Risk Management Methodology Research Articles

The identification and analysis of risks for civilian ports adapted to military uses

Ports are part of the economic engine of a country, as they play a very important role in the maritime transport chain, either as a node or as a logistics platform. Therefore, they must be protected, maintained, and managed to guarantee their operability. Naval bases, which are generally seaports, are a specific type of port. They are points of support for fleets that contribute in a necessary way to the protection and defense of the territorial waters of a nation and on occasions, to other civil authorities. Even though these ports do not have a purely economic function, their role in national defense makes them critical infrastructures. It is because of this defensive character that military ports are the target of certain threats, such as terrorist attacks.Terrorism has increased considerably over the past years, making it increasingly difficult to predict due to changes in its modus operandi. After 9/11, the world made a formidable effort to prevent this attack from repeating. Among the most outstanding actions in the port sector, the development of the concept of critical infrastructure and the development of the ISPS Code stand out.Nowadays, it can be said that risk management can help to face possible measures against terrorist attacks, as it can determine how to update its current and future infrastructure. The purpose of this article is the divulgation of an investigation, which develops a methodology of risk management to apply in civilian ports adapted to military uses. The proposed methodology tries to simplify the process as much as possible, reducing the steps to be taken, in such a way that risk management becomes simple and functional. Moreover, it tries to exemplify the application of the proposed methodology in a civil port, in Malaga, Spain. The reason behind choosing a civilian port rather than a military port, is due to security reasons, since they must maintain its confidentiality and reserve its information. Finally, the proposed methodology could be applied on different areas, such as coastal management.

Spatio-Temporal Graph for Improvement of Decision-Making in Risks Treatment

Failures that hinder the proper functioning of complex systems are characterised by frequencies of occurrence, rates of evolution and variables periodicities. Indeed, a good design of this kind of systems requires the elaboration of an adapted analysis and modelling approach, which takes into account the spatial-temporal dynamics of the systems elements dysfunction. This paper proposes a Spatio-temporal modelling approach integrated into a risk management methodology. This modelling allows both to describe the evolution of the system in space and in time, and to follow the spatial and temporal scope of a failure of the system in order to improve decision making in choosing the appropriate corrective action. The elements of the methodology are illustrated and validated by a case study of a wireless sensor network system.

Risk Management Methodology for Transport Infrastructure Security

The development of transport infrastructure is associated with risks, expressed in the likelihood of harm to the road users’ health during road accidents and their consequences. The risk management process is aimed at reducing the influence of factors that contribute to the occurrence of an accident and increase the consequences’ severity after it. This article proposes a risk management methodology within five stages: identification, analysis and evaluation, processing, development of recommendations, and monitoring. For each step, we describe the methods and models that allow us to effectively solve the problem of risk management. We proposed a risk management algorithm based on feedback. We tested the adequacy of the methodology on a specific example: we conducted an analysis, an assessment, and proposed risk management measures in the field of ensuring road safety in a small town.

ICT Governance and Management Macroprocesses of a Brazilian Federal Government Agency

The process of identifying and managing Information and Communication Technology (ICT) risks has become a concern and a challenge for public and private organizations. In this context, risk management methodologies within the Brazilian Federal Public Administration organizations have become indispensable to help the managers of these organizations in decision making, especially in the distribution of public funds, elaboration of public policies focused on transparency, social actions contemplating indemnities, and social benefits, among others. In addition, the various ICT projects controlled by the public administration need a methodology to perform their management of ICT resources. In this article, we present the Governance and Risk Management methodology used to model the Administrative Council for Economic Defense (CADE) macro processes. The proposed methodology used the risk management process aligned to the ISO 31000 standards. This alignment was necessary for mapping CADE’s risk events, regardless of their complexity. The modeled ICT risk processes will support the organization’s managers in decision making and may be used or customized by any other organization of the Brazilian Federal Public Administration.

Comparing quantitative probability of occurrence to a risk matrix approach: A study of chlorine residual data

Implementation of water safety planning methods globally has focused primarily on developing an evidence base to demonstrate the benefits of the WSP methodology for risk management in water systems. However, little work has been completed to understand the appropriateness of the risk matrix method currently used to capture levels of risk for system-specific hazardous events. This study examines two quantitative risk calculations (probability density functions and event trees) compared to the risk matrix method employed in water safety planning. This analysis was undertaken to understand if the risk matrix provides an accurate estimation of risk in a water system. Two data sets were collected from nine water supply systems, both continuous inline monitoring and grab samples collected in water distribution systems (discrete events) for chlorine residual data. Using quantitative risk calculations, our study found the risk matrix does not accurately estimate risk compared to water quality data from a water system. In thirty-four (77%) of the forty-four possible scenarios investigated, the risk matrix method provided an underestimation or overestimation compared to the probability calculated using water quality data. The probabilities calculated using continuous data and the event tree method provided the closest estimations to the risk matrix, indicating larger data sets with simpler methods may be more likely to match WSP results. The lack of accuracy obtained reveals the need for a re-evaluation of the risk matrix within a water safety plan (WSP), particularly for systems with data available to perform advanced risk analysis. The risk matrix method has been used historically for systems with little data; however, for water systems with advanced water quality monitoring, adding quantitative probability calculations to a water safety plan has the potential to increase accuracy of risk assessment in water safety planning.

Contribution to developing a new environmental risk management methodology for industrial sites

A fundamental requirement of any environmental management system for industrial sites is the identification and assessment of risk. To meet international standards in terms of environmental protection and preservation, industrial sites should ensure that a comprehensive environmental risk management process is in place by systematically identifying and managing risks arising from internal and external factors. The purpose of this study was to develop a new methodology to determine the significance of environmental hazardous situations associated with a process or activity. It uses qualitative or quantitative techniques to pinpoint weaknesses in design, operation, and lines of defense provided by engineering and administrative controls, which can lead to an environmentally hazardous event. It may also provide an assessment of risk resulting from the magnitude of the consequence and the probability of the environmental event occurring. The fundamental principle of this new risk-based hazard methodology is that whilst risk cannot be eliminated, it should be possible to reduce to ALARP (as low as reasonably practicable), and the environmental risk matrix could be a useful tool for establishing if an environmental risk rating is tolerable or not based on the likelihood and consequences. The outcome of this study is developing a new environmental risk matrix based on different consequences (health, environmental, reputation, and business interruption) with likelihood criteria. This matrix could be applied by industrial sites to identify and control their environmental risks.

Practice-relevant model validation: distributional parameter risk analysis in financial model risk management

An objective of model validation within organisations is to provide guidance on model selection decisions that balance the operational effectiveness and structural complexity of competing models. We consider a practice-relevant model validation scenario where a financial quantitative analysis team seeks to decide between incumbent and alternative models on the basis of parameter risk. We devise a model risk management methodology that gives a meaningful distributional assessment of parameter risk in a setting where market calibration and historical estimation procedures must be jointly applied. Such a scenario is typically driven by data constraints that preclude market calibration only. We demonstrate our proposed methodology in a natural gas storage modelling context, where model usage is necessary to support profit and loss reporting, and to inform trading and hedging strategy. We leverage our distributional parameter risk approach to devise an accessible technique to support model selection decisions.

Correction to: Risk management methodology in the supply chain: a case study applied

Correction to: Risk management methodology in the supply chain: a case study applied

Forecasting aviation safety occurrences

AbstractWe present a general framework for aviation safety occurrence forecasting. This is a major component of a methodology for aviation safety risk management at national level. It covers novel models as well as novel combinations of earlier models. Having good quality occurrence and severity forecasting models is paramount to properly manage risks, maintain the confidence of its users and preserve the status of aviation as a safe transportation mode. The problem is involved due to the presence of complex effects like seasonality, trends, or stress that impact the rates of various occurrences and the uncertainty about future number of operations.

Systematic approach to cross-contamination risk management in the production of medicinal products

Introduction. Good Manufacturing Practice (GMP) requires drug manufacturers to apply risk management principles in their operations. One of the main risks to the quality and safety of pharmaceuticals is cross-contamination. The introduction of a systematic approach to contamination risk management requires manufacturers to make a comprehensive assessment of both production processes and the organization of production sites (premises, equipment, systems, etc.). Therefore, the transition to the current GMP requirements for operating production sites may require significantly higher financial and labor costs than for projected production facilities.Aim. Development of a scientifically based program and methodology for cross-contamination risk management for existing pharmaceutical industries, taking into account compliance with the harmonized GMP requirements of the Russian Federation and the EAEU and world practice.Materials and methods. In the course of the study, methods of risk management, analysis and systematization of data and a process approach were used.Results and discussion. The key aspects of the organization of the co-manufacturing of medicines are outlined. A step-by-step approach to risk management, involving a preliminary assessment of the conformity of a production organization with GMP requirements is described. The proposed scheme is aimed at ensuring the continuous functioning of the cross-contamination risk management process.Conclusion. The presented risk management methodology aims to conduct a proper assessment of the risks of cross-contamination for multiproduct pharmaceutical enterprises. This technique allows to identify areas that need improvement to ensure compliance of manufacturing sites with GMP requirements, which ultimately contributes to improving the quality of medicines.

Towards a Software Tool Supporting Decisions in Planning Heap Revitalization Processes

This paper presents an advanced risk management methodology which supports the planning of the revitalization process of post-mining heaps. More specifically, it supports decision-makers in the selection of the most advantageous revitalization actions with respect to the defined criteria embracing risk and cost–benefit parameters as well as different qualitative factors. This methodology was elaborated with a view to software implementation and is a good example of ICT adoption in emerging domains of application. The question is how to organize the revitalization decision process and support it with a software tool. The methodology and tool are based on three pillars: risk, cost–benefit, and qualitative criteria assessments of the considered revitalization actions in order to select the target for the implementation of the given heap. This paper presents the methodology implemented in the software as well as its validation on an extensive example. The steps described in the example allow the decision-maker to identify a target revitalization alternative. The conclusions focus on the solution’s feasibility and the software implementation and extensions.

Ecologically Responsible Entrepreneurship and Its Contribution to the Green Economy’s Sustainable Development: Financial Risk Management Prospects

This paper’s goal is to develop a scientific methodology of financial risk management of ecologically responsible entrepreneurship for the sustainable development of the green economy. The originality of this paper is due to the fact that, for the first time, the financial risks of the green economy are considered through the prism of its sustainability. The paper’s novelty is due to the modelling and quantitative measuring of the impact of the COVID-19 pandemic and the financial and economic crisis on the financial risks to the green economy’s sustainability, in addition to the development of precise quantitative recommendations for financial risk management of the green economy. This enables an increase in its sustainability and reduces ecological disproportion in regions of the world (reducing the differences in the green economy’s sustainability among regions of the world through the management of green investments). The paper’s contribution to the literature consists of specifying the theory of financial risks to the green economy. According to the specified fundamental provisions of this theory, the essence of the process of green economy development is clarified (the “black box” is opened) as the increase in its contribution to sustainable development. As the indicator of achieving this development, an increase in the green economy’s sustainability is offered. A new source of achieving the goal is proposed, consisting of a financial risk management of ecologically responsible entrepreneurship based on (private) green investments.

Food allergens: threshold levels and methodologies for risk management

Food allergies and allergen management are important problems of the public health and food industry. The idea of determining allergen concentrations in food ingredients and food products that are capable of causing severe allergic reactions is of great interest for regulatory bodies as well as consumer associations and the industry all over the world. In this connection, scientists proposed different approaches to determining the basis for assessment of severity of risks of food allergens for health of patients suffering from food allergy similar to methods of risk assessment for other hazards associated with food products (for example, chemical, microbiological). To assess risk of allergens, three different approaches were proposed: i) traditional risk assessment using the no observed adverse effect level (NOAEL)) and uncertainty factors; (ii) approach based on the benchmark dose (BMD)) and margin of exposure (MoE)); and (iii) probability models. These approaches can be used in risk management in food production and in the development of warning marking about the presence of allergens. The reliability of risk assessment will depend on a type, quality and quantity of data used for determining both population threshold levels (or threshold distributions) and an impact of an allergenic product/ingredient on a particular individual.

Process development and validation of expanded regulatory T cells for prospective applications: an example of manufacturing a personalized advanced therapy medicinal product

BackgroundA growing number of clinical trials have shown that regulatory T (Treg) cell transfer may have a favorable effect on the maintenance of self-tolerance and immune homeostasis in different conditions such as graft-versus-host disease (GvHD), solid organ transplantation, type 1 diabetes, and others. In this context, the availability of a robust manufacturing protocol that is able to produce a sufficient number of functional Treg cells represents a fundamental prerequisite for the success of a cell therapy clinical protocol. However, extended workflow guidelines for nonprofit manufacturers are currently lacking. Despite the fact that different successful manufacturing procedures and cell products with excellent safety profiles have been reported from early clinical trials, the selection and expansion protocols for Treg cells vary a lot. The objective of this study was to validate a Good Manufacturing Practice (GMP)-compliant protocol for the production of Treg cells that approaches the whole process with a risk-management methodology, from process design to completion of final product development. High emphasis was given to the description of the quality control (QC) methodologies used for the in-process and release tests (sterility, endotoxin test, mycoplasma, and immunophenotype).ResultsThe GMP-compliant protocol defined in this work allows at least 4.11 × 109 Treg cells to be obtained with an average purity of 95.75 ± 4.38% and can be used in different clinical settings to exploit Treg cell immunomodulatory function.ConclusionsThese results could be of great use for facilities implementing GMP-compliant cell therapy protocols of these cells for different conditions aimed at restoring the Treg cell number and function, which may slow the progression of certain diseases.

An Efficient Rare Event Simulation-Based Methodology for Pricing and Risk Management of Financial Derivatives

An Efficient Rare Event Simulation-Based Methodology for Pricing and Risk Management of Financial Derivatives

АКТУАЛЬНОСТЬ И ПРАКТИКА УПРАВЛЕНИЯ РИСКАМИ ПРЕДПРИЯТИЯ (ПРОЕКТА) НА ПРИМЕРЕ ОТЕЧЕСТВЕННОЙ КОРПОРАЦИИ

The article presents an example of consulting on the development and implementation of a risk management system and methodology in a domestic corporation.

THE MAIN APPROACHES TO EVALUATING THE EFFECTIVENESS OF APPLYING THE RISK ANALYSIS AND MANAGEMENT METHODOLOGY AT ENERGY COMPANY

At present, it is difficult to imagine the provision of any global services without the introduction of information and communication technologies. The energy company of the Islamic Republic of Iran is territorially distributed, and without a corporate information and telecommunications network, it would cease to exist. In a geographically distributed company on 1,648,195 sq.km, there are several hundred access points and several thousand users of the corporate information and telecommunications network and, therefore, it is very important to understand the possible risks, their assessment and management. In such large geographically distributed corporate information and telecommunications networks with high load, for the use of big data, you need to have a complete picture of risks in order to develop risk models. Without a picture of possible risks, it is impossible to build scenarios for various negative and emergency situations. If we consider the probability of a negative event occurring in the corporate information and telecommunications network as a risk, then its definition, analysis and taking measures to minimize the negative consequences is called risk management. One of the main properties of the risks of a corporate information and telecommunications network is their uncertainty. A geographically distributed corporate network is highly exposed to external factors that can directly affect the quality of its functioning. The occurrence of such situations is difficult to predict.

СОБОЛЕВА Г. Г. ПРОЦЕС УПРАВЛІННЯ РИЗИКАМИ ДЛЯ БІЗНЕСУ

The purpose of the article is to provide theoretical and methodological substantiation of the risk management process at an enterprise. Research methodology. Methodology of research. informational, logical generalization and scientific abstraction, structural analysis. Findings. Development of the most optimal risk management measures to reduce unplanned financial losses, strengthen and increase the competitiveness of enterprises. Development of methods for determining the degree of risk to which the enterprise is exposed in its activities. In other words, we need to know what risk is, how to assess its level and how to avoid losses that it can entail, how to manage risk and how to create and manage a corporate system of risks. Market operations with increased risk bring the greatest profit. However, everything requires moderation. The risk should be calculated at the maximum acceptable level. As you know, all market assessments are of a multifaceted nature. It is important not to be afraid of mistakes in your market activities, because no one is safe from them, and most importantly, not to repeat mistakes, constantly adjust the system of actions in terms of maximum profit. The main goal of management, especially in today's conditions, is to ensure that in the worst case, there could be only a certain decrease in profits, but in no case would the issue of bankruptcy arise. Therefore, special attention is paid to the continuous improvement of risk management - risk management. Relevance of the topic - generalization and analysis of risk management assessment models, study of the theoretical concept and methodology of risk management for use in practice. Effective management of a modern enterprise requires an integrated approach that takes into account all possible consequences and risks. Business risk management is one of the most important components of the business management process. The practical significance of the research results. Practical application of the proposed theoretical and methodological substantiations will increase the effectiveness of the risk management strategy at the enterprise. Thus, at each stage, different methods of risk management are used.

Risk management in public administration

With the growth of risks and uncertainties at the regional and national levels of management, the integration of risk management methodology into the sphere of public administration is becoming increasingly important. Examples of the implementation of risks in the field of public administration are the insufficient consideration of foreign economic risks in state policy, the negative dynamics of socio-economic indicators at the regional level, the increase in the cost of state programs, the delay in the timing of necessary public procurement, the failure to fulfill obligations to the population. The goals of state authorities are to minimize risks to society in a specialized area, for example, smoothing the risks of fluctuations in the economic situation, reducing risks in the areas of budget, tax, insurance, currency, banking, reducing demographic risks, risks of reducing the standard of living and income of the population, analyzing environmental and man-made risks, reducing the likelihood of their implementation and minimizing losses.

The Relevance of Enterprise Risk Management Methodologies to European Project Funding Calls: The Case of Grant “Performance and Excellence in the Field of Environment and Renewable Energy through Modern Cluster Entities”

Capital providers, such as shareholders on capital markets or European funding providers, are interested in the net present value of discounted cash flow and the risks or opportunities that may contribute to financial planning in a negative or positive way. Since the Sarbanes Oxley act, corporations listed on US capital markets are demanded to practice enterprise risk management. There are several methodologies in place: the COSO framework, ISO 31 0000, RIMs Risk Maturity. These are holistic approaches to risk management in all business aspects, with a designated methodology. This methodology will be the scholarly literature review in this article, whose goal to elaborate the reference enterprise risk management methodologies and their relevance in empirical data analysis, European project funding calls. European projects demand risk management and mitigation, but do not offer a reference framework to do this. The article purposes to make European funds easy to understand as their requirements are explained and the most suitable scientific solution is sought. The methodology is a descriptive case study, with instrumental value. Findings are that funding authorities, be they capital markets or public funds, benefit highly in their decisions by the integration of opportunities and risks. The research concerns the suitability of enterprise risk management with European funds, and the conclusion of a perfect match confirms theory, brings it new scope, and may be of high practical use as for the coherent and timely documentation of European project funding calls.