ISO 22000 Audit Checklist

Audit Checklist - ISO 22000:2005

Clause Requirement Doc ref

Conformance

Observations & objective evidenceStage

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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

Job / Cert n°: Organization: Date:

Auditor(s): Location: Visit n°:

Template: GP 4102 Issue n°: 1 Page n°: 1 of 19



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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)








Documents

ISO 22000 Audit Checklist