The assurance as a result of blood chemical analysis by ISO-GUM and QE

Abstract

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. © 2010 IOP Publishing Ltd.