Deviations, CAPA, complaints and recall

Procedure

1. Immediately protect patients and staff: stop work, isolate materials and alert the responsible person. Urgent clinical care comes before paperwork.
2. Record time, product, lots, facts and available evidence without deleting original data. Separate facts from assumptions.
3. Assess scope and other batches sharing the material, equipment or process. Quarantine potentially affected items.
4. The responsible person determines communication with prescribers, recipients and authorities under applicable obligations. Maintain recall records and quantity reconciliation.
5. Analyse root cause and assign corrective/preventive actions, owners and deadlines. Retraining alone is insufficient when the system causes the error.
6. Verify CAPA effectiveness and document closure. Periodically exercise a mock recall to demonstrate traceability.

Edition-specific detail

Record immediate containment, affected batches and shared materials. Separate correction of the incident from root cause, corrective and preventive action. Recall reconciles produced, supplied, recovered and unaccounted quantities in F-007/F-018. Closure requires effectiveness evidence and a dated responsible-person decision.

Related forms

F-007, F-018