Abstract

Corrective and preventive action (CAPA) systems are widely used in many industries to assess how a quality management system (QMS) is performing. Investigations using CAPA systems are crucial to keeping up with continuous improvements, but those investigations can sometimes be flawed. Common missteps when working with a CAPA system can lead improvement projects astray. These pitfalls include lack of investigation plans, lack of time to complete investigations, lack of trending in incidents, unidentified root causes, root causes that have not been addressed, focus on symptoms rather than causes, lack of preventive actions, inability to verify that root causes have been fixed, multiple CAPA systems causing issues with each other, human error and overreliance on software. When utilizing a CAPA system to identify issues with a QMS, avoiding these pitfalls can lead to a successful investigation.