01 IDENTIFYOOS vs. OOT results and the regulatory expectations surrounding them │ 02 INVESTIGATEPhase 1 investigations, hypotheses, remeasurement, retesting and resampling │ 03 DOCUMENTQuality documentation, roles and responsibilities, and defensible investigation records │ 04 CONCLUDEEvaluate findings, report results and determine an appropriate investigation outcome │ 05 PREVENTUse investigation findings and case studies to reduce future OOS occurrences |
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