Quality Strategy Study Of Medical Device Company J

Industry 4.0 developed very fast and powered by the application of artificial intelligence,intelligent production,Internet of things.Medical device industry is also entering into 4.0,product replacement is faster than before.In the period of great changes,how to make the quality management of medical devices not only guarantee the product safety but also support the realization of the company's strategy,will become a key part of enterprise competition.As a leader of medical device industry,J company found that the traditional quality management model faced many problems when it come into new product surgical platform.For example,the new product quality is not stable,the product delivery time is too long,and the quality cost is too high,so there is an urgent need to improvement.The purpose of this paper is to analysis the problems J company faced,combined with total quality management,DMAIC improvement method,data quality and quality cost theory,to explore the countermeasures and summary the implementation results.This paper summarized the quality strategy to traditional quality management need combine with industrial 4.0 technology,use data quality management and transform quality's organization and responsibility.After implementation,the quality cost has 33%low down,right first time has 13%increase,the product recall has 68%low down,product delivery time reduce to 3 months from 1 year,quality also be able to focus quality strategy,simplify process and integrate quality resource.That strategy success supported the transformation of digital surgery platform.This paper is a primary study of quality management under industry 4.0,provide a sample for quality management support company strategy,and also provide references for medical device company especially company who want to enter into industry 4.0.