An extended systematic literature review on provision of evidence for safety certification <s> Textual Templates (3%): <s> This paper deals with the approach for assessing the safety critical computer-based railway systems. It presents the method used for planning and conducting an assessment. This paper provides a precise and workable assessment criteria of safety critical digital architecture. It lists the generic measures/techniques used to construct a safe architecture. The objective of this paper is to present the activities related to the assessment of safety digital architectures. It gives a set of criteria used for judging the compliance with the quality and the safety requirements. The criteria are drawn from standards requirements and best practices. These criteria have been applied to assess various case studies used in the European project named ACRuDA (Assessment and Certification Rules for Digital Architecture). <s> BIB001 </s> An extended systematic literature review on provision of evidence for safety certification <s> Textual Templates (3%): <s> This article summarizes the experiences undergone while supporting ABB Business Units (BUs) in achieving functional safety certification according to IEC 61508 for their safety related products. Being part of a large global organization, ABB BUs enjoy certain freedom in the way they implement their product development process both for hardware and software. Many times these processes are inherited from long standing and successful development tradition from companies that have been later incorporated by ABB. Given so, when faced to the increased demand of IEC 61508 compliant products, the BUs find themselves implementing IEC 61508 and adapting their development processes from scratch for each new product. As a consequence, there are many different ways throughout the organization of implementing similar artifacts with the same scope (i.e. templates, lifecycles, reports, etc.). Since the BUs have recognized that this is clearly not efficient for redundancy, repetition, and finally costs reasons we have undertaken the task of creating a generic process to be used as framework for developing safety compliant products according to IEC 61508 that can be reused for different products across BUs. The requirements of this framework are that it has to be easier to use than the original standard; self-contained (i.e. no need to look up information over the original standard), flexible (i.e. applicable for different kind of products across different BUs); be certifiable by any major certification body; coupled with ABB's stage-gate business decision model; and most importantly: be attractive to BUs so that it can be widely adopted throughouto the organization. In order to satisfy those requirements we have developed a method and a set of components that we call "Safety Add-on", to create and manage functional safety design and development activities according to IEC 61508. The Functional Safety Management module of the Safety Add-on has been certified by TUV Rheinland and is being successfully used by several BUs across ABB. <s> BIB002 </s> An extended systematic literature review on provision of evidence for safety certification <s> Textual Templates (3%): <s> Safety-critical systems have become increasingly software reliant and the current development process of “build, then integrate” has become unaffordable.1,2 This paper examines two major contributors to today's exponential growth in cost: system-level faults that are not discovered until late in the development process; and multiple truths of analysis results when predicting system properties through model-based analysis and validating them against system implementations. We discuss the root causes of such system-level problems, and an architecture-centric model-based analysis approach of different operational quality aspects from an architecture model. A key technology is the SAE Architecture Analysis & Design Language (AADL) standard for embedded software-reliant system. It supports a single source approach to analysis of operational qualities such as responsiveness, safety-criticality, security, and reliability through model annotations. The paper concludes with a summary of an industrial case study that demonstrates the feasibility of this approach. <s> BIB003 </s> An extended systematic literature review on provision of evidence for safety certification <s> Textual Templates (3%): <s> Safety regulations for medical device software are stipulated in numerous international standards. IEC 62304 addresses software life-cycle processes and identifies core processes, software development activities, and tasks that aim for high-integrity software as a prerequisite for dependability of medical devices controlled by this software. However, these standards prescribe neither a process model nor particular software engineering methods to accomplish the normative requirements. Hence, the manufacturer has to argue in the software development and quality management plans that the selected methods cover the required tasks and are appropriate in order to accomplish high-quality artifacts. ::: ::: We propose a method for assessing quality- and engineering-centric arguments in dependability cases to assure IEC 62304-compliant software development. Our method is based on an activity-based quality model representing the impact of facts about methods and design artifacts on development activities. The impact makes the relation between characteristics of design artifacts and activities contributing to the software safety process explicit. It is derived from state-of-the-art software engineering knowledge and best practices recommended in current safety standards like IEC 61508-3. <s> BIB004 </s> An extended systematic literature review on provision of evidence for safety certification <s> Textual Templates (3%): <s> Abstract Safety-critical computing systems need regulators’ approval before operation. Such a permit issue process is called “certification”. Digital instrumentation and Control (IC thus, regulatory review efficiency can be further improved. <s> BIB005
These templates provide predefined sections or tables along with constraints for structuring evidence in a predefined textual format. We identified the following approaches: , which is used in the railway domain for structuring evidence in a series of reports such as quality management reports and safety management reports. The ACRuDA template BIB001 , which is used to structure evidence according to a pre-defined safety case structure. Template Add-ons BIB002 , which provides a template for predefined set of documents that are to be produced at different system development and safety assurance phases. It also provides suggestions on the required approaches for documentation, semi-formal description, and verification and validation procedures. Figure 3 shows the number of studies that refer to each evidence structuring technique. Two clarifications need to be made in relation to the evidence structuring techniques identified. First, we did not consider unstructured text because it does not provide means for systematically organising evidence information. Second, in the Model-Based Specification category, we only considered techniques that are aimed at specifying the structure of the evidence, as opposed to the structure of, for instance, the system that the evidence is generated or used for. For example, AADL BIB003 has been used for modelling the architecture and design of safety-critical systems, but not for modelling the structure of safety evidence. Hence, AADL was not considered as an evidence structuring technique. In contrast, UML, due to its broader expressiveness, has been used for modelling both systems and safety evidence, and was hence considered. We identified techniques for evidence assessment in 105 of the total 218 studies. We classify these techniques into four categories. The percentage given for each category is the rate of papers in that category over the 105 relevant papers. Some studies referred to more than one type of technique. , which are similar to SEALs but also address confidence propagation rules between arguments and sub-arguments. Our review also identified qualitative methods for assessment that are not based on argumentation. These are: Activity-based quality model BIB004 , which uses quality matrices to assess evidence for compliance with the IEC62304 standard. Evidence-confidence conversion process BIB005 , which assesses safety evidence through a review process that results in the specification of the confidence in the safety of the system.