ISO 22000 Food Safety Management System Audit Checklist

General
The intent of this FSMS (Food Safety Management System) checklist is to assist in the assessment, of
a FSMS against the requirements of ISO 22000:2005. ISO 22000 specifies the requirements for a
FSMS for all organisations within the food chain from feed producers and primary producers through
food manufactures, transport and storage operators and subcontractors to retail and food service
outlets (together with interrelated organisations such as producers of equipment, packaging
material, cleaning agents additives and ingredients).

Process Approach

ISO 22000 requires an organisation to adopt the process approach when establishing a FSMS.

This checklist is designed to be used with ISO 22000: 2005 and applicable statutory, regulatory and
customer
requirements

Audit Checklist

ISO 22000:2005 Requirements System Findings/Audit Evidence

Documentation
Reference if
applicable
4.0 FSMS
4.1 General Requirements
 Is there an established FSMS
 Does the scope specify the products or
product categories, processes and production
sites
 Is there is system to identify food safety
hazards?
 Are the means to communicate (internally and
externally) pertaining to food safety effective?
 Is the FSMS periodically reviewed?
 Have any outsourced processes been
identified within the documented FSMS
4.2.1 Documentation
a. Is the policy (5.2) documented, as well
as the objectives to support the Policy?

b. Has the organization identified the ISO

22000 minimum required documents?

c. Has the organization established documented,

implemented and maintained other procedures to
ensure development, implementation and updating
of the FSMS?

4.2.2 Control of Documents –

Is there a documented procedure for control of
documents?

 Approved prior to use,

 Review, update and re approval
 Changes are effectively identified
  and communicated
 Availability at point of use
 Legibility and readability
 Control over external documents…
 Prevent the inadvertent use of obsolete
documents and identification of obsolete
 documents.
4.2.3 Control of Records Ensure that you check control
over current and past records.
Is there a documented procedure for control of
records?

Does it address

 Identification
 Storage
 Protection
 Retrieval
 Retention time and disposition of records
5.1 Management Commitment
Is the commitment of top management
evident to the assessment team?

Have top management established

business objectives to support food
safety.
5.2 Food Safety Policy
Is the policy documented and is there a method of
communication

 Is it appropriate to the role of the organisation

in the food chain,
 Does it refer to both statutory and regulatory
requirements and with customer food safety
requirements
 Does it address internal and external
communication
 How is it communicated effectively to staff
and any on-site suppliers and contractors
 Is there evidence of review,
 Is it supported by measurable objectives?
(List the objectives, measures and current
status)

5.5 Food Safety Leader

 Has top management designated a Food
Safety Leader? (Name)

5.6 Communication
5.6.1 External Communication –
 Verify how communication takes place
between suppliers and contractors on issues
regarding food safety
 Communication with statutory and regulatory
bodies
 Are food safety requirements from statutory
 and regulatory authorities available?
5.6.2 Internal Communication –
 Verify how communication takes place within
the organization on issues regarding food
safety
5.7 Emergency Preparedness and Response
 Is there a procedure/process for planning and
responding to emergency situations and
accidents,
 Has there been a need to use this process.

5.8 Management Review

5.8.1 Management Review, General
 Has management reviewed the FSMS?
 Are these reviews carried out at planned
intervals?
 Are the reviews focusing on the organization’s
policy objectives and improving?
 Are there records of these reviews?

5.8.2 Management Review, Inputs

Does it include the outcome of other reviews?

 Is there analysis from verification results?

 Changes affecting the FSMS?
 Results provided by corrective actions,
emergencies, accidents, recall and other of
similar nature?
 Review of results of system Updates
 Evaluation of communications whether
consumer, customer, regulatory bodies…?
 Evaluation on the results of internal and
external audits, inspections relating to
processes and products?
6.0 Resource Management
 Selection and training of food safety team
members
 Where applicable criteria for selection and use
of external experts, defined roles and
responsibilities, agreements, contracts, etc.
confirm their availability (if required) for
stage II visit?
 Is there a process for identifying necessary
competencies for personnel who impact food
safety
 What training has been provided and/or
competency been decided
 What process is in place to evaluate
effectiveness of selection and training process
 How are personnel made aware of the
relevance and importance of their individual
activities to food safety and what is the
communication process
 What records are maintained to demonstrate
successful training and communication of
FSMS requirements
  How has the organization provided adequate
resources for the establishment and
maintenance of the infrastructure needed to
meet FSMS requirements (ISO 22000.2005)?
 How has the organization provided adequate
resources for the establishment and
maintenance of the work environment needed
to meet FSMS requirements (ISO
22000.2005)?
7.1 Planning and Realization of Safety
Products, General
7.2.1 PRPs
Has the organization identified Prerequisite
programmes?

List all PRP’s identified by the organization

7.2.2 PRPs
Do the PRP’s relate to statutory & regulatory
requirements

Are they approved by the food safety team

7.2.3 (Information – CODEX, others)

Are documents available specifying how activities
included in PRPs are managed.

Verify that PRPs are being controlled

in accordance with documentation.

 Has consideration been given to…

 Construction of infrastructure…
 Layout relating to the criticality of activities
and personnel..
 Supply of water, air, energy and others
needing…
 Supporting services, including waste
management and sewage disposal…
 Availability of equipment, relating to
cleaning, maintenance and preventive
maintenance…
 Management of purchased product
 Measures to prevent cross contamination,
 Cleaning, hygiene and sanitizing…
 Control of insects and rodents…

Evidence of verification Records

7.3.1 Preliminary steps to enable hazard analysis

Is the information needed for analysis
recorded?

What information is used

Is it updated?

7.3.2 Food Safety Team

Is there a food safety team? Names
 Is the team competent (6.2.2)? Records

7.3.3.1 Product Characteristics – Raw Materials,

Ingredients and product contact materials
Are utensils, ingredients packaging and other
contact materials described in documents which
include information detailed in a-h as
appropriate?

 Chemical, physical and biological

characteristics,
 Composition of products
 Point of origin,
 Method of Production,
 Methods for packaging and delivering,
 Storage conditions for preservation
 Preparation and/or handling before use or
processing,
 Food safety acceptance criteria

Do they address legal and other food

safety requirements

7.3.3.2 Finished Product Characteristics

To the scope determined by hazard analysis, has
the organization described in documents within
the characteristics of the (finished) product,
specifically addressing?

 Name of the product or similar identification,

 Composition of the product (consideration to
allergens),
 Physical, chemical and biological
characteristics and relevant to the product, as
needing,
 Concerns relating to perishable issues in
accordance to the intent of the product and
storage requirements
 Packaging,
 Labelling relating to safe product handling,
preparation and use – consumption and any
warning needing (e.g. allergens), and
 Distribution method(s)

Inclusive, identifying and addressing

legal and regulatory requirements?

This information is descriptive, updated

and maintained inclusive in the light of
changes to the HACCP Plan and/or
PRPs?

.3.4 Intended Use

What document address hazards relating to the
product’s intended use?
 Have these included factors in hazard/risk
analysis?

Relating to the product has the organization

included the concerns of special groups such as
allergenic, newborn, and elderly?

Is this information update in the light of changes

to the FSMS, product, regulations, etc?

7.3.5.1 Flow Diagram, Process Flow and Control

Measures – Flow Diagramming
Has the organisation implemented flow
diagrams as common practice and
method…?

Does the FSMS Team evaluate these

diagrams?

7.3.5.2 Description of Process Flow and Measurement

Control
Is the methodology for analyzing hazards
effective

Are external requirements considered when

analyzing hazards – risks?

As a result of the above does the organization

update PRPs and HACCP Plan(s)

7.4.1 Analysis… General

Are hazards and level of control
determined through analysis by the
FSMS Team?

7.4.2.1 Hazard Identification and Determining Level

of Acceptability
Have all food safety hazards been
identified and levels of acceptability
determined.

7.4.2.2 Identification of hazards, considered:

7.4.2.3 Determining Acceptable Levels…

7.4.3 Hazard – Risk Analysis

Has the organization demonstrated that hazard
analysis focuses on eliminating or reducing
hazards and determining acceptability?
 Has the organization identified hazards to the
satisfaction of the market, expectations, regulatory
and other requirements?

Has the severity for each hazard determined?

Is the methodology effective (based on sound and

acceptable scientific and technological methods –
studies)?

7.4.4 Control Measures, Selection and Evaluation

Do the selected measures prevent, eliminate or
minimize to acceptable levels the hazard(s)?

Hazard analysis captures the essence to classify

and effectively act through PRPs/HACCP Plan?

Do those address…

 …as it relates to the hazard, the magnitude of

the severity?
 …the feasibility to measure and/or monitor
(control)?
 …is the point for measuring/control adequate
(must consider other points in combination)?
 …address the possibility of failure preventing
the inclusion of the hazard to the food?
 …in the eventuality of the measurements/
monitoring/control failing, has the severity of
the hazards been considered?
 …is the previous herein pointers adequate and
affective?
 …has the synergy of other control/
measurement points been considered?

Are the above pointers addresses in

the HACCP Plan/PRPs?

Are the above expressed through

documents, whether records,
procedures, instruction, manuals or
otherwise…?

7.5 Establishing the Operational PRPs

Have the operational prerequisites for
food safety been identified, documented and
implemented?

These address…
  …the hazards needing to control (chemical,
physical, biological)…?
 …are there referencing the control measures
to apply?
 …pertaining to control measures are these
effectively implemented?
 …are the PRPs adequate and effective to
identify and trigger action…?
 …are responsibilities and authorities
determined to taking action?
 …is the above supported through records?

7.6.1 Establishing the HACCP Plan

Are the HACCP Plan(s) documented?

How many HACCPs Plans

Do the plans address…

 the hazard and point of control?

 the reaction…and action need be taken?
 The CCP(s) and respective CL(s)
 procedures for controlling CCP?
 records of monitoring?

7.6.2 Identifying Critical Control Points (CCP)

Is the identification of CCP(s) effective?

7.6.3 Determining the Critical Limits (CL)
Is there a CL for each CCP?

Is each CL measurable?

The scientific mean to justify each CL(s), is it

adequate and effective?

Are these objectives, inclusive when requiring

subjective factors?

7.6.4 Monitoring System – Monitoring CCP(s)

Is there a monitoring system.
Briefly describe

7.6.5 Actions Resulting from Monitoring –

Monitoring Non Conforming CL
7.7 Updating Information and Documents
Specifying the PRPs and HACCP Plan
7.8 Planning Verification
Does planning for verification activities include
determining purpose, method, frequency and
responsibilities?
 What other procedures have been developed and
implemented resulting from planning?

Relating to verification, are the operational

methods and planning (activities) compatible?

7.9 Traceability
Have any traceability audits been conducted. Is
there a traceability system

7.10.1 Control of Non Conformance – Corrections –

Is there a documented system for the control of
Non conformity?

7.10.2 Corrective Action –

Is there a documented procedure address
corrective action.

7.10.3.1 Handling of Potentially Unsafe Products –

General
Are the controls and responses for handing
potentially unsafe product documented?

7.10.3.2 Evaluation for Release

7.10.3.3 Disposition of Non Conforming Product –

7.10.4 Recall –
Is there a documented procedure for
product withdrawal (recall) that
addresses all relevant points
8.1 Validation, Verification and
Improving the FSMS – General

8.2 Validation of Control Measures

Combinations

8.3 Monitoring Control – Monitoring and

Measurement

8.4.1 Verification of the FSMS – Internal Auditing –

Is there a documented procedure addressing
internal audits.

Is there an audit program, auditing to the extent of

the scope of the FSMS?

Are audits focus on adequacy, effectiveness and

providing evidence of sustaining improvements?
(The relation of FSMS with the organization’s
objectives)
 Are the auditors competent

After identifying the need for action, are these

promptly taken by the process owners?

8.4.2 Evaluation of Individual Verification

Results –

8.4.3 Analysis of Results of Verification

Activities

8.5.1 Continual Improvement

Is there evidence that improvements to

the FSMS are directives by top
management
8.5.2 Updating the FSMS