CHECK-LIST

ISO 22000 version 2018

 Compliance
ELEMENTS OF THE STANDARD DESCRIPTION
Yes No
4 - Context of the organization:
4.1 Understanding the organization and its context:
The organization must determine the relevant external and internal issues by
related to its purpose, and which affect its ability to achieve the or the
expected results of his SMSDA.
The organization must identify, review, and update information related to these.
external and internal stakes.

NOTE 1 The stakes may include positive and negative factors or

conditions to be taken into consideration.

NOTE 2 Understanding the context can be facilitated by taking into account

account for external and internal issues including, but not limited to, the aspects
legislative, technological, competitive, commercial, cultural, social and
economic, cybersecurity and food fraud, the protection of
food products and intentional contamination, knowledge and
the performance of the organism, at the international, national, regional or
local.
4.2 Understanding the needs and expectations of stakeholders:
To ensure the organization's ability to provide continuously
products and services that comply with legal and regulatory requirements and
requirements of the client(s) applicable in terms of food safety
food-related, the body must determine:
a) the interested parties that are relevant to the SMSDA;
b) the relevant requirements of the interested parties of the SMSDA.
The organization must identify, review, and update the information related to
interested parties and their requirements.

4.3 Determination of the scope of application of the system

management of food safety:
The organization must determine the limits and applicability of the SMSDA in order to
to establish its scope of application. The scope of application must specify
the products and services, the processes and the production site(s) that are
included in the SMSDA. The scope of application must include the activities,
processes, products or services that may impact security
of food products in finished products.
When the organization establishes this scope, it must take into account:
a) the external and internal stakes referred to in 4.1;
b) the requirements referred to in 4.2.
The scope of application must be available and maintained in the form of a
documented information.
4.4 Food Safety Management System:
The organization must establish, implement, maintain, update and improve
continue a SMSDA, including the necessary processes and their interactions,
in accordance with the requirements of this document
 Compliance
ELEMENTS OF THE STANDARD {"Yes":"Yes","No":"No"}
DESCRIPTION
5 Leadership
5.1 Leadership and engagement:

Management must demonstrate its leadership and commitment to the SMSDA.

en:
a) ensuring that the policy regarding food safety and
the objectives of the SMSDA are established and they are compatible with
the strategic orientation of the organization;
b) ensuring that the requirements related to the SMSDA are integrated into the processes
jobs of the organization;
c) ensuring that the resources required for the SMSDA are available;
d) communicating on the importance of having a management system
effective food security and to comply with
requirements related to SMSDA, legal and regulatory requirements
applicable, and to the requirements related to food safety
established in agreement with the client(s);
e) ensuring that the SMSDA is evaluated and maintained in order to achieve the or the
expected results (see 4.1);
f) guiding and supporting individuals to contribute to effectiveness
to SMSDA;
promoting continuous improvement;
h) supporting other relevant managerial roles in order to demonstrate their
responsibilities in their respective fields.

NOTE In this document, the term "profession" can be interpreted

in a broad sense, that is to say referring to activities related to the purpose of
the organism.
5.2 Policy:

5.2.1 Establishment of the policy regarding food safety

food products:
Management must establish, implement, and maintain a policy regarding
the safety of food products that:
a) is appropriate to the purpose and context of the organization;
b) provides a framework for the establishment and review of SMSDA objectives;
c) includes the commitment to meet the applicable requirements regarding
food safety, including legal requirements and
regulatory and safety requirements for foodstuffs
food products established in agreement with the client(s);
deals with internal and external communication;
e) includes the commitment to the continuous improvement of the SMSDA;
f) addresses the need to ensure security skills
of foodstuffs.

5.2.2 Communication of the policy regarding the safety of food items

food:
The policy regarding food security must:
a) exist/to be presented and to be maintained in the form of information
documented;
b) to be communicated, understood, and applied at all levels within
the organism;
c) to be available to relevant interested parties, as appropriate.

5.2.3 Roles, responsibilities and authorities within the organization:

La direction doit s ’assurer que les responsabilités et autorités des rôles
relevant are assigned, communicated and understood within
the organism.
Management must assign responsibility and authority for:
a) ensure that the SMSDA complies with the requirements of this document;
b) report on the performance of the SMSDA to management;
c) name the team responsible for food safety and the
in charge of this team;
d) designate persons with defined responsibility and authority
to initiate and document one or more actions.
The head of the team responsible for food safety
must be responsible for:
a) ensure that the SMSDA is established, implemented, maintained, and updated;
b) manage and organize the work of the team responsible for food safety
food-related;
c) ensure the relevance of the training and the skills of the team
in charge of food safety (see 7.2);
d) report to management on the effectiveness and relevance of the SMSDA.
All staff must have a responsibility to report to
one or more people identified problems encountered with the SMSDA.
 Compliance
ELEMENTS OF THE STANDARD
Yes No
DESCRIPTION
6 Planning
6.1 Actions to be implemented in response to risks and opportunities:

As part of the planning of its SMSDA, the organization must take into account
the issues mentioned in 4.1 and the requirements mentioned in 4.2 and 4.3, and
determine the risks and opportunities that need to be taken into account
count for:
a) ensure that the SMSDA can achieve the expected results;
b) increase the desired effects;
c) prevent or reduce side effects;
d) to register in a dynamic of continuous improvement.

NOTE: In the context of this document, the concept of risks and

opportunities are limited to events and their related consequences
with the performance and efficiency of the SMSDA. The management of related risks
Public health is the responsibility of public authorities. It is
requires organizations to manage the risks related to the safety of food products
food-related (see 3.22). The requirements for this process are stated
to Article 8.

The organization must plan:

a) the actions to be implemented in response to risks and opportunities;
b) the manner:
1) to integrate and implement these actions within the processes of
SMSDA;
to assess the effectiveness of these actions.
The actions implemented by the organization in response to risks and opportunities
must be proportional:
a) on the impact on the requirements for food safety
food
b) regarding the conformity of food products and services to customers;
c) to the requirements of stakeholders belonging to the food chain.

NOTE 1 Actions taken in response to risks and opportunities may include: avoiding the
risk, take the risk to seize an opportunity, eliminate the source of
risk, modify the probability of occurrence or the consequences, share it
risk or accept the presence of risk based on an informed decision.

NOTE 2 Opportunities can lead to the adoption of new practices

(modification of products or processes), to the use of a new
technology and other desirable and viable solutions to address the
needs of the organization or its clients in terms of food safety
food
6.2 Objectives of the food safety management system
food-related and planning actions to achieve them:

The organization must establish objectives for the SMSDA, at functions and levels.
concerned. The objectives of the SMSDA must:
a) to be in line with the policy related to food safety
food
b) to be measurable (if achievable);
c) take into account the applicable food safety requirements
food-related, including legal and regulatory requirements and the
requirements of the client(s);
d) to be monitored and verified;
to be communicated;
f) to be maintained and updated as needed.

The organization must keep documented information on the objectives of

SMSDA.
When the organization plans how the objectives of its SMSDA will be
attained, he must determine:
what will be done;
b) the resources that will be necessary;
c) who will be responsible;
d) the deadlines;
e) the way the results will be evaluated.
6.3 Planning of modifications:

When the organization determines the need to modify the SMSDA, including the
staff changes, the modifications must be made and
communicated in a planned manner.

The organization must take into account:

a) the objective of the modifications and their possible consequences;
b) the permanent integrity of the SMSDA;
c) the availability of the resources necessary for the effective implementation of
modifications;
d) l’attribution ou la réattribution des responsabilités et autorités.
 Compliance
ELEMENTS OF THE STANDARD
Yes No
DESCRIPTION
7- Support
7.1 Resources

7.1.1 Generalities
The organization must identify and provide the necessary resources for
the establishment, implementation, maintenance, updating and improvement
continue of SMSDA. The organization must take into account:
a) the capabilities and potential constraints of internal resources
existing;
the need for external resources.

7.1.2 Human resources

The organization must ensure that the necessary human resources are available for
The operation and maintenance of an effective SMSDA are competent (see 7.2).
When the assistance of external experts is requested for development,
the implementation, operation or evaluation of the SMSDA, the evidence of
the agreement or contracts defining the competence, responsibility, and
the authority of these external experts must be maintained in the form
documented information.

7.1.3 Infrastructure
The organization must provide the resources for determination, establishment
and the maintenance of the infrastructure necessary for achieving compliance with
requirements of the SMSDA.

NOTE The infrastructure may include:

the grounds, the ships, the buildings and the associated services;
equipment, including hardware and software;
the transport;
the information and communication technologies.

7.1.4 Work Environment

The organization must determine, provide, and maintain the resources for
the establishment, management, and maintenance of the work environment
necessary for obtaining compliance with the requirements of the SMSDA.

NOTE An appropriate environment can be a combination of aspects

humans and physics, such as:
a) social (for example non-discriminatory, calm, non-conflictual);
b) psychological (for example, stress reduction, prevention of burnout,
affective protection;
c) physical (for example temperature, heat, humidity, light, circulation
air, hygiene, noise). These aspects can vary considerably depending on the
products and the services provided.

7.1.5 Elements of the food safety management system

food products developed externally
When an organization establishes, maintains, updates, and continuously improves its
SMSDA using elements of an externally developed SMSDA, including
the PRP, the hazard analysis and the hazard control plan (see 8.5.4),
he must ensure that the provided items are:
a) developed in accordance with the requirements of this document;
b) applicable to the sites, processes, and products of the organization;
c) specially adapted to the processes and products of the organization by
the team responsible for food safety;
d) implemented, maintained, and updated as required by this
document
e) preserved in the form of documented information.

7.1.6 Control of processes, products, or services provided by external providers

external
The organization must:
a) establish and apply criteria for evaluation, selection, monitoring
performance and reassessment of external process suppliers,
of products and/or services;
b) ensure the proper communication of requirements to the service provider(s)
external(s);
c) to ensure that the processes, products or services provided by
external providers do not compromise the organization's ability to
constantly meet the requirements of the SMSDA;
d) retain documented information regarding these activities and all
the necessary actions resulting from assessments and reassessments.

7.2 Compétences :

The organization must:

a) determine the necessary skills of the person or persons, including
those of external service providers, performing, under its control, work that has
an impact on food safety performance
food-related and on the effectiveness of the SMSDA;
b) ensure that these people, including the team responsible for security of
foodstuffs and the parties responsible for the implementation of the plan
mastery of hazards, are competent based on initial training or
professional and/or relevant experience;
c) ensure that the team responsible for food security has
multidisciplinary knowledge and experience in
development and implementation of SMSDA (including, but not limited to
limiters, the products provided by the organization, the processes, the equipment and
the dangers related to food safety in the context of
scope of application of the SMSDA)
d) if necessary, take actions to acquire the skills
necessary and evaluate the effectiveness of these actions;
e) to maintain appropriate documented information as evidence
said skills.

NOTE The possible actions may include training,

the management or reassignment of active personnel or recruitment,
directly or through subcontracting, from competent individuals.

7.3 Sensibilisation :

The organization must ensure that all relevant persons carrying out a
work under the control of the organization are made aware:
a) to the policy regarding food safety;
b) to the objectives of the SMSDA relevant to their task(s);
c) to the importance of their individual contribution to the effectiveness of the SMSDA, y
understood the beneficial effects of performance improvement in
food safety matters;
d) the consequences of failing to comply with the SMSDA requirements.

7.4 Communication :

7.4.1 Generalities
The organization must determine the needs for internal and external communication.
relevant for SMSDA, including:
a) on which subjects to communicate;
b) At what times to communicate;
c) with whom to communicate;
d) how to communicate;
e) which communicates.
The organization must ensure that the requirement for effective communication is
composed of all the people whose activities have an impact on the
food safety.

7.4.2 External communication

The organization must ensure that sufficient information is
communicated externally and are available for interested parties from
the food chain.
The organization must establish, implement, and maintain communication
effective with:
a) external service providers;
b) the clients and/or consumers, regarding:
1) product information related to food safety
food products to allow handling, display, storage,
the preparation, distribution, and use within the chain
food or by the consumer;
2) the dangers related to food safety identified
as requiring to be mastered by other organizations in the
food chain, and/or by consumers;
3) the contractual provisions, requests for information and the
orders, including their amendments;
4) customer and/or consumer feedback, especially the
complaints;
c) the legal and regulatory authorities;
d) other organizations that influence or are concerned with,
the effectiveness or the updating of the SMSDA.

The designated persons must have responsibility and authority.

defined for external communication of information concerning the
food safety. If applicable, the information obtained
through external communication must be integrated as
what input elements for the management review (see 9.3) and for the update
of the SMSDA (see 4.4 and 10.3).
External communication evidence must be kept in the form
documented information.

7.4.3 Internal Communication

The organization must establish, implement, and maintain an effective system
allowing to communicate on topics that have an impact on security
of foodstuffs.
To maintain the effectiveness of the SMSDA, the organization must ensure that the team
the food safety officer is informed in a timely manner
changes made regarding:
a) the products or the new products;
b) raw materials, ingredients, and services;
c) the production systems and equipment;
d) the production facilities, the location of the equipment and
the ambient environment;
e) cleaning and disinfection programs;
f) the conditioning, storage, and distribution systems;
g) the skills and/or the assignment of responsibilities and authorizations;
h) the applicable legal and regulatory requirements;
i) knowledge regarding the dangers related to food safety
food and control measures;
j) the requirements of the client(s), the sector and others, observed by
the organism
k) requests for information and relevant communications from the parties
external interested parties;
l) complaints and alerts reporting dangers related to safety
foodstuffs associated with the finished product;
m) other conditions affecting the safety of the products
food

The team responsible for food safety must ensure that

this information is integrated during the update of the SMSDA (see 4.4 and
10.3)
Management must ensure that relevant information is integrated into
as input elements for the management review (see 9.3).

7.5 Documented information

7.5.1 Généralités
The SMSDA of the organization must include:
a) the documented information required by this document;
b) the documented information that the organization deems necessary for
the effectiveness of SMSDA;
c) documented information and security requirements of
foodstuffs required by legal and regulatory authorities and by
the clients.

NOTE The scope of information documented within the framework of a SMSDA

may vary depending on the organization based on:
the size of the organization, its areas of activity and processes,
products and services;
the complexity of processes and their interactions;
the competence of individuals.

7.5.2 Creation and updating of documented information

When creating and updating, the organization must ensure that:
a) the identification and description of documented information (their title,
date, author, reference number for example);
b) their format (language, software version, graphics, for example) and support
(electronics, paper, for example);
c) the review carried out to determine their relevance and adequacy and their
Approval is appropriate.

7.5.3 Mastery of documented information

The documented information required by the SMSDA and by the present
documents must be mastered to ensure:
a) that they are available and suitable for use, when and where they
are necessary;
b) that they are adequately protected (for example from any loss of
confidentiality, inappropriate use or loss of integrity.

To manage documented information, the organization must put in place

Perform the following activities, when applicable:
a) distribution, access, retrieval and use;
b) storage and protection, including preservation of readability;
c) mastery of modifications (for example, version control);
d) conservation and elimination.

The documented information from external sources that the organization deems
necessary for the planning and operation of the SMSDA must be
identified as appropriate and controlled.

The documented information retained as evidence of compliance

must be protected from any unintentional alteration.
NOTE Access may involve a decision regarding the authorization to consult
documented information only, or the authorization and authority of
consult and modify the documented information.
 Compliance
ELEMENTS OF THE STANDARD
Yes No
DESCRIPTION
8-Execution of operational activities
8.1 Operational Planning and Control

The organization must plan, implement, control, maintain, and update.

the processes necessary to meet the requirements regarding
the development of safe products and carry out the actions determined in 6.1, in:
a) establishing criteria for these processes;
b) implementing the control of these processes according to the criteria;
c) preserving documented information in a sufficient manner to
to have the assurance of demonstrating that the processes have been carried out as
planned.
The organization must control the planned changes, analyze the
consequences of unexpected changes and, if necessary, conduct some
actions to limit any negative effect. The organization must ensure that the
outsourced processes are controlled (see 7.1.6).

8.2 Prerequisite Programs (PRP)

The organization must establish, implement, maintain, and update one or more
PRP to facilitate the prevention and/or reduction of contaminants (including
the dangers related to food safety in products,
transformation des produits et l’environnement de travail.
The PRP or PRPs must be:
a) adapted to the organism and its context regarding safety
foodstuffs
b) adaptés à la taille et au type d’opération, ainsi qu’à la nature des produits
manufactured and/or handled;
c) implemented at all levels of the production system, either under the
in the form of general application programs, either in the form of
programs applicable to a given product or process;
approved by the food safety team.

When choosing and/or developing the PRP(s), the organization must ensure to
what the applicable legal and regulatory requirements are as well as those
established in agreement with the client(s) be identified. It is appropriate that
the organization takes into account:
a) the applicable part of the ISO/TS 22002 series;
b) standards, codes of good practice and guidelines
applicable.
During the development of the PRP(s), the organization must take into account
consideration
a) the construction and layout of buildings and associated facilities;
b) the layout of the premises, in particular the zoning, the workspace and the
installations intended for employees;
c) the supply of air, water, energy and others;
d) pest control, waste and wastewater disposal and the
related services;
the appropriate nature of the equipment and their accessibility in terms of
cleaning and maintenance;
f) the processes of referencing and monitoring suppliers (such as the
raw materials, ingredients, chemicals, and packaging;
g) the reception of incoming materials, storage, shipping, transportation and
the handling of products;
h) preventive measures against cross-contamination;
i) cleaning and disinfection;
j) personnel hygiene;
k) information on products and consumer awareness;
l) all the other necessary elements.
Documented information must specify the choice, the development,
surveillance applicable and verification of the PRP(s).

8.3 Traceability System

The traceability system must allow for the unique identification of
suppliers of incoming materials and the first step of the circuit of
distribution of the finished product. During the establishment and implementation of the
traceability system, the following points, at a minimum, must be taken into account
account
a) listing of batches of materials, ingredients, and intermediate products
received with finished products;
b) reprocessing/recycling of materials/products;
c) distribution of the finished product.
The organization must ensure that legal and regulatory requirements are met.
applicable requirements as well as the client's requirements are identified.
Documented information as evidence of the traceability system
must be kept for a defined period, at least the duration of
product life. The organization must verify and submit the effectiveness for testing
traceability system.

NOTE When appropriate, it is expected that the system verification

include the reconciliation of finished product quantities with the quantity
of ingredients as proof of effectiveness.

8.4 Preparation and response to emergency situations

8.4.1 Generalities
Management must ensure that arrangements are in place to respond.
in potential emergency situations or incidents that may have a
impact on food safety, and what is relevant
for the role of the organism in the food chain.
Documented information must be established and maintained for management
these situations and incidents.

8.4.2 Management of emergency situations and incidents

The organization must:
a) respond to emergency situations and real incidents by:
ensuring that the applicable legal and regulatory requirements
to be identified;
2) communicating internally;
3) communicating externally (for example with suppliers, customers,
the competent authorities, the media;
b) undertake appropriate actions according to the scale of the emergency situation,
or the incident, and on the potential impact on food safety
to reduce the consequences;
c) periodically simulate the arrangements, if feasible;
d) review and, if necessary, update the documented information after the
occurrence of an incident, an emergency situation or the realization of
simulations.

NOTE Emergency situations that may impact safety

foodstuffs and/or production are, for example, disasters
natural, environmental accidents, bioterrorism, accidents on
the workplace, public health emergencies, and other accidents
such as the interruption of essential services like water supply,
of electricity or refrigeration.

8.5 Mastery of hazards

8.5.1 Initial steps for hazard analysis

[Link] Generalities
In order to proceed with the hazard analysis, the documented information
initials must be collected, maintained, and updated by the team
in charge of food safety. This must notably include:
a) the applicable legal and regulatory requirements and the requirements of
(de) client(s);
b) the products provided by the organization, its processes and its equipment;
c) the dangers related to food safety relevant in the
framework of the SMSDA.

[Link] Characteristics of raw materials, ingredients and

materials in contact with the product
The organization must ensure that all legal and regulatory requirements are met.
applicable in terms of food safety are identified
for all raw materials, ingredients and materials in
contact with the product.
The organization must maintain documented information regarding
the entire set of raw materials, ingredients, and materials in
contact with the product as required for the realization of
the hazard analysis (see 8.5.2), including information related to
following points, as applicable:
a) the biological, chemical, and physical characteristics;
b) the composition of the formulated ingredients, including the additives and the
technological auxiliaries;
c) the source (for example, animal, mineral, or plant);
d) the place of origin (provenance);
e) the production method;
f) the packaging and delivery method;
g) the storage conditions and shelf life;
h) preparation and/or handling before use or transformation;
i) the acceptance criteria related to the safety of food or the
specifications regarding the purchased materials and ingredients, taking into account
their intended uses.

[Link] Characteristics of finished products

The organization must ensure that all legal and regulatory requirements
applicable in terms of food safety are identified
for all finished products intended to be made.
The organization must maintain documented information concerning the
characteristics of finished products in relation to the needs of implementation
from the analysis of hazards (see 8.5.2), including information related to
following points, as applicable:
a) the name of the product or a similar identification;
b) the composition;
c) the relevant biological, chemical, and physical characteristics for the
food safety;
d) the expected shelf life and the anticipated storage conditions;
e) the conditioning;
f) labeling related to food safety and/or the
instructions for handling, preparation and intended use;
g) the methods of distribution and delivery.

[Link] Intended use

The intended use, including the reasonably expected handling of the
finished product, and unintended uses due to poor
manipulations and reasonably foreseeable misuses of the product
finished, must be taken into account, and must be maintained under
documented information, to the extent of the needs of the
realization of the hazard analysis (see 8.5.2).
If applicable, consumer/user groups must be
identified for each product.
The groups of consumers/users known to be particularly
vulnerable to specific safety-related hazards of goods
Food products must be identified.
[Link] Flowcharts and process descriptions:

[Link].1 Development of flowcharts:

The team responsible for food safety must establish, maintain
and update flowcharts in the form of documented information
for the products or product categories and the processes covered by the
SMSDA.
Flowcharts provide a graphical representation of the
process. When conducting the hazard analysis, the diagrams of
flux should serve as a basis for assessing the possible presence, increase,
reduction or introduction of dangers related to food safety
food.
Flowcharts must be clear, precise, and detailed enough.
as needed for the conduct of the hazard analysis. The
Flow diagrams must, where applicable, contain the following elements:
a) the sequence and interaction of the functioning steps;
b) outsourced processes;
c) the point of introduction of raw materials, ingredients, auxiliaries
technological, materials
of conditioning/packaging, utilities and intermediate products in the workflow
of production;
d) the points of recovery and recycling;
e) the exit or disposal points for finished and intermediate products,
derivatives and waste.

[Link].2 On-site confirmation of flow diagrams:

The team responsible for food safety must confirm on
ensure the accuracy of the flow diagrams, update them if necessary and
preserve in the form of documented information.

[Link].3 Description of processes and the process environment

The team responsible for food safety must describe, in the
measurement of the needs for conducting the hazard analysis:
a) the layout of the premises, including the areas for handling goods
food products and other products;
b) the processing equipment and the materials in contact, the
technological auxiliaries and the flow of materials;
c) the existing SOPs, the process parameters, any measures
of mastery and/or the rigor with which they are applied, or the
provisions that may influence the safety of food products
food
d) external requirements (for example, arising from legal authorities and
regulatory or client-related) that may impact the choice and the
rigor of control measures.
The variations resulting from the expected seasonal changes or
changes in the organization of positions must be included, if applicable
if necessary.
Descriptions must be updated as needed and maintained.
in the form of documented information.

8.5.2 Hazard Analysis

[Link] General Information:
The team responsible for food safety must carry out a
hazard analysis based on initial information to determine
what are the dangers to master. The level of mastery must ensure the
food safety and, where applicable, a combination of
control measures must be used.

[Link] Identification of hazards and determination of levels

acceptable
The organization must identify and document all safety-related hazards.
reasonably foreseeable foodstuffs in relation to the type
of product, the type of process and the process environment.

The identification must be based on the following elements:

a) the initial information and the data collected in accordance with 8.5.1;
b) the experience;
c) internal and external information including, as far as possible,
epidemiological data, scientific data, and other historical data;
d) information from the food chain regarding hazards
related to food safety concerning product safety
finished products, intermediate products, and foodstuffs at the time of
their consumption;
e) the legal and regulatory requirements and the requirements of the client(s).

NOTE 1 The experience may include information from staff and

external experts familiar with the product and/or processes in others
installations.
NOTE 2 Legal and regulatory requirements may include objectives
on food safety (OSA/FSOs). The Codex Alimentarius Commission
defines the OSA as the 'maximum frequency and/or maximum concentration
of a danger presented by a food at the time of its consumption and which
ensure or contribute to ensuring the appropriate level of protection (DPA/ALOP)
It is appropriate that the dangers be examined in sufficient detail.
to allow for their assessment and the selection of control measures
appropriate.
The organization must identify the step(s) (for example, receipt of
raw materials, processing, distribution, and delivery) to which each
danger related to food safety may be present, be
introduce, increase or persist.

When identifying hazards, the organization must take into account:

a) the previous and following steps of the food chain;
b) all the steps of the flowchart;
c) the equipment associated with the process, the related services,
the process environment and the personnel.
The organization must determine the acceptable level in the finished product of
each of the dangers identified in relation to food safety
food-related, whenever possible.

When determining acceptable levels, the organization must:

a) ensure that legal and regulatory requirements and the requirements of
(des) applicable clients are identified;
b) take into account the intended use of the finished products;
c) take into account any other relevant information.

The organization must maintain documented information regarding the

determination of acceptable levels and their justification.

[Link] Hazard assessment:

For each identified hazard related to food safety,
the organization must conduct a risk assessment to determine if its
prevention or its reduction to an acceptable level is essential.
The organism must assess each hazard related to food safety.
foodstuffs according to:
a) the probability of occurrence in the finished product before the application of measures
of mastery;
the severity of its harmful effects on health related to use
planned (see [Link]).
The organization must identify any significant hazards related to the safety of the goods.
food-related.
The methodology used must be described and the result of the evaluation of
dangers must be maintained in the form of documented information.

[Link] Selection and ranking of the control measures

Based on the hazard assessment, the organization must select a
control measure or a combination of appropriate control measures
allowing to prevent or reduce to the acceptable levels defined the
dangers identified as significant for food safety
food.
The organization must classify the identified control measures and
selected according to whether they should be managed as PRPO (see 3.30)
or at the level of the CCP (see 3.11).

The ranking must be done using a systematic approach. For

each of the selected control measures, the following elements
must be evaluated:
a) the probability of failure of its operation;
b) the severity of the consequences in case of failure of its operation;
this evaluation must include:
1) the impact on the hazards identified as significant for safety
foodstuffs;
2) the positioning in relation to other control measures;
if the control measure is specifically established and applied in view of
reduce the dangers to an acceptable level;
4) whether it is an individual measure or part of a combination
of control measures.
Furthermore, for each control measure, the systematic approach must
include an assessment of the feasibility of:
a) the establishment of measurable critical limits and/or action criteria
measurables/observables;
b) monitoring to detect any non-compliance with the critical limit and/or
measurable/observable action criteria;
c) the application of corrections as quickly as possible in case of non-compliance.
The decision-making process and the results of the selection and
ranking of control measures must be maintained in the form
documented information.
External requirements (such as legal and regulatory requirements)
and the requirements of the client(s)), which may impact the choice and
the rigor of the control measures must also be maintained under
form of documented information.

8.5.3 Validation of the control measures and combinations of

control measures
The team responsible for food safety must validate that the
selected control measures allow to achieve the level of control
foreseen significant dangers related to the safety of goods
food products. This validation must be carried out before the implementation of the
or control measures and combinations of control measures to
include in the hazard control plan (see 8.5.4), and following any
modification made to this one (see 7.4.2, 7.4.3, 10.2 and 10.3).
When the validation result indicates that the control measure(s)
do not allow to achieve the expected level of proficiency, the team responsible for
Food safety must change and reassess the one or more
control measures and/or the combinations of control measures.
The team responsible for food safety must maintain the
validation method and evidence of the capability of the measurement(s)
mastery to reach the expected level of mastery in the form of information
documented.

NOTE A modification may include changes at the level of a

or control measures (i.e., the process parameters, the
rigor and/or their combination) and/or changes in technologies
of raw material manufacturing, the characteristics of the finished product, the
distribution methods and the intended use of finished products.

8.5.4 Hazard Control Plan (HACCP/PRPO Plan)

[Link] Generalities
The organization must establish, implement, and maintain a control plan for
hazards. The hazard control plan must be maintained in the form of
documented information and must contain the following information for
each control measure at the level of each CCP or each PRPO:
a) the danger or dangers related to food safety that must be
controlled at the level of the CCP or by the PRPO;
b) the critical limits at the CCP level or the action criterion(s) for
the PRPO;
c) the measures taken for monitoring;
d) the corrections to be made in case of non-compliance with critical limits
or action criteria;
e) the responsibilities and authorities;
f) the surveillance recordings.

[Link] Determination of critical limits and action criteria

Critical limits at the level of the CCPs and action criteria for the PRPO
must be specified. The reasons for their determination must be
maintained in the form of documented information.
The critical limits at the CCP level must be measurable.
compliance with critical limits must ensure that the acceptable level is not
surpassed.
The action criteria for the PRPO must be measurable or observable.
Compliance with the action criteria must contribute to the assurance that the level
acceptable is not exceeded.

[Link] Monitoring systems at CCP level and for PRPO

At each CCP, a monitoring system must be established for each
control measure or combination of control measures with a view to
detect any non-compliance with critical limits. This system must include all
the programmed measures related to the critical limit(s).
For each PRPO, a monitoring system must be established for measurement.
of control or a combination of control measures to detect any
non-compliance with the action criterion.
The monitoring system, at each CCP and for each PRPO, must be
consisting of documented information including:
a) the measurements or observations providing results within a range of
appropriate time;
b) the methods or monitoring devices used;
c) the applicable calibration methods or, for PRPO, the methods
equivalents for the
verification of the reliability of measurements or observations (see 8.7);
d) the frequency of monitoring;
e) the results of the monitoring;
f) the responsibility and authority associated with oversight;
g) the responsibility and authority associated with evaluating the results of the
surveillance.

At each CCP, the method and frequency of monitoring must allow

to timely detect any non-compliance with critical limits, in order to be able to
quickly proceed to the isolation and evaluation of the product (see 8.9.4).
For each PRPO, the method and frequency of monitoring must be
proportional to the probability of failure and to the severity of
consequences.
When monitoring a PRPO is based on subjective data
coming from observations
(such as a visual inspection), the method must be supported by instructions.
or specifications.

[Link] Actions taken when critical limits or action criteria

have not been respected
The organization must specify the corrections (see 8.9.2) and the corrective actions.
(see 8.9.3) to be undertaken when the critical limits or action criterion
have not been respected and must ensure that:
a) potentially dangerous products are not released (see 8.9.4);
b) the cause of non-conformity is identified;
c) the parameter(s) mastered at the level of the CCP or by the PRPO are
new compliant with critical limits or action criteria;
d) recurrence is avoided.
The organization must carry out corrections in accordance with 8.9.2 and
corrective actions in accordance with 8.9.3.

[Link] Implementation of the Hazard Control Plan:

The organization must implement and maintain a control plan.
dangers and keep evidence of its implementation in the form
documented information.
8.6 Updating information specifying the PRPs and the plan of
control of hazards

After establishing the hazard control plan, the organization must, if

necessary, update the following information:
a) the characteristics of raw materials, ingredients and
materials in contact with the product;
b) the characteristics of finished products;
c) the intended use;
d) flow diagrams and descriptions of processes and their
environments.
The organization must ensure that the hazard control plan and/or the
PRP are up to date.

8.7 Mastery of surveillance and measurement activities

The organization must provide evidence of the appropriateness of the methods.

specified monitoring and measurement as well as the equipment used
for monitoring and measurement activities, in relation to the PRP(s)
and the hazard control plan.
The monitoring and measuring equipment used must be:
a) calibrated or verified at specified intervals before use;
b) settled or reset as needed;
c) identified in order to determine the validity of the calibration;
protected against settings that could invalidate the results of
measure
e) protected against any damage and deterioration.

Calibration and verification results must be kept in the form

documented information. The calibration of all equipment must be
based on international or national measurement standards. In the absence
of the standard, the reference used for calibration or verification must be
preserved in the form of documented information.

The organization must assess the validity of previous measurement results when
the equipment or the process environment proves to be non-compliant
the requirements. The organization must take appropriate action regarding
equipment or the process environment and any product
concerned by the non-compliance.

The assessment and resulting actions must be maintained in written form.

documented information.

As part of the SMSDA, the software used for monitoring and

measure must be validated by the organization, the software supplier or a
tiers before use. The organization must maintain information
documented on the validation activities and the software must be
updated in a timely manner.

Whenever changes occur, including configurations

of software/commercial software modifications, they must be
authorized, documented, and validated before being implemented.

NOTE Generally, the use of commercial software within their range

The planned application can be considered sufficiently validated.

8.8 Verification related to PRP and the hazard control plan

8.8.1 Verification:

The organization must establish, implement, and maintain activities of

verification. The planning of the verification must define the objective, the
methods, frequencies, and responsibilities of verification activities.
The verification activities must confirm the following points:
a) the or the PRP are implemented and are effective;
b) the hazard control plan is implemented and is effective;
c) the danger levels are at identified acceptable levels;
d) the input elements of the hazard analysis are updated;
e) the other actions determined by the organization are implemented and are
effective.

The organization must ensure that audit activities are not

carried out by the person responsible for monitoring the same activities.
The results of the verification must be kept in the form
documented information must be communicated.

When verification relies on tests conducted on samples of

finished products or directly resulting from the process, and when these samples
present non-conformities with regard to the acceptable level defined for the
danger related to food safety (see [Link]), the organization must
treat the lot or lots of concerned products as potentially dangerous
(see [Link]) and apply corrective actions in accordance with 8.9.3

.
8.8.2 Analysis of the results of the verification activities:

The team responsible for food safety must conduct a

analysis of the verification results that should be used as an element
entry for the SMSDA performance evaluation (see 9.1.2).

8.9 Control of product and process non-conformities

8.9.1 Generalities:
The organization must ensure that the data from the monitoring of
PRPO and CCP are evaluated by designated individuals who are
competent and have the authority to implement corrections and actions
correctives.

8.9.2 Corrections :
The organization must ensure that when critical limits at the CCP level
and/or the action criteria for PRPO are not met, the products
those concerned are identified and controlled in terms of their use and their
liberation.

The organization must establish, maintain, and update documented information.

including:
a method for identification, evaluation, and correction for products
concerned in order to ensure their proper future;
b) the provisions for reviewing the corrections made.

When the critical limits at the level of the CCP are not respected, the
affected products must be identified and considered as products
potentially dangerous (see 8.9.4).

When the action criteria for a PRPO are not met, the points
the following must be implemented:
a) the determination of the consequences of this failure in terms of
food safety;
b) the determination of the cause or causes of failure;
c) the identification of the relevant products and their fate in accordance with 8.9.4.

The organization must keep the evaluation results in the form

documented information.

Documented information must be retained to describe the

corrections made to non-compliant products and processes, including:
a) the nature of non-conformity;
b) the cause or causes of non-compliance;
c) the consequences resulting from non-compliance.

8.9.3 Corrective Actions:

The need for corrective actions must be assessed when the critical limits
at the level of the CCP and/or the action criteria for the PRPO are not
respected.

The organization must establish and maintain documented information specifying

the appropriate actions to identify and eliminate the cause of non-conformities
detected, to prevent recurrence and to return to control of
process after the identification of a non-conformity.

These actions must include the following points:

the review of non-conformities identified by customer complaints
and/or consumers and/or reports of official controls;
b) la revue des tendances des résultats de surveillance pouvant indiquer une
loss of control;
c) the determination of the cause or causes of non-conformities;
d) the determination and implementation of actions to ensure that the
non-conformities do not recur;
e) the documentation of the results of the corrective actions undertaken;
f) the verification of the corrective actions taken to ensure their effectiveness
efficiency.
The organization must retain documented information on all the
corrective actions.

8.9.4 Fate of potentially hazardous products:

[Link] Generalities:
The organization must undertake one or more actions aimed at preventing entry.
of potentially dangerous products in the food chain, unless
that he can demonstrate that:

a) the relevant dangers related to the safety of the products

foodstuffs have been reduced to acceptable defined levels;
b) the relevant hazards related to food safety
food levels will be reduced to acceptable levels identified before entry
in the food chain; or
c) the product always meets the defined acceptable level(s) of the or the
dangers related to food safety despite the
non-compliance.

The organization must maintain control over the products that have been identified as
potentially dangerous until the products have been evaluated and that
their destiny had been determined.

If products, which are no longer under the control of the organization, are, by the
Following, determined as dangerous, the organization must notify the parties.
relevant interested parties and initiate a withdrawal/recall (see 8.9.5).

The controls and associated responses of relevant stakeholders

as well as the authorization to dispose of potentially hazardous products
must be retained in the form of documented information.

[Link] Assessment for release:

Each batch of products affected by non-compliance must be evaluated.
The products concerned by the non-compliance with the critical limits at the level of
CCPs should not be released but should be treated in accordance with
[Link].

The products concerned by non-compliance with the action criterion for PRPO
must be released as safe only if one of the following conditions
applies
a) any other evidence than the surveillance system that shows that the
control measures have been
revealed to be effective;
b) the evidence indicating that the combined effect of the control measures for this
particular product
satisfied with the expected performance (that is to say, at acceptable levels
identified);
c) the results of sampling, analysis, and/or other activities of
verification demonstrating that the products concerned comply with
acceptable levels identified for the relevant hazards related to
food safety.

The evaluation results for the release of the products must be

stored in the form of documented information.

[Link] Fate of non-compliant products

Products that are not acceptable for release must be:
a) subject to a new transformation or to a subsequent transformation at
inside or outside the organism in order to ensure the reduction to a
acceptable levels of danger related to food safety; or
b) redirected for another use provided that it has no impact
on food safety in the food chain; or
c) destroyed and/or disposed of as waste.

Documented information must be kept regarding the outcome.

non-conforming products, including the identification of the person or persons
having the approving authority.
8.9.5 Withdrawal/recall
The organization must be able to guarantee the withdrawal/recall within a reasonable timeframe of
all batches of finished products identified as potentially dangerous
by naming the qualified persons vested with the authority to initiate
and implement the withdrawal/call.

The organization must establish and maintain documented information for:

a) inform the relevant stakeholders (for example, legal authorities
and regulatory, the clients and/or consumers);
b) define the fate of withdrawn/recall products as well as that of products
still in stock
c) carry out the sequence of actions to be taken.

The withdrawn/recall products and the finished products still in stock must be
secured or kept under the control of the organization until their acceptance
charge in accordance with [Link].

The cause, scope, and outcome of a withdrawal/recall must be kept.

in the form of documented information and reported to management as
what input elements for the management review (see 9.3).

The organization must verify the implementation and effectiveness of withdrawals/recalls by

the use of appropriate techniques (for example simulations of
withdrawal/recall or practices of withdrawals/recalls) and maintain some
documented information.
 Compliance
ELEMENTS OF THE STANDARD
Yes No
DESCRIPTION
9 Performance Evaluation
9.1 Surveillance, measurement, analysis and evaluation

9.1.1 Generalities
The organization must determine:
a) what is necessary to monitor and measure;
b) the methods of monitoring, measuring, analyzing, and evaluating, according to the
because, to ensure the validity of the results;
c) when monitoring and measurement should be carried out;
d) when the results of monitoring and measurement should be analyzed
and assessed;
e) who must analyze and evaluate the results of the monitoring and measurement.

The organization must retain relevant documented information such as

proofs of results.

The organization must evaluate the performance as well as the effectiveness of the SMSDA.

9.1.2 Analysis and evaluation

The organization must analyze and evaluate the appropriate data and information.
issues of surveillance and measurement, including the results of activities
verification related to PRPs and the hazard control plan (see 8.8
and 8.5.4), internal audits (see 9.2) and external audits.

The analysis must be carried out in order to:

a) to confirm that the overall performance of the system meets the
provisions set forth and the requirements of the SMSDA established by
the organism;
b) to identify the need for updates or improvements to
SMSDA;
c) to identify trends indicating a higher incidence of products
potentially
dangerous or process failures;
to establish the information for the planning of the internal audit program
regarding the status and importance of the domains to be audited;
to provide evidence of the effectiveness of the corrections and actions
correctives.

The results of the analysis as well as the subsequent activities must be

kept in the form of documented information. The results must be
reported to management and used as input for the review of
direction (see 9.3) and the updating of the SMSDA (see 10.3).

NOTE Data analysis methods may include techniques

statistics.

9.2 Internal Audit:

The organization must conduct internal audits at planned intervals to
provide information to determine whether the SMSDA:
is compliant:
1) to the organization's specific requirements concerning the SMSDA;
to the requirements of this document;
b) is effectively implemented and maintained.

The organization must:

a) plan, establish, implement and maintain one or more programs
of the audit, covering in particular the frequency, methods, responsibilities,
the planning requirements and the report. The program(s)
audits must take into account the importance of the processes involved, of the
modifications made to the SMSDA and the results of the monitoring,
measure and previous audits;
b) define the audit criteria and the scope of each audit;
c) select competent auditors and conduct audits to ensure
the objectivity and impartiality of the audit process;
d) ensure that the results of the audits are reported to the responsible team.
on food safety and to the relevant authority;
e) to keep documented information as evidence of implementation
work of the audit program and audit results;
f) make the necessary corrections and initiate corrective actions
necessary within the agreed deadlines;
g) determine whether the SMSDA meets the intentions of the policy related to the
food safety (see 5.2) and the objectives of the SMSDA (see
6.2).

The monitoring activities of the organization must include the verification of actions
companies and the report of verification results.

NOTE ISO 19011 provides guidelines for the auditing of systems

management.

9.3 Management Review

9.3.1 General provisions:

At scheduled intervals, management must conduct a review of the SMSDA implemented.
put in place by the organization, in order to ensure that it is always appropriate, adequate
and efficient.

9.3.2 Input elements for the management review:

The management review must take into account:
a) the progress of actions decided at the end of management reviews
previous
b) the modifications of relevant external and internal stakes for the SMSDA,
including changes within the organization and its context (see
4.1);
c) information on the performance and effectiveness of the SMSDA, including the
trends regarding:
1) the result(s) of the system update activities (see 4.4
and 10.3);
2) the results of monitoring and measurement;
3) the analysis of the results of the verification activities related to the PRPs
and the hazard control plan (see 8.8.2);
4) non-conformities and corrective actions;
5) the results of the audit (internal and external);
6) inspections (for example regulatory, client);
7) the performance of external service providers;
8) the review of risks and opportunities and the effectiveness of actions
companies to respond to it (see 6.1);
9) the degree of achievement of the SMSDA objectives;
d) the adequacy of resources;
e) any emergency situation, incident (see 8.4.2) or withdrawal/recall (see 8.9.5)
that occurred;
f) the relevant information obtained through communication
external (see 7.4.2) and internal (see 7.4.3), including requests and
claims from interested parties;
g) the opportunities for continuous improvement.

The data must be presented in a way that allows management

to associate them with the objectives stated in the SMSDA.

9.3.3 Output elements of the management review:

The outputs of the management review must include:
a) the decisions and actions related to opportunities for improvement
continue;
b) any potential updates and changes to be made to the SMSDA, including
understood the resource needs as well as the revision of the related policy
to the safety of food products and the objectives of the SMSDA.

The organization must retain documented information as evidence

output elements of management reviews.

Compliance
ELEMENTS OF THE STANDARD
Yes No
DESCRIPTION
10 Improvement
10.1 Non-compliance and corrective actions
When a non-conformity occurs, the organization must:
a) react to non-compliance, and if applicable:
1) act to master it and correct it;
2) face the consequences;
b) assess whether it is necessary to take action to eliminate the
causes of non-compliance,
so that it does not reproduce or appear elsewhere, in:
1) reviewing the non-conformity;
2) researching and analyzing the causes of non-compliance;
3) searching if similar non-compliances exist or could exist
possibly happen;
c) implement all necessary actions;
d) assess the effectiveness of any corrective action implemented;
e) modify the SMSDA, if necessary.

Corrective actions must be appropriate to the consequences of non-

compliances encountered.
The organization must maintain documented information as evidence:
a) of the nature of non-conformities and any action taken subsequently;
b) results of any corrective action.
10.2 Continuous Improvement
The organization must continuously improve relevance, adequacy, and effectiveness.
from SMSDA.

Management must ensure that the organization continuously improves the effectiveness of
SMSDA through communication (see 7.4), management review
(see 9.3), of the internal audit (see 9.2), of the analysis of the results of the activities
of verification (see 8.8.2), of the validation of the control measures and
from or combinations of control measures (see 8.5.3), actions
correctives (see 8.9.3) and the update of the SMSDA (see 10.3).

10.3 Actualization of the security management system

food products
Management must ensure that the SMSDA is continuously updated. For this
To do this, the team responsible for food safety must assess the
SMSDA à des intervalles planifiés. L’équipe doit examiner la nécessité de
review the hazard analysis (see 8.5.2), the established hazard control plan
(see 8.5.4) and the established PRPs (see 8.2). The updating activities must
to be based on the following elements, derived from:
a) of communication, both external and internal (see 7.4);
b) any other information regarding relevance, adequacy and
the effectiveness of the SMSDA;
c) conclusions from the analysis of the results of the verification activities (see
9.1.2);
d) conclusions from the management review (see 9.3).

The system update activities must be kept in the form of

documented and reported information as input elements for the
management review (see 9.3).