International – Recasting CAPA as a continuous improvement process

This article summarizes a white paper developed by the Medical Device Innovation Consortium (MDIC) under the case-for-quality program. The white paper recasts the corrective and preventive action (CAPA) process as a continuous improvement process for driving higher product quality and improved patient safety.

Today’s CAPA process has become highly focused on compliance. This focus leaves manufacturers struggling to determine which issues require a structured CAPA process and which can be resolved in alternative ways. The concept of a risk-based approach is not in itself new ‒ it is explicit in the International Organization for Standardization’s (ISO’s) 13485:2016 standard1 and is included in the preamble to US Quality System Regulation (comment 159).2 Nevertheless, many medical device companies still take a conservative approach and apply a one-size-fits-all method, subjecting most issues to a rigid and heavily documented CAPA process…