CAPA That Works

Corrective and preventive action that really stops problems from coming back: when to open one, how to find the root cause behind "human error", how to plan…

This course is for the people who open, investigate, run and review corrective and preventive actions in a medical device company: quality managers, CAPA owners, process owners, engineers and regulatory people. It follows a CAPA from the decision to open it, through containment, root cause analysis and the Dirty Dozen, to the action plan, the effectiveness check, preventive action and the learning that stays in the system. It rests on the requirements of ISO 13485 and on what the EU MDR, the FDA QMSR and MDSAP add to them, and on my experience of over 20 years with CAPA, the same experience I put into the procedures I write, my articles and my trainings. Four lessons walk through a set of corrective and preventive action forms, field by field, so you can compare them with your own.

This course is for QA/RA managers and engineers who run the CAPA system, and for engineers and process owners who are handed a CAPA and need to close it properly. It also suits managers who review CAPA status in management review and want to know what a good CAPA looks like.

Decide, by written criteria, when a problem needs a CAPA and when a correction is enough. Describe the problem precisely, find its full extent and contain it before the root cause is known. Find the real root cause, and look past "human error" to the conditions that made the error likely. Plan actions that remove the cause without creating new risk, and define at the start how you will prove they worked. Open preventive actions from trends and other early signals, and use CAPA results in management review. Build a workplace where people report problems instead of fixing them quietly. Prepare a CAPA file that holds up when an auditor or an FDA investigator reads it.