Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement

Doc ref

Stage 1

Stage 2

Observations & objective evidence

4
4.1. 4.1 4.1

FOOD SAFETY MANAGEMENT SYSTEM

GENERAL REQUIREMENTS Scope of the FSMS defined 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. 4.2.2.

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

a) b) c) d) e) f) g)

Approval of documents for adequacy prior to issue Review, update and re-approve Changes and current revision status identified Relevant versions of documents available at points of use Legible and readily identifiable Identification and control of external documents Prevent unintended use of obsolete documents, and to suitably identify them if they are retained for any purpose 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

4.2.3

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 1 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement MANAGEMENT RESPONSIBILITY

MANAGEMENT COMMITMENT
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)

Doc ref

Stage 1

Stage 2

Observations & objective evidence

5
5.1. 5.1

5.2. a) b)

FOOD SAFETY POLICY

Appropriate to the role in the food chain Commits to comply with statutory, regulatory and customer FS requirements Communicated and understood within the organization (5.6.) Reviewed for continued suitability (5.8) Supported by measurable objectives

c) d) e) 5.3. a) b) 5.4.

FOOD SAFETY MANAGEMENT SYSTEM PLANNING

To meet the objectives To maintain the FSM integrity when changes are implemented

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

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 2 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause 5.6. 5.6.1.

Requirement
COMMUNICATION
External communication Implemented effective arrangements for communicating with :

Doc ref

Stage 1

Stage 2

Observations & objective evidence

a) b)

Suppliers and contractors Customers / Consumers: product information (see 7.3.3.2) enquiries contracts / order handling customer feedback / complaints

c) d)

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

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 3 of 19

Audit Checklist - ISO 22000:2005

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:

Doc ref

Stage 1

Stage 2

Observations & objective evidence

a) b) c) d) e) f) g) h) i) j) k) l) m)

Products or new products Raw materials, ingredients and services Production systems and equipment Production premises, location of equipment, surrounding environment Cleaning and sanitation programs Packaging, storage and distribution systems Personnel qualification level / allocation of responsibilities and authorizations Regulatory requirements Knowledge regarding food safety hazards and control measures Customer, sector and other requirements Relevant enquiries from external interested parties Complaints indicating hazards associated with the product Any condition which have an impact on food safety

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 4 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause 5.8. 5.8.1. 5.8.2. a) b) c) d) e) f) g) 5.8.3. a) b) c) d)

Requirement
MANAGEMENT REVIEW
At planned intervals Records maintained Inputs: Follow-up actions from previous reviews Verification activities (see 8.3.3) Changes related FS (see 5.6.2) Emergency situations, accidents (see 5.7) and recalls (see 7.10.4) System up-dating activities (see 8.5.2) Communication activities including customer feed-back (see 5.6.1) External audits or inspections Outputs: Assurance of food safety (see 4.1.) Improved effectiveness of the FSMS (see 8.5.) Resource needs (see 6.1) Revisions of the FSP and objectives (see 5.2).

Doc ref

Stage 1

Stage 2

Observations & objective evidence

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 5 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement RESOURCE MANAGEMENT

HUMAN RESOURCES
For personnel relevant in FS Identify necessary competencies Training Specific training for personnel responsible of monitoring, corrections, and corrective actions Evaluation of implementation and effectiveness Awareness of contribution to FS Awareness of need for effective communication Records of training and other actions Agreement or contracts with external experts involved in FSM INFRASTRUCTURE (see 7.2.3.) WORK ENVIRONMENT (see 7.2.3.)

Doc ref

Stage 1

Stage 2

Observations & objective evidence

6
6.2. 6.2.2 a) b) c)

d) e) f) g) 6.2.1. 6.3. 6.4.

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 6 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement PLANNING AND REALIZATION OF SAFE PRODUCTS

PRPs
PRPs shall be Appropiate to the organizational needs Appropiate to the size and type of operation and product Implemented across: General programmes Specific programmes

Doc ref

Stage 1

Stage 2

Observations & objective evidence

7
7.2. 7.2.2. a) b) c)

d) 7.2.3.

Approved by FST According to Legal requirements Customer requirements Recognized guidelines Codex Alimentarius Codes of practices

Specific documents to manage PRPs 7.5. a) b) c) d) e) f) 7.2.3. a) Establishing the operational PRPs

Documentation for each programme: Hazards controlled Control measure(s) Monitoring procedures Corrections/ corrective actions Responsibility & Authority Records of monitoring Elements of PRPs
Lay-out, design and construction of buildings and facilities: Location Perimeter and grounds Walls Floors Ceilings Windows Doors Lighting Ventilation

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 7 of 19

Audit Checklist - ISO 22000:2005

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

Doc ref

Stage 1

Stage 2

Observations & objective evidence

c) d) e)

Supplies of air, water, energy and other utilities Supporting services including waste and sewage disposal Equipment including its preventative maintenance, sanitary design and accessibility for maintenance and cleaning for each unit 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

f)

g)

Measures for the prevention of cross contamination

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 8 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause h)

Requirement
Cleaning and sanitizing: Cleaning practices Cleaning schedules Control and verification of effectiveness Documented procedures / records 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 GMPs Protective clothing Jewellery Cuts and grazes Hand cleaning Notification of relevant infectious disease or conditions Medical screening Training

Doc ref

Stage 1

Stage 2

Observations & objective evidence

i)

Pest control:

j)

Personnel hygiene:

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 9 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause 7.3. 7.3.1.

Requirement
PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS
General Relevant information needed to conduct the hazard analysis documented, collected, maintained and updated

Doc ref

Stage 1

Stage 2

Observations & objective evidence

7.3.2.

Food Safety Team (FST) (5.5.) FST Leader appointed by Top Management with responsibility:

a) b) c) d)

To manage the FST Training & education of FST members To ensure that FSMS is established, implemented, maintained and updated To report to Top Management about FSMS Multi-disciplinary knowledge and experience Records demonstrate the required expertise for all team members

7.3.3. 7.3.3.1.

Product characteristics Raw materials, ingredients and product-contact materials Specifications with: Biological, chemical and physical characteristics Ingredients including additives and processing aids Origin Method of production Delivery methods and packaging Storage conditions and shelf life Preparation and/or handling before use or processing Food safety related acceptance criteria or specifications of purchased materials and ingredients appropriate to their intended uses Relevant legislation/ regulations documented Specifications updated

a) b) c) d) e) f) g) h)

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 10 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause 7.3.3.2. a) b) c) d) e) f)

Requirement
Characteristics of end products Specifications with: Name Composition Biological, chemical and physical characteristics Intended shelf life and storage conditions. Intended use (see 7.3.4.) Packaging Labelling relating to food safety and/or instructions for handling, preparation and usage Method(s)of distribution Relevant legislation/ regulations documented Specifications updated

Doc ref

Stage 1

Stage 2

Observations & objective evidence

g)

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. 7.3.5.1. Flow diagrams, process steps and control measures Flow diagrams For each product / process category covered by the FSMS Sufficient detail / schematic overview Including a) b) c) d) e) Sequence / interaction of steps Outsourced processes and subcontracted work Inputs (raw materials, ingredients, intermediate products) Reworking and recycling Outputs (end, intermediate, byproducts, waste) Verified by FST (records)

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 11 of 19

Audit Checklist - ISO 22000:2005

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

Doc ref

Stage 1

Stage 2

Observations & objective evidence

7.4. 7.4.2. 7.4.2.1.

HAZARD ANALYSIS
Hazard identification and determination of acceptable levels Identified & recorded Specific for the type of product / process and facilities Based on :

a) b) c) d) e) 7.4.2.2. a) b) c) 7.4.2.3.

Preliminary information about product / process and control measures (7.3.) Experience External information including epidemiological and other data historical Information from the food chain Step (s) related which each hazard Considering : Prior subsequent steps Equipment utilities surroundings Priorsubsequent links in the food chain Permissible levels of the hazard in the end product defined in compliance with legal / customer requirements, and the intended use (Records) 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

7.4.3.

Methodology described and results recorded

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 12 of 19

Audit Checklist - ISO 22000:2005

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:

Doc ref

Stage 1

Stage 2

Observations & objective evidence

a) b) c) d) e) f) g)

Effect on identified food safety hazards relative to the intensity applied Feasibility for monitoring Place within the system relative to other control measures Likelihood of failure in the functioning Severity of the consequence Specifically to eliminate/reduce the level of the hazard(s) 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) b)

Associate hazards are effectively controlled End Products meet the defined acceptable levels If a) / b) are failed modification & reassessment of: Control measures Raw materials Technologies Product characteristics Distribution Intend of use

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 13 of 19

Audit Checklist - ISO 22000:2005

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.)

Doc ref

Stage 1

Stage 2

Observations & objective evidence

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) b) c) d) e) f) 8.3.

Measurements that provide results within an adequate time frame Monitoring devices identified Calibration methods (8.3.) Frequency Responsibility & Authority Records / methods 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 Adjusted or re-adjusted as necessary The calibration status identified Safeguarded 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

b) c) d) e)

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 14 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause 7.6.5. 7.10. 7.10.1. a) b)

Requirement
Actions when monitoring results exceed critical limits CONTROL OF NONCONFORMITY Corrections A procedure to: Identify & assess of affected end products Review the corrections carried out Approved by the responsible person Records with information on the nature of the nonconformity, cause, consequence and traceability

Doc ref

Stage 1

Stage 2

Observations & objective evidence

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) b) c) d) e) f) g) 7.10.3. 7.10.3.1

Review NCs (complaints included) Review trends Determine cause of NCs Evaluate the need for CAs Determine and implementing CAs Records of CAs Reviewing CAs Handling of potentially unsafe products 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 a) b) c)

Evaluation for release Product is released as safe when: Others evidence indicates that the control measures have been effective Combined effect of the control measures has been effective Analysis (or other verification activities) indicate that the product is safe

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 15 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement

Doc ref

Stage 1

Stage 2

Observations & objective evidence

7.10.3.3. Disposition of nonconforming products Products not acceptable for release have to be: a) b) 7.9. Reprocessed to ensure that the hazards are controlled Destroyed 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. a) b) WITHDRAWALS To facilitate a recall: 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

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 16 of 19

Audit Checklist - ISO 22000:2005

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:

Doc ref

Stage 1

Stage 2

Observations & objective evidence

a) b) c)

The PRPs are implemented The hazard analysis is continually updated The operational PRPs and the elements within the HACCP plan are implemented and effective 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

d)

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) b) c) d) 8.4.3.

Procedures and communication channels (5.6. / 7.7.) Conclusions of the hazard analysis / operational PRPs / HACCP plan PRPs Human resources / Training

Analysis of results of verification activities

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

a) b) c) d) e)

Confirm that FSMS meets the planned arrangements Identify the need for updating / improving the FSMS Identify trends Establish information for planning internal audits Confirm effectiveness of corrections & CAs

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 17 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause

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

Doc ref

Stage 1

Stage 2

Observations & objective evidence

8
8.4. 8.4.1.

VALIDATION, VERIFICATION AND IMPROVEMENT OF THE FMS

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

a) b)

Conforms with the planned arrangements 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. 8.5.1.

IMPROVEMENT
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) b) c) d)

Communication (5.6) Suitability-adequacy-effectiveness of FSMS Analysis of results of verifications activities (8.4.3.) Management review (5.8.2)

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 18 of 19

Audit Checklist - ISO 22000:2005

Conformance Clause

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

Doc ref

Stage 1

Stage 2

Observations & objective evidence

Job / Cert n: Auditor(s): Template: GP 4102

Organization: Location: Issue n: 1

Date: Visit n: Page n: 19 of 19