PDATR59中英文对照(利用统计学进行产品监控)

UtilizationofStatisticalMethodsForProductionMonitoringTechnicalReportNo.59控制图：单值................................................223.3MOVINGRANGECONTROLCHARTS移动极差控制图.......................................243.4AVERAGEANDVARIABILITYCHARTS均值图和变异性图....................................253.5HISTOGRAMS柱状图.....................................................................................263.6PROCESSCAPABILITY(CPK,PPK)工艺能力（CPK，PPK）...............................303.7EXPONENTIALLYWEIGHTEDMOVINGAVERAGECHARTS指数加权移动平均控制图343.8CUSUMCHARTS累积和图.............................................................................363.9EXAMPLESOFEFFICIENTMIXTUREOFTHESTATISTICALTOOLBOX统计工具箱有效混合使用的实例.....................................................................................................384.0ACCEPTANCESAMPLING验收抽样...........................................................404.1TYPICALAPPLICATIONS典型应用...................................................................404.2KEYTERMS关键术语....................................................................................404.3TYPESOFSAMPLING抽样类型.......................................................................414.4TYPESOFACCEPTANCEPLANS接收方案类型.................................................414.5PROSANDCONS优缺点................................................................................425.0APPENDICES:TECHNICALDETAILSANDEXAMPLES附件：技术细节和实例445.1RUNCHARTS运行图.....................................................................................44控制图表：单值............................................465.3MOVINGRANGECONTROLCHARTS移动极差控制图.......................................525.4AVERAGEANDVARIABILITYCHARTS均值图和变异性图....................................575.5HISTOGRAMS直方图......................................................................................705.6CPK＇，PPKFORPROCESSCAPABILITY过程能力CPK,PPK值.............................715.7EXPONENTIALLYWEIGHTEDMOVINGAREACHARTS(EWMA)指数加权移动区域图（EWMA）........................................................................................................765.8CUSUMCHARTS累积和图.............................................................................805.9SAMPLING抽样.............................................................................................86，statisticalmethodshavebeenrediscoveredasvitaltoolsforsuccessfuldevelopmentandmanufacturing.Industrieslikeautomotive，electronics，andconsumerproductsgrowandchangepartlyasaresultofadoptingstatisticalmethods.随着生产商期望提高产品质量，统计方法逐渐成为开发和生产成功的重要工具。汽车、电子、消费品行业也部分因为采用统计方法发展和改变。Thepharmaceuticalandbiopharmaceuticalindustryincreasinglyrecognizestheimportanceofstatisticalmethodstoconsistentlycreateproductsthatconformtopredeterminedqualitycharacteristics.Statisticalmethodsprovideobjectiveevidenceinmeetingthisgoalandarefundamentalforunderstandingtheprocess，whichenablesfurtherimprovementanddevelopment.制药和生物制药工业越来越认识到统计方法的重要性，以持续生产符合预定质量标准的产品。统计方法为符合这一目的提供了客观证据，也是理解工艺的基础，使持续改进和开发成为可能。Industryandregulatorybodiesareworkingtogethertoprovideguidanceandframeworksontheuseofstatisticalmethods.TheInternationalConferenceonHarmonization，InternationalStandardsOrganizationandEuropeanUnionhaveprovidedguidanceontheuseofstatisticalmethods.工业和监管部门正在一起努力建立统计方法使用指南和框架。ICH、ISO、EU已经有了统计方法的指南。Inlightoftheincreasedfocusonthistopic，thisPDATaskForcerecognizedtheneedtoprovideguidancetohelpcompaniesidentifyandusestatisticalmethods.TheprimaryobjectiveofthisTaskForcewastoconveytheappropriateuseofstatisticalmethodsatalevelmostcanunderstand.鉴于人们对这一主题越来越重视，PDA工作组认识到应该建立指南帮助公司识别和使用统计方法。该工作组的基本目的是让大多数人能够适当应用统计方法。1.1PurposeandScope目的和范围Thepurposeofthisdocumentistopresentrelevantandeasy-to-usestatisticalprocesscontrol(SPC)methodsthatareapplicabletothepharmaceutical/biopharmaceuticalindustry.Advancedstatisticalmethods，suchasmultivariatemodelsandDesignofExperiment(DoE)willnotbeconsidered.AnoverviewofacceptancesamplingisalsoincludedinSection4.0.本文件是为了提供的相关、易用的统计过程控制方法，以应用于制药/生物制药工业。高级统计方法，如多变量模型和试验设计（DoE）不包含在内。4.0节对接收取样进行了概述。1.2ImplementationtoSupportDecisionMaking利用统计方法为决策提供支持Statisticalmethodsareintendedtoimprovethequalityofdecision-making.Theyaresimplyameanstoaresult.Ifthemanufacturerdoesnotfirstunderstandwhyitisutilizingastatisticalmethod，problemssuchasfailingtodetectimportantsignalsorover-dete