ENV-2026-04421

A measured value exceeds the method's acceptance limit but was not flagged as out-of-specification. Unflagged OOS results can be reported as passing in error.

Chromatographic peaks were manually integrated but no justification or before/after comparison was retained. Manual integration must be documented to remain defensible.

The sample identifier on the bench worksheet does not match the identifier in the instrument sequence. Inconsistent identifiers create ambiguity about which sample produced the result.

A reported value was edited after it had moved to an approved state, and no change reason was captured. Silent edits to original data break the chain of custody.