as of 2018 - 08 - 01
14.G Test results outside defined criteria (OOX)
14.G.1 Introduction
14.G.2 History and significance
14.G.3 Terminology and definitions
14.G.4 Out-of-Specification (OOS)
14.G.4.1 Receiving the OOS result and starting the OOS process
14.G.4.2 Error analysis
14.G.4.3 Full-scale investigation
14.G.4.4 Retesting
14.G.4.5 Evaluating the retesting results
14.G.4.6 Concluding the OOS procedure and subsequent measures
14.G.4.7 Exceptions and special cases
14.G.5 Out-of-Expectation (OOE)
14.G.5.1 What is the purpose of the OOE process?
14.G.5.2 What must an OOE result not be?
14.G.6 Out-of-Trend (OOT)
14.G.6.1 What is the purpose of the OOT process?
14.G.6.2 How is an OOT result identified?
14.G.7 OOX results during calibration and qualification
14.G.7.1 Out-of-Calibration (OOC)
14.G.7.2 Out-of-Limit (OOL)
14.G.8 OOX process during transfer and validations
14.G.8.1 OOX process during method transfer
14.G.8.2 OOX process during validation
14.G.9 OOX process and outsourcing
14.G.10 OOX process and document management system
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