Search

The manuscript calls for establishing a standard for electroconvulsive devices by manufacturers for better regulation in India. This is most relevant in the context of two recent developments, (a) Notification of medical devices rules, 2017 with classification of ECT as Class C and (b) Recent change in classification of ECT devices by US-FDA in 2018. The establishment of standards would help in upregulating the standard of ECT devices as well as ECT practices. [ABSTRACT FROM AUTHOR]

Background: Despite considerable efforts made in recent years, the industrial accident rate and the fatality rate in the Republic of Korea are much higher than those in most developed countries in Europe and North America. Industrial safety policies and safety regulations are also known to be ineffective and inefficient in some cases. Methods: This study focuses on the quantitative evaluation of the effectiveness of direct safety regulations such as safety certification, self-declaration of conformity, and safety inspection of industrial machines in the Republic of Korea. Implications on safety policies to restructure the industrial safety system associated with industrial machines are also explored. Results: Analysis of causes in industrial accidents associated with industrial machines confirms that technical causes need to be resolved to reduce both the frequency and the severity of such industrial accidents. Statistical analysis also confirms that the indirect effects of safety device regulation on users are limited for a variety of reasons. Safety device regulation needs to be shifted to complement safety certification and self-declaration of conformity for more balanced direct regulations on manufacturers and users. An example of cost-benefit analysis on conveyor justifies such a transition. Conclusion: Industrial safety policies and regulations associated with industrial machines must be directed towards eliminating the sources of danger at the stage of danger creation, thereby securing the safe industrial machines. Safety inspection further secures the safety of workers at the stage of danger use. The overall balance between such safety regulations is achieved by proper distribution of industrial machines subject to such regulations and the intensity of each regulation. Rearrangement of industrial machines subject to safety certification and self-declaration of conformity to include more movable industrial machines and other industrial machines with a high level of danger is also suggested.

Abstract The development of automated driving systems presents a special challenge to the existing regulatory regimes for road vehicles. Automated driving systems shift the responsibility for roadway and traffic monitoring, decision making, and vehicle control from the driver to the automated driving system, which will necessitate a shift of the responsibility for traffic law violations and crashes from the individual driver toward the manufacturers of the automated driving systems. However, the opportunities for automated driving systems to improve transportation system performance and safety are great, and rapid innovation needs to be balanced against the risks to public safety from poorly engineered or hastily released systems competing for first-on-the-market status. Furthermore, in the absence of clearly defined standards and testing procedures, it is not yet clear how safety can be certified by the developer, a regulatory agency, or a third party. This paper describes California's pioneering efforts to grapple with these challenges after its legislature passed a law requiring the development of regulations to govern the testing and operation of automated vehicles on public roads, and it provides recommendations regarding what should and should not be incorporated into such regulations. [ABSTRACT FROM AUTHOR]

OBJECTIVES: The aim of this study was to evaluate if safety certification reduces the risk of work injury among experienced manual tree-fallers. METHODS: This study used a retrospective cohort study design. Experienced manual tree-fallers employed in the Canadian province of British Columbia (N=3251) between 2003–2008 were enumerated from a mandatory faller registry. Registry records with demographic and certification data were linked to workers’ compensation claims for injury outcomes. Data were analyzed using discrete time survival analysis over a two-year period, centered on certification date with pre- and post-certification demarcated into four three-month periods. Models were adjusted for demographic, occupation/industry, previous injury, and seasonal/temporal effects. RESULTS: The relative risk (RR) of work injury during the post certification periods were elevated in comparison to the pre-certification reference period, but the 95% confidence intervals included “1” for all estimates by the end of follow-up, suggesting no statistically significant increased risk of injury. Results were consistent across different outcome measures of acute injury (ie, fracture or amputations) (N=186), musculoskeletal injury (ie, back strain) (N=137), and serious injury claims (ie, long duration, high cost and/or fatal) (N=155). CONCLUSION: Certification did not reduce the risk of work injury among experienced tree-fallers in the province of British Columbia. Non-statistically significant increases in the observed risk of work injury in the months immediately following certification may be attributable to an intervention effect or a methodological limitation related to a lack of individual-level, time-at-risk exposure data.

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]

• An analysis of the industrial accident prevention effect of the hazardous machine safety certification system was performed. • The necessity of the safety certification system was confirmed using three statistical methods. • Surveys, industrial accident data analysis, field surveys, and expert interviews were conducted. • It was confirmed that the safety certification system has a positive effect on industrial accident prevention. • The safety certification system must ensure efficiency by considering the safety policy and industrial environment of each country. The "4th industrial revolution" is accelerating changes in technology, industry, and machinery, and the "Internet of everything" (IoE) requires comprehensive integration of people and machines. Despite the development of these technologies, fatal accidents continue to occur due to malfunctions of dangerous machinery, so the importance of the safety certification system is increasing, but there are few objective analysis data. In this study, the necessity of a safety certification system was confirmed by analyzing the effect of the safety certification system on the prevention effect of industrial accidents in three methods. Based on these analysis results, the industrial accident prevention effect of the current safety certification system and necessary supplementary tasks were derived. Safety certification systems for more than 30 machines and equipment are in operation in South Korea. In this research, the press, crane, catapult, and lift machines most commonly used in industrial fields were analyzed. This study was conducted in five steps: a safety certification system operation status investigation, a survey and interviews, an analysis of dangerous machinery and equipment accidents, focus group interviews, and study of the direction of safety certification systems in consideration of recent IoE developments. As a result of the analysis, various opinions were presented on the safety certification system by subject, and it was found that it was necessary to prepare supplementary measures for the advancement of the safety certification system advancement, expand its field applicability, and improve the efficiency of safety certification. [ABSTRACT FROM AUTHOR]

An EN 50129-compliant safety case should include process-related evidence in terms of quality as well as safety management. Potentially innovative engineering methods developed in academic settings could act as process-related evidence. However, to ease their acceptance within the rail industrial settings, the adequacy of these methods need to be justified. In this paper, we extend our previous work and we provide a broader justification including performance aspects aimed at showing that the entire MBA (Model-Based design methodology for Assessing performance and safety requirements of critical systems) is partly compliant with EN 50128. To do that, we tackle safety and performance process-related compliance as follows: we first manually check if MBA includes EN 50128-compliant process elements, then we model MBA in compliance with Software Process Engineering Meta-model 2.0, then, we derive process-based arguments from the MBA process model by using the MDSafeCer (Model Driven Safety Certification) method. By doing so, we provide a twofold contribution: we further validate MDSafeCer in the rail domain and we strengthen MBA. [ABSTRACT FROM AUTHOR]

SACM (Structured Assurance Case Metamodel) is a standard for assurance case specification and exchange. It consists of an argumentation metamodel and an evidence metamodel for justifying that a system satisfies certain requirements. For assurance of safety-critical systems, SACM can be used to manage safety evidence and to specify safety cases. The standard is a promising initiative towards harmonizing and improving system assurance practices, but its suitability for safety evidence management needs to be further studied. To this end, this paper studies how SACM 1.1 supports this activity according to requirements from industry and from prior work. We have analysed the notion of evidence in SACM, its evidence lifecycle, the classes and associations of the evidence metamodel, and the link of this metamodel with the argumentation one. As a result, we have identified several improvement opportunities and extension possibilities in SACM. The notions of evidence and evidence assertion should be clarified, the overlaps between metamodel elements should be reduced, and a wider support to the lifecycle of the artefacts used as safety evidence could be provided. Addressing these aspects will allow SACM to better fit safety evidence management needs and practices, especially beyond the scope of a safety case. The results and the conclusions drawn are especially valuable for practitioners interested in SACM adoption and vendors interested in developing tool support for SACM-based safety evidence management. [ABSTRACT FROM AUTHOR]

Reuse of systems and subsystem is a common practice in safety-critical systems engineering. Reuse can improve system development and assurance, and there are recommendations on reuse for some domains. Cross-domain reuse, in which a previously certified product typically needs to be assessed against different safety standards, has however received little attention. No guidance exists for this reuse scenario despite its relevance in industry, thus practitioners need new means to tackle it. This paper aims to fill this gap by presenting a systematic approach for reuse of safety certification artefacts across standards and domains. The approach is based on the analysis of the similarities and on the specification of maps between standards. These maps are used to determine the safety certification artefacts that can be reused from one domain to another and reuse consequences. The approach has been validated with practitioners in a case study on the reuse of an execution platform from railway to avionics. The results show that the approach can be effectively applied and that it can reduce the cost of safety certification across standards and domains. Therefore, the approach is a promising way of making cross-domain reuse more cost-effective in industry. [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]

Abstract: To ensure the safety of avionic systems, civil avionic software and hardware regulated by certification authorities must be certified based on applicable standards (e.g., DO-178B and DO-254). The overall safety integrity of an avionic system, comprising software and hardware, should be considered at the system level. Thus, software and hardware components should be planned, developed and certified in a unified, harmonized manner to ensure the integral safety of the entire avionic system. One of the reasons for the high development costs of avionic systems complying with standards may be a lack of sufficient understanding of how to employ these standards efficiently. Therefore, it is important to understand the similarities and differences between DO-178B and DO-254 to effectively manage the processes required by these standards, to minimize cost, and to ultimately ensure the safety of the entire avionic system. Thus, the goal of this paper is to compare various aspects of DO-178B and DO-254 comprehensively. The paper may serve as a useful supplementary material for the practitioner to understand the rationales behind and the differences between two main standards used in avionic industries. [Copyright &y& Elsevier]

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]