Merx_Principles of HACCP Auditing
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Transcript of 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
© PT MERKADI MANAGEMENT CONSULTING 2Auditing HACCP System April 2007
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
© PT MERKADI MANAGEMENT CONSULTING 3Auditing HACCP System April 2007
Inspection
HACCPRaw materials
End product
Black box Raw materials
End product ?
© PT MERKADI MANAGEMENT CONSULTING 4Auditing HACCP System April 2007
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
© PT MERKADI MANAGEMENT CONSULTING 5Auditing HACCP System April 2007
Auditing steps
Planning andPreparing
Conducting an audit
Analysing the results
Agreeing oncorrective actions
Verifying effective completion
© PT MERKADI MANAGEMENT CONSULTING 6Auditing HACCP System April 2007
The Essence of Auditing
Are you doing
what you say you do
and is it appropriate ?
© PT MERKADI MANAGEMENT CONSULTING 7Auditing HACCP System April 2007
assurance
time
qualityCORRECT
DO
CHECK PLAN
The weakest part of a system determines it’s strength
© PT MERKADI MANAGEMENT CONSULTING 8Auditing HACCP System April 2007
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
© PT MERKADI MANAGEMENT CONSULTING 9Auditing HACCP System April 2007
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
© PT MERKADI MANAGEMENT CONSULTING 10Auditing HACCP System April 2007
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
© PT MERKADI MANAGEMENT CONSULTING 11Auditing HACCP System April 2007
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.
© PT MERKADI MANAGEMENT CONSULTING 12Auditing HACCP System April 2007
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.
© PT MERKADI MANAGEMENT CONSULTING 13Auditing HACCP System April 2007
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…………………
© PT MERKADI MANAGEMENT CONSULTING 14Auditing HACCP System April 2007
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!
© PT MERKADI MANAGEMENT CONSULTING 15Auditing HACCP System April 2007
Structure of a compliance audit day
Opening meeting
Investigation
Analysing the results
Fact reporting
Agreement of corrective action
Closing meeting
© PT MERKADI MANAGEMENT CONSULTING 16Auditing HACCP System April 2007
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.
© PT MERKADI MANAGEMENT CONSULTING 17Auditing HACCP System April 2007
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.
© PT MERKADI MANAGEMENT CONSULTING 18Auditing HACCP System April 2007
Investigating
Effective observing
Effective questioning
Effective listening
Effective recording
© PT MERKADI MANAGEMENT CONSULTING 19Auditing HACCP System April 2007
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
© PT MERKADI MANAGEMENT CONSULTING 20Auditing HACCP System April 2007
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
© PT MERKADI MANAGEMENT CONSULTING 21Auditing HACCP System April 2007
Effective questioning
Who does
What ?
Where ?
When ?
Why ?
How ?
© PT MERKADI MANAGEMENT CONSULTING 22Auditing HACCP System April 2007
Effective listening
verbally ?
(non)verbally?
© PT MERKADI MANAGEMENT CONSULTING 23Auditing HACCP System April 2007
Effective recording
Who was
Where ?
When ?
Not acting according
to certain standards ?
and
What went wrong ?
© PT MERKADI MANAGEMENT CONSULTING 24Auditing HACCP System April 2007
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
© PT MERKADI MANAGEMENT CONSULTING 25Auditing HACCP System April 2007
Analysing, reporting and corrective actions
© PT MERKADI MANAGEMENT CONSULTING 26Auditing HACCP System April 2007
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?
© PT MERKADI MANAGEMENT CONSULTING 27Auditing HACCP System April 2007
Follow Up
Planning andPreparing
Conducting an audit
Analysing the results
Agreeing oncorrective actions
Verifying effective completion
© PT MERKADI MANAGEMENT CONSULTING 28Auditing HACCP System April 2007
The End