Glossary · Manufacturing
What Is Out-of-Specification Investigation?
An out-of-specification investigation is the structured enquiry carried out when a test result falls outside the specification, to establish whether the cause was the product, the sample or the analytical method. It is documented, and the batch normally may not be released until the question is resolved.
Why it matters when you source
What a factory does with a failing result says more than its pass rate. Ask whether out-of-specification results are recorded and investigated, or retested until they pass, because a retest-until-pass culture hides systematic problems in the formula.
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