I would like to point out that no matter how creative and methodical you are, there will be risks that you will not be aware of until something goes wrong. The Failure Mode and Effects Analysis tool is a live document in that its gets updated repeatedly to include new failure modes or corrective/preventive actions which mitigate new or old risks. Something like an FDA audit may uncover new risks which you did not think of before and so you need to figure out a way to prove it is under control. The project team would then have to brainstorm procedure changes or protocols which can be executed to determine the severity, occurrence, and or detection of such a failure. As Dr.Simon pointed out the team also needs to determine if it is a failure in the manufacturing process or the design of the product as those are two completely different documents, at least in my company.