Optimization of setup operations through the application of SMED techniques. The Zambon S.p.A. case

The aim of this paper is to provide companies in the pharmaceutical sector and more broadly within the manufacturing industry with a simple, effective, and logically structured procedure for applying the SMED methodology to improve equipment setup processes. The ultimate goal is to reduce machine changeover times on pharmaceutical packaging lines through a step-by-step approach grounded in Lean Management principles and techniques. The project was developed within the operational context of Zambon S.p.A., a leading company in the pharmaceutical industry, and is based on real needs observed on one of its packaging lines. The first section introduces the theoretical foundations of Lean Manufacturing and Lean Thinking, which represent the conceptual basis for the work carried out.The second section focuses on the practical application of the methodology at Zambon, starting with a detailed analysis of current setup procedures and the critical issues affecting changeover performance. The project then proposes a series of structured interventions aimed at improving efficiency and standardizing the format changeover process on a line particularly affected by frequent and time-consuming setup operations. The initiative addresses the planning, measurement, and analysis phases, followed by the development of a SMED-based improvement strategy tailored to Zambon's production environment. Nonetheless, the methodology and tools introduced, while designed around a specific context, are adaptable to other pharmaceutical packaging operations and, with appropriate modifications, to various industrial settings. The integration of SMED with established Lean tools, such as 5S, Kaizen, Poka-Yoke, visual management, and Total Productive Maintenance (TPM), led to a significant reduction in changeover times. This result enables Zambon’s production planning team to manage orders more flexibly, taking into account the newly optimized setup times, increasing machine availability, and minimizing non-value-added activities. Finally, the project delivers a practical and replicable model for format changeovers alongside the definition of a standardized procedure , which previously did not exist. A set of complementary actions was implemented to simplify the tasks of maintenance personnel, improve ergonomics, and enhance the overall efficiency of the changeover process.