Corrective Action and Preventive Action (CAPA) System is one of the elements of a good Quality Management System. It is a useful tool to implement corrective actions and preventive actions resulting from the investigation of complaints, product rejections, nonconformances, recalls, deviations, audits, regulatory inspections and findings, and trends from process performance and product quality monitoring. A structured approach to the investigation process should be used with the objective of determining the root cause. The level of effort, formality, and documentation of the investigation should be commensurate with the level of risk. CAPA methodology should result in product and process improvements and enhanced product and process understanding.
The following are seven basic steps of implementing an effective corrective or preventive action capable of satisfying quality assurance andregulatory documentation:
- Identification of the nonconformity.
- Evaluation of the magnitude of the problem and potential impact.
- Investigation with assignments of responsibility.
- Performed a thorough Analysis of the problem with appropriate documentation.
- Created an Action Plan listing all the tasks that must be completed to correct and/or prevent the problem.
- The Implementation plan.
- A thorough Follow up with verification of the completion of all tasks, and an assessment of the appropriateness and effectiveness of the actions taken.
|Format Laporan Tindakan Pembetulan dan Tindakan Pencegahan (CAPA) dan Nota Penerangan Format Laporan CAPA|
|Nota Penerangan Format Laporan CAPA|
|Format Laporan CAPA|