A safety analysis approach to clinical workflows : application and evaluation

Clinical workflows are safety critical workflows as they have the potential to cause harm or death to patients. Their safety needs to be considered as early as possible in the development process. Effective safety analysis methods are required to ensure the safety of these high-risk workflows, because errors that may happen through routine workflow could propagate within the workflow to result in harmful failures of the system’s output. This paper shows how to apply an approach for safety analysis of clinic al workflows to analyse the safety of the workflow within a radiology department and evaluates the approach in terms of usability and benefits. The outcomes of using this approach include identification of the root causes of hazardous workflow failures that may put patients’ lives at risk. We show that the approach is applicable to this area of healthcare and is able to present added value through the detailed information on possible failures, of both their causes and effects; therefore, it has the potential to improve the safety of radiology and other clinical workflows

A synthesis of logic and bio-inspired techniques in the design of dependable systems

Much of the development of model-based design and dependability analysis in the design of dependable systems, including software intensive systems, can be attributed to the application of advances in formal logic and its application to fault forecasting and verification of systems. In parallel, work on bio-inspired technologies has shown potential for the evolutionary design of engineering systems via automated exploration of potentially large design spaces. We have not yet seen the emergence of a design paradigm that effectively combines these two techniques, schematically founded on the two pillars of formal logic and biology, from the early stages of, and throughout, the design lifecycle. Such a design paradigm would apply these techniques synergistically and systematically to enable optimal refinement of new designs which can be driven effectively by dependability requirements. The paper sketches such a model-centric paradigm for the design of dependable systems, presented in the scope of the HiP-HOPS tool and technique, that brings these technologies together to realise their combined potential benefits. The paper begins by identifying current challenges in model-based safety assessment and then overviews the use of meta-heuristics at various stages of the design lifecycle covering topics that span from allocation of dependability requirements, through dependability analysis, to multi-objective optimisation of system architectures and maintenance schedules

Engineering failure analysis and design optimisation with HiP-HOPS

The scale and complexity of computer-based safety critical systems, like those used in the transport and manufacturing industries, pose significant challenges for failure analysis. Over the last decade, research has focused on automating this task. In one approach, predictive models of system failure are constructed from the topology of the system and local component failure models using a process of composition. An alternative approach employs model-checking of state automata to study the effects of failure and verify system safety properties. In this paper, we discuss these two approaches to failure analysis. We then focus on Hierarchically Performed Hazard Origin & Propagation Studies (HiP-HOPS) - one of the more advanced compositional approaches - and discuss its capabilities for automatic synthesis of fault trees, combinatorial Failure Modes and Effects Analyses, and reliability versus cost optimisation of systems via application of automatic model transformations. We summarise these contributions and demonstrate the application of HiP-HOPS on a simplified fuel oil system for a ship engine. In light of this example, we discuss strengths and limitations of the method in relation to other state-of-the-art techniques. In particular, because HiP-HOPS is deductive in nature, relating system failures back to their causes, it is less prone to combinatorial explosion and can more readily be iterated. For this reason, it enables exhaustive assessment of combinations of failures and design optimisation using computationally expensive meta-heuristics. (C) 2010 Elsevier Ltd. All rights reserved

An approach to safety analysis of clinical workflows

A clinical workflow considers the information and processes that are involved in providing a clinical service. They are safety critical since even minor faults have the potential to propagate and consequently cause harm to a patient, or even for a patient's life to be lost. Experiencing these kinds of failures has a destructive impact on all the involved parties. Due to the large number of processes and tasks included in the delivery of a clinical service, it can be difficult to determine the individuals or the processes that are responsible for adverse events, since such an analysis is typically complex and slow to do manually. Using automated tools to carry out an analysis can help in determining the root causes of potential adverse events and consequently help in avoiding preventable errors through either the alteration of existing workflows, or the design of a new workflow. This paper describes a technical approach to safety analysis of clinical workflows, utilising a safety analysis tool (Hierarchically-Performed Hazard Origin and Propagation Studies (HiP-HOPS)) that is already in use in the field of mechanical systems. The paper then demonstrates the applicability of the approach to clinical workflows by applying it to analyse the workflow in a radiology department. We conclude that the approach is applicable to this area of healthcare and provides a mechanism both for the systematic identification of adverse events and for the introduction of possible safeguards in clinical workflows

A synthesis of logic and biology in the design of dependable systems

The technologies of model-based design and dependability analysis in the design of dependable systems, including software intensive systems, have advanced in recent years. Much of this development can be attributed to the application of advances in formal logic and its application to fault forecasting and verification of systems. In parallel, work on bio-inspired technologies has shown potential for the evolutionary design of engineering systems via automated exploration of potentially large design spaces. We have not yet seen the emergence of a design paradigm that combines effectively and throughout the design lifecycle these two techniques which are schematically founded on the two pillars of formal logic and biology. Such a design paradigm would apply these techniques synergistically and systematically from the early stages of design to enable optimal refinement of new designs which can be driven effectively by dependability requirements. The paper sketches such a model-centric paradigm for the design of dependable systems that brings these technologies together to realise their combined potential benefits

Power quality and electromagnetic compatibility: special report, session 2

The scope of Session 2 (S2) has been defined as follows by the Session Advisory Group and the Technical Committee: Power Quality (PQ), with the more general concept of electromagnetic compatibility (EMC) and with some related safety problems in electricity distribution systems. Special focus is put on voltage continuity (supply reliability, problem of outages) and voltage quality (voltage level, flicker, unbalance, harmonics). This session will also look at electromagnetic compatibility (mains frequency to 150 kHz), electromagnetic interferences and electric and magnetic fields issues. Also addressed in this session are electrical safety and immunity concerns (lightning issues, step, touch and transferred voltages). The aim of this special report is to present a synthesis of the present concerns in PQ&EMC, based on all selected papers of session 2 and related papers from other sessions, (152 papers in total). The report is divided in the following 4 blocks: Block 1: Electric and Magnetic Fields, EMC, Earthing systems Block 2: Harmonics Block 3: Voltage Variation Block 4: Power Quality Monitoring Two Round Tables will be organised: - Power quality and EMC in the Future Grid (CIGRE/CIRED WG C4.24, RT 13) - Reliability Benchmarking - why we should do it? What should be done in future? (RT 15

Formal transformation methods for automated fault tree generation from UML diagrams

With a growing complexity in safety critical systems, engaging Systems Engineering with System Safety Engineering as early as possible in the system life cycle becomes ever more important to ensure system safety during system development. Assessing the safety and reliability of system architectural design at the early stage of the system life cycle can bring value to system design by identifying safety issues earlier and maintaining safety traceability throughout the design phase. However, this is not a trivial task and can require upfront investment. Automated transformation from system architecture models to system safety and reliability models offers a potential solution. However, existing methods lack of formal basis. This can potentially lead to unreliable results. Without a formal basis, Fault Tree Analysis of a system, for example, even if performed concurrently with system design may not ensure all safety critical aspects of the design. [Continues.]</div

Automatic allocation of safety requirements to components of a software product line

Safety critical systems developed as part of a product line must still comply with safety standards. Standards use the concept of Safety Integrity Levels (SILs) to drive the assignment of system safety requirements to components of a system under design. However, for a Software Product Line (SPL), the safety requirements that need to be allocated to a component may vary in different products. Variation in design can indeed change the possible hazards incurred in each product, their causes, and can alter the safety requirements placed on individual components in different SPL products. Establishing common SILs for components of a large scale SPL by considering all possible usage scenarios, is desirable for economies of scale, but it also poses challenges to the safety engineering process. In this paper, we propose a method for automatic allocation of SILs to components of a product line. The approach is applied to a Hybrid Braking System SPL design