QMS Change Recommendation System Using Dependency Graphs
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Solution Overview
Problem
Change management in Quality Management Systems (QMS) for medical devices is complex due to integrated and referential processes, leading to asynchronous changes that increase regulatory risks and harm, with non-linear impacts governed by latent network topology, making it difficult to evaluate and mitigate risks effectively.
Innovation Solution
A recommendation system that uses natural language processing and graph-theoretic techniques to extract structured metadata, identify meaningful relationships, and calculate potential risks from changes in QMS objects, providing real-time visibility and recommendations to mitigate risks through a derived dependency network.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If quality management processes are highly integrated and referential to ensure comprehensive quality control, then product quality and safety are improved, but the complexity of evaluating risk from changes increases significantly
Solution Approach 1:
The patent segments the complex QMS document network into a structured dependency graph where documents are nodes and relationships are edges. This segmentation allows the system to break down the overwhelming complexity of change risk evaluation into manageable local assessments of document dependencies, making the evaluation process tractable while maintaining comprehensive quality control.
Solution Approach 2:
The patent introduces an intermediary computational layer (the dependency graph analysis system) that mediates between the complex integrated QMS processes and the change risk evaluation. This intermediary automatically traces document relationships and calculates risk metrics, reducing the complexity burden on users while preserving the comprehensive nature of quality management.
2Adaptability or versatility
If changes are made frequently to keep pace with market competition and regulatory requirements, then adaptability and responsiveness are improved, but the risk of asynchronous changes and regulatory violations increases
Solution Approach 1:
The patent implements preliminary action by automatically analyzing document dependencies and calculating risk metrics before changes are implemented. The system pre-identifies which documents are affected by proposed changes and alerts users to potential compliance issues, allowing them to take corrective action before making changes that could violate regulations.
Solution Approach 2:
The patent incorporates feedback mechanisms where the system continuously monitors the QMS document network, automatically detects changes, and provides real-time alerts about potential compliance risks. This feedback loop enables organizations to maintain high adaptability while ensuring regulatory compliance by immediately notifying users of problematic asynchronous changes.
3Device complexity
If implicit associations between QMS documents are not captured, then the simplicity of the system is maintained, but the ability to identify relevant risks and dependencies is reduced
Solution Approach 1:
The patent replaces manual documentation and tracking of document relationships with an automated computational system using natural language processing and graph theory. This substitution captures implicit associations between QMS documents that would be impossible to track manually, preserving system simplicity from the user perspective while preventing loss of critical risk information through automated analysis.
Data Source
AI summary
A quality management system (QMS) contains a collection of documents and content relating to interdependent policies, processes, and procedures required for planning, manufacturing, and marketing complex products. Change management refers to the way a company manages modifications to products and processes within their business and the potential impacts of those changes. A core part of change management is to understand what may be impacted by the change, why it impacted, and how to assess and or identify the risk of the change throughout the company and quality/regulatory processes. The impact assessment is a core part of the process to ensure one does not make changes that create a product and/or process failures as well as evaluating the regulatory impact of such changes. The disclosure pertains to a recommendation system for change management that maps the dependencies between the document contained in the QMS, allows the searching for related documents based on user-supplied criteria, and includes interactive visualization of inter-document dependencies.