Improving Efficiency in the Decommissioning of Pharmaceutical Equipment & Systems

Abstract

This study presents a structured, data driven framework to improve the efficiency, traceability, and compliance of pharmaceutical equipment decommissioning processes. Using the Lean Six Sigma DMAIC methodology, the project addressed key inefficiencies (such as inconsistent documentation, delayed evidence review, and gaps in process monitoring) through targeted interventions such as standardized checklists, peer-review checkpoints, and formalized documentation protocols. Post-implementation analysis of 64 decommissioning reports yielded a sigma level of 2.0 and a 68.95% process yield, establishing an initial benchmark for ongoing monitoring. Although baseline data were unavailable, three core performance metrics (decommissioning efficiency, traceability, and documentation accuracy) were defined to support future evaluation and continuous improvement. Aligned with Good Manufacturing Practices (GMP) and Environmental Health and Safety (EHS) standards, the framework offers a replicable model for optimizing compliance-driven decommissioning activities. These findings contribute to best practices in pharmaceutical operations by improving process consistency, reducing delays, and supporting scalable standardization. Keywords - Asset Lifecycle, Decommissioning Processes, Lean Six Sigma, Pharmaceutical Equipment.