CAPA process improvement using a standards-based criteria approach.

摘要

The medical device industry has struggled with the corrective and preventive action process since the FDA has been auditing the process. This thesis discusses how to pursue improvements to the Corrective Action Preventive Action (CAPA) process. First, the report examines FDA observations. Second, this thesis discusses the changes necessary to mitigate observations. Third, the report explains what management policies and procedures need to be implemented to maintain a successful process.;To illustrate how to achieve a successful CAPA process, training and development plans are introduced. In addition to a discussion on investigation and root cause analysis techniques, a standard is presented that supports process consistency. Management's commitment to an effective CAPA system is a significant step toward an improved quality system. Improving the quality management system allows a company to make a significant leap forward in manufacturing better products, reducing cost, and elevating its position in the industry.