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Accuracy hides error meaning
Ninety-five percent accuracy may be excellent for one use and unacceptable for another. Ask what the five percent errors contain. A small number of missed critical complaints, incorrect release recommendations, or unsupported validation conclusions can matter more than hundreds of correct low-impact classifications.
Measure performance by failure
Predefine metrics tied to the intended use: critical misses, unsupported claims, source correctness, false findings, calibration, repeatability, subgroup performance, reviewer recovery, and prohibited actions. State denominators and confidence. Averages can conceal poor performance for rare records, languages, formats, or edge conditions.
Accept the use, not the score
The release conclusion should define the supported population, permitted decisions, restrictions, controls, fallback, monitoring thresholds, and reassessment criteria. Review every critical event and unresolved uncertainty. Do not ask whether ninety-five percent is acceptable in isolation. Ask whether the complete controlled use is acceptably safe and effective for its GxP purpose.