This review provide an overview of the various documentation of quality management system, which includes deviations, OOS and CAPA. A detailed case study of deviations, out-of-Specification and CAPA generation is beneficial for improving pharmaceutical capabilities and understanding the documentation associated with a quality management system. It is essential for understanding deviations and out-of-spec in the pharmaceutical industry. The quality of medicines means that they meet the required specifications. The quality management system in the pharmaceutical industry is essential because the drugs or pharmaceutical products are delivered directly to the customer's body. Therefore, identity, purity, safety, and the quality of the products are critical. A Deviation can define as "a deviation from an approved instruction or established standard" The deviation process helps identify potential risks to product quality and patient safety and establish the root cause. Once the root cause identifies, appropriate corrective and preventive actions take to prevent reoccurrence. OOS defines as "A result that is outside the specifications or acceptance criteria established by the manufacturer or laboratory" As the industry moves to newer and more complicated products, quality control procedures must be in place to ensure consistent product quality. "CAPA defined by corrections.
Emerging technologies such as artificial intelligence, blockchain, additive manufacturing, advanced robotics, autonomous vehicles, and the Internet of Things are frequently mentioned as part of “Industry 4.0.” As such, how will they influence operations and supply chain management? We answer this question by providing a brief review of the evolution of technologies and operations management (OM) over time. Because terms such as “Industry 4.0” do not have a precise definition, we focus on more fundamental issues raised by Industry 4.0 emerging technologies for research in OM. We propose a theory of disruptive debottlenecking and the SACE framework by classifying emerging technologies in terms of the functionalities they enable: sense, analyze, collaborate, and execute. Subsequently, we review the nascent but rapidly growing literature at the interface between digital technologies and OM. Our review suggests that one way to assess the value of Industry 4.0 technologies can be via their influence on adding revenues, differentiating, reducing costs, optimizing risks, innovating, and transforming business models and processes. Finally, we conclude by proposing an agenda for further research.
As the maritime industry accelerates its transition toward decarbonization, electric automated guided vehicles utilizing battery swapping stations (BSSs) have emerged as a critical solution for green automated container terminals. However, the adoption of this low-carbon technology faces dual challenges: high capital investment and significant demand uncertainty. Traditional replacement strategies, often relying on fixed cycles or empirical judgment, fail to adequately account for battery performance degradation and demand fluctuations, leading to resource mismatches and hindering the economic sustainability of electrification. To address these issues, this paper proposes a multi-period decision-making model for optimizing battery investment and replacement strategies under uncertainty. The model manages batteries in age-based groups and optimizes procurement timing and usage allocation to minimize the total operational cost in net present value, ensuring a cost-effective transition to green logistics. To handle demand uncertainty without relying on precise distributional information, we establish distributionally robust chance constraints based on the Wasserstein distance. Furthermore, we propose an approximation method using Conditional Value-at-Risk (CVaR) and derive its closed-form expression through duality theory. Numerical experiments validate the model’s effectiveness. Comparative analysis demonstrates that the CVaR method exhibits superior robustness in extreme demand scenarios compared to expectation-based approaches, providing a theoretical foundation for reliable and resilient energy management in decarbonized terminals.
Science, General. Including nature conservation, geographical distribution
Abstract This study explores the influence of climate risk on properties of firms’ financial reporting practices with observations collected from 64 countries between 2005 and 2016. We use a country-level climate risk indicator developed by Germanwatch to measure the degree of damage from extreme weather events, and find that climate risk positively influences firms’ engagements in both accruals-based and real earnings management. Furthermore, we document that the above-mentioned effects of climate risk are moderated by the quality of country-level public governance. Subsample analysis suggests that the main effect of climate risk on earnings management is more pronounced for firms from developed countries, for firms in environment-sensitive industries, and for firms reporting losses. Our findings, which are supported by a battery of robustness tests, have important implication for regulators and policymakers.
The maritime transport of liquefied gases poses significant safety and environmental hazards such as fire, explosion, toxic gas emissions, and air pollution. The main objective of this study was to systematically identify, analyze, and prioritise the potential risks associated with the operation of liquefied gas tankers using a hybrid methodological framework. This framework integrates Fuzzy Delphi, Fuzzy DEMATEL, and Fault Tree Analysis (FTA) techniques to provide a comprehensive risk assessment. Initially, 20 key risk factors were identified through expert consensus using the Fuzzy Delphi method. The causal relationships between these factors were then assessed using Fuzzy DEMATEL to understand their interdependencies. Based on these results, accident probabilities were further analyzed using FTA modelling. The results show that fires, explosions, and large gas leaks are the most serious threats. Equipment failures—often caused by corrosion and operational errors by crew members—are also significant contributors. In contrast, cyber-related risks were found to be of lower criticality. The study highlights the need for improved crew training, rigorous inspection mechanisms, and the implementation of robust preventive risk controls. It also suggests that the prioritisation of these risks may need to be reevaluated as autonomous ship technologies become more widespread. By mapping the interrelated structure of operational hazards, this research contributes to a more integrated and strategic approach to risk management in the LNG/LPG shipping industry.
Andrea De Marco, Davide Berardi, Marta Galuppi
et al.
The everyday functioning of infrastructures and the capacity of their owners to provide high-quality services are critical to the well-being of communities and societies. When disruptions endanger society's well-being, security, and economy, some of these infrastructures are relevant and, as a result, are designated as critical for an entire nation. Therefore, research has focused on a peculiar infrastructure ability, or capacity, that summarizes these concepts in one word: resilience; its quantification, however, is not straightforward. Many authors have attempted to assess resilience using different subjects, infrastructures, resilience phases, and models. Therefore, through a systematic literature review based on the PRISMA protocol, this work presents an overview of quantitative methods and techniques developed over the past decade to numerically assess the resilience of critical infrastructures (CIs). A total of 111 papers were included in the study, which focused on studies published between April 2014 and April 2024. This article focuses on a model-based classification, highlighting strengths and weaknesses in the proposed methodologies, and performs a SWOT analysis on the modeling approaches identified within the retrieved papers. Future works could be useful to extend this research to those papers that describe and quantify single domains, stages, and features of CIs resilience, exploring the possibility of searching protocols to identify and correctly address them.
Abstract Pipelines are the most vital energy-transportation mediums of today’s energy-intensive economies. To a level, pipeline integrity is tied to the continuous development and robustness of modern societies, where major failures may result in dire environmental, societal, and economic consequences. Therefore, pipeline safety and integrity are crucial for a sustainable future and responsible development. Pipeline integrity management has been a topic of interest for regulators, practitioners, and academicians alike. Over the past four decades, integrity management has evolved from prescriptive visual inspection and assessment to risk-based integrity management using real-time data. This paper aims to capture the evolution of risk-based methods in integrity management, focusing on the last two decades. The paper answers four primary questions: 1 What is integrity management, and how has it evolved? 2 How does the concept of risk fit in integrity management? 3 What are the methods used to assess and manage pipeline integrity? 4 How will integrity accommodate Industry 4.0? This article briefly defines the term integrity, how it has progressed and subsequently provides a structured review and analysis of the public domain literature. The paper focuses on risk-based methods adopted to different integrity management elements and applied at different stages of the pipeline’s life cycle. The paper concludes by evaluating the research progress, the gaps in knowledge, and their implication on adopting Industry 4.0.
This article aims to study the transformation of seismic risk in Istanbul’s urban areas, focusing specifically on developments in the building sector. Since the 1999 earthquakes in the Marmara region, many laws, codes and standards governing building materials have been established in Turkey as a response to the threat of earthquake-induced building collapse. Describing successive assemblages of actors involved in using building tools to negotiate seismic risk management, we examine how risk and the urban environment are evolving conjointly. The first part of the analysis examines the construction sector’s regulatory framework since 1999, which has shifted responsibility for seismic risk from the state to construction industry actors; that is, service providers, construction auditors, material producers and civil engineers. It then goes on to explain the choices made by players in the building industry who favor the demolition and reconstruction of buildings rather than their rehabilitation. This process, however, generates economic and financial risks correlated with that of building collapse, the interactions of which highlight controversies surrounding the circumvention of construction standards, sometimes leading to increased individual vulnerability. We conclude that earthquake hazards are gradually being diluted into a more complex assemblage of risks, involving the interdependence of multiple factors that play a role in the fragility of the built environment and the actors concerned.
This study compares leadership communication styles across different corporate governance structures within the Vietnamese banking sector. Content analysis of 120 shareholder letters reveals distinct patterns in how state-owned banks, private banks, family-influenced banks, and banks with foreign strategic alliances emphasize internal collaboration, external pressures, risk management, expansion, innovation, leadership, and social responsibility. State-owned banks prioritize external regulations and individual accountability, reflecting their complex stakeholder environment. In contrast, private banks focus on expansion and visionary leadership, aligning with competitive market pressures. Family-influenced banks demonstrate a reliance on informal networks and growth ambitions, while banks with foreign alliances surprisingly exhibit less emphasis on visionary and social responsibility messaging, potentially reflecting a focus on performance metrics or differing communication norms. This comparative analysis highlights the nuanced ways corporate governance structures shape leadership communication styles, offering valuable insights for practitioners seeking to optimize their communication strategies and for researchers exploring the interplay between corporate structures and leadership behavior in the banking industry.
Marina Tavra, Anka Lisec, Morena Galešić Divić
et al.
The increasing occurrence of disasters worldwide has motivated researchers to continuously evaluate potential technological advances to support disaster management (DM) as well as emergency response. The advent of Volunteered Geographic Information (VGI) offers the possibility of near real-time data collection or the possibility of massive disaster and post-disaster data collection. VGI is a type of geographic information provided by volunteers who have no formal training in geoinformatics and geographic information systems (GIS). The objective of this review aimed to examine research publications that address VGI in the context of DM, focusing on VGI data quality. From the collected metadata of publications published in the Web of Science (WoS) on crowdsourcing and VGI in the context of DM, we extracted and processed those articles related to data quality using the text mining method and a bibliometric approach. The research addresses the quality of VGI data and its fit for purpose for DM studies that rely on accurate and reliable geographic information for successful management through identified topics. The article concludes by highlighting the potential of VGI to provide valuable information for DM, while also pointing to the need for further research to identify and improve the quality of VGI data.
Abstract In Industry 4.0 environment, supply chains have become prone to various risks due to rapid globalization and process digitalization. The uncertainties and unplanned and unnatural events that are internal to supply chain networks and external to the environment of a firm pertaining to global supply chains are regarded as supply chain risks. The objective of this study is to identify and analyze the various emerging supply chain risks for strategy formulation in Industry 4.0 environment. Based on a systematic literature review and experts’ opinion, different supply chain risks in the present business environment have been analyzed. Major identified risks are operational and manufacturing process risk, behavioural risk, demand risk, governmental and organisational risk, system risk, financial risk, product recovery risk, social and environmental risk, supply risk, disruption risk, cyber security, and safety risk. For developing risk mitigation strategies, risk prioritization is very important. Sufficient research has not been done on ranking and categorization of these risks in the Industry 4.0 environment. Therefore, this study has tried to rank these emerging supply chain risks by the Technique for Order Preferences by Similarity to an Ideal Solution (TOPSIS) approach. These risks are further categorized as cause and effect using a Decision Making Trial and Evaluation Laboratory (DEMATEL). This classification of risks will facilitate top management of the organization in formulating strategies for risk mitigations in the Industry 4.0 environment. The findings of the study imply that supply chain managers should focus on disruption risk; cyber security and safety risk in the current Industry 4.0 environment. As supply chain risk management is an emerging research area in Industry 4.0 environment, the findings of this study will be very useful for industry professionals and researchers for further studies.
Juan Vicente Barraza de la Paz, Luis Alberto Rodríguez-Picón, Víctor Morales-Rocha
et al.
The large amount of information handled by organizations has increased their dependance on information technologies, which has made information security management a complex task. This is mainly because they cover areas such as physical and environmental security, organization structure, human resources and the technologies used. Information security frameworks can minimize the complexity through the different documents that contain guidelines, standards, and requirements to establish the procedures, policies, and processes for every organization. However, the selection of an appropriate framework is by itself a critical and important task, as the framework must adapt to the characteristics of an organization. In this paper, a general vision of the newest versions of the NIST CSF, ISO/IEC 27001:2022, and MAGERIT frameworks is provided by comparing their characteristics in terms of their approaches to the identification, assessment, and treatment of risks. Furthermore, their key characteristics are analyzed and discussed, which should facilitate the consideration of any of these frameworks for the risk management of complex manufacturing organizations.
Rimsha Habeeb, Mohammed M. A. Almazah, Ijaz Hussain
et al.
AbstractDrought monitoring is a complicated issue as it requires multiple meteorological variables to monitor and anticipate drought accurately. Therefore, developing a method that enables researchers, data scientists, and planners to comprehend drought mitigation policies more accurately is essential. In this research, based on the concepts behind the calculation of the Standardized Precipitation Evapotranspiration Index (SPEI), a new drought index is proposed for regional drought monitoring: the Modified Standardized Precipitation Evapotranspiration Index (MSPEI). The potential of the proposed index is based on the estimation of Reference Evapotranspiration (ETo). Therefore, the Modified Hargreaves-Samani (MHS) equation based on fuzzy logic calibration is used to estimate ETo. The proposed index is validated on ten meteorological stations in Pakistan at a one-month time scale. Afterward, based on the Pearson correlation, the performance of the proposed index is compared with the commonly used drought index (SPEI). Results showed a significant correlation (r > 0.7) between the quantitative values of MSPEI and SPEI for all ten stations. Moreover, a modified Tjostheims coefficient is used to estimate and test the spatial correlation between SPEI and MSPEI for different drought classes. According to our findings, the association between the SW, ND, ED, EW, MW, and SD patterns of MSPEI and SPI is 0.74, 0.834, 0.673, 0.592, 0.393, and 0.434, respectively. Meanwhile, considering the significance of future drought trend detection, this research is further extended to detect the future trend of MSPEI by using the Hurst index. In accordance with the results, Bahawalnagar, Sialkot, Lahore, Kotli, and Gilgit all have HI values greater than 0.5 (0.63, 0.58, 0.56, 0.55, and 0.53, respectively). In contrast, Muzaffarabad, Skardu, and Jhelum have HI values 0.47, 0.45 and 0.38, respectively; however, HI values of 0.5 are observed at Dera Ismail Khan (DIK) and Islamabad. Therefore, this research provides a basis for developing and enhancing drought hazard characterization, encouraging researchers and policymakers to monitor and forecast regional droughts using a more accurate drought index.
Abolfazl Alvand, S. Mirhosseini, M. Ehsanifar
et al.
Abstract Nowadays, focusing on risk management is one of the core objectives of any organization. Failing to assess project risks during the planning stage could be hazardous throughout the entire project lifecycle. Therefore, risk assessment is so important and various methods have been developed for it. One of the most important risk assessment methods is Failure Mode and Effects Analysis (FMEA). Despite the widespread applications of this method in various industries and organizations, FMEA is associated with some shortcomings that can lead to unrealistic results. In order to identify and evaluate the risks affecting construction projects and cover some shortcomings of the FMEA technique suggested an integrated model based on FMEA, Stepwise Weight Assessment Ratio Analysis (SWARA), and Weighted Aggregated Sum Product Assessment (WASPAS) methods under fuzzy environment in this research. To this end, a case study about the construction projects of the Iranian Road and Urban Development Organization is presented to illustrate the potential benefits and application of the proposed integrated approach. The results suggest that the new integrated model is more capable and accurate in identifying and prioritizing risk compared to the conventional FMEA technique and can provide useful information to help manage the risks of construction projects.
Inspection and Maintenance methods development have a pivotal role in preventing the uncertainty-induced risks in the oil and gas industry. A key aspect of inspection is evaluating the risk of equipment from the scheduled and monitored assessment in the dynamic system. This activity includes assessing the modification factor's Probability of Failure (PoF) and calculating the equipment's remaining useful life (RUL). The traditional inspection model constitutes a partial solution to grouping the vast amount of real-data inspection and observations at equal intervals. This literature review aims to offer a comprehensive review concerning the benefit of Machine Learning (ML) in managing the risk while incorporating time-series forecasting studies and an overview of Risk-Based Inspection (RBI) methods (e.g. quantitative, semi-quantitative, and qualitative). A literature review with a deductive approach is used to discuss the improvement of the clustering Gaussian Mixture Model (GMM) to overcome the non-circular shape data that may show in the K-Means models. Machine Learning classifiers such as Decision Trees, Logistic Regression, Support Vector Machines, K-nearest neighbours, and Random Forests were selected to provide a platform for risk assessment and give a promising prediction towards the actual condition and their severity level of equipment. This work approaches complementary tools and grows interest in embedded artificial intelligence in Risk Management systems and can be used as the basis of more robust guidance to organize complexity in handling inspection data, but further and future research is required.
Publication of new releases of professional standards in different areas is always a challenge for experts since usually after such events organizations, which declare following principles formulated in those standards formally or informally, start implementing new processes. That is why it is necessary to understand the difference between the new release of a standard and a previous one. That circumstance is extremely important since risk management standards from the ISO family declare that the risk management has to become an intrinsic essential part of all business processes in an organization. In case of Russian national standards GOST R ISO 31000:2019 and GOST R ISO 31000:2010 Russian professional community didn’t perform the work mentioned above. The reason was the COVID-19 pandemic which influenced the economics in general and activity of all professional communities in particular. The aim of the article under consideration is to fill in that gap.
In March 2021, the Basel Committee on Banking Supervision published new ‘Principles for Operational Resilience’, which define resilience as a bank’s ability to respond to and recover from disruptions, and the Bank of England published a ‘Statement of Policy on Operational Resilience’ that financial services firms should be able to prevent disruption occurring to the extent practicable, adapt systems and processes to continue to provide services and functions in the event of an incident, return to normal running promptly when a disruption is over and learn and evolve from both incidents and near misses. Both publications use the concept of a ‘disruption’ for a rare/plausible/severe event, which can be viewed through the prism of Frank Knight’s distinction between ‘known’ risk and ‘unknown’ uncertainty. We know that a pandemic, a financial crisis or even a global cyberattack can happen within a lifetime, but we do not know the probability and cannot estimate a frequency by number. A more general approach for risk — as applied in risksensitive industries — extended the traditional view of risk in ‘repeated games’ to rare events with catastrophic impact and includes our ‘strength of knowledge’ as a crucial factor in determining how much the past can be forecasted into the future. This approach and best practices from risksensitive industries such as power grids can help to integrate operational resilience into existing operational risk management in the financial services industry. Nonetheless, any precautionary measure of redundancy, flexibility and adaptivity requires additional investments and is antagonistic to the paradigm of economies of scale with minimisation of buffers. Therefore, the governance of operational resilience will require a fundamental and new understanding about rare ‘severe but plausible scenarios’, which might happen beyond typical timescales of management in a bank and require an intertemporal investment, which transcends usual economic reporting timescales.
This research is aimed to analyze the impact of the coronavirus pandemic on professional football clubs, identify the problems they face and propose strategic anti-crisis measures. The work is based on the analysis of the mapping study on measuring the economic impact of COVID-19 on the sport sector in the EU, provided by European Commission; analytical reports from Deloitte and KPMG containing empirical data on European football, academic research by foreign scientists examining the impact of the pandemic on the football industry. The study resulted in the author's strategic measures to improve the efficiency of football clubs in the face of restrictions caused by the spread of coronavirus, and a system of performance indicators (KPI), concerning the business developments during a pandemic. These results can be used in the strategic management of football clubs, as well as in the development strategies of federations, leagues and individual clubs, and can lead to an increase in the overall efficiency of their activities and the achievement of economic and social results. For the first time, the work carried out a comprehensive study of the consequences of the pandemic for the development of the football industry and offered the author’s view of solving current problems and finding new ways to develop the football business.