Title: Lean-OEE Integration for Productivity Improvement and GMP Compliance in a High-Mix Pharmaceutical Packaging System: A Case Study
Authors: Naniek Utami Handayani, Dian Patria Pambudi, Muhammad Raja Shafa Aulia Jalal, I Gede Indra Aryasa
Volume: 10
Issue: 2
Pages: 32-47
Publication Date: 2026/02/28
Abstract:
This study investigates productivity degradation in a high-mix pharmaceutical packaging system operating under Good Manufacturing Practice constraints. The objective is to develop and validate an integrated Lean-Overall Equipment Effectiveness framework capable of diagnosing systemic inefficiencies beyond traditional utilization metrics. A single-case study design was employed within a regulated pharmaceutical packaging department. Value Stream Mapping, defect analysis, workload assessment, and Overall Equipment Effectiveness decomposition were combined with simulation-based evaluation to quantify performance losses and test improvement scenarios. The results reveal that high equipment utilization did not correspond to high productivity. Quality losses were identified as the dominant contributor to performance degradation, followed by performance losses related to setup instability and workload imbalance. Waiting waste significantly increased lead time. Integrated improvement scenarios reduced total lead time by approximately 22%, increased yield from 0.628 to 0.803, and improved throughput by 63.6%. Sensitivity analysis confirmed that these gains remained robust under moderate parameter variation. The findings demonstrate that productivity in regulated high-mix systems is driven by the interaction of quality stability, process variability, and human workload rather than equipment availability alone. The study contributes a systemic Lean-Overall Equipment Effectiveness diagnostic framework that integrates operational efficiency with compliance considerations. The results highlight the importance of defect reduction, setup stabilization, and workload balancing for sustainable productivity improvement in pharmaceutical packaging environments.