This control plane turns synthetic deviation and CAPA exports into one review surface: root-cause packet continuity, accountable ownership, effectiveness checks, recurrence pressure, retraining evidence, and final batch disposition completeness before downstream handoff.
| Risk | Owner | Subject | Observed state |
|---|---|---|---|
| high Investigation |
Manufacturing QA | Root-cause packet | One critical deviation is still missing the signed root-cause narrative after manufacturing handoff. |
| high Ownership |
Quality Systems | CAPA ownership assignment | Two blocking CAPAs are still missing a final accountable owner in the release queue. |
| high Effectiveness |
Process Excellence | Effectiveness check packet | One closed CAPA does not yet have an effectiveness verification packet attached. |
| medium Recurrence |
Process Excellence | Deviation recurrence trend | Repeat deviation frequency rose above the internal recurrence threshold this week. |
| medium Training |
Manufacturing QA | Operator retraining packet | Retraining signoff is still missing for one operator cohort tied to the deviation cluster. |
| high Disposition |
Quality Systems | Final batch disposition packet | The batch disposition packet is missing one reviewer signature and one linked evidence proof. |