ISO 22000:2005 Compliance Audit

• Document No.

• Audit Title

• Auditor

• Audit Site

• Auditee

• Conducted on

  Date
• Location
  Address

• Auditor signature required upon completion.

  Sign

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

• 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

4.1 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

5.1 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

6.1 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

7.1 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

8.1 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