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ISO 22000:2005 compliance audit

The purpose of this audit is for the Auditor to check compliance to the standards of ISO 22000:2005 Food Safety Management; to conduct an assessment of hygienic standards in all aspects of food handling procedures carried out in the operation and to ensure that all relevant corrective actions are carried out and documented.

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Internal Auditing Procedure
Internal Inspection and Auditing Procedure
Who are the person(s) responsible for FSMS
e.g. Food Safety Team Leader
Who is the Approval Authority for FSMS
e.g. COO
Where is information located
e.g. FSMS information is kept in a centralized location on the operations master server
What is the revision timing / frequency
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
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
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
e.g. The audit program and audit plan form part of the audit procedure
What is the training requirement / criteria / frequency for FSMS
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
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
Auditee contact details
Define the scope of the audit
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
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
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
e.g. The preliminary agenda for the site audit will be issued 5 working days prior to the audit inspection.
Proposed date for completion
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
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
does the scope specify the products or product categories, processes and production lines
Is there a system to identify food safety hazards
Are the means to communicate (internally & externally) pertaining to food safety effective
Is the FSMS periodically reviewed
Have any outsourced processes been identified within the documented FSMS
4.2.1 Documentation
Is the policy (5.2) documented
Do objectives support the policy
Has the organization identified the ISO 22000:2005 minimum requirement documents
Has the organization established documented, implemented and maintained other procedures to ensure development, implementation and updating of the FSMS
4.2.2 Control of Documents
Is there a documented procedure for control of documents
Approved prior to use
Review, update and re-approve
Changes are effectively identified and documented
Availability at point of use
Legibility and readability
Control over external documents
Prevent the inadvertent use of obsolete documents and identification of obsolete documents
4.2.3 Control of Records
Is there are document procedure for control of records
Identification
Storage
Protection
Retrieval
Retention time and disposition of records
5.0 Management Responsibility
5.1 Management Commitment
Is the commitment of top management evident to the Auditor
Have top management established business objectives to support food safety
5.2 Food Safety Policy
Is the policy documented and is there a method of communication
Is it appropriate to the role of the organization in the food chain
Does it refer to both statutory and regulatory requirements and with customer food safety requirements
Does it communicate effectively to staff and any on-site suppliers or contractors
Is there evidence of reviews
is it supported by measurable objectives (list the objectives, measures and current status)
5.3 Food Safety Management System Planning
Is there documented evidence that the FSMS is planned implemented, monitored and maintained
5.4 Responsibility & Authority
Are responsibilities and authorities clearly defined and documented
5.5 Food Safety Team Leader
Has top management designated a food safety leader (name)
5.6 Communication
Are methods of communication evident and clear
How are top management communicating effectively, what tools or methods do they use
5.6.1 External Communication
Verify how communication takes place between suppliers and contractors on issues regarding food safety
Communication with statutory and regulatory bodies
Are food safety requirements from statutory and regulatory authorities available
5.6.2 Internal Communication
Verify how communication takes place within the organisation on issues regarding food safety
5.7 Emergency Preparedness & Response
Is there a documented procedure / process for planning and responding to emergency situations and accidents
Has there been any need to use this process
5.8 Management Review
Has management reviewed the FSMS
Are reviews carried out at planned intervals
Do reviews focus on the organisations policy objectives and improvements
Does it include the outcome if the other reviews
Does it include analysis from verification results
Changes affecting the FSMS
Results of corrective actions, emergencies, accidents, recalls and other similar
Review of results from system up-dates
Evaluation of communications whether consumer, customer, regulatory bodies
Evaluation on the results of internal and external audits, inspections relating to products and processes
6.0 Resource Management
6.1 Provision of Resource
Selection and training criteria documented for food safety team members
Where applicable criteria for selection and use of external experts, defined roles and responsibilities
There is a process for identifying necessary competencies for personnel who impact food safety
6.2 Human Resource
What training has been provided and / or competency been decided
What process is in place to evaluate effectiveness of selection and training process
How are personnel made aware of the relevance and importance of their individual activities to food safety and what is the communication process
What records are maintained to demonstrate successful training and communication of FSMS
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)
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
7.2.1 List all the PRPs identified by the organization
7.2.2 Do the PRPs relate to statutory and regulatory requirements
7.2.2 Are PRPs approved by the food safety team
7.2.3 Information based on CODEX (or any other)
Are documents available specifying how activities included in PRPs are managed
Verify that PRPs are being controlled in accordance with documentation
Has consideration been given to construction of infrastructure
Has consideration been given to the criticality of activities and personnel
Has consideration been given to the supply of water, air, energy and other needs
Has consideration been given to supporting services including waste management and sewage disposal
Has consideration been given to the availability of equipment relating to cleaning, maintenance and preventative maintenance
Has consideration been given to measures to prevent cross contamination
Has consideration been given to cleaning, hygiene and sanitation
Has consideration been given to the control of insects and pests
Is there evidence of verification records for the control of all the above
7.3 Preliminary Steps to enable Hazard Analysis
7.3.1 Preliminary steps to enable hazard analysis
Is the information needed for analysis recorded
What information is used
Is it updated frequently and as necessary
7.3.2 food Safety Team
Is there a food safety team
List the people in the team
Is the team competent (6.2.2) and are there records to verify competence
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
Chemical, physical and biological characteristics for above are documented
Composition for products is defined
Point of origin is defined
Method of production is defined
Methods for packaging and delivery are defined
Storage conditions are defined
Preparation and / or handling specifications before use or processing are defined
Food safety acceptance criteria is defined
Are legal, regulatory and any other food safety requirements met
7.3.3.2 Finished Product Characteristics
The hazard analysis has documented the characteristics of the finished product
The composition of the product is considered, and includes allergens
The name of how the product is identified is documented
Biological, chemical and physical characteristics relevant to the product are defined
Concerns relating to the intent of product and storage requirements have been addressed / defined
Packaging requirements have been identified and defined
Labeling relating to safe product handling, preparation and use (including any warnings) have been identified and defined)
Distribution methods have been defined
Legal and regulatory requirements have been identified and defined
Information is descriptive, detailed, updated and maintained inclusive to changes to the HACCP plan or PRPs
7.3.4 Intended use
What documents are available that address hazards relating to the products intended use
Have these included factors raised in hazard analysis
Has the organization included the concerns of any special groups i.e. children, pregnant women, elderly
Is this information updated when there are changes to FSMS, scientific research or regulations
7.3.5.1 Flow diagrams, process flow and control measure
Has the organization implemented flow diagrams as common practice
Have the flow diagrams been approved by the food safety team
7.3.5.2 description of process flow and measure control
Is the method used for identifying hazards effective
Are external requirements considered when analyzing hazards
Does the organization update HACCP and PRP plans
7.4 Hazard Analysis
Are hazards and control methods determined by the food safety team
7.4.2.1 Hazard identification and determining level of acceptability
4.4.2.2 Are all hazards identified acceptably
7.4.2.3 Are the level of control determined acceptably
7.4.3 Hazard Analysis
Has the organization demonstrated that hazard analysis focuses on eliminating and reducing hazards and is their determination acceptable
Has the organization identified hazards to the satisfaction of legal and regulatory expectations
Has the severity of the risk been determined
Is the methodology for determining severity of risk based on sound and acceptable scientific and technological methods or studies
7.4.4 Control methods, section and evaluation
Do the selected measures prevent, eliminate or minimize the hazard to an acceptable level
Hazard analysis is effective for HACCP and PRPs through the scope of the FSMS
Hazard analysis refers to the hazard and the magnitude of the severity
There are documented methods to measure, monitor and control all identified hazards
The control point and measure for controlling is accurate and adequate, it considered other control points in combination
It addresses the possibility of failure preventing the inclusion of the hazard affecting the process or the food
Are all the above adequate and effective
Has the synergy of other control measure points been considered
Are the above addressed in the HACCP / PRP
Are the above expressed through documents, records, procedures, instructions, manuals, handbooks or other wise
7.5 Establishing the Operational Prerequisite Programs (OPRPs)
Have OPRPs documented and implemented
OPRPs address (please list)
OPRP hazards are identified as Biological, Chemical and Physical and are controlled
OPRP documents reference the control measures to be applied
OPRP control methods are effectively implemented
OPRPs are adequate and effective to trigger corrections
Responsibilities and authorities are determined for actions or corrections
Supported by records
7.6 Establishing the HACCP Plan
7.6.1 HACCP Plan
Is the HACCP Plan documented
How many HACCP plans are there
Does the plan address the hazard point of control
Does the plan address the reaction or action needed to be taken in the event of a deviation or fault
The CCPs and respective Critical Limits are identified
Procedures for controlling CCPs are documented
Record for monitoring CCPs are available for checking
7.6.2 Identifying critical control points
Is the identification of CCPs effective
7.6.3 Determining Critical Limits
Is there a CL for each CCP
Is each CL measurable
The scientific means to justify each CL is adequate and effective
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
7.8 Verification Planning
Does verification planning define and document activity & purpose, method, frequency and responsibilities
What other procedures have been developed and implemented as a result of verification planning
Relating to verification, are the preparation methods and planning activities compatible
7.9 Traceability System
Is there a documented system for traceability
Have there been any internal traceability audits or mock exercises
7.10 Control of Non-Conformity
7.10.2 Is there a documented procedure to address corrective actions
7.10.3.1 Handling potentially unsafe products: Are the controls and responses for handling potentially unsafe products documented
7.10.3.2 There is a documented procedure and defined criteria of evaluation for the release of non-conforming product
7.10.3.3 There is a documented procedure for the disposition of non-conforming products
7.10.4 There is a documented procedure for product withdrawal or recall that addresses all relevant points
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
8.2 Validation of control measure combinations
Is there any documented or observed evidence of validation of control method combinations
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
8.4 Food Safety Management System verification
Is there a documented procedure addressing internal audits
Is there any audit program auditing within the scope of the FSMS
Do audits focus on adequacy, effectiveness and providing evidence of sustaining improvements in relation to the organizations food safety objectives
Are auditors competent
After identifying the need for action are they promptly taken by the process owner
8.4.3 How are the results of verification activities analysed
8.5 Improvement
8.5.1 Is there any evidence that improvements to the FSMS are directed to top management
8.5.2 Is there any evidence that the FSMS is updated as part of continual improvements
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Please note that this checklist template is a hypothetical appuses-hero 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.