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2002


Title: Failure mode and effects analysis as an informed consent tool for investigational cardiothoracic devices

Source: ASAIO JOURNAL

Author: Bramstedt, KA

Year: 2002

Abstract: The informed consent process is one of the most critical segments of any device clinical trial. Informed consent requires that patients be provided with ample and accurate information about the risks and benefits of trial participation in a manner that respects their learning ability. Knowing this, the dilemma for clinical investigators lies in identifying the risks without having had clinical experience with the device in question. it is offered that the device manufacturer's FMEA (failure mode and effects analysis) document can be a valuable aid in determining the potential clinical risks of investigational devices, and thus should be available to clinical investigators for their preparation of informed consent documentation.


Title: Environmental health and safety (EHS) investigation of CVD exhaust system: Identification and mitigation of potential release of process gases and by-products

Source: ENVIRONMENTAL ISSUES WITH MATERIALS AND PROCESSES FOR THE ELECTRONICS AND SEMICONDUCTOR INDUSTRIES V

Author: Chandna, L; Bustamante-Reynoso, A; Nauert, C; Hendricksen, K

Year: 2002

Abstract: Motorola Semiconductor Products Sector has undergone the initiative to reduce perfluorocompound (PFC) emissions by converting from the standard in-situ cleaning chemistries on chemical vapor deposition (CVD) processes to NF3-based cleans. As a result, the severity of a post-plasma fluorine release is potentially greater than with the in-situ clean. Motorola conducted a safety evaluation on a typical CVD exhaust system to identify and mitigate the risk of a potential release. The evaluation utilized a failure modes effects analysis (FMEA) risk assessment to systematically identify the causes that could lead to a potential release of process gases or byproducts. Any release would requirean exhaust system failure that results in positive static pressure. Controls to detect a pressure fault and to prevent the release would have to be non-functional. The recommendations are divided into three categories. Primary recommendations are essential to risk reduction and release prevention.. Secondary recommendations should be considered to further reduce the risk.. The tertiary recommendations provide suggestions for future studies.


Title: Application of RCM to a medium scale industry

Source: RELIABILITY ENGINEERING & SYSTEM SAFETY

Author: Deshpande, VS; Modak, JP

Year: 2002

Abstract: The factors which are assuming considerable importance in cost effective decision making of operation of any industrial enterprise are in the order of significance liability, safety and environmental conditions. Hence, preventive maintenance (PM) optimisation is providing wide opportunities and challenges to everyone involved in all aspects of operation of industrial enterprise. Reliability centred maintenance (RCM) methodology offers the best available strategy for PM optimisation. It incorporates a new understanding of the ways in which equipment fails. In this paper, the concept of RCM has been applied to steel melting shop of a medium scale steel industry. By systematically applying the RCM methodology, failures, failure causes and effects on the system are analysed. To preserve the system function, PM categories are suggested for various failure modes in the components such as (1) time directed (2) condition directed (3) failure finding (4) run to failure. Features of predictive maintenance of a medium scale steel industry are deduced through this paper in a rather generalised form. 0 2002 Elsevier Science Ltd. All rights reserved.


Title: FMEA of marine systems: Moving from prescriptive to risk-based design and classification

Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2002 PROCEEDINGS

Author: Farquharson, J; McDuffee, J; Seah, AK; Matsumoto, T

Year: 2002

Abstract: For more than 100 years, the American Bureau of Shipping (ABS) has been developing standards - called Rules - for building and classing ships. Through experience, the Rules implicitly identify hazards and prescribe safeguards against them. For example, the Rules (1) address the reliability of propulsion and maneuvering systems to help safeguard against external hazards, (2) impose safety requirements on machinery systems to help safeguard against hazards inherent in the machinery itself, and (3) specify minimum acceptable structural scantlings as a measure to safeguard against structural failure. The difficulty in fairly imposing prescriptive safeguards is the diversity of ship designs, operating scenarios, maintenance practices, and numerous other factors that affect the potential risk to which a ship is exposed. Inevitably, this means that the Rules may not be entirely comprehensive in some instances, while overly onerous in others. This paper describes the results of recent studies by ABS to provide risk-based guidelines for performing a failure mode and effects analysis (FMEA) on high-speed crafts and propulsion remote control systems, This approach describes how frequency and severity categories can be used in the FMEA to guide designers in assessing the risk and reliability of the system. Recognizing that many designers may not be familiar with these risk tools, the guideline provides step-by-step instructions on how to prepare, conduct, and document the analysis.


Title: Reliability qualification of semiconductor devices based on physics-of-failure and risk and opportunity assessment

Source: QUALITY AND RELIABILITY ENGINEERING INTERNATIONAL

Author: Gerling, WH; Preussger, A; Wulfert, FW

Year: 2002

Abstract: Qualification frequently is a time-critical activity at the end of a development project. As time-to-market is a competitive issue, the most efficient qualification efforts are of interest. A concept is outlined, which proactively integrates qualification into the development process and provides a systematic procedure as a support tool to development and gives early focus on required activities. It converts; requirements for a product into measures of development and qualification in combination with a risk and opportunity assessment step and accompanies the development process as a guiding and recording tool for advanced quality planning and confirmation. The collected data enlarge the knowledge database for DFR/BIR (designing for reliability/building-in reliability) to be used for future projects. The procedure challenges and promotes teamwork of all the disciplines involved. Based on the physics-of-failure concept the reliability qualification methodology is re-arranged with regard to the relationships between design, technology, manufacturing and the different product life phases at use conditions. It makes use of the physics-of-failure concept by considering the potential individual failure mechanisms and relates most of the reliability aspects to the technology rather than to the individual product design. Evaluation of complex products using common reliability models and the definition of sample sizes with respect to systematic inherent product properties and fractions of defects are discussed. Copyright (C) 2002 John Wiley Sons, Ltd.


Title: FMEA - Friend or foe

Source: INSTRUMENTATION, SYSTEMS, AND AUTOMATION CONFERENCE PROCEEDINGS

Author: Hecht, H; Hecht, M

Year: 2002

Abstract: The value of FMEA for I&C systems is being questioned because its conventional format does not appear suited to digital components where failures in software and in large scale integrated circuits predominate. It is shown that new design techniques and tools help overcome these difficulties and at the same time reduce the cost. An often overlooked benefit of FMEA is that it can show deficiencies in failure detection that, when not corrected, can impose high costs during the OM phase.


Title: Failure scenario FMEA: Theoretical and applicative aspects

Source: AMST 02: ADVANCED MANUFACTURING SYSTEMS AND TECHNOLOGY, PROCEEDINGS

Author: Locatelli, E; Valsecchi, N; Maccarini, G; Bugini, A

Year: 2002

Abstract: This paper aims to give a new growth perspective of Failure Modes and Effects Analysis that can be called "Expected Costs of Failure Scenarios". Traditional FMEA discipline has been used to evaluate Failure Effects in aerospace and automotive industry since '60 [1, 2] and today is applied to anticipate Failure Modes of products and services already in design session concerning different industry contexts. The evaluation of Failure Effects perceived by the customer through the common Risk Priority Number does not offer certainty of success in giving priorities intervention on risk reduction due to its lack of perceiving the Failure Cost sustained by industry. If FMEA focuses on Failure Costs of Failure Scenarios we can derive new intervention priorities based on total Expected Costs of Cause & Effect chain of events. In these "scenarios" the priorities are based on the cost of the whole product life cycle and are connected with the corrective actions which are to be planned, even if they are often in conflict with the classic RPN ranking.


Title: Analyzing fuzziness in product quality & reliability information-flow during time-driven product-development-process

Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2002 PROCEEDINGS

Author: Lu, Y; Brombacher, AC; Den Ouden, E; Korvers, PMW

Year: 2002

Abstract: This paper provides a different angle to look at quality and reliability (Q&R) problem prediction in a time-driven product-development-process (PDP) where the Q&R information is highly uncertain. Through a case study, it is demonstrated that many of the critical Q&R problems in such a product development cannot be predicted due to highly fuzzy Q&R information. Therefore, a new tool, Reliability and Quality Matrix (RQM), was developed to overcome this difficulty. It is shown that RQM can not only quantitatively indicate the severity level of an identified Q&R problem but also reflect on its associated uncertainty level due to fuzzy Q&R information. RAM was developed as an enhancement of Failure Mode Effect Analysis (FMEA) or Quality Function Deployment (QFD). If the quality of the input information is very good, RQM then presents only the results from FMEA or QFD. However, if uncertainty in the input information is obviously high, RQM can act as uncertainty/fuzziness reduction tool to strengthen the weakness of FMEA and QFD when dealing with fuzzy information.


Title: System-FMEA as method in development of agricultural machinery electronics

Source: CONFERENCE: AGRICULTURAL ENGINEERING 2002

Author: Martinus, M

Year: 2002

Abstract: In the project "Process Safety of Agricultural Machinery Electronics", supported by the German research fund DFG, functional safety of electronic controlled tractor-implement combinations and self propelled,agricultural machinery is investigated. Systern-FMEA stands for a method, which characterizes potential failure cases according to their reason and consequence and assesses the risk of the failure cases according to probability-of occurrence, probability of detection, and significance. The systematic strategy of FMEA as well as important rules and general conditions in adaptation, to. automated agricultural processes are demonstrated generally and by example.


Title: Maintenance-cost modeling for a refrigerated-trailer fleet

Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2002 PROCEEDINGS

Author: Nutter, DW; Cassady, CR; Taylor, GD; Wong, CT

Year: 2002

Abstract: The distribution of many perishable products (e.g. frozen foods) requires the use of refrigerated trailers. Like most other systems, refrigerated trailers are subject to failures and repair upon failure. The purpose of this study was to model the costs of operational failures and repairs related to the refrigeration systems used in a fleet of refrigerated trailers. C Specifically, we applied the following methodology to a fleet of refrigerated trailers affiliated with a large processed meat company, but the work presented in this paper is applicable to any organization havinu refrigerated transportation systems. We began by applying Failure Mode and Effects Analysis (FMEA), Fault Tree Analysis (FTA). Pareto analysis, and traditional statistical analysis to data gathered from the maintenance history of the fleet. Thirteen failure modes for the refrigeration systems were identified, hut a simpliked model focused on compressor failures and Ill "other" failures. In addition, the refrigeration system data allowed classifying each trailer as "new" or "old". These simplifications led to the e estimation of four failures rates, one for each failure type (compressor, other) and trailer type (new, old) combination. Given the unit costs associated with refrigeration system failures, we used a simulation model to estimate the number of reefer failures and costs due to both delays in delivery and refrigeration system repairs. Finally, a designed experiment in conjunction with our simulation model was used to construct a linear regression model for estimating, refrigeration system maintenance costs given the values of five experimental factors. These factors c U are: an MTBF multiplier - to model potential changes in failure rates a repair time multiplier - to model changes in repair technology a delay time multiplier - to model changes in trailer scheduling and repair crew, response tirne the percentage of failures resulting in delivery delay - also to model changes in scheduling and response time and the percentage of trailers in the fleet classified is old - to model changes to the makeup of the fleet.


Title: IDD: Integrating diagnosis in the design of automotive systems

Source: ECAI 2002: 15TH EUROPEAN CONFERENCE ON ARTIFICIAL INTELLIGENCE, PROCEEDINGS

Author: Picardi, C; Bray, R; Cascio, F; Console, L; Dague, P; Dressler, O; Millet, D; Rehfus, B; Struss, P; Vallee, C

Year: 2002

Abstract: In this paper we overview the achievements of the IDD European project, which aims at defining a new framework for the design of automotive systems. In particular, starting from the weaknesses of the current design process, especially as regards issues related to diagnosis (diagnosability analysis, generation of the FMEA - Failure Mode Effect Analysis, generation of on-board diagnostic software), the project aims at defining a new process in which these issues are integrated within the design of a system and of its control strategies. The project also aims at defining and implementing a software toolkit supporting the new process. The toolkit integrates applications for design and simulation (e.g., Matlab Simulink) and model-based reasoning systems for diagnosis-related tasks.


Title: Safety assessment for ITER-FEAT tritium systems

Source: FUSION ENGINEERING AND DESIGN

Author: Pinna, T; Rizzello, C

Year: 2002

Abstract: The design of the equipment and confinement barriers of ITER-FEAT should be consistent with the basic safety requirement that-no emergency plan involving evacuation of the nearby population is required in case of the worst credible accident. Extensive probabilistic and deterministic analyses have been done to select abnormal event sequences, and to ensure that all potential consequences are within project guidelines. The paper deals with the work done for the tritium systems. A Bottom-Up methodology based on component level Failure Mode and Effect Analysis has been applied to point out accident initiators. Once possible accident sequences have been identified, detailed deterministic analyses on bounding events confirmed that the accidents in tritium plant are not a concern from a safety point of view. The no-evacuation goal of ITER-FEAT is attained also for accidents where 'ultimate safety margin' are challenged, as in case of hydrogen-air reactions in cold box or in hard shell, enclosing the process equipment of the isotope separation system. (C) 2002 Elsevier Science B.V. All rights reserved.


Title: Automated multiple failure FMEA

Source: RELIABILITY ENGINEERING & SYSTEM SAFETY

Author: Price, CJ; Taylor, NS

Year: 2002

Abstract: Failure mode and effects analysis (FNEA) is typically performed by a team of engineers working together. In general, they will only consider single point failures in a system. Consideration of all possible combinations of failures is impractical for all but the simplest example systems. Even if the task of producing the FMEA report for the full multiple failure scenario were automated, it would still be impractical for the engineers to read, understand and act on all of the results. This paper shows how approximate failure rates for components can be used to select the most likely combinations of failures for automated investigation using simulation. The important information can be automatically identified from the resulting report, making it practical for engineers to study and act on the results. The strategy described in the paper has been applied to a range of electrical subsystems, and the results have confirmed that the strategy described here works well for realistically complex systems. (C) 2002 Elsevier Science Ltd. All rights reserved.


Title: Effective automated sneak circuit analysis

Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2002 PROCEEDINGS

Author: Price, CJ; Hughes, N

Year: 2002

Abstract: The automated sneak analysis software described in this paper works well on classic sneak examples. It correctly identifies sneak paths without falsely reporting on non-existent sneaks. It has been tried out on much larger real-world examples, and reproduces the kind of behavior that it had demonstrated on the classic sneaks. Future development of the tool will enable the exploration of internal states of complex components such as ECUs. In addition of provision to complete a sneak analysis in the presence of failures will further enhance the tool. The use of simulation and identification of significant system operation has enabled this level of performance. The system is able to use qualitative simulation early in the design process, to identify potential sneaks as early as possible. It can use the industry-standard simulator Saber later in the design process, to give a more detailed analysis. In each case, component models are not specific to sneak circuit analysis, but can be used to verify the operation of the design, to generate a failure modes and effects analysis (FMEA) report. and to provide information useful for building diagnostic systems.


Title: High reliability prototype quadrupole for the next linear collider

Source: IEEE TRANSACTIONS ON APPLIED SUPERCONDUCTIVITY

Author: Rago, CE; Spencer, CM; Wolf, Z; Yocky, G

Year: 2002

Abstract: The Next Linear Collider (NLC) will require over 5600 magnets, each of which must be highly reliable and/or quickly repairable in order that the NLC reach its 85% overall availability goal. A multidiscipline engineering team was assembled at SLAC to develop a more reliable electromagnet design than historically had been achieved at SLAC. This team carried out a Failure Mode and Effects Analysis (FMEA) on a standard SLAC quadrupole magnet system. They overcame a number of longstanding design prejudices, producing 10 major design changes. This paper describes how a prototype magnet was constructed and the extensive testing carried out on it to prove full functionality with an improvement in reliability. The magnet's fabrication cost will be compared to the cost of a magnet with the same requirements made in the historic SLAC way. The NLC will use over 1600 of these 12.7 mm bore quadrupoles with a range of integrated strengths from 0.6 to 132 Tesla, a maximum gradient of 135 Tesla per meter, an adjustment range of 0 to -20% and core lengths from 324 mm to 972 mm. The magnetic center must remain stable to within I micron during the 20% adjustment. A magnetic measurement set-up has been developed that can measure sub-micron shifts of a magnetic center. The prototype satisfied the center shift requirement over the full range of integrated strengths.


Title: The NASA risk management program

Source: PROCEEDINGS OF THE JOINT ESA-NASA SPACE-FLIGHT SAFETY CONFERENCE

Author: Rutledge, PJ; Stamatelatos, MG; Chandler, FT; Moyer, RW

Year: 2002

Abstract: This paper will describe NASA's vision and mission, and how NASA's risk management program has and will continue to contribute to the successful achievement of these goals. It will review the origins and accomplishments of the first five years of NASA's risk management program, its current status, and its future direction. The program began as a NASA Carnegie Mellon Software Engineering Institute joint development project focused on creating a customized "Continuous Risk Management" (CRM) training course for NASA. As a part of this effort, requirements consistent with the training were incorporated in NASA's top-level program, project management procedures, and guidelines. To date, CRM training has been administered by an agency-wide network of "certified" instructors to numerous project teams, including nearly 2000 participants. Across the agency, NASA programs and projects are implementing risk management. The need to use CRM has been reinforced by the Mars 1998 mission failures and other studies. Recently, a strategic alliance between NASA safety and mission assurance and procurement communities has resulted in changes to NASA's supplement to the Federal Acquisition Regulations, enabling earlier, risk-based acquisition management. The NASA Administrator has placed major impetus on improving the risk identification and risk analysis steps of risk management by emphasizing tools and methodologies including fault tree analysis (FTA), failure modes and effects analysis (FMEA), and probabilistic risk assessment (PRA). The implementation of risk management in NASA is periodically verified and validated through a number of formal review mechanisms. The paper will expand on all of the preceding.


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

Source: FOOD CONTROL

Author: Scipioni, A; Saccarola, G; Centazzo, A; Arena, F

Year: 2002

Abstract: 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, Elledi 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 Elledi and as a model of FMEA design for similar company. (C) 2002 Elsevier Science Ltd. All rights reserved.


Title: The failure-analysis matrix: A kinder, gentler alternative to FMEA for information systems

Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2002 PROCEEDINGS

Author: Signor, MC

Year: 2002

Abstract: The author's goal for this paper was the creation of a usable Failure-Analysis Matrix (FAM) model as an alternative to Failure Modes and Effects Analysis (FMEA) for prioritizing solutions to failures in information systems. The author created the FAM by using repeated cycles of development and usability assessment. The FAM worksheets are much smaller than the FMEA worksheets, requiring less scrolling. The FAM helps identify the most important potential failures or failures and helps prioritize possible solutions using approximate expected costs. This new tool provides integrated data entry and reporting. The FAM may be used without having detailed information. The FAM is a new quality tool that is easy to learn and easy to use. The FAM is an Excel worksheet that shows the most important potential failures and quickly prioritizes possible solutions using approximate expected costs. The author has completed the development of the FAM. Readers may download the FAM and its instructions from http://www.nova.edu/similar tosignormi/fam.htm.


Title: Basic analysis on severe accidents for chemical PCB detoxification plant using the UV/catalyst method

Source: JOURNAL OF CHEMICAL ENGINEERING OF JAPAN

Author: Watanabe, A; Ohara, A; Tajima, N

Year: 2002

Abstract: Implementation of polychlorinated biphenyls detoxification is being accelerated globally. We have developed an environmentally sound chemical polychlorinated biphenyls detoxification plant (codenamed: HM1), using the Ultraviolet ray (UV)/Catalyst Method. Safety analysis greatly facilitates communication on the subject of risk between the entity wishing to construct and operate the plant and the local residents. In the UV/Catalyst Method, PCB is mixed with sodium hydroxide (NaOH) and isopropyl alcohol (IPA: solvent) to realize PCB concentration in IPA of 1 wt% and subsequently PCB is dechlorinated by two independent process steps. The first step is the UV irradiating process (UV process), and the second step is the catalyst reaction process. As a result, biphenyl, NaOH, acetone, and water are generated after PCB is dechlorinated. A distilling column is designed in order to separate IPA from the solution, and IPA can be recycled many times as a solvent of PCB. IPA and acetone may form an inflammable mixture after leakage. Concerning HM1, first, hazardous events which produce severe accidents were identified by Failure Mode and Effect Analysis (FMEA); and secondly, leak of isopropyl alcohol (IPA), that causes fire/explosion, is defined as the most serious event. Based on this result, numerical safety analyses were carried out and the following findings were obtained. (.) Thermal runaway experiment of residual liquid in the bottom of a distilling column: It was confirmed experimentally that no possibility of thermal runaway exists. (.) Stress analysis of the distilling column after fire/explosion: The strength of the distilling column was proved. (.) Impact evaluation concerning the surrounding facilities and residents after fire/explosion: It was confirmed that impact would be slight. (.) Impact evaluation concerning exposure of residents to PCB: Exposure of residents to PCB would be negligibly small. (.) In conclusion, the standardized methodologies for both safety evaluations and procedures concerning PCB plants were proposed and their validity verified.


Title: Fuzzy assessment of FMEA for engine systems

Source: RELIABILITY ENGINEERING & SYSTEM SAFETY

Author: Xu, K; Tang, LC; Xie, M; Ho, SL; Zhu, ML

Year: 2002

Abstract: When performing failure mode and effects analysis (FMEA) for quality assurance and reliability improvement, interdependencies among various failure modes with uncertain and imprecise information are very difficult to be incorporated for failure analysis. Consequently, the validity of the results may be questionable. This paper presents a fuzzy-logic-based method for FMEA to address this issue. A platform for a fuzzy expert assessment is integrated with the proposed system to overcome the potential difficulty in sharing information among experts from various disciplines. The FMEA of diesel engine's turbocharger system is presented to illustrate the feasibility of such techniques. (C) 2002 Elsevier Science Ltd. All rights reserved.


Title: A methodology for architecture-level reliability risk analysis

Source: IEEE TRANSACTIONS ON SOFTWARE ENGINEERING

Author: Yacoub, SM; Ammar, HH

Year: 2002

Abstract: Risk assessment is an essential process of every software risk management plan, Several risk assessment techniques are based on the subjective judgement of domain experts. Subjective risk assessment techniques are human intensive and error-prone. Risk assessment should be based on product attributes that we can quantitatively measure using product metrics. This paper presents a methodology for reliability risk assessment at the early stages of the development lifecycle, namely, the architecture level. We describe a heuristic risk assessment methodology that is based on dynamic metrics. The methodology uses dynamic complexity and dynamic coupling metrics to define complexity factors for the architecture elements (components and connectors). Severity analysis is performed using Failure Mode and Effect Analysis (FMEA) as applied to architecture models. We combine severity and complexity factors to develop heuristic risk factors for the architecture components and connectors. Based on analysis scenarios, we develop a risk assessment model that represents components, connectors, component risk factors, connector risk factors, and probabilities of component interactions. We also develop a risk analysis algorithm that aggregates risk factors of components and connectors to the architectural level. Using the risk aggregation and the risk analysis model, we show how to analyze the overall risk factor of the architecture as the function of the risk factors of its constituting components and connectors. A case study of a pacemaker architecture is used to illustrate the application of the methodology. The methodology is used to identify critical components and connectors and to investigate the sensitivity of the architecture risk factor to changes in the heuristic risk factors of the architecture elements.


Title: The application of RODON to the FMEA of a microgravity facility subsystem

Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2002 PROCEEDINGS

Author: Zampino, EJ; Burow, D

Year: 2002

Abstract: In March of 2000, R.O.S.E. Informatik GmbH and the Risk Management Office of The NASA Glenn Research Center in Cleveland Ohio decided to collaborate on a pilot application of a computerized model-based reasoning tool called RODON. This collaboration resulted in a failure modes and effects analysis (FMEA) of the Fuel/Premixed-Fuel Supply Manifold: a subassembly intended to be part of the Fluid-Combustion Facility (FCF) which was planned for microgravity experiments on the International Space Station (ISS). Clarification of design details and component pressure-drop test data was provided by the design engineering team. The Fuel/Premixed-Fuel Supply Manifold was first analyzed by a reliability engineer using an analyst-dependent technique which "rests" primarily upon experience, knowledge, and imagination. The output of the RODON-generated FMEA was compared to the analyst-dependent FMEA. The analysis process utilizing RODON revealed errors from the analyst-dependent FMEA and also detected a laboratory test problem.


Title: Design, manufacture and test - Quality cost estimation.

Source: PROCEEDING OF THE 2002 3RD INTERNATIONAL SYMPOSIUM ON QUALITY ELECTRONIC DESIGN

Author: Gilbert, JM; Bell, IM; Johnson, DR

Year: 2002

Abstract: This paper describes the adaptation of the Conformability Analysis technique to the assessment of functional, manufacturing and test capability of PCB level electronic circuits. It combines process capability indices and Failure Modes and Effects Analysis (FMEA) with cost mapping to allow the quality costs associated with design and manufacture induced faults to be estimated and the effetiveness of test strategies in reducing these costs to be determined. It allows the trade-off between these costs and the component, manufacturing process and test costs to be explored. The technique is particularly applicable to the relatively low complexity analogue & mixed signal, safety critical circuits typically found in automotive and aircraft electronic systems.


Title: Design quality estimation for electronic circuits

Source: COMPUTER-BASED DESIGN

Author: Gilbert, JM; Johnson, DR; Bell, IM

Year: 2002

Abstract: The Conformability Analysis technique was developed as a tool for the analysis of mechanical designs and manufacturing processes. It combines process capability indices and Failure Modes and Effects Analysis (FMEA) with a cost mapping to allow the quality costs associated with a design and manufacturing process to be estimated. This paper describes the adaptation of this technique to allow the functional, manufacturing and test process capability of electronic circuits to be found. This has been augmented through the use of response surface modelling to allow both the overall quality costs and the contribution that individual components make to this cost to be estimated. The assessment of test capability allows the cost effectiveness of proposed test strategies in reducing quality costs to be determined. This unified approach to design, manufacture and test quality cost assessment provides the designer with vital insight when balancing quality costs with component, process and test costs.


Title: Use of reliability and risk analysis in project risk assessment

Source: PROBABILISTIC SAFETY ASSESSMENT AND MANAGEMENT, VOL I AND II, PROCEEDINGS

Author: Dykes, AA; Liming, JK; Olson, BK; Carlson, AB

Year: 2002

Abstract: This paper discusses techniques for using traditional risk and reliability methods to investigate potential bottlenecks produced by equipment failures and other off-normal events during batch transfer operations from an underground radioactive waste tank storage system. Process focused Failure Modes, Effects, and Criticality Analyses (FMECA), quantified by Reliability, Availability, and Maintainability (RAM) models tailored to address local operating conditions, are used to model and quantify the expected value of the frequency and duration of delays that can impact each phase of the preparation and execution of a waste batch transfer. These results are used in a Monte Carlo simulation to develop a realistic delivery time distribution so that the risk of vitrification plant processing outage due to lack of feed can be estimated. The FMECA results also provide critical items lists to assist in the improvement of waste feed delivery reliability.


Title: Failure mode and effect analysis for a passive system

Source: PROBABILISTIC SAFETY ASSESSMENT AND MANAGEMENT, VOL I AND II, PROCEEDINGS

Author: Burgazzi, L

Year: 2002

Abstract: The development of a methodology aimed at the reliability assessment of thermal-hydraulic passive safety systems entails, as initial step, a detailed system and safety analysis and Failure Mode and Effect Analysis (FMEA) approach has been chosen to perform the safety analysis at system level. The present study concerns Passive Systems designed for Decay Heat Removal relying upon natural circulation, which foresee, for the most part, a condenser immersed in a cooling pool. The main purposes of the work are: to identify important accident initiators, to find out the possible consequences on the plant deriving from component failures, individuate possible causes, identify mitigating features and systems and classify accident initiators in initiating events of accident sequences. A qualitative overview on accident sequences could be derived from the FMEA tables looking at consequences description and preventive/corrective actions. Moreover criticality analysis is applied (Failure Mode and Effect and Criticality Analysis) to include estimates of the loss frequencies, through failure probabilistic estimation, in order to point out the probabilities/frequencies to have the plant in fault and/or unavailability conditions during passive system operation, assuring therefore a complete set of initiating events of reactor accident sequences. Finally important feedback to the design activities will derive from the FMEA study performed for safety assessment purposes. An important lesson elicited from the analysis is that measures against Common Cause Failures can reduce significantly the probability of failure of the system.


Title: FMEA in preventing medical accidents

Source: ASQ'S 56TH ANNUAL QUALITY CONGRESS PROCEEDINGS

Author: Reiley, TT

Year: 2002

Abstract: A management system capable of fostering quality improvement in an organization such as a health-systems pharmacy must have a firm foundation. A firm foundation consists of consistent policies, procedures and processes and their documentation. An organization must understand how these activities are carried out in the present reality in order to improve them to create a new, improved future reality. ISO 9001:2000 provides guidance for the creation of a firm foundation of a high quality management system, itself capable of fostering quality improvement throughout the organization. One of the processes operating in healthcare delivery systems is that of medicating. Reducing medication errors is one of our nation's current hot topics and will require healthcare delivery systems to document and then improve those processes that allow such errors to occur. Medication errors or accidents represent a subset of adverse drug affects and account for more than 10% of medical errors. Humans have a propensity to commit errors; medication accidents occur when errors occur and latent system faults are present. Much has been written and reported on the causes of and most effective ways to prevent medication errors. Despite this wealth of research, medication errors continue to plague healthcare systems. Methods to error proof critical processes in ordering, preparing, dispensing and administrating medications have themselves been subject to error. Manufacturing, aerospace, chemical and other industries have been successful in error proofing their processes and creating workplace safety. A specific tool to achieve comprehensive and rapid improvement in safety in non-healthcare industries has been the application of Failure Modes and Effects Analysis, sometimes referred to as Failure Mode Effects and Criticality Analysis. This tool is commonly known as FMEA. FMEA examines all potential causes or modes of failure, of critical processes and of methods designed to prevent failure of those processes. Each mode is studied for potential effects. Three measures are made of each mode and effect: severity, ease of detection and rate of occurrence. The resulting Criticality Scores can be used to identify those modes most in need of further error proofing and, when tracked, serve as proxies of effectiveness of medication error prevention. FMEA provides health-system pharmacies an opportunity to apply and study a manufacturing industry tool in the prevention of medication errors.

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