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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
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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
Identified person(s) to receive reports problems with the FMS
Designated personnel to initiate and record actions
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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 / 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
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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
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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).
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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, 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.)
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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
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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
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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
Jewellery
Cuts and grazes
Hand cleaning
Notification of relevant infectious disease or conditions
Medical screening
Training
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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
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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)
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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
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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
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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
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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
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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
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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
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Records reported Top Management. Input to the management review and for updating the FSMS
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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