iso 22000

INTRODUCTION TO ISO 22000:2005 FOOD SAFETY MANAGEMENT SYSTEM

CONTENT ISO 22000:2005 1. Scope 2. Normative Reference 3. Terms & Definitions 4. Food Safety Management System 5. Management Responsibility 6. Resource Management 7. Planning & Realization of Safe Products 8. Validation, Verification & Improvement of the Food Safety Management System 2005-01

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AIM OF ISO 22000:2005

To harmonize on a global scale the requirements for food safety management for businesses within the food chain

It requires an organization to include any applicable food safety related statutory & regulatory requirements into its food safety management system

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INTRODUCTION

Food Safety

Food Borne HAZARD

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At point of consumption

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FOOD CHAIN

With all kinds of transportation used Feed Producers 2005-01

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INTER-RELATED ORGANIZATION

Additives & Ingredient

Equipment

PRODUCERS of Packaging Material Cleaning agent

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Service Providers

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KEY ELEMENTS of ISO 22000 Interactive Communication

System Management ISO 22000 Prerequisite Programmed

HACCP Principles 2005-01

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Key of Food Safety Management System Food chain facilities Hazard Analysis process Control Measure

PRP

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Operational PRP

HACCP plan 8

ISO 22000:2005 SCOPE and NORMATIVE REFERENCE

Who can implement? All size organizations involved in any aspect of food chain that can consistently demonstrate its ability to control food safety hazards and provide safe products

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Organization in the Food Chain Direct organization: Feed producers, harvesters, farmers, producers of ingredients, food producers, retailers, food services, catering services, cleaning & sanitation services, transportation, storage & distribution services. Indirect organization: Supplier of equipment, cleaning & sanitation agents, packaging material, and other food contact material 2005-01

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ISO 22000:2005 The requirements enable organization to: plant, implement, operate, maintain & update system aimed to provide safe products for consumer demonstrate compliance with safety statutory & regulatory evaluate & assess customer requirements and demonstrate conformity to enhance customer satisfaction effectively communicate food safety issues to suppliers, customers & relevant interested parties in the food chain

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ISO 22000:2005…….

conforms with stated food safety policy demonstrate conformity to relevant interested parties seek certification or registration, make self assessment or self declaration to conform with standard

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NORMATIVE REFERENCE

ISO 9000:2000 Quality Management Systems – Fundamentals & vocabulary

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ISO 22000:2005 TERMS & DEFINITION

Terms & Definitions Food safety Concept that food will not cause harm to the consumer when it is prepared and/or eaten according to its intended use Food chain Sequence of the stages and operations involved in the production, processing, distribution, storage and handling of a food and its ingredients, from primary production to consumption Food safety hazard Biological, chemical or physical agent in, or condition of, food with the potential to cause an adverse health 2005-01

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Terms & Definitions …. Control measure action or activity that can be used to prevent or eliminate a food safety hazard or reduce it to an acceptable level PRP (prerequisite programmed) basic conditions and activities that are necessary to maintain a hygienic environment throughout the food chain suitable for production, handling and provision of safe food for human consumption Critical limit Criterion which separates acceptability from unacceptability 2005-01

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Terms & Definitions …. Critical control point step at which control can be applied and is essential to prevent or eliminate a food safety hazard or reduce it to an acceptable level Operational PRP PRP identified by the hazard analysis as essential in order to control the likelihood of introducing food safety hazard and/or the contamination or proliferation of food safety hazards in the product(s) or in the processing environment Verification Confirmation, through the provision of objective evidence that specified requirements have been fulfilled 2005-01

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FOOD SAFETY HAZARD and CONTROL MEASURE 1.

HAZARD IDENTIFICATION Refer to CODEX ALIMENTARIUS CAP/RCP 119 Rev 4 (2003) 1.1. BIOLOGICAL HAZARD Include microbiological organisms such as bacteria, viruses, fungi and parasites. Control measures can be heat, cold, chemicals, physical and mechanical check, radiation

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FOOD SAFETY HAZARD and CONTROL MEASURE 1.

HAZARD IDENTIFICATION 1.2. CHEMICAL HAZARD May be naturally occurring or added during the processing of food. Example: allergens, pesticides, antibiotics or hormones, disinfectants. Control measures can be labeling, primary production control, correct handling.

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FOOD SAFETY HAZARD and CONTROL MEASURE 1.

HAZARD IDENTIFICATION 1.3. PHYSICAL HAZARD Are Foreign objects in food (sharp, hard, chocking). Source from contamination and/or poor practice. Control measures can be sorting, sieving, metal detecting.

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FOOD SAFETY HAZARD and CONTROL MEASURE 2.

HOW TO CONDUCT A HAZARD ANALYSIS Must be conducted for each existing product, process type and for each new product and every any changes. Review should include:

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Incoming material

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Evaluate processing operations

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Observe actual operating practice

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FOOD SAFETY HAZARD and CONTROL MEASURE 3.

CONTROL MEASURE Are any actions and activities that can be used to prevent or eliminate or reduce a food safety hazard to an acceptable level Risk analysis methods should be implemented

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FOOD SAFETY HAZARD and CONTROL MEASURE 4.

RISK ASSESSMENT Consideration should be given to:

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Likely occurrence of hazard and severity of their adverse health effects

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Qualitative and/or quantitative evaluation of the presence of hazard

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Survival or multiplication of microorganism

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Production or persistence in food of toxins, chemicals or physical agents

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Conditions leading to above 7

FOOD SAFETY HAZARD and CONTROL MEASURE 5.

RISK MANAGEMENT Management will need to identify existing countermeasures and recommend appropriate options. Consider threat and vulnerability [severity]

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ISO 22000:2005

4. Food Safety Management System

4.1 General Requirements

Define the SCOPE Shall specify

Products/ Product categories

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Processes

Production sites

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4.1 General Requirements The organization shall: a) identify, evaluate, control Æ hazards that reasonably expected to occur Æ product do not harm the consumer b) communicate safety issue of products throughout the food chain c) communicate food safety management system throughout the organization d) evaluate periodically & update the system to reflect the organization's activities and recent information on hazards subject to control 2005- REV 0

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4.1 General Requirements OUTSOURCE PROCESS Shall be controlled products

processes

Type of control shall be Identified & Documented 2005- REV 0

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4.2 Documentation Requirements 4.2.1. General Documentation shall include: Statements of safety Policy & Objectives Procedure & records Guidance for effective development, implementation & updating the system 2005- REV 0

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4.2 Documentation Requirements 4.2.2. Control of Documents Shall ensure all proposed changes are reviewed prior to implementation to determine Effects on food safety

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Impact on the food safety management system

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4.2 Documentation Requirements

Documented procedure: Approve, Review & update, identified changes & revision status, available at point of use, legible & readily identified, external document, obsolete documents

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4.2 Documentation Requirements 4.2.3. Control of records Records as: evidence of conformity to requirements effective operation of the food safety management system Records shall: Legible, readily identifiable & retrievable Documented procedure: Correction, identification, storage, protection, retrieval, retention time & disposition of records 2005- REV 0

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ISO 22000:2005

See food safety hazard and control measure

ISO 22000:2005

5. Management Responsibility

5. Management Responsibility 5.1. Management Commitment a. Business objectives to support food safety b. Communicate the importance to meet Æ ISO 22000, statutory & regulatory, customer requirements c. Establish food safety policy d. Conduct management reviews e. Ensure the availability of resources

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5. Management Responsibility 5.2. Food Safety Policy Shall define, document & communicate a) Appropriate with organization's role in the food chain b) Conforms with statutory & regulatory, also customer requirements c) Communicate, implement & maintain at all levels d) Suitability is reviewed e) Adequately address communication f) Support by measurable objectives 2005- REV 0

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5. Management Responsibility 5.3. Food Safety Management System Planning a. Planning to meet 4.1 & objectives b. Maintain integrity of food safety management system when changes are planned & implemented 5.4. Responsibility & Authority Shall be defined & communicated to ensure effective operation & maintenance of food safety management system Appoint personnel to handle safety problem 2005- REV 0

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5. Management Responsibility 5.5. Food Safety Team Leader Shall be appointed by Top Management with responsibility & authority: a. Manage the team & its work b. Training & education the team members c. Establish, implement, maintain, update FSMS* d. Report to top management *FSMS = food safety management system 2005- REV 0

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5.6. Communication 5.6.1. External Communication Supplier & contractor

Customers & consumers

Food Authorities

Other organizations

Provide information on food safety aspects of products Food safety requirements from regulatory & customers Appointed personnel Input for updating system & for management review 2005- REV 0

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5.6. Communication 5.6.2. Internal Communication Effective arrangement to communicate issue that have an impact on food safety Changes need to be informed to the safety team: Products/ new products; raw material, ingredients & services; production systems & equipment; production premises, location of equipments, surrounding environment; cleaning & sanitation programmed; packaging, storage & distribution systems; personnel qualification; statutory & regulatory requirements; hazards & control measure; customer; enquiries from external; complaint; other conditions with impact to food safety. 2005- REV 0

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5. Management Responsibility 5.7. Emergency Preparedness & Response Top management shall establish, implement & maintain procedure to manage potential emergency situations & accidents that can impact to food safety relevant with the role of the organization in the food chain.

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5. Management Responsibility 5.8. Management Review 5.8.1. General Review at planned intervals to ensure its suitability, adequacy, & effectiveness. Assess opportunity for improvement & the need to change. Review the food safety policy Record shall be maintained

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5.8. Management Review 5.8.2. Review Input Follow up from previous review

Analysis of verification

Emergency, accident, withdrawals

INPUT

Communication, customer feed back

External audit/ inspections

Changes

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Review & Updating System 20

5.8. Management Review 5.8.3. Review Output Decision & Action Assurance of food safety

Resource needs OUTPUT

Improvement of FSMS*

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Revise policy & objectives

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ISO 22000:2005

6. Resource Management

6. Resource Management 6.1. Provision of resources Shall provide adequate resource for establishment, implementation, maintenance & updating of FSMS* 6.2. Human resources 6.2.1. General Competent personnel [appropriate education, training, skills & experience] to carry out activities related with food safety. Where external expert is required, records of agreement for responsibility & authority shall be available. 2005- REV 0

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6.2. Human resources 6.2.2. Competence, Awareness & Training The organization shall: identify competency of personnel Æ impact on food safety provide training or take other action ensure trained personnel to handle monitoring, corrections & corrective action evaluate the implementation & effectiveness ensure awareness of personnel in contributing to food safety ensure effective communication is understood maintain appropriate record 2005- REV 0

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6. Resource Management 6.3. Infrastructure The organization shall provide the resources for establishment, maintenance of the necessary infrastructure 6.4. Work environment The organization shall provide the resources for establishment, management and maintenance of the necessary work environment

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ISO 22000:2005

7. Planning and Realization of Safe Products

7. Planning & Realization of Safe Products 7.1. General The organization shall plan & develop the processes for the realization of safe products 7.2. Prerequisite Programmed 7.2.1. PRP(s) to control: a) Likelihood hazards from work environment b) Biological, chemical & physical contamination, cross contamination between products c) Hazard(s) levels in the product & processing environment 2005- REV 0

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7.2. Prerequisite Programmed 7.2.2. The PRP(s) shall be: a. Appropriate to the organizational needs b. Appropriate to the size & type of the operation & nature of products c. Implemented across the entire production system d. Approved by the food safety team 7.2.3. Selecting & establishing PRP(s) shall consider & utilize appropriate information

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7.2. Prerequisite Programmed Items shall be considered: a. Construction & lay-out of building; also utilities b. Lay-out of premises c. Supplies of air, water, energy d. Supporting services including waste & sewage disposal e. Suitability of equipment [cleaning, maintenance & preventative maintenance ]

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7.2. Prerequisite Programmed f. Management of purchase materials, supplies, disposals & handling of products g. Prevention of cross contamination h. Cleaning & sanitizing i. Pest control j. Personnel hygiene k. Other aspects as appropriate

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7.2. Prerequisite Programmed PRP(s) shall be:

Verified as planned

Modified as necessary

Records shall be maintained

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7.3. Preliminary Steps to Enable Hazard Analysis 7.3.1. General All relevant information to conduct hazard analysis shall be collected, maintained, updated & documented. Record shall be maintained 7.3.2. Food Safety Team Shall be appointed Shall have a combination of multidiscipline knowledge & experience Records shall be maintained 2005- REV 0

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7.3. Preliminary Steps to Enable Hazard Analysis 7.3.3. Product Characteristic 7.3.3.1. Raw materials, ingredient & product contact materials Specify as appropriate: biological, chemical & physical characteristic composition (including additives & processing aids) origin method of production 2005- REV 0

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7.3.3. Product Characteristic Specify as …… delivery methods & packaging storage conditions & shelf life preparation &/ handling before use & processing food safety related to acceptance criteria or purchased materials Statutory & regulatory shall be identified Specification shall be kept updated 2005- REV 0

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7.3.3. Product Characteristic 7.3.3.2. End product characteristics Specify as appropriate: Product name Composition Biological, chemical & physical characteristics relevant to food safety Intended shelf life & storage conditions Packaging

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7.3.3. Product Characteristic Specify ….. Labeling relating to food safety &/ instruction for handling, preparation & usage Method (s) of distribution

Statutory & regulatory shall be identified Specification shall be kept updated

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7.3. Preliminary Steps to Enable Hazard Analysis 7.3.4. Intended Use Information for users & consumers: intended use & handling of the end product product & process category vulnerable group of consumers mishandling & misuse of end product

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7.3. Preliminary Steps to Enable Hazard Analysis 7.3.5. Flow diagrams, process steps & control measure 7.3.5.1. Flow diagrams Products or process category

Shall be

Clear, accurate, detail

As a basis for hazards analysis 2005- REV 0

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7.3.5. Flow diagrams, process steps & control measure Include as appropriate: a. The sequence & interaction of all steps b. Outsourced processes & subcontracted work c. Input of raw materials, ingredients & intermediate products d. Output of end products, intermediate products, by products & waste Safety team shall verify the accuracy by site checking

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7.3.5. Flow diagrams, process steps & control measure 7.3.5.2. Description of process steps & control measure Specify existing control measure, process parameter, &/ stringency applied or procedure that influence food safety External requirements shall also be specified

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7.4. HAZARD ANALYSIS 7.4.1. General Safety team determines hazards need to be controlled and the control measure 7.4.2. Hazard identification & determination of acceptable level All hazards that are reasonably expected to occur [product, process, facilities] shall be identified & recorded 2005- REV 0

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7.4. HAZARD ANALYSIS Identification shall be based on: collected data & information experience external information information from food chain

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7.4. HAZARD ANALYSIS

Identified hazards

Acceptable level determine consider

Statutory & regulatory Customer requirements Experiences Intended use 2005- REV 0

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7.4. HAZARD ANALYSIS 7.4.3. Hazard Assessment To determine the hazards whether its elimination/reduction is essential to produce safe food, and whether its control is needed to meet the acceptable level. Hazard evaluation: Severity of adverse health effects

Likelihood of their occurrence

Record Æ methodology & results 2005- REV 0

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7.4. HAZARD ANALYSIS 7.4.4. Selection & assessment of control measure Control Measure Æ shall prevent, eliminate or reduce the hazard to acceptable level Control measure is categorized as: Operational PRP(s) HACCP plan Method & parameter used shall be specified & recorded 2005- REV 0

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7.4. HAZARD ANALYSIS Assessment of control measure refer to: a) Hazard versus intensity applied b) Feasibility for monitoring c) Its place within the system d) Severity of consequences if failure e) Control measure specifically to eliminate or reduce hazards f) Synergistic effects g) Likelihood of failure 2005- REV 0

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7.5. Establishing the Operational PRP(s) Include: a. Identified hazard & control b. Monitoring procedure c. Correction & corrective actions d. Responsibility & authority

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7.6. Establishing the HACCP Plan 7.6.1. HACCP Plan “Shall be documented” Include information: a) Hazard(s) to be controlled

e) Corrective action(s)

b) Control measure(s)

f) Responsibility for monitoring

c) Critical limit(s) d) Monitoring procedure(s)

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g) Record(s) of monitoring

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7.6. Establishing the HACCP Plan 7.6.2. Identification of critical control points Hazard need to be controlled, CCP shall be identified 7.6.3. Determination of critical limits for critical control points Applied for each CCP Measurable Documented the rationale Based on subjective data 2005- REV 0

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7.6. Establishing the HACCP Plan 7.6.4. System for the monitoring CCP(s) Cover: a. Measurements/observations Æ result Æ time frame b. Monitoring device c. Calibration methods d. Monitoring frequency e. Responsibility & authority f. Records

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u r t ins

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7.6. Establishing the HACCP Plan 7.6.5. Actions when monitoring exceed critical limits Corrections & corrective actions: •

Shall be planned & specified

•

Identify root cause

•

Bring limit under control

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Prevent recurrence Documented procedure to handle potential unsafe products

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7.7. Updating of Preliminary Information & Documents Information shall be updated: È Product characteristic È Intended use È Flow diagram È Process steps È Control measures È PRP(s) procedure & instructions È HACCP Plan

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7.8. Verification Planning Shall establish: Purpose, methods, frequencies & responsibility Shall confirm: Implementation of PRP Update input for hazard analysis Effective implementation of operational PRP(s) & HACCP plan & company procedure s d r Hazard levels still acceptable o c re Record is maintained 2005- REV 0

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7.9. Traceability System Ba

tch o

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aw

Product lots ma te

ria

Delivery records

l

Processing

Traceability system shall be able to identify: Raw material from immediate suppliers Finished products distribution to immediate distributors 2005- REV 0

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7.9. Traceability System

Records keeping shall: accordance to statutory & regulatory, accordance to customer requirements consider shelf life of products

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7.10. Control of Nonconformity 7.10.1. Corrections If Critical limits are exceeded; loss control of PRP(s) Documented procedure define: Identification & assessment of affected products Review of implemented corrections Corrections shall: approved by responsible person records Æ nonconformity, cause & consequence, traceability for affected lots 2005- REV 0

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7.10. Control of Nonconformity 7.10.2. Corrective Actions Procedures: a. Review non-conformity [including customer complaints] b. Review trends during monitoring c. Determine the cause(s) d. Evaluate action to prevent reoccur e. Determine & implement action f. Record action taken g. Review effectiveness of action taken 2005- REV 0

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7.10. Control of Nonconformity 7.10.3. Handling of potentially unsafe products The organization shall prevent the nonconforming products entering the food chain

Nonconformance products shall be hold Released unsafe product Æ notify relevant parties & initiate withdrawal Keep records related with unsafe products

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7.10. Control of Nonconformity 7.10.3.1. Evaluation of release Nonconformance product can be released as safe product if: evidence other control is effective, result of sampling, analysis or verification show within acceptable level. 7.10.3.2. Disposition of NC products Reprocess within/outside to eliminate/reduce the hazard 2005- REV 0

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Destruction/disposal as waste 59

7.10. Control of Nonconformity 7.10.4. Withdrawals Appointed authorized personnel to initiate & execute Establish procedure: - notification to relevant interested parties [regulatory authorities, customers &/ consumers] - handling withdrawn products & products in stock - sequence actions to be taken in the event of withdrawal Records & traceability 2005- REV 0

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7.10. Control of Nonconformity The cause, extent & result of withdrawal as an input to management review The programmed shall be verified & recorded through appropriate technique [challenge testing, mock withdrawal, practice withdrawal]

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ISO 22000:2005

8. Validation, Verification and Improvement of the FSMS

8. Validation, Verification and Improvement of the FSMS 8.2. Validation of control measure combination Shall validate: a. Capability of selected control measure b. Effectiveness of control measure

If not comply a & b Æ shall be modified & reassessed

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8. Validation, Verification and Improvement of the FSMS 8.3. Control of monitoring & measuring Measuring equipment & methods used shall: be calibrated/ verified at specific interval or prior to use [refer to international/ national standards] be identified Æ calibration status be safeguarded from adjustment be protected from damage & deterioration

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8. Validation, Verification and Improvement of the FSMS 8.3. Control of monitoring … If the result of validation is not conform: Action taken on the equipment & product affected Record is maintained Usage of computer software shall be confirmed prior initial used & reconfirm as necessary.

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8.4. Food Safety Management System 8.4.1. Internal audit To determine FSMS

Effective implemented & updated

Conform to planned arrangement Define criteria, scope, frequency & methods c re

ds r o p

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re u d

Independent auditor Follow up nonconformity without delay Verification corrective action taken 66

8.4. Food Safety Management System 8.4.2. Evaluation of individual verification results The evaluation result is not conform, to review: a. Procedures & communication channels b. Hazard analysis, operational PRP(s), HACCP plan c. PRP(s) d. Human resource management & training activities

Verification by product testing if it is not conform Æ handle as potentially unsafe product 2005- REV 0

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8.4. Food Safety Management System 8.4.3. Analysis of results of verification activities Analyze the result of verification activities, internal audits and external audits Purpose: Confirm the performance meets planned arrangements, Standard, FSMS requirements established by the organization Identify the need for updating/improvement Identify the trends for potential unsafe Input for Internal audit programmed Evidence effectiveness of CAPA 2005- REV 0

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8.5. Improvement 8.5.1. Continual Improvement Management Review

Communication through Internal audit

FSMS updating

Validation of Control measure

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8.5. Improvement 8.5.2. FSMS Updating Evaluate FSMS at planned intervals Input: Communication Other information concerning suitability, adequacy & effectiveness of the FSMS Result of verification activities Output from management review 2005- REV 0

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FROM FARM TO PLATE

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