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Validation of Visual Test Method

Q.

Are you aware of any medical device manufacturer who has validated visual inspection for part 2 compliance without identifying it as a special process?

A.

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.

Last updated on 2008-05-15 21:46:08 UTC
Keywords: visual inspection, test method, special process, attribute, test method validation

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