Quality Improvement in a Medical Device Manufacturing Process Applying Six Sigma Tools
Rondón Nieves, Luis Daniel
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Abstract - The current manufacturing process of a medical device product has great opportunities on scrap percent reduction, which has been impacting the material and labor costs of the product, as well as in defects per million (DPMs) reduction, to improve the quality of this product. The current scrap percent has been affecting the production yield and complaints from clients (surgeons) have been increasing during the last Fiscal Year. The Six Sigma structure DMAIC: Define, Measure, Analyze, Improve, and Control, will be the key for the success of this project. The expected benefits are the evaluation, recommendation, and implementation of any opportunity of quality improvement that results in a positive impact to the clients at a low cost of production for the company. The main research contribution is that this project provides the customers (surgeons and their patients) an instrument that always actuate as established in the specifications to save humans lives. Key Terms Medical Devices, Process Optimization, Quality Improvement, Six Sigma.