Risk Analysis Process Research Articles

Visualization of a hole and accident preventive measures based on the Swiss cheese model developed by risk management and process approach

It is important to find the characteristics of holes theorized in the Swiss cheese model created by Reason when preventive measures are taken. Reason does not explain where the holes open and how the holes move and shut. The objectives of this research are to find the characteristics of a hole, visualize the development of the hole and propose accident preventive measures to shut the hole. I investigated four real cases of three types of marine accidents using risk management and process approach. The focus of the study was on the processes both of the Safety Management System and risk management imbedded in the procedures at the time of the accidents. I found the following results. A hole in a defensive layer opened during the process of plan or check imbedded in the Safety Management System and moved through the Plan-Do-Check-Act (PDCA) cycle. The hole in the defensive layer moved or affected the development of the hole in another defensive layer at the local workplace. The hole in another defensive layer at the local workplace opened during the process of risk identification or risk analysis and moved through risk management process. Shutting the hole was drawn in a structured manner by the method of risk reduction. With a focus on process, the development of holes was visualized. These findings indicate that the characteristics of holes and their visualization can show the location where efforts toward preventive measures should be directed effectively and efficiently.

A Pattern-Based and Tool-Supported Risk Analysis Method Compliant to ISO 27001 for Cloud Systems

To benefit from cloud computing and the advantages it offers, obstacles regarding the usage and acceptance of clouds have to be cleared. For cloud providers, one way to obtain customers' confidence is to establish security mechanisms when using clouds. The ISO 27001 standard provides general concepts for establishing information security in an organization. Risk analysis is an essential part in the ISO 27001 standard for achieving information security. This standard, however, contains ambiguous descriptions. In addition, it does not stipulate any method to identify assets, threats, and vulnerabilities. In this paper, the authors present a method for cloud computing systems to perform risk analysis according to the ISO 27001. The authors' structured method is tailored to SMEs. It relies upon patterns to describe context and structure of a cloud computing system, elicit security requirements, identify threats, and select controls, which ease the effort for these activities. The authors' method guides companies through the process of risk analysis in a structured manner. Furthermore, the authors provide a model-based tool for supporting the ISO 27001 standard certification. The authors' tool consists of various plug-ins for conducting different steps of their method.

Risk analysis methods of the water resources system under uncertainty

The main characteristic of the water resources system (WRS) is its great complexity and uncertainty, which makes it highly desirable to carry out a risk analysis of the WRS. The natural environmental, social economic conditions as well as limitations of human cognitive ability are possible sources of the uncertainties that need to be taken into account in the risk analysis process. In this paper the inherent stochastic uncertainty and cognitive subjective uncertainty of the WRS are discussed first, from both objective and subjective perspectives. Then the quantitative characterization methods of risk analysis are introduced, including three criteria (reliability, resiliency and vulnerability) and five basic optimization models (the expected risk value model, conditional value at risk model, chance-constrained risk model, minimizing probability of risk events model, and the multi-objective optimization model). Finally, this paper focuses on the various methods of risk analysis under uncertainty, which are summarized as random, fuzzy and mixed methods. A more comprehensive risk analysis methodology for the WRS is proposed based on the comparison of the advantages, disadvantages and applicable conditions of these three methods. This paper provides a decision support of risk analysis for researchers, policy makers and stakeholders of the WRS.

Medical device risk management and safety cases.

Safety assurance cases have been used in different industry sectors such as nuclear power, transportation, and military systems for many years. In 2010, the U.S. Food and Drug Administration (FDA) launched the Infusion Pump Improvement Initiative to address observed infusion pump safety problems. As part of this initiative, the agency began to review safety assurance cases submitted within premarket device notifications for drug infusion pumps.1 At this time, the FDA has not specified a format for safety assurance case submissions. Therefore, seeing a wide variation in safety case organization, content, and soundness is not surprising. Based on review of numerous safety case submissions received to date, a common approach followed by many manufacturers has been to convert existing risk/hazard analysis work (typically presented in tabular format) to a graphical representation. The result, in general, was numerous diagrams that were difficult to review, comprehend, and develop confidence in. This report discusses how artifacts from a risk management process based on ANSI/ AAMI/ISO 14971:20072 might be organized into a safety assurance case and how the safety case development process can contribute to the risk analysis process. Notions of argument and evidence sufficiency and their relationship to confidence are introduced. A sample risk analysis and safety case pattern using ANSI/ AAMI/ISO 14971:2007 artifacts are presented. Also, a sample design safety case template is presented that demonstrates how the safety case approach is broader than ANSI/AAMI/ISO 14971:2007. The terminology used in this article is based on ANSI/AAMI/ISO 14971:20072 and ISO/IEC TR15026-1:2010,3 though certain terms are not explicitly defined in these standards.

Development of economic consequence methodology for process risk analysis.

A comprehensive methodology for economic consequence analysis with appropriate models for risk analysis of process systems is proposed. This methodology uses loss functions to relate process deviations in a given scenario to economic losses. It consists of four steps: definition of a scenario, identification of losses, quantification of losses, and integration of losses. In this methodology, the process deviations that contribute to a given accident scenario are identified and mapped to assess potential consequences. Losses are assessed with an appropriate loss function (revised Taguchi, modified inverted normal) for each type of loss. The total loss is quantified by integrating different loss functions. The proposed methodology has been examined on two industrial case studies. Implementation of this new economic consequence methodology in quantitative risk assessment will provide better understanding and quantification of risk. This will improve design, decision making, and risk management strategies.

A framework to determine the effectiveness of dietary exposure mitigation to chemical contaminants

In order to ensure the food safety, risk managers may implement measures to reduce human exposure to contaminants via food consumption. The evaluation of the effect of a measure is often an overlooked step in risk analysis process. The aim of this study was to develop a systematic approach for determining the effectiveness of mitigation measures to reduce dietary exposure to chemical contaminants. Based on expert opinion, a general framework for evaluation of the effectiveness of measures to reduce human exposure to food contaminants was developed. The general outline was refined by application to three different cases: 1) methyl mercury in fish and fish products, 2) deoxynivalenol in cereal grains, and 3) furan in heated products. It was found that many uncertainties and natural variations exist, which make it difficult to assess the impact of the mitigation measure. Whenever possible, quantitative methods should be used to describe the current variation and uncertainty. Additional data should be collected to cover natural variability and reduce uncertainty. For the time being, it is always better for the risk manager to have access to all available information, including an assessment of uncertainty; however, the proposed methodology provides a conceptual framework for addressing these systematically.

Risk assessment challenges to 20:20 vision

Decision makers need reproducible, believable results to support investment decisions. A wide variety of hazard identification and risk analysis methods are available to support process safety decisions. All methods require knowledge in the fundamentals of process design and experience in the process operation under consideration. Every method has uncertainty and no method yields any better reflection of the risk than the level of engagement that the analyst or team has in the assessment. Traditional approaches work well on processes with a long history of operation, but are difficult to apply in the rapidly evolving environment of modern manufacturing. This article discusses the challenges that the risk analysis process is facing in today's work environment. These challenges include understanding that the calculations are only a model for process safety events that harm people, events with low calculated likelihood can still occur, and management systems with metrics are critical to sustain the performance of the identified protection layers. These challenges are met by adapting current tools and work processes for recording process data to also collect data on abnormal operation and protection layer failure. © 2014 American Institute of Chemical Engineers Process Saf Prog 34: 119–125, 2015

Review of Various Approaches for Assessing Public Health Risks in Regulatory Decision Making: Choosing the Right Approach for the Problem

Stakeholders in the public health risk analysis community can possess differing opinions about what is meant by "conduct a risk assessment." In reality, there is no one-size-fits-all risk assessment that can address all public health issues, problems, and regulatory needs. Although several international and national organizations (e.g., Codex Alimentarius Commission, Office International des Epizooties, Food and Agricultural Organization, World Health Organization, National Research Council, and European Food Safety Authority) have addressed this issue, confusion remains. The type and complexity of a risk assessment must reflect the risk management needs to appropriately inform a regulatory or nonregulatory decision, i.e., a risk assessment is ideally "fit for purpose" and directly applicable to risk management issues of concern. Frequently however, there is a lack of understanding by those not completely familiar with risk assessment regarding the specific utility of different approaches for assessing public health risks. This unfamiliarity can unduly hamper the acceptance of risk assessment results by risk managers and may reduce the usefulness of such results for guiding public health policies, practices, and operations. Differences in interpretation of risk assessment terminology further complicate effective communication among risk assessors, risk managers, and stakeholders. This article provides an overview of the types of risk assessments commonly conducted, with examples primarily from the food and agricultural sectors, and a discussion of the utility and limitations of these specific approaches for assessing public health risks. Clarification of the risk management issues and corresponding risk assessment design needs during the formative stages of the risk analysis process is a key step for ensuring that the most appropriate assessment of risk is developed and used to guide risk management decisions.

TEORETICKÉ ASPEKTY METODIKY ANALÝZY RIZIK VE VYBRANÉM PODNIKATELSKÉM SUBJEKTU

The risk, crisis, crisis management, crisis regulation and risk management are currently often used terms. It is late to search a cause of crisis in time, when the crisis had broken out and their destructive effects are displaying. It is more suitable to focus on preventive control of business assets. The goal of this article is to suggest a methodical process of risk analysis with focus on protection of carrying business assets. The suggested methodical process of the analysis comes out a persuasion that primary attention is needed to give a protection of carrying business assets. Carrying assets are those which create potentials of business success and in case of their destroying, damaging or loss will originate to subject major or even existence loss. To such chosen carrying business assets are identified threats coming out parts of macro environment (political, legal, economical, social, demographic, technical and technological, ecological) and threats from an field environment. To the identification of threats in field environment is used an analysis of five forces model according Porter. As a final step of the suggested methodical process of risk analysis is a creation of a risk matrix to each carrying asset. In this matrix is drawn the risk, which is described with a qualified estimation of occurrence its proba­bility and with an estimation of amount of possible damage, which can be caused by risk. According location the identified risk in the risk matrix is suggested the way of the regulation single risks.It is possible to choose between five basic strategies: Strategy “Take”, Strategy of crisis plans, Strategy of risk treatment, Strategy of risk transfer and Strategy “Terminate”. Single strategies are possible to combine between each other. The combination is suitable in cases, when there is threaten a big loss with a high probability.

Probabilistic Risk Analysis for Highway Construction Management

Construction management is the totality of activities that address the managerial and technological aspects of highway construction, conducted during the planning, design, construction, and post-construction phases of the project, for the purpose of achieving scope, quality level, cost, schedule and other project performance objectives. The ability to better understand potential risks and how to manage those yields benefits far in excess of the costs of adopting risk management practices. In this paper, the most common set of processes including risk identification, assessment, analysis, mitigation, allocation, monitoring and updating are discussed, and the relationship between the computational method (the model) and its required inputs and available outputs is illustrated. The methodology and systematic process of probabilistic risk analysis, Monte Carlo simulation methods is conducted, and a comprehensive case study of probabilistic risk analysis for a highway construction management is given out, in which the sensitivity analysis and other output from the simulation model are illustrated to support the risk management plan. It is obviously that the probabilistic risk analysis of Monte Carlo simulation could provide very important information for a decision maker.

The Need for a Comprehensive Approach to Managing Confined Space Entry: Summary of the Literature and Recommendations for Next Steps

Despite all the regulatory and standard-setting efforts that have been made in North America, judging from the most recent statistics many fatal incidents related to work in confined spaces still occur. In Canada, fatal incidents in the province of Quebec reveal failures in and absence of the identification and preparation of work situations in confined spaces and in risk management. In this study, we performed a literature review consisting of 77 documents on existing hazards and risk assessment for confined spaces. Moreover, we formulated proposals regarding the design of specific and improved tools for assessing such risks. We found that atmospheric hazards monopolized attention in the literature on confined spaces, while risk estimation specific to confined space interventions received little practical coverage overall, apart from atmospheric hazards. The parameters used to establish classes or groupings of confined spaces in existing tools were imprecise. The development of a risk analysis process that is (i) more systematic and based on the concepts recognized in risk management standards, (ii) multidisciplinary, and (iii) adapted to the specific characteristics of confined spaces is therefore needed. Such a process will better support managers and occupational health and safety (OH&S) personnel in their efforts to prioritize and reduce risks. Suggestions on such a risk analysis tool and categorization of interventions in confined spaces are proposed in this article. Lastly, risk analysis tools adapted to confined space interventions are needed to ensure the inherently safe design of these spaces.

Stretching risk management standards: multi-organizational perspectives

Purpose – Standard frameworks for project risk management (RM) are currently mostly focussed on single-firm organizations, whereas in practice, construction project RM involves multiple organizations. The purpose of this paper is to identify and systematically maps practical processes that bridge the gap between single-organizational RM standards and multi-organizational RM (MORM) needs. Design/methodology/approach – This case study covers three large construction management (CM) projects in Finland. The 35 interviews with project owners, project management consultants, design groups, and contractors identify the participants’ positions on RM roles, integration within organizations, and further development requests. Findings – Most (16 of 21) of the identified RM practices are multi-organizational; i.e. they involve two or more organizations. Compared to single-organizational standards, MORM practices involve less emphasis on detailed risk analysis processes but highlight both participant selection and managing collaborative performance. Research limitations/implications – The research results are attached to Finnish CM projects but may be applicable to other types of collaboration-based construction projects, such as alliances and public-private partnerships. The efficiency of the MORM model requires further evaluation in future research. Practical implications – A model for MORM is a systematic presentation of the research results. The model provides guidance for efficiently setting up MORM processes and for refining multi-organizational research. Originality value – The multi-organizational interfaces of RM processes are mainly overlooked in the current literature, standards, and frameworks. This research provides a rare explication of parallel MORM processes.

The role of AVO in prospect risk assessment

Essentially all companies exploring for oil and gas should perform a risk analysis to understand the uncertainties in their interpretations and to properly value order prospects in a company’s drilling portfolio. For conventional exploration in clastic environments, primarily sands encased in shales, a key component of the risk analysis process is evaluating direct hydrocarbon indicators, which can have a significant impact on the final risk value. We investigate the role AVO plays in the risk assessment process as a portion of a comprehensive and systematic DHI evaluation. Documentation of the geologic context and quantification of data quality and DHI characteristics, including AVO characteristics, is necessary to properly assess a prospect’s risk. A DHI consortium database of over 230 drilled prospects provides statistics to determine the importance of data quality elements, primarily in class 2 and 3 geologic settings. The most important AVO interpretation characteristics are also identified based on statistical results and correlated with well success rates. A significant conclusion is the relevance of AVO in risk analysis when it is the dominant component in the DHI portion of the risk. Critical in the risk assessment process is understanding the role AVO and DHI analysis play when prospects approach class 1 geologic settings. The impact that hydrocarbons have on the seismic response is significantly diminished in this setting versus the other AVO classes. All of these observations confirm the necessity of properly evaluating a prospect’s geologic setting and implementing a consistent and systematic risk analysis process including appropriate DHI and AVO components.

Overview and modeling of mechanical and thermomechanical impact of underground coal gasification exploitation

From an economic point of view Underground Coal Gasification (UCG) is a promising technology that can be used to reach coal resources that are difficult or expensive to by conventional mining methods. Furthermore, the process addresses safety concerns, by avoiding the presence of workers underground. An optimal UCG process requires the integration of various scientific fields (chemistry, geochemistry, geomechanics) and the demonstration of limited of environmental impacts. This paper focuses on the mechanical component of the UCG operation and its impact on the surrounding environment in terms of stability and land subsidence. The mechanical components are also considered. Underground mining by coal combustion UCG challenges include the mechanical behavior of the site and of stability of the overburden rock layers. By studying the underground reactor, its inlet and outlet, we confirm the key role played by mechanical damage and thermo-mechanical phenomena are identified. Deformation or collapse above the cavity may cause a collapse in the overlying layers or subsidence at the surface level. These phenomena are highly dependent on the thermoporomechanical behavior of the rock surrounding the cavity (the host rocks). Unlike conventional methods, the UCG technology introduces an additional variable into the physical problem: the high temperatures, which evolve with time and space. In this framework, we performed numerical analyses of the coal site that could be exploited using this method. The numerical results presented in this paper are derived from models based on different assumptions describing a raw geological background. Several 3D (3 dimensional) and 2D (2 dimensional, plane) nonlinear finite element modelings are performed based on two methods. The first assumes a rock medium as a perfect thermo-elastoplastic continuum. In the second, in order to simulate large space scale crack propagation explicitly, we develop a method based upon finite element deactivation. This method is built on a finite element mesh refinement and uses Mohr-Coulomb failure criterion. Based on the analysis of the numerical results, we can highlight two main factors influencing the behavior and the mechanical stability of the overburden, and consequently the UCG process evolution. The first is the size of the cavity. This geometrical parameter, which is common to all types of coal exploitation, is best controlled using the classic exploitation method. We show that in the case of UCG, the shape of the cavity and its evolution over time can be modified considerably by the thermomechanical behavior of the host rocks. The second is the presence of a heat source whose location and intensity evolve over time. Even if thermal diffusivity of the rock is low and only a small distance from the coal reactor is thermally affected, we show that the induced mechanical changes extend significantly in the overburden, and that subsidence can therefore be estimated at the surface. We conclude the integration of the mechanical analysis into a risk analysis process mechanical analysis can be integrated in a thorough risk analysis.

Debris flows risk analysis and direct loss estimation: the case study of Valtellina di Tirano, Italy

Landslide risk analysis is one of the primary studies providing essential instructions to the subsequent risk management process. The quantification of tangible and intangible potential losses is a critical step because it provides essential data upon which judgments can be made and policy can be formulated. This study aims at quantifying direct economic losses from debris flows at a medium scale in the study area in Italian Central Alps. Available hazard maps were the main inputs of this study. These maps were overlaid with information concerning elements at risk and their economic value. Then, a combination of both market and construction values was used to obtain estimates of future economic losses. As a result, two direct economic risk maps were prepared together with risk curves, useful to summarize expected monetary damage against the respective hazard probability. Afterwards, a qualitative risk map derived using a risk matrix officially provided by the set of laws issued by the regional government, was prepared. The results delimit areas of high economic as well as strategic importance which might be affected by debris flows in the future. Aside from limitations and inaccuracies inherently included in risk analysis process, identification of high risk areas allows local authorities to focus their attention on the “hot-spots”, where important consequences may arise and local (large) scale analysis needs to be performed with more precise cost-effectiveness ratio. The risk maps can be also used by the local authorities to increase population’s adaptive capacity in the disaster prevention process.

Ecological risk analysis and genetically modified salmon: management in the face of uncertainty.

The commercialization of growth hormone transgenic Atlantic salmon for aquaculture has become a controversial public policy issue. Concerns exist over the potential ecological effects of this biotechnology should animals escape captivity. From within an ecological risk-analysis framework, science has been sought to provide decision makers with evidence upon which to base regulatory decisions pertaining to genetically modified salmon. Here I review the available empirical information on the potential ecological and genetic effects of transgenic salmon and discuss the underlying eco-evolutionary science behind the topic. I conclude that data gaps and irreducible epistemic uncertainties limit the role of scientific inference in support of ecological risk management for transgenic salmon. I argue that predictive uncertainties are pervasive in complex eco-evolutionary systems and that it behooves those involved in the risk-analysis process to accept and communicate these limitations in the interest of timely, clear, and cautious risk-management options.

COMPARATIVE ANALYSIS OF TECHNOLOGICAL AND NATECH RISK FOR TWO PETROLEUM PRODUCT TANKS LOCATED IN SEISMIC AREA

The failure of process equipment due to the impact of natural hazards, the so-called Natech events, have generated several industrial accidents, such as Fukushima, Japan - 2011, Ichihara, Japan - 2011, Tupras, Turkey - 1999, Northridge, US - 1994 etc., causing the release of large quantities of hazardous materials in the environment. Earthquakes occupy a leading position in the list of natural hazards with Natech potential, causing serious damage and the loss of containment in process equipment. The present study reveals the importance of Natech risk analyses for industrial sites. The aim of the study is to compare the Individual Risk (IR) and Societal Risk (SR) results between conventional technological risk and Natech risk, related to a possible Natech event triggered by an earthquake for two petroleum products storage tanks, located in an urban area in the South-Eastern part of Romania. The results show an increase of approximately one order of magnitude in the Natech risk compared to technological risk for the selected study area. Results highlight the fact that Natech scenarios should be included in the risk analysis process for technological sites located in natural hazard prone areas and applied for land-use planning purposes as well.

The interface of functional safety with process safety and risk analysis

The fundamental requirement of the IEC 61511/ISA 84 standard on Safety Instrumented Systems (SIS) is to establish the Safety Integrity Levels (SILs) required for Safety Instrumented Functions (SIFs) by evaluating process risks and comparing them to risk tolerance criteria. This article addresses issues that impact the determination of SILs for SIFs and their implications for use of the standard. The issues largely revolve around the interface of the standard with process safety and risk analysis. They include the justification for relative contributions to risk reduction from SIS and non‐SIS protection layers, use of appropriate risk tolerance criteria, difficulties with defining hazardous events consistently, the appropriateness of different SIL determination methods, the importance of fully considering common cause failures, the importance of addressing uncertainties, the need to verify risk reduction for non‐SIS as well as SIS protection layers, the role of systematic failures, and the need to ensure quality in supporting process hazard analysis studies. © 2013 American Institute of Chemical Engineers Process Saf Prog 32: 346–350, 2013

Information Technology Risk Management Using Frap (A Case of Insurance Company)

The purpose of this study was to determine how the application of information technology and the risks of what might happen. Research methods used include literature studies, field studies by conducting observations, interview and study documentation. The approach used to conduct risk management of information technology is a method of Facilitated Risk Analysis Process (FRAP). The results are the discovery of the risks of using information technology. The conclusions of this study demonstrate the application of information technology is good enough because it takes only a little improvement in information technology risk management.

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