ABSTRACT
A product audit is a contractor or internal audit that is focused on determining the cause of a problem unique to a product, or a problem that appears unique to a single product. The approach is similar to the one commonly employed by the Food and Drug Administration (FDA) inspectors in the United States for many years. Recently, the FDA has modified their approach, especially for routine audits, by using something called QSIT (Quality System Inspection Technique). QSIT is covered in the next chapter.
