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All CAPA questions

Question 3 of 6 Intermediate Scenario

How do you test whether you identified a root cause rather than a symptom?

Short answer

Test whether the proposed cause plausibly explains the observed events and whether removing it changes the failure pathway. Correlation or a generic “human error” label is insufficient.

Why

Suppose sample mix-ups cluster on the night shift. Shift correlation could reflect workload, confusing storage bins, scanner uptime or training, not an intrinsic night-shift problem. Map the process timeline, compare good and failed runs, interview people without blame and inspect equipment and software evidence.

Use a structured fault tree or a cautious five-whys exercise, then test competing hypotheses. If incorrect sample IDs cease in a controlled challenge only after enforcing scanner validation, that supports a causal mechanism more strongly than retraining alone. Multiple interacting causes may remain and must be documented.

A defensible root-cause statement predicts where the system would fail again, identifies actionable controls and survives attempts to disprove it.

Common mistakes

  • Stopping at “analyst did not follow SOP” without explaining why the system permitted it