Building Your Bill of Materials (BOM) to Accommodate Crossfunctional Needs
Mark Rutkiewicz, VP of Quality at Innovize and Founder of Consiliso LLC, explains how to structure a Bill of Materials (BOM) to serve as a single source of truth for Design History Files (DHF), Device Master Records (DMR), and Device History Records (DHR). He details the necessary metadata, including part numbers, reference designators, and operational steps, to bridge the gap between design engineering and manufacturing workflows. Rutkiewicz emphasizes designing flexible quality systems that accommodate complex hierarchies, alternate parts, and rules of interchangeability to prevent documentation errors and ensure regulatory compliance.