A major approach to an inspection is to review problems or defective product which a firm has identified and review their investigation.  How a firmís management investigates and reacts to the investigation will provide information on their level of compliance and quality commitments.  Since a requirement of validation  by its definition is consistency, it will also provide direction for the inspection.  A process yielding rejected or defective product is probably not validated.  The problem is not specifically with the product rejected, but with other released or future production coming out of the same process or system that led to product failure.


From a compliance perspective,. It would be easier to support regulatory and/or administrative actions which might be recommended because of the existence of product failure, particularly if itís the firmís own test results.


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