Complaint Handling and CAPA management are two cornerstone processes of any effective Quality Management System (QMS). Both processes drive quality improvements and can be used as overall indicators of the effectiveness of an organization’s QMS.
The key underlying objectives in both processes include producing clear audit trails, reviewing, and assessing relevant quality data, relying on root cause analysis, and verifying the effectiveness of actions taken to correct or prevent the issue.
It is to keep in mind that a complaint in itself triggers an investigative process. This should identify the issues, how they affect the customer and what are the root causes of the problem. Also, similarly to the nonconformance, a single incident likely will not trigger a CAPA, but the same sort of complaint repeatedly happening could.
In this video whitepaper, we will talk about the various problems related to escalating complaints to CAPA.