One of the most challenging processes plaguing manufacturers is Corrective and Preventive Action (CAPA). While essential for any regulated organization, it is often misunderstood, poorly implemented, and lacks diligent management. Failure to implement an effective CAPA process usually stems from the inability to identify risks of nonconformities and the negative impact on both product and consumer safety.
Documenting a CAPA workflow is vital to success. Valuable input, such as which including processes will be monitored, applicable personnel, failure or potential failure points and severity, and appropriate actions to implement best practice.
Not all issues need to become CAPAs. Using trending and feedback will help to identify what will constitute a CAPA.
Proper root cause determination is the foundation of a good CAPA process. Root cause needs to be understood, specific to the issue, and consistent.
Managers need to be involved and responsible for the implementation and operation of the CAPA process.
Carrying out the actions identified in the CAPA process to effect change. Ensuring that changes drive effective continual improvement.
We want to express our sincere appreciation for AlvaMed’s outstanding support throughout our MDSAP and CAPA project. With AlvaMed by our side, we not only achieved regulatory adherence but also fortified our quality management systems. AlvaMed’s partnership has been transformative, and we recommend their services to anyone seeking a smooth pathway through the medical device regulatory requirements.
Mark and his group have consistently provided exceptional deliverables in a timely and cost effective manner.
MedTech Client
CAPA is often the area most cited for nonconformities from third-party audits/inspections.
The CAPA process should employ risk-based decision making for each quality issue (such as a complaint or nonconformity) to determine the action to be taken.
The shifting emphasis from corrective action to preventive action is the basis for using the quality management system for its intended purpose of a proactive approach. Less reliance on reactive actions which strain resources and more on ensuring issues don’t arise helps maintain business continuity.
Schedule time with Mark to learn how AlvaMed can simplify your CAPA programs.
