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Iso 22000 PDF
Iso 22000 PDF
Iso 22000 PDF
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
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INTRODUCTION
Food Safety
At point of
Food Borne HAZARD consumption
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FOOD CHAIN
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
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ISO 22000:2005
SCOPE
and
NORMATIVE REFERENCE
Who can implement?
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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
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ISO 22000:2005.
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NORMATIVE REFERENCE
ISO 9000:2000
Quality Management Systems Fundamentals & vocabulary
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ISO 22000:2005
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
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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
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4.1 General Requirements
OUTSOURCE PROCESS
Shall be controlled
processes products
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4.2 Documentation Requirements
4.2.1. General
Documentation shall include:
Statements of safety
Policy & Objectives
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4.2 Documentation Requirements
to determine
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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
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
5. Management Responsibility
5. Management Responsibility
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5. Management Responsibility
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5. Management Responsibility
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5. Management Responsibility
5.8.1. General
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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
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5.8. Management Review
5.8.3. Review Output
Assurance of Resource
food safety needs
OUTPUT
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ISO 22000:2005
6. Resource Management
6. Resource Management
6.2.1. General
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6.2. Human resources
6.2.2. Competence, Awareness & Training
6.3. Infrastructure
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ISO 22000:2005
7.1. General
The organization shall plan & develop the processes for the
realization of safe products
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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
Verified as Modified as
planned necessary
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7.3. Preliminary Steps to Enable
Hazard Analysis
7.3.1. General
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
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7.3.3. Product Characteristic
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
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7.3. Preliminary Steps to Enable
Hazard Analysis
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7.3. Preliminary Steps to Enable
Hazard Analysis
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
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7.3.5. Flow diagrams, process steps &
control measure
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7.4. HAZARD ANALYSIS
7.4.1. General
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7.4. HAZARD ANALYSIS
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7.4. HAZARD ANALYSIS
consider
Hazard evaluation:
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7.4. HAZARD ANALYSIS
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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
Shall be documented
Include information:
a) Hazard(s) to be controlled e) Corrective action(s)
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7.6. Establishing the HACCP Plan
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7.6. Establishing the HACCP Plan
Cover:
a. Measurements/observations result 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
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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
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7.9. Traceability System
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7.10. Control of Nonconformity
7.10.1. Corrections
Corrections shall:
approved by responsible person
records nonconformity, cause & consequence,
traceability for affected lots
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7.10. Control of Nonconformity
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
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7.10. Control of Nonconformity
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7.10. Control of Nonconformity
7.10.4. Withdrawals
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7.10. Control of Nonconformity
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ISO 22000:2005
8. Validation, Verification
and Improvement
of the FSMS
8. Validation, Verification and
Improvement of the FSMS
Shall validate:
a. Capability of selected control measure
b. Effectiveness of control measure
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8. Validation, Verification and
Improvement of the FSMS
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8. Validation, Verification and
Improvement of the FSMS
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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
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
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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
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
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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