When developing a CAPA program, a controlling policy must be in place either as a standalone document (policy) or incorporated into the Quality Manual. A policy is a controlled document that typically includes: title, purpose, mission, scope (all quality subsystems that feed into CAPA), and responsibilities.

Depending upon the organizational structure of CAPA within each company, a CAPA system is the responsibility of top management constituted into a quality council that includes all managers with executive functions along with a CAPA administrator. The policy is the base upon which the system is to be built.

A CAPA system is a quality improvement vehicle that is the basis of both reactions to deficiencies and of proactively addressing the prevention of deficiencies. The controlling policy for the system should establish the foundation for this quality improvement vehicle. A CAPA policy should emphasize the active involvement and support of top management and the need for recruiting and assigning a Management Representative (MR) responsible for quality system management. The MR should report directly to appropriate executive management.

Download the accompanying article, "How To Set Up A CAPA Program From Scratch"