Sub-Part J - Laboratory Operations

10.4 - Laboratory Out of Specification Investigation

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If the result of any test or examination fails to meet the established specification or trend, the lot and any other implicated lots must be quarantined and an out of specification (OOS) investigation conducted to determine the validity of the result. That lot may only be retested and released if the investigation clearly determines a laboratory error in the original result. 

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An archery arrow has missed the circle target of red and white rings and is in the yellow outer board out of specification