| At present, China is a super country in manufacture industry of the world, but not a super country in high quality product manufacture. Many corporations are still in extensive pattern of management with high cost, low quality and long cycle. Benefit from development of China, demographic dividend and inadequate supervision of the authority, these corporations still can survival and develop. But nowadays China become more and more internationalization. With the integration of global manufacturing today, we must solve existing problems and make effort to adapt to the development of the world.Orthopedic device is one of the fastest-growing industry.Due regulatory threshold gradually eliminate, orthopedic manufacturing enterprises also face the same challenge to improving quality and reduce the cost as other industries. Some companies choose to high inspection frequency to control quality, but take high cost; some companies choose low inspection frequency but take risk for low quality product release. It Is challenge for whole orthopedic industry to find a solution to balance the requirement from customer and with low cost.6 sigma is a systematic process for improvement. Through definition, measurement, analysis, improvement and control(DMAIC) based on existing process to eliminate defects and remove valueless process, so as to improve quality, reduce cost and shorten the cycle eventually meet customer requirements.Not only lots of management tools of six sigma can be used directly, also lots of data analysis tools to help to find out root cause. There are large amounts of data before and after improvement lead to a quantitative conclusion.This thesis reviewed six sigma usage at domestic and abroad with practical case, introduced some six sigma tools. With a specific case that meniscus product manufacturing process improvement in J company to discuss the problems encountered in mechanical processing of production, how to use six sigma to solve these problems and the final result. The thesis includes production problem summary, background analysis, feasibility analysis, risk assessment, measurement system analysis, estimate current actual production capacity. Improve and verify production capability through improving key factors. At last, sustain to improve the solution with long-term management. In this case, J company saved not only more than $30000 labor cost a year also the potential new equipment investments.Analysis results show that six sigma is data analysis tool as well as management method. In the process of a project, the measurement system need to be verified firs; Process capability effect directly to the product quality; Professional knowledge and management method are both essential to the success of a project. |