Reduction of Cosmetic Defects Due to Criteria Misalignment at a Medical Device Manufacturing Line Using DMAIC Methodology

Abstract

For the last few years, the economy of Puerto Rico has been negatively affected, increasing the operational cost of the industries in the Island. The Pharma / Medical Device industry is not excluded of this situation. In addition, regulatory agencies have been increasing their requirements and conditions that enforce activities to ensure that the products or devices being manufactured meets or exceeds the expectations of clients and regulatory agencies across the world and to protect the public health. In this challenging business environment is essential for the industry to invest in new equipment and technologies to address the required corrective and preventive actions to ensure the quality and efficacy of the goods to be manufactured. All this factors makes Pharma and Medical Devices companies to reduce and/or eliminate their unnecessary scrap to maintain competitive costs. Companies focus on production efficiencies and often drive attention to inefficiencies due to scrap or reworks that are performed during the manufacturing process. Lean Six Sigma Methodology is focused on business and process improvements based on decrease of process variation, waste elimination, process improvement and customer satisfaction. This project has been developed under the Lean Six Sigma principles and using DMAIC five-step approach, in order to identify opportunities to enable the company to reduce cosmetic defects at the neuromodulation manufacturing line at MPROC Juncos. Key Terms - Cosmetic Defects, DMAIC, Lean Six Sigma, Medical Devices.