婴幼儿配方乳粉企业的质量安全管理体系及优化研究

发布时间：2018-03-28 22:03

本文选题：婴幼儿配方乳粉　切入点：质量安全管理体系　出处：《苏州大学》2013年硕士论文

【摘要】：食品安全已经不仅仅涉及人类健康和生命安全，而且也关系到国家经济的发展和社会的稳定。婴幼儿配方乳粉是属于特殊膳食用食品，为满足婴幼儿生长发育所需要按特殊配方而专门加工的食品。由于婴幼儿是弱小敏感人群，其产品的质量和安全关系尤其重大，近十年来国内发生的重大质量安全事件及市场抽查结果，都凸显了婴幼儿配方乳粉的质量和安全的脆弱性，因此作为婴幼儿配方的企业无论是自身未来的可持续发展还是对社会必须承担的责任，都需要考虑建立一个严密的全方位控制的质量安全管控体系，来保证生产出高质量高安全的产品。本文采用文献分析法、访谈法、理论分析法和实证分析法，，通过对婴幼儿配方乳粉的质量特性与药品的质量特性进行分析比较，认为药品要求的有效性、安全性、稳定性和一致性也是婴幼儿配方乳粉所必须具备的；药品GMP是目前药品生产质量控制运用的质量管理体系，大量文献、实证案例及国家法规的强制实施均能证明其有效性，而药品GMP对比食品GMP，无论是从条款、要求程度和内容上都有较强的优越性；目前大多数婴幼儿配方乳粉的生产企业除了引用ISO9001和HACCP体系以外，仅实行食品GMP卫生规范，因此本文引入药品GMP管理体系进行优化，再结合一般婴幼儿配方乳粉生产企业应用的ISO9001和HACCP体系，使三大体系的文件有机融合，建立以药品GMP为基础的，优化的婴幼儿配方乳粉特有的质量安全管理体系；本文第五章和第六章以一家婴幼儿配方乳粉生产企业为例，从企业的实际情况出发，以企业层面的微观数据为依据进行实证解析，按优化的质量安全管理体系制定出切实可行的优化方案，从企业文化、组织框架、文件体系、培训、执行到定期回顾、效果评价进行了一系列的对理论体系的有效验证。国家2013年9月将对婴幼儿配方乳粉企业由质量监督管理局转至食药监管理总局管理，管理方式将会转化为食品监管方式转为药品监管方式，因此本文也符合质量管理趋势，为企业如何提高婴幼儿配方乳粉的生产质量，并满足政府、市场和消费者要求提供了方法和途径。
[Abstract]:Food safety is not only related to human health and life safety, but also related to the national economic development and social stability. Infant formula milk powder is a special dietary food. Food specially prepared for the growth and development of infants and young children. Since infants and young children are small and sensitive people, the quality and safety of their products are of particular importance. The major quality and safety incidents in China and the results of market spot checks in the past decade have highlighted the fragility of the quality and safety of formula milk powder for infants and young children. Therefore, as infant formula enterprises, regardless of their own future sustainable development or the responsibility to the society, we need to consider the establishment of a strict all-around quality and safety control system. To ensure the production of high quality and high safety products. In this paper, literature analysis, interview, theoretical analysis and empirical analysis were used to analyze and compare the quality characteristics of infant formula milk powder with those of medicine, and the results showed that the drug requirement was effective and safe. The stability and consistency are also necessary for infant formula milk powder. Drug GMP is a quality management system used in drug production quality control at present. A large number of literature, empirical cases and the enforcement of national laws and regulations can prove its effectiveness. In contrast to food GMP, drug GMP has strong advantages in terms of terms, requirements, and contents. At present, most enterprises producing infant formula milk powder only apply food GMP hygienic norms, except for citing ISO9001 and HACCP systems. Therefore, this paper introduces the drug GMP management system to optimize, and then combines the ISO9001 and HACCP systems used by the general infant formula milk powder production enterprises, so that the three systems of document organic integration, the establishment of drug GMP as the basis, The fifth and sixth chapters of this paper take an infant formula milk powder production enterprise as an example, proceed from the actual situation of the enterprise, On the basis of microcosmic data at the enterprise level, an empirical analysis is carried out. According to the optimized quality and safety management system, a feasible optimization scheme is worked out, from corporate culture, organizational framework, document system, training, implementation to regular review. In September 2013, the State transferred the infant formula milk powder enterprises from the quality Supervision Bureau to the Administration of Food and Drug Administration. The management mode will be transformed into the food supervision mode to the drug supervision mode, therefore this article also conforms to the quality management trend, for the enterprise how to improve the infant formula milk powder production quality, and satisfies the government, Market and consumer requirements provide ways and means.
【学位授予单位】：苏州大学
【学位级别】：硕士
【学位授予年份】：2013
【分类号】：F426.82;F203;F273.2

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