C4A – Root Cause Analysis – Starting at the Beginning

November 10, 2020 @ 10:00 am – 11:00 am


By John E Lincoln


CAPA and the related actions of Failure Investigation and Root Cause Analysis (RCA) is a major tool in product complaint, non-conformance, and OOS failure investigations, and hazard analysis / risk management and mitigation activities. 

A compliant CAPA system is required to to “close-the-loop” complaints, non-conformances, out-of specification conditions, and must also include proper impact analysis / actions. As such CAPA is a major element of cGMP compliance (one of the four key inputs of QSIT, the FDA’s Quality Systems Inspection Technique), and is also a key source of regulatory problems. 

How can companies allocate scarce resources to those activities that have the greatest impact to product quality / safety, minimize resources on minor issues, and still satisfy the regulatory agencies? Use the proper Failure Investigation, Root Cause Analysis methodologies, not just to satisfy regulatory requirements, but to facilitate a closed-loop problem resolution system to reduce “fire fighting” and minimize costly product quality problems. 

Comments are closed.

Powered by WordPress. Designed by WooThemes