The importance of uniform audit terminology

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ach company has its vocabulary. Abbreviations that are known by everyone on the inside but not so much on the outside. Humans tend to make words shorter when we feel lazy. When we want to save time. Not only in speech but also in writing.

If you work in a company with only one or two auditors, then audit terminology may not be the biggest issue. But when you’re Novartis, MSD, or Glaxo, you might have a few more auditors in the organization.

We recently worked with a GMP audit company that wanted to trend it’s supplier audit observations. Unfortunately, nobody (outside of the GMP auditors themselves) understood the terminology in the audit reports. Non-uniform data is never the best starting point for statistical analysis.

If you’re reading this post, you’re probably well aware of the different words to describe an audit observation. One may call it a finding; another person may argue it’s a shortcoming. Most regulatory authorities (EU/U.S. FDA/WHO) call it a deficiency.

your organization’s terminology

We always recommend having a uniform GMP audit terminology within your organization. Please make a list of the abbreviations/terms commonly used and test them against the regulatory guidelines.

Are we using different words? Perhaps it’s time to change them. And since habits are hard to change, have the audit reports checked by someone outside the audit team every once in a while. Is everything clear? Are the abbreviations industry standards like FMEA/HPLC/GMP, etc.? If not, address the auditors using constructive feedback.

Make it a “problem” for both parties. The auditors may feel they’re doing their job. They did the audit; they wrote the report. What’s the issue? The other side needs those trends to risk rank their suppliers. Is it that hard for the auditors to use different words? Find a solution that gradually implements the changes for both sides while keeping everyone happy.

Auditee audit terminology

Forget the previous case for a moment. What if you have a uniform audit terminology, but the auditee starts throwing terms/abbreviations and all kinds of words you’ve never heard of or which are plain wrong?

During a recent GMP audit, we spoke to a Quality Manager who stated that he:

Performed an FMEA according to ICH Q9, and as such, we wouldn’t need to waste time on it.

Auditee’s Quality Manager

What’s the problem with that statement?

After all, the “FMEA” is mentioned in ICH Q9.

And maybe we shouldn’t spend too much time on it when there are more important items to attend to. But, the real problem is, the FMEA is mentioned. But there’s no explanation in ICH Q9 on how to perform an FMEA. This indicated to us that the auditee did not thoroughly understand what is in ICH Q9.

Maybe the auditee didn’t mean anything with the statement but it may put auditors or government inspectors on a path that will make them examine your risk assessments and procedures more thoroughly.

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f you are the GMP auditor, always check statements made by the auditee. Just mentioning a regulatory / industry guidance is easy. Knowing it, having it implemented, and understanding it is a whole different level.

About the author

julian.koster@pcs-nl.com

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