Turn a Nonconformity Into a CAPA
Write a corrective-action record that separates symptom, root cause, action, and effectiveness check.
A label orientation defect recurred after operator retraining. The CAPA record has a correction, but it does not prove the system cause was removed. Root cause analysis should connect evidence to the cause, corrective action to the cause, and effectiveness evidence to recurrence prevention. The common trap is choosing the easiest action, usually retraining or reminding people, before proving whether the process design, fixture, document, material, or detection control caused the nonconformity. Before Problem: label reversed. Cause: operator error. Action: retrain operators. Effectiveness: training record completed. After Problem: label reversed on 7 of 120 units. Cause: fixture allowed two orientations…
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