Simplifying CAPA: Seven StepsSource: MasterControl
Troubleshooting problems and attempting to identify and prevent potential problems is a typical activity for most businesses. Problems impact on a company financially and the ability to correct existing problems or implement controls to prevent potential problems is essential for continued customer satisfaction and efficient business practice.
The missing element in this process is often adequate documentation of the actions taken. Properly documented actions provide important historical data for a continuous quality improvement plan and are essential for any product that must meet regulatory requirements demanded by FDA and ISO. This is the reason for the implementation of a formal Corrective Action / Preventive Action (CAPA) program. CAPA is a major area of concern for both the FDA and ISO 9000. They have recognized that maintaining and monitoring quality systems is the key to success and effectiveness.