Authors:
Julieth Patricia Castellanos-Ardila
and
Barbara Gallina
Affiliation:
IDT, Mälardalen University, Västerås, Sweden
Keyword(s):
Process Recertification, Systematic Reuse, Automated Compliance Checking, ISO 14971.
Abstract:
Revisions of safety-related standards lead to the release of new versions. Consequently, products and processes need to be recertified. To support that need, product line-oriented best practices have been adopted to systematize reuse at various levels, including the engineering process itself. As a result, Safety-oriented Process Line Engineering (SoPLE) is introduced to systematize reuse of safety-oriented process-related artifacts. To systematize reuse of artifacts during automated process compliance checking, SoPLE was conceptually combined with a logic-based framework. However, no integrated and tool-supported solution was provided. In this paper, we focus on process recertification (interpreted as the need to show process plan adherence with the new version of the standard) and propose a concrete technical and tool-supported methodological framework for reusing (safety-oriented) compliance artifacts while recertifying. We illustrate the benefits of our methodological framework b
y considering ISO 14971 versions, and measuring the enabled reuse.
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