质量风险净现值成本管理教材VIP免费

摘要制药企业在经历了前一轮的GMP强制认证后，在推行全面质量管理已稍有成效，但质量问题不仅是技术部门的问题，而且还是财务部门的问题。建设全面质量体系需要投入一定量的费用，然而一定量的质量投入能为企业带来多少效益，是否既能降低质量风险，又能符合经济原则，最终使产品成本下降？单纯依靠传统质量成本管理方法已难以满足现代企业对产品质量零缺陷的要求。本文通过在质量成本管理中引入风险管理方法和净现值分析方法，举例新版GMP实施在即，A公司原注射剂车间利用风险管理方法FMEA（FailureModeandEffectsAnalysis)，对质量风险进行辨识和控制，同时结合净现值法（NPV）分析，对影响产品成本的设计提出改造方案，最后对比改造前后的试产成本。阐述企业不能忽视对质量成本的管理，尤其需要从设计阶段入手，辨识质量风险，结合净现值计算方法，采取有效措施降低产品成本，才能适应当今激烈竞争的微利时代。关键词：质量风险净现值成本管理12ApplicationofQualityRiskManagementandNPVAnalysisinbuildingthemodernsystemofQualityCostManagementAbstractSincetheenforcementofGMPcertificationinChina,manypharmaceuticalcompanieshavemadegoodprogressinqualitymanagement.Whileimprovingproductqualitywillhelpthemanufacturerstomeetcompliancerequirementandbenefitthecustomers,itoftenrequiresfinancialinvestment.Thishasraisedsomequestions:willtheinvestmentinqualityimprovementbenefitthecompaniesandtheshareholdersinthelongrun?Cantheinvestmentreducetherisktoqualitywithoutincreasingthecostofmanufacturedgoods?Andlastbutnotleast,howtotransformthetraditionalqualitymanagementapproachtoeffectivelyaddresstoday’squalityandcompliancechallengesfacedbythepharmaceuticalindustry?Inthisthesis,theconceptofcostofquality,andriskmanagementmethodologieswereintroduced.AnexamplewasusedtoillustratehowtoapplyFMEA(FailureModeandEffectAnalysis)toproactivelyidentifyandmitigaterisk.,andthentojudgetheimprovementinvestment’sfinancialusingtheNPV(NetPresentValue).Thecostsofmanufacturedgoodswerecomparedbeforeandaftertheimplementationofimprovementmeasures.Itdemonstratedthattheinvestmentmadetoimprovethequalityhassignificantlyreducedtherisktoquality.Furthermore,thecostofmanufacturedgoodswasalsoreducedpostimprovement.Keywords:QualityRiskNPVCostofmanagement3目录序言.............................................................7第一章质量成本的管理概述...........................................8一、质量成本的定义.............................................81.IS09000国际标准...........................................82.哈林顿的不良质量成本观.....................................83.克劳斯比的质量成本观.......................................84.费根堡姆的质量成本观.......................................95.《管理会计国际惯例》.......................................96.我国的质量成本观...........................................9二、药品生产企业中的质量成本构成................................91.预防成本（CostofPrevention）.............................92.鉴定（检验）成本（CostofAppraisal）....................103.内部失败成本（CostofInternalFailure）..................104.外部失败成本（CostofExternalFailure）..................10三、质量成本要素分析...........................................11四、推行质量成本管理的意义及其局限性...........................121.推行质量成本管理的意义....................................122.传统质量成本管理的局限性..................................12五、如何构建新的质量成本管理体系...............................131.质量源于设计..............................................132.引入...