Strategic Traceability for Safety-Critical Projects

Abstract

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.