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failure modes and effects analysis of pediatric I-131 MIBG therapy: Program design and potential pitfalls

PEDIATRIC BLOOD & CANCER 2022年第12期69卷 e29996页

作者： Maughan, Nichole M. Garcia-Ramirez, Jose L. Huang, Frederick S. Willis, Daniel N. Iravani, Amir Amurao, Maxwell Luechtefeld, David Mhlanga, Joyce C. Perkins, Stephanie M. Zoberi, Jacqueline E. Washington Univ Dept Radiat Oncol Sch Med St Louis MO 63110 USA Washington Univ Dept Pediat Div Hematol & Oncol Sch Med St Louis MO 63110 USA Washington Univ Dept Radiol Div Nucl Med Sch Med St Louis MO 63110 USA Washington Univ Div Radiat Safety Dept Environm Hlth & Safety St Louis MO 63110 USA

Background There is growing interest among pediatric institutions for implementing iodine-131 (I-131) meta-iodobenzylguanidine (MIBG) therapy for treating children with high-risk neuroblastoma. Due to regulations on the medical use of radioactive material (RAM), and the complexity and safety risks associated with the procedure, a multidisciplinary team involving radiation therapy/safety experts is required. Here, we describe methods for implementing pediatric I-131 MIBG therapy and evaluate our program's robustness via failure modes and effects analysis (FMEA). Methods We formed a multidisciplinary team, involving pediatric oncology, radiation oncology, and radiation safety staff. To evaluate the robustness of the therapy workflow and quantitatively assess potential safety risks, an FMEA was performed. failure modes were scored (1-10) for their risk of occurrence (O), severity (S), and being undetected (D). Risk priority number (RPN) was calculated from a product of these scores and used to identify high-risk failure modes. Results A total of 176 failure modes were identified and scored. The majority (94%) of failure modes scored low (RPN <100). The highest risk failure modes were related to training and to drug-infusion procedures, with the highest S scores being (a) caregivers did not understand radiation safety training (O = 5.5, S = 7, D = 5.5, RPN = 212);(b) infusion training of staff was inadequate (O = 5, S = 8, D = 5, RPN = 200);and (c) air in intravenous lines/not monitoring for air in lines (O = 4.5, S = 8, D = 5, RPN = 180). Conclusion Through use of FMEA methodology, we successfully identified multiple potential points of failure that have allowed us to proactively mitigate risks when implementing a pediatric MIBG program.

关键词： failure modes and effects analysis MIBG therapy program commissioning

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failure modes and effects analysis based on neutrosophic analytic hierarchy process: method and application

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SOFT COMPUTING 2021年第16期25卷 11035-11052页

作者： Yucesan, Melih Gul, Muhammet Munzur Univ Dept Mech Engn TR-62000 Tunceli Turkey Munzur Univ Dept Emergency Aid & Disaster Management TR-62000 Tunceli Turkey

failure modes and effects analysis (FMEA) is a commonly used method in risk evaluation. In this paper, a novel FMEA model based on neutrosophic analytic hierarchy process (NAHP) is proposed to overcome shortcomings of the risk prioritization of classical FMEA. Neutrosophic sets approach real-world decision-making problems from a three-aspect structure (i.e., truthiness, indeterminacy and falsity). Therefore, initially, AHP is merged with neutrosophic sets to assign importance weights to risk parameters in FMEA. The encountered failure modes are then prioritized with respect to the previously weighted risk parameters. Each element in AHP comparison matrices is considered as triangular neutrosophic numbers, and score functions are used to transform NAHP elements to deterministic values. The flexibility of determining the weight to each parameter of FMEA (severity, occurrence and detection) and evaluation of each failure mode against these parameters are more well-suited to the real decision-making condition. Finally, a case study in the textile industry is provided to show the applicability of the novel model. Sensitivity and comparative analysis are also performed to validate the results.

关键词： failure modes and effects analysis Neutrosophic set Analytic hierarchy process Textile industry

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Possibilistic chance-constrained data envelopment analysis framework for failure modes and effects analysis

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APPLIED SOFT COMPUTING 2023年 147卷

作者： Zhou, Jing Liu, Yu Univ Elect Sci & Technol China Sch Mech & Elect Engn Chengdu 611731 Sichuan Peoples R China Univ Elect Sci & Technol China Ctr Syst Reliabil & Safety Chengdu 611731 Sichuan Peoples R China 2006 Xiyuan Ave Chengdu 611731 Sichuan Peoples R China

failure modes and effects analysis (FMEA) is an intensively used risk analysis technique for prioritizing failure modes of products, systems, and services. Traditionally, FMEA assumes deterministic and precise values for risk factors. In engineering scenarios, the observed values of decision-makers on risk factors are, however, potentially stochastic and imprecise in nature due to the lack of adequate knowledge and experience. On the other hand, the structural correlation between risks (or failure modes) and induced factors (e.g., the loss cost and recovery time of products, systems, and services) is rarely reported in FMEA. To this end, we develop a possibilistic chance-constrained data envelopment analysis (DEA) framework to overcome the above deficiencies. In this framework, three differentiated categories of DEA approaches (namely, series, parallel, and network structure DEA) are devised to characterize such structural correlation. More specially, the Me measure is introduced to handle imprecise parameters associated with risk factors. Simultaneously, decision-makers are endowed to express flexible attitudes on these imprecise parameters. Moreover, in order to reveal the mechanism of risk priority of failure modes, the proposed framework enables decision-makers to offer optimistic and pessimistic attitudes on risk input and propagation, respectively. A case study of a production system, along with some comparisons and discussions, is given to demonstrate the effectiveness and merits of the proposed framework. As indicated from this case study, no matter which DEA approach is conducted, the risk priority of failure modes is stable in a stochastic environment. (c) 2023 Elsevier B.V. All rights reserved.

关键词： Data envelopment analysis failure modes and effects analysis Possibilistic chance-constrained programming Production system

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A holistic failure modes and effects analysis for university plastic injection laboratory under Bayesian Network

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APPLIED SOFT COMPUTING 2023年 147卷

作者： Yucesan, Melih Gul, Muhammet Pamucar, Dragan Munzur Univ Dept Emergency Aid & Disaster Management TR-62000 Tunceli Turkiye Istanbul Univ Sch Transportat & Logist TR-34116 Istanbul Turkiye Univ Belgrade Fac Org Sci Dept Operat Res & Stat Belgrade Serbia Yuan Ze Univ Coll Engn Taoyuan Taiwan

University Research & Development (R&D) laboratories are facilities used for research and manufactur-ing activities in engineering and basic science fields. Various filling materials are used in plastic R&D laboratories to improve the mechanical properties of thermoplastics or to recycle waste materials. The use of filling materials causes changes in plastic production parameters. This study dealt with the risks arising from extrusion, injection and shredder in a plastic injection laboratory, which led to the inability to manufacture the appropriate product under a holistic methodology. The proposed holistic methodology merges the concepts of failure mode and effects analysis (FMEA), fuzzy best-worst method (FBWM), and a rule-based three-hierarchical Bayesian network (RB-THBN). First, 15 root risks have been identified under a three-stage hierarchy with the support of laboratory decision makers. Then, questionnaires were created using the FMEA concept. The importance values (degree of belief-DoB) of three different FMEA parameters (severity, occurrence and detection) by experts for each risk have been calculated with FBWM. And finally, the RB-THBN has been created, and the final risk values have been computed using the linear utility function for the network. The system has been analyzed via a Bayesian modeling software. A validity test and a control measures planning has also been executed. According to the results, the highest root risk has been determined as "E2-The prepared mixture is not homogeneous"with a crisp risk score of 0.639559. In addition, "failure due to extrusion"has been determined as the highest risk category with a score of 0.564059. It was discussed in detail that these risks arise from homogenization and how the used mixture should be homogenized. A comparative study among traditional FMEA, FMEA extended under FBWM and the proposed approach is performed to observe the differences in final ranking of root risks and to highlight the arguments that

关键词： failure modes and effects analysis Transportation Best-worst method Bayesian network Rule-based Plastic injection

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Cost-effective approach to quality assurance via failure modes and effects analysis for the development of GIRMOS for the Gemini North Telescope 11

Cost-effective approach to quality assurance via failure mod...

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Conference on Modeling, Systems Engineering, and Project Management for Astronomy XI

作者： Barnet, Mark Sivanandam, Suresh Frenzel, Francis Christie, Scott Barbod, Shawn Diaz, Ruben Tschimmel, Martin Univ Toronto Dunlap Inst Astron & Astrophys 50 St George St Toronto ON M5S 3H4 Canada Dominion Astrophys Observ NRC Herzberg Astron & Astrophys NRC HAA 5071 West Saanich Rd Victoria BC V9E 2E7 Canada Assoc Univ Res Astron NSFs Natl Opt Infrared Astron Res Lab Washington DC USA

ISBN: (纸本)9781510675216;9781510675223

The Gemini Infra-Red Multi-Object Spectrograph (GIRMOS) is a high-resolution integral-field spectroscope and imager being built by a consortium of Canadian universities and institutions, along with the International Gemini Observatory (Gemini) and the Korea Astronomy and Space Science Institute (KASI). The team needed a cost-effective way to bring a degree in Product and Quality Assurance to bear on instrument development, but without availability of a dedicated team. Advice and support from the Thirty Meter Telescope (TMT) Systems Engineering Team enabled GIRMOS to tailor and scale the TMT approach to fit within the available resources of a much smaller project. This failure modes and effects analysis (FMEA) method more easily allowed geographically distributed subsystem teams to work independently within an agreed-upon FMEA framework that rolled up into a System-level analysis. The TMT FMEA framework reduced the effort involved in all the follow-on work that used the same data set, namely sparing analysis, reliability and uptime analyses, and accelerated life testing.

关键词： FMEA FMECA GIRMOS Gemini failure modes and effects analysis Systems Engineering

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Kick-off Your Reliability Program with a Requirements failure modes and effects analysis

Kick-off Your Reliability Program with a Requirements Failur...

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69th Annual Reliability and Maintainability Symposium (RAMS)

作者： Franqui, Jaime Newell, Shawn Raytheon Missiles & Def 1847 West Main Rd Portsmouth RI 02871 USA Raytheon Missiles & Def 401 Jan Davis Dr Huntsville AL 35806 USA

ISBN: (纸本)9781665460538

Thoroughly checking requirements in the very early stages of development is extremely important to reducing the risk of out-of-phase rework later in the program's lifecycle. Therefore, one of a development program's first goals is to converge on achievable system design requirements that satisfy the customer's functional and performance needs. Part of this system design requirements development activity is quantifying risks and risk mitigations associated with the requirements, where risk mitigation may include creating new requirements or changing existing requirements. Conducting a Requirements failure modes and effects analysis (FMEA) during this early stage of development is an excellent way of reviewing and cutting potential gaps or ambiguous requirements that lead to out-of-program-phase rework. This paper explains what a Requirements FMEA is and its key steps using practical examples. Furthermore, this paper will show the reader how to perform a Requirements FMEA using Model Based Systems Engineering (MBSE) methods for even greater benefits.

关键词： failure modes and effects analysis Requirements analysis Risk Mitigation

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Combining failure modes and effects analysis and cause-effect analysis: a novel method of risk analysis to reduce anaphylaxis due to contrast media

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INTERNATIONAL JOURNAL FOR QUALITY IN HEALTH CARE 2022年第1期34卷

作者： Koike, Daisuke Yamakami, Junichi Miyashita, Terumi Kataoka, Yumi Nishida, Hiroshi Hattori, Hidekazu Yasuda, Ayuko Fujita Hlth Univ Hosp Dept Qual & Safety Healthcare 1-98 Dengakugakubo Toyoake Aichi 4701192 Japan Nagoya Univ ASUISHI Project Grad Sch Med Showa Ku 65 Tsurumai Cho Nagoya Aichi 4668550 Japan Fujita Hlth Univ Hosp Dept Radiol 1-98 Dengakugakubo Toyoake Aichi 4701192 Japan Fujita Hlth Univ Dept Radiol Sch Med 1-98 Dengakugakubo Toyoake Aichi 4701192 Japan

Background: Contrast media agents are essential for computed tomography (CT)-based diagnoses. However, they can cause fatal adverse effects such as anaphylaxis in patients. Although it is rare, the chances of anaphylaxis increase with the number of examinations. Objective: We aimed to design a quality improvement initiative to reduce patient risk to contrast media agents. Methods: We analysed CT processes using contrast iodine in a tertiary-care academic hospital that performs approximately 14 000 CT scans per year in Japan. We applied a combination of failure modes and effects analysis (FMEA) and cause-effect analysis to reduce the risk of patients developing allergic reactions to iodine-based contrast agents during CT imaging. Results: Our multidisciplinary team comprising seven professionals analysed the data and designed a 56-process flowchart of CT imaging with iodine. We obtained 177 failure modes, of which 15 had a risk-probability number higher than 100. We identified the two riskiest processes and developed cause-and-effect diagrams for both: one was related to the exchange of information between the radiation and hospital information system regarding the patient's allergy, the other was due to education and structural deficiencies in observation following the exam. Conclusion: The combined method of FMEA and cause-and-effect analysis reveals high-risk processes and suggests measures to reduce these risks. FMEA is not well-known in healthcare but has significant potential for improving patient safety. Our findings emphasise the importance of adopting new techniques to reduce patient risk and carry out best practices in radiology.

关键词： radiology anaphylaxis risk assessment failure modes and effects analysis cause-effect diagram quality improvement

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Enhancing reliability of failure modes and effects analysis dealing with linguistic distribution assessments: A consistency based approach

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ENGINEERING APPLICATIONS OF ARTIFICIAL INTELLIGENCE 2024年 133卷

作者： Jia, Xiang Wang, Ying-Ming Martinez, Luis Fuzhou Univ Decis Sci Inst Fujian 350116 Peoples R China Univ Jaen Dept Comp Sci Jaen 23071 Spain Fuzhou Univ Decis Sci Inst Key Lab Spatial Data Min & Informat Sharing Minist Educ Fujian 350116 Peoples R China

failure modes and effects analysis is a proactive reliability-management engineering technique, it has been applied to improve reliability of processes, products, and services. Traditional failure modes and effects analysis method manifests three deficiencies with regard to form of risk assessments, determination of risk factor weights, and exploitation of failure modes' risk levels. Although numerous studies have contributed to surmount these deficiencies, existing failure modes and effects analysis methods still face such issues. Moreover, a novel drawback has raised when failure modes and effects analysis participants adopt linguistic terms as risk assessments of failure modes, the reliability of linguistic distribution assessments as well as failure modes and effects analysis groups (participants with similar knowledge background are previously classified into a failure modes and effects analysis group) is overlooked. Therefore, this paper introduces the transformation of linguistic distribution assessments into fuzzy preference relations, as more effective modeling for investigating consistency, by using the newly defined possibility degrees of linguistic distribution assessments will be applied to devise four algorithms for enhancing reliability of assessments. Hence, the three deficiencies of traditional failure modes and effects analysis method are solved by means of a novel failure modes and effects analysis framework. Finally, a real example with respect to ranking failure modes of worm wheel grinding machine is developed to verify the performance and advantages of the proposed method, in which ten failure modes are ranked and the one with the highest risk level is selected, and consistency of risk assessments is improved to be acceptable.

关键词： failure modes and effects analysis Linguistic distribution assessments Fuzzy preference relations Weighting determination method

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Personalized individual semantics-based approach for linguistic failure modes and effects analysis with incomplete preference information

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IISE TRANSACTIONS 2020年第11期52卷 1275-1296页

作者： Zhang, Hengjie Dong, Yucheng Xiao, Jing Chiclana, Francisco Herrera-Viedma, Enrique Hohai Univ Business Sch Nanjing Peoples R China Sichuan Univ Business Sch Ctr Network Big Data & Decis Making Chengdu Peoples R China Nanjing Univ Sci & Technol Sch Econ & Management Nanjing Peoples R China De Montfort Univ Sch Comp Sci & Informat Inst Artificial Intelligence Leicester Leics England Univ Granada Andalusian Res Inst Data Sci & Computat Intellige Granada Spain King Abdulaziz Univ Fac Engn Dept Elect & Comp Engn Jeddah Saudi Arabia

failure modes and effects analysis (FMEA) is a very useful reliability-management instrument for detecting and mitigating risks in various fields. The linguistic assessment approach has recently been widely used in FMEA. Words mean different things to different people, so FMEA members may present Personalized Individual Semantics (PIS) in their linguistic assessment information. This article presents the design of a PIS-based FMEA approach, in which members express their opinions over failure modes and risk factors using Linguistic Distribution Assessment Matrices (LDAMs) and also provide their opinions over failure modes using incomplete Additive Preference Relations (APRs). A preference information preprocessing method with a two-stage optimization model is presented to generate complete APRs with acceptable consistency levels from incomplete APRs. Then, a deviation minimum-based optimization model is designed to personalize individual semantics by minimizing the deviation between APR and the numerical assessment matrix derived from the corresponding LDAM. This is followed by the development of a ranking process to generate the risk ordering of failure modes. A case study and a detailed comparison analysis are presented to show the effectiveness of the PIS-based linguistic FMEA approach.

关键词： Reliability management failure modes and effects analysis personalized individual semantics consistency optimization

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Assessment of Water Supply Dam failure Risk: Development of New Stochastic failure modes and effects analysis

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WATER RESOURCES MANAGEMENT 2020年第5期34卷 1827-1841页

作者： Ardeshirtanha, Khalil Sharafati, Ahmad Islamic Azad Univ Sci & Res Branch Dept Civil Engn Tehran Iran

This study presents an innovative stochastic approach based on the failure modes and effects analysis to evaluate the failure risk of Amir Kabir dam in Iran. To compute the risk priority number, several risk factors including, occurrence probability, severity, and detectability are quantified using expert opinions. In this way, the participant experts are divided into four groups including;dam operation staff, water company staff, academic staff and, other experts. Moreover, the weights of the expert groups are also considered to compute the risk priority number. Hence, a new failure modes and effects analysis called modified stochastic failure modes and effects analysis is provided by considering weights of expert groups and risk factors. Furthermore, Monte Carlo simulation is used to consider the weights uncertainty and compute a stochastic-based risk priority number. Results show that the first priority failure modes of the upstream and downstream basins of Amir Kabir dam are the human-based failure modes while a nature-based failure mode is observed with most priority in dam body. In general, the proposed stochastic failure risk method provides reliable results with low uncertainty to evaluate the failure modes through a risk assessment process.

关键词： Dam failure risk failure modes and effects analysis Risk priority number Monte Carlo simulation Amir Kabir dam

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