Question: A test result from a Quality Control method generated an Out of Specification (OOS) result. During the Phase 1 investigation of the OOS result, it

A test result from a Quality Control method generated an Out of Specification (OOS) result. During the Phase 1 investigation of the OOS result, it was discovered that the QC analyst who performed the test did not closely follow the Standard Operating Procedure (SOP) that describes the steps of the test. During the preparation work as described in the SOP, the analyst did not dilute the samples as specified in the SOP.

Discuss what steps should be taken after this outcome of the Phase 1 investigation.

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