Out of specification (OOS)
Also called: OOS result
A test result outside the approved specification or acceptance criteria, which must be investigated before a batch decision.
FDA’s guidance on OOS results sets out a phased investigation, starting with the laboratory work and extending to manufacturing if no lab error is found. A batch can’t be released on an OOS result until it is resolved.
OOS results on distributed product may also have to be reported.
Where it goes wrong
An OOS found at a contract lab can take days to reach the sponsor’s QA, eating into reporting deadlines.
What Spurby does
Starts the clock from the first message about the result, and alerts QA.
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