Use Of Failure Mode And Effects Analysis Research Articles

Use of the failure mode and effect analysis tool in the clinical medication process in an intensive care unit

Objective: To describe failure modes and establish contingency measures related to the clinical medication process using medical prescriptions of patients admitted to an Intensive Respiratory Therapy Unit (UTIR), using the Failure Mode and Effects Analysis (FMEA) tool. Methods: This is a descriptive and cross-sectional study carried out in an Intensive Care Unit of a public hospital in Fortaleza, Brazil, from November/2015 to March/2016. Study population included adults aging ≥ 18 years in intensive care at the UTIR. The study included the medical prescriptions released on Mondays, Wednesdays, and Fridays. The study was divided in five phases: situational diagnosis, formation of a multiprofessional team, assessment of failure modes (FM), monitoring of FM and calculation of the priority coefficient (PC). In the FM assessment, scoring of the three indicators of the FMEA was used within a range of 1-10, whereas a score of 10 characterized the most concerning situation. Therefore, the indicators gravity (G), prevalence (P) and detection (D) were analyzed. The study was carried out with an active interaction between the subjects of the group and several in-person and virtual sessions were performed. Drugs used in the study were categorized for therapeutic class, according to the Anatomical Therapeutic Chemical Classification System. Data analysis was performed using Microsoft Office Excel® 2013 software. Results: 301 prescriptions were analyzed, with the identification of 452 FMs, which related mostly to systemic antibacterials (21.6%, n = 8), psycholeptics (13.5%, n = 5) and antithrombotic agents (10.8%, n = 4). FMs were divided in eleven categories, from which “drug interaction” (36.8%; n = 14), “dose adjustment” (21.1%, n = 8) and “food-drug interaction” (7.9%, n = 3) were the most frequent. The PC of the detected FMs varied between 28 and 294, and 42.1% (n = 16) of them presented PC above 100. Median of the indicators G (6 – min: 3; max: 9), D (7 – min: 3; max 7) and priority coefficient (72 – min: 28; max: 294) indicate that FM had generally moderate gravity, low prevalence and low detection. For the majority of FMs (72.7%, n = 28), the chosen conduct was ‘not to accept’ and the established contingency measure included a sentinel event notification. Conclusion: The use of FMEA enabled the identification, classification, and prioritization of risks of the clinical medication process in the UTIR. This study indicates the need to implement measures that increase safety in the clinical practice of the study Intensive Care Unit.

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.

Mid-Life Refurbishment Maintenance Strategy to Sustain Performance and Reliability of Train System

Mid-Life Refurbishment (MLR) is a process conducted in many industries to improve or extend the life span of assets such as machines, infrastructures and systems. The objective of MLR works execution is to extend the life span, sustain the train performance and achieve system reliability. Typically, the refurbishment scope consists of overhaul, upgrading and rectification works. The biggest challenge is to determine) the scope of refurbishment works and to create equilibrium between the feasibility and viability of the project. Therefore, the main objective of this paper is to discuss the current practice of performing MLR maintenance through the utilization of Failure Mode and Effect Analysis (FMEA) and to transform the existing FMEA used by the automotive industry to fulfil the needs of Rolling Stock. The use of FMEA is critical in determining) the scope of train refurbishment work. It was carried out at the initial stages of the process in order to determine Risk Priority Number (RPN) to prioritize the type of refurbishment plans and scope. The design of the FMEA Worksheets, De-sign of FMEA severity Evaluation Criteria, Design of Occurrence Evaluation Criteria and Design of FMEA Prevention/Detection Criteria were adopted and adapted from the generic format so that it is coherent with Railway Industries. The results based on the transformation framework, the plan and scope of overhaul, upgrading and rectification were defined using the FMEA. Out of the 80 elements of MLR works that were analyzed using the FMEA approach, it was found that 46 elements needed overhaul, 23 elements needed upgrading and 11 elements needed rectification works. Finally, the application of the FMEA helped determine the MLR scope of work from 13 systems. The case study was taken from the Malaysia LRT Project, and currently the fleet has been in operation for more than 20 years (operated since year 1998).

The use of FMEA for the Quality Control Analysis of Greige Fabrics (case study in the Weaving Department of PT. Unitex, Tbk)

PT Unitex, Tbk, is a textile company in Bogor. The problem that is found in this company is the number of defects that occur in the weaving section, namely reaching. If conditions like this are allowed, it will cause losses to the company. With these conditions, PT Unitex wants to reduce the number of defects to a minimum.For this reason, the main problem raised in this study is how to control the quality of defective fabrics produced by PT Unitex, Tbk, to support and evaluate the quality control policies implemented by PT Unitex, Tbk by using Pareto diagram tools, and fishbone diagrams later in analysis using the Failure Mode And Effect Analysis (FMEA) method. The results of this research are obtained: In the period July -December 2018, 5 types of fabric defects were most dominant, namely OSA TOSHI, NIHON DOSHI, USUDAN, TATE GIRE, and ATSUDAN. Analysis of Failure Mode and Effect Analysis of the causes of failure obtained from the fishbone diagram obtained the highest severity value for human factors, the highest occurrence value for less precision and control, and the highest detection value for engine maintenance.

RISK ANALYSIS AND PRIORITIZATION IN WATER SUPPLY NETWORK MAINTENANCE WORKS THROUGH THE FAILURE MODES AND EFFECTS ANALYSIS: OCCUPATIONAL SAFETY FMEA APPLICATION

Goal: In this work, the application of FMEA (failure mode and effects analysis) in the execution of maintenance of water network in a medium size city in the state of Maranhão was approached. FMEA (failure mode and effects analysis) with occupational safety approach is applied in the execution of water supply network maintenance in a medium size city in the state of Maranhão. This work shows that FMEA is an effective tool for risk prioritization in work process. The FMEA application with use of index reference table can become faster than application without reference table - and thus spread the tool for risk analysis.
 Design / Methodology / Approach: A photographic records was carried out in loco and the main risks to the workers were enumerated and based on the obtained data, a risk analysis was elaborated with the application of FMEA (Failure modes and effects analysis).
 Results: The maintenance services teams of the supply system are subject to a high risk of accidents caused mainly by the working conditions precariousness. It was observed that the services of manual excavations and the lack of use of PPE (helmet, gloves, pants suitable for flooded environments and etc.) have high risk index (RPN) and that the mismanagement added to the unsafe behavior were the main factors to accident occurrence in this type of work.
 Limitations of the investigation: The study studied the reality found in a medium-sized city with precarious working conditions. Further studies can compare the work reality of other teams in cities of different sizes, with better working conditions. Other limitation of this work is the impossibility of work situation improvement and posterior tool application – a study with this magnitude is non-trivial and needs future research.
 Practical implications: The great achievement of this work is to demonstrate that FMEA - a tool that is widely used in maintenance management and product engineering - is able to identify and prioritize risks based on its preliminary risk index obtained - contributing to reduce the difficulty of index choices previously cited in literature and disseminate the FMEA utilization for employee safety and occupational health. Such a tool has a great capacity for quantitative description of the risks, showing that the FMEA is very useful in the work safety sector for the organization of correction plans.
 Originality / Value: The difficulties of using the tool mentioned in the available literature were minimized with the use of the reference table, showing that the use of FMEA can become faster and thus spread the tool for risk analysis.

Failure mode and effects analysis for proactive healthcare risk evaluation: A systematic literature review.

Failure mode and effects analysis (FMEA) is a valuable reliability management tool that can preemptively identify the potential failures of a system and assess their causes and effects, thereby preventing them from occurring. The use of FMEA in the healthcare setting has become increasingly popular over the last decade, being applied to a multitude of different areas. The objective of this study is to review comprehensively the literature regarding the application of FMEA for healthcare risk analysis. An extensive search was carried out in the scholarly databases of Scopus and PubMed, and we only chose the academic articles which used the FMEA technique to solve healthcare risk analysis problems. Furthermore, a bibliometric analysis was performed based on the number of citations, publication year, appeared journals, authors, and country of origin. A total of 158 journal papers published over the period of 1998 to 2018 were extracted and reviewed. These publications were classified into four categories (ie, healthcare process, hospital management, hospital informatization, and medical equipment and production) according to the healthcare issues to be solved, and analyzed regarding the application fields and the utilized FMEA methods. FMEA has high practicality for healthcare quality improvement and error reduction and has been prevalently employed to improve healthcare processes in hospitals. This research supports academics and practitioners in effectively adopting the FMEA tool to proactively reduce healthcare risks and increase patient safety, and provides an insight into its state-of-the-art.

Operational risk analysis with Fuzzy FMEA (Failure Mode and Effect Analysis) approach (Case study: Optimus Creative Bandung)

Industrial development in Indonesia, manufacturing and services, are required to be able to manage the company very well. However, in practice, the company’s activities are always faced with risks. In general, the risk can be defined as a situation faced by a person or a company in which there is a possibility that harm. The level of risk faced losses due to highly variable depending on the cause and effect influence. To be able to manage (risk management), it can use FMEA (Failure Mode and Effect Analysis). FMEA is a method of analyzing potential failure are applied in product development, system engineering and operational management and is one of a qualitative risk assessment. Using FMEA can also note the value of the RPN (Risk Priority Number) to determine improvement priorities at risk. But there are weaknesses in the use of FMEA, namely RPN calculation is only done by multiplying the severity, occurence and detection alone and irrespective of the degree of importance of each input, to the FMEA method is integrated using fuzzy logic. Fuzzy FMEA is aimed at obtaining the highest fuzzyRPN value which will be used as the focus of improvements to minimize the possibility of these risks occur back. The results were obtained 7 out of 18 types of risks that have a high priority for repairs. Risk troublesome computer (hank / die) while doing photo editing scored the highest RPN 540 (scale 1-1000) and also the highest FRPN 9 (scale 1-10). There is a difference in value between RPN and FRPN. FRPN value obtained from the fuzzification, generate value by taking into account the degree of interest of any given input.

Recognising and referring children exposed to domestic abuse: a multi-professional, proactive systems-based evaluation using a modified Failure Mode and Effects Analysis (FMEA)

Failure Modes and Effects Analysis (FMEA) is a prospective quality assurance methodology increasingly used in healthcare, which identifies potential vulnerabilities in complex, high-risk processes and generates remedial actions. We aimed, for the first time, to apply FMEA in a social care context to evaluate the process for recognising and referring children exposed to domestic abuse within one Midlands city safeguarding area in England. A multidisciplinary, multi-agency team of 10 front-line professionals undertook the FMEA, using a modified methodology, over seven group meetings. The FMEA included mapping out the process under evaluation to identify its component steps, identifying failure modes (potential errors) and possible causes for each step and generating corrective actions. In this article, we report the output from the FMEA, including illustrative examples of the failure modes and corrective actions generated. We also present an analysis of feedback from the FMEA team and provide future recommendations for the use of FMEA in appraising social care processes and practice. Although challenging, the FMEA was unequivocally valuable for team members and generated a significant number of corrective actions locally for the safeguarding board to consider in its response to children exposed to domestic abuse.

Use of Failure Mode and Effects Analysis to Improve Emergency Department Handoff Processes.

The purpose of this article is to describe a quality improvement process using failure mode and effects analysis (FMEA) to evaluate systems handoff communication processes, improve emergency department (ED) throughput and reduce crowding through development of a standardized handoff, and, ultimately, improve patient safety. Risk of patient harm through ineffective communication during handoff transitions is a major reason for breakdown of systems. Complexities of ED processes put patient safety at risk. An increased incidence of submitted patient safety event reports for handoff communication failures between the ED and inpatient units solidified a decision to implement the use of FMEA to identify handoff failures to mitigate patient harm through redesign. The clinical nurse specialist implemented an FMEA. Handoff failure themes were created from deidentified retrospective reviews. Weekly meetings were held over a 3-month period to identify failure modes and determine cause and effect on the process. A functional block diagram process map tool was used to illustrate handoff processes. An FMEA grid was used to list failure modes and assign a risk priority number to quantify results. Multiple areas with actionable failures were identified. A majority of causes for high-priority failure modes were specific to communications. Findings demonstrate the complexity of transition and handoff processes. The FMEA served to identify and evaluate risk of handoff failures and provide a framework for process improvement. A focus on mentoring nurses to quality handoff processes so that it becomes habitual practice is crucial to safe patient transitions. Standardizing content and hardwiring within the system are best practice. The clinical nurse specialist is prepared to provide strong leadership to drive and implement system-wide quality projects.

Implementation of FMEA into Mass Production Process to Identify and Eliminate Causes of Defects

Each enterprise that concentrates on boosting its position on a market tries to optimize mechanisms of its activity. It can be realized mainly by development in such directions as extending shares on the market, cost reduction, introducing more effective methods of production and risk management. Increasing the level of customers’ satisfaction is reached by use of FMEA (Failure Mode and Effect Analysis) as a tool of continuous development of products and processes realized by conducting their cyclic analyses. Their results build a foundation for introducing new solutions as corrective actions that eliminate causes of defects and at the same time lead to process and product improvement.The advantages of FMEA have resulted in its implementation into nearly every branch of a modern industry, both for unitary and mass production. An example of application of FMEA in mass production is a production process of beverage cans. This process is multistage, extraordinarily precise, technologically complicated and burdened by a great amount of factors that hypothetically can cause defects.The application of proper preventive actions aimed at defining both potential and factual causes of defects is an essential element of increasing the effectiveness a of production line with the simultaneous production cost reduction and boosting the level of customer satisfaction.In the article, the use of FMEA in mass production on the basis of a beverage can manufacturing has been analysed. On its basis, the potential causes of defects have been isolated and eliminated.

Implementation of reliability-centred FMEA in a cable cutting process

Reliability is an important criterion affecting the automobile buying decision of customers. One of the most important components in automobiles is the cables ensuring the electricity current. Even the smallest breakdowns in these cables create crucial problems. Because of that, it is aimed to work with zero error in the production phase. In this study, the objective is the determination of possible and present errors in the cutting phase of electric cables and avoidance from these errors before they occur. In this regard, failure mode and effects analysis (FMEA) methodology is used, which is an analysis done for prevention and identification of all possible error types. Preventions found by FMEA have been implemented and high risk priority numbers (RPNs) are reduced in a cable cutting process. The study shows that significant improvement in possible errors can be ensured with the use of FMEA.

Applying failure mode and effects analysis for successful knowledge management

Knowledge management (KM) is essential to enhancing the competitive edge of organisations. However, not all enterprises apply KM successfully; in KM research, a focus on critical success factors (CSFs) can result in a limited field since failure can still occur. It is only through looking at critical failure factors (CFFs) that a complete prevention can be achieved. In short, focusing on CFFs may be more valuable than looking at CSFs. This paper focuses on applying a failure mode and effects analysis (FMEA) to prevent KM failure. It tracks a typical FMEA approach using interviews with respected experts. This method was tested and practiced for reducing risks by 11 companies in Taiwan. The results have shown that the average risk priority number in projects dropped dramatically from 299.3 to 20.6 – an improvement rate of 93.1%. All experts in the study agree that the use of FMEA enhances KM implementation. In addition, 14 common failure modes have been noted for further prevention. Due to the limitation in interviews, the practices could not be implemented across departments and levels, leading to a biased sample.

Redução das irregularidades identificadas na aplicação do FMEA de processo: um estudo em produtos estampados

A Análise do Modo e Efeito da Falha (FMEA, Failure Mode and Effect Analysis) é um dos requisitos exigidos pela ISO/TS 16949. Entretanto, pesquisam mostram irregularidades no seu desenvolvimento, por parte dos fornecedores das automotivas. O objetivo desse estudo é identificar essas irregularidades, visando sugerir meios para minimizar esse problema. Para isso, questionários são aplicados em sete fornecedores de uma empresa automotiva, incluindo a análise de dez FMEA´s de cada um deles. O trabalho identifica as irregularidades no desenvolvimento do FMEA para um processo de estampagem e ressalta sete fatores que contribuem para que elas aconteçam. Baseado nesses dados, uma estratégia é sugerida, a qual inclui uma planilha de FMEA parcialmente parametrizada, a qual é testada em três destes fornecedores, mostrando uma melhoria significativa.

The reduction of irregularities in the use of “process FMEA”

PurposeUse of failure mode and effect analysis (FMEA) is a requirement of ISO/TS 16949. However, research has shown that there are inconsistencies in the way the technique is applied in automotive suppliers. The aim of this study is to identify these irregularities and to propose a strategy to minimize them.Design/methodology/approachQuestionnaires were applied in seven of the main suppliers to a European automotive company, and ten FMEAs from each company were analyzed.FindingsThe study identifies irregularities in the development of process FMEAs and highlights seven factors that contribute to these inconsistencies. Based on these data, a strategy including a partially preconfigured FMEA form is suggested. When tested with three of the suppliers, the strategy was found to result in a significant improvement.Originality/valueThe study describes an application strategy for automotive companies to correct problems associated with the use of FMEAs. The strategy includes a partly parameterized spreadsheet for a cold stamping process that allows companies to implement their process FMEA in a collaborative supply chain environment.

SU‐GG‐J‐14: Failure Mode and Effect Analysis (FMEA)‐Based Quality Assurance for Dynamic MLC Tracking Systems

Purpose: Effective QA for newly introduced radiotherapy technology has received increased attention within the radiotherapy community and the general public. This work aims to develop and implement a FMEA‐based quality management (QM) framework for dynamic MLC (DMLC) tumor tracking systems. Methods: A systematic FMEA was performed for a prototype tumor tracking system that uses the Calypso system for position monitoring and a DMLC for real‐time beam adaptation. A process tree of DMLC tracking delivery was mapped and potential failure modes were identified. For each failure mode, a risk probability number (RPN 1:1000) was calculated from the product of the probability of occurrence, severity of effect and detectability of failure. Based on the insights obtained from FMEA, commissioning and QA procedures were developed to check (i) coordinate transformation, (ii) system latency, (iii) delivery accuracy, (iv) delivery efficiency and (v) system response to error conditions. Results: Failures modes with RPN ≥ 20 were: delivery accuracy, efficiency and data communication integrity. These were recommended to be tested monthly. Failure modes with RPN < 20 were: coordinate transformation, latency error and target out‐of‐range error. These were recommended only during comprehensive testing e.g., commissioning, annual testing and after major software/hardware upgrades. The total time taken for monthly QA was ∼35 minutes while that taken for comprehensive testing was ∼3.5 hours. Conclusion: FMEA proved to be a powerful and flexible tool to develop a QM framework for DMLC tracking. We conclude that the use of FMEA ensures efficient allocation of valuable clinical resources because the most critical failure modes receive the most attention. Finally, consistent with the goals of FMEA, this framework can serve as the basis of a dynamic QM program that is continuously updated with increasing intra‐ and inter‐institutional experience.Conflict of interest: This work was partially supported by Varian and Calypso

Failure mode and effects analysis (FMEA) in the context of risk management in new product development

PurposeEffectively managing risk is an essential element of successful project management. In this sense, the present study seeks to propose a systematisation of technical risk management through the use of FMEA to optimise the decision making process in new product development (NPD).Design/methodology/approachThe methodological approach adopted in this paper is a case study at an automaker in Brazil. Data were gathered from various sources, mostly participant observation and document analysis of two important NPD programmes. The risk management system was described and its influence on programs development analysed.FindingsResults included a reduction in the number of project and test planning loopings as well as a reduced number of prototypes needed to approve product components. In addition, there was a positive influence on the product development decision‐making process, evidenced by better allocation of resources among projects at the programme.Research limitations/implicationsThe study is limited to a single case study which considers two major NPD programmes. Replications among other units of analysis are needed to further validate current findings.Originality/valueThis paper is one of the few published studies that report and discuss the FMEA within a broad context of risk analysis.

FMEA applied to cladding systems - reducing the risk of failure

Failure Mode and Effects Analysis (FMEA) is a systematic and analytical quality planning tool for identifying and addressing what potentially could go wrong with a product or process. The project ‘Failure Mode and Effects Analysis (FMEA) in the cladding industry’ describes the FMEA technique, investigates failures of cladding on a system, component and process level, and maps the cladding supply chain and cladding-related decision making. The level of knowledge of failures and the fragmented industry structure prevents rigorous use of FMEA exemplified by other industries. However, a simplified form of FMEA can be performed based on the research findings to prioritize and inform decision-making and facilitate site inspection/supervision. L'analyse des modes de défaillance et de leurs conséquences (AMDC) est un outil systématique de planification de la qualité qui sert à détecter tout ce qui pourrait nuire à un produit ou un processus et à y remédier. Le projet ‘Analyse des modes de défaillance et de leurs conséquences chez les fabricants de bardage’ a pour objectif de décrire la technique AMDC, d'étudier les défaillances de bardages au niveau système, composant et processus, et d'établir une correspondance entre la chaîne d'approvisionnement en bardages et le processus décisionnel en matière de bardage. Le niveau de connaissances en ce qui concerne les défaillances et la structure fragmentée de cette industrie empâchent l'utilisation rigoureuse de l'AMDC comme en attesient d'autres industries. Une forme simplifice de l'AMDC peut toutefois être utilisée sur la base des résultats de recherches, qui permet d'indiquer au processus décisionnel les priorités et de faciliter les interventions d'inspection et de surveillance sur les chantiers.

Improving manufacturing reliability in IC package assembly using FMEA technique

The author presents the basic potential failure mode and effect analysis (FMEA) technique as applied to IC assembly and shows how the technique is useful for complex package assembly and multichip module assembly. The FMEA technique can be described as a systemized group of activities intended to: (a) recognize and evaluate the potential failure modes and causes associated with the designing and manufacturing of an IC package; (b) identify actions which could eliminate or reduce the chance of the potential failure occurring; and (c) document the process. The use of FMEA for improving the manufacturability and manufacturing reliability of packages by a systematic and quantified analysis of the package design and process is also discussed.< <ETX xmlns:mml="http://www.w3.org/1998/Math/MathML" xmlns:xlink="http://www.w3.org/1999/xlink">&gt;</ETX>

Failure mode and effects analysis in the U.K. motor industry: A state‐of‐the‐art study

AbstractThis paper reports the main findings of a questionnaire survey on the use of failure mode and effects analysis (FMEA) in the United Kingdom motor industry. Survey data were obtained from 78 organizations. Among the main findings are: the majority of suppliers only started to use FMEA because it was a contractual requirement of their customer; however, a number of them are now seeking to make more use of the technique to facilitate their process of quality improvement; FMEA is treated by the majority of organizations as a team activity; engineers still view FMEA as a hard slog; more use should be made of computerized aids to reduce the effort in preparing and updating the FMEA; and the main difficulties encountered in the use of FMEA are related to time constraints, poor organizational understanding of the importance of FMEA, inadequate training and lack of management commitment. It is also pointed out that organizations are not satisfied with the current training courses on FMEA.