Root Cause Analysis - Starting at the Beginning
November 10, 2020 - CA USCompliance4All
compliance4all14@gmail.com
Phone:8004479407
Overview: 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.