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1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2QualityManagementSystemMonitoring&Reporting---AResource&CommunicationviewonPharmaceuticalQualityManagementSysteminChinaAbstractThethesiscanbesummarizedasastoryaboutfourhands,twoquestions,onemethodology,onemodel,threestatements,threephases,andonevistaofthefuture.Themonitoringandreportingactivitiesofaqualitymanagementsystem,inthecontextofthedialogueamongfourhands---thegovernmenthand,theinvisiblehand,theexecutive’shand,andthequalitymanager’shand,isdiscussedinthisthesiswithafocusontwokeyquestions:howtoappropriatelydetectanddescribetheriskofaqualitymanagementsystem?Howtoappropriatelydetectanddefinetheneedofresourcesbythequalitymanagementsystem?Bycomparingthequalitymonitoringandreportingwithfinancereportings,amodel-basedtotalinspectionmethodologyisproposedandaqualityeconomicstatementmodelisestablished.Thethesisalsodiscusseshowthequalityeconomicstatementmodelcanhelptoanswerthetwokeyquestionsthroughthethreephasesofqualitysystemlifecycle,i.e.theestablishmentphase,themaintainingphase,andthecontinuousimprovementphase.Attheendofthethesis,avistaofthefutureaboutthepotentialsofthemodel-basedtotalinspectionmethodology,asthebasisofqualitymanagementsystemmonitoringandreportingactivities,ispresented.Keywords:QualityManagementSystemMonitoring&Reportingfourhandsmodel-basedtotalinspectionmethodologyqualityeconomicstatementmodel3目录摘要..................................................................................................................................................................3第1章序言...........................................................................................................................................................7第2章前提假设和前提知识.............................................................................................................................122.1质量管理活动是需要资源的...................................................................................................................132.2企业其它经营活动也是需要资源的.......................................................................................................142.3企业的资源是有限的（稀缺的）...........................................................................................................142.4质量管理体系所需的资源并不完全在质量经理的控制之下...............................................................142.5企业家，包括高层经理，倾向于低估资源需求...................................................................................152.6质量管理体系的资源需求有时必须通过监测与报告活动来沟通解决..............................................162.7监测与报告活动本身也需要资源...........................................................................................................162.8不对经济效益负责，则对资源使用效率相对不敏感............................................................................172.9从收入分配看，中国是一个图钉型的社会...........................................................................................172.10从医疗资源配置角度看，中国是一个倒金字塔型的社会.................................................................192.11单讲道德是没有用的.............................................................................................................................20第3章体系模型.................................................................................................................................................223.1决策机制..................................................................................................................................................223.2组织机构..................................................................................................................................................243.3报告机制..................................................................................................................................................283.4文件结构..................................................................................................................................................293.5受控标准..................................................................................................................................................303.6体系模型...................................................................................................................................................313.7资源需求..................................................................................................................................................323.8范式转换..................................................................................................................................................35第4章体系成像............................................................................................................................................