GMP Intelligence for Quality, Leadership & Operations

“Did the action remove the cause, and can we show it?”

Effectiveness criteria defined before implementation, checked against real data afterwards. Where retraining recurs against similar events, the record documents a pattern rather than a set of incidents.

“Are laboratory events feeding the same system?”

OOS and OOT outcomes should enter the CAPA system on the same terms as production events, and laboratory root causes need the same evidential standard.

“Is the process still generating the failure?”

Where the design invites the error, a training action is a delay rather than a correction. Investigation also consumes production and engineering time, so recurrence is capacity spent twice.

“What does an open action mean for certification?”

Where a batch is affected by an unresolved deviation, Annex 16 sets expectations and the rationale for certifying must be documented.

“How will this read to an inspectorate?”

Overdue actions are visible in your own records, and a repeat finding is treated far more seriously than a first because it shows the previous correction did not work.