard analysis and the hazard control plan (see 8.5.4), the organization shall
elements of the ensure that the provided elements are:
food safety a) developed in conformance with requirements of this document;
management b) applicable to the sites, processes and products of the organization;
system c) specifically adapted to the processes and products of the organization by the
food safety team;
d) implemented, maintained and updated as required by this document;
e) retained as documented information.
Auditor Response
7.1.6 The organization shall:

Control of a) establish and apply criteria for the evaluation, selection, monitoring of
externally performance and re- evaluation of external providers of processes, products
provided and/or services;
processes, b) ensure adequate communication of requirements to the external provider(s);
products or c) ensure that externally provided processes, products or services do not
services adversely affect the organization's ability to consistently meet the
requirements of the FSMS;
d) retain documented information of these activities and any necessary actions
as a result of the evaluations and re-evaluations.
Auditor Response

7.2 The organization shall:
Competence a) determine the necessary competence of person(s), including external
providers, doing work under its control that affects its food safety performance
and effectiveness of the FSMS;
b) ensure that these persons, including the food safety team and those
responsible for the operation of the hazard control plan, are competent on the
basis of appropriate education, training and/or experience;
c) ensure that the food safety team has a combination of multi-disciplinary
knowledge and experience in developing and implementing the FSMS
(including, but not limited to, the organization’s products, processes,
equipment and food safety hazards within the scope of the FSMS);
d) where applicable, take actions to acquire the necessary competence, and
evaluate the effectiveness of the actions taken;
e) retain appropriate documented information as evidence of competence.
NOTE: Applicable actions can include, for example, the provision of training to,
the mentoring of, or the re- assignment of currently employed persons; or the
hiring or contracting of competent persons.
Auditor Response
7.3 The organization shall ensure that all relevant persons doing work under the
Awareness organization’s control shall be aware of:
a) the food safety policy;
b) the objectives of the FSMS relevant to their task(s):
c) their individual contribution to the effectiveness of the FSMS, including the
benefits of improved food safety performance;
d) the implications of not conforming with the FSMS requirements.
Auditor Response
7.4 The organization shall determine the internal and external communications
Communication relevant to the FSMS, including:
general a) on what it will communicate;
b) when to communicate;
c) with whom to communicate;
d) how to communicate;
e) who communicates.
The organization shall ensure that the requirement for
Auditor Response

7.4.2 The organization shall ensure that sufficient information is communicated
External externally and is available for interested parties of the food chain.
communication The organization shall establish, implement and maintain effective
communications with:
a) external providers and contractors;
b) customers and/or consumers, in relation to:
1) product information related to food safety, to enable the handling,
display, storage, preparation, distribution and use of the product within the
food chain or by the consumer;
2) identified foods safety hazards that need to be controlled by other
organizations in the food chain and/or by consumers;
3) contractual arrangements, enquiries and orders, including their
amendments;
4) customer and/or consumer feedback, including complaints;
c) statutory and regulatory authorities;
d) other organizations that have an impact on, or will be affected by, the
effectiveness or updating of the FSMS.
Designated persons shall have defined responsibility and authority for the
external communication of any information concerning food safety. Where
relevant, information obtained through external communication shall be
included as input for management review (see 9.3) and for updating the FSMS
(see 4.4 and 10.3).
Evidence of external communication shall be retained as documented
information.
Auditor Response

7.4.3 The organization shall establish, implement, and maintain an effective system
Internal for communicating issues having an impact on food safety. To maintain the
communication effectiveness of the FSMS, the organization shall ensure that the food safety
team is informed in a timely manner of changes in the following:
a) products or new products;
b) raw materials, ingredients and services;
c) production systems and equipment;
d) production premises, location of equipment and surrounding environment;
e) cleaning and sanitation programs;
f) packaging, storage and distribution systems;
g) competencies and/or allocation of responsibilities and authorizations;
h) applicable statutory and regulatory requirements;
i) knowledge regarding food safety hazards and control measures;
j) customer, sector and other requirements that the organization observes;
k) relevant enquiries and communications from external interested parties;
l) complaints and alerts indicating food safety hazards associated with the end
product;
m) other conditions that have an impact on food safety.
The food safety team shall ensure that this information is included when
updating the FSMS (see 4.4 and 10.3).
Top management shall ensure that relevant information is included as input to
the management review (see 9.3).
Auditor Response
7.5.1 The organization’s FSMS shall include:

Documentation a) documented information required by this document;
information b) documented information determined by the organization as being necessary
general for the effectiveness of the FSMS;
c) documented information and food safety requirements required by
statutory, regulatory authorities and customers.
NOTE: The extent of documented information for a FSMS can differ from one
organization to another due to:
a) the size of organization and its type of activities, processes, products and
services;
b) the complexity of processes and their interactions;
c) the competence of persons.
Auditor Response
7.5.2 When creating and updating documented information, the organization shall
Documentation ensure appropriate:
information a) identification and description (e.g. a title, date, author, or reference
creating and number);
updating b) format (e.g. language, software version, graphics) and media (e.g. paper,
electronic);
c) review and approval for suitability and adequacy.
Auditor Response

7.5.3.1 Documented information required by the FSMS and by this document shall be
Control of controlled to ensure:
documented a) it is available and suitable for use, where and when it is needed;
information b) it is adequately protected (e.g. from loss of confidentiality, improper use, or
loss of integrity).
Auditor Response
7.5.3.2 For the control of documented information, the organization shall address the
Control of following activities, as applicable:
documented a) distribution, access, retrieval and use;
information b) storage and preservation, including preservation of legibility;
c) control of changes (e.g. version control);
d) retention and disposition.
Documented information of external origin determined by the organization to
be necessary for the planning and operation of the FSMS shall be identified, as
appropriate, and controlled.
Documented information retained as evidence of conformity shall be protected
from unintended alterations.
NOTE: Access can imply a decision regarding the permission to view the
documented information only, or the permission and authority to view and
change the documented information.
Auditor Response
8 Operation
8.1 The organization shall plan, implement, control, maintain and update the
Operational processes needed to meet requirements for the realization of safe products,
planning and and to implement the actions determined in 6.1, by:
control a) establishing criteria for the processes;
b) implementing control of the processes in accordance with the criteria;
c) keeping documented information to the extent necessary to have the
confidence to demonstrate that the processes have been carried out as
planned.
The organization shall control planned changes and review the consequences of
unintended changes, taking action to mitigate any adverse effects, as
necessary. The organization shall ensure that outsourced processes are
controlled (see 7.1.6).
Auditor Response
8.2.1 The organization shall establish, implement, maintain and update PRP(s) to
Prerequisite facilitate the prevention and/or reduction of contaminants (including food
programs (PRPs) safety hazards) in the products, product processing and work environment.
Auditor Response

8.2.2 The PRP(s) shall be:
Prerequisite a) appropriate to the organization and its context with regard to food safety;
programs (PRPs) b) appropriate to the size and type of the operation and the nature of the
products being manufactured and/or handled;
c) implemented across the entire production system, either as programs
applicable in general or as programs applicable to a particular product or
process;
d) approved by the food safety team.
Auditor Response
8.2.3 When selecting and/or establishing PRP(s), the organization shall ensure that
Prerequisite applicable statutory, regulatory, and mutually agreed customer requirements
programs (PRPs) are identified. The organization should consider:
a) the applicable part of the ISO/TS 22002 series;
b) applicable standards, codes of practice and guidelines.
Auditor Response
8.2.4 When establishing PRP(s) the organization shall consider:

Prerequisite a) construction, layout of buildings and associated utilities;
programs (PRPs) b) layout of premises, including zoning, workspace and employee facilities;
c) supplies of air, water, energy and other utilities;
d) pest control, waste and sewage disposal and supporting services;
e) the suitability of equipment and its accessibility for cleaning and
maintenance;
f) supplier approval and assurance processes (e.g. raw materials, ingredients,
chemicals and packaging);
g) reception of incoming materials, storage, dispatch, transportation and
handling of products;
h) measures for the prevention of cross contamination;
i) cleaning and disinfecting;
j) personal hygiene;
k) product information/consumer awareness;
l) others, as appropriate.
Documented information shall specify the selection, establishment, applicable
monitoring and verification of the PRP(s).
Auditor Response

8.3 The traceability system shall be able to uniquely identify incoming material
Traceability from the suppliers and the first stage of the distribution route of the end
product. When establishing and implementing the traceability system, the
following shall be considered as a minimum:
a) relation of lots of received materials, ingredients and intermediate products
to the end products;
b) reworking of materials/products;
c) distribution of the end product.
The organization shall ensure that applicable statutory, regulatory and
customer requirements are identified.
Documented information as evidence of the traceability system shall be
retained for a defined period to include, as a minimum, the shelf life of the
product. The organization shall verify and test the effectiveness of the
traceability system.
NOTE: Where appropriate, the verification of the system is expected to include
the reconciliation of quantities of end products with the quantity of ingredients
as evidence of effectiveness.
Auditor Response
8.4.1 Top management shall ensure procedures are in place to respond to potential
Emergency emergency situations or incidents that can have an impact on food safety that
preparedness are relevant to the role of the organization in the food chain.
Documented information shall be established and maintained to manage these
situations and incidents.
Auditor Response

Handling a) respond to actual emergency situations and incidents by:
emergencies and 1) ensuring applicable statutory and regulatory requirements are identified;
incidents 2) communicating internally;
3) communicating externally (e.g. suppliers, customers, appropriate authorities,
media);
b) take action to reduce the consequences of the emergency situation,
appropriate to the magnitude of the emergency or incident and the potential
food safety impact;
c) periodically test procedures where practical;
d) review and, where necessary, update the documented information after the
occurrence of any incident, emergency situation or tests.
NOTE: Examples of emergency situations that can affect food safety and/or
production are natural disasters, environmental accidents, bioterrorism,
workplace accidents, public health emergencies and other accidents, e.g.
interruption of essential services such as water, electricity or refrigeration
supply.
Auditor Response

8.5.1 To carry out the hazard analysis, preliminary documented information shall be
Preliminary steps collected, maintained, and updated by the food safety team. This shall include,
to enable hazard but not be limited to:
analysis a) applicable statutory, regulatory and customer requirements;
b) the organization’s products, processes, and equipment;
c) food safety hazards relevant to the FSMS.
Auditor Response
8.5.1.2 The organization shall ensure that all applicable statutory and regulatory food
Characteristics of safety requirements are identified for all raw materials, ingredients, and
raw materials, product contact materials.
ingredients, and The organization shall maintain documented information concerning all raw
product contact materials, ingredients and product contact materials to the extent needed to
materials conduct the hazard analysis (see 8.5.2), including the following, as appropriate:
a) biological, chemical and physical characteristics;
b) composition of formulated ingredients, including additives and processing
aids;
c) source (e.g. animal, mineral or vegetable);
d) place of origin (provenance);
e) method of production;
f) method of packaging and delivery;
g) storage conditions and shelf life;
h) preparation and/or handling before use or processing;
i) acceptance criteria related to food safety or specifications of purchased
materials and ingredients appropriate to their intended use.
Auditor Response
8.5.1.3 The organization shall ensure that all applicable statutory and regulatory food
Characteristics of safety requirements are identified for all the end products intended to be
end products produced.
The organization shall maintain documented information concerning the
characteristics of end products to the extent needed to conduct the hazard
analysis (see 8.5.2), including information on the following, as appropriate:
a) product name or similar identification;
b) composition;
c) biological, chemical and physical characteristics relevant for food safety;
d) intended shelf life and storage conditions;
e) packaging;
f) labelling relating to food safety and/or instructions for handling, preparation
and intended use;
g) method(s) of distribution and delivery.
Auditor Response

8.5.1.4 Intended The intended use, including reasonably expected handling of the end product
use and any unintended use but reasonably expected mishandling and misuse of
the end product, shall be considered and shall be maintained as documented
information to the extent needed to conduct the hazard analysis (see 8.5.2).
Where appropriate, groups of consumers/users shall be identified for each
product.
Groups of consumers/users known to be especially vulnerable to specific food
safety hazards shall be identified.
Auditor Response
8.5.1.5 The food safety team shall establish, maintain, and update flow diagrams as
Flow diagrams and documented information for the products or product categories and the
description of processes covered by the FSMS.
processes Flow diagrams provide a graphic representation of the process. Flow diagrams
shall be used when conducting the hazard analysis as a basis for evaluating the
possible occurrence, increase, decrease or introduction of food safety hazards.
Flow diagrams shall be clear, accurate and sufficiently detailed to the extent
needed to conduct the hazard analysis. Flow diagrams shall, as appropriate,
include the following:
a) the sequence and interaction of the steps in the operation;
b) any outsourced processes;
c) where raw materials, ingredients, processing aids, packaging materials,
utilities and intermediate products enter the flow;
d) where reworking and recycling take place;
e) where end products, intermediate products, by-products and waste are
released or removed.
Auditor Response
8.5.1.5.2 The food safety team shall confirm on-site the accuracy of the flow diagrams,
Flow diagrams and update the flow diagrams where appropriate and retain as documented
description of information.
processes
Auditor Response

8.5.1.5.3 The food safety team shall describe, to the extent needed to conduct the
Flow diagrams and hazard analysis:
description of a) the layout of premises, including food and non-food handling areas;
processes b) processing equipment and contact materials, processing aids and flow of
materials;
c) existing PRPs, process parameters, control measures (if any) and/or the
strictness with which they are applied, or procedures that can influence food
safety;
d) external requirements (e.g. from statutory and regulatory authorities or
customers) that can impact the choice and the strictness of the control
measures.
The variations resulting from expected seasonal changes or shift patterns shall
be included as appropriate.
The descriptions shall be updated as appropriate and maintained as
documented information.
Auditor Response
8.5.2.1 The food safety team shall conduct a hazard analysis, based on the preliminary
Hazard analysis information, to determine the hazards that need to be controlled. The degree
of control shall ensure food safety and, where appropriate, a combination of
control measures shall be used.
Auditor Response
8.5.2.2.1 The organization shall identify and document all food safety hazards that are
Hazard reasonably expected to occur in relation to the type of product, type of process
identification and and process environment.
determination of The identification shall be based on:
acceptable levels a) the preliminary information and data collected in accordance with 8.5.1;
b) experience;
c) internal and external information including, to the extent possible,
epidemiological, scientific and other historical data;
d) information from the food chain on food safety hazards related to the safety
of the end products, intermediate products and the food at the time of
consumption;
e) statutory, regulatory and customer requirements.
NOTE 1: Experience can include information from staff and external experts
who are familiar with the product and/or processes in other facilities.
NOTE 2: Statutory and regulatory requirements can include food safety
objectives (FSOs). The Codex Alimentarius Commission defines FSOs as “The
maximum frequency and/or concentration of a hazard in a food at the time of
consumption that provides or contributes to the appropriate level of protection
(ALOP)”. Hazards should be considered in sufficient detail to enable hazard
assessment and the selection of appropriate control measures.
Auditor Response

8.5.2.2.2 The organization shall identify step(s) (e.g. receiving raw materials, processing,
Hazard distribution and delivery) at which each food safety hazard can be present, be
identification and introduced, increase or persist.
determination of When identifying hazards, the organization shall consider:
acceptable levels a) the stages preceding and following in the food chain;
b) all steps in the flow diagram;
c) the process equipment, utilities/services, process environment and persons.
Auditor Response
8.5.2.2.3 The organization shall determine the acceptable level in the end product of
Hazard each food safety hazard identified, whenever possible.
identification and When determining acceptable levels, the organization shall:
determination of a) ensure that applicable statutory, regulatory and customer requirements are
acceptable levels identified;
b) consider the intended use of end products;
c) consider any other relevant information.
The organization shall maintain documented information concerning the
determination of acceptable levels and the justification for the acceptable
levels.
Auditor Response
8.5.2.3 The organization shall conduct, for each identified food safety hazard, a hazard
Hazard assessment assessment to determine whether its prevention or reduction to an acceptable
level is essential.
The organization shall evaluate each food safety hazard with regard to:
a) the likelihood of its occurrence in the end product prior to application of
control measures;
b) the severity of its adverse health effects in relation to the intended use (see
8.5.1.4).
The organization shall identify any significant food safety hazards.
The methodology used shall be described, and the result of the hazard
assessment shall be maintained as documented information.
Auditor Response

8.5.2.4.1 Based on the hazard assessment, the organization shall select an appropriate
Selection and control measure or combination of control measures that will be capable of
categorization of preventing or reducing the identified significant food safety hazards to defined
control measure(s) acceptable levels.
The organization shall categorize the selected identified control measure(s) to
be managed as OPRP(s) (see 3.30) or at CCPs (see 3.11).
The categorization shall be carried out using a systematic approach. For each of
the control measures selected, there shall be an assessment of the following:
a) the likelihood of failure of its functioning;
b) the severity of the consequence in the case of failure of its functioning; this
assessment shall include:
1) the effect on identified significant food safety hazards;
2) the location in relation to other control measure(s);
3) whether it is specifically established and applied to reduce the hazards to an
acceptable level;
4) whether it is a single measure or is part of combination of control
measure(s).
Auditor Response
8.5.2.4.2 In addition, for each control measure, the systematic approach shall include an
Selection and assessment of the feasibility of:
categorization of a) establishing measurable critical limits and/or measurable/observable action
control measure(s) criteria;
b) monitoring to detect any failure to remain within critical limit and/or
measurable/observable action criteria;
c) applying timely corrections in case of failure.
The decision-making process and results of the selection and categorization of
the control measures shall be maintained as documented information.
External requirements (e.g. statutory, regulatory and customer requirements)
that can impact the choice and the strictness of the control measures shall also
be maintained as documented information.
Auditor Response

8.5.3.1 The food safety team shall validate that the selected control measures can
Validation of achieve the intended control of the significant food safety hazard(s). This
control measure(s) validation shall be done prior to implementation of control measure(s) and
and combinations combinations of control measures to be included in the hazard control plan (see
of control 8.5.4) and after any change therein (see 7.4.2, 7.4.3, 10.2 and 10.3).
measures When the result of validation shows that the control measures(s) is (are) not
capable of achieving the intended control, the food safety team shall modify
and re-assess the control measure(s) and/or combination(s) of control
measure(s).
The food safety team shall maintain the validation methodology and evidence
of capability of the control measure(s) to achieve the intended control as
NOTE: Modification can include changes in control measure(s) (i.e. process
parameters, rigour and/or their combination) and/or change(s) in the
manufacturing technologies for raw materials, end product characteristics,
methods of distribution and intended use of the end products.
Auditor Response
8.5.4.1 The organization shall establish, implement and maintain a hazard control plan.
Hazard control The hazard control plan shall be maintained as documented information and
plan (HACCP/OPRP shall include the following information for each control measure at each CCP or
plan) OPRP:
a) food safety hazard(s) to be controlled at the CCP or by the OPRP;
b) critical limit(s) at CCP or action criteria for OPRP;
c) monitoring procedure(s);
d) correction(s) to be made if critical limits or action criteria are not met;
e) responsibilities and authorities;
f) records of monitoring.
Auditor Response
8.5.4.2 Critical limits at CCPs and action criteria for OPRPs shall be specified. The
Determination of rationale for their determination shall be maintained as documented
critical limits and information.
action criteria Critical limits at CCPs shall be measurable. Conformance with critical limits shall
ensure that the acceptable level is not exceeded.
Action criteria for OPRPs shall be measurable or observable. Conformance with
action criteria shall contribute to the assurance that the acceptable level is not
exceeded.
Auditor Response

8.5.4.3 Monitoring At each CCP, a monitoring system shall be established for each control measure
systems at CCPs or combination of control measure(s) to detect any failure to remain within the
and for OPRPs critical limits. The system shall include all scheduled measurements relative to
the critical limit(s).
For each OPRP, a monitoring system shall be established for the control
measure or combination of control measure(s) to detect failure to meet the
action criterion.
The monitoring system, at each CCP and for each OPRP, shall consist of
documented information, including:
a) measurements or observations that provide results within an adequate time
frame;
b) monitoring methods or devices used;
c) applicable calibration methods or, for OPRPs, equivalent methods for
verification of reliable measurements or observations (see 8.7);
d) monitoring frequency;
e) monitoring results;
f) responsibility and authority related to monitoring;
g) responsibility and authority related to evaluation of monitoring results.
At each CCP, the monitoring method and frequency shall be capable of timely
detection of any failure to remain within critical limits, to allow timely isolation
and evaluation of the product (see 8.9.4).
For each OPRP, the monitoring method and frequency shall be proportionate to
the likelihood of failure and the severity of consequences.
When monitoring an OPRP is based on subjective data from observations (e.g.
visual inspection), the method shall be supported by instructions or
specifications.
Auditor Response
8.5.4.4 The organization shall specify corrections (see 8.9.2) and corrective actions (see
Actions when 8.9.3) to be taken when critical limits or action criterion are not met and shall
critical limits or ensure that:
action criteria are a) the potentially unsafe products are not released (see 8.9.4);
not met b) the cause of nonconformity is identified;
c) the parameter(s) controlled at the CCP or by the OPRP is (are) returned
within the critical limits or action criteria;
d) recurrence is prevented.
The organization shall make corrections in accordance with 8.9.2 and corrective
actions in accordance with 8.9.3.
Auditor Response
8.5.4.5 The organization shall implement and maintain the hazard control plan and
Implementation of retain evidence of the implementation as documented information.
the hazard control
plan
Auditor Response

8.6 Following the establishment of the hazard control plan, the organization shall
Updating the update the following information, if necessary:
information a) characteristics of raw materials, ingredients and product-contact materials;
specifying the PRPs b) characteristics of end products;
and the hazard c) intended use;
control plan d) flow diagrams and descriptions of processes and process environment.
The organization shall ensure that the hazard control plan and/or the PRP(s) are
up to date.
Auditor Response
8.7 The organization shall provide evidence that the specified monitoring and
Control of measuring methods and equipment in use are adequate for the monitoring and
monitoring and measuring activities related to the PRP(s) and the hazard control plan.
measuring The monitoring and measuring equipment used shall be:
a) calibrated or verified at specified intervals prior to use;
b) adjusted or re-adjusted as necessary;
c) identified to enable the calibration status to be determined;
d) safeguarded from adjustments that would invalidate the measurement
results;
e) protected from damage and deterioration.
The results of calibration and verification shall be retained as documented
information. The calibration of all the equipment shall be traceable to
international or national measurement standards; where no standards exist,
the basis used for calibration or verification shall be retained as documented
information.
The organization shall assess the validity of the previous measurement results
when the equipment or process environment is found not to conform to
requirements. The organization shall take appropriate action in relation to the
equipment or process environment and any product affected by the non-
conformance.
The assessment and resulting action shall be maintained as documented
information.
Software used in monitoring and measuring within the FSMS shall be validated
by the organization, software supplier or third party prior to use. Documented
information on validation activities shall be maintained by the organization and
the software shall be updated in a timely manner.
Whenever there are changes, including software configuration/modifications to
commercial off-the- shelf software, they shall be authorized, documented and
validated before implementation.
NOTE: Commercial off-the-shelf software in general use within its designed
application range can be considered to be sufficiently validated.
Auditor Response

8.8.1 The organization shall establish, implement and maintain verification activities.
Verification The verification planning shall define purpose, methods, frequencies and
related to PRPs responsibilities for the verification activities.
and the hazard The verification activities shall confirm that:
control plan a) the PRP(s) are implemented and effective;
b) the hazard control plan is implemented and effective;
c) hazard levels are within identified acceptable levels;
d) input to the hazard analysis is updated;
e) other actions determined by the organization are implemented and effective.
The organization shall ensure that verification activities are not carried out by
the person responsible for monitoring the same activities.
Verification results shall be retained as documented information and shall be
communicated.
Where verification is based on testing of end product samples or direct process
samples and where such test samples show nonconformity with the acceptable
level of the food safety hazard (see 8.5.2.2), the organization shall handle the
affected lot(s) of product as potentially unsafe (see 8.9.4.3) and apply
corrective actions in accordance with 8.9.3.
Auditor Response
8.8.2 The food safety team shall conduct an analysis of the results of verification that
Analysis of results shall be used as an input to the performance evaluation of the FSMS (see 9.1.2).
of verification
activities
Auditor Response
8.9.1 The organization shall ensure that data derived from the monitoring of OPRPs
Control of product and at CCPs are evaluated by designated persons who are competent and have
and process the authority to initiate corrections and corrective actions.
nonconformities
Auditor Response
8.9.2.1 Corrections The organization shall ensure that when critical limits at CCP(s) and/or action
criteria for OPRPs are not met, the products affected are identified and
controlled with regard to their use and release.
The organization shall establish, maintain and update documented information
that includes:
a) a method of identification, assessment and correction for affected products
to ensure their proper handling;
b) arrangements for review of the corrections carried out.
Auditor Response

8.9.2.2 Corrections When critical limits at CCPs are not met, affected products shall be identified
and handled as potentially unsafe products (see 8.9.4).
Auditor Response
8.9.2.3 Corrections Where action criteria for an OPRP are not met, the following shall be carried
out:
a) determination of the consequences of that failure with respect to food
safety;
b) determination of the cause(s) of failure;
c) identification of the affected products and handling in accordance with 8.9.4.
The organization shall retain results of the evaluation as documented
information.
Auditor Response
8.9.2.4 Corrections Documented information shall be retained to describe corrections made on

nonconforming products and processes, including:
a) the nature of the nonconformity;
b) the cause(s) of the failure;
c) the consequences as a result of the nonconformity.
Auditor Response
8.9.3 The need for corrective actions shall be evaluated when critical limits at CCP(s)
Corrective actions and/or action criteria for OPRPs are not met.
The organization shall establish and maintain documented information that
specifies appropriate actions to identify and eliminate the cause of detected
nonconformities, to prevent recurrence, and to return the process to control
after a nonconformity is identified.
These actions shall include:
a) reviewing nonconformities identified by customer and/or consumer
complaints and/or regulatory inspection reports;
b) reviewing trends in monitoring results that can indicate loss of control;
c) determining the cause(s) of nonconformities;
d) determining and implementing actions to ensure that nonconformities do
not recur;
e) documenting the results of corrective actions taken;
f) verifying corrective actions taken to ensure that they are effective.
The organization shall retain documented information on all corrective actions.
Auditor Response

8.9.4.1 The organization shall take action(s) to prevent potentially unsafe products
Handling of from entering the food chain, unless it can demonstrate that:
potentially unsafe a) the food safety hazard(s) of concern is (are) reduced to the defined
products acceptable levels;
b) the food safety hazard(s) of concern will be reduced to identified acceptable
levels prior to entering the food chain; or
c) the product still meets the defined acceptable level(s) of the food safety
hazard(s) of concern despite the nonconformity.
The organization shall retain products that have been identified as potentially
unsafe under its control until the products have been evaluated and the
disposition has been determined.
If products that have left the control of the organization are subsequently
determined to be unsafe, the organization shall notify relevant interested
parties and initiate a withdrawal/recall (see 8.9.5).
The controls and related responses from relevant interested parties and
authorization for dealing with potentially unsafe products shall be retained as
Auditor Response
8.9.4.2 Evaluation Each lot of products affected by the nonconformity shall be evaluated.
for release Products affected by failure to remain within critical limits at CCPs shall not be
released, but shall be handled in accordance with 8.9.4.3.
Products affected by failure to meet action criterion for OPRPs shall only be
released as safe when any of the following conditions apply:
a) evidence other than the monitoring system demonstrates that the control
measures have been effective;
b) evidence shows that the combined effect of the control measures for that
particular product conforms to the performance intended (i.e. identified
acceptable levels);
c) the results of sampling, analysis and/or other verification activities
demonstrate that the affected products conform to the identified acceptable
levels for the food safety hazard(s) concerned.
Results of evaluation for release of products shall be retained as documented
information.
Auditor Response
8.9.4.3 Disposition Products that are not acceptable for release shall be:
of nonconforming a) reprocessed or further processed within or outside the organization to
products ensure that the food safety hazard is reduced to acceptable levels; or
b) redirected for other use as long as food safety in the food chain is not
affected; or
c) destroyed and/or disposed as waste.
Documented information on the disposition of nonconforming products,
including the identification of the person(s) with approving authority shall be
retained.
Auditor Response

8.9.5 Withdrawal/ The organization shall be able to ensure the timely withdrawal/recall of lots of
recall end products that have been identified as potentially unsafe, by appointing
competent person(s) having the authority to initiate and carry out the
withdrawal/recall.
The organization shall establish and maintain documented information for:
a) notifying relevant interested parties (e.g. statutory and regulatory
authorities, customers and/or consumers);
b) handling withdrawn/recalled products as well as products still in stock;
c) performing the sequence of actions to be taken.
Withdrawn/recalled products and end products still in stock shall be secured or
held under the control of the organization until they are managed in
accordance with 8.9.4.3.
The cause, extent and result of a withdrawal/recall shall be retained as
documented information and reported to the top management as input for the
management review (see 9.3).
The organization shall verify the implementation and effectiveness of
withdrawals/recalls through the use of appropriate techniques (e.g. mock
withdrawal/recall or practice withdrawal/recall) and retain documented
information.
Auditor Response
9 Performance evaluation
9.1 The organization shall determine:

Monitoring, a) what needs to be monitored and measured;
measurement, b) the methods for monitoring, measurement, analysis and evaluation, as
analysis, and applicable, to ensure valid results;
evaluation c) when the monitoring and measuring shall be performed;
d) when the results from monitoring and measurement shall be analysed and
evaluated;
e) who shall analyse and evaluate the results from monitoring and
measurement.
The organization shall retain appropriate documented information as evidence
of the results.
The organization shall evaluate the performance and the effectiveness of the
FSMS.
Auditor Response

9.1.2 The organization shall analyse and evaluate appropriate data and information
Analysis and arising from monitoring and measurement, including the results of verification
evaluation activities related to PRPs and the hazard control plan (see 8.8 and 8.5.4), the
internal audits (see 9.2) and external audits.
The analysis shall be carried out:
a) to confirm that the overall performance of the system meets the planned
arrangements and the FSMS requirements established by the organization;
b) to identify the need for updating or improving the FSMS;
c) to identify trends that indicate a higher incidence of potentially unsafe
products or process failures;
d) to establish information for planning of the internal audit program related to
the status and importance of areas to be audited;
e) to provide evidence that corrections and corrective actions are effective.
The results of the analysis and the resulting activities shall be retained as
documented information. The results shall be reported to top management and
used as input to the management review (see 9.3) and the updating of the
FSMS (see 10.3).
Auditor Response
9.2.1 The organization shall conduct internal audits at planned intervals to provide
Internal audit information on whether the FSMS:
a) conforms to:
1) the organization’s own requirements for its FSMS;
2) the requirements of this document;
b) is effectively implemented and maintained.
Auditor Response

Internal audit a) plan, establish, implement and maintain (an) audit program(s), including the
frequency, methods, responsibilities, planning requirements and reporting,
which shall take into consideration the importance of the processes concerned,
changes in the FSMS, and the results of monitoring, measurement and previous
audits;
b) define the audit criteria and scope for each audit;
c) select competent auditors and conduct audits to ensure objectivity and the
impartiality of the audit process;
d) ensure that the results of the audits are reported to the food safety team
and relevant management;
e) retain documented information as evidence of the implementation of the
audit program and the audit results;
f) make the necessary correction and take the necessary corrective action
within the agreed time frame;
g) determine if the FSMS meets the intent of the food safety policy (see 5.2)
and objectives of the FSMS (see 6.2).
Follow-up activities by the organization shall include the verification of the
actions taken and the reporting of the verification results.
Auditor Response
9.3.1 Top management shall review the organization’s FSMS, at planned intervals, to
Management ensure its continuing suitability, adequacy, and effectiveness.
Review
Auditor Response

9.3.2 Management Management review input.
review input The management review shall consider:
a) the status of actions from previous management reviews;
b) changes in external and internal issues that are relevant to the FSMS,
including changes in the organization and its context (see 4.1);
c) information on the performance and the effectiveness of the FSMS, including
trends in:
1) result(s) of system updating activities (see 4.4 and 10.3);
2) monitoring and measurement results;
3) analysis of the results of verification activities related to PRPs and the
hazard control plan (see 8.8.2);
4) nonconformities and corrective actions;
5) audit results (internal and external);
6) inspections (e.g. regulatory, customer);
7) the performance of external providers;
8) the review of risks and opportunities and of the effectiveness of actions
taken to address them (see 6.1);
9) the extent to which objectives of the FSMS have been met;
d) the adequacy of resources;
e) any emergency situation, incident (see 8.4.2) or withdrawal/recall (see 8.9.5)
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 FSMS.
Auditor Response
9.3.3 Management The outputs of the management review shall include:

review output a) decisions and actions related to continual improvement opportunities;
b) any need for updates and changes to the FSMS, including resource needs and
revision of the food safety policy and objectives of the FSMS.
The organization shall retain documented information as evidence of the
results of management reviews.
Auditor Response

10 Improvement
10.1.1 When a nonconformity occurs, the organization shall:

Nonconformity a) react to the nonconformity and, as applicable:
and corrective 1) take action to control and correct it;
action 2) deal with the consequences;
b) evaluate the need for action to eliminate the cause(s) of the nonconformity,
in order that it does not recur or occur elsewhere, by:
1) reviewing the nonconformity;
2) determining the causes of the nonconformity;
3) determining if similar nonconformities exist, or could potentially occur;
c) implement any action needed;
d) review the effectiveness of any corrective action taken;
e) make changes to the FSMS, if necessary.
Corrective actions shall be appropriate to the effects of the nonconformities
encountered.
Auditor Response
10.1.2 The organization shall retain documented information as evidence of:

Nonconformity a) the nature of the nonconformities and any subsequent actions taken;
and corrective b) the results of any corrective action.
action
Auditor Response
10.2 The organization shall continually improve the suitability, adequacy and
Continual effectiveness of the FSMS.
improvement Top management shall ensure that the organization continually improves the
effectiveness of the FSMS through the use of communication (see 7.4),
management review (see 9.3), internal audit (see 9.2), analysis of results of
verification activities (see 8.8.2), validation of control measure(s) and
combination(s) of control measure(s) (see 8.5.3), corrective actions (see 8.9.3)
and FSMS updating (see 10.3).
Auditor Response

10.3 Top management shall ensure that the FSMS is continually updated. To achieve
Update of the food this, the food safety team shall evaluate the FSMS at planned intervals. The
safety team shall consider whether it is necessary to review the hazard analysis (see
management 8.5.2), the established hazard control plan (see 8.5.4) and the established PRPs
system (see 8.2). The updating activities shall be based on:
a) input from communication, external as well as internal (see 7.4);
b) input from other information concerning the suitability, adequacy and
effectiveness of the FSMS;
c) output from the analysis of results of verification activities (see 9.1.2);
d) output from management review (see 9.3).
System updating activities shall be retained as documented information and
reported as input to the management review (see 9.3).
Auditor Response
ISO 22002-1:2009 Audit Report

4 Construction and Layout of Buildings
4.1 Buildings shall be designed, constructed, and maintained in a manner

General Requirements appropriate to the nature of the processing operations to be carried
out, the food safety hazards associated with those operations and the
potential sources of contamination from the plant environs. Buildings
shall be of durable construction that presents no hazard to the
product.
NOTE: An example of "durable construction" is self-draining roofs that
do not leak.
Auditor Response
4.2 Consideration shall be given to potential sources of contamination

Environment from the local environment.
Food production should not be carried out in areas where potentially
harmful substances could enter the product.
The effectiveness of measures taken to protect against potential
contaminants shall be periodically reviewed.
Auditor Response
4.3 The site boundaries shall be clearly Identified. Access to the site shall
Locations of establishments be controlled.
The site shall be maintained in good order. Vegetation shall be tended
or removed. Roads, yards, and parking areas shall be drained to
prevent standing water and shall be maintained.
Auditor Response

5 Layout of Premises and Workspace
5.1 Internal layouts shall be designed, constructed, and maintained to

General requirements facilitate good hygiene and manufacturing practices. The movement
patterns of materials, products and people, and the layout of
equipment, shall be designed to protect against potential
contamination sources.
Auditor Response
5.2 The building shall provide adequate space, with a logical flow of
Internal design, layout, and materials, products and personnel, and physical separation of raw
traffic patterns from processed areas.
NOTE: Examples of physical separation include walls, barriers or
partitions, or sufficient distance to minimize risk.
Openings Intended for transfer of materials shall be designed to
minimize entry of foreign matter and pests.
Auditor Response
5.3 Process area walls and floors shall be washable or cleanable, as

Internal structures and appropriate for the process or product hazard. Materials of
fittings construction shall be resistant to the cleaning system applied.
Wall floor junctions and corners shall be designed to facilitate
cleaning.
It is recommended that wall floor junctions be rounded in processing
areas.
Floors shall be designed to avoid standing water.
In wet process areas, floors shall be sealed and drained. Drains shall
be trapped and covered.
Ceilings and overhead fixtures shall be designed to minimize build-up
of dirt and condensation.
External opening windows, roof vents or fan, where present, shall be
insect screened.
External opening doors shall be closed or screened when not in use.
Auditor Response
5.4 Equipment shall be designed and located so as to facilitate good

Location of equipment hygiene practices and monitoring. Equipment shall be located to
permit access for operation, cleaning, and maintenance.
Auditor Response
5.5 In-line and on-line test facilities shall be controlled to minimize risk of
Laboratory facilities product contamination. Microbiology laboratories shall be designed,
located, and operated so as to prevent contamination of people, plant
and products. They shall not open directly on to a production area.
Auditor Response

5.6 Temporary structures shall be designed, located, and constructed to
Temporary or mobile avoid pest harbourage and potential contamination of products.
premises and vending Additional hazards associated with temporary structures and vending
machines machines shall be assessed and controlled.
Auditor Response
5.7 Facilities used to store ingredients, packaging and products shall

Storage of food, packaging provide protection from dust, condensation, drains, waste, and other
materials, ingredients and sources of contamination.
non-food chemicals Storage areas shall be dry and well ventilated. Monitoring and control
of temperature and humidity shall be applied where specified.
Storage areas shall be designed or arranged to allow segregation of
raw materials, work In progress and finished products.
All materials and products shall be stored off the floor and with
sufficient space between the material and the walls to allow
Inspection and pest control activities to be carried out.
The storage area shall be designed to allow maintenance and
cleaning, prevent contamination and minimize deterioration.
A separate, secure (locked or otherwise access controlled) storage
area shall be provided for cleaning materials, chemicals and other
hazardous substances.
Exceptions for bulk or agricultural crop materials shall be documented
In the food safely management system.
Auditor Response
6 Utilities - Air, Water, Energy
6.1 The provision and distribution routes for utilities to and around
General requirements processing and storage areas shall be designed to minimize the risk of
product contamination.
Utilities' quality shall be monitored to minimize product
contamination risk.
Auditor Response

6.2 The supply of potable water shall be sufficient to meet the needs of
Water supply the production process(es). Facilities for storage, distribution and,
where needed, temperature control of the water shall be designed to
meet specified water quality requirements.
Water used as a product ingredient, including ice or steam (including
culinary steam), or in contact with products or product surfaces, shall
meet specified quality and microbiological requirements relevant to
the product.
Water for cleaning or applications where there is a risk of indirect
product contact (e.g. jacketed vessels, heat exchangers) shall meet
specified quality and microbiological requirements relevant to the
application.
Where water supplies are chlorinated, checks shall ensure that the
residual chlorine level at the point of use remains within limits given
in relevant specifications.
Non-potable water shall have a separate supply system that Is
labelled and not connected to the potable water system. Take
measures to prevent non-potable water refluxing into the potable
system.
It Is recommended that water that can come into contact with the
product should flow through pipes that can be disinfected.
Auditor Response
6.3 Boiler chemicals, if used, shall be either:

Boiler chemicals a) approved food additives that meet relevant additive specifications;
or
b) additives that have been approved by the relevant regulatory
authority as safe for use in water intended for human consumption.
Boiler chemicals shall be stored in a separate, secure (locked or
otherwise access-controlled) area when not in immediate use.
Auditor Response
6.4 The organization shall establish requirements for filtration, humidity (RH%)
Air quality and ventilation 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 shall be put in place and monitored.
Ventilation (natural or mechanical shall be provided to remove excess or
unwanted steam, dust and odours, and to facilitate drying after wet cleaning.
Room air supply quality shall be controlled to minimize risk from airborne
microbiological contamination. Protocols for air quality monitoring and
control shall be established in areas where products that support the growth
or survival of microorganisms are exposed.
Ventilation systems shall be 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.
Auditor Response

6.5 Compressed air, carbon dioxide, nitrogen and other gas systems used in
Compressed air and other manufacturing and/or filling shall be constructed and maintained so as to
gases prevent contamination. Gases intended for direct or incidental product
contact (including those used for transporting, blowing or drying
materials, products, or equipment) shall be from a source approved for
food contact use, filtered to remove dust, off and water. Where oil is
used for compressors and there is potential for the air to come into
contact with the product, the off used shall be food grade.
Use of off free compressors is recommended. Requirements for filtration,
humidity (RH%) and microbiology shall be specified. Filtration of the air
should be as close to the point of use as Is practicable.
Auditor Response
6.6 The lighting provided (natural or artificial) shall allow personnel to

Lighting operate in a hygienic manner.
The intensity of the lighting should be appropriate to the nature of the
operation.
Light fixtures shall be protected to ensure that materials, product, or
equipment are not contaminated in the case of breakages.
Auditor Response
7 Waste Disposal
7.1 Systems shall be in place to ensure that waste materials are identified,
General requirements collected, removed, and disposed of in a manner that prevents
contamination of products or production areas.
Auditor Response
7.2 Containers for waste and Inedible or hazardous substances shall be:
Containers for waste and a) clearly Identified for their Intended purpose;
inedible or hazardous b) located in a designated area;
substances c) constructed of impervious material that can be readily cleaned and
sanitized;
d) closed when not in immediate use;
e) locked where the waste may pose a risk to the product.
Auditor Response
7.3 Provision shall be made for the segregation, storage, and removal of
Waste management and waste.
removal Accumulation of waste shall not be allowed in food-handling or storage
areas. Removal frequencies shall be managed to avoid accumulations,
with a minimum daily removal. Labelled materials, products or printed
packaging designated as waste shall be disfigured or destroyed to ensure
that trademarks cannot be reused. Removal and destruction shall be
carried out by approved disposal contractors. The organization shall
retain records of destruction.
Auditor Response

7.4 Drains shall be designed, constructed, and located so that the risk of
Drains and drainage contamination of materials or products is avoided. Drains shall have
capacity sufficient to remove expected flow loads. Drains shall not
pass over processing lines.
Drainage direction shall not flow from a contaminated area to a clean
area.
Auditor Response
8 Equipment Suitability, Cleaning and Maintenance
8.1 Food contact equipment shall be designed and constructed to

General requirements facilitate cleaning, disinfection, and maintenance. Contact surfaces
shall not affect, or be affected by, the intended product or cleaning
system.
Food contact equipment shall be constructed of durable materials
able to resist repeated cleaning.
Auditor Response
8.2 Equipment shall be able to meet established principles of hygienic

Hygienic design design, including:
a) smooth, accessible, cleanable surfaces, self draining In wet process
areas;
b) use of materials compatible with Intended products and cleaning or
flushing agents;
c) framework not penetrated by holes or nuts and bolls.
Piping and ductwork shall be cleanable, drainable, and with no dead
ends.
Equipment shall be designed to minimize contact between the
operator's hands and the products.
Auditor Response
8.3 Product contact surfaces shall be constructed from materials designed

Product contact surface for food use. They shall be impermeable and rust or corrosion free.
Auditor Response
8.4 Equipment used for thermal processes shall be able to meet the
Temperature control and temperature gradient and holding conditions given in relevant
monitoring equipment product specifications.
Equipment shall provide for the monitoring and control of the
temperature.
Auditor Response

8.5 Wet and dry-cleaning programs shall be documented to ensure that
Cleaning plant, utensils, and all plant, utensils and equipment are cleaned at defined frequencies.
equipment The programs shall 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.
Auditor Response
8.6 A preventive maintenance program shall be in place.

Preventive and corrective The preventive maintenance program shall include all devices used to
maintenance monitor and/or control food safety hazards.
NOTE: Examples of such devices include screens and filters (including
air filters), magnets, metal detectors and X-ray detectors.
Corrective maintenance shall be carried out in such a way that
production on adjoining lines or equipment Is not at risk of
contamination.
Maintenance requests that impact product safety shall be given
priority.
Temporary fixes shall not put product safety at risk. A request for
replacement by a permanent repair shall be included In the
maintenance schedule.
Lubricants and heat transfer fluids shall be food grade where there is
a risk of direct or indirect contact with the product.
The procedure for releasing maintained equipment back to
production shall include clean up, sanitizing, where specified In
process sanitation procedures, and pre-use inspection.
Local area PRP requirements shall apply to maintenance areas and
maintenance activities in process areas. Maintenance personnel shall
be trained in the product hazards associated with their activities.
Auditor Response
9 Management of Purchased Materials
9.1 Purchasing of materials that impact food safely shall be controlled to

General requirements ensure that the suppliers used have the capability to meet the
specified requirements. The conformance of incoming materials to
specified purchase requirements shall be verified.
Auditor Response

9.2 There shall be a defined process for the selection, approval and
Selection and management monitoring of suppliers. The process used shall be justified by hazard
of suppliers assessment, including the potential risk to the final product, and shall
include:
a) assessment of the suppliers ability to meet quality and food safety
expectations, requirements and specifications;
b) description of how suppliers are assessed;
NOTE: Examples of a description of how suppliers are assessed
include:
1) audit of the supplying site prior to accepting materials for
production;
2) appropriate third party certification.
c) monitoring the performance of the supplier to assure continued
approval status.
NOTE: Monitoring includes conformity with material or product
specifications, fulfilment of COA requirements, satisfactory audit
outcomes.
Auditor Response
9.3 Delivery vehicles shall be checked prior to, and during, unloading to
Incoming material verify that the quality and safety of the material has been maintained
requirements during transit (e.g. integrity of seals, freedom from Infestation,
(raw/ingredients/packaging) existence of temperature records).
Materials shall be Inspected, tested or covered by GOA to verify
conformity with specified requirements prior to acceptance or use.
The method of verification shall be documented.
NOTE: The Inspection frequency and scope can be based on the
hazard presented by the material and the risk assessment of the
specific suppliers.
Materials that do not conform to relevant specifications shall be
handled under a documented procedure that ensures they are
prevented from unintended use. Access points to bulk material
receiving lines shall be identified, capped and locked. Discharge Into
such systems shall take place only after approval and verification of
the material to be received.
Auditor Response
10 Measures for Prevention of Cross-contamination
10.1 Programs shall be in place to prevent, control and detect

General requirements contamination. Measures to prevent physical, allergen and
microbiological contamination shall be included.
Auditor Response

10.2 Areas where potential for microbiological cross-contamination exists
Microbiological cross- (airborne or from traffic patterns) shall be identified and a
contamination segregation (zoning) plan implemented. A hazard assessment shall be
carried out to determine potential contamination sources.
Susceptibility of the product and control measures suitable for these
areas as follows:
a) separation of raw from finished or ready to eat (RTE} products;
b) structural segregation-physical barriers, walls or separate buildings;
c) access controls with requirements to change into required
workwear;
d) traffic patterns or equipment segregation - people, materials,
equipment and tools (including use of dedicated tools);
e) air pressure differentials.
Auditor Response
10.3 Allergen management Allergens present in the product, either by design or by potential
manufacturing cross-contact, shall be declared. The declaration shall
be on the label for consumer products, and on the label or the
accompanying documentation for products intended for further
processing.Products shall be protected from unintended allergen
cross-contact by cleaning and line change-over practices and/or
product sequencing.
NOTE: Manufacturing cross-contact can arise from either.
1) traces of product from the previous production run that cannot be
adequately cleaned from the product line due to technical limitations;
or
2) when contact Is likely to occur, in the normal manufacturing
process, with products or ingredients that are produced on separate
lines, or in the same or adjacent processing areas. Rework containing
allergen(s) shall be used only:
a) in products that contain the same allergen(s) by design; or
b) through a process that Is demonstrated to remove or destroy
the allergenic material. NOTE: For general rework requirements, see
Clause 14. Employees handling food should receive specific training in
allergen awareness and associated manufacturing practices.
Auditor Response

10.4 Where brittle materials are used, periodic inspection requirements
Physical contamination and defined procedures in case of breakage shall be put in place.
Brittle materials, such as glass and hard plastic components in
equipment, should be avoided where possible.
Glass breakage records shall be maintained.
Based on hazard assessment, measures shall be put in place to
prevent, control or detect potential contamination.
NOTE 1: Examples of such measures Include:
a) adequate covers over equipment or containers for exposed
materials or products;
b) use of screens, magnets, sieves or filters;
c) use of detection or rejection devices such as metal detectors or X-
ray.
NOTE 2: Sources of potential contamination Include wooden pallets
and tools, rubber seals, and personal protective clothing and
equipment.
Auditor Response
11 Cleaning and Sanitizing
11.1 Cleaning and sanitizing programs shall be established to ensure that

General requirements the food-processing equipment and environment are maintained in a
hygienic condition. Programs shall be monitored for continuing
suitability and effectiveness.
Auditor Response
11.2 Facilities and equipment shall be maintained in a condition that

Cleaning and sanitizing facilitates wet or dry cleaning and/or sanitation.
agents and tools Cleaning and sanitizing agents and chemicals shall be clearly
identified, food grade, stored separately and used only in accordance
with the manufacturer’s instructions.
Tools and equipment shall be of hygienic design and maintained in a
condition that does not present a potential source of extraneous
matter.
Auditor Response

11.3 Cleaning and sanitizing programs shall be established and validated by
Cleaning and sanitizing the organization to ensure that all parts of the establishment and
programs equipment are cleaned and/or sanitized to a defined schedule,
including the cleaning of cleaning equipment.
Cleaning and/or sanitizing programs shall specify at a minimum:
a) areas, items of equipment and utensils to be cleaned and/or
sanitized;
b) responsibility for the tasks specified;
c) cleaning/sanitizing method and frequency;
d) monitoring and verification arrangements;
e) post-clean inspections;
f) pre start-up inspections.
Auditor Response
11.4 CIP systems shall be separated from active product lines. Parameters
Cleaning in place (CIP) for CIP systems shall be defined and monitored (including type,
systems concentration, contact time and temperature of any chemicals used).
Auditor Response
11.5 Cleaning and sanitation programs shall be monitored at frequencies

Monitoring sanitation specified by the organization to ensure their continuing suitability and
effectiveness effectiveness.
Auditor Response
12 Pest Control
12.1 Hygiene, cleaning, incoming materials inspection and monitoring

General requirements procedures shall be implemented to avoid creating an environment
conducive to pest activity.
Auditor Response
12.2 The establishment shall have a nominated person to manage pest

Pest control programs control activities and/or deal with appointed expert contractors.
Pest management programs shall be documented and shall identify
target pests, and address plans, methods, schedules, control
procedures and, where necessary, training requirements.
Programs shall include a list of chemicals that are approved for use in
specified areas of the establishment.
Auditor Response

12.3 Buildings shall be maintained in good repair. Holes, drains and other
Preventing access potential pest access points shall be sealed.
External doors, windows or ventilation openings shall be designed to
minimize the potential for entry of pests.
Auditor Response
12.4 Storage practices shall be designed to minimize the availability of food

Harbourage and infestations and water to pests.
Material found to be infested shall be handled in such a way as to
prevent contamination of other materials, products or the
establishment.
Potential pest harbourage (e.g. burrows, undergrowth, stored items)
shall be removed.
Where outside space is used for storage, stored items shall be
protected from weather or pest damage (e.g. bird droppings).
Auditor Response
12.5 Pest-monitoring programs shall include the placing of detectors and

Monitoring and detection traps in key locations to identify pest activity. A map of detectors and
traps shall be maintained. Detectors and traps shall be designed and
located so as to prevent potential contamination of materials,
products or facilities.
Detectors and traps shall be of robust, tamper-resistant construction.
They shall be appropriate for the target pest.
The detectors and traps shall be inspected at a frequency intended to
identify new pest activity. The results of inspections shall be analysed
to identify trends.
Auditor Response
12.6 Eradication measures shall be put in place immediately after evidence

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

13 Personnel Hygiene and Employee Facilities
13.1 Requirements for personal hygiene and behaviours proportional to

General requirements the hazard posed to the process area or product shall be established
and documented. All personnel, visitors and contractors shall be
required to comply with the documented requirements.
Auditor Response
13.2 Personnel hygiene facilities shall be available to ensure that the

Personnel hygiene facilities degree of personal hygiene required by the organization can be
and toilets maintained. The facilities shall be located close to the points where
hygiene requirements apply and shall be clearly designated.
Establishments shall:
a) provide adequate numbers, locations and means of hygienically
washing, drying and, where required, sanitizing hands (including
wash-basins, supply of hot and cold or temperature controlled water,
and soap and/or sanitizer);
b) have sinks designated for hand washing, whose taps should not be
hand operated, separate from sinks for food use and equipment-
cleaning stations;
c) provide an adequate number of toilets of appropriate hygienic
design, each with hand-washing, drying and, where required,
sanitizing facilities;
d) have employee hygiene facilities that do not open directly on to
production, packing or storage areas;
e) have adequate changing facilities for personnel;
f) have changing facilities sited to enable personnel handling food to
move to the production area In such a way that risk to the cleanliness
of their workwear is minimized.
Auditor Response
13.3 Staff canteens and designated areas for food storage and
Staff canteens and consumption shall be situated so that the potential for cross-
designated eating areas contamination of production areas is minimized.
Staff canteens shall be managed to ensure hygienic storage of
ingredients and preparation, storage and serving of prepared foods.
Storage conditions and storage, cooking and holding temperatures,
and time limitations, shall be specified.
Employees' own food shall be stored and consumed in designated
areas only.
Auditor Response

13.4 Personnel who work in, or enter into, areas where exposed products
Workwear and protective and/or materials are handled shall wear work clothing that is fit for
clothing purpose, clean and in good condition (e.g. free from rips, tears or
fraying material).
Clothing mandated for food protection or hygiene purposes shall not
be used for any other purpose.
Workwear shall not have buttons. Workwear shall not have outside
pockets above waist level. Zips or press stud fastenings are
acceptable.
Workwear shall be laundered to standards and at intervals suitable
for the intended use of the garments.
Workwear shall provide adequate coverage to ensure that hair,
perspiration, etc. cannot contaminate the product.
Hair, beards, and moustaches shall be protected (i.e. completely
enclosed) by restraints unless hazard analysis indicates otherwise.
Where gloves are used for product contact, they shall be clean and In
good condition. Use of latex gloves should be avoided where possible.
Shoes for use in processing areas shall be fully enclosed and made
from non-absorbent materials.
Personal protective equipment, where required, shall be designed to
prevent product contamination, and maintained in hygienic condition.
Auditor Response
13.5 Subject to legal restrictions in the country of operation, employees

Health status shall undergo a medical examination prior to employment in food
contact operations (including site catering), unless documented
hazard or medical assessment indicates otherwise.
Additional medical examinations, where permitted, shall be carried
out at intervals defined by the organization.
Auditor Response
13.6 Where permitted by law, employees shall be required to report the

Illness and injuries following conditions to management for possible exclusion from food-
handling areas: jaundice, diarrhoea, vomiting, fever, sore throat with
fever, visibly infected skin lesions (boils, cuts or sores) and discharges
from the ear, eye or nose.
People known or suspected to be infected with, or carrying, a disease
or illness transmissible through food shall be prevented from handling
food or materials that come into contact with food.
In food-handling areas, personnel with wounds or burns shall be
required to cover them with specified dressings. Any lost dressing
shall be reported to supervision Immediately.
NOTE: Dressings should be brightly coloured and metal detectable
where appropriate.
Auditor Response

13.7 Personnel in food production areas shall be required to wash and,
Personal cleanliness where required, sanitize hands:
a) before starting any food-handling activities;
b) immediately after using the toilet or blowing the nose;
c) immediately after handling any potentially contaminated material.
Personnel shall be required to refrain from sneezing or coughing over
materials or products. Spitting (expectorating) shall be prohibited.
Fingernails shall be kept clean and trimmed.
Auditor Response
13.8 A documented policy shall describe the behaviours required of

Personal behaviour personnel in processing, packing and storage areas. The policy shall at
a minimum cover:
a) permissibility of smoking, eating, chewing in designated areas only;
b) control measures to minimize hazards presented by permitted
jewellery, such as that worn by personnel in processing and storage
areas, taking into account religious, ethnic, medical and cultural
imperatives;
c) permissibility of personal items, such as smoking materials and
medicines, in designated areas only;
d) prohibition of the use of nail polish, false nails and false eyelashes;
e) prohibition of carrying of writing implements behind the ears;
f) maintenance of personal lockers so that they are kept free from
rubbish and soiled\ clothing;
g) prohibition of storage of product contact tools and equipment in
personal lockers.
Auditor Response
14 Rework
14.1 Rework shall be stored, handled, and used in such a way that product
General requirements safety, quality, traceability, and regulatory compliance are
maintained.
Auditor Response
14.2 Stored rework shall be protected from exposure to microbiological,

Storage, identification, and chemical or extraneous matter contamination.
traceability Segregation requirements for rework (e.g. allergen) shall be
documented and met.
Rework shall be clearly identified and/or labelled to allow traceability.
Traceability records for rework shall be maintained.
The rework classification or the reason for rework designation shall be
recorded (e.g. product name, production date, shift, line of origin,
shelf-life).
Auditor Response

14.3 Where rework is incorporated into a product as an "in-process step",
Rework usage the acceptable quantity, type and conditions of rework use shall be
specified. The process step and method of addition, including any
necessary pre-processing stages, shall be defined.
Where rework activities involve removing a product from filled or
wrapped packages, controls shall be put in place to ensure the
removal and segregation of packaging materials and to avoid
contamination of the product with extraneous matter.
Auditor Response
15 Product Recall Procedures
15.1 Systems shall be in place to ensure that products failing to meet

General requirements required food safety standards can be identified, located, and
removed from all necessary points of the supply chain.
Auditor Response
15.2 A list of key contacts in the event of a recall shall be maintained.

Product recall requirements Where products are withdrawn due to immediate health hazards, the
safety of other products produced under the same conditions shall be
evaluated. The need for public warnings shall be considered.
Auditor Response
16 Warehousing
16.1 Materials and products shall be stored in clean, dry, well-ventilated

General requirements spaces protected from dust, condensation, fumes, odours, or other
sources of contamination.
Auditor Response
16.2 Effective control of warehousing temperature, humidity and other

Warehousing requirements environmental conditions shall be provided where required by
product or storage specifications.
It is recommended that where products are stacked, consideration is
given to measures necessary to protect the lower layers.
Waste materials and chemicals (cleaning products, lubricants, and
pesticides) shall be stored separately.
A separate area or other means of segregating materials identified as
non-conforming shall be provided.
Specified stock rotation systems (FIFO/FEFO) shall be observed.
Gasoline or diesel-powered fork-lift trucks shall not be used in food
ingredient or product storage areas.
Auditor Response

16.3 Vehicles, conveyances, and containers shall be maintained in a state
Vehicles, conveyances, and of repair, cleanliness, and condition consistent with requirements
containers given in relevant specifications.
Vehicles, conveyances, and containers shall provide protection against
damage or contamination of the product. Control of temperature and
humidity shall be applied and recorded where required by the
organization.
Where the same vehicles, conveyances, and containers are used for
food and non-food products, cleaning shall be carried out between
loads.
Bulk containers shall be dedicated to food use only. Where required
by the organization, bulk containers shall be dedicated to a specified
material.
Auditor Response
17 Product Information and Consumer Awareness
17 Information shall be presented to consumers in such a way as to

Product information and enable them to understand its importance and make informed
consumer awareness choices.
Information may be provided by labelling or other means, such as
company websites and advertisements, and may include storage,
preparation and serving instructions applicable to the product.
Auditor Response
18 Food Defense, Biovigilance, and Bioterrorism
18.1 Each establishment shall assess the hazard to products posed by

General requirements potential acts of sabotage, vandalism or terrorism and shall put in
place proportional protective measures.
Auditor Response
18.2 Potentially sensitive areas within the establishment shall be identified,

Access controls mapped, and subjected to access control.
Where feasible, access should be physically restricted by use of locks,
electronic card key or alternative systems.
Auditor Response

Additional FSSC Requirements
2.5.1 Management of Services and Purchased Materials
A) Management of services In addition to clause 7.1.6 of ISO 22000:2018, the organization shall
and purchased materials 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).
Auditor Response
B) Management of services The organization shall have a documented procedure for procurement
and purchased materials in emergency situations to ensure that products still conform to
specified requirements and the supplier has been evaluated.
Auditor Response
C) Management of services In addition to ISO/TS 22002-1:2009 clause 9.2, the organization shall
and purchased materials have a policy for the procurement of animals, fish and seafood that
are subject to control of prohibited substances (e.g. pharmaceutical,
veterinary medicines, heavy metals and pesticides).
Auditor Response
D) Management of services The organization shall establish, implement, and maintain a review of
and purchased materials process for product specifications to ensure continued compliance
with food safety, legal and customer requirements.
Auditor Response
2.5.2 Product Labeling

Product labeling The organization shall ensure that the finished product is labelled
according to all applicable statutory and regulatory requirements in
the country of intended sale, including allergen and customer specific
requirements. Where product is unlabelled, all relevant product
information shall be made available to ensure the safe use of the food
by the customer or consumer.
Auditor Response

2.5.3 Food Defense
2.5.3.1 Threat assessment 1) The organization shall have a documented and implemented threat
assessment procedure in place that:
a) identifies potential threats,
b) develops control measures, and
c) prioritises them against the identified threats.
2) To identify the threats, the organization shall assess the
susceptibility of its products to potential food defense acts.
Auditor Response
2.5.3.2 Control measures The organization shall put in place appropriate control measures to
reduce or eliminate the identified threats.
Auditor Response
2.5.3.3 Plan 1) All policies, procedures and records are included in a food defense
plan supported by the organization’s Food Safety Management
System for all its products.
2) The plan shall comply with applicable legislation.
Auditor Response
2.5.4 Food Fraud
2.5.4.1 Vulnerability 2.5.4.1 Vulnerability assessment

assessment 1) The organization shall have a documented and implemented
vulnerability assessment procedure in place that:
a) identifies potential vulnerabilities,
b) develops control measures, and
c) prioritises them against the identified vulnerabilities.
2) To identify the vulnerabilities, the organization shall assess the
susceptibility of its products to potential food fraud acts.
Auditor Response
2.5.4.2 Control measures The organization shall put in place appropriate control measures to
reduce or eliminate the identified vulnerabilities.
Auditor Response
2.5.4.3 Plan 1) All policies, procedures and records are included in a food fraud
prevention plan supported by the organization’s Food Safety
Management System for all its products.
2) The plan shall comply with applicable legislation.
Auditor Response

2.5.5 Logo Usage
Logo Usage 1) Certified organizations are entitled to use the FSSC 22000 logo. The
FSSC 22000 logo may be used on the organization’s printed matter,
website, and other promotional material subject to the following
design specifications:
Auditor Response
Logo Usage 2) Use of the logo in black and white is permitted when all other text
and imagines are in black and white.
Auditor Response
Logo Usage 3) To avoid the impression that the CB has certified or approved any
product, process or service supplied by the certified organization the
FSSC 22000 logo is not allowed to be used on:
a) a product,
b) its labelling,
c) its packaging,
d) in any other manner that implies FSSC 22000 approves a
product, process, or service.
Auditor Response
2.5.6 Management of Allergens
Management of allergens 1) A documented allergen management plan shall be in place that

includes:
a) risk assessment addressing potential allergen cross
contamination;
b) control measures to reduce or eliminate the risk of cross
contamination;
c) validation and verification of effective implementation.
Auditor Response
Management of allergens 2) All finished products intentionally or potentially containing

allergenic materials are labeled according to the allergen labelling
regulations in the country of manufacture and country of destination.
Auditor Response

2.5.7 Environmental Monitoring
Environmental monitoring The organization shall ensure that an environmental monitoring

program is in place to verify the effectiveness of cleaning and
sanitation programs that shall meet the verification requirements as
described in ISO 22000.
Auditor Response
2.5.10 Storage and Warehousing
Storage and warehousing The organization shall establish, implement, and maintain a procedure
and specified stock rotation system that includes FEFO principles in
conjunction with the FIFO requirements.
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 with chilling or freezing.
Auditor Response
Storage and warehousing In addition to ISO/TS 22002:2009 clause 16.2, the organization shall
have specified requirements in place that define post-slaughter time
and temperature in relation with chilling or freezing of the products.
Auditor Response
2.5.11 Hazard Control and Measures for Preventing Cross-Contamination
Hazard control and The organization shall have specified requirements for an inspection
measures for preventing process at lairage and/or at evisceration to ensure animals are fit for
cross-contamination human consumption.
Auditor Response
2.5.12 PRP Verification
PRP verification The organization shall establish, implement and maintain routine (e.g.
monthly) sit inspections/PRP check 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.
Auditor Response

2.5.13 Product Development
PRP verification A product design and development procedure shall b 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
e) The need to conduct production and shelf-life trails to validate
product formulation and processes are capable of producing a safe
product and meet customer requirements.
Auditor Response

FSNS Certification &amp; Audit FSSC 22000 Checklist

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FSNS Certification &amp; Audit FSSC 22000 Checklist

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FSSC 22000 Self-Assessment Checklist

It is intended for organizations in the following food chain categories:

Food Manufacturing (Category C)

Production Of Biochemicals (Category K)

Contact an FSNS Certification & Audit Specialist

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

5.2.2 The food safety policy shall:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

5.3.2 The food safety team leader shall be responsible for:

6.1.2 The organization shall plan:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

7.1.5 When an organization establishes, maintains, updates and continually improves

7.1.6 The organization shall:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

7.5.1 The organization’s FSMS shall include:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

8.2.4 When establishing PRP(s) the organization shall consider:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

8.4.2 The organization shall:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

8.9.2.4 Corrections Documented information shall be retained to describe corrections made on

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

9.1 The organization shall determine:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

9.3.3 Management The outputs of the management review shall include:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

10.1.1 When a nonconformity occurs, the organization shall:

10.1.2 The organization shall retain documented information as evidence of:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

ISO 22002-1:2009 Audit Report

4.1 Buildings shall be designed, constructed, and maintained in a manner

4.2 Consideration shall be given to potential sources of contamination

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

5.1 Internal layouts shall be designed, constructed, and maintained to

5.3 Process area walls and floors shall be washable or cleanable, as

5.4 Equipment shall be designed and located so as to facilitate good

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

5.7 Facilities used to store ingredients, packaging and products shall

6 Utilities - Air, Water, Energy

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

6.3 Boiler chemicals, if used, shall be either:

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

6.6 The lighting provided (natural or artificial) shall allow personnel to

888.525.9788 (OPTION 4) AUDITING@FSNS.COM

8 Equipment Suitability, Cleaning and Maintenance

8.1 Food contact equipment shall be designed and constructed to

FSNS Certification & Audit FSSC 22000 Checklist

FSNS Certification & Audit FSSC 22000 Checklist