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 18

) Reviewed for continued suitability (5.2. 5.1.8.6.2.3.8) Supported by measurable objectives c) d) e) 5.6.1 5. a) b) FOOD SAFETY POLICY Appropriate to the role in the food chain Commits to comply with statutory.3) – communicating (5.) – policy (5. 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 18 . regulatory and customer FS requirements Communicated and understood within the organization (5.) – resources (6) Doc ref Stage 1 Stage 2 Observations & objective evidence 5 5.2) – management review (5.ISO 22000:2005 Conformance Clause Requirement MANAGEMENT RESPONSIBILITY MANAGEMENT COMMITMENT Evidence of top management commitment to the FSMS and its continual improvement: objectives (5.Audit Checklist .

Audit Checklist .6.2) 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.3.ISO 22000:2005 Conformance Clause 5.6. Records maintained. especially to hazards that need to be controlled. 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 7.1.3. 5. 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 18 .

Audit Checklist . location of equipment. ingredients and services Production systems and equipment Production premises.ISO 22000:2005 Conformance Clause 5. legal and customer FS requirements Implemented effective arrangements for communicating with relevant personnel in FS: FST is informed of changes. surrounding environment Cleaning and sanitation programs Packaging. Requirement Internal communication The Top management has communicated to the organization the importance of meeting this standard.6.2. 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 18 . 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. storage and distribution systems Personnel qualification level / allocation of responsibilities and authorizations Regulatory requirements Knowledge regarding food safety hazards and control measures Customer.

Audit Checklist .2) Emergency situations.8.2).) Resource needs (see 6.5.8.6.4) System up-dating activities (see 8. 5.10.) Improved effectiveness of the FSMS (see 8.7) and recalls (see 7.3.2. accidents (see 5.ISO 22000:2005 Conformance Clause 5.6. a) b) c) d) Requirement MANAGEMENT REVIEW At planned intervals Records maintained Inputs: Follow-up actions from previous reviews Verification activities (see 8.3) Changes related FS (see 5.1.1. 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 18 .5.1) External audits or inspections Outputs: Assurance of food safety (see 4.8.2) Communication activities including customer feed-back (see 5.8. 5. a) b) c) d) e) f) g) 5.1) Revisions of the FSP and objectives (see 5.3.

corrections. Job / Cert n°: Auditor(s): Template: GP 4102 Organization: Location: Issue n°: 1 Date: Visit n°: Page n°: 6 of 18 .4.1.3. 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 7.3.2.2 a) b) c) d) e) f) g) 6.) Doc ref Stage 1 Stage 2 Observations & objective evidence 6 6.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.Audit Checklist . 6. 6.2.2.) WORK ENVIRONMENT (see 7.3.2. 6.2.

a) b) c) d) 7.3. 7.2. 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.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.Audit Checklist .5.3.2. a) b) c) d) e) f) 7.2.2.2. 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 18 . Approved by FST According to • • • • • Legal requirements Customer requirements Recognized guidelines Codex Alimentarius Codes of practices Specific documents to manage PRPs 7.

sanitary design and accessibility for maintenance and cleaning for each unit Management of purchased materials. 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. 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 18 .Audit Checklist .ISO 22000:2005 Conformance Clause b) Requirement Lay/out of premises.

screens. security perimeter for inspection in storage. etc..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.Audit Checklist . Location of all measures Plan/diagram for electric fly killers / baits / traps Risk of product contamination with chemicals GMP´s 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 18 .

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. ingredients and product-contact materials Specifications with: Biological. implemented.3. Product characteristics Raw materials.1.3. 7. Requirement PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS General Relevant information needed to conduct the hazard analysis documented.5.ISO 22000:2005 Conformance Clause 7. Food Safety Team (FST) (5.2. 7.) 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.3.3.1.3.Audit Checklist . maintained and updated Doc ref Stage 1 Stage 2 Observations & objective evidence 7.3. 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 18 .3. collected.

3. intermediate.3. chemical and physical characteristics Intended shelf life and storage conditions. byproducts.ISO 22000:2005 Conformance Clause 7.5.1. specially vulnerable groups of population Descriptions updated 7. 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. 7. preparation and usage Method(s)of distribution Relevant legislation/ regulations documented Specifications updated Doc ref Stage 1 Stage 2 Observations & objective evidence g) 7.5. ingredients. 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 18 .2. Flow diagrams.) Packaging Labelling relating to food safety and/or instructions for handling.3.3.Audit Checklist .3. a) b) c) d) e) f) Requirement Characteristics of end products Specifications with: Name Composition Biological.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. Intended use (see 7. intermediate products) Reworking and recycling Outputs (end.3.4.

1.2.3.4.4. a) b) c) 7. Preliminary information about product / process and control measures (7.2.2.2.2. 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 18 .ISO 22000:2005 Conformance Clause 7. 7.Audit Checklist .2.4. 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.3.5. 7.) 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 Prior–subsequent links in the food chain Permissible levels of the hazard in the end product defined in compliance with legal / customer requirements. Including: • • Likely occurrence Severity of the adverse health effects 7.3. 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) 7.4.4.4.3. 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.

Audit Checklist .2. Categorized in General Control Measures (managed through PRPs) or Specific Control Measures (related to CCP’s).4. selected from the control measures defined in 7.4. 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 18 . Validation of control measure combinations Prior to implementation and after any change of General/Specific Control Measures. 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.ISO 22000:2005 Conformance Clause 7.3. Requirement Selection and assessment of control measures Identified & document control measures that are to be applied.5.

Selection documented 7. 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.Audit Checklist . 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 18 . Requirement ESTABLISHING HACCP Plan Identification of CCPs Hazard to be controlled by specific control measures ►CCP (7. 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. specifications. Measurements that provide results within an adequate time frame Monitoring devices identified Calibration methods (8.6.3.4. where no such standards exist. 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) 8.6. 7.6.6.4.4.3.2.) Frequency Responsibility & Authority Records / methods Control of monitoring and measuring To ensure valid results (if necessary).) Doc ref Stage 1 Stage 2 Observations & objective evidence 7. measuring equipment have to be controlled: a) Calibrated / verified against measurement standards.3.ISO 22000:2005 Conformance Clause 7. education/training.

3.ISO 22000:2005 Conformance Clause 7.1. 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. 7.5. 7. 7.3.3. cause.10.6.10.10.Audit Checklist . 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. consequence and traceability Doc ref Stage 1 Stage 2 Observations & objective evidence 7. 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.10.2.10. Records A procedure to: a) b) c) d) e) f) g) 7.2 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 18 .10.1 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 don´t enter the food chain unless it is possible to assure that the hazards have been reduced to acceptable levels.

Reported to the top management as input to management review (see 5.3. extent and result of a recall.4. Disposition of nonconforming products Products not acceptable for release have to be: a) b) 7. Records 5.8. 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.3.2).9. Based on the shelf life 7. Effectiveness of the programme recall verified.10.ISO 22000:2005 Conformance Clause Requirement Doc ref Stage 1 Stage 2 Observations & objective evidence 7.7. 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 18 .10.Audit Checklist . 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.

ISO 22000:2005 Conformance Clause 7.4. Procedures and communication channels (5.8. Review: a) b) c) d) 8. 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 Records reported Top Management. / 7.3. 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.Audit Checklist .4. Requirement Verification planning Establish. Input to the management review and for updating the FSMS Job / Cert n°: Auditor(s): Template: GP 4102 Organization: Location: Issue n°: 1 Date: Visit n°: Page n°: 17 of 18 .6.) Conclusions of the hazard analysis / operational PRPs / HACCP plan PRPs Human resources / Training Analysis of results of verification activities Are analysed by the FST. Evaluation of individual verification results Are evaluated systematically by the FST NCs with the planned arrangements ► actions to achieve conformity.2. including the results of internal & external audits.7.

records To determine whether FSMS system: a) b) Conforms with the planned arrangements Is effectively implemented and maintained Audit programme planned: considers status. VERIFICATION AND IMPROVEMENT OF THE FMS FSMS VERIFICATION Internal audit Documented procedure that defines responsibilities – reporting .8.10. Updating the FSMS FST evaluate the FSMS at planned intervals.) – management review (5.5. and if it is necessary review the HA.2) Updating of FSMS recorded and reported : input of management review (5.4.2.6) Suitability-adequacy-effectiveness of FSMS Analysis of results of verifications activities (8.4.2.) – CCAA (7. IMPROVEMENT Continual improvement FSMS continually improved through: communication (5. PRP(s) and HACCP plan Consider: a) b) c) d) Communication (5.3.5. frequency and methods defined Objectivity and impartiality of auditors Corrective actions carried out on time by responsible for the area Verification of actions recorded 8.2.1.) – validation of control measure combinations (8.Audit Checklist . VALIDATION.ISO 22000:2005 Conformance Clause Requirement Doc ref Stage 1 Stage 2 Observations & objective evidence 8 8.4. scope. and results of previous audits Criteria.) – analysis of results of verification activities (8.) Management review (5.2.3.) – internal audit (8.1.8.6. 8. 8. importance of processes and areas to be audited.8.4.4.1.5.4.) – evaluation of individual verification results (8.2) Job / Cert n°: Auditor(s): Template: GP 4102 Organization: Location: Issue n°: 1 Date: Visit n°: Page n°: 18 of 18 .) – FSMS updating 8.

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