Application Of Failure Mode And Effects Analysis Research Articles

MITIGATING OPERATION, QUALITY AND REGULATORY CHALLENGES IN THE PACKAGED DRINKING WATER INDUSTRY: A FAILURE MODE EFFECT ANALYSIS (FMEA) APPROACH

Access to safe drinking water is vital for human development; however, challenges arising from industrialization, agriculture, and population growth threaten its availability. The packaged drinking water industry, a crucial alternative, encounters difficulties in meeting quality, operational, and regulatory requirements. Refillable polyethylene terephthalate (PET) jars, undergoing multiple cycles of refilling, pose higher risks of contamination, requiring more attention. This study advocates the use of a proactive method, Failure Mode and Effects Analysis (FMEA), to anticipate and prevent problems in the processing and refilling of PET water jars before they occur, promoting a proactive approach to quality and risk management. Findings reveal inadequate cleaning of PET water jars with the highest Risk Priority Number (RPN) of 378, followed by aging of UV lamp, scaling on the UV lamp shield impacting the disinfection of product water and biological contamination due to unsanitary practices during manual filling of jars, each with RPNs of 315, 324, and 270. Addressing these top contributors promises substantial improvements in water quality. Implementing corrective actions reduced RPNs to 81, 54, 36, & 36, respectively. This systematic application of FMEA yielded significant improvements in quality, safety, and reliability within the packaged drinking water industry. Proactive strategies developed through FMEA hold promise beyond the packaged drinking water industry, improving water quality management.

Analysis on the application of FMEA in 'instrument and equipment surface cleaning and disinfection' in hospitals based on standardization and cleaning and disinfection information system management.

To analyze the application of 'instrument and equipment surface cleaning and disinfection' in hospitals based on standardization and the management of cleaning and disinfection information systems. Employees and all cleaning and disinfected instruments and equipment from 56 inpatient departments in our hospital were selected as the subjects of observation. The period before the intervention (January 2023) was designated as the control group, while the period after the intervention (July 2023) was designated as the study group. In the control group, the instruments and equipment under routine management were disinfected. The research team applied the Failure Mode and Effects Analysis (FMEA) method to clean and disinfect the surfaces of instruments and equipment on the basis of standardization and cleaning and disinfection information system management. Employees' theoretical knowledge points and operational skill scores before and after the intervention were compared and evaluated. The changes in the risk priority coefficient (RPN) values of high-risk factors were analyzed. Fifty-six clinical medical staff from 56 inpatient departments in the hospital were selected to evaluate the clinical satisfaction of the cleaning and disinfection management of instruments and equipment before and after the intervention, and the clinical satisfaction of the two groups was compared. The scores of theoretical knowledge and operational skills of the staff in the research group were significantly higher than those in the control group. The passing rates of theoretical knowledge and operational skills in the control group and the research group were 44.64 and 94.64% respectively, and 55.36 and 96.43%, respectively. The qualified rate of theoretical knowledge and operational skills of staff in the study group was significantly higher than that in the control group (p < 0.05). The RPN scores of medical personnel, environment, system and system guarantee factors in the control group were 80, 80, 80, and 100, respectively. The RPN scores of medical personnel factors, environmental factors, system factors and system guarantee factors in the research group were 6, 24, 24, and 36, respectively. Through standardization and cleaning and disinfection information system management, the theoretical knowledge and technical operation capabilities of cleaning can be effectively improved.

Using a Critical FMEA Approach to Identify Equity-Related Failures in Usability Evaluations of Health Technologies

Design issues that affect the usability of health technologies for marginalized populations may lead to further exacerbating health inequity. To address this concern, we propose the use of failure modes and effects analysis (FMEA) to systematically identify potential inequities that result from usability evaluation methods. This new application of FMEA grounds the traditional FMEA in critical theory and introduces two key concepts: the equity failure mode and reflexivity. To test our approach, we engaged 13 usability practitioners with expertise in healthcare in a series of four workshops. We found that when participants located themselves reflexively in their practice of usability evaluation, they were able to identify more nuanced equity failure modes. Through reflecting on our experience using this method, we aim to illustrate that the critical FMEA is a viable approach human factors practitioners and researchers can use to anticipate equity failure modes in design and evaluation methods.

The risk-based operational safety strategy for Perkin-Elmer/Cetus DNA Thermal Cycler PCR systems

Introduction: this article was conducted in the field of polymerase chain reaction (PCR) test safety, where it is essential to understand the contribution and impact of risk analysis methods to improve test safety medical diagnosis at the institutional level. In this context, the current study focuses on failure modes and effects analysis (FMEA) applied to the Perkin-Elmer/Cetus deoxyribonucleic acid (DNA) thermocycler.Objective: to describe the application of FMEA to improve the operational safety of Perkin-Elmer/Cetus DNA thermal cyclers used in medical diagnostics in ataxic patients. Methods: to carry out this study, a methodology based on an exhaustive review of the scientific literature available in academic databases and relevant sources was used. Previous studies on FMEA analysis of DNA thermocyclers in common and expanded forms were collected and analyzed.Results: the results obtained demonstrated that FMEA is an effective tool to identify and evaluate possible failure modes of Perkin-Elmer/Cetus DNA thermal cyclers. Several defects were identified and their consequences, causes and classification based on their severity and frequency were determined. Likewise, corrective actions are proposed to reduce the identified risks.Conclusions: early identification of possible failure modes and implementation of corrective actions can reduce risk and guarantee the quality of the diagnoses carried out and therefore improve operational safety

Application of FMEA and FTA techniques for assessing the occurrence of LOCA in a TRIGA MARK I Reactor

This study presents a framework merging failure mode and effect analysis (FMEA) and fault tree analysis (FTA) techniques to evaluate loss of coolant accident (LOCA) in the Brazilian Reactor TRIGA IPR-RI. At first, FMEA identified failure modes and prioritized risk management based on the risk priority number (RPN). Subsequently, FTA established logical relationships between these failure modes, revealing minimal cut sets. Results indicated that the path involving “loss of coolant from reactor tank” correlate to an externally caused leak, exhibiting a low probability and, consequently, a low RPN. On the other hand, the path involving “loss of coolant through primary circuit rupture without a pump shutdown” highlighted high RPN due to the lack of shutdown signals from the monitoring indicators. Finally, FTA unveiled that LOCA associates with a primary circuit rupture and the simultaneous failure of safety mechanisms, including ultimately human error.

Failure mode and effect analysis using VIKOR method based on interval-valued linguistic Z-numbers

Failure mode and effect analysis (FMEA) is an effective quality management tool used to improve product quality and reliability. However, with the application of FMEA, its shortcomings are exposed regarding risk assessment, weight determination, and failure mode risk prioritization. This paper proposes a new FMEA model using VlseKriterijumska Optimizacija I Kompromisno Resenje (VIKOR) method based on the Interval-valued linguistic Z-numbers (IVLZNs). Specifically, IVLZNs and the Interval-valued linguistic Z-numbers weighted arithmetic averaging (IVLZNWAA) operator are used to evaluate and aggregate risk information of failure modes; the maximum deviation method is used to determine the weight of risk factors; the IVLZNs-VIKOR method is used to determine the risk priority of failure modes. Then, a numerical example is given to verify the effectiveness of the proposed model. Finally, a comparative analysis is made to demonstrate the feasibility and rationality of the proposed method.

Proposing the Use of Failure Mode and Effect Analysis (FMEA) as Risk Assessment Tool in Construction

The aim of this research was to improve the analysis of risks in construction projects in Egypt through proposing the implementation of FMEA as a risk assessment tool. First, an extensive literature review was conducted to identify the relevant risks in the Egyptian construction industry. Second, a questionnaire survey was carried out to determine the impact, probability, and detection of the identified risk factors according to experts working in the construction sector in Egypt. Third, an analysis of these risks was carried out using traditional PMI’s risk assessment, FMEA, and the integration of fuzzy logic with FMEA fundamentals. The reached results demonstrated that FMEA and risk management are quite similar in different aspects, but FMEA has an additional dimension to PMI’s risk analysis, which is “detection”. Such dimension affects how risks are managed and plays a major role in developing better strategies for controlling and detecting risks. This added depth provides more insights about the project and enables construction parties to make better preparations and decisions in their projects. The findings indicated that FMEA has a significant potential in the construction industry if it is properly applied. Findings of this research are envisaged to promote the application of FMEA as an upgrade to the currently applied PMI’s risk management practice; thus, enhancing the efficiency, visualization, and eventually the decision making.

Proposal of a facilitating methodology for fuzzy FMEA implementation with application in process risk analysis in the aeronautical sector

PurposeThis study aims to propose a facilitating methodology for the application of Fuzzy FMEA (Failure Mode and Effect Analysis), comparing the traditional approach with fuzzy variations, supported by a case application in the aeronautical sector.Design/methodology/approachBased on experts' opinions in risk analysis within the aeronautical sector, rules governing the relationship between severity, occurrence, detection and risk factor were defined. This served as input for developing a fuzzyfied FMEA tool using the Matlab Fuzzy Logic Toolbox. The tool was applied to the sealing process in a company within the aeronautical sector, using triangular and trapezoidal membership functions, and the results were compared with the traditional FMEA approach.FindingsThe results of the comparative application of traditional FMEA and fuzzyfied FMEA using triangular and trapezoidal functions have yielded valuable insights into risk analysis. The findings indicated that fuzzyfied FMEA maintained coherence with the traditional analysis in identifying higher-risk effects, aligning with the prioritization of critical failure modes. Additionally, fuzzyfied FMEA allowed for a more refined prioritization by accounting for variations in each variable through fuzzy rules, thereby improving the accuracy of risk analysis and providing a more realistic representation of potential hazards. The application of the developed fuzzyfied FMEA approach showed promise in enhancing risk assessment in the aeronautical sector by considering uncertainties and offering a more detailed and context-specific analysis compared to conventional FMEA.Practical implicationsThis study emphasizes the potential of fuzzyfied FMEA in enhancing risk assessment by accurately identifying critical failure modes and providing a more realistic representation of potential hazards. The application case reveals that the proposed tool can be integrated with expert knowledge to improve decision-making processes and risk mitigation strategies within the aeronautical industry. Due to its straightforward approach, this facilitating methodology could also prove beneficial in other industrial sectors.Originality/valueThis paper presents the development and application of a facilitating methodology for implementing Fuzzy FMEA, comparing it with the traditional approach and incorporating variations using triangular and trapezoidal functions. This proposed methodology uses the Toolbox Fuzzy Logic of Matlab to create a fuzzyfied FMEA tool, enabling a more nuanced and context-specific risk analysis by considering uncertainties.

A dynamic failure mode and effect analysis (FMEA) method for CNC machine tool in service

To solve the problems such as uncertain evaluation information, high dependence on experts, and no consideration of the degradation of machine operating performance to failure risk in the practical application of FMEA in CNC machine tool operation and maintenance, a dynamic failure mode and effect analysis (FMEA) method for CNC machine tool in service is proposed, operation and maintenance data is introduced to the traditional failure risk analysis, which makes semantics criteria and data-driven method are systematically integrated, resulting in better performance of quantitative assessment and risk ranking of dynamic fault risk. Afterward, the fault classification and maintenance strategy of the CNC machine tool based on risk priority number (RPN) is proposed, which provides decision support for efficient operation and maintenance of the CNC machine tool. Finally, a machining center is taken as an example to verify the feasibility and effectiveness of the method.

Overview of Failure Mode and Effects Analysis (FMEA): A Patient Safety Tool.

Overview of Failure Mode and Effects Analysis (FMEA): A Patient Safety Tool.

A new risk assessment framework for safety in oil and gas industry: Application of FMEA and BWM based picture fuzzy MABAC

As one of the riskiest sector, oil and gas production, transportation and storage operations create dangers for workers. Since health hazards and dangerous conditions can result in fatalities or damages, safety precautions are vital in oil and gas industry. As accident types, fire and explosions are among the most frequent primary coincidences and vary from different causes. The aim of this study is to identify and prioritize fire and explosion risks in the midstream section of the oil and gas industry. For this aim, the common causes of fire and explosions were evaluated to take preventive measures or mitigation strategies. To prioritize risk factors cause fire and explosions in the midstream section of the oil and gas industry, a new risk assessment framework that consists of Best-Worst Method (BWM) and Picture Fuzzy multi-attributive border approximation area comparison (PF-MABAC) method based on Failure Mode and Effect Analysis (FMEA) was proposed. Accordingly, while the weights of risk parameters in FMEA were determined using BWM, to follow proper safety precautions risk factors were evaluated using PF-MABAC method. To demonstrate the effectiveness and practicality of the proposed risk assessment approach, case studies were conducted. At the end, sensitivity analysis was performed to validate and prove robustness of the proposed risk assessment framework via results of a real case.

Proactive Risk Assessment Through Failure Mode and Effect Analysis (FMEA) for Haemodialysis Facilities: A Pilot Project.

Haemodialysis (HD) is one of the methods for renal replacement therapy in the management of advanced chronic kidney disease through an osmosis process that allows purification of blood in the dialysis machine. The complexity of the dialytic procedure often requires the presence of a multi-specialist, multi-disciplinary team. The dialysis process is an important target for clinical risk management. Failure Mode and Effect Analysis (FMEA) is a proactive technique, considered a purposeful and dynamic tool for clinical risk management. FMEA is noted in five phases that allow a preliminary assessment of a definite process through identification and classification of risk priorities. This study represents the first of a two-phase project where FMEA is applied to HD in the setting of San Feliciano Hospital. The dialysis center performs ~12,000 dialysis sessions per year. The dialysis process is divided into different stages. A total of 31 failure modes were identified in the whole dialysis stages; more than 2/3 of the failure modes were related to the only connecting of the patient to the dialysis machine. The first phase of the study clearly remarked that the most critical step of the dialytic process is represented by the connection between the patient and the machine, as expected. Indeed, in order to have the dialysis set up, an arteriovenous fistula must be surgically created prior to the procedure and it is one of the most important issues in the HD process because of the necessity of a constant revision of it. FMEA application to HD is a useful tool, easy to be implemented and it is likely to nimbly reveal the practical and potential solutions to the critical steps of the procedure.

Case Study on a Potential Application of Failure Mode and Effects Analysis in Assessing Compliance Risks

Assessing and reducing compliance risks can now be considered one of the core criteria for business success. While failure mode and effect analysis (FMEA) is widely used in engineering, its application in the financial sector is quite novel, primarily related to compliance risk assessment. This paper presents the results of exploratory research based on the potential application of FMEA in a focus group of compliance experts at one of the largest Central and Eastern European commercial banks. This study aims to establish a process for assessing compliance risks that builds on the strengths of both the qualitative and quantitative assessment methods. Applying FMEA based on a nominal group technique and further statistical analysis provides an opportunity to compare expert assessments and the consensus level of the participants. As a result, the similarity or difference of the assessment patterns can be quantified, providing objective feedback on the evaluation. Finally, this paper proposes lifting the detectability of failures as an evaluation dimension to the same level of importance as the probability and impact of non-compliance and using agreement testing statistical methods.

Application of FMEA and AHP in Elevated Highway Construction Project Risk Assessment

Background: By investigating accidents in industries, it can be concluded that a significant proportion of work-related accidents occur in the construction industry. The present study aimed to apply a hybrid model in identifying and prioritizing risks in a construction project with new machinery. Methods: In this study, the methodological shortcomings of the traditional failure mode and effects analysis (FMEA) method and the need to prioritize control measures were modified by the analytical hierarchy of process (AHP). The FMEA was used for risk identification and risk assessment in the elevated highway construction project, then AHP accidents were prioritized according to their physical, psychological, economic, and socio-political burden. Results: In the AHP structure, several sub-criteria for each criterion were considered and weighted for each item. The five activities included crane collapse, falling from a height, collapse, and electrocution devices that their risk priority number is more than 250 weighted by the AHP. Discussion: Based on the literature, the traditional FMEA has many shortcomings that need to be corrected by other methods. This study aimed to modify the traditional FMEA method using a hybrid model. Conclusion: The findings of this study showed that in urban projects, hazards threaten workers, citizens, and company properties. In addition to accidents, deaths, and injuries, they have negative consequences, such as health, psychological, economic, and socio-political impacts. Accidents cause loss of human life, worker's mental health problems, damage to equipment or property, worker's productivity loss, and affect the profit and reputation of the organization. Due to many deficiencies of the conventional risk priority number (RPN) in the FMEA method, it was criticized, and to enhance the performance of the FMEA in risk analysis, various risk priority models have been proposed.

Literature review and prospect of the development and application of FMEA in manufacturing industry

In order to enable failure mode and effects analysis (FMEA) to play a better quality control role in complex manufacturing products or systems, the current research status of FMEA is reviewed from failure mode identification, risk assessment, and industrial standard application. Firstly, the research status of system failure identification is summarized from the following aspects: the breakthrough point of identification, the types of identification methods, and the normalized description of failure modes. Then, sort out the research status of risk assessment from five aspects: risk factor evaluation criteria, risk assessment opinion expression, expert opinion consensus, risk opinion assessment aggregation, and sensitivity analysis, and find out research hotspots and blind spots; finally, the changes of FMEA standards in various fields are summarized and compared, and the future development trend of FMEA in the context of intelligent manufacturing is discussed.

Application of FMEA in Solving the Financial Inclusion Issue in India

Failure mode and effect analysis (FMEA) is an operational tool which systematically, proactively evaluates the method to spot where the potential failure might occur and identify the potential causes, which would help to reduce the relevant impact of various failures in the process. Financial inclusion generally understood to mean the method of ensuring access to appropriate financial products and services needed by all sections of society including vulnerable groups at an economical cost. It's an immediate impact on the expansion of the economy of the country. This paper analyses the effect of Indian citizen participation in financial inclusion and identifies issues faced by the individuals during investments in financial products. The paper is based on the primary data. Here, Failure mode and effect analysis (FMEA) is used to analyse the risk associated with the investment process which the general public will face while investing and eliminate or reduce the risk by providing solutions for the development of future processes or take appropriate risk mitigation methods. Hence the outcome of this research paper will be useful for financial institutions which are in need to optimize their resources for selling the financial products and spreading awareness about the same.

Agricultural Risk Management Using Fuzzy TOPSIS Analytical Hierarchy Process (AHP) and Failure Mode and Effects Analysis (FMEA)

Failure mode and effects analysis (FMEA) is a popular technique in reliability analyses. In a typical FMEA, there are three risk factors for each failure modes: Severity (S), occurrence (O), and detectability (D). These will be included in calculating a risk priority number (RPN) multiplying the three aforementioned factors. The literature review reveals some noticeable efforts to overcome the shortcomings of the traditional FMEA. The objective of this paper is to extend the application of FMEA to risk management for agricultural projects. For this aim, the factor of severity in traditional FMEA is broken down into three sub-factors that include severity on cost, the severity on time, and severity on the quality of the project. Moreover, in this study, a fuzzy technique for order preference by similarity to ideal solution (TOPSIS) integrated with a fuzzy analytical hierarchy process (AHP) was used to address the limitations of the traditional FMEA. A sensitivity analysis was done by weighing the risk assessment factors. The results confirm the capability of this Hybrid-FMEA in addressing several drawbacks of the traditional FMEA application. The risk assessment factors changed the risk priority between the different projects by affecting the weights. The risk of water and energy supplies and climate fluctuations and pests were the most critical risk in agricultural projects. Risk control measures should be applied according to the severity of each risk. Some of this research’s contributions can be abstracted as identifying and classifying the risks of investment in agricultural projects and implementing the extended FMEA and multicriteria decision-making methods for analyzing the risks in the agriculture domain for the first time. As a management tool, the proposed model can be used in similar fields for risk management of various investment projects.

Fire Risk Assessment in Healthcare Settings: Application of FMEA Combined with Multi‐Criteria Decision Making Methods

Fire is one of the most dangerous phenomena causing major casualties and financial losses in hospitals and healthcare settings. In order to prevent and control the fire sources, first risk assessment should be conducted. Failure Mode and Effect Analysis (FMEA) is one of the techniques widely used for risk assessment. However, Risk Priority Number (RPN) in this technique does not take into account the weight of the risk parameters. In addition, indirect relationships between risk parameters and expert opinions are not considered in decision making in this method. The aim is to conduct fire risk assessment of healthcare setting using the application of FMEA combined with Multi‐Criteria Decision Making (MCDM) methods. First, a review of previous studies on fire risk assessment was conducted and existing rules were identified. Then, the factors influencing fire risk were classified according to FMEA criteria. In the next step, weights of fire risk criteria and subcriteria were determined using Intuitionistic Fuzzy Multiplicative Best-Worst Method (IFMBWM) and different wards of the hospital were ranked using Interval-Valued Intuitionistic Fuzzy Combinative Distance-based Assessment (IVIFCODAS) method. Finally, a case study was performed in one of the hospitals of Shiraz University of Medical Sciences. In this study, fire alarm system (0.4995), electrical equipment and installations (0.277), and flammable materials (0.1065) had the highest weight, respectively. The hospital powerhouse also had the highest fire risk, due to the lack of fire extinguishers, alarms and fire detection, facilities located in the basement floor, boilers and explosive sensitivity, insufficient access, and housekeeping. The use of MCDM methods in combination with the FMEA method assesses the risk of fire in hospitals and health centers with great accuracy.

A case study on FMEA-based improvement for managing new product development risk

PurposeThe purpose of this paper is to explore the applicability of the failure mode and effects analysis (FMEA) as an effective tool for decreasing failure risk in the early phase of the new product development (NPD), which adds to existing literature on the application of FMEA in NPD.Design/methodology/approachThrough the application of action research (AR) methodology, it was possible to develop a case study examining the use of FMEA to decrease NPD risk in an early phase of NPD execution.FindingsThe importance and immediate gains of identifying NPD failures support FMEA's usefulness for NPD risk decrease. Moreover, its user-friendliness, timeliness and cost advantages facilitate the introduction of FMEA in the early phase of NPD execution.Originality/valueFMEA is a well-known method used in manufacturing companies to identify and correct failures in products, processes and systems. This article explores the lack of practice-oriented evidence on the use of FMEA in the early phase of NPD execution and provides support to its applicability and effectiveness.

Failure mode and effects analysis of linac-based liver stereotactic body radiotherapy.

Although stereotactic body radiation therapy (SBRT) is an attractive noninvasive approach for liver irradiation, it presents specific challenges associated with respiration-induced liver motion, daily tumor localization due to liver deformation, and poor visualization of target with respect to adjacent normal liver in computed tomography (CT). We aim to identify potential hazards and develop a set of mitigation strategies to improve the safety of our liver SBRT program, using failure mode and effect analysis (FMEA). A multidisciplinary group consisting of two physicians, three physicists, two dosimetrists, and two therapists was formed. A process map covering ten major stages of the liver SBRT program from the initial diagnosis to posttreatment follow-up was generated. A total of 102 failure modes (FM), together with their causes and effects, were identified. The occurrence (O), severity (S), and lack of detectability (D) were independently scored using a scale from 1 (lowest risk) to 10 (largest risk). The ranking was done using the risk probability number (RPN) defined as the product of average O, S, and D numbers for each mode. Two fault tree analyses were performed. The failure modes with the highest RPN values as well as highest severity score were considered for investigation and a set of mitigation strategies was developed to address these. The median RPN (RPNmed ) values for all modes ranged from of 9 to 105 and the highest median S score (Smed ) was 8. Fourteen FMs were identified to be significant by both RPNmed and Smed (top ten RPNmed ranked and highest Smed FMs) and 12 of them were considered for risk mitigation efforts. The remaining two were omitted due to either sufficient checks already in place, or lack of practical mitigation strategies. Implemented measures consisted of five physics tasks, two physician tasks, and three workflow changes. The application of FMEA to our liver SBRT program led to the identification of potential FMs and allowed improvement measures to enhance the safety of our clinical practice.