FMEA Methodology Research Articles

Improving the process of setting-up the extrusion line based on a systematic approach

The article is devoted to the description of the application of a systems approach with the aim of improving the process of setting-up the equipment of cable manufacturing, namely, the extrusion line. First, a risk-based approach was used to identify the bottlenecks of the setting-up process using the FMEA methodology. Secondly, the most critical operations of the setting-up process were considered in terms of measurement authenticity. In this context, the analysis of the stability of the measuring process, an analysis of the bias linearity and an analysis of repeatability and reproducibility were carried out. Using the measurement system analysis, it was managed to reveal four main factors influencing the variation of the measuring process and recommendations were made to improve each of them. Corrective actions have been developed, after the implementation of which the level of general repeatability and reproducibility of the measurement process has passed into the category of acceptable. Thus, applying the principles of a systematic approach and using the tools recommended by IATF 16949 “Measurement system analysis” and “Potential failure mode and effects analysis”, we managed to achieve a new level of quality of the process setting-up an cable manufacturing, reduce the risk level of the process and minimize costs.

FMEA Methodology Capabilities in Environmental Risk Management

FMEA Methodology Capabilities in Environmental Risk Management

АНАЛИЗ РИСКОВ И ВОЗМОЖНОСТЕЙ ПРОЦЕССОВ МЕНЕДЖМЕНТА КАЧЕСТВА НА ОСНОВЕ SWOT-АНАЛИЗА

In the new version of ISO 9000 standard of 2015 edition, the replacement of preventive actions of the previous standard for risks management took place. To be the advanced tool of management of risks related to the QMS processes, SWOT-analysis can be considered that is recommended by the international ISO 31000 standards including the general instructions for identifying, management and selection of risk estimation methods. However, the traditional SWOT-analysis technique has a number of disadvantages. In particular, it has practically no formalization methods when estimating and selecting the external and internal factors of influence of the environment on an organization in the context of risks and opportunities for the development strategies formation created by them that increases the complexity of their implementation and decreases the credibility of obtained data. The solution of this issue is possible on the base of the procedure of integration of FMEA methodology and SWOT-analysis elements offered in this paper in order to prove statistically the influence of risks and opportunities caused by the environment on the processes management in the QMS of an organization. The procedure is aimed both at the estimation of risks influence on the object under the study that is generally typical for the majority of techniques applied today and at the estimation of the opportunities resulting from the processes management. The approach considered allows identifying the priority risks and opportunities influencing the QMS processes management based on the statistical validity of their selection that improves the reliability of data obtained in the result of the study.

FMEA TECHNIQUES USED IN ENVIRONMENTAL RISK ASSESSMENT

Other industries or strategic installations cities after the industrialization process, a large percentage of urban land use, consciously or unconsciously to have been allocated. Investigation and detection of black spots and dangerous in systems and processes to prevent accidents is of particular importance. Risks in the project, are unknown events that may happen in the event of a negative or positive impact on project objectives is effective. Each event has specific causes and consequences are distinguishable. The consequences of these events directly in time, cost and quality. Therefore, effective project risk identification and to determine the effect of special importance. Organizations should be able to use a variety of methods to assess the risk of one or a combination of the select few. This article introduces the risk assessment and FMEA methodology has been focused on the process of doing that.

Introducing a change in hospital policy using FMEA methodology as a tool to reduce patient hazards.

BackgroundIntravenous potassium chloride (IV KCl) solutions are widely used in hospitals for treatment of hypokalemia. As ampoules of concentrated KCL must be diluted before use, critical incidents have been associated with its preparation and administration. Currently, we have introduced ready-to-use diluted KCl infusion solutions to minimize the use of high-alert concentrated KCl. Since this process may be associated with considerable risks, we embraced a proactive hazard analysis as a tool to implement a change in high-alert drug usage in a hospital setting.MethodsFailure mode and effect analysis (FMEA) is a systematic tool to analyze and identify risks in system operations. We used FMEA to examine the hazards associated with the implementation of the ready-to-use solutions. A multidisciplinary team analyzed the risks by identifying failure modes, conducting a hazard analysis and calculating the criticality index (CI) for each failure mode. A 1-day survey was performed as an evaluation step after a trial run period of approximately 4 months.ResultsSix major possible risks were identified. The most severe risks were prioritized and specific recommendations were formulated. Out of 28 patients receiving IV KCl on the day of the survey, 22 received the ready-to-use solutions and 6 received the concentrated solutions as instructed. Only 1 patient received inappropriate ready-to-use KCl.ConclusionsUsing the FMEA tool in our study has proven once again that by creating a gradient of severity of potential vulnerable elements, we are able to proactively promote safer and more efficient processes in health care systems. This article presents a utilization of this method for implementing a change in hospital policy regarding the routine use of IV KCl.

Optimization of desolvation process for fabrication of lactoferrin nanoparticles using quality by design approach

The present work deals with the design and process optimization for preparation of lactoferrin nanoparticles as carrier for delivery of curcumin (CLf-NPs) using quality by design (QbD) approach. Desolvation technique was selected for preparation of Lf-NPs. The concept of QbD was followed in stepwise manner including risk analysis FMEA methodology. Plackett–Burman screening design employing eight factors and two levels was selected for screening study and custom design was selected for further analysis. Curcumin was used as model polyphenol for assessing the encapsulating efficiency of Lf-NPs.

FMEA Methodology for Quality Improvement in Sheet Metal Industry

FMEA Methodology for Quality Improvement in Sheet Metal Industry

Integrating SWOT analysis into the FMEA methodology to improve corrective action decision making

Improving the method for selecting risk-based competing improvement strategies has equal importance with failure risk quantification in the FMEA methodology. Nevertheless, there are few studies which focus on this issue. Furthermore, the influence of factors relating to the business environment which may support or derail improvement efforts is not considered in previous studies. In order to address these limitations, a model is proposed in which the impact of environmental factors is considered by integrating SWOT analysis into the FMEA method in order to support the appraisal of competing risk-based improvement efforts. The impact of SWOT variables is deployed using a decision support model based upon the benefit, cost, opportunity, risk and organisational readiness index (BCOR2) approach in order for the FMEA team to select from competing corrective actions. A case example from industry is provided in which the proposed model is applied. This example illustrates that this new model contributes successfully to good practice by identifying the most appropriate corrective action option to take and improves upon the decisions provided by existing developments of the FMEA methodology.

EP-1317: Risk analysis based on FMEA methodology allows to deter the risk of human error in the field of SBRT

EP-1317: Risk analysis based on FMEA methodology allows to deter the risk of human error in the field of SBRT

Improvement Strategy Selection in FMEA – Classification, Review and New Opportunity Roadmaps

Failure risk reprioritization and improvement strategy selection are two inseparable parts in FMEA methodology. Nevertheless, the previous studies on the new research opportunities provide very scanty discussions on the latter part. This paper presents an initial survey to classify literature related to improvement strategy selection methodology in FMEA. Systematic literature review using various reference databases is undertaken. Driven by new paradigms and recent trends on managing business operation, many studies have been dedicated to advance improvement strategy selection based on FMEA. The result of our survey, however, indicated that all those previous endeavours do not seem to be sufficient. Based on some observable gaps from the previous references, new research roadmaps in selecting improvement efforts are presented.

A comparison between three different centers for clinical risk assessment in cord blood banking activities by FMEA methodology

A comparison between three different centers for clinical risk assessment in cord blood banking activities by FMEA methodology

Quantitative dynamic reliability evaluation of AP1000 passive safety systems by using FMEA and GO-FLOW methodology

The passive safety systems utilized in advanced pressurized water reactor (PWR) design such as AP1000 should be more reliable than that of active safety systems of conventional PWR by less possible opportunities of hardware failures and human errors (less human intervention). The objectives of present study are to evaluate the dynamic reliability of AP1000 plant in order to check the effectiveness of passive safety systems by comparing the reliability-related issues with that of active safety systems in the event of the big accidents. How should the dynamic reliability of passive safety systems properly evaluated? And then what will be the comparison of reliability results of AP1000 passive safety systems with the active safety systems of conventional PWR.For this purpose, a single loop model of AP1000 passive core cooling system (PXS) and passive containment cooling system (PCCS) are assumed separately for quantitative reliability evaluation. The transient behaviors of these passive safety systems are taken under the large break loss-of-coolant accident in the cold leg. The analysis is made by utilizing the qualitative method failure mode and effect analysis in order to identify the potential failure mode and success-oriented reliability analysis tool called GO-FLOW for quantitative reliability evaluation. The GO-FLOW analysis has been conducted separately for PXS and PCCS systems under the same accident. The analysis results show that reliability of AP1000 passive safety systems (PXS and PCCS) is increased due to redundancies and diversity of passive safety subsystems and components, and four stages automatic depressurization system is the key subsystem for successful actuation of PXS and PCCS system. The reliability results of PCCS system of AP1000 are more reliable than that of the containment spray system of conventional PWR. And also GO-FLOW method can be utilized for reliability evaluation of passive safety systems.

Risk Assessment of Non-repetitive Production Processes

The purpose of this paper is to support the process of production batch size definition in non-repetitive production like MTO or ETO based on reliability assessment. Although theory supposes the production batch size to be equal to customer order, situation observed in real production systems is different. Production often protects itself against manufacturing process unreliability resulting in non-conformed parts with overproduction. To manage the production wisely, the process risk should be evaluated. High ratio of setup costs to unit production costs should be taken into consideration as well as potential risk of each operation. This paper describes a proposed way, coming from the idea of FMEA methodology, to assess the risk and calculate costs related to process unreliability. The result then supports the batch size definition.

The Multilevel Prognosis System Based on Matrices and Digraphs Methods

The author of this article considers new approach based on operational reliability models, written in the form of matrices and digraphs methods. At a core of the method the author used the theory of systems and their decomposition consistent with the FMEA methodology [, that allows a simplification of the distribution of elements within the system into smaller parts having a greater susceptibility to the error analysis and forecasting of their states. The method mainly refers to decentralized systems, linked via reciprocal relationships (that can be applied to manufacturing work centres, transport lines, etc.), containing subsystems that use the control, power, noise and mass flows streams. Article includes also main assumptions of described method, realizability studies, application areas and significant restrictions.

GRP-073 Failure Mode and Effect Analysis in Improving the Safety of the Chemotherapy Process

BackgroundMedication errors in chemotherapy have a high potential to cause harm. Errors may occur during different steps of the medication process.Failure Mode and Effect Analysis (FMEA) is a proactive risk...

Aplicação sistêmica do modo de análise de falhas e efeitos (FMEA) para o desenvolvimento de indicadores de desempenho de empresas de pequeno porte

O setor florestal brasileiro emprega direta e indiretamente 6,5 milhões de pessoas, e, dessas, 2,5 milhões estão empregadas no subsetor de madeira processada mecanicamente. O parque industrial voltado à produção de madeira serrada dispõe de aproximadamente 10.000 unidades, predominando as empresas de pequeno porte, das quais 74,6% têm capacidade instalada menor que 10.000 m³/ano e 24,7% entre 10.000 e 30.000 m³/ano. As empresas de pequeno porte caracterizam-se por apresentar baixo nível tecnológico, mão de obra pouco especializada e dificuldade de estabelecer itens de controle que possibilitem o gerenciamento eficaz do processo produtivo. Considerando a importância socioeconômica e as dificuldades gerenciais e os benefícios que um sistema de medição de desempenho pode trazer para as pequenas e médias empresas, este trabalho teve como objetivo identificar os fatores críticos do processo de produção de esquadrias de madeira em uma empresa de pequeno porte. Para isso, utilizou-se a metodologia análise do modo de falhas e seus efeitos (FMEA), para identificação das falhas potenciais, e a partir delas desenvolver indicadores de desempenho. Foram identificados 24 modos de falha, e todos foram considerados críticos, sendo analisados e monitorados, observando-se que existe potencial de melhoria no processo analisado.

Robust Design Failure Mode and Effects Analysis in Designing for Six Sigma

Mode and Effects Analysis (FMEA) is a methodology that has been used in most industries for many years. Typically, the Design FMEAs are developed early in the product development cycle, in conjunction with the product risk analysis, product architecture and product requirements. Robust Design FMEA, the subject of this paper, is an enhancement to the currently in use Design FMEA by anticipating safety and reliability failure modes through the use of a Parameter Diagram (P-Diagram). The Design FMEAs have gone through a metamorphosis of sorts in the last decade, as a focus on severity and occurrence has replaced Risk Priority Number- (RPN-) driven activities. In large part this is due to the measurement of risk outcomes, resulting from associated RPNs being misinterpreted. As so many practitioners of the Design FMEA believe that the RPN is the most important outcome. However, the Design FMEA methodology must consider taking actions as soon as it is practical.

FMEA methodology design, implementation and integration with HACCP system in a food company

This paper reports the description of FMEA methodology design and implementation in a food company, where, integrated with HACCP system, it is used as a tool to assure products quality, and as a mean to improve operational performance of the production cycle. The work was developed in an Italian confectionery industry, Elledı̀ SpA, in co-operation with part of the internal staff, chosen as FMEA team members, and was focused on the study of wafer biscuit production lines. All the work done permits to increase company knowledge and control capacity on processes and products. The generated data can be used as a useful technical database for future update of FMEA in Elledı̀ and as a model of FMEA design for similar company.