No / Failure Mode and Effects Analysis (FMEA) is a proactive risk assessment tool used to identify potential vulnerabilities in complex, high-risk processes and to generate remedial actions before the processes result in adverse events. FMEA is increasingly used to proactively assess and improve the safety of complex health care processes such as drug administration and blood transfusion. A central feature of FMEA is that it is undertaken by a multidisciplinary team, and because it entails numerous analytical steps, it takes a series of several meetings. Composing a team of busy health care professionals with the appropriate knowledge, skill mix, and logistical availability for regular meetings is, however, a serious challenge. Despite this, information and advice on FMEA team assembly and meetings scheduling are scarce and diffuse and often presented without the accompanying rationale. The Multidisciplinary Team Assemble an eight-member team composed of clinically active health care staff, from every profession involved in delivery of the process—and who regularly perform it; staff from a range of seniority levels; outsider(s) to the process—and perhaps even to health care; a leader (and facilitator); and researchers. Scheduling Plan for 10–15 hours of team meeting time for first-time, narrowly defined FMEAs, scheduled as four to six meetings lasting 2 to 3 hours each, spaced weekly to biweekly. Meet in a venue that seats the team around one table and is off the hospital floor but within its grounds. Conclusions FMEA, generally acknowledged to be a useful addition to the patient safety toolkit, is a meticulous and time- and resource-intensive methodology, and its successful completion is highly dependent on the team members’ aptitude and on the facility’s and team members’ commitment to hold regular, productive meetings.

No / Objectives: To empirically compare 2 different commonly used failure mode and effects analysis (FMEA) scoring procedures with respect to their resultant failure mode scores and prioritization: a mathematical procedure, where scores are assigned independently by FMEA team members and averaged, and a consensus procedure, where scores are agreed on by the FMEA team via discussion. Methods: A multidisciplinary team undertook a Healthcare FMEA of chemotherapy administration. This included mapping the chemotherapy process, identifying and scoring failure modes (potential errors) for each process step, and generating remedial strategies to counteract them. Failure modes were scored using both an independent mathematical procedure and a team consensus procedure. Results: Almost three-fifths of the 30 failure modes generated were scored differently by the 2 procedures, and for just more than one-third of cases, the score discrepancy was substantial. Using the Healthcare FMEA prioritization cutoff score, almost twice as many failure modes were prioritized by the consensus procedure than by the mathematical procedure. Conclusions: This is the first study to empirically demonstrate that different FMEA scoring procedures can score and prioritize failure modes differently. It found considerable variability in individual team members' opinions on scores, which highlights the subjective and qualitative nature of failure mode scoring. A consensus scoring procedure may be most appropriate for FMEA as it allows variability in individuals' scores and rationales to become apparent and to be discussed and resolved by the team. It may also yield team learning and communication benefits unlikely to result from a mathematical procedure.

Yes / The process of generating FMEA following document-centric approach is tedious and susceptible to human error. This paper presents preliminary methodology for robotic manufacturing process modelling in MBSE environment with a scope of automating multiple steps of the modelling process using ontology. This is followed by the reasoning towards automatic generation of process FMEA from the MBSE model. The proposed methodology allows to establish robust and self-synchronising links between process-relevant information, reduce the likelihood of human error, and scale down time expenses.

Organizations are expected by their shareholders to continually deliver above industry returns on capital invested and to remain competitive in the industry of choice through productivity, safety and quality. The maintenance function is a key area in which competitiveness through efficiencies and world–class performance can be attained by focusing on the prevention and reduction of long and costly equipment repair times. The question is: how can the mean time to repair of equipment already installed in the plant be reduced? To answer the above question correctly and comprehensively, the research explored mixed methods in finding answers. Quantitative methodology using a survey was used for data collection. Observations and interviews were held with maintenance personnel to uncover information that couldn’t have been obtained by means of a survey. The survey was limited to equipment performance measures, human factors, environmental factors, planning, spare parts, maintainability, procedures and training. To test consistency and accuracy of representation of the total population under study, a reliability test was done by using Cronbach’s alpha coefficient. To determine whether there are any differences between groups, an ANOVA test was used. Cohen’s d–value was used to determine practically significant differences between one set of data with another and correlation analysis was used to determine the relationships between the variables. The approach designed and delivered by this research flowed from the existing body of knowledge, case studies and survey findings. The approach adopts some of the elements of the failure mode and effects analysis (FMEA) procedure and differs from other work that has been done by others by taking into account the competency and experience of maintenance personnel and assigning to them factors which are used to compute anew MTTR of the equipment. The cost of implementing the recommended corrective actions for realising the new MTTR is determined and evaluated against an improved equipment availability that will be achieved as a result of the recommended corrective actions assuming that the failure rate of the equipment remains constant. This evaluation step imbedded within the approach is valuable for the maintenance function and management for decision making in ensuring that resources at the organization’s disposal are used productively. Validation and test results of the approach showed that the MTTR of equipment installed in the plant can be reduced. The results also indicated that through the use of the designed approach a regular pattern of repair or replacement times can be followed well in advance and that it is practical, user friendly and it also delivers on its objective of offering a structure for analysis and decision making aimed at reducing the MTTR. Included with this dissertation is feedback information that can be included in a maintenance job card feedback section to capture information about factors that can be improved to lower the MTTR as part of a continuous improvement process. Included also is a spare part development and management procedure that can be used by the maintenance function. Recommendations on training of maintenance personnel on the maintainability of equipment, the FMEA procedure and maintenance procedures are highlighted. Information that flowed from this approach will be valuable for continuous plant performance improvement and during the design, installation and operation stages of a blast furnace. / Thesis (M.Ing. (Development and Management Engineering))--North-West University, Potchefstroom Campus, 2012.

Organizations are expected by their shareholders to continually deliver above industry returns on capital invested and to remain competitive in the industry of choice through productivity, safety and quality. The maintenance function is a key area in which competitiveness through efficiencies and world–class performance can be attained by focusing on the prevention and reduction of long and costly equipment repair times. The question is: how can the mean time to repair of equipment already installed in the plant be reduced? To answer the above question correctly and comprehensively, the research explored mixed methods in finding answers. Quantitative methodology using a survey was used for data collection. Observations and interviews were held with maintenance personnel to uncover information that couldn’t have been obtained by means of a survey. The survey was limited to equipment performance measures, human factors, environmental factors, planning, spare parts, maintainability, procedures and training. To test consistency and accuracy of representation of the total population under study, a reliability test was done by using Cronbach’s alpha coefficient. To determine whether there are any differences between groups, an ANOVA test was used. Cohen’s d–value was used to determine practically significant differences between one set of data with another and correlation analysis was used to determine the relationships between the variables. The approach designed and delivered by this research flowed from the existing body of knowledge, case studies and survey findings. The approach adopts some of the elements of the failure mode and effects analysis (FMEA) procedure and differs from other work that has been done by others by taking into account the competency and experience of maintenance personnel and assigning to them factors which are used to compute anew MTTR of the equipment. The cost of implementing the recommended corrective actions for realising the new MTTR is determined and evaluated against an improved equipment availability that will be achieved as a result of the recommended corrective actions assuming that the failure rate of the equipment remains constant. This evaluation step imbedded within the approach is valuable for the maintenance function and management for decision making in ensuring that resources at the organization’s disposal are used productively. Validation and test results of the approach showed that the MTTR of equipment installed in the plant can be reduced. The results also indicated that through the use of the designed approach a regular pattern of repair or replacement times can be followed well in advance and that it is practical, user friendly and it also delivers on its objective of offering a structure for analysis and decision making aimed at reducing the MTTR. Included with this dissertation is feedback information that can be included in a maintenance job card feedback section to capture information about factors that can be improved to lower the MTTR as part of a continuous improvement process. Included also is a spare part development and management procedure that can be used by the maintenance function. Recommendations on training of maintenance personnel on the maintainability of equipment, the FMEA procedure and maintenance procedures are highlighted. Information that flowed from this approach will be valuable for continuous plant performance improvement and during the design, installation and operation stages of a blast furnace. / Thesis (M.Ing. (Development and Management Engineering))--North-West University, Potchefstroom Campus, 2012.

O presente trabalho apresenta um modelo de aplicação de ferramentas de projeto integradas ao longo das fases de desenvolvimento de produto, neste caso, aplicadas na melhoria do produto suporte para fixação de cilindro de gás natural veicular. O foco do trabalho é apresentar a integração de ferramentas nas fases de Projeto Informacional, Projeto Conceitual e Projeto Detalhado do Processo de Desenvolvimento de Produtos. Entende-se por integração a escolha de ferramentas que permitam conduzir o fluxo de informação ao longo das fases de desenvolvimento de produtos, de tal forma que a informação de saída de uma ferramenta seja a informação de entrada da ferramenta subseqüente. As ferramentas integradas a partir da fase de Projeto Informacional foram a Pesquisas de Mercado Qualitativa e Quantitativa, com a finalidade de identificar as demandas dos clientes. As demandas dos clientes foram os dados de entrada da Matriz da Qualidade (Quality Function Deployment - QFD), resultando nos requisitos do produto e suas respectivas especificações-meta. A partir dos requisitos do produto, diferentes conceitos (configurações) foram gerados, apoiados pela Matriz Morfológica no Projeto Conceitual. Na seqüência utilizou-se a ferramenta de Projeto de Experimentos (Design of Experiments - DOE) para avaliar a estimativa de preço frente às possíveis configurações do produto. Com a Matriz de Pugh, alternativas de conceito de produto foram avaliadas possibilitando a escolha do melhor conceito de produto. No Projeto Detalhado, foi aplicada ferramenta de Análise dos Modos de Falha e seus Efeitos (Failure Mode and Effects Analysis - FMEA), utilizado de forma integrada com o QFD, para identificar as falhas atuais e potenciais e seus efeitos em sistemas e processo. Em função das demandas identificadas, foram definidas e implementadas melhorias no produto. Observou-se a adequabilidade destas ferramentas de projeto para aplicação de forma integrada, garantindo um fluxo contínuo de informações rastreáveis e que tendem a levar à uma reduzida chance de perdas ao longo do processo. / There are few examples in literature about the integration of project tools along the product development phases. The main research objective in thesis is to integrate some tools that facilitate the information flow along the product development phases, more specifically in Informational Project, Conceptual Project and Detailed Project phases. The product improvement “support for Vehicular Natural Gas” was the object of study in thesis. The main idea is that the information output from one tool is the input information of the subsequent tool. Starting from the Informational Project phase it was performed qualitative and quantitative market researches with the purpose of identifying the customers' demands for the studied product. The customers’ demands were the entrance data of the QFD (Quality Function Deployment) tool resulting in the product requirements and their respective specifications-goal. In Concept Project the product requirements were converted in functions and further different concepts were generated through the Morphologic Analysis. In the sequence, it was used the DOE (Design for experiments) tool to evaluate the estimate price to the possible products' configurations. The Pugh Matrix tool was used for concepts evaluation and choice. The FMEA (Failure Mode and Effects Analysis) tool integrated with QFD was useful for current and potential failures identification and impact analysis in the system and process. With the application of these five tools the users’ demands were identified and improvements to the product were performed. The chosen tools proved to be adequate for integration, assuring that a continuous trackable information flow was attained with presumable reduced information loss, along the Product Development Process phases.

O presente trabalho apresenta um modelo de aplicação de ferramentas de projeto integradas ao longo das fases de desenvolvimento de produto, neste caso, aplicadas na melhoria do produto suporte para fixação de cilindro de gás natural veicular. O foco do trabalho é apresentar a integração de ferramentas nas fases de Projeto Informacional, Projeto Conceitual e Projeto Detalhado do Processo de Desenvolvimento de Produtos. Entende-se por integração a escolha de ferramentas que permitam conduzir o fluxo de informação ao longo das fases de desenvolvimento de produtos, de tal forma que a informação de saída de uma ferramenta seja a informação de entrada da ferramenta subseqüente. As ferramentas integradas a partir da fase de Projeto Informacional foram a Pesquisas de Mercado Qualitativa e Quantitativa, com a finalidade de identificar as demandas dos clientes. As demandas dos clientes foram os dados de entrada da Matriz da Qualidade (Quality Function Deployment - QFD), resultando nos requisitos do produto e suas respectivas especificações-meta. A partir dos requisitos do produto, diferentes conceitos (configurações) foram gerados, apoiados pela Matriz Morfológica no Projeto Conceitual. Na seqüência utilizou-se a ferramenta de Projeto de Experimentos (Design of Experiments - DOE) para avaliar a estimativa de preço frente às possíveis configurações do produto. Com a Matriz de Pugh, alternativas de conceito de produto foram avaliadas possibilitando a escolha do melhor conceito de produto. No Projeto Detalhado, foi aplicada ferramenta de Análise dos Modos de Falha e seus Efeitos (Failure Mode and Effects Analysis - FMEA), utilizado de forma integrada com o QFD, para identificar as falhas atuais e potenciais e seus efeitos em sistemas e processo. Em função das demandas identificadas, foram definidas e implementadas melhorias no produto. Observou-se a adequabilidade destas ferramentas de projeto para aplicação de forma integrada, garantindo um fluxo contínuo de informações rastreáveis e que tendem a levar à uma reduzida chance de perdas ao longo do processo. / There are few examples in literature about the integration of project tools along the product development phases. The main research objective in thesis is to integrate some tools that facilitate the information flow along the product development phases, more specifically in Informational Project, Conceptual Project and Detailed Project phases. The product improvement “support for Vehicular Natural Gas” was the object of study in thesis. The main idea is that the information output from one tool is the input information of the subsequent tool. Starting from the Informational Project phase it was performed qualitative and quantitative market researches with the purpose of identifying the customers' demands for the studied product. The customers’ demands were the entrance data of the QFD (Quality Function Deployment) tool resulting in the product requirements and their respective specifications-goal. In Concept Project the product requirements were converted in functions and further different concepts were generated through the Morphologic Analysis. In the sequence, it was used the DOE (Design for experiments) tool to evaluate the estimate price to the possible products' configurations. The Pugh Matrix tool was used for concepts evaluation and choice. The FMEA (Failure Mode and Effects Analysis) tool integrated with QFD was useful for current and potential failures identification and impact analysis in the system and process. With the application of these five tools the users’ demands were identified and improvements to the product were performed. The chosen tools proved to be adequate for integration, assuring that a continuous trackable information flow was attained with presumable reduced information loss, along the Product Development Process phases.

O presente trabalho apresenta um modelo de aplicação de ferramentas de projeto integradas ao longo das fases de desenvolvimento de produto, neste caso, aplicadas na melhoria do produto suporte para fixação de cilindro de gás natural veicular. O foco do trabalho é apresentar a integração de ferramentas nas fases de Projeto Informacional, Projeto Conceitual e Projeto Detalhado do Processo de Desenvolvimento de Produtos. Entende-se por integração a escolha de ferramentas que permitam conduzir o fluxo de informação ao longo das fases de desenvolvimento de produtos, de tal forma que a informação de saída de uma ferramenta seja a informação de entrada da ferramenta subseqüente. As ferramentas integradas a partir da fase de Projeto Informacional foram a Pesquisas de Mercado Qualitativa e Quantitativa, com a finalidade de identificar as demandas dos clientes. As demandas dos clientes foram os dados de entrada da Matriz da Qualidade (Quality Function Deployment - QFD), resultando nos requisitos do produto e suas respectivas especificações-meta. A partir dos requisitos do produto, diferentes conceitos (configurações) foram gerados, apoiados pela Matriz Morfológica no Projeto Conceitual. Na seqüência utilizou-se a ferramenta de Projeto de Experimentos (Design of Experiments - DOE) para avaliar a estimativa de preço frente às possíveis configurações do produto. Com a Matriz de Pugh, alternativas de conceito de produto foram avaliadas possibilitando a escolha do melhor conceito de produto. No Projeto Detalhado, foi aplicada ferramenta de Análise dos Modos de Falha e seus Efeitos (Failure Mode and Effects Analysis - FMEA), utilizado de forma integrada com o QFD, para identificar as falhas atuais e potenciais e seus efeitos em sistemas e processo. Em função das demandas identificadas, foram definidas e implementadas melhorias no produto. Observou-se a adequabilidade destas ferramentas de projeto para aplicação de forma integrada, garantindo um fluxo contínuo de informações rastreáveis e que tendem a levar à uma reduzida chance de perdas ao longo do processo. / There are few examples in literature about the integration of project tools along the product development phases. The main research objective in thesis is to integrate some tools that facilitate the information flow along the product development phases, more specifically in Informational Project, Conceptual Project and Detailed Project phases. The product improvement “support for Vehicular Natural Gas” was the object of study in thesis. The main idea is that the information output from one tool is the input information of the subsequent tool. Starting from the Informational Project phase it was performed qualitative and quantitative market researches with the purpose of identifying the customers' demands for the studied product. The customers’ demands were the entrance data of the QFD (Quality Function Deployment) tool resulting in the product requirements and their respective specifications-goal. In Concept Project the product requirements were converted in functions and further different concepts were generated through the Morphologic Analysis. In the sequence, it was used the DOE (Design for experiments) tool to evaluate the estimate price to the possible products' configurations. The Pugh Matrix tool was used for concepts evaluation and choice. The FMEA (Failure Mode and Effects Analysis) tool integrated with QFD was useful for current and potential failures identification and impact analysis in the system and process. With the application of these five tools the users’ demands were identified and improvements to the product were performed. The chosen tools proved to be adequate for integration, assuring that a continuous trackable information flow was attained with presumable reduced information loss, along the Product Development Process phases.

In the automotive industry, the Safety Function-FMEA according to ISO 26262 and its application to functional safety relevant systems is a well-established process in the form of Automotive Safety Integrity Levels (ASILs). These represent the failure mitigation that must be applied to ensure an acceptable residual risk of malfunctioning behaviour. The DIN EN ISO 13849 (ISO 13849) already describes a process to reduce risks for machines which starts with a Hazard And Risk Analysis (HARA) as described in DIN EN ISO 12100 and concludes with the Safety Requirements Specification (SRS). The SRS is a functional and technical safety concept defining requirements and guidelines to make sure the design conforms to defined safety goals. ISO 13849 lists important faults and failures for various technologies. The defined Safety Functions (SFs) can be classified in corresponding categories that lead to the particular hardware/system structure. This applies to mechatronic systems consisting of at least one sensor, one control unit and one actuator to monitor the system and effect a response in case of failure. Compared to the methods described in ISO 13849, the Safety Function-FMEA allows systematic identification of additional failures resulting from combinations of effects, rather than only listing the main failure causes. Based on the complexity of the machines it is highly recommended to perform a Safety Function-FMEA as a complementary method to assess and improve the overall safety of machinery.

The need for safety components in safety-related control systems arises in developing basic principles for preventing mechanical accidents and protecting safety for people and machines, especially in the development of automated drive systems for mobile construction machinery. An important parameter when using safety-relevant components respectively safety devices of automation technology-according to E DIN EN ISO 13849-1:2020-08 - in mobile machinery is the Diagnostic Coverage. The Diagnostic Coverage measures the effectiveness of the diagnosis as the ratio of the failure rate of noticed dangerous failures and failure rate of total dangerous failures. Because single- and dual-channel safety circuits from the Safety Related Parts of Control Systems (SRP/CS) might fail or get defective, a known level of Diagnostic Coverage helps to design such systems. As a supplementary method, the paper discusses the possibility of deriving a failure rate from empiric investigations via the context of fault classification known for electrical components from DIN EN 61508.-6:2011-02. Test procedures are not available in the development phase of new machines and new components in the field of mobile machines. Nevertheless, the Diagnostic Coverage is required for the calculation and design process. Similar to this test approach, the fault behaviour of technical products, defined in the FMEA (Failure Mode and Effects Analysis), can be applied to estimate the fault conditions in parallel to the design development as a first step. The target of estimating the diagnostic coverage already in the development phase of safety-relevant hydraulic components and systems can thus be achieved more effectively, and is illustrated in the article employing an example. The Diagnostic Coverage must be determined to classify the entire SRP/CS and each individual component according to ISO 13849 in category 2 and categories 3 & 4. In practice, this means that the calculation must be executed for the respective sensors, the controller and the actuator individually, and the entire functional channel as a whole in the single- or dual-channel safety circuit system. This enables an initial estimate and calculation of the Diagnostic Coverage according to ISO 13849 in the development phase without executing time-consuming prototype tests or test results from the field. This results in time savings and an increase in effectiveness of the internal work processes. Furthermore, the early avoidance of potential systematic risks of product and process failures, allows to reduce the costs of the development phase significantly.