What constitutes a nonconforming result and how should it be handled?

What constitutes a nonconforming result and how should it be handled?

• A. A result within pre-defined acceptance criteria; flagged, re-tested or validated, investigated for root cause, and documented.
• B. A result within pre-defined acceptance criteria; flagged for review.
• C. A result outside pre-defined acceptance criteria; ignored and not re-tested.
• D. A result outside pre-defined acceptance criteria; flagged, re-tested or validated, investigated for root cause, and documented.

Answer: (D)

A nonconforming result is one that falls outside the predefined acceptance criteria. This signals that the result may not be reliable for decision-making and needs careful handling to protect data integrity and safety. The best way to handle it is to: flag the result for review, re-test or re-validate to confirm whether the finding is reproducible, investigate to determine the root cause (method, instrument, sample, or procedure issues), and document all actions and findings. This sequence ensures the result is verified, traced, and, if necessary, acted upon through corrective steps. If the re-test still shows deviation, the result should be disposed of according to the lab’s established procedures (e.g., quarantine or rejection) and trigger any required CAPA or escalation.

A nonconforming result is one that falls outside the predefined acceptance criteria. This signals that the result may not be reliable for decision-making and needs careful handling to protect data integrity and safety.

The best way to handle it is to: flag the result for review, re-test or re-validate to confirm whether the finding is reproducible, investigate to determine the root cause (method, instrument, sample, or procedure issues), and document all actions and findings. This sequence ensures the result is verified, traced, and, if necessary, acted upon through corrective steps. If the re-test still shows deviation, the result should be disposed of according to the lab’s established procedures (e.g., quarantine or rejection) and trigger any required CAPA or escalation.