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INTRODUCTION TOISO 22000:2005FOOD SAFETY
MANAGEMENT SYSTEM
2005-01 2
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 3
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
2005-01 4
INTRODUCTION
Food Safety
Food Borne HAZARDAt point of consumption
2005-01 5
FOOD CHAIN
Feed Producers
With all kinds of transportation used
2005-01 6
INTER-RELATED ORGANIZATION
PRODUCERS of
Equipment
Packaging Material
Cleaning agent
Additives & Ingredient
Service Providers
2005-01 7
KEY ELEMENTS of ISO 22000
Interactive Communication
System Management
Prerequisite Programmed
HACCP Principles
ISO 22000
2005-01 8
Key of Food Safety Management System
Hazard Analysisfacilities
processControl
Measure
PRP Operational PRP
HACCP plan
Food chain
ISO 22000:2005
SCOPE and
NORMATIVE REFERENCE
2005-01 10
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
2005-01 11
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 12
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
2005-01 13
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
2005-01 14
NORMATIVE REFERENCE
ISO 9000:2000
Quality Management Systems – Fundamentals & vocabulary
ISO 22000:2005
TERMS & DEFINITION
2005-01 16
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, foodwith the potential to cause an adverse health
2005-01 17
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
2005-01 18
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 reduceit 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 theproduct(s) or in the processing environment
Verification
Confirmation, through the provision of objective evidence that specified requirements have been fulfilled
2005-01 2
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
2005-01 3
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.
2005-01 4
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.
2005-01 5
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
2005-01 6
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
2005-01 7
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
2005-01 8
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]
ISO 22000:2005
4. Food Safety Management System
2005- REV 0 3
4.1 General Requirements
Define the SCOPE
Products/ Product categories
Processes Production sites
Shall specify
2005- REV 0 4
4.1 General Requirements
The organization shall:
a) identify, evaluate, control hazards that reasonably expected to occur 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 5
4.1 General Requirements
OUTSOURCE PROCESS
processes products
Shall be controlled
Type of control shall be Identified & Documented
2005- REV 0 6
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 7
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
to determine
2005- REV 0 8
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
2005- REV 0 9
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
5. Management Responsibility
2005- REV 0 12
5. Management Responsibility
5.1. Management Commitment
a. Business objectives to support food safety
b. Communicate the importance to meet ISO 22000, statutory & regulatory, customer requirements
c. Establish food safety policy
d. Conduct management reviews
e. Ensure the availability of resources
2005- REV 0 13
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 14
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
Appoint personnel to handle safety problem
2005- REV 0 15
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 16
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 17
5.6. Communication
5.6.2. Internal CommunicationEffective 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 18
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.
2005- REV 0 19
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
2005- REV 0 20
5.8. Management Review
5.8.2. Review Input
Follow up from previous review
Analysis of verification
Changes
Emergency, accident, withdrawals
Communication, customer feed
back
External audit/ inspections
INPUT
Review & Updating System
2005- REV 0 21
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
6. Resource Management
2005- REV 0 23
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 24
6.2. Human resources
6.2.2. Competence, Awareness & Training
The organization shall:
identify competency of personnel 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 25
6. Resource Management
6.3. Infrastructure
The organization shall provide the resources for establishment, maintenance of the necessary
infrastructure
6.4. Work environmentThe organization shall provide the resources for establishment, management and maintenance
of the necessary work environment
ISO 22000:2005
7. Planning and Realization of Safe Products
2005- REV 0 27
7. Planning & Realization of Safe Products
7.1. GeneralThe 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 28
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
2005- REV 0 29
7.2. Prerequisite ProgrammedItems 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 ]
2005- REV 0 30
7.2. Prerequisite Programmedf. 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
2005- REV 0 31
7.2. Prerequisite Programmed
PRP(s) shall be:
Verified as planned
Modified as necessary
Records shall be maintained
2005- REV 0 32
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 TeamShall be appointed
Shall have a combination of multidiscipline knowledge & experience
Records shall be maintained
2005- REV 0 33
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 34
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 35
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
2005- REV 0 36
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
2005- REV 0 37
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
2005- REV 0 38
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
2005- REV 0 39
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
2005- REV 0 40
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
2005- REV 0 41
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 42
7.4. HAZARD ANALYSIS
Identification shall be based on:
collected data & information
experience
external information
information from food chain
2005- REV 0 43
7.4. HAZARD ANALYSIS
Identified hazards Acceptable leveldetermine
Statutory & regulatory
Customer requirements
Experiences
Intended use
consider
2005- REV 0 44
7.4. HAZARD ANALYSIS
7.4.3. Hazard AssessmentTo 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
Record methodology & results
2005- REV 0 45
7.4. HAZARD ANALYSIS
7.4.4. Selection & assessment of control measure
Control Measure 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 46
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 47
7.5. Establishing the Operational PRP(s)
Include:
a. Identified hazard & control
b. Monitoring procedure
c. Correction & corrective actions
d. Responsibility & authority
2005- REV 0 48
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
2005- REV 0 49
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 50
7.6. Establishing the HACCP Plan
7.6.4. System for the monitoring CCP(s)
Cover:
a. Measurements/observations result time frame
b. Monitoring device
c. Calibration methods
d. Monitoring frequency
e. Responsibility & authority
f. Records
procedure
instructio
ns
records
2005- REV 0 51
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
2005- REV 0 52
7.7. Updating of Preliminary Information & Documents
Information shall be updated:
Product characteristic
Intended use
Flow diagram
Process steps
Control measures
PRP(s) procedure & instructions
HACCP Plan
2005- REV 0 53
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 maintainedrecords
2005- REV 0 54
7.9. Traceability System
Product lots
Batch of Raw materialProcessing
Delivery records
Traceability system shall be able to identify:
Raw material from immediate suppliers
Finished products distribution to immediate distributors
2005- REV 0 55
7.9. Traceability System
Records keeping shall:
accordance to statutory & regulatory,
accordance to customer requirements
consider shelf life of products
2005- REV 0 56
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 nonconformity, cause & consequence, traceability for affected lots
2005- REV 0 57
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 58
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 notify relevant parties & initiate withdrawal
Keep records related with unsafe products
2005- REV 0 59
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
or
2005- REV 0 60
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 61
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
of the FSMS
2005- REV 0 63
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 shall be modified & reassessed
2005- REV 0 64
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 calibration status
be safeguarded from adjustment
be protected from damage & deterioration
8. Validation, Verification and Improvement of the FSMS
2005- REV 0 65
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
records
procedure
8.4. Food Safety Management System
2005- REV 0 67
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 handle as potentially unsafe product
2005- REV 0 68
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
8.4. Food Safety Management System
2005- REV 0 69
8.5. Improvement
8.5.1. Continual Improvement
CommunicationManagement
Review
Internal audit
Evaluation of individual verification resultsValidation of Control measure
throughFSMS updating
2005- REV 0 70
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 records
2005- REV 0 71
FROM FARM TO PLATE
2005- REV 0 72