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!

What is an What is an audit?audit?

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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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My auditee My auditee experience …experience …

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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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We dreaded the thought of We dreaded the thought of ‘Margot’ ‘Margot’

.

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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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Mental Change as an auditeeMental Change as an auditee

.

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And now, And now, me,me,

the auditor!….the auditor!….

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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.

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Thank youThank you

Do you have any …

Questions?

Comments?

Experiences ?

… you’d like to share?