Beyond CAPA: Using Risk Assessment To Streamline Your Quality System

With all the processes associated with managing a quality and compliance management system, corrective action and preventive action (CAPA) is a prominent feature. In many cases, if an event is found in the system, a CAPA is generated. No matter the scope or severity, CAPA is the ultimate catchall for events in the system.

The result - thousands upon thousands of CAPAs, with varying degrees of severity, assigned in the order they were created, like a pile of virtual papers stacking up on the QA manager's inbox. This becomes a problem when the "critical" CAPAs - those events that have the most impact on the business as a whole, become lost in the pile, hidden among non-critical, immediately correctible events, and virtually invisible to the enterprise.

This paper describes a new risk-based methodology that will effectively reduce CAPAs as a whole. By employing this methodology, crucial CAPAs are extracted to determine the overall business impact, correct the problem, and implement the change throughout the enterprise.