Systemic Bottleneck Elimination and Throughput Optimization Using Integrated Lean-Simulation Methods across Regulated Industries

Regulated industries such as pharmaceuticals, medical devices, food processing may be subject to bottlenecks which reduce throughput, cost and slow down operations critical in compliance. Although conventional Lean instruments can be used in finding areas of inefficiencies, by being dynamic and complex, these systems are beyond the helpfulness of the conventional Lean tools. The present paper proposes an Integrated Lean-Simulation Framework, which integrates the Lean methodologies and simulation modeling in order to optimize the system performance. The strategy allows teams to see prior necessary adjustments on how to eliminate bottlenecks, simulate a what-if situation, and perform the changes with a minimal risk. The example of case studies in various regulated industries shows gains in throughput, lead time, and utilization of resources owing to an increase in compliance without decreasing compliance. The framework provides a scalable data driven continuous improvement offering in high compliance environments, the bridge between operational excellence and digital transformation.