A Data-Driven Approach for Root Cause Analysis in Medical Device Manufacturing

Medical device manufacturers have numerous responsibilities for validating the safety and efficacy of their products. Mistakes, even small ones, can be life-threatening for patients. Hence, a structured process of RCA is critical. It means moving away from opinions and assumptions to an objective, fact-based rooting of the problem through a data-driven RCA that uses data from multiple sources. Applying Root Cause Analysis helps manufacturers develop a robust CAPA that prevents recurrence and systematically enhances product quality. This article emphasizes the significance of data-driven Root Cause Analysis (RCA) in medical device manufacturing, which is crucial for ensuring patient safety and product effectiveness. The example case studies demonstrate how these methods are applied in practice.