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ISO 22000:2005 Compliance Audit

Internal Auditing Procedure

Internal Inspection and Auditing Procedure

Who are the person(s) responsible for FSMS

Yes No N/A

e.g. Food Safety Team Leader

Who is the Approval Authority for FSMS

Yes No N/A

e.g. COO

Where is information located

Yes No N/A

e.g. FSMS information is kept in a centralized location on the operations master server

What is the revision timing / frequency

Yes No N/A

e.g. revision occurs annually or if there is a change to management, a system failure, process change or revision in related scientific or regulatory information.

What is the goal of the audit

Yes No N/A

e.g. The goal is to ensure that FSMS is working correctly and efficiently. To identify and correct faults that may injure customer or stakeholders to the business, to verify that training and resource is adequate and implemented effectively

Define the Scope of the FSMS

Yes No N/A

e.g. The audit and inspection is relevant to all food handling operations starting from receiving to sale of goods. The audit may be upgraded to include suppliers of food, chemicals, services or equipment that may impact on the safety of food

Describe the content of the FSMS

Yes No N/A

e.g. The audit program and audit plan form part of the audit procedure

What is the training requirement / criteria / frequency for FSMS

Yes No N/A

Internal Auditors and Inspectors shall be trained in food safety customer requirements either by education or through practical hands on experience. As a minimum Internal Auditors should be HACCP trained.

Inspection and Audit Program

Describe the Audit

Yes No N/A

e.g. The audit is a quantitative measure of the standards being followed based on a scoring system defined in this handbook. A report is emailed to senior management and relevant managers listing corrective actions and target dates for accomplishment. Photographs can be included in the report as supporting evidence. review of completed corrective actions form part of the audit criteria. Full criteria is based on the clauses of international standard ISO 22000:2005 (4: Food Safety Management System, 5: Management Responsibility, 6: Resource Management, 7: Planning & Realization of Safe Products, 8: Validation, verification and improvement of the food safety management system). The results of the audit are used as a verification tool for the food safety training plan.

Inspection and Audit Plan

Auditor contact details

Yes No N/A

(check name not set)

Auditee contact details

Yes No N/A

Define the scope of the audit

Yes No N/A

e.g. Fresh food handling areas including receiving, storage & warehousing, processing (Bakery / Delicatessen / Rotisserie), sale of ready-to-eat and ready-to-cook foods. Operation teams are advised in advance when the audit will be conducted and the scope of what will be checked and who will be required.

Define the scheduled frequency and duration of the audit, include desk audit, site audit and delivery of final report

Yes No N/A

e.g. Audits are carried out bi-annualy, at six month intervals, and involves an announced audit based on defined criteria. The audit may take 3 full working days: 1 day to complete a site audit, 1 day to complete a desk audit and 1 day to complete the report. The final report shall be issued by email within 5 working days of day 3 being completed. NB: If changes to the audit date is needed this shall be advised to relevant parties by email.

Date for receipt of desk audit documentation and time frame for document review

Yes No N/A

e.g. Documents shall be reviewed on site as part of the 1 day desk audit, It shall be carried out for each relevant section. Any records can be removed from the section for review. It should be agreed a return date no longer than 3 days.

Define the preliminary agenda for the site audit

Yes No N/A

e.g. The preliminary agenda for the site audit will be issued 5 working days prior to the audit inspection.

Proposed date for completion

Yes No N/A

e.g. Proposed follow up dates will be agreed on the last day of the audit and included in the report

Outcome of the audit or inspection

Yes No N/A

e.g. Non-Conformance Corrective Actions or Corrections are raised verbally or formally by email report

4.0 Food Safety Management System (Desk Audit)

4.1 General Requirements

Is there an established FSMS

Yes No N/A

does the scope specify the products or product categories, processes and production lines

Yes No N/A

Is there a system to identify food safety hazards

Yes No N/A

Are the means to communicate (internally & externally) pertaining to food safety effective

Yes No N/A

Is the FSMS periodically reviewed

Yes No N/A

Have any outsourced processes been identified within the documented FSMS

Yes No N/A

4.2.1 Documentation

Is the policy (5.2) documented

Yes No N/A

Do objectives support the policy

Yes No N/A

Has the organization identified the ISO 22000:2005 minimum requirement documents

Yes No N/A

Has the organization established documented, implemented and maintained other procedures to ensure development, implementation and updating of the FSMS

Yes No N/A

4.2.2 Control of Documents

Is there a documented procedure for control of documents

Yes No N/A

Approved prior to use

Yes No N/A

Review, update and re-approve

Yes No N/A

Changes are effectively identified and documented

Yes No N/A

Availability at point of use

Yes No N/A

Legibility and readability

Yes No N/A

Control over external documents

Yes No N/A

Prevent the inadvertent use of obsolete documents and identification of obsolete documents

Yes No N/A

4.2.3 Control of Records

Is there are document procedure for control of records

Yes No N/A

Identification

Yes No N/A

Storage

Yes No N/A

Protection

Yes No N/A

Retrieval

Yes No N/A

Retention time and disposition of records

Yes No N/A

5.0 Management Responsibility

5.1 Management Commitment

Is the commitment of top management evident to the Auditor

Yes No N/A

Have top management established business objectives to support food safety

Yes No N/A

5.2 Food Safety Policy

Is the policy documented and is there a method of communication

Yes No N/A

Is it appropriate to the role of the organization in the food chain

Yes No N/A

Does it refer to both statutory and regulatory requirements and with customer food safety requirements

Yes No N/A

Does it communicate effectively to staff and any on-site suppliers or contractors

Yes No N/A

Is there evidence of reviews

Yes No N/A

is it supported by measurable objectives (list the objectives, measures and current status)

Yes No N/A

5.3 Food Safety Management System Planning

Is there documented evidence that the FSMS is planned implemented, monitored and maintained

Yes No N/A

5.4 Responsibility & Authority

Are responsibilities and authorities clearly defined and documented

Yes No N/A

5.5 Food Safety Team Leader

Has top management designated a food safety leader (name)

Yes No N/A

5.6 Communication

Are methods of communication evident and clear

Yes No N/A

How are top management communicating effectively, what tools or methods do they use

Yes No N/A

5.6.1 External Communication

Verify how communication takes place between suppliers and contractors on issues regarding food safety

Yes No N/A

Communication with statutory and regulatory bodies

Yes No N/A

Are food safety requirements from statutory and regulatory authorities available

Yes No N/A

5.6.2 Internal Communication

Verify how communication takes place within the organisation on issues regarding food safety

Yes No N/A

5.7 Emergency Preparedness & Response

Is there a documented procedure / process for planning and responding to emergency situations and accidents

Yes No N/A

Has there been any need to use this process

Yes No N/A

5.8 Management Review

Has management reviewed the FSMS

Yes No N/A

Are reviews carried out at planned intervals

Yes No N/A

Do reviews focus on the organisations policy objectives and improvements

Yes No N/A

Does it include the outcome if the other reviews

Yes No N/A

Does it include analysis from verification results

Yes No N/A

Changes affecting the FSMS

Yes No N/A

Results of corrective actions, emergencies, accidents, recalls and other similar

Yes No N/A

Review of results from system up-dates

Yes No N/A

Evaluation of communications whether consumer, customer, regulatory bodies

Yes No N/A

Evaluation on the results of internal and external audits, inspections relating to products and processes

Yes No N/A

6.0 Resource Management

6.1 Provision of Resource

Selection and training criteria documented for food safety team members

Yes No N/A

Where applicable criteria for selection and use of external experts, defined roles and responsibilities

Yes No N/A

There is a process for identifying necessary competencies for personnel who impact food safety

Yes No N/A

6.2 Human Resource

What training has been provided and / or competency been decided

Yes No N/A

What process is in place to evaluate effectiveness of selection and training process

Yes No N/A

How are personnel made aware of the relevance and importance of their individual activities to food safety and what is the communication process

Yes No N/A

What records are maintained to demonstrate successful training and communication of FSMS

Yes No N/A

6.3 Infrastructure

How has the organization provided adequate resources for the establishment and maintenance of the infrastructure needed to meet FSMS requirements (ISO22000:2005)

Yes No N/A

Work Environment

7.0 Planning & Realization of Safe Products

7.1 General Requirements

The organization shall plan and develop the processes needed for the realization of safe products. The organisation shall implement, operate and ensure the effectiveness of the planned activities and any changes to those activities. this includes PRP / OPRP and HACCP

7.2 Prerequisite Programs (PRPs)

7.2.1 Has the organization identified PRPs

Yes No N/A

7.2.1 List all the PRPs identified by the organization

Yes No N/A

7.2.2 Do the PRPs relate to statutory and regulatory requirements

Yes No N/A

7.2.2 Are PRPs approved by the food safety team

Yes No N/A

7.2.3 Information based on CODEX (or any other)

Are documents available specifying how activities included in PRPs are managed

Yes No N/A

Verify that PRPs are being controlled in accordance with documentation

Yes No N/A

Has consideration been given to construction of infrastructure

Yes No N/A

Has consideration been given to the criticality of activities and personnel

Yes No N/A

Has consideration been given to the supply of water, air, energy and other needs

Yes No N/A

Has consideration been given to supporting services including waste management and sewage disposal

Yes No N/A

Has consideration been given to the availability of equipment relating to cleaning, maintenance and preventative maintenance

Yes No N/A

Has consideration been given to measures to prevent cross contamination

Yes No N/A

Has consideration been given to cleaning, hygiene and sanitation

Yes No N/A

Has consideration been given to the control of insects and pests

Yes No N/A

Is there evidence of verification records for the control of all the above

Yes No N/A

7.3 Preliminary Steps to enable Hazard Analysis

7.3.1 Preliminary steps to enable hazard analysis

Is the information needed for analysis recorded

Yes No N/A

What information is used

Yes No N/A

Is it updated frequently and as necessary

Yes No N/A

7.3.2 food Safety Team

Is there a food safety team

Yes No N/A

List the people in the team

Is the team competent (6.2.2) and are there records to verify competence

Yes No N/A

7.3.3.1 Product characteristics, raw materials, ingredients and product contact materials

Are utensils, ingredients, packaging and other contact materials described in documents which include detailed information appropriate

Yes No N/A

Chemical, physical and biological characteristics for above are documented

Yes No N/A

Composition for products is defined

Yes No N/A

Point of origin is defined

Yes No N/A

Method of production is defined

Yes No N/A

Methods for packaging and delivery are defined

Yes No N/A

Storage conditions are defined

Yes No N/A

Preparation and / or handling specifications before use or processing are defined

Yes No N/A

Food safety acceptance criteria is defined

Yes No N/A

Are legal, regulatory and any other food safety requirements met

Yes No N/A

7.3.3.2 Finished Product Characteristics

The hazard analysis has documented the characteristics of the finished product

Yes No N/A

The composition of the product is considered, and includes allergens

Yes No N/A

The name of how the product is identified is documented

Yes No N/A

Biological, chemical and physical characteristics relevant to the product are defined

Yes No N/A

Concerns relating to the intent of product and storage requirements have been addressed / defined

Yes No N/A

Packaging requirements have been identified and defined

Yes No N/A

Labeling relating to safe product handling, preparation and use (including any warnings) have been identified and defined)

Yes No N/A

Distribution methods have been defined

Yes No N/A

Legal and regulatory requirements have been identified and defined

Yes No N/A

Information is descriptive, detailed, updated and maintained inclusive to changes to the HACCP plan or PRPs

Yes No N/A

7.3.4 Intended use

What documents are available that address hazards relating to the products intended use

Yes No N/A

Have these included factors raised in hazard analysis

Yes No N/A

Has the organization included the concerns of any special groups i.e. children, pregnant women, elderly

Yes No N/A

Is this information updated when there are changes to FSMS, scientific research or regulations

Yes No N/A

7.3.5.1 Flow diagrams, process flow and control measure

Has the organization implemented flow diagrams as common practice

Yes No N/A

Have the flow diagrams been approved by the food safety team

Yes No N/A

7.3.5.2 description of process flow and measure control

Is the method used for identifying hazards effective

Yes No N/A

Are external requirements considered when analyzing hazards

Yes No N/A

Does the organization update HACCP and PRP plans

Yes No N/A

7.4 Hazard Analysis

Are hazards and control methods determined by the food safety team

Yes No N/A

7.4.2.1 Hazard identification and determining level of acceptability

4.4.2.2 Are all hazards identified acceptably

Yes No N/A

7.4.2.3 Are the level of control determined acceptably

Yes No N/A

7.4.3 Hazard Analysis

Has the organization demonstrated that hazard analysis focuses on eliminating and reducing hazards and is their determination acceptable

Yes No N/A

Has the organization identified hazards to the satisfaction of legal and regulatory expectations

Yes No N/A

Has the severity of the risk been determined

Yes No N/A

Is the methodology for determining severity of risk based on sound and acceptable scientific and technological methods or studies

Yes No N/A

7.4.4 Control methods, section and evaluation

Do the selected measures prevent, eliminate or minimize the hazard to an acceptable level

Yes No N/A

Hazard analysis is effective for HACCP and PRPs through the scope of the FSMS

Yes No N/A

Hazard analysis refers to the hazard and the magnitude of the severity

Yes No N/A

There are documented methods to measure, monitor and control all identified hazards

Yes No N/A

The control point and measure for controlling is accurate and adequate, it considered other control points in combination

Yes No N/A

It addresses the possibility of failure preventing the inclusion of the hazard affecting the process or the food

Yes No N/A

Are all the above adequate and effective

Yes No N/A

Has the synergy of other control measure points been considered

Yes No N/A

Are the above addressed in the HACCP / PRP

Yes No N/A

Are the above expressed through documents, records, procedures, instructions, manuals, handbooks or other wise

Yes No N/A

7.5 Establishing the Operational Prerequisite Programs (OPRPs)

Have OPRPs documented and implemented

Yes No N/A

OPRPs address (please list)

Yes No N/A

OPRP hazards are identified as Biological, Chemical and Physical and are controlled

Yes No N/A

OPRP documents reference the control measures to be applied

Yes No N/A

OPRP control methods are effectively implemented

Yes No N/A

OPRPs are adequate and effective to trigger corrections

Yes No N/A

Responsibilities and authorities are determined for actions or corrections

Yes No N/A

Supported by records

Yes No N/A

7.6 Establishing the HACCP Plan

7.6.1 HACCP Plan

Is the HACCP Plan documented

Yes No N/A

How many HACCP plans are there

Yes No N/A

Does the plan address the hazard point of control

Yes No N/A

Does the plan address the reaction or action needed to be taken in the event of a deviation or fault

Yes No N/A

The CCPs and respective Critical Limits are identified

Yes No N/A

Procedures for controlling CCPs are documented

Yes No N/A

Record for monitoring CCPs are available for checking

Yes No N/A

7.6.2 Identifying critical control points

Is the identification of CCPs effective

Yes No N/A

7.6.3 Determining Critical Limits

Is there a CL for each CCP

Yes No N/A

Is each CL measurable

Yes No N/A

The scientific means to justify each CL is adequate and effective

Yes No N/A

7.6.4 Monitoring systems

Is there a monitoring system in place (briefly describe)

7.6.5 Are there any actions or any monitoring non-conformance resulting from monitoring CL

7.7 Updating of preliminary information and documents specifying the PRPs and the HACCP Plan

Is there documented evidence to support and necessary update with reference to product characteristics, intended use, flow diagrams, process steps or control methods

Yes No N/A

7.8 Verification Planning

Does verification planning define and document activity & purpose, method, frequency and responsibilities

Yes No N/A

What other procedures have been developed and implemented as a result of verification planning

Yes No N/A

Relating to verification, are the preparation methods and planning activities compatible

Yes No N/A

7.9 Traceability System

Is there a documented system for traceability

Yes No N/A

Have there been any internal traceability audits or mock exercises

Yes No N/A

7.10 Control of Non-Conformity

7.10.2 Is there a documented procedure to address corrective actions

Yes No N/A

7.10.3.1 Handling potentially unsafe products: Are the controls and responses for handling potentially unsafe products documented

Yes No N/A

7.10.3.2 There is a documented procedure and defined criteria of evaluation for the release of non-conforming product

Yes No N/A

7.10.3.3 There is a documented procedure for the disposition of non-conforming products

Yes No N/A

7.10.4 There is a documented procedure for product withdrawal or recall that addresses all relevant points

Yes No N/A

8.0 Validation, Verification and Improvement of the Food Safety Management System

8.1 General Requirements

Is there documented evidence of validations, verification and continual improvements

Yes No N/A

8.2 Validation of control measure combinations

Is there any documented or observed evidence of validation of control method combinations

Yes No N/A

8.3 Control of monitoring and measuring

Do records for monitoring and measuring demonstrate good practice i.e. all CCPs are within the defined CL, and any CAs are documented

Yes No N/A

8.4 Food Safety Management System verification

Is there a documented procedure addressing internal audits

Yes No N/A

Is there any audit program auditing within the scope of the FSMS

Yes No N/A

Do audits focus on adequacy, effectiveness and providing evidence of sustaining improvements in relation to the organizations food safety objectives

Yes No N/A

Are auditors competent

Yes No N/A

After identifying the need for action are they promptly taken by the process owner

Yes No N/A

8.4.3 How are the results of verification activities analysed

Yes No N/A

8.5 Improvement

8.5.1 Is there any evidence that improvements to the FSMS are directed to top management

Yes No N/A

8.5.2 Is there any evidence that the FSMS is updated as part of continual improvements

Yes No N/A

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Please note that this checklist template is a hypothetical example and provides only standard information. The template does not aim to replace, among other things, workplace, health and safety advice, medical advice, diagnosis or treatment, or any other applicable law. You should seek your professional advice to determine whether the use of such a checklist is appropriate in your workplace or jurisdiction.