CAPA (Corrective and Preventive Action)

CAPA is the formal, documented system for detecting quality problems, investigating root cause, implementing corrections and preventive controls, and verifying effectiveness so issues do not recur. FDA’s CAPA inspection guide frames CAPA as collecting and analyzing quality data, identifying and investigating product and quality problems, and taking effective corrective or preventive action to prevent recurrence. 
 
For medical devices, 21 CFR 820.100 requires CAPA procedures that include analyzing quality data, investigating causes of nonconformities, identifying actions, verifying or validating actions, implementing and recording changes, and sharing CAPA information for management review.