| A Medical Device Co.,Ltd was founded in the early 1990 s,2005 by the foreign acquisition of listed companies,to become an important part of its development in China.A Company is a collection of medical device R&D and production.Enterprise after 30 years of development,formed a complete set of quality system and quality management methods.But in recent years with the NMPA pressure regulation and enterprise itself under the background of seeking product upgrade,the existing medical device quality management method obviously unable to adapt to the change of environment and product upgrading,NMPA frequently "flight check" also allows businesses to feel more pressure.How to maintain high quality for medical devices in A company,has become an important topic of company management,also is an urgent problem on the development road of A company.Based on three important production line of A company and the company’s existing quality management system as the research object,through analyzing the quality data collected during company’s daily operating,summarizes the three problems as quality system documents and the actual decoupling,employees lack of knowledge of quality training and corporate risk management form is more important than content according to statistical process control and quality fluctuation theory.Using continuous improvement and risk management related knowledge,improve the company’s product quality management system via incoming quality management,change management,nonconformance management and document management process.Strengthen the construction of company based quality awareness of employees through staff training management and risk management.Puts forward the preliminary ideas for the construction of digital system and using Power APPs preliminary platform to achieve the company quality data and the data of production and material system connectivity,assist enterprise development,provide safeguard for the smooth implementation of optimization scheme. |
PDF Full Text Request