| In recent years,the categories of medical devices are increasing rapidly,but the level of product quality control in most related enterprises is low,resulting in a large number of medical device use risk.How to improve the product quality of medical device is a challenge that every medical device enterprise has to face and a research topic.The development of quality management has entered the stage of Lean quality management,which is based on total quality management,through quantitative analysis of key quality data,key quality indicators of continuous optimization and improvement,to achieve excellence standards,such as DMAIC-based Six Sigma management method,has become an important management measure to improve the level of enterprise quality and core competitiveness.F Company is a professional r & D,production,sales of rehabilitation medical devices company.In recent years,with the increase of production and sales volume,the product quality problems are also increasing,which can not be solved by existing quality management strategies.In the light of the above,this paper takes how to reduce the after-sales maintenance rate of the newly-installed W medical device products of F Company as the research object.First of all,through the search,search domestic and foreign literature and other relevant information,to understand the current status of research on quality management of medical device related enterprises and products at home and abroad,as well as the application status of Six Sigma Theory DMAIC model research and the commonly used methods and tools for quality improvement,according to the situation of F Company,the status of quality management and the characteristics and problems of W product,the Six Sigma DMAIC model is chosen as the improvement research method.Through the five stages of Six Sigma DMAIC model(definition,measurement,analysis,improvement,control),the following tasks are completed in turn: define the improvement target of W product,determine the improvement implementation plan of W product,verify the stability and reliability of the measurement system through the MINITAB software through process factor analysis and potential failure mode and effects analysis as the main potential factors contributing to the high maintenance rate of the W product,through the process analysis and test design,the main basic factors that cause the high maintenance rate and the bad rate of W product are obtained,then through the material and process improvement,inspection basis and action optimization to achieve product quality improvement,through the establishment of standards and systems and enhance staff training and quality awareness,control the results of improvement.In order to make the Six Sigma DMAIC model to improve the quality of W product continuously and effectively,F Company has established the guarantee system from three aspects of organization,personnel and capital.Through more than one year research and implementation of DMAIC to improve the model,the failure rate of W product of F Company has been significantly reduced.This study indicates that DMAIC model can provide a new method and approach to improve the quality of medical device products,which can help the medical industry manufacturers to improve their performance and achieve success in the market.The results of this study can not only provide a reference for other aspects of the company’s product quality improvement,but also for other similar products in the same industry to provide a reference for quality improvement. |
