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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

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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

At point of
Food Borne HAZARD consumption

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FOOD CHAIN

With all kinds of


transportation used

Feed
Producers
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INTER-RELATED ORGANIZATION

Additives &
Equipment
Ingredient

PRODUCERS
of
Packaging
Material
Service
Cleaning Providers
agent

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KEY ELEMENTS of ISO 22000

Interactive Communication

System Management

ISO 22000

Prerequisite Programmed

HACCP Principles
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Key of Food Safety Management System

Food chain
facilities
Hazard Analysis
process
Control
Measure

PRP Operational HACCP


PRP plan

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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

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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
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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
Criterion which separates acceptability from unacceptability

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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
Risk analysis methods should be implemented

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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.
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 Processes Production sites


categories

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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

Shall be controlled

processes products

Type of control shall be


Identified & Documented

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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

to determine

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 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
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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
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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

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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


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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
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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.
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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
Emergency,
accident,
Follow up from withdrawals
previous review
Communication,
customer feed
back
Analysis of INPUT
verification
External audit/
inspections

Changes Review & Updating


System

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5.8. Management Review
5.8.3. Review Output

Decision & Action

Assurance of Resource
food safety needs

OUTPUT

Improvement Revise policy &


of FSMS* 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.

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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
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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
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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 Modified as
planned 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
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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

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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
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

Shall be
Products or Clear, accurate,
process category detail

As a basis for
hazards analysis

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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

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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
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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 Likelihood of their


health effects occurrence

Record Æ methodology & results


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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 e) Corrective action(s)

b) Control measure(s) f) Responsibility for


monitoring
c) Critical limit(s)
g) Record(s) of monitoring
d) Monitoring procedure(s)

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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 ure ns
d o
oc e u cti o r d s
r
pr ins
t rec
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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
ds
Hazard levels still acceptable o r
c
re
Record is maintained
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7.9. Traceability System

Ba
tch
o fR Product lots
aw
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

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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
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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
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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 or Destruction/disposal


eliminate/reduce the hazard 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]

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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
Effective implemented &
To determine updated
FSMS

Conform to planned
arrangement

Define criteria, scope, frequency & methods

ds Independent auditor
o r re
c u
re e d Follow up nonconformity without delay
ro c
p
Verification corrective action taken
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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. 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
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8.5. Improvement

8.5.1. Continual Improvement

Management
Communication Review
through
Internal audit FSMS updating

Validation of u lts
o n r e s
Control measure fi c at i
u al v eri
in d i vi d
n of
al u atio
E v

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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 s
o r d
Output from management review rec

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FROM FARM TO PLATE

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