Big changes are afoot when it comes to CAPA. Ten medtech manufacturing sites are playing in a pilot program that uses a novel framework that shifts corrective and preventive action from a one-size-fits-all method to a more nuanced approach that separates higher-risk events from others that don’t need to be elevated to the level of a traditional CAPA. Medtronic quality/regulatory expert Kathryn Merrill weighs in.
If there’s one acronym that can send chills down the spine of even the most experienced medtech manufacturer, it’s probably “CAPA.”
Short for “corrective and preventive action” – or “corrective action, preventive action,” depending on who you talk to – CAPA...