CAPA and the related tools 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, as well as product improvement. A compliant CAPA system is required to  "close-the-loop" on complaints, non-conformances, out-of-specification conditions, reduce “fire fighting”. It must 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. A viable, pro-active CAPA system proves compliance to regulatory agencies more than any other CGMP component. 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? 

Expectations for meaningful, results-driven, "bullet proof – closed loop" risk-driven CAPA (Corrective and Preventive Action) Systems that addresses and resolves underlying product problems are increasing among regulatory agencies worldwide, with good reason.  EU’s ISO 14971 (Device Risk Management) and the FDA’s QSIT and ICH Q9, underscore this increased emphasis. A valid closed-loop CAPA system captures all sources of product problems and then utilizes root cause analysis for true problem (not symptom) resolution. Growing high-profile field problems indicate that effective CAPA is still not the industry norm. The billions of dollars spent by industry annually on quality / GMP are not providing the product safety or efficacy seemingly promised. And for most companies, the fixes are not rocket-science, but proper up-front risk-based, closed-loop CAPA, an integral part of a viable Quality Management / cGMP planning, implementation and execution system.