Intelligent management method and system for medical instrument production quality

Abstract

This invention discloses an intelligent management method and system for medical device manufacturing quality, relating to the field of data analysis technology. The method includes: integrating and processing quality management data, regulatory data, and process flow data throughout the entire lifecycle of medical device manufacturing to obtain multi-source heterogeneous data; performing entity recognition based on the multi-source heterogeneous data to construct knowledge triples; constructing an initial knowledge graph for medical device manufacturing quality management based on the knowledge triples, and optimizing the initial knowledge graph based on a time-series awareness dimension; performing anomaly diffusion analysis on the medical device manufacturing process based on the target knowledge graph to conduct quality analysis of the medical device manufacturing process; and constructing a causal traceability graph based on the quality analysis results to perform source tracing reasoning for quality deviations, obtaining deviation cause location results and source tracing guidance information. This invention completes source tracing reasoning from quality deviations to their root causes, making the source tracing basis for medical devices clearer.

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