Reduction of Material Variance for the Top Offender in Terumo

Abstract

Material variance associated with Suture Bondex Plus was identified as a significant cost opportunity in the final assembly process of the Angio-Seal® vascular closure device at Terumo Puerto Rico. This project applied the Six Sigma DMAIC methodology to investigate and reduce over-consumption while maintaining product quality and regulatory compliance. Financial variance reports and process-level review were used to establish baseline performance and confirm that scrap was not a primary contributor. Root cause analysis tools, including a Fishbone (Ishikawa) diagram and targeted “Why” questioning, determined that the absence of a standardized method to store and manage usable suture between shifts was the main contributor to material loss. A designated and standardized suture storage method was implemented, supported by updated work instructions and associate training. Weekly material variance decreased from $2,830 in a high-variance week to $1,809 during implementation and to $1,467 in the following week. These results confirmed improved material control and reduced variance without compromising product quality or compliance. Key Terms ⎯ Lean Manufacturing, Process Optimization, Root Cause Analysis, Standardized Work.