The two sides of the audit experience: Auditee and Auditor Kate Noble Graduate School of Biomedical Engineering University of New South Wales TechTrain 2004

2 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 audit?

4 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

5 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

6 My auditee experience …

7 In the beginning … 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)

8 The 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

9 Along came ‘Margot’ … (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!

10 The Inquisition - eg SOPs Vernier calipers Data security File transfer Data crosschecks

11 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!

12 We dreaded the thought of ‘Margot’.

13 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 outsider Felt resentful. Felt demoralized

14 Mental Change as an auditee.

15 And now, me, the auditor!….

16 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

17 Auditor 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

18 Auditor 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

19 Yet another mental change 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’!

20 My experiences Particularly during the pre-audit briefing, I have come up against Resentment Hostility Frustration Suspicion Inertia Anger Mistrust

21 My approach I 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

22 My 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:

23 My 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

24 My 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

25 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

26 In conclusion … Audits raise awareness of what is needed An audit is about documentation Write it down!

27 Time is a great teacher, but unfortunately it kills all its pupils Hector Berlios Thanks to my colleagues at UNSW, the research company, and also to ‘Margot’, for the opportunity to learn from these experiences.

28 Thank you Do you have any …  Questions?  Comments?  Experiences ? … you’d like to share?