DMAIC-Based Optimization of In-Process Monitoring for Scrap Reduction in a Regulated Industry

Abstract

Process monitoring and control are critical for quality assurance in the regulated medical device industry, supporting ongoing verification of processes and confirming they remain capable and in control. Many in-process monitoring activities require destructive testing, thereby increasing scrap costs. This project focuses on Line X, where in-process monitoring scrap significantly increased scrap costs, totaling $0.279 per unit over six months. Production volume growth forecasts and new product introductions suggest that the current monitoring strategy will further affect manufacturing efficiency. DMAIC methodology was applied to evaluate and optimize the in-process monitoring strategy. The project objective was to reduce monthly scrap costs associated with monitoring samples in Line X, focusing on destructive tests such as mechanical integrity and leak testing. All modifications were required to maintain product quality and regulatory compliance, and to prevent nonconforming units from reaching the customer. The optimized sampling strategy reduced costs and implemented controls to sustain improvements. Keywords ⎯ DMAIC, In-Process Monitoring, Sampling Strategy, Scrap Reduction.