Improvement of the Statistical Techniques Quality System Element in a Medical Device Industry
Murillo Pagán, Roberto M.
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Abstract - This project is focused on reducing the compliance risk of a Medical Device Manufacturer by improving its Statistical Techniques Quality System Element. Lean Sigma Methodology was used to identify the inputs or major contributors to the compliance risk. The Methodology section explains further how the tools were used. By reducing the compliance risk, the organization expects to achieve zero observations related to Statistical Techniques on regulatory inspections performed by the Food and Drug Administration (FDA). Key Terms - Compliance Risk, DMAIC, FDA, Statistical Techniques