ISO 22000 Audit Checklist

Audit Checklist - ISO 22000:2005

Conformance Clause

4

Requirement

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Stage 1

Stage 2

Observations & objective evidence

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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Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement

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.

Stage 1

Stage 2

Observations & objective evidence

FOOD SAFETY MANAGEMENT SYSTEM PLANNING

a)

To meet the objectives

b)

To maintain the FSM integrity when changes are implemented

5.4.

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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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Audit Checklist - ISO 22000:2005

Conformance Clause 5.6. 5.6.1.

Requirement

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COMMUNICATION External communication Implemented effective arrangements for communicating with :

a) b)

c) d)

Suppliers and contractors Customers / Consumers: •

product information (see 7.3.3.2)

•

enquiries

•

contracts / order handling

•

customer feedback / complaints

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

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Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement

5.6.2.

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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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Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement

5.8.

MANAGEMENT REVIEW

5.8.1.

At planned intervals

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Observations & objective evidence

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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Audit Checklist - ISO 22000:2005

Conformance Clause

6 6.2.

Requirement

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RESOURCE MANAGEMENT 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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Audit Checklist - ISO 22000:2005

Conformance Clause

Requirement

7

PLANNING AND REALIZATION OF SAFE PRODUCTS

7.2. 7.2.2.

Stage 2

Observations & objective evidence

PRPs shall be Appropiate to the organizational needs

b)

Appropiate to the size and type of operation and product

c)

Implemented across:

d)

Stage 1

PRPs

a)

7.2.3.

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•

General programmes

•

Specific programmes

Approved by FST 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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Audit Checklist - ISO 22000:2005

Conformance Clause b)

Requirement

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Observations & objective evidence

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:

g)

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•

Raw materials

•

Ingredients

•

Packaging

•

Chemicals

•

Waste

•

Sewage

•

Storage of raw materials / packaging / in process / end products

•

Transportation

Measures for the prevention of cross contamination

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Audit Checklist - ISO 22000:2005

Conformance Clause h)

i)

j)

Requirement

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Observations & objective evidence

Cleaning and sanitizing: •

Cleaning practices

•

Cleaning schedules

•

Control and verification of effectiveness

•

Documented procedures / records

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

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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Audit Checklist - ISO 22000:2005

Conformance Clause 7.3. 7.3.1.

Requirement

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PRELIMINARY STEPS TO ENABLE HAZARD ANALYSIS 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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Audit Checklist - ISO 22000:2005

Conformance Clause 7.3.3.2.

Requirement

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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, byproducts, waste) Verified by FST (records)

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Audit Checklist - ISO 22000:2005

Conformance Clause 7.3.5.2.

Requirement

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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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Audit Checklist - ISO 22000:2005

Conformance Clause 7.4.4.

Requirement

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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 & reassessment of: •

Control measures

•

Raw materials

•

Technologies

•

Product characteristics

•

Distribution

•

Intend of use

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Audit Checklist - ISO 22000:2005

Conformance Clause 7.6. 7.6.2.

Requirement

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ESTABLISHING HACCP Plan 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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Audit Checklist - ISO 22000:2005

Conformance Clause 7.6.5.

Requirement

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Observations & objective evidence

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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Audit Checklist - ISO 22000:2005

Conformance Clause

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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) b)

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

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Audit Checklist - ISO 22000:2005

Conformance Clause 7.8.

Requirement

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Observations & objective evidence

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 Job / Cert n°:

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Audit Checklist - ISO 22000:2005

Conformance Clause

8

Requirement

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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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