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1、此处是大标题样稿字样十五此处是大标题样稿字样十五 字以内字以内 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Definition of Quality 质量的定义 To most of the world (普遍上普遍上) degree of excellence(优异程度优异程度) To the ISO world (在在ISO领域领域) degree of agreement between characteristics and requirements 特性与要求的吻合程度特性与要求的吻合程度 More importantly (更
2、重要更重要) to our clients?(对客户对客户) 2 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Quality Control vs. Quality Assurance(质量控制与质量保证) Quality control is a series of measurements used to assess the quality of the analytical data 质量控制是一系列测量质量控制是一系列测量,以评价以评价 分析数据的质量分析数据的质量 How well is the test fulfilling
3、requirements? 试验满足要求的程度如何试验满足要求的程度如何? 3 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Quality Control vs. Quality Assurance (质量 控制与质量保证) Quality assurance is a management plan to ensure the integrity of data (a system) 质量保证是一种管理计划质量保证是一种管理计划,以确以确 保数据的完整性保数据的完整性(一种体系一种体系) Provides confidence that
4、requirements will be fulfilled 为要求是否得到满足提供信心为要求是否得到满足提供信心 4 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Qualities of Analytical Methods 分析方法的质量 Accuracy(准确度准确度) Precision(精密度精密度) Selectivity(选择性选择性) Sensitivity(灵敏度灵敏度) Linearity(线性线性) Range(范围范围) Robustness / Ruggedness(稳健性稳健性/稳度稳度) 5 Excellenc
5、eonaGlobalScaleExcellenceonaGlobalScale Accuracy(准确度) Degree of agreement between the “true” value and the measured value(真值与测量真值与测量 值之间的一致程度值之间的一致程度) 6 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Accuracy (准确度) What is the “true” value?(什么是真值什么是真值) Theoretical(理论值理论值) Consensus(公议值公议值) Accepte
6、d / Assigned(可接受可接受/赋值赋值) 7 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Accuracy (准确度) Expressed as (表示为表示为) the ratio between the assayed value and the “true” value (% recovery) 分析值与真值间的比分析值与真值间的比(%回收率回收率) the difference between the assay and the accepted true value (% Error) 分析与可接受真值间的差分析与可接受
7、真值间的差(%误差误差) 8 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Precision(精密度) Closeness of agreement between measurements(测量间的一致程度测量间的一致程度) Repeatability (r) same conditions, short time interval (same run) short term precision 重复性重复性(r)-相同条件下相同条件下短时间间隔短时间间隔-短期内精密度短期内精密度 Intermediate precision same
8、lab different day, analyst, instrument 中间精密度中间精密度-同一实验室不同日期同一实验室不同日期,分析人员分析人员,仪器仪器 Reproducibility (R) agreement between batches or between labs 复现性复现性-批间或实验室间的一致性批间或实验室间的一致性 9 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Precision (精密度) Expressed as Standard Deviation, Relative Standard Deviati
9、on or Relative Percent Difference 表示为标准偏差、相对标准偏表示为标准偏差、相对标准偏 差、相对百分差差、相对百分差 10 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Sensitivity(灵敏度) Degree of response to a change in analyte concentration resolution 被分析物浓度变化的响应变化被分析物浓度变化的响应变化 程度程度-分辩率分辩率 Lowest concentration that can be distinguished fr
10、om background noise detection limit 能从背景噪音识别出的最低浓能从背景噪音识别出的最低浓 度度-检测限检测限 11 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Sensitivity (灵敏度) Limit of detection vs. Limit of quantification(检测限与定量限)检测限与定量限) Limit of detection (LOD) is the level that we can say whether an analyte is present or not 检测
11、限是我们判断被分析物是否存在的含量水平检测限是我们判断被分析物是否存在的含量水平 Limit of quantitation (LOQ) is the level that we can quantify the analyte with a specified accuracy (20%) 定量限是我们按规定准确度(定量限是我们按规定准确度(20%)能对被分析物量)能对被分析物量 化的含量水平化的含量水平 12 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Selectivity(选择性) Ability to detect the ana
12、lyte in a complex matrix 检测复杂基体中被析物的能力检测复杂基体中被析物的能力 Ability to exclude non-analyte species from signal 通过信号排除非被分析物的能力通过信号排除非被分析物的能力 Usually inversely related to sensitivity 通常与灵敏度成反比通常与灵敏度成反比 13 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Linearity(线性) Ability to produce a response that is dire
13、ctly proportional to the concentration of the analyte 所产生的反应与被分析物浓度所产生的反应与被分析物浓度 成正比的能力成正比的能力 Only holds true within a given range 只在给定范围内是真实的只在给定范围内是真实的 14 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Linearity (线性) Expressed as correlation coefficient (r) or coefficient of determination (r2) 表
14、示为相关系数表示为相关系数(r)或测定系数或测定系数 (r2) r2=ssxy2/ssxx ssyy 15 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Range(范围) The interval between the highest and lowest concentration for which the method has shown to have suitable levels of accuracy, precision and linearity. 在方法具有适宜的准确度、精在方法具有适宜的准确度、精 密度和线性的条件下
15、,最高和密度和线性的条件下,最高和 最低浓度范围最低浓度范围 16 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Robustness(稳健性) Ability of method to be unaffected by small changes in method (internal) conditions(方法不因条件的较小变化(内部)方法不因条件的较小变化(内部) 而受影响的能力)而受影响的能力) Temperature(温度)温度) pH Composition of mobile phase(流动相组成)流动相组成) Useful
16、 when method moves from development to production(从方法开发到从方法开发到 使用很有用)使用很有用) 17 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Quality Control Measures 质量控制手段 Calibration standards(校准校准 标准)标准) Blanks(空白)空白) Recovery studies(回收率研回收率研 究)究) Precision studies(精密度研精密度研 究)究) Sensitivity studies(灵敏度研灵敏度研 究)究) Detection Limit(检测限)检测限) Quantitation limit(定量限)定量限) 20 ExcellenceonaGlobalScaleExcellenceonaGlobalScale Calibration (校准) Directly affects accuracy (直接影响