Wednesday, September 14, 2011

The FDA's Audit Playbook and Auditor Etiquette

Want to know how the FDA is going to audit your Quality System?
Want to evaluate your system for yourself?
Why not use the FDA's own Guide to Inspections of Quality Systems (all 107 pages)?

This is one touch stone I use when I create, run, evaluate, and re-tune a Quality System. I am constantly asking myself how what I am seeing/hearing/reviewing is providing the quality and quantity of information I will need to successfully answer these questions.

How do you measure up? Where are you strong? Weak? Look for the root causes of your answers.

... meanwhile ...

When the auditor shows up...

Here are some reasonable expectations of how an auditor should behave and treat the subjects of the audit. Audit preparation includes considering how you are going to recognize and react to inappropriate auditor behavior.

Wouldn't it be interesting if the auditor set these expectations right in the beginning of the audit process?

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