Many people have been helped by orthopedic implants in recovering their ability to walk and reducing their discomfort. Still, many times, revision surgeries are required when there are minor inconsistencies in the design of the parts. The main purpose of this paper is to discuss how SPC, when used properly in machining orthopedic implants, may greatly decrease issues with consistency and, as a result, the number of basic surgeries that need revision. The study makes use of practical information from a high-precision medical device manufacturing environment to explain how key control charts, Cp/Cpk figures, and similar tools improve product accuracy and make it simpler to predict outcomes. It appears from the findings that using SPC improves the results for patients, saves costs in the long run, and boosts the quality of treatment in orthopedics. This paper bridges the gap between statistical manufacturing theory and its practical application to human health by proposing a scalable model for quality improvement in the medical device industry.

Orthopedic Implants, Statistical Process Control, SPC, Machining Tolerance, Quality Control, Revision Surgery, Medical Device Manufacturing

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Borror, C. M. (2009). The Certified Quality Engineer Handbook (3rd ed.). ASQ Quality Press.