Re: Safety factor
Hello,
Are you asking about fatigue and its impact on the inspector's error rate? Or are you asking about fatigue of a metal or other part under stress test? Or are you referring to something else?
If, as I suspect you are asking about acceptable inspection error levels arising from inspector fatigue, for medical devices I would say none is allowable; the inspection program should be designed to eliminate inspector error.
However, I hasten to add that medical device is not my specialty so I invite others to correct me.