What the inspector wrote
Deviation DEV-24-0187 concluded that the root cause was operator error and the CAPA was retraining of the operator concerned. The same failure mode had been recorded in three previous deviations in the preceding fourteen months, each with the same conclusion and the same corrective action. No assessment of contributing factors, procedure design or equipment had been performed.
Cited against EU GMP Chapter 1, 1.4(xiv); ICH Q10 3.2.2
Why it was cited
'Human error' describes what happened, not why it was possible. Inspectors treat it as a stopping point that the investigator chose rather than a conclusion the evidence forced. When the same error recurs with different people, the system, not the person, is the cause.
This is one of the most cited categories in EU and UK inspection deficiency data for a reason: it is easy to write, it closes the record quickly, and it prevents nothing.
What would have prevented it
- Make 'human error' unacceptable as a final root cause without a documented contributing-factor analysis (procedure clarity, workload, equipment design, environment, training method).
- Trend deviations by failure mode, not just by product, so the third occurrence is visible as a repeat.
- Require CAPA effectiveness checks that measure recurrence, not completion of retraining.
Written from the deficiency categories published by EU and UK regulators. Details are illustrative and do not describe a specific named site.