Improving Product Changeover in Pharmaceutical Manufacturing Through Lean Six Sigma

Abstract

Pharmaceutical bulk manufacturing is essential for producing important lifesaving drugs, but often faces significant challenges during changeovers that can lead to production delays and increased costs for the company. This study focuses on applying Lean Six Sigma methodologies to streamline complex changeover processes within a pharmaceutical manufacturing facility. With tools such as fishbone diagrams and Pareto analysis, root causes were identified, and solutions were implemented to reduce changeover delays. An Andon board was implemented which reduced operator response times to alarms by 39%, helping to mitigate delays caused by equipment malfunctions. Standardized flowcharts provided consistency which helps in reducing human error and confusion during the process. The 5S initiative reduced wasted time and unnecessary movement during changeovers. The successful application of these methodologies in this study highlights the potential for Lean Six Sigma to drive significant operational improvements in highly regulated environments like pharmaceutical manufacturing. Key Terms - Changeover, Continuous Improvement, DMAIC, Lean Six Sigma, Pharmaceutical Manufacturing.