The main steps of CAPA quality management system include:
1. problem identification: identify problems and nonconformities within the organization through quality review, internal audit and customer feedback.
2. Problem analysis: analyze the identified problems and find out the root causes and influencing factors of the problems.
3. Corrective measures: take corrective measures to solve the problems that have occurred and ensure that the problems will not happen again.
4. Preventive measures: Take preventive measures to prevent the recurrence of similar problems, and prevent the occurrence of problems by improving processes and training employees.
5. Implementation and verification: Implement corrective and preventive measures, and verify and evaluate their effectiveness.
6. Monitoring and review: continuously monitor and review the effectiveness of corrective and preventive measures, and make timely adjustments and improvements.
The goal of CAPA quality management system is to improve the quality of products and services, reduce the occurrence of defects and nonconformities, improve customer satisfaction, and enhance the competitiveness and sustainable development ability of the organization through continuous improvement.
When implementing CAPA quality management system, organizations can refer to the requirements of ISO 900 1 quality management system to ensure the effectiveness of CAPA process and meet the requirements of standards. In addition, organizations can make CAPA processes and methods suitable for them according to their own needs and characteristics, and constantly improve and optimize them.
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