Review of Quality Control 质量控制概要
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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,以确保数据的完 整性(一种体系)
– Provides confidence that requirements will be fulfilled
Review of Quality Control 质量控制概要
We will cover(内容)
– Terminபைடு நூலகம்logy
• 术语
– Characteristics of Analytical Methods
• 分析方法特性
– Types of QC samples and how they relate to the characteristics
Expressed as (表示为)
– the ratio between the assayed value and the “true” value (% recovery)
• 分析值与真值间的比(%回收率)
– the difference between the assay and the accepted true value (% Error)
5
Excellence on a Global Scale
Accuracy(准确度)
Degree of agreement between the “true” value and the measured value(真值与测量 值之间的一致程度)
6
Excellence on a Global Scale
• 特性与要求的吻合程度
More importantly (更重要)
– to our clients?(对客户)
2
Excellence on a Global Scale
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
• 复现性®-批间或实验室间的一致性
9
Excellence on a Global Scale
Precision (精密度)
Expressed as Standard Deviation, Relative Standard Deviation or Relative Percent Difference
• 为要求是否得到满足提供信心
4
Excellence on a Global Scale
Qualities of Analytical Methods 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)
• QC样品类型和特性
1
Excellence on a Global Scale
Definition of Quality 质量的定义
To most of the world (普遍上)
– degree of excellence(优异程度)
To the ISO world (在ISO领域)
– degree of agreement between characteristics and requirements
• 分析与可接受真值间的差(%误差)
8
Excellence on a Global Scale
Precision(精密度)
Closeness of agreement between measurements(测量间的一致程度)
– Repeatability (r) – same conditions, short time interval (same run) – short term precision
Accuracy (准确度)
What is the “true” value?(什么是真值)
• Theoretical(理论值) • Consensus(公议值) • Accepted / Assigned(可接受/赋值)
7
Excellence on a Global Scale
Accuracy (准确度)
Lowest concentration that can be distinguished from background noise – detection limit
– 能从背景噪音识别出的最低浓度-检测限
11
Excellence on a Global Scale
Sensitivity （灵敏度）
– 质量控制是一系列测量,以评价分析数据的 质量
– How well is the test fulfilling requirements?
• 试验满足要求的程度如何?
3
Excellence on a Global Scale
Quality Control vs. Quality Assurance (质量控制与质量保证)
– 表示为标准偏差、相对标准偏差、相对百分 差
10
Excellence on a Global Scale
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程度-分辩率
• 重复性(r)-相同条件下\短时间间隔-短期内精密度
– Intermediate precision – same lab different day, analyst, instrument
• 中间精密度-同一实验室不同日期,分析人员,仪器
– Reproducibility (R) – agreement between batches or between labs
– 质量保证是一种管理计划,以确保数据的完 整性(一种体系)
– Provides confidence that requirements will be fulfilled
Review of Quality Control 质量控制概要
We will cover(内容)
– Terminபைடு நூலகம்logy
• 术语
– Characteristics of Analytical Methods
• 分析方法特性
– Types of QC samples and how they relate to the characteristics
Expressed as (表示为)
– the ratio between the assayed value and the “true” value (% recovery)
• 分析值与真值间的比(%回收率)
– the difference between the assay and the accepted true value (% Error)
5
Excellence on a Global Scale
Accuracy(准确度)
Degree of agreement between the “true” value and the measured value(真值与测量 值之间的一致程度)
6
Excellence on a Global Scale
• 特性与要求的吻合程度
More importantly (更重要)
– to our clients?(对客户)
2
Excellence on a Global Scale
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
• 复现性®-批间或实验室间的一致性
9
Excellence on a Global Scale
Precision (精密度)
Expressed as Standard Deviation, Relative Standard Deviation or Relative Percent Difference
• 为要求是否得到满足提供信心
4
Excellence on a Global Scale
Qualities of Analytical Methods 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)
• QC样品类型和特性
1
Excellence on a Global Scale
Definition of Quality 质量的定义
To most of the world (普遍上)
– degree of excellence(优异程度)
To the ISO world (在ISO领域)
– degree of agreement between characteristics and requirements
• 分析与可接受真值间的差(%误差)
8
Excellence on a Global Scale
Precision(精密度)
Closeness of agreement between measurements(测量间的一致程度)
– Repeatability (r) – same conditions, short time interval (same run) – short term precision
Accuracy (准确度)
What is the “true” value?(什么是真值)
• Theoretical(理论值) • Consensus(公议值) • Accepted / Assigned(可接受/赋值)
7
Excellence on a Global Scale
Accuracy (准确度)
Lowest concentration that can be distinguished from background noise – detection limit
– 能从背景噪音识别出的最低浓度-检测限
11
Excellence on a Global Scale
Sensitivity （灵敏度）
– 质量控制是一系列测量,以评价分析数据的 质量
– How well is the test fulfilling requirements?
• 试验满足要求的程度如何?
3
Excellence on a Global Scale
Quality Control vs. Quality Assurance (质量控制与质量保证)
– 表示为标准偏差、相对标准偏差、相对百分 差
10
Excellence on a Global Scale
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程度-分辩率
• 重复性(r)-相同条件下\短时间间隔-短期内精密度
– Intermediate precision – same lab different day, analyst, instrument
• 中间精密度-同一实验室不同日期,分析人员,仪器
– Reproducibility (R) – agreement between batches or between labs