Difference between OOS-OOT-OOC-OOE:
When it comes to handling deviations in analysis results, the terms OOS, OOT, OOC and OOE always come up. But how are these terms defined?
This is a result that does not meet the established acceptance criteria outlined in official compendia or company documentation.
The result does not fall within a prediction interval or fails to meet the statistical process control criteria.
In the case of a result that does not conform to the predefined acceptance criteria for the instrument calibration, this will be termed Out of Calibration (OOC).
When a series of results over a short period of time shows an atypical, aberrant or anomalous pattern, this is called an OOE result. Typically, an OOE result is one in which the specifications are met, but the analysis is not within the range of variability expected.
The difference between OOS-OOT-OOC-OOE will help you to understand the terminologies.
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