Corrective and preventive action (CAPA) can be viewed differently by employees within pharmaceuticals and medical device companies. Some see CAPAs as simply an onerous task given to them to complete in order to “stay compliant,” while others look at CAPAs as simply a number based metric that needs to be reduced. However, the best view of CAPAs is as a complete system with a life-cycle made up of phases. The CAPA system should not be viewed as simply the required outcome of a deviation or event, but instead, a beginning to end system that not only provides the tools for the identification, evaluation, and investigation of a deviation, but also the tools to determine, implement, and check effectiveness of a resolution. It is clear that CAPA and its associated tools is the mechanism that enables a quality system to be “self-correcting.” Using this phase-based system will provide a systematic approach to review the Quality system data. Benefits of this approach include:

• Assurance that quality issues are resolved
• Rework and scrap numbers are reduced
• Customer complaints are reduced
• Promotion of continuous improvement
• An aligned method for problem solving
• Regulatory requirements are met
• Business needs are met

Why is CAPA so Important Anyway?