Re: Audit Readiness Procedure
I am not familiar with FDA regulations, so I am basing this response from my experience in ISO (so bear with me if I am way off here).
The company I work for does not have an Audit Readiness procedure. Don't train your people how to act during an audit, instead train them on the requirements of the FDA regulations. If people are acting within these requirements, you should always be audit ready. Which, in my opinion, is the right/best thing to do anyway.
On a side note, take the statement "Don't train your people how to act during an audit..." with a grain of salt. You should train your people how to act during an audit, but not with the intent of passing the audit if/when it happens, instead do so with the intent of helping the audit go smoother. Train on things such as, if someone doesn't understand a question, ask the auditor to repeat the question in an understandable way, or what to do if someone doesn't know an answer (pointing to the appropriate person is better than "I don't know" or guessing), etc.
When you are informed that an audit will be conducted, it shouldn't be scramble mode to get things ready. Things should already be compliant and ready for the audit. That, in my opinion, is the point of standardization. This shouldn't require a procedure.
I hope I'm not too far off base here, and I hope this helps.