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首页> 外文会议>13th IMEKO TC1-TC7 joint symposium 2010 >THE ASSURANCE AS A RESULT OF BLOOD CHEMICAL ANALYSIS BY ISO-GUM AND QE
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THE ASSURANCE AS A RESULT OF BLOOD CHEMICAL ANALYSIS BY ISO-GUM AND QE

机译：通过ISO-Gum和QE进行血液化学分析的结果

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The Quality Assurance (QA) of measurand has been discussed over many years by Quality Engineering (QE). It is need to more discuss about ISO standard. It is mining to find out root fault element for improvement of measured accuracy, and it remove. The accuracy assurance needs to investigate the Reference Material (RM) for calibration and an improvement accuracy of data processing. This research follows the accuracy improvement in field of data processing by how to improve of accuracy. As for the fault element relevant to measurement accuracy, in many cases, two or more element is buried exist. The QE is to assume the generating frequency of fault state, and it is solving from higher ranks for fault factor first by "Failure Mode and Effects Analysis (FMEA)". Then QE investigate the root cause over the fault element by "Root Cause Analysis (RCA)" and "Fault Tree Analysis (FTA)" and calculate order to the generating element of assume specific fault. These days comes, the accuracy assurance of measurement result became duty in the Professional Test (PT). ISO standard was legislated by ISO-GUM (Guide of express Uncertainty in Measurement) as guidance of an accuracy assurance in 1993[1] for QA. Analysis method of ISO-GUM is changed into Exploratory Data Analysis (EDA) from Analysis of Valiance (ANOVA). EDA calculate one by one until an assurance performance is obtained according to "Law of the propagation of uncertainty". If the truth value was unknown, ISO-GUM is changed into reference value. A reference value set up by the EDA and it does check with a Key Comparison (KC) method. KC is comparing between null hypothesis and frequency hypothesis. It performs operation of assurance by ISO-GUM in order of standard uncertainty, the combined uncertainty of many fault elements and an expansion uncertain for assurance. An assurance value is authorized by multiplying the final expansion uncertainty [2] by K of coverage factor. K-value is calculated from the Effective Free Degree (EFD) which thought the number of samples is important. Free degree is based on maximum likelihood method of an improved information criterion (AIC) for a Quality Control (QC). The assurance performance of ISO-GUM is come out by set up of the confidence interval [3] and is decided. The result of research of "Decided level/Minimum Detectable Concentration (DL/MDC)" was able to profit by the operation. QE has developed for the QC of industry. However, these have been processed by regression analysis by making frequency probability of a statistic value into normalized distribution. The occurrence probability of the statistics value of a fault element which is accompanied element by a natural phenomenon becomes an abnormal distribution in many cases. The abnormal distribution needs to obtain an assurance value by other method than statistical work of type B in ISO-GUM. It is tried fusion the improvement of worker by QE became important for reservation of the reliability of measurement accuracy and safety. This research was to make the result of Blood Chemical Analysis (BCA) in the field of clinical test.
机译：质量工程（QE）已经讨论了被测量物的质量保证（QA）多年。有必要对ISO标准进行更多讨论。正在挖掘找出根本的故障元素以提高测量精度，然后将其删除。准确性保证需要研究参考材料（RM）进行校准和提高数据处理的准确性。本研究通过提高精度来跟踪数据处理领域中的精度。至于与测量精度有关的故障元素，在许多情况下，存在两个或多个元素。 QE假设故障状态的发生频率，并且首先通过“故障模式和影响分析（FMEA）”从较高的级别上对故障因素进行求解。然后，QE通过“根本原因分析（RCA）”和“故障树分析（FTA）”调查故障要素的根本原因，并计算出假设为特定故障的生成要素的顺序。这些天来，测量结果的准确性保证已成为专业测试（PT）的职责。 ISO标准由ISO-GUM（测量中的明确不确定度指南）立法，作为1993年质量保证的准确性保证的指南。 ISO-GUM的分析方法从效价分析（ANOVA）变为探索性数据分析（EDA）。 EDA逐一计算，直到根据“不确定性传播法”获得保证性能。如果真值未知，则将ISO-GUM更改为参考值。由EDA设置的参考值，并使用密钥比较（KC）方法进行检查。 KC在零假设和频率假设之间进行比较。它按照标准不确定性，许多故障元素的组合不确定性和扩展不确定性的顺序执行通过ISO-GUM进行的保证操作。通过将最终扩展不确定性[2]乘以覆盖因子K来确定保证值。 K值是根据有效自由度（EFD）计算得出的，该值认为样本数量很重要。自由度基于用于质量控制（QC）的改进信息标准（AIC）的最大似然法。 ISO-GUM的保证性能由置信区间[3]的设置决定。 “确定水平/最小可检测浓度（DL / MDC）”的研究结果可以通过该操作获利。 QE是针对行业QC开发的。但是，通过将统计值的频率概率归一化为分布，通过回归分析进行了处理。在许多情况下，伴随自然现象的要素所伴随的故障要素的统计值的出现概率成为异常分布。异常分布需要通过ISO-GUM中B类的统计工作以外的其他方法来获取保证值。尝试融合QE对工人的改进对保持测量精度和安全性的可靠性很重要。这项研究是为了在临床测试领域获得血液化学分析（BCA）的结果。

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