Sample records for risk management process

  1. An Extensible Information Grid for Risk Management

    NASA Technical Reports Server (NTRS)

    Maluf, David A.; Bell, David G.

    2003-01-01

    This paper describes recent work on developing an extensible information grid for risk management at NASA - a RISK INFORMATION GRID. This grid is being developed by integrating information grid technology with risk management processes for a variety of risk related applications. To date, RISK GRID applications are being developed for three main NASA processes: risk management - a closed-loop iterative process for explicit risk management, program/project management - a proactive process that includes risk management, and mishap management - a feedback loop for learning from historical risks that escaped other processes. This is enabled through an architecture involving an extensible database, structuring information with XML, schemaless mapping of XML, and secure server-mediated communication using standard protocols.

  2. Sustaining a Mature Risk Management Process: Ensuring the International Space Station for a Vibrant Future

    NASA Technical Reports Server (NTRS)

    Raftery, Michael; Carter-Journet, Katrina

    2013-01-01

    The International Space Station (ISS) risk management methodology is an example of a mature and sustainable process. Risk management is a systematic approach used to proactively identify, analyze, plan, track, control, communicate, and document risks to help management make risk-informed decisions that increase the likelihood of achieving program objectives. The ISS has been operating in space for over 14 years and permanently crewed for over 12 years. It is the longest surviving habitable vehicle in low Earth orbit history. Without a mature and proven risk management plan, it would be increasingly difficult to achieve mission success throughout the life of the ISS Program. A successful risk management process must be able to adapt to a dynamic program. As ISS program-level decision processes have evolved, so too has the ISS risk management process continued to innovate, improve, and adapt. Constant adaptation of risk management tools and an ever-improving process is essential to the continued success of the ISS Program. Above all, sustained support from program management is vital to risk management continued effectiveness. Risk management is valued and stressed as an important process by the ISS Program.

  3. NASA's Risk Management System

    NASA Technical Reports Server (NTRS)

    Perera, Jeevan S.

    2013-01-01

    Phased-approach for implementation of risk management is necessary. Risk management system will be simple, accessible and promote communication of information to all relevant stakeholders for optimal resource allocation and risk mitigation. Risk management should be used by all team members to manage risks - not just risk office personnel. Each group/department is assigned Risk Integrators who are facilitators for effective risk management. Risks will be managed at the lowest-level feasible, elevate only those risks that require coordination or management from above. Risk informed decision making should be introduced to all levels of management. ? Provide necessary checks and balances to insure that risks are caught/identified and dealt with in a timely manner. Many supporting tools, processes & training must be deployed for effective risk management implementation. Process improvement must be included in the risk processes.

  4. NASA's Risk Management System

    NASA Technical Reports Server (NTRS)

    Perera, Jeevan S.

    2011-01-01

    Leadership is key to success. Phased-approach for implementation of risk management is necessary. Risk management system will be simple, accessible and promote communication of information to all relevant stakeholders for optimal resource allocation and risk mitigation. Risk management should be used by all team members to manage risks -- risk office personnel. Each group is assigned Risk Integrators who are facilitators for effective risk management. Risks will be managed at the lowest-level feasible, elevate only those risks that require coordination or management from above. Risk reporting and communication is an essential element of risk management and will combine both qualitative and quantitative elements. Risk informed decision making should be introduced to all levels of management. Provide necessary checks and balances to insure that risks are caught/identified and dealt with in a timely manner. Many supporting tools, processes & training must be deployed for effective risk management implementation. Process improvement must be included in the risk processes.

  5. Risk Management Issues - An Aerospace Perspective

    NASA Technical Reports Server (NTRS)

    Perera, Jeevan S.

    2011-01-01

    Phased-approach for implementation of risk management is necessary. Risk management system will be simple, accessible and promote communication of information to all relevant stakeholders for optimal resource allocation and risk mitigation. Risk management should be used by all team members to manage risks--risk office personnel. Each group is assigned Risk Integrators who are facilitators for effective risk management. Risks will be managed at the lowest-level feasible, elevate only those risks that require coordination or management from above. Risk reporting and communication is an essential element of risk management and will combine both qualitative and quantitative elements.. Risk informed decision making should be introduced to all levels of management. Provide necessary checks and balances to insure that risks are caught/identified and dealt with in a timely manner, Many supporting tools, processes & training must be deployed for effective risk management implementation. Process improvement must be included in the risk processes.

  6. Managing Risk for Cassini During Mission Operations and Data Analysis (MOandDA)

    NASA Technical Reports Server (NTRS)

    Witkowski, Mona M.

    2002-01-01

    A Risk Management Process has been tailored for Cassini that not only satisfies the requirements of NASA and JPL, but also allows the Program to proactively identify and assess risks that threaten mission objectives. Cassini Risk Management is a team effort that involves both management and engineering staff. The process is managed and facilitated by the Mission Assurance Manager (MAM), but requires regular interactions with Program Staff and team members to instill the risk management philosophy into the day to day mission operations. While Risk Management is well defined for projects in the development phase, it is a relatively new concept for Mission Operations. The Cassini team has embraced this process and has begun using it in an effective, proactive manner, to ensure mission success. It is hoped that the Cassini Risk Management Process will form the basis by which risk management is conducted during MO&DA on future projects. proactive in identifying, assessing and mitigating risks before they become problems. Cost ehtiveness is achieved by: Comprehensively identifying risks Rapidly assessing which risks require the expenditure of pruject cewums Taking early actions to mitigate these risks Iterating the process frequently, to be responsive to the dynamic internal and external environments The Cassini Program has successfully implemented a Risk Management Process for mission operations, The initial SRL has been developed and input into he online tool. The Risk Management webbased system has been rolled out for use by the flight team and risk owners we working proactive in identifying, assessing and mitigating risks before they become problems. Cost ehtiveness is achieved by: Comprehensively identifying risks Rapidly assessing which risks require the expenditure of pruject cewums Taking early actions to mitigate these risks Iterating the process frequently, to be responsive to the dynamic internal and external environments The Cassini Program has successfully implemented a Risk Management Process for mission operations, The initial SRL has been developed and input into he online tool. The Risk Management webbased system has been rolled out for use by the flight team and risk owners we working put into place will become visible and will be illusmted in future papers.

  7. Enhanced Capabilities for Subcritical Experiments (ECSE) Risk Management Plan

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Urban, Mary Elizabeth

    Risk is a factor, element, constraint, or course of action that introduces an uncertainty of outcome that could impact project objectives. Risk is an inherent part of all activities, whether the activity is simple and small, or large and complex. Risk management is a process that identifies, evaluates, handles, and monitors risks that have the potential to affect project success. The risk management process spans the entire project, from its initiation to its successful completion and closeout, including both technical and programmatic (non-technical) risks. This Risk Management Plan (RMP) defines the process to be used for identifying, evaluating, handling, andmore » monitoring risks as part of the overall management of the Enhanced Capabilities for Subcritical Experiments (ECSE) ‘Project’. Given the changing nature of the project environment, risk management is essentially an ongoing and iterative process, which applies the best efforts of a knowledgeable project staff to a suite of focused and prioritized concerns. The risk management process itself must be continually applied throughout the project life cycle. This document was prepared in accordance with DOE O 413.3B, Program and Project Management for the Acquisition of Capital Assets, its associated guide for risk management DOE G 413.3-7, Risk Management Guide, and LANL ADPM AP-350-204, Risk and Opportunity Management.« less

  8. 77 FR 13585 - Electricity Subsector Cybersecurity Risk Management Process Guideline

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-03-07

    ... DEPARTMENT OF ENERGY Electricity Subsector Cybersecurity Risk Management Process Guideline AGENCY: Office of Electricity Delivery and Energy Reliability, Department of Energy. ACTION: Notice of public... Electricity Subsector Cybersecurity Risk Management Process guideline. The guideline describes a risk...

  9. 77 FR 30517 - Electricity Subsector Cybersecurity Risk Management Process

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-05-23

    ... DEPARTMENT OF ENERGY Electricity Subsector Cybersecurity Risk Management Process AGENCY: Office of Electricity Delivery and Energy Reliability, Department of Energy. ACTION: Notice of publication. SUMMARY... Electricity Subsector Cybersecurity Risk Management Process guideline. The guideline describes a risk...

  10. Risk-Informed Decision Making: Application to Technology Development Alternative Selection

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon; Maggio, Gaspare; Everett, Christopher

    2010-01-01

    NASA NPR 8000.4A, Agency Risk Management Procedural Requirements, defines risk management in terms of two complementary processes: Risk-informed Decision Making (RIDM) and Continuous Risk Management (CRM). The RIDM process is used to inform decision making by emphasizing proper use of risk analysis to make decisions that impact all mission execution domains (e.g., safety, technical, cost, and schedule) for program/projects and mission support organizations. The RIDM process supports the selection of an alternative prior to program commitment. The CRM process is used to manage risk associated with the implementation of the selected alternative. The two processes work together to foster proactive risk management at NASA. The Office of Safety and Mission Assurance at NASA Headquarters has developed a technical handbook to provide guidance for implementing the RIDM process in the context of NASA risk management and systems engineering. This paper summarizes the key concepts and procedures of the RIDM process as presented in the handbook, and also illustrates how the RIDM process can be applied to the selection of technology investments as NASA's new technology development programs are initiated.

  11. Clinical engineering and risk management in healthcare technological process using architecture framework.

    PubMed

    Signori, Marcos R; Garcia, Renato

    2010-01-01

    This paper presents a model that aids the Clinical Engineering to deal with Risk Management in the Healthcare Technological Process. The healthcare technological setting is complex and supported by three basics entities: infrastructure (IS), healthcare technology (HT), and human resource (HR). Was used an Enterprise Architecture - MODAF (Ministry of Defence Architecture Framework) - to model this process for risk management. Thus, was created a new model to contribute to the risk management in the HT process, through the Clinical Engineering viewpoint. This architecture model can support and improve the decision making process of the Clinical Engineering to the Risk Management in the Healthcare Technological process.

  12. Risk management in medical product development process using traditional FMEA and fuzzy linguistic approach: a case study

    NASA Astrophysics Data System (ADS)

    Kirkire, Milind Shrikant; Rane, Santosh B.; Jadhav, Jagdish Rajaram

    2015-12-01

    Medical product development (MPD) process is highly multidisciplinary in nature, which increases the complexity and the associated risks. Managing the risks during MPD process is very crucial. The objective of this research is to explore risks during MPD in a dental product manufacturing company and propose a model for risk mitigation during MPD process to minimize failure events. A case study approach is employed. The existing MPD process is mapped with five phases of the customized phase gate process. The activities during each phase of development and risks associated with each activity are identified and categorized based on the source of occurrence. The risks are analyzed using traditional Failure mode and effect analysis (FMEA) and fuzzy FMEA. The results of two methods when compared show that fuzzy approach avoids the duplication of RPNs and helps more to convert cognition of experts into information to get values of risk factors. The critical, moderate, low level and negligible risks are identified based on criticality; risk treatments and mitigation model are proposed. During initial phases of MPD, the risks are less severe, but as the process progresses the severity of risks goes on increasing. The MPD process should be critically designed and simulated to minimize the number of risk events and their severity. To successfully develop the products/devices within the manufacturing companies, the process risk management is very essential. A systematic approach to manage risks during MPD process will lead to the development of medical products with expected quality and reliability. This is the first research of its kind having focus on MPD process risks and its management. The methodology adopted in this paper will help the developers, managers and researchers to have a competitive edge over the other companies by managing the risks during the development process.

  13. Assessing and Managing Multiple Risks in a Changing World ...

    EPA Pesticide Factsheets

    Roskilde University hosted a November 2015 workshop on “Environmental Risk – Assessing and Managing Multiple Risks in a Changing World”. Thirty attendees from 9 countries developed consensus recommendations regarding: implementation of a common currency (ecosystem services) for holistic environmental risk assessment and management; improvements to risk assessment and management in a complex, human-modified, and changing world; appropriate development of protection goals in a 2-stage process involving both universal and site-, region-, or problem-specific protection goals; addressing societal issues; risk management information needs; conducting risk assessment of risk management; and development of adaptive and flexible regulatory systems. We encourage both cross- and inter-disciplinary approaches to address 10 recommendations: 1) adopt ecosystem services as a common currency for risk assessment and management; 2) consider cumulative stressors (chemical and non-chemical) and determine which dominate to best manage and restore ecosystem services; 3) fully integrate risk managers and communities of interest into the risk assessment process; 4) fully integrate risk assessors and communities of interest into the risk management process; 5) consider socio-economics and increase transparency in both risk assessment and risk management; 6) recognize the ethical rights of humans and ecosystems to an adequate level of protection; 7) determine relevant reference con

  14. Assessing and managing multiple risks in a changing world ...

    EPA Pesticide Factsheets

    Roskilde University (Denmark) hosted a November 2015 workshop, Environmental Risk—Assessing and Managing Multiple Risks in a Changing World. This Focus article presents the consensus recommendations of 30 attendees from 9 countries regarding implementation of a common currency (ecosystem services) for holistic environmental risk assessment and management; improvements to risk assessment and management in a complex, human-modified, and changing world; appropriate development of protection goals in a 2-stage process; dealing with societal issues; risk-management information needs; conducting risk assessment of risk management; and development of adaptive and flexible regulatory systems. The authors encourage both cross-disciplinary and interdisciplinary approaches to address their 10 recommendations: 1) adopt ecosystem services as a common currency for risk assessment and management; 2) consider cumulative stressors (chemical and nonchemical) and determine which dominate to best manage and restore ecosystem services; 3) fully integrate risk managers and communities of interest into the risk-assessment process; 4) fully integrate risk assessors and communities of interest into the risk-management process; 5) consider socioeconomics and increased transparency in both risk assessment and risk management; 6) recognize the ethical rights of humans and ecosystems to an adequate level of protection; 7) determine relevant reference conditions and the proper ecological c

  15. A review of risk management process in construction projects of developing countries

    NASA Astrophysics Data System (ADS)

    Bahamid, R. A.; Doh, S. I.

    2017-11-01

    In the construction industry, risk management concept is a less popular technique. There are three main stages in the systematic approach to risk management in construction industry. These stages include: a) risk response; b) risk analysis and evaluation; and c) risk identification. The high risk related to construction business affects each of its participants; while operational analysis and management of construction related risks remain an enormous task to practitioners of the industry. This paper tends towards reviewing the existing literature on construction project risk managements in developing countries specifically on risk management process. The literature lacks ample risk management process approach capable of capturing risk impact on diverse project objectives. This literature review aims at discovering the frequently used techniques in risk identification and analysis. It also attempts to identify response to clarifying the different classifications of risk sources in the existing literature of developing countries, and to identify the future research directions on project risks in the area of construction in developing countries.

  16. Decision making for wildfires: A guide for applying a risk management process at the incident level

    Treesearch

    Mary A. Taber; Lisa M. Elenz; Paul G. Langowski

    2013-01-01

    This publication focuses on the thought processes and considerations surrounding a risk management process for decision making on wildfires. The publication introduces a six element risk management cycle designed to encourage sound risk-informed decision making in accordance with Federal wildland fire policy, although the process is equally applicable to non-Federal...

  17. Risk Management Structured for Today's Environment

    NASA Technical Reports Server (NTRS)

    Greenfield, Michael A.

    1998-01-01

    In NPG (NASA Procedures and Guidelines) 7120.5A, we define risk management as "an organized, systematic decision-making process that efficiently identifies, analyzes, plans, tracks, controls, and communicates and documents risk in order to increase the likelihood of achieving program/project goals." Effective risk management depends upon a thorough understanding of the concept of risk, the principles of risk management and the formation of a disciplined risk management process. In human spaceflight programs, NASA has always maintained a rigorous and highly structured risk management effort. When lives are at stake, NASA's missions must be 100% safe; the risk management approach used in human spaceflight has always been comprehensive.

  18. Integrated Risk Management Within NASA Programs/Projects

    NASA Technical Reports Server (NTRS)

    Connley, Warren; Rad, Adrian; Botzum, Stephen

    2004-01-01

    As NASA Project Risk Management activities continue to evolve, the need to successfully integrate risk management processes across the life cycle, between functional disciplines, stakeholders, various management policies, and within cost, schedule and performance requirements/constraints become more evident and important. Today's programs and projects are complex undertakings that include a myriad of processes, tools, techniques, management arrangements and other variables all of which must function together in order to achieve mission success. The perception and impact of risk may vary significantly among stakeholders and may influence decisions that may have unintended consequences on the project during a future phase of the life cycle. In these cases, risks may be unintentionally and/or arbitrarily transferred to others without the benefit of a comprehensive systemic risk assessment. Integrating risk across people, processes, and project requirements/constraints serves to enhance decisions, strengthen communication pathways, and reinforce the ability of the project team to identify and manage risks across the broad spectrum of project management responsibilities. The ability to identify risks in all areas of project management increases the likelihood a project will identify significant issues before they become problems and allows projects to make effective and efficient use of shrinking resources. By getting a total team integrated risk effort, applying a disciplined and rigorous process, along with understanding project requirements/constraints provides the opportunity for more effective risk management. Applying an integrated approach to risk management makes it possible to do a better job at balancing safety, cost, schedule, operational performance and other elements of risk. This paper will examine how people, processes, and project requirements/constraints can be integrated across the project lifecycle for better risk management and ultimately improve the chances for mission success.

  19. 76 FR 57723 - Electricity Sector Cybersecurity Risk Management Process Guideline

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-09-16

    ... DEPARTMENT OF ENERGY Electricity Sector Cybersecurity Risk Management Process Guideline AGENCY... public comment on DOE's intent to publish the Electricity Sector Cybersecurity Risk Management Process... electricity sector organizations and adds to the body of resources that help refine the definition and...

  20. New Tools and Methods for Assessing Risk-Management Strategies

    DTIC Science & Technology

    2004-03-01

    Theories to evaluate the risks and benefits of various acquisition alternatives and allowed researchers to monitor the process students used to make a...revealed distinct risk-management strategies. 15. SUBJECT TERMS risk managements, acquisition process, expected value theory , multi-attribute utility theory ...Utility Theories to evaluate the risks and benefits of various acquisition alternatives, and allowed us to monitor the process subjects used to arrive at

  1. A Proactive and Top-Down Approach to Managing Risk at NASA

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon

    2010-01-01

    Our ultimate goal is to manage risk in a holistic and coherent fashion across the Agency: a) The RIDM process is intended to risk-inform direction-setting decisions. c) The CRM process is intended to manage risk associated with the implementation of baseline performance requirements. Currently we are working on: a) Enhancements to the CRM process. b) Better integration of the RIDM and CRM processes. c) Better integration of institutional risk considerations into RM framework.

  2. Risk Management for the International Space Station

    NASA Technical Reports Server (NTRS)

    Sebastian, J.; Brezovic, Philip

    2002-01-01

    The International Space Station (ISS) is an extremely complex system, both technically and programmatically. The Space Station must support a wide range of payloads and missions. It must be launched in numerous launch packages and be safely assembled and operated in the harsh environment of space. It is being designed and manufactured by many organizations, including the prime contractor, Boeing, the NASA institutions, and international partners and their contractors. Finally, the ISS has multiple customers, (e.g., the Administration, Congress, users, public, international partners, etc.) with contrasting needs and constraints. It is the ISS Risk Management Office strategy to proactively and systematically manages risks to help ensure ISS Program success. ISS program follows integrated risk management process (both quantitative and qualitative) and is integrated into ISS project management. The process and tools are simple and seamless and permeate to the lowest levels (at a level where effective management can be realized) and follows the continuous risk management methodology. The risk process assesses continually what could go wrong (risks), determine which risks need to be managed, implement strategies to deal with those risks, and measure effectiveness of the implemented strategies. The process integrates all facets of risk including cost, schedule and technical aspects. Support analysis risk tools like PRA are used to support programatic decisions and assist in analyzing risks.

  3. Guidelines for developing NASA (National Aeronautics and Space Administration) ADP security risk management plans

    NASA Technical Reports Server (NTRS)

    Tompkins, F. G.

    1983-01-01

    This report presents guidance to NASA Computer security officials for developing ADP security risk management plans. The six components of the risk management process are identified and discussed. Guidance is presented on how to manage security risks that have been identified during a risk analysis performed at a data processing facility or during the security evaluation of an application system.

  4. From Process to Product: Your Risk Process at Work

    NASA Technical Reports Server (NTRS)

    Kundrot, Craig E.; Fogarty, Jenifer; Charles, John; Buquo, Lynn; Sibonga, Jean; Alexander, David; Horn, Wayne G.; Edwards, J. Michelle

    2010-01-01

    The Space Life Sciences Directorate (SLSD) and Human Research Program (HRP) at the NASA/Johnson Space Center work together to address and manage the human health and performance risks associated with human space flight. This includes all human system requirements before, during, and after space flight, providing for research, and managing the risk of adverse long-term health outcomes for the crew. We previously described the framework and processes developed for identifying and managing these human system risks. The focus of this panel is to demonstrate how the implementation of the framework and associated processes has provided guidance in the management and communication of human system risks. The risks of early onset osteoporosis, CO2 exposure, and intracranial hypertension in particular have all benefitted from the processes developed for human system risk management. Moreover, we are continuing to develop capabilities, particularly in the area of information architecture, which will also be described. We are working to create a system whereby all risks and associated actions can be tracked and related to one another electronically. Such a system will enhance the management and communication capabilities for the human system risks, thereby increasing the benefit to researchers and flight surgeons.

  5. Software And Systems Engineering Risk Management

    DTIC Science & Technology

    2010-04-01

    RSKM 2004 COSO Enterprise RSKM Framework 2006 ISO/IEC 16085 Risk Management Process 2008 ISO/IEC 12207 Software Lifecycle Processes 2009 ISO/IEC...1 Software And Systems Engineering Risk Management John Walz VP Technical and Conferences Activities, IEEE Computer Society Vice-Chair Planning...Software & Systems Engineering Standards Committee, IEEE Computer Society US TAG to ISO TMB Risk Management Working Group Systems and Software

  6. [Does clinical risk management require a structured conflict management?].

    PubMed

    Neumann, Stefan

    2015-01-01

    A key element of clinical risk management is the analysis of errors causing near misses or patient damage. After analyzing the causes and circumstances, measures for process improvement have to be taken. Process management, human resource development and other established methods are used. If an interpersonal conflict is a contributory factor to the error, there is usually no structured conflict management available which includes selection criteria for various methods of conflict processing. The European University Viadrina in Frankfurt (Oder) has created a process model for introducing a structured conflict management system which is suitable for hospitals and could fill the gap in the methodological spectrum of clinical risk management. There is initial evidence that a structured conflict management reduces staff fluctuation and hidden conflict costs. This article should be understood as an impulse for discussion on to what extent the range of methods of clinical risk management should be complemented by conflict management.

  7. Risk management frameworks for human health and environmental risks.

    PubMed

    Jardine, Cindy; Hrudey, Steve; Shortreed, John; Craig, Lorraine; Krewski, Daniel; Furgal, Chris; McColl, Stephen

    2003-01-01

    A comprehensive analytical review of the risk assessment, risk management, and risk communication approaches currently being undertaken by key national, provincial/state, territorial, and international agencies was conducted. The information acquired for review was used to identify the differences, commonalities, strengths, and weaknesses among the various approaches, and to identify elements that should be included in an effective, current, and comprehensive approach applicable to environmental, human health and occupational health risks. More than 80 agencies, organizations, and advisory councils, encompassing more than 100 risk documents, were examined during the period from February 2000 until November 2002. An overview was made of the most important general frameworks for risk assessment, risk management, and risk communication for human health and ecological risk, and for occupational health risk. In addition, frameworks for specific applications were reviewed and summarized, including those for (1)contaminated sites; (2) northern contaminants; (3) priority substances; (4) standards development; (5) food safety; (6) medical devices; (7) prescription drug use; (8) emergency response; (9) transportation; (10) risk communication. Twelve frameworks were selected for more extensive review on the basis of representation of the areas of human health, ecological, and occupational health risk; relevance to Canadian risk management needs; representation of comprehensive and well-defined approaches; generalizability with their risk areas; representation of "state of the art" in Canada, the United States, and/or internationally; and extent of usage of potential usage within Canada. These 12 frameworks were: 1. Framework for Environmental Health Risk Management (US Presidential/Congressional Commission on Risk Assessment and Risk Management, 1997). 2. Health Risk Determination: The Challenge of Health Protection (Health and Welfare Canada, 1990). 3. Health Canada Decision-Making Framework for Identifying, Assessing and Managing Health Risks (Health Canada, 2000). 4. Canadian Environmental Protection Act: Human Health Risk Assessment of Priority Substances(Health Canada, 1994). 5. CSA-Q8550 Risk Management: Guidelines for Decision-Makers (Canada Standards Association, 1997). 6. Risk Assessment in the Federal Government: Managing the Process (US National Research Council, 1983). 7. Understanding Risk: Informing Decisions in a Democratic Society (US National Research Council, 1996). 8. Environmental Health Risk Assessment (enHealth Council of Australia, 2002). 9. A Framework for Ecological Risk Assessment (CCME, 1996). 10. Ecological Risk Assessments of Priority Substances Under the Canadian Environmental Protection Act (Environment Canada, 1996).11. Guidelines for Ecological Risk Assessment (US EPA, 1998b). 12. Proposed Model for Occupational Health Risk Assessment and Management (Rampal & Sadhra, 1999). Based on the extensive review of these frameworks, seven key elements that should be included in a comprehensive framework for human health, ecological, and occupational risk assessment and management were identified: 1. Problem formulation stage. 2. Stakeholder involvement. 3. Communication. 4. Quantitative risk assessment components. 5. Iteration and evaluation. 6. Informed decision making. 7. Flexibility. On the basis of this overarching approach to risk management, the following "checklist" to ensure a good risk management decision is proposed: - Make sure you're solving the right problem. - Consider the problem and the risk within the full context of the situation, using a broad perspective. - Acknowledge, incorporate, and balance the multiple dimensions of risk. - Ensure the highest degree of reliability for all components of the risk management process. - Involve interested and effected parties from the outset of the process. - Commit to honest and open communication between all parties. - Employ continuous evaluation throughout the process (formative, process, and outcome evaluation), and be prepared to change the decision if new information becomes available. Comprehensive and sound principles are critical to providing structure and integrity to risk management frameworks. Guiding principles are intended to provide an ethical grounding for considering the many factors involved in risk management decision making. Ten principles are proposed to guide risk management decision making. The first four principles were adapted and modified from Hattis (1996) along with the addition of two more principles by Hrudey (2000). These have been supplemented by another four principles to make the 10 presented. The principles are based in fundamental ethical principles and values. These principles are intended to be aspirational rather than prescriptive--their application requires flexibility and practical judgement. Risk management is inherently a process in search of balance among competing interests and concerns. Each risk management decision will be "balancing act" of competing priorities, and trade-offs may sometimes have to be made between seemingly conflicting principles. The 10 decision-making principles, with the corresponding ethical principle in italics are: 1. Do more good than harm (beneficence, nonmalificence).- The ultimate goal of good risk management is to prevent or minimize risk, or to "do good" as much as possible. 2. Fair process of decision making (fairness, natural justice). - Risk management must be just, equitable, impartial, unbiased, dispassionate, and objective as far as possible given the circumstances of each situation. 3. Ensure an equitable distribution of risk (equity). - An equitable process of risk management would ensure fair outcomes and equal treatment of all concerned through an equal distribution of benefits and burdens (includes the concept of distributive justice, i.e., equal opportunities for all individuals). 4. Seek optimal use of limited risk management resources (utility). - Optimal risk management demands using limited resources where they will achieve the most risk reduction of overall benefit. 5. Promise no more risk management that can be delivered (honesty).- Unrealistic expectations of risk management can be avoided with honest and candid public accounting of what we know and don't know, and what we can and can't do using risk assessment and risk management. 6. Impose no more risk that you would tolerate yourself (the Golden Rule). - The Golden Rule is important in risk management because it forces decision makers to abandon complete detachment from their decisions so they may understand the perspectives of those affected. 7. Be cautious in the face of uncertainty ("better safe than sorry"). - Risk management must adopt a cautious approach when faced with a potentially serous risk, even if the evidence is uncertain. 8. Foster informed risk decision making for all stakeholders (autonomy). - Fostering autonomous decision making involves both providing people with the opportunity to participate, and full and honest disclosure of all the information required for informed decisions. 9. Risk management processes must be flexible and evolutionary to be open to new knowledge and understanding (evolution, evaluation, iterative process). - The incorporation of new evidence requires that risk management be a flexible, evolutionary, and iterative process, and that evaluation is employed at the beginning and througthout the process. 10. the complete elimination fo risk is not possible (life is not risk free).- Risk is pervasive in our society, and cannot be totally eliminated despite an oft-expressed public desire for "zero risk". However, the level of risk that may ve tolerable by any individual is dependent on values of beliefs, as well as scientific information. Each agency must continue to employ a process that meets the needs of their specific application of risk management. A single approach cannot satisfy the diverse areas to which risk decisions are being applied. However, with increasing experience in the application of the approaches, we are evolving to a common understanding of the essential elements and principles required for successful risk assessment, risk management, and risk communication. Risk management will continue to be a balancing act of competing priorities and needs. Flexibility and good judgement are ultimately the key to successfully making appropriate risk decisions.

  8. Assessing and managing multiple risks in a changing world-The Roskilde recommendations.

    PubMed

    Selck, Henriette; Adamsen, Peter B; Backhaus, Thomas; Banta, Gary T; Bruce, Peter K H; Burton, G Allen; Butts, Michael B; Boegh, Eva; Clague, John J; Dinh, Khuong V; Doorn, Neelke; Gunnarsson, Jonas S; Hauggaard-Nielsen, Henrik; Hazlerigg, Charles; Hunka, Agnieszka D; Jensen, John; Lin, Yan; Loureiro, Susana; Miraglia, Simona; Munns, Wayne R; Nadim, Farrokh; Palmqvist, Annemette; Rämö, Robert A; Seaby, Lauren P; Syberg, Kristian; Tangaa, Stine R; Thit, Amalie; Windfeld, Ronja; Zalewski, Maciej; Chapman, Peter M

    2017-01-01

    Roskilde University (Denmark) hosted a November 2015 workshop, Environmental Risk-Assessing and Managing Multiple Risks in a Changing World. This Focus article presents the consensus recommendations of 30 attendees from 9 countries regarding implementation of a common currency (ecosystem services) for holistic environmental risk assessment and management; improvements to risk assessment and management in a complex, human-modified, and changing world; appropriate development of protection goals in a 2-stage process; dealing with societal issues; risk-management information needs; conducting risk assessment of risk management; and development of adaptive and flexible regulatory systems. The authors encourage both cross-disciplinary and interdisciplinary approaches to address their 10 recommendations: 1) adopt ecosystem services as a common currency for risk assessment and management; 2) consider cumulative stressors (chemical and nonchemical) and determine which dominate to best manage and restore ecosystem services; 3) fully integrate risk managers and communities of interest into the risk-assessment process; 4) fully integrate risk assessors and communities of interest into the risk-management process; 5) consider socioeconomics and increased transparency in both risk assessment and risk management; 6) recognize the ethical rights of humans and ecosystems to an adequate level of protection; 7) determine relevant reference conditions and the proper ecological context for assessments in human-modified systems; 8) assess risks and benefits to humans and the ecosystem and consider unintended consequences of management actions; 9) avoid excessive conservatism or possible underprotection resulting from sole reliance on binary, numerical benchmarks; and 10) develop adaptive risk-management and regulatory goals based on ranges of uncertainty. Environ Toxicol Chem 2017;36:7-16. © 2016 SETAC. © 2016 SETAC.

  9. Identifying risks in the realm of enterprise risk management.

    PubMed

    Carroll, Roberta

    2016-01-01

    An enterprise risk management (ERM) discipline is comprehensive and organization-wide. The effectiveness of ERM is governed in part by the strength and breadth of its practices and processes. An essential element in decision making is a thorough process by which organizational risks and value opportunities can be identified. This article will offer identification techniques that go beyond those used in traditional risk management programs and demonstrate how these techniques can be used to identify risks and opportunity in the ERM environment. © 2016 American Society for Healthcare Risk Management of the American Hospital Association.

  10. Systems Security Engineering Capability Maturity Model SSE-CMM Model Description Document

    DTIC Science & Technology

    1999-04-01

    management is the process of accessing and quantifying risk , and establishing an acceptable level of risk for the organization. Managing risk is an...Process of assessing and quantifying risk and establishing acceptable level of risk for the organization. [IEEE 13335-1:1996] Security Engineering

  11. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Glantz, C.S.; DiMassa, F.V.; Pelto, P.J.

    The Western Area Power Administration (Western) views environmental protection and compliance as a top priority as it manages the construction, operation, and maintenance of its vast network of transmission lines, substations, and other facilities. A recent Department of Energy audit of Western`s environmental management activities recommends that Western adopt a formal environmental risk program. To accomplish this goal, Western, in conjunction with Pacific Northwest Laboratory, is in the process of developing a centrally coordinated environmental risk program. This report presents the results of this design effort, and indicates the direction in which Western`s environmental risk program is heading. Western`s environmentalmore » risk program will consist of three main components: risk communication, risk assessment, and risk management/decision making. Risk communication is defined as an exchange of information on the potential for threats to human health, public safety, or the environment. This information exchange provides a mechanism for public involvement, and also for the participation in the risk assessment and management process by diverse groups or offices within Western. The objective of risk assessment is to evaluate and rank the relative magnitude of risks associated with specific environmental issues that are facing Western. The evaluation and ranking is based on the best available scientific information and judgment and serves as input to the risk management process. Risk management takes risk information and combines it with relevant non-risk factors (e.g., legal mandates, public opinion, costs) to generate risk management options. A risk management tool, such as decision analysis, can be used to help make risk management choices.« less

  12. PDA survey of quality risk management practices in the pharmaceutical, devices, & biotechnology industries.

    PubMed

    Ahmed, Ruhi; Baseman, Harold; Ferreira, Jorge; Genova, Thomas; Harclerode, William; Hartman, Jeffery; Kim, Samuel; Londeree, Nanette; Long, Michael; Miele, William; Ramjit, Timothy; Raschiatore, Marlene; Tomonto, Charles

    2008-01-01

    In July 2006 the Parenteral Drug Association's Risk Management Task Force for Aseptic Processes, conducted an electronic survey of PDA members to determine current industry practices regarding implementation of Quality Risk Management in their organizations. This electronic survey was open and publicly available via the PDA website and targeted professionals in our industry who are involved in initiating, implementing, or reviewing risk management programs or decisions in their organizations. One hundred twenty-nine members participated and their demographics are presented in the sidebar "Correspondents Profile". Among the major findings are: *The "Aseptic Processing/Filling" operation is the functional area identified as having the greatest need for risk assessment and quality risk management. *The most widely used methodology in industry to identify risk is Failure Mode and Effects Analysis (FMEA). This tool was most widely applied in assessing change control and for adverse event, complaint, or failure investigations. *Despite the fact that personnel training was identified as the strategy most used for controlling/minimizing risk, the largest contributors to sterility failure in operations are still "Personnel". *Most companies still rely on "Manufacturing Controls" to mitigate risk and deemed the utilization of Process Analytical Technology (PAT) least important in this aspect. *A majority of correspondents verified that they did not periodically assess their risk management programs. *A majority of the correspondents desired to see case studies or examples of risk analysis implementation (as applicable to aseptic processing) in future PDA technical reports on risk management.

  13. Managing Research in a Risk World

    NASA Technical Reports Server (NTRS)

    Anton, W.; Havenhill, M.

    2014-01-01

    The Office of Chief Medical Officer (OCHMO) owns all human health and performance risks managed by the Human System Risk Board (HSRB). While the HSRB manages the risks, the Human Research Program (HRP) manages the research portion of the overall risk mitigation strategy for these risks. The HSRB manages risks according to a process that identifies and analyzes risks, plans risk mitigation and tracks and reviews the implementation of these strategies according to its decisions pertaining to the OCHMO risk posture. HRP manages risk research work using an architecture that describes evidence-based risks, gaps in our knowledge about characterizing or mitigating the risk, and the tasks needed to produce deliverables to fill the gaps and reduce the risk. A planning schedule reflecting expected research milestones is developed, and as deliverables and new evidence are generated, research progress is tracked via the Path to Risk Reduction (PRR) that reflects a risk's research plan for a design reference mission. HRP's risk research process closely interfaces with the HSRB risk management process. As research progresses, new deliverables and evidence are used by the HSRB in conjunction with other operational and non-research evidence to inform decisions pertaining to the likelihood and consequence of the risk and risk posture. Those decisions in turn guide forward work for research as it contributes to overall risk mitigation strategies. As HRP tracks its research work, it aligns its priorities by assessing the effectiveness of its contributions and maintaining specific core competencies that would be invaluable for future work for exploration missions.

  14. Achieving a Risk-Informed Decision-Making Environment at NASA: The Emphasis of NASA's Risk Management Policy

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon

    2010-01-01

    This slide presentation reviews the evolution of risk management (RM) at NASA. The aim of the RM approach at NASA is to promote an approach that is heuristic, proactive, and coherent across all of NASA. Risk Informed Decision Making (RIDM) is a decision making process that uses a diverse set of performance measures along with other considerations within a deliberative process to inform decision making. RIDM is invoked for key decisions such as architecture and design decisions, make-buy decisions, and budget reallocation. The RIDM process and how it relates to the continuous Risk Management (CRM) process is reviewed.

  15. 77 FR 9237 - Agency Information Collection Activities; Proposed Collection; Comment Request; Risk Management...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-02-16

    ... Activities; Proposed Collection; Comment Request; Risk Management Program Requirements and Petitions To..., non-chemical manufacturers, etc. Title: Risk Management Program Requirements and Petitions to Modify... regulated substance in a process develop and implement a risk management program and submit a risk...

  16. Development of risk-based air quality management strategies under impacts of climate change.

    PubMed

    Liao, Kuo-Jen; Amar, Praveen; Tagaris, Efthimios; Russell, Armistead G

    2012-05-01

    Climate change is forecast to adversely affect air quality through perturbations in meteorological conditions, photochemical reactions, and precursor emissions. To protect the environment and human health from air pollution, there is an increasing recognition of the necessity of developing effective air quality management strategies under the impacts of climate change. This paper presents a framework for developing risk-based air quality management strategies that can help policy makers improve their decision-making processes in response to current and future climate change about 30-50 years from now. Development of air quality management strategies under the impacts of climate change is fundamentally a risk assessment and risk management process involving four steps: (1) assessment of the impacts of climate change and associated uncertainties; (2) determination of air quality targets; (3) selections of potential air quality management options; and (4) identification of preferred air quality management strategies that minimize control costs, maximize benefits, or limit the adverse effects of climate change on air quality when considering the scarcity of resources. The main challenge relates to the level of uncertainties associated with climate change forecasts and advancements in future control measures, since they will significantly affect the risk assessment results and development of effective air quality management plans. The concept presented in this paper can help decision makers make appropriate responses to climate change, since it provides an integrated approach for climate risk assessment and management when developing air quality management strategies. Development of climate-responsive air quality management strategies is fundamentally a risk assessment and risk management process. The risk assessment process includes quantification of climate change impacts on air quality and associated uncertainties. Risk management for air quality under the impacts of climate change includes determination of air quality targets, selections of potential management options, and identification of effective air quality management strategies through decision-making models. The risk-based decision-making framework can also be applied to develop climate-responsive management strategies for the other environmental dimensions and assess costs and benefits of future environmental management policies.

  17. Continuous Risk Management: A NASA Program Initiative

    NASA Technical Reports Server (NTRS)

    Hammer, Theodore F.; Rosenberg, Linda

    1999-01-01

    NPG 7120.5A, "NASA Program and Project Management Processes and Requirements" enacted in April, 1998, requires that "The program or project manager shall apply risk management principles..." The Software Assurance Technology Center (SATC) at NASA GSFC has been tasked with the responsibility for developing and teaching a systems level course for risk management that provides information on how to comply with this edict. The course was developed in conjunction with the Software Engineering Institute at Carnegie Mellon University, then tailored to the NASA systems community. This presentation will briefly discuss the six functions for risk management: (1) Identify the risks in a specific format; (2) Analyze the risk probability, impact/severity, and timeframe; (3) Plan the approach; (4) Track the risk through data compilation and analysis; (5) Control and monitor the risk; (6) Communicate and document the process and decisions.

  18. Continuous Risk Management at NASA

    NASA Technical Reports Server (NTRS)

    Hammer, Theodore F.; Rosenberg, Linda

    1999-01-01

    NPG 7120.5A, "NASA Program and Project Management Processes and Requirements" enacted in April, 1998, requires that "The program or project manager shall apply risk management principles..." The Software Assurance Technology Center (SATC) at NASA GSFC has been tasked with the responsibility for developing and teaching a systems level course for risk management that provides information on how to comply with this edict. The course was developed in conjunction with the Software Engineering Institute at Carnegie Mellon University, then tailored to the NASA systems community. This presentation will briefly discuss the six functions for risk management: (1) Identify the risks in a specific format; (2) Analyze the risk probability, impact/severity, and timeframe; (3) Plan the approach; (4) Track the risk through data compilation and analysis; (5) Control and monitor the risk; (6) Communicate and document the process and decisions. This risk management structure of functions has been taught to projects at all NASA Centers and is being successfully implemented on many projects. This presentation will give project managers the information they need to understand if risk management is to be effectively implemented on their projects at a cost they can afford.

  19. Dynamic Data Management Based on Archival Process Integration at the Centre for Environmental Data Archival

    NASA Astrophysics Data System (ADS)

    Conway, Esther; Waterfall, Alison; Pepler, Sam; Newey, Charles

    2015-04-01

    In this paper we decribe a business process modelling approach to the integration of exisiting archival activities. We provide a high level overview of existing practice and discuss how procedures can be extended and supported through the description of preservation state. The aim of which is to faciliate the dynamic controlled management of scientific data through its lifecycle. The main types of archival processes considered are: • Management processes that govern the operation of an archive. These management processes include archival governance (preservation state management, selection of archival candidates and strategic management) . • Operational processes that constitute the core activities of the archive which maintain the value of research assets. These operational processes are the acquisition, ingestion, deletion, generation of metadata and preservation actvities, • Supporting processes, which include planning, risk analysis and monitoring of the community/preservation environment. We then proceed by describing the feasability testing of extended risk management and planning procedures which integrate current practices. This was done through the CEDA Archival Format Audit which inspected British Atmospherics Data Centre and National Earth Observation Data Centre Archival holdings. These holdings are extensive, comprising of around 2PB of data and 137 million individual files which were analysed and characterised in terms of format based risk. We are then able to present an overview of the risk burden faced by a large scale archive attempting to maintain the usability of heterogeneous environmental data sets. We conclude by presenting a dynamic data management information model that is capable of describing the preservation state of archival holdings throughout the data lifecycle. We provide discussion of the following core model entities and their relationships: • Aspirational entities, which include Data Entity definitions and their associated Preservation Objectives. • Risk entities, which act as drivers for change within the data lifecycle. These include Acquisitional Risks, Technical Risks, Strategic Risks and External Risks • Plan entities, which detail the actions to bring about change within an archive. These include Acquisition Plans, Preservation Plans and Monitoring plans • The Result entities describe the successful outcomes of the executed plans. These include Acquisitions, Mitigations and Accepted Risks.

  20. Summary of Results from the Risk Management Program for the Mars Microrover Flight Experiment

    NASA Technical Reports Server (NTRS)

    Shishko, Robert; Matijevic, Jacob R.

    2000-01-01

    On 4 July 1997, the Mars Pathfinder landed on the surface of Mars carrying the first planetary rover, known as the Sojourner. Formally known as the Microrover Flight Experiment (MFEX), the Sojourner was a low cost, high-risk technology demonstration, in which new risk management techniques were tried. This paper summarizes the activities and results of the effort to conduct a low-cost, yet meaningful risk management program for the MFEX. The specific activities focused on cost, performance, schedule, and operations risks. Just as the systems engineering process was iterative and produced successive refinements of requirements, designs, etc., so was the risk management process. Qualitative risk assessments were performed first to gain some insights for refining the microrover design and operations concept. These then evolved into more quantitative analyses. Risk management lessons from the manager's perspective is presented for other low-cost, high-risk space missions.

  1. Risk Management

    DTIC Science & Technology

    2011-06-02

    actively attack the risks, they will actively attack you.” -Tom Gib Why do Risk Management? 8 “The first step in the risk management process is to...opportunities to manage and improve our chances of success. - Roger Vanscoy “If you do not actively attack the risks, they will actively attack ...our risks provides opportunities to manage and improve our chances of success. - Roger Vanscoy “If you do not actively attack the risks, they will

  2. Decisionmaking under risk in invasive species management: risk management theory and applications

    Treesearch

    Shefali V. Mehta; Robert G. Haight; Frances R. Homans

    2010-01-01

    Invasive species management is closely entwined with the assessment and management of risk that arises from the inherently random nature of the invasion process. The theory and application of risk management for invasive species with an economic perspective is reviewed in this synthesis. Invasive species management can be delineated into three general categories:...

  3. Improving the U.S. Navy’s Execution of Technical Authority through a Common Risk Management and Technical Assessment Process

    DTIC Science & Technology

    2008-09-01

    ITP . Assessment Indicators: • Has the risk management team (RMT) provided a risk management plan (RMP)? − Does the RMP provide an organized...processes. Diskettes, which contain the necessary programs for accessing BMP◊NET from IBM -compatible or Macintosh computers with a modem, and answers to

  4. Risk Quantification of Systems Engineering Documents Improves Probability of DOD Project Success

    DTIC Science & Technology

    2009-09-01

    comprehensive risk model for DoD milestone review documentation as well as recommended changes to the Capability Maturity Model Integration ( CMMI ) Project...Milestone Documentation, Project Planning, Rational Frame, Political Frame, CMMI Project Planning Process Area, CMMI Risk Management Process Area...well as recommended changes to the Capability Maturity Model Integration ( CMMI ) Project Planning and Risk Management process areas. The intent is to

  5. Risk management through staff education.

    PubMed

    Seisser, M A; Epstein, A L

    1998-01-01

    The staff members of a healthcare organization are recognized as students of risk management. The risk manager, through application of the fundamentals of andragogy (i.e., learning strategies specific to adult learners), is in an advantageous position to assist staff in successfully applying risk management thought processes and related actions.

  6. Risk Management in Biologics Technology Transfer.

    PubMed

    Toso, Robert; Tsang, Jonathan; Xie, Jasmina; Hohwald, Stephen; Bain, David; Willison-Parry, Derek

    Technology transfer of biological products is a complex process that is important for product commercialization. To achieve a successful technology transfer, the risks that arise from changes throughout the project must be managed. Iterative risk analysis and mitigation tools can be used to both evaluate and reduce risk. The technology transfer stage gate model is used as an example tool to help manage risks derived from both designed process change and unplanned changes that arise due to unforeseen circumstances. The strategy of risk assessment for a change can be tailored to the type of change. In addition, a cross-functional team and centralized documentation helps maximize risk management efficiency to achieve a successful technology transfer. © PDA, Inc. 2016.

  7. Research Priorities in Environmental Risk Assessment. Workshop on Research Needs in Environmental Toxicology and Chemistry Held in Breckenridge, Colorado on August 16-21, 1987

    DTIC Science & Technology

    1988-06-30

    accordance with SETAC’s goal of providing a forum for communication among professionals involved with the use, protection, and management of the...templated action. Risk assessment provides technical input to risk management , the process of making decisions about the acceptability of risks and the need... management and computerized information-processing capabilities needed for risk assessment is also essential. Aquatic Toxicology In order to quantify and

  8. Business continuity and risk management at a strategic level: Case study of the Flemish government.

    PubMed

    Bouve, Joris; Steens, Herman-Peter; Ruebens, Martin

    2018-01-01

    The Flemish government comprises a number of different departments and agencies with the autonomy to optimise their service level in a proactive and resilient manner. Recently, the Flemish government defined four organisational values: openness, decisiveness, trust and agility. In addition, the Internal Audit Agency developed guidelines concerning internal control and organisational management, in which risk management was emphasised. In combination with goal setting and process management, this paper considers risk management as a starting point for the overall management of Flemish government entities. The paper then develops tools to support the establishment of business continuity and risk management processes. These tools fit into the organisation's strategic framework and are easy to understand, pragmatically designed and flexible in their use. The paper goes on to illustrate how the Department of the Chancellery and Public Governance is implementing BCM and risk management, and how it is integrating BCM, risk management and crisis management. It will then focus on the Flemish government's long-term strategy across the boundaries between the different entities and the question of how risk management can become a useful tool for policy makers.

  9. Involvement and Influence of Healthcare Providers, Family Members, and Other Mutation Carriers in the Cancer Risk Management Decision-Making Process of BRCA1 and BRCA2 Mutation Carriers.

    PubMed

    Puski, Athena; Hovick, Shelly; Senter, Leigha; Toland, Amanda Ewart

    2018-03-29

    Deciding between increased cancer screening or prophylactic surgery and the timing of such procedures can be a difficult and complex process for women with BRCA mutations. There are gaps in our understanding of involvement of others in the decision-making process for women with BRCA mutations. This study evaluated the management decision-making process of women with BRCA mutations, focusing on the involvement of others. Grounded theory was used to analyze and code risk management decision-making information from interviews with 20 BRCA mutation carriers. Unaffected at-risk participants with a BRCA mutation, those under age 40, and those with no children described having a difficult time making risk management decisions. Physicians were an integral part of the decision-making process by providing decisional support and management recommendations. Family members and other mutation carriers filled similar yet distinct roles by providing experiential information as well as decisional and emotional support for carriers. Participants described genetic counselors as short-term providers of risk information and management recommendations. The study findings suggest that unaffected at-risk women, women under 40, and those who do not have children may benefit from additional support and information during the decision-making process. Genetic counselors are well trained to help women through this process and connect them with resources, and may be under-utilized in long-term follow-up for women with a BRCA mutation.

  10. Climate Change Risk Management: CRE Adaptation Projects and the Risk Management Process

    EPA Pesticide Factsheets

    This document describes National Estuary Program partner projects that demonstrate how risk management can be successfully applied to address environmental challenges in our country’s coastal areas.

  11. Program Risk Planning with Risk as a Resource

    NASA Technical Reports Server (NTRS)

    Ray, Paul S.

    1998-01-01

    The current focus of NASA on cost effective ways of achieving mission objectives has created a demand for a change in the risk management process of a program. At present, there is no guidelines as to when risk taking is justified due to high cost for a marginal improvement in risk. As a remedial step, Dr. Greenfield of NASA, developed a concept of risk management with risk as a resource. In the report, the following topics are addressed: (1) the risk management approach; (2) planning risk and program life cycle; (3) key components of a typical program; (4) the risk trading methodology; (5) review and decision process; (6) merits of the proposed risk planning approach; and (7) recommendations.

  12. [The workplace injury trends in the petrochemical industry: from data analysis to risk management].

    PubMed

    Campo, Giuseppe; Martini, Benedetta

    2013-01-01

    The most recent INAIL data show that, in 2009-2011, the accident frequency rate and the severity rate of workplace injuries in the chemical industry are lower than for the total non-agricultural workforce. The chemical industry, primarily because of the complex and hazardous work processes, requires an appropriate system for assessing and monitoring specific risks.The implementation of Responsible Care, a risk management system specific for the chemical industry, in 1984, has represented a historical step in the process of critical awareness of risk management by the chemical companies. Responsible Care is a risk management system specifically designed on the risk profiles of this type of enterprise, which integrates safety, health and environment. A risk management system, suitable for the needs of a chemical company, should extend its coverage area, beyond the responsible management of products throughout the entire production cycle, to the issues of corporate responsibility.

  13. A practical discussion of risk management for manufacturing of pharmaceutical products.

    PubMed

    Mollah, A Hamid; Baseman, Harold S; Long, Mike; Rathore, Anurag S

    2014-01-01

    Quality risk management (QRM) is now a regulatory expectation, and it makes good business sense. The goal of the risk assessment is to increase process understanding and deliver safe and effective product to the patients. Risk analysis and management is an acceptable and effective way to minimize patient risk and determine the appropriate level of controls in manufacturing. While understanding the elements of QRM is important, knowing how to apply them in the manufacturing environment is essential for effective process performance and control. This article will preview application of QRM in pharmaceutical and biopharmaceutical manufacturing to illustrate how QRM can help the reader achieve that objective. There are several areas of risk that a drug company may encounter in pharmaceutical manufacturing, specifically addressing oral solid and liquid formulations. QRM tools can be used effectively to identify the risks and develop strategy to minimize or control them. Risks are associated throughout the biopharmaceutical manufacturing process-from raw material supply through manufacturing and filling operations to final distribution via a controlled cold chain process. Assessing relevant attributes and risks for biotechnology-derived products is more complicated and challenging for complex pharmaceuticals. This paper discusses key risk factors in biopharmaceutical manufacturing. Successful development and commercialization of pharmaceutical products is all about managing risks. If a company was to take zero risk, most likely the path to commercialization would not be commercially viable. On the other hand, if the risk taken was too much, the product is likely to have a suboptimal safety and efficacy profile and thus is unlikely to be a successful product. This article addresses the topic of quality risk management with the key objective of minimizing patient risk while creating an optimal process and product. Various tools are presented to aid implementation of these concepts. © PDA, Inc. 2014.

  14. ePORT, NASA's Computer Database Program for System Safety Risk Management Oversight (Electronic Project Online Risk Tool)

    NASA Technical Reports Server (NTRS)

    Johnson, Paul W.

    2008-01-01

    ePORT (electronic Project Online Risk Tool) provides a systematic approach to using an electronic database program to manage a program/project risk management processes. This presentation will briefly cover the standard risk management procedures, then thoroughly cover NASA's Risk Management tool called ePORT. This electronic Project Online Risk Tool (ePORT) is a web-based risk management program that provides a common framework to capture and manage risks, independent of a programs/projects size and budget. It is used to thoroughly cover the risk management paradigm providing standardized evaluation criterion for common management reporting, ePORT improves Product Line, Center and Corporate Management insight, simplifies program/project manager reporting, and maintains an archive of data for historical reference.

  15. 77 FR 37903 - Agency Information Collection Activities; Submission to OMB for Review and Approval; Comment...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2012-06-25

    ... Activities; Submission to OMB for Review and Approval; Comment Request; Risk Management Program Requirements... information about the electronic docket, go to www.regulations.gov . Title: Risk Management Program... process develop and implement a risk management program and submit a risk management plan to EPA. The...

  16. Systematic implementation of clinical risk management in a large university hospital: the impact of risk managers.

    PubMed

    Sendlhofer, Gerald; Brunner, Gernot; Tax, Christa; Falzberger, Gebhard; Smolle, Josef; Leitgeb, Karina; Kober, Brigitte; Kamolz, Lars Peter

    2015-01-01

    For health care systems in recent years, patient safety has increasingly become a priority issue. National and international strategies have been considered to attempt to overcome the most prominent hazards while patients are receiving health care. Thereby, clinical risk management (CRM) plays a dominant role in enabling the identification, analysis, and management of potential risks. CRM implementation into routine procedures within complex hospital organizations is challenging, as in the past, organizational change strategies using a top-down approach have often failed. Therefore, one of our main objectives was to educate a certain number of risk managers in facilitating CRM using a bottom-up approach. To achieve our primary purpose, five project strands were developed, and consequently followed, introducing CRM: corporate governance, risk management (RM) training, CRM process, information, and involvement. The core part of the CRM process involved the education of risk managers within each organizational unit. To account for the size of the existing organization, we assumed that a minimum of 1 % of the workforce had to be trained in RM to disseminate the continuous improvement of quality and safety. Following a roll-out plan, CRM was introduced in each unit and potential risks were identified. Alongside the changes in the corporate governance, a hospital-wide CRM process was introduced resulting in 158 trained risk managers correlating to 2.0 % of the total workforce. Currently, risk managers are present in every unit and have identified 360 operational risks. Among those, 176 risks were scored as strategic and clustered together into top risks. Effective meeting structures and opportunities to share information and knowledge were introduced. Thus far, 31 units have been externally audited in CRM. The CRM approach is unique with respect to its dimension; members of all health care professions were trained to be able to identify potential risks. A network of risk managers supported the centrally coordinated CRM process. There is a strong commitment among management, academia, clinicians, and administration to foster cooperation. The introduction of CRM led to a visible shift with regard to patient safety culture throughout the entire organization. Still, there is a long way to go to keep people engaged in CRM and work on national and international patient safety initiatives to continuously decrease potential hazards.

  17. An Investigation of Network Enterprise Risk Management Techniques to Support Military Net-Centric Operations

    DTIC Science & Technology

    2009-09-01

    this information supports the decison - making process as it is applied to the management of risk. 2. Operational Risk Operational risk is the threat... reasonability . However, to make a software system fault tolerant, the system needs to recognize and fix a system state condition. To detect a fault, a fault...Tracking ..........................................51 C. DECISION- MAKING PROCESS................................................................51 1. Risk

  18. Risk management perspective for climate service development - Results from a study on Finnish organizations

    NASA Astrophysics Data System (ADS)

    Harjanne, Atte; Haavisto, Riina; Tuomenvirta, Heikki; Gregow, Hilppa

    2017-10-01

    Weather, climate and climate change can cause significant risks to businesses and public administration. However, understanding these processes can also create opportunities. Information can help to manage these risks and opportunities, but in order to do so, it must be in line with how risk management and decision making works. To better understand how climate risks and opportunities are reflected in different organizational processes and what types of information is needed and used, we conducted a study on the perceptions and management of weather and climate risks in Finnish organizations and on their use of weather and climate information. In addition, we collected feedback on how the existing climate information tools should be developed. Data on climate risk management was collected in an online survey and in one full-day workshop. The survey was aimed to the Finnish public and private organizations who use weather and climate data and altogether 118 responses were collected. The workshop consisted of two parts: weather and climate risk management processes in general and the development of the current information tools to further address user needs.

    We found that climate risk management in organizations is quite diverse and often de-centralized and that external experts are considered the most useful sources of information. Consequently, users emphasize the need for networks of expertise and sector-specific information tools. Creating such services requires input and information sharing from the user side as well. Better temporal and spatial accuracy is naturally asked for, but users also stressed the need for transparency when it comes to communicating uncertainties, and the availability and up-to-datedness of information. Our results illustrate that weather and climate risks compete and blend in with other risks and changes perceived by the organizations and supporting information is sought from different types of sources. Thus the design and evaluation of climate services should take into account the context of existing and developing processes in organizational risk management.

  19. Implementation of Risk Management in NASA's CEV Project- Ensuring Mission Success

    NASA Astrophysics Data System (ADS)

    Perera, Jeevan; Holsomback, Jerry D.

    2005-12-01

    Most project managers know that Risk Management (RM) is essential to good project management. At NASA, standards and procedures to manage risk through a tiered approach have been developed - from the global agency-wide requirements down to a program or project's implementation. The basic methodology for NASA's risk management strategy includes processes to identify, analyze, plan, track, control, communicate and document risks. The identification, characterization, mitigation plan, and mitigation responsibilities associated with specific risks are documented to help communicate, manage, and effectuate appropriate closure. This approach helps to ensure more consistent documentation and assessment and provides a means of archiving lessons learned for future identification or mitigation activities.A new risk database and management tool was developed by NASA in 2002 and since has been used successfully to communicate, document and manage a number of diverse risks for the International Space Station, Space Shuttle, and several other NASA projects and programs including at the Johnson Space Center. Organizations use this database application to effectively manage and track each risk and gain insight into impacts from other organization's viewpoint to develop integrated solutions. Schedule, cost, technical and safety issues are tracked in detail through this system.Risks are tagged within the system to ensure proper review, coordination and management at the necessary management level. The database is intended as a day-to- day tool for organizations to manage their risks and elevate those issues that need coordination from above. Each risk is assigned to a managing organization and a specific risk owner who generates mitigation plans as appropriate. In essence, the risk owner is responsible for shepherding the risk through closure. The individual that identifies a new risk does not necessarily get assigned as the risk owner. Whoever is in the best position to effectuate comprehensive closure is assigned as the risk owner. Each mitigation plan includes the specific tasks that will be conducted to either decrease the likelihood of the risk occurring and/or lessen the severity of the consequences if they do occur. As each mitigation task is completed, the responsible managing organization records the completion of the task in the risk database and then re-scores the risk considering the task's results. By keeping scores updated, a managing organization's current top risks and risk posture can be readily identified including the status of any risk in the system.A number of metrics measure risk process trends from data contained in the database. This allows for trend analysis to further identify improvements to the process and assist in the management of all risks. The metrics will also scrutinize both the effectiveness and compliance of risk management requirements.The risk database is an evolving tool and will be continuously improved with capabilities requested by the NASA project community. This paper presents the basic foundations of risk management, the elements necessary for effective risk management, and the capabilities of this new risk database and how it is implemented to support NASA's risk management needs.

  20. The Research on Safety Management Information System of Railway Passenger Based on Risk Management Theory

    NASA Astrophysics Data System (ADS)

    Zhu, Wenmin; Jia, Yuanhua

    2018-01-01

    Based on the risk management theory and the PDCA cycle model, requirements of the railway passenger transport safety production is analyzed, and the establishment of the security risk assessment team is proposed to manage risk by FTA with Delphi from both qualitative and quantitative aspects. The safety production committee is also established to accomplish performance appraisal, which is for further ensuring the correctness of risk management results, optimizing the safety management business processes and improving risk management capabilities. The basic framework and risk information database of risk management information system of railway passenger transport safety are designed by Ajax, Web Services and SQL technologies. The system realizes functions about risk management, performance appraisal and data management, and provides an efficient and convenient information management platform for railway passenger safety manager.

  1. Risk Management in Australian Science Education: A Model for Practice.

    ERIC Educational Resources Information Center

    Forlin, Peter

    1995-01-01

    Provides a framework that incorporates the diverse elements of risk management in science education into a systematic process and is adaptable to changing circumstances. Appendix contains risk management checklist for management, laboratory and storage, extreme biological and chemical hazards, protective equipment, waste disposal, electrical…

  2. Risk Management Implementation Tool

    NASA Technical Reports Server (NTRS)

    Wright, Shayla L.

    2004-01-01

    Continuous Risk Management (CM) is a software engineering practice with processes, methods, and tools for managing risk in a project. It provides a controlled environment for practical decision making, in order to assess continually what could go wrong, determine which risk are important to deal with, implement strategies to deal with those risk and assure the measure effectiveness of the implemented strategies. Continuous Risk Management provides many training workshops and courses to teach the staff how to implement risk management to their various experiments and projects. The steps of the CRM process are identification, analysis, planning, tracking, and control. These steps and the various methods and tools that go along with them, identification, and dealing with risk is clear-cut. The office that I worked in was the Risk Management Office (RMO). The RMO at NASA works hard to uphold NASA s mission of exploration and advancement of scientific knowledge and technology by defining and reducing program risk. The RMO is one of the divisions that fall under the Safety and Assurance Directorate (SAAD). I worked under Cynthia Calhoun, Flight Software Systems Engineer. My task was to develop a help screen for the Continuous Risk Management Implementation Tool (RMIT). The Risk Management Implementation Tool will be used by many NASA managers to identify, analyze, track, control, and communicate risks in their programs and projects. The RMIT will provide a means for NASA to continuously assess risks. The goals and purposes for this tool is to provide a simple means to manage risks, be used by program and project managers throughout NASA for managing risk, and to take an aggressive approach to advertise and advocate the use of RMIT at each NASA center.

  3. IT Operational Risk Measurement Model Based on Internal Loss Data of Banks

    NASA Astrophysics Data System (ADS)

    Hao, Xiaoling

    Business operation of banks relies increasingly on information technology (IT) and the most important role of IT is to guarantee the operational continuity of business process. Therefore, IT Risk management efforts need to be seen from the perspective of operational continuity. Traditional IT risk studies focused on IT asset-based risk analysis and risk-matrix based qualitative risk evaluation. In practice, IT risk management practices of banking industry are still limited to the IT department and aren't integrated into business risk management, which causes the two departments to work in isolation. This paper presents an improved methodology for dealing with IT operational risk. It adopts quantitative measurement method, based on the internal business loss data about IT events, and uses Monte Carlo simulation to predict the potential losses. We establish the correlation between the IT resources and business processes to make sure risk management of IT and business can work synergistically.

  4. Implementing the EU Floods Directive (2007/60/EC) in Austria: Flood Risk Management Plans

    NASA Astrophysics Data System (ADS)

    Neuhold, Clemens

    2013-04-01

    he Directive 2007/60/EC of the European Parliament and of the Council of 23 October 2007 on the assessment and management of flood risks (EFD) aims at the reduction of the adverse consequences for human health, the environment, cultural heritage and economic activity associated with floods in the Community. This task is to be achieved based on three process steps (1) preliminary flood risk assessment (finalised by the end of 2011), (2) flood hazard maps and flood risk maps (due 2013) and (3) flood risk management plans (due 2015). Currently, an interdisciplinary national working group is defining the methodological framework for flood risk management plans in Austria supported by a constant exchange with international bodies and experts. Referring to the EFD the components of the flood risk management plan are (excerpt): 1. conclusions of the preliminary flood risk assessment 2. flood hazard maps and flood risk maps and the conclusions that can be drawn from those maps 3. a description of the appropriate objectives of flood risk management 4. a summary of measures and their prioritisation aiming to achieve the appropriate objectives of flood risk management The poster refers to some of the major challenges in this process, such as the legal provisions, coordination of administrative units, definition of public relations, etc. The implementation of the EFD requires the harmonisation of legal instruments of various disciplines (e.g. water management, spatial planning, civil protection) enabling a coordinated - and ideally binding - practice of flood risk management. This process is highly influenced by the administrative organisation in Austria - federal, provincial and municipality level. The Austrian approach meets this organisational framework by structuring the development of the flood risk management plan into 3 time-steps: (a) federal blueprint, (b) provincial editing and (c) federal finishing as well as reporting to the European Commission. Each time-step addresses different administrative levels and spatial scales accompanied by the active involvement of interested parties.

  5. Earth Sciences Data and Information System (ESDIS) program planning and evaluation methodology development

    NASA Technical Reports Server (NTRS)

    Dickinson, William B.

    1995-01-01

    An Earth Sciences Data and Information System (ESDIS) Project Management Plan (PMP) is prepared. An ESDIS Project Systems Engineering Management Plan (SEMP) consistent with the developed PMP is also prepared. ESDIS and related EOS program requirements developments, management and analysis processes are evaluated. Opportunities to improve the effectiveness of these processes and program/project responsiveness to requirements are identified. Overall ESDIS cost estimation processes are evaluated, and recommendations to improve cost estimating and modeling techniques are developed. ESDIS schedules and scheduling tools are evaluated. Risk assessment, risk mitigation strategies and approaches, and use of risk information in management decision-making are addressed.

  6. [Development of whole process quality control and management system of traditional Chinese medicine decoction pieces based on traditional Chinese medicine quality tree].

    PubMed

    Yu, Wen-Kang; Dong, Ling; Pei, Wen-Xuan; Sun, Zhi-Rong; Dai, Jun-Dong; Wang, Yun

    2017-12-01

    The whole process quality control and management of traditional Chinese medicine (TCM) decoction pieces is a system engineering, involving the base environment, seeds and seedlings, harvesting, processing and other multiple steps, so the accurate identification of factors in TCM production process that may induce the quality risk, as well as reasonable quality control measures are very important. At present, the concept of quality risk is mainly concentrated in the aspects of management and regulations, etc. There is no comprehensive analysis on possible risks in the quality control process of TCM decoction pieces, or analysis summary of effective quality control schemes. A whole process quality control and management system for TCM decoction pieces based on TCM quality tree was proposed in this study. This system effectively combined the process analysis method of TCM quality tree with the quality risk management, and can help managers to make real-time decisions while realizing the whole process quality control of TCM. By providing personalized web interface, this system can realize user-oriented information feedback, and was convenient for users to predict, evaluate and control the quality of TCM. In the application process, the whole process quality control and management system of the TCM decoction pieces can identify the related quality factors such as base environment, cultivation and pieces processing, extend and modify the existing scientific workflow according to their own production conditions, and provide different enterprises with their own quality systems, to achieve the personalized service. As a new quality management model, this paper can provide reference for improving the quality of Chinese medicine production and quality standardization. Copyright© by the Chinese Pharmaceutical Association.

  7. Application of Risk Assessment Tools in the Continuous Risk Management (CRM) Process

    NASA Technical Reports Server (NTRS)

    Ray, Paul S.

    2002-01-01

    Marshall Space Flight Center (MSFC) of the National Aeronautics and Space Administration (NASA) is currently implementing the Continuous Risk Management (CRM) Program developed by the Carnegie Mellon University and recommended by NASA as the Risk Management (RM) implementation approach. The four most frequently used risk assessment tools in the center are: (a) Failure Modes and Effects Analysis (FMEA), Hazard Analysis (HA), Fault Tree Analysis (FTA), and Probabilistic Risk Analysis (PRA). There are some guidelines for selecting the type of risk assessment tools during the project formulation phase of a project, but there is not enough guidance as to how to apply these tools in the Continuous Risk Management process (CRM). But the ways the safety and risk assessment tools are used make a significant difference in the effectiveness in the risk management function. Decisions regarding, what events are to be included in the analysis, to what level of details should the analysis be continued, make significant difference in the effectiveness of risk management program. Tools of risk analysis also depends on the phase of a project e.g. at the initial phase of a project, when not much data are available on hardware, standard FMEA cannot be applied; instead a functional FMEA may be appropriate. This study attempted to provide some directives to alleviate the difficulty in applying FTA, PRA, and FMEA in the CRM process. Hazard Analysis was not included in the scope of the study due to the short duration of the summer research project.

  8. Marine and Hydrokinetic Technology Development Risk Management Framework

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Snowberg, David; Weber, Jochem

    2015-09-01

    Over the past decade, the global marine and hydrokinetic (MHK) industry has suffered a number of serious technological and commercial setbacks. To help reduce the risks of industry failures and advance the development of new technologies, the U.S. Department of Energy (DOE) and the National Renewable Energy Laboratory (NREL) developed an MHK Risk Management Framework. By addressing uncertainties, the MHK Risk Management Framework increases the likelihood of successful development of an MHK technology. It covers projects of any technical readiness level (TRL) or technical performance level (TPL) and all risk types (e.g. technological risk, regulatory risk, commercial risk) over themore » development cycle. This framework is intended for the development and deployment of a single MHK technology—not for multiple device deployments within a plant. This risk framework is intended to meet DOE’s risk management expectations for the MHK technology research and development efforts of the Water Power Program (see Appendix A). It also provides an overview of other relevant risk management tools and documentation.1 This framework emphasizes design and risk reviews as formal gates to ensure risks are managed throughout the technology development cycle. Section 1 presents the recommended technology development cycle, Sections 2 and 3 present tools to assess the TRL and TPL of the project, respectively. Section 4 presents a risk management process with design and risk reviews for actively managing risk within the project, and Section 5 presents a detailed description of a risk registry to collect the risk management information into one living document. Section 6 presents recommendations for collecting and using lessons learned throughout the development process.« less

  9. Estimating and controlling workplace risk: an approach for occupational hygiene and safety professionals.

    PubMed

    Toffel, Michael W; Birkner, Lawrence R

    2002-07-01

    The protection of people and physical assets is the objective of health and safety professionals and is accomplished through the paradigm of anticipation, recognition, evaluation, and control of risks in the occupational environment. Risk assessment concepts are not only used by health and safety professionals, but also by business and financial planners. Since meeting health and safety objectives requires financial resources provided by business and governmental managers, the hypothesis addressed here is that health and safety risk decisions should be made with probabilistic processes used in financial decision-making and which are familiar and recognizable to business and government planners and managers. This article develops the processes and demonstrates the use of incident probabilities, historic outcome information, and incremental impact analysis to estimate risk of multiple alternatives in the chemical process industry. It also analyzes how the ethical aspects of decision-making can be addressed in formulating health and safety risk management plans. It is concluded that certain, easily understood, and applied probabilistic risk assessment methods used by business and government to assess financial and outcome risk have applicability to improving workplace health and safety in three ways: 1) by linking the business and health and safety risk assessment processes to securing resources, 2) by providing an additional set of tools for health and safety risk assessment, and 3) by requiring the risk assessor to consider multiple risk management alternatives.

  10. Cognitive mapping tools: review and risk management needs.

    PubMed

    Wood, Matthew D; Bostrom, Ann; Bridges, Todd; Linkov, Igor

    2012-08-01

    Risk managers are increasingly interested in incorporating stakeholder beliefs and other human factors into the planning process. Effective risk assessment and management requires understanding perceptions and beliefs of involved stakeholders, and how these beliefs give rise to actions that influence risk management decisions. Formal analyses of risk manager and stakeholder cognitions represent an important first step. Techniques for diagramming stakeholder mental models provide one tool for risk managers to better understand stakeholder beliefs and perceptions concerning risk, and to leverage this new understanding in developing risk management strategies. This article reviews three methodologies for assessing and diagramming stakeholder mental models--decision-analysis-based mental modeling, concept mapping, and semantic web analysis--and assesses them with regard to their ability to address risk manager needs. © 2012 Society for Risk Analysis.

  11. The Study Elements and Indicators of Risk Management System for Secondary Schools in Thailand

    ERIC Educational Resources Information Center

    Wandee, Methenan; Sirisuthi, Chaiyuth; Leamvijarn, Subunn

    2017-01-01

    The purposes of this research aimed 1) to study the elements and indicators of risk management system for secondary schools in Thailand. 2) to study suitable the elements and indicators of the risk management system for secondary schools in Thailand. 3) to study the results of CFA (Confirmatory Factors Analysis) risk management process of risk…

  12. Guidelines for Automatic Data Processing Physical Security and Risk Management. Federal Information Processing Standards Publication 31.

    ERIC Educational Resources Information Center

    National Bureau of Standards (DOC), Washington, DC.

    These guidelines provide a handbook for use by federal organizations in structuring physical security and risk management programs for their automatic data processing facilities. This publication discusses security analysis, natural disasters, supporting utilities, system reliability, procedural measures and controls, off-site facilities,…

  13. Calysto: Risk Management for Commercial Manned Spaceflight

    NASA Technical Reports Server (NTRS)

    Dillaman, Gary

    2012-01-01

    The Calysto: Risk Management for Commercial Manned Spaceflight study analyzes risk management in large enterprises and how to effectively communicate risks across organizations. The Calysto Risk Management tool developed by NASA's Kennedy Space Center's SharePoint team is used and referenced throughout the study. Calysto is a web-base tool built on Microsoft's SharePoint platform. The risk management process at NASA is examined and incorporated in the study. Using risk management standards from industry and specific organizations at the Kennedy Space Center, three methods of communicating and elevating risk are examined. Each method describes details of the effectiveness and plausibility of using the method in the Calysto Risk Management Tool. At the end of the study suggestions are made for future renditions of Calysto.

  14. Development of funding project risk management tools.

    DOT National Transportation Integrated Search

    2013-11-01

    Funding project risk management is a process for identifying, assessing, and prioritizing project funding risks. To plan to : minimize or eliminate the impact of negative events, one must identify what projects have higher risk to respond to potentia...

  15. Evaluation of Risk Management Strategies for a Low-Cost, High-Risk Project

    NASA Technical Reports Server (NTRS)

    Shishko, Robert; Jorgensen, Edward J.

    1996-01-01

    This paper summarizes work in progress to define and implement a risk management process tailored to a low-cost, high-risk, NASA mission -the Microrover Flight Experiment (MFEX, commonly called the Mars microrover).

  16. CERT Resilience Management Model: A Maturity Model Approach to Managing Operational Resilience

    DTIC Science & Technology

    2010-07-28

    manufacturing, and energy 8 years @ SEI concentrating in information security risk management BS-Accounting; MBA Frequent lecturer in Carnegie...impact Move all operational risk management activities in the same direction Optimize cost/effectiveness Meet mission no-matter-what How do you...processes Effective operational risk management requires harmonization: convergence of these activities working toward the same goals Operational

  17. Ecological Risk Assessment Guidance for Superfund: Process for Designing and Conducting Ecological Risk Assessments - Interim Final

    EPA Pesticide Factsheets

    This document provides guidance to site managers and Remedial Project Managers who are legally responsible for the management of a site on how to design and conduct technically defensible ecological risk assessments for the Superfund program.

  18. Risk assessment in the upstream crude oil supply chain: Leveraging analytic hierarchy process

    NASA Astrophysics Data System (ADS)

    Briggs, Charles Awoala

    For an organization to be successful, an effective strategy is required, and if implemented appropriately the strategy will result in a sustainable competitive advantage. The importance of decision making in the oil industry is reflected in the magnitude and nature of the industry. Specific features of the oil industry supply chain, such as its longer chain, the complexity of its transportation system, its complex production and storage processes, etc., pose challenges to its effective management. Hence, understanding the risks, the risk sources, and their potential impacts on the oil industry's operations will be helpful in proposing a risk management model for the upstream oil supply chain. The risk-based model in this research uses a three-level analytic hierarchy process (AHP), a multiple-attribute decision-making technique, to underline the importance of risk analysis and risk management in the upstream crude oil supply chain. Level 1 represents the overall goal of risk management; Level 2 is comprised of the various risk factors; and Level 3 represents the alternative criteria of the decision maker as indicated on the hierarchical structure of the crude oil supply chain. Several risk management experts from different oil companies around the world were surveyed, and six major types of supply chain risks were identified: (1) exploration and production, (2) environmental and regulatory compliance, (3) transportation, (4) availability of oil, (5) geopolitical, and (6) reputational. Also identified are the preferred methods of managing risks which include; (1) accept and control the risks, (2) avoid the risk by stopping the activity, or (3) transfer or share the risks to other companies or insurers. The results from the survey indicate that the most important risk to manage is transportation risk with a priority of .263, followed by exploration/production with priority of .198, with an overall inconsistency of .03. With respect to major objectives the most preferred risk management policy option based on the result of the composite score is accept and control risk with a priority of .446, followed by transfer or share risk with a priority of .303. The least likely option is to terminate or forgo activity with a priority of .251.

  19. 12 CFR 3.101 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... internal risk rating and segmentation system; risk parameter quantification system; data management and... advanced IRB systems, operational risk management processes, operational risk data and assessment systems... generated on an arm's-length basis between the seller and the obligor (intercompany accounts receivable and...

  20. The application of risk management in sport.

    PubMed

    Fuller, Colin; Drawer, Scott

    2004-01-01

    The process of risk management can be implemented as part of a best practice management system within the sport and leisure sector. The process enables risk factors that might lead to injuries to be identified and the levels of risk associated with activities to be estimated and evaluated. This information can be utilised proactively by sports governing bodies and participants to identify preventive and therapeutic interventions in order to reduce the frequency of occurrence and/or severity of injuries within their sports. The acceptability of risk within specific sports, however, is dependent on the perceptions of the participants involved. Copyright 2004 Adis Data Information BV

  1. Issues Management Process Course # 38401

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Binion, Ula Marie

    The purpose of this training it to advise Issues Management Coordinators (IMCs) on the revised Contractor Assurance System (CAS) Issues Management (IM) process. Terminal Objectives: Understand the Laboratory’s IM process; Understand your role in the Laboratory’s IM process. Learning Objectives: Describe the IM process within the context of the CAS; Describe the importance of implementing an institutional IM process at LANL; Describe the process flow for the Laboratory’s IM process; Apply the definition of an issue; Use available resources to determine initial screening risk levels for issues; Describe the required major process steps for each risk level; Describe the personnelmore » responsibilities for IM process implementation; Access available resources to support IM process implementation.« less

  2. 17 CFR 18.04 - Statement of reporting trader.

    Code of Federal Regulations, 2011 CFR

    2011-04-01

    ... the reduction of risks in the conduct and management of a commercial enterprise: (i) Commercial... appropriate to the reduction of risks in the conduct and management of a commercial enterprise: (i) Commercial..., merchandising or processing of a cash commodity, asset or liability risk management by depository institutions...

  3. Risk-Based Approach for Microbiological Food Safety Management in the Dairy Industry: The Case of Listeria monocytogenes in Soft Cheese Made from Pasteurized Milk.

    PubMed

    Tenenhaus-Aziza, Fanny; Daudin, Jean-Jacques; Maffre, Alexandre; Sanaa, Moez

    2014-01-01

    According to Codex Alimentarius Commission recommendations, management options applied at the process production level should be based on good hygiene practices, HACCP system, and new risk management metrics such as the food safety objective. To follow this last recommendation, the use of quantitative microbiological risk assessment is an appealing approach to link new risk-based metrics to management options that may be applied by food operators. Through a specific case study, Listeria monocytogenes in soft cheese made from pasteurized milk, the objective of the present article is to practically show how quantitative risk assessment could be used to direct potential intervention strategies at different food processing steps. Based on many assumptions, the model developed estimates the risk of listeriosis at the moment of consumption taking into account the entire manufacturing process and potential sources of contamination. From pasteurization to consumption, the amplification of a primo-contamination event of the milk, the fresh cheese or the process environment is simulated, over time, space, and between products, accounting for the impact of management options, such as hygienic operations and sampling plans. A sensitivity analysis of the model will help orientating data to be collected prioritarily for the improvement and the validation of the model. What-if scenarios were simulated and allowed for the identification of major parameters contributing to the risk of listeriosis and the optimization of preventive and corrective measures. © 2013 Society for Risk Analysis.

  4. Managing Risk to Ensure a Successful Cassini/Huygens Saturn Orbit Insertion (SOI)

    NASA Technical Reports Server (NTRS)

    Witkowski, Mona M.; Huh, Shin M.; Burt, John B.; Webster, Julie L.

    2004-01-01

    I. Design: a) S/C designed to be largely single fault tolerant; b) Operate in flight demonstrated envelope, with margin; and c) Strict compliance with requirements & flight rules. II. Test: a) Baseline, fault & stress testing using flight system testbeds (H/W & S/W); b) In-flight checkout & demos to remove first time events. III. Failure Analysis: a) Critical event driven fault tree analysis; b) Risk mitigation & development of contingencies. IV) Residual Risks: a) Accepted pre-launch waivers to Single Point Failures; b) Unavoidable risks (e.g. natural disaster). V) Mission Assurance: a) Strict process for characterization of variances (ISAs, PFRs & Waivers; b) Full time Mission Assurance Manager reports to Program Manager: 1) Independent assessment of compliance with institutional standards; 2) Oversight & risk assessment of ISAs, PFRs & Waivers etc.; and 3) Risk Management Process facilitator.

  5. Taking Risk Assessment and Management to the Next Level: Program-Level Risk Analysis to Enable Solid Decision-Making on Priorities and Funding

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Nelson, J. G.; Morton, R. L.; Castillo, C.

    2011-02-01

    A multi-level (facility and programmatic) risk assessment was conducted for the facilities in the Nevada National Security Site (NNSS) Readiness in Technical Base and Facilities (RTBF) Program and results were included in a new Risk Management Plan (RMP), which was incorporated into the fiscal year (FY) 2010 Integrated Plans. Risks, risk events, probability, consequence(s), and mitigation strategies were identified and captured, for most scope areas (i.e., risk categories) during the facilitated risk workshops. Risk mitigations (i.e., efforts in addition to existing controls) were identified during the facilitated risk workshops when the risk event was identified. Risk mitigation strategies fell intomore » two broad categories: threats or opportunities. Improvement projects were identified and linked to specific risks they mitigate, making the connection of risk reduction through investments for the annual Site Execution Plan. Due to the amount of that was collected, analysis to be performed, and reports to be generated, a Risk Assessment/ Management Tool (RAMtool) database was developed to analyze the risks in real-time, at multiple levels, which reinforced the site-level risk management process and procedures. The RAMtool database was developed and designed to assist in the capturing and analysis of the key elements of risk: probability, consequence, and impact. The RAMtool calculates the facility-level and programmatic-level risk factors to enable a side-by-side comparison to see where the facility manager and program manager should focus their risk reduction efforts and funding. This enables them to make solid decisions on priorities and funding to maximize the risk reduction. A more active risk management process was developed where risks and opportunities are actively managed, monitored, and controlled by each facility more aggressively and frequently. risk owners have the responsibility and accountability to manage their assigned risk in real-time, using the RAMtool database.« less

  6. Identifying Home Care Clinicians’ Information Needs for Managing Fall Risks

    PubMed Central

    Alhuwail, Dari

    2016-01-01

    Summary Objectives To help manage the risk of falls in home care, this study aimed to (i) identify home care clinicians’ information needs and how they manage missing or inaccurate data, (ii) identify problems that impact effectiveness and efficiency associated with retaining, exchanging, or processing information about fall risks in existing workflows and currently adopted health information technology (IT) solutions, and (iii) offer informatics-based recommendations to improve fall risk management interventions. Methods A case study was carried out in a single not-for-profit suburban Medicare-certified home health agency with three branches. Qualitative data were collected over a six month period through observations, semi-structured interviews, and focus groups. The Framework method was used for analysis. Maximum variation sampling was adopted to recruit a diverse sample of clinicians. Results Overall, the information needs for fall risk management were categorized into physiological, care delivery, educational, social, environmental, and administrative domains. Examples include a brief fall-related patient history, weight-bearing status, medications that affect balance, availability of caregivers at home, and the influence of patients’ cultures on fall management interventions. The unavailability and inaccuracy of critical information related to fall risks can delay necessary therapeutic services aimed at reducing patients’ risk for falling and thereby jeopardizing their safety. Currently adopted IT solutions did not adequately accommodate data related to fall risk management. Conclusion The results highlight the essential information for fall risk management in home care. Home care workflows and health IT solutions must effectively and efficiently retain, exchange, and process information necessary for fall risk management. Interoperability and integration of the various health IT solutions to make data sharing accessible to all clinicians is critical for fall risk management. Findings from this study can help home health agencies better understand their information needs to manage fall risks. PMID:27437035

  7. Financial risk management of pharmacy benefits.

    PubMed

    Saikami, D

    1997-10-01

    Financial risk management of pharmacy benefits in integrated health systems is explained. A managed care organization should assume financial risk for pharmacy benefits only if it can manage the risk. Horizontally integrated organizations often do not have much control over the management of drug utilization and costs. Vertically integrated organizations have the greatest ability to manage pharmacy financial risk; virtual integration may also be compatible. Contracts can be established in which the provider is incentivized or placed at partial or full risk. The main concerns that health plans have with respect to pharmacy capitation are formulary management and the question of who should receive rebates from manufacturers. The components needed to managed pharmacy financial risk depend on the type of contract negotiated. Health-system pharmacists are uniquely positioned to take advantage of opportunities opening up through pharmacy risk contracting. Functions most organizations must provide when assuming pharmacy financial risk can be divided into internal and external categories. Internally performed functions include formulary management, clinical pharmacy services and utilization management, and utilization reports for physicians. Functions that can be outsourced include claims processing and administration, provider- and customer support services, and rebates. Organizations that integrate the pharmacy benefit across the health care continuum will be more effective in controlling costs and improving outcomes than organizations that handle this benefit as separate from others. Patient care should not focus on payment mechanisms and unit costs but on developing superior processes and systems that improve health care.

  8. [Biological evaluation within a risk management process].

    PubMed

    Zhuang, Fei; Ding, Biao

    2007-07-01

    Bio-evaluation within the medical device quality/risk management system is a risk analyzing and assessing process. On the basis of data from characterization of materials, scientific literatures, application history, bio-toxicology testing and so on, weighing the benefit and the risk, bio-evaluation does a conclusion to "take" or "quit" the product design. There is no "zero risk" though "no toxicity" always is the most desirable conclusion in a testing report. The application history data is the most comprehensive among the information available, since no testing system can "clone" the human body. In addition, the capital cost has to be taken into account when bringing the sophisticated testing technologies into the evaluating system. Investigating the #G95-1 of FDA CDRH and the changes of ISO 10993-1, the trend to integrate bio-evaluation into a quality/risk management process can be figured out.

  9. DDP - a tool for life-cycle risk management

    NASA Technical Reports Server (NTRS)

    Cornford, S. L.; Feather, M. S.; Hicks, K. A.

    2001-01-01

    At JPL we have developed, and implemented, a process for achieving life-cycle risk management. This process has been embodied in a software tool and is called Defect Detection and Prevention (DDP). The DDP process can be succinctly stated as: determine where we want to be, what could get in the way and how we will get there.

  10. [Analysis and countermeasure for quality risk in process of traditional Chinese medicine preparations].

    PubMed

    Yang, Ming; Yang, Yuan-Zhen; Wang, Ya-Qi; Wu, Zhen-Feng; Wang, Xue-Cheng; Luo, Jing

    2017-03-01

    Product quality relies on not only testing methods,but also the design and development, production control and product manufacturing all aspects of logistics management. Quality comes from the process control level.Therefore, it is very important to accurately identify the factors that may induce quality risk in the production process and quality control measures correspondingly.This article systematically analyzes the source of the quality risk of all aspects of the production process in traditional Chinese medicine preparation. Discussing ways and methods of quality risk identification of traditional Chinese medicine preparation and providing references for perfecting the whole process quality management of traditional Chinese medicine preparation. Copyright© by the Chinese Pharmaceutical Association.

  11. [Global risk management].

    PubMed

    Sghaier, W; Hergon, E; Desroches, A

    2015-08-01

    Risk management is a fundamental component of any successful company, whether it is in economic, societal or environmental aspect. Risk management is an especially important activity for companies that optimal security challenge of products and services is great. This is the case especially for the health sector institutions. Risk management is therefore a decision support tool and a means to ensure the sustainability of an organization. In this context, what methods and approaches implemented to manage the risks? Through this state of the art, we are interested in the concept of risk and risk management processes. Then we focus on the different methods of risk management and the criteria for choosing among these methods. Finally we highlight the need to supplement these methods by a systemic and global approach including through risk assessment by the audits. Copyright © 2015 Elsevier Masson SAS. All rights reserved.

  12. The effectiveness of risk management: an analysis of project risk planning across industries and countries.

    PubMed

    Zwikael, Ofer; Ahn, Mark

    2011-01-01

    This article examines the effectiveness of current risk management practices to reduce project risk using a multinational, multi-industry study across different scenarios and cultures. A survey was administered to 701 project managers, and their supervisors, in seven industries and three diverse countries (New Zealand, Israel, and Japan), in multiple languages during the 2002-2007 period. Results of this study show that project context--industry and country where a project is executed--significantly impacts perceived levels of project risk, and the intensity of risk management processes. Our findings also suggest that risk management moderates the relationship between risk level and project success. Specifically, we found that even moderate levels of risk management planning are sufficient to reduce the negative effect risk levels have on project success. © 2010 Society for Risk Analysis.

  13. The NASA Continuous Risk Management Process

    NASA Technical Reports Server (NTRS)

    Pokorny, Frank M.

    2004-01-01

    As an intern this summer in the GRC Risk Management Office, I have become familiar with the NASA Continuous Risk Management Process. In this process, risk is considered in terms of the probability that an undesired event will occur and the impact of the event, should it occur (ref., NASA-NPG: 7120.5). Risk management belongs in every part of every project and should be ongoing from start to finish. Another key point is that a risk is not a problem until it has happened. With that in mind, there is a six step cycle for continuous risk management that prevents risks from becoming problems. The steps are: identify, analyze, plan, track, control, and communicate & document. Incorporated in the first step are several methods to identify risks such as brainstorming and using lessons learned. Once a risk is identified, a risk statement is made on a risk information sheet consisting of a single condition and one or more consequences. There can also be a context section where the risk is explained in more detail. Additionally there are three main goals of analyzing a risk, which are evaluate, classify, and prioritize. Here is where a value is given to the attributes of a risk &e., probability, impact, and timeframe) based on a multi-level classification system (e.g., low, medium, high). It is important to keep in mind that the definitions of these levels are probably different for each project. Furthermore the risks can be combined into groups. Then, the risks are prioritized to see what risk is necessary to mitigate first. After the risks are analyzed, a plan is made to mitigate as many risks as feasible. Each risk should be assigned to someone in the project with knowledge in the area of the risk. Then the possible approaches to choose from are: research, accept, watch, or mitigate. Next, all risks, mitigated or not, are tracked either individually or in groups. As the plan is executed, risks are re-evaluated, and the attribute values are adjusted as necessary. Metrics are established and monitored as tools for risk tracking. Also a trigger or threshold should be set on the metric data that indicates when an action is needed. Results of this tracking are usually evaluated and reported in a relevant format at weekly or monthly meetings. Choosing controls is the subsequent step, which involves the effects of the tracking. The three basic controls are: close, continue tracking, and re- plan. Finally communicate & document is the last step, but occurs throughout the process. It is vital that main risks, plans, changes, and progress are known by everyone in the project. A good way to keep everyone updated and inform other projects of common issues is by thoroughly documenting project risks. NASA sees value in risk management and believes that projects have greater probability or success by using the NASA Continuous Risk Management Process.

  14. Managing IT service management implementation complexity: from the perspective of the Warfield Version of systems science

    NASA Astrophysics Data System (ADS)

    Wan, Jiangping; Jones, James D.

    2013-11-01

    The Warfield version of systems science supports a wide variety of application areas, and is useful to practitioners who use the work program of complexity (WPOC) tool. In this article, WPOC is applied to information technology service management (ITSM) for managing the complexity of projects. In discussing the application of WPOC to ITSM, we discuss several steps of WPOC. The discovery step of WPOC consists of a description process and a diagnosis process. During the description process, 52 risk factors are identified, which are then narrowed to 20 key risk factors. All of this is done by interviews and surveys. Root risk factors (the most basic risk factors) consist of 11 kinds of common 'mindbugs' which are selected from an interpretive structural model. This is achieved by empirical analysis of 25 kinds of mindbugs. (A lesser aim of this research is to affirm that these mindbugs developed from a Western mindset have corresponding relevance in a completely different culture: the Peoples Republic of China.) During the diagnosis process, the relationships among the root risk factors in the implementation of the ITSM project are identified. The resolution step of WPOC consists of a design process and an implementation process. During the design process, issues related to the ITSM application are compared to both e-Government operation and maintenance, and software process improvement. The ITSM knowledge support structure is also designed at this time. During the implementation process, 10 keys to the successful implementation of ITSM projects are identified.

  15. Bridging the gap between preventive and restorative dentistry: identification of caries risk factors and strategies for minimizing risk.

    PubMed

    Maragliano-Muniz, Pamela

    2013-10-01

    Following the introduction of CAMBRA (Caries Management by Risk Assessment) in 2007, a number of recommendations for office protocols were introduced, and many companies have formulated products and procedures for implementing CAMBRA. As a result, the implementation of a caries management program can be confounding and overwhelming to a dental practitioner. Understanding risk factors as they contribute to the caries process can help mitigate confusion and guide the practitioner when selecting materials for their practice. Ultimately, knowing how the risk factors play a role in the progression of dental caries will lead to appropriate risk management and product recommendations. The purpose of this article is to discuss the contribution of risk factors to the caries process and to introduce strategies that restorative dentists can utilize to minimize caries risk.

  16. Continuous Risk Management: An Overview

    NASA Technical Reports Server (NTRS)

    Rosenberg, Linda; Hammer, Theodore F.

    1999-01-01

    Software risk management is important because it helps avoid disasters, rework, and overkill, but more importantly because it stimulates win-win situations. The objectives of software risk management are to identify, address, and eliminate software risk items before they become threats to success or major sources of rework. In general, good project managers are also good managers of risk. It makes good business sense for all software development projects to incorporate risk management as part of project management. The Software Assurance Technology Center (SATC) at NASA GSFC has been tasked with the responsibility for developing and teaching a systems level course for risk management that provides information on how to implement risk management. The course was developed in conjunction with the Software Engineering Institute at Carnegie Mellon University, then tailored to the NASA systems community. This is an introductory tutorial to continuous risk management based on this course. The rational for continuous risk management and how it is incorporated into project management are discussed. The risk management structure of six functions is discussed in sufficient depth for managers to understand what is involved in risk management and how it is implemented. These functions include: (1) Identify the risks in a specific format; (2) Analyze the risk probability, impact/severity, and timeframe; (3) Plan the approach; (4) Track the risk through data compilation and analysis; (5) Control and monitor the risk; (6) Communicate and document the process and decisions.

  17. Risk-Based Contaminated Land Investigation and Assessment

    NASA Astrophysics Data System (ADS)

    Davis, Donald R.

    With increasing frequency, problems of environmental contamination are being analyzed from a risk perspective. Risk-Based Contaminated Land Investigation and Assessment is written for those who wish to present the results of their examination of contaminated land in terms of risk.The opening chapters introduce the concepts of risk analysis for contaminated land. Risk management and the risk assessment process are based on a source-pathway-target framework. Readers are warned against an “over-reliance on the identification of contaminants rather than the potential pathways by which targets may be exposed to these hazards.” In the risk management framework presented in this book, risk evaluation and resultant decision making are seen as part of both the risk assessment and risk reduction process. The sharp separation of risk assessment from risk management as seen in the National Academy of Sciences' (NAS) risk assessment paradigm is not advocatedsemi; perhaps this is because the NAS' concern was regulatory decision while the book's concern is the assessment of a specific site.

  18. [What Surgeons Should Know about Risk Management].

    PubMed

    Strametz, R; Tannheimer, M; Rall, M

    2017-02-01

    Background: The fact that medical treatment is associated with errors has long been recognized. Based on the principle of "first do no harm", numerous efforts have since been made to prevent such errors or limit their impact. However, recent statistics show that these measures do not sufficiently prevent grave mistakes with serious consequences. Preventable mistakes such as wrong patient or wrong site surgery still frequently occur in error statistics. Methods: Based on insight from research on human error, in due consideration of recent legislative regulations in Germany, the authors give an overview of the clinical risk management tools needed to identify risks in surgery, analyse their causes, and determine adequate measures to manage those risks depending on their relevance. The use and limitations of critical incident reporting systems (CIRS), safety checklists and crisis resource management (CRM) are highlighted. Also the rationale for IT systems to support the risk management process is addressed. Results/Conclusion: No single tool of risk management can be effective as a standalone instrument, but unfolds its effect only when embedded in a superordinate risk management system, which integrates tailor-made elements to increase patient safety into the workflows of each organisation. Competence in choosing adequate tools, effective IT systems to support the risk management process as well as leadership and commitment to constructive handling of human error are crucial components to establish a safety culture in surgery. Georg Thieme Verlag KG Stuttgart · New York.

  19. [Process management in the hospital pharmacy for the improvement of the patient safety].

    PubMed

    Govindarajan, R; Perelló-Juncá, A; Parès-Marimòn, R M; Serrais-Benavente, J; Ferrandez-Martí, D; Sala-Robinat, R; Camacho-Calvente, A; Campabanal-Prats, C; Solà-Anderiu, I; Sanchez-Caparrós, S; Gonzalez-Estrada, J; Martinez-Olalla, P; Colomer-Palomo, J; Perez-Mañosas, R; Rodríguez-Gallego, D

    2013-01-01

    To define a process management model for a hospital pharmacy in order to measure, analyse and make continuous improvements in patient safety and healthcare quality. In order to implement process management, Igualada Hospital was divided into different processes, one of which was the Hospital Pharmacy. A multidisciplinary management team was given responsibility for each process. For each sub-process one person was identified to be responsible, and a working group was formed under his/her leadership. With the help of each working group, a risk analysis using failure modes and effects analysis (FMEA) was performed, and the corresponding improvement actions were implemented. Sub-process indicators were also identified, and different process management mechanisms were introduced. The first risk analysis with FMEA produced more than thirty preventive actions to improve patient safety. Later, the weekly analysis of errors, as well as the monthly analysis of key process indicators, permitted us to monitor process results and, as each sub-process manager participated in these meetings, also to assume accountability and responsibility, thus consolidating the culture of excellence. The introduction of different process management mechanisms, with the participation of people responsible for each sub-process, introduces a participative management tool for the continuous improvement of patient safety and healthcare quality. Copyright © 2012 SECA. Published by Elsevier Espana. All rights reserved.

  20. Decision Making and Risk Management in Adventure Sports Coaching

    ERIC Educational Resources Information Center

    Collins, Loel; Collins, Dave

    2013-01-01

    Adventure sport coaches practice in environments that are dynamic and high in risk, both perceived and actual. The inherent risks associated with these activities, individuals' responses and the optimal exploitation of both combine to make the processes of risk management more complex and hazardous than the traditional sports where risk management…

  1. Aquaculture: Incorporating risk assessment and risk management into public policies on genetically modified finfish and shellfish

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Hallerman, E.M.; Kapuscinski, A.R.

    Genetically modified finfish and shellfish pose economic benefits to aquaculture, but also pose ecological and genetic risks to ecosystems receiving such organisms. Realization of benefits with minimization of risks posed by a new technology can be addressed through the processes of risk assessment and risk management. Public policies adopted by individual countries will reflect differences in the outocme of risk assessment and risk management processes resulting from differences among the receiving ecosystems and sets of human values at issue. A number of countries and international institutions have begun development of policies for oversight of genetically modified aquatic organisms. In themore » United States, a working group commissioned by the U.S. Department of Agriculture incorporated risk assessment and risk management principles into draft performance standards for safely conducting research with genetically modified finfish and shellfish. The performance standards address research with a broad range of aquatic GMO`s and compliance is intended to be voluntary. In contrast, the Canadian policy mandates adherence to specified guidelines for experiments with transgenic aquatic organisms; establishment as national policy is expended soon.« less

  2. 12 CFR 217.101 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... management and maintenance system; and control, oversight, and validation system for credit risk of wholesale... advanced IRB systems, operational risk management processes, operational risk data and assessment systems... the seller and the obligor (intercompany accounts receivable and receivables subject to contra...

  3. Risk management in waste water treatment.

    PubMed

    Wagner, M; Strube, I

    2005-01-01

    With the continuous restructuring of the water market due to liberalisation, privatisation and internationalisation processes, the requirements on waste water disposal companies have grown. Increasing competition requires a target-oriented and clearly structured procedure. At the same time it is necessary to meet the environment-relevant legal requirements and to design the processes to be environment-oriented. The implementation of risk management and the integration of such a management instrument in an existing system in addition to the use of modern technologies and procedures can help to make the operation of the waste water treatment safer and consequently strengthen market position. The risk management process consists of three phases, risk identification, risk analysis/risk assessment and risk handling, which are based on each other, as well as of the risk managing. To achieve an identification of the risks as complete as possible, a subdivision of the kind of risks (e.g. legal, financial, market, operational) is suggested. One possibility to assess risks is the portfolio method which offers clear representation. It allows a division of the risks into classes showing which areas need handling. The determination of the appropriate measures to handle a risk (e.g. avoidance, reduction, shift) is included in the concluding third phase. Different strategies can be applied here. On the one hand, the cause-oriented strategy, aiming at preventive measures which aim to reduce the probability of occurrence of a risk (e.g. creation of redundancy, systems with low susceptibility to malfunction). On the other hand, the effect-oriented strategy, aiming to minimise the level of damage in case of an undesired occurrence (e.g. use of alarm systems, insurance cover).

  4. Do Italian Companies Manage Work-Related Stress Effectively? A Process Evaluation in Implementing the INAIL Methodology

    PubMed Central

    Di Tecco, Cristina; Ronchetti, Matteo; Ghelli, Monica; Russo, Simone; Persechino, Benedetta

    2015-01-01

    Studies on Intervention Process Evaluation are attracting growing attention in the literature on interventions linked to stress and the wellbeing of workers. There is evidence that some elements relating to the process and content of an intervention may have a decisive role in implementing it by facilitating or hindering the effectiveness of the results. This study aimed to provide a process evaluation on interventions to assess and manage risks related to work-related stress using a methodological path offered by INAIL. The final sample is composed of 124 companies participating to an interview on aspects relating to each phase of the INAIL methodological path put in place to implement the intervention. INAIL methodology has been defined as useful in the process of assessing and managing the risks related to work-related stress. Some factors related to the process (e.g., implementation of a preliminary phase, workers' involvement, and use of external consultants) showed a role in significant differences that emerged in the levels of risk, particularly in relation to findings from the preliminary assessment. Main findings provide information on the key aspects of process and content that are useful in implementing an intervention for assessing and managing risks related to work-related stress. PMID:26504788

  5. Do Italian Companies Manage Work-Related Stress Effectively? A Process Evaluation in Implementing the INAIL Methodology.

    PubMed

    Di Tecco, Cristina; Ronchetti, Matteo; Ghelli, Monica; Russo, Simone; Persechino, Benedetta; Iavicoli, Sergio

    2015-01-01

    Studies on Intervention Process Evaluation are attracting growing attention in the literature on interventions linked to stress and the wellbeing of workers. There is evidence that some elements relating to the process and content of an intervention may have a decisive role in implementing it by facilitating or hindering the effectiveness of the results. This study aimed to provide a process evaluation on interventions to assess and manage risks related to work-related stress using a methodological path offered by INAIL. The final sample is composed of 124 companies participating to an interview on aspects relating to each phase of the INAIL methodological path put in place to implement the intervention. INAIL methodology has been defined as useful in the process of assessing and managing the risks related to work-related stress. Some factors related to the process (e.g., implementation of a preliminary phase, workers' involvement, and use of external consultants) showed a role in significant differences that emerged in the levels of risk, particularly in relation to findings from the preliminary assessment. Main findings provide information on the key aspects of process and content that are useful in implementing an intervention for assessing and managing risks related to work-related stress.

  6. Mission Assurance Analysis Protocol (MAAP): Assessing Risk in Complex Environments

    DTIC Science & Technology

    2005-09-01

    5 1.7 Focus on Risk .................................................................................. 6 2 Defining Risk ...20 CMU/SEI-2005-TN-032 4.4 Extrinsic and Intrinsic Risk ............................................................. 21 5 Operational Risk in...Section 5 , "Operational Risk in Distributed Processes," we look at the characteristics of operational risk in processes where management control is

  7. Impact of HMO ownership on management processes and utilization outcomes.

    PubMed

    Ahern, M; Molinari, C

    2001-05-01

    To examine the effects of health maintenance organization (HMO) ownership characteristics on selected utilization outcomes and management processes affecting utilization. We used 1995 HMO data from the American Association of Health Plans. Using regression analysis, we examined the relation between HMO utilization (hospital discharges, days, and average length of stay; cardiac catheterization procedures; and average cost of outpatient prescriptions) and the structural characteristics of HMOs: ownership type (insurance company, hospital, physician, independent, and national managed care company), HMO size, for-profit status, model type, geographic region, and payer mix. HMO ownership type is significantly associated with medical management processes, including risk sharing by providers, risk sharing by consumers, and other management strategies. Relative to hospital-owned HMOs, insurance company-owned HMOs have fewer hospital discharges, fewer hospital days, and longer lengths of stay. National managed care organization-owned HMOs have fewer cardiac catheterizations and lower average outpatient prescription costs. Independently owned HMOs have more cardiac catheterizations. For-profit HMOs have lower prescription costs. Relative to hospital-owned HMOs, insurance company-owned HMOs are more likely to use hospital risk sharing and provider capitation and less likely to use out-of-pocket payments for hospital use and a closed formulary. National managed care organization-owned HMOs are less likely to use provider capitation, out-of-pocket payments for hospital use, catastrophic case management, and hospital risk sharing. Physician-hospital-owned HMOs are less likely to use catastrophic case management. For-profit HMOs are more likely to use hospital risk sharing and catastrophic case management. HMO ownership type affects utilization outcomes and management strategies.

  8. Managing Risk in Systems Development.

    ERIC Educational Resources Information Center

    DePaoli, Marilyn M.; And Others

    Stanford University's use of a risk assessment methodology to improve the management of systems development projects is discussed. After examining the concepts of hazard, peril, and risk as they relate to the system development process, three ways to assess risk are covered: size, structure, and technology. The overall objective for Stanford…

  9. Correlational Study of Risk Management and Information Technology Project Success

    ERIC Educational Resources Information Center

    Gillespie, Seth J.

    2014-01-01

    Many IT projects fail despite the best efforts to keep these projects within budget, schedule, and scope. Few studies have looked at the effect of project risk management tools and techniques on project success. The primary focus of this study was to examine the extent to which utilization of project risk management processes influence project…

  10. 12 CFR Appendix E to Part 208 - Capital Adequacy Guidelines for State Member Banks; Market Risk Measure

    Code of Federal Regulations, 2012 CFR

    2012-01-01

    .... A bank subject to this appendix must have a risk management system that meets the following minimum... management and is independent from business trading units. (2) The bank's internal risk measurement model must be integrated into the daily management process. (3) The bank's policies and procedures must...

  11. Through the Eyes of Higher Education Attorneys: How Department Chairs Are Navigating the Waters of Legal Issues and Risk Management

    ERIC Educational Resources Information Center

    Hustoles, Carol L. J.

    2012-01-01

    Legal and risk management issues substantially impact the operations of colleges and universities, which face escalating compliance requirements in an increasingly litigious environment. Failing to assess legal liability issues and to constructively address them with risk management processes create vulnerability to claims and litigation,…

  12. An evaluation of a risk-based environmental regulation in Brazil: Limitations to risk management of hazardous installations

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Naime, Andre, E-mail: andre.naime.ibama@gmail.com

    The environmental regulation of hazardous projects with risk-based decision-making processes can lead to a deficient management of human exposure to technological hazards. Such an approach for regulation is criticized for simplifying the complexity of decisions involving the economic, social, and environmental aspects of the installation and operation of hazardous facilities in urban areas. Results of a Brazilian case study indicate that oil and gas transmission pipelines may represent a threat to diverse communities if the relationship between such linear projects and human populations is overlooked by regulatory bodies. Results also corroborate known challenges to the implementation of EIA processes andmore » outline limitations to an effective environmental and risk management. Two preliminary topics are discussed to strengthen similar regulatory practices. Firstly, an effective integration between social impact assessment and risk assessment in EIA processes to have a more comprehensive understanding of the social fabric. Secondly, the advancement of traditional management practices for hazardous installations to pursue a strong transition from assessment and evaluation to management and control and to promote an effective interaction between land-use planning and environmental regulation.« less

  13. National Aeronautics and Space Administration Marshall Space Flight Center Space Transportation Directorate Risk Management Implementation Program

    NASA Technical Reports Server (NTRS)

    Duarte, Luis Alberto; Kross, Denny (Technical Monitor)

    2001-01-01

    The US civil aerospace program has been a great contributor to the creation and implementation of techniques and methods to identify, analyze, and confront risk. NASA has accomplished mission success in many instances, but also has had many failures. Anomalies have kept the Agency from achieving success on other occasions, as well. While NASA has mastered ways to prevent risks, and to quickly and effectively react and recover from anomalies or failures, it was not until few years ago that a comprehensive Risk Management process started being implemented in some of its programs and projects. A Continuous Risk Management (CRM) cycle process was developed and has been promoted and used successfully in programs and projects across the Agency.

  14. ESMD Risk Management Workshop: Systems Engineering and Integration Risks

    NASA Technical Reports Server (NTRS)

    Thomas, L. Dale

    2005-01-01

    This report has been developed by the National Aeronautics and Space Administration (NASA) Exploration Systems Mission Directorate (ESMD) Risk Management team in close coordination with the Systems Engineering Team. This document provides a point-in-time, cumulative, summary of key lessons learned derived from the SE RFP Development process. Lessons learned invariably address challenges and risks and the way in which these areas have been addressed. Accordingly the risk management thread is woven throughout the document.

  15. The role of Indigenous knowledge in environmental health risk management in Yukon, Canada

    PubMed Central

    Friendship, Katelyn A.; Furgal, Chris M.

    2012-01-01

    Objectives This project aimed to gain better understandings of northern Indigenous risk perception related to food safety and to identify the role that Indigenous knowledge (IK) plays in risk management processes to support more effective and culturally relevant benefit-risk (B-R) management strategies. Study design The project used an exploratory qualitative case study design to investigate the role and place of IK in the management of environmental contaminants exposure via consumption of traditional foods in Yukon First Nations (YFNs). Methods Forty-one semi-directive interviews with Traditional Food Knowledge Holders and Health and Environment Decision-makers were conducted. A review and analysis of organizational documents related to past risk management events for the issue was conducted. Thematic content analysis was used to analyze transcripts and documents for key themes related to the research question. Results There was a recognized need by all participants for better collaboration between scientists and YFN communities. YFNs have been involved in identifying and defining community concerns about past risk issues, setting a local context, and participating in communications strategies. Interviewees stressed the need to commit adequate time for building relationships, physically being in the community, and facilitating open communication. Conducting community-based projects was identified as critical for collaboration and for cooperative learning and management of these issues. Conclusions The perception of “effective” benefit-risk management is significantly influenced by the efforts made to include local communities in the process. A set of common guiding principles within a process that brings together people and knowledge systems may provide a more effective way forward in cross-cultural, multiple knowledge system contexts for complex benefit-risk issues than a prescriptive rigid framework. PMID:22868192

  16. Reframing climate change assessments around risk: recommendations for the US National Climate Assessment

    DOE PAGES

    Weaver, C. P.; Moss, Richard H.; Ebi, Kristie L.; ...

    2017-07-21

    Climate change is a risk management challenge for society, with uncertain but potentially severe outcomes affecting natural and human systems, across generations. Managing climate-related risks will be more difficult without a base of knowledge and practice aimed at identifying and evaluating specific risks, and their likelihood and consequences, as well as potential actions to promote resilience in the face of these risks. Here, we suggest three improvements to the process of conducting climate change assessments to better characterize risk and inform risk management actions.

  17. Reframing climate change assessments around risk: recommendations for the US National Climate Assessment

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Weaver, C. P.; Moss, Richard H.; Ebi, Kristie L.

    Climate change is a risk management challenge for society, with uncertain but potentially severe outcomes affecting natural and human systems, across generations. Managing climate-related risks will be more difficult without a base of knowledge and practice aimed at identifying and evaluating specific risks, and their likelihood and consequences, as well as potential actions to promote resilience in the face of these risks. Here, we suggest three improvements to the process of conducting climate change assessments to better characterize risk and inform risk management actions.

  18. Risk, Error and Accountability: Improving the Practice of School Leaders

    ERIC Educational Resources Information Center

    Perry, Lee-Anne

    2006-01-01

    This paper seeks to explore the notion of risk as an organisational logic within schools, the impact of contemporary accountability regimes on managing risk and then, in turn, to posit a systems-based process of risk management underpinned by a positive logic of risk. It moves through a number of steps beginning with the development of an…

  19. Quantifying risk and accuracy in cancer risk assessment: the process and its role in risk management problem-solving.

    PubMed

    Turturro, A; Hart, R W

    1987-01-01

    A better understanding of chemical-induced cancer has led to appreciation of similarities to problems addressed by risk management of radiation-induced toxicity. Techniques developed for cancer risk assessment of toxic substances can be generalized to toxic agents. A recent problem-solving approach for risk management of toxic substances developed for the U.S. Department of Health and Human Services, and the role of risk assessment and how uncertainty should be treated within the context of this approach, is discussed. Finally, two different methods, research into the assumptions underlying risk assessment and the modification of risk assessment/risk management documents, are used to illustrate how the technique can be applied.

  20. Being Accountable or Filling in Forms: Managers and Clinicians' Views About Communicating Risk.

    PubMed

    Clancy, Leonie; Happell, Brenda

    2017-01-01

    Assessment, documentation, and prevention of risk are central to mental health services. However, there is a paucity of research examining how risk is perceived by key stakeholders including managers and clinicians. Qualitative, exploratory design. In-depth interviews were held with 22 senior managers and 21 clinicians. Communicating risk was a major theme to emerge. For managers, accountability was a primary consideration in communicating risk and therefore influential over nursing practice. Clinicians were more likely to view the organizational processes of communicating risk as a bureaucratic exercise. The significant difference between managers and clinicians is problematic for achieving consumer-focused mental health service delivery, a more critical approach to risk is essential in preserving the therapeutic relationship. © 2015 Wiley Periodicals, Inc.

  1. Modeling Finite-Time Failure Probabilities in Risk Analysis Applications.

    PubMed

    Dimitrova, Dimitrina S; Kaishev, Vladimir K; Zhao, Shouqi

    2015-10-01

    In this article, we introduce a framework for analyzing the risk of systems failure based on estimating the failure probability. The latter is defined as the probability that a certain risk process, characterizing the operations of a system, reaches a possibly time-dependent critical risk level within a finite-time interval. Under general assumptions, we define two dually connected models for the risk process and derive explicit expressions for the failure probability and also the joint probability of the time of the occurrence of failure and the excess of the risk process over the risk level. We illustrate how these probabilistic models and results can be successfully applied in several important areas of risk analysis, among which are systems reliability, inventory management, flood control via dam management, infectious disease spread, and financial insolvency. Numerical illustrations are also presented. © 2015 Society for Risk Analysis.

  2. Selected Aspects Of The Risk In The Supply Chain In Context Of The Supplier Quality Management

    NASA Astrophysics Data System (ADS)

    Koblen, Ivan; Lestyánszka Škůrková, Katarína

    2015-06-01

    The introductory part of the paper underlines the importance of "Risk-based thinking" in the Quality Management System (QMS) and risk in the supply chain, as a principle part of the QMS. After introducing the key terms, the authors focused on the principle part of the article - explanation of the external and internal supply chain risks and the main factors concerning the supply risks, demand risks and environmental risks (as cardinal types of external supply chain risks) as well as the manufacturing and process risks, network/planning and control risks (as most important types of internal supply chain risks). The authors inform on the selected supply chain risk management tools, especially on those which are linked to the appropriate utilization of quality management tools.

  3. Military Ecological Risk Assessment Framework (MERAF) for Assessment of Risks of Military Training and Testing to Natural Resources

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Suter II, G.W.

    2003-06-18

    The objective of this research is to provide the DoD with a framework based on a systematic, risk-based approach to assess impacts for management of natural resources in an ecosystem context. This risk assessment framework is consistent with, but extends beyond, the EPA's ecological risk assessment framework, and specifically addresses DoD activities and management needs. MERAF is intended to be consistent with existing procedures for environmental assessment and planning with DoD testing and training. The intention is to supplement these procedures rather than creating new procedural requirements. MERAF is suitable for use for training and testing area assessment and management.more » It does not include human health risks nor does it address specific permitting or compliance requirements, although it may be useful in some of these cases. Use of MERAF fits into the National Environmental Policy Act (NEPA) process by providing a consistent and rigorous way of organizing and conducting the technical analysis for Environmental Impact Statements (EISs) (Sigal 1993; Carpenter 1995; Canter and Sadler 1997). It neither conflicts with, nor replaces, procedural requirements within the NEPA process or document management processes already in place within DoD.« less

  4. Establishing a proactive safety and health risk management system in the fire service.

    PubMed

    Poplin, Gerald S; Pollack, Keshia M; Griffin, Stephanie; Day-Nash, Virginia; Peate, Wayne F; Nied, Ed; Gulotta, John; Burgess, Jefferey L

    2015-04-19

    Formalized risk management (RM) is an internationally accepted process for reducing hazards in the workplace, with defined steps including hazard scoping, risk assessment, and implementation of controls, all within an iterative process. While required for all industry in the European Union and widely used elsewhere, the United States maintains a compliance-based regulatory structure, rather than one based on systematic, risk-based methodologies. Firefighting is a hazardous profession, with high injury, illness, and fatality rates compared with other occupations, and implementation of RM programs has the potential to greatly improve firefighter safety and health; however, no descriptions of RM implementation are in the peer-reviewed literature for the North American fire service. In this paper we describe the steps used to design and implement the RM process in a moderately-sized fire department, with particular focus on prioritizing and managing injury hazards during patient transport, fireground, and physical exercise procedures. Hazard scoping and formalized risk assessments are described, in addition to the identification of participatory-led injury control strategies. Process evaluation methods were conducted to primarily assess the feasibility of voluntarily instituting the RM approach within the fire service setting. The RM process was well accepted by the fire department and led to development of 45 hazard specific-interventions. Qualitative data documenting the implementation of the RM process revealed that participants emphasized the: value of the RM process, especially the participatory bottom-up approach; usefulness of the RM process for breaking down tasks to identify potential risks; and potential of RM for reducing firefighter injury. As implemented, this risk-based approach used to identify and manage occupational hazards and risks was successful and is deemed feasible for U.S. (and other) fire services. While several barriers and challenges do exist in the implementation of any intervention such as this, recommendations for adopting the process are provided. Additional work will be performed to determine the effectiveness of select controls strategies that were implemented; however participants throughout the organizational structure perceived the RM process to be of high utility while researchers also found the process improved the awareness and engagement in actively enhancing worker safety and health.

  5. Supply chain risk management in newspaper company: House of risk approach

    NASA Astrophysics Data System (ADS)

    Ratnasari, Sintya; Hisjam, Muhammad; Sutopo, Wahyudi

    2018-02-01

    In the supply chain (SC) of newspapers, the printing company is the main entity that has several processes, i.e. procure raw materials, print plate and newspapers, and also distribute newspaper to consumers. The existing risks in the newspaper printing company are quite high. A wide range of disturbances or risks needs to be identified to map out the characteristics of the risk sources that will impact on the performance of the supply chain. Therefore, the printing companies need to manage their supply chain risk of the five major SC processes (such as plan, source, deliver, make, and return). In a case study of a newspaper company in Surakarta, the company have not implemented a risk management process that affects the company. This study is aimed to map the risks in the printing company and formulate risk mitigation alternatives to mitigate the risks. The house of risk (HOR) method was chosen to select a set of proactive actions deemed cost-effective in managing SC Risks in the newspaper company. The model consisting of two stages, the first stage (HOR1) was done by identifying risk, risk causing agents and then measured the severity and occurrences to calculate the Aggregate Risk Priority (ARP) value. The second stage (HOR2) is intended to formulate and prioritize the action of mitigation that the company should pursue to reduce the probability of risk agents to occur. The result shows that the innovative model of HOR in Newspaper Company was presented. There are 24 risk events, 20 causing agents and two priority risks in HOR1. The HOR 2 was proposed 9 ranks of mitigation strategy for priority risk agents, from the easiest to the hardest strategy for the company to implement it.

  6. A quality risk management model approach for cell therapy manufacturing.

    PubMed

    Lopez, Fabio; Di Bartolo, Chiara; Piazza, Tommaso; Passannanti, Antonino; Gerlach, Jörg C; Gridelli, Bruno; Triolo, Fabio

    2010-12-01

    International regulatory authorities view risk management as an essential production need for the development of innovative, somatic cell-based therapies in regenerative medicine. The available risk management guidelines, however, provide little guidance on specific risk analysis approaches and procedures applicable in clinical cell therapy manufacturing. This raises a number of problems. Cell manufacturing is a poorly automated process, prone to operator-introduced variations, and affected by heterogeneity of the processed organs/tissues and lot-dependent variability of reagent (e.g., collagenase) efficiency. In this study, the principal challenges faced in a cell-based product manufacturing context (i.e., high dependence on human intervention and absence of reference standards for acceptable risk levels) are identified and addressed, and a risk management model approach applicable to manufacturing of cells for clinical use is described for the first time. The use of the heuristic and pseudo-quantitative failure mode and effect analysis/failure mode and critical effect analysis risk analysis technique associated with direct estimation of severity, occurrence, and detection is, in this specific context, as effective as, but more efficient than, the analytic hierarchy process. Moreover, a severity/occurrence matrix and Pareto analysis can be successfully adopted to identify priority failure modes on which to act to mitigate risks. The application of this approach to clinical cell therapy manufacturing in regenerative medicine is also discussed. © 2010 Society for Risk Analysis.

  7. A comprehensive Network Security Risk Model for process control networks.

    PubMed

    Henry, Matthew H; Haimes, Yacov Y

    2009-02-01

    The risk of cyber attacks on process control networks (PCN) is receiving significant attention due to the potentially catastrophic extent to which PCN failures can damage the infrastructures and commodity flows that they support. Risk management addresses the coupled problems of (1) reducing the likelihood that cyber attacks would succeed in disrupting PCN operation and (2) reducing the severity of consequences in the event of PCN failure or manipulation. The Network Security Risk Model (NSRM) developed in this article provides a means of evaluating the efficacy of candidate risk management policies by modeling the baseline risk and assessing expectations of risk after the implementation of candidate measures. Where existing risk models fall short of providing adequate insight into the efficacy of candidate risk management policies due to shortcomings in their structure or formulation, the NSRM provides model structure and an associated modeling methodology that captures the relevant dynamics of cyber attacks on PCN for risk analysis. This article develops the NSRM in detail in the context of an illustrative example.

  8. Equipment management risk rating system based on engineering endpoints.

    PubMed

    James, P J

    1999-01-01

    The equipment management risk ratings system outlined here offers two significant departures from current practice: risk classifications are based on intrinsic device risks, and the risk rating system is based on engineering endpoints. Intrinsic device risks are categorized as physical, clinical and technical, and these flow from the incoming equipment assessment process. Engineering risk management is based on verification of engineering endpoints such as clinical measurements or energy delivery. This practice eliminates the ambiguity associated with ranking risk in terms of physiologic and higher-level outcome endpoints such as no significant hazards, low significance, injury, or mortality.

  9. Research and development supporting risk-based wildfire effects prediction for fuels and fire management: Status and needs

    Treesearch

    Kevin Hyde; Matthew B. Dickinson; Gil Bohrer; David Calkin; Louisa Evers; Julie Gilbertson-Day; Tessa Nicolet; Kevin Ryan; Christina Tague

    2013-01-01

    Wildland fire management has moved beyond a singular focus on suppression, calling for wildfire management for ecological benefit where no critical human assets are at risk. Processes causing direct effects and indirect, long-term ecosystem changes are complex and multidimensional. Robust risk-assessment tools are required that account for highly variable effects on...

  10. 12 CFR 217.122 - Qualification requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... related processes; (ii) Have and document a process (which must capture business environment and internal... current business activities, risk profile, technological processes, and risk management processes; and (ii... assessment systems. (D) Business environment and internal control factors. The Board-regulated institution...

  11. 12 CFR 324.122 - Qualification requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... related processes; (ii) Have and document a process (which must capture business environment and internal... current business activities, risk profile, technological processes, and risk management processes; and (ii... assessment systems. (D) Business environment and internal control factors. The FDIC-supervised institution...

  12. Framework for managing mycotoxin risks in the food industry.

    PubMed

    Baker, Robert C; Ford, Randall M; Helander, Mary E; Marecki, Janusz; Natarajan, Ramesh; Ray, Bonnie

    2014-12-01

    We propose a methodological framework for managing mycotoxin risks in the food processing industry. Mycotoxin contamination is a well-known threat to public health that has economic significance for the food processing industry; it is imperative to address mycotoxin risks holistically, at all points in the procurement, processing, and distribution pipeline, by tracking the relevant data, adopting best practices, and providing suitable adaptive controls. The proposed framework includes (i) an information and data repository, (ii) a collaborative infrastructure with analysis and simulation tools, (iii) standardized testing and acceptance sampling procedures, and (iv) processes that link the risk assessments and testing results to the sourcing, production, and product release steps. The implementation of suitable acceptance sampling protocols for mycotoxin testing is considered in some detail.

  13. 12 CFR 37.8 - Safety and soundness requirements.

    Code of Federal Regulations, 2011 CFR

    2011-01-01

    ... effective risk management and control processes over its debt cancellation contracts and debt suspension... manage the risks associated with debt cancellation contracts and debt suspension agreements in accordance... the products. A bank also should assess the adequacy of its internal control and risk mitigation...

  14. 12 CFR 37.8 - Safety and soundness requirements.

    Code of Federal Regulations, 2010 CFR

    2010-01-01

    ... effective risk management and control processes over its debt cancellation contracts and debt suspension... manage the risks associated with debt cancellation contracts and debt suspension agreements in accordance... the products. A bank also should assess the adequacy of its internal control and risk mitigation...

  15. Health-care process improvement decisions: a systems perspective.

    PubMed

    Walley, Paul; Silvester, Kate; Mountford, Shaun

    2006-01-01

    The paper seeks to investigate decision-making processes within hospital improvement activity, to understand how performance measurement systems influence decisions and potentially lead to unsuccessful or unsustainable process changes. A longitudinal study over a 33-month period investigates key events, decisions and outcomes at one medium-sized hospital in the UK. Process improvement events are monitored using process control methods and by direct observation. The authors took a systems perspective of the health-care processes, ensuring that the impacts of decisions across the health-care supply chain were appropriately interpreted. The research uncovers the ways in which measurement systems disguise failed decisions and encourage managers to take a low-risk approach of "symptomatic relief" when trying to improve performance metrics. This prevents many managers from trying higher risk, sustainable process improvement changes. The behaviour of the health-care system is not understood by many managers and this leads to poor analysis of problem situations. Measurement using time-series methodologies, such as statistical process control are vital for a better understanding of the systems impact of changes. Senior managers must also be aware of the behavioural influence of similar performance measurement systems that discourage sustainable improvement. There is a risk that such experiences will tarnish the reputation of performance management as a discipline. Recommends process control measures as a way of creating an organization memory of how decisions affect performance--something that is currently lacking.

  16. Positioning the Learning Asset Portfolio as a Key Component in an Organization's Enterprise Risk Management Strategy

    ERIC Educational Resources Information Center

    McAliney, Peter J.

    2009-01-01

    This article presents a process for valuing a portfolio of learning assets used by line executives across industries to value traditional business assets. Embedded within the context of enterprise risk management, this strategic asset allocation process is presented step by step, providing readers the operational considerations to implement this…

  17. An Analysis of Department of Energy Cost Proposal Process and Effectiveness

    DTIC Science & Technology

    2011-10-11

    processes to mitigate and manage risk , rather than derive upfront assessment and quantification of proposal risk (DoE, 2008a). The proposal...2. GM 2- Enhance the Federal Contract and Project Management Workforce Substantially Complete 3. GM 3 - Improve Project Risk Assessment ...proposal, contract proposal evaluation, risk , cost analysis = = ^Åèìáëáíáçå=oÉëÉ~êÅÜ=mêçÖê~ã= do^ar^qb=p`elli=lc=_rpfkbpp=C=mr_if`=mlif`v - ii

  18. Using Risk Assessment Methodologies to Meet Management Objectives

    NASA Technical Reports Server (NTRS)

    DeMott, D. L.

    2015-01-01

    Corporate and program objectives focus on desired performance and results. ?Management decisions that affect how to meet these objectives now involve a complex mix of: technology, safety issues, operations, process considerations, employee considerations, regulatory requirements, financial concerns and legal issues. ?Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures. Using a risk assessment methodology is only a starting point. ?A risk assessment program provides management with important input in the decision making process. ?A pro-active organization looks to the future to avoid problems, a reactive organization can be blindsided by risks that could have been avoided. ?You get out what you put in, how useful your program is will be up to the individual organization.

  19. Improving Our Odds: Success through Continuous Risk Management

    NASA Technical Reports Server (NTRS)

    Greenhalgh, Phillip O.

    2009-01-01

    Launching a rocket, running a business, driving to work and even day-to-day living all involve some degree of risk. Risk is ever present yet not always recognized, adequately assessed and appropriately mitigated. Identification, assessment and mitigation of risk are elements of the risk management component of the "continuous improvement" way of life that has become a hallmark of successful and progressive enterprises. While the application of risk management techniques to provide continuous improvement may be detailed and extensive, the philosophy, ideals and tools can be beneficially applied to all situations. Experiences with the use of risk identification, assessment and mitigation techniques for complex systems and processes are described. System safety efforts and tools used to examine potential risks of the Ares I First Stage of NASA s new Constellation Crew Launch Vehicle (CLV) presently being designed are noted as examples. Recommendations from lessons learned are provided for the application of risk management during the development of new systems as well as for the improvement of existing systems. Lessons learned and suggestions given are also examined for applicability to simple systems, uncomplicated processes and routine personal daily tasks. This paper informs the reader of varied uses of risk management efforts and techniques to identify, assess and mitigate risk for improvement of products, success of business, protection of people and enhancement of personal life.

  20. Documentary analysis of risk-assessment and safety-planning policies and tools in a mental health context.

    PubMed

    Higgins, Agnes; Doyle, Louise; Morrissey, Jean; Downes, Carmel; Gill, Ailish; Bailey, Sive

    2016-08-01

    Despite the articulated need for policies and processes to guide risk assessment and safety planning, limited guidance exists on the processes or procedures to be used to develop such policies, and there is no body of research that examines the quality or content of the risk-management policies developed. The aim of the present study was to analyse the policies of risk and safety management used to guide mental health nursing practice in Ireland. A documentary analysis was performed on 123 documents received from 22 of the 23 directors of nursing contacted. Findings from the analysis revealed a wide variation in how risk, risk assessment, and risk management were defined. Emphasis within the risk documentation submitted was on risk related to self and others, with minimal attention paid to other types of risks. In addition, there was limited evidence of recovery-focused approaches to positive risk taking that involved service users and their families within the risk-related documentation. Many of the risk-assessment tools had not been validated, and lacked consistency or guidance in relation to how they were to be used or applied. The tick-box approach and absence of space for commentary within documentation have the potential to impact severely on the quality of information collected and documented, and subsequent clinical decision-making. Managers, and those tasked with ensuring safety and quality, need to ensure that policies and processes are, where possible, informed by best evidence and are in line with national mental health policy on recovery. © 2016 Australian College of Mental Health Nurses Inc.

  1. MO-E-9A-01: Risk Based Quality Management: TG100 In Action

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Huq, M; Palta, J; Dunscombe, P

    2014-06-15

    One of the goals of quality management in radiation therapy is to gain high confidence that patients will receive the prescribed treatment correctly. To accomplish these goals professional societies such as the American Association of Physicists in Medicine (AAPM) has published many quality assurance (QA), quality control (QC), and quality management (QM) guidance documents. In general, the recommendations provided in these documents have emphasized on performing device-specific QA at the expense of process flow and protection of the patient against catastrophic errors. Analyses of radiation therapy incidents find that they are most often caused by flaws in the overall therapymore » process, from initial consult through final treatment, than by isolated hardware or computer failures detectable by traditional physics QA. This challenge is shared by many intrinsically hazardous industries. Risk assessment tools and analysis techniques have been developed to define, identify, and eliminate known and/or potential failures, problems, or errors, from a system, process and/or service before they reach the customer. These include, but are not limited to, process mapping, failure modes and effects analysis (FMEA), fault tree analysis (FTA), and establishment of a quality management program that best avoids the faults and risks that have been identified in the overall process. These tools can be easily adapted to radiation therapy practices because of their simplicity and effectiveness to provide efficient ways to enhance the safety and quality of treatment processes. Task group 100 (TG100) of AAPM has developed a risk-based quality management program that uses these tools. This session will be devoted to a discussion of these tools and how these tools can be used in a given radiotherapy clinic to develop a risk based QM program. Learning Objectives: Learn how to design a process map for a radiotherapy process. Learn how to perform a FMEA analysis for a given process. Learn what Fault tree analysis is all about. Learn how to design a quality management program based upon the information obtained from process mapping, FMEA and FTA.« less

  2. Student Activities. Managing Liability.

    ERIC Educational Resources Information Center

    Bennett, Barbara; And Others

    This monograph suggests ways that college or university administrations can undertake a systematic and careful review of the risks posed by students' activities. Its purpose is to provide guidance in integrating the risk management process into a school's existing approaches to managing student organizations and activities. It is noted that no…

  3. [Risk management project: reactive or proactive approach?].

    PubMed

    Vastola, Pasquale; Saracino, Donato M T

    2006-01-01

    Risk management in healthcare refers to the process of developing strategies aimed at preventing and controlling the risk of occurrence of errors and harmful events. The final objective is primarily that of increasing patient safety and secondarily, that of reducing the financial burden of adverse events. The implementation of a risk management system is therefore of vital strategic importance. Nevertheless, a fundamental question that needs to be answered in the operational phase is: should a proactive or reactive approach to risk management be taken? In our view, proactive risk management has many advantages over a reactive approach and is therefore preferable. The reactive approach should be taken exclusively to obtain information regarding risk and errors, in the preliminary, as well as monitoring and follow-up phases of the project.

  4. Integrated Risk and Knowledge Management Program -- IRKM-P

    NASA Technical Reports Server (NTRS)

    Lengyel, David M.

    2009-01-01

    The NASA Exploration Systems Mission Directorate (ESMD) IRKM-P tightly couples risk management and knowledge management processes and tools to produce an effective "modern" work environment. IRKM-P objectives include: (1) to learn lessons from past and current programs (Apollo, Space Shuttle, and the International Space Station); (2) to generate and share new engineering design, operations, and management best practices through preexisting Continuous Risk Management (CRM) procedures and knowledge-management practices; and (3) to infuse those lessons and best practices into current activities. The conceptual framework of the IRKM-P is based on the assumption that risks highlight potential knowledge gaps that might be mitigated through one or more knowledge management practices or artifacts. These same risks also serve as cues for collection of knowledge particularly, knowledge of technical or programmatic challenges that might recur.

  5. General RMP Guidance - Chapter 5: Management System

    EPA Pesticide Factsheets

    If you have at least one Program 2 or Program 3 process, you are required to develop a management system to oversee the implementation of the risk management program elements, and designate responsibility for making process safety a constant priority.

  6. [Hospital risk management from the viewpoint of insurers].

    PubMed

    Gausmann, Peter; Petry, Franz Michael

    2004-10-01

    The present article deals with the significance of risk management in hospitals from the viewpoint of liability insurers. From the perspective of insurance companies, the liability risk of a hospital and its personnel has considerably increased during the past 25 years. The present risk situation is characterized by a growing number of reported liability cases, as well as by an enormous increase of average compensation claims. This development has led some insurance companies to financial deficits in the segment of hospital liability. While some insurers have withdrawn their activities from this market segment, others have reacted by raising their premiums. Since in Germany the premiums usually depend on the number of beds held by a hospital, the problem of rising premiums is exacerbated by the general increase of the number of clinical cases in the face of a parallel reduction of the number of beds. In the process of finding new criteria or methods for adequate premium calculation, a key role will be played by the individual future risk development of a hospital and by the evaluation of this risk by its insurance company. An extensive system of clinical quality management supported by elements of risk management will have persistent positive effects on the development of individual insurance premiums and on the insurability of clinical liability. Risk management is defined as the totality of measures taken by a company to identify risks that could lead to reduced success. Clinical risk management must be regarded in the context of a general trend that is not limited to the field of health service. In this process, the handling of errors and their causes plays a central role. Further variants of hospital risk management are the technical and economic risk management, both of which are increasingly important and are in part implemented in the German legislation. Clinical risk management has originated from the U.S., where as early as in the nineteen-seventies instruments and methods have been developed to avoid errors. Important application fields are anesthetics, surgery, orthopedics, and obstetrics. Risk management is primarily a task of the internal personnel of a hospital. The support by external consultants promises additional benefits for the hospital. Measures of classical risk management usually are essential elements of any quality management system; as such, they are therefore certifiable. Certification alone, however, does not prove the sustained efficiency of a risk-prevention system.

  7. Probabilistic soil erosion modeling using the Erosion Risk Management Tool (ERMIT) after wildfires

    Treesearch

    P. R. Robichaud; W. J. Elliot; J. W. Wagenbrenner

    2011-01-01

    The decision of whether or not to apply post-fire hillslope erosion mitigation treatments, and if so, where these treatments are most needed, is a multi-step process. Land managers must assess the risk of damaging runoff and sediment delivery events occurring on the unrecovered burned hillslope. We developed the Erosion Risk Management Tool (ERMiT) to address this need...

  8. DOD Financial Management: Ongoing Challenges in Implementing the Financial Improvement and Audit Readiness Plan

    DTIC Science & Technology

    2011-09-15

    programs and operations at high risk of being vulnerable to fraud, waste, and abuse.1 Despite several reform initiatives, DOD’s financial management...remains on GAO’s high- risk list today. Long- standing and pervasive weaknesses in DOD’s financial management and related business processes and systems...GAO has identified as being at high risk of waste, fraud, abuse, and mismanagement. The seven specific DOD high- risk areas are (1) approach to

  9. Multicriteria Decision Framework for Cybersecurity Risk Assessment and Management.

    PubMed

    Ganin, Alexander A; Quach, Phuoc; Panwar, Mahesh; Collier, Zachary A; Keisler, Jeffrey M; Marchese, Dayton; Linkov, Igor

    2017-09-05

    Risk assessors and managers face many difficult challenges related to novel cyber systems. Among these challenges are the constantly changing nature of cyber systems caused by technical advances, their distribution across the physical, information, and sociocognitive domains, and the complex network structures often including thousands of nodes. Here, we review probabilistic and risk-based decision-making techniques applied to cyber systems and conclude that existing approaches typically do not address all components of the risk assessment triplet (threat, vulnerability, consequence) and lack the ability to integrate across multiple domains of cyber systems to provide guidance for enhancing cybersecurity. We present a decision-analysis-based approach that quantifies threat, vulnerability, and consequences through a set of criteria designed to assess the overall utility of cybersecurity management alternatives. The proposed framework bridges the gap between risk assessment and risk management, allowing an analyst to ensure a structured and transparent process of selecting risk management alternatives. The use of this technique is illustrated for a hypothetical, but realistic, case study exemplifying the process of evaluating and ranking five cybersecurity enhancement strategies. The approach presented does not necessarily eliminate biases and subjectivity necessary for selecting countermeasures, but provides justifiable methods for selecting risk management actions consistent with stakeholder and decisionmaker values and technical data. Published 2017. This article is a U.S. Government work and is in the public domain in the U.S.A.

  10. The Spatial Distributions and Variations of Water Environmental Risk in Yinma River Basin, China.

    PubMed

    Di, Hui; Liu, Xingpeng; Zhang, Jiquan; Tong, Zhijun; Ji, Meichen

    2018-03-15

    Water environmental risk is the probability of the occurrence of events caused by human activities or the interaction of human activities and natural processes that will damage a water environment. This study proposed a water environmental risk index (WERI) model to assess the water environmental risk in the Yinma River Basin based on hazards, exposure, vulnerability, and regional management ability indicators in a water environment. The data for each indicator were gathered from 2000, 2005, 2010, and 2015 to assess the spatial and temporal variations in water environmental risk using particle swarm optimization and the analytic hierarchy process (PSO-AHP) method. The results showed that the water environmental risk in the Yinma River Basin decreased from 2000 to 2015. The risk level of the water environment was high in Changchun, while the risk levels in Yitong and Yongji were low. The research methods provide information to support future decision making by the risk managers in the Yinma River Basin, which is in a high-risk water environment. Moreover, water environment managers could reduce the risks by adjusting the indicators that affect water environmental risks.

  11. Risk assessment techniques with applicability in marine engineering

    NASA Astrophysics Data System (ADS)

    Rudenko, E.; Panaitescu, F. V.; Panaitescu, M.

    2015-11-01

    Nowadays risk management is a carefully planned process. The task of risk management is organically woven into the general problem of increasing the efficiency of business. Passive attitude to risk and awareness of its existence are replaced by active management techniques. Risk assessment is one of the most important stages of risk management, since for risk management it is necessary first to analyze and evaluate risk. There are many definitions of this notion but in general case risk assessment refers to the systematic process of identifying the factors and types of risk and their quantitative assessment, i.e. risk analysis methodology combines mutually complementary quantitative and qualitative approaches. Purpose of the work: In this paper we will consider as risk assessment technique Fault Tree analysis (FTA). The objectives are: understand purpose of FTA, understand and apply rules of Boolean algebra, analyse a simple system using FTA, FTA advantages and disadvantages. Research and methodology: The main purpose is to help identify potential causes of system failures before the failures actually occur. We can evaluate the probability of the Top event.The steps of this analize are: the system's examination from Top to Down, the use of symbols to represent events, the use of mathematical tools for critical areas, the use of Fault tree logic diagrams to identify the cause of the Top event. Results: In the finally of study it will be obtained: critical areas, Fault tree logical diagrams and the probability of the Top event. These results can be used for the risk assessment analyses.

  12. General RMP Guidance - Chapter 7: Prevention Program (Program 3)

    EPA Pesticide Factsheets

    Many Program 3 processes are already addressed by the OSHA Process Safety Management Program, which covers on-site consequences. So for compliance with the risk management program, process hazard analysis teams must consider potential offsite consequences.

  13. Risk Tradeoffs in Adaptive Ecosystem Management: The Case of the U.S. Forest Service

    NASA Astrophysics Data System (ADS)

    Stern, Marc J.; Martin, Caysie A.; Predmore, S. Andrew; Morse, Wayde C.

    2014-06-01

    Natural resource planning processes on public lands in the United States are driven in large part by the requirements of the National Environmental Policy Act (NEPA), which dictates general processes for analyzing and disclosing the likely impacts of proposed actions. The outcomes of these processes are the result of multiple factors, many related to the manifold smaller incremental decisions made by agency personnel directing the processes. Through interviews with decision makers, team leaders, and team members on five NEPA processes within the U.S. Forest Service, this study examines those incremental decisions. Risk, in particular external relationship risk, emerged as a dominant lens through which agency personnel weigh and make process-related decisions. We discuss the tradeoffs associated with agency actors' emphasis on this form of risk and their potential implications for adaptive ecosystem management and organizational performance.

  14. Risk Assessment Methodology for Hazardous Waste Management (1998)

    EPA Pesticide Factsheets

    A methodology is described for systematically assessing and comparing the risks to human health and the environment of hazardous waste management alternatives. The methodology selects and links appropriate models and techniques for performing the process.

  15. Identification of Commercial Items Risk Factors

    DTIC Science & Technology

    2003-03-01

    performance measures, vendors availability of support, testing and managing organizational change . 1. Process Risk Factor: Commercial Standards Military...support, testing and managing organizational change . C. ASSESSING RESULTS Completing the questions and assessing/compiling the results should help...to performance measures, vendors availability of support, testing and managing organizational change . SECTION I Service

  16. Quality risk management in pharmaceutical development.

    PubMed

    Charoo, Naseem Ahmad; Ali, Areeg Anwer

    2013-07-01

    The objective of ICH Q8, Q9 and Q10 documents is application of systemic and science based approach to formulation development for building quality into product. There is always some uncertainty in new product development. Good risk management practice is essential for success of new product development in decreasing this uncertainty. In quality by design paradigm, the product performance properties relevant to the patient are predefined in target product profile (TPP). Together with prior knowledge and experience, TPP helps in identification of critical quality attributes (CQA's). Initial risk assessment which identifies risks to these CQA's provides impetus for product development. Product and process are designed to gain knowledge about these risks, devise strategies to eliminate or mitigate these risks and meet objectives set in TPP. By laying more emphasis on high risk events the protection level of patient is increased. The process being scientifically driven improves the transparency and reliability of the manufacturer. The focus on risk to the patient together with flexible development approach saves invaluable resources, increases confidence on quality and reduces compliance risk. The knowledge acquired in analysing risks to CQA's permits construction of meaningful design space. Within the boundaries of the design space, variation in critical material characteristics and process parameters must be managed in order to yield a product having the desired characteristics. Specifications based on product and process understanding are established such that product will meet the specifications if tested. In this way, the product is amenable to real time release, since specifications only confirm quality but they do not serve as a means of effective process control.

  17. The integration of the risk management process with the lifecycle of medical device software.

    PubMed

    Pecoraro, F; Luzi, D

    2014-01-01

    The application of software in the Medical Device (MD) domain has become central to the improvement of diagnoses and treatments. The new European regulations that specifically address software as an important component of MD, require complex procedures to make software compliant with safety requirements, introducing thereby new challenges in the qualification and classification of MD software as well as in the performance of risk management activities. Under this perspective, the aim of this paper is to propose an integrated framework that combines the activities to be carried out by the manufacturer to develop safe software within the development lifecycle based on the regulatory requirements reported in US and European regulations as well as in the relevant standards and guidelines. A comparative analysis was carried out to identify the main issues related to the application of the current new regulations. In addition, standards and guidelines recently released to harmonise procedures for the validation of MD software have been used to define the risk management activities to be carried out by the manufacturer during the software development process. This paper highlights the main issues related to the qualification and classification of MD software, providing an analysis of the different regulations applied in Europe and the US. A model that integrates the risk management process within the software development lifecycle has been proposed too. It is based on regulatory requirements and considers software risk analysis as a central input to be managed by the manufacturer already at the initial stages of the software design, in order to prevent MD failures. Relevant changes in the process of MD development have been introduced with the recognition of software being an important component of MDs as stated in regulations and standards. This implies the performance of highly iterative processes that have to integrate the risk management in the framework of software development. It also makes it necessary to involve both medical and software engineering competences to safeguard patient and user safety.

  18. Structured decision making for managing pneumonia epizootics in bighorn sheep

    USGS Publications Warehouse

    Sells, Sarah N.; Mitchell, Michael S.; Edwards, Victoria L.; Gude, Justin A.; Anderson, Neil J.

    2016-01-01

    Good decision-making is essential to conserving wildlife populations. Although there may be multiple ways to address a problem, perfect solutions rarely exist. Managers are therefore tasked with identifying decisions that will best achieve desired outcomes. Structured decision making (SDM) is a method of decision analysis used to identify the most effective, efficient, and realistic decisions while accounting for values and priorities of the decision maker. The stepwise process includes identifying the management problem, defining objectives for solving the problem, developing alternative approaches to achieve the objectives, and formally evaluating which alternative is most likely to accomplish the objectives. The SDM process can be more effective than informal decision-making because it provides a transparent way to quantitatively evaluate decisions for addressing multiple management objectives while incorporating science, uncertainty, and risk tolerance. To illustrate the application of this process to a management need, we present an SDM-based decision tool developed to identify optimal decisions for proactively managing risk of pneumonia epizootics in bighorn sheep (Ovis canadensis) in Montana. Pneumonia epizootics are a major challenge for managers due to long-term impacts to herds, epistemic uncertainty in timing and location of future epizootics, and consequent difficulty knowing how or when to manage risk. The decision tool facilitates analysis of alternative decisions for how to manage herds based on predictions from a risk model, herd-specific objectives, and predicted costs and benefits of each alternative. Decision analyses for 2 example herds revealed that meeting management objectives necessitates specific approaches unique to each herd. The analyses showed how and under what circumstances the alternatives are optimal compared to other approaches and current management. Managers can be confident that these decisions are effective, efficient, and realistic because they explicitly account for important considerations managers implicitly weigh when making decisions, including competing management objectives, uncertainty in potential outcomes, and risk tolerance.

  19. Defining the Process of a Cardiovascular Risk Assessment Program: Lessons Learnt From Cardiac Assessment of Elite Soccer Players in the United Kingdom.

    PubMed

    Speers, Christopher; Seth, Ajai Narain; Patel, Kiran Chhaganbhai; Rakhit, Dhrubo Jyoti; Gillett, Mark James

    2017-12-14

    Retrospectively analyze the cardiac assessment process for elite soccer players, and provide team physicians with a systematic guide to managing longitudinal cardiac risk. Descriptive Epidemiology Study. Cardiac assessments incorporating clinical examination, 12-lead ECG, echocardiography, and health questionnaire. Soccer players at 5 professional clubs in England, the United Kingdom. Data was retrospectively collected, inspected, and analyzed to determine their clinical management and subsequent follow-up. Over 2 years, 265 soccer players, aged 13 to 37 years with 66% of white European ethnicity, were included in the cohort. Eleven percent had "not-normal" assessments, of these assessments, 83% were considered gray screens, falling into three broad categories: structural cardiac features (including valvular abnormalities), functional cardiac features, and electrocardiogram changes. After cardiology consultation, all assessments were grouped into low, enhanced and high-risk categories for ongoing longitudinal risk management. Overall clear-cut pathology was identified in 2%. Cardiovascular assessment is a vital tool in identifying athletes at risk of sudden cardiac death to mitigate their risk through surveillance, intervention, or participation restriction. The decision whether a player is fit to play or not requires a robust risk assessment followed by input from a multidisciplinary team that includes both the team physician and cardiologist. This educational article proposes a clinical management pathway to aid clinicians with this process. Sudden cardiac death is the important medical cause of death during exercise. The team physician should assume responsibility for the management of the longitudinal risk of their players' cardiac assessments in conjunction with sports cardiologist.

  20. Stratospheric Aerosol and Gas Experiment, SAGE III on ISS, An Earth Science Mission on the International Space Station, Schedule Risk Analysis, A Project Perspective

    NASA Technical Reports Server (NTRS)

    Bonine, Lauren

    2015-01-01

    The presentation provides insight into the schedule risk analysis process used by the Stratospheric Aerosol and Gas Experiment III on the International Space Station Project. The presentation focuses on the schedule risk analysis process highlighting the methods for identification of risk inputs, the inclusion of generic risks identified outside the traditional continuous risk management process, and the development of tailored analysis products used to improve risk informed decision making.

  1. Exploration Systems Development (ESD) Approach to Enterprise Risk Management

    NASA Technical Reports Server (NTRS)

    Bauder, Stephen P.

    2014-01-01

    The National Aeronautics and Space Administration (NASA) Exploration Systems Development (ESD) Division has implemented an innovative approach to Enterprise Risk Management under a unique governance structure and streamlined integration model. ESD's mission is to design and build the capability to extend human existence to deep space. The Enterprise consists of three Programs: Space Launch System (SLS), Orion, and Ground Systems Development and Operations (GSDO). The SLS is a rocket and launch system that will be capable of powering humans, habitats, and support systems to deep space. Orion will be the first spacecraft in history capable of taking humans to multiple destinations within deep space. GSDO is modernizing Kennedy's spaceport to launch spacecraft built and designed by both NASA and private industry. ESD's approach to Enterprise Risk Management is commensurate with affordability and a streamlined management philosophy. ESD Enterprise Risk Management leverages off of the primary mechanisms for integration within the Enterprise. The Enterprise integration approach emphasizes delegation of authority to manage and execute the majority of cross-program activities and products to the individual Programs, while maintaining the overall responsibility for all cross-program activities at the Division. The intent of the ESD Enterprise Risk Management approach is to improve risk communication, to avoid replication and/or contradictory strategies, and to minimize overhead process burden. This is accomplished by the facilitation and integration of risk information within ESD. The ESD Division risks, Orion risks, SLS risks, and GSDO risks are owned and managed by the applicable Program. When the Programs have shared risks with multiple consequences, they are jointly owned and managed. When a risk is associated with the integrated system that involves more than one Program in condition, consequence, or mitigation plan, it is considered an Exploration Systems Integration (ESI) Risk. An ESI risk may require visibility and risk handling by multiple organizations. The Integrated Risk Working Group (IRWG) is a small team of Risk experts that are responsible for collaborating and communicating best practices. In addition, the forum facilitates proper integration of risks across the Enterprise. The IRWG uses a Continuous Risk Management approach for facilitating the identification, analysis, planning, tracking, and controlling of ESI Risks. The ESD Division, Programs, and Integrated Task Teams identify ESI Risks. The IRWG maintains a set of metrics for understanding Enterprise Risk process and the overall Risk Posture. The team is also actively involved in the modeling of risk for Enterprise Performance Management. With the Enterprise being constrained in Schedule and Budget, and with significant technical complexity, the appropriate use of Risk Management techniques is crucial to the success of the Enterprise. The IRWG achieves this through the modified approach, providing a forum for collaboration on risks that cross boundaries between the separate entities.

  2. Best practices: Use of an administrative review committee at New Hampshire Hospital to mitigate risk with high-profile patients.

    PubMed

    de Nesnera, Alexander; Folks, David G

    2010-07-01

    An increasing number of patients manifesting violent and aggressive behaviors are treated at New Hampshire Hospital. Over the past ten years, the volume of referrals on an involuntary emergency petition has increased 70%. New Hampshire Hospital has successfully initiated its Administrative Review Committee, which confers a risk management process to mitigate potential liability for the hospital and treating clinicians for these high-risk patients. This best practice is viewed as helpful by clinicians and by the hospital's legal counsel. Hospitals treating similar high-risk patients may also benefit from developing a similar committee and risk management process.

  3. Communicating Risk to Program Managers

    NASA Technical Reports Server (NTRS)

    Shivers, C. Herbert

    2005-01-01

    Program Managers (PM) can protect program resources and improve chances of success by anticipating, understanding and managing risks. Understanding the range of potential risks helps one to avoid or manage the risks. A PM must choose which risks to accept to reduce fire fighting, must meet the expectations of stakeholders consistently, and avoid falling into costly "black holes" that may open. A good risk management process provides the PM more confidence to seize opportunities save money, meet schedule, even improve relationships with people important to the program. Evidence of managing risk and sound internal controls can mean better support from superiors for the program by building a trust and reputation from being on top of issues. Risk managers have an obligation to provide the PM with the best information possible to allow the benefits to be realized (Small Business Consortium, 2004). The Institute for Chartered Accountants in England and Wales sees very important benefits for companies in providing better information about what they do to assess and manage key business risks. Such information will: a) provide practical forward-looking information; b) reduce the cost of capital; c) encourage better risk management; and d) improve accountability for stewardship, investor protection and the usefulness of financial reporting. We are particularly convinced that enhanced risk reporting will help listed companies obtain capital at the lowest possible cost (The Institute of Chartered Accountants in England &Wales, June 2002). Risk managers can take a significant role in quantifying the success of their department and communicating those figures to executive (program) management levels while pushing for a broader risk management role. Overall, risk managers must show that risk management work matters in the most crucial place-the bottom line- as they prove risk management can be a profit center (Sullivan, 2004).

  4. Review of ecological-based risk management approaches used at five Army Superfund sites.

    PubMed

    Poucher, Sherri L; Tracey, Gregory A; Johnson, Mark S; Haines, Laurie B

    2012-04-01

    Factors used in environmental remedial decision making concerning ecological risk are not well understood or necessarily consistent. Recent Records of Decision (RODs) for Army CERCLA sites were reviewed to select case studies where remedial management occurred in response to ecological risks. Thirty-four Army RODs were evaluated representing decisions promulgated between 1996 and 2004. Five were selected based on assessments that remedial actions were clearly linked to concern for ecological receptors. The Ecological Risk Assessment (ERA) approach and the subsequent risk management process were reviewed for each site. The case studies demonstrated that the ERA findings, as well as critical management decisions regarding interpretation of identified ecological risks, were determinants of remedial action objectives. Decisions regarding the selection of remedial alternatives were based on a set of criteria prescribed by Superfund requirements and guidance. Remedial alternative evaluations require protection of human health and the environment, but protective conditions were determined using different methods at each site. Examining the remedial management process for the 5 case study sites revealed that uncertainty in the risk assessment and decisions regarding appropriate spatial scales for both risk assessment and remediation were important factors influencing remedial action decisions. The case reviews also revealed that levels of documentation were variable from site to site. In the future, more detailed documentation of decision criteria and the development of criteria that consider the resilience of the site will result in more technically defensible ecological risk management. Copyright © 2011 SETAC.

  5. A risk analysis for production processes with disposable bioreactors.

    PubMed

    Merseburger, Tobias; Pahl, Ina; Müller, Daniel; Tanner, Markus

    2014-01-01

    : Quality management systems are, as a rule, tightly defined systems that conserve existing processes and therefore guarantee compliance with quality standards. But maintaining quality also includes introducing new enhanced production methods and making use of the latest findings of bioscience. The advances in biotechnology and single-use manufacturing methods for producing new drugs especially impose new challenges on quality management, as quality standards have not yet been set. New methods to ensure patient safety have to be established, as it is insufficient to rely only on current rules. A concept of qualification, validation, and manufacturing procedures based on risk management needs to be established and realized in pharmaceutical production. The chapter starts with an introduction to the regulatory background of the manufacture of medicinal products. It then continues with key methods of risk management. Hazards associated with the production of medicinal products with single-use equipment are described with a focus on bioreactors, storage containers, and connecting devices. The hazards are subsequently evaluated and criteria for risk evaluation are presented. This chapter concludes with aspects of industrial application of quality risk management.

  6. 12 CFR 3.122 - Qualification requirements.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... related processes; (ii) Have and document a process (which must capture business environment and internal... association's current business activities, risk profile, technological processes, and risk management...) Business environment and internal control factors. The national bank or Federal savings association must...

  7. Naval Ship Maintenance: An Analysis of the Dutch Shipbuilding Industry using the Knowledge Value Added, Systems Dynamics, and Integrated Risk Management Methodologies

    DTIC Science & Technology

    2013-04-01

    and Integrated Risk Management Methodologies 5a. CONTRACT NUMBER 5b. GRANT NUMBER 5c. PROGRAM ELEMENT NUMBER 6. AUTHOR(S) 5d. PROJECT NUMBER 5e...supply chains, risk management with real options, and sustainability . [dnford@nps.edu] Thomas J. Housel—Housel specializes in valuing intellectual...maintenance services for the RDN. Damen Schelde has used an ILS since 2002 to manage the shipbuilding process from project initiation through the

  8. Risk Management for Human Support Technology Development

    NASA Technical Reports Server (NTRS)

    jones, Harry

    2005-01-01

    NASA requires continuous risk management for all programs and projects. The risk management process identifies risks, analyzes their impact, prioritizes them, develops and carries out plans to mitigate or accept them, tracks risks and mitigation plans, and communicates and documents risk information. Project risk management is driven by the project goal and is performed by the entire team. Risk management begins early in the formulation phase with initial risk identification and development of a risk management plan and continues throughout the project life cycle. This paper describes the risk management approach that is suggested for use in NASA's Human Support Technology Development. The first step in risk management is to identify the detailed technical and programmatic risks specific to a project. Each individual risk should be described in detail. The identified risks are summarized in a complete risk list. Risk analysis provides estimates of the likelihood and the qualitative impact of a risk. The likelihood and impact of the risk are used to define its priority location in the risk matrix. The approaches for responding to risk are either to mitigate it by eliminating or reducing the effect or likelihood of a risk, to accept it with a documented rationale and contingency plan, or to research or monitor the risk, The Human Support Technology Development program includes many projects with independently achievable goals. Each project must do independent risk management, considering all its risks together and trading them against performance, budget, and schedule. Since the program can succeed even if some projects fail, the program risk has a complex dependence on the individual project risks.

  9. Managing risks in the project pipeline.

    DOT National Transportation Integrated Search

    2013-08-01

    This research focuses on how to manage the risks of project costs and revenue uncertainties over the long-term, and identifies significant : process improvements to ensure projects are delivered on time and as intended, thus maximizing the miles pave...

  10. 12 CFR 324.101 - Definitions.

    Code of Federal Regulations, 2014 CFR

    2014-01-01

    ... quantification system; data management and maintenance system; and control, oversight, and validation system for...-supervised institution's advanced IRB systems, operational risk management processes, operational risk data...-length basis between the seller and the obligor (intercompany accounts receivable and receivables subject...

  11. Risk Management Considerations for Interoperable Acquisition

    DTIC Science & Technology

    2006-08-01

    Electronics Engineers (IEEE) to harmonize the standards for software (IEEE 12207 ) and system (IEEE 15288) life-cycle processes. A goal of this harmonization...management ( ISO /IEC 16085) is being generalized to apply to the systems level. The revised, generalized standard will add require- ments and guidance for the...risk management. The documents include the following: • ISO /IEC Guide 73: Risk Management—Vocabulary—Guidelines for use in stan- dards [ ISO 02

  12. Risk management. National Aeronautics and Space Administration (NASA). Interim rule adopted as final with changes.

    PubMed

    2000-11-22

    This is a final rule amending the NASA FAR Supplement (NFS) to emphasize considerations of risk management, including safety, security (including information technology security), health, export control, and damage to the environment, within the acquisition process. This final rule addresses risk management within the context of acquisition planning, selecting sources, choosing contract type, structuring award fee incentives, administering contracts, and conducting contractor surveillance.

  13. Armed To Learn: Aiming At California K 12 School Gun Policy

    DTIC Science & Technology

    2016-03-01

    involvement in, or presence of, any militia. In District of Columbia v. Heller in 2008, the Supreme Court changed the long-standing collective rights...research focused on decision-making processes that are based on risk management principles fostered by the Insurance Institute of America. Risk...Management, 3rd ed. (Malvern, PA: Insurance Institute of America, 2003), http://www.theinstitutes.org/guide/designations/associate-risk-management

  14. [Outsourcing in long-term care: a risk management approach].

    PubMed

    Guimarães, Cristina Machado; Carvalho, José Crespo de

    2012-05-01

    This article seeks to investigate outsourcing decisions in supply chain management of healthcare organizations, namely the motives and constraints behind the decision, the selection criteria for activities to be outsourced to third parties, the type of possible agreements, and the impact of this decision on the organization per se. A case study of the start-up phase of a Long-term Care unit with an innovative approach and high levels of customization was conducted to understand the outsourcing process in a start-up context (not in the standard context of organizational change) and a risk evaluation matrix was created for outsourcing activities in order to define and implement a performance monitoring process. This study seeks to understand how to evaluate and assess the risks of an outsourcing strategy and proposes a monitoring model using risk management tools. It was shown that the risk management approach can be a solution for monitoring outsourcing in the organizational start-up phase. Conclusions concerning dissatisfaction with the results of outsourcing strategies adopted are also presented.

  15. Towards a Framework for Managing Risk Associated with Technology-Induced Error.

    PubMed

    Borycki, Elizabeth M; Kushniruk, Andre W

    2017-01-01

    Health information technologies (HIT) promised to streamline and modernize healthcare processes. However, a growing body of research has indicated that if such technologies are not designed, implemented or maintained properly this may lead to an increased incidence of new types of errors which the authors have referred to as "technology-induced errors". In this paper, framework is presented that can be used to manage HIT risk. The framework considers the reduction of technology-induced errors at different stages by managing risks associated with the implementation of HIT. Frameworks that allow health information technology managers to employ proactive and preventative approaches that can be used to manage the risks associated with technology-induced errors are critical to improving HIT safety and managing risk associated with implementing new technologies.

  16. Do Service Users with Intellectual Disabilities Want to Be Involved in the Risk Management Process? A Thematic Analysis

    ERIC Educational Resources Information Center

    Kilcommons, Aoiffe M.; Withers, Paul; Moreno-Lopez, Agueda

    2012-01-01

    Background: Involving ID service users in risk decision making necessitates consideration of an individual's ability to assess the implications and associated risks and thus make an informed choice. This calls for research on service users' awareness and understanding of risk management (RM). Method: Thirteen people in a residential ID service who…

  17. TU-AB-BRD-04: Development of Quality Management Program

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Thomadsen, B.

    2015-06-15

    Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

  18. Integrated risk management

    NASA Technical Reports Server (NTRS)

    Hunsucker, J. L.

    1993-01-01

    The purpose of this report is to first present a basis or foundation for the building of an integrated risk management plan and them to present the plan. The integration referred to is across both the temporal and the hierarchical dimensions. Complexity, consequence, and credibility seem to be driving the need for the consideration of risk. Reduction of personal bias and reproducibility of the decision making process seem to be driving the consideration of a formal risk plan. While risk can be used as either a selection tool or a control tool, this paper concentrates on the selection usage. Risk relies on stated purpose. The tightness of the definition of purpose and success is directly reflected in the definition and control of risk. Much of a risk management plan could be designed by the answers to the questions of why, what, who, when, and where. However, any plan must provide the following information about a threat or risk: likelihood, consequence, predictability, reliability, and reproducibility. While the environment at NASA is seen as warm, but not hot, for the introduction of a risk program, some encouragement is seen if the following problems are addressed: no champion, no commitment of resource, confused definitions, lack of direction and focus, a hard sell, NASA culture, many choices of assessment methods, and cost. The plan is designed to follow the normal method of doing work and is structured to follow either the work break down structure or a functional structure very well. The parts of the plan include: defining purpose and success, initial threat assessment, initial risk assessment, reconciling threats and parameters, putting part of the information down and factoring the information back into the decision process as it comes back up, and developing inferences. Two major suggestions are presented. One is to build an office of risk management to be used as a resource by managers in doing the risk process. Another is to form a pilot program to try out the details in the plan and modify the method where needed.

  19. Road Infrastructure Safety Management in Poland

    NASA Astrophysics Data System (ADS)

    Budzynski, Marcin; Jamroz, Kazimierz; Kustra, Wojciech; Michalski, Lech; Gaca, Stanislaw

    2017-10-01

    The objective of road safety infrastructure management is to ensure that when roads are planned, designed, built and used road risks can be identified, assessed and mitigated. Road transport safety is significantly less developed than that of rail, water and air transport. The average individual risk of being a fatality in relation to the distance covered is thirty times higher in road transport that in the other modes. This is mainly because the different modes have a different approach to safety management and to the use of risk management methods and tools. In recent years Poland has had one of the European Union’s highest road death numbers. In 2016 there were 3026 fatalities on Polish roads with 40,766 injuries. Protecting road users from the risk of injury and death should be given top priority. While Poland’s national and regional road safety programmes address this problem and are instrumental in systematically reducing the number of casualties, the effects are far from the expectations. Modern approaches to safety focus on three integrated elements: infrastructure measures, safety management and safety culture. Due to its complexity, the process of road safety management requires modern tools to help with identifying road user risks, assess and evaluate the safety of road infrastructure and select effective measures to improve road safety. One possible tool for tackling this problem is the risk-based method for road infrastructure safety management. European Union Directive 2008/96/EC regulates and proposes a list of tools for managing road infrastructure safety. Road safety tools look at two criteria: the life cycle of a road structure and the process of risk management. Risk can be minimized through the application of the proposed interventions during design process as reasonable. The proposed methods of risk management bring together two stages: risk assessment and risk response occurring within the analyzed road structure (road network, road stretch, road section, junction, etc.). The objective of the methods is to help road authorities to take rational decisions in the area of road safety and road infrastructure safety and understand the consequences occurring in the particular phases of road life cycle. To help with assessing the impact of a road project on the safety of related roads, a method was developed for long-term forecasts of accidents and accident cost estimation as well as a risk classification to identify risks that are not acceptable risks. With regard to road safety audits and road safety inspection, a set of principles was developed to identify risks and the basic classification of mistakes and omissions. This work has added to the Polish experience of preparing and implementing such tools within the competent road authorities.

  20. The new risk paradigm for chemical process security and safety.

    PubMed

    Moore, David A

    2004-11-11

    The world of safety and security in the chemical process industries has certainly changed since 11 September, but the biggest challenges may be yet to come. This paper will explain that there is a new risk management paradigm for chemical security, discuss the differences in interpreting this risk versus accidental risk, and identify the challenges we can anticipate will occur in the future on this issue. Companies need to be ready to manage the new chemical security responsibilities and to exceed the expectations of the public and regulators. This paper will outline the challenge and a suggested course of action.

  1. Space Station logistics policy - Risk management from the top down

    NASA Technical Reports Server (NTRS)

    Paules, Granville; Graham, James L., Jr.

    1990-01-01

    Considerations are presented in the area of risk management specifically relating to logistics and system supportability. These considerations form a basis for confident application of concurrent engineering principles to a development program, aiming at simultaneous consideration of support and logistics requirements within the engineering process as the system concept and designs develop. It is shown that, by applying such a process, the chances of minimizing program logistics and supportability risk in the long term can be improved. The problem of analyzing and minimizing integrated logistics risk for the Space Station Freedom Program is discussed.

  2. Analysis of Contracting Processes, Internal Controls, and Procurement Fraud Schemes

    DTIC Science & Technology

    2013-06-01

    Government Accountability Office (GAO) has kept DoD Contract Management on its High Risk Series list since 1992 (GAO, 2009). In addition, the GAO also...adopted from the Committee of Sponsoring Organizations of the Treadway Commission ( COSO ) (1992). There are five components: control environment, risk ...2001). 2. Risk Assessment Risk assessment is the identification, analysis, and management of risk faced by an organization. It entails identifying

  3. Managing Programmatic Risk for Complex Space System Developments

    NASA Technical Reports Server (NTRS)

    Panetta, Peter V.; Hastings, Daniel; Brumfield, Mark (Technical Monitor)

    2001-01-01

    Risk management strategies have become a recent important research topic to many aerospace organizations as they prepare to develop the revolutionary complex space systems of the future. Future multi-disciplinary complex space systems will make it absolutely essential for organizations to practice a rigorous, comprehensive risk management process, emphasizing thorough systems engineering principles to succeed. Project managers must possess strong leadership skills to direct high quality, cross-disciplinary teams for successfully developing revolutionary space systems that are ever increasing in complexity. Proactive efforts to reduce or eliminate risk throughout a project's lifecycle ideally must be practiced by all technical members in the organization. This paper discusses some of the risk management perspectives that were collected from senior managers and project managers of aerospace and aeronautical organizations by the use of interviews and surveys. Some of the programmatic risks which drive the success or failure of projects are revealed. Key findings lead to a number of insights for organizations to consider for proactively approaching the risks which face current and future complex space systems projects.

  4. Adoption of Building Information Modelling in project planning risk management

    NASA Astrophysics Data System (ADS)

    Mering, M. M.; Aminudin, E.; Chai, C. S.; Zakaria, R.; Tan, C. S.; Lee, Y. Y.; Redzuan, A. A.

    2017-11-01

    An efficient and effective risk management required a systematic and proper methodology besides knowledge and experience. However, if the risk management is not discussed from the starting of the project, this duty is notably complicated and no longer efficient. This paper presents the adoption of Building Information Modelling (BIM) in project planning risk management. The objectives is to identify the traditional risk management practices and its function, besides, determine the best function of BIM in risk management and investigating the efficiency of adopting BIM-based risk management during the project planning phase. In order to obtain data, a quantitative approach is adopted in this research. Based on data analysis, the lack of compliance with project requirements and failure to recognise risk and develop responses to opportunity are the risks occurred when traditional risk management is implemented. When using BIM in project planning, it works as the tracking of cost control and cash flow give impact on the project cycle to be completed on time. 5D cost estimation or cash flow modeling benefit risk management in planning, controlling and managing budget and cost reasonably. There were two factors that mostly benefit a BIM-based technology which were formwork plan with integrated fall plan and design for safety model check. By adopting risk management, potential risks linked with a project and acknowledging to those risks can be identified to reduce them to an acceptable extent. This means recognizing potential risks and avoiding threat by reducing their negative effects. The BIM-based risk management can enhance the planning process of construction projects. It benefits the construction players in various aspects. It is important to know the application of BIM-based risk management as it can be a lesson learnt to others to implement BIM and increase the quality of the project.

  5. 78 FR 15931 - Sunshine Act Meeting; Request for Comments on Draft Evaluation of Recommended Practice on Fatigue...

    Federal Register 2010, 2011, 2012, 2013, 2014

    2013-03-13

    ... Evaluation of Recommended Practice on Fatigue Risk Management Systems for Personnel in the Refining and... and Health Administration: 2001-05-I-DE-1 (Process Safety Management coverage of atmospheric storage tanks); 2005-04-I-TX-9 (Process Safety Management requirement for organizational management of change...

  6. Anger Management for At-Risk Youth.

    ERIC Educational Resources Information Center

    Freeman, John G.; And Others

    This paper focuses on the development of a counseling intervention for use with youth in managing their anger. The anger-management materials described combine elements of a cognitive-behavioral approach with a process orientation to help at-risk youth maintain a career. It is noted that students are taught a strategy for dealing with anger and…

  7. Managing Risk on the Final Frontier

    NASA Technical Reports Server (NTRS)

    Lengyel, David M.; Newman, J. S.

    2009-01-01

    The National Aeronautics and Space Administration (NASA). Exploration Systems Mission Directorate (ESMD) has combined the Continuous Risk Management (CRM) discipline with innovative knowledge management (KM) practices to more effectively enable the accomplishment of work. CRM enables proactive problem identification and problem solving in the complex world of rocket science. while KM is used to improve this process.

  8. Do service users with intellectual disabilities want to be involved in the risk management process? A thematic analysis.

    PubMed

    Kilcommons, Aoiffe M; Withers, Paul; Moreno-Lopez, Águeda

    2012-09-01

    Involving ID service users in risk decision making necessitates consideration of an individual's ability to assess the implications and associated risks and thus make an informed choice. This calls for research on service users' awareness and understanding of risk management (RM). Thirteen people in a residential ID service who were reviewed under the risk management process (RMP) participated in the research. Thematic analysis explored participants' knowledge and understanding of risk management to establish ability to make informed choice. Two main meta-themes (lack of awareness about RM and awareness about RM) and four meta-themes (extent of RM awareness, locus of control, compliance and empowerment) emerged. Nine of 13 participants demonstrated some knowledge and awareness of RM and wanted to contribute to the RMP, despite not being consulted about or given the opportunity to be involved in RM. The majority of service users in this sample had some awareness of the purpose of RM and could make partially informed decisions about whether they would like to be involved in the RMP. The findings highlight the need for professionals to actively attempt to involve ID service users in the management of their own risk. © 2012 Blackwell Publishing Ltd.

  9. Effective Risk Management in Innovative Projects: A Case Study of the Construction of Energy-efficient, Sustainable Building of the Laboratory of Intelligent Building in Cracow

    NASA Astrophysics Data System (ADS)

    Krechowicz, Maria

    2017-10-01

    Many construction projects fail to meet deadlines or they exceed the assumed budget. This scenario is particularly common in the case of innovative projects, in which too late identification of a high risk of delays and exceeding the assumed costs makes a potentially profitable project untenable. A high risk level, far exceeding the level of risk in standard non-innovative projects, is a characteristic feature of the realization phase of innovative projects. This is associated not only with greater complexity of the design and construction phases, but also with the problems with application of new technologies and prototype solutions, lack of qualified personnel with suitable expertise in specialized areas, and with the ability to properly identify the gaps between available and required knowledge and skills. This paper discusses the process of effective risk management in innovative projects on the example of the realization phase of an innovative, energy-efficient and sustainable building of the Laboratory of Intelligent Building in Cracow - DLJM Lab, from the point of view of DORBUD S.A., its general contractor. In this paper, a new approach to risk management process for innovative construction projects is proposed. Risk management process was divided into five stages: gathering information, identification of the important unwanted events, first risk assessment, development and choice of risk reaction strategies, assessment of the residual risk after introducing risk reactions. 18 unwanted events in an innovative construction project were identified. The first risk assessment was carried out using two-parametric risk matrix, in which the probability of unwanted event occurrence and its consequences were analysed. Three levels of risks were defined: tolerable, controlled and uncontrolled. Risk reactions to each defined unwanted event were developed. The following risk reaction types were considered: risk retention, risk reduction, risk transfer and risk elimination. Three-parametric risk matrix was developed to make it possible to assess risk after implementing risk reactions. The possibility of implementing risk management was inversely proportional to the probability of unwanted event occurrence and its contribution to the project outcome. Introducing this risk management strategy allowed to significantly reduce the risk of the innovative construction project. It proved to be an effective tool to reduce risk to an acceptable level. It had a significant contribution to carrying out the project within the assumed time, budget and quality standards.

  10. Analysis of the risk management decisionmaking processes and the decision support systems in the wildland fire agencies

    Treesearch

    Patrick Withen

    2007-01-01

    This paper offers an analysis of the strengths, weaknesses, opportunities, and threats in the risk management process, decision support systems (DSSs), and other types of decisionmaking, including recognition primed decisionmaking, bricolage with the goal of improving DSSs and decisionmaking. DSSs may be thought of as any technology or knowledge that is used as an aid...

  11. The role of risk perception in making flood risk management more effective

    NASA Astrophysics Data System (ADS)

    Buchecker, M.; Salvini, G.; Di Baldassarre, G.; Semenzin, E.; Maidl, E.; Marcomini, A.

    2013-11-01

    Over the last few decades, Europe has suffered from a number of severe flood events and, as a result, there has been a growing interest in probing alternative approaches to managing flood risk via prevention measures. A literature review reveals that, although in the last decades risk evaluation has been recognized as key element of risk management, and risk assessment methodologies (including risk analysis and evaluation) have been improved by including social, economic, cultural, historical and political conditions, the theoretical schemes are not yet applied in practice. One main reason for this shortcoming is that risk perception literature is mainly of universal and theoretical nature and cannot provide the necessary details to implement a comprehensive risk evaluation. This paper therefore aims to explore a procedure that allows the inclusion of stakeholders' perceptions of prevention measures in risk assessment. It proposes to adopt methods of risk communication (both one-way and two-way communication) in risk assessment with the final aim of making flood risk management more effective. The proposed procedure not only focuses on the effect of discursive risk communication on risk perception, and on achieving a shared assessment of the prevention alternatives, but also considers the effects of the communication process on perceived uncertainties, accepted risk levels, and trust in the managing institutions. The effectiveness of this combined procedure has been studied and illustrated using the example of the participatory flood prevention assessment process on the Sihl River in Zurich, Switzerland. The main findings of the case study suggest that the proposed procedure performed well, but that it needs some adaptations for it to be applicable in different contexts and to allow a (semi-) quantitative estimation of risk perception to be used as an indicator of adaptive capacity.

  12. Pharmaceutical supply chain risk assessment in Iran using analytic hierarchy process (AHP) and simple additive weighting (SAW) methods.

    PubMed

    Jaberidoost, Mona; Olfat, Laya; Hosseini, Alireza; Kebriaeezadeh, Abbas; Abdollahi, Mohammad; Alaeddini, Mahdi; Dinarvand, Rassoul

    2015-01-01

    Pharmaceutical supply chain is a significant component of the health system in supplying medicines, particularly in countries where main drugs are provided by local pharmaceutical companies. No previous studies exist assessing risks and disruptions in pharmaceutical companies while assessing the pharmaceutical supply chain. Any risks affecting the pharmaceutical companies could disrupt supply medicines and health system efficiency. The goal of this study was the risk assessment in pharmaceutical industry in Iran considering process's priority, hazard and probability of risks. The study was carried out in 4 phases; risk identification through literature review, risk identification in Iranian pharmaceutical companies through interview with experts, risk analysis through a questionnaire and consultation with experts using group analytic hierarchy process (AHP) method and rating scale (RS) and risk evaluation of simple additive weighting (SAW) method. In total, 86 main risks were identified in the pharmaceutical supply chain with perspective of pharmaceutical companies classified in 11 classes. The majority of risks described in this study were related to the financial and economic category. Also financial management was found to be the most important factor for consideration. Although pharmaceutical industry and supply chain were affected by current political conditions in Iran during the study time, but half of total risks in the pharmaceutical supply chain were found to be internal risks which could be fixed by companies, internally. Likewise, political status and related risks forced companies to focus more on financial and supply management resulting in less attention to quality management.

  13. DOD Financial Management: Improvement Needed in DOD Components’ Implementation of Audit Readiness Effort

    DTIC Science & Technology

    2011-09-01

    DOD Financial Management Abbreviations AFB Air Force Base COSO Committee of Sponsoring Organizations of the Treadway... Management and mismanagement.11 All of DOD’s programs on GAO’s High- Risk List relate to its business operations, including systems and processes... Management maintains audit readiness through risk -based periodic testing of internal controls utilizing the OMB Circular No. A-123, Appendix A

  14. Integrating fire behavior models and geospatial analysis for wildland fire risk assessment and fuel management planning

    Treesearch

    Alan A. Ager; Nicole M. Vaillant; Mark A. Finney

    2011-01-01

    Wildland fire risk assessment and fuel management planning on federal lands in the US are complex problems that require state-of-the-art fire behavior modeling and intensive geospatial analyses. Fuel management is a particularly complicated process where the benefits and potential impacts of fuel treatments must be demonstrated in the context of land management goals...

  15. How EPA Protects Workers from Pesticide Risk

    EPA Pesticide Factsheets

    EPA protects workers from pesticide risk through the risk assessment and risk management processes, as well as via specific worker safety programs such as the worker protection standard and other initiatives.

  16. The Spatial Distributions and Variations of Water Environmental Risk in Yinma River Basin, China

    PubMed Central

    Di, Hui; Liu, Xingpeng; Tong, Zhijun; Ji, Meichen

    2018-01-01

    Water environmental risk is the probability of the occurrence of events caused by human activities or the interaction of human activities and natural processes that will damage a water environment. This study proposed a water environmental risk index (WERI) model to assess the water environmental risk in the Yinma River Basin based on hazards, exposure, vulnerability, and regional management ability indicators in a water environment. The data for each indicator were gathered from 2000, 2005, 2010, and 2015 to assess the spatial and temporal variations in water environmental risk using particle swarm optimization and the analytic hierarchy process (PSO-AHP) method. The results showed that the water environmental risk in the Yinma River Basin decreased from 2000 to 2015. The risk level of the water environment was high in Changchun, while the risk levels in Yitong and Yongji were low. The research methods provide information to support future decision making by the risk managers in the Yinma River Basin, which is in a high-risk water environment. Moreover, water environment managers could reduce the risks by adjusting the indicators that affect water environmental risks. PMID:29543706

  17. [Risk management--a new aspect of quality assessment in intensive care medicine: first results of an analysis of the DIVI's interdisciplinary quality assessment research group].

    PubMed

    Stiletto, R; Röthke, M; Schäfer, E; Lefering, R; Waydhas, Ch

    2006-10-01

    Patient security has become one of the major aspects of clinical management in recent years. The crucial point in research was focused on malpractice. In contradiction to the economic process in non medical fields, the analysis of errors during the in-patient treatment time was neglected. Patient risk management can be defined as a structured procedure in a clinical unit with the aim to reduce harmful events. A risk point model was created based on a Delphi process and founded on the DIVI data register. The risk point model was evaluated in clinically working ICU departments participating in the register data base. The results of the risk point evaluation will be integrated in the next data base update. This might be a step to improve the reliability of the register to measure quality assessment in the ICU.

  18. Proposal on How To Conduct a Biopharmaceutical Process Failure Mode and Effect Analysis (FMEA) as a Risk Assessment Tool.

    PubMed

    Zimmermann, Hartmut F; Hentschel, Norbert

    2011-01-01

    With the publication of the quality guideline ICH Q9 "Quality Risk Management" by the International Conference on Harmonization, risk management has already become a standard requirement during the life cycle of a pharmaceutical product. Failure mode and effect analysis (FMEA) is a powerful risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to biopharmaceutical processes brings about some difficulties. The proposal presented here is intended to serve as a brief but nevertheless comprehensive and detailed guideline on how to conduct a biopharmaceutical process FMEA. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. The application for such a biopharmaceutical process FMEA is widespread. It can be useful whenever a biopharmaceutical manufacturing process is developed or scaled-up, or when it is transferred to a different manufacturing site. It may also be conducted during substantial optimization of an existing process or the development of a second-generation process. According to their resulting risk ratings, process parameters can be ranked for importance and important variables for process development, characterization, or validation can be identified. Health authorities around the world ask pharmaceutical companies to manage risk during development and manufacturing of pharmaceuticals. The so-called failure mode and effect analysis (FMEA) is an established risk analysis tool that has been used for decades in mechanical and electrical industries. However, the adaptation of the FMEA methodology to pharmaceutical processes that use modern biotechnology (biopharmaceutical processes) brings about some difficulties, because those biopharmaceutical processes differ from processes in mechanical and electrical industries. The proposal presented here explains how a biopharmaceutical process FMEA can be conducted. It includes a detailed 1-to-10-scale FMEA rating table for occurrence, severity, and detectability of failures that has been especially designed for typical biopharmaceutical processes. With the help of this guideline, different details of the manufacturing process can be ranked according to their potential risks, and this can help pharmaceutical companies to identify aspects with high potential risks and to react accordingly to improve the safety of medicines.

  19. Microbiological performance of a food safety management system in a food service operation.

    PubMed

    Lahou, E; Jacxsens, L; Daelman, J; Van Landeghem, F; Uyttendaele, M

    2012-04-01

    The microbiological performance of a food safety management system in a food service operation was measured using a microbiological assessment scheme as a vertical sampling plan throughout the production process, from raw materials to final product. The assessment scheme can give insight into the microbiological contamination and the variability of a production process and pinpoint bottlenecks in the food safety management system. Three production processes were evaluated: a high-risk sandwich production process (involving raw meat preparation), a medium-risk hot meal production process (starting from undercooked raw materials), and a low-risk hot meal production process (reheating in a bag). Microbial quality parameters, hygiene indicators, and relevant pathogens (Listeria monocytogenes, Salmonella, Bacillus cereus, and Escherichia coli O157) were in accordance with legal criteria and/or microbiological guidelines, suggesting that the food safety management system was effective. High levels of total aerobic bacteria (>3.9 log CFU/50 cm(2)) were noted occasionally on gloves of food handlers and on food contact surfaces, especially in high contamination areas (e.g., during handling of raw material, preparation room). Core control activities such as hand hygiene of personnel and cleaning and disinfection (especially in highly contaminated areas) were considered points of attention. The present sampling plan was used to produce an overall microbiological profile (snapshot) to validate the food safety management system in place.

  20. Managing health and safety risks: Implications for tailoring health and safety management system practices.

    PubMed

    Willmer, D R; Haas, E J

    2016-01-01

    As national and international health and safety management system (HSMS) standards are voluntarily accepted or regulated into practice, organizations are making an effort to modify and integrate strategic elements of a connected management system into their daily risk management practices. In high-risk industries such as mining, that effort takes on added importance. The mining industry has long recognized the importance of a more integrated approach to recognizing and responding to site-specific risks, encouraging the adoption of a risk-based management framework. Recently, the U.S. National Mining Association led the development of an industry-specific HSMS built on the strategic frameworks of ANSI: Z10, OHSAS 18001, The American Chemistry Council's Responsible Care, and ILO-OSH 2001. All of these standards provide strategic guidance and focus on how to incorporate a plan-do-check-act cycle into the identification, management and evaluation of worksite risks. This paper details an exploratory study into whether practices associated with executing a risk-based management framework are visible through the actions of an organization's site-level management of health and safety risks. The results of this study show ways that site-level leaders manage day-to-day risk at their operations that can be characterized according to practices associated with a risk-based management framework. Having tangible operational examples of day-to-day risk management can serve as a starting point for evaluating field-level risk assessment efforts and their alignment to overall company efforts at effective risk mitigation through a HSMS or other processes.

  1. Strengthening the management of ESA - the Inter-Directorate Reform of Corporate and Risk Management

    NASA Astrophysics Data System (ADS)

    Feustel-Büechl, Jörg; Arend, Harald; Derio, Eric; Infante, Giovanni; Kreiner, Gerhard; Phaler, Jesse; Tabbert, Michael

    2007-02-01

    ESA has undertaken the Inter-Directorate Reform of Corporate and Risk Management to strengthen the Agency's internal operations. The reform was completed at the end of 2006, encompassing five dedicated projects on Risk Management, Agency-Wide Controlling System, Project Plan and Integrated Project Review, General Budget Structure and Charging Policy, and Corporate Information Systems. It has contributed to improved management of the Agency's internal operations by engaging all internal stakeholders in a common objective, introducing improvements to planning and management methods, elaborating consolidated information structures and tools, contributing to enhanced transparency and accountability, and by providing qualified new policies, processes and tools.

  2. Case Study: University of Anyplace: Strategic Legal Risk Review.

    ERIC Educational Resources Information Center

    Hall, John T.; Ferguson, Rowan

    2000-01-01

    Considers legal issues and risks faced by a fictional American university as it seeks to establish an operation based in London. Addresses the first step in the process of risk management, the risk review exercise, and provides an explanation of the legal issues involved to allow progression to the second stage in the process (evaluation of the…

  3. Use of mechanistic simulations as a quantitative risk-ranking tool within the quality by design framework.

    PubMed

    Stocker, Elena; Toschkoff, Gregor; Sacher, Stephan; Khinast, Johannes G

    2014-11-20

    The purpose of this study is to evaluate the use of computer simulations for generating quantitative knowledge as a basis for risk ranking and mechanistic process understanding, as required by ICH Q9 on quality risk management systems. In this specific publication, the main focus is the demonstration of a risk assessment workflow, including a computer simulation for the generation of mechanistic understanding of active tablet coating in a pan coater. Process parameter screening studies are statistically planned under consideration of impacts on a potentially critical quality attribute, i.e., coating mass uniformity. Based on computer simulation data the process failure mode and effects analysis of the risk factors is performed. This results in a quantitative criticality assessment of process parameters and the risk priority evaluation of failure modes. The factor for a quantitative reassessment of the criticality and risk priority is the coefficient of variation, which represents the coating mass uniformity. The major conclusion drawn from this work is a successful demonstration of the integration of computer simulation in the risk management workflow leading to an objective and quantitative risk assessment. Copyright © 2014. Published by Elsevier B.V.

  4. Assessment of public perception of radioactive waste management in Korea.

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Trone, Janis R.; Cho, SeongKyung; Whang, Jooho

    2011-11-01

    The essential characteristics of the issue of radioactive waste management can be conceptualized as complex, with a variety of facets and uncertainty. These characteristics tend to cause people to perceive the issue of radioactive waste management as a 'risk'. This study was initiated in response to a desire to understand the perceptions of risk that the Korean public holds towards radioactive waste and the relevant policies and policy-making processes. The study further attempts to identify the factors influencing risk perceptions and the relationships between risk perception and social acceptance.

  5. A Tutorial on Probablilistic Risk Assessement and its Role in Risk-Informed Decision Making

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon

    2010-01-01

    This slide presentation reviews risk assessment and its role in risk-informed decision making. It includes information on probabilistic risk assessment, typical risk management process, origins of risk matrix, performance measures, performance objectives and Bayes theorem.

  6. Closing Intelligence Gaps: Synchronizing the Collection Management Process

    DTIC Science & Technology

    information flow. The US military divides the world into six distinct geographic areas with corresponding commanders managing risk and weighing...analyzed information , creating a mismatch between supply and demand. The result is a burden on all facets of the intelligence process. However, if the target...system, or problem requiring analysis is not collected, intelligence fails. Executing collection management under the traditional tasking process

  7. PSP, TSP, XP, CMMI...Eating the Alphabet Soup!

    DTIC Science & Technology

    2011-05-19

    Operations and Reports, 1215 Jefferson Davis Highway, Suite 1204, Arlington VA 22202-4302. Respondents should be aware that notwithstanding any other...4 Q tit t Continuous process improvement Organizational Performance Management Causal Analysis and Resolution Level Focus Process Areas Requirements...Project Management process standardization Risk management Decision Analysis and Resolution Product Integration 2 M d R i t t anage Basic Project

  8. A Climate Change Risk and Resilience Assessment Process

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Myers, Lisa

    This presentation summarizes a site-specific climate resilience planning process applied at two different U.S. Department of Energy sites, in Colorado and along the Gulf Coast that federal site managers can use to identify and analyze potential climate-related risks and explore resilience options to minimize those risks.

  9. A New Process for Organizing Assessments of Social, Economic, and Environmental Outcomes: Case Study of Wildland Fire Management in the USA

    EPA Science Inventory

    Ecological risk assessments typically are organized using the processes of planning (a discussion among managers, stakeholders, and analysts to clarify ecosystem management goals and assessment scope) and problem formulation (evaluation of existing information to generate hypothe...

  10. A new process for organizing assessments of social, economic and environmental outcomes: case study of wildland fire management in the U.S.A.

    EPA Science Inventory

    Ecological risk assessments typically are organized using the processes of planning (a discussion among managers, stakeholders and analysis to clarify ecosystem management goals and assessment scope) and problem formulation (evaluation of existing information to generate hypothes...

  11. Proposal for a Security Management in Cloud Computing for Health Care

    PubMed Central

    Dzombeta, Srdan; Brandis, Knud

    2014-01-01

    Cloud computing is actually one of the most popular themes of information systems research. Considering the nature of the processed information especially health care organizations need to assess and treat specific risks according to cloud computing in their information security management system. Therefore, in this paper we propose a framework that includes the most important security processes regarding cloud computing in the health care sector. Starting with a framework of general information security management processes derived from standards of the ISO 27000 family the most important information security processes for health care organizations using cloud computing will be identified considering the main risks regarding cloud computing and the type of information processed. The identified processes will help a health care organization using cloud computing to focus on the most important ISMS processes and establish and operate them at an appropriate level of maturity considering limited resources. PMID:24701137

  12. Proposal for a security management in cloud computing for health care.

    PubMed

    Haufe, Knut; Dzombeta, Srdan; Brandis, Knud

    2014-01-01

    Cloud computing is actually one of the most popular themes of information systems research. Considering the nature of the processed information especially health care organizations need to assess and treat specific risks according to cloud computing in their information security management system. Therefore, in this paper we propose a framework that includes the most important security processes regarding cloud computing in the health care sector. Starting with a framework of general information security management processes derived from standards of the ISO 27000 family the most important information security processes for health care organizations using cloud computing will be identified considering the main risks regarding cloud computing and the type of information processed. The identified processes will help a health care organization using cloud computing to focus on the most important ISMS processes and establish and operate them at an appropriate level of maturity considering limited resources.

  13. [Maturity Levels of Quality and Risk Management at the University Hospital Schleswig-Holstein].

    PubMed

    Jussli-Melchers, Jill; Hilbert, Carsten; Jahnke, Iris; Wehkamp, Kai; Rogge, Annette; Freitag-Wolf, Sandra; Kahla-Witzsch, Heike A; Scholz, Jens; Petzina, Rainer

    2018-05-16

    Quality and risk management in hospitals are not only required by law but also for an optimal patient-centered and process-optimized patient care. To evaluate the maturity levels of quality and risk management at the University Hospital Schleswig-Holstein (UKSH), a structured analytical tool was developed for easy and efficient application. Four criteria concerning quality management - quality assurance (QS), critical incident reporting system (CIRS), complaint management (BM) and process management (PM) - were evaluated with a structured questionnaire. Self-assessment and external assessment were performed to classify the maturity levels at the UKSH (location Kiel and Lübeck). Every quality item was graded into four categories from "A" (fully implemented) to "D" (not implemented at all). First of all, an external assessment was initiated by the head of the department of quality and risk management. Thereafter, a self-assessment was performed by 46 clinical units of the UKSH. Discrepancies were resolved in a collegial dialogue. Based on these data, overall maturity levels were obtained for every clinical unit. The overall maturity level "A" was reached by three out of 46 (6.5%) clinical units. No unit was graded with maturity level "D". 50% out of all units reached level "B" and 43.5% level "C". The distribution of the four different quality criteria revealed a good implementation of complaint management (maturity levels "A" and "B" in 78.3%), whereas the levels for CIRS were "C" and "D" in 73.9%. Quality assurance and process management showed quite similar distributions for the levels of maturity "B" and "C" (87% QS; 91% PM). The structured analytical tool revealed maturity levels of 46 clinical units of the UKSH and defined the maturity levels of four relevant quality criteria (QS, CIRS, BM, PM). As a consequence, extensive procedures were implemented to raise the standard of quality and risk management. In future, maturity levels will be reevaluated every two years. This qualitative maturity level model enables in a simple and efficient way precise statements concerning presence, manifestation and development of quality and risk management. © Georg Thieme Verlag KG Stuttgart · New York.

  14. General RMP Guidance - Chapter 9: Risk Management Plan

    EPA Pesticide Factsheets

    You must submit one risk management plan (RMP) to EPA for all of your covered processes. The internet-based RMP*eSubmit allows you to submit your RMP in EPA's Central Data Exchange (CDX), where you can access and change/correct existing RMPs.

  15. Modeling Open Architecture and Evolutionary Acquisition: Implementation Lessons from the ARCI Program for the Rapid Capability Insertion Process

    DTIC Science & Technology

    2009-04-22

    Implementation Issues Another RCIP implementation risk is program management burnout . The ACRI program manager specifically identified the potential...of burnout in his program management team due to the repeated, intense Integration phases. To investigate the possibility and severity of this risk to...the ACRI simulation. This suggests that the burnout risk will be larger for RCIP than it was for ACRI. Successfully implementing a sustainable RCIP

  16. TU-AB-BRD-01: Process Mapping

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Palta, J.

    2015-06-15

    Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

  17. Mapping Disaster Risk Reduction and Climate Change Adaptation: progress in South Africa

    NASA Astrophysics Data System (ADS)

    Storie, Judith M.

    2018-05-01

    Disaster Risk Reduction (DRR) and Climate Change Adaptation (CCA) strategies in Africa are on the increase. South Africa is no different, and a number of strategies have seen the light in aid of reducing disaster risk and adapting to cli-mate change. The DRR and CCA processes include the mapping of location and extent of known and potential hazards, vulnerable communities and environments, and opportunities that may exist to manage these risks. However, the mapping of often fast-changing urban and rural spaces in a standardized manner presents challenges that relate to processes, scales of data capture, level of detail recorded, software and compatibility related to data formats and net-works, human resources skills and understanding, as well as differences in approaches to the nature in which the map-ping processes are executed and spatial data is managed. As a result, projects and implementation of strategies that re-late to the use of such data is affected, and the success of activities based on the data may therefore be uncertain. This paper investigates data custodianship and data categories that is processed and managed across South Africa. It explores the process and content management of disaster risk and climate change related information and defines the challenges that exist in terms of governance. The paper also comments on the challenges and potential solutions for the situation as it gives rise to varying degrees of accuracy, effectiveness for use, and applicability of the spatial data available to affect DRR and improve the value of CCA programmes in the region.

  18. The application of quality risk management to the bacterial endotoxins test: use of hazard analysis and critical control points.

    PubMed

    Annalaura, Carducci; Giulia, Davini; Stefano, Ceccanti

    2013-01-01

    Risk analysis is widely used in the pharmaceutical industry to manage production processes, validation activities, training, and other activities. Several methods of risk analysis are available (for example, failure mode and effects analysis, fault tree analysis), and one or more should be chosen and adapted to the specific field where they will be applied. Among the methods available, hazard analysis and critical control points (HACCP) is a methodology that has been applied since the 1960s, and whose areas of application have expanded over time from food to the pharmaceutical industry. It can be easily and successfully applied to several processes because its main feature is the identification, assessment, and control of hazards. It can be also integrated with other tools, such as fishbone diagram and flowcharting. The aim of this article is to show how HACCP can be used to manage an analytical process, propose how to conduct the necessary steps, and provide data templates necessary to document and useful to follow current good manufacturing practices. In the quality control process, risk analysis is a useful tool for enhancing the uniformity of technical choices and their documented rationale. Accordingly, it allows for more effective and economical laboratory management, is capable of increasing the reliability of analytical results, and enables auditors and authorities to better understand choices that have been made. The aim of this article is to show how hazard analysis and critical control points can be used to manage bacterial endotoxins testing and other analytical processes in a formal, clear, and detailed manner.

  19. Using Risk Assessment Methodologies to Meet Management Objectives

    NASA Technical Reports Server (NTRS)

    DeMott, D. L.

    2015-01-01

    Current decision making involves numerous possible combinations of technology elements, safety and health issues, operational aspects and process considerations to satisfy program goals. Identifying potential risk considerations as part of the management decision making process provides additional tools to make more informed management decision. Adapting and using risk assessment methodologies can generate new perspectives on various risk and safety concerns that are not immediately apparent. Safety and operational risks can be identified and final decisions can balance these considerations with cost and schedule risks. Additional assessments can also show likelihood of event occurrence and event consequence to provide a more informed basis for decision making, as well as cost effective mitigation strategies. Methodologies available to perform Risk Assessments range from qualitative identification of risk potential, to detailed assessments where quantitative probabilities are calculated. Methodology used should be based on factors that include: 1) type of industry and industry standards, 2) tasks, tools, and environment 3) type and availability of data and 4) industry views and requirements regarding risk & reliability. Risk Assessments are a tool for decision makers to understand potential consequences and be in a position to reduce, mitigate or eliminate costly mistakes or catastrophic failures.

  20. Incident reporting.

    PubMed

    Wilson, J

    Healthcare delivery is a risky business. People view the NHS in the same light as other commercial businesses such as the hotel, retail and airline industries. The White Paper 'The New NHS: Modern, Dependable' (Secretary of State for Health, 1997) places statutory responsibilities on managers and clinicians to provide a quality service and to have accountability for clinical governance and performance management. Quality and risk are two sides of the same coin, i.e. if you have good quality you have low risk, and this firmly supports the clinical effectiveness agenda. Healthcare organizations in all sectors of care delivery need to demonstrate their high levels of achievement and commitment to continuous quality improvements. Risk management is a process for identifying, assessing and evaluating risks which have adverse effects on the quality, safety and effectiveness of service delivery, and taking positive action to eliminate or reduce them. Having an open, honest and blame-free organization which is open to improving processes and systems of care is a big step towards having staff who are committed to quality and getting things right. Near-miss, incident and indicator recording and reporting are cornerstones of any quality and risk management system.

  1. Project risk management in the construction of high-rise buildings

    NASA Astrophysics Data System (ADS)

    Titarenko, Boris; Hasnaoui, Amir; Titarenko, Roman; Buzuk, Liliya

    2018-03-01

    This paper shows the project risk management methods, which allow to better identify risks in the construction of high-rise buildings and to manage them throughout the life cycle of the project. One of the project risk management processes is a quantitative analysis of risks. The quantitative analysis usually includes the assessment of the potential impact of project risks and their probabilities. This paper shows the most popular methods of risk probability assessment and tries to indicate the advantages of the robust approach over the traditional methods. Within the framework of the project risk management model a robust approach of P. Huber is applied and expanded for the tasks of regression analysis of project data. The suggested algorithms used to assess the parameters in statistical models allow to obtain reliable estimates. A review of the theoretical problems of the development of robust models built on the methodology of the minimax estimates was done and the algorithm for the situation of asymmetric "contamination" was developed.

  2. Reducing Risk for the Next Generation Nuclear Plant

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    John M. Beck II; Harold J. Heydt; Emmanuel O. Opare

    2010-07-01

    The Next Generation Nuclear Plant (NGNP) Project, managed by the Idaho National Laboratory (INL), is directed by the Energy Policy Act of 2005, to research, develop, design, construct, and operate a prototype forth generation nuclear reactor to meet the needs of the 21st Century. As with all large projects developing and deploying new technologies, the NGNP has numerous risks that need to be identified, tracked, mitigated, and reduced in order for successful project completion. A Risk Management Plan (RMP) was created to outline the process the INL is using to manage the risks and reduction strategies for the NGNP Project.more » Integral to the RMP is the development and use of a Risk Management System (RMS). The RMS is a tool that supports management and monitoring of the project risks. The RMS does not only contain a risk register, but other functionality that allows decision makers, engineering staff, and technology researchers to review and monitor the risks as the project matures.« less

  3. Managing the potential risks of using bacteria-laden water in mineral processing to protect freshwater.

    PubMed

    Liu, Wenying; Moran, Chris J; Vink, Sue

    2013-06-18

    The minerals industry is being driven to access multiple water sources and increase water reuse to minimize freshwater withdrawal. Bacteria-laden water, such as treated effluent, has been increasingly used as an alternative to freshwater for mineral processing, in particular flotation, where conditions are favorable for bacterial growth. However, the risk posed by bacteria to flotation efficiency is poorly understood. This could be a barrier to the ongoing use of this water source. This study tested the potential of a previously published risk-based approach as a management tool to both assist mine sites in quantifying the risk from bacteria, and finding system-wide cost-effective solutions for risk mitigation. The result shows that the solution of adjusting the flotation chemical regime could only partly control the risk. The second solution of using tailings as an absorbent was shown to be effective in the laboratory in reducing bacterial concentration and thus removing the threat to flotation recovery. The best solution is likely to combine internal and external approaches, that is, inside and outside processing plants. Findings in this study contribute possible methods applicable to managing the risk from water-borne bacteria to plant operations that choose to use bacteria-containing water, when attempting to minimize freshwater use, and avoiding the undesirable consequences of increasing its use.

  4. A dynamic process of health risk assessment for business continuity management during the World Exposition Shanghai, China, 2010.

    PubMed

    Sun, Xiaodong; Keim, Mark; Dong, Chen; Mahany, Mollie; Guo, Xiang

    2014-01-01

    Reports of health issues related to mass gatherings around the world have indicated a potential for public health and medical emergencies to occur on a scale that could place a significant impact on business continuity for national and international organisations. This paper describes a risk assessment process for business continuity management that was performed as part of the planning efforts related to the World Expo 2010 Shanghai China (Expo), the world's largest mass gathering to date. Altogether, 73 million visitors attended the Expo, generating over US$2bn of revenue. During 2008 to 2010, the Shanghai Municipal Center for Disease Control and Prevention performed a dynamic series of four disaster risk assessments before and during the Expo. The purpose of this assessment process was to identify, analyse and evaluate risks for public health security during different stages of the Expo. This paper describes an overview of the novel approach for this multiple and dynamic process of assessment of health security risk for ensuring business continuity.

  5. Exploring the effect of at-risk case management compensation on hospital pay-for-performance outcomes: tools for change.

    PubMed

    Granata, Randy L; Hamilton, Karen

    2015-01-01

    Acute care nurse case managers are charged with compliance oversight, managing throughput, and ensuring safe care transitions. Leveraging the roles of nurse case managers and social workers during care transitions translates into improved fiscal performance under the Affordable Care Act. This article aims to equip leaders in the field of case management with tools to facilitate the alignment of case management systems with hospital pay-for-performance measures. A quality improvement project was implemented at a hospital in south Alabama to examine the question: for acute care case managers, what is the effect of key performance indictors using an at-risk compensation model in comparison to past nonincentive models on hospital readmissions, lengths of stay, and patient satisfaction surrounding the discharge process. Inpatient acute care hospital. The implementation of an at-risk compensation model using key performance indicators, Lean Six Sigma methodology, and Creative Health Care Management's Relationship-Based Care framework demonstrated reduced length of stay, hospital readmissions, and improved patient experiences. Regulatory changes and new models of reimbursement in the acute care environment have created the perfect storm for case management leaders. Hospital fiscal performance is dependent on effective case management processes and the ability to optimize scarce resources. The quality improvement project aimed to further align case management systems and structures with hospital pay-for-performance measures. Tools for change were presented to assist leaders with the change acceleration process.

  6. Risky Business

    NASA Technical Reports Server (NTRS)

    Yarbrough, Katherine

    2015-01-01

    During my internship I worked on two major projects, recommending improvements for the Center's Risk Management Workshop and helping with the strategic planning efforts for Safety and Mission Assurance (S&MA). The risk management improvements is the key project I worked on this semester through my internship, while the strategic planning is the secondary assignment. S&MA Business Office covers both aspects in its delegation, getting both spans some of the work done in the office. A risk is a future event with a negative consequence that has some probability of occurring. Safety and Mission Assurance identifies, analyzes, plans, and tracks risk. The directorate offers the Center a Risk Management Workshop, and part of the ongoing efforts of S&MA is to make continuous improvements to the RM Workshop. By using the Project Management Institute's (PMI) Standard for Risk Management, I performed a gap analysis to make improvements for our materials. I benchmarked the PMI's Risk Management Standard, compared our Risk Management Workshop materials to PMI's standard, and identified any gaps in our material. My major findings were presented to the Business Office of S&MA for a decision on whether or not to incorporate the improvements. These suggestions were made by attending JSC working group meetings, Health, Safety and Environment (HSE) panel reviews and various risk review meetings. The improvements provide better understanding of risk management processes and enhanced risk tracking knowledge and skills. Risk management is an integral part of any engineering discipline, getting exposed to this section of engineering will greatly help shape my career in the future. Johnson Space Center is a world leader in risk management processes; learning risk management here gives me a huge advantage over my peers, as well as understanding decision making in the context of risk management will help me to be a well-rounded engineer. Strategic planning is an area I had not previously studied. Helping with the strategic planning efforts in S&MA has taught me how organizations think and function as a whole. S&MA is adopting a balanced scorecard approach to strategic planning. As part of this planning method strategic themes, objectives, and initiatives are formed. I attended strategic theme team workshops that formed the strategy map for the directorate and gave shape to the plan. Also during these workshops the objectives were discussed and built. Learning the process for strategic planning has helped me better understand how organizations and businesses function, which also helps me to be a more effective employee. Other assignments I had during my internship included completing the Safety and Mission Assurance Technical Excellent Program (STEP) Level 1, as well as doing a two week rotation through the Space Exploration division in S&MA, specifically working with a thermal protection systems (TPS) engineer. While working there, I learned about the Orion capsule and the SpaceX Dragon cargo capsule. I attended meetings to prepare the engineers for the upcoming Critical Design Reviews for both capsules and reviewed test data. Learning risk management, strategic planning, and working in the Space Exploration division has taught me about many aspects of S&MA. My internship at NASA has given me new experiences and taught me numerous subjects that I would have otherwise not learned. This opportunity has expanded my educational horizons and is helping me to become a more useful engineer and employee.

  7. [How the information system can contribute to the implementation of a risk management program in a hospital?].

    PubMed

    Staccini, P; Quaranta, J F; Staccini-Myx, A; Veyres, P; Jambou, P

    2003-09-01

    Nowadays, information system is recognised as one of the key points of the management strategy. An information system is regarded conceptualised as a mean to link 3 aspects of a firm (structure, organisation rules and staff). Its design and implementation have to meet the objectives of medical and economical evaluation, especially risk management objectives. In order to identify, analyse, reduce and prevent the occurrence of adverse events, and also to measure the efficacy and efficiency of the production of care services, the design of information systems should be based on a process analysis in order to describe and classify all the working practices within the hospital. According to various methodologies (usually top-down analysis), each process can be divided into activities. Each activity (especially each care activity) can be described according to its potential risks and expected results. For care professionals performing a task, the access to official or internal guidelines and the adverse events reporting forms has also to be defined. Putting together all the elements of such a process analysis will contribute to integrate, into daily practice, the management of risks, supported by the information system.

  8. Managing risk during care transitions when approaching end of life: A qualitative study of patients' and health care professionals' decision making.

    PubMed

    Coombs, Maureen A; Parker, Roses; de Vries, Kay

    2017-07-01

    Increasing importance is being placed on the coordination of services at the end of life. To describe decision-making processes that influence transitions in care when approaching the end of life. Qualitative study using field observations and longitudinal semi-structured interviews. Field observations were undertaken in three sites: a residential care home, a medical assessment unit and a general medical unit in New Zealand. The Supportive and Palliative Care Indicators Tool was used to identify participants with advanced and progressive illness. Patients and family members were interviewed on recruitment and 3-4 months later. Four weeks of fieldwork were conducted in each site. A total of 40 interviews were conducted: 29 initial interviews and 11 follow-up interviews. Thematic analysis was undertaken. Managing risk was an important factor that influenced transitions in care. Patients and health care staff held different perspectives on how such risks were managed. At home, patients tolerated increasing risk and used specific support measures to manage often escalating health and social problems. In contrast, decisions about discharge in hospital were driven by hospital staff who were risk-adverse. Availability of community and carer services supported risk management while a perceived need for early discharge decision making in hospital and making 'safe' discharge options informed hospital discharge decisions. While managing risk is an important factor during care transitions, patients should be able to make choices on how to live with risk at the end of life. This requires reconsideration of transitional care and current discharge planning processes at the end of life.

  9. Draugen HSE-case - occupational health risk management

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Glas, J.J.P.; Kjaer, E.

    1996-12-31

    The Draugen HSE-Case serves as a risk management tool. Originally, risk management included only major safety hazards to personnel, environment and assets. Work Environment risks such as ergonomics, psycho-social factors and exposure to chemicals and noise, was not given the same attention. The Draugen HSE-Case addresses this weakness and extends all work environment risks. In order to promote line responsibility and commitment, relevant personnel is involved in the Case development. {open_quotes}THESIS{degrees}, a software application, is used to systematize input and to generate reports. The Draugen HSE-case encompasses: HSE risk analyses related to specific activities; Control of risk related to workmore » environment; Established tolerability criteria; Risk reducing measures; Emergency contingency measures; and Requirements for Competence and Follow-up. The development of Draugen HSE-Case is a continuous process. It will serve to minimize the potential of occupational illnesses, raise general awareness, and make occupational health management more cost-effective.« less

  10. [Medical record management and risk management processes. State of the art and new normative guidelines about the organization and the management of the sanitary documentation in the National Health System or Hospital Trusts].

    PubMed

    Spolaore, P; Murolo, G; Sommavilla, M

    2003-01-01

    Recent health care reforms, the start of accreditation processes of health institutions, and the introduction also in the health system of risk management concepts and instruments, borrowed from the enterprise culture and the emphasis put on the protection of privacy, render evident the need and the urgency to define and to implement improvement processes of the organization and management of the medical documentation in the hospital with the aim of facilitation in fulfilment of regional and local health authorities policies about protection of the safety and improvement of quality of care. Currently the normative context that disciplines the management of medical records inside the hospital appears somewhat fragmentary, incomplete and however not able to clearly orientate health operators with the aim of a correct application of the enforced norms in the respect of the interests of the user and of local health authority. In this job we individuate the critical steps in the various phases of management process of the clinical folder and propose a new model of regulations, with the purpose to improve and to simplify the management processes and the modalities of compilation, conservation and release to entitled people of all clinical documentation.

  11. Guidelines for Risk-Based Changeover of Biopharma Multi-Product Facilities.

    PubMed

    Lynch, Rob; Barabani, David; Bellorado, Kathy; Canisius, Peter; Heathcote, Doug; Johnson, Alan; Wyman, Ned; Parry, Derek Willison

    2018-01-01

    In multi-product biopharma facilities, the protection from product contamination due to the manufacture of multiple products simultaneously is paramount to assure product quality. To that end, the use of traditional changeover methods (elastomer change-out, full sampling, etc.) have been widely used within the industry and have been accepted by regulatory agencies. However, with the endorsement of Quality Risk Management (1), the use of risk-based approaches may be applied to assess and continuously improve established changeover processes. All processes, including changeover, can be improved with investment (money/resources), parallel activities, equipment design improvements, and standardization. However, processes can also be improved by eliminating waste. For product changeover, waste is any activity not needed for the new process or that does not provide added assurance of the quality of the subsequent product. The application of a risk-based approach to changeover aligns with the principles of Quality Risk Management. Through the use of risk assessments, the appropriate changeover controls can be identified and controlled to assure product quality is maintained. Likewise, the use of risk assessments and risk-based approaches may be used to improve operational efficiency, reduce waste, and permit concurrent manufacturing of products. © PDA, Inc. 2018.

  12. [A systemic risk analysis of hospital management processes by medical employees--an effective basis for improving patient safety].

    PubMed

    Sobottka, Stephan B; Eberlein-Gonska, Maria; Schackert, Gabriele; Töpfer, Armin

    2009-01-01

    Due to the knowledge gap that exists between patients and health care staff the quality of medical treatment usually cannot be assessed securely by patients. For an optimization of safety in treatment-related processes of medical care, the medical staff needs to be actively involved in preventive and proactive quality management. Using voluntary, confidential and non-punitive systematic employee surveys, vulnerable topics and areas in patient care revealing preventable risks can be identified at an early stage. Preventive measures to continuously optimize treatment quality can be defined by creating a risk portfolio and a priority list of vulnerable topics. Whereas critical incident reporting systems are suitable for continuous risk assessment by detecting safety-relevant single events, employee surveys permit to conduct a systematic risk analysis of all treatment-related processes of patient care at any given point in time.

  13. TU-AB-BRD-00: Task Group 100

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    2015-06-15

    Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

  14. TU-AB-BRD-03: Fault Tree Analysis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Dunscombe, P.

    2015-06-15

    Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

  15. TU-AB-BRD-02: Failure Modes and Effects Analysis

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Huq, M.

    2015-06-15

    Current quality assurance and quality management guidelines provided by various professional organizations are prescriptive in nature, focusing principally on performance characteristics of planning and delivery devices. However, published analyses of events in radiation therapy show that most events are often caused by flaws in clinical processes rather than by device failures. This suggests the need for the development of a quality management program that is based on integrated approaches to process and equipment quality assurance. Industrial engineers have developed various risk assessment tools that are used to identify and eliminate potential failures from a system or a process before amore » failure impacts a customer. These tools include, but are not limited to, process mapping, failure modes and effects analysis, fault tree analysis. Task Group 100 of the American Association of Physicists in Medicine has developed these tools and used them to formulate an example risk-based quality management program for intensity-modulated radiotherapy. This is a prospective risk assessment approach that analyzes potential error pathways inherent in a clinical process and then ranks them according to relative risk, typically before implementation, followed by the design of a new process or modification of the existing process. Appropriate controls are then put in place to ensure that failures are less likely to occur and, if they do, they will more likely be detected before they propagate through the process, compromising treatment outcome and causing harm to the patient. Such a prospective approach forms the basis of the work of Task Group 100 that has recently been approved by the AAPM. This session will be devoted to a discussion of these tools and practical examples of how these tools can be used in a given radiotherapy clinic to develop a risk based quality management program. Learning Objectives: Learn how to design a process map for a radiotherapy process Learn how to perform failure modes and effects analysis analysis for a given process Learn what fault trees are all about Learn how to design a quality management program based upon the information obtained from process mapping, failure modes and effects analysis and fault tree analysis. Dunscombe: Director, TreatSafely, LLC and Center for the Assessment of Radiological Sciences; Consultant to IAEA and Varian Thomadsen: President, Center for the Assessment of Radiological Sciences Palta: Vice President of the Center for the Assessment of Radiological Sciences.« less

  16. Development and application of a probabilistic method for wildfire suppression cost modeling

    Treesearch

    Matthew P. Thompson; Jessica R. Haas; Mark A. Finney; David E. Calkin; Michael S. Hand; Mark J. Browne; Martin Halek; Karen C. Short; Isaac C. Grenfell

    2015-01-01

    Wildfire activity and escalating suppression costs continue to threaten the financial health of federal land management agencies. In order to minimize and effectively manage the cost of financial risk, agencies need the ability to quantify that risk. A fundamental aim of this research effort, therefore, is to develop a process for generating risk-based metrics for...

  17. A fuzzy model for assessing risk of occupational safety in the processing industry.

    PubMed

    Tadic, Danijela; Djapan, Marko; Misita, Mirjana; Stefanovic, Miladin; Milanovic, Dragan D

    2012-01-01

    Managing occupational safety in any kind of industry, especially in processing, is very important and complex. This paper develops a new method for occupational risk assessment in the presence of uncertainties. Uncertain values of hazardous factors and consequence frequencies are described with linguistic expressions defined by a safety management team. They are modeled with fuzzy sets. Consequence severities depend on current hazardous factors, and their values are calculated with the proposed procedure. The proposed model is tested with real-life data from fruit processing firms in Central Serbia.

  18. Integrated Environmental Risk Assessment and Whole-Process Management System in Chemical Industry Parks

    PubMed Central

    Shao, Chaofeng; Yang, Juan; Tian, Xiaogang; Ju, Meiting; Huang, Lei

    2013-01-01

    Chemical industry parks in China are considered high-risk areas because they present numerous risks that can damage the environment, such as pollution incidents. In order to identify the environmental risks and the principal risk factors in these areas, we have developed a simple physical model of a regional environmental risk field (ERF) using existing dispersal patterns and migration models. The regional ERF zoning was also conducted and a reference value for diagnostic methods was developed to determine risk-acceptable, risk-warning, and risk-mitigation zones, which can provide a risk source layout for chemical industry parks. In accordance with the environmental risk control requirements, this study focused on the three stages of control and management of environmental risk and established an environmental risk management system including risk source identification and assessment, environmental safety planning, early risk warning, emergency management, assessment of environmental effects, and environmental remediation of pollution accidents. By using this model, the environmental risks in Tianjin Binhai New Area, the largest chemical industry park in China, were assessed and the environmental risk zoning map was drawn, which suggested the existence of many unacceptable environmental risks in this area. Thus, relevant suggestions have been proposed from the perspective of the adjustment of risk source layout, intensified management of environmental risk control and so on. PMID:23603866

  19. Integrated environmental risk assessment and whole-process management system in chemical industry parks.

    PubMed

    Shao, Chaofeng; Yang, Juan; Tian, Xiaogang; Ju, Meiting; Huang, Lei

    2013-04-19

    Chemical industry parks in China are considered high-risk areas because they present numerous risks that can damage the environment, such as pollution incidents. In order to identify the environmental risks and the principal risk factors in these areas, we have developed a simple physical model of a regional environmental risk field (ERF) using existing dispersal patterns and migration models. The regional ERF zoning was also conducted and a reference value for diagnostic methods was developed to determine risk-acceptable, risk-warning, and risk-mitigation zones, which can provide a risk source layout for chemical industry parks. In accordance with the environmental risk control requirements, this study focused on the three stages of control and management of environmental risk and established an environmental risk management system including risk source identification and assessment, environmental safety planning, early risk warning, emergency management, assessment of environmental effects, and environmental remediation of pollution accidents. By using this model, the environmental risks in Tianjin Binhai New Area, the largest chemical industry park in China, were assessed and the environmental risk zoning map was drawn, which suggested the existence of many unacceptable environmental risks in this area. Thus, relevant suggestions have been proposed from the perspective of the adjustment of risk source layout, intensified management of environmental risk control and so on.

  20. Risk Management in Construction Project: Taking Fairness into Account

    NASA Astrophysics Data System (ADS)

    Górecki, Jarosław; Bizon-Górecka, Jadwiga

    2017-10-01

    Risk management requires a comprehensive review of possible hazards, their possible outcomes as well as some recommendations about minimizing the risk. The study emphasises that the project risk management refers to an analysis of the risk factors and a creation of the strategy minimising negative effects of the risk. It was pointed out that a construction project is this kind of projects that can be defined as a unique process of high complexity (design documentation, various stages of creating the building), which has clearly defined time frames and a given financial limit. It is executed as a team work, by qualified or highly qualified specialists of different matters, for example masonry, precast, etc. Additionally, it requires a use of modern equipment and an adequate preparation of the investment. Therefore, the risk management focuses on the problems allowing for troubleshooting. A basis of the risk management is to recognise the fundamentals, which are crucial for the construction project management, i.e. an object perspective, including technological, supporting and management processes as well as an entity perspective - project stakeholders. Construction projects require also an acquaintance with the specificity of the branch. The article refers to the risk management in construction project and, in particular, a phenomenon of participants’ fairness in such projects. The problem of fairness of the entities involved in a project should be understood as a fair play, according to the arrangements agreed in a contract and compatible with current formal procedures and social rules. It was indicated that fairness can be treated as an important factor in predicting the success of such projects. Interviews conducted among contractors in Kuyavian-Pomeranian region showed varied fairness requirements put to individual participants of construction projects. The article presents results of the research. It shows a desired attitude of the surveyed enterprises towards a problem of the fair behaviour. These behaviours, relating to individual stakeholders, have been underlined in different phases of the construction projects’ life cycle.

  1. Imagining flood futures: risk assessment and management in practice.

    PubMed

    Lane, Stuart N; Landström, Catharina; Whatmore, Sarah J

    2011-05-13

    The mantra that policy and management should be 'evidence-based' is well established. Less so are the implications that follow from 'evidence' being predictions of the future (forecasts, scenarios, horizons) even though such futures define the actions taken today to make the future sustainable. Here, we consider the tension between 'evidence', reliable because it is observed, and predictions of the future, unobservable in conventional terms. For flood risk management in England and Wales, we show that futures are actively constituted, and so imagined, through 'suites of practices' entwining policy, management and scientific analysis. Management has to constrain analysis because of the many ways in which flood futures can be constructed, but also because of commitment to an accounting calculus, which requires risk to be expressed in monetary terms. It is grounded in numerical simulation, undertaken by scientific consultants who follow policy/management guidelines that define the futures to be considered. Historical evidence is needed to deal with process and parameter uncertainties and the futures imagined are tied to pasts experienced. Reliance on past events is a challenge for prediction, given changing probability (e.g. climate change) and consequence (e.g. development on floodplains). So, risk management allows some elements of risk analysis to become unstable (notably in relation to climate change) but forces others to remain stable (e.g. invoking regulation to prevent inappropriate floodplain development). We conclude that the assumed separation of risk assessment and management is false because the risk calculation has to be defined by management. Making this process accountable requires openness about the procedures that make flood risk analysis more (or less) reliable to those we entrust to produce and act upon them such that, unlike the 'pseudosciences', they can be put to the test of public interrogation by those who have to live with their consequences. © 2011 Royal Society

  2. Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland.

    PubMed

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

    The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain.

  3. Food allergy and risk assessment: Current status and future directions

    NASA Astrophysics Data System (ADS)

    Remington, Benjamin C.

    2017-09-01

    Risk analysis is a three part, interactive process that consists of a scientific risk assessment, a risk management strategy and an exchange of information through risk communication. Quantitative risk assessment methodologies are now available and widely used for assessing risks regarding the unintentional consumption of major, regulated allergens but new or modified proteins can also pose a risk of de-novo sensitization. The risks due to de-novo sensitization to new food allergies are harder to quantify. There is a need for a systematic, comprehensive battery of tests and assessment strategy to identify and characterise de-novo sensitization to new proteins and the risks associated with them. A risk assessment must be attuned to answer the risk management questions and needs. Consequently, the hazard and risk assessment methods applied and the desired information are determined by the requested outcome for risk management purposes and decisions to be made. The COST Action network (ImpARAS, www.imparas.eu) has recently started to discuss these risk management criteria from first principles and will continue with the broader subject of improving strategies for allergen risk assessment throughout 2016-2018/9.

  4. Improved safety culture and labor-management relations attributed to changing at-risk behavior process at Union Pacific.

    DOT National Transportation Integrated Search

    2009-09-01

    Changing At-Risk Behavior (CAB) is a safety process that is being conducted at Union Pacifics San Antonio Service Unit (SASU) with the aim of improving road and yard safety. CAB is an example of a proactive safety risk-reduction method called Clea...

  5. Risk management and post-marketing surveillance of CNS drugs.

    PubMed

    Henningfield, Jack E; Schuster, Charles R

    2009-12-01

    Drugs affecting the central nervous system span a broad range of chemical entities, dosage forms, indications, and risks. Unintended consequences include potential abuse and overdose in non-patient drug abusers, deliberate tampering of drug dosage forms, and criminal behavior associated with diversion. Regulators must consider diverse factors to find the appropriate conditions of approval to minimize unintended consequences while enabling a level of access desired by health care providers and patients. This commentary appears as part of a special issue of Drug and Alcohol Dependence that focuses on risk management and post-marketing surveillance and addresses key issues that pose real-world challenges to pharmaceutical sponsors and regulators in particular. For example, in the U.S., Controlled Substances Act drug scheduling can be considered a risk management strategy but its legal authorities and administrative processes are independent from those of risk management (including Risk Evaluation and Mitigation Strategies or REMS); better harmonization of these approaches is vital from drug development and regulatory perspectives. Risk management would ideally be implemented on a strong science foundation demonstrating that the tools employed to mitigate risks and ensure safe use are effective. In reality, research and evaluation of tools in this area is in its infancy and will necessarily be an evolutionary process; furthermore, there is little precedent for linking interventions and program evolution to unintended consequences such as regional outbreaks of abuse and diversion. How such issues are resolved has the potential to stimulate or stifle innovations in drug development and advance or imperil health care.

  6. Improvement of nuclear power plants within the perspective of applications of lean manufacturing practices

    NASA Astrophysics Data System (ADS)

    Malek, A. K.; Muhammad, H. I.; Rosmaini, A.; Alaa, A. S.; Falah, A. M.

    2017-09-01

    Development and improvement process are essential to the companies and factories of various kinds and this necessity is related aspects of cost, time and risk that can be avoided, these aspects are available at the nuclear power stations essential demands cannot be ignored. The lean management technique is one of the recent trends in the management system. Where the lean management is stated as the system increases the customer value and reduces the wastage process in an industry or in a power plants. Therefore, there is an urgent necessity to ensure the development and improvement in nuclear power plants in the pre-established in process of being established and stage of the management and production. All of these stages according to the study are closely related to the necessity operationalize and apply lean manufacturing practices that these applications are ineffective and clear contribution to reduce costs and control of production processes and the process of reducing future risks that could be exposed to the station.

  7. Guidelines for contingency planning NASA (National Aeronautics and Space Administration) ADP security risk reduction decision studies

    NASA Technical Reports Server (NTRS)

    Tompkins, F. G.

    1984-01-01

    Guidance is presented to NASA Computer Security Officials for determining the acceptability or unacceptability of ADP security risks based on the technical, operational and economic feasibility of potential safeguards. The risk management process is reviewed as a specialized application of the systems approach to problem solving and information systems analysis and design. Reporting the results of the risk reduction analysis to management is considered. Report formats for the risk reduction study are provided.

  8. [Medical safety management in the setting of a clinical reference laboratory--risk management efforts in clinical testing].

    PubMed

    Seki, Akira; Miya, Tetsumasa

    2011-03-01

    As a result of recurring medical accidents, risk management in the medical setting has been given much attention. The announcement in August, 2000 by the Ministry of Health committee for formulating a standard manual for risk management, of a "Risk management manual formulation guideline" has since been accompanied by the efforts of numerous medical testing facilities to develop such documents. In 2008, ISO/TS 22367:2008 on "Medical laboratories-Reduction of error through risk management and continual improvement" was published. However, at present, risk management within a medical testing facility stresses the implementation of provisional actions in response to a problem after it has occurred. Risk management is basically a planned process and includes "corrective actions" as well as "preventive actions." A corrective action is defined as identifying the root cause of the problem and removing it, and is conducted to prevent the problem from recurring. A preventive action is defined as identifying of the any potential problem and removing it, and is conducted to prevent a problem before it occurs. Presently, I shall report on the experiences of our laboratory regarding corrective and preventive actions taken in response to accidents and incidents, respectively.

  9. Enhancing the ecological risk assessment process.

    PubMed

    Dale, Virginia H; Biddinger, Gregory R; Newman, Michael C; Oris, James T; Suter, Glenn W; Thompson, Timothy; Armitage, Thomas M; Meyer, Judith L; Allen-King, Richelle M; Burton, G Allen; Chapman, Peter M; Conquest, Loveday L; Fernandez, Ivan J; Landis, Wayne G; Master, Lawrence L; Mitsch, William J; Mueller, Thomas C; Rabeni, Charles F; Rodewald, Amanda D; Sanders, James G; van Heerden, Ivor L

    2008-07-01

    The Ecological Processes and Effects Committee of the US Environmental Protection Agency Science Advisory Board conducted a self-initiated study and convened a public workshop to characterize the state of the ecological risk assessment (ERA), with a view toward advancing the science and application of the process. That survey and analysis of ERA in decision making shows that such assessments have been most effective when clear management goals were included in the problem formulation; translated into information needs; and developed in collaboration with decision makers, assessors, scientists, and stakeholders. This process is best facilitated when risk managers, risk assessors, and stakeholders are engaged in an ongoing dialogue about problem formulation. Identification and acknowledgment of uncertainties that have the potential to profoundly affect the results and outcome of risk assessments also improves assessment effectiveness. Thus we suggest 1) through peer review of ERAs be conducted at the problem formulation stage and 2) the predictive power of risk-based decision making be expanded to reduce uncertainties through analytical and methodological approaches like life cycle analysis. Risk assessment and monitoring programs need better integration to reduce uncertainty and to evaluate risk management decision outcomes. Postdecision audit programs should be initiated to evaluate the environmental outcomes of risk-based decisions. In addition, a process should be developed to demonstrate how monitoring data can be used to reduce uncertainties. Ecological risk assessments should include the effects of chemical and nonchemical stressors at multiple levels of biological organization and spatial scale, and the extent and resolution of the pertinent scales and levels of organization should be explicitly considered during problem formulation. An approach to interpreting lines of evidence and weight of evidence is critically needed for complex assessments, and it would be useful to develop case studies and/or standards of practice for interpreting lines of evidence. In addition, tools for cumulative risk assessment should be developed because contaminants are often released into stressed environments.

  10. RMP Guidance for Warehouses - Chapter 5: Management System

    EPA Pesticide Factsheets

    Your management system should oversee the implementation of the risk management program elements, and designate and assign responsibility in order to make process safety a constant priority. Includes sample documentation.

  11. CONSIDERATIONS IN RISK COMMUNICATION: A DIGEST OF RISK COMMUNICATION AS A RISK MANAGEMENT TOOL

    EPA Science Inventory

    Risk communication is the process of informing people about hazards. Like all communication, communicating risk is a two-way exchange in which you inform the target community about possible hazards, but also gather information about those affected by the risk. The purpose of risk...

  12. Translating reference doses into allergen management practice: challenges for stakeholders.

    PubMed

    Crevel, René W R; Baumert, Joseph L; Luccioli, Stefano; Baka, Athanasia; Hattersley, Sue; Hourihane, Jonathan O'B; Ronsmans, Stefan; Timmermans, Frans; Ward, Rachel; Chung, Yong-joo

    2014-05-01

    Risk assessment describes the impact of a particular hazard as a function of dose and exposure. It forms the foundation of risk management and contributes to the overall decision-making process, but is not its endpoint. This paper outlines a risk analysis framework to underpin decision-making in the area of allergen cross-contact. Specifically, it identifies challenges relevant to each component of the risk analysis: risk assessment (data gaps and output interpretation); risk management (clear and realistic objectives); and risk communication (clear articulation of risk and benefit). Translation of the outputs from risk assessment models into risk management measures must be informed by a clear understanding of the model outputs and their limitations. This will lead to feasible and achievable risk management objectives, grounded in a level of risk accepted by the different stakeholders, thereby avoiding potential unintended detrimental consequences. Clear, consistent and trustworthy communications actively involving all stakeholders underpin these objectives. The conclusions, integrating the perspectives of different stakeholders, offer a vision where clear, science-based benchmarks form the basis of allergen management and labelling, cutting through the current confusion and uncertainty. Finally, the paper recognises that the proposed framework must be adaptable to new and emerging evidence. Copyright © 2014 ILSI Europe. Published by Elsevier Ltd.. All rights reserved.

  13. Risk assessment and management approaches on mental health units.

    PubMed

    Woods, P

    2013-11-01

    This exploratory and descriptive study took place in one Canadian province. The study aimed to: (1) to identify and describe the nature and extent of current risk assessment and management approaches used in the adult inpatient mental health and forensic units; and (2) to identify good practice and shortfalls in the nature and extent of the approaches currently utilized. Data were collected from 48 participants through nine focus groups. Participants reported that they used a clinical approach to risk assessment. They had also not considered risk assessment and management as a proactive structured process. Education and training was also limited and skills were developed over time through practice. Five keys issues are discussed as important: reliance on clinical judgement alone is not the best choice to make; the need to consider risk as a whole concept; risk management being more reactive than proactive; education and training; and client involvement in risk assessment. © 2012 John Wiley & Sons Ltd.

  14. Appraising longitudinal trends in the strategic risks cited by risk managers in the international water utility sector, 2005-2015.

    PubMed

    Chalker, Rosemary T C; Pollard, Simon J T; Leinster, Paul; Jude, Simon

    2018-03-15

    We report dynamic changes in the priorities for strategic risks faced by international water utilities over a 10year period, as cited by managers responsible for managing them. A content analysis of interviews with three cohorts of risk managers in the water sector was undertaken. Interviews probed the focus risk managers' were giving to strategic risks within utilities, as well as specific questions on risk analysis tools (2005); risk management cultures (2011) and the integration of risk management with corporate decision-making (2015). The coding frequency of strategic (business, enterprise, corporate) risk terms from 18 structured interviews (2005) and 28 semi-structured interviews (12 in 2011; 16 in 2015) was used to appraise changes in the perceived importance of strategic risks within the sector. The aggregated coding frequency across the study period, and changes in the frequency of strategic risks cited at three interview periods identified infrastructure assets as the most significant risk over the period and suggests an emergence of extrinsic risk over time. Extended interviews with three utility risk managers (2016) from the UK, Canada and the US were then used to contextualise the findings. This research supports the ongoing focus on infrastructure resilience and the increasing prevalence of extrinsic risk within the water sector, as reported by the insurance sector and by water research organisations. The extended interviews provided insight into how strategic risks are now driving the implementation agenda within utilities, and into how utilities can secure tangible business value from proactive risk governance. Strategic external risks affecting the sector are on the rise, involve more players and are less controllable from within a utility's own organisational boundaries. Proportionate risk management processes and structures provide oversight and assurance, whilst allowing a focus on the tangible business value that comes from managing strategic risks well. Copyright © 2017 The Authors. Published by Elsevier B.V. All rights reserved.

  15. Evaluation of volcanic risk management in Merapi and Bromo Volcanoes

    NASA Astrophysics Data System (ADS)

    Bachri, S.; Stöetter, J.; Sartohadi, J.; Setiawan, M. A.

    2012-04-01

    Merapi (Central Java Province) and Bromo (East Java Province) volcanoes have human-environmental systems with unique characteristics, thus causing specific consequences on their risk management. Various efforts have been carried out by many parties (institutional government, scientists, and non-governmental organizations) to reduce the risk in these areas. However, it is likely that most of the actions have been done for temporary and partial purposes, leading to overlapping work and finally to a non-integrated scheme of volcanic risk management. This study, therefore, aims to identify and evaluate actions of risk and disaster reduction in Merapi and Bromo Volcanoes. To achieve this aims, a thorough literature review was carried out to identify earlier studies in both areas. Afterward, the basic concept of risk management cycle, consisting of risk assessment, risk reduction, event management and regeneration, is used to map those earlier studies and already implemented risk management actions in Merapi and Bromo. The results show that risk studies in Merapi have been developed predominantly on physical aspects of volcanic eruptions, i.e. models of lahar flows, hazard maps as well as other geophysical modeling. Furthermore, after the 2006 eruption of Merapi, research such on risk communication, social vulnerability, cultural vulnerability have appeared on the social side of risk management research. Apart from that, disaster risk management activities in the Bromo area were emphasizing on physical process and historical religious aspects. This overview of both study areas provides information on how risk studies have been used for managing the volcano disaster. This result confirms that most of earlier studies emphasize on the risk assessment and only few of them consider the risk reduction phase. Further investigation in this field work in the near future will accomplish the findings and contribute to formulate integrated volcanic risk management cycles for both Merapi and Bromo. Keywords: Risk management, volcanoes hazard, Merapi and Bromo Volcano Indonesia

  16. Understanding Pre-Quantitative Risk in Projects

    NASA Technical Reports Server (NTRS)

    Cooper, Lynne P.

    2011-01-01

    Standard approaches to risk management in projects depend on the ability of teams to identify risks and quantify the probabilities and consequences of these risks (e.g., the 5 x 5 risk matrix). However, long before quantification does - or even can - occur, and long after, teams make decisions based on their pre-quantitative understanding of risk. These decisions can have long-lasting impacts on the project. While significant research has looked at the process of how to quantify risk, our understanding of how teams conceive of and manage pre-quantitative risk is lacking. This paper introduces the concept of pre-quantitative risk and discusses the implications of addressing pre-quantitative risk in projects.

  17. Focus on Resiliency: A Process-Oriented Approach to Security

    DTIC Science & Technology

    2005-11-01

    by ANSI Std Z39-18 © 2005 Carnegie Mellon University CSI v1.0 2 Agenda About the SEI Characterizing the problem Security, resiliency, and risk A...2005 Carnegie Mellon University CSI v1.0 5 SEI Technical Programs Product Line Systems Dynamic Systems Software Engineering Process Management...University CSI v1.0 7 What is the problem? Is your organization’s security capability sufficient to identify and manage risks that result from failed

  18. A Systems Modeling Approach for Risk Management of Command File Errors

    NASA Technical Reports Server (NTRS)

    Meshkat, Leila

    2012-01-01

    The main cause of commanding errors is often (but not always) due to procedures. Either lack of maturity in the processes, incompleteness of requirements or lack of compliance to these procedures. Other causes of commanding errors include lack of understanding of system states, inadequate communication, and making hasty changes in standard procedures in response to an unexpected event. In general, it's important to look at the big picture prior to making corrective actions. In the case of errors traced back to procedures, considering the reliability of the process as a metric during its' design may help to reduce risk. This metric is obtained by using data from Nuclear Industry regarding human reliability. A structured method for the collection of anomaly data will help the operator think systematically about the anomaly and facilitate risk management. Formal models can be used for risk based design and risk management. A generic set of models can be customized for a broad range of missions.

  19. 76 FR 22662 - Notice of Intent To Apply Certain Supervisory Guidance to Savings and Loan Holding Companies

    Federal Register 2010, 2011, 2012, 2013, 2014

    2011-04-22

    ... information that is used to assess inherent risks and internal control processes. Such activities include... management and information systems; and internal controls. The financial condition rating is supported by... appropriate standards of capitalization, liquidity, and risk management consistent with the principles of...

  20. Risk Management: Getting the Most for Your Insurance Dollars

    ERIC Educational Resources Information Center

    Abramson, Paul

    1973-01-01

    Analyze what insurance is intended to do by going through the risk management process: identify exposures to loss, measure their financial impact on the institution, rationalize the means of controlling exposures, prevent loss, and set up a program to minimize the impact of loss through insurance or other means. (Author)

  1. Need of risk management practice amongst bumiputera contractors in Malaysia construction industries

    NASA Astrophysics Data System (ADS)

    Syuhada Fadzil, Nur; Noor, Nurazuwa Md; Rahman, Ismail Abdul

    2017-11-01

    Malaysia construction industry has been growing continuously with double-digit growth for the past two decades. There are many issues surrounded the industry such as delay in delivery, cost overrun, quality and safety. In bumiputera contractor’s context, the literature review found that 32 issues were encountered in the construction project. These issues can be handled properly with the application of risk management. According to previous researchers, application of risk management in Malaysia construction industry is at the low level where it is implemented in traditional ways that are brainstorming and checklist. These were due to lack of knowledge, the high cost of hiring experts and avoiding extra cost. Besides that, this study also intentions to analyse the risk categories in the construction industry as well as identify risk management process to resolve the construction issues. Hence, this paper presents issues engulfed by Bumiputera contractors which can partly be resolved by applying risk management practice in carrying out the construction activity. This may inspire the contractors to apply the risk management practice in ensuring the success of their construction project.

  2. INDOOR AIR ASSESSMENT - A REVIEW OF INDOOR AIR QUALITY RISK CHARACTERIZATION

    EPA Science Inventory

    Risk assessment methodologies provide a mechanism for incorporating scientific evidence and Judgments Into the risk management decision process. isk characterization framework has been developed to provide a systematic approach for analysis and presentation of risk characterizati...

  3. Use of risk assessment panels during revision of the Tongass Land and Resource Management Plan.

    Treesearch

    Charles G. Shaw

    1999-01-01

    This paper describes the process used to conduct the 16 risk assessment panels and a subsistence working group held during revision of the Tongass land management plan. It provides an overview of how results from the panels were used by forest managers in plan-related decisionmaking, discusses some reactions to the effort, and identifies some opportunities to improve...

  4. The reliability-quality relationship for quality systems and quality risk management.

    PubMed

    Claycamp, H Gregg; Rahaman, Faiad; Urban, Jason M

    2012-01-01

    Engineering reliability typically refers to the probability that a system, or any of its components, will perform a required function for a stated period of time and under specified operating conditions. As such, reliability is inextricably linked with time-dependent quality concepts, such as maintaining a state of control and predicting the chances of losses from failures for quality risk management. Two popular current good manufacturing practice (cGMP) and quality risk management tools, failure mode and effects analysis (FMEA) and root cause analysis (RCA) are examples of engineering reliability evaluations that link reliability with quality and risk. Current concepts in pharmaceutical quality and quality management systems call for more predictive systems for maintaining quality; yet, the current pharmaceutical manufacturing literature and guidelines are curiously silent on engineering quality. This commentary discusses the meaning of engineering reliability while linking the concept to quality systems and quality risk management. The essay also discusses the difference between engineering reliability and statistical (assay) reliability. The assurance of quality in a pharmaceutical product is no longer measured only "after the fact" of manufacturing. Rather, concepts of quality systems and quality risk management call for designing quality assurance into all stages of the pharmaceutical product life cycle. Interestingly, most assays for quality are essentially static and inform product quality over the life cycle only by being repeated over time. Engineering process reliability is the fundamental concept that is meant to anticipate quality failures over the life cycle of the product. Reliability is a well-developed theory and practice for other types of manufactured products and manufacturing processes. Thus, it is well known to be an appropriate index of manufactured product quality. This essay discusses the meaning of reliability and its linkages with quality systems and quality risk management.

  5. Prototype development of a web-based participative decision support platform in risk management

    NASA Astrophysics Data System (ADS)

    Aye, Zar Chi; Olyazadeh, Roya; Jaboyedoff, Michel; Derron, Marc-Henri

    2014-05-01

    This paper discusses the proposed background architecture and prototype development of an internet-based decision support system (DSS) in the field of natural hazards and risk management using open-source geospatial software and web technologies. It is based on a three-tier, client-server architecture with the support of boundless (opengeo) framework and its client side SDK application environment using customized gxp components and data utility classes. The main purpose of the system is to integrate the workflow of risk management systematically with the diverse involvement of stakeholders from different organizations dealing with natural hazards and risk for evaluation of management measures through the active online participation approach. It aims to develop an adaptive user friendly, web-based environment that allows the users to set up risk management strategies based on actual context and data by integrating web-GIS and DSS functionality associated with process flow and other visualization tools. Web-GIS interface has been integrated within the DSS to deliver maps and provide certain geo-processing capabilities on the web, which can be easily accessible and shared by different organizations located in case study sites of the project. This platform could be envisaged not only as a common web-based platform for the centralized sharing of data such as hazard maps, elements at risk maps and additional information but also to ensure an integrated platform of risk management where the users could upload data, analyze risk and identify possible alternative scenarios for risk reduction especially for floods and landslides, either quantitatively or qualitatively depending on the risk information provided by the stakeholders in case study regions. The level of involvement, access to and interaction with the provided functionality of the system varies depending on the roles and responsibilities of the stakeholders, for example, only the experts (planners, geological services, etc.) can have access to the alternative definition component to formulate the risk reduction measures. The development of such a participative platform would finally lead to an integrated risk management approach highlighting the needs to deal with involved experts and civil society in the decision-making process for evaluation of risk management measures through the active participation approach. The system will be applied and evaluated in four case study areas of the CHANGES project in Europe: Romania, North Eastern Italy, French Alps and Poland. However, the framework of the system is designed in a generic way so as to be applicable in other regions to achieve the high adaptability and flexibility of the system. The research has been undertaken as a part of the CHANGES project funded by the European Commission's 7th framework program.

  6. Risk management: FIFA's approach for protecting the health of football players

    PubMed Central

    Fuller, Colin W; Junge, Astrid; Dvorak, Jiri

    2012-01-01

    Background Sport and exercise have long-term health benefits, but there is also a risk that participants will sustain injuries and/or ill health from these activities. For this reason, international sports governing bodies have a responsibility to identify the risks that exist within their sport and to provide guidance to participants and other stakeholders on how these risks can be controlled within acceptable levels. Purpose To demonstrate how Fédération Internationale de Football Association (FIFA), as football's governing body, uses a risk management framework to identify, quantify, mitigate and communicate the risks of injury and ill health in football for men, women and children in all environments. Method All the research papers published by FIFA's Medical Assessment and Research Centre (F-MARC) during the period 1994 to 2011 were reviewed and categorised according to an established sport-related risk management framework. Conclusions F-MARC investigated and mitigated 17 areas of risk to footballers' health in a coherent and consistent approach through the process of risk management. PMID:22143999

  7. Risk management: FIFA's approach for protecting the health of football players.

    PubMed

    Fuller, Colin W; Junge, Astrid; Dvorak, Jiri

    2012-01-01

    Sport and exercise have long-term health benefits, but there is also a risk that participants will sustain injuries and/or ill health from these activities. For this reason, international sports governing bodies have a responsibility to identify the risks that exist within their sport and to provide guidance to participants and other stakeholders on how these risks can be controlled within acceptable levels. To demonstrate how Fédération Internationale de Football Association (FIFA), as football's governing body, uses a risk management framework to identify, quantify, mitigate and communicate the risks of injury and ill health in football for men, women and children in all environments. All the research papers published by FIFA's Medical Assessment and Research Centre (F-MARC) during the period 1994 to 2011 were reviewed and categorised according to an established sport-related risk management framework. F-MARC investigated and mitigated 17 areas of risk to footballers' health in a coherent and consistent approach through the process of risk management.

  8. A Risk Management Framework to Characterize Black Swan Risks: A Case Study of Lightning Effects on Insensitive High Explosives

    NASA Astrophysics Data System (ADS)

    Sanders, Gary A.

    Effective and efficient risk management processes include the use of high fidelity modeling and simulation during the concept exploration phase as part of the technology and risk assessment activities, with testing and evaluation tasks occurring in later design development phases. However, some safety requirements and design architectures may be dominated by the low probability/high consequence "Black Swan" vulnerabilities that require very early testing to characterize and efficiently mitigate. Failure to address these unique risks has led to catastrophic systems failures including the space shuttle Challenger, Deepwater Horizon, Fukushima nuclear reactor, and Katrina dike failures. Discovering and addressing these risks later in the design and development process can be very costly or even lead to project cancellation. This paper examines the need for risk management process adoption of early hazard phenomenology testing to inform the technical risk assessment, requirements definition and conceptual design. A case study of the lightning design vulnerability of the insensitive high explosives being used in construction, mining, demolition, and defense industries will be presented to examine the impact of this vulnerability testing during the concept exploration phase of the design effort. While these insensitive high explosives are far less sensitive to accidental initiation by fire, impact, friction or even electrical stimuli, their full range of sensitivities have not been characterized and ensuring safe engineering design and operations during events such as lightning storms requires vulnerability testing during the risk assessment phase.

  9. Implementation of cold risk management in occupational safety, occupational health and quality practices. Evaluation of a development process and its effects at the finnish maritime administration.

    PubMed

    Risikko, Tanja; Remes, Jouko; Hassi, Juhani

    2008-01-01

    Cold is a typical environmental risk factor in outdoor work in northern regions. It should be taken into account in a company's occupational safety, health and quality systems. A development process for improving cold risk management at the Finnish Maritime Administration (FMA) was carried out by FMA and external experts. FMA was to implement it. Three years after the development phase, the outcomes and implementation were evaluated. The study shows increased awareness about cold work and few concrete improvements. Concrete improvements in occupational safety and health practices could be seen in the pilot group. However, organization-wide implementation was insufficient, the main reasons being no organization-wide practices, unclear process ownership, no resources and a major reorganization process. The study shows a clear need for expertise supporting implementation. The study also presents a matrix for analyzing the process.

  10. OVERVIEW OF RISK ASSESSMENT FOR TOXIC AND PATHOGENIC AGENTS

    EPA Science Inventory

    Risk assessment is a process that defines the adverse health consequences of exposure to toxic or pathogenic agents. hen used in regulatory decision making, risk assessment is an important component of risk management, which "combines the risk assessment with the directives of re...

  11. [Risk management from the judicial perspective].

    PubMed

    Ulsenheimer, Klaus

    2003-11-01

    The jurisdification of medicine is an unstoppable force that finds its visible expression in a medical liability boom which--apart from the negative impact of legal and out-of-court proceedings on the bond of the doctor-patient relationship--bears considerable economic disadvantages for the providers of care. It is therefore necessary to fight in particular the legally influenced causes of medical liability for which risk management seems to be a suitable, effective tool. As the examples taken from the jurisdiction in the organisational sector will demonstrate, risk management pinpoints the sources of trouble so that we are able to learn from current errors and provide appropriate remedies for the future. Risk management, though, is not a "unique event", but a dynamic, repetitive process that has to be institutionally secured by appointing a risk manager so that the proposals discussed, recommendations and essential measures can actually be implemented.

  12. Quality Risk Management: Putting GMP Controls First.

    PubMed

    O'Donnell, Kevin; Greene, Anne; Zwitkovits, Michael; Calnan, Nuala

    2012-01-01

    This paper presents a practical way in which current approaches to quality risk management (QRM) may be improved, such that they better support qualification, validation programs, and change control proposals at manufacturing sites. The paper is focused on the treatment of good manufacturing practice (GMP) controls during QRM exercises. It specifically addresses why it is important to evaluate and classify such controls in terms of how they affect the severity, probability of occurrence, and detection ratings that may be assigned to potential failure modes or negative events. It also presents a QRM process that is designed to directly link the outputs of risk assessments and risk control activities with qualification and validation protocols in the GMP environment. This paper concerns the need for improvement in the use of risk-based principles and tools when working to ensure that the manufacturing processes used to produce medicines, and their related equipment, are appropriate. Manufacturing processes need to be validated (or proven) to demonstrate that they can produce a medicine of the required quality. The items of equipment used in such processes need to be qualified, in order to prove that they are fit for their intended use. Quality risk management (QRM) tools can be used to support such qualification and validation activities, but their use should be science-based and subject to as little subjectivity and uncertainty as possible. When changes are proposed to manufacturing processes, equipment, or related activities, they also need careful evaluation to ensure that any risks present are managed effectively. This paper presents a practical approach to how QRM may be improved so that it better supports qualification, validation programs, and change control proposals in a more scientific way. This improved approach is based on the treatment of what are called good manufacturing process (GMP) controls during those QRM exercises. A GMP control can be considered to be any control that is put in place to assure product quality and regulatory compliance. This improved approach is also based on how the detectability of risks is assessed. This is important because when producing medicines, it is not always good practice to place a high reliance upon detection-type controls in the absence of an adequate level of assurance in the manufacturing process that leads to the finished medicine.

  13. Multi-hazard risk analysis for management strategies

    NASA Astrophysics Data System (ADS)

    Kappes, M.; Keiler, M.; Bell, R.; Glade, T.

    2009-04-01

    Risk management is very often operating in a reactive way, responding to an event, instead of proactive starting with risk analysis and building up the whole process of risk evaluation, prevention, event management and regeneration. Since damage and losses from natural hazards raise continuously more and more studies, concepts (e.g. Switzerland or South Tyrol-Bolozano) and software packages (e.g. ARMAGEDOM, HAZUS or RiskScape) are developed to guide, standardize and facilitate the risk analysis. But these approaches focus on different aspects and are mostly closely adapted to the situation (legislation, organization of the administration, specific processes etc.) of the specific country or region. We propose in this study the development of a flexible methodology for multi-hazard risk analysis, identifying the stakeholders and their needs, processes and their characteristics, modeling approaches as well as incoherencies occurring by combining all these different aspects. Based on this concept a flexible software package will be established consisting of ArcGIS as central base and being complemented by various modules for hazard modeling, vulnerability assessment and risk calculation. Not all modules will be developed newly but taken from the current state-of-the-art and connected or integrated into ArcGIS. For this purpose two study sites, Valtellina in Italy and Bacelonnette in France, were chosen and the hazards types debris flows, rockfalls, landslides, avalanches and floods are planned to be included in the tool for a regional multi-hazard risk analysis. Since the central idea of this tool is its flexibility this will only be a first step, in the future further processes and scales can be included and the instrument thus adapted to any study site.

  14. Assessing secondary soil salinization risk based on the PSR sustainability framework.

    PubMed

    Zhou, De; Lin, Zhulu; Liu, Liming; Zimmermann, David

    2013-10-15

    Risk assessment of secondary soil salinization, which is caused in part by the way people manage the land, is an essential challenge to agricultural sustainability. The objective of our study was to develop a soil salinity risk assessment methodology by selecting a consistent set of risk factors based on the conceptual Pressure-State-Response (PSR) sustainability framework and incorporating the grey relational analysis and the Analytic Hierarchy Process methods. The proposed salinity risk assessment methodology was demonstrated through a case study of developing composite risk index maps for the Yinchuan Plain, a major irrigation agriculture district in northwest China. Fourteen risk factors were selected in terms of the three PSR criteria: pressure, state, and response. The results showed that the salinity risk in the Yinchuan Plain was strongly influenced by the subsoil and groundwater salinity, land use, distance to irrigation canals, and depth to groundwater. To maintain agricultural sustainability in the Yinchuan Plain, a suite of remedial and preventative actions were proposed to manage soil salinity risk in the regions that are affected by salinity at different levels and by different salinization processes. The weight sensitivity analysis results also showed that the overall salinity risk of the Yinchuan Plain would increase or decrease as the weights for pressure or response risk factors increased, signifying the importance of human activities on secondary soil salinization. Ideally, the proposed methodology will help us develop more consistent management tools for risk assessment and management and for control of secondary soil salinization. Copyright © 2013 Elsevier Ltd. All rights reserved.

  15. Chemical Mixtures and Epidemiologic Fundamentals for Risk Assessment Applications

    EPA Science Inventory

    Risk management options are increasingly being considered early in the risk assessment process to help scope the considerations and bound the inherent complexities related to potential exposures, risk and future clean-up decisions (including acceptable pollutant levels) related t...

  16. Security Risks: Management and Mitigation in the Software Life Cycle

    NASA Technical Reports Server (NTRS)

    Gilliam, David P.

    2004-01-01

    A formal approach to managing and mitigating security risks in the software life cycle is requisite to developing software that has a higher degree of assurance that it is free of security defects which pose risk to the computing environment and the organization. Due to its criticality, security should be integrated as a formal approach in the software life cycle. Both a software security checklist and assessment tools should be incorporated into this life cycle process and integrated with a security risk assessment and mitigation tool. The current research at JPL addresses these areas through the development of a Sotfware Security Assessment Instrument (SSAI) and integrating it with a Defect Detection and Prevention (DDP) risk management tool.

  17. Guidance documents: Continued support to improve operations of fish hatcheries and field sites to reduce the impact or prevent establishment of New Zealand Mudsnails and other invasive mollusks

    USGS Publications Warehouse

    Moffitt, Christine M.

    2017-01-01

    This project tested and revised a risk assessment/management tool authored by Moffitt and Stockton designed to provide hatchery biologists and others a structure to measure risk and provide tools to control, prevent or eliminate invasive New Zealand mudsnails (NZMS) and other invasive mollusks in fish hatcheries and hatchery operations. The document has two parts: the risk assessment tool, and an appendix that summarizes options for control or management.The framework of the guidance document for risk assessment/hatchery tool combines approaches used by the Hazard Analysis and Critical Control Points (HACCP) process with those developed by the Commission for Environmental Cooperation (CEC), of Canada, Mexico, and the United States, in the Tri-National Risk Assessment Guidelines for Aquatic Alien Invasive Species. The framework approach for this attached first document assesses risk potential with two activities: probability of infestation and consequences of infestation. Each activity is treated equally to determine the risk potential. These two activities are divided into seven basic elements that utilize scientific, technical, and other relevant information in the process of the risk assessment. To determine the probability of infestation four steps are used that have scores reported or determined and averaged. This assessment follows a familiar HACCP process to assess pathways of entry, entry potential, colonization potential, spread potential. The economic, environmental and social consequences are considered as economic impact, environmental impact, and social and cultural influences.To test this document, the Principal Investigator worked to identify interested hatchery managers through contacts at regional aquaculture meetings, fish health meetings, and through the network of invasive species managers and scientists participating in the Western Regional Panel on Aquatic Nuisance Species and the 100th Meridian Initiative's Columbia River Basin Team, and the Western New Zealand Mudsnail Conference in Seattle. Targeted hatchery workshops were conducted with staff at Dworshak National Fish Hatchery Complex (ID), Similkameen Pond, Oroville WA, and Ringold Springs State Hatchery (WA).As a result of communications with hatchery staff, invasive species managers, and on site assessments of hatchery facilities, the document was modified and enhanced. Additional resources were added to keep it up to date. The result is a more simplified tool that can lead hatchery or management personnel through the process of risk assessment and provide an introduction to the risk management and communication process.In addition to the typical HACCP processes, this tool adds steps to rate and consider uncertainty and the weight of evidence regarding options and monitoring results . Uncertainty of outcome exists in most tools that can be used to control or prevent NZMS or other invasive mollusks from infesting an area. In additional this document emphasizes that specific control tools and plans must be tailored to each specific setting to consider the economic, environmental and social influences. From the testing and evaluation process, there was a strong recognition that a number of control and prevention tools previously suggested and reported in the literature from laboratory and small scale trials may not be compatible with regional and national regulations, economic constraints, social or cultural constraints, engineering or water chemistry characteristics of each facility.The options for control are summarized in the second document, Review of Control Measures for Hatcheries Infested with NZMS (Appendix A) that provides sources for additional resources and specific tools, and guidance regarding the feasibility and success of each approach. This tool also emphasizes that management plans need to be adaptive and incorporate oversight from professionals familiar with measuring risks of fish diseases, and treatments (e.g. the fish health practitioners and water quality and effluent management teams). Finally, with such a team, the adaptive management approach must be ongoing, and become a regular component of hatchery operations.Although it was the intent that this two part document would be included as part of the revised National Management and Control Plan for the NZMS proposed by the U.S. Fish and Wildlife Service (USFWS) and others, it is provided as a stand-alone document.

  18. YOUNG ADULT DATING RELATIONSHIPS AND THE MANAGEMENT OF SEXUAL RISK.

    PubMed

    Manning, Wendy D; Giordano, Peggy C; Longmore, Monica A; Flanigan, Christine M

    2012-04-01

    Young adult involvement in sexual behavior typically occurs within a relationship context, but we know little about the ways in which specific features of romantic relationships influence sexual decision-making. Prior work on sexual risk taking focuses attention on health issues rather than relationship dynamics. We draw on data from the Toledo Adolescent Relationships Study (TARS) (n = 475) to examine the association between qualities and dynamics of current/most recent romantic relationships such as communication and emotional processes, conflict, demographic asymmetries, and duration and the management of sexual risk. We conceptualize 'risk management' as encompassing multiple domains, including (1) questioning the partner about previous sexual behaviors/risks, (2) using condoms consistently, and (3) maintaining sexual exclusivity within the relationship. We identify distinct patterns of risk management among dating young adults and find that specific qualities and dynamics of these relationships are linked to variations in risk management. Results from this paper suggest the need to consider relational dynamics in efforts to target and influence young adult sexual risk-taking and reduce STIs, including HIV.

  19. ERM for Health Care Organizations: An Economic Enterprise Risk Management Innovation Program (E2RMhealth care).

    PubMed

    da Silva Etges, Ana Paula Beck; Grenon, Veronique; de Souza, Joana Siqueira; Kliemann Neto, Francisco José; Felix, Elaine Aparecida

    2018-05-14

    In recent years, health care organizations have looked to enterprise risk management (ERM) for novel systems to obtain more accurate data on which to base risk strategies. This study proposes a conceptual ERM framework specifically designed for health care organizations. We explore how hospitals in the United States and Brazil are structuring and implementing ERM processes within their management structure. This study incorporates interviews with 15 chief risk officers (8 from the United States and 7 from Brazil) with qualitative data analysis using NVivo (QSR International software). The interviews confirm that adopting ERM for health care organizations has gained momentum and become a priority, and that the demand for risk economic assessment orientation is common among health care risk managers. We propose an ERM model for health care (Economic Enterprise Risk Management in Health Care) divided into four maturity levels and complemented by an implementation timeline. The model is accompanied by guidelines to orient the gradual implementation of ERM, including orientation to perform risk economic assessment. Copyright © 2018. Published by Elsevier Inc.

  20. Failure mode effect analysis and fault tree analysis as a combined methodology in risk management

    NASA Astrophysics Data System (ADS)

    Wessiani, N. A.; Yoshio, F.

    2018-04-01

    There have been many studies reported the implementation of Failure Mode Effect Analysis (FMEA) and Fault Tree Analysis (FTA) as a method in risk management. However, most of the studies usually only choose one of these two methods in their risk management methodology. On the other side, combining these two methods will reduce the drawbacks of each methods when implemented separately. This paper aims to combine the methodology of FMEA and FTA in assessing risk. A case study in the metal company will illustrate how this methodology can be implemented. In the case study, this combined methodology will assess the internal risks that occur in the production process. Further, those internal risks should be mitigated based on their level of risks.

  1. A Strategy of Dialogue for Communicating Hazard and Risk Information Between the Science and Emergency Management Sectors

    NASA Astrophysics Data System (ADS)

    Eisner, R. K.

    2015-12-01

    This presentation will describe a collaborative dialogue process between earth scientists and emergency management officials that focused on translation of science into policy, building long term trust based relationships between sectors and unified presentation of hazards, risks and consequence management to public officials and the general public. The author will describe the structure and process of the California Earthquake Prediction Evaluation Council (CEPEC) in assessing the credibility of long and short term earthquake predictions, assessment of risk, and the formulation of public communication strategies and preparatory actions by government agencies. For nearly 4 decades, earth scientists, politically appointed state officials and emergency managers have engaged in ongoing discussions of the policy implications of research on potential seismic risk. Some discussions were scheduled and occurred over months, and others were ad hoc and occurred in the minutes between potential precursory incidents and possible large events. The effectiveness of this process was dependent on building respect for ones counterparts expertise, bias and responsibilities, clear communication of data, uncertainty and knowledge of the physical models assumed, history and probabilities; and the physical and political consequences of possible events; and the costs and economic and social disruption of alternative preparedness actions. But, the dialogue included political and social scientists, representatives of the print and broadcast media, political and management officials from federal, state and local governments. The presentation will provide an assessment of the effectiveness of the collaborative dialogue process and lessons on sustaining a long term partnership among the participating federal, state and local officials.

  2. Risks with older adults in acute care settings: UK occupational therapists' and physiotherapists' perceptions of risks associated with discharge and professional practice.

    PubMed

    Atwal, Anita; McIntyre, Anne; Wiggett, Claire

    2012-06-01

    Internationally, there is evidence that hospital discharge to home for older adults is a complex and challenging process that is dependent upon multidisciplinary team working. At the centre of the discharge process is the management of risk, which involves occupational therapists and other healthcare professionals managing perceived dangers and determining why some dangers are seen as presenting risks while others are not. This study did not aim to explore interprofessional differences but to ascertain a greater understanding of professionals' perceptions of risk in acute care settings. This qualitative study utilised 12 semi-structured interviews with seven occupational therapists and five physiotherapists in the United Kingdom (UK). During the interview, therapists were asked to read and answer questions on a validated vignette. The interview data were subjected to thematic content analysis and the vignettes to template analysis. Our research is one of the first studies to explore therapists' perceptions of risk with older adults in acute care settings. Our study has highlighted that perception of risk does have an impact on discharge decision-making and location. Therapists used negative terminology to refer to patients who wanted to take risks, which could be a reflection of the therapists' anxiety. Mental capacity, and patients' functioning and safety were key factors in risk decision-making with older adults. Our research has highlighted the potential value of multidisciplinary working to manage risk situations and the need for reflection and discussion regarding how persons who do not have capacity wishes are managed within acute care settings. There is a need to develop an interprofessional care pathway to guide clinicians through the risk decision-making process which needs to ensure that the client's opinions and wishes are taken into account throughout. © 2011 The Authors. Scandinavian Journal of Caring Sciences © 2011 Nordic College of Caring Science.

  3. Defense in Depth: Foundation for Secure and Resilient IT Enterprises

    DTIC Science & Technology

    2006-09-01

    Quantifying risk means understanding the possibility of the risk existing or coming to fruition. Here the home user attempts to measure the...Management Process of assessing and quantifying risk and establishing an acceptable level of risk for the organization Risk can be mitigated, but

  4. Aspects of the BPRIM Language for Risk Driven Process Engineering

    NASA Astrophysics Data System (ADS)

    Sienou, Amadou; Lamine, Elyes; Pingaud, Hervé; Karduck, Achim

    Nowadays organizations are exposed to frequent changes in business environment requiring continuous alignment of business processes on business strategies. This agility requires methods promoted in enterprise engineering approaches. Risk consideration in enterprise engineering is getting important since the business environment is becoming more and more competitive and unpredictable. Business processes are subject to the same quality requirements as material and human resources. Thus, process management is supposed to tackle value creation challenges but also the ones related to value preservation. Our research considers risk driven business process design as an integral part of enterprise engineering. A graphical modelling language for risk driven business process engineering was introduced in former research. This paper extends the language and handles questions related to modelling risk in organisational context.

  5. The Careful Puppet Master: Reducing risk and fortifying acceptance testing with Jenkins CI

    NASA Astrophysics Data System (ADS)

    Smith, Jason A.; Richman, Gabriel; DeStefano, John; Pryor, James; Rao, Tejas; Strecker-Kellogg, William; Wong, Tony

    2015-12-01

    Centralized configuration management, including the use of automation tools such as Puppet, can greatly increase provisioning speed and efficiency when configuring new systems or making changes to existing systems, reduce duplication of work, and improve automated processes. However, centralized management also brings with it a level of inherent risk: a single change in just one file can quickly be pushed out to thousands of computers and, if that change is not properly and thoroughly tested and contains an error, could result in catastrophic damage to many services, potentially bringing an entire computer facility offline. Change management procedures can—and should—be formalized in order to prevent such accidents. However, like the configuration management process itself, if such procedures are not automated, they can be difficult to enforce strictly. Therefore, to reduce the risk of merging potentially harmful changes into our production Puppet environment, we have created an automated testing system, which includes the Jenkins CI tool, to manage our Puppet testing process. This system includes the proposed changes and runs Puppet on a pool of dozens of RedHat Enterprise Virtualization (RHEV) virtual machines (VMs) that replicate most of our important production services for the purpose of testing. This paper describes our automated test system and how it hooks into our production approval process for automatic acceptance testing. All pending changes that have been pushed to production must pass this validation process before they can be approved and merged into production.

  6. Operational Resiliency Management: An Introduction to the Resiliency Engineering Framework

    DTIC Science & Technology

    2006-09-20

    Maturity Model Integration (CMMI) . 5 © 2006 Carnegie Mellon University y FRB Bus Con Conference 2006 Managing Today’s Operational Risk Challenges ...Bus Con Conference 2006 A model is needed to. . . Identify and prioritize risk exposures Define a process improvement roadmap Measure and facilitate...University y FRB Bus Con Conference 2006 Why use a “model” approach? Provides an operational risk roadmap Vendor-neutral, standardized, unbiased

  7. Software Acquisition Risk Management Key Process Area (KPA) - A Guidebook Version 1.0.

    DTIC Science & Technology

    1997-08-01

    Budget - Software Project Management Practices and Techniques. McGraw-Hill International (UK) Limited, 1992. [Boehm 81 ] Boehm, Barry . Software...Engineering Economics. Englewood Cliffs, N.J.: Prentice-Hall, Inc., 1981. [Boehm 89] Boehm, Barry . IEEE Tutorial on Software Risk Management. New York: IEEE...95] [Mayrhauser 90] [Moran 90] [Myers 96] [NRC 89] [Osborn 53] [Paulk 95] [ Pressman 92] [Pulford 96] [Scholtes 88] [Sisti 94] [STSC 96

  8. Awareness and Perceptions of Food Safety Risks and Risk Management in Poultry Production and Slaughter: A Qualitative Study of Direct-Market Poultry Producers in Maryland

    PubMed Central

    Baron, Patrick; Frattaroli, Shannon

    2016-01-01

    The objective of this study was to document and understand the perceptions and opinions of small-scale poultry producers who market directly to consumers about microbial food safety risks in the poultry supply chain. Between January and November 2014, we conducted semi-structured, in-depth interviews with a convenience sample of 16 owner-operators of Maryland direct-market commercial poultry farms. Three overarching thematic categories emerged from these interviews that describe: 1) characteristics of Maryland direct-market poultry production and processing; 2) microbial food safety risk awareness and risk management in small-scale poultry production, slaughter and processing; and 3) motivations for prioritizing food safety in the statewide direct-market poultry supply chain. Key informants provided valuable insights on many topics relevant to evaluating microbial food safety in the Maryland direct-market poultry supply chain, including: direct-market poultry production and processing practices and models, perspectives on issues related to food safety risk management, perspectives on direct-market agriculture economics and marketing strategies, and ideas for how to enhance food safety at the direct-market level of the Maryland poultry supply chain. The findings have policy implications and provide insights into food safety in small-scale commercial poultry production, processing, distribution and retail. In addition, the findings will inform future food safety research on the small-scale US poultry supply chain. PMID:27341034

  9. Imbedding HACCP principles in dairy herd health and production management: case report on calf rearing

    PubMed Central

    2008-01-01

    Driven by consumer demands, European legislation has suggested the use of HACCP (Hazard Analysis Critical Control Point) as the quality risk management programme for the whole dairy chain. Until now, an exception has been made for primary producers, but as regulations evolve, on-farm HACCP-like programmes should be ready to assure food safety as well as animal health and animal welfare. In our field experiment, the HACCP-concept was used to combine both optimal farm management and formalisation of quality assurance in an on-farm situation in the Netherlands. The process of young stock rearing was chosen, since its importance for the future of the farm is often underestimated. Hazards and their associated risk factors can be controlled within the farm-specific standards and tolerances, as targets can be controlled by corrective measures and by implementation of farm-specific worksheets. The veterinarian is pivotal for the facility-based HACCP team, since he/she has knowledge about on-farm risk assessment and relations between clinical pathology, feed and farm management. The HACCP concept in combination with veterinary herd health and production management programmes offers a promising approach to optimise on-farm production processes (i.e., young stock rearing) in addition to a structural approach for quality risk management on dairy farms. PMID:21851722

  10. Imbedding HACCP principles in dairy herd health and production management: case report on calf rearing.

    PubMed

    Boersema, Jsc; Noordhuizen, Jptm; Vieira, A; Lievaart, Jj; Baumgartner, W

    2008-09-01

    Driven by consumer demands, European legislation has suggested the use of HACCP (Hazard Analysis Critical Control Point) as the quality risk management programme for the whole dairy chain. Until now, an exception has been made for primary producers, but as regulations evolve, on-farm HACCP-like programmes should be ready to assure food safety as well as animal health and animal welfare. In our field experiment, the HACCP-concept was used to combine both optimal farm management and formalisation of quality assurance in an on-farm situation in the Netherlands. The process of young stock rearing was chosen, since its importance for the future of the farm is often underestimated. Hazards and their associated risk factors can be controlled within the farm-specific standards and tolerances, as targets can be controlled by corrective measures and by implementation of farm-specific worksheets. The veterinarian is pivotal for the facility-based HACCP team, since he/she has knowledge about on-farm risk assessment and relations between clinical pathology, feed and farm management. The HACCP concept in combination with veterinary herd health and production management programmes offers a promising approach to optimise on-farm production processes (i.e., young stock rearing) in addition to a structural approach for quality risk management on dairy farms.

  11. Risk Management of P2P Internet Financing Service Platform

    NASA Astrophysics Data System (ADS)

    Yalei, Li

    2017-09-01

    Since 2005, the world’s first P2P Internet financing service platform Zopa in UK was introduced, in the development of “Internet +” trend, P2P Internet financing service platform has been developed rapidly. In 2007, China’s first P2P platform “filming loan” was established, marking the P2P Internet financing service platform to enter China and the rapid development. At the same time, China’s P2P Internet financing service platform also appeared in different forms of risk. This paper focuses on the analysis of the causes of risk of P2P Internet financing service platform and the performance of risk management process. It provides a solution to the Internet risk management plan, and explains the risk management system of the whole P2P Internet financing service platform and the future development direction.

  12. Problem Formulation in Knowledge Discovery via Data Analytics (KDDA) for Environmental Risk Management

    PubMed Central

    Li, Yan; Thomas, Manoj; Osei-Bryson, Kweku-Muata; Levy, Jason

    2016-01-01

    With the growing popularity of data analytics and data science in the field of environmental risk management, a formalized Knowledge Discovery via Data Analytics (KDDA) process that incorporates all applicable analytical techniques for a specific environmental risk management problem is essential. In this emerging field, there is limited research dealing with the use of decision support to elicit environmental risk management (ERM) objectives and identify analytical goals from ERM decision makers. In this paper, we address problem formulation in the ERM understanding phase of the KDDA process. We build a DM3 ontology to capture ERM objectives and to inference analytical goals and associated analytical techniques. A framework to assist decision making in the problem formulation process is developed. It is shown how the ontology-based knowledge system can provide structured guidance to retrieve relevant knowledge during problem formulation. The importance of not only operationalizing the KDDA approach in a real-world environment but also evaluating the effectiveness of the proposed procedure is emphasized. We demonstrate how ontology inferencing may be used to discover analytical goals and techniques by conceptualizing Hazardous Air Pollutants (HAPs) exposure shifts based on a multilevel analysis of the level of urbanization (and related economic activity) and the degree of Socio-Economic Deprivation (SED) at the local neighborhood level. The HAPs case highlights not only the role of complexity in problem formulation but also the need for integrating data from multiple sources and the importance of employing appropriate KDDA modeling techniques. Challenges and opportunities for KDDA are summarized with an emphasis on environmental risk management and HAPs. PMID:27983713

  13. Problem Formulation in Knowledge Discovery via Data Analytics (KDDA) for Environmental Risk Management.

    PubMed

    Li, Yan; Thomas, Manoj; Osei-Bryson, Kweku-Muata; Levy, Jason

    2016-12-15

    With the growing popularity of data analytics and data science in the field of environmental risk management, a formalized Knowledge Discovery via Data Analytics (KDDA) process that incorporates all applicable analytical techniques for a specific environmental risk management problem is essential. In this emerging field, there is limited research dealing with the use of decision support to elicit environmental risk management (ERM) objectives and identify analytical goals from ERM decision makers. In this paper, we address problem formulation in the ERM understanding phase of the KDDA process. We build a DM³ ontology to capture ERM objectives and to inference analytical goals and associated analytical techniques. A framework to assist decision making in the problem formulation process is developed. It is shown how the ontology-based knowledge system can provide structured guidance to retrieve relevant knowledge during problem formulation. The importance of not only operationalizing the KDDA approach in a real-world environment but also evaluating the effectiveness of the proposed procedure is emphasized. We demonstrate how ontology inferencing may be used to discover analytical goals and techniques by conceptualizing Hazardous Air Pollutants (HAPs) exposure shifts based on a multilevel analysis of the level of urbanization (and related economic activity) and the degree of Socio-Economic Deprivation (SED) at the local neighborhood level. The HAPs case highlights not only the role of complexity in problem formulation but also the need for integrating data from multiple sources and the importance of employing appropriate KDDA modeling techniques. Challenges and opportunities for KDDA are summarized with an emphasis on environmental risk management and HAPs.

  14. Quality transitivity and traceability system of herbal medicine products based on quality markers.

    PubMed

    Liu, Changxiao; Guo, De-An; Liu, Liang

    2018-05-15

    Due to a variety of factors to affect the herb quality, the existing quality management model is unable to evaluate the process control. The development of the concept of "quality marker" (Q-marker) lays basis for establishing an independent process quality control system for herbal products. To ensure the highest degree of safety, effectiveness and quality process control of herbal products, it is aimed to establish a quality transitivity and traceability system of quality and process control from raw materials to finished herbal products. Based on the key issues and challenges of quality assessment, the current status of quality and process controls from raw materials to herbal medicinal products listed in Pharmacopoeia were analyzed and the research models including discovery and identification of Q-markers, analysis and quality management of risk evaluation were designed. Authors introduced a few new technologies and methodologies, such as DNA barcoding, chromatographic technologies, fingerprint analysis, chemical markers, bio-responses, risk management and solution for quality process control. The quality and process control models for herbal medicinal products were proposed and the transitivity and traceability system from raw materials to the finished products was constructed to improve the herbal quality from the entire supply and production chain. The transitivity and traceability system has been established based on quality markers, especially on how to control the production process under Good Engineering Practices, as well as to implement the risk management for quality and process control in herbal medicine production. Copyright © 2018 Elsevier GmbH. All rights reserved.

  15. Report: Fiscal Year 2013 Federal Information Security Management Act Report

    EPA Pesticide Factsheets

    Report #14-P-0033, November 26, 2013. The EPA’s network and data could be exploited without processes to evaluate risks and timely remediate vulnerabilities. Data processed by EPA contractors could be at risk because adequate controls may not be in place.

  16. Risk Management in Complex Construction Projects that Apply Renewable Energy Sources: A Case Study of the Realization Phase of the Energis Educational and Research Intelligent Building

    NASA Astrophysics Data System (ADS)

    Krechowicz, Maria

    2017-10-01

    Nowadays, one of the characteristic features of construction industry is an increased complexity of a growing number of projects. Almost each construction project is unique, has its project-specific purpose, its own project structural complexity, owner’s expectations, ground conditions unique to a certain location, and its own dynamics. Failure costs and costs resulting from unforeseen problems in complex construction projects are very high. Project complexity drivers pose many vulnerabilities to a successful completion of a number of projects. This paper discusses the process of effective risk management in complex construction projects in which renewable energy sources were used, on the example of the realization phase of the ENERGIS teaching-laboratory building, from the point of view of DORBUD S.A., its general contractor. This paper suggests a new approach to risk management for complex construction projects in which renewable energy sources were applied. The risk management process was divided into six stages: gathering information, identification of the top, critical project risks resulting from the project complexity, construction of the fault tree for each top, critical risks, logical analysis of the fault tree, quantitative risk assessment applying fuzzy logic and development of risk response strategy. A new methodology for the qualitative and quantitative risk assessment for top, critical risks in complex construction projects was developed. Risk assessment was carried out applying Fuzzy Fault Tree analysis on the example of one top critical risk. Application of the Fuzzy sets theory to the proposed model allowed to decrease uncertainty and eliminate problems with gaining the crisp values of the basic events probability, common during expert risk assessment with the objective to give the exact risk score of each unwanted event probability.

  17. Risk-based Process Development of Biosimilars as Part of the Quality by Design Paradigm.

    PubMed

    Zalai, Dénes; Dietzsch, Christian; Herwig, Christoph

    2013-01-01

    In the last few years, several quality by design (QbD) studies demonstrated the benefit of systematic approaches for biopharmaceutical development. However, only very few studies identified biosimilars as a special case of product development. The targeted quality profile of biosimilars is strictly defined by the originator's product characteristic. Moreover, the major source of prior knowledge is the experience with the originator product itself. Processing this information in biosimilar development has a major effect on risk management and process development strategies. The main objective of this contribution is to demonstrate how risk management can facilitate the implementation of QbD in early-stage product development with special emphasis on fitting the reported approaches to biosimilars. Risk assessments were highlighted as important tools to integrate prior knowledge in biosimilar development. The risk assessment process as suggested by the International Conference on Harmonization (ICH Q9) was reviewed and three elements were identified to play a key role in targeted risk assessment approaches: proper understanding of target linkage, risk assessment tool compliance, and criticality threshold value. Adjusting these steps to biosimilar applications helped to address some unique challenges of these products such as a strictly defined quality profile or a lack of process knowledge. This contribution demonstrates the need for tailored risk management approaches for the risk-based development of biosimilars and provides novel tools for the integration of additional knowledge available for these products. The pharmaceutical industry is facing challenges such as profit loss and price competition. Companies are forced to rationalize business models and to cut costs in development as well as manufacturing. These trends recently hinder the implementation of any concepts that do not offer certain financial benefit or promise a long return of investment. Quality by design (QbD) is a concept that is currently struggling for more acceptance from the side of the pharmaceutical industry. To achieve this, the major goals of QbD have to be revisited and QbD tools have to be subsequently developed. This contribution offers an example as to how implement risk management in early-stage biosimilar development as part of the QbD concept. The main goal was to go beyond the conventional QbD workflow and to adjust risk management to the challenges of biosimilar products. Accordingly, instead of using methods like failure mode and effects analysis, recommendations of the ICH Q9 guideline were reviewed and put into practice by creating tailored risk assessment tools. The novelty of this contribution is to report those tailored tools ready-to-use for early bioprocess development of biosimilars along QbD principles.

  18. Using Role-Play for Expert Science Communication with Professional Stakeholders in Flood Risk Management

    ERIC Educational Resources Information Center

    McEwen, Lindsey; Stokes, Alison; Crowley, Kate; Roberts, Carolyn

    2014-01-01

    This paper explores role-play pedagogies in learning and communicating about cutting-edge flood science by flood risk management professionals in local government. It outlines role-play process/structure and evaluates participant perceptions of their learning experiences. Issues were impacts of prior role-play experience on attitudes brought to…

  19. Management of high-risk perioperative systems.

    PubMed

    Dain, Steven

    2006-06-01

    The perioperative system is a complex system that requires people, materials, and processes to come together in a highly ordered and timely manner. However, when working in this high-risk system, even well-organized, knowledgeable, vigilant, and well-intentioned individuals will eventually make errors. All systems need to be evaluated on a continual basis to reduce the risk of errors, make errors more easily recognizable, and provide methods for error mitigation. A simple approach to risk management that may be applied in clinical medicine is discussed.

  20. Demonstrating PQS Effectiveness and Driving Continual Improvement: Evidence-Based Risk Reduction.

    PubMed

    Ramnarine, Emma; O'Donnell, Kevin

    2018-04-18

    Product knowledge grows and evolves during the life of a product. In order to maintain a state of control and deliver product with consistent quality throughout its commercial life, continuous improvement and product lifecycle management become essential. The practical link between product and process knowledge, risk-based control strategies, and continual improvement and innovation can be made stronger through evidence-based risk reduction. Regulatory relief and flexibility in post approval change management and overall product lifecycle management will only be possible with effective application of science and risk-based concepts and demonstrated effectiveness of the PQS in assuring a state of control. Copyright © 2018, Parenteral Drug Association.

  1. Probabilistic framework for product design optimization and risk management

    NASA Astrophysics Data System (ADS)

    Keski-Rahkonen, J. K.

    2018-05-01

    Probabilistic methods have gradually gained ground within engineering practices but currently it is still the industry standard to use deterministic safety margin approaches to dimensioning components and qualitative methods to manage product risks. These methods are suitable for baseline design work but quantitative risk management and product reliability optimization require more advanced predictive approaches. Ample research has been published on how to predict failure probabilities for mechanical components and furthermore to optimize reliability through life cycle cost analysis. This paper reviews the literature for existing methods and tries to harness their best features and simplify the process to be applicable in practical engineering work. Recommended process applies Monte Carlo method on top of load-resistance models to estimate failure probabilities. Furthermore, it adds on existing literature by introducing a practical framework to use probabilistic models in quantitative risk management and product life cycle costs optimization. The main focus is on mechanical failure modes due to the well-developed methods used to predict these types of failures. However, the same framework can be applied on any type of failure mode as long as predictive models can be developed.

  2. RCRA/UST, superfund, and EPCRA hotline training module. Introduction to accidental release prevention program (CAA section 112(r); 40 CFR part 68). Updated as of November 1995

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    1996-03-01

    The module explains the purpose of Section 112(r) of the Clean Air Act and how it relates to the goals and requirements of the Emergency Planning and Community Right-to-know Act (EPCRA). It describes the promulgation of the list of regulated substances. It discusses the risk management planning requirements and explains how the risk management rule is being promulgated. It identifies the presidential review and describes the similarity of the risk management program to the occupational health and safety administration`s process safety management standard.

  3. Model for integrated management of quality, labor risks prevention, environment and ethical aspects, applied to R&D&I and production processes in an organization

    NASA Astrophysics Data System (ADS)

    González, M. R.; Torres, F.; Yoldi, V.; Arcega, F.; Plaza, I.

    2012-04-01

    It is proposed an integrated management model for an organization. This model is based on the continuous improvement Plan-Do-Check-Act cycle and it intends to integrate the environmental, risk prevention and ethical aspects as well as research, development and innovation projects management in the general quality management structure proposed by ISO 9001:2008. It aims to fulfill the standards ISO 9001, ISO 14001, OSHAS 18001, SGE 21 y 166002.

  4. Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk.

    PubMed

    Eyles, John; Heddle, Nancy; Webert, Kathryn; Arnold, Emmy; McCurdy, Bronwen

    2011-08-24

    Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches.

  5. Do expert assessments converge? An exploratory case study of evaluating and managing a blood supply risk

    PubMed Central

    2011-01-01

    Background Examining professional assessments of a blood product recall/withdrawal and its implications for risk and public health, the paper introduces ideas about perceptions of minimal risk and its management. It also describes the context of publicly funded blood transfusion in Canada and the withdrawal event that is the basis of this study. Methods Interviews with 45 experts from administration, medicine, blood supply, laboratory services and risk assessment took place using a multi-level sampling framework in the aftermath of the recall. These experts either directly dealt with the withdrawal or were involved in the management of the blood supply at the national level. Data from these interviews were coded in NVivo for analysis and interpretation. Analytically, data were interpreted to derive typifications to relate interview responses to risk management heuristics. Results While all those interviewed agreed on the importance of patient safety, differences in the ways in which the risk was contextualized and explicated were discerned. Risk was seen in terms of patient safety, liability or precaution. These different risk logics are illustrated by selected quotations. Conclusions Expert assessments did not fully converge and it is possible that these different risk logics and discourses may affect the risk management process more generally, although not necessarily in a negative way. Patient safety is not to be compromised but management of blood risk in publicly funded systems may vary. We suggest ways of managing blood risk using formal and safety case approaches. PMID:21864330

  6. A model study of the Haihe river passenger ferry risk based on AHP

    NASA Astrophysics Data System (ADS)

    Du, Jinyin; Xu, Yanming; Du, Chunzhi; Jin, Zhenhua

    2017-05-01

    The core function of maritime is water safety supervision, whose emphasis and difficulty is ferry. In combination with the practical situation of Haihe river passenger ferry operation management, this paper analyzes Haihe river passenger ferry risk from four aspects "human, machinery, environment and management", and establishes the ferry risk index system. By using AHP (Analytic Hierarchy Process), the ferry risk evaluation model is established. By using the ferry model, the application of Ferry Zhengyanfa7 in Tianjin Haihe river crossing is evaluated, whose safety situation is verified to be between "relatively high risk" and "high risk".

  7. A new process for organizing assessments of social, economic, and environmental outcomes: case study of wildland fire management in the USA

    Treesearch

    Randall JF Bruins; Wayne R Jr. Munns; Stephen J Botti; Steve Brink; David Cleland; Larry Kapustka; Danny Lee; al. et

    2010-01-01

    Ecological risk assessments typically are organized using the processes of planning (a discussion among managers, stakeholders, and analysts to clarify ecosystem management goals and assessment scope) and problem formulation (evaluation of existing information to generate hypotheses about adverse ecological effects, select assessment endpoints, and develop an analysis...

  8. Combination of uncertainty theories and decision-aiding methods for natural risk management in a context of imperfect information

    NASA Astrophysics Data System (ADS)

    Tacnet, Jean-Marc; Dupouy, Guillaume; Carladous, Simon; Dezert, Jean; Batton-Hubert, Mireille

    2017-04-01

    In mountain areas, natural phenomena such as snow avalanches, debris-flows and rock-falls, put people and objects at risk with sometimes dramatic consequences. Risk is classically considered as a combination of hazard, the combination of the intensity and frequency of the phenomenon, and vulnerability which corresponds to the consequences of the phenomenon on exposed people and material assets. Risk management consists in identifying the risk level as well as choosing the best strategies for risk prevention, i.e. mitigation. In the context of natural phenomena in mountainous areas, technical and scientific knowledge is often lacking. Risk management decisions are therefore based on imperfect information. This information comes from more or less reliable sources ranging from historical data, expert assessments, numerical simulations etc. Finally, risk management decisions are the result of complex knowledge management and reasoning processes. Tracing the information and propagating information quality from data acquisition to decisions are therefore important steps in the decision-making process. One major goal today is therefore to assist decision-making while considering the availability, quality and reliability of information content and sources. A global integrated framework is proposed to improve the risk management process in a context of information imperfection provided by more or less reliable sources: uncertainty as well as imprecision, inconsistency and incompleteness are considered. Several methods are used and associated in an original way: sequential decision context description, development of specific multi-criteria decision-making methods, imperfection propagation in numerical modeling and information fusion. This framework not only assists in decision-making but also traces the process and evaluates the impact of information quality on decision-making. We focus and present two main developments. The first one relates to uncertainty and imprecision propagation in numerical modeling using both classical Monte-Carlo probabilistic approach and also so-called Hybrid approach using possibility theory. Second approach deals with new multi-criteria decision-making methods which consider information imperfection, source reliability, importance and conflict, using fuzzy sets as well as possibility and belief function theories. Implemented methods consider information imperfection propagation and information fusion in total aggregation methods such as AHP (Saaty, 1980) or partial aggregation methods such as the Electre outranking method (see Soft Electre Tri ) or decisions in certain but also risky or uncertain contexts (see new COWA-ER and FOWA-ER- Cautious and Fuzzy Ordered Weighted Averaging-Evidential Reasoning). For example, the ER-MCDA methodology considers expert assessment as a multi-criteria decision process based on imperfect information provided by more or less heterogeneous, reliable and conflicting sources: it mixes AHP, fuzzy sets theory, possibility theory and belief function theory using DSmT (Dezert-Smarandache Theory) framework which provides powerful fusion rules.

  9. Traceability System For Agricultural Productsbased on Rfid and Mobile Technology

    NASA Astrophysics Data System (ADS)

    Sugahara, Koji

    In agriculture, it is required to establish and integrate food traceability systems and risk management systems in order to improve food safety in the entire food chain. The integrated traceability system for agricultural products was developed, based on innovative technology of RFID and mobile computing. In order to identify individual products on the distribution process efficiently,small RFID tags with unique ID and handy RFID readers were applied. On the distribution process, the RFID tags are checked by using the readers, and transit records of the products are stored to the database via wireless LAN.Regarding agricultural production, the recent issues of pesticides misuse affect consumer confidence in food safety. The Navigation System for Appropriate Pesticide Use (Nouyaku-navi) was developed, which is available in the fields by Internet cell-phones. Based on it, agricultural risk management systems have been developed. These systems collaborate with traceability systems and they can be applied for process control and risk management in agriculture.

  10. How normative interpretations of climate risk assessment affect local decision-making: an exploratory study at the city scale in Cork, Ireland.

    PubMed

    McDermott, T K J; Surminski, S

    2018-06-13

    Urban areas already suffer substantial losses in both economic and human terms from climate-related disasters. These losses are anticipated to grow substantially, in part as a result of the impacts of climate change. In this paper, we investigate the process of translating climate risk data into action for the city level. We apply a commonly used decision-framework as our backdrop and explore where in this process climate risk assessment and normative political judgements intersect. We use the case of flood risk management in Cork city in Ireland to investigate what is needed for translating risk assessment into action at the local city level. Evidence presented is based on focus group discussions at two stakeholder workshops, and a series of individual meetings and phone-discussions with stakeholders involved in local decision-making related to flood risk management and adaptation to climate change, in Ireland. Respondents were chosen on the basis of their expertise or involvement in the decision-making processes locally and nationally. Representatives of groups affected by flood risk and flood risk management and climate adaptation efforts were also included. The Cork example highlights that, despite ever more accurate data and an increasing range of theoretical approaches available to local decision-makers, it is the normative interpretation of this information that determines what action is taken. The use of risk assessments for decision-making is a process that requires normative decisions, such as setting 'acceptable risk levels' and identifying 'adequate' protection levels, which will not succeed without broader buy-in and stakeholder participation. Identifying and embracing those normative views up-front could strengthen the urban adaptation process-this may, in fact, turn out to be the biggest advantage of climate risk assessment: it offers an opportunity to create a shared understanding of the problem and enables an informed evaluation and discussion of remedial action.This article is part of the theme issue 'Advances in risk assessment for climate change adaptation policy'. © 2018 The Author(s).

  11. How normative interpretations of climate risk assessment affect local decision-making: an exploratory study at the city scale in Cork, Ireland

    NASA Astrophysics Data System (ADS)

    McDermott, T. K. J.; Surminski, S.

    2018-06-01

    Urban areas already suffer substantial losses in both economic and human terms from climate-related disasters. These losses are anticipated to grow substantially, in part as a result of the impacts of climate change. In this paper, we investigate the process of translating climate risk data into action for the city level. We apply a commonly used decision-framework as our backdrop and explore where in this process climate risk assessment and normative political judgements intersect. We use the case of flood risk management in Cork city in Ireland to investigate what is needed for translating risk assessment into action at the local city level. Evidence presented is based on focus group discussions at two stakeholder workshops, and a series of individual meetings and phone-discussions with stakeholders involved in local decision-making related to flood risk management and adaptation to climate change, in Ireland. Respondents were chosen on the basis of their expertise or involvement in the decision-making processes locally and nationally. Representatives of groups affected by flood risk and flood risk management and climate adaptation efforts were also included. The Cork example highlights that, despite ever more accurate data and an increasing range of theoretical approaches available to local decision-makers, it is the normative interpretation of this information that determines what action is taken. The use of risk assessments for decision-making is a process that requires normative decisions, such as setting `acceptable risk levels' and identifying `adequate' protection levels, which will not succeed without broader buy-in and stakeholder participation. Identifying and embracing those normative views up-front could strengthen the urban adaptation process-this may, in fact, turn out to be the biggest advantage of climate risk assessment: it offers an opportunity to create a shared understanding of the problem and enables an informed evaluation and discussion of remedial action. This article is part of the theme issue `Advances in risk assessment for climate change adaptation policy'.

  12. NASA Risk Management Handbook. Version 1.0

    NASA Technical Reports Server (NTRS)

    Dezfuli, Homayoon; Benjamin, Allan; Everett, Christopher; Maggio, Gaspare; Stamatelatos, Michael; Youngblood, Robert; Guarro, Sergio; Rutledge, Peter; Sherrard, James; Smith, Curtis; hide

    2011-01-01

    The purpose of this handbook is to provide guidance for implementing the Risk Management (RM) requirements of NASA Procedural Requirements (NPR) document NPR 8000.4A, Agency Risk Management Procedural Requirements [1], with a specific focus on programs and projects, and applying to each level of the NASA organizational hierarchy as requirements flow down. This handbook supports RM application within the NASA systems engineering process, and is a complement to the guidance contained in NASA/SP-2007-6105, NASA Systems Engineering Handbook [2]. Specifically, this handbook provides guidance that is applicable to the common technical processes of Technical Risk Management and Decision Analysis established by NPR 7123.1A, NASA Systems Engineering Process and Requirements [3]. These processes are part of the \\Systems Engineering Engine. (Figure 1) that is used to drive the development of the system and associated work products to satisfy stakeholder expectations in all mission execution domains, including safety, technical, cost, and schedule. Like NPR 7123.1A, NPR 8000.4A is a discipline-oriented NPR that intersects with product-oriented NPRs such as NPR 7120.5D, NASA Space Flight Program and Project Management Requirements [4]; NPR 7120.7, NASA Information Technology and Institutional Infrastructure Program and Project Management Requirements [5]; and NPR 7120.8, NASA Research and Technology Program and Project Management Requirements [6]. In much the same way that the NASA Systems Engineering Handbook is intended to provide guidance on the implementation of NPR 7123.1A, this handbook is intended to provide guidance on the implementation of NPR 8000.4A. 1.2 Scope and Depth This handbook provides guidance for conducting RM in the context of NASA program and project life cycles, which produce derived requirements in accordance with existing systems engineering practices that flow down through the NASA organizational hierarchy. The guidance in this handbook is not meant to be prescriptive. Instead, it is meant to be general enough, and contain a sufficient diversity of examples, to enable the reader to adapt the methods as needed to the particular risk management issues that he or she faces. The handbook highlights major issues to consider when managing programs and projects in the presence of potentially significant uncertainty, so that the user is better able to recognize and avoid pitfalls that might otherwise be experienced.

  13. Transient ischaemic attacks clinics provide equivalent and more efficient care than early in-hospital assessment.

    PubMed

    Martínez-Martínez, M M; Martínez-Sánchez, P; Fuentes, B; Cazorla-García, R; Ruiz-Ares, G; Correas-Callero, E; Lara-Lara, M; Díez-Tejedor, E

    2013-02-01

    Clinics for early management of transient ischaemic attacks (TIAs) have been developed in some stroke centres, resulting in reduced recurrence rates compared to appointment-based outpatient management, thus saving on hospitalization. We analysed the care process, recurrence rates and economic impact of the first year of work in our early-management TIA clinic and compared these with our previous in-hospital study protocols for low- and moderate-risk TIA patients. This was a prospective evaluation of the management of low- to moderate-risk TIA patients, comparing a new TIA clinic model (2010) with a previous hospitalization model (2009). Demographic data, vascular risk factor profiles, diagnostic test performance, secondary prevention measures, final aetiological diagnoses and cerebrovascular recurrences at 7 and 90 days were compared between in-hospital and TIA clinic assessed patients. We also carried out an economic comparison of the costs of each model's process. Two hundred and eleven low- to moderate-risk TIA patients were included, of whom 40.8% were hospitalized. There were no differences between the TIA clinic assessed and in-hospital assessed patients in terms of risk factor diagnosis and secondary prevention measures. The stroke recurrence rate (2.4% vs. 1.2%; P = 0.65) was low and similar for both groups (CI 95%, 0.214-20.436; P = 0.52). Cost per patient was €393.28 for clinic versus €1931.18 for in-hospital management. Outpatient management resulted in a 77.8% reduction in hospitalizations. Transient ischaemic attacks clinics are efficient for the early management of low- to moderate-risk TIA patients compared to in-hospital assessment, with no higher recurrence rates and at almost one-fifth the cost. © 2012 The Author(s) European Journal of Neurology © 2012 EFNS.

  14. Estimation and evaluation of management options to control and/or reduce the risk of not complying with commercial sterility.

    PubMed

    Pujol, Laure; Albert, Isabelle; Magras, Catherine; Johnson, Nicholas Brian; Membré, Jeanne-Marie

    2015-11-20

    In a previous study, a modular process risk model, from the raw material reception to the final product storage, was built to estimate the risk of a UHT-aseptic line of not complying with commercial sterility (Pujol et al., 2015). This present study was focused on demonstrating how the model (updated version with uncertainty and variability separated and 2(nd) order Monte Carlo procedure run) could be used to assess quantitatively the influence of management options. This assessment was done in three steps: pinpoint which process step had the highest influence on the risk, identify which management option(s) could be the most effective to control and/or reduce the risk, and finally evaluate quantitatively the influence of changing process setting(s) on the risk. For Bacillus cereus, it was identified that during post-process storage in an aseptic tank, there was potentially an air re-contamination due to filter efficiency loss (efficiency loss due to successive in-place sterilizations after cleaning operations), followed by B. cereus growth. Two options were then evaluated: i) reducing by one fifth of the number of filter sterilizations before renewing the filters, ii) designing new UHT-aseptic lines without an aseptic tank, i.e. without a storage period after the thermal process and before filling. Considering the uncertainty in the model, it was not possible to confirm whether these options had a significant influence on the risk associated with B. cereus. On the other hand, for Geobacillus stearothermophilus, combinations of heat-treatment time and temperature enabling the control or reduction in risk by a factor of ca. 100 were determined; for ease of operational implementation, they were presented graphically in the form of iso-risk curves. For instance, it was established that a heat treatment of 138°C for 31s (instead of 138°C for 25s) enabled a reduction in risk to 18×10(-8) (95% CI=[10; 34]×10(-8)), instead of 578×10(-8) (95% CI=[429; 754]×10(-8)) initially. In conclusion, a modular risk model, as the one exemplified here with a UHT-aseptic line, is a valuable tool in process design and operation, bringing definitive quantitative elements into the decision making process. Copyright © 2015 Elsevier B.V. All rights reserved.

  15. Analysing the external supply chain risk driver competitiveness: a risk mitigation framework and business continuity plan.

    PubMed

    Blos, Mauricio F; Wee, Hui-Ming; Yang, Joshua

    2010-11-01

    Innovation challenges for handling supply chain risks have become one of the most important drivers in business competitiveness and differentiation. This study analyses competitiveness at the external supply chain level as a driver of risks and provides a framework for mitigating these risks. The mitigation framework, also called the supply chain continuity framework, provides insight into six stages of the business continuity planning (BCP) process life cycle (risk mitigation management, business impact analysis, supply continuity strategy development, supply continuity plan development, supply continuity plan testing and supply continuity plan maintenance), together with the operational constructs: customer service, inventory management, flexibility, time to market, ordering cycle time and quality. The purpose of the BCP process life cycle and operational constructs working together is to emphasise the way in which a supply chain can deal with disruption risks and, consequently, bring competitive advantage. Future research will consider the new risk scenarios and analyse the consequences to promote the improvement of supply chain resilience.

  16. Improving flood risk mapping in Italy: the FloodRisk open-source software

    NASA Astrophysics Data System (ADS)

    Albano, Raffaele; Mancusi, Leonardo; Craciun, Iulia; Sole, Aurelia; Ozunu, Alexandru

    2017-04-01

    Time and again, floods around the world illustrate the devastating impact they can have on societies. Furthermore, the expectation that the flood damages can increase over time with climate, land-use change and social growth in flood prone-areas has raised the public and other stakeholders' (governments, international organization, re-insurance companies and emergency responders) awareness for the need to manage risks in order to mitigate their causes and consequences. In this light, the choice of appropriate measures, the assessment of the costs and effects of such measures, and their prioritization are crucial for decision makers. As a result, a priori flood risk assessment has become a key part of flood management practices with the aim of minimizing the total costs related to the risk management cycle. In this context, The EU Flood Directive 2007/60 requires the delineation of flood risk maps on the bases of most appropriate and advanced tools, with particular attention on limiting required economic efforts. The main aim of these risk maps is to provide the required knowledge for the development of flood risk management plans (FRMPs) by considering both costs and benefits of alternatives and results from consultation with all interested parties. In this context, this research project developed a free and open-source (FOSS) GIS software, called FloodRisk, to operatively support stakeholders in their compliance with the FRMPs. FloodRisk aims to facilitate the development of risk maps and the evaluation and management of current and future flood risk for multi-purpose applications. This new approach overcomes the limits of the expert-drive qualitative (EDQ) approach currently adopted in several European countries, such as Italy, which does not permit a suitable evaluation of the effectiveness of risk mitigation strategies, because the vulnerability component cannot be properly assessed. Moreover, FloodRisk is also able to involve the citizens in the flood management process, enhancing their awareness. This FOSS approach can promotes transparency and accountability through a process of "guided discovery". Moreover, the immediacy with which information is presented by the qualitative flood risk map, can facilitate and speed up the process of knowledge acquisition. An application of FloodRisk model is showed on a pilot case in "Serio" Valley, (North Italy), and its strengths and limits, in terms of additional efforts required in its application compared with EDQ procedure, have been highlighted focusing on the utility of the results provided for the development of FRMPs. Although they still present limits which prevent the FloodRisk application without critically consider the peculiarities of the investigated area in terms of available knowledge on hazard, exposure and vulnerability, the proposed approach surely produces an increase in available knowledge of flood risk and its drivers. This further information cannot be neglected for defining risk mitigation objectives and strategies. Hence, considering the ongoing efforts in the improvement of data availability and quality, FloodRisk could be a suitable tool for the next revision of flood risk maps due by December 2019, supporting effectively Italian and EU practitioners in the delineation of FRMPs (and for flood risk management in general).

  17. Evaluating Process Effectiveness to Reduce Risk

    NASA Technical Reports Server (NTRS)

    Shepherd, Christena C.

    2017-01-01

    It is well documented that government agencies do not have the same incentive as the private sector to focus on process effectiveness and continual improvement of those processes. It is also well documented whenever government agencies fail to deliver efficient, effective, consistent, and fair services to the citizens. In spite of the various "reinventing government" and "effectiveness initiatives" of the past decades, and in spite of the efforts on the part of many agencies to improve, government in general still lags behind industry in creating a culture of effective processes and systems. While the tragic events that unfolded recently in Flint, Michigan, teach us that running government "like a business" does not always take the needs of the citizenry into account, there are many lessons and techniques from the private sector that government agencies can use to improve. The incentive to improve, while mandated by various administrations1, needs to come from within the workforce, in order to effectively take root. The best, most effective incentive is to reduce, control or eliminate risk. Government agencies face some of the same risks as the private sector, while some are unique. While ISO 310002 has been around since 2009, risk has taken on increased visibility within the private sector with the advent of the emphasis on risk-based thinking in ISO 9001:20153. The relationship between risk-based thinking and effective processes is simple and direct. Those processes that are well thought out and standardized (i.e. Plan-Do-Check-Act), will have taken into account the applicable policy, statutory, regulatory, safety, quality and technical parameters, which may not occur to someone performing the process with minimal experience or training; and thus protect the employees, the public and the agency from statutory and regulatory violations; delay in providing services; non-delivery of services; harm to public or employee safety and health; cost overruns; breaches in security; loss of confidence in government; failure of publicly funded projects; damage to the environment; ethics violations, and the list goes on; with local, national and even international consequences. The Plan-Do-Check-Act process, also known as the "process approach" can be used at any time to establish and standardize a process, and it can also be used to check periodically for "process creep" (i.e., informal, unauthorized changes that have occurred over time), any necessary updates and improvements. While ISO 9001 compliance is not mandated for all government agencies, if interpreted correctly, it can be useful in establishing a framework and implementing effective management systems and processes.4 Another method that can be used to evaluate effectiveness is the scorecard definitions in Mallory's Process Management Standard5 as a basis for evaluating work on the process level on effective, and continuously improved and improving processes. With processes on the lower end of the scale, agencies are vulnerable to a great many risks, with employees and managers making up many of the rules as they go, leading to the above listed negative results. Without clear guidance for nominal operations, off-nominal situations can, and do, increase the likelihood of chaos. In an increasingly technical environment, with inter-agency communication and collaboration becoming the norm, agencies need to come to grips with the fact that processes can become rapidly outdated, and that the technical community should take on an increased role in the maturation of the agency's processes. Industry has long known that effective processes are also efficient, and process improvement methods such as Kaizen, Lean, Six Sigma, 5S, and mistake proofing lead to increased productivity, improved quality, and decreased cost. Again, government agencies have different concerns, but inefficiencies and mistakes can have dire and wide reaching consequences for the public that they serve. While no one goes to work planning to cause harm, it is up to agencies to establish upper level systems, which make establishment and compliance with processes possible. Again, Mallory provides us with a Systems Management Standard6, similar to the Process Management Standard, with a scale of 0-5 for systems effectiveness and maturity. Deming determined that "eighty-five percent of the reasons for failure are deficiencies in the systems and process rather than the employee. The role of management is to change the process rather than badgering individual employees to do better." 7 It is not just the working level employees who need effective processes, but the mid-and upper level managers as well. A disciplined management culture sets the tone for the employees, aids both routine and off-nominal decision-making, and incorporates risk -based thinking into the systems and processes as a matter of normal activity. Figure 1, illustrates the relationship between ineffective and effective processes and risk, through the use of the "stoplight" colors that are commonly used to show serious situations (red), situations which may be improving or deteriorating depending on trends (yellow), and situations that are under control and continuously improved (green).

  18. A positive risk approach when clients choose to live at risk: a palliative case discussion.

    PubMed

    De Bono, Christopher E; Henry, Blair

    2016-09-01

    The article discusses recent approaches in the literature about clients who chose to live at risk in their homes. It argues for a positive risk-based approach and a tool to help manage risk in the home, and applies these to a hypothetical end-of-life scenario. Historically, safety plans to consider risk management involved a culture of risk aversion supported by sometimes paternalistic motives intended to protect vulnerable clients. New findings in the literature engage in a process that respects the ethical principles underlying harm reduction philosophies. The literature also argues for a perspective that moves away from viewing risk as only harmful, to one that supports a positive understanding of risk as part of a client's informed choice. A risk support management plan, based on a positive approach, can provide a way to both support a client's choice to live at risk, anticipate for expected complications, and inform the creation of a contingency plan to address concerns as they may arise. The added value of a structured approach like the one proposed here for risk support management plans is that it provides adequate due diligence and informed decision-making when planning for risk-taking in complex situations.

  19. Cyber crime: can a standard risk analysis help in the challenges facing business continuity managers?

    PubMed

    Vande Putte, Danny; Verhelst, Marc

    Risk management has never been easy. Finding efficient mitigating measures is not always straightforward. Finding measures for cyber crime, however, is a really huge challenge because cyber threats are changing all the time. As the sophistication of these threats is growing, their impact increases. Moreover, society and its economy have become increasingly dependent on information and communication technologies. Standard risk analysis methodologies will help to score the cyber risk and to place it in the risk tolerance matrix. This will allow business continuity managers to figure out if there is still a gap with the maximum tolerable outage for time-critical business processes and if extra business continuity measures are necessary to fill the gap.

  20. An exploration of how clinician attitudes and beliefs influence the implementation of lifestyle risk factor management in primary healthcare: a grounded theory study

    PubMed Central

    Laws, Rachel A; Kemp, Lynn A; Harris, Mark F; Davies, Gawaine Powell; Williams, Anna M; Eames-Brown, Rosslyn

    2009-01-01

    Background Despite the effectiveness of brief lifestyle intervention delivered in primary healthcare (PHC), implementation in routine practice remains suboptimal. Beliefs and attitudes have been shown to be associated with risk factor management practices, but little is known about the process by which clinicians' perceptions shape implementation. This study aims to describe a theoretical model to understand how clinicians' perceptions shape the implementation of lifestyle risk factor management in routine practice. The implications of the model for enhancing practices will also be discussed. Methods The study analysed data collected as part of a larger feasibility project of risk factor management in three community health teams in New South Wales (NSW), Australia. This included journal notes kept through the implementation of the project, and interviews with 48 participants comprising 23 clinicians (including community nurses, allied health practitioners and an Aboriginal health worker), five managers, and two project officers. Data were analysed using grounded theory principles of open, focused, and theoretical coding and constant comparative techniques to construct a model grounded in the data. Results The model suggests that implementation reflects both clinician beliefs about whether they should (commitment) and can (capacity) address lifestyle issues. Commitment represents the priority placed on risk factor management and reflects beliefs about role responsibility congruence, client receptiveness, and the likely impact of intervening. Clinician beliefs about their capacity for risk factor management reflect their views about self-efficacy, role support, and the fit between risk factor management ways of working. The model suggests that clinicians formulate different expectations and intentions about how they will intervene based on these beliefs about commitment and capacity and their philosophical views about appropriate ways to intervene. These expectations then provide a cognitive framework guiding their risk factor management practices. Finally, clinicians' appraisal of the overall benefits versus costs of addressing lifestyle issues acts to positively or negatively reinforce their commitment to implementing these practices. Conclusion The model extends previous research by outlining a process by which clinicians' perceptions shape implementation of lifestyle risk factor management in routine practice. This provides new insights to inform the development of effective strategies to improve such practices. PMID:19825189

  1. Risk management systems for health care and safety development on transplantation: a review and a proposal.

    PubMed

    Pretagostini, R; Gabbrielli, F; Fiaschetti, P; Oliveti, A; Cenci, S; Peritore, D; Stabile, D

    2010-05-01

    Starting from the report on medical errors published in 1999 by the US Institute of Medicine, a number of different approaches to risk management have been developed for maximum risk reduction in health care activities. The health care authorities in many countries have focused attention on patient safety, employing action research programs that are based on quite different principles. We performed a systematic Medline research of the literature since 1999. The following key words were used, also combining boolean operators and medical subheading terms: "adverse event," "risk management," "error," and "governance." Studies published in the last 5 years were particularly classified in various groups: risk management in health care systems; safety in specific hospital activities; and health care institutions' official documents. Methods of action researches have been analysed and their characteristics compared. Their suitability for safety development in donation, retrieval, and transplantation processes were discussed in the reality of the Italian transplant network. Some action researches and studies were dedicated to entire national healthcare systems, whereas others focused on specific risks. Many research programs have undergone critical review in the literature. Retrospective analysis has centered on so-called sentinel events to particularly analyze only a minor portion of the organizational phenomena, which can be the origin of an adverse event, an incident, or an error. Sentinel events give useful information if they are studied in highly engineered and standardized organizations like laboratories or tissue establishments, but they show several limits in the analysis of organ donation, retrieval, and transplantation processes, which are characterized by prevailing human factors, with high intrinsic risk and variability. Thus, they are poorly effective to deliver sure elements to base safety management improvement programs, especially regarding multidisciplinary systems with high complexity. In organ transplantation, the possibility to increase safety seems greater using proactive research, mainly centred on organizational processes together with retrospective analyses but not limited to sentinel event reports. Copyright (c) 2010. Published by Elsevier Inc.

  2. [The hospital perspective: disease management and integrated health care].

    PubMed

    Schrappe, Matthias

    2003-06-01

    Disease Management is a transsectoral, population-based form of health care, which addresses groups of patients with particular clinical entities and risk factors. It refers both to an evidence-based knowledge base and corresponding guidelines, evaluates outcome as a continuous quality improvement process and usually includes active participation of patients. In Germany, the implementation of disease management is associated with financial transactions for risk adjustment between health care assurances [para. 137 f, Book V of Social Code (SGB V)] and represents the second kind of transsectoral care, besides a program designed as integrated health care according to para. 140 a ff f of Book V of Social Code. While in the USA and other countries disease management programs are made available by several institutions involved in health care, in Germany these programs are offered by health care insurers. Assessment of disease management from the hospital perspective will have to consider three questions: How large is the risk to compensate inadequate quality in outpatient care? Are there synergies in internal organisational development? Can the risk of inadequate funding of the global "integrated" budget be tolerated? Transsectoral quality assurance by valid performance indicators and implementation of a quality improvement process are essential. Internal organisational changes can be supported, particularly in the case of DRG introduction. The economic risk and financial output depends on the kind of disease being focussed by the disease management program. In assessing the underlying scientific evidence of their cost effectiveness, societal costs will have to be precisely differentiated from hospital-associated costs.

  3. Use of failure mode effect analysis (FMEA) to improve medication management process.

    PubMed

    Jain, Khushboo

    2017-03-13

    Purpose Medication management is a complex process, at high risk of error with life threatening consequences. The focus should be on devising strategies to avoid errors and make the process self-reliable by ensuring prevention of errors and/or error detection at subsequent stages. The purpose of this paper is to use failure mode effect analysis (FMEA), a systematic proactive tool, to identify the likelihood and the causes for the process to fail at various steps and prioritise them to devise risk reduction strategies to improve patient safety. Design/methodology/approach The study was designed as an observational analytical study of medication management process in the inpatient area of a multi-speciality hospital in Gurgaon, Haryana, India. A team was made to study the complex process of medication management in the hospital. FMEA tool was used. Corrective actions were developed based on the prioritised failure modes which were implemented and monitored. Findings The percentage distribution of medication errors as per the observation made by the team was found to be maximum of transcription errors (37 per cent) followed by administration errors (29 per cent) indicating the need to identify the causes and effects of their occurrence. In all, 11 failure modes were identified out of which major five were prioritised based on the risk priority number (RPN). The process was repeated after corrective actions were taken which resulted in about 40 per cent (average) and around 60 per cent reduction in the RPN of prioritised failure modes. Research limitations/implications FMEA is a time consuming process and requires a multidisciplinary team which has good understanding of the process being analysed. FMEA only helps in identifying the possibilities of a process to fail, it does not eliminate them, additional efforts are required to develop action plans and implement them. Frank discussion and agreement among the team members is required not only for successfully conducing FMEA but also for implementing the corrective actions. Practical implications FMEA is an effective proactive risk-assessment tool and is a continuous process which can be continued in phases. The corrective actions taken resulted in reduction in RPN, subjected to further evaluation and usage by others depending on the facility type. Originality/value The application of the tool helped the hospital in identifying failures in medication management process, thereby prioritising and correcting them leading to improvement.

  4. Project risk and appeals in U.S. Forest Service planning

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Stern, Marc J., E-mail: mjstern@vt.edu; Predmore, S. Andrew, E-mail: spred2@uis.edu; Morse, Wayde C., E-mail: morsewc@auburn.edu

    2013-09-15

    The National Environmental Policy Act (NEPA) requires U.S. Forest Service planning processes to be conducted by interdisciplinary teams of resource specialists to analyze and disclose the likely environmental impacts of proposed natural resource management actions on Forest Service lands. Multiple challenges associated with these processes have been a source of frustration for the agency. One of these challenges involves administrative appeals through which public entities can challenge a Forest Service decision following a NEPA process. These appeals instigate an internal review process and can result in an affirmation of the Forest Service decision, a reversal of that decision, or additionalmore » work that re-initiates all or part of the NEPA process. We examine the best predictors of appeals and their outcomes on a representative sample of 489 Forest Service NEPA processes that were decided between 2007 and 2009. While certain factors associated with pre-existing social contexts (such as a history of controversy) or pre-determined elements of a proposed action (such as the extraction of forest products) predispose certain processes to a higher risk of appeals, other practices and process-related strategies within the control of the agency also appear to bear meaningful influence on the occurrence of appeals and their outcomes. Appeals and their outcomes were most strongly related to programmatic, structural (turnover of personnel in particular), and relationship risks (both internal and external) within the processes, suggesting the need for greater focus within the agency on cultivating positive internal and external relationships to manage the risk of appeals. -- Highlights: ► We examined appeals and their outcomes on 489 U.S. Forest Service NEPA processes. ► Project type, context, team turnover, and personal relationships predicted appeals. ► External relationship management and staff turnover best predicted appeal outcomes. ► Positive internal and external relationships appear to reduce appeal risks.« less

  5. DOD Acquisition Information Management

    DTIC Science & Technology

    1994-09-30

    instead of on a real- time management information flow. The process of identifying risks and implementing corrective actions is lengthened by using the current system; performance measurement and reporting are impeded.

  6. MONITORED NATURAL ATTENUATION OF MTBE AS A RISK MANAGEMENT OPTION AT LEAKING UNDERGROUND STORAGE TANK SITES

    EPA Science Inventory

    This report reviews the current state of knowledge on the transport and fate of MTBE in ground water, with emphasis on the natural processes that can be used to manage the risk associated with MTBE in ground water or that contributes to natural attenuation of MTBE as a remedy. I...

  7. FMEA: a model for reducing medical errors.

    PubMed

    Chiozza, Maria Laura; Ponzetti, Clemente

    2009-06-01

    Patient safety is a management issue, in view of the fact that clinical risk management has become an important part of hospital management. Failure Mode and Effect Analysis (FMEA) is a proactive technique for error detection and reduction, firstly introduced within the aerospace industry in the 1960s. Early applications in the health care industry dating back to the 1990s included critical systems in the development and manufacture of drugs and in the prevention of medication errors in hospitals. In 2008, the Technical Committee of the International Organization for Standardization (ISO), licensed a technical specification for medical laboratories suggesting FMEA as a method for prospective risk analysis of high-risk processes. Here we describe the main steps of the FMEA process and review data available on the application of this technique to laboratory medicine. A significant reduction of the risk priority number (RPN) was obtained when applying FMEA to blood cross-matching, to clinical chemistry analytes, as well as to point-of-care testing (POCT).

  8. Review of various approaches for assessing public health risks in regulatory decision making: choosing the right approach for the problem.

    PubMed

    Dearfield, Kerry L; Hoelzer, Karin; Kause, Janell R

    2014-08-01

    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.

  9. An agent based architecture for high-risk neonate management at neonatal intensive care unit.

    PubMed

    Malak, Jaleh Shoshtarian; Safdari, Reza; Zeraati, Hojjat; Nayeri, Fatemeh Sadat; Mohammadzadeh, Niloofar; Farajollah, Seide Sedighe Seied

    2018-01-01

    In recent years, the use of new tools and technologies has decreased the neonatal mortality rate. Despite the positive effect of using these technologies, the decisions are complex and uncertain in critical conditions when the neonate is preterm or has a low birth weight or malformations. There is a need to automate the high-risk neonate management process by creating real-time and more precise decision support tools. To create a collaborative and real-time environment to manage neonates with critical conditions at the NICU (Neonatal Intensive Care Unit) and to overcome high-risk neonate management weaknesses by applying a multi agent based analysis and design methodology as a new solution for NICU management. This study was a basic research for medical informatics method development that was carried out in 2017. The requirement analysis was done by reviewing articles on NICU Decision Support Systems. PubMed, Science Direct, and IEEE databases were searched. Only English articles published after 1990 were included; also, a needs assessment was done by reviewing the extracted features and current processes at the NICU environment where the research was conducted. We analyzed the requirements and identified the main system roles (agents) and interactions by a comparative study of existing NICU decision support systems. The Universal Multi Agent Platform (UMAP) was applied to implement a prototype of our multi agent based high-risk neonate management architecture. Local environment agents interacted inside a container and each container interacted with external resources, including other NICU systems and consultation centers. In the NICU container, the main identified agents were reception, monitoring, NICU registry, and outcome prediction, which interacted with human agents including nurses and physicians. Managing patients at the NICU units requires online data collection, real-time collaboration, and management of many components. Multi agent systems are applied as a well-known solution for management, coordination, modeling, and control of NICU processes. We are currently working on an outcome prediction module using artificial intelligence techniques for neonatal mortality risk prediction. The full implementation of the proposed architecture and evaluation is considered the future work.

  10. Risk aversion and risk seeking in multicriteria forest management: a Markov decision process approach

    Treesearch

    Joseph Buongiorno; Mo Zhou; Craig Johnston

    2017-01-01

    Markov decision process models were extended to reflect some consequences of the risk attitude of forestry decision makers. One approach consisted of maximizing the expected value of a criterion subject to an upper bound on the variance or, symmetrically, minimizing the variance subject to a lower bound on the expected value.  The other method used the certainty...

  11. [Clinical and managerial autonomy. Perception of the coordinators of the health centers in Mallorca, Spain].

    PubMed

    Tamborero Cao, Gaspar; Gómez Nadal, Amalia; García Pineda, Atanasio; Miguélez Chamorro, Angélica; Canet Martorell, Rosa; Esteva Cantó, Magdalena

    2011-12-01

    The self-management has been linked with increased efficiency and job satisfaction. Before any changes aimed at a more autonomous management is important to know the position of professionals and managers. objective: To assess the importance attached by the coordinators of the health centers (HC) to the clinical and managerial autonomy, knowing their decision making capacity and their expectations about the feasibility of implementing a project of self-management. cross-sectional study, application questionnaire. Primary Care, 2009. All the coordinators of the HC of Mallorca (N = 47). 27 questions that explore the coordinator's opinion about the importance of the components of the self-management, its ability to present intervention, the propensity / aversion to risk, leadership, and the feasibility of a self-management. response rate: 42/47 (89,4%). 42 (100%) attaches the highest importance to the management of human resources, 41 (97,6%) to demand management and 40 (95,2%) to the management of waiting lists. 15 (35,7%) would take a financial risk, 14 (33,3%) were considered trained and 18 (42,9%) were willing to lead a process of self-management. 14 (33,3%) thought that the professionals in your team would not be interested in a process of self-management and 29 (69%) believed that others could develop HC of Mallorca. The respondents were coordinators have a limited ability to decide on the components of the self-management, being risk averse and make a little leadership ability and willingness to self-management projects.

  12. Social capacity building towards flood risk resilience in England: The impact of shifts in risk governance

    NASA Astrophysics Data System (ADS)

    Begg, C.; Walker, G.

    2012-04-01

    CapHaz-Net - capacity building for natural hazards in Europe: towards more resilient societies - sees efforts to reduce vulnerability to natural hazards as a social endeavor. One of the findings from this project is the importance of as well as the advantages and pitfalls of participation within the natural hazard management process. Although participation is seen to be important it is still only a small part of the overall management process. However, as European societies see shifts in risk governance from the state to the local level, how are these participation processes likely to change? This paper takes these findings and looks at England as a case study. This case study focuses on the Big Society which promises to be the change that will remedy what Prime Minister David Cameron sees as a broken society. The idea has been put into practice through the Localism Act. The Act seeks not to totally repeal state control but to make decision-making processes more democratic. This includes less bureaucracy for local government to deal with and more space for innovation when dealing with local issues and support for volunteers, mutuals, co-ops, charities and social enterprises to get involved in decision-making and provision of services. But how is this shift going to be everything that it promises to be? And, what does this shift mean for flood risk management? Moreover, how are local people engaged to become involved in shaping the decisions that affect them? By conducting interviews with key stakeholders, this research aims at gaining an understanding of forms of participation that exist in the British context and the public reaction to such opportunities. In turn, this research aims to understand the boundaries of localism in regards to the delivery of flood risk management.

  13. Risk management for the Space Exploration Initiative

    NASA Technical Reports Server (NTRS)

    Buchbinder, Ben

    1993-01-01

    Probabilistic Risk Assessment (PRA) is a quantitative engineering process that provides the analytic structure and decision-making framework for total programmatic risk management. Ideally, it is initiated in the conceptual design phase and used throughout the program life cycle. Although PRA was developed for assessment of safety, reliability, and availability risk, it has far greater application. Throughout the design phase, PRA can guide trade-off studies among system performance, safety, reliability, cost, and schedule. These studies are based on the assessment of the risk of meeting each parameter goal, with full consideration of the uncertainties. Quantitative trade-off studies are essential, but without full identification, propagation, and display of uncertainties, poor decisions may result. PRA also can focus attention on risk drivers in situations where risk is too high. For example, if safety risk is unacceptable, the PRA prioritizes the risk contributors to guide the use of resources for risk mitigation. PRA is used in the Space Exploration Initiative (SEI) Program. To meet the stringent requirements of the SEI mission, within strict budgetary constraints, the PRA structure supports informed and traceable decision-making. This paper briefly describes the SEI PRA process.

  14. Managing multihazards risk in metropolitan USA

    NASA Astrophysics Data System (ADS)

    Aktan, A. Emin; Comfort, Louise K.; Shanis, Donald S.

    2003-07-01

    This proposal outlines an action plan for risk management in the Delaware Valley Metropolitan Region. This plan is consistent with the goals for strengthening homeland security announced by President Bush, and is designed to complement efforts currently under development by Pennsylvania Emergency Management Agency and Department of Health. This plan proposes the formation of a Delaware Valley Risk Management Consortium, representing the critical disciplines and organizations related to risk assessment and management. This group would have membership from academic institutions, government agencies, industry, and nonprofit organizations. This Consortium would develop a systemic scope of work with the appropriate recommendations for technology acquisition, development and integration with risk management policies and procedures. This scope of work would include the development of two related information systems for the Delaware Valley Region. The first would be a comprehensive 'health monitoring' system to assess the continuity of operations, which would use integrated remote sensing and imaging, information gathering, communication, computation, and, information processing and management over wide-area networks covering the entire metropolitan area. The second would use real-time information from the health monitoring system to support interactive communication, search and information exchange needed to coordinate action among the relevant agencies to mitigate risk, respond to hazards and manage its resources efficiently and effectively.

  15. AN OPTIMAL MAINTENANCE MANAGEMENT MODEL FOR AIRPORT CONCRETE PAVEMENT

    NASA Astrophysics Data System (ADS)

    Shimomura, Taizo; Fujimori, Yuji; Kaito, Kiyoyuki; Obama, Kengo; Kobayashi, Kiyoshi

    In this paper, an optimal management model is formulated for the performance-based rehabilitation/maintenance contract for airport concrete pavement, whereby two types of life cycle cost risks, i.e., ground consolidation risk and concrete depreciation risk, are explicitly considered. The non-homogenous Markov chain model is formulated to represent the deterioration processes of concrete pavement which are conditional upon the ground consolidation processes. The optimal non-homogenous Markov decision model with multiple types of risk is presented to design the optimal rehabilitation/maintenance plans. And the methodology to revise the optimal rehabilitation/maintenance plans based upon the monitoring data by the Bayesian up-to-dating rules. The validity of the methodology presented in this paper is examined based upon the case studies carried out for the H airport.

  16. Governance of environmental risk: new approaches to managing stakeholder involvement.

    PubMed

    Benn, Suzanne; Dunphy, Dexter; Martin, Andrew

    2009-04-01

    Disputes concerning industrial legacies such as the disposal of toxic wastes illustrate changing pressures on corporations and governments. Business and governments are now confronted with managing the expectations of a society increasingly aware of the social and environmental impacts and risks associated with economic development and demanding more equitable distribution and democratic management of such risks. The closed managerialist decision-making of the powerful bureaucracies and corporations of the industrial era is informed by traditional management theory which cannot provide a framework for the adequate governance of these risks. Recent socio-political theories have conceptualised some key themes that must be addressed in a more fitting approach to governance. We identify more recent management and governance theory which addresses these themes and develop a process-based approach to governance of environmental disputes that allows for the evolving nature of stakeholder relations in a highly complex multiple stakeholder arena.

  17. [Management, quality of health and occupational safety and hospital organization: is integration possible?].

    PubMed

    Corrao, Carmela Romana Natalina

    2011-01-01

    The evolution of the national and European legislation has progressively transformed the working environments into organized environments. Specific models for its management are being proposed, which should be integrated into general management strategies. In the case of hospitals this integration should consider the peculiar organizational complexity, where the management of the occupational risk needs to be integrated with clinical risk management and economic risk management. Resources management should also consider that Occupational Medicine has not a direct monetary benefit for the organisation, but only indirect health consequences in terms of reduction of accidents and occupational diseases. The deep and simultaneous analysis of the current general management systems and the current management methods of occupational safety and health protection allows one to hyphotesise a possible integration between them. For both of them the Top Management is the main responsible of the quality management strategies and the use of specific documents in the managerial process, such as the document of risks evaluation in the occupational management and the quality manual in the general management, is of paramount importance. An integrated management has also the scope to pursue a particular kind of quality management, where ethics and job satisfaction are innovative, as established by recent European guidelines, management systems and national legislations.

  18. Rheumatologist and Primary Care Management of Cardiovascular Disease Risk in Rheumatoid Arthritis: Patient and Provider Perspectives.

    PubMed

    Bartels, Christie M; Roberts, Tonya J; Hansen, Karen E; Jacobs, Elizabeth A; Gilmore, Andrea; Maxcy, Courtney; Bowers, Barbara J

    2016-04-01

    Despite increased cardiovascular disease (CVD) risk, rheumatoid arthritis (RA) patients often lack CVD preventive care. We examined CVD preventive care processes from RA patient and provider perspectives to develop a process map for identifying targets for future interventions to improve CVD preventive care. Thirty-one participants (15 patients, 7 rheumatologists, and 9 primary care physicians [PCPs]) participated in interviews that were coded using NVivo software and analyzed using grounded theory techniques. Patients and providers reported that receipt of preventive care depends upon identifying and acting on risk factors, although most noted that both processes rarely occurred. Engagement in these processes was influenced by various provider-, system-, visit-, and patient-related conditions, such as patient activation or patients' knowledge about their risk. While nearly half of patients and PCPs were unaware of RA-CVD risk, all rheumatologists were aware of risk. Rheumatologists reported not systematically identifying risk factors, or, if identified, they described communicating about CVD risk factors via clinic notes to PCPs instead of acting directly due to perceived role boundaries. PCPs suggested that scheduling PCP visits could improve CVD risk management, and all participants viewed comanagement positively. Findings from this study illustrate important gaps and opportunities to support identifying and acting on CVD risk factors in RA patients from the provider, system, visit, and patient levels. Future work should investigate professional role support through improved guidelines, patient activation, and system-based RA-CVD preventive care strategies. © 2016, American College of Rheumatology.

  19. A Holistic Approach for Risk Management During Design

    NASA Technical Reports Server (NTRS)

    Meshkat, Leila

    2006-01-01

    In this paper, an approach for the identification, assessment, mitigation and continuous management of risks during the process of designing a space mission is presented. This approach has been developed by observing the risk patterns that occur at the Project Design Center of the Jet Propulsion Laboratory (TeamX) which develops conceptual, concurrent design of Space Missions. TeamX develops an end-to-end conceptual design of a Space Mission in a matter of one or two weeks. As the risk chair in TeamX, the author has had the opportunity to observe the risk patterns that occur during design over the course of many design sessions. This paper introduces an abstraction and generalization of those patterns. Risk is defined as anything that can go wrong, along with its approximate likelihood and consequence. The indicators, and causes, and effects of these risks are cross cutting across the multiple levels of people and processes involved in the design, and the actual design product itself.

  20. GeoProMT: A Collaborative Platform Supporting Natural Hazards Project Management From Assessment to Resilience

    NASA Astrophysics Data System (ADS)

    Renschler, C.; Sheridan, M. F.; Patra, A. K.

    2008-05-01

    The impact and consequences of extreme geophysical events (hurricanes, floods, wildfires, volcanic flows, mudflows, etc.) on properties and processes should be continuously assessed by a well-coordinated interdisciplinary research and outreach approach addressing risk assessment and resilience. Communication between various involved disciplines and stakeholders is the key to a successful implementation of an integrated risk management plan. These issues become apparent at the level of decision support tools for extreme events/disaster management in natural and managed environments. The Geospatial Project Management Tool (GeoProMT) is a collaborative platform for research and training to document and communicate the fundamental steps in transforming information for extreme events at various scales for analysis and management. GeoProMT is an internet-based interface for the management of shared geo-spatial and multi-temporal information such as measurements, remotely sensed images, and other GIS data. This tool enhances collaborative research activities and the ability to assimilate data from diverse sources by integrating information management. This facilitates a better understanding of natural processes and enhances the integrated assessment of resilience against both the slow and fast onset of hazard risks. Fundamental to understanding and communicating complex natural processes are: (a) representation of spatiotemporal variability, extremes, and uncertainty of environmental properties and processes in the digital domain, (b) transformation of their spatiotemporal representation across scales (e.g. interpolation, aggregation, disaggregation.) during data processing and modeling in the digital domain, and designing and developing tools for (c) geo-spatial data management, and (d) geo-spatial process modeling and effective implementation, and (e) supporting decision- and policy-making in natural resources and hazard management at various spatial and temporal scales of interest. GeoProMT is useful for researchers, practitioners, and decision-makers, because it provides an integrated environmental system assessment and data management approach that considers the spatial and temporal scales and variability in natural processes. Particularly in the occurrence or onset of extreme events it can utilize the latest data sources that are available at variable scales, combine them with existing information, and update assessment products such as risk and vulnerability assessment maps. Because integrated geo-spatial assessment requires careful consideration of all the steps in utilizing data, modeling and decision-making formats, each step in the sequence must be assessed in terms of how information is being scaled. At the process scale various geophysical models (e.g. TITAN, LAHARZ, or many other examples) are appropriate for incorporation in the tool. Some examples that illustrate our approach include: 1) coastal parishes impacted by Hurricane Rita (Southwestern Louisiana), 2) a watershed affected by extreme rainfall induced debris-flows (Madison County, Virginia; Panabaj, Guatemala; Casita, Nicaragua), and 3) the potential for pyroclastic flows to threaten a city (Tungurahua, Ecuador). This research was supported by the National Science Foundation.

  1. [The digital information platform after-sale service of medical equipment].

    PubMed

    Cao, Shaoping; Li, Bin

    2015-01-01

    This paper describes the after-sale service of medical equipment information management platform, with large data sharing resources to further enhance customer service in the whole management process of medical service, to strengthen quality management, to control medical risk.

  2. Clinician time used for decision making: a best case workflow study using cardiovascular risk assessments and Ask Mayo Expert algorithmic care process models.

    PubMed

    North, Frederick; Fox, Samuel; Chaudhry, Rajeev

    2016-07-20

    Risk calculation is increasingly used in lipid management, congestive heart failure, and atrial fibrillation. The risk scores are then used for decisions about statin use, anticoagulation, and implantable defibrillator use. Calculating risks for patients and making decisions based on these risks is often done at the point of care and is an additional time burden for clinicians that can be decreased by automating the tasks and using clinical decision-making support. Using Morae Recorder software, we timed 30 healthcare providers tasked with calculating the overall risk of cardiovascular events, sudden death in heart failure, and thrombotic event risk in atrial fibrillation. Risk calculators used were the American College of Cardiology Atherosclerotic Cardiovascular Disease risk calculator (AHA-ASCVD risk), Seattle Heart Failure Model (SHFM risk), and CHA2DS2VASc. We also timed the 30 providers using Ask Mayo Expert care process models for lipid management, heart failure management, and atrial fibrillation management based on the calculated risk scores. We used the Mayo Clinic primary care panel to estimate time for calculating an entire panel risk. Mean provider times to complete the CHA2DS2VASc, AHA-ASCVD risk, and SHFM were 36, 45, and 171 s respectively. For decision making about atrial fibrillation, lipids, and heart failure, the mean times (including risk calculations) were 85, 110, and 347 s respectively. Even under best case circumstances, providers take a significant amount of time to complete risk assessments. For a complete panel of patients this can lead to hours of time required to make decisions about prescribing statins, use of anticoagulation, and medications for heart failure. Informatics solutions are needed to capture data in the medical record and serve up automatically calculated risk assessments to physicians and other providers at the point of care.

  3. Investigations regarding the evaluation of specific intellectual property production risks within Quality Management System

    NASA Astrophysics Data System (ADS)

    Pakocs, R.; Lupulescu, N. B.

    2016-11-01

    This paper is a theoretical research concerning methods for risk assessment of specific intellectual property production risks that are identified in the product achievement stage within the Quality Management System. In order to realize this, we will start by identifying the specific intellectual property production risks and by proposing some new calculating formulas for minimalizing their negative effects. The theoretical model proposed assessment of specific intellectual property production risks, will be realized based on 3 hypothetical situations. This study intends to reduce the intellectual property risks identified in the production process of commercial societies that have an industrial profile.

  4. Using Geographical Information Systems (GIS) as an instrument of water resource management: a case study from a GIS-based Water Safety Plan in Germany.

    PubMed

    Wienand, I; Nolting, U; Kistemann, T

    2009-01-01

    Following international developments and the new WHO Drinking Water Guidelines (WHO 2004) a process-orientated concept for risk, monitoring and incident management has been developed and implemented in this study. The concept will be reviewed with special consideration for resource protection (first barrier of the multi-barrier system) and in turn, for the Water Safety Plan (WSP) which adequately considers-beyond the current framework of legal requirements-possible new hygienic-microbiologically relevant risks (especially emerging pathogens) for the drinking water supply. The development of a WSP within the framework of risk, monitoring and incident management includes the application of Geographical Information Systems (GIS). In the present study, GIS was used for visualization and spatial analysis in decisive steps in the WSP. The detailed process of GIS-supported implementation included the identification of local participants and their tasks and interactions as an essential part of risk management. A detailed ecological investigation of drinking water conditions in the catchment area was conducted in addition to hazard identification, risk assessment and the monitoring of control measures. The main task of our study was to find out in which steps of the WSP the implementation of GIS could be integrated as a useful, and perhaps even an essential tool.

  5. Methodology for Designing Operational Banking Risks Monitoring System

    NASA Astrophysics Data System (ADS)

    Kostjunina, T. N.

    2018-05-01

    The research looks at principles of designing an information system for monitoring operational banking risks. A proposed design methodology enables one to automate processes of collecting data on information security incidents in the banking network, serving as the basis for an integrated approach to the creation of an operational risk management system. The system can operate remotely ensuring tracking and forecasting of various operational events in the bank network. A structure of a content management system is described.

  6. On the Risk Management and Auditing of SOA Based Business Processes

    NASA Astrophysics Data System (ADS)

    Orriens, Bart; Heuvel, Willem-Jan V./D.; Papazoglou, Mike

    SOA-enabled business processes stretch across many cooperating and coordinated systems, possibly crossing organizational boundaries, and technologies like XML and Web services are used for making system-to-system interactions commonplace. Business processes form the foundation for all organizations, and as such, are impacted by industry regulations. This requires organizations to review their business processes and ensure that they meet the compliance standards set forth in legislation. In this paper we sketch a SOA-based service risk management and auditing methodology including a compliance enforcement and verification system that assures verifiable business process compliance. This is done on the basis of a knowledge-based system that allows integration of internal control systems into business processes conform pre-defined compliance rules, monitor both the normal process behavior and those of the control systems during process execution, and log these behaviors to facilitate retrospective auditing.

  7. YOUNG ADULT DATING RELATIONSHIPS AND THE MANAGEMENT OF SEXUAL RISK

    PubMed Central

    Manning, Wendy D.; Giordano, Peggy C.; Longmore, Monica A.; Flanigan, Christine M.

    2012-01-01

    Young adult involvement in sexual behavior typically occurs within a relationship context, but we know little about the ways in which specific features of romantic relationships influence sexual decision-making. Prior work on sexual risk taking focuses attention on health issues rather than relationship dynamics. We draw on data from the Toledo Adolescent Relationships Study (TARS) (n = 475) to examine the association between qualities and dynamics of current/most recent romantic relationships such as communication and emotional processes, conflict, demographic asymmetries, and duration and the management of sexual risk. We conceptualize ‘risk management’ as encompassing multiple domains, including (1) questioning the partner about previous sexual behaviors/risks, (2) using condoms consistently, and (3) maintaining sexual exclusivity within the relationship. We identify distinct patterns of risk management among dating young adults and find that specific qualities and dynamics of these relationships are linked to variations in risk management. Results from this paper suggest the need to consider relational dynamics in efforts to target and influence young adult sexual risk-taking and reduce STIs, including HIV. PMID:23805015

  8. Confluence and Contours: Reflexive Management of Environmental Risk.

    PubMed

    Soane, Emma; Schubert, Iljana; Pollard, Simon; Rocks, Sophie; Black, Edgar

    2016-06-01

    Government institutions have responsibilities to distribute risk management funds meaningfully and to be accountable for their choices. We took a macro-level sociological approach to understanding the role of government in managing environmental risks, and insights from micro-level psychology to examine individual-level risk-related perceptions and beliefs. Survey data from 2,068 U.K. citizens showed that lay people's funding preferences were associated positively with beliefs about responsibility and trust, yet associations with perception varied depending on risk type. Moreover, there were risk-specific differences in the funding preferences of the lay sample and 29 policymakers. A laboratory-based study of 109 participants examined funding allocation in more detail through iterative presentation of expert information. Quantitative and qualitative data revealed a meso-level framework comprising three types of decisionmakers who varied in their willingness to change funding allocation preferences following expert information: adaptors, responders, and resistors. This research highlights the relevance of integrated theoretical approaches to understanding the policy process, and the benefits of reflexive dialogue to managing environmental risks. © 2015 Society for Risk Analysis.

  9. Embedding quality improvement and patient safety at Liverpool Women's NHS Foundation Trust.

    PubMed

    Scholefield, Helen

    2007-08-01

    The provision of safe high-quality care in obstetrics and gynaecology is a key target in the UK National Health Service (NHS), in part because of the high cost of litigation in this area. Good risk management processes should improve safety and reduce the cost of litigation to the NHS. This chapter looks at structures and processes for improving quality and patient safety, using the stepwise approach described by the National Patient Safety Authority (NPSA). This encompasses building a safety culture, leading and supporting staff, integrating risk management activity, promoting reporting, involving and communicating with patients and the public, learning and sharing safety lessons, and implementing solutions to prevent harm. Examples from the Liverpool Women's NHS Foundation Trust are used to illustrate these steps, including how they were developed, what obstacles had to be overcome, ongoing challenges, and whether good risk management has translated into better, safer health care.

  10. [Quality assurance of hospital medical records as a risk management tool].

    PubMed

    Terranova, Giuseppina; Cortesi, Elisabetta; Briani, Silvia; Giannini, Raffaella

    2006-01-01

    A retrospective analysis of hospital medical records was performed jointly by the Medicolegal department of the Pistoia Local Health Unit N. 3 and by the management of the SS. Cosma and Damiano di Pescia Hospital. Evaluation was based on ANDEM criteria, JCAHO standards, and the 1992 discharge abstract guidelines of the Italian Health Ministry. In the first phase of the study, data were collected and processed for each hospital ward and then discussed with clinicians and audited. After auditing, appropriate actions were agreed upon for correcting identified problems. Approximately one year later a second smaller sample of medical records was evaluated and a higher compliance rate with the established corrective actions was found in all wards for all data categories. In this study the evaluation of medical records can be considered in the wider context of risk management, a multidisciplinary process directed towards identifying and monitoring risk through the use of appropriate quality indicators.

  11. 2015/2016 Quality Risk Management Benchmarking Survey.

    PubMed

    Waldron, Kelly; Ramnarine, Emma; Hartman, Jeffrey

    2017-01-01

    This paper investigates the concept of quality risk management (QRM) maturity as it applies to the pharmaceutical and biopharmaceutical industries, using the results and analysis from a QRM benchmarking survey conducted in 2015 and 2016. QRM maturity can be defined as the effectiveness and efficiency of a quality risk management program, moving beyond "check-the-box" compliance with guidelines such as ICH Q9 Quality Risk Management , to explore the value QRM brings to business and quality operations. While significant progress has been made towards full adoption of QRM principles and practices across industry, the full benefits of QRM have not yet been fully realized. The results of the QRM Benchmarking Survey indicate that the pharmaceutical and biopharmaceutical industries are approximately halfway along the journey towards full QRM maturity. LAY ABSTRACT: The management of risks associated with medicinal product quality and patient safety are an important focus for the pharmaceutical and biopharmaceutical industries. These risks are identified, analyzed, and controlled through a defined process called quality risk management (QRM), which seeks to protect the patient from potential quality-related risks. This paper summarizes the outcomes of a comprehensive survey of industry practitioners performed in 2015 and 2016 that aimed to benchmark the level of maturity with regard to the application of QRM. The survey results and subsequent analysis revealed that the pharmaceutical and biopharmaceutical industries have made significant progress in the management of quality risks over the last ten years, and they are roughly halfway towards reaching full maturity of QRM. © PDA, Inc. 2017.

  12. Sustainable improvement of animal health care by systematic quality risk management according to the HACCP concept.

    PubMed

    Noordhuizen, J P; Welpelo, H J

    1996-12-01

    This paper addresses the principles of the Hazard Analysis Critical Control Point (HACCP) concept as applied to animal health management strategy. Characteristics of the concept were analysed and compared with those of current animal health care strategies for disease risk identification and herd health management, insurance, and certification. HACCP is a hybrid strategy of quality control at both production process and product level. Animal health is considered a particular quality feature. We show that process control (expressed in terms of controlling both general and specific disease risk factors) and product control (expressed in terms of testing animals or animal products for specific disease agents) could form the basis for improving animal health. We conclude that HACCP provides ample opportunity for preventive health action and risk management at a relatively low cost in terms of labour, finance and documentation expenditure, at both the farm and sector level. Epidemiological field studies are currently needed to identify critical control points and to design HACCP procedures for livestock producers. In the long run, HACCP based animal health care can be further developed into a quality control systems approach to cover all aspects that are related, either directly or indirectly, to animal health.

  13. A Method for Dynamic Risk Assessment and Management of Rockbursts in Drill and Blast Tunnels

    NASA Astrophysics Data System (ADS)

    Liu, Guo-Feng; Feng, Xia-Ting; Feng, Guang-Liang; Chen, Bing-Rui; Chen, Dong-Fang; Duan, Shu-Qian

    2016-08-01

    Focusing on the problems caused by rockburst hazards in deep tunnels, such as casualties, damage to construction equipment and facilities, construction schedule delays, and project cost increase, this research attempts to present a methodology for dynamic risk assessment and management of rockbursts in D&B tunnels. The basic idea of dynamic risk assessment and management of rockbursts is determined, and methods associated with each step in the rockburst risk assessment and management process are given, respectively. Among them, the main parts include a microseismic method for early warning the occurrence probability of rockburst risk, an estimation method that aims to assess potential consequences of rockburst risk, an evaluation method that utilizes a new quantitative index considering both occurrence probability and consequences for determining the level of rockburst risk, and the dynamic updating. Specifically, this research briefly describes the referenced microseismic method of warning rockburst, but focuses on the analysis of consequences and associated risk assessment and management of rockburst. Using the proposed method of risk assessment and management of rockburst, the occurrence probability, potential consequences, and the level of rockburst risk can be obtained in real-time during tunnel excavation, which contributes to the dynamic optimisation of risk mitigation measures and their application. The applicability of the proposed method has been verified by those cases from the Jinping II deep headrace and water drainage tunnels at depths of 1900-2525 m (with a length of 11.6 km in total for D&B tunnels).

  14. Business Management Concept Areas for Two-Year Postsecondary Institutions

    ERIC Educational Resources Information Center

    Gentry, Lee; Gentry, Eileen

    1978-01-01

    A core of educational concepts in business ownership and management for two-year postsecondary institutions is outlined: economic systems, economic decisionmaking, organizational structure, management principles, marketing factors, accounting, legal obligations, financial structure, risk-taking and insurance, taxes, data processing, and social…

  15. WORKSHOP ON MERCURY IN PRODUCTS, PROCESSES, WASTE AND THE ENVIRONMENT: ELIMINATING, REDUCING AND MANAGING RISKS FROM NON-COMBUSTION SOURCES (PROGRAM FLYER)

    EPA Science Inventory

    The Workshop is designed to achieve three goals:
    1. Convey public and private sector perspectives on the management of mercury in products, processes, and wastes;
    2. Present ongoing efforts that address mercury prevention, elimination, noncombustion treatment and disposal; ...

  16. Knowledge management system for risk mitigation in supply chain uncertainty: case from automotive battery supply chain

    NASA Astrophysics Data System (ADS)

    Marie, I. A.; Sugiarto, D.; Surjasa, D.; Witonohadi, A.

    2018-01-01

    Automotive battery supply chain include battery manufacturer, sulphuric acid suppliers, polypropylene suppliers, lead suppliers, transportation service providers, warehouses, retailers and even customers. Due to the increasingly dynamic condition of the environment, supply chain actors were required to improve their ability to overcome various uncertainty issues in the environment. This paper aims to describe the process of designing a knowledge management system for risk mitigation in supply chain uncertainty. The design methodology began with the identification of the knowledge needed to solve the problems associated with uncertainty and analysis of system requirements. The design of the knowledge management system was described in the form of a data flow diagram. The results of the study indicated that key knowledge area that needs to be managed were the knowledge to maintain the stability of process in sulphuric acid process and knowledge to overcome the wastes in battery manufacturing process. The system was expected to be a media acquisition, dissemination and storage of knowledge associated with the uncertainty in the battery supply chain and increase the supply chain performance.

  17. Tsunami Risk Management in Pacific Island Countries and Territories (PICTs): Some Issues, Challenges and Ways Forward

    NASA Astrophysics Data System (ADS)

    Dominey-Howes, Dale; Goff, James

    2013-09-01

    The Pacific is well known for producing tsunamis, and events such as the 2011 Tōhoku-oki, Japan disaster demonstrate the vulnerability of coastal communities. We review what is known about the current state of tsunami risk management for Pacific Island countries and territories (PICTs), identify the issues and challenges associated with affecting meaningful tsunami disaster risk reduction (DRR) efforts and outline strategies and possible ways forward. Small island states are scattered across the vast Pacific region and these states have to varying degrees been affected by not only large tsunamis originating in circum-Pacific subduction zones, but also more regionally devastating events. Having outlined and described what is meant by the risk management process, the various problems associated with our current understanding of this process are examined. The poorly understood hazard related to local, regional and distant sources is investigated and the dominant focus on seismic events at the expense of other tsunami source types is noted. We reflect on the challenges of undertaking numerical modelling from generation to inundation and specifically detail the problems as they relate to PICTs. This is followed by an exploration of the challenges associated with mapping exposure and estimating vulnerability in low-lying coastal areas. The latter part of the paper is devoted to exploring what mitigation of the tsunami risk can look like and draw upon good practice cases as exemplars of the actions that can be taken from the local to regional level. Importantly, given the diversity of PICTs, no one approach will suit all places. The paper closes by making a series of recommendations to assist PICTs and the wider tsunami research community in thinking through improvements to their tsunami risk management processes and the research that can underpin these efforts.

  18. Science-Driven Approach to Disaster Risk and Crisis Management

    NASA Astrophysics Data System (ADS)

    Ismail-Zadeh, A.

    2014-12-01

    Disasters due to natural extreme events continue to grow in number and intensity. Disaster risk and crisis management requires long-term planning, and to undertake that planning, a science-driven approach is needed to understand and assess disaster risks and to help in impact assessment and in recovery processes after a disaster. Science is used in assessments and rapid modeling of the disaster impact, in forecasting triggered hazards and risk (e.g., a tsunami or a landslide after a large earthquake), in contacts with and medical treatment of the affected population, and in some other actions. At the stage of response to disaster, science helps to analyze routinely the disaster happened (e.g., the physical processes led to this extreme event; hidden vulnerabilities; etc.) At the stage of recovery, natural scientists improve the existing regional hazard assessments; engineers try to use new science to produce new materials and technologies to make safer houses and infrastructure. At the stage of disaster risk mitigation new scientific methods and approaches are being developed to study natural extreme events; vulnerability of society is periodically investigated, and the measures for increasing the resilience of society to extremes are developed; existing disaster management regulations are improved. At the stage of preparedness, integrated research on disaster risks should be developed to understand the roots of potential disasters. Enhanced forecasting and early warning systems are to be developed reducing predictive uncertainties, and comprehensive disaster risk assessment is to be undertaken at local, regional, national and global levels. Science education should be improved by introducing trans-disciplinary approach to disaster risks. Science can help society by improving awareness about extreme events, enhancing risk communication with policy makers, media and society, and assisting disaster risk management authorities in organization of local and regional training and exercises.

  19. An Integrated Web-based Decision Support System in Disaster Risk Management

    NASA Astrophysics Data System (ADS)

    Aye, Z. C.; Jaboyedoff, M.; Derron, M. H.

    2012-04-01

    Nowadays, web based decision support systems (DSS) play an essential role in disaster risk management because of their supporting abilities which help the decision makers to improve their performances and make better decisions without needing to solve complex problems while reducing human resources and time. Since the decision making process is one of the main factors which highly influence the damages and losses of society, it is extremely important to make right decisions at right time by combining available risk information with advanced web technology of Geographic Information System (GIS) and Decision Support System (DSS). This paper presents an integrated web-based decision support system (DSS) of how to use risk information in risk management efficiently and effectively while highlighting the importance of a decision support system in the field of risk reduction. Beyond the conventional systems, it provides the users to define their own strategies starting from risk identification to the risk reduction, which leads to an integrated approach in risk management. In addition, it also considers the complexity of changing environment from different perspectives and sectors with diverse stakeholders' involvement in the development process. The aim of this platform is to contribute a part towards the natural hazards and geosciences society by developing an open-source web platform where the users can analyze risk profiles and make decisions by performing cost benefit analysis, Environmental Impact Assessment (EIA) and Strategic Environmental Assessment (SEA) with the support of others tools and resources provided. There are different access rights to the system depending on the user profiles and their responsibilities. The system is still under development and the current version provides maps viewing, basic GIS functionality, assessment of important infrastructures (e.g. bridge, hospital, etc.) affected by landslides and visualization of the impact-probability matrix in terms of socio-economic dimension.

  20. Model of areas for identifying risks influencing the compliance of technological processes and products

    NASA Astrophysics Data System (ADS)

    Misztal, A.; Belu, N.

    2016-08-01

    Operation of every company is associated with the risk of interfering with proper performance of its fundamental processes. This risk is associated with various internal areas of the company, as well as the environment in which it operates. From the point of view of ensuring compliance of the course of specific technological processes and, consequently, product conformity with requirements, it is important to identify these threats and eliminate or reduce the risk of their occurrence. The purpose of this article is to present a model of areas of identifying risk affecting the compliance of processes and products, which is based on multiregional targeted monitoring of typical places of interference and risk management methods. The model is based on the verification of risk analyses carried out in small and medium-sized manufacturing companies in various industries..

  1. Continuous Risk Management

    NASA Technical Reports Server (NTRS)

    Sabelhaus, Phil

    2002-01-01

    Risk identification is an ongoing activity that takes place during the routine project work flow. Project activities such as programmatic and technical meetings, telecons, reviews, and other forms of communication often bring to light project risks. When this occurs, we record and analyze the risk on a Risk Information Sheet. This process helps the project team identify and cope with project risks throughout the life of the project.

  2. A risk assessment approach for fresh fruits.

    PubMed

    Bassett, J; McClure, P

    2008-04-01

    To describe the approach used in conducting a fit-for-purpose risk assessment of microbiological human pathogens associated with fresh fruit and the risk management recommendations made. A qualitative risk assessment for microbiological hazards in fresh fruit was carried out based on the Codex Alimentarius (Codex) framework, modified to consider multiple hazards and all fresh (whole) fruits. The assessment determines 14 significant bacterial, viral, protozoal and nematodal hazards associated with fresh produce, assesses the probable level of exposure from fresh fruit, concludes on the risk from each hazard, and considers and recommends risk management actions. A review of potential risk management options allowed the comparison of effectiveness with the potential exposure to each hazard. Washing to a recommended protocol is an appropriate risk management action for the vast majority of consumption events, particularly when good agricultural and hygienic practices are followed and with the addition of refrigerated storage for low acid fruit. Additional safeguards are recommended for aggregate fruits with respect to the risk from protozoa. The potentially complex process of assessing the risks of multiple hazards in multiple but similar commodities can be simplified in a qualitative assessment approach that employs the Codex methodology.

  3. LOD BIM Element specification for Railway Turnout Systems Risk Mitigation using the Information Delivery Manual

    NASA Astrophysics Data System (ADS)

    Gigante-Barrera, Ángel; Dindar, Serdar; Kaewunruen, Sakdirat; Ruikar, Darshan

    2017-10-01

    Railway turnouts are complex systems designed using complex geometries and grades which makes them difficult to be managed in terms of risk prevention. This feature poses a substantial peril to rail users as it is considered a cause of derailment. In addition, derailment deals to financial losses due to operational downtimes and monetary compensations in case of death or injure. These are fundamental drivers to consider mitigating risks arising from poor risk management during design. Prevention through design (PtD) is a process that introduces tacit knowledge from industry professionals during the design process. There is evidence that Building Information Modelling (BIM) can help to mitigate risk since the inception of the project. BIM is considered an Information System (IS) were tacit knowledge can be stored and retrieved from a digital database making easy to take promptly decisions as information is ready to be analysed. BIM at the model element level entails working with 3D elements and embedded data, therefore adding a layer of complexity to the management of information along the different stages of the project and across different disciplines. In order to overcome this problem, the industry has created a framework for model progression specification named Level of Development (LOD). The paper presents an IDM based framework for design risk mitigation through code validation using the LOD. This effort resulted on risk datasets which describe graphically and non-graphically a rail turnout as the model progresses. Thus, permitting its inclusion within risk information systems. The assignment of an LOD construct to a set of data, requires specialised management and process related expertise. Furthermore, the selection of a set of LOD constructs requires a purpose based analysis. Therefore, a framework for LOD constructs implementation within the IDM for code checking is required for the industry to progress in this particular field.

  4. Sociocultural and ecological factors influencing management of edible and non-edible plants: the case of Ixcatlán, Mexico.

    PubMed

    Rangel-Landa, Selene; Casas, Alejandro; García-Frapolli, Eduardo; Lira, Rafael

    2017-10-30

    Identifying factors influencing plant management allows understanding how processes of domestication operate. Uncertain availability of resources is a main motivation for managing edible plants, but little is known about management motives of non-edible resources like medicinal and ceremonial plants. We hypothesized that uncertain availability of resources would be a general factor motivating their management, but other motives could operate simultaneously. Uncertainty and risk might be less important motives in medicinal than in edible plants, while for ceremonial plants, symbolic and spiritual values would be more relevant. We inventoried edible, medicinal, and ceremonial plants in Ixcatlán, Oaxaca, Mexico, and conducted in-depth studies with 20 native and naturalized species per use type; we documented their cultural importance and abundance by interviewing 25 households and sampling vegetation in 33 sites. Consumption amounts and preferences were studied through surveys and free listings with 38 interviewees. Management intensity and risk indexes were calculated through PCA and their relation analyzed through regression analyses. Canonical methods allowed identifying the main sociocultural and ecological factors influencing management of plants per use type. Nearly 64, 63, and 55% of all ceremonial, edible, and medicinal wild plants recorded, respectively, are managed in order to maintain or increase their availability, embellishing environments, and because of ethical reasons and curiosity. Management intensity was higher in edible plants under human selection and associated with risk. Management of ceremonial and medicinal plants was not associated with indexes of risk or uncertainty in their availability. Other sociocultural and ecological factors influence management intensity, the most important being reciprocal relations and abundance perception. Plant management through practices and collectively regulated strategies is strongly related to control of risk and uncertainty in edible plants, compared with medicinal and ceremonial plants, in which reciprocal interchanges, curiosity, and spiritual values are more important factors. Understanding how needs, worries, social relations, and ethical values influence management decisions is important to understand processes of constructing management strategies and how domestication could be started in the past and are operated at the present.

  5. Spatiotemporal Visualization of Tsunami Waves Using Kml on Google Earth

    NASA Astrophysics Data System (ADS)

    Mohammadi, H.; Delavar, M. R.; Sharifi, M. A.; Pirooz, M. D.

    2017-09-01

    Disaster risk is a function of hazard and vulnerability. Risk is defined as the expected losses, including lives, personal injuries, property damages, and economic disruptions, due to a particular hazard for a given area and time period. Risk assessment is one of the key elements of a natural disaster management strategy as it allows for better disaster mitigation and preparation. It provides input for informed decision making, and increases risk awareness among decision makers and other stakeholders. Virtual globes such as Google Earth can be used as a visualization tool. Proper spatiotemporal graphical representations of the concerned risk significantly reduces the amount of effort to visualize the impact of the risk and improves the efficiency of the decision-making process to mitigate the impact of the risk. The spatiotemporal visualization of tsunami waves for disaster management process is an attractive topic in geosciences to assist investigation of areas at tsunami risk. In this paper, a method for coupling virtual globes with tsunami wave arrival time models is presented. In this process we have shown 2D+Time of tsunami waves for propagation and inundation of tsunami waves, both coastal line deformation, and the flooded areas. In addition, the worst case scenario of tsunami on Chabahar port derived from tsunami modelling is also presented using KML on google earth.

  6. Achieving Effective Risk Management Reduction Throughout Decommissioning at the Columbus Closure Project

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Anderson, K.D.

    2006-07-01

    Nuclear facility decontamination, dismantlement, and demolition activities provide a myriad of challenges along the path to reaching a safe, effective, and compliant decommissioning. Among the challenges faced during decommissioning, is the constant management and technical effort to eliminate, mitigate, or minimize the potential of risks of radiation exposures and other hazards to the worker, the surrounding community, and the environment. Management strategies to eliminate, mitigate, or minimize risks include incorporating strong safety and As Low As Reasonably Achievable (ALARA) principles into an integrated work planning process. Technical and operational strategies may include utilizing predictive risk analysis tools to establish contaminationmore » limits for demolition and using remote handling equipment to reduce occupational and radiation exposures to workers. ECC and E2 Closure Services, LLC (Closure Services) have effectively utilized these management and technical tools to eliminate, mitigate, and reduce radiation exposures under contract to the U.S. Department of Energy (DOE) for the decontamination and decommissioning Columbus Closure Project (CCP). In particular, Closure Services achieved significant dose reduction during the dismantling, decontamination, and demolition activities for Building JN-1. Management strategies during the interior dismantlement, decontamination, and demolition of the facility demanded an integrated work planning processes that involved project disciplines. Integrated planning processes identified multiple opportunities to incorporate the use of remote handling equipment during the interior dismantling and demolition activities within areas of high radiation. Technical strategies employed predictive risk analysis tools to set upper bounding contamination limits, allowed for the radiological demolition of the building without exceeding administrative dose limits to the worker, general public, and the environment. Adhering to management and technical strategies during the dismantlement, decontamination, and demolition of Building JN-1 enabled Closure Services to achieve strong ALARA performance, maintain absolute compliance under the regulatory requirements and meeting licensing conditions for decommissioning. (authors)« less

  7. Security Risk Assessment Process for UAS in the NAS CNPC Architecture

    NASA Technical Reports Server (NTRS)

    Iannicca, Dennis C.; Young, Dennis P.; Thadani, Suresh K.; Winter, Gilbert A.

    2013-01-01

    This informational paper discusses the risk assessment process conducted to analyze Control and Non-Payload Communications (CNPC) architectures for integrating civil Unmanned Aircraft Systems (UAS) into the National Airspace System (NAS). The assessment employs the National Institute of Standards and Technology (NIST) Risk Management framework to identify threats, vulnerabilities, and risks to these architectures and recommends corresponding mitigating security controls. This process builds upon earlier work performed by RTCA Special Committee (SC) 203 and the Federal Aviation Administration (FAA) to roadmap the risk assessment methodology and to identify categories of information security risks that pose a significant impact to aeronautical communications systems. A description of the deviations from the typical process is described in regards to this aeronautical communications system. Due to the sensitive nature of the information, data resulting from the risk assessment pertaining to threats, vulnerabilities, and risks is beyond the scope of this paper.

  8. Security Risk Assessment Process for UAS in the NAS CNPC Architecture

    NASA Technical Reports Server (NTRS)

    Iannicca, Dennis Christopher; Young, Daniel Paul; Suresh, Thadhani; Winter, Gilbert A.

    2013-01-01

    This informational paper discusses the risk assessment process conducted to analyze Control and Non-Payload Communications (CNPC) architectures for integrating civil Unmanned Aircraft Systems (UAS) into the National Airspace System (NAS). The assessment employs the National Institute of Standards and Technology (NIST) Risk Management framework to identify threats, vulnerabilities, and risks to these architectures and recommends corresponding mitigating security controls. This process builds upon earlier work performed by RTCA Special Committee (SC) 203 and the Federal Aviation Administration (FAA) to roadmap the risk assessment methodology and to identify categories of information security risks that pose a significant impact to aeronautical communications systems. A description of the deviations from the typical process is described in regards to this aeronautical communications system. Due to the sensitive nature of the information, data resulting from the risk assessment pertaining to threats, vulnerabilities, and risks is beyond the scope of this paper

  9. Managing fear in public health campaigns: a theory-based formative evaluation process.

    PubMed

    Cho, Hyunyi; Witte, Kim

    2005-10-01

    The HIV/AIDS infection rate of Ethiopia is one of the world's highest. Prevention campaigns should systematically incorporate and respond to at-risk population's existing beliefs, emotions, and perceived barriers in the message design process to effectively promote behavior change. However, guidelines for conducting formative evaluation that are grounded in proven risk communication theory and empirical data analysis techniques are hard to find. This article provides a five-step formative evaluation process that translates theory and research for developing effective messages for behavior change. Guided by the extended parallel process model, the five-step process helps message designers manage public's fear surrounding issues such as HIV/AIDS. An entertainment education project that used the process to design HIV/AIDS prevention messages for Ethiopian urban youth is reported. Data were collected in five urban regions of Ethiopia and analyzed according to the process to develop key messages for a 26-week radio soap opera.

  10. Radioactive and mixed waste - risk as a basis for waste classification. Symposium proceedings No. 2

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    NONE

    The management of risks from radioactive and chemical materials has been a major environmental concern in the United states for the past two or three decades. Risk management of these materials encompasses the remediation of past disposal practices as well as development of appropriate strategies and controls for current and future operations. This symposium is concerned primarily with low-level radioactive wastes and mixed wastes. Individual reports were processed separately for the Department of Energy databases.

  11. Defense AT&L (Volume 36, Number 2, March-April 2007)

    DTIC Science & Technology

    2007-04-01

    87 28 The Pursuit of Courage, Judg- ment, and Luck Maj. Dan Ward, USAF Maj. Chris Quaid, USAF Conventional wisdom states that a closed risk is a good...example) that could be as much as 50 percent dirt. Many agencies were buying adobe bricks that were not kiln -fired, so within two or three seasons of...all too many PMs think a good risk management process simply identifies and mitigates the bad things that can happen. Conventional risk manage- ment

  12. Insurance World in Transition: Changes in Global Risk Taking and Risk Assessment

    NASA Astrophysics Data System (ADS)

    Michel, Gero; Tiampo, Kristy

    2015-04-01

    Catastrophe insurance risk assessment, risk taking, and regulation has evolved over the last 20 years and is gearing up for significant further change in the years ahead. Changes in regulation and influx of capital have put profit margins for catastrophe risk products under pressure despite the fact that changes in climate as well as increasing insurance penetration is expected to heighten demand. As a result, reinsurance strategies are moving away from catastrophe risk. In addition, lower margins require cheaper and more efficient risk assessment methods and processes which are contrary to evolving analytical tools and methods that had increased expenses in line with growing margins over the last decade. New capital providers are less familiar with and less willing to accept complex supply chains for risk management, relationship-driven business and tedious data exchange and management processes. Risk takers claim new measures and ask for more flexibility in the use of tools. The current concepts of catastrophe insurance risk assessment are hence under thorough scrutiny. This presentation deals with the changing landscape in catastrophe insurance risk assessment and risk hedging and discusses changes in catastrophe risk assessment products and demand. How likely is it that private, small and nimble hazard and risk consulting groups - increasingly emanating from larger science organizations - will replace large established firms in their role to assess risk? What role do public-private academic partnerships play in assuming risk for catastrophe insurance and what role could they play in the future? What are the opportunities and downsides of the current changes in risk taking and hedging? What is needed from the scientific community in order to fill the gaps in risk management and who is likely to take advantage of the current changes?

  13. Lifestyle risk management--a qualitative analysis of women's descriptions of taking hormone therapy following surgically induced menopause.

    PubMed

    Crowe, Marie; Burrell, Beverly; Whitehead, Lisa

    2012-08-01

    This article is a report of a study that examined how women describe their decisions in relation to the use of menopausal hormone therapy following surgical menopause. Women who have had a surgically induced menopause generally experience more intense menopausal symptoms than natural menopause and are regularly prescribed menopausal hormone therapy. Since 2002 the risks associated with this therapy have been widely reported. This study is a qualitative analysis of semi-structured interviews between March and May 2009 with 30 participants who had experienced surgical menopause and were, or had in the past, taken menopausal hormone therapy. This was a community sample recruited in Christchurch, New Zealand. A risk management theoretical approach underpinned the analysis. The womens' descriptions of managing the risks associated with menopausal therapy fell into two main themes: Life has to go on and Waiting for someone to tell me. All these women had either made an active decision to continue on treatment because of the impact of menopausal symptoms or took their doctor's advice to continue. A less dominant theme but one that was also evident was Relying on my body to get me through in which the women had decided to discontinue treatment because they regarded it as unnatural. The study provided insights into how women utilize an experiential reasoning process to manage the health and lifestyle risks associated with taking menopausal hormone therapy. Nurses need to be aware of how this process influences women's reasoning processes when working with women following surgical menopause. © 2011 Blackwell Publishing Ltd.

  14. Architecture for Integrated Medical Model Dynamic Probabilistic Risk Assessment

    NASA Technical Reports Server (NTRS)

    Jaworske, D. A.; Myers, J. G.; Goodenow, D.; Young, M.; Arellano, J. D.

    2016-01-01

    Probabilistic Risk Assessment (PRA) is a modeling tool used to predict potential outcomes of a complex system based on a statistical understanding of many initiating events. Utilizing a Monte Carlo method, thousands of instances of the model are considered and outcomes are collected. PRA is considered static, utilizing probabilities alone to calculate outcomes. Dynamic Probabilistic Risk Assessment (dPRA) is an advanced concept where modeling predicts the outcomes of a complex system based not only on the probabilities of many initiating events, but also on a progression of dependencies brought about by progressing down a time line. Events are placed in a single time line, adding each event to a queue, as managed by a planner. Progression down the time line is guided by rules, as managed by a scheduler. The recently developed Integrated Medical Model (IMM) summarizes astronaut health as governed by the probabilities of medical events and mitigation strategies. Managing the software architecture process provides a systematic means of creating, documenting, and communicating a software design early in the development process. The software architecture process begins with establishing requirements and the design is then derived from the requirements.

  15. From aviation to medicine: applying concepts of aviation safety to risk management in ambulatory care.

    PubMed

    Wilf-Miron, R; Lewenhoff, I; Benyamini, Z; Aviram, A

    2003-02-01

    The development of a medical risk management programme based on the aviation safety approach and its implementation in a large ambulatory healthcare organisation is described. The following key safety principles were applied: (1). errors inevitably occur and usually derive from faulty system design, not from negligence; (2). accident prevention should be an ongoing process based on open and full reporting; (3). major accidents are only the "tip of the iceberg" of processes that indicate possibilities for organisational learning. Reporting physicians were granted immunity, which encouraged open reporting of errors. A telephone "hotline" served the medical staff for direct reporting and receipt of emotional support and medical guidance. Any adverse event which had learning potential was debriefed, while focusing on the human cause of error within a systemic context. Specific recommendations were formulated to rectify processes conducive to error when failures were identified. During the first 5 years of implementation, the aviation safety concept and tools were successfully adapted to ambulatory care, fostering a culture of greater concern for patient safety through risk management while providing support to the medical staff.

  16. From aviation to medicine: applying concepts of aviation safety to risk management in ambulatory care

    PubMed Central

    Wilf-Miron, R; Lewenhoff, I; Benyamini, Z; Aviram, A

    2003-01-01

    

 The development of a medical risk management programme based on the aviation safety approach and its implementation in a large ambulatory healthcare organisation is described. The following key safety principles were applied: (1) errors inevitably occur and usually derive from faulty system design, not from negligence; (2) accident prevention should be an ongoing process based on open and full reporting; (3) major accidents are only the "tip of the iceberg" of processes that indicate possibilities for organisational learning. Reporting physicians were granted immunity, which encouraged open reporting of errors. A telephone "hotline" served the medical staff for direct reporting and receipt of emotional support and medical guidance. Any adverse event which had learning potential was debriefed, while focusing on the human cause of error within a systemic context. Specific recommendations were formulated to rectify processes conducive to error when failures were identified. During the first 5 years of implementation, the aviation safety concept and tools were successfully adapted to ambulatory care, fostering a culture of greater concern for patient safety through risk management while providing support to the medical staff. PMID:12571343

  17. System Interdependency Modeling in the Design of Prognostic and Health Management Systems in Smart Manufacturing.

    PubMed

    Malinowski, M L; Beling, P A; Haimes, Y Y; LaViers, A; Marvel, J A; Weiss, B A

    2015-01-01

    The fields of risk analysis and prognostics and health management (PHM) have developed in a largely independent fashion. However, both fields share a common core goal. They aspire to manage future adverse consequences associated with prospective dysfunctions of the systems under consideration due to internal or external forces. This paper describes how two prominent risk analysis theories and methodologies - Hierarchical Holographic Modeling (HHM) and Risk Filtering, Ranking, and Management (RFRM) - can be adapted to support the design of PHM systems in the context of smart manufacturing processes. Specifically, the proposed methodologies will be used to identify targets - components, subsystems, or systems - that would most benefit from a PHM system in regards to achieving the following objectives: minimizing cost, minimizing production/maintenance time, maximizing system remaining usable life (RUL), maximizing product quality, and maximizing product output. HHM is a comprehensive modeling theory and methodology that is grounded on the premise that no system can be modeled effectively from a single perspective. It can also be used as an inductive method for scenario structuring to identify emergent forced changes (EFCs) in a system. EFCs connote trends in external or internal sources of risk to a system that may adversely affect specific states of the system. An important aspect of proactive risk management includes bolstering the resilience of the system for specific EFCs by appropriately controlling the states. Risk scenarios for specific EFCs can be the basis for the design of prognostic and diagnostic systems that provide real-time predictions and recognition of scenario changes. The HHM methodology includes visual modeling techniques that can enhance stakeholders' understanding of shared states, resources, objectives and constraints among the interdependent and interconnected subsystems of smart manufacturing systems. In risk analysis, HHM is often paired with Risk Filtering, Ranking, and Management (RFRM). The RFRM process provides the users, (e.g., technology developers, original equipment manufacturers (OEMs), technology integrators, manufacturers), with the most critical risks to the objectives, which can be used to identify the most critical components and subsystems that would most benefit from a PHM system. A case study is presented in which HHM and RFRM are adapted for PHM in the context of an active manufacturing facility located in the United States. The methodologies help to identify the critical risks to the manufacturing process, and the major components and subsystems that would most benefit from a developed PHM system.

  18. System Interdependency Modeling in the Design of Prognostic and Health Management Systems in Smart Manufacturing

    PubMed Central

    Malinowski, M.L.; Beling, P.A.; Haimes, Y.Y.; LaViers, A.; Marvel, J.A.; Weiss, B.A.

    2017-01-01

    The fields of risk analysis and prognostics and health management (PHM) have developed in a largely independent fashion. However, both fields share a common core goal. They aspire to manage future adverse consequences associated with prospective dysfunctions of the systems under consideration due to internal or external forces. This paper describes how two prominent risk analysis theories and methodologies – Hierarchical Holographic Modeling (HHM) and Risk Filtering, Ranking, and Management (RFRM) – can be adapted to support the design of PHM systems in the context of smart manufacturing processes. Specifically, the proposed methodologies will be used to identify targets – components, subsystems, or systems – that would most benefit from a PHM system in regards to achieving the following objectives: minimizing cost, minimizing production/maintenance time, maximizing system remaining usable life (RUL), maximizing product quality, and maximizing product output. HHM is a comprehensive modeling theory and methodology that is grounded on the premise that no system can be modeled effectively from a single perspective. It can also be used as an inductive method for scenario structuring to identify emergent forced changes (EFCs) in a system. EFCs connote trends in external or internal sources of risk to a system that may adversely affect specific states of the system. An important aspect of proactive risk management includes bolstering the resilience of the system for specific EFCs by appropriately controlling the states. Risk scenarios for specific EFCs can be the basis for the design of prognostic and diagnostic systems that provide real-time predictions and recognition of scenario changes. The HHM methodology includes visual modeling techniques that can enhance stakeholders’ understanding of shared states, resources, objectives and constraints among the interdependent and interconnected subsystems of smart manufacturing systems. In risk analysis, HHM is often paired with Risk Filtering, Ranking, and Management (RFRM). The RFRM process provides the users, (e.g., technology developers, original equipment manufacturers (OEMs), technology integrators, manufacturers), with the most critical risks to the objectives, which can be used to identify the most critical components and subsystems that would most benefit from a PHM system. A case study is presented in which HHM and RFRM are adapted for PHM in the context of an active manufacturing facility located in the United States. The methodologies help to identify the critical risks to the manufacturing process, and the major components and subsystems that would most benefit from a developed PHM system. PMID:28664162

  19. Improved water allocation utilizing probabilistic climate forecasts: Short-term water contracts in a risk management framework

    NASA Astrophysics Data System (ADS)

    Sankarasubramanian, A.; Lall, Upmanu; Souza Filho, Francisco Assis; Sharma, Ashish

    2009-11-01

    Probabilistic, seasonal to interannual streamflow forecasts are becoming increasingly available as the ability to model climate teleconnections is improving. However, water managers and practitioners have been slow to adopt such products, citing concerns with forecast skill. Essentially, a management risk is perceived in "gambling" with operations using a probabilistic forecast, while a system failure upon following existing operating policies is "protected" by the official rules or guidebook. In the presence of a prescribed system of prior allocation of releases under different storage or water availability conditions, the manager has little incentive to change. Innovation in allocation and operation is hence key to improved risk management using such forecasts. A participatory water allocation process that can effectively use probabilistic forecasts as part of an adaptive management strategy is introduced here. Users can express their demand for water through statements that cover the quantity needed at a particular reliability, the temporal distribution of the "allocation," the associated willingness to pay, and compensation in the event of contract nonperformance. The water manager then assesses feasible allocations using the probabilistic forecast that try to meet these criteria across all users. An iterative process between users and water manager could be used to formalize a set of short-term contracts that represent the resulting prioritized water allocation strategy over the operating period for which the forecast was issued. These contracts can be used to allocate water each year/season beyond long-term contracts that may have precedence. Thus, integrated supply and demand management can be achieved. In this paper, a single period multiuser optimization model that can support such an allocation process is presented. The application of this conceptual model is explored using data for the Jaguaribe Metropolitan Hydro System in Ceara, Brazil. The performance relative to the current allocation process is assessed in the context of whether such a model could support the proposed short-term contract based participatory process. A synthetic forecasting example is also used to explore the relative roles of forecast skill and reservoir storage in this framework.

  20. Safe drinking water in regional NSW, Australia.

    PubMed

    Byleveld, Paul M; Leask, Sandy D; Jarvis, Leslie A; Wall, Katrina J; Henderson, Wendy N; Tickell, Joshua E

    2016-04-15

    The New South Wales (NSW) Public Health Act 2010 requires water suppliers to implement a drinking water quality assurance program that addresses the 'Framework for management of drinking water quality' in the Australian drinking water guidelines. NSW Health has recognised the importance of a staged implementation of this requirement and the need to support regional water utilities. To date, NSW Health has assisted 74 regional utilities to develop and implement their management systems. The Public Health Act 2010 has increased awareness of drinking water risk management, and offers a systematic process to identify and control risks. This has benefited large utilities, smaller suppliers, and remote and Aboriginal communities. Work is continuing to ensure implementation of the process by private suppliers and water carters.

  1. WORKSHOP ON ENVIRONMENTALLY CONSCIOUS CHEMICAL PROCESS DESIGN

    EPA Science Inventory

    To encourage the consideration of environmental issues during chemical process design, the USEPA has developed techniques and software tools to evaluate the relative environmental impact of a chemical process. These techniques and tools aid in the risk management process by focus...

  2. Benchmarking CIN3+ risk as the basis for incorporating HPV and Pap cotesting into cervical screening and management guidelines

    PubMed Central

    Katki, Hormuzd A.; Schiffman, Mark; Castle, Philip E.; Fetterman, Barbara; Poitras, Nancy E.; Lorey, Thomas; Cheung, Li C.; Raine-Bennett, Tina R.; Gage, Julia C.; Kinney, Walter K.

    2013-01-01

    Objective In 2012, the United States Preventive Services Task Force (USPSTF) and a consensus of 25 organizations endorsed concurrent cytology and HPV testing (“cotesting”) for cervical cancer screening. Past screening and management guidelines were implicitly based on risks defined by Pap-alone, without consideration of HPV test results. To promote management that is consistent with accepted practice, new guidelines incorporating cotesting should aim to achieve equal management of women at equal risk of cervical intraepithelial neoplasia grade 3 and cancer (CIN3+). Methods We estimated cumulative 5-year risks of CIN3+ for 965,360 women aged 30–64 undergoing cotesting at Kaiser Permanente Northern California 2003–2010. We calculated the implicit risk thresholds for Pap-alone and applied them for new management guidance on HPV and Pap cotesting, citing 2 examples: HPV-positive/ASC-US and HPV-negative/Pap-negative. We call this guidance process “benchmarking”. Results LSIL, for which immediate colposcopy is prescribed, carries 5-year CIN3+ risk of 5.2%, suggesting that test results with similar risks should be managed with colposcopy. Similarly, ASC-US (2.6% risk) is managed with 6–12 month follow-up and Pap-negative (0.26% risk) is managed with 3-year follow-up. The 5-year CIN3+ risk for women with HPV-positive/ASC-US was 6.8% (95%CI 6.2% to 7.6%). This is greater than the 5.2% risk implicitly leading to referral to colposcopy, consistent with current management recommendations that HPV-positive/ASC-US should be referred for immediate colposcopy. The 5-year CIN3+ risk for women with HPV-negative/Pap-negative was 0.08% (95%CI 0.07% to 0.09%), far below the 0.26% implicitly required for a 3-year return and justifying a longer (e.g., 5-year) return. Conclusions Using the principle of “equal management of equal risks,” benchmarking to implicit risk thresholds based on Pap-alone can be used to achieve safe and consistent incorporation of cotesting. PMID:23519302

  3. Prevention of MSD within OHSMS/IMS: a systematic review of risk assessment strategies.

    PubMed

    Yazdani, Amin; Wells, Richard

    2012-01-01

    The purpose of this systematic review was to identify and summarize the research evidence on prevention of Musculoskeletal Disorders (MSD) within Occupational Health and Safety Management Systems (OHSMS) and Integrated Management Systems (IMS). Databases in business, management, engineering and health and safety were systematically searched and relevant publications were synthesized. The number of papers that could address the research questions was small. However, the review revealed that many of the techniques to address MSD hazards require substantial background knowledge and training. This may limit employees' involvement in the technical aspects of the risk assessment process. Also these techniques did not usually fit into techniques used by companies to address other risk factors within their management systems. This could result in MSD prevention becoming a separate issue that cannot be managed with company-wide tools. In addition, this review also suggested that there is a research gap concerning the MSD prevention within companies' management systems.

  4. Scientific information and the Tongass land management plan: key findings derived from the scientific literature, species assessments, resource analyses, workshops, and risk assessment panels.

    Treesearch

    Douglas N. Swanston; Charles G. Shaw; Winston P. Smith; Kent R. Julin; Guy A. Cellier; Fred H. Everest

    1996-01-01

    This document highlights key items of information obtained from the published literature and from specific assessments, workshops, resource analyses, and various risk assessment panels conducted as part of the Tongass land management planning process. None of this information dictates any particular decision; however, it is important to consider during decisionmaking...

  5. Annual Statement of Assurance. Fiscal Year 1991

    DTIC Science & Technology

    1991-01-01

    risk) assessment rating process. In orientation sessions, we made a pointed effort to emphasize the statutory root of the IMC Program. We undertook... rating process. Training in the development of the management control plan was also provided using examples and a sample format. To illustrate the...application of IMC principles to the risk rating process, a case study approach was presented in a workshop mode with questions and answers following

  6. [Development and clinical evaluation of an anesthesia information management system].

    PubMed

    Feng, Jing-yi; Chen, Hua; Zhu, Sheng-mei

    2010-09-21

    To study the design, implementation and clinical evaluation of an anesthesia information management system. To record, process and store peri-operative patient data automatically, all kinds of bedside monitoring equipments are connected into the system based on information integrating technology; after a statistical analysis of those patient data by data mining technology, patient status can be evaluated automatically based on risk prediction standard and decision support system, and then anesthetist could perform reasonable and safe clinical processes; with clinical processes electronically recorded, standard record tables could be generated, and clinical workflow is optimized, as well. With the system, kinds of patient data could be collected, stored, analyzed and archived, kinds of anesthesia documents could be generated, and patient status could be evaluated to support clinic decision. The anesthesia information management system is useful for improving anesthesia quality, decreasing risk of patient and clinician, and aiding to provide clinical proof.

  7. Best practices: The Administrative Review Committee at New Hampshire Hospital: a one-year follow-up.

    PubMed

    de Nesnera, Alexander; Folks, David G

    2012-06-01

    New Hampshire Hospital implemented an Administrative Review Committee (ARC), a best practice that provides a risk management process to mitigate potential liability for the hospital and clinicians treating high-profile, high-risk patients. This column reports on the first year of the ARC's operation, during which the committee reviewed 206 patients. The authors describe four patient groups and their distinguishing characteristics. The ARC is accepted by clinicians as an important venue to present high-risk clinical cases and to obtain risk management guidance and consultation. The committee has become an integral part of the hospital culture.

  8. Post-Challenger evaluation of space shuttle risk assessment and management

    NASA Technical Reports Server (NTRS)

    1988-01-01

    As the shock of the Space Shuttle Challenger accident began to subside, NASA initiated a wide range of actions designed to ensure greater safety in various aspects of the Shuttle system and an improved focus on safety throughout the National Space Transportation System (NSTS) Program. Certain specific features of the NASA safety process are examined: the Critical Items List (CIL) and the NASA review of the Shuttle primary and backup units whose failure might result in the loss of life, the Shuttle vehicle, or the mission; the failure modes and effects analyses (FMEA); and the hazard analysis and their review. The conception of modern risk management, including the essential element of objective risk assessment is described and it is contrasted with NASA's safety process in general terms. The discussion, findings, and recommendations regarding particular aspects of the NASA STS safety assurance process are reported. The 11 subsections each deal with a different aspect of the process. The main lessons learned by SCRHAAC in the course of the audit are summarized.

  9. Advancements in Risk-Informed Performance-Based Asset Management for Commercial Nuclear Power Plants

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Liming, James K.; Ravindra, Mayasandra K.

    2006-07-01

    Over the past several years, ABSG Consulting Inc. (ABS Consulting) and the South Texas Project Nuclear Operating Company (STPNOC) have developed a decision support process and associated software for risk-informed, performance-based asset management (RIPBAM) of nuclear power plant facilities. RIPBAM applies probabilistic risk assessment (PRA) tools and techniques in the realm of plant physical and financial asset management. The RIPBAM process applies a tiered set of models and supporting performance measures (or metrics) that can ultimately be applied to support decisions affecting the allocation and management of plant resources (e.g., funding, staffing, scheduling, etc.). In general, the ultimate goal ofmore » the RIPBAM process is to continually support decision-making to maximize a facility's net present value (NPV) and long-term profitability for its owners. While the initial applications of RIPBAM have been for nuclear power stations, the methodology can easily be adapted to other types of power station or complex facility decision-making support. RIPBAM can also be designed to focus on performance metrics other than NPV and profitability (e.g., mission reliability, operational availability, probability of mission success per dollar invested, etc.). Recent advancements in the RIPBAM process focus on expanding the scope of previous RIPBAM applications to include not only operations, maintenance, and safety issues, but also broader risk perception components affecting plant owner (stockholder), operator, and regulator biases. Conceptually, RIPBAM is a comprehensive risk-informed cash flow model for decision support. It originated as a tool to help manage plant refueling outage scheduling, and was later expanded to include the full spectrum of operations and maintenance decision support. However, it differs from conventional business modeling tools in that it employs a systems engineering approach with broadly based probabilistic analysis of organizational 'value streams'. The scope of value stream inclusion in the process can be established by the user, but in its broadest applications, RIPBAM can be used to address how risk perceptions of plant owners and regulators are impacted by plant performance. Plant staffs can expand and refine RIPBAM models scope via a phased program of activities over time. This paper shows how the multi-metric uncertainty analysis feature of RIPBAM can apply a wide spectrum of decision-influencing factors to support decisions designed to maximize the probability of achieving, maintaining, and improving upon plant goals and objectives. In this paper, the authors show how this approach can be extremely valuable to plant owners and operators in supporting plant value-impacting decision-making processes. (authors)« less

  10. Managed Moves: School and Local Authority Staff Perceptions of Processes, Success and Challenges

    ERIC Educational Resources Information Center

    Bagley, Christopher; Hallam, Susan

    2015-01-01

    The current research aimed to increase understanding of the processes of managed moves for children at risk of exclusion from school, particularly exploring what contributed to success and the nature of the challenges experienced. The study was conducted in one English local authority where 11 school staff and 5 local authority staff were…

  11. Pharmacological treatments and risks for the food chain.

    PubMed

    Girardi, C; Odore, R

    2008-09-01

    Veterinarians play a pivotal role in public health control, in particular in the management of risks deriving from pharmacological treatments of food-producing animals. Veterinary medicinal products can represent a risk for animal health and welfare (side effects, decreased efficacy), for farmers and practitioners administering the drug, for consumers of food of animal origin (presence of residues, occurrence of antibiotic resistance) and for the environment. According to pending European guidelines, risk management starts from marketing authorisation that must be based on risk evaluation and can be denied when the risk/benefit ratio is not favourable considering the advantages for animal health and welfare and for safety of consumers. Veterinarians can prevent and control risks by using correct pharmacological criteria to choose and administer medicinal products and undertaking risk-based inspection of residues of drugs in food of animal origin. Moreover, a major tool for veterinarians to prevent and control drug-borne risk is "pharmacovigilance". Risks for the environment are usually assessed during the pre-marketing approval process, however veterinarians, as risk managers, should educate farmers about correct drug handling and disposal, and periodically verify that suggested measures are applied.

  12. Distributed Information System Development: Review of Some Management Issues

    NASA Astrophysics Data System (ADS)

    Mishra, Deepti; Mishra, Alok

    Due to the proliferation of the Internet and globalization, distributed information system development is becoming popular. In this paper we have reviewed some significant management issues like process management, project management, requirements management and knowledge management issues which have received much attention in distributed development perspective. In this literature review we found that areas like quality and risk management issues could get only scant attention in distributed information system development.

  13. Institutionalizing Lessons Learned

    NASA Technical Reports Server (NTRS)

    McBrayer, Robert O.; Thomas, Dale

    2001-01-01

    The NASA Integrated Action Team (NIAT) was formed by the NASA Administrator in March 2000. The purpose of this team was to identify the actions that NASA must take to address systemic findings reported in 4 different anomaly investigations. Team membership represented senior managers from all the field centers and NASA Headquarters. NIAT report addressed 165 findings and developed 17 action plans that are described in five themes: people and teams, technology, risk, formulation rigor, and communications. The NIAT actions present a systems solution for strengthening formulation and implementation of programs and improving the environment for their support. NIAT results included: enhancing success by avoiding failures that could have been prevented through good planning and sound practice; ensuring that prudent risks do not compromise safety; and ensuring that mission risks are objectively assessed, appropriately mitigated and consciously accepted by the program team and customers. Definitions of Faster, Better, Cheaper and Success Criteria were also developed and included as part of the NIAT report. As a result of the NIAT report, program and project management process changes were incorporated into NASA's quality system documentation, including NPG 7120.513, "NASA Program and Project Management Processes and Requirements. This paper describes the NIAT results and the resulting updates to NPG 7120.5 that keep this program and project management description a living process.

  14. Effect of HIV/AIDS on the control environment.

    PubMed

    Coetzee, Philna

    2006-07-01

    The management of organizations is responsible for risk management and control systems. HIV/AIDS could be a great threat in the achievement of strategic business objectives, implicating a great concern for management. Management needs to understand this possible risk. This study aims to identify the effect that HIV/AIDS could have on the different elements of the control environment. The archival research method was used. It was established that no formal research was conducted to date on the effect of HIV/AIDS on the control environment as a whole. Various studies have included the effect of HIV/AIDS on certain factors of the control environment. These studies will be discussed briefly to identify relevant findings. The study indicated that the disease could affect various aspects of the control environment, namely: competency of the workforce (e.g. productivity, quality of work, absenteeism, loss of skills and knowledge, training and recruitment, etc.); organizational structure (e.g. increase use of technology labour, disruption of processes, level of employees affected by the disease); human resource (HR) policies and practices (e.g. legislation applicable, prevention and awareness programmes, compensation and benefits). Research limitation: HIV/AIDS is a relatively new potential risk to organizations. Knowledge of the disease is limited. HIV/AIDS is also a very sensitive issue as people fear the disease and do not like to discuss its existence. Government determined that it should be a non-notifiable disease and the disease is currently greatly stigmatized. The databases of companies investigated by other research studies were not developed to gather all the relevant information. Management should be aware that HIV/AIDS poses a possible risk to organizations. Data on the effect of HIV/AIDS should be gathered and used in the decision-making process on how to manage this risk. To be able to fulfil this duty, management first has to determine: whether HIV/AIDS is a risk; the relevant cost involved that the disease is costing the organization; how to control these costs.

  15. A contemporary perspective on capitated reimbursement for imaging services.

    PubMed

    Schwartz, H W

    1995-01-01

    Capitation ensures predictability of healthcare costs, requires acceptance of a premium in return for providing all required medical services and defines the actual dollar amount paid to a physician or hospital on a per member per month basis for a service or group of services. Capitation is expected to dramatically affect the marketplace in the near future, as private enterprise demands lower, more stable healthcare costs. Capitation requires detailed quantitative and financial data, including: eligibility and benefits determination, encounter processing, referral management, claims processing, case management, physician compensation, insurance management functions, outcomes reporting, performance management and cost accounting. It is important to understand actuarial risk and capitation marketing when considering a capitation contract. Also, capitated payment methodologies may vary to include modified fee-for-service, incentive pay, risk pool redistributions, merit, or a combination. Risk is directly related to the ability to predict utilization and unit cost of imaging services provided to a specific insured population. In capitated environments, radiologists will have even less control over referrals than they have today and will serve many more "covered lives"; long-term relationships with referring physicians will continue to evaporate; and services will be provided under exclusive, multi-year contracts. In addition to intensified use of technology for image transfer, telecommunications and sophisticated data processing and tracking systems, imaging departments must continue to provide the greatest amount of appropriate diagnostic information in a timely fashion at the lowest feasible cost and risk to the patient.

  16. Conceptualization and Pilot Testing of a Core Competency-Based Training Workshop in Suicide Risk Assessment and Management: Notes From the Field.

    PubMed

    Cramer, Robert J; Bryson, Claire N; Eichorst, Morgam K; Keyes, Lee N; Ridge, Brittany E

    2017-03-01

    As professional psychology training programs and continuing education have moved toward competency based approaches, it has become equally important to develop uniform, evidence-based approaches for suicide risk assessment and management. The present article presents a workshop curriculum based on established core competencies in suicide risk assessment and management. Drawing on theories suicide risk formation, the workshop features an integration of didactic, process, and experiential components. We present pilot data from 2 small group workshops (n = 17): 1 from a clinical psychology doctoral program and 1 from a university counseling center. Workshop participation yielded increases in (a) the ability to recognize appropriate clinician responses to suicidal client statements, (b) self-perceptions of general capacity to interface with suicidal patients and mastery of the 10 core competencies, (c) factual knowledge concerning suicide risk assessment and management, and (d) the self-rated ability to assess and manage a suicidal patient. We discuss statistical and generalizability limitations as well as implications for future modification, implementation, and provision of this training method. © 2016 Wiley Periodicals, Inc.

  17. Avoiding Drought Risks and Social Conflict Under Climate Change

    NASA Astrophysics Data System (ADS)

    Towler, E.; Lazrus, H.; Paimazumder, D.

    2014-12-01

    Traditional drought research has mainly focused on physical drought risks and less on the cultural processes that also contribute to how drought risks are perceived and managed. However, as society becomes more vulnerable to drought and climate change threatens to increase water scarcity, it is clear that drought research would benefit from a more interdisciplinary approach. To assess avoided drought impacts from reduced climate change, drought risks need to be assessed in the context of both climate prediction as well as improved understanding of socio-cultural processes. To this end, this study explores a risk-based framework to combine physical drought likelihoods with perceived risks from stakeholder interviews. Results are presented from a case study on how stakeholders in south-central Oklahoma perceive drought risks given diverse cultural beliefs, water uses, and uncertainties in future drought prediction. Stakeholder interviews (n=38) were conducted in 2012 to understand drought risks to various uses of water, as well as to measure worldviews from the cultural theory of risk - a theory that explains why people perceive risks differently, potentially leading to conflict over management decisions. For physical drought risk, drought projections are derived from a large ensemble of future climates generated from two RCPs that represent higher and lower emissions trajectories (i.e., RCP8.5 and RCP4.5). These are used to develop a Combined Drought Risk Matrix (CDRM) that characterizes drought risks for different water uses as the products of both physical likelihood (from the climate ensemble) and risk perception (from the interviews). We use the CRDM to explore the avoided drought risks posed to various water uses, as well as to investigate the potential for reduction of conflict over water management.

  18. Method ranks competing projects by priorities, risk. [A method to help prioritize oil and gas pipeline project goals

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Moeckel, D.R.

    A practical, objective guide for ranking projects based on risk-based priorities has been developed by Sun Pipe Line Co. The deliberately simple system guides decisions on how to allocate scarce company resources because all managers employ the same criteria in weighing potential risks to the company versus benefits. Managers at all levels are continuously having to comply with an ever growing amount of legislative and regulatory requirements while at the same time trying to run their businesses effectively. The system primarily is designed for use as a compliance oversight and tracking process to document, categorize, and follow-up on work concerningmore » various issues or projects. That is, the system consists of an electronic database which is updated periodically, and is used by various levels of management to monitor progress of health, safety, environmental and compliance-related projects. Criteria used in determining a risk factor and assigning a priority also have been adapted and found useful for evaluating other types of projects. The process enables management to better define potential risks and/or loss of benefits that are being accepted when a project is rejected from an immediate work plan or budget. In times of financial austerity, it is extremely important that the right decisions are made at the right time.« less

  19. The role of risk-based prioritization in total quality management

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Bennett, C.T.

    1994-10-01

    The climate in which government managers must make decisions grows more complex and uncertain. All stakeholders - the public, industry, and Congress - are demanding greater consciousness, responsibility, and accountability of programs and their budgets. Yet, managerial decisions have become multifaceted, involve greater risk, and operate over much longer time periods. Over the last four or five decades, as policy analysis and decisions became more complex, scientists from psychology, operations research, systems science, and economics have developed a more or less coherent process called decision analysis to aid program management. The process of decision analysis - a systems theoretic approachmore » - provides the backdrop for this paper. The Laboratory Integrated Prioritization System (LIPS) has been developed as a systems analytic and risk-based prioritization tool to aid the management of the Tri-Labs` (Lawrence Livermore, Los Alamos, and Sandia) operating resources. Preliminary analyses of the effects of LIPS has confirmed the practical benefits of decision and systems sciences - the systematic, quantitative reduction in uncertainty. To date, the use of LIPS - and, hence, its value - has been restricted to resource allocation within the Tri-Labs` operations budgets. This report extends the role of risk-based prioritization to the support of DOE Total Quality Management (TQM) programs. Furthermore, this paper will argue for the requirement to institutionalize an evolutionary, decision theoretic approach to the policy analysis of the Department of Energy`s Program Budget.« less

  20. Applicability of risk-based management and the need for risk-based economic decision analysis at hazardous waste contaminated sites.

    PubMed

    Khadam, Ibrahim; Kaluarachchi, Jagath J

    2003-07-01

    Decision analysis in subsurface contamination management is generally carried out through a traditional engineering economic viewpoint. However, new advances in human health risk assessment, namely, the probabilistic risk assessment, and the growing awareness of the importance of soft data in the decision-making process, require decision analysis methodologies that are capable of accommodating non-technical and politically biased qualitative information. In this work, we discuss the major limitations of the currently practiced decision analysis framework, which evolves around the definition of risk and cost of risk, and its poor ability to communicate risk-related information. A demonstration using a numerical example was conducted to provide insight on these limitations of the current decision analysis framework. The results from this simple ground water contamination and remediation scenario were identical to those obtained from studies carried out on existing Superfund sites, which suggests serious flaws in the current risk management framework. In order to provide a perspective on how these limitations may be avoided in future formulation of the management framework, more matured and well-accepted approaches to decision analysis in dam safety and the utility industry, where public health and public investment are of great concern, are presented and their applicability in subsurface remediation management is discussed. Finally, in light of the success of the application of risk-based decision analysis in dam safety and the utility industry, potential options for decision analysis in subsurface contamination management are discussed.

  1. Confluence and Contours: Reflexive Management of Environmental Risk

    PubMed Central

    Schubert, Iljana; Pollard, Simon; Rocks, Sophie; Black, Edgar

    2015-01-01

    Government institutions have responsibilities to distribute risk management funds meaningfully and to be accountable for their choices. We took a macro‐level sociological approach to understanding the role of government in managing environmental risks, and insights from micro‐level psychology to examine individual‐level risk‐related perceptions and beliefs. Survey data from 2,068 U.K. citizens showed that lay people's funding preferences were associated positively with beliefs about responsibility and trust, yet associations with perception varied depending on risk type. Moreover, there were risk‐specific differences in the funding preferences of the lay sample and 29 policymakers. A laboratory‐based study of 109 participants examined funding allocation in more detail through iterative presentation of expert information. Quantitative and qualitative data revealed a meso‐level framework comprising three types of decisionmakers who varied in their willingness to change funding allocation preferences following expert information: adaptors, responders, and resistors. This research highlights the relevance of integrated theoretical approaches to understanding the policy process, and the benefits of reflexive dialogue to managing environmental risks. PMID:26720858

  2. Managing Risk in Safety Critical Operations - Lessons Learned from Space Operations

    NASA Technical Reports Server (NTRS)

    Gonzalez, Steven A.

    2002-01-01

    The Mission Control Center (MCC) at Johnson Space Center (JSC) has a rich legacy of supporting Human Space Flight operations throughout the Apollo, Shuttle and International Space Station eras. Through the evolution of ground operations and the Mission Control Center facility, NASA has gained a wealth of experience of what it takes to manage the risk in Safety Critical Operations, especially when human life is at risk. The focus of the presentation will be on the processes (training, operational rigor, team dynamics) that enable the JSC/MCC team to be so successful. The presentation will also share the evolution of the Mission Control Center architecture and how the evolution was introduced while managing the risk to the programs supported by the team. The details of the MCC architecture (e.g., the specific software, hardware or tools used in the facility) will not be shared at the conference since it would not give any additional insight as to how risk is managed in Space Operations.

  3. Supporting the risk management process with land information: a case study of Australia.

    PubMed

    Potts, Katie Elizabeth; Rajabifard, Abbas; Bennett, Rohan Mark

    2017-04-01

    It is frequently argued that, at the parcel level, stakeholders are capable of and well supported in managing their land-related risks. Yet, evidence from the contemporary Australian context suggests otherwise: numerous large-scale disaster events have revealed that citizens are ill-prepared to respond and recover adequately. This paper begins with the premise that information, specifically land information, could better support parcel-level risk preparation, mitigation, response, and recovery. State land administration organisations in Australia primarily maintain this information and make it accessible. Land information is used regularly across all levels of government to support risk management activities; however, such application has not always occurred at the parcel and citizen level. Via a case study approach, this paper initially explores the land information available in Australia to stakeholders interested in parcel-level detail, and then goes on to propose how the utilisation of parcel-level land information could serve to enhance risk management practices. © 2017 The Author(s). Disasters © Overseas Development Institute, 2017.

  4. Spatially based management of agricultural phosphorus pollution from diffuse sources: the SCIMAP risk based approach

    NASA Astrophysics Data System (ADS)

    Reaney, S. M.; Heathwaite, L.; Lane, S. N.; Buckley, C.

    2007-12-01

    Pollution of rivers from agricultural phosphorus is recognised as a significant global problem and is a major management challenge as it involves processes that are small in magnitude, distributed over large areas, operating at fine spatial scales and associated with certain land use types when they are well connected to the receiving waters. Whilst some of these processes have been addressed in terms of water quality forecasting models and field measurements, we lack effective tools to prioritise where action should be taken to remediate the diffuse pollution problem. From a management perspective, the required information is on 'what to do where' rather than absolute values. This change in focus opens up the problem to be considered in a probabilistic / relative framework rather than concentrating on absolute values. The SCIMAP risk management framework is based on the critical source area concept whereby a risk and a connection are required to generate a problem. Treatments of both surface and subsurface hydrological connectivity have been developed. The approach is based on the philosophy that for a point to be considered connected there needs to be a continuous flow path to the receiving water. This information is calculated by simulating the possible flow paths from the source cell to the receiving water and recording the required catchment wetness to allow flow along that route. This algorithm gives information on the ease at which each point in the landscape can export risk along surface and subsurface pathways to the receiving waters. To understand the annual dynamics of the locational diffuse P risk, a temporal risk framework has been developed. This risk framework accounts for land management activies within the agricultural calendar. These events include the application of fertiliser, the P additions from livestock and the offtake of P in crops. Changes to these risks can be made to investigate management options. The SCIMAP risk mapping framework has been applied to 12 catchments in England as part of the DEFRA / Environment Agency's Catchment Sensitive Farming programme. Result from these catchments will be presented.

  5. Common Elements of Risk

    DTIC Science & Technology

    2006-04-01

    8 Figure 5 : Threat and Operational Risk .................................................................... 9 Figure 6: Work Process...technical note might be applied to selected risk management topics. Finally, Section 5 , “Conclusion,” completes the report by summarizing the history...addressed in Section 5 . CMU/SEI-2006-TN-014 5 So far, our discussion has focused on the conceptual aspects of risk . The next section explores risk’s

  6. Overview and Status of the Bioastronautics Critical Path Roadmap (BCPR)

    NASA Technical Reports Server (NTRS)

    Charles, John

    2004-01-01

    Viewgraphs on the status and overview of the Bioastronautics Critical Path Roadmap (BCPR) are presented. The topics include: 1) BCPR Objectives; 2) BCPR and OBPR Program Management; 3) BCPR Disciplines & Cross-Cutting Areas; 4) Characteristics of BCPR Reference Missions; 5) Bioastronautics Timetable (notional); 6) BCPR Processes Risk Identification, Assessment, and Management; 7) Types of BCPR Risks; 8) Enabling Questions Categories; 9) Risk Mitigation Status; 10) Defining Levels of Accepted Risk; 11) BCPR Integration; 12) BCPR Implementation, Integration, and Validation; 13) BCPR Refinement Schedule; 14) Academy Review; 15) Rating Bioastronautics Risks; 16) Risk Rating Exercises; 17) Human Health Risk Assessment Criteria (examples); 18) A Recent Risk Rating Exercise; 19) Consensus Workshop Background; 20) Consensus Workshop Rating Analysis; 21) Consensus Workshop Selected Preliminary Recommendations; and 22) Access to BCPR Content.

  7. Role of mathematical models in assessment of risk and in attempts to define management strategy.

    PubMed

    Flamm, W G; Winbush, J S

    1984-06-01

    Risk assessment of food-borne carcinogens is becoming a common practice at FDA. Actual risk is not being estimated, only the upper limit of risk. The risk assessment process involves a large number of steps and assumptions, many of which affect the numerical value estimated. The mathematical model which is to be applied is only one of the factors which affect these numerical values. To fulfill the policy objective of using the "worst plausible case" in estimating the upper limit of risk, recognition needs to be given to a proper balancing of assumptions and decisions. Interaction between risk assessors and risk managers should avoid making or giving the appearance of making specific technical decisions such as the choice of the mathematical model. The importance of this emerging field is too great to jeopardize it by inappropriately mixing scientific judgments with policy judgments. The risk manager should understand fully the points and range of uncertainty involved in arriving at the estimates of risk which must necessarily affect the choice of the policy or regulatory options available.

  8. Incident Management: Process into Practice

    ERIC Educational Resources Information Center

    Isaac, Gayle; Moore, Brian

    2011-01-01

    Tornados, shootings, fires--these are emergencies that require fast action by school district personnel, but they are not the only incidents that require risk management. The authors have introduced the National Incident Management System (NIMS) and the Incident Command System (ICS) and assured that these systems can help educators plan for and…

  9. ArcFuels10 system overview

    Treesearch

    Nicole M. Vaillant; Alan A. Ager; John Anderson

    2013-01-01

    Fire behavior modeling and geospatial analyses can provide tremendous insight for land managers as they grapple with the complex problems frequently encountered in wildfire risk assessments and fire and fuels management planning. Fuel management often is a particularly complicated process in which the benefits and potential impacts of fuel treatments need to be...

  10. Use of a systematic risk analysis method (FMECA) to improve quality in a clinical laboratory procedure.

    PubMed

    Serafini, A; Troiano, G; Franceschini, E; Calzoni, P; Nante, N; Scapellato, C

    2016-01-01

    Risk management is a set of actions to recognize or identify risks, errors and their consequences and to take the steps to counter it. The aim of our study was to apply FMECA (Failure Mode, Effects and Criticality Analysis) to the Activated Protein C resistance (APCR) test in order to detect and avoid mistakes in this process. We created a team and the process was divided in phases and sub phases. For each phase we calculated the probability of occurrence (O) of an error, the detectability score (D) and the severity (S). The product of these three indexes yields the RPN (Risk Priority Number). Phases with a higher RPN need corrective actions with a higher priority. The calculation of RPN showed that more than 20 activities have a score higher than 150 and need important preventive actions; 8 have a score between 100 and 150. Only 23 actions obtained an acceptable score lower than 100. This was one of the first experience of application of FMECA analysis to a laboratory process, and the first one which applies this technique to the identification of the factor V Leiden, and our results confirm that FMECA could be a simple, powerful and useful tool in risk management and helps to identify quickly the criticality in a laboratory process.

  11. Integration of Biosafety into Core Facility Management

    PubMed Central

    Fontes, Benjamin

    2013-01-01

    This presentation will discuss the implementation of biosafety policies for small, medium and large core laboratories with primary shared objectives of ensuring the control of biohazards to protect core facility operators and assure conformity with applicable state and federal policies, standards and guidelines. Of paramount importance is the educational process to inform core laboratories of biosafety principles and policies and to illustrate the technology and process pathways of the core laboratory for biosafety professionals. Elevating awareness of biohazards and the biosafety regulatory landscape among core facility operators is essential for the establishment of a framework for both project and material risk assessment. The goal of the biohazard risk assessment process is to identify the biohazard risk management parameters to conduct the procedure safely and in compliance with applicable regulations. An evaluation of the containment, protective equipment and work practices for the procedure for the level of risk identified is facilitated by the establishment of a core facility registration form for work with biohazards and other biological materials with potential risk. The final step in the biocontainment process is the assumption of Principal Investigator role with full responsibility for the structure of the site-specific biosafety program plan by core facility leadership. The presentation will provide example biohazard protocol reviews and accompanying containment measures for core laboratories at Yale University.

  12. Coordinating ecological restoration options analysis and risk assessment to improve environmental outcomes.

    PubMed

    Kapustka, Lawrence A; Bowers, Keith; Isanhart, John; Martinez-Garza, Cristina; Finger, Susan; Stahl, Ralph G; Stauber, Jenny

    2016-04-01

    Ecological risk assessment as currently practiced has hindered consideration of ecosystem services endpoints and restoration goals in the environmental management process. Practitioners have created barriers between procedures to clean up contaminated areas and efforts to restore ecosystem functions. In this article, we examine linkages between contaminant risk assessment approaches and restoration efforts with the aim of identifying ways to improve environmental outcomes. We advocate that project managers and other stakeholders use an ecological planning framework, with restoration options included upfront in the risk assessment. We also considered the opportunities to incorporate ecosystem services as potential assessment endpoints in the Problem Formulation stages of a risk assessment. Indeed, diverse perspectives of stakeholders are central to understand the relevance of social, cultural, economic, and regional ecology as influences on future use options for the landscape being restored. The measurement endpoints used to characterize the existing ecological conditions for selected ecosystem services can also be used to evaluate restoration success. A regional, landscape, or seascape focus is needed throughout the risk assessment process, so that restoration efforts play a more prominent role in enhancing ecosystem services. In short, we suggest that practitioners begin with the question of "how can the ecological risk assessment inform the decision on how best to restore the ecosystem?" © 2015 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals, Inc. on behalf of SETAC.

  13. Exposure assessment and risk management of engineered nanoparticles: Investigation in semiconductor wafer processing

    NASA Astrophysics Data System (ADS)

    Shepard, Michele N.

    Engineered nanomaterials (ENMs) are currently used in hundreds of commercial products and industrial processes, with more applications being investigated. Nanomaterials have unique properties that differ from bulk materials. While these properties may enable technological advancements, the potential risks of ENMs to people and the environment are not yet fully understood. Certain low solubility nanoparticles are more toxic than their bulk material, such that existing occupational exposure limits may not be sufficiently protective for workers. Risk assessments are currently challenging due to gaps in data on the numerous emerging materials and applications as well as method uncertainties and limitations. Chemical mechanical planarization (CMP) processes with engineered nanoparticle abrasives are used for research and commercial manufacturing applications in the semiconductor and related industries. Despite growing use, no published studies addressed occupational exposures to nanoparticles associated with CMP or risk assessment and management practices for these scenarios. Additional studies are needed to evaluate potential sources of workplace exposure or emission, as well as to help test and refine assessment methods. This research was conducted to: identify the lifecycle stages and potential exposure sources for ENMs in CMP processes; characterize worker exposure; determine recommended engineering controls and compare risk assessment models. The study included workplace air and surface sampling and an evaluation of qualitative risk banding approaches. Exposure assessment results indicated the potential for worker contact with ENMs on workplace surfaces but did not identify nanoparticles readily dispersed in air during work tasks. Some increases in respirable particle concentrations were identified, but not consistently. Measured aerosol concentrations by number and mass were well below current reference values for poorly soluble low toxicity nanoparticles. From application and evaluation of qualitative risk assessment approaches, differences in control banding models and results were identified, although output generally agreed with conclusions from air sampling as to whether an upgrade in site engineering controls was recommended. This research helped to improve understanding of potential worker exposures to ENMs in CMP processes, as well as the methods for risk assessment and management of metal oxide nanoparticles in occupational environments.

  14. Status quo of management of the human tissue banks in Taiwan.

    PubMed

    Chou, Ching-Pang; Chou, Szu-Cheng; Chen, Ying-Hua; Chen, Yu-Hsuan; Lee, Ming-Shin

    2017-03-01

    As the technologies associated with transplantation and biological tissue engineering continue to advance, human cells and tissues form an integral part to the practice of regenerative medicine. The patient's use of tissues entails the risk of introducing, transmitting and spreading communicable diseases. To prevent such risk and to ensure that the human organs, tissues and cells remain intact and functional after being handled and processed, the transplanted tissues must be subject to good management standards through all stages of collection, screening, processing, storage and distribution as the safety of the users is of the utmost importance. On February 2009, the government of Taiwan promulgated the Regulations for Administration on Human Organ Bank that requires all human tissues banks to adhere to the Good Tissue Practice for Human Organ, Tissue and Cell in terms of establishment and operation in order to cope with the international management trend and the development and management need of the domestic industry. Six years have passed since the law became effective. This article seeks to introduce the current management mechanism and status quo of management of human tissue banks in Taiwan. We also conducted statistical analysis of the data relating to the tissue banks to identify potential risks and the room for improvement. The study concludes that human tissue banks in Taiwan are on the right track with their management practice, leading to a state of steady development and progress.

  15. Design of Knowledge Management System for Diabetic Complication Diseases

    NASA Astrophysics Data System (ADS)

    Fiarni, Cut

    2017-01-01

    This paper examines how to develop a Model for Knowledge Management System (KMS) for diabetes complication diseases. People with diabetes have a higher risk of developing a series of serious health problems. Each patient has different condition that could lead to different disease and health problem. But, with the right information, patient could have early detection so the health risk could be minimized and avoided. Hence, the objective of this research is to propose a conceptual framework that integrates social network model, Knowledge Management activities, and content based reasoning (CBR) for designing such a diabetes health and complication disease KMS. The framework indicates that the critical knowledge management activities are in the process to find similar case and the index table for algorithm to fit the framework for the social media. With this framework, KMS developers can work with healthcare provider to easily identify the suitable IT associated with the CBR process when developing a diabetes KMS.

  16. Prototype Software Assurance Framework (SAF): Introduction and Overview

    DTIC Science & Technology

    2017-04-05

    Introduction 1 1 Process Management (Category 1) 6 1.1 Process Definition (Area 1.1) 6 1.2 Infrastructure Standards (Area 1.2) 6 1.3 Resources (Area 1.3) 7...1.4 Training (Area 1.4) 8 2 Project Management (Category 2) 9 2.1 Project Plans (Area 2.1) 9 2.2 Project Infrastructure (Area 2.2) 10 2.3 Project...Monitoring (Area 2.3) 10 2.4 Project Risk Management (Area 2.4) 11 2.5 Supplier Management (Area 2.5) 11 3 Engineering (Category 3) 13 3.1 Product

  17. Radiation hazards in scoliosis management

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Drummond, D.; Ranallo, F.; Lonstein, J.

    1983-10-01

    Safe radiography in scoliosis management is based on a sound knowledge of 1) the radiographic imaging process, 2) the degree of risk to the patient from radiation exposure, and 3) the radiographic requirements to both evaluate and follow patients with spine deformity. This paper is a current review of the subject and work done at the authors' centers. It includes recommendations for reducing the radiation risk while maintaining necessary diagnostic information.

  18. [Risk Management: concepts and chances for public health].

    PubMed

    Palm, Stefan; Cardeneo, Margareta; Halber, Marco; Schrappe, Matthias

    2002-01-15

    Errors are a common problem in medicine and occur as a result of a complex process involving many contributing factors. Medical errors significantly reduce the safety margin for the patient and contribute additional costs in health care delivery. In most cases adverse events cannot be attributed to a single underlying cause. Therefore an effective risk management strategy must follow a system approach, which is based on counting and analysis of near misses. The development of defenses against the undesired effects of errors should be the main focus rather than asking the question "Who blundered?". Analysis of near misses (which in this context can be compared to indicators) offers several methodological advantages as compared to the analysis of errors and adverse events. Risk management is an integral element of quality management.

  19. An evaluation of HACCP implementation status in UK small and medium enterprises in food manufacturing.

    PubMed

    Fielding, L M; Ellis, L; Beveridge, C; Peters, A C

    2005-04-01

    To reduce foodborne illnesses, hazard and risk-based quality management systems are essential. Small and medium sized companies (SMEs) tend to have a poor understanding of such systems and limited adoption of the Hazard Analysis Critical Control Point system (HACCP). The requirement for full HACCP implementation by 2006 will place an even greater burden on these businesses. The aim of this project is to assess the current levels of understanding of hazards and risks in SMEs in the manufacturing sector. A questionnaire survey was made of 850 SMEs, including microbusinesses. This determined the industry sector and processes carried out, whether the company operated hazard-based quality management and the knowledge of the technical manager regarding the associated hazards and risks. Follow-up visits to the manufacturing plant observed the processes and the operatives to determine their level of understanding. A benchmarking audit was carried out and each company was rated. The results show that the majority of respondents stated that they operated hazard analysis-based quality management. The ability of the respondents to correctly define a hazard or risk or identify different types of hazard was, however, poor. There was no correlation between business type and audit score. The microbusinesses did, however, perform significantly less well than the larger SMEs.

  20. Risk Acceptance Personality Paradigm: How We View What We Don't Know We Don't Know

    NASA Technical Reports Server (NTRS)

    Massie, Michael J.; Morris, A. Terry

    2011-01-01

    The purpose of integrated hazard analyses, probabilistic risk assessments, failure modes and effects analyses, fault trees and many other similar tools is to give managers of a program some idea of the risks associated with their program. All risk tools establish a set of undesired events and then try to evaluate the risk to the program by assessing the severity of the undesired event and the likelihood of that event occurring. Some tools provide qualitative results, some provide quantitative results and some do both. However, in the end the program manager and his/her team must decide which risks are acceptable and which are not. Even with a wide array of analysis tools available, risk acceptance is often a controversial and difficult decision making process. And yet, today's space exploration programs are moving toward more risk based design approaches. Thus, risk identification and good risk assessment is becoming even more vital to the engineering development process. This paper explores how known and unknown information influences risk-based decisions by looking at how the various parts of our personalities are affected by what they know and what they don't know. This paper then offers some criteria for consideration when making risk-based decisions.

  1. Safety risk assessment using analytic hierarchy process (AHP) during planning and budgeting of construction projects.

    PubMed

    Aminbakhsh, Saman; Gunduz, Murat; Sonmez, Rifat

    2013-09-01

    The inherent and unique risks on construction projects quite often present key challenges to contractors. Health and safety risks are among the most significant risks in construction projects since the construction industry is characterized by a relatively high injury and death rate compared to other industries. In construction project management, safety risk assessment is an important step toward identifying potential hazards and evaluating the risks associated with the hazards. Adequate prioritization of safety risks during risk assessment is crucial for planning, budgeting, and management of safety related risks. In this paper, a safety risk assessment framework is presented based on the theory of cost of safety (COS) model and the analytic hierarchy process (AHP). The main contribution of the proposed framework is that it presents a robust method for prioritization of safety risks in construction projects to create a rational budget and to set realistic goals without compromising safety. The framework provides a decision tool for the decision makers to determine the adequate accident/injury prevention investments while considering the funding limits. The proposed safety risk framework is illustrated using a real-life construction project and the advantages and limitations of the framework are discussed. Copyright © 2013 National Safety Council and Elsevier Ltd. All rights reserved.

  2. Program risk analysis handbook

    NASA Technical Reports Server (NTRS)

    Batson, R. G.

    1987-01-01

    NASA regulations specify that formal risk analysis be performed on a program at each of several milestones. Program risk analysis is discussed as a systems analysis approach, an iterative process (identification, assessment, management), and a collection of techniques. These techniques, which range from extremely simple to complex network-based simulation, are described in this handbook in order to provide both analyst and manager with a guide for selection of the most appropriate technique. All program risk assessment techniques are shown to be based on elicitation and encoding of subjective probability estimates from the various area experts on a program. Techniques to encode the five most common distribution types are given. Then, a total of twelve distinct approaches to risk assessment are given. Steps involved, good and bad points, time involved, and degree of computer support needed are listed. Why risk analysis should be used by all NASA program managers is discussed. Tools available at NASA-MSFC are identified, along with commercially available software. Bibliography (150 entries) and a program risk analysis check-list are provided.

  3. RiskLab - a joint Teaching Lab on Hazard and Risk Management

    NASA Astrophysics Data System (ADS)

    Baruffini, Mi.; Baruffini, Mo.; Thuering, M.

    2009-04-01

    In the future natural disasters are expected to increase due to climatic changes that strongly affect environmental, social and economical systems. For this reason and because of the limited resources, governments require analytical risk analysis for a better mitigation planning. Risk analysis is a process to determine the nature and extent of risk by estimating potential hazards and evaluating existing conditions of vulnerability that could pose a potential threat or harm to people, property, livelihoods and environment. This process has become a generally accepted approach for the assessment of cost-benefit scenarios; originating from technical risks it is being applied to natural hazards for several years now in Switzerland. Starting from these premises "Risk Lab", a joint collaboration between the Institute of Earth Sciences of the University of Applied Sciences of Southern Switzerland and the Institute for Economic Research of the University of Lugano, has been started in 2006, aiming to become a competence centre about Risk Analysis and Evaluation. The main issue studied by the lab concerns the topic "What security at what price?" and the activities follow the philosophy of the integral risk management as proposed by PLANAT, that defines the process as a cycle that contains different and interrelated phases. The final aim is to change the population and technician idea about risk from "defending against danger" to "being aware of risks" through a proper academic course specially addressed to young people. In fact the most important activity of the laboratory consists in a degree course, offered both to Engineering and Architecture students of the University of Applied Sciences of Southern Switzerland and Economy Students of the University of Lugano. The course is structured in two main parts: an introductive, theoretical part, composed by class lessons, where the main aspects of natural hazards, risk perception and evaluation and risk management are presented and analyzed, and a second part, composed by practical activities, where students can learn specific statistical methods and test and use technical software. Special importance is given to seminars held by experts or members of Civil Protection and risk management institutes. Excursions are often organized to directly see and study practical case studies (Eg. The city of Locarno and the lake Maggiore inundations). The course is organized following a "classical" structure (it's mainly held in a class or in an informatics lab), but students can also benefit from a special web portal, powered by "e.coursers" , the official USI/SUPSI Learning Management System , where they can find issues and documents about natural hazards and risk management. The main pedagogical value is that students can attend a course which is entirely devoted to dealing with natural and man-made hazards and risk, allowing them to resume geological, space planning and economic issues and to face real case studies in a challenging and holistic environment. The final aim of the course is to provide students an useful and integrated "toolbox", essential to cope with and to resolve the overwhelming problems due to vulnerability and danger increase of the present-day society. The course has by now reached the third academic year and the initial results are encouraging: beyond the knowledge and expertise acquired, the graduate students, that are now for the most part working in engineering studies or private companies, have shown to have acquired a mentality devoted to understanding and managing risk. REFERENCES PLANAT HTTP://WWW.CENAT.CH/INDEX.PHP?USERHASH=79598753&L=D&NAVID=154 ECOURSES HTTP://CORSI.ELEARNINGLAB.ORG/ NAHRIS HTTP://WWW.NAHRIS.CH/

  4. Evolution and Implementation of the NASA Robotic Conjunction Assessment Risk Analysis Concept of Operations

    NASA Astrophysics Data System (ADS)

    Newman, L.; Hejduk, M.; Frigm, R.; Duncan, M.

    2014-09-01

    On-orbit collisions pose a significant mission risk to satellites operating in the space environment. Recognizing the likelihood and consequence of on-orbit collisions, NASA has taken several proactive measures to mitigate the risk of both a catastrophic loss of mission and the increase in the space debris population. In fall 2004, NASA GSFC established an Agency-wide, institutionalized process and service for identifying and reacting to predicted close approaches. The team responsible for executing this mission is the NASA Robotic Conjunction Assessment Risk Analysis (CARA) team. By fall 2005, this process had resulted in the execution of the first collision avoidance maneuver by a NASA unmanned satellite. In February 2008, NASA adopted a policy, documented in NASA Procedural Requirement 8715.6a Process for Limiting Orbital Debris that directed maneuverable satellites to have such an on-orbit collision mitigation process. In 2009, NASA decided to require support for all operational satellites. By January 2014, the CARA team has processed nearly 500,000 close approach messages from the Joint Space Operations Center (JSpOC) and has assisted our mission customers with planning and executing over 75 collision avoidance maneuvers for unmanned satellites in LEO, GEO, and HEO orbital regimes. With the increase in number of operational missions supported; growth in the orbital debris environment due to events such as the intentional destruction of the Fengyun 1-C satellite in 2007 and collision between Iridium-33 and Cosmos-2251; and improvements to the United States Space Surveillance Network (SSN) and its ability to track, catalog, and screen against small debris objects, the demands on the CARA process have consequently required the CARA Concept of Operations (CONOPS) to evolve to manage those demands. This evolution is centered on the ability to effectively and efficiently manage JSpOC, CARA, and Mission Operations resources, applying operational and analytical efforts for conjunction events that pose significant collision risk and rapidly discarding conjunction events that do not. While the overall CARA methodology is largely unaffected, this CONOPS evolution manifests itself in several aspects of the CARA process: required data and information, communication of those data and information, and courses of actions based on those data and information. The changes affect all relevant stakeholders, including the CARA team at NASA GSFC, GSFC-dedicated Orbital Safety Analysts at the JSpOC, and Mission Operations flight teams and management. In each step of the CARA process, the CONOPS ensures that necessary (whether situational or actionable) information be sent to stakeholders to facilitate an effective and efficient management of resources and appropriate protection of data. The most significant paradigm shift is the movement to risk-based reporting. Since the consequence of the on-orbit collision scenario can be catastrophic, the CARA risk-based framework hinges on the collision probability, Pc, as the encapsulation of collision risk. This CONOPS characterizes collision risk as Red (high collision risk), Yellow (potential for becoming a high collision risk), or Green (low collision risk) based on the operationally-computed Pc. Using this risk characterization schema, the amount and content of conjunction information and analyses is determined and communicated to mission stakeholders. Major technical analyses that have been conducted in support of this CONOPS include defining risk-based thresholds for red, yellow, and green criteria; determining when conjunction-related information may not be mature enough to be actionable; and accounting for uncertainties in all the inputs to the process so that a nuanced assessment of risk can be made. This paper summarizes the analyses executed and decisions rendered during the implementation of this evolved CONOPS. Historical conjunction events of note are used as example scenarios of each risk characterization.

  5. Periodontal Management by Risk Assessment: A Pragmatic Approach.

    PubMed

    Mullins, Joanna M; Even, Joshua B; White, Joel M

    2016-06-01

    An evidence-based periodontal disease risk assessment and diagnosis system has been developed and combined with a clinical decision support and management program to improve treatment and measure patient outcomes. There is little agreement on a universally accepted periodontal risk assessment, periodontal diagnosis, and treatment management tool and their incorporation into dental practice to improve patient care. This article highlights the development and use of a practical periodontal management and risk assessment program that can be implemented in dental settings. The approach taken by Willamette Dental Group to develop a periodontal disease risk assessment, periodontal diagnosis, and treatment management tool is described using evidence-based best practices. With goals of standardized treatment interventions while maintaining personalized care and improved communication, this process is described to facilitate its incorporation into other dental settings. Current electronic health records can be leveraged to enhance patient-centered care through the use of risk assessments and standardized guidelines to more effectively assess, diagnose, and treat patients to improve outcomes. Dental hygienists, and other committed providers, with their emphasis on prevention of periodontal disease can be principal drivers in creation and implementation of periodontal risk assessments and personalized treatment planning. Willamette Dental Group believes that such evidence-based tools can advance dentistry to new diagnostic and treatment standards. Copyright © 2016 Elsevier Inc. All rights reserved.

  6. Probabilistic Risk Assessment Procedures Guide for NASA Managers and Practitioners (Second Edition)

    NASA Technical Reports Server (NTRS)

    Stamatelatos,Michael; Dezfuli, Homayoon; Apostolakis, George; Everline, Chester; Guarro, Sergio; Mathias, Donovan; Mosleh, Ali; Paulos, Todd; Riha, David; Smith, Curtis; hide

    2011-01-01

    Probabilistic Risk Assessment (PRA) is a comprehensive, structured, and logical analysis method aimed at identifying and assessing risks in complex technological systems for the purpose of cost-effectively improving their safety and performance. NASA's objective is to better understand and effectively manage risk, and thus more effectively ensure mission and programmatic success, and to achieve and maintain high safety standards at NASA. NASA intends to use risk assessment in its programs and projects to support optimal management decision making for the improvement of safety and program performance. In addition to using quantitative/probabilistic risk assessment to improve safety and enhance the safety decision process, NASA has incorporated quantitative risk assessment into its system safety assessment process, which until now has relied primarily on a qualitative representation of risk. Also, NASA has recently adopted the Risk-Informed Decision Making (RIDM) process [1-1] as a valuable addition to supplement existing deterministic and experience-based engineering methods and tools. Over the years, NASA has been a leader in most of the technologies it has employed in its programs. One would think that PRA should be no exception. In fact, it would be natural for NASA to be a leader in PRA because, as a technology pioneer, NASA uses risk assessment and management implicitly or explicitly on a daily basis. NASA has probabilistic safety requirements (thresholds and goals) for crew transportation system missions to the International Space Station (ISS) [1-2]. NASA intends to have probabilistic requirements for any new human spaceflight transportation system acquisition. Methods to perform risk and reliability assessment in the early 1960s originated in U.S. aerospace and missile programs. Fault tree analysis (FTA) is an example. It would have been a reasonable extrapolation to expect that NASA would also become the world leader in the application of PRA. That was, however, not to happen. Early in the Apollo program, estimates of the probability for a successful roundtrip human mission to the moon yielded disappointingly low (and suspect) values and NASA became discouraged from further performing quantitative risk analyses until some two decades later when the methods were more refined, rigorous, and repeatable. Instead, NASA decided to rely primarily on the Hazard Analysis (HA) and Failure Modes and Effects Analysis (FMEA) methods for system safety assessment.

  7. Occupational Risks Associated with Solid Waste Management in the Informal Sector of Gweru, Zimbabwe

    PubMed Central

    Jerie, Steven

    2016-01-01

    This study identifies and analyses the occupational risks associated with solid waste management practices in the informal enterprises of Gweru. Many concerns have been raised about the potential harm from waste to the environment and the general public, but the risks and consequent costs of occupational hazards in waste management have received little attention in the rush to adopt or adapt technologies such as composting. A multimethods research design that triangulates qualitative and quantitative research paradigms is employed in this study. The quantitative design involves physical characterisation of solid waste through material component separation and measurements as well as a questionnaire survey that investigates the risks associated with waste management. The qualitative component includes interviews, open-ended questionnaires, and field observations. Occupational risks occur at every stage in the waste management process, from the point where workers handle waste in the enterprises for collection or recycling to the point of ultimate disposal. Key findings from the study revealed that solid waste management practices are dominated by manual handling tasks hence the higher incidents of muscular-skeletal disorders. Other safety and health hazards associated with waste management in the informal enterprises of Gweru include incidents of diarrhoea, viral hepatitis, and higher incidents of obstructive and restrictive disorders. PMID:27418935

  8. Occupational Risks Associated with Solid Waste Management in the Informal Sector of Gweru, Zimbabwe.

    PubMed

    Jerie, Steven

    2016-01-01

    This study identifies and analyses the occupational risks associated with solid waste management practices in the informal enterprises of Gweru. Many concerns have been raised about the potential harm from waste to the environment and the general public, but the risks and consequent costs of occupational hazards in waste management have received little attention in the rush to adopt or adapt technologies such as composting. A multimethods research design that triangulates qualitative and quantitative research paradigms is employed in this study. The quantitative design involves physical characterisation of solid waste through material component separation and measurements as well as a questionnaire survey that investigates the risks associated with waste management. The qualitative component includes interviews, open-ended questionnaires, and field observations. Occupational risks occur at every stage in the waste management process, from the point where workers handle waste in the enterprises for collection or recycling to the point of ultimate disposal. Key findings from the study revealed that solid waste management practices are dominated by manual handling tasks hence the higher incidents of muscular-skeletal disorders. Other safety and health hazards associated with waste management in the informal enterprises of Gweru include incidents of diarrhoea, viral hepatitis, and higher incidents of obstructive and restrictive disorders.

  9. Effect of risk aversion on prioritizing conservation projects.

    PubMed

    Tulloch, Ayesha I T; Maloney, Richard F; Joseph, Liana N; Bennett, Joseph R; Di Fonzo, Martina M I; Probert, William J M; O'Connor, Shaun M; Densem, Jodie P; Possingham, Hugh P

    2015-04-01

    Conservation outcomes are uncertain. Agencies making decisions about what threat mitigation actions to take to save which species frequently face the dilemma of whether to invest in actions with high probability of success and guaranteed benefits or to choose projects with a greater risk of failure that might provide higher benefits if they succeed. The answer to this dilemma lies in the decision maker's aversion to risk--their unwillingness to accept uncertain outcomes. Little guidance exists on how risk preferences affect conservation investment priorities. Using a prioritization approach based on cost effectiveness, we compared 2 approaches: a conservative probability threshold approach that excludes investment in projects with a risk of management failure greater than a fixed level, and a variance-discounting heuristic used in economics that explicitly accounts for risk tolerance and the probabilities of management success and failure. We applied both approaches to prioritizing projects for 700 of New Zealand's threatened species across 8303 management actions. Both decision makers' risk tolerance and our choice of approach to dealing with risk preferences drove the prioritization solution (i.e., the species selected for management). Use of a probability threshold minimized uncertainty, but more expensive projects were selected than with variance discounting, which maximized expected benefits by selecting the management of species with higher extinction risk and higher conservation value. Explicitly incorporating risk preferences within the decision making process reduced the number of species expected to be safe from extinction because lower risk tolerance resulted in more species being excluded from management, but the approach allowed decision makers to choose a level of acceptable risk that fit with their ability to accommodate failure. We argue for transparency in risk tolerance and recommend that decision makers accept risk in an adaptive management framework to maximize benefits and avoid potential extinctions due to inefficient allocation of limited resources. © 2014 Society for Conservation Biology.

  10. Regulatory Science in Professional Education.

    PubMed

    Akiyama, Hiroshi

    2017-01-01

    In the field of pharmaceutical sciences, the subject of regulatory science (RS) includes pharmaceuticals, food, and living environments. For pharmaceuticals, considering the balance between efficacy and safety is a point required for public acceptance, and in that balance, more importance is given to efficacy in curing disease. For food, however, safety is the most important consideration for public acceptance because food should be essentially free of risk. To ensure food safety, first, any hazard that is an agent in food or condition of food with the potential to cause adverse health effects should be identified and characterized. Then the risk that it will affect public health is scientifically analyzed. This process is called risk assessment. Second, risk management should be conducted to reduce a risk that has the potential to affect public health found in a risk assessment. Furthermore, risk communication, which is the interactive exchange of information and opinions concerning risk and risk management among risk assessors, risk managers, consumers, and other interested parties, should be conducted. Food safety is ensured based on risk analysis consisting of the three components of risk assessment, risk management, and risk communication. RS in the field of food safety supports risk analysis, such as scientific research and development of test methods to evaluate food quality, efficacy, and safety. RS is also applied in the field of living environments because the safety of environmental chemical substances is ensured based on risk analysis, similar to that conducted for food.

  11. Using data and quality monitoring to enhance maternity outcomes: a qualitative study of risk managers' perspectives.

    PubMed

    Simms, Rebecca A; Yelland, Andrew; Ping, Helen; Beringer, Antonia J; Draycott, Timothy J; Fox, Robert

    2014-06-01

    Risk management is a core part of healthcare practice, especially within maternity services, where litigation and societal costs are high. There has been little investigation into the experiences and opinions of those staff directly involved in risk management: lead obstetricians and specialist risk midwives, who are ideally placed to identify how current implementation of risk management strategies can be improved. A qualitative study of consultant-led maternity units in an English region. Semistructured interviews were conducted with the obstetric and midwifery risk management leads for each unit. We explored their approach to risk management, particularly their opinions regarding quality monitoring and related barriers/issues. Interviews were recorded, transcribed and thematically analysed. Twenty-seven staff from 12/15 maternity units participated. Key issues identified included: concern for the accuracy and validity of their local data, potential difficulties related to data collation, the negative impact of external interference by national regulatory bodies on local clinical priorities, the influence of the local culture of the maternity unit on levels of engagement in the risk management process, and scepticism about the value of benchmarking of maternity units without adjustment for population characteristics. Local maternity risk managers may provide valuable, clinically relevant insights into current issues in clinical data monitoring. Improvements should focus on the accuracy and ease of data collation with a need for an agreed maternity indicators set, populated from validated databases, and not reliant on data collection systems that distract clinicians from patient activity and quality improvement. It is clear that working relationships between risk managers, their own clinical teams and external national bodies require improvement and alignment. Further discussion regarding benchmarking between maternity units is required prior to implementation. These findings are likely to be relevant to other clinical specialties. Published by the BMJ Publishing Group Limited. For permission to use (where not already granted under a licence) please go to http://group.bmj.com/group/rights-licensing/permissions.

  12. TMT approach to observatory software development process

    NASA Astrophysics Data System (ADS)

    Buur, Hanne; Subramaniam, Annapurni; Gillies, Kim; Dumas, Christophe; Bhatia, Ravinder

    2016-07-01

    The purpose of the Observatory Software System (OSW) is to integrate all software and hardware components of the Thirty Meter Telescope (TMT) to enable observations and data capture; thus it is a complex software system that is defined by four principal software subsystems: Common Software (CSW), Executive Software (ESW), Data Management System (DMS) and Science Operations Support System (SOSS), all of which have interdependencies with the observatory control systems and data acquisition systems. Therefore, the software development process and plan must consider dependencies to other subsystems, manage architecture, interfaces and design, manage software scope and complexity, and standardize and optimize use of resources and tools. Additionally, the TMT Observatory Software will largely be developed in India through TMT's workshare relationship with the India TMT Coordination Centre (ITCC) and use of Indian software industry vendors, which adds complexity and challenges to the software development process, communication and coordination of activities and priorities as well as measuring performance and managing quality and risk. The software project management challenge for the TMT OSW is thus a multi-faceted technical, managerial, communications and interpersonal relations challenge. The approach TMT is using to manage this multifaceted challenge is a combination of establishing an effective geographically distributed software team (Integrated Product Team) with strong project management and technical leadership provided by the TMT Project Office (PO) and the ITCC partner to manage plans, process, performance, risk and quality, and to facilitate effective communications; establishing an effective cross-functional software management team composed of stakeholders, OSW leadership and ITCC leadership to manage dependencies and software release plans, technical complexities and change to approved interfaces, architecture, design and tool set, and to facilitate effective communications; adopting an agile-based software development process across the observatory to enable frequent software releases to help mitigate subsystem interdependencies; defining concise scope and work packages for each of the OSW subsystems to facilitate effective outsourcing of software deliverables to the ITCC partner, and to enable performance monitoring and risk management. At this stage, the architecture and high-level design of the software system has been established and reviewed. During construction each subsystem will have a final design phase with reviews, followed by implementation and testing. The results of the TMT approach to the Observatory Software development process will only be preliminary at the time of the submittal of this paper, but it is anticipated that the early results will be a favorable indication of progress.

  13. PRA and Conceptual Design

    NASA Technical Reports Server (NTRS)

    DeMott, Diana; Fuqua, Bryan; Wilson, Paul

    2013-01-01

    Once a project obtains approval, decision makers have to consider a variety of alternative paths for completing the project and meeting the project objectives. How decisions are made involves a variety of elements including: cost, experience, current technology, ideologies, politics, future needs and desires, capabilities, manpower, timing, available information, and for many ventures management needs to assess the elements of risk versus reward. The use of high level Probabilistic Risk Assessment (PRA) Models during conceptual design phases provides management with additional information during the decision making process regarding the risk potential for proposed operations and design prototypes. The methodology can be used as a tool to: 1) allow trade studies to compare alternatives based on risk, 2) determine which elements (equipment, process or operational parameters) drives the risk, and 3) provide information to mitigate or eliminate risks early in the conceptual design to lower costs. Creating system models using conceptual design proposals and generic key systems based on what is known today can provide an understanding of the magnitudes of proposed systems and operational risks and facilitates trade study comparisons early in the decision making process. Identifying the "best" way to achieve the desired results is difficult, and generally occurs based on limited information. PRA provides a tool for decision makers to explore how some decisions will affect risk before the project is committed to that path, which can ultimately save time and money.

  14. Application of ICH Q9 Quality Risk Management Tools for Advanced Development of Hot Melt Coated Multiparticulate Systems.

    PubMed

    Stocker, Elena; Becker, Karin; Hate, Siddhi; Hohl, Roland; Schiemenz, Wolfgang; Sacher, Stephan; Zimmer, Andreas; Salar-Behzadi, Sharareh

    2017-01-01

    This study aimed to apply quality risk management based on the The International Conference on Harmonisation guideline Q9 for the early development stage of hot melt coated multiparticulate systems for oral administration. N-acetylcysteine crystals were coated with a formulation composing tripalmitin and polysorbate 65. The critical quality attributes (CQAs) were initially prioritized using failure mode and effects analysis. The CQAs of the coated material were defined as particle size, taste-masking efficiency, and immediate release profile. The hot melt coated process was characterized via a flowchart, based on the identified potential critical process parameters (CPPs) and their impact on the CQAs. These CPPs were prioritized using a process failure mode, effects, and criticality analysis and their critical impact on the CQAs was experimentally confirmed using a statistical design of experiments. Spray rate, atomization air pressure, and air flow rate were identified as CPPs. Coating amount and content of polysorbate 65 in the coating formulation were identified as critical material attributes. A hazard and critical control points analysis was applied to define control strategies at the critical process points. A fault tree analysis evaluated causes for potential process failures. We successfully demonstrated that a standardized quality risk management approach optimizes the product development sustainability and supports the regulatory aspects. Copyright © 2016 American Pharmacists Association®. Published by Elsevier Inc. All rights reserved.

  15. Ordinary risks and accepted fictions: how contrasting and competing priorities work in risk assessment and mental health care planning.

    PubMed

    Coffey, Michael; Cohen, Rachel; Faulkner, Alison; Hannigan, Ben; Simpson, Alan; Barlow, Sally

    2017-06-01

    Communication and information sharing are considered crucial to recovery-focused mental health services. Effective mental health care planning and coordination includes assessment and management of risk and safety. Using data from our cross-national mixed-method study of care planning and coordination, we examined what patients, family members and workers say about risk assessment and management and explored the contents of care plans. Thematic analysis of qualitative research interviews (n = 117) with patients, family members and workers, across four English and two Welsh National Health Service sites. Care plans were reviewed (n = 33) using a structured template. Participants have contrasting priorities in relation to risk. Patients see benefit in discussions about risk, but cast the process as a worker priority that may lead to loss of liberty. Relationships with workers are key to family members and patients; however, worker claims of involving people in the care planning process do not extend to risk assessment and management procedures for fear of causing upset. Workers locate risk as coming from the person rather than social or environmental factors, are risk averse and appear to prioritize the procedural aspects of assessment. Despite limitations, risk assessment is treated as legitimate work by professionals. Risk assessment practice operates as a type of fiction in which poor predictive ability and fear of consequences are accepted in the interests of normative certainty by all parties. As a consequence, risk adverse options are encouraged by workers and patients steered away from opportunities for ordinary risks thereby hindering the mobilization of their strengths and abilities. © 2016 The Authors. Health Expectations Published by John Wiley & Sons Ltd.

  16. Semi Automatic Ontology Instantiation in the domain of Risk Management

    NASA Astrophysics Data System (ADS)

    Makki, Jawad; Alquier, Anne-Marie; Prince, Violaine

    One of the challenging tasks in the context of Ontological Engineering is to automatically or semi-automatically support the process of Ontology Learning and Ontology Population from semi-structured documents (texts). In this paper we describe a Semi-Automatic Ontology Instantiation method from natural language text, in the domain of Risk Management. This method is composed from three steps 1 ) Annotation with part-of-speech tags, 2) Semantic Relation Instances Extraction, 3) Ontology instantiation process. It's based on combined NLP techniques using human intervention between steps 2 and 3 for control and validation. Since it heavily relies on linguistic knowledge it is not domain dependent which is a good feature for portability between the different fields of risk management application. The proposed methodology uses the ontology of the PRIMA1 project (supported by the European community) as a Generic Domain Ontology and populates it via an available corpus. A first validation of the approach is done through an experiment with Chemical Fact Sheets from Environmental Protection Agency2.

  17. A microseismic workflow for managing induced seismicity risk as CO 2 storage projects

    DOE Office of Scientific and Technical Information (OSTI.GOV)

    Matzel, E.; Morency, C.; Pyle, M.

    2015-10-27

    It is well established that fluid injection has the potential to induce earthquakes—from microseismicity to large, damaging events—by altering state-of-stress conditions in the subsurface. While induced seismicity has not been a major operational issue for carbon storage projects to date, a seismicity hazard exists and must be carefully addressed. Two essential components of effective seismic risk management are (1) sensitive microseismic monitoring and (2) robust data interpretation tools. This report describes a novel workflow, based on advanced processing algorithms applied to microseismic data, to help improve management of seismic risk. This workflow has three main goals: (1) to improve themore » resolution and reliability of passive seismic monitoring, (2) to extract additional, valuable information from continuous waveform data that is often ignored in standard processing, and (3) to minimize the turn-around time between data collection, interpretation, and decision-making. These three objectives can allow for a better-informed and rapid response to changing subsurface conditions.« less

  18. Decision making regarding prophylactic mastectomy: stability of preferences and the impact of anticipated feelings of regret.

    PubMed

    van Dijk, Sandra; van Roosmalen, Mariëlle S; Otten, Wilma; Stalmeier, Peep F M

    2008-05-10

    Women who test positive for a BRCA1/2 mutation face difficult choices to manage their breast cancer risk; one of these choices is whether to opt for prophylactic mastectomy. Few data are available about this decision-making process. The current study provides data regarding the stability of risk-management preferences over time and the factors that are associated with these preferences. We analyzed data from 338 women who opted for breast cancer antigen (BRCA) testing. First, we prospectively assessed preferences of 80 BRCA mutation carriers at five different points in time ranging from 1 week after blood sampling up to 9 months after BRCA-test disclosure. Second, we applied univariate and multivariate regression analyses to examine which medical, sociodemographic, and psychological factors are related to a preference for prophylactic mastectomy. Ninety percent of the women already indicated a preference regarding risk management at baseline. Moreover, most women had stable preferences over time. Furthermore, anticipated feelings of regret in case of a hypothetical breast cancer diagnosis in the near future were strongly related to risk-management preference (odds ratio = 8.93; P < .0001). Women seem to decide at a relatively early stage about their risk-management preferences. Many of them may be sensitive to the possibility of regret in case of a bad outcome. We discuss whether possible regret in the future is a rational reason for opting for prophylactic mastectomy, or whether it signifies an emotional coping process or strategy in which the future costs are no longer fully considered.

  19. Development of economic consequence methodology for process risk analysis.

    PubMed

    Zadakbar, Omid; Khan, Faisal; Imtiaz, Syed

    2015-04-01

    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. © 2014 Society for Risk Analysis.

  20. The risk concept and its application in natural hazard risk management in Switzerland

    NASA Astrophysics Data System (ADS)

    Bründl, M.; Romang, H. E.; Bischof, N.; Rheinberger, C. M.

    2009-05-01

    Over the last ten years, a risk-based approach to manage natural hazards - termed the risk concept - has been introduced to the management of natural hazards in Switzerland. Large natural hazard events, new political initiatives and limited financial resources have led to the development and introduction of new planning instruments and software tools that should support natural hazard engineers and planners to effectively and efficiently deal with natural hazards. Our experience with these new instruments suggests an improved integration of the risk concept into the community of natural hazard engineers and planners. Important factors for the acceptance of these new instruments are the integration of end-users during the development process, the knowledge exchange between science, developers and end-users as well as training and education courses for users. Further improvements require the maintenance of this knowledge exchange and a mindful adaptation of the instruments to case-specific circumstances.

  1. Risk prioritisation using the analytic hierarchy process

    NASA Astrophysics Data System (ADS)

    Sum, Rabihah Md.

    2015-12-01

    This study demonstrated how to use the Analytic Hierarchy Process (AHP) to prioritise risks of an insurance company. AHP is a technique to structure complex problems by arranging elements of the problems in a hierarchy, assigning numerical values to subjective judgements on the relative importance of the elements and synthesizing the judgements to determine which elements have the highest priority. The study is motivated by wide application of AHP as a prioritisation technique in complex problems. It aims to show AHP is able to minimise some limitations of risk assessment technique using likelihood and impact. The study shows AHP is able to provide consistency check on subjective judgements, organise a large number of risks into a structured framework, assist risk managers to make explicit risk trade-offs, and provide an easy to understand and systematic risk assessment process.

  2. Risk analysis of hematopoietic stem cell transplant process: failure mode, effect, and criticality analysis and hazard analysis critical control point methods integration based on guidelines to good manufacturing practice for medicinal product ANNEX 20 (February 2008).

    PubMed

    Gianassi, S; Bisin, S; Bindi, B; Spitaleri, I; Bambi, F

    2010-01-01

    The collection and handling of hematopoietic stem cells (HSCs) must meet high quality requirements. An integrated Quality Risk Management can help to identify and contain potential risks related to HSC production. Risk analysis techniques allow one to "weigh" identified hazards, considering the seriousness of their effects, frequency, and detectability, seeking to prevent the most harmful hazards. The Hazard Analysis Critical Point, recognized as the most appropriate technique to identify risks associated with physical, chemical, and biological hazards for cellular products, consists of classifying finished product specifications and limits of acceptability, identifying all off-specifications, defining activities that can cause them, and finally establishing both a monitoring system for each Critical Control Point and corrective actions for deviations. The severity of possible effects on patients, as well as the occurrence and detectability of critical parameters, are measured on quantitative scales (Risk Priority Number [RPN]). Risk analysis was performed with this technique on manipulation process of HPC performed at our blood center. The data analysis showed that hazards with higher values of RPN with greater impact on the process are loss of dose and tracking; technical skills of operators and manual transcription of data were the most critical parameters. Problems related to operator skills are handled by defining targeted training programs, while other critical parameters can be mitigated with the use of continuous control systems. The blood center management software was completed by a labeling system with forms designed to be in compliance with standards in force and by starting implementation of a cryopreservation management module. Copyright 2010 Elsevier Inc. All rights reserved.

  3. Space Transportation System Liftoff Debris Mitigation Process Overview

    NASA Technical Reports Server (NTRS)

    Mitchell, Michael; Riley, Christopher

    2011-01-01

    Liftoff debris is a top risk to the Space Shuttle Vehicle. To manage the Liftoff debris risk, the Space Shuttle Program created a team with in the Propulsion Systems Engineering & Integration Office. The Shutt le Liftoff Debris Team harnesses the Systems Engineering process to i dentify, assess, mitigate, and communicate the Liftoff debris risk. T he Liftoff Debris Team leverages off the technical knowledge and expe rtise of engineering groups across multiple NASA centers to integrate total system solutions. These solutions connect the hardware and ana lyses to identify and characterize debris sources and zones contribut ing to the Liftoff debris risk. The solutions incorporate analyses sp anning: the definition and modeling of natural and induced environmen ts; material characterizations; statistical trending analyses, imager y based trajectory analyses; debris transport analyses, and risk asse ssments. The verification and validation of these analyses are bound by conservative assumptions and anchored by testing and flight data. The Liftoff debris risk mitigation is managed through vigilant collab orative work between the Liftoff Debris Team and Launch Pad Operation s personnel and through the management of requirements, interfaces, r isk documentation, configurations, and technical data. Furthermore, o n day of launch, decision analysis is used to apply the wealth of ana lyses to case specific identified risks. This presentation describes how the Liftoff Debris Team applies Systems Engineering in their proce sses to mitigate risk and improve the safety of the Space Shuttle Veh icle.

  4. Spatial and temporal variation in evacuee risk perception throughout the evacuation and return-entry process.

    PubMed

    Siebeneck, Laura K; Cova, Thomas J

    2012-09-01

    Developing effective evacuation and return-entry plans requires understanding the spatial and temporal dimensions of risk perception experienced by evacuees throughout a disaster event. Using data gathered from the 2008 Cedar Rapids, Iowa Flood, this article explores how risk perception and location influence evacuee behavior during the evacuation and return-entry process. Three themes are discussed: (1) the spatial and temporal characteristics of risk perception throughout the evacuation and return-entry process, (2) the relationship between risk perception and household compliance with return-entry orders, and (3) the role social influences have on the timing of the return by households. The results indicate that geographic location and spatial variation of risk influenced household risk perception and compliance with return-entry plans. In addition, sociodemographic characteristics influenced the timing and characteristics of the return groups. The findings of this study advance knowledge of evacuee behavior throughout a disaster and can inform strategies used by emergency managers throughout the evacuation and return-entry process. © 2012 Society for Risk Analysis.

  5. OPP Guidance for Submission of State and Tribal Water Quality Monitoring Data

    EPA Pesticide Factsheets

    This guidance describes the process to submit state and tribal surface and groundwater monitoring data for consideration in exposure characterizations for ecological and and human health risk assessments and in risk management decisions for pesticides.

  6. EPA'S HUMAN EXPOSURE MEASUREMENT PROGRAM

    EPA Science Inventory

    The goal of NERL's Exposure Research Program is to improve the scientific basis for conducting human exposure assessments that are part of the EPA's risk assessment, risk management and compliance process. Overall, we aim to address aggregate and cumulative exposures that pose...

  7. We Don't Need Any Stinking AFSRB!

    NASA Technical Reports Server (NTRS)

    Henwood, Barton

    2008-01-01

    Flight Test supports four needs: a) Management approval to proceed; b) Establish a record of accountability; c) Inject expert insight into the risk management process; and d) Mitigate the human factors vulnerabilities associated with small group teaming and project ownership.

  8. Using ecological production functions to link ecological processes to ecosystem services.

    EPA Science Inventory

    Ecological production functions (EPFs) link ecosystems, stressors, and management actions to ecosystem services (ES) production. Although EPFs are acknowledged as being essential to improve environmental management, their use in ecological risk assessment has received relatively ...

  9. Environmental audits and process flow mapping to assess management of solid waste and wastewater from a healthcare facility: an Italian case study.

    PubMed

    Vaccari, Mentore; Montasser, Waleed; Tudor, Terry; Leone, Luigi

    2017-05-01

    In Europe, there are an increasing number of policy and legislative drivers for a more sustainable approach to the management of natural resources as well as for the mitigation of environmental health risks. However, despite significant progress in recent years, there is still some way to go to achieve circularity of process, as well as risk mitigation within organisations. Using a case study of the Gardone Val Trompia hospital in northern Italy, this manuscript offers a novel holistic examination of strategies to enhance resource efficiency and environmental health within a key sector, i.e. the healthcare sector. Through the use of environmental audits and process flow mapping, trends in waste and wastewater arisings and the associated financial and environmental costs and risks were identified. Recommendations for developing more resource efficient approaches as well as mitigating the environmental and public health risks are suggested. These include strategies for improved resource efficiency (including reduction in the hazardous waste) and reduced environmental impacts during the containment, transport and treatment of the waste.

  10. Stalking and Violence.

    PubMed

    Ostermeyer, Britta; Friedman, Susan Hatters; Sorrentino, Renee; Booth, Brad D

    2016-12-01

    The three widely known stalker classifications assist in categorizing stalkers, which allows for better management of violence risk. Although 80% of stalking is done by men, women also engage in stalking, and their violence risk should not be underestimated. Juvenile stalkers do exist and juvenile stalking is also associated with violence. Clinicians can become a victim of stalking and may become victims of stalking by proxy, a special type of stalking behavior where the stalker involves other people or agencies to communicate with or track their victim. A careful stalking violence risk assessment is essential in the intervention and risk management process. Copyright © 2016 Elsevier Inc. All rights reserved.

  11. Participatory ergonomics: co-developing interventions to reduce the risk of musculoskeletal symptoms in business drivers.

    PubMed

    Gyi, Diane; Sang, Katherine; Haslam, Cheryl

    2013-01-01

    The participatory process within four case study organisations with a target population of high mileage business drivers is described. The aim was to work with drivers and their managers to co-develop intervention activities to raise awareness of musculoskeletal health in drivers, including use of the car as a mobile office and manual handling from the car. Train-the-trainer sessions were delivered in each organisation, along with the co-production of training materials. The effectiveness of these activities were evaluated using three sources of data: post-intervention questionnaires, interviews with organisation 'champions' and observations from the research team's diaries. The approach raised management awareness of the risks to drivers and was successful in affecting change, and as such, participatory research should consider the early stages of a project as part of any intervention activities. The research team also reflect on conducting applied longitudinal research in the field. Raising awareness of the risks of musculoskeletal disorders in drivers who work from their vehicle is important. This paper reflects on research in the field and provides guidance on the participatory process and evaluating intervention activities. The participatory process was successful in affecting change at management level.

  12. [The role of a specialised risk analysis group in the Veterinary Services of a developing country].

    PubMed

    Urbina-Amarís, M E

    2003-08-01

    Since the World Trade Organization (WTO) Agreement on the Application of Sanitary and Phytosanitary Measures was established, risk analysis in trade, and ultimately in Veterinary and Animal Health Services, has become strategically important. Irrespective of their concept (discipline, approach, method, process), all types of risk analysis in trade involve four periods or phases:--risk identification-- risk assessment--risk management--risk information or communication. All veterinarians involved in a risk analysis unit must have in-depth knowledge of statistics and the epidemiology of transmissible diseases, as well as a basic knowledge of veterinary science, economics, mathematics, data processing and social communication, to enable them to work with professionals in these disciplines. Many developing countries do not have enough well-qualified professionnals in these areas to support a risk analysis unit. This will need to be rectified by seeking strategic alliances with other public or private sectors that will provide the required support to run the unit properly. Due to the special nature of its risk analysis functions, its role in supporting decision-making, and the criteria of independence and transparency that are so crucial to its operations, the hierarchical position of the risk analysis unit should be close to the top management of the Veterinary Service. Due to the shortage of personnel in developing countries with the required training and scientific and technical qualifications, countries with organisations responsible for both animal and plant health protection would be advised to set up integrated plant and animal risk analysis units. In addition, these units could take charge of all activities relating to WTO agreements and regional agreements on animal and plant health management.

  13. Environmental Risk Assessment of dredging processes - application to Marin harbour (NW Spain)

    NASA Astrophysics Data System (ADS)

    Gómez, A. G.; García Alba, J.; Puente, A.; Juanes, J. A.

    2014-04-01

    A methodological procedure to estimate the environmental risk of dredging operations in aquatic systems has been developed. Environmental risk estimations are based on numerical models results, which provide an appropriated spatio-temporal framework analysis to guarantee an effective decision-making process. The methodological procedure has been applied on a real dredging operation in the port of Marin (NW Spain). Results from Marin harbour confirmed the suitability of the developed methodology and the conceptual approaches as a comprehensive and practical management tool.

  14. Optimizing claims payment for successful risk management.

    PubMed

    Frates, Janice; Ginty, Mary Jo; Baker, Linda

    2002-05-01

    Disputed claims and delayed payments are among the principal sources of provider and vendor dissatisfaction with managed care payment systems. Timely and accurate claims-payment systems are essential to ensure provider and vendor satisfaction, fiscal stability, and regulatory compliance. A focused analysis of conditions contributing to late payment of claims can disclose problems in provider, vendor, or payer operational and billing procedures, contracting processes, information systems, or human resources management. Resolution of these conditions equips claims-processing staff with tools to resolve problem claims promptly, thereby lowering costs.

  15. Managing Auditory Risk from Acoustically Impulsive Chemical Demonstrations

    ERIC Educational Resources Information Center

    Macedone, Jeffrey H.; Gee, Kent L.; Vernon, Julia A.

    2014-01-01

    Chemical demonstrations are an integral part of the process of how students construct meaning from chemical principles, but may introduce risks to students and presenters. Some demonstrations are known to be extremely loud and present auditory hazards; little has been done to assess the risks to educators and students. Using laboratory-grade…

  16. Implementation of quality by design toward processing of food products.

    PubMed

    Rathore, Anurag S; Kapoor, Gautam

    2017-05-28

    Quality by design (QbD) is a systematic approach that begins with predefined objectives and emphasizes product and process understanding and process control. It is an approach based on principles of sound science and quality risk management. As the food processing industry continues to embrace the idea of in-line, online, and/or at-line sensors and real-time characterization for process monitoring and control, the existing gaps with regard to our ability to monitor multiple parameters/variables associated with the manufacturing process will be alleviated over time. Investments made for development of tools and approaches that facilitate high-throughput analytical and process development, process analytical technology, design of experiments, risk analysis, knowledge management, and enhancement of process/product understanding would pave way for operational and economic benefits later in the commercialization process and across other product pipelines. This article aims to achieve two major objectives. First, to review the progress that has been made in the recent years on the topic of QbD implementation in processing of food products and second, present a case study that illustrates benefits of such QbD implementation.

  17. Risk communication and the Precautionary Principle.

    PubMed

    Biocca, Marco

    2004-01-01

    The perception of risks for environment and health deriving from globalization processes and an uncontrolled use of modern technologies is growing everywhere. The greater the capacity of controlling living conditions, the larger is the possibility of misusing this power. In environmental and occupational health research we tend to reduce the complexity of the observed phenomena in order to facilitate conclusions. In social and political sciences complexity is an essential element of the context, which needs to be continuously considered. The Precautionary Principle is a tool for facing complexity and uncertainty in health risk management. This paper is aimed at demonstrating that this is not only a problem of technical risk assessment. Great attention should also be paid to improve risk communication. Communication between the stakeholders (experts, decision makers, political and social leaders, media, groups of interest and people involved) is possibly the best condition to be successful in health risk management. Nevertheless, this process usually runs up against severe obstacles. These are not only caused by existing conflicts of interest. Differences in values, languages, perceptions, resources to have access to information, and to express one's own point of view are other key aspects.

  18. Optimizing spacecraft design - optimization engine development : progress and plans

    NASA Technical Reports Server (NTRS)

    Cornford, Steven L.; Feather, Martin S.; Dunphy, Julia R; Salcedo, Jose; Menzies, Tim

    2003-01-01

    At JPL and NASA, a process has been developed to perform life cycle risk management. This process requires users to identify: goals and objectives to be achieved (and their relative priorities), the various risks to achieving those goals and objectives, and options for risk mitigation (prevention, detection ahead of time, and alleviation). Risks are broadly defined to include the risk of failing to design a system with adequate performance, compatibility and robustness in addition to more traditional implementation and operational risks. The options for mitigating these different kinds of risks can include architectural and design choices, technology plans and technology back-up options, test-bed and simulation options, engineering models and hardware/software development techniques and other more traditional risk reduction techniques.

  19. European Software Engineering Process Group Conference (2nd Annual), EUROPEAN SEPG󈨥. Delegate Material, Tutorials

    DTIC Science & Technology

    1997-06-17

    There is Good and Bad News With CMMs8 *bad news: process improvement takes time *good news: the first benefit Is better schedule management With PSP s...e g similar supp v EURO not sudden death toolset for assessment and v EURO => Business benefits detailed analysis) . EURO could collapse (low risk...from SPI live on even after year 2000. Priority BENEFITS Actions * Improved management and application development processes * Strengthened Change

  20. Psychodynamic Perspective on Therapeutic Boundaries

    PubMed Central

    Bridges, Nancy A.

    1999-01-01

    Discussion of boundaries in therapeutic work most often focuses on boundary maintenance, risk management factors, and boundary violations. The psychodynamic meaning and clinical management of boundaries in therapeutic relationships remains a neglected area of discourse. Clinical vignettes will illustrate a psychodynamic, developmental-relational perspective using boundary dilemmas to deepen and advance the therapeutic process. This article contributes to the dialogue about the process of making meaning and constructing therapeutically useful and creative boundaries that further the psychotherapeutic process. PMID:10523432

  1. Risk assessment for enterprise resource planning (ERP) system implementations: a fault tree analysis approach

    NASA Astrophysics Data System (ADS)

    Zeng, Yajun; Skibniewski, Miroslaw J.

    2013-08-01

    Enterprise resource planning (ERP) system implementations are often characterised with large capital outlay, long implementation duration, and high risk of failure. In order to avoid ERP implementation failure and realise the benefits of the system, sound risk management is the key. This paper proposes a probabilistic risk assessment approach for ERP system implementation projects based on fault tree analysis, which models the relationship between ERP system components and specific risk factors. Unlike traditional risk management approaches that have been mostly focused on meeting project budget and schedule objectives, the proposed approach intends to address the risks that may cause ERP system usage failure. The approach can be used to identify the root causes of ERP system implementation usage failure and quantify the impact of critical component failures or critical risk events in the implementation process.

  2. Risk management of emergency service vehicle crashes in the United States fire service: process, outputs, and recommendations.

    PubMed

    Bui, David P; Pollack Porter, Keshia; Griffin, Stephanie; French, Dustin D; Jung, Alesia M; Crothers, Stephen; Burgess, Jefferey L

    2017-11-17

    Emergency service vehicle crashes (ESVCs) are a leading cause of death in the United States fire service. Risk management (RM) is a proactive process for identifying occupational risks and reducing hazards and unwanted events through an iterative process of scoping hazards, risk assessment, and implementing controls. We describe the process, outputs, and lessons learned from the application of a proactive RM process to reduce ESVCs in US fire departments. Three fire departments representative of urban, suburban, and rural geographies, participated in a facilitated RM process delivered through focus groups and stakeholder discussion. Crash reports from department databases were reviewed to characterize the context, circumstances, hazards and risks of ESVCs. Identified risks were ranked using a risk matrix that considered risk likelihood and severity. Department-specific control measures were selected based on group consensus. Interviews, and focus groups were used to assess acceptability and utility of the RM process and perceived facilitators and barriers of implementation. Three to six RM meetings were conducted at each fire department. There were 7.4 crashes per 100 personnel in the urban department and 10.5 per 100 personnel in the suburban department; the rural department experienced zero crashes. All departments identified emergency response, backing, on scene struck by, driver distraction, vehicle/road visibility, and driver training as high or medium concerns. Additional high priority risks varied by department; the urban department prioritized turning and rear ending crashes; the suburban firefighters prioritized inclement weather/road environment and low visibility related crashes; and the rural volunteer fire department prioritized exiting station, vehicle failure, and inclement weather/road environment related incidents. Selected controls included new policies and standard operating procedures to reduce emergency response, cameras to enhance driver visibility while backing, and increased training frequency and enhanced training. The RM process was generally acceptable to department participants and considered useful. All departments reported that the focused and systematic analysis of crashes was particularly helpful. Implementation of controls was a commonly cited challenge. Proactive RM of ESVCs in three US fire departments was positively received and supported the establishment of interventions tailored to each department's needs and priorities.

  3. Managing Analysis Models in the Design Process

    NASA Technical Reports Server (NTRS)

    Briggs, Clark

    2006-01-01

    Design of large, complex space systems depends on significant model-based support for exploration of the design space. Integrated models predict system performance in mission-relevant terms given design descriptions and multiple physics-based numerical models. Both the design activities and the modeling activities warrant explicit process definitions and active process management to protect the project from excessive risk. Software and systems engineering processes have been formalized and similar formal process activities are under development for design engineering and integrated modeling. JPL is establishing a modeling process to define development and application of such system-level models.

  4. Validation of Air Force Hazard Assessment Rating Methodology.

    DTIC Science & Technology

    1985-09-01

    the product of the probability and magnitude of each undesirable possible outcome, integrated or summed over all undesirable outcomes [28:5]. Risk...is difficult to keep risk management factors out of the risk assessment process (27:35). Site Contamination. Since site contamination is a major part...same standards for risks from new products and industries as it does for old products and industries. The risks of new products are screened very

  5. Risk management and lessons learned solutions for satellite product assurance

    NASA Astrophysics Data System (ADS)

    Larrère, Jean-Luc

    2004-08-01

    The historic trend of the space industry towards lower cost programmes and more generally a better economic efficiency raises a difficult question to the quality assurance community: how to achieve the same—or better—mission success rate while drastically reducing the cost of programmes, hence the cost and level of quality assurance activities. EADS Astrium Earth Observation and Science (France) Business Unit have experimented Risk Management and Lessons Learned on their satellite programmes to achieve this goal. Risk analysis and management are deployed from the programme proposal phase through the development and operations phases. Results of the analysis and the corresponding risk mitigation actions are used to tailor the product assurance programme and activities. Lessons learned have been deployed as a systematic process to collect positive and negative experience from past and on-going programmes and feed them into new programmes. Monitoring and justification of their implementation in programmes is done under supervision from the BU quality assurance function. Control of the system is ensured by the company internal review system. Deployment of these methods has shown that the quality assurance function becomes more integrated in the programme team and development process and that its tasks gain focus and efficiency while minimising the risks associated with new space programmes.

  6. A simple method to identify areas of environmental risk due to manure application.

    PubMed

    Flores, Héctor; Arumí, José Luis; Rivera, Diego; Lagos, L Octavio

    2012-06-01

    The management of swine manure is becoming an important environmental issue in Chile. One option for the final disposal of manure is to use it as a biofertilizer, but this practice could impact the surrounding environment. To assess the potential environmental impacts of the use of swine manure as a biofertilizer, we propose a method to identify zones of environmental risk through indices. The method considers two processes: nutrient runoff and solute leaching, and uses available information about soils, crops and management practices (irrigation, fertilization, and rotation). We applied the method to qualitatively assess the environmental risk associated with the use of swine manure as a biofertilizer in an 8,000-pig farm located in Central Chile. Results showed that the farm has a moderate environmental risk, but some specific locations have high environmental risks, especially those associated with impacts on areas surrounding water resources. This information could assist the definition of better farm-level management practices, as well as the preservation of riparian vegetation acting as buffer strips. The main advantage of our approach is that it combines qualitative and quantitative information, including particular situations or field features based on expert knowledge. The method is flexible, simple, and can be easily extended or adapted to other processes.

  7. Natural-technological risk assessment and management

    NASA Astrophysics Data System (ADS)

    Burova, Valentina; Frolova, Nina

    2016-04-01

    EM-DAT statistical data on human impact and economic damages in the 1st semester 2015 are the highest since 2011: 41% of disasters were floods, responsible for 39% of economic damage and 7% of events were earthquakes responsible for 59% of total death toll. This suggests that disaster risk assessment and management still need to be improved and stay the principle issue in national and international related programs. The paper investigates the risk assessment and management practice in the Russian Federation at different levels. The method is proposed to identify the territories characterized by integrated natural-technological hazard. The maps of the Russian Federation zoning according to the integrated natural-technological hazard level are presented, as well as the procedure of updating the integrated hazard level taking into account the activity of separate processes. Special attention is paid to data bases on past natural and technological processes consequences, which are used for verification of current hazard estimation. The examples of natural-technological risk zoning for the country and some regions territory are presented. Different output risk indexes: both social and economic, are estimated taking into account requirements of end-users. In order to increase the safety of population of the Russian Federation the trans-boundaries hazards are also taken into account.

  8. Risks posed by climate change to the delivery of Water Framework Directive objectives in the UK.

    PubMed

    Wilby, R L; Orr, H G; Hedger, M; Forrow, D; Blackmore, M

    2006-12-01

    The EU Water Framework Directive (WFD) is novel because it integrates water quality, water resources, physical habitat and, to some extent, flooding for all surface and groundwaters and takes forward river basin management. However, the WFD does not explicitly mention risks posed by climate change to the achievement of its environmental objectives. This is despite the fact that the time scale for the implementation process and achieving particular objectives extends into the 2020s, when climate models project changes in average temperature and precipitation. This paper begins by reviewing the latest UK climate change scenarios and the wider policy and science context of the WFD. We then examine the potential risks of climate change to key phases of the River Basin Management Process that underpin the WFD (such as characterisation of river basins and their water bodies, risk assessments to identify pressures and impacts, programmes of measures (POMs) options appraisal, monitoring and modelling, policy and management activities). Despite these risks the WFD could link new policy and participative mechanisms (being established for the River Basin Management Plans) to the emerging framework of national and regional climate change adaptation policy. The risks are identified with a view to informing policy opportunities, objective setting, adaptation strategies and the research agenda. Key knowledge gaps have already been identified during the implementation of the WFD, such as the links between hydromorphology and ecosystem status, but the overarching importance of linking climate change to these considerations needs to be highlighted. The next generation of (probabilistic) climate change scenarios will present new opportunities and challenges for risk analysis and policy-making.

  9. Bibliography. College and University Business Administration.

    ERIC Educational Resources Information Center

    National Association of College and University Business Officers, Washington, DC.

    This regularly-updated bibliography is organized by chapter and is generally limited to publications that have specific application to colleges and universities. The chapters include: business administration in higher education; institutional planning; management information systems and data processing; risk management and insurance;…

  10. 48 CFR 34.202 - Integrated Baseline Reviews.

    Code of Federal Regulations, 2011 CFR

    2011-10-01

    ... inherent risks in offerors'/contractors' performance plans and the underlying management control systems...) The degree to which the management process provides effective and integrated technical/schedule/cost... 48 Federal Acquisition Regulations System 1 2011-10-01 2011-10-01 false Integrated Baseline...

  11. HIV testing and sexual risk reduction counseling in office-based buprenorphine/naloxone treatment.

    PubMed

    Edelman, E Jennifer; Moore, Brent A; Caffrey, Sarah; Sikkema, Kathleen J; Jones, Emlyn S; Schottenfeld, Richard S; Fiellin, David A; Fiellin, Lynn E

    2013-01-01

    We assessed the feasibility and preliminary efficacy of human immunodeficiency virus (HIV) testing with sexual risk reduction counseling for opioid-dependent patients initiating office-based buprenorphine/naloxone treatment. We conducted a 14-week randomized, controlled trial with 30 patients (original target of 114) assigned to receive buprenorphine/naloxone induction/stabilization and HIV testing with Brief Sexual Risk Management (BSRM) or Enhanced Sexual Risk Management (ESRM). We evaluated process measures and compared outcomes at baseline and during the 3-month follow-up. Similar proportions of patients receiving BSRM and ESRM underwent HIV testing (93% vs 80%; P = 0.28) and completed counseling sessions (80% vs 67%; P = 0.40). Brief Sexual Risk Management sessions were shorter than ESRM sessions (15.4 vs 23.4 minutes), with comparable manual adherence (P = 0.80). Outcomes did not vary by BSRM versus ESRM. Although the recruitment of opioid-dependent patients with sexual risk behaviors is challenging, HIV testing with sexual risk reduction counseling in office-based buprenorphine/naloxone treatment practice is feasible. Interventions to decrease sexual risk behaviors among a segment of this population are necessary.

  12. Integrating service user and practitioner expertise within a web-based system for collaborative mental-health risk and safety management.

    PubMed

    Buckingham, Christopher D; Adams, Ann; Vail, Laura; Kumar, Ashish; Ahmed, Abu; Whelan, Annie; Karasouli, Eleni

    2015-10-01

    To develop a decision support system (DSS), myGRaCE, that integrates service user (SU) and practitioner expertise about mental health and associated risks of suicide, self-harm, harm to others, self-neglect, and vulnerability. The intention is to help SUs assess and manage their own mental health collaboratively with practitioners. An iterative process involving interviews, focus groups, and agile software development with 115 SUs, to elicit and implement myGRaCE requirements. Findings highlight shared understanding of mental health risk between SUs and practitioners that can be integrated within a single model. However, important differences were revealed in SUs' preferred process of assessing risks and safety, which are reflected in the distinctive interface, navigation, tool functionality and language developed for myGRaCE. A challenge was how to provide flexible access without overwhelming and confusing users. The methods show that practitioner expertise can be reformulated in a format that simultaneously captures SU expertise, to provide a tool highly valued by SUs. A stepped process adds necessary structure to the assessment, each step with its own feedback and guidance. The GRiST web-based DSS (www.egrist.org) links and integrates myGRaCE self-assessments with GRiST practitioner assessments for supporting collaborative and self-managed healthcare. Copyright © 2015. Published by Elsevier Ireland Ltd.

  13. Computer-Aided Nodule Assessment and Risk Yield Risk Management of Adenocarcinoma: The Future of Imaging?

    PubMed

    Foley, Finbar; Rajagopalan, Srinivasan; Raghunath, Sushravya M; Boland, Jennifer M; Karwoski, Ronald A; Maldonado, Fabien; Bartholmai, Brian J; Peikert, Tobias

    2016-01-01

    Increased clinical use of chest high-resolution computed tomography results in increased identification of lung adenocarcinomas and persistent subsolid opacities. However, these lesions range from very indolent to extremely aggressive tumors. Clinically relevant diagnostic tools to noninvasively risk stratify and guide individualized management of these lesions are lacking. Research efforts investigating semiquantitative measures to decrease interrater and intrarater variability are emerging, and in some cases steps have been taken to automate this process. However, many such methods currently are still suboptimal, require validation and are not yet clinically applicable. The computer-aided nodule assessment and risk yield software application represents a validated tool for the automated, quantitative, and noninvasive tool for risk stratification of adenocarcinoma lung nodules. Computer-aided nodule assessment and risk yield correlates well with consensus histology and postsurgical patient outcomes, and therefore may help to guide individualized patient management, for example, in identification of nodules amenable to radiological surveillance, or in need of adjunctive therapy. Copyright © 2016 Elsevier Inc. All rights reserved.

  14. Patient safety in external beam radiotherapy, results of the ACCIRAD project: Recommendations for radiotherapy institutions and national authorities on assessing risks and analysing adverse error-events and near misses.

    PubMed

    Malicki, Julian; Bly, Ritva; Bulot, Mireille; Godet, Jean-Luc; Jahnen, Andreas; Krengli, Marco; Maingon, Philippe; Prieto Martin, Carlos; Skrobala, Agnieszka; Valero, Marc; Jarvinen, Hannu

    2018-05-02

    The ACCIRAD project, commissioned by the European Commission (EC) to develop guidelines for risk analysis of accidental and unintended exposures in external beam radiotherapy (EBRT), was completed in the year 2014. In 2015, the "General guidelines on risk management in external beam radiotherapy" were published as EC report Radiation Protection (RP)-181. The present document is the third and final report of the findings from the ACCIRAD project. The main aim of this paper is to describe the key features of the risk management process and to provide general guidelines for radiotherapy departments and national authorities on risk assessment and analysis of adverse error-events and near misses. The recommendations provided here and in EC report RP-181 are aimed at promoting the harmonisation of risk management systems across Europe, improving patient safety, and enabling more reliable inter-country comparisons. Copyright © 2018 Elsevier B.V. All rights reserved.

  15. Creating a framework for the prioritization of biosecurity risks to the New Zealand dairy industry.

    PubMed

    Muellner, P; Hodges, D; Ahlstrom, C; Newman, M; Davidson, R; Pfeiffer, D; Marshall, J; Morley, C

    2018-03-25

    The New Zealand dairy sector relies on robust biosecurity measures to control and mitigate a wide range of threats to the industry. To optimize the prioritization of organisms and manage the risk they pose to the sector in a transparent and credible way, the Dairy Biosecurity Risk Evaluation Framework (D-BRiEF) was developed. This comprehensive framework was specifically designed for decision support, using a standardized approach to address the full spectrum of biosecurity threats to the sector, including exotic and endemic animal disease organisms, pest plants and insects. D-BRiEF is underpinned by three main processes, namely (i) hazard identification; (ii) multicriteria risk assessment; and (iii) communication for risk management. Expert knowledge and empirical data, including associated uncertainty, are harnessed in a standardized format. Results feed into a probability-impact model that was developed in close collaboration with dairy sector economists to provide overall comparative 10-year quantitative economic impact estimates for each assessed risk organism. A description of the overarching framework, which applies to diverse organism groups, is presented with detailed methodology on both endemic and exotic animal disease risk organisms. Examples of visual outputs are included, although actual ranking results are not reported due to industry confidentiality. D-BRiEF can provide a decision advantage to DairyNZ biosecurity risk managers and sector stakeholders by creating a transparent process that can be interrogated and updated at multiple levels to fully understand the layers of risk posed by different organisms. © 2018 Blackwell Verlag GmbH.

  16. Summary of evidence-based guideline update: Evaluation and management of concussion in sports

    PubMed Central

    Giza, Christopher C.; Kutcher, Jeffrey S.; Ashwal, Stephen; Barth, Jeffrey; Getchius, Thomas S.D.; Gioia, Gerard A.; Gronseth, Gary S.; Guskiewicz, Kevin; Mandel, Steven; Manley, Geoffrey; McKeag, Douglas B.; Thurman, David J.; Zafonte, Ross

    2013-01-01

    Objective: To update the 1997 American Academy of Neurology (AAN) practice parameter regarding sports concussion, focusing on 4 questions: 1) What factors increase/decrease concussion risk? 2) What diagnostic tools identify those with concussion and those at increased risk for severe/prolonged early impairments, neurologic catastrophe, or chronic neurobehavioral impairment? 3) What clinical factors identify those at increased risk for severe/prolonged early postconcussion impairments, neurologic catastrophe, recurrent concussions, or chronic neurobehavioral impairment? 4) What interventions enhance recovery, reduce recurrent concussion risk, or diminish long-term sequelae? The complete guideline on which this summary is based is available as an online data supplement to this article. Methods: We systematically reviewed the literature from 1955 to June 2012 for pertinent evidence. We assessed evidence for quality and synthesized into conclusions using a modified Grading of Recommendations Assessment, Development and Evaluation process. We used a modified Delphi process to develop recommendations. Results: Specific risk factors can increase or decrease concussion risk. Diagnostic tools to help identify individuals with concussion include graded symptom checklists, the Standardized Assessment of Concussion, neuropsychological assessments, and the Balance Error Scoring System. Ongoing clinical symptoms, concussion history, and younger age identify those at risk for postconcussion impairments. Risk factors for recurrent concussion include history of multiple concussions, particularly within 10 days after initial concussion. Risk factors for chronic neurobehavioral impairment include concussion exposure and APOE ε4 genotype. Data are insufficient to show that any intervention enhances recovery or diminishes long-term sequelae postconcussion. Practice recommendations are presented for preparticipation counseling, management of suspected concussion, and management of diagnosed concussion. PMID:23508730

  17. Comparative risk analysis of technological hazards (a review).

    PubMed Central

    Kates, R W; Kasperson, J X

    1983-01-01

    Hazards are threats to people and what they value and risks are measures of hazards. Comparative analyses of the risks and hazards of technology can be dated to Starr's 1969 paper [Starr, C. (1969) Science 165, 1232-1238] but are rooted in recent trends in the evolution of technology, the identification of hazard, the perception of risk, and the activities of society. These trends have spawned an interdisciplinary quasi profession with new terminology, methodology, and literature. A review of 54 English-language monographs and book-length collections, published between 1970 and 1983, identified seven recurring themes: (i) overviews of the field of risk assessment, (ii) efforts to estimate and quantify risk, (iii) discussions of risk acceptability, (iv) perception, (v) analyses of regulation, (vi) case studies of specific technological hazards, and (vii) agenda for research. Within this field, science occupies a unique niche, for many technological hazards transcend the realm of ordinary experience and require expert study. Scientists can make unique contributions to each area of hazard management but their primary contribution is the practice of basic science. Beyond that, science needs to further risk assessment by understanding the more subtle processes of hazard creation and by establishing conventions for estimating risk and for presenting and handling uncertainty. Scientists can enlighten the discussion of tolerable risk by setting risks into comparative contexts, by studying the process of evaluation, and by participating as knowledgeable individuals, but they cannot decide the issue. Science can inform the hazard management process by broadening the range of alternative control actions and modes of implementation and by devising methods to evaluate their effectiveness. PMID:6580625

  18. Evaluation of wholesale electric power market rules and financial risk management by agent-based simulations

    NASA Astrophysics Data System (ADS)

    Yu, Nanpeng

    As U.S. regional electricity markets continue to refine their market structures, designs and rules of operation in various ways, two critical issues are emerging. First, although much experience has been gained and costly and valuable lessons have been learned, there is still a lack of a systematic platform for evaluation of the impact of a new market design from both engineering and economic points of view. Second, the transition from a monopoly paradigm characterized by a guaranteed rate of return to a competitive market created various unfamiliar financial risks for various market participants, especially for the Investor Owned Utilities (IOUs) and Independent Power Producers (IPPs). This dissertation uses agent-based simulation methods to tackle the market rules evaluation and financial risk management problems. The California energy crisis in 2000-01 showed what could happen to an electricity market if it did not go through a comprehensive and rigorous testing before its implementation. Due to the complexity of the market structure, strategic interaction between the participants, and the underlying physics, it is difficult to fully evaluate the implications of potential changes to market rules. This dissertation presents a flexible and integrative method to assess market designs through agent-based simulations. Realistic simulation scenarios on a 225-bus system are constructed for evaluation of the proposed PJM-like market power mitigation rules of the California electricity market. Simulation results show that in the absence of market power mitigation, generation company (GenCo) agents facilitated by Q-learning are able to exploit the market flaws and make significantly higher profits relative to the competitive benchmark. The incorporation of PJM-like local market power mitigation rules is shown to be effective in suppressing the exercise of market power. The importance of financial risk management is exemplified by the recent financial crisis. In this dissertation, basic financial risk management concepts relevant for wholesale electric power markets are carefully explained and illustrated. In addition, the financial risk management problem in wholesale electric power markets is generalized as a four-stage process. Within the proposed financial risk management framework, the critical problem of financial bilateral contract negotiation is addressed. This dissertation analyzes a financial bilateral contract negotiation process between a generating company and a load-serving entity in a wholesale electric power market with congestion managed by locational marginal pricing. Nash bargaining theory is used to model a Pareto-efficient settlement point. The model predicts negotiation results under varied conditions and identifies circumstances in which the two parties might fail to reach an agreement. Both analysis and agent-based simulation are used to gain insight regarding how relative risk aversion and biased price estimates influence negotiated outcomes. These results should provide useful guidance to market participants in their bilateral contract negotiation processes.

  19. Concept of Operations for the Next Generation Air Transportation System. Version 3.0

    DTIC Science & Technology

    2010-01-01

    its operations, and establishes SMS requirements, responsibilities, and accountabilities • Safety Risk Management ( SRM ). The formal process within...the SMS that consists of describing the system; identifying the hazards; and assessing, analyzing, and mitigating the risk. The SRM process is...number of aircraft through the terminal airspace during peak traffic periods. Each of these features contributes to an environment that supports

  20. Effects of stochastic interest rates in decision making under risk: A Markov decision process model for forest management

    Treesearch

    Mo Zhou; Joseph Buongiorno

    2011-01-01

    Most economic studies of forest decision making under risk assume a fixed interest rate. This paper investigated some implications of this stochastic nature of interest rates. Markov decision process (MDP) models, used previously to integrate stochastic stand growth and prices, can be extended to include variable interest rates as well. This method was applied to...

  1. Application of risk-based multiple criteria decision analysis for selection of the best agricultural scenario for effective watershed management.

    PubMed

    Javidi Sabbaghian, Reza; Zarghami, Mahdi; Nejadhashemi, A Pouyan; Sharifi, Mohammad Bagher; Herman, Matthew R; Daneshvar, Fariborz

    2016-03-01

    Effective watershed management requires the evaluation of agricultural best management practice (BMP) scenarios which carefully consider the relevant environmental, economic, and social criteria involved. In the Multiple Criteria Decision-Making (MCDM) process, scenarios are first evaluated and then ranked to determine the most desirable outcome for the particular watershed. The main challenge of this process is the accurate identification of the best solution for the watershed in question, despite the various risk attitudes presented by the associated decision-makers (DMs). This paper introduces a novel approach for implementation of the MCDM process based on a comparative neutral risk/risk-based decision analysis, which results in the selection of the most desirable scenario for use in the entire watershed. At the sub-basin level, each scenario includes multiple BMPs with scores that have been calculated using the criteria derived from two cases of neutral risk and risk-based decision-making. The simple additive weighting (SAW) operator is applied for use in neutral risk decision-making, while the ordered weighted averaging (OWA) and induced OWA (IOWA) operators are effective for risk-based decision-making. At the watershed level, the BMP scores of the sub-basins are aggregated to calculate each scenarios' combined goodness measurements; the most desirable scenario for the entire watershed is then selected based on the combined goodness measurements. Our final results illustrate the type of operator and risk attitudes needed to satisfy the relevant criteria within the number of sub-basins, and how they ultimately affect the final ranking of the given scenarios. The methodology proposed here has been successfully applied to the Honeyoey Creek-Pine Creek watershed in Michigan, USA to evaluate various BMP scenarios and determine the best solution for both the stakeholders and the overall stream health. Copyright © 2015 Elsevier Ltd. All rights reserved.

  2. RMP Guidance for Chemical Distributors - Chapter 3: Five-Year Accident History

    EPA Pesticide Factsheets

    A five year accident history must be completed for each covered process, and all accidental release events meeting specified criteria must be reported in the Risk Management Plan (RMP) for that process.

  3. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Chen, Allan; Mills, Evan; Vine, Edward.

    The promotion of technologies and services for insurance loss reduction and loss prevention is as old as the fields of insurance and risk management. This report addresses a new category of risk management opportunity involving technologies and procedures that use energy more efficiently or supply renewable energy. While the economic benefits of these measures are of interest to energy consumers seeking to reduce their energy expenditures, we have found that they also offer a novel and largely untapped pathway for achieving traditional risk management objectives. Most of the technologies described in this report were supported by government- sponsored RD Dmore » programs over many years of effort. These technologies have many benefits, including insurance loss reduction and prevention. The insurance and risk management communities could take advantage of these technologies, either independently or in cost-sharing partnerships with existing R D programs. In this report, we present a compilation of energy-efficiency and renewable energy projects (e.g., energy-efficient halogen torchiere replacements) and techniques (e.g., infrared cameras to detect fire hazards) that are currently being investigated at the U.S. Department of Energy's national laboratories and which the insurance and risk management communities could encourage their customers to use to address their short-term and long-term needs. Once the loss-prevention benefits of these technologies and techniques (many of which are not yet available in the marketplace) are sufficiently demonstrated, insurers can promote their use through informational programs and perhaps financial incentives (e.g., risk-adjusted insurance premium schemes) through the insurance regulatory and rate-making processes. We identified 78 technologies and techniques being investigated by nine national laboratories which can help to reduce insurance losses and manage risks, especially those associated with power failures, fire and wind damage, and home or workplace indoor air quality hazards. All help to reduce insurance losses in one or more of the following categories: boiler and machinery, builder's risk, business interruption, commercial property insurance, completed operations liability, comprehensive general liability, contractors liability, environmental liability, product liability, professional liability, service interruption, workers' compensation, health/life insurance, and homeowners insurance. We identify examples of existing collaborations between the national laboratories and the insurance industry, and indicate research activities being conducted by the insurance and risk management communities that would benefit from the work of the national laboratories. We also describe some of the risk factors associated with energy-efficient and renewable energy technologies. For the future, significant progress could be made through interdisciplinary collaborative applied research (i.e., integrating the actuarial sciences with the physical or engineering sciences). This collaboration could be sponsored jointly by the U.S. Department of Energy and the insurance and risk management communities (as well as working through the insurance regulatory and rate-making processes).« less

  4. DOE Office of Scientific and Technical Information (OSTI.GOV)

    Chen, Allan; Mills, Evan; Vine, Edward

    The promotion of technologies and services for insurance loss reduction and loss prevention is as old as the fields of insurance and risk management. This report addresses a new category of risk management opportunity involving technologies and procedures that use energy more efficiently or supply renewable energy. While the economic benefits of these measures are of interest to energy consumers seeking to reduce their energy expenditures, we have found that they also offer a novel and largely untapped pathway for achieving traditional risk management objectives. Most of the technologies described in this report were supported by government- sponsored RD&D programsmore » over many years of effort. These technologies have many benefits, including insurance loss reduction and prevention. The insurance and risk management communities could take advantage of these technologies, either independently or in cost-sharing partnerships with existing R&D programs. In this report, we present a compilation of energy-efficiency and renewable energy projects (e.g., energy-efficient halogen torchiere replacements) and techniques (e.g., infrared cameras to detect fire hazards) that are currently being investigated at the U.S. Department of Energy's national laboratories and which the insurance and risk management communities could encourage their customers to use to address their short-term and long-term needs. Once the loss-prevention benefits of these technologies and techniques (many of which are not yet available in the marketplace) are sufficiently demonstrated, insurers can promote their use through informational programs and perhaps financial incentives (e.g., risk-adjusted insurance premium schemes) through the insurance regulatory and rate-making processes. We identified 78 technologies and techniques being investigated by nine national laboratories which can help to reduce insurance losses and manage risks, especially those associated with power failures, fire and wind damage, and home or workplace indoor air quality hazards. All help to reduce insurance losses in one or more of the following categories: boiler and machinery, builder's risk, business interruption, commercial property insurance, completed operations liability, comprehensive general liability, contractors liability, environmental liability, product liability, professional liability, service interruption, workers' compensation, health/life insurance, and homeowners insurance. We identify examples of existing collaborations between the national laboratories and the insurance industry, and indicate research activities being conducted by the insurance and risk management communities that would benefit from the work of the national laboratories. We also describe some of the risk factors associated with energy-efficient and renewable energy technologies. For the future, significant progress could be made through interdisciplinary collaborative applied research (i.e., integrating the actuarial sciences with the "physical" or "engineering" sciences). This collaboration could be sponsored jointly by the U.S. Department of Energy and the insurance and risk management communities (as well as working through the insurance regulatory and rate-making processes).« less

  5. Capability maturity models for offshore organisational management.

    PubMed

    Strutt, J E; Sharp, J V; Terry, E; Miles, R

    2006-12-01

    The goal setting regime imposed by the UK safety regulator has important implications for an organisation's ability to manage health and safety related risks. Existing approaches to safety assurance based on risk analysis and formal safety assessments are increasingly considered unlikely to create the step change improvement in safety to which the offshore industry aspires and alternative approaches are being considered. One approach, which addresses the important issue of organisational behaviour and which can be applied at a very early stage of design, is the capability maturity model (CMM). The paper describes the development of a design safety capability maturity model, outlining the key processes considered necessary to safety achievement, definition of maturity levels and scoring methods. The paper discusses how CMM is related to regulatory mechanisms and risk based decision making together with the potential of CMM to environmental risk management.

  6. Towards the assessment and management of contaminated dredged materials.

    PubMed

    Agius, Suzanne J; Porebski, Linda

    2008-04-01

    Environment Canada's Disposal at Sea Programme hosted the Contaminated Dredged Material Management Decisions Workshop in Montreal, Quebec, Canada, on 28-30 November 2006. The workshop brought together over 50 sediment assessment and management experts from academic, industrial, and regulatory backgrounds and charged them with drafting a potential framework to assess contaminated dredged materials and compare the risks of various disposal alternatives. This article summarizes the recommendations made during the workshop concerning the development of sediment assessment tools, the interpretation of these tools, and the essential attributes of a comparative risk assessment process. The major outcomes of the workshop include a strong recommendation to develop a national dredging or sediment management strategy, a potential decision-making framework for the assessment of dredged materials and comparative risk assessment of disposal options, and the expansion of minimum sediment characterization requirements for nonroutine disposal permit applications.

  7. The German clinical risk management survey for hospitals: Implementation levels and areas for improvement in 2015.

    PubMed

    Manser, Tanja; Frings, Janina; Heuser, Gregory; Mc Dermott, Fiona

    2016-01-01

    Despite the growing recognition of the need to implement systematic approaches for managing the risks associated with healthcare, few studies have investigated the level of implementation for clinical risk management (CRM) at a national level. Therefore, this study aimed to assess the current level of CRM implementation in German hospitals and to explore differences across hospital types. From March to June 2015, persons responsible for CRM in 2,617 hospitals and rehabilitation clinics in Germany were invited to participate in a voluntary online survey assessing the level of implementation for various aspects of CRM: CRM strategy, structures and processes; risk assessment (risk identification, risk analysis, risk evaluation) with a focus on incident reporting systems; risk mitigation measures; and risk monitoring and reporting. 572 hospitals participated in the survey (response rate 22 %). Most of these hospitals had a formalised, binding CRM strategy (72 %). 66 % had a centralised and 34 % a decentralised CRM structure. We also found that, despite a broad range of risk assessment methods being applied, there was a lack of integration of risk information from different data sources. Hospitals also reported a high level of implementation of critical incident reporting systems with a strong preference for local (74 %) over transorganisational systems. This study provides relevant data to inform targeted interventions concerning CRM implementation at a national level and to consider the specific context of different types of hospitals more carefully in this process. The approach to CRM assessment illustrated in this article could be the basis of a system for monitoring CRM over time and, thus, for evaluating the impact of strategy decisions at the policy level on CRM development. Copyright © 2016. Published by Elsevier GmbH.

  8. Evaluating changes to reservoir rule curves using historical water-level data

    USGS Publications Warehouse

    Mower, Ethan; Miranda, Leandro E.

    2013-01-01

    Flood control reservoirs are typically managed through rule curves (i.e. target water levels) which control the storage and release timing of flood waters. Changes to rule curves are often contemplated and requested by various user groups and management agencies with no information available about the actual flood risk of such requests. Methods of estimating flood risk in reservoirs are not easily available to those unfamiliar with hydrological models that track water movement through a river basin. We developed a quantile regression model that uses readily available daily water-level data to estimate risk of spilling. Our model provided a relatively simple process for estimating the maximum applicable water level under a specific flood risk for any day of the year. This water level represents an upper-limit umbrella under which water levels can be operated in a variety of ways. Our model allows the visualization of water-level management under a user-specified flood risk and provides a framework for incorporating the effect of a changing environment on water-level management in reservoirs, but is not designed to replace existing hydrological models. The model can improve communication and collaboration among agencies responsible for managing natural resources dependent on reservoir water levels.

  9. A systematic review of socio-economic assessments in support of coastal zone management (1992-2011).

    PubMed

    Le Gentil, Eric; Mongruel, Rémi

    2015-02-01

    Cooperation between the social and natural sciences has become essential in order to encompass all the dimensions of coastal zone management. Socio-economic approaches are increasingly recommended to complement integrated assessment in support of these initiatives. A systematic review of the academic literature was carried out in order to analyze the main types of socio-economic assessments used to inform the coastal zone management process as well as their effectiveness. A corpus of 1682 articles published between 1992 and 2011 was identified by means of the representative coverage approach, from which 170 were selected by applying inclusion/exclusion criteria and then classified using a content analysis methodology. The percentage of articles that mention the use of socio-economic assessment in support of coastal zone management initiatives is increasing but remains relatively low. The review examines the links between the issues addressed by integrated assessments and the chosen analytical frameworks as well as the various economic assessment methods which are used in the successive steps of the coastal zone management process. The results show that i) analytical frameworks such as 'risk and vulnerability', 'DPSIR', 'valuation', 'ecosystem services' and 'preferences' are likely to lead to effective integration of social sciences in coastal zone management research while 'integration', 'sustainability' and 'participation' remain difficult to operationalize, ii) risk assessments are insufficiently implemented in developing countries, and iii) indicator systems in support of multi-criteria analyses could be used during more stages of the coastal zone management process. Finally, it is suggested that improved collaboration between science and management would require that scientists currently involved in coastal zone management processes further educate themselves in integrated assessment approaches and participatory methodologies. Copyright © 2014 Elsevier Ltd. All rights reserved.

  10. The management of women at high risk for the development of breast cancer: risk estimation and preventative strategies.

    PubMed

    Sakorafas, George H

    2003-04-01

    Despite recent progress in the diagnostic and therapeutic approaches to the management of women with breast cancer, at least one third of these women will ultimately die from their disease. This resulted in a new focus on breast cancer prevention, especially for the woman designed as "high-risk". The continuing challenge is to identify reliable markers to accurately recognize this group of women, who are more likely to develop breast cancer. This will allow a targeted specific counseling and the application of preventative measures. Management options in high-risk women include intensive cancer surveillance, chemoprevention (mainly using tamoxifen), and prophylactic surgery (preferentially total mastectomy). Cancer surveillance is the most preferred management option. Currently, no data exists comparing prophylactic mastectomy vs. surveillance vs. chemoprevention. Thus, despite significant advances in our understanding of the biology of breast cancer, many questions remain unanswered concerning the optimal management of the high-risk woman. Patient counseling has a central role in the decision-making process and should be based on a multidisciplinary approach. The individual woman will make the final decision based on the amount of risk she is willing to accept. It is hoped that other preventative methods, such as gene therapy based on an accurate identification of specific genetic changes, will be developed in the future.

  11. Imaging X-Ray Polarimetry Explorer (IXPE) Risk Management

    NASA Technical Reports Server (NTRS)

    Alexander, Cheryl; Deininger, William D.; Baggett, Randy; Primo, Attina; Bowen, Mike; Cowart, Chris; Del Monte, Ettore; Ingram, Lindsey; Kalinowski, William; Kelley, Anthony; hide

    2018-01-01

    The Imaging X-ray Polarimetry Explorer (IXPE) project is an international collaboration to build and fly a polarization sensitive X-ray observatory. The IXPE Observatory consists of the spacecraft and payload. The payload is composed of three X-ray telescopes, each consisting of a mirror module optical assembly and a polarization-sensitive X-ray detector assembly; a deployable boom maintains the focal length between the optical assemblies and the detectors. The goal of the IXPE Mission is to provide new information about the origins of cosmic X-rays and their interactions with matter and gravity as they travel through space. IXPE will do this by exploiting its unique capability to measure the polarization of X-rays emitted by cosmic sources. The collaboration for IXPE involves national and international partners during design, fabrication, assembly, integration, test, and operations. The full collaboration includes NASA Marshall Space Flight Center (MSFC), Ball Aerospace, the Italian Space Agency (ASI), the Italian Institute of Astrophysics and Space Planetology (IAPS)/Italian National Institute of Astrophysics (INAF), the Italian National Institute for Nuclear Physics (INFN), the University of Colorado (CU) Laboratory for Atmospheric and Space Physics (LASP), Stanford University, McGill University, and the Massachusetts Institute of Technology. The goal of this paper is to discuss risk management as it applies to the IXPE project. The full IXPE Team participates in risk management providing both unique challenges and advantages for project risk management. Risk management is being employed in all phases of the IXPE Project, but is particularly important during planning and initial execution-the current phase of the IXPE Project. The discussion will address IXPE risk strategies and responsibilities, along with the IXPE management process which includes risk identification, risk assessment, risk response, and risk monitoring, control, and reporting.

  12. IEC 61511 and the capital project process--a protective management system approach.

    PubMed

    Summers, Angela E

    2006-03-17

    This year, the process industry has reached an important milestone in process safety-the acceptance of an internationally recognized standard for safety instrumented systems (SIS). This standard, IEC 61511, documents good engineering practice for the assessment, design, operation, maintenance, and management of SISs. The foundation of the standard is established by several requirements in Part 1, Clauses 5-7, which cover the development of a management system aimed at ensuring that functional safety is achieved. The management system includes a quality assurance process for the entire SIS lifecycle, requiring the development of procedures, identification of resources and acquisition of tools. For maximum benefit, the deliverables and quality control checks required by the standard should be integrated into the capital project process, addressing safety, environmental, plant productivity, and asset protection. Industry has become inundated with a multitude of programs focusing on safety, quality, and cost performance. This paper introduces a protective management system, which builds upon the work process identified in IEC 61511. Typical capital project phases are integrated with the management system to yield one comprehensive program to efficiently manage process risk. Finally, the paper highlights areas where internal practices or guidelines should be developed to improve program performance and cost effectiveness.

  13. Developing Coastal Adaptation to Climate Change in the New York City Infrastructure-Shed: Process, Approach, Tools, and Strategies

    NASA Technical Reports Server (NTRS)

    Rosenzweig, Cynthia; Solecki, William D.; Blake, Reginald; Bowman, Malcolm; Faris, Craig; Gornitz, Vivien; Horton, Radley; Jacob, Klaus; LeBlanc, Alice; Leichenko, Robin; hide

    2010-01-01

    While current rates of sea level rise and associated coastal flooding in the New York City region appear to be manageable by stakeholders responsible for communications, energy, transportation, and water infrastructure, projections for sea level rise and associated flooding in the future, especially those associated with rapid icemelt of the Greenland and West Antarctic Icesheets, may be beyond the range of current capacity because an extreme event might cause flooding and inundation beyond the planning and preparedness regimes. This paper describes the comprehensive process, approach, and tools developed by the New York City Panel on Climate Change (NPCC) in conjunction with the region s stakeholders who manage its critical infrastructure, much of which lies near the coast. It presents the adaptation approach and the sea-level rise and storm projections related to coastal risks developed through the stakeholder process. Climate change adaptation planning in New York City is characterized by a multi-jurisdictional stakeholder-scientist process, state-of-the-art scientific projections and mapping, and development of adaptation strategies based on a risk-management approach.

  14. The role of paediatric nurses in medication safety prior to the implementation of electronic prescribing: a qualitative case study.

    PubMed

    Farre, Albert; Heath, Gemma; Shaw, Karen; Jordan, Teresa; Cummins, Carole

    2017-04-01

    Objectives To explore paediatric nurses' experiences and perspectives of their role in the medication process and how this role is enacted in everyday practice. Methods A qualitative case study on a general surgical ward of a paediatric hospital in England, one year prior to the planned implementation of ePrescribing. Three focus groups and six individual semi-structured interviews were conducted, involving 24 nurses. Focus groups and interviews were audio-recorded, transcribed, anonymized and subjected to thematic analysis. Results Two overarching analytical themes were identified: the centrality of risk management in nurses' role in the medication process and the distributed nature of nurses' medication risk management practices. Nurses' contribution to medication safety was seen as an intrinsic feature of a role that extended beyond just preparing and administering medications as prescribed and placed nurses at the heart of a dynamic set of interactions, practices and situations through which medication risks were managed. These findings also illustrate the collective nature of patient safety. Conclusions Both the recognized and the unrecognized contributions of nurses to the management of medications needs to be considered in the design and implementation of ePrescribing systems.

  15. Risk evaluation and mitigation strategies for drugs with abuse liability: public interest, special interest, conflicts of interest, and the industry perspective.

    PubMed

    Wright, Curtis; Schnoll, Sidney; Bernstein, David

    2008-10-01

    Risk evaluation and mitigation strategies (REMS) formerly known as Risk Minimization Action Plans (RiskMAPs) are a regulatory technique for dealing with anticipated risks of new medications and are especially important for new drugs with abuse potential. This paper describes the origin and history of risk-management plans for drugs that might be abused, the proper use of these plans in minimizing the risk to the public, and the special difficulties inherent in managing risks for drugs with abuse potential. Drugs with abuse liability are distinctive since the risks inherent in manufacture and distribution include not only risks to patients prescribed the medications, but also risks to the general public including subgroups in the population not intended to get the drug and who receive no medical benefit from the medication. The crafting of risk-management plans intended to protect nonpatient populations is unique for these products. The content, extent, and level of intensity of these plans affect areas of medical ethics, civil liability, and criminal prosecution. The need for risk-management plans for drugs with abuse liability can potentially act as a deterrent to investment and is a factor in decisions concerning the development of new medications for the treatments of pain, ADHD, anxiety disorders, and addictions. This paper provides a framework for moving the process of REMS development forward and criteria for evaluating the probity and adequacy of such programs.

  16. Meeting CCS communication challenges head-on: Integrating communications, planning, risk assessment, and project management

    USGS Publications Warehouse

    Greenberg, S.; Gauvreau, L.; Hnottavange-Telleen, K.; Finley, R.; Marsteller, S.

    2011-01-01

    The Midwest Geological Sequestration Consortium, Schlumberger Carbon Services, and Archer Daniels Midland has implemented a comprehensive communications plan at the Illinois Basin - Decatur Project (IBDP), a one million metric tonne Carbon Capture and Storage project in Decatur, IL, USA funded by the U.S. Department of Energy's National Energy Technology Laboratory. The IBDP Communication Plan includes consortium information, funding and disclaimer citations, description of target audiences, media communications guidelines, paper and presentations guidelines, site visit information, crisis communication, on-site photography regulations, and other components. The creation, development, and implementation processes for the IBDP Communication Plan (the Plan) are shared in this paper. New communications challenges, such as how to address add-on research requests, data sharing and management, scope increase, and contract agreements have arisen since the Plan was completed in January 2009, resulting in development of new policies and procedures by project management. Integrating communications planning, risk assessment, and project management ensured that consistent, factual information was developed and incorporated into project planning, and constitutes the basis of public communications. Successful integration has allowed the IBDP to benefit from early identification and mitigation of the potential project risks, which allows more time to effectively deal with unknown and unidentified risks that may arise. Project risks and risks associated with public perception can be managed through careful planning and integration of communication strategies into project management and risk mitigation. ?? 2011 Published by Elsevier Ltd.

  17. Obsolescence Risk Assessment Process Best Practice

    NASA Astrophysics Data System (ADS)

    Romero Rojo, F. J.; Roy, R.; Kelly, S.

    2012-05-01

    A component becomes obsolete when it is no longer available from the original manufacturer to the original specification. In long-lifecycle projects, obsolescence has become a major problem as it prevents the maintenance of the system. This is the reason why obsolescence management is now an essential part of the product support activities in sectors such as defence, aerospace, nuclear and railway; where systems need to be supported for several decades. The obsolescence risk assessment for the bill of materials (BoM) is a paramount activity in order to manage obsolescence proactively and cost-effectively. This is the reason why it was necessary to undertake a benchmarking study to develop best practice in this process. A total of 22 obsolescence experts from 13 different organisations/projects from across UK and USA have participated in this study. Their current processes and experience have been taken into account in the development of the best practice process for obsolescence risk assessment. The key factors that have to be analysed in the risk assessment process for each component in the BoM are: number of manufacturers, years to end of life, stock available, consumption rate and operational impact criticality. For the very high risk components, a more detailed analysis is required to inform the decisions regarding the most suitable mitigation strategies. On the contrary, for the low risk components, a fully proactive approach is neither appropriate nor cost effective. Therefore, it is advised for these components that obsolescence issues are dealt with reactively. This process has been validated using case studies with several experts from industry and is currently being implemented by the UK Ministry of Defence as technical guidance within the JSP 886 Volume 7 Part 8.13 standards.

  18. Application of a generic bow-tie based risk analysis framework on risk management of sea ports and offshore terminals.

    PubMed

    Mokhtari, Kambiz; Ren, Jun; Roberts, Charles; Wang, Jin

    2011-08-30

    Ports and offshore terminals are critical infrastructure resources and play key roles in the transportation of goods and people. With more than 80 percent of international trade by volume being carried out by sea, ports and offshore terminals are vital for seaborne trade and international commerce. Furthermore in today's uncertain and complex environment there is a need to analyse the participated risk factors in order to prioritise protective measures in these critically logistics infrastructures. As a result of this study is carried out to support the risk assessment phase of the proposed Risk Management (RM) framework used for the purpose of sea ports and offshore terminals operations and management (PTOM). This has been fulfilled by integration of a generic bow-tie based risk analysis framework into the risk assessment phase as a backbone of the phase. For this reason Fault Tree Analysis (FTA) and Event Tree Analysis (ETA) are used to analyse the risk factors associated within the PTOM. This process will eventually help the port professionals and port risk managers to investigate the identified risk factors more in detail. In order to deal with vagueness of the data Fuzzy Set Theory (FST) and possibility approach are used to overcome the disadvantages of the conventional probability based approaches. Copyright © 2011 Elsevier B.V. All rights reserved.

  19. Risk management policy and black-box warnings: a qualitative analysis of US FDA proceedings.

    PubMed

    Cook, Daniel M; Gurugubelli, Rama K; Bero, Lisa A

    2009-01-01

    The US FDA increasingly applies risk management to drug safety policy. Little is known about the process by which the FDA approves labelling changes. Although advisory committees can recommend any of the risk management tools, including the use of 'black-box warnings', it is unknown whether they deliberate on these questions or how they apply the principles of risk minimization or management during their considerations of drug licensing. To examine the process by which risk management is considered by the FDA, including the role of FDA advisory committees. We also aimed to identify and describe drug labelling changes and additions, including the prevalence of black-box warnings. We electronically obtained publicly available information regarding drug approvals, drug revisions and advisory committee meetings over 3 years (2004-6) from the FDA. Data in the form of meeting transcripts and full histories of labelling changes were collected on drugs discussed by advisory committees. We then searched and qualitatively analysed the meeting transcripts to identify themes in the discussion. We also created a database of all prescription drug labelling changes for 3 years and examined which drugs have had the most changes. We describe the risk management consideration process and report the frequency and characteristics of labelling changes. Excerpts from the transcripts are selected to illustrate both typical and atypical features of the discussion. A total of 174 black-box changes were made in the 3-year period of our study, of which 77 were new black-box warnings and 97 were revisions in black-box warnings. Of 77 new black-box warning additions, only 11 drugs were discussed by the advisory committees. Of the 17 most frequently revised drug labels in these 3 years, two were discussed in the advisory committee meetings. Advisory meeting discussions revealed confusion about black-box warnings and emphasized potential consequences of the warnings rather than their content. The safety labelling of drugs on the market is changed often. Panels of advisors consider only a few drugs, rarely discuss the labelling requirements, and display confusion about applying black-box warnings. The creation and application of black-box warnings on prescription medications should receive closer attention from the FDA and its advisors.

  20. Risk evaluation of highway engineering project based on the fuzzy-AHP

    NASA Astrophysics Data System (ADS)

    Yang, Qian; Wei, Yajun

    2011-10-01

    Engineering projects are social activities, which integrate with technology, economy, management and organization. There are uncertainties in each respect of engineering projects, and it needs to strengthen risk management urgently. Based on the analysis of the characteristics of highway engineering, and the study of the basic theory on risk evaluation, the paper built an index system of highway project risk evaluation. Besides based on fuzzy mathematics principle, analytical hierarchy process was used and as a result, the model of the comprehensive appraisal method of fuzzy and AHP was set up for the risk evaluation of express way concessionary project. The validity and the practicability of the risk evaluation of expressway concessionary project were verified after the model was applied to the practice of a project.

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