The provided reference focuses primarily on OOS (Out-of-Specification). The reference does not mention "ooc". Therefore, this answer will focus on defining OOS.
OOS stands for Out-of-Specification, a term used to describe test results that fall outside predetermined limits.
Understanding OOS
An Out-of-Specification (OOS) situation arises when a measurable result from testing exceeds established acceptable criteria at a particular point in time (as per the provided reference). In other words, it indicates a failure to meet pre-defined quality standards.
Key Aspects of OOS
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Predetermined Specification: A crucial component of determining OOS is the existence of pre-defined specifications. These are the acceptable limits or criteria that a test result must fall within to be considered acceptable.
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Reportable Result: The result must be one that is formally reported and used for decision-making.
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Single Point in Time: The OOS determination is based on a result obtained at a specific point in time during the testing process.
Example: OOS in Pharmaceutical Manufacturing
Imagine a pharmaceutical company testing the potency of a batch of tablets. The specification for potency might be 95-105% of the labeled amount. If a test result shows the potency to be 92%, this would be considered an OOS result. The company would then need to investigate the cause of the OOS.
Why is OOS Important?
OOS results can have significant implications, particularly in regulated industries like pharmaceuticals. They trigger investigations to determine the root cause of the deviation and ensure the quality and safety of products. An OOS result necessitates corrective actions to prevent recurrence.
OOS Investigation
When an OOS result is obtained, a thorough investigation is usually required. This investigation typically involves:
- Initial Assessment: Confirming the OOS result and identifying any obvious errors.
- Laboratory Investigation: Reviewing the testing procedure, equipment, and analyst training.
- Full-Scale Investigation: Expanding the investigation to include manufacturing processes, raw materials, and other potential contributing factors if the laboratory investigation doesn't identify the cause.
