merx_principles of haccp auditing

© PT MERKADI MANAGEMENT CONSULTING 1Auditing HACCP System April 2007

Auditing HACCP System

Richard Merx

PT MERKADI Management [email protected]

FAO ToT Course on GMP & HACCP


Content Why auditing?

What is an audit?

Norms and standards

Different types and levels of audits

Planning and preparation of an audit

Structure of an audit day

Audit reporting

Follow up


Inspection

HACCPRaw materials

End product

Black box Raw materials

End product ?


ISO Definition of Audit

A quality audit is a systematic, independent

examination to determine whether quality

activities and related results comply with

planned arrangements and whether these

arrangements are implemented effectively

and are suitable to achieve objectives


Auditing steps

Planning andPreparing

Conducting an audit

Analysing the results

Agreeing oncorrective actions

Verifying effective completion


The Essence of Auditing

Are you doing

what you say you do

and is it appropriate ?


assurance

time

qualityCORRECT

DO

CHECK PLAN

The weakest part of a system determines it’s strength


Norms and standards defined by: The customer (by contract)

GMP / GLP / GAP agreed terms of delivery

The Government (mandatory by law) food & hygiene environmental laws health & safety regulations

The company itself (voluntary) own policy European quality award

ISO ((Inter)national accepted norms ISO 9000 series


Different types & levels of Audits

First party internal audit

Second party external or extrinsic

Third party independent

First level documentation audit

Second level compliance audit


Preparation of an auditResponsibilities of the auditor Agree with the audit customer

about goal of the audit frame of reference who will carry out the audit audit dates how to report the results

Collecting background information organogram number of employees overview of the procedures groundplan


Preparation of an auditResponsibilities of the auditor

Gathering information on previous audits

Informing the audit customer which documents are necessary to prepare and conduct the audit

Studying applicable norms/standards

Give positive or negative advice.


Preparation of an auditResponsibilities of the auditee

Agree with the norm or standard of the audit

Agree with auditor(s)

Instruct and inform personnel

Provide facilities for auditor(s)

Provide entrance for auditors.


Why are buyers demanding 3rd party audits?

Limit their liability in courts Prevent government intrusion Good public relations Adds value to their product Protection of consumers But most of all…………………


Why are buyers demanding 3rd party audits?

Limit their liability in courts Prevent government intrusion Good public relations Adds value to their product Protection of consumers But most of all…………………

Because they can!


Structure of a compliance audit day

Opening meeting

Investigation


Fact reporting

Agreement of corrective action

Closing meeting


Opening meeting Introduction of auditor(s) and representatives of

the company

Explanation what auditor(s) are going to do this

day

Comfirm applicable standard

Explanation of random tests during the audit

Non-conformity classification

How and where are the findings presented

Confirm the scope of the HACCP system.


Opening meeting Confirm auditor read last version of the HACCP

manual Confidentiality Programme confirmation Confirm all employees know an audit is carried

out this day Ask whether certain persanal safety rules apply

for auditors Guide Are there any questions left.


Investigating

Effective observing

Effective questioning

Effective listening

Effective recording


Audit checklist (1)

HACCP system requirementsQuestionnaire prepared according to the criteria for checking HACCP system

PresentYes / No

CompleteYes / No

OperationalYes / No

General Info on the company

Step 1 Info on HACCP team

Step 2 Info on end product specifications

Step 3 Description of intended use

Step 4 Info on process and verification

Step 5 Info on preventive measures and procedures

Step 6 Info on hazard analysis


Audit checklist (2)

HACCP system requirementsQuestionnaire prepared according to the criteria for checking HACCP system

PresentYes / No

CompleteYes / No

OperationalYes / No

Step 7 Info on decision tree

Step 8 Info on targets, tolerances and CL

Step 9 Info on monitoring system

Step 10 Info on corrective actions

Step 11 Info on verification procedures

Step 12 Info on HACCP manual


Effective questioning

Who does

What ?

Where ?

When ?

Why ?

How ?


Effective listening

verbally ?

(non)verbally?


Effective recording

Who was

Where ?

When ?

Not acting according

to certain standards ?

and

What went wrong ?


Different audit strategies

Trace forwards, from raw material to end product

Trace backwards, from end product to raw material

Trace backwards from CCP back to raw material

Departemental, all activities in one department are audited

Element selection, one specific item of the frame of reference is audited, especially useful for assessment of critical activities


Analysing, reporting and corrective actions


Closing meeting

• Thank for hospitality

• Reconfirm confidentiality

• Resume what has been done

• Present the facts reports and agreement on

corrective actions

• If relevant a summary of the end meeting

• Questions?


Follow Up

Planning andPreparing

Conducting an audit


Agreeing oncorrective actions

Verifying effective completion


The End

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