质量管理体系的监测与报告教案.docxVIP

摘要本文可以概括为 4 只手，2 个问题，1 个方法论，1 个模型，3 张表，3 个阶段，1 个展望?即本文将质量管理体系的监测与报告，放在 4 只手政府之手?市场之手?企业家之手?质量经理之手之间对话的背景下，围绕 2 个核心问题（如何发现和描绘质量体 系的整体风险？如何发现和定义质量管理体系的资源需求？）展开讨论，通过将质量监 测报告与财务报告体系进行类比，提出了 1 个方法论（基于质量管理体系模型的全数统计方法论），建立了 1 个模型即质量经济报表模型，包括 3 张质量管理基本报表（受控 状态表?质量损益表?CAPA 流量表）；并对质量经济报表模型在质量管理体系生命周 期的 3 个阶段（体系建设阶段?体系维持阶段?体系持续改进阶段）可能发挥的作用进 行了探讨?本文结尾部分对应用基于质量管理体系模型的全数统计方法论，作为质量管 理体系监测与报告活动的基本思路，在未来可能的实践和发展进行了展望?关键词：质量管理体系 监测与报告 4 只手 基于模型的全数统计方法论质量经济报表模型Quality Management System Monitoring ReportingA Resource Communication view on Pharmaceutical Quality Management System in ChinaAbstractThe thesis can be summarized as a story about four hands, two questions, one methodology, one model, three statements, three phases, and one vista of the future.The monitoring and reporting activities of a quality management system, in the context of the dialogue among four hands the government hand, the invisible hand, the executive’s hand, and the quality manager’s hand, is discussed in this thesis with a focus on two key questions: how to appropriately detect and describe the risk of a quality management system? How to appropriately detect and define the need of resources by the quality management system?By comparing the quality monitoring and reporting with finance reportings, a model-based total inspection methodology is proposed and a quality economic statement model is established.The thesis also discusses how the quality economic statement model can help to answer the two key questions through the three phases of quality system life cycle, i.e. the establishment phase, the maintaining phase, and the continuous improvement phase.At the end of the thesis, a vista of the future about the potentials of the model-based total inspection methodology, as the basis of quality management system monitoring and reporting activities, is presented.Keywords:Quality Management SystemMonitoring Reportingfour hands model-based total inspection methodologyquality economic statement model目录摘要3第 1 章 序言