a step closer towards globalization: iso 22000 ... -...

A step closer towards Globalization: ISO 22000 and PAS 220 in practice.

Vel Pillay

Manager, Food Safety Programs - Americas

A step closer towards Globalization: ISO 22000 and PAS 220 in practice.

Agenda

• Background

• ISO 22000 – A Process based model

FSMS Layout and weaknesses encountered in assessment• FSMS Layout and weaknesses encountered in assessment

• Some advantages of the FSMS

• Tips on implementation

A Process based model

FSMS Layout and weaknesses encountered in assessmentFSMS Layout and weaknesses encountered in assessment

BackgroundBackground

His “14 Recommendations” Changed the History of Japan and The World!

Edwards Deming – the visionary

1950 – Deming introduced the concept of Quality Control/Management to top management in Japan and outline the techniques to achieve better results.

Outcome: Sales of Japanese cars soared to a new height in reliability . It dominated the auto industry for decades to come

Between 1979 – 1982 – Ford lost $3 billion

Deming was hired to help build quality into the Ford brand cars. By 1986, Ford became the most profitable America auto company with earnings exceeding GM for the first time since 1920

His “14 Recommendations” Changed the History of Japan and The World!

Quality Control/Management to top in Japan and outline the techniques to achieve better results.

14

Outcome: Sales of Japanese cars soared to a new height in quality and . It dominated the auto industry for decades to come

Deming was hired to help build quality into the Ford brand cars. By 1986, Ford became the most profitable America auto company with earnings

Deming TeachingsSome of the Salient points:

• Learn to appreciate the system and understand the system is a network of interdependent processes that work together

• A system will not manage itself – you need to manage it

•There is no substitute for knowledge – institute a vigorous program of education and self-improvement.

•Management is an integral part of the process and needs to understand the •Management is an integral part of the process and needs to understand the processes and be committed to it.

• Cease dependence on inspection, Build quality into the product in the first place

• Plan do check and act

All these principles were incorporated into ISO 9001 when it was ratified in 2000. The same principles were also incorporated into ISO 22000

and understand the overall processes– A system is a network of interdependent processes that work together

you need to manage it

institute a vigorous program of

is an integral part of the process and needs to understand the

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is an integral part of the process and needs to understand the

, Build quality into the product in the first

All these principles were incorporated into ISO 9001 when it was ratified in 2000. The same principles were also incorporated into ISO 22000

The Process Based approachapproach

The Process Based approachapproach

Management Engagements

Guided by FSMS

CustomersLegislation

ScienceResearchGeneral

ProductionCompetency

Process based Model of ISO 9001 extended to FSMS

Requirements

Management Resources

Implementation of FSMSProduct Realisation

Entrée

Competency Company

RECIPIENTS

Management Engagements

Guided by FSMS Product characteristics =

Satisfied Customer

Process based Model of ISO 9001 extended to FSMS

Satisfaction

Measure,analyze , control and

Improve

Implementation of FSMSProduct Realisation

SortieSafe

Product

Customer

Evolution References

Quality Control

(Detection) Prevention

HACCP

1970s1980s

Evolution References

Food Safety Management System

Prevention Pilot Studies

HACCP

20051980s

Principle of ISO-22000

Verification

Modification

-requirements-materials-processes-products-PRP’s

Riskanalysis

Hazardidentification

Validation

Implementation

Riskanalysis operational

PRP´s

Control measures

HACCP planCCP´s

Continuous Improvement

Control Measures

Validate/Verify

Concept of a typical Food Safety Management System

Management Systemcomponents

Control Measures

Hazard Analysis & Critical Control Points

GMP/PRPs

Administration

Continuous Improvement

Control Measures

Validate/Verify

Concept of a typical Food Safety Management System

OPRPs

CCPs

Resources

Control Measures

Hazard Analysis & Critical Control Points

GMP/PRPs

CCPs

Food Safety Management System Layout

1 Scope2 Normative reference3 Terms and definitions4 FSMS5 Management responsibility6 Resource management7 Planning (includes “establish the HACCP)7 Planning (includes “establish the HACCP)8 Validation, verification and improvement of

the FSMS

Food Safety Management System Layout

Management responsibility

(includes “establish the HACCP)(includes “establish the HACCP)Validation, verification and improvement of

29

ISO 22000, PAS 220 & FSSC 22000ISO 22000, PAS 220 & FSSC 22000

LRQA: Business unit <set on slide master>

Taking Stock of FSSC 22000January 2011, the foundation for Food Safety System Certification started issuing accredited certificates for FSSC 22000.

FSSC Certificates Issued

600

700

0

100

200

300

400

500

600

Jan-1

0Mar-

10May

-10Ju

l-10

Sep-1

0Nov-1

0Ja

n-11

Mar-11

May-11

We believe the number is underestimated

Taking Stock of FSSC 22000January 2011, the foundation for Food Safety System Certification started issuing

FSSC Certificates Issued

May-11

Jul-1

1Sep

-11

FSSC CertificatesIssued


Overview of FSMS and some comments based on audit experiencebased on audit experienceOverview of FSMS and some comments based on audit experiencebased on audit experience


Clause 4 – Food Safety Management SystemRequirements: Food safety hazards are identified, evaluated and controlled and

appropriate information is communicated internally and externally and the system is updated.

Clause 4 also covered the administrative side including records

Some comments based on audit experience:• Not all hazards or potential hazards are identified in the hazard analysis• Not all documented procedures required by the standard are available• There is no differentiation between records and documents and the control required

for records are not available

Food Safety Management SystemRequirements: Food safety hazards are identified, evaluated and controlled and

appropriate information is communicated internally and externally and the

Clause 4 also covered the administrative side – document requirements

Some comments based on audit experience:Not all hazards or potential hazards are identified in the hazard analysisNot all documented procedures required by the standard are availableThere is no differentiation between records and documents and the control required


Clause 5 – Management ResponsibilityManagement Commitment: Top management shall provide evidence of its

commitment to the development and implementation of the FSMS and improve its effectiveness

Some comments based on audit experience:• Food safety policy is not well defined and updated• Objectives are not measurable and not based on previous challenges encountered• Objectives are not measurable and not based on previous challenges encountered• Lack of commitment from management • Management system planning is inadequate• Choosing the food safety team leader• Responsibility and authority of key members of the FSMS

Management ResponsibilityManagement Commitment: Top management shall provide evidence of its

commitment to the development and implementation of the FSMS and

Some comments based on audit experience:Food safety policy is not well defined and updatedObjectives are not measurable and not based on previous challenges encounteredObjectives are not measurable and not based on previous challenges encountered

Management system planning is inadequate

Responsibility and authority of key members of the FSMS


Clause 5 – CommunicationExternal and Internal communication: the Organization shall establish, implement

and maintain effective arrangement for communication with the supply chain and internally

Some comments based on audit experience:• Communication channels are not as clear as it should be• Records of communications are not readily available• Records of communications are not readily available• Evidence of communication with statutory and regulatory bodies are not available• Management of Changes are not communicated to the FST in a timely manner• Not all aspects of management of changes are communicated internally

CommunicationExternal and Internal communication: the Organization shall establish, implement

and maintain effective arrangement for communication with the supply chain

Some comments based on audit experience:Communication channels are not as clear as it should beRecords of communications are not readily availableRecords of communications are not readily availableEvidence of communication with statutory and regulatory bodies are not availableManagement of Changes are not communicated to the FST in a timely mannerNot all aspects of management of changes are communicated internally


Clause 6 – Human ResourcesThe food safety team and the other personnel carrying out activities having an

impact on food safety shall be competent and shall have appropriate training and education

This section also covers Infrastructure and Work Environment

Some comments based on audit experience:Some comments based on audit experience:• Food Safety Team Leader is not chosen on basis of competency• Food Safety Tem is not multidisciplinary• Not all members of the Food Safety Team are properly trained• infrastructure and work environment

Human ResourcesThe food safety team and the other personnel carrying out activities having an

impact on food safety shall be competent and shall have appropriate training

This section also covers Infrastructure and Work Environment

Some comments based on audit experience:Some comments based on audit experience:Food Safety Team Leader is not chosen on basis of competency

Not all members of the Food Safety Team are properly trained

LRQA: Business unit <set on slide master>Clause 7 – Planning and Realization of safe products

The Organization shall plan and develop the processes needed for the realization of safe products

Some comments based on audit experience:• Weak HACCP program• Vulnerable population not considered for intended use• Poor record keeping for hazard identification, assessment• Poor record keeping for hazard identification, assessment• Lack of understanding between oPRPs and CCPs• Lack of use of decision tree or other tools in the determination of control measures• Not properly assessing Correction and corrective actions• Not properly dealing with non conformities• Inappropriate verification planning

Planning and Realization of safe products

The Organization shall plan and develop the processes needed for the realization

Some comments based on audit experience:

Vulnerable population not considered for intended usePoor record keeping for hazard identification, assessmentPoor record keeping for hazard identification, assessmentLack of understanding between oPRPs and CCPsLack of use of decision tree or other tools in the determination of control measuresNot properly assessing Correction and corrective actionsNot properly dealing with non conformities

LRQA: Business unit <set on slide master>Clause 8 – Validation, verification and improvement of the FSMS The food safety team shall plan and implement the processes needed to validate

control measures and to verify and improve the FSMS

Some comments based on audit experience:• Lack of understanding of validation and verification • Inappropriate evaluation of verification results• Inappropriate evaluation of verification results• Incomplete analysis of results of verification and the proper use of the information• No focus on Continual improvement • Not updating FSMS system using a holistic approach

Validation, verification and improvement of

The food safety team shall plan and implement the processes needed to validate control measures and to verify and improve the FSMS

Some comments based on audit experience:Lack of understanding of validation and verification Inappropriate evaluation of verification resultsInappropriate evaluation of verification resultsIncomplete analysis of results of verification and the proper use of the information

Not updating FSMS system using a holistic approach

Some advantages of the FSMS

• Holistic approach

• System evaluation vs checklist approach

• Ultimate aim is continual improvement

• Can be integrated with other ISO standards

• International standard

• Base is ISO 22000 and the food sector is developing pre-requisite for other segments of the food industry

Some advantages of the FSMS

System evaluation vs checklist approach

Ultimate aim is continual improvement

Can be integrated with other ISO standards

Management

Base is ISO 22000 and the food sector is developing requisite for other segments of the food industry

FSMS Implementation Tips

• Keep it simple

•Do not recreate the wheel – work with what you have already got

•Start in a logical sequence of implementation

•Instill a culture of food safety from the start

• Ensure management understands the level of commitment needed

• Consider that the ultimate objectives are to control hazards and continually improve your processes

• Adopt the Plan do check Act in all your processes

• Think and Justify actions

FSMS Implementation Tips

work with what you have already

Start in a logical sequence of implementation

Instill a culture of food safety from the start

Ensure management understands the level of commitment

Consider that the ultimate objectives are to control hazards and continually improve your processes

Adopt the Plan do check Act in all your processes

LRQA: Business unit <set on slide master>Thoughts to ponder….

“The process based approach is analogous to a spider web that relies oninterconnection of a systematic structure to provide flexibility and strength preventing acatastrophic failure.”

Mark Overland, Corporate Certification Manager, CargillMark Overland, Corporate Certification Manager, Cargill

It is not the certificate on the wall that you want but the solid wall behind the certificate

“The process based approach is analogous to a spider web that relies oninterconnection of a systematic structure to provide flexibility and strength preventing a

Mark Overland, Corporate Certification Manager, CargillMark Overland, Corporate Certification Manager, Cargill

It is not the certificate on the wall that you want but the solid wall behind the

Any Questions?

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a step closer towards globalization: iso 22000 ... -...

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