Opportunity or Burden?
The case for reinvigorating the closed analytical loop
- Quality Progress
- July 2020
- Volume 53 Issue 7
- pp. 26-33
- Verbitsky, David E., Duffy, Grace L.
- Management & Performance Systems, Eustis, FL.
Over the years, the traditional failure analysis-corrective and preventive action (FA-CAPA) approach has fallen out of favor, in part because it was misunderstood, misused and feared. Clearly, the current safety, quality and reliability environment demands the immediate restoration of an improved deterministic analytical FA-CAPA loop. The authors justify and propose an enhanced and modified legacy approach based on an original systemic early failure analysis (SEFA) method and enhanced CAPA closed loop. A multifaceted SEFA-CAPA revitalizes a product’s safety, quality and reliability, and associated innovation, profitability and technology, resulting in synergetic continuous improvement. A systemic closed analytical loop should be a natural, indispensable part of International Organization for Standardization, industrial and corporate standards and procedures.