ISO 22000 Audit Check List

Audit Checklist - ISO 22000:2005
Conformance
Clause Requirement Doc ref Observations & objective evidence
Y N
4 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 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
Conformance
Y N
5 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
Needed to add in the Job describtion for
Identified person(s) to receive reports
En: Mohamed Bahi El Dieen
problems with the FMS
Designated personnel to initiate and
record actions
Conformance
Y N
5.6. COMMUNICATION
5.6.1. External communication
Implemented effective arrangements for
communicating with :
a) Suppliers and contractors
b) Customers / Consumers:
 product information (see
7.3.3.2)
 enquiries
 contracts / order handling
 customer feedback / QP-16 Customer complains pro.
complaints
c) Food authorities
d) 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
Conformance
Y N
5.6.2. 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
Conformance
Y N
5.8. MANAGEMENT REVIEW Needed to added the Emergency situations,

accidents in the inputs .
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).
Conformance
Y N
6 RESOURCE MANAGEMENT
6.2. 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, There is no Specific training for personnel
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.)
Conformance
Y N
7 PLANNING AND REALIZATION

OF SAFE PRODUCTS
7.2. PRPs
7.2.2. PRPs shall be
a) Appropiate to the organizational needs
b) Appropiate to the size and type of
operation and product
c) Implemented across:
 General programmes
 Specific programmes
d) Approved by FST
7.2.3. 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
Conformance
Y N
b) 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:
 Raw materials
 Ingredients
 Packaging
 Chemicals
 Waste
 Sewage
 Storage of raw materials /
packaging / in process / end
products
 Transportation
g) Measures for the prevention of cross
contamination
Conformance
Y N
h) Cleaning and sanitizing:

 Cleaning practices
 Cleaning schedules
 Control and verification of
effectiveness
 Documented procedures /
records
i) 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
j) Personnel hygiene:
 GMP´s
 Protective clothing
Some staff don’t wearing protective clothing
 Jewellery and left out door clothing in food areas
 Cuts and grazes
 Hand cleaning
 Notification of relevant
infectious disease or
conditions
 Medical screening
 Training
Conformance
Y N
7.3. 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
Conformance
Y N
7.3.3.2. 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, by-
products, waste)
Verified by FST (records)
Conformance
Y N
7.3.5.2. 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) Prior–subsequent 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
Conformance
Y N
7.4.4. 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
CCP’s), 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 & re-
assessment of:
 Control measures
 Raw materials
 Technologies
 Product characteristics
 Distribution
 Intend of use
Conformance
Y N
7.6. ESTABLISHING HACCP Plan

7.6.2. 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
Conformance
Y N
7.6.5. 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 don´t 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
Conformance
Y N
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) Authority & Responsibility appointed by
top management
b) 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
Conformance
Y N
7.8. 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
Conformance
Y N
8 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. 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)

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Audit Checklist - ISO 22000:2005

4 FOOD SAFETY MANAGEMENT SYSTEM

5.6.2. Internal communication

5.8. MANAGEMENT REVIEW Needed to added the Emergency situations,

7 PLANNING AND REALIZATION

b) Lay/out of premises, including

h) Cleaning and sanitizing:

7.3. PRELIMINARY STEPS TO ENABLE

7.3.3.2. Characteristics of end products

7.3.5.2. Description of process steps and

7.4.4. Selection and assessment of control

7.6. ESTABLISHING HACCP Plan

7.6.5. Actions when monitoring results

a) Review NCs (complaints included)

7.10.3.3. Disposition of nonconforming products

7.8. Verification planning

8 VALIDATION, VERIFICATION AND IMPROVEMENT OF THE FMS

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