iso 22000

INTRODUCTION TO

ISO 22000:2005

FOOD SAFETY

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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

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AIM OF ISO 22000:2005

It requires an organization to include any applicable food safety related statutory & regulatory requirements

into its food safety management system To harmonize on a global scale the

requirements for food safety management for businesses within the food chain

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INTRODUCTION

Food Safety

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FOOD CHAIN

Feed Producers

With all kinds of transportation used

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INTER-RELATED ORGANIZATION

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KEY ELEMENTS of ISO 22000

Interactive Communication

System Management

Prerequisite Programmed

HACCP Principles

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Key of Food Safety Management System

Hazard Analysis facilities process Control Measure PRP Operational PRP HACCP plan Food chain

ISO 22000:2005

SCOPE

and

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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

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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

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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

ISO 22000:2005

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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

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Terms & Definitions ….

Control measure

<Food safety> 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)

<food safety> 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

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Terms & Definitions ….

Critical control point

<food safety> 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

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FOOD SAFETY HAZARD and

CONTROL MEASURE

1. HAZARD IDENTIFICATION

Refer to CODEX ALIMENTARIUS CAP/RCP 1-19 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: - Incoming material

- Evaluate processing operations - 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

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FOOD SAFETY HAZARD and

CONTROL MEASURE

4. RISK ASSESSMENT

Consideration should be given to:

- Likely occurrence of hazard and severity of their adverse health effects

- Qualitative and/or quantitative evaluation of the presence of hazard

- Survival or multiplication of microorganism - Production or persistence in food of toxins,

chemicals or physical agents - Conditions leading to above

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FOOD SAFETY HAZARD and

CONTROL MEASURE

5. RISK MANAGEMENT

Management will need to identify existing countermeasures and recommend appropriate options.

ISO 22000:2005

4. Food Safety

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4.1 General Requirements

Processes Production sites Shall specify

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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

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4.1 General Requirements

OUTSOURCE PROCESS

processes products

Shall be controlled

Type of control shall be

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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

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4.2 Documentation Requirements

4.2.2. Control of Documents

Shall ensure all proposed changes are reviewed prior to implementation

Effects on food safety _{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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4.2.3. Control of records

4.2 Documentation Requirements

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

ISO 22000:2005

See food safety hazard and

control measure

ISO 22000:2005

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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

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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

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5.

Management

Responsibility

5.3. Food Safety Management System Planning

5.4. Responsibility & Authority

a. Planning to meet 4.1 & objectives

b. Maintain integrity of food safety management system when changes are planned & implemented

Shall be defined & communicated to ensure effective operation & maintenance of food safety management system

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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

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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

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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

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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

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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

Review & Updating System

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5.8. Management Review

5.8.3. Review Output

OUTPUT

Decision & Action

Assurance of food safety Improvement of FSMS* Resource needs

Revise policy & objectives

ISO 22000:2005

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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.

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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

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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

ISO 22000:2005

7. Planning and Realization

of Safe Products

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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

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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 &

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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 &

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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

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7.2. Prerequisite Programmed

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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

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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

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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

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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

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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 As a basis for hazards analysis Clear, accurate, detail Shall be

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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

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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

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7.4. HAZARD ANALYSIS

Identification shall be based on: collected data & information experience

external information

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7.4. HAZARD ANALYSIS

Identified hazards Acceptable level determine

Statutory & regulatory Customer requirements

Experiences Intended use

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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.

Likelihood of their occurrence

Hazard evaluation:

Severity of adverse health effects

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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

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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

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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 b) Control measure(s) c) Critical limit(s) d) Monitoring procedure(s) e) Corrective action(s) f) Responsibility for monitoring 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

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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 procedu re instru ction s record s

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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 • 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

Hazard levels still acceptable

Record is maintained rec

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7.9. Traceability System

Traceability system shall be able to identify: Raw material from immediate suppliers

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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

Documented procedure define:

Identification & assessment of affected products Review of implemented corrections

If Critical limits are exceeded; loss control of PRP(s)

Corrections shall:

approved by responsible person

records Æ nonconformity, cause & consequence, traceability for affected lots

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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

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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

Destruction/disposal as waste

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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

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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]

ISO 22000:2005

8. Validation, Verification

and Improvement

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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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8.3. 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

8. Validation, Verification and

Improvement of the FSMS

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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.

8. Validation, Verification and

Improvement of the FSMS

2005- REV 0 66 8.4.1. Internal audit To determine FSMS Conform to planned arrangement

Effective implemented & updated

Define criteria, scope, frequency & methods Independent auditor

Follow up nonconformity without delay Verification corrective action taken record

s

proce

dure

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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

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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

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8.5. Improvement

8.5.1. Continual Improvement

Communication Management _Review

Internal audit Evaluation of individual ve rification resu lts Validation of Control measure through FSMS updating

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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 record s

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