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Car manufacturers relentlessly replace or augment the functionality of mechanical subsystems with electronic components. Most such subsystems (e.g., steer-by-wire) are safety related, hence, subject to regulation. ISO-26262, the dominant standard for road vehicles, regards software faults as systematic, while differentiating hardware faults between systematic and random. The analysis of systematic faults entails rigorous processes and qualitative considerations. The increasing complexity of modern on-board computers, however, questions the very notion of treating the violation of execution-time envelopes for software programs as a systematic fault. Modern hardware in fact reduces the user's ability to delve deep enough into the fabric of hardware–software interaction to gage its extent of contribution to the worst-case execution time (WCET). Changing the nature of the WCET-analysis problem may help address that challenge effectively. To this end, we propose a solution that should allow ISO-26262 to quantify the likelihood of execution-time exceedance events, relating it to target failure metrics employed in support of certification arguments, similarly to random faults in hardware. To this end, we inject randomization in the timing behavior of the computer hardware to relieve the user from the need to control hard-to-reach low-level parts, and use measurement-based probabilistic timing analysis to quantify, constructively, the failure rates resulting from the likelihood of execution-time exceedance events. [ABSTRACT FROM AUTHOR]

In the railway domain, standards such as the EN5012x family prescribe processes to be followed for the management and certification of safety-critical systems. This results in a need to model processes and retrieve process-based arguments to prove that the system achieved the required safety level in order to reduce time and cost spent in the certification process. In this paper, we present the application of the MDSafeCer, i.e. a model-driven safety certification method, for railways. In particular, we model in SPEM 2.0 the safety requirements process according to what described in the safety plan, and we show how it is possible to extract safety evidence to prove the compliance of this process to the EN50128 standard. [ABSTRACT FROM AUTHOR]

Worldwide medical device embedded software certification practices are currently focused on manufacturing best practices. In Brazil, the national regulatory agency does not hold a local certification process for software-intensive medical devices and admits international certification (e.g. FDA and CE) from local and international industry to operate in the Brazilian health care market. We present here a product-based certification process as a candidate process to support the Brazilian regulatory agency ANVISA in medical device software regulation. Center of Strategic Technology for Healthcare (NUTES) medical device embedded software certification is based on a solid safety quality model and has been tested with reasonable success against the Class I risk device Generic Infusion Pump (GIP). [ABSTRACT FROM AUTHOR]

As software becomes more pervasive and complex, it's increasingly important to ensure that a system will be safe even in the presence of residual software faults (or bugs). Software fault injection consists of the deliberate introduction of software faults for assessing the impact of faulty software on a system and improving its fault tolerance. SFI has been included as a recommended practice in recent safety standards and has therefore gained interest among practitioners, but it's still unclear how it can be effectively used for certification purposes. In this article, the authors discuss the adoption of SFI in the context of safety certification, present a tool for the injection of realistic software faults, and show the usage of that tool in evaluating and improving the robustness of an operating system used in the avionic domain. [ABSTRACT FROM PUBLISHER]

The article explores the rationale, methods and findings of a standard setting session conducted to create minimum passing scores for a testing process proposed to be used as a component of the Gearing Up for Safety certification process in U.S. Gearing Up is an agricultural production safety training curriculum for youth created to meet the requirements of the Agricultural Hazardous Occupations Order (AgHOs). The test is proposed to be taken by youth workers seeking jobs to perform functions specified under the AgHOs, which primary objective is to provide necessary training to agricultural production workers. AgHOs training program is designed to ensure that the workers will meet the minimum safety and training requirements as indicated in the Code of the Federal Regulations.

Safety‐critical systems are of paramount importance for many application domains, where safety properties are a key driver to engineer critical aspects and avoid system failures. For the benefits of large‐scale reuse, software product lines (SPL) have been adopted in critical systems industry. However, the integration of safety analysis in the SPL development process is nontrivial. Also, the different usage contexts of safety‐critical systems complicates component fault modeling tasks and the identification of potential hazards. In this light, better methods become necessary to estimate the impact of dependability properties during Hazard Analysis and Risk Assessment. Existing methods incorporating the analysis of safety properties in SPL are limited as they do not include hazard analysis and component fault modeling. In this paper, we present the novel DEPendable Software Product Line Engineering (DEPendable‐SPLE) approach, which extends traditional SPL processes to support the reuse of safety assets. We also present a detailed analysis of the impact of product and context features on the SPL design, safety analysis, and safety requirements. We applied DEPendable‐SPLE to a realistic case study from the aerospace domain to illustrate how to model and reuse safety properties. DEPendable‐SPLE reduced the effort of safety analysis for certifying system variants. [ABSTRACT FROM AUTHOR]