Improvement Processes – Corrective and Preventive Actions

This chapter overviews the stages of corrective and preventive actions (CAPA) process and its implementation. Promoting continuous improvement of effectiveness and efficiency is one of the important objectives of software quality assurance (SQA). The CAPA process has become one of the main tools used to achieve this objective. Successful operation of a CAPA process includes the following activities: information collection, analysis of information, development of solutions and improved methods, implementation of improved methods, and follow‐up of CAPA activities. Proper performance of CAPA activities depends on the existence of a permanent core organizational unit as well as many
ad hoc
team members. The permanent CAPA body, commonly called the Corrective Action Board (CAB) committee, activates the CAPA process by screening information, appointing members of targeted
ad hoc
CAPA teams, promoting implementation, and following up the process.