Introducing ISO 22000 - The Easy Way to Certification

Introducing ISO 220000:2005 – The

Easy Way to Certification

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Who are ISO ?

The International Organization for Standardization (ISO) was established in 1947 and is an association of 157 members, which each represent their own country. ISO employs a system of Technical Committees and Working Groups to develop International Standards.

British Standards Institute is the National Standards Body that represents the United Kingdom at ISO www.bsigroup.com

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http://9001manual.com/foodqualitymanual.php

What is ISO 22000:2005?

ISO 22000:2005 is an international standard that specifies requirements for a food safety management system where an organization in the food chain needs to demonstrate its ability to control food safety hazards in order to ensure that food is safe at the time of human consumption.

ISO 22000:2005 is applicable to all organizations in the food chain, regardless of size, that want to implement systems that consistently provide safe products.

ISO published ISO 22000 on September 1, 2005.



What is ISO 22000:2005?

ISO 22000 is designed for the certification of established Food Safety Management Systems and so an organisations FSMS can be certified as compliant with this standard by an independent body.

An organisation can be in compliance with ISO 22000:2005 without being formally certified by an accredited body. An organisation can apply the food safety management system and state that the FSMS complies with ISO 22000, however, the system is likely to have more credibility with customers if it has been approved by an independent body.



What is ISO 22000:2005?

In order to comply with ISO 22000 an organisation shall:

Plan, implement, maintain and update a food safety management system to supply products that are safe for the consumerDemonstrate compliance with applicable customer, statutory and regulatory food safety requirementsDemonstrate compliance with recognised industry codes of practiceEffectively communicate food safety issues to suppliers, customers and relevant parties in the food chainConform to the stated food safety policyDemonstrate such conformity to relevant interested parties



What is ISO 22000:2005?

ISO 22000 integrates the principles of the Hazard Analysis and Critical Control Point (HACCP) system developed by the Codex Alimentarius Commission with prerequisite programmes. Hazard analysis is the key to an effective food safety management system.ISO 22000 assists in defining the system requirements to gather the information and knowledge in order to establish an effective combination of control measures. ISO 22000 requires that all hazards that may be reasonably expected to occur in the food chain, including hazards that may be associated with the process and facilities used, are identified and assessed. During hazard analysis, the FSMS ensures hazard control by combining the prerequisite programmes, operational prerequisite programmes and HACCP plans.



What is ISO 22000:2005?

ISO has developed additional standards that are related to ISO 22000. These standards are known as the ISO 22000 family of standards: ISO 22000:2005 - Food safety management systems requirements for any organization in the food chain. ISO TS 22003:2007 - Food safety management systems for bodies providing audit and certification of food safety management systems. ISO TS 22004:2005 - Food safety management systems - Guidance on the application of ISO 22000:2005. ISO 22005:2007 - Traceability in the feed and food chain - General principles and basic requirements for system design and implementation.ISO 22000 can also be closely incorporated with the quality management system of ISO 9001.



ISO 22000 combines generally recognized key elements to ensure food safety along the food chain :

Interactive Communication

HACCP Principles

System Management

Prerequisite programmes


ISO 22000:2005 Key Elements


Interactive Communication

Clear communication along the food chain is essential to ensure that all relevant food safety hazards are identified and adequately controlled at each step. This implies communication of the needs of the organization to organizations both upstream and downstream in the food chain.

Communication with customers and suppliers, based on the information generated through systematic hazard analysis, will also assist in establishing customer and supplier requirements in terms of feasibility, need and impact on the end product.




System Management

The most effective food safety systems are designed, operated and updated within the framework of a structured management system and incorporated into the overall management activities of the organization.

This provides maximum benefit for the organization and interested parties. ISO 22000 is aligned with the requirements of ISO 9001:2000 in order to enhance the compatibility of the two standards and to ease their joint or integrated implementation.





HACCP Principles

ISO 22000 combines the Codex Alimentarius HACCP (Hazard Analysis and Critical Control Points) principles and application steps, developed by CodexAlimentarius, with prerequisite programmes.

It uses the hazard analysis to determine the strategy for hazard control.



Prerequisite ProgrammesThe effective production of safe products requires a detailed HACCP plan and the integration of two categories of Prerequisite programmes:Infrastructure and maintenance programmesOperational prerequisite programmes

Infrastructure and maintenance programmes address basic hygienic requirements and accepted good agricultural, manufacturing, storage, transport and veterinary practices of a permanent nature.

Operational prerequisite programmes are implemented to control identified food safety hazards in the product or processing environment




About ISO 22000:2005

ISO 22000 is a food safety management system standard that lays down the requirements needed to demonstrate the control food safety hazards in order to ensure that food is safe for consumption. The requirements of this ISO 22000 are generic and so ISO 22000 is applicable to all organizations that are involved in the food chain, regardless of size and complexity that want to implement systems that consistently provide safe products. Organizations that are directly involved that would benefit from ISO 22000 certification include feed producers, farmers, producers of ingredients, food manufacturers, retailers, food services, catering services, organizations providing cleaning and sanitation services, transportation, storage and distribution services. Other organizations that are indirectly involved that may benefit from ISO 22000 certification include suppliers of equipment, cleaning agents, packaging materials, and other food contact materials.



ISO 22000 Definitions

Food SafetyThe concept that food will not cause harm to the consumer when it is eaten according to its intended use. Food safety is related to the occurrence of food safety hazards.Food ChainThe sequences in the production, processing, distribution, storage and handling of a food, including its ingredients, from primary production to consumer. This includes the production of feed for food-producing animals and for animals intended for food production. The scope of this definition also includes the production of materials intended to come into contact with food.Food Safety PolicyA statement of food safety intent formally expressed by senior management.




Food Safety HazardA biological, chemical or physical agent in food(including allergens), or condition of food, with the potential to cause an adverse health effect. In the context of feed and feed ingredients, relevant food safety hazards are those that may be present in and/or on feed and feed ingredients and that may subsequently be transferred to food through animal consumption of feed and may thus have the potential to cause an adverse human health effect. For producers of food chain packaging materials, cleaning agents and similar products, relevant food safety hazards are those hazards that can be directly or indirectly transferred to food because of the intended use of the products and thus have the potential to cause an adverse human health effect.



Risk

Risk is defined as the combination of the probability of occurrence of harm and the severity of that harm. The term "hazard" is not to be confused with the term "risk" which, in the context of food safety, means a function of the probability of an adverse health effect and the severity of that effect when exposed to a specified hazard.

Flow Diagram

A flow diagram is a schematic and systematic presentation of the sequence and interactions of steps



End Product

A product that will not undergo any further processing or transformation by the organization prior to delivery to the customer/consumer. This may be a raw material to the next organisation or consumer depending on it’s position in the food chain.

Control Measure

An action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level.



Critical Control Point (CCP)

A step in the process at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level.

Critical Limit

A critical limit is the maximum or minimum value to which a physical, biological, or chemical hazard must be controlled at a critical control point to prevent, eliminate, or reduce to an acceptable level. Critical limits are established to determine whether a CCP remains in control and the product is safe.



Prerequisite Programme (PRP)

Base conditions and activities that are necessary to maintain a safe environment for the production, handling and provision of safe end products. These are infrastructure and maintenance prerequisites that an organisation has decided are the minimum pre-conditional hygienic conditions.



Operational Prerequisite Programme (Operational PRP)A prerequisite programme identified by the hazard analysis as essential in order to control food safety hazards in the product or in the process.

An operational prerequisite programme is a specified procedure(s) or instruction(s), specific to the nature and size of the operation, that enhances and/or maintains operational conditions to enable more effective control of food safety hazards and/or that controls the likelihood of introducing food safety hazards and their contamination of or proliferation in the product(s) and product processing environment.

Types of operational prerequisites include:Physical contamination controls ( e.g. Metal detection)Chemical contamination controls (e.g. Cleaning controls)Prevention of cross contamination (e.g. Allergen controls)



Control Point (CP) Any point, step or procedure at which control can be applied so that potential quality deficiencies can be prevented; eliminated or reduced to an acceptable level. The loss of control may not lead to an unacceptable food safety risk.

MonitoringObservations or measurements to assess whether control measures are operating as intended.

Correction The action taken to eliminate a detected nonconformity and potentially unsafe product. A correction can be taken in conjunction with a corrective action. Examples include reprocessing, disposal, and alternate use.



Corrective Action Measures taken to rectify conditions adverse to quality and safety. It includes action taken to prevent recurrences of the problem.

Validation

The process obtaining adequate evidence that the control measures managed by the HACCP plan and by the operational PRPs are capable of being effective.

Verification

Confirmation through the provision of objective evidence that specified requirements have been fulfilled.



Updating

An activity to ensure application of the most recent information.

Non-Conformance

A deficiency in characteristics, documentation or process implementation, which means product requirements have not been achieved.

HACCP

HACCP stands for Hazard Analysis and Critical Control Point. It was developed by the Codex Alimentarius Commission. HACCP is a system used to identify, prevent, and control food safety hazards.


ISO 22000 - HACCP Principles

A HACCP system is based on 7 principles that identify specific hazards and implements measures for their control:

Principle 1Prepare a flow diagram of the steps in the process. Conduct a hazard analysis by identifying potential hazards. Assess likelihood of occurrence of these hazards and identify control options

Principle 2Identify the Critical Control Points in the process using the decision tree

Principle 3Establish Critical Limits for each CCP


ISO 22000 – HACCP Principles

Principle 4Establish a monitoring system to ensure control of the Critical Control Point by scheduled testing or observations

Principle 5Establish the corrective action to be taken when monitoring indicates that a particular Critical Control Point is moving out of control

Principle 6Establish documentation concerning all procedures and records appropriate to these principles and their application

Principle 7 Validate and Verify that HACCP is working effectively


ISO 22000 – HACCP Plan

HACCP Plan

The HACCP system is used to develop a HACCP plan. An HACCP plan is a document that describes how an organisation manages and controls its food safety hazards.

An HACCP plan contains:

i.Critical control points (CCPs)ii.Process steps where the CCP appliesiii.Hazards that will be controlled at each CCPiv.Control measures that will be used at each CCPv.Critical limits that will be applied at each CCPvi.Procedures that will be used to monitor CCPsvii.Corrections that will be taken when critical limits are exceeded


ISO 22000:2005 Standard

The ISO 22000:2005 Sections:Section 1: Scope Section 2: Normative Reference Section 3: Terms and definitions Section 4: Food Safety Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning and Realization of Safe ProductsSection 8: Verification, Validation and Improvement of the Food Safety Management System


The next few slides show tables that match our ISO 22000 food safety management system document templates to the clauses of the ISO 22000:2005 Standard:

Section 4: Food Safety Management System Section 5: Management Responsibility Section 6: Resource Management Section 7: Planning and Realization of Safe ProductsSection 8: Verification, Validation and Improvement of the Food Safety Management System


ISO 22000:2005 Standard

ISO 22000 Standard - Section 4: Food Safety Management System summary of the ISO 22000 compliance

ISO 22000 SectionISO 22000 Manual

ReferenceISO 22000 Manual Document

4. Food Safety Management System

4.1 General Requirements QM001Quality and Food Safety Management System

4.2 Documentation QM002 QMS Manual Summary

4.2.2 Document Control QM003 Document Control

4.2.2 Document Control QM004Customer, Statutory and Regulatory Conformance

4.2.3 Record Control QM005 Record Control


ISO 22000 Standard – Section 5: Management Responsibility



5. Management Responsibility

5.1 Management Commitment QM006 Management Commitment

5.2 Food Safety Policy QM007Quality and Food Safety Policy/Objectives

5.3 FSQMS Planning QM001 Quality Management System

5.4 Responsibility & Authority

QM008Responsibility, Authority and Communication

5.5 Food Safety Team Leader

5.6 Communication

5.6.1 External Communication

5.6.2 Internal Communication

5.7 Contingency preparedness and response

QM025QM027QM028

Control of Nonconforming Product Crisis ManagementProduct Recall

5.8 Management Review QM009 Management Review


ISO 22000 Standard – Section 7: Planning and Realisation of Safe Products



7. Planning and Realisation of Safe Products

7.1 General Planning and Realisation of Safe Products

QM012Planning Product Realization and Contract Review

QM020 HACCP System

7.2 Prerequisite Programmes

QM011Infrastructure and Work Environment

QM015 Prerequisite programmes

7.3 Preliminary steps to enable Hazard analysis

QM020 HACCP System

7.4 Hazard Analysis QM020 HACCP System





7.5 Operational Control

7.5 Establishing the Operational PRPs QM020 HACCP System

7.5 Establishing the Operational Pre-requisites

PRP 001PRP 002PRP 003PRP 004PRP 005PRP 006PRP 007PRP 008PRP 009PRP 010PRP 011PRP 012PRP 013PRP 014PRP 015PRP 016PRP 017PRP 018PRP 019PRP 020PRP 021

Management of Hygiene and HousekeepingManagement of Pest ControlControl of Visitors and ContractorsManagement of CleaningDespatch and DistributionMaintenanceWaste ManagementHygiene PolicyGlass PolicyIngredients Foreign Body Control PolicyMetal DetectionNut Handling ProcedureControl of KnivesControl of Brittle MaterialsGlass & Brittle Material Breakage ProcedureTypes of AllergenStorageAllergen Control ProceduresFood Defence SystemControl of First Aid DressingsHACCP Prerequisites





7. Planning and Realisation of Safe Products (ISO 22000)

7.6 Establishing the HACCP plan QM020 HACCP System

7.7 Updating of preliminary information and documents specifying the PRP(s) and

HACCP plan

QM020 HACCP System

7.8 Verification Planning QM021Verification, Validation and Improvement

7.9 Traceability System QM016 Identification and Traceability

7.10.1 Corrections QM025QM026

Control of Non Conforming ProductCorrective Action and Preventive Action7.10.2 Corrective Actions

7.10.3 Handling of Potentially unsafe products

QM025 Control of Non Conforming Product

7.10.4 WithdrawalsQM025QM027QM028

Control of Non-Conforming ProductCrisis ManagementProduct Recall


ISO 22000 Standard – Section 8: Validation, Verification and Improvement of the FSQMS



8. Validation, Verification and Improvement of the FSQMS

8.1 General QM020Hazard Analysis and Critical Control Points

8.2 Validation of Control Measure Combinations

QM021QM027

Verification, Validation and ImprovementCalibration

8.3 Control of Monitoring and Measuring

QM019 Calibration

8.4 FSQMS Verification QM021 Verification, Validation and Improvement

8.4.1 Internal audits QM023 Internal Audit

8.4.2 Evaluation of Individual Verification results

QM021 Verification, Validation and Improvement

8.4.3 Analysis of results of Verification activities

QM021 Verification, Validation and Improvement

8.5 Improvement QM021 Verification, Validation and Improvement

8.5.1 Continual Improvement QM021 Verification, Validation and Improvement

8.5.2 FSQMS updating QM021 Verification, Validation and Improvement


ISO 22000 Standard

ISO 22000: uses a similar structure to the ISO 9001:2008 quality management system standard. This should make it a bit easier for ISO 9001 certified organizations to achieve ISO 22000 certification. Our document QM 002 Food Safety Quality Manual Summary shows the connections between ISO 9001 and ISO 22000 and how the ISO 22000 manual is compliant with both.ISO 22000 has a structured approach to combining the HACCP plan with prerequisite programmes and operational prerequisite programmes into a single integrated food safety management system.Prerequisite programmes (PRPs) are activities and practices that must be performed in order to establish and maintain a hygienic environment and are often referred to with terms such as “Good Manufacturing Practice”.


ISO 22000 Implementation

The process of implementing ISO 22000 must start with Senior Management as defined in section 5 management responsibility.

The standard requires senior management to demonstrate commitment to the food safety management system (FSMS). This needs to be supported by food safety policy and objectives. These should lead to the planning and development of the FSMS.



The following slides show the typical steps in developing a FSMS compliant with ISO 22000:2005.


ISO 22000 Implementation – Senior Management Responsibilities

i. Demonstrate a commitment to food safetyii. Issue a food safety policyiii. Establish food safety objectivesiv. Define the scope and boundaries of the FSMS.v. Plan the establishment of the FSMS.vi. Provide adequate support to establish the FSMS.vii. Ensure there is adequate infrastructure and

work environment. viii. Appoint a food safety team leaderix. Appoint the food safety teamx. FSMS responsibilities and authorities are

documented and communicatedxi. Establish food safety communication systemsxii. Provide the resources required to establish,

document, implement, maintain and update the FSMS.


ISO 22000 Implementation – Management Responsibilities

xiii. Implement training and awareness programs.xiv. Ensure personnel are competent particularly in

terms of food safetyxv. Ensure that systems are in place to manage

potential emergency situations and accidents. xvi. Establish, implement and maintain

infrastructure and maintenance prerequisite programs (PRPs) to control food safety hazards

xvii. Establish , implement and maintain operational prerequisite programs (PRPs) to control food safety hazards

xviii. The food safety team describe product characteristics are described for raw materials, ingredients and product contact materials (such as packaging). Key information should be documented usually in specifications and legal food safety requirements identified.


ISO 22000 Implementation – Food Safety Team Role

xix. The characteristics of end products are described and documented

xx. The intended use of the end product is described including vulnerable groups

xxi. Flow diagrams are prepared for all products and processes including all the steps in the process

xxii. Food safety control measures are identifiedxxiii. Perform a food safety hazard analysisxxiv. Identify and document food safety hazardsxxv. Specify acceptable levels for each hazardxxvi. Assess the food safety hazardsxxvii. Select and assess control measures for each

food safety hazardxxviii.Decide if control measures are to be part of

operational prerequisite programs or the HACCP plan. HACCP 004 HACCP Calculator aids this process.


ISO 22000 Implementation – Food Safety Team Role

xxix. Establish the operational PRPsxxx. Prepare the HACCP planxxxi. Identify critical control points (CCP)s for each

food safety hazardxxxii. Determine the critical limit for each CCPxxxiii.Determine and establish monitoring procedures

and records for each CCPxxxiv.Determine the corrections and corrective

actions to be taken when monitoring results exceed critical limits

xxxv. Allocate responsibility and authority for monitoring and recording, corrections and corrective actions

xxxvi.Document the HACCP plan xxxvii.Validate that the control measures and

combination of control measures are capable of achieving the intended level of control of the food safety hazards.



xxxviii.The management team ensure all staff are competent and adequately trained in the requirements of the prerequisite programmes, operational prerequisite programmes and the HACCP Plan

xxxix.The food safety team update the preliminary information based on the HACCP plan and prerequisites programmes and amend the operational PRP’s and HACCP plan if necessary

xl. The management establish a product traceability system

xli. The system is used to identify and correct nonconforming products. Evaluate data and take corrective actions.



xlii. A system is put in place to control products that are potentially unsafe including withdrawal procedures

xliii. A system is put in place to control monitoring and measuring methods and monitoring devices

xliv. Systems are put in place to control FSMS documents and records

xlv. Systems are put in place to verify that the FSMS is implemented effectively including internal audits

xlvi. The food safety team evaluate the results of verification activities

xlvii. The senior management team carry out food safety management reviews



xlviii.The senior management team implement actions to continually improve the FSMS

xlix. The food safety team update the FSMS as necessary by reviewing data collected and information including customer feedback, audit reports, results of verification activities and management review output and decide if the hazard analysis, design of operational PRPs and the HACCP plan need review.

The ISO 22000 Internal Audit /Gap analysis Checklists supplied as part of the ISO 22000 manual package will assist in implementing a FSMS or integrating ISO 22000 into an existing management system.


That’s the end of this presentation

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Introducing ISO 22000 - The Easy Way to Certification