Detailed presentation on ISO 22000

1. Food Safety
Management System
Dr. Naveen Kumar
Shoolini University of Biotechnology and
Management Sciences, Solan (HP)

2. Content
 ISO: introduction
 Food safety
 ISO 22000:
• Introduction
• Benefits
• Key elements
• Structure
• Concerns
 Conclusion

3. What is ISO ?
• International organisation for standardization
– Set up in 1947; located in Geneva, Switzerland
– Non-governmental
– A network of national standards bodies (148 countries)
– A bridge between public and private sectors
• An ISO Standard
– Voluntary (no legal authority)
– Purpose:
• To facilitates exchanges (trade) - harmonizing national standards
• Meet a real need (market driven)
• Well-known ISO management standards:
– ISO 9000 (generic quality management)
– ISO 14000 (generic environmental management)

4.  Assurance that food will not cause harm to the
consumer when it is prepared and/or eaten
according to its intended use.
Codex Alimentarius
Food Safety

5.  Protecting People
 Keeping the Employees and Customers
 Preventing Food Safety Errors
Food Safety

6. Entry of Hazards in Food Chain

7. FAMI-QS
GMO
ISO 9001
GMP standard for Corrugated &
Solid Board
EFSIS
IFS
GFSI
Guide
SQF
AG 9000
McDonalds system
Kraft food system
Nestlé NQS
Eurepgap
Friesland Coberco FSS
DS 3027
BRC-IoP
BRC-Food
Ducth HACCP
Irish HACCP
M&S system
Aldi system
GMP
GTP
Global food standards
ISO 22000:2005

8. ISO 22000:2005
 A management system designed to enable organizations
to control food safety hazards along the food chain in
order to ensure that food is safe at the time of
consumption.
 Developed by ISO/TC 34 and published on September 1,
2005
ISO 22000:2005, clause 1

9. Food Safety Management System
 Why it is required?
 Intense farming and processing of food
 Increase in meals consumed outside home
 Increase in ready to eat foods
 More traveling across the world
 Increased amount of exotic imported foods
 Increase in number of susceptible people
Datta K., 2010

10. Features
 First global food safety standard.
 Harmonizes the voluntary international standards.
 Employs proven management system principles.
 Enables a common understanding of what a food safety
management system is.
 Requires legal compliance checking
 Integrates existing good practice
 Internal and external monitoring
ISO 22000:2005

11.  Benefits
 A family of standards
 Integrated food chain approach
 Continuous improvement
 Internationality : a passport for exporting
 Tailor – made approach
ISO 22000:2005

12. Current approach
 Starting point: flow diagram
 Focus on determining CCPs
 Limited documentation of
hazard analysis
 Tends to result in static
control system
 Semi-quantitative approach
ISO 22000 approach
 Starting point: output ÷input
 Focus on determining control
measure combination
 Full documentation of hazard
analysis
 Encourage dynamic control
system
 Enable a quantitative
approach
Main difference to current approach

13.  Consideration to effect of the food chain on
organization’s operation
 Identification, application and management of a system
of processes within the organization
 Ongoing control over linkage, combination and
interaction of individual processes within the system of
processes
Food chain and process approach

14. Process Approach
A desired result is achieved more efficiently when related
resources and activities are managed as a process

15. FSMS Process model

16. Key elements
Interactive
Communication
System Approach
to FSM
Pre-requisite
Programs
HACCP
Principles
ISO 22000:2005
Control Food Safety
Hazards

17.  Scope
 Normative references
 Terms and definitions
 Requirements
ISO 22000 : structure

18.  All requirements of this International Standard are
generic and are intended to be applicable to all
organisations in the food chain, regardless of type,
size and complexity.
 This includes organizations directly or indirectly involved
in one or more steps of the food chain
 The standard allows small and/or less developed
organization to implement an externally developed
combination of control measures
Scope

19. • Annex A (informative)
Cross reference between ISO 22000:2005 and ISO 9001:2000
• Annex B (informative)
Cross references between HACCP principles and ISO 22000
• Annex C (informative)
Codex references providing examples of control measures,
including prerequisite programmes and guidance for their
selection and use
Normative referencesNormative references

20.  Risk & Hazard
 Risk : probability of getting ill by ingesting a certain hazard &
the severity of that illness
 Hazard : agent causing the illness
 Risk analysis & hazard analysis
 Risk analysis : governmental task
 Hazard analysis : industry task
 Monitoring - Verification - Validation
Terms that are often confusedTerms that are often confused
During operation
Documenting that
control measure
functions as
intended
After operation
Documenting that
monitoring work &
degree of intended
control has been
delivered
Prior to operation
Documenting that
control measure is
capable of delivering
needed effects

21.  Section 4: Food Safety Management System
(FSMS) – General Requirements
 Section 5: Management Responsibility
 Section 6: Resource Management
 Section 7: Planning and Realization of Safe
Products
 Section 8: Validation, Verification & Improvement
of the Food Safety Management System
ISO 22000 standard - Requirements

22.  Establish a food safety management system
 Documentation requirements
 Develop FSMS documents
 Control of documents
 Control of records
Section 4: FSMS general requirement
ALMARAI QUALITY ASSURANCE
MANUAL : MILK AND LABAN NUMBER : ML-012
APPLIED AT : CENTRAL PROCESSING PLANT ISSUED : 11/03/01
APPROVED BY : REVISION NO. : 01
PM-M&L
AUTHOR (S) : Randy
SUBJECT : RE-USING OF BOTTLES
1.0 PURPOSE
To specify the steps to be followed for re-using of bottles at the debagging area.
2.0 PROCEDURE
2.1 Use red poly bags for bottles, which are damaged and cannot be re-used.
2.2 Use white poly bags for bottle, which can be re-used.
2.3 Bottles collected from inside sleever machines or from the floor to be put
in red poly bags.
2.4 Red bags containing damage or dirty bottle should be sent back to Blow
Moulding section.
2.5 Re-used bottle shall be used immediately, periodically within the shift. If
not possible, ensure that the plastic bags are tightly closed (to prevent
any contamination) and sent back to Blow Moulding section.
2.6 Clean gloves shall be worn before handling the bottles.
2.7 Remove sleeves and erase codes found on the bottle before sending to
Blow Moulding section.
2.8 Carton boxes shall not be used for collecting bottles without polythene
bags.
3.0 ATTACHMENTS
N/A

23.  Management commitment
 Food Safety Policy
 Food safety management system planning
 Responsibility and authority
Section 5 – Management Responsibility

24.  Food safety team leader
 Communications
– External communication
– Internal communication
 Emergency preparedness and response
– Documented procedures to manage potential emergency
situations and accidents
 Management Review
– Review input: Food safety related requirements
– Review output
Section 5 – Management Responsibility

25. Section 6 – Resource Management
• Provide adequate FSMS resources
– Establish
– Implement
– Maintain
– Update
 Provide adequate human Resource
– Competence, Awareness and Training
• Provide adequate infrastructure

26.  Work Environment
– Measures to prevent cross contamination
– Work space requirements
– Protective work wear requirements
– Availability and location of employee facilities
Section 6 – Resource Management

27.  The organization shall plan and develop the processes
needed for the realization of safe products
 The organization shall implement, operate and ensure
the effectiveness of the planned activities and any
change to those activities including;
– Pre-requisite programmes ( PRPs)
– Operational PRPs
– HACCP plan
Section 7- Planning and Realization of Safe ProductsSection 7- Planning and Realization of Safe Products

28.  Establish prerequisite programmes (PRPs)
 Preliminary steps to enable hazard analysis
 Hazard analysis
 Establishing the operational prerequisite
programmes (oPRPs)
 Establishing the HACCP plan
Section 7- Planning and Realization of Safe ProductsSection 7- Planning and Realization of Safe Products

29.  The organization shall update the following information
– Product characteristics
– Intended use
– Process steps
– Control measures
– HACCP plan
– Procedures instructions specifying PRPs
• Plan and perform verification activities
Section 7- Planning and Realization of Safe ProductsSection 7- Planning and Realization of Safe Products

30.  Traceability system
– The system shall enables the identification of product
lots and their relation to batches of raw material,
processing and delivery records.
– The system shall be able to identify incoming material
from the suppliers and the initial distribution route of the
product.
Section 7- Planning and Realization of Safe Products

31. • Control of non conformity
– Corrections
– Corrective actions
– Handling potentially unsafe products
– Evaluation of release
– Disposition of Nonconforming products
– Withdrawals
Section 7-Planning and Realization of Safe Products

32.  Confirm and validate food safety method
 FSMS verification
– Internal audits
– Evaluation of individual verification results
– Analysis of results of verification activities
 Improvement
Section 8 - Validation, Verification & ImprovementSection 8 - Validation, Verification & Improvement

33. Certification AgenciesCertification Agencies

34. How to get ISO 22000 CertificationHow to get ISO 22000 Certification
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Development of ISO 22000 Plans &
Other Documents
Development of ISO 22000 Plans &
Other Documents
Pre-requisite Programs (PRPs /
GMP’s)
Implementation of the SystemImplementation of the System
Conducting the Internal AuditConducting the Internal Audit
Selection of Certification BodySelection of Certification Body
Pre-assessment by third partyPre-assessment by third party
Certification audit by third partyCertification audit by third party
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36.  Initial difficulties
 Readability and cross referencing
 No proven track record of benefits of the integrated food
chain approach
 Current depth of auditor experience and expertise
 Ongoing concerns
 Additional cost / investment for manufacturers to ensure
acceptable certification
 Ownership and international structure means relatively
lengthy procedures for amendments
 Quality is not directly addressed
Concerns

37. • Common understanding of benefits
• Deriving forces: food producers, retailer and
national authorities
• Manoeuvre between authorities, clients and
internal company demands
• Ultimate objective: to put safe food on the
table of consumer
Conclusion