Uncertainty estimation of Blood Chemical Analysis by QA Engineering

The Quality Assurance (QA) of analysis result has been discussed over many years by Quality Engineering (QE). Upgrade by many ISO standards is required for it. It is mining to find out the root element of fault for improvement of measurement accuracy, and it remove. The accuracy assurance needs to investigate the exact Reference Material (RM) for calibration and an data processing for accuracy. This research is performing in field of data processing for the accuracy improvement as how to improve of accuracy. As for the fault element relevant to measurement accuracy, two or more element is existed in many cases. The QE is to assume the generating frequency of fault state, and it is solved beginning from higher ranks for fault factor "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. Late the accuracy assurance of analysis result became duty in the Professional Test (PT). ISO standard was regulated by ISO-GUM (Guide of express Uncertainty in Measurement) [1] as guidance of an accuracy assurance in 1993 for QA.