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Relevant bibliographies by topics / Risk management process

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Academic literature on the topic 'Risk management process'

Author: Grafiati

Published: 4 June 2021

Last updated: 12 June 2025

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Journal articles on the topic "Risk management process"

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Эпштейн, Дэн. "Risk Management Process." Управление проектами и программами 1 (2020): 52–70. http://dx.doi.org/10.36627/2075-1214-2020-1-1-52-70.

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Andreevna, Katanaeva Marina. "The Process-based Model of Risk Management in the Quality Management System." Journal of Advanced Research in Dynamical and Control Systems 12, SP4 (2020): 1077–87. http://dx.doi.org/10.5373/jardcs/v12sp4/20201581.

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Ganguly, Kunal K., and Prabir Bandyopdhyay. "Supply Risk Management Process." International Journal of Risk and Contingency Management 3, no. 4 (2014): 17–31. http://dx.doi.org/10.4018/ijrcm.2014100102.

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The purpose of this study was to develop and analyze an interpretative structural framework for the Supply Risk Management Process (SRMP). The research questions were focused on understanding the casual factors as well as the link between the SRMP and Supplier Selection (SS) process. The Interpretative Structural Modeling (ISM) approach was used to develop a structural framework for the SRMP. An extensive literature followed by discussion with managers in different Indian Automobile companies was completed to identify the strategic enablers for the SRMP. Thirteen strategic enablers were identified and classified into four categories. An Indian Automobile manufacturing company was selected as a case study participant to serve as an authentic practice-based example of the model. The SRMP enablers and the SS factors were applied to the case study organization and analyzed. The significance of this study was that the SRMP enablers and SS factors assist managers to set priorities for decision making purposes. This allows supply chain managers to take proactive steps in order to reduce risk and improve the performance of the organization in the early SRMP stages.

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Madsen, Freddy. "The Risk Management Process." Prehospital and Disaster Medicine 15, S1 (2000): S9. http://dx.doi.org/10.1017/s1049023x00027850.

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Gemmer, A. "Risk management: moving beyond process." Computer 30, no. 5 (1997): 33–43. http://dx.doi.org/10.1109/2.589908.

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Van Loon, Han. "Process Optimization: A management process to reduce risk." IT Professional 9, no. 99 (2007): x1. http://dx.doi.org/10.1109/mitp.2007.4374044.

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Mayakova, Anna. "Risk management of sociocultural process: digital revolution." Economic Annals-ХХI 186, no. 11-12 (2020): 48–57. http://dx.doi.org/10.21003/ea.v186-06.

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Risks and threats play an important role in the development of the sociocultural sphere, while risk management makes it possible to identify and predict them. In this regard, it is relevant, expedient and necessary to undertake an attempt to adapt the economic methodology of risk management to the sociocultural process by means of socio-humanitarian revision of risk management and the formation of an integrated model of sociocultural risk management based on the relevant methodology. Such a model will provide an opportunity for a more detailed approach to the process of assessing and controlling the occurrence of risk, as well as increasing the predictability of potential risk based on the accumulated scientific and practical knowledge and previous experience. The approach to the problem proposed by the author will expand the theoretical and methodological base not only of socio-humanitarian science, but also innovation, general management theory and the risk management methodology itself. The purpose of the paper is to define the specifics and main trends of risk management in relation to the sociocultural process, as well as assess the possibilities of applying this methodology for managing and preventing sociocultural risks. Basing on sociocultural and interdisciplinary approaches, risk management techniques, crisis concepts and the socio-technical landscape of digital reality, an integrated risk management model was formed in relation to the socio-cultural process. It will create an effective mechanism for predicting risk and reducing its impact on the sociocultural process, focused on solving the problems of stabilization and development of objects and processes, and can also be used as a tool in the procedure for making and implementing decisions in strategic planning and project management. Based on the results of this study, a set of main trends in risk management will be formulated in relation to the sociocultural process. The authors of the paper consider the possibilities of using this methodology for managing and preventing sociocultural risks and form an integrated model of risk management in relation to the sociocultural process in the context of a digital revolution.

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Khudarganov, Kamoladdin. "DESCRIPTION OF THE PHYTOSANITARY RISK ANALYSIS PROCESS PERFORMED ON THE LAWN TO DETERMINE A PHYTOSANITARY RISK MANAGEMENT." American Journal of Agriculture and Biomedical Engineering 04, no. 03 (2022): 15–19. http://dx.doi.org/10.37547/tajabe/volume04issue03-02.

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This standard provides a detailed description of the phytosanitary risk analysis process performed on the lawn to determine if a pest may be a quarantine pest. The application of flour to risk assessment, as well as the harmonized processes required to select a phytosanitary risk management option, are described.

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Denney, Dennis. "Well Planning: A Risk-Management Process." Journal of Petroleum Technology 64, no. 09 (2012): 124–26. http://dx.doi.org/10.2118/0912-0124-jpt.

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Ramkrishnan, Hemalatha, and Rohan Mammen. "Development of Risk Management Process Tool." International Journal of Management Studies VI, no. 1(2) (2019): 32. http://dx.doi.org/10.18843/ijms/v6i1(2)/04.

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Dissertations / Theses on the topic "Risk management process"

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Černák, Peter. "Risk Management." Master's thesis, Vysoká škola ekonomická v Praze, 2009. http://www.nusl.cz/ntk/nusl-76579.

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The Master's Thesis deals with the topic of risk management in a non-financial company. The goal of this Thesis is to create a framework for review of risk management process and to practically apply it in a case study. Objectives of the theoretical parts are: stating the reasons for risk management in non-financial companies, addressing the main parts of risk management and providing guidance for review of risk management process. A special attention is paid to financial risks. The practical part applies the framework created in the theoretical part on a case study -- review/gap analysis of risk management process in a Czech non-financial companies operating in utilities. Risk management process in this company is described with a special attention to management of financial risk. Author's own remarks on the process and recommendations are stated in the practical part.

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Ledezema, Lazo Edmundo, and Ingrid Nataly Quiroga Fernández. "Risk Management in the Biding Process." Thesis, KTH, Tillämpad maskinteknik (KTH Södertälje), 2012. http://urn.kb.se/resolve?urn=urn:nbn:se:kth:diva-98627.

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Alimohamadi, Bardia, and Ameneh Seddigh. "Lean Implementation into Risk Management Process." Thesis, Högskolan i Borås, Institutionen Ingenjörshögskolan, 2009. http://urn.kb.se/resolve?urn=urn:nbn:se:hb:diva-19568.

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Any business management process involves a relevant risk management process whereas proper integration of risk management process following the lean guidelines can result in an efficient risk management process. This is a vital advantageous character for successful companies of this era. However, in real world business, many cases have been observed with different types of hidden wastes associated with their risk management process. These wastes act as obstacles to create value for their customer.Hence, the need for an integrated risk management process enabled with a lean perspective is growing in all levels of business and industry. Lean management and risk management process are in close interaction whether we see it or not. There would be two options ahead of organizations. First option is to ignore this mutual relationship between lean management and risk management process and the other option is to try to understand this interaction in detail with a continuous effort to make it more efficient. This conscious approach to the issue can turn into an efficient integration in successful cases. Integration process towards having a lean risk management is a tricky journey that requires proper understanding of the issue among the associated people and smart strategic decision making along with proper tactical knowledge and know-hows. In the current thesis work, we have tried to apply lean philosophy in order to recognize the wastes and non value added activities. This integration process starts with recognizing the context of risk management in a target organization. It is critical to recognize the risk management process steps because it is necessary to analyze the process steps one by one. Importance of following the flow principle of lean philosophy is a must in order to attain to a streamlined progress in the work. Consequently eight typical lean wastes should be identified in the relevant risk management process steps. In order to be able to eliminate the identified non value added activities, lean tools would be applied at this stage of the work. In other words, the root causes to the process wastes would be tracked down with the aim of eliminating or reducing them.Through proper application of lean tools in the integration process, we would get to a level of improved effectiveness and efficiency in our organization. In a comprehensive lean risk management integration strategy, the future state of risk management process would be drawn following lean principles with an eye on extension work for developing the lean risk management policies throughout the supply chain. This lean extension program is a key to catch hidden synergies in risk management process of the whole supply chain. Inbuilt KPIs and process metrics would be the proper provision for enabling the organization be in a state of continuous thrive for perfection.Applications of lean principles make a quick response enterprise with proper level of flexibility which results in an aware personnel attitude in a lean risk management working environment. Mixing the factor of improved internal efficiency with our risk management process, would help us have a better control over our associated risks. The result to this integration work would be a lean organization with continuously growing voracity to make improvements to the status of lean risk management process.

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Mitra, Amlan. "Developing an integrated risk management system in emergency management process /." This resource online, 1992. http://scholar.lib.vt.edu/theses/available/etd-12232009-020038/.

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Hamilton, R. Alexander. "Governing through risk : synthetic biology and the risk management process." Thesis, London School of Economics and Political Science (University of London), 2015. http://etheses.lse.ac.uk/3206/.

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In recent years, synthetic biology – an emerging science that promises to ‘democratize’ bioengineering – has emerged as a key site of regulatory interest and concern. In the United States, in particular, these concerns have largely been voiced in relation to synthetic biology’s perceived capacity to enable an act of bioterrorism. This thesis examines the regulatory response – a ‘risk management process’ – that has been mounted to address this contingency, and which seeks to ‘secure’ and ‘sustain’ a science characterized by sharply contrasting expectations. In particular, this thesis engages with the discursive and non-discursive practices enacted by diverse scientific and technical experts determined to assess and manage ‘risks’ that threaten to exceed the very capacity of risk, as a ‘calculative rationality’, to tame chance and legitimize responsible action. Yet, in the face of uncertainty, and in stark contrast to the ‘risk society’ thesis, this thesis underlines that uncertainty is not an inhibition to risk management, but a call for more intensive and more creative ways of organizing uncertainty, enabling action in the present. Indeed, in the case of regulating synthetic biology, risk management is, above all, tailored to finding practical ‘solutions’ to seemingly intractable policy ‘problems’. In addition to its contribution to recent scholarship that has drawn on Foucault’s concept of ‘governmentality’ to examine how diverse social problems, ranging from climate change to terrorism, are ‘governed through risk’, this thesis critically examines how biotechnology’s pairing with the perceived threat of bioterrorism is influencing the manner in which modern biology is understood, represented, practiced and controlled. Thus, the case of synthetic biology examined in this thesis not only provides a lens through which to advance risk theory in sociology, but also serves as a vector through which to explore changing configurations of ‘risk’ and ‘risk responsibility’ in the contemporary life sciences.

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Brown, Robert G. "A risk management process for complex projects." Thesis, This resource online, 1995. http://scholar.lib.vt.edu/theses/available/etd-07212009-040553/.

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Aleixo, Gonçalo Granja. "Risk management of new product development process." Master's thesis, FCT - UNL, 2009. http://hdl.handle.net/10362/2577.

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Dissertation submitted to Faculdade de Ciências e Tecnologia of Universidade Nova de Lisboa for the achievement of Integrated Master´s degree in Industrial Management Engineering<br>Winners in today´s global changing environment, are those who continuously pursuit innovations in order to guarantee their sustainability. If in the presence of a certain environment many enterprises makes enormous mistakes, in an uncertain environment as the development of innovations, these mistakes will be multiplied. Moreover, since little effort has been made in developing empirical models, metrics and tools to manage risks in product development, this work aspires to satisfy the necessity of high-tech enterprises with a useful and pragmatic approach to manage the risks of their new product development (NPD) process. Besides it provides for enterprise´s innovation life cycle, a NPD risk management methodology with efficient techniques to manage risks in advance and during the development of new products, it will provide a new conceptualization of enterprises’ innovation and NPD process, for supporting future research in the innovation field. This master thesis will explore the innovation field, revealing that radical and incremental innovations are complementary during the innovation life cycle and accomplished through distinct process of developing new products. Through this new perspective, this work succeed in providing a NPD risk management model for both type of innovations aiming a universal best practice to identify, analyze, and manage risks in the NPD process.

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Yakin, Cenkler. "Quantifying Risk Management Process In A Software Organization." Master's thesis, METU, 2006. http://etd.lib.metu.edu.tr/upload/12607138/index.pdf.

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This study presents a quantifying risk management process and its application on a software organization in terms of risk items mitigated, exposures covered, costs, and expected exposures covered. Risk management is defined as setting forth a discipline and environment of proactive decisions and actions to assess continuously what can go wrong (risks), to determine what risks are important to deal with, and to implement strategies to deal with those risks. Risk management can be applied in all of the business areas. In the literature, there are sources for risk management. Some of them are qualitative, and some of them are quantitative. However, there is no much source about the application study of a quantifying risk management process on a software organization. In order to obtain insight about this issue, this study presents a quantifying risk management system to the literature and also compares the quantifying risk management policies on the data set of a software organization by finding out and analyzing their performance with respect to designated decision parameters and preference profiles for risk items mitigated, exposures covered, costs, and expected exposures covered. At the end of this study, suitable quantifying risk management policies for each profile are recommended by considering the analysis of the data set as base.

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Schoerner, Daniel (Daniel Richard). "Developing a process for supply chain risk management." Thesis, Massachusetts Institute of Technology, 2009. http://hdl.handle.net/1721.1/50093.

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Thesis (M.B.A.)--Massachusetts Institute of Technology, Sloan School of Management; and, (S.M.)--Massachusetts Institute of Technology, Dept. of Electrical Engineering and Computer Science; in conjunction with the Leaders for Manufacturing Program at MIT, 2009.<br>Includes bibliographical references (p. 65).<br>In today's competitive markets, companies look for any advantage they can build over their competitors. A number of companies recognize that supply chain excellence is an opportunity to create such an advantage. A superior supply chain provides manufacturing flexibility, fast on-time delivery, and lower cost products than those of a lesser competitor. Risk management concepts are beginning to be applied to supply chains in ever-broadening scope. Companies reliant on their supply chains now seek innovative ways to manage risk to the supply chain and ensure its smooth operation. Implementing a risk management process for the supply chain can generate long term value for a company by improving continuity of supply and component quality. By identifying risks to the supply of necessary components and then assessing the risk of each component's availability and quality, it is possible to gain a comprehensive understanding of the risk to the supply chain for a given product or product family. This understanding of the risk to the supply chain allows managers to make decisions based on the expected costs and assists them in determining the appropriate risk mitigation activities.<br>by Daniel Schoerner.<br>S.M.<br>M.B.A.

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Qazi, Abroon. "Supply chain risk management : exploring an integrated process for managing interdependent risks and risk mitigation strategies." Thesis, University of Strathclyde, 2017. http://digitool.lib.strath.ac.uk:80/R/?func=dbin-jump-full&object_id=27944.

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The goal of this research is to investigate interdependency modelling of supply chain risks, and to develop and empirically evaluate a supply chain risk management process that not only integrates all stages of the process but also captures interdependencies between risks and risk mitigation strategies. The proposed process is tailored to the risk management needs of both conventional and project driven supply chains. Project driven supply chains necessitate experimenting untested (unique) strategies depending on the level of project complexity whereas in the case of conventional supply chains, there is generally a consensus in establishing interdependencies between risks and the efficacy of strategies. A systematic literature review methodology was employed to identify research gaps and establish the research agenda. In order to gain an insight into industrial practice, empirical research was conducted in South Australia involving semi-structured interviews with experts in project risk management that resulted in the development of a project complexity and risk management (ProCRiM) process. The research gaps identified and the findings of the empirical research helped in developing dependency based probabilistic supply chain risk measures that can be readily used for assessing and managing risks associated with global supply chains. In order to capture interdependencies between supply chain risks, strategies and performance measures, two case studies were conducted in reputed supply chains involving semi-structured interviews and focus group sessions that resulted in the development of two risk management frameworks: an adapted version of ProCRiM applicable to project driven supply chains and a framework specific to conventional supply chains. The research also focused on investigating the merits and challenges associated with implementing the proposed process. In order to capture the risk appetite of a decision maker, a process namely supply chain risk network management is developed and illustrated through a simulation study.

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Books on the topic "Risk management process"

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McFadzean, Evelyn. The risk management process. University of Strathclyde, Centre for Facilities Management, 1993.

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Cameron, Ian T. Process systems risk management. Elsevier, 2005.

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Cameron, I. T. Process systems risk management. Elsevier, 2005.

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Kenney, William F. Process risk management systems. VCH Publishers, 1993.

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Process reliability and risk management. Van Nostrand Reinhold, 1992.

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Trade compliance risk management process. The Service, 1999.

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Pickett, K. H. Spencer. Auditing the risk management process. Wiley, 2005.

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Stephen, Horn, ed. Essentials of the risk management process. Insurance Institute of America, 1985.

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Sampath, D. K. Risk management in the judicial process. National Judicial Academy, 2004.

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Gorrod, Martin. Risk management systems: Process, technology, and trends. Palgrave Macmillan, 2004.

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Book chapters on the topic "Risk management process"

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Spellman, Frank R., Lorilee Medders, Paul Fuller, and Gordon Graham. "Risk Management Process." In Handbook of Risk and Insurance Strategies for Certified Public Risk Officers and Other Water Professionals. CRC Press, 2021. http://dx.doi.org/10.1201/9781003207146-26.

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Sheedy, Elizabeth. "Risk Management Process Overview." In Risk Governance. Routledge, 2021. http://dx.doi.org/10.4324/9781003123736-7.

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Flaus, Jean-Marie. "The Risk Management Process (ISO31000)." In Risk Analysis. John Wiley & Sons, Inc., 2013. http://dx.doi.org/10.1002/9781118790021.ch4.

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Shefrin, Hersh. "Process, Pitfalls, and Culture." In Behavioral Risk Management. Palgrave Macmillan US, 2016. http://dx.doi.org/10.1057/9781137445629_6.

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Madigan, Michael L. "Composite Risk Management Process." In Handbook of Emergency Management Concepts. CRC Press, 2017. http://dx.doi.org/10.1201/b22489-7.

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Banks, Erik. "The Risk Management Process." In Risk and Financial Catastrophe. Palgrave Macmillan UK, 2009. http://dx.doi.org/10.1057/9780230243323_4.

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Olson, David L., and Desheng Wu. "Enterprise Risk Management Process." In Enterprise Risk Management Models. Springer Berlin Heidelberg, 2010. http://dx.doi.org/10.1007/978-3-642-11474-8_2.

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Catalano, Thomas. "Risk Evaluation Process." In Application of Project Management Principles to the Management of Pharmaceutical R&D Projects. Springer International Publishing, 2020. http://dx.doi.org/10.1007/978-3-030-57527-4_5.

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Hunziker, Stefan. "Creating Value Through ERM Process." In Enterprise Risk Management. Springer Fachmedien Wiesbaden, 2019. http://dx.doi.org/10.1007/978-3-658-25357-8_3.

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Hunziker, Stefan. "Creating Value Through ERM Process." In Enterprise Risk Management. Springer Fachmedien Wiesbaden, 2021. http://dx.doi.org/10.1007/978-3-658-33523-6_3.

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Conference papers on the topic "Risk management process"

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Benedetti-Doumic, Arielle. "GALILEO risk management process." In AIAA Guidance, Navigation, and Control Conference and Exhibit. American Institute of Aeronautics and Astronautics, 2001. http://dx.doi.org/10.2514/6.2001-4172.

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Md.Sum, Rabihah. "Risk Management Decision Making." In The International Symposium on the Analytic Hierarchy Process. Creative Decisions Foundation, 2013. http://dx.doi.org/10.13033/isahp.y2013.073.

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Rokou, Elena, and Konstantinos Kirytopoulos. "Supply Chain Risk Management Using ANP." In International Symposium on the Analytic Hierarchy Process. Creative Decisions Foundation, 2014. http://dx.doi.org/10.13033/isahp.y2014.163.

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Khalaf, Fouad, and Mahmoud Abu El Ela Aly. "The Risk Management Process - An Overview." In SPE International Conference on Health, Safety, and Environment in Oil and Gas Exploration and Production. Society of Petroleum Engineers, 2008. http://dx.doi.org/10.2118/111580-ms.

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van Cleeff, André. "A risk management process for consumers." In the 2010 workshop. ACM Press, 2010. http://dx.doi.org/10.1145/1900546.1900561.

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McManus, Charles Dudley, Patrick Edward Leach, Paul Wicker, and Steven Riley Anderson. "Well Planning: A Risk Management Process." In SPE Deepwater Drilling and Completions Conference. Society of Petroleum Engineers, 2012. http://dx.doi.org/10.2118/156332-ms.

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Van Sant, John, Gerald A. Klein, and Robin L. Dillon. "NASA Risk Management Metrics — Evaluating the Effectiveness of the Risk Management Process." In 2020 IEEE Aerospace Conference. IEEE, 2020. http://dx.doi.org/10.1109/aero47225.2020.9172324.

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Contessoto, Allan G., Laís A. Sant’ Ana, Rogéria C. G. Souza, et al. "Improving risk identification process in project management." In The 28th International Conference on Software Engineering and Knowledge Engineering. KSI Research Inc. and Knowledge Systems Institute Graduate School, 2016. http://dx.doi.org/10.18293/seke2016-180.

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Pecharich, Jeremy L., Kendra Cook, Wesley Walker, Michel D. Ingham, Kymie Tan, and Stephen Watson. "Cyber Risk Management Process for Space Missions." In ASCEND 2020. American Institute of Aeronautics and Astronautics, 2020. http://dx.doi.org/10.2514/6.2020-4114.

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Guanling, Zhou, Dong Nanping, and Yu Lijie. "Process Risk Management in B2B E-Business." In 2009 Third International Symposium on Intelligent Information Technology Application. IEEE, 2009. http://dx.doi.org/10.1109/iita.2009.31.

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Reports on the topic "Risk management process"

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Mylrea, Michael E., Sri Nikhil G. Gourisetti, Md Touhiduzzaman, Mark D. Watson, and Jerry E. Castleberry. Risk Management Framework Process Map. Office of Scientific and Technical Information (OSTI), 2018. http://dx.doi.org/10.2172/1494806.

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Powell, Charisa, Konrad Hauck, Tami Reynolds, Anuj Sanghvi, M. Touhiduzzaman, and Joshua Van Natta. Distributed Energy Resources Cybersecurity Framework: Applying the NIST Risk Management Process. Office of Scientific and Technical Information (OSTI), 2020. http://dx.doi.org/10.2172/1710147.

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Gallagher, Brian P., Christopher J. Alberts, and Richard E. Barbour. Software Acquisition Risk Management Key Process Area (KPA) - A Guidebook Version 1.0. Defense Technical Information Center, 1997. http://dx.doi.org/10.21236/ada328098.

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Gallagher, Brian P. Software Acquisition Risk Management Key Process Area (KPA)- A Guidebook Version 1.02. Defense Technical Information Center, 1999. http://dx.doi.org/10.21236/ada370385.

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Taber, Mary A., Lisa M. Elenz, and Paul G. Langowski. Decision making for wildfires: A guide for applying a risk management process at the incident level. U.S. Department of Agriculture, Forest Service, Rocky Mountain Research Station, 2013. http://dx.doi.org/10.2737/rmrs-gtr-298.

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Negron, S. B., B. L. Jr Lee, and R. W. Jr Tayloe. Validation of MCNP4a for highly enriched uranium using the Battelle process safety and risk management IBM RS/6000 workstation. Office of Scientific and Technical Information (OSTI), 1996. http://dx.doi.org/10.2172/188622.

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Bridges, Todd, Jeffrey King, Jonathan Simm, et al. Overview : International Guidelines on Natural and Nature-Based Features for Flood Risk Management. Engineer Research and Development Center (U.S.), 2021. http://dx.doi.org/10.21079/11681/41945.

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The application of natural and nature‑based features (NNBF) has grown steadily over the past 20 years, supported by calls for innovation in flood risk management (FRM) and nature‑based solutions from many different perspectives and organizations. Technical advancements in support of NNBF are increasingly the subject of peer‑reviewed and other technical literature. A variety of guidance has been published by numerous organizations to inform program‑level action and technical practice for specific types of nature‑based solutions. This effort to develop international guidelines on the use of NNBF was motivated by the need for a comprehensive guide that draws directly on the growing body of knowledge and experience from around the world to inform the process of conceptualizing, planning, designing, engineering, constructing, and operating NNBF.

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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part II. Institute of Validation Technology, 2006. http://dx.doi.org/10.1080/21506590.wp7142006agko-rmsdii.

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highlight the need for patient-focused and value-adding qualification, validation, and change control programmes for manufacturing and regulating medicinal products in the EU, which are cost-effective and in-line with current regulatory requirements and guidance. To this end, a formal risk management solution was presented that seeks to demonstrate, in a practical way, how Regulators and Industry in the EU may achieve these goals. This solution represents a formal and rigorous approach to risk management, offering a scientific and practical means for determining and managing, on a risk basis, the scope and extent of qualification and validation, and the likely impact of changes. Based on a ten-step, systematic process, this approach offers a ready-to-use and documented risk management methodology for these activities. This tool is not intended for use in all situations, or to address all risk areas or concerns encountered in GMP and Regulatory Compliance environments. Rather, its use should be commensurate with the complexity and/or criticality of the issue to be addressed, and in many instances, and in-line with ICH Q9 principles, a more informal approach to risk management may be more useful, and indeed proportionate.

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O'Donnell, Kevin, and Anne Greene. A Risk Management Solution Designed to Facilitate Risk-Based Qualification, Validation, and Change Control Activities within GMP and Pharmaceutical Regulatory Compliance Environments in the EU—Part I. Institute of Validation Technology, 2006. http://dx.doi.org/10.1080/21506590.wp7132006agko-rmsdfrbq.

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Abstract:

A risk management solution is described that is designed to facilitate risk-based qualification, validation, and change control activities within GMP and regulatory compliance environments in the EU. This solution is based upon a set of pre-defined, fundamental principles and design criteria, which were considered important. It offers a documented and ready-to-use ten-step process for determining and managing, on a risk basis, the scope and extent of qualification and validation, and the likely impact of changes.

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Long, Michael, Daniel Bush, Stephen Briggs, et al. An Army guide to navigating the cyber security process for Facility Related Control Systems : cybersecurity and risk management framework explanations for the real world. Engineer Research and Development Center (U.S.), 2020. http://dx.doi.org/10.21079/11681/35294.

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