Argument-Driven Safety Engineering of a Generic Infusion Pump with Digital Dependability Identities.

Creating a sound argumentation of why a system is sufficiently safe is a major part of the assurance process. Today, compiling a safety case and maintaining its validity after changes are time-consuming manual work. By using the concept provided by Digital Dependability Identities (DDI) , we present a systematic approach for creating a model-connected safety argument that is formally related to safety models such as hazard and risk assessment, safety analysis, architecture, safety requirements or validation. The comprehensively traced DDI model provides the traceability basis to guide argument-driven safety engineering processes. Flaws in arguments or evidence emerging through changes in the product development process are addressed by DDI-based automation. The case study described in this paper evaluates the DDI approach based on the publicly available safety assurance documentation of a Generic Infusion Pump (GIP) system. The evaluation demonstrates that DDIs can capture the relevant safety aspects of the GIP system.