The goal of every program or project manager is to have a safe reliable product and to have an understanding of the residual risk of operating that product. Two very important systems engineering analysis tools to achieve those objectives are Hazard Analysis and Failure Modes and Effects Analysis. Sometimes seen strictly as Safety and Reliability tasks, these analyses are key to a successful program or project and require input from all stakeholders. When viewed in the Systems Engineering process, Safety and Reliability are truly specialty disciplines within Systems Engineering. Hazard Analysis is used to improve system safety while Failure Modes and Effects Analysis is used to identify ways to increase product reliability; both analyses are required to improve systems design and fully capture the risk for a system or program. Depending on how the analyses are scoped, there could be a perception of overlap and duplication of effort. This paper will present a systems engineering approach to show the need and benefits for performing both types of analyses. Both analysis processes are required to ensure that all possible hazardous conditions and failure modes have been identified and addressed to minimize overall risk to the program/project and to ensure a safe and reliable system. / text

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.

Purpose – In the last years companies are challenged by the increasing of innovation, product complexity and customisation, continuous and rapid changes in technology. A company’s successfulness in the market depends on the ability to quickly adapt to changes through innovation and efficiency in its products and services. Risk analysis might lead to success using different tools within the New Product Development (NPD)process, such as Design and Process Failure Mode and Effects Analysis (DFMEA andPFMEA). This study aims to identify how the integration between DFMEA and PFMEA might enhance the co-development of product and production to overcome the challenges in the NPD. To address the purpose, three research questions have been formulated: (1) Are DFMEA and PFMEA linked in the literature and how are they connected? (2) Which are the main challenges and opportunities to integrate DFMEA andPFMEA from a practical point of view? (3) How to improve DFMEA and PFMEAintegration for enhanced co-development of product and production? Method – The research has an inductive approach and data collection was carried out using qualitative methods, such as documents reviews, interviews and workshops. The chosen strategies were a literature review and a case study. Firstly, literature review was conducted in order to identify the connection between DFMEA and PFMEA and feasible methods to integrate them. Thereafter, documentation from two companies and recorded interviews were reviewed to gain information from a practical perspective. Lastly, two workshops were performed to explore further connections between DFEMA and PFMEA by collaborating with the responsible from the two analysed companies. Findings & Analysis – In the literature, three suitable methods that linked DFMEAand PFMEA were identified. After reviewing the documentation from the companies and the recorded interviews and performing two workshops, two different situations were depicted. The companies are implementing different templates and their processes are slightly different. For this reason, a SWOT analysis helped comparing the two companies to identify their challenges and opportunities to integrate DFMEA and PFMEA. The three methods, the comparison between the companies and other reflections helped contribute to the knowledge and improve companies’ processes. Limitations – The main limitation of the study regards time constraints. There are several paths this research can pursue since there was not enough time to further explore in this thesis. In fact, it was intended to find a method to test in the companies and gain results after the test. In the end, the results are suggestions for further research and methods for integrating DFMEA and PFMEA

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.

Yes / Risk Management is one of the most relevant approaches and systematic application of strategies, procedures and practices management that have been introduced in literature to identifying and analysing risks which exist through the whole life of a product or a process. As a quality management tool, the novelty of this paper suggests a modified Failure Modes and Effect Analysis (FMEA) for understanding the non-technical risk comprehensively, and to attain a systemic methodology by decomposing the risk for nine risk categories including an appropriate 84 Risk Indicators (RI's) within all those categories through the Life Cycle (LC) stages of power plants. These risk categories have been identified as: economic risks, environmental and safety health risks, social risks, technological risks, customer/demand risks, supply chain risks, internal and operational business process risks, human resources risks and management risks. These indicators are collected from literatures. The enhanced FMEA has combined the exponential and the weighted geometric mean (WGM) to calculate the Exponential Weighted Geometric Mean-RPN (EWGM-RPN). The EWGM-RPN can be used to evaluate the risk level, after which the high-risk areas can be determined. Subsequently, effective actions either preventive or corrective can be taken in time to reduce the risk to an acceptable level. However, in this paper the FMEA will not adapt an action plan. Due to that, all RPN's will be considered depending on the point scale (1 to 5) afterward, the results will be combined and extended later with AHP. This developed methodology is able to boost effective decision- making about risks, improve the awareness towards the risk management at power plants, and assist the top management to have an acceptable and preferable understanding of the organisation than lower level managers do who are close to the day-to-day (tactical plan). Additionally, this will support the organisation to develop strategic plans which are for long term. And the essential part of applying this methodology is the economic benefit. Also, this paper includes developed sustainability perspective indicators with a new fourth pillar, which is the technological dimension. The results of the analysis show that the potential strategic makers should pay special attention to the environmental and internal and operational business process risks. The developed methodology will be applied and validated for different power plants in the Middle East. An expanded validation is required to completely prove drawbacks and benefits after completing the Analytical Hierarchy Process (AHP) model. / Hashemite University, Jordan

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.

The diploma thesis deals with the issue of risk management during order processing in the production company, named Slévárna Kuřim, a.s., which produces castings. The first part of the thesis presents the theoretical background. In the practical part, a specific company is introduced, an order processing is described, and all possible risks that may occur during order processing are identified. Their identification is done by using selected tools - the FMEA method and the Ishikawa diagram. The goal of the diploma thesis is to identify possible risks based on performed analysis and for the most serious risks propose measures that would minimize them.

The diploma thesis deals the risk management during order processing in the engineering company Balák stroje Tišnov Ltd., a producer of custom machines. The aim of the diploma theses is to identify and evaluate the risks that may arise during the order processing. A partial aim is to propose a list of recommendations to minimize the most serious risks. The thesis is divided into three parts, where the first part of the thesis is focused on theoretical basis. The second part – analytical part contains the introduction of the company, the research part, description of the order processing and risks identification and evaluation, using selected methods – FMEA and Ishikawa diagram. The last part contains proposals for mitigating the most serious risks.