Confidence: Its role in dependability cases for risk assessment

Society is increasingly requiring quantitative assessment of risk and associated dependability cases. Informally, a dependability case comprises some reasoning, based on assumptions and evidence, that supports a dependability claim at a particular level of confidence. In this paper we argue that a quantitative assessment of claim confidence is necessary for proper assessment of risk. We discuss the way in which confidence depends upon uncertainty about the underpinnings of the dependability case (truth of assumptions, correctness of reasoning, strength of evidence), and propose that probability is the appropriate measure of uncertainty. We discuss some of the obstacles to quantitative assessment of confidence (issues of composability of subsystem claims; of the multi-dimensional, multi-attribute nature of dependability claims; of the difficult role played by dependence between different kinds of evidence, assumptions, etc). We show that, even in simple cases, the confidence in a claim arising from a dependability case can be surprisingly low

Enhancing Covid-19 Decision-Making by Creating an Assurance Case for Simulation Models

Simulation models have been informing the COVID-19 policy-making process. These models, therefore, have significant influence on risk of societal harms. But how clearly are the underlying modelling assumptions and limitations communicated so that decision-makers can readily understand them? When making claims about risk in safety-critical systems, it is common practice to produce an assurance case, which is a structured argument supported by evidence with the aim to assess how confident we should be in our risk-based decisions. We argue that any COVID-19 simulation model that is used to guide critical policy decisions would benefit from being supported with such a case to explain how, and to what extent, the evidence from the simulation can be relied on to substantiate policy conclusions. This would enable a critical review of the implicit assumptions and inherent uncertainty in modelling, and would give the overall decision-making process greater transparency and accountability.Comment: 6 pages and 2 figure

Safety-Critical Systems and Agile Development: A Mapping Study

In the last decades, agile methods had a huge impact on how software is developed. In many cases, this has led to significant benefits, such as quality and speed of software deliveries to customers. However, safety-critical systems have widely been dismissed from benefiting from agile methods. Products that include safety critical aspects are therefore faced with a situation in which the development of safety-critical parts can significantly limit the potential speed-up through agile methods, for the full product, but also in the non-safety critical parts. For such products, the ability to develop safety-critical software in an agile way will generate a competitive advantage. In order to enable future research in this important area, we present in this paper a mapping of the current state of practice based on {a mixed method approach}. Starting from a workshop with experts from six large Swedish product development companies we develop a lens for our analysis. We then present a systematic mapping study on safety-critical systems and agile development through this lens in order to map potential benefits, challenges, and solution candidates for guiding future research.Comment: Accepted at Euromicro Conf. on Software Engineering and Advanced Applications 2018, Prague, Czech Republi

A lightweight assessment method for medical device software processes

This paper outlines the MDevSPICE-Adept process assessment method. MDevSPICE-Adept is a lightweight process assessment method that has been created for the MDevSPICE software process assessment model which is currently being developed for the medical device industry. MDevSPICE is a fully validated release of a medical device software process assessment model (formerly known as Medi SPICE), which was developed by the authors. While the MDevSPICE process assessment model is detailed and comprehensive, there is industry demand for a lightweight medical device software process assessment method. To address this requirement the MDevSPICE-Adept method has been developed. Details on how this has taken place and the procedures for implementing an MDevSPICE-Adept process assessment are presented. Information is also provided regarding how an MDevSPICE process assessment was undertaken in an Irish based medical device company. A summary of the issues identified from this process assessment and the actions taken to facilitate process improvement is also presented. Finally, plans for future work are discussed

Patient safety competencies in undergraduate nursing students: a rapid evidence assessment

Aims To identify patient safety competencies, and determine the clinical learning environments that facilitate the development of patient safety competencies in nursing students. Background Patient safety in nursing education is of key importance for health professional environments, settings, and care systems. To be effective, safe nursing practice requires a good integration between increasing knowledge and the different clinical practice settings. Nurse educators have the responsibility to develop effective learning processes and ensure patient safety. Design Rapid Evidence Assessment. Data Sources MEDLINE, CINAHL, SCOPUS, and ERIC were searched, yielding 500 citations published between 1 January 2004 - 30 September 2014. Review Methods Following the Rapid Evidence Assessment process, 17 studies were included in this review. Hawker's (2002) quality assessment tool was used to assess the quality of the selected studies. Results Undergraduate nursing students need to develop competencies to ensure patient safety. The quality of the pedagogical atmosphere in the clinical setting has an important impact on the students’ overall level of competence. Active student engagement in clinical processes stimulates their critical reasoning, improves interpersonal communication, and facilitates adequate supervision and feedback. Conclusion Few studies describe the nursing students’ patient safety competencies and exactly what they need to learn. In addition, studies describe only briefly which clinical learning environments facilitate the development of patient safety competencies in nursing students. Further research is needed to identify additional pedagogical strategies and the specific characteristics of the clinical learning environments that encourage the development of nursing students’ patient safety competencies

Critical appraisal of the clinical practice guideline for the management of dyslipidaemia and prevention of cardiovascular disease: AACE 2017 guidelines.

Objective: This study aims to appraise 2017 AACE Guidelines for Management of Dyslipidemia and Prevention of Cardiovascular Disease by using Appraisal of Guidelines for Research and Evaluation II (AGREE II) tool. Method: A total of seven investigators who have obtained a postgraduate Doctor of Pharmacy or Masters of Clinical Pharmacy, appraised the dyslipidaemia guidelines independently, by using AGREE II tool. Key findings: Among all the domains, the highest-scoring domain was the clarity of presentation (87%), and the lowest was the applicability (26%). The assessors gave the top ranking for both ‘scope and purpose’ (78%) and ‘Editorial independence’ (79%). The overall guideline assessment was 61%. Most of the investigators (four out of seven) recommended using the guidelines in clinical practice with modifications. Conclusion: The appraisal obtained in this article can be utilized by guideline developers to improve the quality of their upcoming guidelines. Healthcare professionals can be aware of guideline limitations and the importance of quality assessment of the guideline before applying their recommendations whenever possible by using Agree II tool

The administrative burden reduction policy boom in Europe: comparing mechanisms of policy diffusion

Much has been written on the diffusion of public management and regulatory reform tools. Available evidence suggests that cross-national policy diffusion is an increasingly significant phenomenon, especially in the European context. While internationalisation of policy discourses and expert communities are regarded as key driving forces of policy diffusion, public management reforms are also said to be particularly vulnerable to mechanisms of 'diffusion without convergence'. This paper analyses the case of policies aiming at reducing administrative burdens of regulations through the lens of the literature on policy diffusion. The diffusion of the so-called Standard Cost Model for measuring administrative burden between 2003 and 2007 is used as a case to explore the mechanisms facilitating policy diffusion in this domain. The analysis reveals patterns of rapid diffusion. This policy boom has been driven by a combination of different mechanisms of policy diffusion rather than by a single driving factor

Comparative analysis of existing food safety culture evaluation systems

The purpose of the research was firstly, to analyze existing culture evaluation systems for commonalities and differences in research quality, applied validation strategies, and content. Secondly, to suggest a simple structure of food safety cultural dimensions to help unify the culture evaluation field. To achieve these goals, a comparison of eight culture evaluation models applied to varing degrees in the food industry was conducted. The systems were found to vary significantly in applied validation strategies but through deductive, textual data analysis, five dimensions were identified that cover elements present in all the models. Transparency is needed when using applied research methodologies to continually increase quality and trustworthiness of culture research in the food safety domain and this field would benefit from both further commonality of approach to validation strategy and structure and adoption of an overarching structural framework

The European Regulatory Framework and its implementation in influencing organic inspection and certification systems in the EU

The report presents a review of the most important European and international legislation that set the framework for organic certification, of reports prepared by international agencies working with organic standard setting and certification, and of relevant scientific literature. It discusses problems, future challenges of the organic control systems in Europe leading to suggestions for improvement. Food quality assurance is of key importance for the future development of the Common Agricultural Policy of the EU. A large number of mandatory and voluntary assurance and certification schemes exist for agriculture and in the food industry leading to the risk of increased costs for producers and confusion of consumers. Such schemes include the setting of requirements and bodies that undertake control and provide certificates. Requirements can be divided into statutory regulations regarding food safety and good agricultural practice and standards for voluntary attributes. Basic requirements of food safety, animal health and animal welfare are controlled by the Official Food and Feed Control (OFFC) systems, governed by Council Regulation (EC) 882/2004. Third party certification provides credibility to claims related to voluntary standards and is communicated to the consumers through the use of certification marks. The EU has developed a legislative basis for quality claims in relation to geographical indications, traditional specialities and organic farming and considers introducing labelling rules in relation to animal welfare, environmental impact and the origin of raw materials. Organic certification is one of a number of overlapping and competing schemes. The development of organic standards and certification in Europe started with private standards and national rules, leading to Regulation (EEC) 2092/1991. The requirements for competent authorities, control bodies and operators in this regulation regarding the control systems are reviewed. The discussion highlights the low level of knowledge among consumers of the requirements of organic certification, a weak emphasis of the control system on operator responsibility for organic integrity, issues of competition and surveillance of control bodies, a lack of consideration of risk factors in designing the inspection systems and a lack of transparency. A total revision of the European Regulations on organic production began in 2005. One important change introduced by the new Council Regulation (EC) 834/2007 for Organic Food and Farming is that the organic control system is placed under the umbrella of Council Regulation (EC) 882/2004 on Official Food and Feed Controls. Regulation (EC) 834/2007 also requires that control bodies have to be accredited according to general requirements for bodies operating product certification systems (ISO Guide 65/EN 45011). From July 2010 packaged organic products will have to carry the new EU logo as well as the compulsory indication of the control body. The report reviews the requirements for competent authorities, control bodies and operators from the various legal sources. The discussion highlights a lack of clarity on the impact of the OFFC regulation on the organic control system including how risk based inspections are to be implemented and the potential for in-consistencies in the enforcement of the regulation. A number of international initiatives concerned with the harmonisation of organic standards and to a lesser extent certification are reviewed, such as the International Task Force on Harmonisation and Equivalence (ITF)1 Two main alternative guarantee systems for organic production have been developed and researched by a number of organisations including IFOAM, ISEAL, FAO and the EU Commission. Smallholder Group Certification based on an Internal Control System (ICS) and Participatory Guarantee Systems (PGS) could also represent ways to minimize certification costs also for European farmers, in particular for operators that market directly or through very short supply chains. Both systems also illustrate examples of certification systems with a focus on system development and improvement. , the European Organic Certifiers Council (EOOC), the International Social and Environmental Accreditation and Labelling Alliance (ISEAL) and the Anti-Fraud Initiative (AFI). The multilateral initiatives have led to a better understanding of current problems and the scope and limitations for harmonisation. They have also contributed to the sharing of tools and methods and the identification of best practice. Apart from organic farming the European Union has two other food quality schemes: Regulation (EC) 510/2006 on geographical indications and Regulation (EC) 509/2006 on traditional specialities. The report explores the potential for combining these with organic certification, and draws lessons for organic certification based on Italian experience. The final chapter summarises problems and challenges from the previous chapters. Suggestions for improvements of the organic control system focus on two issues: the need for further harmonisation of the surveillance of control bodies and enforcement of the regulation and how operators’ responsibility for further development of organic systems could be supported in the control and certification system