I 摘要 婴幼儿是弱小敏感人群，其产品的质量安全至关重要，三聚氰胺事件引起了社会 对婴幼儿配方乳粉安全性的关注，自事件发生后，乳粉市场的监管和抽查更为严格， 因此作为婴幼儿配方乳粉生产企业，不管是为企业的战略性长期发展考虑，还是出于 企业的社会责任感，都需建立一个完善的质量管理体系，确保产品的质量。如何优化 企业的质量管理体系，提升产品质量，重建消费者对国产奶粉的信心是企业需要高度 重视的发展问题。 本研究的理论意义，以药品良好质量管理规范、食品良好质量管理规范、ISO质 量管理体系、SSOP卫生标准操作程序和HACCP危害分析和关键控制点体系为基础， 拟将多个质量管理体系进行一体化设计改进G公司的质量管理体系，为质量管理体系 优化的理论研究提供了全新的视角。 本研究的实践意义，拟改进G公司的质量管理体系，融入全面质量管理的理念， 落实全过程质量管理，最大限度地降低婴幼儿配方乳粉生产过程中的风险，有利于推 动质量管理的全员参与，对提高产品质量，实现质量管理体系高效执行，提升企业质 量管理水平，提高企业的核心竞争力都产生了重要的影响。本文还期望通过对G公司 的质量管理体系优化研究，能够对婴幼儿配方乳粉生产企业的质量管理体系优化和高 效运行产生一定的指导意义，为深化我国的婴幼儿配方乳粉供给侧改革，提升我国婴 幼儿配方乳粉的质量作贡献。 本文以G公司为研究对象，运用了文献分析法、经验总结法、实证调查与案例分 析法等方法对G公司的质量管理体系进行研究分析和优化设计。通过参考国内外对质 量管理体系、食品质量管理体系的应用研究，对比多个质量管理体系的区别、联系及 运行的效果，从原料的采购与验收过程管理、生产过程管理、销售过程管理三方面分 析G公司现行质量管理体系的运行现状。结合监管部门的日常检查、产品抽样检测及 消费者投诉情况，发现G公司质量管理体系的存在问题。以问题为导向，深入研究和 分析，结合药品GMP，将ISO22000质量管理体系、SSOP卫生标准操作程序、HACCP 危害分析和关键控制点体系有机结合，对G公司的质量管理体系实行一体化设计，从 成立食品安全小组、食品安全体系策划、前提方案和可操作性前提方案的编写、HACCP 计划、人力资源、基础设施管理、实验室控制、原材料与供应商管理、生产与放行管 理、文件记录管理、监控质量控制、年度回顾、验证改进方面提出优化方案，并将优 化效果前后进行比较，得出G公司高效运行质量管理体系，提高婴幼儿配方乳粉的生 产质量的方法。 关键词：婴幼儿配方乳粉企业；质量管理体系；优化研究 广东工业大学硕士学位论文 II Abstract Infants are weak and sensitive, and the quality and safety of their products are vital. The melamine incident has caused concern about the safety of infant formula milk powder.Since the incident, the supervision and spot checks of the milk powder market have become stricter.Therefore, as a manufacturer of infant formula milk powder, whether it is a strategic measure formulated for the long-term development of the enterprise and occupying the market, or a corporate social responsibility, it is necessary to consider establishing a strict comprehensive control quality management system to ensure Quality of products. How to optimize the company's quality management system, improve product quality, and rebuild consumer confidence in domestic milk powder is a development issue that companies need to attach great importance to. The theoretical significance of this research is theoretically based on the Good Manufacturing Practices of Pharmaceutical and Good Manufacturing Practices of food， ISO quality management system, Sanitation Standard Operation Procedure and Hazard Analysis Critical Control Point system. It is planned to integrate the design of multiple quality management systems improved the quality management system of G company, which provides a new perspective for the theoretical research of quality management system optimization. The practical significance of this research is to improve the quality management system of G company, integrate the concept of total quality management, implement the whole process quality management, and minimize the risks in the production of infant formula milk powder. It is conducive to promoting the full participation of quality management, which has an important impact on improving product quality, achieving efficient and orderly implementation of the quality management system, improving the quality management level of the enterprise, and improving the core competitiveness of the company in the market. This article also hopes that through the research on the optimization of the company's quality management system, it can have a certain guiding significance for the optimization and efficient operation of the quality management system of infant formula milk powder manufacturers, and to deepen the reform of the supply side of infant formula milk in China, to contribute to improving the quality of infant formula in China. This article takes G company as the research object, and uses the methods of literature analysis, experience summary, empirical investigation and case analysis to investigate, analyze and optimize the design of G company's quality management system. By referring to Abstract III the application research on quality management system and food quality management system at home and abroad, comparing the differences, connections and operation effects of multiple quality management systems, this article analyzes the operation status of G company's current quality management system from the aspects of raw material procurement and acceptance process management, production process management, and sales process management. Based on the daily inspections, product sampling tests conducted by the regulatory authorities and complaints of consumers, this article finds the problems in the company's quality management system. This article is problem-oriented and conducts in-depth research and analysis, which combines with Pharmaceutical GMP, the ISO22000 quality management system, Sanitation Standard Operation Procedure and Hazard Analysis Critical Control Point system combined to implement an integrated design of G company's quality management system. Furthermore, this article puts forward optimization plans from establishment of food safety team, food safety system planning, preparation of prerequisite programs and operable prerequisite programs, HACCP plan, human resources, infrastructure management, laboratory control, raw material and supplier management, production and release management, documentation management , monitoring quality control, annual review, verification and improvement. At the same time, the optimization effect is compared before and after, and a method of efficiently operating the quality management system of G Company to improve the production quality of infant formula milk powder is obtained. Keywords:Infant formula milk powder enterprises;Quality management system； Optimization research 广东工业大学硕士学位论文 IV 目 录 摘要 ............. I Abstract ...... II 目 录 .......... IV Contents ... VII 第一章 绪论 1 1.1 研究背景 ........................... 1 1.2研究目标 ............................ 2 1.3研究内容与方法 ................ 2 1.3.1 研究内容 .................... 2 1.3.2 研究方法 .................. 3 1.3.3 研究技术路线 ............ 3 1.4 论文创新点 ....................... 4 第二章 文献综述 ....................... 6 2.1相关管理标准 .................... 6 2.1.1 质量管理体系定义和内涵 ....................... 6 2.1.2 ISO质量管理体系 ...... 6 2.1.3危害分析和关键控制点体系 .................... 7 2.1.4 GMP良好生产质量管理规范 ................... 8 2.1.5卫生标准操作程序 ..... 8 2.2 相关质量管理理论 ........... 8 2.2.1 朱兰质量管理学说 .... 8 2.2.2 戴明质量管理学说 .... 9 2.2.3 克劳士比质量管理学说 ........................... 9 2.2.4 费根堡姆质量管理学说 ........................... 9 2.2.5 休哈特的质量管理学说 ......................... 10 2.3 国内外食品质量管理体系应用研究综述 .... 10 2.3.1 ISO质量管理体系 .... 10 2.3.2危害分析和关键控制点体系 .................. 11 目 录 V 2.3.3良好生产质量管理规范 .......................... 11 2.3.4卫生标准操作程序 ... 12 2.4 国内外婴幼儿配方乳粉行业研究 ................ 12 2.4.1 国际婴幼儿配方乳粉行业研究 ............. 12 2.4.2 国内同行业竞争者研究 ......................... 14 2.5 相关论文研究成果述评 . 15 2.6 相关理论评述 ................. 16 第三章 G公司质量管理体系概述