| Twenty-first Century big data bursts of era,all walks of life are faced with opportunities and challenges,in the face of increasingly fierce market competition environment,the quality of products has become the basic elements of enterprise competition.Correspondingly,the quality management of the enterprise is also from the narrow inspection management to the overall quality management.And the implementation of total quality management must be established on the basis of people oriented,strengthen the quality awareness,improve the comprehensive quality of the staff and the implementation of the quality responsibility system.The emphasis here is no longer a single product quality,but the establishment of the entire enterprise quality management system.Quality management refers to an organization is a kind of integrated anagement in order to meet the needs of customers in all sectors and levels within the organization,the management behavior by continuously improve the quality and reduce defects to obtain quality output(quality output [1]).At present,China’s pharmaceutical industry in the development stage,is a highly regulated industry,drug quality management level to a large extent with the drug regulatory agencies and regulatory policies linked to the policy.The whole enterprise quality management system and production,sales,management,social contribution and so on closely linked together.The medicine industry is a highly integrated high-tech industry group,which is the national economy.One of the important industries,the pharmaceutical industry is a special industry,involving the national health,economic development and social stability,and people’s daily life is closely related.With the development of productivity,and more rapidly,the product quality requirements are increasingly high,quality management is not limited to the manufacturing process,the whole process must be throughout the enterprise production and management activities,the methods should also be positive in many aspects,in view of the reasons,thoughts and methods of comprehensive quality the resulting management.[2]In this paper,quality management,project management and pharmaceutical enterprises based on the establishment of quality management system and other relevant classical theory,based on consulting a large number of related fields the latest research results,combined with the government quality award project XP pharmaceutical company case,and in practice the full implementation of the quality management of pharmaceutical enterprises,perfect quality system seriously to explore.The application of process method and system for management of pharmaceutical enterprises,in the whole process of project quality management,points out the important meaning of the pledge system for the entire project to establish the integration and operation of the project quality,the purpose is to explore a suitable for pharmaceutical enterprises to implement the complete theoretical system of quality management.After in-depth research,to keep and improve the effectiveness of the implementation of the quality management system,combining with the actual experience of management company,Corporate Events according to the size and complexity of design or improvement for quality system structure of enterprises,the preparation of quality related content,provide the required quality system for the successful operation of management responsibility,resource allocation,setting quality policies,plans and objectives,through process management,product quality control system,risk analysis,corrective and preventive measures,change management,regularly on the quality system of continuing suitability,adequacy and effectiveness evaluation,to ensure that the program of key performance indicators in the monitoring system effectively and improve the quality of management,the "full","comprehensive","whole process management"."Quality is the life of enterprise" as the core values,the implementation of the whole staff,the whole process of quality management,always adhere to the "strict regulations,quality first,quality continuous improvement.Over the years,with advanced technology,high quality products,good after-sales service has made good performance,the development of a full range of drive.Finally,in a company as a case,using quality management theory to the analysis of the company’s quality management design,quality management process control and quality management evaluation results,evaluation of the quality management in the use of the results of the quality management system. |