质量控制概要(PPT 73)中英文简介开始
RevIEw of Quality Control质量控制概要 We will cover(内容) Terminology 术语 Characteristics of Analytical Methods 分析方法特性 Types of QC samples and how they relate to the characteristics QC样品类型和特性 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 特性与要求的吻合程度 More importantly (更重要) to our clIEnts?(对客户) 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,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? 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,以确保数据的完整性(一种体系) Provides confidence that requirements will be fulfilled 为要求是否得到满足提供信心 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) 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) 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)
Accuracy (准确度) 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) 分析与可接受真值间的差(%误差) 质量控制概要(PPT 73)中英文简介结束,下载后阅读全部内容 |