Research On Quality Management Optimization Of Traditional Chinese Medicine Slices In M Company

M Pharmaceutical Co.,Ltd.was founded in 1993 and became one of the holding subsidiaries of a listed pharmaceutical group in 2013.It is a large-scale traditional Chinese medicine(TCM)company that focuses on the cultivation,preliminary processing of TCM,and the production,research and development and sales of TCM slices.In the years of exploration and practice,a relatively complete quality control and management system was established,but in the context of the high-pressure regulatory situation of the FDA,the market supply is saturated,and the competition is intensifying,the existing quality management measures are obviously unable to adapt to market changes and industrial upgrades,and even caught enterprises off guard during frequent "fly inspections" by regulatory agencies.Overall,QM problems has become the biggest obstacle to the sustainable development of the M company.This dissertation takes the entire production chain of TCM slices of M company as the research object,meanwhile,focuses on a series of quality management problems during the production process,and combine theoretical knowledge and tools related to quality management.In-depth analysis of the causes of quality management problems from the current quality management system,goals,related document maintenance,process link settings,system implementation,organization structure and staffing arrangements,etc.Then based on the diagnosed problems and the reasons,while draw on advanced experience in the quality management of TCM slices production domestic and overseas.This paper puts forward the optimization scheme of quality management of TCM slices production,and finally evaluates the new scheme by using the quantitative method based on balanced scorecard performance.It is considered that the implementation of quality management based on the integration of information and industrialization,the construction of quality tracking traceability system framework based on radio frequency technology and the post-TQM system are the development direction of quality management optimization of TCM slices production for M company in the future.