质量控制概要中英文二

ReviewofQualityControl

质量控制概要Wewillcover(内容)Terminology术语CharacteristicsofAnalyticalMethods分析方法特性TypesofQCsamplesandhowtheyrelatetothecharacteristicsQC样品类型和特性1DefinitionofQuality

质量的定义Tomostoftheworld(普遍上)degreeofexcellence(优异程度)TotheISOworld(在ISO领域)degreeofagreementbetweencharacteristicsandrequirements特性与要求的吻合程度Moreimportantly(更重要)toourclients?(对客户)2QualityControlvs.QualityAssurance(质量控制与质量保证)Qualitycontrolisaseriesofmeasurementsusedtoassessthequalityoftheanalyticaldata质量控制是一系列测量,以评价分析数据的质量Howwellisthetestfulfilling

requirements?试验满足要求的程度如何?3QualityControlvs.QualityAssurance(质量控制与质量保证)Qualityassuranceisamanagementplantoensuretheintegrityofdata(asystem)质量保证是一种管理计划,以确保数据的完整性(一种体系)Providesconfidencethatrequirementswillbefulfilled为要求是否得到满足提供信心4QualitiesofAnalyticalMethods

分析方法的质量Accuracy(准确度)Precision(精密度)Selectivity(选择性)Sensitivity(灵敏度)Linearity(线性)Range(范围)Robustness/Ruggedness(稳健性/稳度)5Accuracy(准确度)Degreeofagreementbetweenthe“true”valueandthemeasuredvalue(真值与测量值之间的一致程度)6Accuracy(准确度)Whatisthe“true”value?(什么是真值)Theoretical(理论值)Consensus(公议值)Accepted/Assigned(可接受/赋值)7Accuracy(准确度)Expressedas(表示为)theratiobetweentheassayedvalueandthe“true”value(%recovery)分析值与真值间的比(%回收率)thedifferencebetweentheassayandtheacceptedtruevalue(%Error)分析与可接受真值间的差(%误差)8Precision(精密度)Closenessofagreementbetweenmeasurements(测量间的一致程度)Repeatability(r)–sameconditions,shorttimeinterval(samerun)–shorttermprecision重复性(r)-相同条件下\短时间间隔-短期内精密度Intermediateprecision–samelabdifferentday,analyst,instrument中间精密度-同一实验室不同日期,分析人员,仪器Reproducibility(R)–agreementbetweenbatchesorbetweenlabs复现性®-批间或实验室间的一致性9Precision(精密度)ExpressedasStandardDeviation,RelativeStandardDeviationorRelativePercentDifference表示为标准偏差、相对标准偏差、相对百分差10Sensitivity（灵敏度））Degreeofresponsetoachangeinanalyteconcentration–resolution被分析物物浓度变变化的响响应变化化程度-分辩率率Lowestconcentrationthatcanbedistinguishedfrombackgroundnoise––detectionlimit能从背景景噪音识识别出的的最低浓浓度-检检测限11Sensitivity（（灵敏度））Limitofdetectionvs.Limitofquantification（检测限与与定量限限）Limitofdetection(LOD)isthelevelthatwecansaywhetherananalyteispresentornot检测限是我们们判断被分析析物是否存在在的含量水平平Limitofquantitation(LOQ)isthelevelthatwecanquantifytheanalytewithaspecifiedaccuracy(20%)定量限是我们们按规定准确确度（20%）能对被分分析物量化的的含量水平12Selectivity（选择性）Abilitytodetecttheanalyteinacomplexmatrix检测复杂基体体中被析物的的能力Abilitytoexcludenon-analytespeciesfromsignal通过信号排除除非被分析物物的能力Usuallyinverselyrelatedtosensitivity通常与灵敏度度成反比13Linearity（线性）Abilitytoproducearesponsethatisdirectlyproportionaltotheconcentrationoftheanalyte所产生的反应应与被分析物物浓度成正比比的能力Onlyholdstruewithinagivenrange只在给定范围围内是真实的的14Linearity（（线性）Expressedascorrelationcoefficient(r)orcoefficientofdetermination(r2)表示为相关系系数(r)或测定系数(r2)r2=ssxy2/ssxxssyy15Range（（范围）Theintervalbetweenthehighestandlowestconcentrationforwhichthemethodhasshowntohavesuitablelevelsofaccuracy,precisionandlinearity.在方法具有适适宜的准确度度、精密度和和线性的条件件下，最高和和最低浓度范范围16Robustness（（稳健性）Abilityofmethodtobeunaffectedbysmallchangesinmethod(internal)conditions（方法不因条件件的较小变化化（内部）而而受影响的能能力）Temperature（温度）pHCompositionofmobilephase（流动相组成））Usefulwhenmethodmovesfromdevelopmenttoproduction（（从方法开发到到使用很有用用）17Ruggedness（（稳度）Abilityofmethodtobeunaffectedbyexternalconditions（方法不受外界界条件影响的的能力）Differentanalysts（不同的分析人人员）Differentlaboratories（不同的实验室室）Differentreagentlots（不同批的试剂剂）Differentinstruments（不同的仪器））18Ruggedness（（稳度）Usefulfortechnologytransfer（（对技术推广很很有用）19QualityControlMeasures质量控制手段段Calibrationstandards（校准标准）Blanks（空白）Recoverystudies（回收率研究））Precisionstudies（精密度研究））Sensitivitystudies（灵敏度研究））DetectionLimit（（检测限）Quantitationlimit（定量限）20Calibration(校准)Directlyaffectsaccuracy(直接影响准确确度)Preparationofstandards(标准制备)Matrix(基体)Stability(稳定性)Signaltype:peakarea,peakheight信号类型:峰峰面积,峰高高21Calibration(校准)Calibrationcurves(校准曲线)1storder––straightline(一级-直线)Quadratic––acceptablebutrequiresmorepoints(二次方程-可可以接受,但但需要更多点点)Internalstandards(内标)Refinescalibrationresponse(增强校准响应应)Addedtosamplesandstandards(加入样品和标标准中)Mustbehaveliketheanalyte(象被分析物一一样表现)Cannotbeinsamples––rareelements,deuteratedcompounds(样品中没有-稀有元素,含重氘的化化合物)22Calibration(校准)Calibrationverification(校准验证)Repeatedcalibrationstandard重复校准标准准Intervalmaybeevery20samples(ICPMS)oronceeveryrun(GC-FID)间隔:20个个样品(ICPMS)每次(GC-FID)23Blanks(空白)Usedtomonitorcontamination(监测污染)Reagentblanks(试剂空白)Instrumentblanks(仪器空白)Fieldblanks(场地空白)Tripblanks(路途空白)Procedural/methodblanks(程序/方法空空白)Matrixblanks(基体空白)Others?(其它)24RecoveryStudies（（回收率研究究）Usedtomonitoraccuracy（（监测准确度度）Matrixspikes（基体加标））Fortifiedblanks（（增加加标））Surrogates（替代）ReferenceMaterials（参考物质））25MatrixSpikes（基体加标））Knownamountofanalyteaddedtosample在样品中加加入已知量量的被分析析物Importantwithcomplexmatrix对复杂基体体很重要Generallyaddedpriortoextractionprocess（通常在提取取前加入））Sometimesdifficulttoknowamounttospikeaheadoftime（有时很难提提前知道加加标量）26FortifiedBlanks（（增强空白））Analytespikeintoreagentblank在试剂空白白中加入被被分析物标标样Carriedthroughsamplepreparationprocess在样品准备备过程中加加入27Surrogate（替代）Compoundwithsimilarpropertiestotargetanalyte与被分析物物具有相近近特性的化化合物Addedtoallsamples(unknownsandQC)butnotstandards在所有样品品(未知的的和QC)中加入，但但标样中不不加Usedtomonitormethodperformanceonasample(matrix)specificbasis应基于特定定样品（基基体），用用于监测方方法表现28ReferenceMaterials参考物质质Matrixmatchedmaterialswithknownconcentrationofanalytes（被分析物物已知浓浓度的基基体匹配配的物质质）Maybeexternalorin-house（（外部或或室内））Sources（来源）NIST(US)NRC(Canada)EuropeanUnion（欧盟）CommercialVendors（（商业渠道道）29ReferenceMaterials参考物质质Usedprimarilytomonitoraccuracy主要用于于监测准准确度Maybeusedforotherquality用于其它它质量目目的measures(precision,sensitivity)测量（精精密度、、灵敏度度）BestoverallQC?（最好的全全面质量量控制？？）Expensive（（费用高））30PrecisionStudies（精密度研研究）Duplicates（重复）Fieldduplicates（场地重复复）Labduplicates（实验室重重复）Instrumentduplicates（（仪器重复复）Inter-labsplits（室内分样样）Usedtoidentifyvarianceindifferentprocesses（（用于识别别不同过过程的变变异）31SensitivityStudies灵敏度研研究Usuallyperformedinitially,thenperiodicallythereafter通常最开开始要做做，以后后定期做做Multiplereplicatesofablankorlow-levelstandard空白或低低含量标标准多次次重复32SensitivityStudies灵敏度研研究DetectionLimit––noquantitation检测限-非定量量QuantitationLimit––Accuracycriteriaadded定量限–准确度准准则33SensitivityStudies灵敏度研研究DetectionLimit––99%certaintythattheconcentrationisgreaterthanzero––thattheanalyteispresentinthesample（检测限——99%确定浓浓度大于于0-样样品中有有被分析析物）Uncertaintyishigh(+/-100%ormore)不确定度度高（+/-100%或更高））QuantitationLimit（（定量限限）Lowestconcentrationthatcanbedeterminedwithagivenaccuracy(e.g.20%relativeerror)在一定定准确确度下下（如如20%相相对误误差））可以以测定定出的的最低低浓度度34Linearity（线性））Determinedinitiallyandthenasneeded最开始始时测测定，，然后后需要要时测测定DynamicLinearRangerelatestodetectorresponse动态线线性范范围与与检测测器响响应有有关Alsoconsiderpreparationlimitations也可以以认为为是准准备中中的限限制Solubilities（（溶解度度）Extractionefficiencies（提取率率）Derivitizingreactions（（衍生反反应））35WhatdowerunasQC?为什么么要做做质量量控制制Itdependson:（（取决于于）Typeofinstrumentation仪器类类型StageofMethodDevelopment方法开开发阶阶段Typeofanalysis分析类类型36WhatdowerunasQC?为什么么要做做质量量控制制StageofMethodDevelopment方法开开发阶阶段Validation（（确认））Verification/Qualification（（验证/判断断）Routineanalysis（（日常分分析））37WhatdowerunasQC?为什么么要做做质量量控制制TypeofAnalysis（（分析类类型））Assay（分析））Impurities（（杂质））Limits（（限制））Content（含量））Identification（（识别））38QualityDataRequiredatMethodValidation（（方法确确认所所需的的质量量数据据）DataRequired所需数据I.D.名称ImpurityTesting杂质检测AssayContent分析含量Quant.量Limit限Accuracy准确度NOYESNOYESPrecision精密度NOYESNOYESSelectivity选择性YESYESYESYESDetectionlimit检测限NOMAYBE可能YESNOQuantitationlimit定量限NOYESNOMAYBE可能Linearity线性NOYESNOYESRange范围NOYESNOYES39QualityDataRequiredinRoutineAnalysis日常分分析所所需质质量数数据DataRequired所需数据I.D.名称ImpurityTesting杂质检测AssayContent分析含量Quant.量Limit限Accuracy准确度NOYESNOYESPrecision精密度NOYESNOYESSelectivity选择性NOMAYBE1NOMAYBE1Detectionlimit检测限NONONONOQuantitationlimit定量限NOMAYBENOMAYBELinearity线性NOYESNOYESRange范围NONONONO1––mayberequiredwhenworkinginunknownmatrix40ReviewofQualityAssurance质量保证概概述Wewillcover（内容）DefinitionandDescriptionofQA质量保证的的定义和描描述ToolsinaQASystem（（QA体系的工具具）ProficiencyTesting（能力验证））CertifiedReferenceMaterials（有证标准物物质）ValidatedMethods（经过确认的的方法）41QualityAssurance（质量保证））QualityAssurance质量保证Plannedactionsdesignedtoprovideconfidencethatqualityrequirementswillbefulfilled为质量要求求得到满足足提供信心心而设计的的有计划的的活动QualityAssuranceSystem质量保证体体系Asetofprocessesappliedwithinadefinedstructuretogeneratedesiredoutcomes在规定的结结构内产生生预期结果果所采用的的一组过程程Thegoodmanagementofgoodscience良好的科学学良好的管管理42QualitySystemComponents质量体系组组成Management管理Plan策划Performance实施Do做Assessment评价Review评审436PillarsofQA/QCQA/QC的六个基础础Management管理Facilities设施Personnel人员CRM’s有证标准物物质PT’’s能力力验验证证ValidatedMethods经确确认认的的方方法法44ProficiencyTesting能力力验验证证Providesexternalassessmentofperformance为表表现现提提供供外外部部评评审审Providesabasisforcorrectiveandpreventiveaction为纠纠正正和和预预防防措措施施提提供供基基础础45InformationGained搜集集信信息息Comparisonofperformanceagainstanexternalstandard将表表现现与与外外部部标标准准比比较较Comparisonagainstpastperformance与过过去去的的表表现现比比较较Comparisonagainstpeer(competitor)labs与同同行行（（竞竞争争者者比比较较））Identificationofunsatisfactoryperformers识别别出出不不满满意意的的操操作作者者46TypesofPT能力力验验证证类类型型Specificanalyte/matrixcombination特定定被被分分析析物物/基基体体结结合合Mercuryinfish（（鱼中中的的汞汞））Benzeneinair（（空气气中中的的苯苯））Fieldofanalysis（（场地地分分析析））MetalsbyICP（（ICP测金属）PesticidesbyGC/MS（GC/MS测杀虫剂）47Samples样品Sub-sampledfrombulksupply从批中抽取样样本Discretesamplesplitanddistributed谨慎分割样品品并分发48InterlaboratoryComparisons实验室间比对对Collaborativestudies协同研究Certificationstudies认证研究Round-robinstudies循环研究49SelectionofPTprogramsPT方案的选择Availabilityofrelevantprograms是否有相关方方案Organizationofrelevantprograms相关方案的组组织Anyprogramisusuallybetterthannothing只有要方案，，总比没有好好50AssessmentofPTProgramsPT方案的评价Beforecommittinglong-termconsider在实施前应考考虑Statisticsusedtointerpretdata解释结果的统统计技术How“true”valueisdetermined真值如何确定定Theoretical理论值Refereelab参考实验室Consensus公议值51ScoringofParticipants参加者的评价价Z–score（Z值）Deviationfrom““true””valuedividedbysigma测得值与真值值之差除以σSigmamaybeanaccepteddeviationorstatisticallydeterminedineachroundσ可能是可接受受的偏差或每每轮测试的统统计结果52Scoring

Z-值GenerallyaZ-score（（Z-值）<2isconsideredsatisfactory（满意）>2,<3isconsideredquestionable（可疑）>3isconsideredunsatisfactory（离群）scoresmustbewithin2–sigmaZ-值必须在2-σ之间53LaboratoryInterpretation实验室的解释释Viewresultsincontext（从整体上看结结果）Dotheyagreewithin-houseQCdata是否与室内质质量控制数据据一致Trendanalysis(considerhowsigmaisdetermined)趋势分析（考考虑σ是如何确定的的）Performanceofotherparticipants其它参加者的的表现54LaboratoryInterpretation实验室的解释释Comparemethodologyandre-calculateifpossible比较方法，如如果可能重新新计算Compareuncertaintyagainstin-houseestimates将不确定度与与室内评估比比较55CorrectiveActions纠正措施Determinewhentotakeaction确定何时采取取措施After1unsatisfactoryscore?一个不满意结结果Aftermany(3)inoneround?一轮中多个（（如三个）不不满意结果After2consecutiveunsatisfactoryscores?连续二个不满满意结果56CorrectiveActions纠正措施Alwaysinvestigate总要调查Include包括QCdata质量控制数据据Calculations,dilutions,transcriptions计算、稀释，，抄写Trainingstatusofanalyst分析人员培训训状况Performancerecordsofequipment设备运行记录录Recordsofcalibrants,reagentsetc.校准品、试剂剂的记录等57CorrectiveActions纠正措施Formulateaction公布措施Executeaction实施措施Checkifactionwassuccessful检查措施是否否有效58GeneralConsiderations几点考虑MoreemphasisisbeingplacedonPTprogramsbyassessors,regulatorsandclients评审员、管理理部门和客户户更多强调PTUsealltheinformationavailable利用所有可得得到的信息HandlePT’slikeroutinesamples(asmuchaspossible)象常规样品一一样处理PT样品（尽可能能）59ThirdPartyAssessment第三方评审AccreditationBodies认可机构AssessperformanceagainstlaboratoryscoperatherthanPTprogramcriteria在一定范围内内评审实验室室的表现，而而不是PT方案准则Consider“fitforpurpose””考虑适宜性60ThirdPartyAssessment第三方评审Regulators政府管理部门门MaybeinvolvedindevelopmentofPTprograms可能参与PT方案的开发Mayrequireassistancefromprogramcoordinatortoassessresults可能需要方案案协调人来帮帮助评审结果果61ThirdPartyAssessment第三方评审Customers客户WhenusingPTresultsasaperformancestandardensuretargetisrealistic当使用用PT结果作作为能能力标标准时时，确确保目目标是是现实实的Mustinvestigateprogram;notjustresults必须调调查方方案，，而不不仅是是结果果62ReferenceMaterials参考物物质5types（5种类型型）Puresubstance（（纯物质质）Standardsolutionsandgasmixtures（标准溶溶液和和气体体混合合物））MatrixRM’s（基体参参考物物质））Physicalproperties（物理特特性））Referenceobjects(artifacts)（参考目目标））（参参考品品）63ReferenceMaterials参考物物质Maybeusedfor可用于于InternalQC内部质质量控控制Methodvalidation方法确确认Calibration校准Estimatinguncertainty评估不不确定定度Training培训64Classification分类CertifiedReferenceMaterials有证参参考物物质Directlytraceable直接溯溯源Eachpropertyhasanuncertaintyassociatedwithit每一特特性有有相应应不确确定度度Referencematerial参考物物质Propertiesarehomogenousandthoroughlycharacterizedtobeusedforcalibrationormethodassessment特性是是均匀匀的，，并完完整定定值，，以用用于校校准或或方法法评价价65Availability可获得得性Generallypoorthereforeexpensive(不容容易易获获得得,费费用用高高)Governmentagencies政府府机机构构NIST,NRC,EU-BCRTradeassociations贸易易协协会会AOAC,AOCA(OilChemists)石油油化化学学Commercialsuppliers商业业供供货货商商66RMinValidation方法法确确认认中中参参考考物物