The two sides of the audit experience: Auditee and Auditor Kate Noble Graduate School of Biomedical...
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Transcript of The two sides of the audit experience: Auditee and Auditor Kate Noble Graduate School of Biomedical...
The two sides of the audit The two sides of the audit experience: experience:
Auditee and Auditor Auditee and Auditor
Kate Noble
Graduate School of Biomedical Engineering
University of New South Wales
TechTrain 2004
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This presentation aims to:This presentation aims to:Reveal audits as valuable,
objective learning tools.Reveal that audits
are impersonal.Highlight the need to write
it down!
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An audit is …An audit is … A check that you are doing what you
said you’d do
A check that it’s appropriate for what you want to achieve
A check of the quality and integrity of the output
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Why do we have audits?Why do we have audits?
For compliance with regulations
To monitor outcomes (GMP,GLP)
For certification and re-certification
To review a system for currency, appropriateness and effectiveness
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In the beginning …In the beginning …
1995 - 2000 GSBME collaborated with a private research company
Audited for ‘GLP’ ie Code of Federal Regulations (Title 21), Part 58 Good Laboratory Practice for Non-clinical laboratory Studies (or 21CFR58)
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The workThe work Writing the Protocol and SOPs Preparation of materials and inclusion
into test systems Maintenance of the test systems Retrieval of materials from the test
systems Various analyses of the materials Maintenance of data bases, daybooks
and the numerous, requisite tracking forms
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Along came ‘Margot’ … Along came ‘Margot’ … (not her real name)(not her real name)
As a requirement for future applications to the FDA. She had read all of our documentation and asked a lot of questions
1. of those responsible for the projects
2. of those responsible for maintaining the system
3. of those who carried out the work – (primarily me)
It was like an inquisition!
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The Inquisition - egThe Inquisition - eg SOPs
Vernier calipers
Data securityFile transfer
Data crosschecks
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The Inquisition The Inquisition Revealed tiny gaps EVERY audit:- numerous corrective actions
and revealed the need for more SOPs each time.
SOPs are controlled documents which need be reviewed and ratified with controlled issue
Any new SOP meant A LOT OF EXTRA WORK!
Already had over 30 SOPs for these projects. We thought we’d been thorough!
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Dreaded ‘Margot’Dreaded ‘Margot’
It was difficult not to take her questions and comments personally!
Felt stupid or negligent Often felt inadequate.Felt my work was being personally attacked
by some outsiderFelt resentful. Felt demoralized
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Me, the OHS auditor ?!!Me, the OHS auditor ?!!
Completed an accredited OHSMS auditor course as part of an OHS degree
Recruited to assist with UNSW OHS internal audits (for WorkCover self-insurer purposes)
Conducted one audit per month at schools around campus on a single aspect of the UNSW OHSMS
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Auditor trainingAuditor training
What is an OHSMS?????
A linked series of OHS documentation
A framework that holds all your OHS procedures together and drives it
How you identify, assess and control the risks
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Auditor trainingAuditor training
Need guidelines for the what the system is to include – auditee and auditor
System must be documented - look for documentation
Prove system exists - Interview employees, documentation
Don’t suggest how to handle non-conformances
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Yet another mental changeYet another mental changeneeded!needed!
From RA, at the bottom of the pile, to ‘interrogating’ Professors!
From auditee to auditor!From QA to OHS
But I didn’t want to be another ‘Margot’!
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My experiencesMy experiences
Particularly during the pre-audit briefing, I have come up against
Resentment Hostility Frustration
Suspicion Inertia Anger Mistrust
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My approachMy approachI anticipated initial negativity Peoples’ initial responses indicate
whether they have had their ‘mental change’
I like to know that the auditee understands the objectives of the audit before I begin
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My approachMy approach
Daybook notes Minutes SOPs, Reports
Training records Orders/Receipts Correspondence
Encouragement & reinforcement
You’re probably doing most of it anyway.
WRITE IT DOWN! If it’s not written down then you can’t prove it happened!
Document, implement, prove it
Examples of evidence you might use:
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My approachMy approach
While OHS is a legal requirement, businesses are more successful (time, money, output) where there is an active and effective management system in place
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My approachMy approach
Document what you are already doing then add the bits that are missing
Tailor to your own workplace
Ensure that the system is used
I give examples of how others have dealt with similar non-conformances
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In conclusion …In conclusion …
An audit is a useful tool for looking at your SYSTEM of doing things.
Do you have a system?
Is it written down?
Is it implemented (with evidence)?
What drives your system?
Any non-conformance indicates a problem with the SYSTEM
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In conclusion …In conclusion …
Audits raise awareness of what is
needed
An audit is about documentation
Write it down!
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Time is a great teacher, Time is a great teacher,
but unfortunately it kills but unfortunately it kills
all its pupilsall its pupilsHector Berlios
Thanks to my colleagues at UNSW, the research company, and also to ‘Margot’, for the opportunity to learn from these experiences.