The Practice Study Of The Quality System Reconstruction Based On Project Schedule Management Theory

With Chinese enterprises accelerate globalization progress and foreign capital increase investment on medical device development and production in China,how to effectively run quality management system compliance with medical device field standards and regulatory in globalized and medical device industry development rapidly environment,in order to secure the medical device's safety and performance and make it compliance with different countries and regions' standard and rule and improve the competitiveness of enterprise is getting more and more attention.It is also the key element of enterprise self-development and suitable with changing environment.According to the enterprise operation strategy change from in “China for China” to in “China for global”,how to build a quality management system that can apply to cross sites and regions,compatible with different company,business group according to project management model,project schedule management method based on project form and aim to have a quick response for regulatory and standard change in different countries and regions,how to mitigate the risk of new quality management system built slowly result in product hold and regulatory and standard non-compliance,given quality management system update bring confliction in existing organization and operations.It will be valuable topic.Project works a key elements and best management method was proved by time.And project is widely existed in product development process.Different from the traditional product development projects,the paper takes the S company system reconstruction as the foundation of the project practice,and discusses how to restructure the activities with the project as the quality management system,and take the project management theory and the progress method as the action guidance,and combine the management theory with the system reconstruction project.In this paper,the quality management system reconstruction of S company is carried out in the form of project,discuss how to use the project management theory and project schedule management method to complete the reconstruction of the quality system efficiently and quickly.Propose the thinking and key point for each stage of the quality management system project.Combining critical chain method and project control methods to formulate the progress plan of the quality management system reconfiguration project and implement the optimization.In order to reduce the risk of the non-conformity of the regulations and standards brought by the slowly quality management system update.Realize the effective control of the system reconstruction project.In this paper,the theory and method of project management and progress management are collected and summarized,and combined with the study of the requirements of the system standards,identify the difference between traditional product development and quality management system reconstruction project,and propose the common steps of quality management system implementation.Secondly,aiming at the characteristics of the quality management system reconstruction project,propose the management idea of quality system reconstruction project.The third validate the implementation steps of the project,the practicality and effectiveness of the project management ideas,critical chain method and optimization methods through project practice of S company.Hope to provide a practical way for other enterprises for reference.