Hasil untuk "Risk in industry. Risk management"

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S2 Open Access 2013
Biomarkers in sepsis

M. Singer

Purpose of review This review discusses the current developments in biomarkers for sepsis. Recent findings With quantum leaps in technology, an array of biomarkers will become available within the next decade as point-of-care tools that will likely revolutionize the management of sepsis. These markers will facilitate early and accurate diagnosis, faster recognition of impending organ dysfunction, optimal selection and titration of appropriate therapies, and more reliable prognostication of risk and outcome. These diagnostics will also enable an improved characterization of the biological phenotype underlying sepsis and thus a better appreciation of the condition. Summary The potential for novel biomarkers in sepsis will need to be properly realized with considerable funding, academic–industry collaborations, appropriate investigations and validation in heterogenous populations, but these developments do hold the capacity to transform patient care and outcomes.

645 sitasi en Medicine
S2 Open Access 2019
The world as it is

Michael Bennett

(Smart D. Health risk management in the Tasmanian abalone diving industry. Diving and Hyperbaric Medicine. 2010;40(2):83-7.) Risk management is a systematic process applied to all aspects of diving operations. The process aims to reduce accidents and adverse outcomes to a minimum. Risk results from a combination of probability and consequence, and where this combination has major or extreme impact, the risk should not be tolerated. Over the four years 2001−2004, the incidence of decompression illness amongst abalone divers in Tasmania was 1.4 cases per 100 divers per year. Risk management in diving encompasses medical fi tness, education and training, dive planning, equipment and maintenance, emergency procedures and equipment, and continual vigilance to remedy new risks as they are identifi ed. There is still much to achieve Diving and Hyperbaric Medicine Volume 40 No. 2 June 2010 84 the AS2299.1 recommendation for annual diving medical assessments. An equally important principle is that divers take responsibility for their own day-to-day fi tness to dive. It goes without saying that many long-term health issues result from individual choices regarding consumption of alcohol, tobacco and other drugs. In abalone divers, longterm health problems from ear and sinus barotrauma are commonly encountered by diving physicians. Time spent in the short term recovering from such conditions is well spent, rather than ‘soldiering on’, thus causing permanent hearing impairment or sinus injury. Divers are encouraged to seek early advice from a diving medicine specialist if they experience health problems after diving. The most common clinical syndrome of DCI resembles a bout of influenza: tiredness and lethergy, inability to concentrate, headache and non-specifi c migratory muscle and joint pains. Occasionally there may be nausea and vomiting. Musculoskeletal pains are common and may be restricted to one joint, most frequently the shoulder, or develop in multiple joints. Skin rashes occur on rare occasions. Other non-neurological symptoms include chest pain, shortness of breath and abdominal pain. Neurological syndromes can range from minor paraesthesiae, numbness and slight unsteadiness, through to paraplegia, hemiplegia, severe cognitive defi cits and even loss of consciousness and seizures. Any of these symptoms and signs may be worsened by ascent to altitude (>300 m) after diving; a signifi cant issue in Tasmania (see below). Early treatment of diving-related illness results in faster and more complete recovery. It is recognised that earlier treatment of DCI results in better outcomes for the diver. For serious neurological DCI, recompression treatment is even more time-critical. In Tasmania, there is a 24-hour diving emergency contact via the Ambulance Tasmania 000 number. The diving medicine specialist is contacted once the alarm is raised, and provides input at the earliest stage to management and transport of the diving casualty. In the majority of cases, divers are treated in the hyperbaric chamber within four hours of an emergency call. Early treatment also prevents long-term sequelae of diving, such as bone necrosis. 2. EDUCATION AND TRAINING Industry-specifi c education and training is an essential process supporting diving safety. Well-trained divers have the skills and knowledge to recognise and prevent hazards, and respond to emergencies. In Tasmania, all abalone divers undergo training in accordance with the Tasmanian Abalone Industry Code of Practice, and this code outlines many risk management procedures. This training constitutes a minimum entry platform from which to launch an abalonediving career. From a medical perspective, additional training beyond the basic minimum is always an advantage, as is the revision of skills, particularly in the area of diver rescue and management of emergencies. Because diving accidents are infrequent, divers and their tenders are at risk of deskilling if emergency procedures are not revised and practised regularly. The divers’ tender is an integral part of the diving team, and has great responsibility in supporting the diver. The current code of practice requires that tenders possess an up-to-date fi rst-aid certifi cate that includes an oxygen therapy course. However, there is no clear process by which currency in fi rst-aid skills is monitored. In addition, there does not appear to be any requirement for rescue training for divers or tenders, or training regarding the specifi c aspects of administration of 100% oxygen to the injured diver. In many situations, the tender is alone on board the dive boat. Whilst the probability of needing to rescue an incapacitated or unconscious diver from the water is low, the consequence of a delay in rescue, or rescue in a vertical position could be catastrophic. It is doubtful whether, currently within the industry, rescue drills and oxygen administration are practised regularly. 3 . D I V E P L A N N I N G A N D E M E R G E N C Y PROCEDURES Planning of the dive is an essential part of risk management. There are several areas that have impacted on the health of Tasmanian abalone divers in recent years. One of the most common problems experienced by abalone divers requiring recompression at RHH is failure of the surface air supply, resulting from compressor malfunction or severance of air hoses (usually due to boat propellers). This forces the diver to undertake an emergency ascent to the dive boat, leading to DCI. At present, emergency bail-out air cylinders with regulators and contents gauges are mandated only for dives deeper than 15 metres’ seawater (msw). It is the author’s opinion that bail-out air supply should be required during all abalone diving, regardless of depth. In an out-of-air situation, this simple risk-management procedure allows the diver to undertake a controlled ascent, thus preventing a potentially fatal rapid ascent in a state of extreme stress. Gas embolism with neurological defi cit has resulted from depths as shallow as 2 msw. The planning process must also consider the remoteness of the dive location, since greater degrees of self-suffi ciency will be required for remote locations. Divers should be in peak physical health when diving in remote areas. Emergency equipment, procedures and links to emergency assistance and recompression facilities must be checked and tested prior to departure. Supplies of oxygen must be suffi cient to provide continuous treatment of an injured diver for the full return distance from the most remote site, with a 50% reserve. Emergency contact numbers should be checked. Remote diving also mandates greater conservatism in diving practice to reduce the risk of accidents.

DOAJ Open Access 2026
Dynamic monitoring of grassland land cover types of Inner Mongolia 1990–2023 and testing the causal relationship between meteorological data and grassland area

Xu He, Rui Zhang, Age Shama et al.

The area of global grassland ecosystems has been continuously declining over the past few decades. For this purpose, this study compared the classification performance of random forest (RF) and support vector machine (SVM) algorithms in large-scale land cover mapping using Landsat series of remotely sensed imagery since 1990 and selecting Inner Mongolia in China's continental cold and arid climate zone as a typical study area. We then applied the Shapley additive explanation (SHAP) method to analyze the sensitivity of remotely sensed features to grassland land types and accurately detected grassland disturbance dynamics using the LandTrendr algorithm. We explored the intrinsic relationship between major climate factors (temperature and precipitation) and grassland area changes using the convergent cross-mapping method. The results show that (1) the classification accuracy of RF model is better than SVM, and the average accuracy of grassland identification reaches 86.6%; (2) the chlorophyll index green, BRE soil index, ratio vegetation index, SR_B7 and altitude have a significant effect on the classification accuracy of grassland remote sensing; and (3) the average annual temperature of the grasslands around the meteorological station increases significantly by 2.13 °C. With the increase of annual mean temperature, the grassland area decreased significantly.

Environmental technology. Sanitary engineering, Environmental sciences
DOAJ Open Access 2025
Advances in the Application of CRISPR-Cas-Based Detection Systems for Safety Monitoring and Control in the Food Supply Chain

WAN Wen-yuan, ZHANG Feng, LIU Zhi-yong et al.

As societal demands for food production and regulation continue to rise, foodborne viruses have become a significant food safety risk. CRISPR-Cas is a gene-editing technology that employs RNA-guided Cas nucleases to achieve precise, site-specific modifications within the genome. This review explores the progress and applications of CRISPR-Cas detection systems in identifying foodborne viruses. It explains the working principles of the CRISPR-Cas system in nucleic acid amplification, signal detection, and amplification, highlighting its advantages in terms of sensitivity, specificity, and rapid response when detecting foodborne viruses in food samples. CRISPR-Cas-based detection methods significantly improve detection efficiency, providing valuable technical support for food industry monitoring. The review also discusses strategies, such as developing industry standards and fostering collaborative efforts to advance the application of this technology in securing food supply chains. It addresses challenges, including system complexity and a lack of standardization in CRISPR-Cas food safety testing. It also envisions its potential to enhance food safety risk management and regulatory efficiency. This review offers theoretical insights and practical guidance for applying CRISPR-Cas detection systems in food safety.

Food processing and manufacture, Nutrition. Foods and food supply
DOAJ Open Access 2025
Assessing the Impact of Occupational Stress on Safety Practices in the Construction Industry: A Case Study of Saudi Arabia

Wael Alruqi, Bandar Alqahtani, Nada Salem et al.

Workplace health and safety issues have long plagued the construction industry. While safety efforts have traditionally focused on physical risks, increasing attention is being paid to mental health and work-related stressors, which can negatively affect both productivity and safety. In Saudi Arabia, the construction sector presents a unique context because of its highly diverse, multinational workforce. Workers of different nationalities often operate on the same job site, leading to potential communication barriers, cultural misunderstandings, and inconsistent safety practices, all of which may amplify stress and safety risks. This research aims to investigate the influence of work-related stressors on construction workers’ safety in Saudi Arabia and identify which stressors most significantly contribute to the risk of injury. A structured questionnaire was distributed to 349 construction workers across 16 job sites in Saudi Arabia. The survey measures ten key stressors identified in the literature, including job site demand, job control, job certainty, skill demand, social support, harassment and discrimination, conflict with supervisors, interpersonal conflict, and job satisfaction. Data were analyzed using logistic regression and Pearson correlation to examine relationships between stressors and self-reported injuries. The findings indicated that work-related stressors significantly predict workplace injury. While the first regression model showed a modest effect size, it was statistically significant. The second model identified job site demand and job satisfaction as the most influential predictors of injury risk. Work-related stressors, particularly high job demands and low job satisfaction, substantially increase the likelihood of injury among construction workers. These findings emphasize the importance of incorporating psychosocial risk management into construction safety practices in Saudi Arabia. Future studies should adopt longitudinal designs to explore causal relationships over time and include qualitative methods such as interviews to gain a deeper understanding. Additionally, factors such as nationality, organizational policies, and management style should be investigated to better understand their moderating effects on the stress–injury relationship.

Building construction
DOAJ Open Access 2025
System model for the formation of organizational and technical processes for the prevention of emergency situations in transport complex projects

Olena Sorochynska, Oleksandr Melnichenko, Ivan Kulbovskyi et al.

The article explores the current challenges related to occupational safety in the transport sector of Ukraine, emphasizing the growing importance of systematic prevention and effective risk management. The study analyzes the main causes of occupational injuries and emergencies, highlighting both technical and organizational shortcomings in existing safety management systems. Particular attention is given to the insufficient implementation of modern risk-oriented approaches and the limited integration of advanced organizational and technical solutions at transport enterprises. The authors substantiate the need to transform traditional occupational safety practices by adopting international standards, such as ISO 45001 and ISO 31010, and by strengthening digitalization processes that enable real-time monitoring of hazards. Based on the results of the analysis, a comprehensive model is proposed for forming organizational and technical prerequisites that aim to reduce injury rates, enhance the efficiency of preventive actions, and improve the reliability of production processes. The model integrates key components such as hazard identification, risk assessment, digital monitoring systems, personnel training, modernization of equipment, and development of a corporate safety culture. It also provides mechanisms for coordinating management decisions, improving regulatory and methodological support, and implementing preventive programs tailored to the specifics of the transport industry. The findings demonstrate that using a systemic approach, supported by digital technologies and analytical tools, significantly strengthens the ability of enterprises to predict and prevent dangerous events. The proposed model can serve as a practical foundation for improving occupational safety management systems, supporting the development of industry programs, and ensuring sustainable and safe functioning of the transport sector.

Transportation engineering
DOAJ Open Access 2025
Numerical study on flashover in aircraft cargo under varying pressure and ventilation conditions

Xuhong Jia, Shupei Tang, Quanyi Liu

A numerical simulation study was conducted to analyze flashover in a full-scale aircraft cargo compartment, utilizing FDS (Fire Dynamics Simulator) and PyroSim (visual modeling) software. The study aims to: (i) examine how varying heat release rates (HRR), pressures, and vent sizes influence the hot gas layer temperature during flashover in confined spaces, and (ii) establish a semi-empirical model to predict flashover. Experimental results indicate that when the vent size is 1.86 m × 1.06 m and the pressure is 101 kPa, the minimum hot gas layer temperature required to trigger flashover is approximately 410 °C. When the pressure is reduced to 80 kPa and 60 kPa, the critical temperature increases to approximately 436 °C and 460 °C, respectively. These findings provide critical temperature benchmarks for predicting flashover in aircraft cargo fires. Furthermore, a semi-empirical engineering calculation model was developed to predict the hot gas layer temperature under various conditions during flashover. Validation against experimental data from the literature demonstrated good agreement (deviation of ≈20 %), confirming the model's applicability in diverse scenarios.

Risk in industry. Risk management
DOAJ Open Access 2025
Spatiotemporal coupling of ecological vulnerability and economic comprehensive level in the source area of the Yellow River in China based on remote sensing, GIS and AHP-CRITIC

Haoxiang Zhang, Qian Song, Shiru Wang et al.

The Yellow River Source Area (YRSA) is ecologically fragile, economically weak, geographically vast and sparsely populated, and faces challenges to its development. Existing studies on the YRSA often neglect the interactions between ecological and socio-economic factors, which is a hot issue in sustainable development research. In this article, the hierarchical analysis method (AHP), CRITIC weighting method, state-function-structure model (SFS), coupled coordination degree model (CCDM), and spatio-temporal geographically weighted regression (GTWR) are used to assess spatio-temporal coupling of ecology and economy and to analyze the influencing factors. The results show that the YRSA is dominated by grassland ecosystem and the ecological vulnerability has been improved to a certain extent. The northeastern region is higher than the southwestern region in terms of economic level, which corresponds to the coupling coordination results. Hot spots are clustered in the north, and cold spots spread from the southeast to the west. The two main factors affecting ecological vulnerability (EV) and economic comprehensive level (ECL) are population density and elevation. This study complements existing knowledge of ecological, economic and human-land systems at the global regional scale. It provides important insights and data to support policy formulation and implementation while contributing to regional ecological and socio-economic improvements.

Environmental technology. Sanitary engineering, Environmental sciences
DOAJ Open Access 2025
Local seismic amplification as a key factor in the instability of dangerous rock masses during earthquakes: a case study

Daping Tai, Meng Zhu, Shengwen Qi et al.

Dangerous rock masses pose a widespread threat to hydraulic and hydropower engineering. This study investigates the seismic response and progressive failure of a dangerous rock mass on a reservoir bank using field surveys, high-resolution satellite imagery, and numerical simulations. A 3D geological model was developed to assess the rock mass stability, with the Factor of Safety (FOS) indicating that it is in a state of limit equilibrium under static conditions. The dynamic analysis was validated through shake table tests, revealing that the rock mass failed in four stages under seismic loading: tilting toward the free face, disintegration, sliding, and accumulation on the lower platform. The seismic response exhibited significant amplification of the dangerous rock mass area, particularly at its boundaries, which is a key reason for the instability of the dangerous rock mass under seismic loading. This amplification is attributed to two mechanisms: (1) the reflection and refraction of seismic waves at undulating terrain, leading to localized energy concentration, and (2) the generation of surface waves at unloading and free surfaces, which interacted with incident waves, further amplifying the effects at the rock edges. These findings provide valuable insights and theoretical guidance for assessing the dynamic stability of dangerous rock masses.

Environmental technology. Sanitary engineering, Environmental sciences
DOAJ Open Access 2025
Strengthening financial regulation and total factor productivity in China

Weiguo Liu, Zhouye Wu, Xuyin Wang

In the context of China's economic transition, total factor productivity (TFP) serves as a metric for assessing industry upgrading and economic performance enhancement. This study specifically examines the impact of China's 2018 New Asset Management Regulations on corporate total factor productivity among Chinese listed companies. Using panel data from 3201 publicly traded companies (2013–2023), we employ a generalized difference-in-differences method with fixed-effects regression models. Analysis reveals that this specific regulatory intervention significantly enhances total factor productivity. The study explains how the 2018 regulations affect total factor productivity through five mechanisms: corporate risk-taking, debt financing costs, innovation levels, human capital investment, and R&D investment ratios. Heterogeneity analysis shows that this particular policy's effects are more pronounced in eastern regions, private companies, and firms with financial management expertise. This research provides specific evidence from China regarding how targeted asset management regulatory reform impacts enterprise productivity, offering insights into the real economic effects of this major financial regulatory intervention.

Finance, Economics as a science
S2 Open Access 2012
Roadmap for implementation of BIM in the UK construction industry

F. Khosrowshahi, Yusuf Arayici

Purpose – Building information modelling (BIM) implementation is a major change management task, involving diversity of risk areas. The identification of the challenges and barriers is therefore an imperative precondition of this change process. This paper aims to diagnose UK's construction industry to develop a clear understanding about BIM adoption and to form an imperative step of consolidating collective movements towards wider BIM implementation and to provide strategies and recommendations for the UK construction industry for BIM implementation.Design/methodology/approach – Through comprehensive literature review, the paper initially establishes BIM maturity concept, which paves the way for the analysis via qualitative and quantitative methods: interviews are carried out with high profile organisations in Finland to gauge the best practice before combining the results with the analysis of survey questionnaire amongst the major contractors in the UK.Findings – The results are established in the form ...

426 sitasi en Engineering
DOAJ Open Access 2024
Safe Management and Risk Evaluation of Pressure Pipes in the Process and Energy Industry

Giovanni Grillone, Antonino Muratore, Eleonora Genco et al.

Process and energy industries include chemical plants, oil refineries and bio-refineries, power plants, etc., in which a variety of pressure equipment/assemblies are located (steam generators, reactors, heat exchangers, pressure tanks, etc.), which use a very wide range of flammable and/or toxic substances. This equipment has historically been controlled, both during construction and operation, while the pressure pipes were considered potentially "dangerous" by the legislation only with the entry into force of the first European Directive 97/23/CE (PED Directive) and the European Directive 2014/68/EU, which modifies and integrates the previous one.The PED directive introduced pressure pipes because they very often cause triggering of accidental events (fires, explosions, toxic releases), involving successively important pressure equipment (steam generators, reactors, heat exchangers, pressure tanks, etc.). Pressure pipes must be particularly monitored and maintained in Seveso establishments (Seveso Directive - 2012/18/EU).In this paper authors suggest to the employer an operational framework for the safe management of residual risks of pressure pipes, during operating phase, due to the installation, use and/or reasonably foreseeable improper use of the aforementioned pipes are described here, showing an application example.It is important to note that, nowadays, there are pipes constructed in accordance with the PED Directive and pipes built before the introduction of these European Directives (the latter lack manufacturer’s certification). Employers in Italy must manage these two different types of pipes in compliance with the Decree of the Ministry of Production Activities No. 329, issued on December 1, 2004, and the Decree of the Ministry of Labour and Social Policies issued on April 11, 2011.Furthermore, authors describe the main effects on the health of workers and citizens living near industrial plants, due to accidents causing fires, explosions and release of toxic substances.Keywords: Pressure Pipes Safety (construction and exercise), incidental events, PED directive, Seveso directive, workers’ health, citizens’ h

Chemical engineering, Computer engineering. Computer hardware
DOAJ Open Access 2024
The Influence of Intrapreneurial Behavior on Task and Contextual Performance of Employees in Healthcare Marketing Organizations: A LISREL Multigroup Modelling Study

Theophilus OAMEN, Banjo Moshood LAWAL

Existing literature on the impact of intrapreneurial behavior on performance has been largely focused on individual and organizational-level performance. As a matter of conjecture, managers are assumed to display higher competence than their subordinates (operational staff) in marketing organisations. Empirical evidence is scanty on the comparison/s between managers and operational staff, on the influence of intrapreneurial behaviors on task and contextual performance in pharmaceutical marketing organisations. This paper builds on role theory to examine employee-level differences (managers vs operational staff) by testing the influence of intrapreneurial behaviors on task and contextual performance in a pharmaceutical marketing context. Covariance-based multigroup structural equation modelling in LISREL was used to develop the model and address this gap. Data was collected using a self-reported online questionnaire from 220 participants composed of managers (n=58) and operational staff (n=162) in the pharmaceutical marketing industry in Nigeria. Confirmatory factor analysis established the validity of constructs. Multigroup confirmatory factor analysis established configural invariance among the groups, justifying a multigroup analysis. Intrapreneurial behavior positively influenced task and contextual performance in the general path model. Risk-taking behavior had no impact on task and contextual performance. Managers showed stronger proactive behavior on task and contextual performance compared to operational staff, while the latter group had stronger innovative behavior impact on task performance only. The study identified the low risk-taking propensity of employees as a gap in intrapreneurial behavior. Therefore, it proposes risk management training for both managers and operational staff. The study concludes that intrapreneurial behavior aligns more with proactivity for managers, while operational staff tend to be more innovative toward their core responsibilities.

S2 Open Access 2011
An Analysis of the Public Perception of Flood Risk on the Belgian Coast

W. Kellens, R. Zaalberg, Tijs Neutens et al.

In recent years, perception of flood risks has become an important topic to policy makers concerned with risk management and safety issues. Knowledge of the public risk perception is considered a crucial aspect in modern flood risk management as it steers the development of effective and efficient flood mitigation strategies. This study aimed at gaining insight into the perception of flood risks along the Belgian coast. Given the importance of the tourism industry on the Belgian coast, the survey considered both inhabitants and residential tourists. Based on actual expert's risk assessments, a high and a low risk area were selected for the study. Risk perception was assessed on the basis of scaled items regarding storm surges and coastal flood risks. In addition, various personal and residence characteristics were measured. Using multiple regression analysis, risk perception was found to be primarily influenced by actual flood risk estimates, age, gender, and experience with previous flood hazards.

377 sitasi en Medicine, Geography
DOAJ Open Access 2021
Research on Management Model Based on Deep Learning

Yuting Zhao

In this study, the focus was on the development of management models and future prediction for the cost and risk by using an improved deep learning (DL) algorithm. Management model can be defined as the management activities that are interlinked and organized inside organization of institutions. Different opportunities and different organizations are offered by different management models. Proper management models lead to strategies and decisions help to success organization. Deep neural network (DNN) is proposed to make good prediction for organization for increasing the cost and reduce risk in companies and institutions. The error of prediction is updated according to variable hidden layers and nodes within iteration. Improved DNN is used and modify weights that have an effect on the features extracted in advance to increase the accuracy and precisions are used. The proposed method is based on dynamic hidden layers with backpropagation and feedforward. Absolute mean relative error (AMRE) and variance (R2) are used for evaluation in term of accuracy. The training system is used with three available datasets from big company, health issue, and industry. Gained result proves the worth of the proposed system and is suitable for predicting complex data and reducing the risk as possible.

Electronic computers. Computer science
S2 Open Access 2020
Evidence-informed Advisory for Ultra-High-Net-Worth Clients: Portfolio Governance and Fiduciary Risk Controls

Akindamola Samuel Akinola, Chizoba Michael Okafor, Omoize Fatimetu Dako et al.

This paper explores evidence-informed advisory frameworks for managing ultra-high-net-worth (UHNW) client portfolios, with a focus on portfolio governance and fiduciary risk controls. The study synthesizes insights from contemporary literature on wealth management, fiduciary duties, investment governance, and risk management practices. By systematically reviewing scholarly research, industry reports, and regulatory guidelines, a conceptual framework is developed to guide financial advisors and family offices in implementing evidence-based decision-making while mitigating fiduciary and operational risks. The framework emphasizes governance mechanisms, risk assessment tools, and decision-support systems to ensure portfolio integrity, compliance, and client trust. The findings highlight the criticality of integrating structured oversight, scenario-based risk modeling, and robust reporting mechanisms into UHNW portfolio management. Implications for practice include enhancing decision transparency, accountability, and risk mitigation, while providing avenues for future empirical validation of advisory frameworks. The paper contributes to wealth management literature by bridging the gap between theoretical fiduciary principles and practical advisory governance, offering a structured approach for UHNW portfolio oversight.

DOAJ Open Access 2019
Methods of Strategic Costing in the Case of Medical Industry Companies

D. A. Endovitsky, A. V. Chepulyanis

The article describes the author’s method of strategic calculation in the case of a certain medical industry enterprise and introduces a model of accounting and analytical support for strategic cost management by life-cycle stages using a process approach and taking into account a risk mechanism. This method makes it possible to generate the strategic cost of a product for the whole market cycle (lifecycle) and perform its comprehensive strategic analysis. The authors propose a form of cost strategic reporting, i.e. strategic cost estimate. To model strategic calculation its mathematical interpretation is provided. The strategic method of calculation is integrated with the balanced scorecard of the enterprise, which results in developing of an integrated system of strategic cost management at all stages of the product life cycle and business processes. To manage risk in strategic cost management the authors developed and applied an empirical scale of risk in costing.

Accounting. Bookkeeping
DOAJ Open Access 2019
Advancing regulatory science and assessment of FDA REMS programs: A mixed-methods evaluation examining physician survey response

Sarah E. Brewer, Elizabeth J. Campagna, Elaine H. Morrato

AbstractPurpose:Food and Drug Administration’s (FDA) Draft Guidance for Industry on pharmaceutical REMS (Risk Evaluation and Mitigation Strategies) assessment and survey methodology highlights physician knowledge–attitudes–behaviors (KAB) surveys as regulatory science tools. This mixed-methods evaluation advances regulatory science and the assessment of FDA REMS programs when using physician surveys. We: (1) reviewed published physician survey response rates; and (2) assessed response bias in a simulation study of secondary survey data using different accrual cut-off strategies.Methods:A systematic literature review was conducted of US physician surveys (2000–2014) on pharmaceutical use (n = 75). Kruskal–Wallis tests were used to examine the relationships between response rates and survey design characteristics. The simulation was conducted using secondary data from a population-based physician KAB survey on diabetes risk management with antipsychotic use in Missouri Medicaid (n = 973 accrued over 30 weeks). Survey item responses were compared using Pearson’s chi-square tests for two faster completion simulations: Fixed Sample (n = 300) and Fixed Time (8 weeks).Results:Survey response rates ranged from 7% to 100% (median = 48%, IQR = 34%–68%). Surveys of targeted populations and surveys using member lists were associated with higher response rates (p = 0.02). In the simulation, 9 of 20 (45%) KAB items, including diabetes screening advocacy, differed significantly using the smaller Fixed Sample strategy (achieved in 12 days) versus full accrual. Fewer response differences were found using the Fixed Time strategy (2 of 20 [10%] items).Conclusions:Published data on physician surveys report low response rates with most associated with the sample source selected. FDA REMS assessments should include formal evaluation of survey accrual and response bias.

DOAJ Open Access 2019
Effective KPI Setting to Process Safety Management System in Design Phase for Oil and Gas Plant Projects

Masayuki Tanabe, Atsumi Miyake

Following major accidents, such as the Seveso and the Piper Alpher, design phase process safety performance has been improved by applying a "risk based' regulations (e.g. safety case regulations) and Plant Owner Company standards as efforts to enhance safety in the oil and gas industry. However, major accident events continue to occur. This is inevitable, since risk cannot be nil if hazardous materials are being handled. A potential area for further improvement of the process safety performance, especially in the design phase, is the a "quality' of process safety information, which is the foundation of the safety management system of the operational process. Thus, managing process safety activities, which requires establishing high-quality process safety information, is the ultimate objective of process safety management in the design phase. In this paper, the following aspects are discussed and suggested:Some important elements of Process Safety Management (PSM) System in design phase are discussed, such as approach evaluating difficulties/ characteristics of technical Process Safety requirements in project, Process Safety organization structure types depending on level of technical Process Safety requirements, and approach developing effective communication channel with related engineering disciplines. Design process safety Key Performance Indicator (KPI) tiers are proposed, which are not available as industrial practice differently from Operation Phase PS-KPI. Since the evaluation of design process safety management performance is not straightforward, as records of process safety incidents are applicable only during the operational phase. A simple model allowing numerical indications of design PS KPI performance evaluation is proposed using a Markov model. Where no numerical indicator is available, the review or monitoring of Plan-Do-Check-Act (PDCA) is not effective and does not fully capture specific remedial action plans. Based on reference data from actual project, a sensitivity study has been conducted in order to identify effective Design Phase PSM performance improvement parameters.

Chemical engineering, Computer engineering. Computer hardware

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