CHECKLIST AUDIT ISO 22000

Conformance
Clause

Requirement

FOOD SAFETY MANAGEMENT SYSTEM

4.1.

GENERAL REQUIREMENTS

4.1

Scope of the FSMS defined

4.1

Scope of the FSMS specifying:

Product categories

Processes

Production sites

4.1

Any outsourced processes related to

food safety are controlled, identified and
documented within the FSMS

4.2.

DOCUMENTATION REQUIREMENTS

4.2.2.

Control of documents
A documented procedure for control of
documents required by the FSMS,
includes:

a)

Approval of documents for adequacy

prior to issue

b)

Review, update and re-approve

c)

Changes and current revision status

identified

d)

Relevant versions of documents

available at points of use

e)

Legible and readily identifiable

f)

Identification and control of external

documents

g)

Prevent unintended use of obsolete

documents, and to suitably identify them
if they are retained for any purpose

4.2.3

Doc ref

Control of records
Procedure for efficient & accurate record
keeping to provide evidence of
conformity to requirements and of the
effective operation of the FSMS
Records legible, readily identifiable and
retrievable
Control of the correction, identification,
storage, protection, retrieval, retention
time and disposition of records

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause

Requirement
MANAGEMENT RESPONSIBILITY

5.1.

MANAGEMENT COMMITMENT

5.1

Evidence of top management

commitment to the FSMS and its
continual improvement: objectives (5.3)
communicating (5.6.2.) policy (5.2)
management review (5.8.) resources
(6)

5.2.

FOOD SAFETY POLICY

a)

Appropriate to the role in the food chain

b)

Commits to comply with statutory,

regulatory and customer FS
requirements

c)

Communicated and understood within

the organization (5.6.)

d)

Reviewed for continued suitability (5.8)

e)

Supported by measurable objectives

5.3.

FOOD SAFETY MANAGEMENT

SYSTEM PLANNING

a)

To meet the objectives

b)

To maintain the FSM integrity when

changes are implemented

5.4.

RESPONSIBILITY AND AUTHORITY

R&A are defined and communicated
within the organization
Identified person(s) to receive reports
problems with the FMS
Designated personnel to initiate and
record actions

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
5.6.
5.6.1.

Requirement
COMMUNICATION
External communication
Implemented effective arrangements for
communicating with :

a)
b)

c)
d)

Suppliers and contractors

Customers / Consumers:

product information (see

7.3.3.2)

enquiries

contracts / order handling

customer feedback / complaints

Food authorities
Other organizations that could be
affected
Provided information on FS aspects of
products that may be relevant to other
organizations, especially to hazards that
need to be controlled. Records
maintained.
Legal and customer FS requirements
recorded
Designated personnel to manage the
external communication

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
5.6.2.

Requirement
Internal communication
The Top management has
communicated to the organization the
importance of meeting this standard,
legal and customer FS requirements
Implemented effective arrangements
for communicating with relevant
personnel in FS:
FST is informed of changes, especially:

a)

Products or new products

b)

Raw materials, ingredients and

services

c)

Production systems and equipment

d)

Production premises, location of

equipment, surrounding environment

e)

Cleaning and sanitation programs

f)

Packaging, storage and distribution

systems

g)

Personnel qualification level / allocation

of responsibilities and authorizations

h)

Regulatory requirements

i)

Knowledge regarding food safety

hazards and control measures

j)

Customer, sector and other

requirements

k)

Relevant enquiries from external

interested parties

l)

Complaints indicating hazards

associated with the product

m)

Any condition which have an impact on

food safety

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause

Requirement

5.8.

MANAGEMENT REVIEW

5.8.1.

At planned intervals
Records maintained

5.8.2.

Inputs:

a)

Follow-up actions from previous

reviews

b)

Verification activities (see 8.3.3)

c)

Changes related FS (see 5.6.2)

d)

Emergency situations, accidents (see

5.7) and recalls (see 7.10.4)

e)

System up-dating activities (see 8.5.2)

f)

Communication activities including

customer feed-back (see 5.6.1)

g)

External audits or inspections

5.8.3.

Outputs:

a)

Assurance of food safety (see 4.1.)

b)

Improved effectiveness of the FSMS

(see 8.5.)

c)

Resource needs (see 6.1)

d)

Revisions of the FSP and objectives

(see 5.2).

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause

6
6.2.

Requirement
RESOURCE MANAGEMENT
HUMAN RESOURCES

6.2.2

For personnel relevant in FS

a)

Identify necessary competencies

b)

Training

c)

Specific training for personnel

responsible of monitoring, corrections,
and corrective actions

d)

Evaluation of implementation and

effectiveness

e)

Awareness of contribution to FS

f)

Awareness of need for effective

communication

g)

Records of training and other actions

6.2.1.

Agreement or contracts with external

experts involved in FSM

6.3.

INFRASTRUCTURE (see 7.2.3.)

6.4.

WORK ENVIRONMENT (see 7.2.3.)

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause

Requirement

PLANNING AND REALIZATION

OF SAFE PRODUCTS

7.2.
7.2.2.

PRPs
PRPs shall be

a)

Appropiate to the organizational needs

b)

Appropiate to the size and type of

operation and product

c)

Implemented across:

d)
7.2.3.

General programmes

Specific programmes

Approved by FST
According to

Legal requirements

Customer requirements

Recognized guidelines

Codex Alimentarius

Codes of practices

Specific documents to manage PRPs

7.5.

Establishing the operational PRPs

Documentation for each programme:

a)

Hazards controlled

b)

Control measure(s)

c)

Monitoring procedures

d)

Corrections/ corrective actions

e)

Responsibility & Authority

f)

Records of monitoring

7.2.3.

Elements of PRPs

a)

Lay-out, design and construction of

buildings and facilities:

Location

Perimeter and grounds

Walls

Floors

Ceilings

Windows

Doors

Lighting

Ventilation

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
b)

Requirement
Lay/out of premises, including
workspace and employee facilities:

Process flow

Working space and storage

Segregation Low/High risk

areas/process

Segregation design

Washing and cleaning

locations

Changing facilities

Hand washing facilities

Toilets

Catering facilities

c)

Supplies of air, water, energy and other

utilities

d)

Supporting services including waste

and sewage disposal

e)

Equipment including its preventative

maintenance, sanitary design and
accessibility for maintenance and
cleaning for each unit

f)

Management of purchased materials,

disposals and handling of products:

g)

Raw materials

Ingredients

Packaging

Chemicals

Waste

Sewage

Storage of raw materials /

packaging / in process / end
products

Transportation

Measures for the prevention of cross

contamination

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
h)

i)

j)

Requirement
Cleaning and sanitizing:

Cleaning practices

Cleaning schedules

Control and verification of

effectiveness

Documented procedures /
records

Pest control:

Competent pest control

Documented procedures /
records

Physical measures: drains,

hermetically sealed doors,
screens, security perimeter for
inspection in storage, etc,.

Location of all measures

Plan/diagram for electric fly

killers / baits / traps

Risk of product contamination

with chemicals

Personnel hygiene:

GMPs

Protective clothing

Jewellery

Cuts and grazes

Hand cleaning

Notification of relevant
infectious disease or
conditions

Medical screening

Training

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
7.3.

Requirement
PRELIMINARY STEPS TO ENABLE
HAZARD ANALYSIS

7.3.1.

General
Relevant information needed to
conduct the hazard analysis
documented, collected, maintained and
updated

7.3.2.

Food Safety Team (FST) (5.5.)

FST Leader appointed by Top
Management with responsibility:

a)

To manage the FST

b)

Training & education of FST members

c)

To ensure that FSMS is established,

implemented, maintained and updated

d)

To report to Top Management about

FSMS
Multi-disciplinary knowledge and
experience
Records demonstrate the required
expertise for all team members

7.3.3.

Product characteristics

7.3.3.1.

Raw materials, ingredients and

product-contact materials
Specifications with:

a)

Biological, chemical and physical

characteristics

b)

Ingredients including additives and

processing aids

c)

Origin

d)

Method of production

e)

Delivery methods and packaging

f)

Storage conditions and shelf life

g)

Preparation and/or handling before use

or processing

h)

Food safety related acceptance criteria

or specifications of purchased
materials and ingredients appropriate
to their intended uses
Relevant legislation/ regulations
documented
Specifications updated

10

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
7.3.3.2.

Requirement
Characteristics of end products
Specifications with:

a)

Name

b)

Composition

c)

Biological, chemical and physical

characteristics

d)

Intended shelf life and storage

conditions. Intended use (see 7.3.4.)

e)

Packaging

f)

Labelling relating to food safety and/or

instructions for handling, preparation
and usage

g)

Method(s)of distribution
Relevant legislation/ regulations
documented
Specifications updated

7.3.4.

Intended use
Identified & documented appropriate
information about :

The reasonably expected

handling of the product

Any unintended but

reasonably expected
mishandling and misuse of the
product

Group of consumers identified,

specially vulnerable groups of
population
Descriptions updated
7.3.5.

Flow diagrams, process steps and

control measures

7.3.5.1.

Flow diagrams
For each product / process category
covered by the FSMS
Sufficient detail / schematic overview
Including

a)

Sequence / interaction of steps

b)

Outsourced processes and

subcontracted work

c)

Inputs (raw materials, ingredients,

intermediate products)

d)

Reworking and recycling

e)

Outputs (end, intermediate, byproducts, waste)

Verified by FST (records)

11

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
7.3.5.2.

Requirement
Description of process steps and
control measures
Control measures/process parameters/
procedures related to food safety
described
Legal and customer requirements
described
Descriptions updated

7.4.

HAZARD ANALYSIS

7.4.2.

Hazard identification and determination

of acceptable levels

7.4.2.1.

Identified & recorded

Specific for the type of product /
process and facilities
Based on :

a)

Preliminary information about product /

process and control measures (7.3.)

b)

Experience

c)

External information including

epidemiological and other data historical

d)

Information from the food chain

e)

Step (s) related which each hazard

7.4.2.2.

Considering :

a)

Prior subsequent steps

b)

Equipment utilities surroundings

c)

Priorsubsequent links in the food chain

7.4.2.3.

Permissible levels of the hazard in the

end product defined in compliance with
legal / customer requirements, and the
intended use (Records)

7.4.3.

Hazard assessment
To identify which hazards are of such a
nature that their elimination or
reduction and control is essential.
Including:

Likely occurrence

Severity of the adverse health

effects

Methodology described and results

recorded

12

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
7.4.4.

Requirement
Selection and assessment of control
measures
Identified & document control
measures that are to be applied,
selected from the control measures
defined in 7.3.5.2.
Categorized in General Control
Measures (managed through PRPs) or
Specific Control Measures (related to
CCPs), regarding to:

a)

Effect on identified food safety hazards

relative to the intensity applied

b)

Feasibility for monitoring

c)

Place within the system relative to

other control measures

d)

Likelihood of failure in the functioning

e)

Severity of the consequence

f)

Specifically to eliminate/reduce the

level of the hazard(s)

g)

Synergistic effects
Methodology of categorization
documented and results recorded

8.2.

Validation of control measure

combinations
Prior to implementation and after any
change of General/Specific Control
Measures, ensure that:

a)

Associate hazards are effectively

controlled

b)

End Products meet the defined

acceptable levels
If a) / b) are failed modification & reassessment of:

13

Control measures

Raw materials

Technologies

Product characteristics

Distribution

Intend of use

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
7.6.
7.6.2.

Requirement
ESTABLISHING HACCP Plan
Identification of CCPs
Hazard to be controlled by specific
control measures CCP (7.4.4.)

7.6.3.

Determination of critical limits

For the monitoring of each CCP
Requirements of legislation
regulations internal risk analysis
clients are met
In terms of measurable parameters
supported by instructions,
specifications, education/training.
Selection documented

7.6.4.

Monitoring of the CCPs

A monitoring system for effective and
efficient control of CCPs
(measurements relative to the critical
limits) established and maintained
Procedures + instructions + records
including:

a)

Measurements that provide results

within an adequate time frame

b)

Monitoring devices identified

c)

Calibration methods (8.3.)

d)

Frequency

e)

Responsibility & Authority

f)

Records / methods

8.3.

Control of monitoring and measuring

To ensure valid results (if necessary),
measuring equipment have to be
controlled:

a)

Calibrated / verified against

measurement standards; where no
such standards exist, the basis used
shall be recorded

b)

Adjusted or re-adjusted as necessary

c)

The calibration status identified

d)

Safeguarded

e)

Protected from damage

Records of calibrations
If no conformance assess the
validity of previous results + treatment
of the equipment / product. Records
Suitability of software confirmed: prior
to initial use + reconfirm

14

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
7.6.5.

Requirement
Actions when monitoring results
exceed critical limits

7.10.

CONTROL OF NONCONFORMITY

7.10.1.

Corrections
A procedure to:

a)

Identify & assess of affected end

products

b)

Review the corrections carried out

Approved by the responsible person
Records with information on the nature
of the nonconformity, cause,
consequence and traceability

7.10.2.

Corrective actions (CAs)

Data derived from the monitoring of
PRPs + CCPs evaluated by designated
person to initiate corrective actions
Initiated when critical limits are
exceeded or lack of conformity with
PRPs. Records
A procedure to:

a)

Review NCs (complaints included)

b)

Review trends

c)

Determine cause of NCs

d)

Evaluate the need for CAs

e)

Determine and implementing CAs

f)

Records of CAs

g)

Reviewing CAs

7.10.3.

Handling of potentially unsafe products

7.10.3.1

NCs product dont enter the food chain

unless it is possible to assure that the
hazards have been reduced to
acceptable levels, and the product is
safe
All lots of products affected by NC
identified and controlled until they have
been evaluated
A procedure with responses +
authorization + actions and controls

7.10.3.2

Evaluation for release

Product is released as safe when:

a)

Others evidence indicates that the

control measures have been effective

b)

Combined effect of the control

measures has been effective

c)

Analysis (or other verification activities)

indicate that the product is safe

15

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause

Requirement

7.10.3.3. Disposition of nonconforming products

Products not acceptable for release
have to be:
a)

Reprocessed to ensure that the

hazards are controlled

b)

Destroyed

7.9.

TRACEABILITY SYSTEM
Identification of product lots and their
relation to batches of:

raw materials (from the

immediate suppliers)

processing

distribution records (to the

immediate distributors)

Records maintained for a defined

period
Meet customers and regulatory
requirements. Based on the shelf life
7.10.4.

WITHDRAWALS
To facilitate a recall:

a)
b)

Authority & Responsibility appointed by

top management
Procedure for:

Notification

Handling of recalled products

as well as involved products
still in stock

Defining the sequence of

actions

Recalled products held under

supervision until their treatment
Records with the cause, extent and
result of a recall. Reported to the top
management as input to management
review (see 5.8.2).
Effectiveness of the programme recall
verified. Records
5.7.

Emergency preparedness and

response
Procedures to manage potential
emergency situations established by
Top management

16

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause
7.8.

Requirement
Verification planning
Establish, document & implement
procedures for verification of the
HACCP system: purpose methods
frequencies responsibilities records
Shall to confirm that:

a)

The PRPs are implemented

b)

The hazard analysis is continually

updated

c)

The operational PRPs and the

elements within the HACCP plan are
implemented and effective

d)

Hazard levels are within identified

acceptable levels
Records communicated to the FST
NCs results in test samples of end
products affected lots handled as
potentially unsafe

8.4.2.

Evaluation of individual
verification results
Are evaluated systematically by the
FST
NCs with the planned arrangements
actions to achieve conformity. Review:

a)

Procedures and communication

channels (5.6. / 7.7.)

b)

Conclusions of the hazard analysis /

operational PRPs / HACCP plan

c)

PRPs

d)

Human resources / Training

8.4.3.

Analysis of results of verification

activities
Are analysed by the FST, including the
results of internal & external audits, in
order to:

a)

Confirm that FSMS meets the planned

arrangements

b)

Identify the need for updating /

improving the FSMS

c)

Identify trends

d)

Establish information for planning

internal audits

e)

Confirm effectiveness of corrections &

CAs
Records reported Top Management.
Input to the management review and
for updating the FSMS

17

Doc ref

Observations & objective evidence

CHECKLIST AUDIT ISO 22000

Conformance
Clause

Requirement

Observations & objective evidence

VALIDATION, VERIFICATION AND IMPROVEMENT OF THE FMS

8.4.

FSMS VERIFICATION

8.4.1.

Internal audit
Documented procedure that defines
responsibilities reporting - records
To determine whether FSMS system:

a)

Conforms with the planned

arrangements

b)

Is effectively implemented and

maintained
Audit programme planned: considers
status, importance of processes and
areas to be audited, and results of
previous audits
Criteria, scope, frequency and methods
defined
Objectivity and impartiality of auditors
Corrective actions carried out on time by
responsible for the area
Verification of actions recorded

8.5.

IMPROVEMENT

8.5.1.

Continual improvement
FSMS continually improved through:
communication (5.6.) management
review (5.8.) internal audit (8.4.1.)
evaluation of individual verification
results (8.4.2.) analysis of results of
verification activities (8.4.3.) validation
of control measure combinations (8.2.)
CCAA (7.10.2.) FSMS updating

8.5.2.

Doc ref

Updating the FSMS

FST evaluate the FSMS at planned
intervals, and if it is necessary review the
HA, PRP(s) and HACCP plan
Consider:

a)

Communication (5.6)

b)

Suitability-adequacy-effectiveness of
FSMS

c)

Analysis of results of verifications

activities (8.4.3.)

d)

Management review (5.8.2)

Updating of FSMS recorded and
reported : input of management review
(5.8.2)

18