质量保证 - Xiamen Traditional Chinese Medicine Co., Ltd.

"Quality benchmark" of industrial enterprises

In 2022, the national market credit rating AA enterprises

QC team management

Quality can be trusted by team management

2014 National industrial enterprise "quality benchmark". ---- Implement production site management based on "GMP risk management" Xiamen Chinese Medicine Factory Co., Ltd. has been implementing total quality management since the 1980s, actively organizing mass quality management activities such as QC group activities, quality month activities, post training and rationalization suggestions among employees, laying a good and solid foundation for the construction of a sound quality management system. After the relocation of the new plant, Xiamen TCM effectively applied the method of GMP risk management to the management of the production site, identified the risks in the management of the production site, analyzed and evaluated them, and eliminated or reduced the existing risks by means of 5S and QC group activities, effectively solved the difficulties in the management of the production site brought by the new plant, new technology and new equipment. It has promoted the continuous improvement of Xiamen TCM quality management system, enhanced the quality management level, and injected new vitality into the sustainable development of the company. Implementation process 1. Introduction and popularization of risk concepts and risk management methods The introduction of quality risk concept and risk management method has been paid high attention by the company's senior management. A risk management committee was established to be responsible for the training, promotion and planning of risk management, and a production site risk management project team was set up to be responsible for the organization, promotion and tracking of production site risk management. Use the risk management method to solve the problems existing in the production site. 2. Application of GMP risk management in production site management Xiamen TCM puts the concept of risk management into the five elements of production site management: human, machine, material, law and environment. Penetrating into the actual site management work, the use of risk management tools to carry out reasonable allocation and optimization combination of various production factors in the workshop site, and combined with some better mass quality management activities, not only to ensure the smooth realization of the goals of the production system, but also to achieve good results. Implementation performance The production site management of Xiamen TCM based on "GMP risk management" has achieved remarkable results, realizing the systematization of the production site management of Xiamen TCM, the ordering of the production process, the standardization of the operation, the localization of the stacking of goods and the cleanliness of the environment. 1. Improve personnel quality and promote class construction 2. Continuous improvement of product quality 3. Sorted out and improved the quality management system 4. Lay a solid foundation for GMP certification The practical experience of "combining GMP with Lean Six Sigma" quality management Over the years, our company has been adhering to the "efficient and pragmatic, continuous improvement; Abide by the contract, customer first "quality policy, inherit the century-old production process, the pursuit of excellence. In 2015, under the enterprise development decision, our company officially introduced the Lean Six Sigma management model. Combining many years of quality management experience, this paper puts forward a quality management system based on pharmaceutical GMP, supplemented by Lean Six Sigma advanced improvement tools and methodology, and organically combines the two. Develop and innovate a quality management road with Xiamen traditional Chinese medicine characteristics. Through the application of Lean Six Sigma tools to the production process statistics, analysis, improvement, and effect summary and confirmation tracking, summed up a set of suitable methods for drug production quality management. The Lean Six Sigma management concept is fully introduced, involving quality awareness, production management, equipment management, training system, etc., to achieve the fine management of the production and manufacturing system. At the same time, in the production process, a variety of quality assurance and control tools and means are comprehensively used to monitor the key process parameters and quality indicators and implement continuous improvement. Achieve the quality objectives of process improvement and continuous improvement of management level. The organic combination of GMP and fine Six Sigma breaks through the current quality management bottleneck, extends the direction of quality management to fine and in-depth, and continuously improves and sublimates, so as to realize the quality management system combined with GMP and lean Six Sigma. After 3 years of continuous exploration and practice, Lean Six Sigma has successfully run through the GMP quality management system. Through a series of improvements, it promotes the quality management to be refined and in-depth. In the process of improvement, it helps Xiamen Traditional Chinese medicine quality management system make a new leap forward and rejuvenate the quality management system. It also injected new vitality into the sustainable development of the company. The innovation of quality management practice. 1, pay attention to visualization and other error prevention management means, improve the level of drug production site management in an all-round way. 2, the use of total equipment management (LTPM management) means to comprehensively improve the level of equipment production and maintenance. 3, the use of process control and other quality control means to ensure that the quality of drug production process is stable and controllable. 4. Carry out lean Six Sigma project to continuously improve the production process and reduce potential quality risks. The effect of quality management practice 1. Improve the construction of GMP quality system. In 2018, the enterprise successfully passed GMP re-certification, which was affirmed by the experts of the GMP inspection team. 2, product quality continues to improve, the product pass rate has reached 100% for many consecutive years, and the product inspection pass rate in the drug administration department has reached 100%. 3, the effect is accurate, user satisfaction, was awarded as the "national implementation of user satisfaction project advanced unit". 4, the steady growth of economic benefits, products are loved and supported by consumers. Exclusive products Babaodan and Babaodan capsule sales of more than 100 million yuan in 2017, ranked first in the market IMS data, clearing liver and gallbladder damp-heat oral dosage form.

Build a quality credit system and implement customer satisfaction projectsThe company will always adhere to the "keep zero distance from the market" business philosophy, continuous improvement, continuous improvement, with the company motto "all for customers, for all customers" as the criterion for work, continue to provide users with the best quality products and services, return to society, return to customers.All along, the company has been focused on the needs of users, clear responsibility to customers, continue to provide users with current and future expectations of products, and as a starting point, formulated the company's quality policy - "efficient and pragmatic, continuous improvement; Abide by the contract, the user above ", the implementation of customer satisfaction project implemented into the company's various work, from research and development to production to sales, covering the whole life cycle of the product quality management system, and constantly improve product consulting, adverse drug reaction monitoring, product quality complaints, product return processing and other product after-sales service system, to ensure and continuously improve the quality of products. Pay attention to and constantly meet the needs of users, improve customer satisfaction.The company follows the self-development policy of continuous improvement, and makes continuous progress with the support of continuous introspection and partners, and is dedicated to providing high-quality products and services for partners and users. In order to further improve the quality of our customer service and enhance the competitive advantage of the enterprise, we have specially commissioned a third-party research agency to conduct a customer satisfaction survey, so as to understand the customer's perception and evaluation of the quality of our products/services, and identify the problems and weak links existing in the product and service level of the enterprise. To provide decision-making reference for the next step of product/service optimization of Xiamen Chinese Medicine Factory Co., LTD. Since 2014, our company has been awarded the title of "Customer Satisfaction Service Unit" for many years, and has established a good brand image in the hearts of the majority of users.

QC team is "in production or work positions engaged in a variety of labor workers, around the enterprise's business strategy, policy objectives and on-site problems, to improve quality, reduce consumption, improve the quality of people and economic benefits for the purpose of organization, the use of quality management theory and methods to carry out activities of the group." QC group is an effective organizational form of mass quality management activities in enterprises, and is one of the effective ways for employees to participate in the implementation of GMP.Since the 1980s, the company has implemented total quality management and encouraged QC activities. To solve practical problems as the starting point, learn from and promote advanced management concepts, technologies and methods, in the production, research and development, management and other specific work links, actively look for topics, technical research, continuous innovation, continuous improvement, not only solved a series of practical problems in production and work, At the same time, the staff's learning ability, application ability, innovation ability, execution ability and self-management ability have been significantly improved. 1, the company won the 2019 national pharmaceutical industry excellent promotion organization;2, the company's general manager, Comrade Wall Shifa, won the 2019 National Quality Management Group activities excellent promoter;3. Mr. Wall Shifa, general manager of the company, won the outstanding leader of Fujian Province Quality Management Group activities in 2020;4. Comrade Lin Lihong of the Quality Management Department was the quality pacesetter of National Quality Management Group activities in 20195. Lin Lihong, Quality Management Department, Excellent promoter of Fujian Provincial Quality Management Group in 2020;6. The QC team of Detection and Analysis Department was awarded the 2019 Excellent Quality Management Team of Fujian Province;7, R & D Department innovation building QC team 2020 Xiamen excellent quality management team8. Comrade Huang Shuyun from the Quality Assurance Department won the excellent promoter of Fujian Provincial Quality Management Group activities in 20219, the company's executive deputy manager, quality responsible Comrade Guan Bin won the 2022 Fujian Province quality management group activities outstanding leader10. You Tianyi from the Technology Department won the excellent promoter of Fujian Provincial Quality Management Group activities in 202211. Babaodan QC Group and Guarantee your Satisfaction QC Group won the first prize of the National pharmaceutical industry Quality Management QC Group Activity in 202112. Xinyu QC Group won the first prize of Fujian Province 2022 Quality Management Group Achievement.13, "Xinyu" QC group and "Excellence" QC group won the first prize of the National pharmaceutical industry quality management QC Group activity in 202214, "Explore for change" QC team won the 2022 Xiamen Quality Management Group Achievement Excellence Award15. "Packaging" QC Group and "Zhongzhi" QC Group won the first prize of 2023 Quality Management Group Achievement of Fujian Quality Management Association16, "Excellence" QC team won the Fujian Provincial Quality Management Association 2023 quality management group results second prize

Team is an active cell of the enterprise, a platform connecting the enterprise and employees, and an important position for cultivating employees and motivating talents. In order to improve the core competitiveness of the enterprise and the level of team management and the quality of the staff, strengthen the quality management work, and improve the quality of products, services and work, the company actively strengthens the construction activities of quality trustworthy team. Since 2019, a total of 11 teams of the company have been awarded the titles of national and provincial quality "trustworthy" teams, as follows: 1. The crushing class won the 2019 Quality trustworthy team of China Quality Association2, packaging class 2 won the 2020 Fujian Quality Association quality trust team3. Babao Dan Class and Equipment Engineering Department operation class won the national pharmaceutical industry quality trustworthy team in 20214. Pill Class won the first prize of Fujian Province Quality Trustworthy Class Group in 20215. The packaging class won the Xiamen Quality Trustworthy Class Group in 20216, storage and transportation class, bacteria test room 2022 Xiamen quality trustworthy class group7, processing class, packaging class three was rated as 2022 Fujian Province first prize quality "trustworthy" team8. The pill class won the 2023 Xiamen Quality Trustworthy Team (professional level) and the 2023 Fujian Province First Prize Quality Trustworthy Team9. The refining class won the 2023 Xiamen Quality Trustworthy Class Group (demonstration level) and the 2023 China Quality Association Quality Trustworthy Class Group