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Are you aware of any medical device manufacturer who has validated visual inspection for part 2 compliance without identifying it as a special process?
Last Updated On May 15, 2008
A “special process” is one for which the product cannot be fully verified (for example the ability of a heat sealing process to meet a seal strength specification cannot be fully tested without destroying the seal). This is why that process must be validated. Visual inspection is a test method (not a process) and should be validated as such.