HACCP method (4)

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HACCP

Hazard Analysis Critical control Point

Dr Sylvie Mialet

part 4 validation /assessment

VetAgro-Sup Campus vétérinaire de

Lyon- France

HACCP method (4)

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HACCP : 7 principles of Codex Alimentarius

Principle n° 1 : Conduct a hazard analysis

– list all potential hazards associated with each step of the process,

– estimate the likely occurrence of hazards and severity of adverse effects,

– consider any measure to control identified hazard.

Principle n° 2 : Determine the Critical Control Points CCP(s)

Principle n° 3 : Establish critical limit(s) for each CCP

Principle n° 4 : Establish a monitoring system for each CCP

Principle n° 5 : Establish corrective actions in order to deal with deviations when occur

Principe n° 6 : Establish verification procedures to determine if the HACCP system isworking effectively

Principe n° 7 : Establish documentation and record keeping

HACCP method (4)

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1. Assemble HACCP team

2. Describe product

3. Identify intended use

4. Construct flow diagram

5. On-site confirmation of flow diagram

6. List all potential hazards, conduct hazard analysis, consider control measures

7. Determine CCP(s)

8. Establish critical limits for each CCP

9. Establish a monitoring system for each CCP

10. Establish corrective actions

11. Establish verification procedures

12. Establish documentation and record keeping

HACCP : 12 steps

HACCP method (4)

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Establishment of

verification procedures

HACCP method (4)

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Establish verification procedures

Definitions (1)

Establish procedures for verification to confirm trhat the HACCP system is workingeffectively, which may include appropriate supplementary tests, together with a review.

3 different aspects :

1- Verification of the application of methods, procedures, tests and other evaluations, in addition to monitoring to determine the compliance with the written HACCP plan (audit of HACCP system : e.g. "check the checkers«, review of records)

2- Validation = Obtaining the evidence that the elements of the HACCP plan are effective toeliminate identified hazards or reduce it to an acceptable level . (for example confirm thatCCP are under control, measures done with standardized equipment, results of microbiologicalanalysis satisfactory for raw materials, environment, end-products...).

3- Give confidence that the elements of the HACCP plan are up to date with technicalinnovation and relevant to control hazards ( for example as regards technical and scientificdocumentation supporting parameters of heat-treatment used during the process).

HACCP method (4)

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Establish verification procedures

Definitions (2)

The frequency of verification must be precised in the HACCP plan :

• The first verification (just after design and implementation of the plan),

• The subsequent verifications (one per year?) or after every change inthe plant or the process

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Establish verification procedures

Definitions (3)

And the role of microbiological analysis ?

• The HACCP plan is the better way to address analysis at relevant stepsor products

• The results, on end-product or environment, may indicate that CCP are not under control. The plan must be reviewed.

•With an HACCP plan less analysis !!

HACCP method (4)

Establish verification procedures - Validation

• Responsibility of the company

• Validation team= HACCP team

• Different questions:- are identified hazards complete and correct ?- are control measures towards these hazards relevant ?- will they be effectively controlled ?- are major CCP well identified ?-...

• May include :- challenge tests- product testing including microbiological testing- swabbing of food control surfaces and analysis..

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HACCP method (4)

Establish verification procedures – verification (1)

• Responsibility of the company

• Scheduled

• Could also be initiated by a change or other findings

• Recorded

• Appropriately skilled and trained staff

• Role of competent authority ( may use reports of inspection)

• Role of third party auditors

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HACCP method (4)

• Demonstrating conformity with the written plan- internal audits of CCP(s)- external audit of suppliers- review of executive corrective actions- use of external third party audit results

• Gathering information - trend analysis- customer complaints- product disposal (cost of non-quality)- end-product testing- monitoring results- random sampling

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Establish verification procedures – verification (2)

HACCP method (4)

Establish verification procedures –Review (1)

• Scheduledoften at least annually

• Triggered- before change- internal factors- external factors

• Internal factors- raw materials/product formulation- process system- factory layout and environment- process equipment- cleaning and desinfecting program

• External factors- emerging pathogens (crisis!)- changes in legislation- new scientific or technicalknowledges- changes in environment

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HACCP method (4)

Synthesis

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Application of HACCP principles

Preparation of HACCP plan

Validation of HACCP plan ( relevant elements)

Implementation of HACCP plan

Verification activities

Review activities Validation of efficiency

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(Synthesis Codex)

Describe product and the intended use

Describe processFlow diagram

Identify HazardsDescription and analysis

Steps HazardsControl

MeasuresCCPCCP

CriticalLimits

CorrectiveActions

Records Referencesof instructions

Verification

Monitoringsystem

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Validates hazard analysis

Validates control measures

Internal procedures or GHP guides

GHP guides, technical documentation, scientific publications…

Applies the HACCP plan and

verifies its efficiency

Controls that FBO:

- applies the HACCP plan

- verifies the efficiency of the

plan

Competent authority :Food business operator

Controls that FBO has validated

his hazard analysis and the

control measures

Roles of Food Business Operator (FBO) / CompetentAuthority (CA)

HACCP method (4)

Quality auditHACCP audit

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HACCP method (4)

Quality audit

• Should be :- systematic- independant- documented

• The auditor collects and evaluates objective evidence to assess wether the requirements have been met

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HACCP method (4)

Types of audit

• Internalcarried out by an organization on its ownoperation ( ISO 9000 for example)

• Externalcarried out by an organization on another, where there is either a contract or intention of purchasing goods/services

• Third partycertification bodiesregulatory authorities...

• Systems

• Compliance

• Investigative

• Full

• Partial

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HACCP method (4)

Intended benefits

• Verification of an established system- « fresh pair of eyes »- independant review- peer review

• Gives confidence in system and productAid to customer relationship ?

• Identification of weaknesses before they become failures !

• Means of maintaining and improving the system

• Proceeds evidence of « due diligence »

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HACCP method (4)

Auditor requirements

• Trained in auditing skillsSystematic/logical

• HACCP expert

• Food technology specialist

• Independant/impartial

• Communication/professionnalInterpersonal skills /polite

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Sometimes 21 for process/technical1 for system /audit

HACCP method (4)

Audit program

• Opening meeting

• Review of the documentation (HACCP plan and PrP programs)

• Selection of critical control points

• Review of CCP procedures, pratices and records

• Collation of findings

• Closing meeting

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HACCP method (4)

Opening meeting

• Introduction (including system of references)

• Confirmation of scope and target of the audit

• Criteria used

• Confidentiality

• Sampling activity = part of the system examined

• Program for the assessment

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HACCP method (4)

A check-list as a tool

• Is a guideline, helps to insurethat all items covered

• Maintains focus and objectivity

• Records the issues of assessment

• Aids consistency betweenassessors

• Ensures transparency of assessment process

• BUT

- may restrict initiative and judgement- must not lead to a « tick-box » approach

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HACCP method (4)

A check-list contains

• It’s your job to list the questions !

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HACCP method (4)

On-site audit activities

• Confirmation of :- correct application of prerequisites- flow diagram- hazard analysis- suitability of identified CCP(s), critical limits and corrective actions- monitoring correctly performed- verification activities

• Information and data gathering

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HACCP method (4)

Examples of records maintained by the auditor

• Personnel interviewed (be careful!)

• Records examined

• Equipment examined

• Product/process details

• Non-compliances ?

• Areas not assessed

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HACCP method (4)

Closing meeting

• Thanks

• Repeat the scope of audit

• Sampling disclaimer = all the things that have not been examined

• Present findings including significance = value of non-compliances / food safety

• Feed-back on the application of HACCP principles, the effectivity and the effectiveness of the system

• Focus on areas which must be addressed

• What time scale ? If serious....immediatly

• Outline next step

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HACCP method (4)

Following the audit

• Report issued areas which must be addressed and areas which should be readdressed

• Evidence submitted in written to demonstrate that actions have been taken (e.g revised plan, documented procedures, records...) on time .

• Need to re-assess

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HACCP method (4)

Observation techniques

• Audit triangle to establish and confirmfacts

OBSERVE

QUESTION CHECK RECORDPROCEDURE

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Look for facts, not opinion

Ensure observations can beverified /witnessed

Chek facts comply withdocumentation to establishconformance / non-conformance

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HACCP method (4)

Audit techniques

• Some skills have to be developped

- efficient questionning- listening skills – record the facts...only the facts!- develop techniques wich establish and maintain rapport- thank each person for their co-operation

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HACCP method (4)

Types of questions

• Open :stimulate discussion and elicit lots of informationswhat, when, how, why, who...

• Closed :may bring audit to a halt !effective to confirm a fact (require a yes / no answer)

• Specific :obtain very specific information and accurate data

• Hypothetical : useful to gauge if errors would be correctlyrecognised / reacted to (what if..., what would you do...)

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