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论文编号：	13099
作者编号：	2320190491
上传时间：	2022/6/6 16:50:28
中文题目：	A公司培养基生产质量管理的流程改善研究
英文题目：	Process improvement study of quality management of culture media production in Company A
指导老师：	杨玉武
中文关键字：	无血清培养基公司；固体培养基；无菌性；质量管理；流程改善
英文关键字：	medium-sized serum-free medium manufacturer；Solid medium；Sterility；Quality management；Process improvement
中文摘要：	中国培养基的产业链的上游是血清等原材料企业，中游是培养基生产企业、下游是疫苗、抗体、基因治疗等制药企业，原材料企业和培养基生产企业的质量改善文献鲜少提及。质量管理一直是制药行业的研究焦点。体现在两方面，一方面是应用于制药企业的管理理念必要性和可行性，包括全面质量管理和六西格玛等，另一方面是符合GMP体系的研究（2020年制药企业取消强制取得GMP证书要求），采用ISO9000验证体系的文献少。我国培养基行业无相应的国家或行业标准。虽然大多数培养基企业通过了ISO9000认证，但相关质量规范并没有真正落实到生产中。各企业执行的各自的内部质量规范，生产出成品的质量水平良莠不齐。因此，如何提高质量，已经称为培养基生产企业面临的重要挑战。 A公司是一家无血清培养基的小型生产企业。质量管理体系的建设借鉴国际和国内大公司，没有结合企业实际情况进行调整和优化。产品质量问题的投诉，严重威胁到A公司的市场地位和生存与发展。 采用案例研究的方式，研究A企业生产过程的质量问题。首先，回顾了质量管理的基本思想和质量管理研究的最新进展。然后，剖析了A公司质量管理的现状，找出造成固体培养基产品质量问题的原因是生产过程中人员和内包装材料质量不稳定造成的外部污染。针对这些原因，提出了四方面质量管理的流程改善方案：强化供应商管理；优化标准操作流程（SOP）；监控工艺执行流程和完善持续改善机制。同时，为确保质量管理流程改善的顺利实施。制定保障措施：体现领导作用；健全培训管理；改善绩效考核制度。通过A公司上述改善方案和保障措施，解决问题同时提高质量管理水平。 本研究丰富质量管理理论应用行业领域，对于培养基生产制造企业有积极的借鉴意义，为同类企业质量管理的研究提供了新的思路。
英文摘要：	The industry chain of Chinese culture media is dominated by raw material companies such as serum in the upstream, culture media manufacturers in the midstream, and pharmaceutical companies such as vaccines, antibodies, and gene therapy in the downstream, with little mention of quality improvement in the literature for raw material companies and culture media manufacturers. Quality management has been the focus of research in the pharmaceutical industry. It is reflected in two aspects: on the one hand, the necessity and feasibility of management concepts applied to pharmaceutical companies, including total quality management and Six Sigma, and on the other hand, research in compliance with the GMP system (the mandatory requirement for pharmaceutical companies to obtain GMP certificates will be abolished in 2020), with little literature on the adoption of the ISO 9000 validation system. There is no corresponding national or industry standard for China's culture media industry. Although most of the culture media enterprises have passed ISO9000 certification, the relevant quality specifications have not really been implemented into production. The respective internal quality norms implemented by each enterprise produce finished products of varying quality levels. Therefore, how to improve quality has been called an important challenge for culture media manufacturers. Company A is a small manufacturer of serum-free culture media. The construction of the quality management system was borrowed from international and domestic large companies, without adjusting and optimizing with the actual situation of the enterprise. Complaints about product quality problems have seriously threatened Company A's market position and survival and development. A case study is used to study the quality problems in the production process of company A. First, the basic ideas of quality management and the latest progress of quality management research are reviewed. Then, the current status of quality management in Company A was analyzed, and the causes of product quality problems of solid media were identified as external contamination caused by unstable quality of personnel and inner packaging materials in the production process. To address these causes, a four-pronged quality management process improvement plan was proposed: strengthening supplier management; optimizing standard operating procedures (SOPs); monitoring the process execution process and improving the continuous improvement mechanism. At the same time, to ensure the smooth implementation of quality management process improvement. Develop guarantee measures: reflect the role of leadership; improve training management; improve the performance assessment system. Through the above improvement programs and safeguard measures in Company A, the problem is solved and the quality management level is improved at the same time. This study enriches the industry field of quality management theory application, has positive significance for culture base manufacturing enterprises, and provides new ideas for the study of quality management in similar enterprises.
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