Risk-based Approach Research Articles

A QUANTITATIVE APPROACH TO ASSESSING AND MANAGING CYBERSECURITY RISKS

Effective cybersecurity risk management requires moving beyond traditional qualitative approaches toward quantitative methods that provide greater precision and objectivity. This article explores the benefits of cyber risk quantification (CRQ), which allows organizations to numerically estimate the likelihood of potential cyber threats and calculate their financial or operational impacts. By translating risks into quantifiable terms, cyber risk quantification (CRQ) provides a standardized framework to prioritize risks based on impacts, evaluate mitigation strategies through cost-benefit analysis, and align cybersecurity practices with business objectives. The quantitative, risk-based approach elevates cybersecurity as an integral part of enterprise risk management focused on protecting critical assets. Despite its analytical rigor, the quantification process leverages proven techniques to simplify risk data into clear metrics. This enables more informed decision-making by eliminating ambiguity, reducing subjective bias, and communicating risks transparently across stakeholders using a common language of risk values.

Some Specific Biological Risks of SARS-CoV-2 Infected Syrian Hamsters at Animal Biosafety Level - Lab 3

The emergence of novel severe acute respiratory syndrome 2 (SARS-CoV-2) has prompted extensive research to identify its pathogenesis, transmission, and reservoir entry in animals. Syrian hamsters (Mesocricetus auratus) are being identified as an ideal animal model for the study of SARS-CoV-2 infection due to their susceptibility and respiratory symptoms similar to that observed in humans. This study focused on the specific biological risks associated with the use of infected Syrian hamsters in animal biosafety level 3 (ABSL-3) laboratories. The professional and psychological training of professionals working with laboratory animals should be a priority. Biological safety requires the involvement of all parties from technical staff to top management. The COVID-19 pandemic has shown a limitation in experimental studies when obtaining the right strain of mice proved difficult. A rare experimental model of Syrian hamsters started to be used in the work, which Syrian hamsters have several distinctive characteristics associated with increased aggressiveness of females, leading to a requirement to keep them isolated and some technical difficulties during manipulations in the biological safety cabinet. Therefore, a risk-based approach must be introduced to reduce the additional risks to workers to an acceptable level. This includes enhanced accuracy in the use of personal protective equipment (PPE), rigorously following biosecurity protocols, and monitoring staff health to detect potential risk of zoonotic transmission. The implementation of international standards and regulations on biological safety and biosecurity is of paramount importance.

UAV Avionics Safety, Certification, Accidents, Redundancy, Integrity and Reliability: A Comprehensive Review and Future Trends

This paper underscores the significance of safety and reliability in the realm of Unmanned Aerial Vehicle (UAV) technologies, and how regulations play a pivotal role in ensuring their responsible use. We have analyzed safety incidents and trends both in Canada and globally, noting a decline in incidents attributed to enhanced regulations. Our comparative analysis of different UAV technologies identified batteries as the most reliable power supply, Global Navigation Satellite System (GNSS) as the most effective navigation system, and Light Detection and Ranging (LiDAR) as the optimal optical sensor due to regulatory compliance and system redundancies. We also examined the regulatory framework in Canada, comparing it with the risk-based approach of the European Union Aviation Safety Agency (EASA) and the efforts of Joint Authorities for Rule-making on Unmanned Systems (JARUS) towards global harmonization. Furthermore, we highlighted emerging trends in automation and flight control technologies, with a focus on European regulations shaping UAV automation trends. In conclusion, by adhering to best practices from other regulatory bodies, embracing emerging trends, and adopting a risk-based approach, Canada can promote the growth of the UAV industry while ensuring safety and reliability in UAV technologies.

Smoking and determination of workworthiness in industrial enterprises of the highlands

The formation of an evidence base for regulatory documents in the field of preliminary and periodic medical examinations is one of the urgent tasks of occupational health in the coming years. In the process of transition to a risk-based approach in occupational health, including in determining suitability for work, objective verification of risk is necessary, and the decision on suitability should be made on its basis. Suitability for work in the unique conditions of the highlands remains one of the least studied topics, since there are only isolated observational studies, the results of which are also not taken into account in the traditional approach of determining suitability. The article provides a brief overview of the association of smoking with various outcomes when working in the highlands. Smoking significantly worsens the prognosis of all outcomes studied in these studies, including even the likelihood of quitting work. The article concludes that it is necessary to plan studies of various outcomes, which can be used as a basis for supplementing and changing the regulatory framework for conducting medical examinations of employees. Particular attention is paid to the need to take into account, among other risk factors, a comprehensive risk assessment when determining suitability for work in mining in the highlands.
 Ethics. The study did not require permission.

Oral Drug Product Administration via Enteral Feeding Tubes: In Vitro Testing.

Medication administration via enteral feeding tubes (EFT) is a necessary practice for patients unable to swallow oral dosage forms due to a medical condition or treatment that affects the ability to swallow or the function of the gastrointestinal tract. Off-label administration of oral drug products via EFT raises concerns for pharmaceutical sponsors, regulators, and healthcare practitioners (HCPs) because of the potential risks this practice introduces to both the patient and the caregiver. These risks can be mitigated by generating data-supported instructions that patients and HCPs can use to ensure safe and accurate administration of oral drug products via EFT. This commentary presents an industry perspective on the testing that should be conducted to enable development of product-specific instructions in the labeling to support or advise against administration of oral drug products via enteral feeding tube. The proposal outlined in this commentary takes a risk-based approach, addressing recommendations from both regulatory agencies as well as considerations for expanding this testing to address needs specific to neonatal and pediatric populations.

A risk-based quantitative approach for priority assessment of ageing bridges accounting for deterioration

The significant role of bridges in transportation networks requires continuous improvement of bridge management strategies, which has been even more exacerbated by the recent bridge collapses worldwide. This study proposes a framework for the prioritization and preliminary risk assessment of existing bridges subjected to seismic and traffic hazards. The proposed method adopts quantitative expressions to define risk in a simplified manner and, consequently, the priority associated with a certain bridge within a bridge stock. The three primary components of risk are considered: vulnerability, exposure, and hazard, which are specified according to the characteristics of the bridge, site, and road network. The bridge state of conservation is accounted for in the vulnerability component through average and critical defect condition indicators. The proposed method is implemented in a case-study of thirty real bridges in northern Italy. The impact of defects on vulnerability and priority ranking of bridges, the assumptions for defects condition and each subcomponent’s contribution to risk classification are discussed. The prioritization results are presented in absolute and normalized formats, with the latter providing a clearer view of the bridges’ relative priority within the stock. Finally, the proposed method’s findings are compared with the current Italian qualitative guidelines for bridge management.

2024 Updates to Cervical Cancer Screening in Canada

The landscape of cervical cancer screening in Canada is about to undergo a major shift from cytology-based screening to testing directly for the presence of high-risk strains of the human papilloma virus (HPV), the persistence of which is known to be a prerequisite for the development of almost all cases of cervical cancer. In 2018, the World Health Organization declared a call to action for the worldwide elimination of cervical cancer by 2040. Subsequently the Canadian Partnership Against Cancer (CPAC) released an action plan outlining the necessary steps for Canada to reach this goal. One of the 3 major priorities identified in the action plan is the transition to primary HPV testing. This transition from screening to testing represents a major shift in infrastructure and also a shift in mindset for clinicians, policymakers, and the public. To help guide this transition, CPAC has collaborated with the Gynecologic Oncology Society of Canada (GOC) and the Society of Canadian Colposcopists (SCC) to release two open-access, evidence‑based guidelines in June 2023. These guidelines address how to manage a positive HPV screening test, and colposcopy in the context of primary HPV‑screening. This paper will outline the evolution of cervical cancer screening in Canada along with the rationale behind the transition to HPV testing. Also included is a discussion on the broad recommendations from the 2023 CPAC/GOC/SCC guidelines, as well as recommendations for age and interval of screening and special populations. Readers of this article in e-journal format can access the Canadian Guideline on the Management of a Positive Human Papillomavirus Test and Guidance for Specific Populations here. Readers may also access the 2023 Canadian Colposcopy Guideline: A Risk-Based Approach to Management and Surveillance of Cervical Dysplasia here.

Risk-based approach in the problems of modeling metrological support for a measuring instrument fleet

Risk-based approach in the problems of modeling metrological support for a measuring instrument fleet

Corporate Governance in Bancassurance Context: An In-Depth Analysis of external Control Mechanisms

Governance stands as a multifaceted area of interest, attracting attention in both political and academic realms on a global scale. Its significance, particularly in economics and management, has been increasingly emphasized due to a series of scandals that have resonated across various contexts, often highlighting common issues associated with power struggles and conflicting interests within organizations. The quest for effective governance demands the implementation of multiple control mechanisms to address and prevent power-related challenges within organizations. In this article, we focus on the governance of companies operating in the context of bancassurance. Indeed, bancassurance companies are of major importance to any economy, which explains the scope of our research that explores the rules and governance mechanisms governing this sector worldwide, as well as their manifestation in our research context. A comprehensive review of the Basel Committee on Banking Supervision forms an integral part of this discussion. This committee plays a central role in setting global banking standards and its governance structure. Notably, the article highlights Bank Al-Maghrib's adoption of Basel III provisions in the Moroccan context and underscores the significant role played by the Credit Institutions Rating Assistance System. Furthermore, the article delves into the pivotal role of the Insurance and Social Welfare Supervisory Authority within the insurance sector, emphasizing the intrinsic connection between solvency and governance. It explores the historical importance of Solvency I and its evolution towards Solvency II, with a focus on the impact of this directive on the European insurance industry. Finally, the paper thoroughly examines the strategic application of the risk-based solvency approach in Moroccan bancassurance, stressing its contribution to enhancing financial robustness and its tailored assessment within the national context.

Enhancing global food safety standards through international collaboration and policy harmonization

In an increasingly interconnected world, ensuring the safety of the global food supply has emerged as a paramount concern. With foodborne illnesses affecting millions annually and international trade in food products reaching unprecedented levels, the need for robust food safety standards has never been more pressing. This abstract explores the vital role of international collaboration and policy harmonization in enhancing global food safety standards, with a focus on the mechanisms, challenges, and potential solutions involved. At the heart of global food safety efforts lie collaborative endeavors among nations facilitated by international organizations such as the World Health Organization (WHO), the Food and Agriculture Organization (FAO), and the Codex Alimentarius Commission. These entities serve as platforms for harmonizing food safety regulations by developing science-based standards, guidelines, and codes of practice. Through regular consultations, expert committees, and consensus-building processes, these organizations foster agreement on key principles and practices governing food safety across diverse national contexts. However, achieving harmonization in food safety policies poses significant challenges. Divergent regulatory frameworks, varying levels of institutional capacity, and disparities in resources among countries can impede efforts to establish uniform standards. Moreover, geopolitical tensions and trade disputes may hinder cooperation, leading to fragmentation in global food safety governance. Addressing these challenges requires concerted efforts to build trust, enhance communication, and promote transparency among stakeholders. Technological innovations offer promising avenues for overcoming barriers to international collaboration and policy harmonization in food safety. Blockchain technology, for instance, enables transparent and tamper-proof recording of food supply chain data, enhancing traceability and accountability. Internet of Things (IoT) devices provide real-time monitoring of food storage and transportation conditions, helping to prevent contamination and spoilage. Artificial Intelligence (AI) algorithms analyze vast datasets to identify emerging food safety risks and inform regulatory decision-making. By leveraging these technologies, countries can strengthen their capacity to implement harmonized food safety standards and improve compliance with international regulations. Furthermore, public-private partnerships play a crucial role in advancing global food safety initiatives. Collaboration between governments, industry stakeholders, academia, and civil society organizations facilitates knowledge sharing, capacity building, and resource mobilization. By pooling expertise and resources, these partnerships enable more effective surveillance, response, and mitigation of food safety risks on a global scale. Moreover, they promote information exchange and best practice dissemination, fostering a culture of continuous improvement in food safety management. Policy harmonization efforts must also embrace risk-based approaches to prioritize interventions and allocate resources effectively. By identifying and assessing food safety hazards based on their likelihood and severity, countries can tailor their regulatory measures to address the most significant risks. Moreover, regular monitoring, evaluation, and review of food safety policies are essential to ensure their relevance, effectiveness, and adaptability in the face of evolving threats and challenges. Enhancing global food safety standards requires sustained international collaboration and policy harmonization. By fostering consensus, leveraging technology, and fostering partnerships, the international community can strengthen the resilience of the global food system, protect public health, and promote equitable access to safe and nutritious food for all.

Multi-objective optimization of structural fire design

Probabilistic risk assessment can be used for determining a design with a residual risk that is As Low As Reasonably Practicable (ALARP). Existing risk-based design approaches however predominantly focus on single objectives, which can be impractical considering the need for structures to meet diverse performance criteria across various dimensions, including monetary costs, environmental costs, and structural performance measures. To address these challenges, this study proposes the use of a multi-objective optimization (MOO) approach within a risk-based framework. Within the MOO framework, design goals for sustainability and resilience are incorporated together with safety objectives. The MOO approach is developed here for the risk-based design of structures exposed to fire. A multi-objective problem is formulated for a reinforced concrete slab in a multi-family dwelling by identifying design parameters, objectives, and constraints. Taking environmental costs into account has little effect on the optimum design obtained through MOO for the case study, except in cases where CO2 emissions are highly valued. A limited increase in investment is observed to render the structure repairable after a fire incident, highlighting the importance of factoring in post-fire reparability in structural fire design.

Perspectives in precautionary allergen labelling of prepackaged foods after the FAO/WHO consultation.

The purpose of this review is to provide an overview of the perspectives regarding precautionary allergen labelling (PAL) of prepackaged foods following the consultation conducted by the Food and Agriculture Organization (FAO) and the WHO. The FAO/WHO consultation provided a comprehensive assessment of the current status and practices of PAL implementation worldwide. One of the key findings highlighted by the Expert Committee was the need for improvement in existing PAL systems. It was noted that many countries lacked uniformity in PAL practices, leading to inconsistencies in labelling and potentially misleading information for consumers. Furthermore, the consultation emphasized the importance of PAL being risk-based, taking into account both the amount and frequency of unintended allergen presence (UAP) in food products. The FAO/WHO consultation shed light on various perspectives and challenges associated with PAL of prepackaged foods. Key findings emphasized the need for improvement in existing PAL systems, including the adoption of a risk-based approach, standardized regulations, and enhanced transparency. Moving forward, collaborative efforts between regulatory agencies, food manufacturers, and consumer advocacy groups will be essential in developing effective PAL strategies that prioritize consumer safety and well being.

Children's experiences of mask-wearing: a systemic review and narrative synthesis.

Masks have been widely used as a preventative tool during the COVID-19 pandemic. However, the use of masks by children has been controversial, with international guidelines recommending a risk-based approach to national policymakers. We aimed to conduct a systematic review that explores children's experiences of mask-wearing, drawing on an evidence base that describes mask-wearing in different contexts including air pollution, and to prevent the spread of infectious disease. We searched MEDLINE, Embase and PsycINFO in June 2021, with repeat searches in August 2022 and January 2024, for primary research studies exploring children's experiences of masks. Included studies reported on participants between 4 and 14 years (inclusive), with no restrictions on language where an English translation was available. Two reviewers independently screened titles and abstracts and reviewed full texts, with discrepancies resolved by a third reviewer. We used the Mixed Methods Appraisal Tool for quality appraisal and narrative synthesis to identify key findings. We also conducted stakeholder consultation (Patient and Public Involvement (PPI)) with nine children, where they submitted annotated drawings of their preferred masks to complement our review findings. We screened 982 titles and abstracts and reviewed 94 full texts. 45 studies were included in the synthesis. Children's experiences of mask-wearing were influenced by their perceived necessity, social norms around their use and parental attitudes. Challenges related to mask-wearing were described, including difficulty reading facial expressions and physical discomfort. Children found it easier to wear masks when sitting and in cooler environments, and they benefited from unmasking during outdoor break time at school. As part of the PPI consultation, children highlighted the importance of mask design and the environmental impact of masks. Children's experiences of mask-wearing were varied and context-dependent, with several mask-design challenges raised. Future policy on mask-wearing needs to consider the context in which mask-wearing would be most beneficial, and how local adaptations to policy can respond to children's needs.

The challenges for implementing Good Clinical Practices in the bioanalytical laboratory: a discussion paper from the European Bioanalysis Forum.

This manuscript reports back from the discussion in the European Bioanalysis Forum community on the challenges observed when implementing Good Clinical Practices in the bioanalytical laboratory. It is not intended to challenge any regulatory requirements but to open a discussion on where the bioanalytical community sees ambiguities on implementing Good Clinical Practices or areas where expectations are either felt not being owned by Bioanalysis or where Good Clinical Practices requirements are at risk of getting contaminated with requirements originating from Good Laboratory Practices. In addition to this, the discussions focused on three additional main challenges: the informed consent withdrawal, expedited reporting of unexpected results and the risk-based approach to quality management, The European Bioanalysis Forum community is continuing discussions, but already this manuscript should help to appreciate the challenges and to try and resolve them, involving all stakeholders.

Risk-based approach in external migration public management

   The presence of risks emergence problem of socio-political conflict, threats to the preservation of Russian identity in the process of including foreign cultural groups of international migrants in Russian society is a consequence of public administration insufficient efficiency when implementing state migration and national policy. Applying the structural-functional method, the authors study public administration in the external migration sphere for compliance with its essential characteristics. The predominant focus of state management in the migration sphere on ensuring the human resources component of the Russian labor market, as well as on control over migration flows is combined with the state management model shortcomings in the sphere of migrants’ inclusion in the host community. External migration state management should be aimed at solving the socio-economic development problems in Russia and ensuring national security and at the same time should minimize potential risks of social and cultural nature. The authors propose a risk-oriented approach in the migration processes state management, based on a comprehensive consideration of tensions that arise both in the labor market of foreign workers and the foreigners’ inclusion in the Russian society. In order to implement the proposed method, it is advisable to define a single subject of state management, which will be able to exercise authority considering the migration process integrity.

The evolution of the EU drinking water policy towards a source-to-mouth approach

ABSTRACT The four-decade evolution of drinking water policy of the European Union is analysed using a policy change framework through documentary analysis and in-depth interviews. Our findings suggest that this policy has always targeted the protection of human health while inching closer to the concept of ‘safely managed drinking water’, which implies the protection of the sources of drinking water and the application of a risk-based approach to the entire water supply chain. Influenced by a variety of factors, it has experienced incremental changes leading to more comprehensive provisions while seeking flexibility to accommodate the diversity of Member States forming the Union.

Venous Thromboembolism Management throughout the COVID-19 Era: Addressing Acute and Long-Term Challenges.

Background: COVID-19 increases the risk of venous thromboembolism (VTE) through a complex interplay of mechanisms collectively referred to as immunothrombosis. Limited data exist on VTE challenges in the acute setting throughout a dynamic long-term follow-up of COVID-19 patients compared to non-COVID-19 patients. The aim of the study was to investigate acute and long-term management and complications in VTE patients with and without COVID-19. Methods: A prospective, observational, single-center cohort study on VTE patients followed from the acute care stage until 24 months post-diagnosis. Results: 157 patients, 30 with COVID-19-associated VTE and 127 unrelated to COVID-19, were enrolled. The mean follow-up was 10.8 (±8.9) months. COVID-19 patients had fewer comorbidities (1.3 ± 1.29 vs. 2.26 ± 1.68, p < 0.001), a higher proportion of pulmonary embolism at baseline (96.7% vs. 76.4%, p = 0.01), and had a lower probability of remaining on anticoagulant therapy after three months (p < 0.003). The most used initial therapy was low-molecular-weight heparin in 130/157 cases, followed by long-term treatment with direct oral anticoagulants in 123/157. Two (6.7%) COVID-19 vs. three (2.4%) non-COVID-19 patients (p = 0.243) had major hemorrhagic events, all of them within the first three months. Four (3.1%) non-COVID-19 patients had VTE recurrence after six months. Three (2.4%) non-COVID-19 patients developed chronic thromboembolic pulmonary hypertension. There were no fatalities among patients with COVID-19, compared to a mortality of 12/127 (9.4%) in the non-COVID-19 subgroup (p = 0.027). Discussion: Our study offers a comprehensive overview of the evolving nature of VTE management, emphasizing the importance of personalized risk-based approaches, including a limited course of anticoagulation for most COVID-19-associated VTE cases and reduced-dose extended therapy for high-risk subsets.

Use case cards: a use case reporting framework inspired by the European AI Act

Despite recent efforts by the Artificial Intelligence (AI) community to move towards standardised procedures for documenting models, methods, systems or datasets, there is currently no methodology focused on use cases aligned with the risk-based approach of the European AI Act (AI Act). In this paper, we propose a new framework for the documentation of use cases that we call use case cards, based on the use case modelling included in the Unified Markup Language (UML) standard. Unlike other documentation methodologies, we focus on the intended purpose and operational use of an AI system. It consists of two main parts: firstly, a UML-based template, tailored to allow implicitly assessing the risk level of the AI system and defining relevant requirements, and secondly, a supporting UML diagram designed to provide information about the system-user interactions and relationships. The proposed framework is the result of a co-design process involving a relevant team of EU policy experts and scientists. We have validated our proposal with 11 experts with different backgrounds and a reasonable knowledge of the AI Act as a prerequisite. We provide the 5 use case cards used in the co-design and validation process. Use case cards allows framing and contextualising use cases in an effective way, and we hope this methodology can be a useful tool for policy makers and providers for documenting use cases, assessing the risk level, adapting the different requirements and building a catalogue of existing usages of AI.

A case study on Norwegian commercial harvesting and production of Saccharina latissima (Part 1): Effect of processing seaweed on chemical hazards, allergens, and microbiological hazards

When producing seaweed for human consumption, incorporating a “Food Safety-by-Design approach” can help protect human health and ensure the safety of future consumers. Post-harvest processing of seaweed is one strategy to reduce undesirable compounds. The study aimed to determine the effects of a commercial processing strategy (blanching and fermentation) of Norwegian-harvested Saccharina latissima (sugar kelp) on the presence of prioritized food safety hazards. We compiled and prioritized food safety hazards to be analyzed based on the current impact of the hazard, the analytical feasibility, and the fit of the hazard to the case study site. Twelve prioritized hazards were included in the case study analyses: arsenic (total and inorganic), iodine, cadmium, lead, mercury, copper, zinc, the allergen tropomyosin, Salmonella spp., Bacillus spp., norovirus, and Vibrio spp. We found that blanching was very effective in reducing iodine concentrations but mildly increased the zinc concentration. Fermentation of blanched seaweed further decreased iodine concentrations and had similar effects on inorganic arsenic, cadmium, and zinc. An unintentional increase in copper was observed. Bacillus cereus was detected in a blanched sample and fermented samples. Vibrio alginolyticus seemed to be introduced during blanching, yet fermentation greatly reduced the detection frequency. Our study illustrates the importance of clearly defining the goals of seaweed processing and optimizing the process for food safety hazards. Meanwhile, it is advised to monitor for unintended effects that may occur during processing, such as, in our case, the introduction of copper and pathogens like B. cereus and Vibrio spp. This study serves as an example for seaweed stakeholders on how to consider a Food Safety-by-Design concept and a risk-based approach during seaweed harvest and post-harvest processing.

The Effect of the Characteristics of the Audit Firm and Client on the Application of the Business Risk Audit Approach

The purpose of this study is to identify the impact of certain fundamental characteristics of audit firms and their clients on the application of the business risk audit approach in Yemen, as well as to identify the responses implemented by these firms and companies to these characteristics. The study uses a descriptive-analytical approach, where the data collected through the questionnaire are described and analyzed using appropriate statistical methods. The study sample included 60 auditors from 42 audit firms and 8 individual offices, with a focus on larger offices and those associated with international audit offices, as they are more likely to apply the business risk-based audit approach. Data was sourced from the Ministry of Industry and Trade’s publications on licensed audit offices. Out of 50 electronic and 10 paper questionnaires distributed, 38 responses were received, representing a response rate of 63.33%. The results showed that the characteristics related to the audit firm have a varying impact on the application of the business risk audit approach and that the specialization of the audit firm in the client's business is the most influential factor in this regard. The results also showed that the characteristics related to audit clients do not affect the application of the business risk audit approach, indicating the existence of other factors that may affect this approach. This study is one of the few studies that address the application of the business risk audit approach in the Yemeni context, highlighting the factors affecting this application and its challenges. The study also provides some recommendations to improve audit quality and deal with business risks.