Improving Production Fixture Availability Using Lean and Six Sigma in a Medical Device Manufacturing Line

Abstract

This design project addressed the problem of production fixture unavailability in a medical device manufacturing line, where missing, misplaced, or delayed fixtures generated avoidable downtime and process interruptions. The main objective was to improve fixture availability and reduce fixture-related downtime through the application of Lean and Six Sigma principles. The methodology followed an applied, non-experimental, observational approach using historical downtime records, fixture usage logs, direct observations, process mapping, cause-and-effect analysis, and statistical evaluation of key performance indicators. The results showed that missing fixtures, misplaced fixtures, and waiting for fixture return were the most frequent baseline causes. Comparative analysis between baseline and post-improvement conditions showed a reduction in mean downtime from 37.53 to 13.53 minutes, a reduction in interruptions from 4.40 to 1.73, and an increase in fixture availability from 80.93% to 95.00%. These findings support the conclusion that a structured fixture management strategy can improve operational efficiency and process stability.