Complaints management and corrective and preventative action (CAPA) fall under the same umbrella of handling systemic quality issues.
Complaints often trigger a CAPA, which makes complaints management one of the subsystems of quality management that feed CAPA.
Other subsystems include audits and non-conformances, areas where quality issues are often identified.
What complaints management and CAPA have in common
Both complaints management and CAPA involve the process of identifying and rectifying a problem or defect.
Complaints are defined by the FDA and ISO 13485:2016 as any communication that reports an issue or dislike in a product after it has been placed on the market. By definition, complaints management is more reactive. It only applies when there’s negative feedback from a customer or client.
CAPA is more proactive. It’s an ongoing process that’s a vital part of a quality management system (QMS) and applies to complaints management and more.
A CAPA can be triggered by a number of processes within the overall QMS, both internal (e.g. risk management) and external (e.g. customer complaints/feedback).
Not all customer complaints will warrant a CAPA. A good complaints management system will be able to handle a complaint without triggering a CAPA.
What complaints should trigger a CAPA?
Responding to every complaint with a CAPA leads to unnecessary paperwork and stress. On the other hand, not initiating a CAPA when it’s necessary can lead to warning letters from the FDA.
This makes it vital to know when it’s appropriate to treat a complaint as “CAPA-worthy”. Abusing the CAPA process can make it less effective.
CAPA is intended to investigate and address systemic quality issues. The focus of a CAPA process should be on preventative action (proactive) with corrective action being more reactive.
This infographic highlights some of the triggers that stem from other QMS subsystems.
Not all complaints will require corrective action. CAPA is usually triggered if the problem is systematic and often requires changes to processes or procedures.
By comparison, if you receive a one-off complaint that can easily be rectified by your complaints management system, triggering a CAPA would be overkill.
Part of your quality management system should be clearly defining for employees which non-conformity traits are serious enough to warrant corrective action.
Complaints management software with built-in CAPA functionality
Using complaints management software gives you a way to easily record and track complaints in a centralized database that ensures accurate resolution. Choosing software that has built-in CAPA features makes it much easier to resolve complaints that require corrective action.
isoTracker offers subscription-based complaints management software with built-in CAPA capabilities. Our software modules work seamlessly with each other to create a streamlined and cloud-based quality management system.
Our 60-day free trial gives you full access to our complaints management and CAPA modules as well as the full package of QMS software. The trial includes walkthrough emails and web-demos, so you can get the full experience of top-performing complaints management software.
