当今，越来越多的企业已经意识到企业的核心竞争力不仅仅是技术创新，还 应该在注重技术创新的同时提升企业的质量管理水平，保证产品质量。兽用疫苗 是一种特殊的商品，在有效防治动物疫病、保障畜牧业发展，促进农民增收、保 护和增进人民健康、提高生活质量、促进经济发展和社会进步等方面起到了十分 重要的作用，其产品质量显得尤为重要。提高兽用疫苗企业的质量管理水平，是 一个非常值得研究的问题。 本文研究的 YB 公司是一家中外合资兽用疫苗企业，以其质量管理现状和存 在问题为切入点，应用 QFD 理论，从顾客对兽用疫苗质量需求及其权重入手， 根据典型的 QFD 瀑布式分解模式，构建质量屋改进模型。运用问卷调查法、德 尔斐专家咨询法、聚类分析法、层次分析法（AHP）、量表法、对比分析法等多 种工具，较系统的分析了满足顾客对产品质量需求的技术要求和实施这些技术要 求的关键影响要素，从而针对性提出了 YB 企业质量管理改进措施。 本文还研究建立了一套兽用疫苗免疫效果的评价体系。该体系对行业来说具 有一定借鉴意义。更重要的是利用此评价体系可以对 YB 企业质量管理改进前后 产品质量竞争力评价，从而达到证实 YB 企业质量管理改进措施落实后效果是否 达到切实的目的。本项工作对于行业内的其它兽用疫苗企业乃至所有制药企业也 具有一定的参考价值。 关 键 词，兽用疫苗，质量管理，QFD 理论，改进措施 论文类型，应用/专题研究浙江工业大学硕士学位论文 基于 QFD 理论兽用疫苗质量管理问题研究 IV RESEARCH OF VETERINARYVACCINE QUALITY MANAGEMENT BASED ON QFD THEORY ABSTRACT Nowadays, more and more enterprises have realized that they should build their core competency not only on technology innovation, but also on the improvement of quality management and the guarantee of product quality. Veterinary vaccine is a special product, it plays an important role in preventing and treating animal diseases, maintaining the development of husbandry industry, increasing farmers’ revenues, protecting and enhancing people’s health, improving life quality, and promoting economic and social development, which all in turn attach more importance to product quality. It is worth studying the way to improve the quality management levels of veterinary vaccine companies. The YB company studied in this thesis is a joint venture producing veterinary vaccines. This thesis takes current quality management situations and existing problems of YB as starting points, considering clients’ demands on vaccine qualities and the weights of their concerns. It applies QFD theory to construct the House of Quality (HOQ) Model using the classical QFD Waterfall Disintegration Model. In this thesis, methods and tools including Questionnaire Survey Method, Delphi Method, Clustering Analysis Method, Analytic Hierarchy Process (AHP), Scaling Method and Comparative Analysis Method are applied to systematically analyze the technical requirements for meeting clients’ demands on product quality as well as the key influencing factors for implementing these technical requirements. Based on these analysis, this thesis further proposes targeted improvement measures for the quality management of YB. Hence, in this thesis, an efficacy evaluation system is established. This system can offer some references to veterinary vaccine industry. Moreover, this system can compare the quality and competitiveness of YB products before and after the quality management improvements, which can further validate the effects of these improvements. As the problems existing in the quality management of YB are representative, solving these problems can also provide a general reference to other veterinary vaccine companies or even to all pharmaceutical companies. KEY WORDS:Veterinary vaccine；Quality management；QFD theory；Improvement measures TYPE OF THESIS:Application Research浙江工业大学硕士学位论文 基于 QFD 理论兽用疫苗质量管理问题研究 III 目 录 1 绪论..........................................................................................................................1 1.1 研究的背景与意义..........................................................................................1 1.1.1 研究的背景.............................................................................................1 1.1.2 研究的意义.............................................................................................1 1.2 国内外兽药质量管理现状..............................................................................2 1.2.1 兽药和质量管理相关概念及其相互间关系.........................................2 1.2.2 国内兽药质量管理现状.........................................................................3 1.2.3 国外兽药质量管理现状.........................................................................5 1.3 研究的目的和内容..........................................................................................6 1.3.1 研究的目的.............................................................................................6 1.3.2 研究的主要内容.....................................................................................7 1.4 研究的方法......................................................................................................8 2 相关理论及其研究综述..................................................................................10 2.1 QFD 理论及其研究综述...............................................................................10 2.1.1 QFD 发展历史......................................................................................10 2.1.2 QFD 理论..............................................................................................10 2.1.3 QFD 应用及研究概述..........................................................................12 2.2 质量管理理论及其研究综述.......................................................................13 2.2.1 质量管理的发展...................................................................................13 2.2.2 质量管理的主要理论...........................................................................14 2.2.3 国内外质量管理研究综述...................................................................15 3 YB 企业的质量管理现状及存在的问题....................................................19 3.1 YB 企业基本概况......................................................................................... 19 3.2 YB 企业质量管理现状................................................................................. 19 3.3 YB 企业质量管理存在的问题..................................................................... 22 3.4 YB 企业质量管理存在问题原因分析......................................................... 23 4 质量屋改进模型的构建及应用....................................................................24 4.1 质量屋模型概述...........................................................................................24 4.2 质量屋改进模型构建...................................................................................26 4.3 质量屋改进模型应用...................................................................................27 4.3.1 顾客需求的获取和权重分析..............................................................27 4.3.2 技术需求获取和分析..........................................................................29浙江工业大学硕士学位论文 基于 QFD 理论兽用疫苗质量管理问题研究 IV 4.3.3 技术需求的权重..................................................................................33 4.3.4 确定技术要求指标与顾客需求之间的关系矩阵..............................34 4.3.5 影响因素获取及其相对权重..............................................................35 4.3.6 改进措施的获取和分析......................................................................38 4.3.7 改进措施的重要度分析......................................................................48 5 兽用疫苗免疫效果评价指标/体系建立.....................................................49 5.1 兽用疫苗免疫效果评价指标确定................................................................49 5.2 评价指标权重的计算....................................................................................50 5.3 评价指标分析................................................................................................53 5.4 YB 公司质量