Strategic Traceability for Safety-Critical Projects

To support any claim that a product is safe for its intended use, manufacturers must establish traceability within that product´s development life cycle. Unfortunately, traceability information submitted to regulators and third parties is often weak, casting doubt rather than confidence in a product´s integrity. This article evaluates traceability information for 10 submissions prepared by manufacturers for review at the US Food and Drug Administration. The authors observed nine widespread traceability problems that affected regulators´ ability to evaluate the product´s safety in a timely manner. To address these problems, the authors present a set of guidelines for implementing strategic traceability in a way that supports safety assessments.