When should you reopen a completed CAPA rather than open a new record?

Why

Record choice sounds administrative, but it shapes what the quality system can learn. If every recurrence is opened as a new CAPA, the history scatters, the metric shows many closed CAPAs, and nobody sees that the same problem was fixed three times. Inspectors notice this pattern.

ICH Q10 expects CAPA effectiveness to be evaluated, and EU GMP Chapter 1 says effectiveness should be monitored and assessed. A recurrence of the same failure mode is direct evidence on effectiveness, so it belongs with the record whose effectiveness it disproves. Reopening makes sense when the root cause was wrong, when an action was not implemented or not sustained, or when the effectiveness check was too weak.

A new record makes sense when investigation shows a different mechanism, such as a second source of particles unrelated to the first. Even then, link the records, because two causes producing the same symptom is itself useful knowledge. Some electronic systems cannot reopen a closed record.

In that case, open a new one that explicitly references the old and states that it supersedes its conclusion. The decision should be based on the investigation, not on what makes metrics look better or avoids reopening a closed item before an audit.