Automatic Analysis Device for Calibration Lot Variation Diagnosis
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Solution Overview
Problem
Existing automatic analysis devices do not effectively support the identification of the cause of variations in measurement values of quality control substances, leading to potential delays in addressing such variations.
Innovation Solution
An automatic analysis device that includes an acquisition unit to measure variation amounts, a calculation unit to predict variation based on calibration solution lot changes, and an estimation unit to determine the cause of these variations by comparing actual and predicted values.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If automatic analysis devices perform quality control using standard solutions, then measurement reliability is maintained, but the ability to quickly identify causes of measurement value variations is insufficient
Solution Approach 1:
The system automatically compares actual measurement values of quality control substances against expected values and triggers causal analysis when variations are detected. This feedback mechanism enables rapid identification of variation causes by continuously monitoring and comparing measurement data with predetermined standards, thereby reducing the time to identify problems while maintaining quality control reliability.
Solution Approach 2:
The system introduces an intermediary analysis process that automatically mediates between quality control measurements and potential cause identification. By using computational units to analyze the relationship between measurement variations and calibration solution characteristics, the system bridges the gap between detecting variation and identifying its cause, enabling faster problem resolution without compromising quality control.
2Measurement precision
If calibration is performed using calibration solutions, then measurement accuracy is improved, but variations in measurement values due to lot changes are not easily detected
Solution Approach 1:
The system continuously monitors measurement values of quality control substances and compares them against expected ranges. When variations are detected, the system automatically initiates causal analysis by comparing calibration solution information before and after lot changes, enabling detection of measurement accuracy issues while identifying their causes through automated feedback loops.
Solution Approach 2:
The system creates a digital copy and comparison framework for calibration solution characteristics across different lots. By storing and comparing calibration solution information (such as concentration values and lot numbers) in a computational manner, the system enables easy detection of variations due to lot changes without requiring physical re-testing, thus maintaining measurement accuracy while simplifying cause detection.
Data Source
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AI summary
Provided is an automatic analysis device that estimates causes of change in measurement values of a quality-control substance. An automatic analysis device that analyzes specimens includes an acquisition unit that acquires amount of change in measurement values of a quality-control substance used for quality control, a calculation unit that calculates a change prediction amount on the basis of a difference value in concentration values of a standard solution used for calibration before and after changing lots, and an estimation unit that estimates causes of change occurring in measurement values of the quality-control substance on the basis of results of comparing the amount of change and the change prediction amount.