Top six pharmaceutical auditing mistakes

BY PETER DEEGAN  |  11 OCTOBER 2022

 

Have you ever seen a good auditor at work? Doubtless you have marvelled at their memory as they recall every rule and regulation whenever they are needed. Perhaps you noticed their ability to identify non-conformances clearly, presenting major findings in such a way that the auditee accepts without conflict?

 

These skills are important for any auditor, so how do they do it? We asked a panel of experienced auditors a simple question: What are the biggest mistakes you see in auditing? This is what they said:

 

1. Inexperienced auditor - The auditor isn’t structured, doesn’t really know the correct sequence on how to audit, doesn’t know or hasn’t read the standards, so doesn’t know the right questions to ask. 

 

2. Audit objectives not defined - The audit agenda does not link to the purpose or objectives of the audit. It covers items which are often out of scope or not relevant.  

 

3. Auditor does not stick to the agenda - The auditor jumps from area to area without sticking to the agenda; often the auditor brings up ‘surprise’ topics! Audits that jump from area to area with no logic to the sequence of the day can feel like time is being wasted unnecessarily. 

 

4. Auditor findings based on personal opinion - The auditor gives non-conformances without any sound reasoning or evidence, or has ‘opinions’ on how corrections should be done, which contradict the factual observations of the audit. 

 

5. Auditor generates conflict - The above reasons can cause an auditee to disagree with the findings, often meaning an argument is likely to ensue.

 

6. Disharmony in the audit team - The audit lead struggles to keep the audit team together and focussed on the task as a ‘team’. A lead auditor that gets contradicted in the closing meeting by another member of the audit team can leave the auditor looking less credible and the auditee confused. 

 

Chances are you’ve experienced one or more of the above mistakes – whether that is being audited or doing the auditing! So how can you fix them? As with all skills, auditing requires practice and coaching by experienced auditors to help you learn and develop your skills. Let’s look at the best approach to avoid the above mistakes: 

 

  • Firstly, you have to start somewhere, you can’t read how to audit from a book, get auditing!
  • Maybe start as a co-auditor, observe how others audit and practice in a safe learning environment. Get feedback from your fellow auditors who can steer and coach you on your progress. 
  • Plan your audit in accordance with tried and tested auditing processes, defined by international standards that will allow you to consistently conduct any audit worldwide – be it internal or external audits, your own lab or a large international supplier 
  • Practice writing audit plans and ensure you know how to stick to them. Learn techniques on how to focus on the subject area and not be distracted
  • Practice how to communicate objectively, accurately and professionally. Learn how to present audit findings without emotion or opinion in a safe, non-conflict environment. 
  • Attend an RSSL Lead Auditor Training Course

 

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