Improved Failure Mode and Effect Analysis: Implementing Risk Assessment and Conflict Risk Mitigation with Probabilistic Linguistic Information

Risk assessment based on failure mode and effects analysis (FMEA) and WASPAS methods under probabilistic double hierarchy linguistic term sets

Objective To analyze the risks of hypertonic glucose injection ( 20%) (hypertonic glucose) in clinical application using failure mode and effect analysis (FMEA) method and improve the relevant management measures. Methods A study group on risk prevention strategies of hypertonic glucose was established in the First People′s Hospital of Hefei. Domestic and foreign literature on medication error cases, preventive measures or management strategies, and data from questionnaires and on-the-spot investigations were collected. The failure modes in the process of hypertonic glucose application were analyzed and assessed. Severity (S), frequency of occurrence (O), and likelihood of detection (D) of the risks related to these failure modes were scored and the risk priority numbers (RPN) were determined. The failure modes with higher RPN were screened out and the corresponding prevention strategies were formulated. The incidence of medication errors and potential hazards, cognition rate of knowledge on drugs, qualification rate of drug storage, and satisfaction rate for management measures before and after the improvement were analyzed comparatively. Results According to the results from literature search, questionnaires, and on-the-spot investigations, a total of 24 failure modes were found in the 6 links relevant with hypertonic glucose application in clinical, which included links of prescription writing and delivery, pharmacist dispensing, nurse dispensing, post-administration monitoring, drug management, and information technology. Ranking the RPN from high to low, 7 major failure modes with higher RPN were selected from the 24 failure modes, including the existence of drugs with similar name and drugs with similar package, wrong drug dispensing, absence of post-administration monitoring, lack of marked labels for drugs, garbles caused by lack of medication knowledge, and untimely record and report of medication errors. The incidences of medication errors and potential safety hazards before and after management improvement were 3.2% (7/216) and 0.4% (1/234), respectively and the difference had no statistical significance (P=0.058). The average cognitive rates of physicians, nurses and pharmacists before and after the improvement were 65.2%(15/23), 54.2%(13/24), 67.9%(19/28) and 95.8%(23/24), 91.7%(22/24), 95.5%(21/22), respectively and the differences were statistically significant (P<0.05 for all). The qualification rates of drug storage before and after management improvement were 70.2%(151/215) and 98.7%(230/233), respectively and the difference was statistically significant (P<0.05). The average satisfaction degrees of medical staff with hyperosmotic glucose management were 81.3%(61/75) and 95.7%(65/70), respectively before and after the management improvement and the difference was statistically significant (P<0.05). Conclusion Failure modes in the process of hypertonic glucose use can be effectively identified using the FMEA method, and the risk events can be effectively reduced after the corresponding improvement measures. Key words: Healthcare failure mode and effect analysis; Glucose solution, hypertonic; Hospital administration; High-alert medicine

Objective To consummate the cleaning process of medical power tool so as to improve the quality of cleaning of medical power tool. Methods The failure mode and effect analysis (FMEA) project group was built up in April 2016. The cleaning process of medical power tool was analyzed with the method of FMEA. The intervention was carried out aiming at high risk factor. Besides, the cleaning process of medical power tool was consummated and improved continually combining the detection results of ATP bioluminescence assay. The risk assessment of the cleaning process of medical power tool was carried out to determine high risk factors and formulate as well as implement improvement measures. The control effect of risk priority number (RPN) of cleaning on medical power tool and cleaning effect were compared before (March 2016) and after (September 2016) FMEA. Results The RPN of the cleaning process of medical power tool decreased from (218.17±89.14) before implementing FMEA to (33.26±9.54) after implementing FMEA. The qualified rate of ATP bioluminescence assay in washing quality increased from 68.6% to 98.5% before and after implementation with a significant difference (χ2=22.94, P<0.01) . Conclusions The application of FMEA can effectively control the risk factors of the cleaning process of medical power tool, improve the cleaning quality of power tool and reduce the opportunity for infection in patients. Key words: Failure mode and effect analysis; Cleaning; Medical power tool; Management

An ELICIT information-based ORESTE method for failure mode and effect analysis considering risk correlation with GRA-DEMATEL

Hazard is a potential source to cause the hostile consequences to physical or mental condition of a person in the workplace. Risk means the effect of uncertainty which may be either positive or negative. Risks assessment is the identification of risk sources, analyzing and evaluating them to understand the degree of safe and healthy work environment. Failure mode and effects analysis (FMEA) is the process of revising the practices as possible to identify potential failure modes in each activity, their root causes and effects on them. The purpose of this research is to analyze hazards and potential risks of work safety commonly occurred in high rise construction sites in Myanmar. Questionaries' are used for categorical data of hazards and potential risks to differentiate between real time and necessary control levels for work safety and introduce the applicable ways to be prevented. The research findings indicate the techniques to control and eliminate the hazards and potential risks through FMEA method and OH&S management system by identifying the critical work situations, the gaps between the control levels, understanding cross functional working relationship, standardizing safety norms and practices, reducing costs and increasing customers' satisfaction.

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.

The technology of wind power is being widely developed worldwide. Ensuring the reliable operation of wind turbine systems is of significance. A popular tool to identify the potential risk of an engineering system is the failure mode and effect analysis (FMEA) method. However, when conducting a FMEA in a complex and uncertain environment, experts may find it challenging to select an appropriate linguistic term for the evaluation. The probabilistic linguistic term sets (PLTSs) are a useful fuzzy set to help experts in describing their assessment. However, different experts may assign different semantic values to the same linguistic terms, and this aspect has not been extensively examined in the existing studies. Therefore, considering the psychological behaviour of experts and the semantics of linguistic terms in the risk ranking process, an improved FMEA based on the probabilistic linguistic information and TODIM (an acronym in Portuguese of interactive and multicriteria decision making) method was developed to identify the risks in wind turbine systems. Furthermore, to demonstrate the utility of the proposed model, it was applied in a floating offshore wind turbine system. The effectiveness and the validity of the model were verified by comparing with some other methods.

With increasing deployment, complexity, and sophistication of equipment and related processes within the clinical imaging environment, system failures are more likely to occur. These failures may have varying effects on the patient, ranging from no harm to devastating harm. Failure mode and effect analysis (FMEA) is a tool that permits the proactive identification of possible failures in complex processes and provides a basis for continuous improvement. This overview of the basic principles and methodology of FMEA provides an explanation of how FMEA can be applied to clinical operations in a radiology department to reduce, predict, or prevent errors. The six sequential steps in the FMEA process are explained, and clinical magnetic resonance imaging services are used as an example for which FMEA is particularly applicable. A modified version of traditional FMEA called Healthcare Failure Mode and Effect Analysis, which was introduced by the U.S. Department of Veterans Affairs National Center for Patient Safety, is briefly reviewed. In conclusion, FMEA is an effective and reliable method to proactively examine complex processes in the radiology department. FMEA can be used to highlight the high-risk subprocesses and allows these to be targeted to minimize the future occurrence of failures, thus improving patient safety and streamlining the efficiency of the radiology department.

One of the prominent techniques in the field of Total Quality Management (TQM) is Failure Mode and Effects Analysis (FMEA). FMEA facilitates the recording of failures and analysing them to provide solutions for preventing their recurrence. During the early periods of FMEA evolution, there were two types namely Design FMEA and Process FMEA (PFMEA) in practice. In recent days, more types such as System FMEA, Service FMEA and Maintenance FMEA are being prescribed by the researchers. Meanwhile, a number of benefits of FMEA implementation have been reported. Yet, FMEA has not found its implementation in various fields. One among them is service field. This paper reports the examination of FMEA implementation in service industry. This direction of research led to the design of an improved model, named as 'Modified service FMEA'. Its implementation was examined in an Indian State Government owned passenger Transport Company. Despite certain practical hurdles, this exercise was successful in developing modified service FMEA table and pinpointing the seriousness of failures through the portrayal of Service Lost (SL) and Cost Lost (CL).

The new version of the GOST ISO/IEC 17025-2019 standard requires the laboratories to plan and carry out actions to eliminate risks and opportunities. Several management tools can be used to identify risks, such as Failure Tree Analysis (FTA), Failure Mode and Effects Analysis (FMEA), Ishikawa diagram, risk matrix, brainstorming, and etc. The result of risk identification in the laboratory is a risk register containing all potential risks that may arise during laboratory activities. FMEA is one of the such registries. The purpose of this study was to demonstrate the possibility of using the FMEA tool for risk assessment in a testing laboratory, taking into account the requirements of GOST ISO/IEC 17025-2019. Two processes were selected and used for FMEA analysis - review of requests, applications and internal laboratory control. As part of the analysis, point estimates (on a ten-point scale) of the Severity of Effect S, the Probability of Occurrence O, and the Likelihood of Detection D. Based on the scores, the risk priority number RPN is calculated. For nonconformities with the RPN value exceeded 100, corrective measures were developed that made it possible to reduce the RPN values to an acceptable laboratory level. It is recommended to analyze the processes using the FMEA method in order to identify the causes of nonconformities and prevent their recurrence periodically. Risk analysis and management are necessary to achieve the intended results in the activities of testing laboratories, maintain and improve the quality management system.

Failure mode and effects analysis (FMEA) is a widely used, powerful tool to identify and assess potential failure modes in products and to make products more reliable. Due to the complexity of products and lack of knowledge, FMEA involves many uncertainties in practice. In previous studies, numerous modified FMEA methods based on fuzzy logic and Dempster-Shafer (D-S) evidence theory have been employed to address these uncertainties. These studies focus on how to handle uncertainties and to identify a more reliable prioritization of risk priority numbers (RPNs). However, studies have not sufficiently examined how many uncertainties are present in resulting RPNs. To better model and process various types of uncertainties in FMEA, two new area-based metrics are constructed in this paper. One is the interval area metric (IAM), which is used in RPN representation. The other is the dimensionless uncertainty metric (DUM), which is used to measure how many uncertainties there are in RPN. IAM is used to rank the risks in failure modes, and DUM is used to rank the uncertainties in failure modes. Then, an expert system is presented to qualitatively evaluate the DUM, which can help FMEA users intuitively judge whether further investigation should be performed to alleviate the epistemic uncertainties in each failure mode. Finally, a practical risk evaluation case regarding the grinding wheel system of a numerically controlled (NC) machine is provided to demonstrate the application and effectiveness of the proposed FMEA. The case study shows that the calculation programs of IAM and DUM do not require any assumptions or need to address conflict among experts. In addition, proposed method can not only give a more accurate rating of each failure mode, but also help designers intuitively see the uncertainty grade of each RPN, which is useful to help them understand FMEA results.

The unmanned aerial vehicle(UAV) power system consists of components that provide flight power for the UAV, which mainly includes three parts: motor, electronic speed controller(ESC), and battery. Since the UAV always operates in the open air, which requires high stability of the power system, the failure mode and effects analysis(FMEA) is particularly significant and it has been widely used to examine potential failures in systems or components. However, the traditional FMEA method has many unreasonable points. In order to better deal with the uncertainty and improve the stability of the UAV power system, we propose a FMEA method which is based on the generalized Dempster-Shafer structures, the failure modes are comprehensively analyzed and the risks are ranked by combining the characteristic information of risk factors with the generalized evidence theory. The new method can not only deal with the uncertainty of risk assessment, but also further improve the reliability of effects analysis. In addition, the FMEA experiment of the UAV power system is carried out in this paper. The experimental results show that the method is effective for practical applications.

Human necessity toward consumable drinking water increases along with population growth. People nowadays have a hard time obtaining clean water because of polluted river. To meet daily necessity of drinking water, a lot of industries open drinking water business, particularly refill drinking water facility (DAMIU). The utilization of refill drinking water facility has its own hazardous risk because of the doubtful quality, moreover if the customers aren’t paying attention towards the security and hygiene. This study used FMEA (Failure Mode Effect and Analysis) to determine the priority of failure incident in refill drinking water treatment process. This FMEA method was used because FMEA has advantage over other method in term of being more feasible and effective for operational improvement while being able to analyze risk in bigger and more complex scale. To determine the failure, we first did risk identification which contained failures information obtained from interview, quality test, and direct observation. Failure causes risk happened in refill drinking water facilities were analyzed using Fishbone method. The location of the study was in Rungkut District, Surabaya. The parameters used were turbidity, TDS, pH, and Total Coliform. Obtained risk should had a value to be measured and determined for the handling priority and to find improvement effort. The measurement value was called as RPN (Risk Priority Number) which was the multiply value of severity, occurrence, and detection. Based on analysis result using fishbone method there were 4 factors which caused failure for total coliform parameter. Then, it was analyzed using FMEA method, and it was found that failure happened within 3 highest priority, which was UV system contact duration, ozone system contact duration, and disinfection tool replacement and maintenance.

Production quality in terms of process efficiency and quality in the manufacturing industry must always be improved in order to maintain customer confidence. PT XYZ as a heavy equipment assembly company is one of the companies that depends on process reliability for a smooth production process. Based on this, the problems raised in this study focus on increasing the efficiency of the process of installing bolts on slew bearings. By using Overall Equipment Efficiency (OEE) and Process Capability (CpK) as the main benchmarks for measuring the quality of the production process where the latest data shows the average OEE value is at 18.53%, while the CpK value for the bolt tightening process is at 0 ,67. The OEE and CpK figures obtained show that the process quality is still not optimal and needs to be improved. The purpose of this research is to identify and prevent as many factors as possible that can lead to process failure. The methods used to evaluate processes and to identify where and how a process might fail are Failure Mode and Effect Analysis (FMEA) and Logic Tree Analysis (LTA). Both methods are used to identify and prevent as many factors as possible that can lead to a process failure. The results of research using the FMEA and LTA methods show that in the process of installing slew bearing bolts there is a process that needs to be improved because the RPN value is quite high, namely above 125. Some suggestions for improvement such as the use of a manipulator arm on a torque tool and the implementation of a manufacturing execution system (MES) can reduce the RPN value from above 125 to 28, where the process obtained is better than before.

The completeness and accuracy of the front pages of electronic medical records (EMRs) are crucial for evaluating hospital performance and for health insurance payments to inpatients. However, the quality of the first page of EMRs in China's medical system is not satisfactory, which can be partly attributed to deficiencies in the EMR system. Failure mode and effects analysis (FMEA) is a proactive risk management tool that can be used to investigate the potential failure modes in an EMR system and analyze the possible consequences. The purpose of this study was to preemptively identify the potential failures of the EMR system in China and their causes and effects in order to prevent such failures from recurring. Further, we aimed to implement corresponding improvements to minimize system failure modes. From January 1, 2020, to May 31, 2022, 10 experts, including clinicians, engineers, administrators, and medical record coders, in Zhejiang People's Hospital conducted FMEA to improve the quality of the front page of the EMR. The completeness and accuracy of the front page and the risk priority numbers were compared before and after the implementation of specific improvement measures. We identified 2 main processes and 6 subprocesses for improving the EMR system. We found that there were 13 potential failure modes, including data messaging errors, data completion errors, incomplete quality control, and coding errors. A questionnaire survey administered to random physicians and coders showed 7 major causes for these failure modes. Therefore, we established quality control rules for medical records and embedded them in the system. We also integrated the medical insurance system and the front page of the EMR on the same interface and established a set of intelligent front pages in the EMR management system. Further, we revamped the quality management systems such as communicating with physicians regularly and conducting special training seminars. The overall accuracy and integrity rate of the front page (P<.001) of the EMR increased significantly after implementation of the improvement measures, while the risk priority number decreased. In this study, we were able to identify the potential failure modes in the front page of the EMR system by using the FMEA method and implement corresponding improvement measures in order to minimize recurring errors in the health care services in China.