I
Look, I don't know how to quote sections so bear with me.
"One piece of equipment had an incomplete validation record" - regardless, though mabey "anal", it shows a problem in the process. Which, even if not at the time could eventually effect a machine producing product for their part, it shows the potential for a problem down the road.
Just deal with it and even if it's trivial to YOU, it was obvious to YOUR customer (perhaps).
It shouldn't matter if THAT particular customers parts were manufactured on that piece of equipment. Your system should ensure ALL equipment is calibrated (as appropriate) maintained, and that records are available to demonstrate such.
"One piece of equipment had an incomplete validation record" - regardless, though mabey "anal", it shows a problem in the process. Which, even if not at the time could eventually effect a machine producing product for their part, it shows the potential for a problem down the road.
Just deal with it and even if it's trivial to YOU, it was obvious to YOUR customer (perhaps).
It shouldn't matter if THAT particular customers parts were manufactured on that piece of equipment. Your system should ensure ALL equipment is calibrated (as appropriate) maintained, and that records are available to demonstrate such.
What I am disputing that this was not in the scope of this audit and therefore should not have been classified as a major or even a finding at all because their product does not and will not run on this equipment.
It should have been an "observation not affecting the results of the audit" as some of our other customers have phrased things like this.

