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The risk-based approach in the control and supervisory activities in the field of land use remains relevant despite significant experience in this area. Since the issues related to the interaction of the branches of supervisory and control bodies from the federal to the municipal level have not yet been resolved. There are no uniform criteria for assigning objects to a particular risk group, considering regional conditions. To analyze the performance of the Rosselkhoznadzor (the Federal Service for Veterinary and Phytosanitary Surveillance) in the field of agricultural land assessment for the Republic of Karachay-Cherkessia, geoinformation technologies were used, which made it possible to give an objective assessment of the effectiveness of the risk-based approach system. Four hundred seventy eight land plots were identified, most of them belongs to land plots that are not classified as medium or moderate risk (68.6 %), about 28 % of all plots are considered as moderate risk, and 3.1 % of land plots are classified as medium risk. Using publicly available sources of information, a land plots database was created with the definition of the risk category. A geoinformation model of the density of land plots (heat map) is constructed using the QGIS software. The thematic maps created made it possible to identify the features of land plots with medium and moderate risk categories. The main feature of the risk-based approach is the absence of land plots subject to routine inspection in the forest zone, foothill subalpine and high-altitude subalpine and alpine meadows, Karachay-Cherkessia Republic, where there are two natural biosphere reserves and many protected natural areas of regional significance. A small number of inspected land plots were also identified within the boundries of specially protected ecological and resort region of the Russian Federation, Caucasian Mineral Waters, which is geographically located in the Karachay-Cherkessia Republic.

To develop a guide of best practices for establishing appropriate controls on nonsterile manufacturing environments for pharmaceutical manufacturers, the Kansai Study Group of the Parenteral Drug Association Japan Chapter explored relevant issues in-depth and published the results of their study, "The Study in Risk-Based Manufacturing Environmental Control for Non-Sterile Drug Products" in the PDA Journal of GMP and Validation in Japan. This review summarizes the background of that study and the structure of the published article and, to help readers make the most of the contents, provides a table displaying the category, subject, problem statement, and points to consider of each topic discussed in the article, as well as examples of central topics (Appendices 1-3).

Testing multiple subjects within a group, with a single test applied to the group (i.e., group testing), is an important tool for classifying populations as positive or negative for a specific binary characteristic in an efficient manner. We study the design of easily implementable, static group testing schemes that take into account operational constraints, heterogeneous populations, and uncertainty in subject risk, while considering classification accuracy- and robustness-based objectives. We derive key structural properties of optimal risk-based designs and show that the problem can be formulated as network flow problems. Our reformulation involves computationally expensive high-dimensional integrals. We develop an analytical expression that eliminates the need to compute high-dimensional integrals, drastically improving the tractability of constructing the underlying network. We demonstrate the impact through a case study on chlamydia screening, which leads to the following insights: (1) Risk-based designs are shown to be less expensive, more accurate, and more robust than current practices. (2) The performance of static risk-based schemes comprised of only two group sizes is comparable to those comprised of many group sizes. (3) Static risk-based schemes are an effective alternative to more complicated dynamic schemes. (4) An expectation-based formulation captures almost all benefits of a static risk-based scheme.

The paper analyzes the legal status of the consumer when concluding and executing a smart contract. The author proves the existence of special risks for citizens associated with the conclusion and execution of a smart contract. In particular, the author considers the risk of a consumer’s misunderstanding of the terms of a smart contract, the risk of a difference between the terms of a smart contract and the terms of a contract set forth in the natural language, the risk of including in a smart contract conditions that infringe on consumer rights (unfair contractual terms), as well as special manifestations of regulatory and operational risks in relation to a smart contract. Currently, in the Russian Federation, as in most foreign jurisdictions, there are no special legal mechanisms aimed at protecting consumer rights from these risks. The “general” mechanisms of consumer protection existing in the Russian jurisdiction are insufficient. Considering this, the author proposes mechanisms for each risk aimed at minimizing its implementation and negative impact on the citizen. The following risk-oriented approach to regulating relations when concluding a smart contract with the participation of a consumer is proposed. A citizen can conclude transactions using a smart contract subject to legislative limitation of his potential losses under a transaction (limiting the transaction price) and the introduction of the proposed legal regulation aimed at minimizing the risks discussed in the paper.

It is shown that in order to justify the extension of the service life of the machine beyond the resource set by the developers, it is necessary to focus on the allowable risks of accidents that can lead to accidents. After all, today for mobile agricultural machinery, the operation of which is associated with high-risk work, the concept of acceptable (acceptable) risk is not used, which does not allow to assess the danger of being on fields, farms and roads without machinery, with exhaustion of installed resources. The purpose of researches is to justify the permissible risk of exploitation of mobile agricultural machinery, in array of details and elements of constructions which have accumulated defects (damage). This paper analyzes the kinetics of accumulation of operational defects in the array of parts of individual components (systems) of tractors. MTZ-80 tractors (82) were chosen as the object of research, as one of the most common in Ukraine. To detect cracks, a developed eddy current flaw detector was used, the sensitivity of which allowed to find cracks several millimeters or larger in length without preparing the surface of the controlled parts. It is shown that the kinetic dependences of the accumulation of operational defects in the parts of tractor units in the analyzed range of service life are monotonically increasing, which can be described by exponential functions with a sufficiently high reliability. It is noted that the obtained dependences are similar to the kinetic dependences of the accumulation of static and dynamic (fatigue) damage obtained as a result of laboratory tests of samples of construction materials, which allows to use approaches to the criteria of the limit state of laboratory samples due to the power load to establish the boundary life of mobile agricultural machinery. However, the kinetics of the intensity of the occurrence of operational cracks in the array of tractor parts is not monotonous and has a maximum in the range of about 11-13 years of operation. This service life can be used as a criterion to stop the operation of the tractor, to carry out defectoscopy of parts and to replace defective parts. With such a long service life of the tractor, there is the greatest probability of sudden destruction of the tractor components and the creation of emergencies.

Approximately 5% to 10% of women diagnosed with breast cancer will have a pathogenic variant (PV) in a hereditary cancer susceptibility gene, and this has significant implications for the management of these patients and their relatives. Despite the benefits of genetic testing, many eligible patients with breast cancer never undergo testing because of various barriers, including complicated testing criteria such as those from the National Comprehensive Cancer Network (NCCN). In 2019, the American Society of Breast Surgeons (ASBrS) proposed germline genetic testing for all patients with breast cancer to increase the identification of PV carriers. In 2020, a Mayo Clinic study highlighted the limitations of these 2 genetic testing guidelines (NCCN and ASBrS) and proposed a hybrid approach of testing all women diagnosed with breast cancer by the age of 65 years and using NCCN criteria for older patients. This commentary presents an updated analysis of the Mayo Clinic data and discusses the rationale for using the age of 60 years rather than 65 years as the cutoff for this hybrid approach. Using an age at diagnosis of ≤60 or ≤65 years for the universal testing of patients with breast cancer detected more PVs (11.9% [16 of 134] and 15.7% [21 of 134], respectively) in comparison with using the NCCN criteria. Lowering the age for universal testing from 65 to 60 years maintained the sensitivity of detecting a PV at >90% while sparing testing for an additional 10% of women. Compared with the testing of all patients, the hybrid approach would allow 31% of all women with breast cancer to forgo testing and result in fewer variants of uncertain significance identified and, therefore, would decrease the chance of harm from misinterpretation of these variants.

Various approaches to first-in-human (FIH) starting dose selection for new molecular entities (NMEs) are designed to minimize risk to trial subjects. One approach uses the minimum anticipated biological effect level (MABEL), which is a conservative method intended to maximize subject safety and designed primarily for NMEs having high perceived safety risks. However, there is concern that the MABEL approach is being inappropriately used for lower risk molecules with negative impacts on drug development and time to patient access. In addition, ambiguity exists in how MABEL is defined and the methods used to determine it. The International Consortium for Innovation and Quality in Pharmaceutical Development convened a working group to understand current use of MABEL and its impact on FIH starting dose selection, and to make recommendations for FIH dose selection going forward. An industry-wide survey suggested the achieved or estimated maximum tolerated dose, efficacious dose, or recommended phase II dose was > 100-fold higher than the MABEL-based starting dose for approximately one third of NMEs, including trials in patients. A decision tree and key risk factor table were developed to provide a consistent, data driven-based, and risk-based approach for selecting FIH starting doses.

Control of elemental impurities in the drug products evolved from the generic visual testing of heavy metals as their sulfides to specific elements of toxicological concern in the final drug products by instrumental analysis. The International Council for Harmonisation (ICH) Q3D (R1) guideline for elemental impurities describes a risk-based approach to identify, assess, and control the potential elemental impurities in drug products within the established permitted daily exposures (PDE). Challenges to this approach include how to assess the risks associated with contributing sources such as utilities, manufacturing equipment, container-closure systems, and excipients. Defining at what stage of development that such assessment should be performed to identify the risk levels can be equally challenging. In this article, we report an approach to control elemental impurities of toxicological concern, compliant to the Q3D (R1) guideline, and a summary of results obtained on multiple protein therapeutic products. This approach follows the elements of Process Validation, i.e., Design, Qualification, and Continuous Verification. The design includes the selection of excipients and their suppliers that meet the Option 1 requirement of Q3D (R1). It also comprises the selection of manufacturing equipment, container-closure systems, and utilities. The qualification includes the testing of the potential sources of elemental impurities, i.e., excipients, utilities, and leachables/extractables from the manufacturing equipment and container-closure systems. The Continuous Verification comes from the testing of representative batches at the initiation of stability studies of clinical or commercial drug product batches and at the end of shelf-life expiry of the drug product, and when changes are made to the manufacturing equipment, sources of excipients and container closure systems, and any formulation changes. Our experience shows that the risk associated with the impurity levels of the ten elements of toxicological concern in the therapeutic protein drug products, parenterally administered, is well below the control threshold (30% PDE) in the drug product recommended by the ICH Guideline. Although our focus is on the injectable therapeutic proteins, this approach can be applied to the products administered via other routes as well.

Using the methodology of assessing the risk from carcinogenic and noncarcinogenic substances to public health, algorithms to estimate the standards for the quality of atmospheric air and potable water are considered. The acceptable levels of risks for various countries and impact groups are analyzed. It is shown that the levels of maximum permissible concentrations of these substances, calculated depending on the acceptable risks, are significantly lower than the current sanitary standards.

The modern era of globalization creates specific socio-ecological conditions for the existence of the world human community, which, in turn, determine the singularity of the epidemiological behaviour of many infectious diseases. The year 2020 has challenged the humanity with a pandemic that is rapidly spreading around the world. Global relationships are fraught with global epidemiological problems. Such manifestations of globalization as intensified international migration of population, roaring international trade in agricultural products, domestic and wild animals and birds, food, raw materials and goods, development of high-speed transport, turn the world into a single global socio-ecological epidemiological system, in which all processes are interconnected and mutually dependent. The purpose of this research is to study and analyse the system of institutional regulation of the health system in the context of a pandemic. The study used such methods as the analysis method, analogies, comparisons, observations, as well as statistical methods to analyse various indicators necessary for research. Using the above methods, a large amount of literature, legislation, regulatory and institutional regulations on this issue was analysed, some existing indicators were summarized, and a conclusion was made about the process of institutional regulation in an unfavourable epidemiological situation. As a result of the study based on a large number of official documents, it was concluded that measures were taken in the Russian Federation to counteract the active spread of a new coronavirus infection. Implementation of the state policy on preventing the spread of the pandemic resulted in no high mortality rate from new coronavirus infection compared to other world states. It should be noted that due to the federal structure of the country, the heads of regions independently decide on the regulation of mechanisms to counter the spread of infection on the territory of the subject. In this regard, it is not possible to promptly update information on the effectiveness of the measures taken. Currently, the risk-based approach described in the article is a mechanism for studying the epidemiological situation, which allows determining the risk factors that affect it and, on this basis, to rank epidemiological problems by their degree of importance. Due to the fact that the pandemic as a new virus was an unexpected risk, the clinical picture remains blurred, but the institutional form of state regulation is fused to protect the rights of citizens to health care under conditions of the pandemic.

Due to the limited availability of end-of-life failure data of power transformers by electric utilities, planning the replacement of power transformers is a challenging task for utility engineers. Transformers can be replaced based on their health indices, but they do not allow utility engineers to quantify risks posed by transformer failures. In that context, the study proposes a novel risk-based approach to plan the replacement of aged power transformers considering their temperature, apparent age, and expected capacity. The approach comprises a methodology that incorporates power transformers' winding hottest-spot temperature and apparent age into the conventional end-of-life failure model, a methodology that calculates the expected capacity of power transformers, a novel transformer ranking index, and a methodology that calculates the optimum year of replacement. Subtransmission and distribution substations were included in the IEEE Reliability Test System to evaluate the performance of the approach. The results show that incorporating the winding hottest-spot temperature and the apparent age into the end-of-life failure model can make a significant improvement on transformer replacement decisions in the event of limited availability of failure data. Results further suggest that end-of-life failures of fans and oil pumps can have an impact on the prioritisation of transformer replacement.

The relevance of the study is associated with the problem of introducing a risk-based approach in the quality management systems (QMS) of organizations from various sectors according to the requirements of ISO 9001:2015. It hereby offers a new feature of risk classification based on their application in management systems concerning various aspects of organizations activity, in particular, risk in QMS (quality risk). The authors’ definition of the term “quality risk” is presented, and the concept of the “risk-based approach in QMS” is clarified. Methodical approaches to the choice of the complexity of the risk-based approach depending on the QMS maturity in an organization and the factors of its environment are developed and tested in 46 organizations from various industries.

Purpose To critically examine two significant developments for the regulation and supervision of virtual assets and virtual assets services providers: the amendment of the Financial Action Task Force (FATF) Recommendation No 15 in October 2018 and the adoption of an Interpretative Note in June 2019. We argue that new FATF standards constitute an appropriate response to money laundering and terrorist financing risks associated with virtual assets, but that they must be followed by firm, consistent and effective implementation at the national level. Design/methodology/approach This paper draws on reports, legislation, legal scholarship and other open source data in order to examine the new FATF standards on virtual assets. Findings The amendment of the FATF Recommendation No 15 in October 2018 and the adoption of an Interpretative Note in June 2019 have been necessary and opportune to forge a global approach to mitigate money laundering risks associated with crypto-assets. The new FATF standards on crypto-asset activities need to be implemented firmly, effectively and consistency to reduce the risk of jurisdiction-shopping by money launderers and terrorism financiers. Originality/value This is one of the first studies examining two important and recent FATF initiatives, the amendment of the FATF Recommendation No 15 in October 2018 and the adoption of an Interpretative Note in June 2019.

The paper presents a systemic analysis of the key factors of risk management for the internal managerial control (IMC) system for public entities in Romania. The risk management approach offers a broad view regarding the necessary tasks for having a rigorous, efficient, effective and transparent use of public funds. The necessity of taking a managerial decision on a current matter has its own peculiarities and effects, involving the actual way and manner in which the entity in question will go further. The effects of this kind of decisions can affect the entity in some precise moments. In this point, risk management should be present, according to the applicable approaches, in order to evaluate, among other things, the vulnerability of the system which is exposed to the effects of a decision that has been taken into account. Developing an internal control system is perceived as a process that involves improving performance and governance, rather than introducing a new, additional system. The paper is presenting some considerations regarding the effectiveness of risk management approach used in Romanian public entities, based on the latest reports published. There are also pointed out some principal causes for this implementation level of Risk management Standard, along with some selective proposals for improving the results of this risk based approach

Produced water is a waste of significant concern due to its high volume being produced every day and complex chemical composition. In order to meet environmental regulations and standards, different techniques can be used to treat produced water. This paper first summarizes produced water composition, its related environmental impact, regulations, and standards, as well as a possible combination of different treatment techniques. This paper aims to develop a generic framework for a risk-based approach to produced water management. The proposed methodology considers the integration of environmental, technical, and economic risks in the decision-making process for produced water management. Environmental risk assessment is conducted by DREAM, Failure Mode and Effects Analysis is used to estimate technical risk, and cost-benefit analysis is performed to calculate economic risk. To integrate all the risk values, acceptable risk levels are set and compared to the calculated risk values. Experts assign weighting factors by using pair-wise comparison. The sum of the multiplied weighting factors to the ratio of calculated-acceptable risk values gives the final integrated risk. This framework can help to examine and select the most suitable treatment or reuse technique or identify potential areas for improvement in a specific site. The estimated risk can be used to justify the selection process. A case study on the produced water treatment in Thunder Horse Oil Field is presented to demonstrate the application of the proposed framework.

The article investigates the essence of the risk-based approach to generating the value of enterprises with transport and logistics specialization. The objective of the study is to determine the content of all components of risk management using the example of this industry. Methodological feature of the components’ study on the risk-based approach is a disclosure of the modern paradigm «Industry 4.0», namely, a comprehensive study of operational, investment and financial activities factors. The key criterion of economic efficiency in the article substantiates the use of the enterprise value indicator. In addition, it is proposed to use the methodology for calculating the impact of Value-at-Risk on the generation of enterprise value. The result of the study of the risk-based approach’s components to the formation of enterprises value indicators in the transport and logistics industry is to obtain a clear algorithm for determining each of the key risk factors inherent in the industry. Particular attention is paid to the description of the manifestation of the IT-system of electronic risks, in particular, hacker attacks and other cybercrimes. The practical uniqueness of the obtained research results lies in the fact that, using the example of BKP (Ukraine), a reasoned risk management policy is developed in full compliance with the ISO 31000 standard. Risks were identified based on the probability of risks and calculation of minimizing the impact of their consequences on the cost indicators of the enterprise. Based on the results of the study, it is established the practical usefulness of the above-described management model for generating of an enterprise value, directly based on the study of the main risk factors for activities of transport and logistics companies in Ukraine, it is substantiated the possibility of its implementation in the practical aspects of the business processes implementation.

The effectiveness of a quality management program of medical care has to meet not just the quality management standards, but also has to be flexible, taking into account the features of a medical organization and the existing problems in the medical care support. The effectiveness of a quality management program is based on feedback, so the quality control of medical care is so important. The study of problems in medical care gives us the ability to improve both, the quality management program of medical care and the quality and scope of medical services constantly.

PurposeQuantitative metrics should be used as a risk management option whenever possible. This work proposes a framework for the risk quantification and the resulting risk-based design of control charts to monitor quality control points.Design/methodology/approachTwo quality control models were considered for the risk quantification analysis. Estimated operating characteristic curves, expressing the defect rate (on a ppm basis) as a function of the sample size, process disturbance magnitude and process capacity, were devised to evaluate the maximum rate of defective product of the processes. The proposed framework applicability on monitoring critical control points in Hazard Analysis and Critical Control Point (HACCP) systems was further evaluated by Monte Carlo simulations.FindingsResults demonstrate that the proposed monitoring systems can be tuned to achieve an admissible failure risk, conveniently expressed as the number of non-conforming items produced per million products, and these risks can be properly communicated. This risk-based approach can be used to validate critical control point monitoring procedures in HACCP plans. The expected rates of non-conforming items sent out to clients estimated through stochastic simulation procedures agree well with theoretical predictions.Practical implicationsThe procedures outlined in this study may be used to establish the statistical validity of monitoring systems that uses control charts. The intrinsic risks of these control systems can be assessed and communicated properly in order to demonstrate the effectiveness of quality control procedures to auditing third parties.Originality/valueThis study provides advancements toward practical directives for the implementation of statistical process control in the food industry. The proposed framework allows the assessment and communication of intrinsic failure risks of quality monitoring systems. It may contribute to the establishment of risk-based thinking in the constitution of quality management systems.

Improving the quality of drugs is the main task of the pharmaceutical industry as a whole. Getting safe and eff ective medications is directly related to minimizing the risks of conducting clinical trials. Maintaining the quality of clinical research based on risk management is a continuous, constant and dynamic process ensuring the success of the study, which in turn leads to the integrity of the data collected, the safety of subjects and compliance with legal requirements, as well as to the financial cost savings of pharmaceutical companies. The cost of research is growing inexorably, and the quality of their research is rapidly declining, so it is important to use a risk-based approach when developing the upcoming clinical trial project.

Currently, the mining industry should be transferred to a risk-based approach in providing state supervision of industrial safety. “Regulatory guillotine” provides for the abolition of all current regulatory and methodological documents in the industry. However, vital risks should be identified and methods of their assessment and safety management based on these assessments should be proposed. The regulatory framework should become more logical and concise. However, the specifics of the mining industry requires not only a reduction in the volume of documents, but also a serious study in terms of ensuring systematic safety requirements, harmonization of industry and industry standards. In the context of a risk-based approach, all control activities go to the level of production units, while the role of personnel qualification is growing, since organizational risks are prevailing in the mining industry. Therefore, training should be one of the important tasks of the reform of the supervision of industrial safety. It will not work out only through the system of additional professional education, because In this system, personnel are mainly trained at the top managerial level, and the lower and middle levels of mining management are carried out by university graduates. This, in turn, requires an increase in the level of professional training of mountain university graduates, which is difficult to implement in the current system of basic engineering education. The current law” on education “ implements a system of constant quality reduction, which requires its adjustment.

The volume of coal mining by underground method in the Russian Federation is about 100 million tons annually and has no tendency to decrease. At the same time, with the development of underground mining, there is a constant complication of mining and geological conditions and an increasing negative impact on the environment. Over the past three years, there have been significant changes in the area of state environmental oversight. Some of them are the introduction of a risk-based approach and the best available technologies into the Russian regulatory system. Now it is legislatively established that development, introduction and application of the best available technologies in a life cycle of the coal-mining enterprise can serve as the basis for lowering of a risk category of coal-mining object. In turn, this should encourage the subsoil user to promote and implement environmental policy at their enterprise. In article features of introduction of risk-oriented approach and the best available technologies and an estimation of prospects of introduction of such methods at the underground coal-mining enterprise are considered. As a result of the analysis the hierarchy of relations of modern legislation in the sphere of ecological supervision, coal-mining enterprise, its possibilities on development of the best available technologies and branches of decisions according to the riskoriented approach is presented.

Pre‐participation cardiovascular screening (PPCS) is recommended by several scientific and sporting organizations on the premise that early detection of cardiac disease provides a platform for individualized risk assessment and management; which has been proven to lower mortality rates for certain conditions associated with sudden cardiac arrest (SCA) and sudden cardiac death (SCD). What constitutes the most effective strategy for PPCS of young athletes remains a topic of considerable debate. The addition of the electrocardiogram (ECG) to the medical history and physical examination undoubtedly enhances early detection of disease, which meets the primary objective of PPCS. The benefit of enhanced sensitivity must be carefully balanced against the risk of potential harm through increased false‐positive findings, costly downstream investigations, and unnecessary restriction/disqualification from competitive sports. To mitigate this risk, it is essential that ECG‐based PPCS programs are implemented by institutions with a strong infrastructure and by physicians appropriately trained in modern ECG standards with adequate cardiology resources to guide downstream investigations. While PPCS is compulsory for most competitive athletes, the current debate surrounding ECG‐based programs exists in a binary form; whereby ECG screening is mandated for all competitive athletes or none at all. This polarized approach fails to consider individualized patient risk and the available sports cardiology resources. The limitations of a uniform approach are highlighted by evolving data, which suggest that athletes display a differential risk profile for SCA/SCD, which is influenced by age, sex, ethnicity, sporting discipline, and standard of play. Evaluation of the etiology of SCA/SCD within high‐risk populations reveals a disproportionately higher prevalence of ECG‐detectable conditions. Selective ECG screening using a risk‐based approach may, therefore, offer a more cost‐effective and feasible approach to PPCS in the setting of limited sports cardiology resources, although this approach is not without important ethical considerations.

The article is devoted to the study of theoretical and methodological aspects of a risk-based approach to ensure an effective enterprise management system. The basic elements of a risk-based approach are disclosed, its essence, goals and objectives are determined. The concept of balance as the basis of a risk-based approach is designated and the content of its main components is disclosed in detail.

The main objective of the paper is to develop a model capable of evaluating the societal impact of rail infrastructure investment in Argentina, using a Multiple Discrete Extreme Value Model (MDCEV) estimated on Stated and Revealed preference data. The decision modelled is the mode and port choice at a planning level, where multiple alternatives can be chosen simultaneously. The relevant variables were the Free Alongside Ship (FAS) price, freight transport cost, travel time and lead time, including non-observed heterogeneity in the modelling. As a consequence, the willingness to pay measures that are used for the cost benefit analysis become non-deterministic. To include this effect simulated WTP measurements were included and compared to a deterministic and risk based approach. Two projects were tested and both showed that the deterministic approach gives higher Benefit/Cost ratio. This paper raises the concern that if non-observed heterogeneity is not considered in project evaluation it may provide misleading results and potentially lead to wrong investment priorities for the public sector.

Introduced and emerging plant diseases as a result of live plant movements are increasingly recognised as a global environmental and economic threat. This presents a fundamental challenge to botanic gardens and other ex situ plant conservation organisations: how to continue this important work while recognising and mitigating the plant health risks. The approach taken by the Royal Botanic Garden Edinburgh is presented as a case study, showing how we have reduced ecological and evolutionary opportunities for pests in ex situ conservation and are monitoring the success of these efforts. We have developed protocols in quarantine and horticultural practice, expanded visitor engagement and public education, and taken a precautionary approach towards plant distribution supported by in-house diagnostics and working closely with statutory authorities. We hope that by sharing activities as well as difficulties, botanic gardens can acknowledge and address the new biosecurity landscape.

The present paper investigates the ongoing validity of the notion of subordination as selection criteria to allocate the labour protections in the contemporary economic framework. The gig economy is deeply affecting the way of working, transforming the employee in a service provider. This phenomenon is partially due to the progressive shift from a firm-based production model towards a market transaction based one. Although its lawfulness is still unclear, it highlights that the way of working is changing in a way that struggles to fit into the classic legal categories. This is mainly due to the fact that the labour protections are usually bestowed moving from a notion of subordination highly focused on the organisational element. Thus, economic actors suffering from the same economic weakness of the employees, but organisationally independent, struggle to obtain the necessary protections. Moving from those remarks the author suggests rethinking the allocation criteria of the labour protections, adopting economic weakness as the main criterion. This category should encompass all the individuals performing a working activity that are not able to significantly influence its financial outcome. The aim of such reform should be to extend the labour protections to all the subjects needing them. The final part of the paper investigates the possible solutions under the current legal framework. The major finding is that under certain circumstances the gig workers can be qualified as temporary employees not of the platform, but of the contractor. In this scenario, the digital platforms should be deemed as job-placement service providers and, thus, they should comply with the relevant provisions. These include the eventual need of administrative authorisations and the free-of-charge principle, whose violations represent, in several jurisdictions, a criminal offence

Corrosion is a significant concern causing tremendous losses to all pipeline operators. To combat this operational issue, new methods and tools are needed to analyze and model degradation, to predict failure, and finally to develop strategies for prevention, control, and mitigation of corrosion in pipelines. A practical inspection and maintenance program is crucial to prevent pipeline failures due to corrosion. Risk-based inspection (RBI) is an increasingly popular and trusted method to assess and develop inspection plans. However, the determination of optimal inspection intervals is still challenging in RBI. The present study aims to develop a dynamic Bayesian network (DBN)-based approach for optimization of inspection intervals. Based on inline inspection data and analytical corrosion propagation models, DBN is applied for the estimation of both the internal and external corrosion damage as well as the probability of failure (PoF). The cost of failure (CoF) is estimated based on typical cost categories relevant to pipeline accidents. Risk is calculated as the product of PoF and CoF. A utility function to combine both the risk and the annual cost of the inspection program is also developed. The optimal interval can be found based on the curve of the utility function. The proposed approach is demonstrated through a real-world case study on an operating pipeline.

The multidimensional problems that archaeological sites and cultural heritage assets face demand effective multiple criteria decision-making, regarding risk impact identification and evaluation. Th...

The risk-based approach to the prevention of healthcare-associated infections (HAIs) is entirely based on the results of a well-organized epidemiological diagnosis, which is aimed primarily at identifying risk factors. The structure of the risk-based approach includes risk identification, risk identification and risk analysis. One of the important points of epidemiological diagnosis is epidemiological observation. For the organization of epidemiological surveillance, both passive and active methods are used. The active method is the most effective, since it is an active search and identification of cases of HAIs using the standard definition of cases and the results of laboratory examination of patients from risk groups. To organize such work, a commission is formed in each medical organization, which should include an epidemiologist, clinical pharmacologist, expert doctor, laboratory assistant, head nurse, and a pharmacy employee. The functions of each participant depend on the organization of the general system for identifying HAIs in this organization. The proposed model of a risk-based approach to the epidemiological diagnosis of HAIs allows timely identification of groups and risk factors both in the context of individual departments and the medical organization as a whole, and, accordingly, to develop effective measures for the prevention of infections associated with the provision of medical care.

Introduction. The authors pay attention to the fact that there exist such technical objects, the reliability evaluation of which — if performed with the use of measures of the “classical” reliability theory (in particular, reliability function and/ or mean operating time to failure) — is ambiguous and poorly interpreted physically. A city sewer network can serve as an example of such an object. The authors consider a situation when the result of the formal sewer network reliability analysis comes into conflict with the physical interpretation of object operation. This generates a need for searching for a more informative reliability indicator peculiar to a city sewer network. Methods. The research is based on the sewer network decomposition-equivalenting method (DEM) developed previously. This method, in turn, is based on the probability theory, reliability theory and mathematical statistics. A database containing the information about all network elements’ failures and restorations over a preceding period, is used as reference material. Results. Operational risk is taken as the reliability measure of a city sewer network. It is defined as the relative volume of sewage, not delivered to treatment facilities of the network due to failures of its elements, in a certain time. A procedure for the quantitative calculation of this measure is developed. Its comprehensiveness and informative richness are demonstrated. The article shapes possible ways of using the “operational risk” indicator when developing a city sewer network renovation strategy. Conclusion. Operational risk as the reliability measure can be used in practice to improve the performance of a city sewer network.

The author creates a model (pyramid) of the causality which occurs under the tax legal regulatory mechanism. There is an analysis of the details of implementation of a risk-based approach by the Russian tax authorities with use of innovative hardware and software system. Having based on the research data the author suggests the way to improve an administrative legal regulatory mechanism which will increase the effectiveness of tax administration and reduce the risk of harm to the public interests. And it is important to comply with a principle of the personification of the responsibility of the individuals. These individuals are real or nominal officials of a company or an individual entrepreneur, and their actions lead to the fact that a taxpayer (the company or individual entrepreneur) had got the unreasonable tax benefit. Invocation of the administrative responsibility to the individuals, as we can suppose, will make it possible to improve the legal regulatory mechanism working within the group of relations which are studied in the research. In addition to this, the study reveals the appropriateness of the change the size of sanctions applying to the officials found responsible for such violations. A sanction should be ranked according to the form of guilty. It appears that a tax legal regulatory mechanism with a risk-based approach should take place given the characteristics it takes on in any independent methodological plane (juridical, psychological, sociological, historical, and political one). As a result, psychological, sociological, and historical factors start working in the process of the juridical construction impact on the object of the legal regulation. And in the long term these factors would enable the mechanism to prevent the illegal beneficial interest of the real beneficiaries to become bot not merely to remove the negative legal, and economic consequences of their misconduct.

Paper is focused on theoretical and practical considerations related to risk management and cyber security based on the cyber kill chain concept introduced by Lockheed Martin. Proposed approach of cyber risk management embedded on the cyber kill chain is new and not reflected in the available literature. Proposed risk management process of identifying, analyzing, evaluating, assessing and ultimately responding to cyber threats and monitoring risks in each stage of the cyber kill chain is the heart of proposed approach. The approach may be used in organizations which are going to implement security mechanisms to align with the in-force requirements or to reduce cyber risks to accepted level. The process of the risk assessment introduced by the authors follows with the description of the example risk evaluation method based on a continuous-time Markov chain as a model of the cyber kill chain.

Introduction. The paper considers the application of a risk-based approach to improving the level of safety of hazardous production facilities. The presented approach ensures optimal use of labor, material and financial resources, contributes to greater efficiency of state control and supervision bodies. Problem Statement. The analysis of the state of HPF industrial safety showed the need to change the principles of assessing the state and monitoring the compliance with industrial safety requirements. Reasonable methods should be used to adequately assess the safety of facilities and the frequency and validity of inspections. Theoretical Part. The use of modern tools for monitoring, collecting and storing information on the state of industrial safety will allow supervisory authorities to plan inspections of hazardous production facilities taking into account their actual condition. This can significantly reduce the administrative burden on businesses. Conclusions. The use of a risk-based approach in planning inspections will ensure a higher level of industrial safety without involving additional resources of regulatory authorities.

This article provides a taxonomy for risk-based testing that serves as a tool to define, tailor, or assess risk-based testing approaches in general and to instantiate risk-based testing approaches for the current testing standards ISO/IEC/IEEE 29119, ETSI EG and OWASP Security Testing Guide in particular. We demonstrate the usefulness of the taxonomy by applying it to the aforementioned standards as well as to the risk-based testing approaches SmartTesting, RACOMAT, PRISMA and risk-based test case prioritization using fuzzy expert systems. In this setting, the taxonomy is used to systematically identify deviations between the standards' requirements and the individual testing approaches so that we are able to position and compare the testing approaches and discuss their potential for practical application.

The need to speed up clinical trial processes in a cost-effective manner, increased importance of data integrity, and ensuring timely compliance to regulatory requirement updates regarding the Trial Master File (TMF), has made the pharmaceutical industry delineate the requirement to maintain a centralized TMF with quality control. With the exponential increase in the number of sponsors using centralized electronic TMF (eTMF), the shift of trend positively impacts the need for data migration requirements in the TMF space. With an objective to serve the readers handling migration projects, this review article discusses the data migration requirements in clinical operations and eTMF in clinical trials, possible techniques to consider avoiding anticipated roadblocks, and a few other key points. The article also focuses on steps to be taken post migration to ensure meeting the quality of the migrated data in terms of regulatory compliance.

Chemistry, manufacturing, and control postapproval changes are an intrinsic part of the life cycle of pharmaceutical products. In this paper, the authors examined the potential impact of such changes on the product quality, safety, and efficacy of biologics. Comparability studies and more specifically analytical comparability are introduced as one of the tools that can support both biomanufacturers and health agencies in ensuring that patient safety and product safety and efficacy is maintained through the proposed changes. Together with a scientific risk-based review approach based on product and process knowledge and the definition of acceptance criteria that will ensure that the product is "essentially similar", what constitutes a holistic comparability study is detailed. ICH Guidelines principles and definitions are used throughout the paper to aid the reader with other appropriate references. Finally, two case studies are presented: change to the manufacturing facility of the drug substance, and change to the manufacturing process of a drug substance intermediate and manufacturing facility.

Это исследование в современных условиях приобретает особую актуальность, поскольку из-за ненадлежащего финансирования мероприятий по охране труда способствует поиску путей рационального их использования для снижения уровня производственного травматизма. Целью исследований является разработка и реализация методов повышения эффективности надзорной деятельности в сфере охраны труда агропромышленного комплекса путем разработки механизмов предотвращения производственны х рисков. Использован комплекс методов по анализу состояния информационно-методического обеспечения надзорной деятельности, статистический анализ производственного травматизма, эконометрический анализ линейных временных трендов производственного травматизма в Украине, ри ск- ориентированный подход. Существующая в Украине система управления охраной труда оказалась недостаточно эффективной в современных условиях. Ослабление механизма государственного регулирования в сфере охраны труда привело к нарушению вертикали государственного надзора, снижению эффективности управления и координации деятельности центральных и местных органов исполнительной власти по созданию безопасных и здоровых условий труда на предприятиях. Исследование было проведено для систем ы управления охраной труда в Украине и рекомендуется в последующем провести для других развивающихся, и сравнить результаты. Применение полученных результатов на практике будет способствовать предотвращению (или ослаблению) тяжести травматизма благодаря своевременному принятию необходимого решения. Сейчас отсутствуют общепринятые дл я отраслей экономики методики, которые бы устанавливали единые подходы к осуществлению государственного надзора с одновременным учетом особенностей различны х отраслей. Оригинальность исследования заключается в том, что разработаны математические модели организации и планирования мероприятий государственного надзора в сфере охраны труда, выполнены аналитические оценки эффективности превентивных мер и инспекционной деятельности.

Veterinary drugs are widely used to protect production-related diseases and promote the growth of farmed fish. The use of large amounts of veterinary drugs may have potential risk and cause adverse effects on both humans and the environment. In this study, we developed risk-based ranking based on a scoring system to be applied in the national residue program. In this approach, the following three factors of veterinary drugs that may occur as residues in fishery products were considered: potency (acceptable daily intake), usage (number of dose and withdrawal period), and residue occurrence. The overall ranking score was calculated using the following equation: potency × usage (sum of the number of sales and withdrawal period) × residue occurrence. The veterinary drugs that were assigned high score by applying this approach were enrofloxacin, amoxicillin, oxolinic acid, erythromycin, and trimethoprim. The risk-based approach for monitoring veterinary drugs can provide a reliable inspection priority in fishery products. The developed ranking system can be applied in web-based systems and residue-monitoring programs and to ensure safe management of fishery products in Korea.