What is CAPA in Medical Device Industry?
Quality management is continuous due to constantly changing requirements, regulations, supplies, and development. Therefore, despite best efforts, it is not unusual for a medical device manufacturer to face nonconformance issues. The earlier it is detected and rectified, the better it is. Early detection and correction can minimize damage to product and reputation, prevent escalation of costs and resource utilization, and reduce the risk of NC.
Some deviations may be easy to correct, but some may need a deeper analysis to identify the root cause. Identifying the root cause and implementing measures to correct it for a more enduring solution is called corrective action. It is called preventive action when an error recurs or if a potential error is identified and action is taken to prevent it from becoming a deviation. Together, corrective action preventive action is called CAPARequest an Online Demo