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8.3.1 Towards Integrating Assurance Cases into Risk‐Based Requirements Management
Author(s) -
Feng David,
Eyster Curt
Publication year - 2012
Publication title -
incose international symposium
Language(s) - English
Resource type - Journals
ISSN - 2334-5837
DOI - 10.1002/j.2334-5837.2012.tb01392.x
Subject(s) - documentation , leverage (statistics) , risk analysis (engineering) , risk management , safety assurance , quality assurance , process management , business , engineering management , operations management , computer science , engineering , external quality assessment , finance , machine learning , programming language
In the medical device industry, the FDA has seen an increase in number of recalls of medical devices due to the ever‐increasing complexity in recent years. Several high profile recalls involving infusion pumps have prompted the FDA to reconsider how device safety should be managed, reviewed and approved. An assurance case has been cited as a promising tool to address this growing concern. An assurance case is a resource‐intensive endeavor that requires additional effort and documentation from device manufacturers. Without a well‐organized requirement infrastructure in place, such “additional effort” can be substantial, to the point where the cost of adoption outweighs the benefit of adoption. In this paper, we present a Risk‐Based Requirements and Assurance Management (RBRAM) system. The RBRAM is an integrated framework that combines Risk‐Based Requirements Management (RBRM) with the assurance case methodologies. Such an integrated system can help manufacturers leverage an existing risk management framework to present a comprehensive assurance case report with minimal ongoing efforts while providing a supplementary approach to reexamine the integrity of the system design in terms of the mission objective, with which device manufacturers intend to assure.