Helena Bigares Grangeia, Cláudia Silva, Sérgio Paulo Simões
et al.
Quality by Design (QbD) was originated in the broad domain of Quality Management and was recently adapted and formalized in specific terms for assisting pharmaceutical companies efforts towards market and operational excellence. However, despite some impressive success stories, the pharmaceutical industry have not yet fully embraced QbD, particularly in routine commercial manufacturing [1,2]. In this review, we aim to analyse the current state of implementation of QbD methodologies and tools in the pharmaceutical industry, extracting patterns and trends and identifying gaps and opportunities that may be considered to improve QbD adoption. For this purpose, a critical analysis of 60 research papers was performed, whose contents were classified, compared and summarized at different abstraction levels. Our analysis reveals the following tools as the frequently adopted for conducting each activity: Risk Assessment (RA) - Ishikawa Diagram, Failure Mode and Effects Analysis (FMEA) and Risk Estimation Matrix (REM); Screening Design of Experiments (DoE) - 2-level Full and Fractional Factorial Designs; Optimisation DoE - Central Composite Design (CCD). Emerging trends include the growing interest in quantifying and managing the impact of raw materials' attributes variability on process and product, as well as the development of Retrospective QbD approaches (rQbD) in complement to standard QbD.
Climate change is a global phenomenon driven by increased greenhouse gas (GHG) emissions, resulting in various environmental impacts. Its effects include increasing global temperatures, which manifest as tangible physical risks such as sea-level rise, land subsidence, and extreme weather events. These phenomena can damage infrastructure, trigger oil spills, contribute to environmental pollution, and generate other detrimental impacts. Numerous studies emphasize that the physical risks posed by climate change have become a central focus in sustainable management within the oil and gas (O&G) industry. The O&G is projected to remain a necessary component of the energy mix for several decades, alongside the development of new and renewable energy (NRE), to ensure national energy security during the transition toward Net Zero Emissions (NZE). This study adopts a qualitative approach to examine the resilience of the O&G industry in addressing climate-related risks. The findings include a risk analysis framework, the development of physical and policy strategies, and potential adaptation scenarios implementable by the industry. These results highlight the urgency of proactive climate adaptation efforts to ensure the long-term sustainability of the O&G sector in the coming decades while supporting Indonesia’s transition to NZE.
Background and objective Natural and human-made disasters have long-term, negative, and sometimes irreparable impacts and consequences. Proper response to these disasters requires effective management of relief services. Influential parties in such operations include humanitarian organizations, donors, and the government. One of the solutions to increase performance in emergency and humanitarian supply chains is to utilize the capacities of non-governmental organizations (NGOs). This study aims to present a collaborative model based on game theory that examines the cooperation between donors, humanitarian organizations, the government, and NGOs.
Method The collaborative model is designed based on the problem of maximum coverage of damaged areas caused by a natural disaster. By considering the number and diversity of players, it takes into account the extent of the disaster and the number of affected areas in relief assistance. It also considers the quality of relief services and the competence of NGOs. This can allow for a default order to prioritize qualified NGOs with the required capacities in the event of a disaster. The developed model was solved using a hypothetical numerical example and GAMS software, and underwent a sensitivity analysis.
Results The results obtained from the model provide valuable insights into the optimal actions of each player in the humanitarian supply chain during a disaster. This model takes into account the capacities and capabilities of each player, as well as the quality of services provided by the private sector, allowing for more efficient allocation of resources and ensuring maximum coverage of affected areas. The model also considers qualitative assessments conducted in the pre-disaster period and allows for prioritization of qualified NGOs during a disaster. This can significantly improve the effectiveness of disaster management efforts.
Conclusion The collaborative model is designed based on the problem of maximum coverage of damaged areas caused by a natural disaster. By considering the number and diversity of players, it takes into account the extent of the disaster and the number of affected areas in relief assistance. This can significantly improve the effectiveness of disaster management efforts. It also considers the quality of relief services and the competence of NGOs.
Risk in industry. Risk management, Industrial safety. Industrial accident prevention
The purpose of this article is to suggest a primer for culture risk, aimed at outlining actionable and practical approaches distinguishing between ‘risk culture’ and ‘culture risk’. The topic, originally addressed by the Financial Stability Board (FSB, 2014), has recently garnered renewed interest due to the Draft Guide on Governance and Risk Culture disseminated by the European Central Bank (ECB, 2024), setting out supervisory expectations, informed by the Capital Requirements Directive (CRD), European Banking Authority (EBA) guidelines, and international standards. Although the subject may be perceived as abstract, nevertheless it holds
significant concrete relevance, despite the inherent challenges of measuring it. Therefore, the purpose is to move beyond the abstract boundaries of principled statements, striving instead to establish a framework that forms the logical foundation for properly managing the culture risk, which could aptly be described as the ‘mother of all risks’. The stated insights may serve as a roadmap for risk
managers who are tasked with addressing a significant and, in many respects, fundamental challenge. The remainder of this article, which is a theoretical paper based on conceptual analysis, is structured as follows: the first section explores definitions of risk culture and culture risk; the second outlines potential roles of corporate functions in mitigating culture risk. The third section examines the
implications for the Risk Appetite Framework. The final section draws preliminary conclusions and sets the stage for future challenges
Olamide Olusegun, Inyang Nyongessien, Sambo Garba
et al.
PurposeThis study examines the factors leading to low service quality in the hospitality industry in northwestern Nigeria, emphasising the lack of digitalisation and supply chain integration. The sector faces challenges, such as security issues and reduced investor and tourist numbers, which affect productivity. Our study explores how digital tools and integrated supply chains can enhance service quality by highlighting employee satisfaction and customer service.Design/methodology/approachUsing a mixed-methods approach, we conducted a web-based survey with 100 hotel employees, semi-structured interviews with six hotel managers and an analysis of relevant organisational documents. Quantitative data were analysed using linear regression and descriptive statistics.FindingsWe identified the interconnections between digital transformation, supply chain integration, employee satisfaction and service quality, culminating in the development of a Digital Integration Satisfaction Model (DISM).Research limitations/implicationsThis study provides useful insights into digital transformation in hospitality but has several limitations. It focuses solely on Northwest Nigeria, limiting generalisability. The small interview sample, while achieving thematic saturation, may not reflect broader managerial views. Reliance on self-reported data raises the risk of response bias. Data were collected over six months, so recent changes may be missed. Additionally, the study emphasises service quality and efficiency, omitting financial metrics like ROI or cost savings, which could provide a more comprehensive assessment.Originality/valueThis study aligns with the technology-organisation-environment (TOE) framework, supply chain management model, Herzberg’s two-factor theory and SERVQUAL model, using the terms digitalisation and technology adoption interchangeably. This study advances the understanding of the critical role of digitalisation and supply chain integration in enhancing hospitality sector performance in a challenging regional context, contributing to both theoretical models and practical insights.
Rajeevan Arunthavanathan, F. Khan, Salim Ahmed
et al.
Abstract Industry 4.0 provides substantial opportunities to ensure a safer environment through online monitoring, early detection of faults, and preventing the faults to failures transitions. Decision making is an important step in abnormal situation management. Assigning risk based on the consequences may provide additional information for abnormal situation management decisions to prevent the accident before it occurs. This paper analyzes the interconnections between the three essential aspects of process safety: fault detection and diagnosis (FDD), risk assessment (RA), and abnormal situation management (ASM) in the context of the current and next generation of process systems. The authors present their thoughts on research directions in process safety in Industry 4.0. This article aims to serve as a road map for the next generation of process safety research to enable safer and sustainable process operations and development.
Abstract The aim of this study was to add to the relatively sparse literature on accident causality in the construction industry by identifying frequent causal factors and connections between causal factors. Using the Construction Accident Causation (ConAC) framework, 176 relatively severe construction accidents investigated by the Labour Inspection Authority in 2015 were analysed. The seven factors most identified were (in rank order): (1) worker actions, (2) risk management, (3) immediate supervision, (4) usability of materials or equipment, (5) local hazards, (6) worker capabilities, and (7) project management. A set theoretic approach was used to identify causal connections between causal factors. Risk management, immediate supervision and worker actions were found to be key causal factors and strongly connected. The analyses identified seven causal factors consistently connected to worker actions, for example immediate supervision and local hazards. Immediate supervision was found to be strongly connected to both worker actions and risk management, underlining the importance of the supervisor controlling unsafe conditions/acts and planning the work to reduce risk. Strong connections were also found between risk management and immediate supervision, and between risk management and worker actions. Risk management and immediate supervision is to a large degree about planning and risk control at different levels, underlining the importance of risk being addressed at different levels and by different actors in construction projects.
Abstract We employ a VARMA DCC-GARCH model to search for portfolio diversification with Bitcoin in global industry portfolios and bond index. We find lower dynamic conditional correlations between Bitcoin and industry portfolios and bond index, allowing an investment in Bitcoin to hedge the risk against industry portfolios and bonds. The most effective hedge in a Bitcoin/industry (bond) portfolio is to short Utilities sector. Results are robust to the use of US industry portfolios and a cryptocurrency index instead of global industry portfolios and Bitcoin, respectively. Our results can help investors make informed decisions with regard to risk management and portfolio analysis.
In the rapidly evolving financial industry landscape, the convergence of digital and physical realms, known as the ‘phygital era’, presents novel challenges for boards that aim to build digital trust and strengthen their financial resilience while fostering responsible innovation and maintaining their competitive edge in the global business arena. These encompass people management, processes and their digital technology portfolio. Building a new phygital culture, upskilling and reskilling the workforce, deploying a mix of intelligent automation and hybrid augmented workflows and deploying frontier technologies responsibly are now on the agenda for forward-thinking boards. The latest deep tech innovation trends in financial services offer exponential pathways for innovative solutions yet increase cybersecurity threats, create new ethical dilemmas and demand a new risk tolerance from board executives. Novel risk management styles, the value of harmonising cyber and ethics programmes, and leadership traits are potentially viable solutions for risk management at the board level in this phygital era. This paper proposes a trifecta that financial industry boards can embrace to adapt their risk governance to the demands of this phygital era: zero trust cybersecurity, ethics by design and risk management by design. By deploying this combination of strategies, boards within the finance industry can successfully navigate the complexities of the phygital era and steer their organisations towards a more secure, trustworthy and sustainable future.
Mohammad Salem Oudat, Basel J. A. Ali, Sameh Abdelhay
et al.
Risk management has emerged as a critical element across several economic sectors, with particular significance in the banking industry. The governing bodies of these industries encounter a multitude of threats stemming from the escalation of an unpredictable economic environment, the intricacy of transactions and big data, and several other concealed factors. The primary aim of the present research is to investigate the impact of certain financial risks, including capital risk, liquidity risk, and operational risk, on the financial performance of both commercial and Islamic banks operating within the banking sector of the United Arab Emirates. The study will focus on the time frame spanning from 2015 to 2022. The data used in this study was sourced from the annual reports of banks, which were acquired from the official websites of the Abu Dhabi Securities Exchange and the Dubai stock market. The most prevalent indicators used to assess a bank's financial performance are Return on Assets (ROA) and Return on Equity (ROE). In contrast, the financial risk metrics included three distinct categories of risk: capital risk, liquidity risk, and operational risk. The findings indicate that there is a statistically significant positive relationship between capital risk and both return on assets (ROA) and return on equity (ROE). However, it was observed that neither liquidity risk nor operational risk had a statistically significant impact on either of the financial performance metrics. Moreover, the size of a bank has a notable and favorable impact on both return on assets (ROA) and return on equity (ROE). The ramifications of the study's conclusions have significant importance for regulators, bank management, and investors. IPolicymakers need to prioritize the enhancement of the regulatory framework pertaining to caboutements in order to the financial stability of banks. Bank managers should give priority to the management of capital risk and the size of the bank in order to their financial performance. In order to optimize profits, it is important for investors to carefully evaluate and take into account the many risk considerations associated with their investment selections.JEL:G20, G21
Deolfa R. Jose Moises, Nnenesi A. Kgabi, Olivia Kunguma
An effective institutional coordination and communication are essential determinants of community disaster resilience capacities and successful execution of disaster risk reduction (DRR) strategies. Several international agreements endorse adopting consolidated, decentralised, participatory approaches to manage hydrometeorological hazards. Yet, the capacity of local governments to develop and implement effective disaster risk reduction strategies remains inconsistent and relatively unknown. In its quest to achieve sustainable economic development, Namibia has developed a DRR legislative framework and enlisted a central body to execute the strategic policy for disaster disruption mitigation and national resilience building. This study adopts a qualitative case study approach to assess the role of the central disaster risk management institution in establishing effective institutional coordination and communication structures for successful flood early warning system operations. Based on its legislative mandate, the study presents a hierarchically contextualised account of the institutions’ empirical progress in DRR streamlining.
Contribution: The study identifies bureaucracy, limited institutional capacities, inadequate funding and response and relief prioritisation as major challenges to system efficacy. It provides directives for better institutional coordination and communication to reduce future harm.
The supply chain of the food industry is crucial for countries, yet it is vulnerable to disruptions caused by natural disasters like floods, frost, and heatwaves, as well as operational shutdowns. These disruptions can trigger a ripple effect throughout the food supply chain, posing significant challenges for the country. Therefore, it is imperative to identify and analyze strategies to mitigate the ripple effect. This research has been conducted in two stages: qualitative and quantitative. The qualitative stage aimed to identify coping strategies, employing thematic analysis. The quantitative stage involved scenario modeling and analysis using fuzzy cognitive maps. The findings revealed 84 primary codes grouped into 21 sub-categories and 4 main categories: "Strategic Management," "Operations Management," "Compilation and Correct Implementation of Laws," and "Supply Chain Management." Analysis of backward scenarios underscored the importance of "supplier relationship management," "cooperation and coordination in the supply chain," and "contingency plans." Conversely, analysis of forward scenarios highlighted the significance of "monitoring environmental changes" and "strategic planning." Focusing on short-term plans, enhancing managers' decision-making and problem-solving skills, refining supplier selection criteria, optimizing supply network design with backup locations, and maintaining safety stock for critical goods are recommended actions for industry stakeholders.IntroductionThe growth of supply chains and their increasing interdependence raise concerns about vulnerability and the likelihood of supply chain failure (Kek et al., 2022). One significant contributor to supply chain failure is the propagation of disruption, commonly known as the ripple effect (Ghadge et al., 2022). The ripple effect exerts various negative impacts on the agricultural supply chain (Wei & Chen, 2010), with factors such as climate change exacerbating these effects on the agricultural sector and food supply chain (Galli et al., 2023). A prominent example of the ripple effect is the COVID-19 pandemic, which led to crises in the food supply chain, including human resource shortages, transportation disruptions, and input cost escalations (Waris et al., 2022). In Iran, the pandemic significantly disrupted the food supply chain, resulting in decreased profitability, sales rates, flexibility, and investment returns (Afzali and Zare Mehrjardi, 2020). Thus, investigating this issue in Iran's food supply is imperative. The objectives of the research are:Identifying strategies to cope with the ripple effect in Iran's food product supply chain.Presenting a fuzzy cognitive map of strategies to cope with the ripple effect in Iran's food product supply chain.Conducting scenario analysis of strategies to cope with the ripple effect in Iran's food product supply chain.Materials and MethodsThis research adopts a mixed-method approach, comprising qualitative and quantitative stages. In the qualitative stage, participants include experts and managers with a minimum of 10 years of experience in the food processing supply chain, possessing academic qualifications, and experience with supply chain disruptions. The statistical population for the quantitative stage encompasses the participants from the qualitative stage, supplemented by university professors with publications in the field of supply chain ripple effects. Thematic analysis is employed in the qualitative part to analyze the data. Subsequently, based on the qualitative findings, a researcher-designed questionnaire is developed for the quantitative phase. The fuzzy cognitive map method is then utilized to analyze the quantitative data gathered.ResultsSemi-structured interviews were conducted with experts to identify strategies for coping with the ripple effect in Iran's food supply chain. From these interviews, 84 primary codes were identified, which were then organized into 21 sub-categories and 4 main categories: "strategic management," "operations management," "drafting and correct implementation of laws," and "supply chain management." Notably, nearly half of the obtained codes were attributed to the "supply chain management" category, indicating its significant importance in addressing the ripple effect. In the second stage of the research, a questionnaire was designed based on the findings of the previous stage and administered to 10 experts for completion. In this questionnaire, experts were asked to assess the importance of each of the 21 sub-categories. Subsequently, FCMapper software was employed to construct a fuzzy cognitive map depicting coping strategies.Table 1: Analysis of strategies to cope with the ripple effectTypeCentralityOutdegreeIndegreeStrategyTotal Componentsordinary17٫295٫7311٫56121ordinary12٫32٫459٫852Total Connectionsdriver10٫1110٫1103191ordinary11٫128٫972٫154Densityreceiver9٫6409٫6450.45ordinary8٫282٫985٫36Connections per Componentordinary16٫914٫8712٫0479.09ordinary10٫278٫911٫368Number of Driver Componentsordinary17٫646٫9110٫7393ordinary10٫586٫434٫1510Number of Receiver Componentsordinary5٫192٫552٫64111driver5٫815٫81012Number of Ordinary Componentsdriver8٫98٫901317ordinary16٫336٫331014Complexity Scoreordinary16٫397٫379٫02150.33ordinary8٫897٫641٫2516ordinary15٫816٫369٫4517ordinary14٫184٫849٫3418ordinary11٫644٫197٫4519ordinary4٫723٫261٫4620ordinary11٫487٫134٫3521As shown in Table 1, 'Environmental change monitoring,' 'Strategic planning,' and 'Technology upgrade' strategies have the highest degree of effectiveness, while 'Inventory management,' 'Contingency programs,' and 'Production flexibility' strategies also exhibit high effectiveness. Furthermore, 'Production flexibility,' 'Contingency plans,' and 'Inventory management' demonstrate the highest degree of centrality. Figure 1 depicts the fuzzy cognitive mapping of strategies to cope with the ripple effect in the supply chain of Iran's food products.Figure 1: Fuzzy cognitive mapping of strategies to cope with the ripple effect To examine the scenarios, three backward and three forward scenarios were designed. In the backward scenario, the most effective variables were selected. Figure 2: The first backward scenario of coping strategiesCooperation and CoordinationSupplier Relationship ManagementContingency PlanningInventory ManagementFigure 3: Second backward scenario of coping strategiesSupplier Relationship ManagementCooperation and CoordinationContingency PlanningFigure 4: The third scenario backward coping strategiesCooperation and CoordinationSupplier Relationship ManagementContingency PlanningProduction FlexibilityFigure 5: Overlap of the backward scenarios of coping strategiesCooperation and Coordination Supplier Relationship Management Production Flexibility Contingency Planning Inventory Management To draw forward scenarios, strategies No. 3, 4, and 8, which represent 'monitoring environmental changes,' 'strategic program,' and 'technology improvement,' respectively, were selected.Figure 6: First forward scenario of coping strategiesMulti-Skilled WorkforceShort Term PlanningHRMTechnology UpgradeMonitoring Environmental Changes Figure 7: Second forward scenario of coping strategiesHRMMulti-skilled WorkforceShort Term Planning Horizontal IntegrationStrategic Planning Figure 8: The third forward scenario of coping strategiesMulti-Skilled Workforce Short Term PlanningHRMTechnology Upgrade Figure 9: Overlap of the forward scenario of coping strategiesMulti-skilled Workforce Short Term Planning HRMTechnology Upgrade Monitoring Environmental changes Horizontal IntegrationStrategic PlanningConclusionsFood product supply chain managers should consider long-term factors, price flexibility, and contract support clauses in contracts with suppliers. For foreign products, it is recommended to contract with companies that have active agencies in the country, as other companies may quickly cease their services due to new sanctions. The purchase of critical parts of the supply chain, known as vertical integration, is recommended to reduce risk. Contingency plans are necessary to cope with the ripple effect, but to develop suitable contingency plans, environmental and political issues must be carefully monitored. As a result, it is necessary to create management teams in food products to investigate environmental issues.
Izzum Wafi'uddin, Imam Santoso, Arif Hidayat
et al.
Integrating sustainability into risk management is essential for the agri-food sector, as it addresses socio-ecological factors in business operations. Failure Mode and Effect Analysis (FMEA) is widely used for risk management but often lacks precise numerical analysis. This paper subsequently evaluates these enhancements to FMEA, with the objective of (1) conducting a comprehensive examination of research on sustainable risk management in the agri-food industry, and (2) Analyze recent research on improving the FMEA method's effectiveness in risk management. The mini-review is systematically organized by collecting articles, selecting them based on publication year and keywords, screening titles, screening for inclusion, assessing quality through a full-text review, extracting, and analyzing data, and finally reporting the findings. An analysis of 20 papers from 2010 to 2024 was conducted, examining a variety of frameworks. The mini-review was chosen for its flexibility and focus, making it ideal for offering insights with less time and resources. The review results suggest that FMEA has been significantly altered to improve its capabilities, mainly through the integration of fuzzy logic and Data Envelopment Analysis (DEA). Fuzzy FMEA reduces uncertainty, while FMEA-DEA assesses direct and indirect relationships between failure modes, improving risk prioritization. The paper concludes by summarizing the application of FMEA-DEA for sustainable risk management in the agri-food sector.
Rasaki Kolawole Fagbenro, R. Sunindijo, Chethana Illankoon
et al.
Despite the significant contribution of the construction industry to national and global economies, the risk it poses to the health and safety of its workers is concerning. With substantial improvement in physical health and safety performance, especially in industrialised and developed economies, attention has shifted to the mental health of construction workers. The construction industry has implemented several worker-focused and management-oriented intervention programs, but problems related to poor mental health persist, and the industry ranks high in suicide figures. Entering the Construction 4.0 era, the use of technologies and new construction methods have been touted to have the potential to improve mental wellbeing. Therefore, this research addresses this lingering problem by: (1) identifying and classifying stressors of mental health and (2) assessing the relevance of adopting prefabricated construction to improving mental health. A two-phased PRISMA-guided systematic review was conducted due to the nonavailability of past studies that combine the concepts of prefabrication and mental health. Mental health stressors were grouped into three categories, with industry-related identified as having an influence on management/organisational and personal stressors. Prefabricated construction, on the other hand, by virtue of its benefits over traditional construction, is found to be capable of eliminating, or at least reducing, the impact of industry-related stressors and, by extension, promoting good mental health.
Adamaria Perrotta, Andrea Monaco, Georgios Bliatsios
Given the nature of the lending industry and its importance for global economic stability, financial institutions have always been keen on estimating the risk profile of their clients. For this reason, in the last few years several sophisticated techniques for modelling credit risk have been developed and implemented. After the financial crisis of 2007-2008, credit risk management has been further expanded and has acquired significant regulatory importance. Specifically, Basel II and III Accords have strengthened the conditions that banks must fulfil to develop their own internal models for estimating the regulatory capital and expected losses. After motivating the importance of credit risk modelling in the banking sector, in this contribution we perform a review of the traditional statistical methods used for credit risk management. Then we focus on more recent techniques based on Machine Learning techniques, and we critically compare tradition and innovation in credit risk modelling. Finally, we present a case study addressing the main steps to practically develop and validate a Probability of Default model for risk prediction via Machine Learning Techniques.