An Out-of-Specification (OOS) limit is the boundary beyond which a test result is considered unacceptable and requires investigation. Based on the provided reference, the OOS limit can be defined as follows:
Understanding OOS Limits
When a test result falls outside the established specification limits, it's classified as an OOS result. These limits define the acceptable range for a given parameter, ensuring product quality and consistency.
Example of an OOS Result
- Specification Limit (Assay): 95.0 - 105.0 % w/w of label claim.
- OOS Result: 94.2 % w/w
In the provided example, a result of 94.2 % w/w for a particular batch is considered OOS because it falls below the lower specification limit of 95.0% w/w.
Key Aspects of OOS Limits
- Established Range: OOS limits are defined by the specification limits set for the specific parameter being measured.
- Product Quality: They ensure product quality by defining the acceptable range for a given test.
- Investigation Trigger: An OOS result requires a thorough investigation to determine the cause.
Table of OOS Definition
| Item | Definition |
|---|---|
| Specification Limit | Established range for an acceptable result |
| OOS Result | Test result falls outside the specification limits. |
| Action | Requires investigation into the cause of the OOS result. |
In summary, any test result that goes beyond the pre-defined specification limits is considered an Out-of-Specification (OOS) result, triggering further investigation to address the deviation.
