Root Cause Analysis for GMP Investigations: Identifying Systemic Failures and Building Effective CAPA

Closed-loop Failure Investigation and Root Cause Analysis is a key part of a bullet-proof CAPA and CGMP compliance. It assures the FDA of a company's proactive CGMP system. Accurate and thorough Failure Investigation and Root Cause Analysis is key to successful CAPA, validation, and other problem-solving programs. Simple tools and work flow are not understood, disseminated, and used consistently. Flow charts, Cause and Effect Diagrams, the 5 Whys, and other statistical tools will be presented and discussed as simple and effective means to accomplish FI/RCA. A breakdown in FI/RCA results in product failures, liability issues, scrap/waste/fall off, and needless recalls which appear on the FDA's website daily. Avoid a "shoot from the hip" approach — define, then attack, and resolve root problems/causes, not just symptoms, using repeatable, systematic, SOP-defined methods as part of a "closed-loop" CAPA system. Code: FDB3751