What is Out of specification (OOS)?

Question

Accepted Answer

Out of specification (OOS) refers to a result that falls outside the predetermined acceptance criteria or specifications.

OOS occurs when a test result does not meet the predefined criteria for quality or safety.
It indicates a deviation from the expected or desired outcome.
OOS can occur in various industries, including pharmaceuticals, manufacturing, and food production.
Examples of OOS include a drug potency level exceeding the acceptable range or a product failing to meet required dimensions.
OOS results require investigation to identify the cause and determine if it is a systematic issue or an isolated incident.

Accepted Answer

When the analysis results are out of our given predetermined or standard specification.

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