ISO 22000 Audit Checklist

8/11/2020 ISO 22000 Audit Checklist - SafetyCulture
Clause 4
Food Safety Management System
General Requirements
Has the organization established, documented and implemented an effective

food safety management system in accordance with the requirements of ISO
22000 standard?
Yes No N/A
Is the FSMS maintained and updated?
Yes No N/A
Is the scope of the FSMS defined?
Yes No N/A
Are the products or product categories, processes and production sites that are
addressed by the food safety management system specified by scope?
Yes No N/A
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Are the food safety hazards that may be reasonably expected to occur in
relation to products within the scope of the system identified, evaluated and
controlled in such manner that the products of theorganization do not, directly
or indirectly, harm the consumer?
Yes No N/A
Are the appropriate information - regarding safety issues related to the products
- communicated throughout the food chain?
Yes No N/A
Are the information - concerning development, implementation and updating of

the FSMS throughout the organization - communicated to the extent necessary
to ensure the food safety required by the ISO 22000 standard?
Yes No N/A
Does the organization periodically evaluate FSMS (and update when necessary)
to ensure that the system reflects the organization's activities and incorporates
the most recent information on the food safety hazards subject to control?
Yes No N/A
Has the organization ensured control over the outsourced processes that may
affect end product conformity?
Yes No N/A
Is the control of such outsourced processes identified and documented within

the FSMS?
Yes No N/A
Documentation Requirements
General
Does the FSMS documentation include:
a) Documented statements of a food safety policy and related objectives?
Yes No N/A
b) Documented procedures and records required by ISO 22000 standard?
Yes No N/A
c) Documents needed by the organization to ensure the effective development,

implementation and updating of the food safety management system?
Yes No N/A
Control of documents
Are the documents - which are required by the food safety management system
- controlled?
Yes No N/A
Do the established controls ensure that all proposed changes are reviewed prior
to implementation to determine their effects on food safety and their impact on
the food safety management system?
Yes No N/A
Does a documented procedure exist to define the controls needed:
a) To approve documents for adequacy prior to issue?
Yes No N/A
b) To review and update as necessary and re-approve documents?
Yes No N/A
c) To ensure that changes and the current revision status of documents are
identified?
Yes No N/A
d) To ensure that relevant versions of applicable documents are available at

points of use?
Yes No N/A
e) To ensure that documents remain legible and readily identifiable?
Yes No N/A
f) To ensure that relevant documents of external origin are identified and their
distribution controlled?
Yes No N/A
g) To prevent the unintended use of obsolete documents, and to apply suitable

identification to them if they are retained for any purpose?
Yes No N/A
Control of records
Are required records established and maintained in order to provide evidence of

conformity to requirements and evidence of the effective operation of the food
safety management system?
Yes No N/A
Do records remain legible, readily identifiable and retrievable?
Yes No N/A
Does a documented procedure exist in order to define the controls needed for
the correction, identification, storage, protection, retrieval, retention time and
disposition of records?
Yes No N/A
Please proceed to Section 5.
Clause 5
Management responsibility
Management commitment
Is top management able to provide evidence of its commitment to the

development and implementation of the food safety management system?
Yes No N/A
Is top management able to provide evidence that the effectiveness of the food safety
management system is continually improved by:
a) Showing food safety is supported by the business objectives of the

organization?
Yes No N/A
b) Communicating to the organization the importance of meeting the

requirements of ISO 22000 standard, any relevant statutory and regulatory
requirements, as well as customer requirements relating to food safety?
Yes No N/A
c) Establishing the food safety policy?
Yes No N/A
d) Conducting management reviews?
Yes No N/A
e) Ensuring the availability of resources?
Yes No N/A
Food safety policy
Has top management defined, documented and communicated its food safety
policy?
Yes No N/A
Does top management ensure that the food safety policy:
a) Is appropriate to the role of the organization in the food chain?
Yes No N/A
b) Conforms with both statutory and regulatory requirements and with mutually
agreed food safety requirements of customers?
Yes No N/A
c) Is communicated, implemented and maintained at all levels of the

organization?
Yes No N/A
d) Is reviewed for continued suitability?
Yes No N/A
e) Adequately addresses communication?
Yes No N/A
f) Is supported by measurable objectives?
Yes No N/A
Food safety management system planning
Does top management ensure that:
a) The planning of the food safety management system is carried out to meet
the requirements in clause 4.1, as well as the objectives of the organization that
support food safety?
Yes No N/A
b) The integrity of the food safety management system is maintained when

changes to the food safety management system are planned and implemented?
Yes No N/A
Responsibility and authority
Does top management ensure that the responsibilities, authorities are defined
and communicated within the organization to ensure the effective operation
and maintenance of the food safety management system?
Yes No N/A
Is the responsibility assigned to all personnel to report the problems with the
food safety management to identified person(s)?
Yes No N/A
Are there designated personnel with defined responsibility and authority to

initiate and record actions?
Yes No N/A
Food safety team leader
Has top management appointed a food safety team leader who, irrespective of other
responsibilities, shall have responsibility and authority:
a) To manage a food safety team and organize its work?
Yes No N/A
b) To ensure relevant training and education of the food safety team member?
Yes No N/A
c) To ensure that the food safety management system is established,

implemented, maintained and updated?
Yes No N/A
d) To report to the organization's top management on the effectiveness and

suitability of the food safety management system?
Yes No N/A
NOTE: The responsibility of the food safety team leader may include liaison with external parties
on matters relating to the food safety management system.
Communication
External communication
Has the organization established, implemented and maintained effective arrangements for
communicating with:
a) Suppliers and contractors?
Yes No N/A
b) Customers or consumers, in particular in relation to product information

(including instructions regarding intended use, specific storage requirements
and, as appropriate, shelf life), inquiries, contracts or order handling including
amendments, and customer feedback including customer complaints?
Yes No N/A
c) Statutory and regulatory authorities?
Yes No N/A
d) Other organizations that have an impact on, or will be affected by, the
effectiveness or updating of the food safety management system?
Yes No N/A
Does such communication provide information on food safety aspects

(especially to known food safety hazards that need to be controlled by other
organizations in the food chain) of the organization's products that may be
relevant to other organizations in the food chain?
Yes No N/A
Are records of communications maintained?
Yes No N/A
Are the food safety requirements - from statutory and regulatory authorities and
customers – available?
Yes No N/A
Are there designated personnel with defined responsibility and authority to

communicate externally any information concerning food safety?
Yes No N/A
Is information obtained through external communication included as input to

system updating and management review?
Yes No N/A
Internal communication
Has the organization established, implemented and maintained effective

arrangements for communicating with personnel on issues having an impact on
food safety?
Yes No N/A
Has the organization ensured that the food safety team is informed in a timely manner of
changes, including but not limited to the following:
a) Products or new products?
Yes No N/A
b) Raw materials, ingredients, and services?
Yes No N/A
c) Production systems and equipment?
Yes No N/A
d) Production premises, location of equipment, and surrounding environment?
Yes No N/A
e) Cleaning and sanitation programmes?
Yes No N/A
f) Packaging, storage and distribution systems?
Yes No N/A
g) Personnel qualification levels and/or allocation of responsibilities and

authorizations?
Yes No N/A
h) Statutory and regulatory requirements?
Yes No N/A
i) Knowledge regarding food safety hazards and control measures?
Yes No N/A
j) Customer, sector, and other requirements that the organization observes?
Yes No N/A
k) Relevant inquiries from external interested parties?
Yes No N/A
l) Complaints indicating food safety hazards associated with the product?
Yes No N/A
m) Other conditions that have an impact on food safety?
Yes No N/A
Does the food safety team ensure that above mentioned information is included
in the updating of the food safety management system?
Yes No N/A
Does top management ensure that relevant information is included as input to

the management review?
Yes No N/A
Emergency preparedness and response
Has top management established, implemented and maintained procedures to

manage potential emergency situations and accidents that can impact food
safety and which are relevant to the role of the organization in the food chain?
Yes No N/A
Management review
General
Does top management review the organization’s food safety management

system, at planned intervals, to ensure its continuing suitability, adequacy and
effectiveness?
Yes No N/A
Does this review include assessing opportunities for improvement and the need
for changes to the food safety management system, including the food safety
policy?
Yes No N/A
Are records from management reviews maintained?
Yes No N/A
Review input
Does the input to management review include information about:
a) Follow-up actions from previous management reviews?
Yes No N/A
b) Analysis of results of verification activities?
Yes No N/A
c) Changing circumstances that can affect food safety?
Yes No N/A
d) Emergency situations, accidents and withdrawals?
Yes No N/A
e) Reviewing results of system-updating activities?
Yes No N/A
f) Review of communication activities, including customer feed-back?
Yes No N/A
g) External audits or inspections?
Yes No N/A
Are the data presented in a manner that enables top management to relate the
information to stated objectives of the food safety management system?
Yes No N/A
Review output
Does the output from the management review include any decisions and actions related to:
a) Assurance of food safety?
Yes No N/A
b) Improvement of the effectiveness of the food safety management system?
Yes No N/A
c) Resource needs?
Yes No N/A
d) Revisions of the organization's food safety policy and related objectives?
Yes No N/A
Please proceed to Section 6
Clause 6
Resource management
Provision of resources
Does the organization provide adequate resources for the establishment,

implementation, maintenance and updating of the food safety management
system?
Yes No N/A
Human resources
General
Are the food safety team and the other personnel carrying out activities having
an impact on food safety, competent on the basis of appropriate education,
training, skills and experience?
Yes No N/A
Are there available records of agreement or contracts defining the responsibility

and authority of external experts, where the assistance of external experts is
required for the development, implementation, operation or assessment of the
food safety management system?
Yes No N/A
Competence, awareness and training
Does the organization:
a) Identify the necessary competencies for personnel whose activities have an

impact on food safety?
Yes No N/A
b) Provide training or take other action to ensure personnel have the necessary
competencies?
Yes No N/A
c) Ensure that personnel responsible for monitoring, corrections and corrective

actions of the food safety management system are trained?
Yes No N/A
d) Evaluate the implementation and the effectiveness of the actions taken in a),
b) and c)?
Yes No N/A
e) Ensure that the personnel are aware of the relevance and importance of their
individual activities in contributing to food safety?
Yes No N/A
f) Ensure that the requirement for effective communication is understood by all

personnel whose activities have an impact on food safety?
Yes No N/A
g) Maintain appropriate records of training and actions described in b) and c)?
Yes No N/A
Infrastructure
Does the organization provide the resources for the establishment and
maintenance of the infrastructure needed to implement the requirements of ISO
22000 standard?
Yes No N/A
Work environment
Does the organization provide the resources for the establishment,

management and maintenance of the work environment needed to implement
the requirements of ISO 22000 standard?
Yes No N/A
Clause 7
Planning and realization of safe products
General
Does the organization plan and develop the processes needed for the
realization of safe products?
Yes No N/A
Does the organization implement, operate and ensure the effectiveness of the
planned activities and any changes to those activities? Note: This includes
PRP(s) as well as operational PRP(s) and/or the HACCP plan.
Yes No N/A
Prerequisite programmes (PRPs)
Has the organization established, implemented and maintained PRP(s) to assist in controlling:
a) The likelihood of introducing food safety hazards to the product through the
work environment?
Yes No N/A
b) Biological, chemical and physical contamination of the product(s), including

cross-contamination between products?
Yes No N/A
c) Food safety hazard levels in the product and product processing

environment?
Yes No N/A
Are the PRP(s):
a) Appropriate to the organizational needs with regard to food safety?
Yes No N/A
b) Appropriate to the size and type of the operation and the nature of the
products being manufactured and/or handled?
Yes No N/A
c) Implemented across the entire production system, either as programmes

applicable in general or as programmes applicable to a particular product or
operational line?
Yes No N/A
d) Approved by the food safety team?
Yes No N/A
Does the organization identify statutory and regulatory requirements related to

the above?
Yes No N/A
Does the organization consider and utilize appropriate information, when

selecting and/or establishing PRP(s)?
Yes No N/A
Does the organization consider the following (when establishing PRP(s)):
a) Construction and layout of buildings and associated utilities?
Yes No N/A
b) Layout of premises, including workspace and employee facilities?
Yes No N/A
c) Supplies of air, water, energy and other utilities?
Yes No N/A
d) Supporting services, including waste and sewage disposal?
Yes No N/A
e) The suitability of equipment and its accessibility for cleaning, maintenance,

and preventative maintenance?
Yes No N/A
f) Management of purchased materials (e.g. raw materials, ingredients,

chemicals, and packaging), supplies (e.g. water, air, steam, and ice), disposals
(e.g. waste and sewage) and handling of products (e.g. storage and
transportation)?
Yes No N/A
g) Measures for the prevention of cross-contamination?
Yes No N/A
h) Cleaning and sanitizing?
Yes No N/A
i) Pest control?
Yes No N/A
j) Personal hygiene?
Yes No N/A
k) Other aspects as appropriate?
Yes No N/A
Is verification of PRP(s) planned?
Yes No N/A
Are PRP(s) modified as necessary?
Yes No N/A
Are records of verifications and modifications maintained?
Yes No N/A
Do documents specify how activities included in the PRP(s) are managed?
Yes No N/A
Preliminary steps to enable hazard analysis
General
Are all relevant information - needed to conduct the hazard analysis - collected,
maintained, updated and documented?
Yes No N/A
Are the records related to hazard analysis maintained?
Yes No N/A
Food safety team
Has a food safety team been appointed?
Yes No N/A
Do the members of the food safety team provide a combination of multi-

disciplinary knowledge and experience in developing and implementing the food
safety management system? Note: This includes, but need not be limited to, the
organization's products, processes, equipment and food safety hazards within
the scope of the food safety management system.
Yes No N/A
Are records - that demonstrate that the food safety team has the required
knowledge and experience - maintained?
Yes No N/A
Product characteristics
Raw material, ingredients, and product contacted material
Are all raw materials, ingredients and product-contact materials described in documents to the
extent needed to conduct the hazard analysis, including the following, as appropriate:
a) Biological, chemical, and physical characteristics?
Yes No N/A
b) Composition of formulated ingredients, including additives and processing

aids?
Yes No N/A
c) Origin?
Yes No N/A
d) Method of production?
Yes No N/A
e) Packaging and delivery methods?
Yes No N/A
f) Storage conditions and shelf life?
Yes No N/A
g) Preparation and/or handling before use or processing?
Yes No N/A
h) Food safety-related acceptance criteria or specifications of purchased

materials and ingredients appropriate to their intended uses?
Yes No N/A
Does the organization identify statutory and regulatory food safety

requirements related to the raw materials, ingredients and product-contact
materials?
Yes No N/A
Are the descriptions kept up-to-date including, when required?
Yes No N/A
Characteristics of end products
Are the characteristics of end products described in documents to the extent needed to conduct
the hazard analysis, including information on the following, as appropriate:
a) Product name or similar identification?
Yes No N/A
b) Composition?
Yes No N/A
c) Biological, chemical and physical characteristics relevant to food safety?
Yes No N/A
d) Intended shelf life and storage conditions?
Yes No N/A
e) Packaging?
Yes No N/A
f) Labeling relating to food safety and/or instructions for handling, preparation,

and usage?
Yes No N/A
g) Method(s) of distribution?
Yes No N/A
Does the organization identify statutory and regulatory food safety

requirements related to the characteristics of end products?
Yes No N/A
Yes No N/A
Intended use
Are the intended use, the reasonably expected handling of the end product, and
any unintended but reasonably expected mishandling and misuse of the end
product considered and described in documents to the extent needed to
conduct the hazard analysis?
Yes No N/A
Are groups of users and, where appropriate, groups of consumers identified for
each product, and consumer groups are known to be especially vulnerable to
specific food safety hazards considered?
Yes No N/A
Yes No N/A
Flow diagrams, process steps, and control measures
Flow diagrams
Are flow diagrams prepared for the products or process categories covered by
the food safety management system?
Yes No N/A
Do flow diagrams provide a basis for evaluating the possible occurrence,

increase or introduction of food safety hazards?
Yes No N/A
Are flow diagrams clear, accurate and sufficiently detailed?
Yes No N/A
Do flow diagrams, as appropriate, include the following:
a) The sequence and interaction of all steps in the operation?
Yes No N/A
b) Any outsourced processes and subcontracted work?
Yes No N/A
c) Where raw materials, ingredients, and intermediate products enter the flow?
Yes No N/A
d) Where reworking and recycling take place?
Yes No N/A
e) Where end products, intermediate products, byproducts, and waste are

released or removed?
Yes No N/A
Does the food safety team verify the accuracy of the flow diagrams by on-site
checking?
Yes No N/A
Are verified flow diagrams maintained as records?
Yes No N/A
Description of process steps and control measures
Are the existing control measures process parameters and/or the rigorousness
with which they are applied, or the procedures that may influence food safety,
described to the extent needed to conduct the hazard analysis?
Yes No N/A
Are external requirements (e.g. regulatory authorities ore costumes) that may
impact the choice or rigorousness of the control measures described and
updated?
Yes No N/A
Hazard analysis
General
Does the food safety team conduct a hazard analysis to determine which
hazards need to be controlled, the degree of control required to ensure food
safety, and which combination of control measures is required?
Yes No N/A
Hazard identification and determination of acceptable levels
Are all food safety hazards that are reasonably expected to occur in relation to
the type of product, type of process and actual processing facilities identified
and recorded?
Yes No N/A
Is the identification based on:
a) The preliminary information and data collected in preliminary steps to enable

hazard analysis?
Yes No N/A
b) Experience?
Yes No N/A
c) External information including, to the extent possible, epidemiological and

other historical data?
Yes No N/A
d) Information from the food chain on food safety hazards that may be of
relevance for the safety of the end products, intermediate products, and the
food at consumption?
Yes No N/A
Are the step(s) (from raw materials, processing, and distribution) - at which
each food safety hazard may be introduced – indicated?
Yes No N/A
Is the consideration - when identifying the hazards - given to:
a) The steps preceding and following the specified operation?
Yes No N/A
b) The process equipment, utilities/services, and surroundings?
Yes No N/A
c) The preceding and following links in the food chain?
Yes No N/A
Are the acceptable level of the food safety hazard in the end product
determined (whenever possible) for each of the food safety hazards identified?
Yes No N/A
Does the determined level take into account established statutory and
regulatory requirements, customer food safety requirements, the intended use
by the customer and other relevant data?
Yes No N/A
Are the justification for, and the result of, the determination of the acceptable
level of the food safety hazard recorded?
Yes No N/A
Hazard assessment
Is a hazard assessment conducted to determine, for each food safety hazard

identified, whether its elimination or reduction to acceptable levels is essential
to the production of a safe food and whether its control is needed to enable the
defined acceptable levels to be met?
Yes No N/A
Is each food safety hazard evaluated according to the possible severity of

adverse health effects and the likelihood of their occurrence?
Yes No N/A
Is the methodology used for the hazard described?
Yes No N/A
Are the results of the food safety hazard assessment recorded?
Yes No N/A
Selection and assessment of control measures
Is an appropriate combination of control measures selected (based on the

hazard assessment), which is capable of preventing, eliminating or reducing
these food safety hazards to defined acceptable levels?
Yes No N/A
Is each of the selected control measures reviewed with respect to its

effectiveness against the identified food safety hazards?
Yes No N/A
Is each selected control measure categorized as to whether it needs to be managed through

operational PRP(s) or by the HACCP plan, using a logical approach that includes assessments
with regard to the following:
a) Its effect on identified food safety hazards relative to the strictness applied?
Yes No N/A
b) Its feasibility for monitoring (e.g. ability to be monitored in a timely manner to

enable immediate corrective actions)?
Yes No N/A
c) It is placed within the system relative to other control measures?
Yes No N/A
d) The likelihood of failure in the functioning of a control measure or significant

processing variability?
Yes No N/A
e) The severity of the consequence(s) in the case of failure in its functioning?
Yes No N/A
f) Whether the control measure is specifically established and applied to

eliminate or significantly reduce the level of hazard(s)?
Yes No N/A
g) Synergistic effects (i.e. interaction that occurs between two or more

measures resulting in their combined effect being higher than the sum of their
individual effects)?
Yes No N/A
Are control measures - categorized as belonging to the HACCP plan –

implemented?
Yes No N/A
Are other control measures implemented as operational PRPs?
Yes No N/A
Are the methodology and parameters - used for this categorization - described
in documents?
Yes No N/A
Are the results of the assessment recorded?
Yes No N/A
Establishing the operational prerequisite programmes (PRPs)
Are the operational PRPs documented?
Yes No N/A
Are the operational PRPs included the following information for each programme:
a) Food safety hazard(s) to be controlled by the programme?
Yes No N/A
b) Control measure(s)?
Yes No N/A
c) Monitoring procedures that demonstrate that the operational PRPs are in

place?
Yes No N/A
d) Corrections and corrective actions to be taken if monitoring shows that the

operational PRPs are not in control?
Yes No N/A
e) Responsibilities and authorities?
Yes No N/A
f) Record(s) of monitoring?
Yes No N/A
Establishing the HACCP plan
HACCP plan
Is the HACCP plan documented?
Yes No N/A
Is the HACCP plan included the following information for each identified critical control point
(CCP):
a) Food safety hazard(s) to be controlled at the CCP?
Yes No N/A
b) Control measure(s)?
Yes No N/A
c) Critical limit(s)?
Yes No N/A
d) Monitoring procedure(s)?
Yes No N/A
e) Corrections and corrective action(s) to be taken if critical limits are

exceeded?
Yes No N/A
f) Responsibilities and authorities?
Yes No N/A
g) Record(s) of monitoring?
Yes No N/A
Identification of critical control points
Are CCP(s) identified for the control measures identified, for each hazard that is
to be controlled by the HACCP plan?
Yes No N/A
Determination of critical limits forCCP(s)
Are critical limits determined for the monitoring established for each CCP?
Yes No N/A
Are critical limits established on such a way to ensure that the identified
acceptable level of the food safety hazard in the end product is not exceeded?
Yes No N/A
Are critical limits measurable?
Yes No N/A
Are the rationale for the chosen critical limits documented?
Yes No N/A
Are critical limits - based on subjective data (such as visual inspection of

product, process, handling, etc.) - supported by instructions or specifications
and/or education and training?
Yes No N/A
System for the monitoring of critical control points
Is a monitoring system established for each CCP to demonstrate that the CCP is
in control?
Yes No N/A
Are all scheduled measurements or observations - relative to the critical limit(s)

- included in the monitoring system?
Yes No N/A
Does the monitoring system consist of relevant procedures, instructions, and records that cover
the following:
a) Measurements or observations that provide results within an adequate time

frame?
Yes No N/A
b) Monitoring devices used?
Yes No N/A
c) Applicable calibration methods?
Yes No N/A
d) Monitoring frequency?
Yes No N/A
e) Responsibility and authority related to monitoring and evaluation of

monitoring results?
Yes No N/A
f) Record requirements and methods?
Yes No N/A
Are the monitoring methods and frequency capable of determining when the
critical limits have been exceeded in time for the product to be isolated before it
is used or consumed?
Yes No N/A
Actions when monitoring results exceed critical limits
Are planned corrections and corrective actions - to be taken when critical limits
are exceeded - specified in the HACCP plan?
Yes No N/A
Do the actions ensure that:
a) The cause of nonconformity is identified?
Yes No N/A
b) The parameter(s) controlled at the CCP is (are) brought back under control?
Yes No N/A
c) Recurrence is prevented?
Yes No N/A
Are documented procedures established and maintained for the appropriate

handling of potentially unsafe products to ensure that they are not released
until they have been evaluated?
Yes No N/A
Updating of preliminary information and documents specifying the PRPs and the HACCP plan
Does the organization update the following information in operational PRP(s) and/or the HACCP
plan, if necessary:
a) Product characteristics?
Yes No N/A
b) Intended use?
Yes No N/A
c) Flow diagrams?
Yes No N/A
d) Process steps?
Yes No N/A
e) Control measures?
Yes No N/A
Are the HACCP plan and the procedures and instructions specifying the PRP(s)
amended, if necessary?
Yes No N/A
Verification planning
Does verification planning define the purpose, methods, frequencies, and

responsibilities for the verification activities?
Yes No N/A
Do the verification activities confirm that:
a) The PRP(s) are implemented?
Yes No N/A
b) Input to the hazard analysis is continually updated?
Yes No N/A
c) The operational PRP(s) and the elements within the HACCP plan are
implemented and effective, d) hazard levels are within identified acceptable
levels?
Yes No N/A
e) Other procedures required by the organization are implemented and

effective?
Yes No N/A
Is the output of verification planning in a form suitable for the organization's

method of operations?
Yes No N/A
Are verification results recorded and communicated to the food safety team?
Yes No N/A
Are verification results provided on such way to enable the analysis of the
results of the verification activities?
Yes No N/A
Are the affected lots of product handled as potentially unsafe, if system

verification is based on testing of end product samples, and where such test
samples show lack of conformity with the acceptable level of the food safety
hazard?
Yes No N/A
Traceability system
Has the organization established and does it apply a traceability system that
enables the identification of product lots and their relation to batches of raw
materials, processing, and delivery records?
Yes No N/A
Is the traceability system able to identify incoming material from the immediate
suppliers and the initial distribution route of the end product?
Yes No N/A
Are traceability records maintained for a defined period for system assessment
to enable the handling of potentially unsafe products and in the event of
product withdrawal?
Yes No N/A
Are records in accordance with statutory and regulatory requirements and

customer requirements?
Yes No N/A
Control of nonconformity
Corrections
Does the organization ensure that when critical limits for CCP(s) are exceeded
or there is a loss of control of operational PRP(s), the end products affected are
identified and controlled with regard to their use and release?
Yes No N/A
Is a documented procedure established and maintained defining:
a) The identification and assessment of affected end products to determine

their proper handling?
Yes No N/A
b) A review of the corrections carried out?
Yes No N/A
Are potentially unsafe products - manufactured under conditions where critical

limits have been exceeded - handled?
Yes No N/A
Are products - manufactured under conditions where operational PRP(s) have

not been conformed with - evaluated with respect to the cause(s) of the
nonconformity and to the consequences thereof in terms of food safety?
Yes No N/A
Are these products, where necessary, handled?
Yes No N/A
Is the evaluation recorded?
Yes No N/A
Are all corrections approved by the responsible person(s), and recorded

together with information on the nature of the nonconformity, its cause(s) and
consequence(s), including information needed for traceability purposes related
to the nonconforming lots?
Yes No N/A
Corrective actions
Are data - derived from the monitoring of operational PRPs and CCPs -
evaluated by designated person(s) with sufficient knowledge and authority to
initiate corrective actions?
Yes No N/A
Are corrective actions initiated when critical limits are exceeded or when there
is a lack of conformity with operational PRP(s)?
Yes No N/A
Has the organization established and does it maintain documented procedures

that specify appropriate actions to identify and eliminate the cause of detected
nonconformities, to prevent recurrence, and to bring the process or system back
into control after nonconformity is encountered?
Note:
These actions include
a) reviewing nonconformities (including customer complaints),
b) reviewing trends in monitoring results that may indicate development
towards loss of control,
c) determining the cause(s) of nonconformities,
d) evaluating the need for action to ensure that nonconformities do not recur,
e) determining and implementing the actions needed,
f) recording the results of corrective actions taken, and
g) reviewing corrective actions taken to ensure that they are effective.
Yes No N/A
Are corrective actions recorded?
Yes No N/A
Handling of potentially unsafe products
General
Does the organization handle nonconforming products by taking action(s) to prevent the
nonconforming product from entering the food chain unless it is possible to ensure that
a) The food safety hazard(s) of concern has(ve) been reduced to the defined
acceptable levels?
Yes No N/A
b) The food safety hazard(s) of concern will be reduced to identified acceptable

levels prior to entering into the food chain?
Yes No N/A
c) The product still meets the defined acceptable level(s) of the food safety
hazard(s) of concern despite the nonconformity?
Yes No N/A
Are all lots of product - that may have been affected by a nonconforming
situation - held under control of the organization until they have been
evaluated?
Yes No N/A
Does the organization notify relevant interested parties and initiate a

withdrawal, if products that have left the control of the organization are
subsequently determined to be unsafe? Note: The term “withdrawal” includes
recall.
Yes No N/A
Are the controls and related responses and authorization for dealing with
potentially unsafe products documented?
Yes No N/A
Evaluation for release
Is each lot of product affected by the nonconformity released as safe only when any of the
following conditions apply:
a) Evidence other than the monitoring system demonstrates that the control
measures have been effective?
Yes No N/A
b) Evidence shows that the combined effect ofthe control measures for that
particular product complies with the performanceintended?
Yes No N/A
c) The results of sampling, analysis and/or other verification activities

demonstrate that the affected lot of product complies with the identified
acceptable levels for the food safety hazard(s) concerned?
Yes No N/A
Disposition of nonconforming products
Is the lot of product - which is not acceptable for release - handled (after evaluation) by one of
the following activities:
a) Reprocessing or further processing within or outside the organization to

ensure that the food safety hazard is eliminated or reduced to acceptable
levels?
Yes No N/A
b) Destruction and/or disposal as waste?
Yes No N/A
Control of nonconformity
Withdrawals
To enable and facilitate the complete and timely withdrawal of lots of end products which have
been identified as unsafe
a) Has top management appointed personnel having the authority to initiate a

withdrawal and personnel responsible for executing the withdrawal?
Yes No N/A
b) Has the organization established and does it maintain a documented

procedure for
1) notification to relevant interested parties (e.g. statutory and regulatory
authorities, customers and/or consumers),
2) handling of withdrawn products as well as affected lots of the products still
in stock, and
3) the sequence of actions to be taken?.
Yes No N/A
Are withdrawn products secured or held under supervision until they are
destroyed, used for purposes other than originally intended, determined to be
safe for the same (or other) intended use, or reprocessed in a manner to ensure
they become safe?
Yes No N/A
Are the cause, extent and result of a withdrawal recorded and reported to top
management as input to the management review?
Yes No N/A
Does the organization verify and record the effectiveness of the withdrawal
programme through the use of appropriate techniques (e.g. challenge testing,
mock withdrawal or practice withdrawal)?
Yes No N/A
Clause 8
Validation, verification, and improvement of the FSMS
General
Does the food safety team plan and implement the processes needed to
validate control measures and/or control measure combinations, and to verify
and improve the food safety management system?
Yes No N/A
Validation of control measure combinations
Does the organization validate (prior to implementation of control measures to be included in

operational PRP(s) and the HACCP plan and after any change therein) that:
a) The selected control measures are capable of achieving the intended control
of the food safety hazard(s) for which they are designated?
Yes No N/A
b) The control measures are effective and capable of, in combination, ensuring
control of the identified food safety hazard(s) to obtain end products that meet
the defined acceptable levels?
Yes No N/A
Are the control measure and/or combinations thereof modified and re-assessed
when the result of the validation shows that one or both of the above elements
cannot be confirmed?
Yes No N/A
Note: Modifications may include changes in control measures (i.e. process

parameters, rigorousness and/or their combination) and/or change(s) in the raw
materials, manufacturing technologies, end product characteristics, methods of
distribution and/or intended use of the end product.
Yes No N/A
Control of monitoring and measuring
Is there evidence that the specified monitoring and measuring methods and
equipment are adequate to ensure the performance of the monitoring and
measuring procedures?
Yes No N/A
Are the measuring equipment and methods used:
a) Calibrated or verified at specified intervals, or prior to use, against

measurement standards traceable to international or national measurement
standards? Note: Where necessary to ensure valid results
Yes No N/A
b) Adjusted or re-adjusted as necessary?
Yes No N/A
c) Identified to enable the calibration status to be determined?
Yes No N/A
d) Safeguarded from adjustments that would invalidate the measurement

results?
Yes No N/A
e) Protected from damage and deterioration?
Yes No N/A
Are records of the results of calibration and verification maintained?
Yes No N/A
Does the organization assess the validity of the previous measurement results
when the equipment or process is found not to conform to requirements?
Yes No N/A
Does the organization take action appropriate for the equipment and any
product affected, If the measuring equipment is non-conforming?
Yes No N/A
Are records of such assessment and resulting actions maintained?
Yes No N/A
Is the ability of computer software confirmed to satisfy the intended application

when used in the monitoring and measurement of specified requirements?
Yes No N/A
Is the confirmation of computer software undertaken prior to initial use and

reconfirmed as necessary?
Yes No N/A
FSMS verification
Internal audit
Does the organization conduct internal audits at planned intervals to determine whether the
food safety management system:
a) Conforms to the planned arrangements, to the food safety management

system requirements established by the organization, and to the requirements
of this International Standard?
Yes No N/A
b) Is effectively implemented and updated?
Yes No N/A
Is an audit programme planned, taking into consideration the importance of the

processes and areas to be audited, as well as any updating actions resulting
from previous audits?
Yes No N/A
Are the audit criteria, scope, frequency, and methods defined?
Yes No N/A
Do the selection of auditors and the conduct of audits ensure objectivity and
impartiality of the audit process?
Yes No N/A
Is it ensured that auditors do not audit their own work?
Yes No N/A
Are the responsibilities and requirements for planning and conducting audits,
and for reporting results and maintaining records defined in documented
procedure?
Yes No N/A
Does the management responsible for the area being audited to ensure that
actions are taken without undue delay to eliminate detected nonconformities
and their causes?
Yes No N/A
Do follow-up activities include the verification of the actions taken and the
reporting of verification results?
Yes No N/A
Evaluation of individual verification results
Does the food safety team systematically evaluate the individual results of
planned verification?
Yes No N/A
Does the organization take action to achieve the required conformity, when
verification does not demonstrate conformity with the planned arrangements?
Yes No N/A
Does action – taken for achieving the required conformity – include (but is not limited to),
review of:
a) Existing procedures and communication channels?
Yes No N/A
b) The conclusions of the hazard analysis, the established operational PRP(s)

and the HACCP plan?
Yes No N/A
c) The PRP(s)?
Yes No N/A
d) The effectiveness of human resource management and of training activities?
Yes No N/A
Analysis of results of verification activities
Does the food safety team analyze the results of verification activities, including
the results of the internal audits and external audits?
Yes No N/A
Is the analysis carried out in order
a) To confirm that the overall performance of the system meets the planned
arrangements and the food safety management system requirements
established by the organization?
Yes No N/A
b) To identify the need for updating or improving the food safety management
system?
Yes No N/A
c) To identify trends which indicate a higher incidence of potentially unsafe

products?
Yes No N/A
d) To establish information for planning of the internal audit programme

concerning the status and importance of areas to be audited?
Yes No N/A
e) To provide evidence that any corrections and corrective actions that have
been taken are effective?
Yes No N/A
Are the results of the analysis and the resulting activities recorded and reported,
in an appropriate manner, to top management as input to the management
review?
Yes No N/A
Are the results of the analysis and the resulting activities used as an input for
updating the food safety management system?
Yes No N/A
Improvement
Continual improvement
Does top management ensure that the organization continually improves the
effectiveness of the food safety management system through the use of:
- communication,
- management review,
- internal audit,
- evaluation of individual verification results,
- analysis of results of verificationactivities,
- validation of control measurecombinations,
- corrective actions and
- food safety management system updating?
Yes No N/A
Updating the food safety management system
Does top management ensure that the food safety management system is
continually updated?
Yes No N/A
Does the food safety team evaluate the food safety management system at
planned intervals in order to achieve that FSMS is continually updated?
Yes No N/A
Does the team consider whether it is necessary to review the hazard analysis,
the established operational PRP(s) and the HACCP plan?
Yes No N/A
Are the evaluation and updating activities based on:
a) Input from communication, external as well as internal?
Yes No N/A
b) Input from other information concerning the suitability, adequacy, and

effectiveness of the food safety management system?
Yes No N/A
c) Output from the analysis of results of verification activities?
Yes No N/A
d) Output from management review?
Yes No N/A
Are system updating activities recorded and reported, in an appropriate manner,

as input to the management review?
Yes No N/A
Completion
Recommendation
Enter text
Inspector's Full name and Signature 
Please note that this checklist is a hypothetical example and provides basic information only. It is not intended to take the place of, among other things,
workplace, health and safety advice; medical advice, diagnosis, or treatment; or other applicable laws. You should also seek your own professional advice to
determine if the use of such checklist is permissible in your workplace or jurisdiction.

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8/11/2020 ISO 22000 Audit Checklist - SafetyCulture

Food Safety Management System

Has the organization established, documented and implemented an effective

Is the FSMS maintained and updated?

Is the scope of the FSMS defined?

Are the information - concerning development, implementation and updating of

Is the control of such outsourced processes identified and documented within

Does the FSMS documentation include:

a) Documented statements of a food safety policy and related objectives?

b) Documented procedures and records required by ISO 22000 standard?

c) Documents needed by the organization to ensure the effective development,

Does a documented procedure exist to define the controls needed:

a) To approve documents for adequacy prior to issue?

b) To review and update as necessary and re-approve documents?

d) To ensure that relevant versions of applicable documents are available at

e) To ensure that documents remain legible and readily identifiable?

g) To prevent the unintended use of obsolete documents, and to apply suitable

Are required records established and maintained in order to provide evidence of

Do records remain legible, readily identifiable and retrievable?

Please proceed to Section 5.

Is top management able to provide evidence of its commitment to the

a) Showing food safety is supported by the business objectives of the

b) Communicating to the organization the importance of meeting the

c) Establishing the food safety policy?

d) Conducting management reviews?

e) Ensuring the availability of resources?

Food safety policy

Does top management ensure that the food safety policy:

a) Is appropriate to the role of the organization in the food chain?

c) Is communicated, implemented and maintained at all levels of the

d) Is reviewed for continued suitability?

e) Adequately addresses communication?

f) Is supported by measurable objectives?

Food safety management system planning

Does top management ensure that:

b) The integrity of the food safety management system is maintained when

Responsibility and authority

Are there designated personnel with defined responsibility and authority to

Food safety team leader

a) To manage a food safety team and organize its work?

c) To ensure that the food safety management system is established,

d) To report to the organization's top management on the effectiveness and

a) Suppliers and contractors?

b) Customers or consumers, in particular in relation to product information

c) Statutory and regulatory authorities?

Does such communication provide information on food safety aspects

Are records of communications maintained?

Are there designated personnel with defined responsibility and authority to

Is information obtained through external communication included as input to

Has the organization established, implemented and maintained effective

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 programmes?

f) Packaging, storage and distribution systems?

g) Personnel qualification levels and/or allocation of responsibilities and

h) Statutory and regulatory requirements?

i) Knowledge regarding food safety hazards and control measures?

j) Customer, sector, and other requirements that the organization observes?