Study On Quality Control Of Infusion Dropper Production In WG Company

With the rapid economic growth in China,the market is becoming increasingly international.It is the best ways to make its customer satisfaction by improving products quality and continuous innovation if a medical device company want to stabilize the domestic market and enter the international market gradually.As a leading enterprise in the medical device industry in China,WG is using automated assembly equipment instead of manual assembly.While automation can significantly increase production,there are still some issues to be solved for WG including that how to keep the stability in manufacturing processes,improve the rate of qualified products and reduce customer complaints.High precision components are required in automated production,otherwise quality problems will be easy to occur and quality costs increased.Takes the quality control of drip chamber of infusion set in the production process in WG as a research object,and summarizes the related theories and its current state on quality management and statistical process control.It makes an introduction of WG and its quality management system,and gives an overview of the production and process status of infusion set products.Used some methods such as Pareto chart,5M1E(man,machine,material,method,environment,measuring),experiment design and regression analysis to finding out that the thickness deviation is the root cause of drip chamber leakage of infusion set.By analyzing the feedback information of Single Use Infusion Products,the author select control chart tool to analyze the stability of injection molding process,and take some control measures such as process method,personnel and production process management for improvement.And then the effectiveness of improvement is verified by using control chart and process capability index tools.Through the improvement process on quality problems of drip chambers leakage for single use infusion set,the rate of qualified product increases immensely,which means that not only the quality cost and customer complain numbers are reduced,but also the core competitiveness of the enterprise is strengthened.