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 ³Failure Mode and Effects Analysis (FMEA)´. Then QE investigate the root cause over the fault element by ³Root Cause Analysis (RCA)´ and ³Fault 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). 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.
Using X-ray angiography, the internal diameter (ID) of 31 sites of arteries in the hindlimb, i.e., the iliac, main femoral, profundal femoral, circumflex femoral, saphenous, and popliteal arteries, was measured in anesthetized rabbits. ID under the control condition was 294-1,796 µm, but was changed to 376-1,828 µm, 127-1,914 µm, and 423-2,098 ,um with administration of hexamethonium bromide, noradrenaline, and phentolamine, respectively. The constrictor effects of noradrenaline and plasma catecholamine were larger in the femoral artery than in the iliac artery. At the transition site from the iliac to the femoral artery, ID per unit length increased from 190 µm/10 mm in the control to 320 ,um/10 mm with noradrenaline. The constrictor effects of sympathetic nerve activity (SNA) on the profundal femoral, circumflex femoral, saphenous, and popliteal arteries varied among 19 out of 20 sites. Plasma catecholamine constricted ID at 18 sites but dilated it at 2 sites. Noradrenaline constricted ID at all 20 sites, particularly in the popliteal and saphenous arteries. It was concluded that the effects of SNA and plasma catecholamine on ID of rabbit hindlimb arteries were qualitatively and quantitatively non-uniform among different arteries and at different sites of the given artery.
International Organization for Standardization (ISO) standard Quality Assurance (QA) is required for final report values in clinical Blood Chemical Analysis (BCA). In the medical field, an External Quality Assurance Scheme (EQAS) is required in order to make wide area medicine system useful and to prevent clinical mistakes stemming from ambiguous data. The fact that QA is based on statistical analysis for many years by Quality Engineering (QE) has been discussed. An improvement so that the ISO need not depend on statistical analysis for QA was proposed. Then ISO published a Guide of express Uncertainty inMeasurement (ISO-GUM) [1] in 1993. There are the two mainly changed parts at ISO-GUM. The first is changing evaluation of the ambiguous data into uncertainty from an error. The second is adding Exploratory Data Analysis (EDA) for the analysismethod to Analysis Of Variance (ANOVA) [2] in order to make abnormal distribution possible. ANOVA was only reported on the current situation of measurement result, while EDA came to be required in investigations of cause by ISO-GUM. This research is to help establish policies ensuring BCA result. This research results were used for information technology (IT) era in medical treatment in the European Union (EU) in 2010.
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