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The automotive industry is currently characterized by a disruptive change in terms of electro-mobility and highly autonomous driving. Similarly, new mobility concepts pose particular challenges for quality assurance measures in automotive product development. Traditional, experience-based approaches for deriving quality assurance strategies do not address these challenges and lead to potentially high failure rates during product operation. Therefore, a risk-based approach for the derivation of feature-specific test strategies is proposed in this thesis, which enables an objective definition of test-end criteria and, through appropriate prioritization, an increase in the efficiency and effectiveness of performed verification and validation activities. On the basis of a two-stage risk assessment, quality assurance measures can initially be defined in early project phases and then be refined for individual product features as soon as the required information is available. A framework for the derivation of test strategies is presented, which considers the current state of the art with regard to functional safety and distinguishes the applied acceptance thresholds for test-end criteria based on previously defined risk classes. The presented approach is evaluated in context of series development projects, where the significance of the risk assessment is verified through data analysis. The test strategy applied in those projects is retrospectively evaluated and compared against the risk-based approach presented in this thesis in terms of achieved effectiveness and efficiency. Finally, two different concepts for measuring quality of automotive products are introduced and suitable product release criteria are defined.

Paralleling the revision and enforcement of regulatory guidance, the Risk-based Approach to Monitoring (RBM) is becoming increasingly important in process management at medical institutions. Although the incorporation of RBM practices is intended to streamline the monitoring of clinical trials, whether it in fact improves the effectiveness of associated duties at participating organizations remains unclear. Regarding RBM and its benefits, we surveyed 391 clinical research coordinators and data managers at Japanese medical facilities. The results of the survey suggest that RBM does in fact decrease the frequency of on-site visits from clinical research associates. Conversely, rather than reducing staff burden as intended, off-site monitoring (by telephone and e-mail) was reported to increase the workload of monitoring personnel. Our survey findings indicate that sponsors need to optimize the use of on-site, off-site, and central monitoring practices to maximize the efficiency of RBM. Regarding central monitoring duties in particular, data regarding the items of “eligibility/enrollment,” “treatment suspension/dose reduction/discontinuation,” and “initial treatment, related PK and tests, etc.” should be checked carefully for errors and omissions, and information entered through electronic data capture mechanisms should be confirmed cross-sectionally.

The article presents the author’s approach to the formation of corporate reporting of public companies using the example of the oil and gas industry. The key risks of sustainable development are disclosed that correspond to the interests of various significant groups of the company’s stakeholders. The approbation results of a typical corporate reporting model for oil and gas companies in the Petrolimex report (Vietnam) are presented.

The planning an audit engagement is the most important component that determines the effectiveness of internal audit services, both from the standpoint of improving the efficiency of the company and users of the results of the internal audit work. The use of statistical tools during the planning phase of the audit engagement can be considered as a component of a risk-based approach to internal audit. This research applies such statistical instruments as the normal distribution, the Kolmogorov–Smirnov test and regression analysis. The methodological support improvement of the internal audit process is one of the ways to perfect a guarantees quality and advice provided by the internal audit unit, as well as to minimize labor costs at the stage of planning an audit and determining the scope of the audit. There had being used such general methods of scientific knowledge as observation and comparison of data, analysis and synthesis, scientific abstraction during the research course. The proposed risk-based methodology for defining the scope and objectives of internal audit engagements using statistical tools was developed in conformity with the International Framework for the Professional Practice of Internal Auditing (Supplementary Guide “Planning an Audit Engagement: Defining Objectives and Scope”). The scope of analytical procedures formed in the process of planning the audit engagement allowed to cover the areas of the process that are most at risk of deviations. The practical significance of the study is considered by the possibility of applying the proposed methodology to define the audit assignment scope and its purpose, select the most effective analytical procedures, and minimize the labor costs of the working group. The developed methodology can be used for the work process organization in internal audit departments of business entities; some of its provisions can be applied in order to conduct a self-assessment of the effectiveness of the internal audit function. The use of statistical data analysis tools and publicly available information processing tools can improve the effectiveness of the internal audit function by the way of focusing on the most risky areas of the audited process. The developed methodological support is based on a risk-oriented approach.

The article systematizes and classifies, according to the degree of verifiability, the types of accounting estimates for personnel costs, which make it possible to ensure the rationality of the audit strategy and the effectiveness of procedures in response to the assessed risks.

The paper investigates organization of internal audit at risk-oriented enterprises. The differences between traditional and risk-oriented approaches of internal audit at enterprises are considered. The risk-oriented internal audit allows us to investigate not only financial risks that arise in internal control and accounting, and the risks of differentiated audit are to evaluate various risks groups: financial, operational, technical, informational, etc. Each group has a corresponding hierarchy. Thus, financial risks include accounting risks (second level), which in accordance with IFRS and GAAP requirements include three groups of economic risks: market risk, credit risk and risk of main activity - third level. The risk-oriented internal audit allows you to evaluate the risks at the level of the enterprise divisions. The introduction of the principles and postulates of the concept of "liability centers" in the enterprise allows, for example, in the implementation of expert risk assessment, use personal opinion of managers and specialists of various units in the formation of the chain of values of the enterprise. The risk-oriented internal audit focuses on assessing risks that are not enough or excessively controlled. At the same time, risks are taken into account by the level of significance on the Luckyert scale: minor, moderate and large. But for each subdivision, the level of materiality can be different - it is necessary to calculate the integral risk for the enterprise in general. The risk map of the financial department of the enterprise is built on the basis of the concept of stakeholders. It has been proved that the risk map allows monitoring of the risks of significant distortion of accounting (financial) and non-financial reporting in terms of responsibility centers. The prospects for further research are determined: the development of internal audit documents using the principles of risk-oriented approach - an audit plan, audit program, audit report, schedule document circulation of internal audit service, etc.

PurposeAccidental loadings such as fire constitute a great majority of potential and actual fatalities in both onshore and offshore installations. In order to prevent human loss and for a safe design of an asset, the risk of fire loading needs to be quantified, in terms of both probability/frequency and consequence aspects. In this paper the authors propose a novel risk-based approach for the assessment against accidental fire loading.Design/methodology/approachIn a conventional passive fire protection (PFP) analysis using ductility level analysis (DLA), fire loads are deterministically applied to a structure whose response is then analyzed. The initial PFP scheme is developed based on the analysis and then optimized. This approach is sometimes misinterpreted as a “risk-based” approach; however, it does not take into account the frequency aspect of the risk assessment. In a risk-based PFP analysis using DLA, fire scenarios are developed in a particular target zone. Then DLA is performed to determine the structural consequence. If personnel safety is of interest, the consequence of the structure is then linked to individual risk (IR) to determine fatalities. The amount of PFP to be applied on the structure is fully based on the risk that is produced by the fire scenarios in target zones.FindingsA new perspective on safe design of onshore/offshore structures for accidental loadings is outlined to estimate the associated risk to potential targets such as personnel as well as asset. The proposed assessment methodology will contribute toward identifying the mitigation measures and safety-critical procedures and equipment and toward a safer design.Originality/valueThis paper presents a new perspective in a safer design of onshore and offshore structures for a fire accidental loading based on risk calculation. Risk is defined as a combination of the frequency and consequence. An event frequency analysis is carried out to determine how often one should expect the event to occur. A consequence analysis is carried out to determine the severity levels of the event. In a risk-based consequence analysis, the severity levels are fully determined based on the risk associated with the event. The proposed novel risk-based assessment methodology against accidental fire loading contributes toward fully understanding the risk from an impact to personnel and to asset perspectives and leads toward safer and optimal design.

Purpose This paper aims to critically explore the factors influencing the regulation of gambling and cryptocurrencies as part of anti-money laundering (AML) initiatives in Bangladesh. As a member of the Asia/Pacific Group on money laundering, Bangladesh must adopt a risk-based approach to regulate these entities. Design/methodology/approach This study applied an exploratory design and investigated the real nature of the challenge Bangladesh facing in adopting a risk-based approach to regulate gambling and cryptocurrencies. Findings This study demonstrates that current regulatory responses towards gambling and cryptocurrencies in Bangladesh are largely influenced by passive wait-and-see policy instead of a proactive risk-based approach, a measure mandated by the Financial Action Task Force (FATF). It demonstrates that these financial entities, which are poorly regulated because of their unclear legal status in Bangladesh and the regulator’s apparent lack of understanding of the type of threats they pose, may facilitate money laundering. Effective risk-based regulation is required to control potential risks. Research limitations/implications This paper focuses on two specific areas –gambling and cryptocurrencies – which are linked to two specific FATF Recommendations: designated non-financial businesses and professions (DNFBPs) and new technologies. Further research is required to investigate the concern from the perspective of other entities. Practical implications The results of this study will help inform policymakers about ways in which current regulatory approaches may need to be modified to better combat money laundering and financing of terrorism. Originality/value According to the authors’ knowledge, this is the first study aiming to explore challenges Bangladesh confronts in implementing a risk-based approach for DNFBPs and new technologies. Therefore, it provides important insights into the dilemma regulators facing in implementing global AML standards within their traditional legislative and regulatory framework.

Oil and Gas (O&G) is one of the largest industrial sectors around the world and threatens both humans and environment. Both the companies and regulatory authorities consistently commit resources to...

In the formation of new model approaches to analyzing the economy from mega-, macro- to meso- and micro-levels, the shift in the focus of assessing the world, regional and national markets and business from the traditionally limited number of macro-indicators of the state of the economy (GDP, profit, growth rate, inflation, exchange rate etc.) to the analysis of complex indicators of the well-being of society (quality of life, income level of various population groups, quality of education, health care, investment structure, etc.) should be taken into account. One of the main objectives of the study was to find the right risk management tools. For this, cases were analysed in which various methods of managing the socio-economic sphere were used. Myths and stereotypes about the behaviour of people in this area were identified. Risk management is a complex and delicate area of scientific research; therefore, creative thinking was required in adapting the research methodology to get around the difficulties and provide a rich overview for study. The problem of introducing risk-based approach (RBA) both in the processes of analyzing the state and development trends of the economy and in the regulation (control) process in various regulatory scenarios also requires a deep study of these issues both at the methodological and applied levels. This problem has significant differences from the usual tasks of RBA in the problems of analysis and regulation of the development processes of complex socio-economic systems.

Purpose This study aims to define how countries can implement a risk-based approach (RBA) for non-profit organisations (NPOs) by measuring how well certain countries have complied with the Financial Action Task Force’s (FATF) “Recommendation 8, criterion 1” (recommendation [8.1]). Design/methodology/approach This study combines a comparative analysis methodology with a descriptive analytical approach to compare three member countries of FATF and FATF-Style Regional Bodies (FSRBs). It uses secondary data sources, namely, FATF guidelines on the subject and FATF reports on mutual evaluation reports. Findings This study examines the variations in compliance with the FATF recommendation (8.1) among three countries recently assessed by the FATF: the UK, Bahrain and the Russian Federation. Although the UK has completely fulfilled these recommendations, Bahrain and Russia have largely fulfilled them. These variations in compliance are mainly attributed to the uneven level of preparedness in the countries’ commitment to the legislative requirements before the process of mutual evaluation. Originality/value This paper offers insight into the progress of legislation and mechanisms (technical compliance) in the three countries with respect to recommendation (8.1). This paper also discusses the evolution of implementing and adopting the RBA among NPOs. This paper concludes with suggestions to other countries in developing a plan that meets the FATF recommendations by considering key factors such as comprehensive assessment of threats to NPOs, periodic reassessment and sharing of success stories.

Background Chemical process industries are among the most important industries which have been faced with many catastrophic accidents. This study aimed to analyze the root causes of the accidents in a chemical process industry.MethodsThis study has been implemented in a chemical process industry using Tripod Delta technique in 2019. The implementation steps included forming an accident analysis team, reviewing accident documents and records, compiling Tripod Delta questionnaires, and determining the general failure types (GFTs) involved in the accident.ResultsThe results showed that procedures (PR), training (TR), and maintenance management (MM) have the most discrepancies in the accident (213, 212, and 202 respectively).In addition, communication (CO), hardware (HW), and design (DE) have the least discrepancies (33, 40, and 76 respectively).ConclusionThe findings indicated that training, standard, and safe procedures as well as maintenance management are determining factors in preventing industrial accidents. Therefore, in order to reduce the accident rates in industries, close attention should be paid to these areas and its indicators with a process and risk based approach.

Risk-oriented economic control and supervisory activity (CND) consists in the fact that the objects of the economy under the supervision and control of the state are differentiated by the degree of probability of causing harm to human life and health, as well as material damage to the environment. The reform of the legislation affected the existing system of the CND, including the procedure for implementing the CND. Thus, the priority in conducting the CND is directed towards preventive measures to prevent violations and provide guarantees to economic entities in interaction with employees of executive authorities. The existing methodology for assessing the effectiveness of the activities of executive authorities, the main purpose of which is to assess the effectiveness of the activities of executive authorities in terms of the effectiveness of budget spending, trends in indicators of living standards, socio-economic development of the region, as well as the degree of implementation of methods and principles of management at the level in the region. At the moment, there is a need to develop indicators that characterize the effectiveness of a particular executive authority, including in the field of ensuring technosphere security. To select the indicators that characterize the effectiveness of the activity, first of all, it is necessary to select the goals that the activities of the executive authority are aimed at achieving.

Risk-oriented economic control and supervisory activity (CSA) consists in the fact that the objects of the economy under the supervision and control of the state are differentiated by the degree of probability of causing harm to human life and health, as well as material damage to the environment. The reform of the legislation affected the existing system of the CSA, including the procedure for implementing the CSA. Thus, the priority in conducting the CSA is directed towards measures to prevent violations and provide guarantees to economic entities in interaction with employees of executive authorities. The existing methodology for assessing the efficiency of the activities of executive authorities, to assess efficiency activities of executive authorities in terms of the efficiency of budget spending, trends in indicators of living standards, social and economic development of the region, as well as the degree of implementation of methods and principles of management at on level. At the moment, there is a need to develop indicators that characterize the efficiency of a particular executive authority, including the field of ensuring technosphere security. To select the indicators that characterize the efficiency of the activity, first of all, it is necessary to select the goals that the activities of the executive authority are aimed at.

The article examines the impact of the risk-oriented approach on the transformation processes of methodological support of control and expert-analytical measures implemented in relation to individual elements of the implemented state programs, which determines the importance of state programs as an object of state audit and control and the need to improve the effectiveness of control processes. It is proposed to use a risk-based approach when planning control measures by subjects of external state financial control in relation to individual subprograms and the main activities of implemented state programs. The paper reveals the essence of the risk-based approach and suggests the use of a roadmap for its implementation as an important element of the methodological tools. The application of a risk-based approach to the structural components of state programs is considered from the point of view of the concentration of control procedures on particularly significant and high-risk elements.

The coronavirus pandemic (COVID-19) represents an unprecedented challenge for the survival of various organisations around the world. The resilience of an organisation depends predominantly on its ability to respond in a timely manner by leveraging optimal decisions, as supported by dynamic knowledge management in assessing rapidly evolving external uncertainties while evaluating real options. Such a capability can be enhanced by a risk-based approach through collaboration among organisations under public health policy directives to implement concerted control measures in a responsive manner. An integrative framework is developed to illustrate an underlying system that embraces dynamic knowledge management to mitigate limitations in the conventional approach based on a single organisation’s perspective. The case of Hong Kong, a highly populated city in Asia, is illustrated to explore the interinstitutional dynamics of knowledge transfer to external stakeholders in protecting public health under an exposed system. Implications for postpandemic management system development for institutional sustainability are articulated. © Operational Research Society 2021.

Determining optimum flood protection levels is challenging in data-poor environments typical of developing countries. This study develops a risk-modelling approach to calculate current flood risks ...

One of the serious economic problems of modern production is losses caused by work-related injuries and occupational diseases, which amount to 4% of GDP. One of the ways to reduce significant economic losses is to change the paradigm from responding to an accident and occupational diseases to preventing negative factors of production processes. Russia is undergoing a large-scale reform of control and supervisory activities and transition to the risk-based approach is under way. According to the risk-based approach, attention of the regulatory authorities should be focused on potentially dangerous objects related to risks 1, 2. The purpose of this article is to analyze innovations in labor protection within the ʺregulatory guillotineʺ in assessing working conditions and managing occupational risks using the example of economic facilities in Irkutsk region and determining economic costs depending on the working conditions. The methods of statistical research, assessment of professional risks and economic costs were used. It was found that every second employee has performed his labor duties under harmful and (or) dangerous working conditions. The most difficult working conditions are typical of extraction, processing and agricultural enterprises, the intensity of labor is maximum during storage and transportation. When predicting professional risks for the main factors of the production process by economic activities, it was found that the maximum risk is observed in the construction, transportation and mining industries. The main reasons for high risks were identified. In Irkutsk region, the actual expenses for compensation and personal protective equipment amounted to 11,235 rubles per one person. Mining enterprises have the highest expenses (95,156.5 thousand rubles); the amount of expenses in the construction industry is 47440.6 thousand rubles; in transportation and storage organizations, it is 359,602.5 thousand rubles. The minimum costs are in companies engaged in agriculture, forestry, hunting, fishing and fish farming. Economic costs are significant and require measures to improve working conditions and ensure the effective modernization of the OSH management system. Currently, transition to the risk-based approach and creation of a system for managing industrial risks are the main tasks of managers at different levels.

Background Risk-based monitoring (RBM) is a slow uptake in some trial sponsors. There are three main reasons for this. First, there is the fear of making large investments into advanced RBM technology solutions. Second, it is considered that RBM is most suitable for large, complex trials. Third, there is the fear of errors in both critical and non-critical data, appearing as reduced on-site monitoring is being conducted. Methods Our RBM team identified, evaluated, and mitigated trial risks, as well as devised a monitoring strategy. The clinical research associate (CRA) assessed the site risks, and the RBM team conducted central monitoring. We compared all data errors and on-site monitoring time between the partial switching sites [sites that had switched to partial source data verification (SDV) and source data review (SDR)] and the 100% SDV and SDR sites (sites that had implemented 100% SDV and SDR). Results Partial switching sites did not require any critical data correction and had a smaller number of data corrections through on-site monitoring than the 100% SDV and SDR sites. The RBM strategy reduced the on-site monitoring time by 30%. Conclusions The results suggest that RBM can be successfully implemented through the use of site risk assessment and central monitoring with practically no additional investment in technology and still produced similar results in terms of subject safety and data quality, as well as the cost savings that have been reported in global complex studies.

The paper suggests a new approach to performance evaluation of universities in Russia and worldwide based on aggregation of the results of ten global rankings and the Database of External Quality Assurance Results (DEQAR). The method of league analysis (MetALeague) allows the authors to integrate the diverse results of ranking and evaluation regardless of considerable variations in ranking methodology and indicators. As a result of MetALeague integration, the Global Aggregated Ranking of higher education institutions has been made. The paper analyses the global rankings and the position of Russian HEIs in these rankings. The authors have also analyzed the positions of countries based on the number of HEIs included in the Global Aggregated Ranking. The due consideration of research results, according to the authors, can propel the leading Russian universities to higher positions in the global educational environment.

The subject of the research is key criminal risks in robotics. The purpose of the article is to confirm or disprove the hypothesis that key criminal risks of using robots may be identified and classified. The author dares to describe the key aspects of the application of risk-based approach in the assessment of robotic activities, identify the key risks of using robots, give a criminological classification. The methodology includes a formal logical method, systematic approach, formal legal interpretation of legal acts and academic literature, SWOT analysis. The main results of the study. The author applies the main provisions of criminal riskology when assessing encroachments involving robots. Key risks and challenges when using robots are identified. The severity of the consequences of harm caused by using robots (from minor to critical risk) is assessed and a matrix of the probability of its occurrence is provided. The author's criminological classification of robots is based on the risk-based approach and is substantiated on two grounds. The first one is the category of public danger and the second is the potential severity of the consequences of harm caused by robots. The causal complex that can lead to criminal risks in robotics is identified. The grounds of such risks are divided into those related to the mechanical subsystem of robots, digital subsystem of robots and power supply subsystem of robots. Conclusions. The risk-based approach is the most progressive and effective basis for regulating the criminal relations in robotics. The author demonstrates the existence of real risks to the peace and security of mankind, life and health of people, objects of wildlife, nonliving material objects from the use of robots. It is necessary to recognize robotics as source of increased potential criminal danger and to adopt appropriate regulation as soon as possible. The necessity and expediency of applying a risk-based approach to robotics is theoretically substantiated, and the characteristics of robots that are important in assessing the criminal potential of their exploitation are evaluated. The conclusions and recom mendations of this paper may become a basis for the implementation of the risk-based approach in legal regulation of robotics. The risk matrix presented in the article can be used to establish a framework for regulatory impact on robotics, assess the consequences of potential harm and minimize it.

Background Cancer patients configure a risk group for complications or death by COVID‐19. For many of them, postponing or replacing their surgical treatments is not recommended. During this pandemic, surgeons must discuss the risks and benefits of treatment, and patients should sign a specific comprehensive Informed consent (IC). Objectives To report an IC and an algorithm developed for oncologic surgery during the COVID‐19 outbreak. Methods We developed an IC and a process flowchart containing a preoperative symptoms questionnaire and a PCR SARS‐CoV‐2 test and described all perioperative steps of this program. Results Patients with negative questionnaires and tests go to surgery, those with positive ones must wait 21 days and undergo a second test before surgery is scheduled. The IC focused both on risks and benefits inherent each surgery and on the risks of perioperative SARS‐CoV‐2 infections or related complications. Also, the IC discusses the possibility of sudden replacement of medical staff member(s) due to the pandemic; the possibility of unexpected complications demanding emergency procedures that cannot be specifically discussed in advance is addressed. Conclusions During the pandemic, specific tools must be developed to ensure safe experiences for surgical patients and prevent them from having misunderstandings concerning their care.

Indicators of industrial injuries in the Russian coal industry remain unacceptably high. Solutions to this problem should be sought in the way of accident prevention, which can be achieved through operational risk management of injuries, implemented by analyzing the state of labor protection for this factor, followed by determining the causes that lead to injuries. On the example of SUEK-Kuzbass JSC, the risks of light, severe, fatal and general injuries were calculated. Based on the individual regression coefficients of the obtained correlations of injury risks, the mines were ranked according to the level of industrial injuries. For a more detailed assessment of the state of labor protection, a matrix of the causes of accidents and their severity is proposed, which displays a qualitative description of the situation at the enterprise.

The article discusses approaches to organizing a risk-based approach in the implementation of internal financial control in public sector organizations. The findings obtained in the course of the study can be used in the activities of the units exercising internal financial control in public sector organizations.