质量控制概要-PHP.pptx

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1、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)degreeofagreementbetweencharacteristi

2、csandrequirements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Howwellisthetestfulfillingrequirements?试验满足要求的程度如何?3QualityControlvs.Quality

3、Assurance(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)

4、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)theratiobetweentheassayedvalueandt

5、he“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Inter

6、mediateprecision–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）De

7、greeofresponsetoachangeinanalyteconcentration–resolution被分析物浓度变化的响应变化程度-分辩率Lowestconcentrationthatcanbedistinguishedfrombackgroundnoise–detectionlimit能从背景噪音识别出的最低浓度-检测限11Sensitivity（灵敏度）Limitofdetectionvs.Limitofquantification（检测限与定量限）Limitofdetection(LOD)isthelevelthatwecansaywhether

8、anana