Title: A conjoint study of quantitative and semi-quantitative assessment of failure in a strudel manufacturing plant by means of FMEA and HACCP, Cause and Effect and Pareto diagram
Source: INTERNATIONAL JOURNAL OF FOOD SCIENCE AND TECHNOLOGY
Author: Arvanitoyannis, IS; Varzakas, TH
Abstract: Failure Mode and Effect Analysis (FMEA) model was applied for the risk assessment of strudel manufacturing. A tentative approach of FMEA application to the strudel industry was attempted in order to identify the potential failures in the flow diagram and to compare them with the critical control points in the strudel processing. Preliminary Hazard Analysis was employed towards analysing and predicting the occurring failure modes in a food chain system (strudel processing plant), based on the functions, characteristics and/or interactions of the ingredients or the processes, upon which the system depends. Critical control points were identified and implemented in the Cause and Effect diagram (also known as Ishikawa, tree diagram and fishbone diagram) in order to reveal the underlying causes of failures. Finally, Pareto diagrams were employed in an attempt to optimise the detection potential of FMEA.
Title: Design process error proofing: Failure modes and effects analysis of the design process
Source: JOURNAL OF MECHANICAL DESIGN
Author: Chao, LP; Ishii, K
Abstract: This paper presents a new application of failure modes and effects analysis (FMEA) on design processes. Our research develops error-proofing methods for the product development process to prevent serious design errors that can compromise project features, time to market, or cost. Design process FMEA is a systematic method which allows product development teams to proactively predict potential problems. The method decomposes the design process into six potential problem areas-knowledge, analysis, communication, execution, change, and organization errors-with a question-based FMEA approach. The paper explains the method, illustrates it through a case study, and discusses its effectiveness. The paper concludes with the proposed work to address design process error-proofing solutions.
Title: Combining service blueprint and FMEA for service design
Source: SERVICE INDUSTRIES JOURNAL
Author: Chuang, PT
Abstract: This paper aims at combining the service blueprint and Failure Modes and Effects Analysis (FMEA) to assist service designers in designing a failure-free service system. In the proposed approach, a blueprint of a service system should be, first, developed to identify the potential fail points and failure modes for both front office and back office service activities. Based on the blueprint, the FMEA tool is then applied to prioritise the critical potential failure modes of the service system and take the required actions to ensure service design performance. An example of a hypermarket service system was used to demonstrate the proposed approach. The example not only identifies the most likely failure modes but also provides the effects and possible causes for each of the most critical failure modes. This implies that the actions to prevent these failures from occurring should be the main focus in the service design stage of the example company. Some managerial implications are also provided.
Title: Fuzzy inference to risk assessment on nuclear engineering systems
Source: APPLIED SOFT COMPUTING
Author: Guimaraes, ACF; Lapa, CMF
Abstract: This paper presents a nuclear case study, in which a fuzzy inference system (FIS) is used as alternative approach in risk analysis. The main objective of this study is to obtain an understanding of the aging process of an important nuclear power system and how it affects the overall plant safety. This approach uses the concept of a pure fuzzy logic system where the fuzzy rule base consists of a collection of fuzzy IF - THEN rules. The fuzzy inference engine uses these fuzzy IF - THEN rules to determine a mapping from fuzzy sets in the input universe of discourse to fuzzy sets in the output universe of discourse based on fuzzy logic principles. The risk priority number (RPN), a traditional analysis parameter, was calculated and compared to fuzzy risk priority number (FRPN) using scores from expert opinion to probabilities of occurrence, severity and not detection. A standard four-loop pressurized water reactor (PWR) containment cooling system (CCS) was used as example case. The results demonstrated the potential of the inference system for subsiding the failure modes and effects analysis (FMEA) in aging studies. (C) 2005 Elsevier B.V. All rights reserved.
Title: A UML based system level failure rate assessment technique for SoC designs
Source: 25th IEEE VLSI Test Symposium, Proceedings
Author: Hosseinabady, M; Neishaburi, MH; Lotfi-Kamran, P; Navabi, Z
Abstract: This paper proposes an analytical method to assess soft-error rate (SER) in the early stages of a System-on-Chip (SoC) platform-based design methodology. The proposed method uses an executable UML model of the SoC for its input. Soft-errors on the design are modeled by disturbances on the value of attributes in the classes of the UML model and disturbances on opcodes of software cores. SER and execution time of each core in the SoC and a Failure Modes and Effects Analysis (FMEA) that determines the severity of each failure mode in the SoC are used to compute the System-Failure Rate (SFR) of the SoC.
Title: Using root cause data analysis for requirements and knowledge elicitation
Source: Engineering Psychology and Cognitive Ergonomics, Proceedings
Author: Jin, ZX; Hajdukiewicz, J; Ho, G; Chan, D; Kow, YM
Abstract: The purpose of this paper is to present a technique, called Knowledge FMEA, for distilling textual raw data which is useful for requirements collection and knowledge elicitation. The authors first give some insights into the diverse characteristics of textual raw data which can lead to higher complexity in analysis and may result in some gaps in interpreting the interviewees' world view. We then outline a Knowledge FMEA procedure as it applies to qualitative data and its key benefits. Examples from a case study are presented to illustrate how to use the technique. Proposed Knowledge FMEA brings many advantages such as forcing the analysts to become deeply immersed in the raw data, identifying how the information is connected in causation, classifying the data according to why, what, how formulations and quantifying the findings for further quantitative analysis.
Title: Using fuzzy self-organising maps for safety critical systems
Source: RELIABILITY ENGINEERING & SYSTEM SAFETY
Author: Kurd, Z; Kelly, TP
Abstract: This paper defines a type of constrained artificial neural network (ANN) that enables analytical certification arguments whilst retaining valuable performance characteristics. Previous work has defined a safety lifecycle for ANNs without detailing a specific neural model. Building on this previous work, the underpinning of the devised model is based upon an existing neuro-fuzzy system called the fuzzy self-organising map (FSOM). The FSOM is type of 'hybrid' ANN which allows behaviour to be described qualitatively and quantitatively using meaningful expressions. Safety of the FSOM is argued through adherence to safety requirements-derived from hazard analysis and expressed using safety constraints. The approach enables the construction of compelling (product-based) arguments for mitigation of potential failure modes associated with the FSOM. The constrained FSOM has been termed a 'safety critical artificial neural network' (SCANN). The SCANN can be used for non-linear function approximation and allows certified learning and generalisation for high criticality roles. A discussion of benefits for real-world applications is also presented. (c) 2006 Elsevier Ltd. All rights reserved.
Title: Decreasing the risk of chemotherapy errors through a failure modes and effects analysis (FMEA) and a focus PDCA (plan, do, check, act) quality improvement model.
Source: ONCOLOGY NURSING FORUM
Author: Roesser, K
Title: FM - a pragmatic tool to model, pragmatic tool analyse and predict complex behaviour of industrial systems
Source: ENGINEERING COMPUTATIONS
Author: Sharma, RK; Kumar, D; Kumar, P
Abstract: Purpose -This paper aims to permit the system reliability analysts/managers/practitioners/ engineers to analyze the system failure behavior using fuzzy methodology (FM) Design/methodology/approach - In order to deal with both qualitative and quantitative information related to system performance the authors have adopted failure mode effect analysis (FMEA) and Petrinets (PNs), the well-known tools for reliability analysis, to build an integrated framework aimed at helping the reliability and maintenance managers in decision-making. Findings - Using the proposed framework an industrial case from the paper mill is examined. From the results it is observed that the limitations associated with the traditional procedure of risk ranking in FMEA are efficiently modeled using fuzzy decision-making system (FDMS) based on FM. Also, the fuzzy synthesis of system failure and repair data helps to quantify the system behavior in a more realistic manner. Originality/value - The simultaneous adoption of the proposed techniques to model, analyze and predict the uncertain behavior of an industrial system will not only help the reliability engineers/managers/practitioners to understand the behavioral dynamics of system but also to plan/adapt suitable maintenance practices to improve system reliability, availability and maintainability (RAM) aspects.
Title: Using risk analysis in process validation
Source: BIOPHARM INTERNATIONAL
Author: Sidor, L; Lewus, P
Abstract: Process validation is used to confirm that the resulting product from a specified process consistently conforms to product requirements. A risk-based approach to process validation provides a rational framework for developing an appropriate scope for validation activities, focusing on processes that have the greatest potential risk to product quality. This article presents a case study in which a risk-based approach was used to evaluate a typical mammalian cell culture and purification process. This risk assessment used a Failure Modes and Effects Analysis (FMEA) to evaluate the impact of potential failures and the likelihood of their occurrence for each unit operation. Unit operations included in the process validation required a risk priority number greater than or equal to a specified threshold value. Unit operations that fell below the threshold were evaluated for secondary criteria such as regulatory expectations or historical commitments. The risk assessment covered the entire process and a portion of the assessment is reviewed here.
Title: Chemotherapy induced neutropenia and relative dose intensity: An evidence based practice project.
Source: ONCOLOGY NURSING FORUM
Author: Vannice, S; Garcia, J; Sweeney, M; Dingley, C; Derieg, M; Trabert, T
Title: Application of failure mode and effect analysis (FMEA), cause and effect analysis, and pareto diagram in conjunction with HACCP to a corn curl manufacturing plant
Source: CRITICAL REVIEWS IN FOOD SCIENCE AND NUTRITION
Author: Varzakas, TH; Arvanitoyannis, IS
Abstract: The Failure Mode and Effect Analysis (FMEA) model has been applied for the risk assessment of corn curl manufacturing. A tentative approach of FMEA application to the snacks industry was attempted in an effort to exclude the presence of GMOs in the final product. This is of crucial importance both from the ethics and the legislation (Regulations EC 1829/2003; EC 1830/2003; Directive EC 18/2001) point of view. The Preliminary Hazard Analysis and the Fault Tree Analysis were used to analyze and predict the occurring failure modes in a food chain system (corn curls processing plant), based on the functions, characteristics, and/or interactions of the ingredients or the processes, upon which the system depends. Critical Control points have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram, and the fishbone diagram). Finally, Pareto diagrams were employed towards the optimization of GMOs detection potential of FMEA.
Title: The changing role of physical testing in vehicle development programmes
Source: JOURNAL OF TERRAMECHANICS
Author: Wilkinson, P
Abstract: The role of physical testing in product development is changing due to the requirements for faster new product development, reduced tolerance of failures in the field and the emergence of computer aided engineering (CAE) technologies. To be used most effectively, testing must be seen as an integral part of the process for reducing risks associated with new product introductions. Quality function deployment (QFD) and failure modes and effects analysis (FMEA) can be used to establish effective test and development plans that integrate the use of virtual and physical testing. By effectively integrating virtual and physical test technologies significant improvements in product performance can be achieved within shorter times and with reduced development and manufacturing costs. The approach was illustrated by a process of reducing in-cab noise during the design of a new truck. (c) 2006 Published by Elsevier Ltd on behalf of ISTVS.
Title: Using a modified failure modes and effects analysis within the structured design recovery framework
Source: FUTURE OF PRODUCT DEVELOPMENT
Author: Urbanic, RJ; ElMaraghy, WH
Abstract: A structured design recovery framework has been designed to meet the challenges associated with creating a robust engineering model for mechanical components. To assist with the testing and verification phase of the design recovery process, a matrix based modified failure modes and effects analysis (FMEA) has been developed, which targets tolerance variations, in order to diagnose potential problems. The information within the design recovery framework is extracted for the modified FMEA analysis. From the FMEA results, testing strategies are suggested based on the component characteristics. An example illustrates the modified FMEA methodology and highlights its merits.
Title: System reliability analysis GO methodology and research on the application
Source: PROCEEDINGS OF THE 2ND INTERNATIONAL CONFERENCE ON RELIABILITY OF ELECTRICAL PRODUCTS AND ELECTRICAL CONTACTS
Author: Wang, SJ; Sun, K; Kang, L; Zhai, GF
Abstract: GO Methodology is a system-reliability-analysis method which is oriented towards success. This article gives a comprehensive comparison between the GO, FTA (Fault Tree Analysis) and FMEA (Failure Modes and Effects Analysis) methods in modeling and applications. Then, we gave an introduction of the basic principles of the GO Methodology and demonstrate the reliability analysis process of the GO Methodology by a concrete example. Finally, the research indicates that the GO Methodology has unique advantages in the analysis of multi-state, time-sequence and flowing systems.
Title: A systematic approach for failure modes and effects analysis of System-On-Chips
Source: 13TH IEEE INTERNATIONAL ON-LINE TESTING SYMPOSIUM PROCEEDINGS
Author: Mariani, R; Boschi, G
Abstract: This paper proposes a method to perform Failure Mode and Effects Analysis (FMEA) on System-On-Chips(SoC). An automatic tool extracts information from the So C description and uses them to estimate the intrinsic criticality of invariant and elementary "sensitive zones" and to compute metrics such failure rates, safe failures fraction and diagnostic coverage. A validation flow based on fault injection and fault simulation is included to cross check the FMEA.
Title: Analysis of system-failure rate caused by soft-errors using a UML-based systematic methodology in an SoC
Source: 13TH IEEE INTERNATIONAL ON-LINE TESTING SYMPOSIUM PROCEEDINGS
Author: Hosseinabady, M; Neishaburi, MH; Navabi, Z; Benso, A; Di Carlo, S; Prinetto, P; Di Natale, G
Abstract: This paper proposes an analytical method to assess the soft-error rate (SER) in the early stages of a System-on-Chip (SoC) platform-based design methodology. The proposed method gets an executable UML (Unified Modeling Language) model of the SoC and the raw soft-error rate of different parts of the platform as its inputs. Soft-errors on the design are modeled by disturbances on the value of attributes in the classes of the UML model and disturbances on opcodes of software cores. The Dynamic behavior of each core is used to determine the propagation probability of each variable disturbance to the core outputs. Furthermore, the SER and the execution time of each core in the SoC and a Failure Modes and Effects Analysis (FMEA) that determines the severity of each failure mode in the SoC are used to compute the System-Failure Rate (SFR) of the Soc.
Title: Failure evaluation and the establishment of an improvement model for product data management introduced to enterprises
Source: INTERNATIONAL JOURNAL OF ADVANCED MANUFACTURING TECHNOLOGY
Author: Chen, SC; Huang, JM; Yang, CC; Lin, WT; Chen, RJ
Abstract: The efficient control of correct and consistent production information is becoming increasingly difficult due to keener global competition and shortening product life cycles. Total e-business is a solution to the urgent requirement for management and organization changes. Product data management (PDM) is an excellent strategy to introduce e-process and personnel reorganization. However, the performance of introducing the PDM system is usually unsatisfying, due to the impact upon personnel and the product flow. An approach of assessing personnel organization and process failure is proposed in this research in order to locate the factors and reasons that cause a failure for a critical decision reference of enterprises planning for the PDM structure and the product flow. A traditional enterprise that introduced the PDM system was taken as an example in this article to explain the application of the failure mode and effects analysis (FMEA) and quality function deployment (QFD) for an efficient introduction of the PDM system.
Title: Application of failure mode and effect analysis and cause and effect analysis and Pareto diagram in conjunction with HACCP to a chocolate-producing industry: A case study of tentative GMO detection at pilot plant scale
Source: INTERNATIONAL JOURNAL OF FOOD SCIENCE AND TECHNOLOGY
Author: Arvanitoyannis, IS; Savelides, SC
Abstract: Although the application of hazard analysis critical control point in the food industry dates back to the 1970s, a more quantitative and reliable approach towards risk assessment became feasible through application of failure mode and effect analysis (FMEA) model. A tentative approach of FMEA application to a filled chocolate-producing industry was attempted in an effort to exclude the presence of genetically modified organisms (GMOs) in the final product. This is of crucial importance both from the moral (ethics) and the legislation (EC 1829/2003; EC 1830/2003; EC 18/2001) point of view. Two structured methods (preliminary hazard analysis and fault tree analysis) were used to analyse and predict the occurring failure modes in food chain system, based on the functions, characteristics and/or interactions of the ingredients or the processes, upon which the system depends. Cause and effect diagram (also known as Ishikawa, tree diagram and fishbone diagram) and Pareto diagram emerged as two very useful and effective tools towards optimising the GMO detection potential of FMEA.
Title: Statistical tools for quality diagnosis: A case study in the meat product industry
Author: Maldonado, R; Graziani, L
Abstract: Diagnosis is a methodological management strategy used to solve tolerance problems and to identify the causes of deviations or defects. Some quality tools (histograms, Ishikawa diagrams, Pareto diagrams, maintenance failure mode effects analysis; FMEA) were applied as a diagnostic strategy at a canned meat enterprise (CME) with net weight problems. The results showed that an average of 75% of the biggest quality problems due to internal defects are caused by low weight, equivalent to a 0.55% defective production with regard to the total production. Of the observations made, 58% were outside specifications; which leads to a real capacity process of 0.004. The low weight problems in a CME are caused in an 80% by the following problems: time-temperature ratio of the mixture, vapor amount, floor plan of the work place, velocity (rpm) and design of the mixing blades, and vapor quality. The most critical components and processes are: time-temperature ratio of the mixture, high and low velocity and design of the mixing blades, vapor control valves and calibration of the heating equipment in the control of the mixing machines; these represent 80% of the fault modes. The quality control system of a CME should include an improvement program based on reduction of the inherent process variability by 83%, displacing the population mean to the left by 98%.
Title: Robustness analysis using FMEA and BBN - Case study for a web-based application
Source: WEBIST 2007: PROCEEDINGS OF THE THIRD INTERNATIONAL CONFERENCE ON WEB INFORMATION SYSTEMS AND TECHNOLOGIES, VOL IT
Author: Calori, LC; Stalhane, T; Ziemer, S
Abstract: Time pressure and quality issues represent important challenges for those who develop web-based systems. The ability to analyze a system's quality and implement improvements early in the development life cycle is of great practical important. For our study we have considered robustness as a critical quality issue. Our objective is to propose a general framework for conducting robustness analysis of web-based systems at an early stage of software development, providing a tool for evaluating failure impact severity and supporting trade-off decisions during the development process. The framework makes use of Jacobson's analysis method to decompose a system in its functional components, Failure Modes and Effects Analysis to identify all failure modes that characterize each component, and Bayesian Belief networks to deal with failure cause-effect relationships and evaluate the uncertainty of their impact.
Title: Electronic prognostics - A case study using global positioning system (GPS)
Source: MICROELECTRONICS RELIABILITY
Author: Brown, DW; Kalgren, PW; Byington, CS; Roemer, MJ
Abstract: Prognostic health management (PHM) of electronic systems presents challenges traditionally viewed as either insurmountable or otherwise not worth the cost of pursuit. Recent changes in weapons platform acquisition and support requirements have spurred renewed interest in electronics PHM, revealing possible applications, accessible data sources, and previously unexplored predictive techniques. The approach, development, and validation of electronic prognostics for a radio frequency (RF) system are discussed in this paper. Conventional PHM concepts are refined to develop a three-tier failure mode and effects analysis (FMEA). The proposed method identifies prognostic features by performing device, circuit, and system-level modeling. Accelerated failure testing validates the identified prognostic features. The results of the accelerated failure tests accurately predict the remaining useful life of a commercial off the shelf (COTS) GPS receiver to within +/- 5 thermal cycles. The solution has applicability to a broad class of mixed digital/analog circuitry, including radar and software defined radio. (c) 2007 Published by Elsevier Ltd.
Title: A language for functional interpretation of model based simulation
Source: ADVANCED ENGINEERING INFORMATICS
Author: Bell, J; Snooke, N; Price, C
Abstract: Functional modelling has been in use for a number of years for the interpretation of the results of model based simulation of engineered systems. Its use enables the automatic generation of a textual design analysis report that interprets the results of qualitative (or numerical) simulation in terms of the system's purpose. We present a novel functional description language that increases the expressiveness of this approach, increasing the range both of systems and design analysis tasks for which the approach can be used. The language also allows closer integration of functional modelling into the design process. The language allows a device function to be decomposed either in terms of subsidiary functions or required effects. We discuss the use of such alternative decompositions and propose a logic of functional description that is used to underpin the proposed language. The language has been used in the interpretation of electromechanical, hydraulic and fluid transfer systems in the automotive and aerospace industries to support Failure Modes and Effects Analysis, Sneak Circuit Analysis, and Diagnosis design analysis tasks. The language is not inherently restricted to these applications and the paper makes use of indicative examples from other domains. (c) 2007 Elsevier Ltd. All rights reserved.
Title: Extending failure modes and effects analysis approach for reliability analysis at the software architecture design level
Source: Architecting Dependable Systems IV
Author: Sozer, H; Tekinerdogan, B; Aksit, M
Abstract: Several reliability engineering approaches have been proposed to identify and recover from failures. A well-known and mature approach is the Failure Mode and Effect Analysis (FMEA) method that is usually utilized together with Fault Tree Analysis (FIFA) to analyze and diagnose the causes of failures. Unfortunately, both approaches seem to have primarily focused on failures of hardware components and less on software components. Moreover, for utilizing FMEA and FTA very often an existing implementation of the system is required to perform the reliability analysis. We propose extensions to FMEA and FTA to utilize them for the reliability analysis of software at the architecture design level. We present the software architecture reliability analysis approach (SARAH) that incorporates the extended FMEA and FTA. The approach is illustrated using an industrial case for analyzing reliability of the software architecture of a Digital TV.
Title: Probabilistic model-checking support for FMEA
Source: FOURTH INTERNATIONAL CONFERENCE ON THE QUANTITATIVE EVALUATION OF SYSTEMS
Author: Grunske, L; Colvin, R; Winter, K
Abstract: Failure Mode and Effect Analysis (FMEA) is a method for assessing cause-consequence relations between component faults and hazards that may occur during the lifetime of a system. The analysis is typically time intensive and informal, and for this reason FMEA has been extended with traditional model checking support. Such support does not take into account the probabilities associated with a component fault occurring, yet such information is crucial to developing hazard reduction strategies for a system. In this paper we propose a method for FMEA which makes use of probabilistic fault injection and probabilistic model checking. Based on this approach safety engineers are able to formally identify if a failure mode occurs with a probability higher than its tolerable hazard rate.
Title: Probabilistic reliability modeling for oil exploration & production (E&P) facilities in the tallgrass prairie preserve
Source: RISK ANALYSIS
Author: Zambrano, L; Sublette, K; Duncan, K; Thoma, G
Abstract: The aging domestic oil production infrastructure represents a high risk to the environment because of the type of fluids being handled (oil and brine) and the potential for accidental release of these fluids into sensitive ecosystems. Currently, there is not a quantitative risk model directly applicable to onshore oil exploration and production (E&P) facilities. We report on a probabilistic reliability model created for onshore exploration and production (E&P) facilities. Reliability theory, failure modes and effects analysis (FMEA), and event trees were used to develop the model estimates of the failure probability of typical oil production equipment. Monte Carlo simulation was used to translate uncertainty in input parameter values to uncertainty in the model output. The predicted failure rates were calibrated to available failure rate information by adjusting probability density function parameters used as random variates in the Monte Carlo simulations. The mean and standard deviation of normal variate distributions from which the Weibull distribution characteristic life was chosen were used as adjustable parameters in the model calibration. The model was applied to oil production leases in the Tallgrass Prairie Preserve, Oklahoma. We present the estimated failure probability due to the combination of the most significant failure modes associated with each type of equipment (pumps, tanks, and pipes). The results show that the estimated probability of failure for tanks is about the same as that for pipes, but that pumps have much lower failure probability. The model can provide necessary equipment reliability information for proactive risk management at the lease level by providing quantitative information to base allocation of maintenance resources to high-risk equipment that will minimize both lost production and ecosystem damage.
Title: Application of failure mode and effect analysis (FMEA), cause and effect analysis and Pareto diagram in conjunction with HACCP to a potato chips manufacturing plant
Source: INTERNATIONAL JOURNAL OF FOOD SCIENCE AND TECHNOLOGY
Author: Arvanitoyannis, IS; Varzakas, TH
Abstract: Failure mode and effect analysis (FMEA) model has been applied for the risk assessment of potato chips manufacturing. A tentative approach of FMEA application to the snacks industry was attempted in order to analyse the critical control points (CCPs) in the processing of potato chips. Preliminary hazard analysis was used to analyse and predict the occurring failure modes in a food chain system (potato processing and potato chips processing plant), based on the functions, characteristics and/or interactions of the ingredients or the processes, upon which the system depends. CCPs have been identified and implemented in the cause and effect diagram (also known as Ishikawa, tree diagram and fishbone diagram). Finally, Pareto diagrams were employed towards the optimisation potential of FMEA.
Title: Patient safety: An ergonomics study of innovative design in pharmaceutical packaging
Source: CONTEMPORARY ERGONOMICS 2007
Author: Buckle, P; Anderson, J; Ward, J; Jeffcott, S; Snadden, C; Gleeson, A; Lim, R; Wadsworth, P
Abstract: Packaging of medication is an area of concern with respect to medication error. This study sought to evaluate how the design might influence errors across the current medication distribution system. This was defined as the warehouse, pharmacy and patient domains. Observations, interviews and proactive risk assessment, in the form of Failure Modes and Effect Analysis or FMEA, were performed on key processes and tasks at warehouses (n = 2), pharmacies (n = 12) and with patients (n = 27). A new packaging design by Almus Pharmaceuticals appeared to carry substantial benefits in all three domains, with the greatest benefits found in the pharmacy. The systems approach undertaken throughout the project has provided further insights and opportunities for improvement of medication provision.
Title: Modeling and assessing the dependability of wireless sensor networks
Source: SRDS 2007: 26TH IEEE INTERNATIONAL SYMPOSIUM ON RELIABLE DISTRIBUTED SYSTEMS, PROCEEDINGS
Author: Cinque, M; Cotroneo, D; Di Martinio, C; Russo, S
Abstract: This paper proposes a flexible framework for dependability modeling and assessing of Wireless Sensor Networks (WSNs). The framework takes into account network related aspects (topology, routing, network traffic) as well as hardware/software characteristics of nodes (type of sensors, running applications, power consumption). It is composed of two basic elements: i) a parametric Stochastic Activity Networks (SAN) failure model, reproducing WSN failure behavior as inferred from a detailed Failure Mode Effect Analysis (FMEA), and ii) an external library reproducing network behavior on behalf of the SAN model. This library specializes the SAN model by feeding it with quantitative parameters obtained by simulation or by experimental campaigns; it is also in charge of updating the network state in response to failure events during the simulation (e.g., routing tree updated due to node failures). The framework is thus suited to evaluate the dependability of several WSNs, with different topologies, routing algorithms, hardware/software platforms, without requiring any changes to its structure. The use of the external library makes the model simpler decoupling the network behavior from the failure behavior Simulation experiments are discussed that provide a quantitative evaluation of WSN dependability for a sample scenario: results show how the proposed framework supports WSN developers to find proper cost-reliability trade-offs for the system being deployed.
Title: Analysis of a SAE AS5643 Mil-1394b based high-speed avionics network architecture for space and defense applications
Source: 2007 IEEE AEROSPACE CONFERENCE, VOLS 1-9
Author: Bai, HW
Abstract: To satisfy the increasing needs of more information transmission among subsystems, and to minimize the latency of data transmission between high-speed processors, the avionics interconnection in future aerospace vehicles is required to provide high bandwidth data path. IEEE 1394 was designed as a high speed (up to 3.2 Gbps) data bus for consumer electronics. The Lockheed Martin's Joint Strike Fighter (JSF) program was the first significant implementation of IEEE 1394b for aerospace vehicles. Its approach has been standardized by SAE AS5643. This article is to explain the standard in details and provide insights into it, using failure modes and effects analysis (FMEA) tools. The analysis results and recommendations could be used for ongoing and future aerospace vehicle programs such as NASA Orion crew exploration vehicle.
Title: Research on a method for analyzing and predicting the life of gyro based on acoustic signal processing
Source: ISTM/2007: 7TH INTERNATIONAL SYMPOSIUM ON TEST AND MEASUREMENT, VOLS 1-7, CONFERENCE PROCEEDINGS
Author: Wei, Z; Hu, B; Zha, F; Wang, TT
Abstract: As an important part of float-type gyroscope used in stabilized compass, the gyro motor aerodynamic bearing is recognized as the life bottleneck according to the Failure Modes, Effects and Criticality Analysis (FMEA). Considering the failure mechanism and running characteristics of the aerodynamic bearing, a method of life prediction based on gyro acoustic signal testing and processing was presented in the paper The signal was collected by data acquisition system. De-noised by wavelet transform, the acoustic signal was separated from the original low SNR collected signal. The reprocessing procedure was accomplished by wavelet package decomposition. The typical signal token, which reflect performance of the aerodynamic bearing, was recognized as the "life off speed" and disturbance in the starting and even running stage separately, and they were found to be apparent in the wavelet package coefficients. So the performance and life of the gyroscopes were properly predicted.
Title: Modeling system behavior for risk and reliability analysis using KBARM
Source: QUALITY AND RELIABILITY ENGINEERING INTERNATIONAL
Author: Sharma, RK; Kumar, D; Kumar, P
Abstract: With advances in technology and the growing complexity of technological systems, the job of the reliability/system analyst has become more challenging as they have to study, characterize, measure and analyze the behavior of systems with the help of various traditional analytical (mathematical and statistical) techniques, which require knowledge of the precise numerical probabilities and component functional dependencies, information which is difficult to obtain. Even if data are available they are often inaccurate and are thus subject to uncertainty, i.e. historical records can only represent the past behavior and may be unable to predict the future behavior of the equipment. To cope with such situations, the knowledge-based approximate reasoning methodologies (KBARMs) provide necessary help. Among them, the fuzzy and grey methodologies are the most viable and effective tools for coping with imprecise, uncertain and subjective information in a consistent and logical manner. In this paper, the authors present a methodological and structured approach (which makes use of both qualitative and quantitative techniques) to model, analyze and predict the failure behavior of two units, namely the forming and press units of a paper machine, using KBARMs. Various system parameters such as repair time, failure rate, mean time between failures, availability and expected number of failures are computed to quantify the system behavior in terms of fuzzy, crisp and defuzzified values. Furthermore, a risk ranking approach based on fuzzy and grey relational analysis is discussed to prioritize various failure causes associated with the components in failure mode and effects analysis (FMEA). Copyright (C) 2007 John Wiley & Sons, Ltd.
Title: A comparison of two approaches to safety analysis based on use cases
Source: CONCEPTUAL MODELING - ER 2007, PROCEEDINGS
Author: Stalhane, T; Sindre, G
Abstract: Engineering has a long tradition in analyzing the safety of mechanical, electrical and electronic systems. Important methods like HazOp and FMEA have also been adopted by the software engineering community. The misuse case method, on the other hand, has been developed by the software community as an alternative to FMEA and preliminary HazOp for software development. To compare the two methods misuse case and FMEA we have run a small experiment involving 42 third year software engineering students. In the experiment, the students should identify and analyze failure modes from one of the use cases for a commercial electronic patient journals system. The results of the experiment show that on the average, the group that used misuse cases identified and analyzed more user related failure modes than the persons using FMEA. In addition, the persons who used the misuse cases scored better on perceived ease of use and intention to use.
Title: Life prediction and reliability assessment of lithium secondary batteries
Source: JOURNAL OF POWER SOURCES
Author: Eom, SW; Kim, MK; Kim, IJ; Moon, SI; Sun, YK; Kim, HS
Abstract: Reliability assessment of lithium secondary batteries was mainly considered. Shape parameter (beta) and scale parameter (eta) were calculated from experimental data based on cycle life test. We also examined safety characteristics of lithium secondary batteries. As proposed by IEC 62133 (2002), we had performed all of the safety/abuse tests such as 'mechanical abuse tests', 'environmental abuse tests', 'electrical abuse tests'. This paper describes the cycle life of lithium secondary batteries, FMEA (failure modes and effects analysis) and the safety/abuse tests we had performed. (c) 2007 Elsevier B.V. All rights reserved.
Title: Optimisation of networked control systems using model-based safety analysis techniques
Source: 2007 IEEE INTERNATIONAL CONFERENCE ON NETWORKING, SENSING, AND CONTROL, VOLS 1 AND 2
Author: Parker, DJ; Papadopoulos, YI
Abstract: We propose a novel approach to the optimization of networked embedded safety critical systems in which Genetic Algorithms are used to find optimal tradeoffs among safety, reliability and cost in the design of such systems. The aim is to automatically evolve initial designs that do not necessarily meet dependability requirements to designs that fulfil such requirements with minimal costs. The approach departs from earlier work in that the safety and reliability model (i.e. a set of system fault trees) is automatically synthesised from an engineering model of the system. It also moves beyond the classical '' success-failure '' model by introducing a failure scheme in which components can exhibit more that one failure modes which include the loss but also the commission of functions as well as value and timing failures. We discuss the approach, and compare the performance of two implementations, based on two different Genetic Algorithms, which have been applied on a set of well known benchmark examples.
Title: Preliminary Probabilistic safety assessment of chinese dual-functional lithium lead-test blanket module for ITER
Source: 22ND IEEE/NPSS SYMPOSIUM ON FUSION ENGINEERING
Author: Hu, L; Wu, Y; Wang, J; Wang, S; FDS Team
Abstract: A Dual Functional Lithium Lead (DFLL) Test Blanket Module (TBM) concept for testing in International Thermonuclear Experimental Reactor (ITER) has been proposed. The safety assessment of DFL-TBM has been carried out applying the Probabilistic Safety Assessment (PSA) approach. The accident sequences have been modeled and quantified through the event tree technique, which allows identifying all possible combinations of success or failure of the safety systems in responding to a selection of initiating events. The identification of Potential Initiator Events is provided by the Failure Mode and Effect Analysis (FMEA) procedure. The outcome of the analysis shows that DFLL-TBM is quite safe and presents no significant hazard to the environment. In addition, a sensitivity analysis of safety systems has been performed.
Title: The maintenance model for the items with compound failure modes
Source: RISK, RELIABILITY AND SOCIETAL SAFETY, VOLS 1-3
Author: Cheng, ZH; Wu, S; Wang, JZ; Zhang, ZW; Bian, JL; Gao, Q
Abstract: Based on failure mode effect analysis (FMEA) of hydraulic system of a certain production plant, this paper finds that main cause of hydraulic system failure is failure mode of wearing and cracking of counter-recoil rod. According to failure mode of wearing, states of counter-recoil rod may be identified as three kinds: normal, potential failure and function failure. According to failure mode of cracking, states of counter-recoil rod may be identified as two kinds: normal and function failure. Under maintenance cost and failure risk are both considered, how to get optimal inspection interval for the counter-recoil rod has become an imperative issue for operators and managements of plant. The paper, by abstracting the practical problems and applying stochastic process methods, develops maintenance model (cost model and failure risk model) for the items with compound failure modes to calculate the risks and costs associated with an inspection strategy. At the same time, procedure and methods for modeling are also presented. Finally, by way of numerical example, the relations between maintenance cost and failure risk of the item are discussed, and optimal inspection interval is determined. According to the optimal inspection interval, failure risk of item can be controlled and maintenance cost can be saved. The model and method in this paper may be directly applied to solving homologous problems.
Title: Validation of similar systems based on FMEA assessment
Source: RISK, RELIABILITY AND SOCIETAL SAFETY, VOLS 1-3
Author: Pickard, K; Leopold, T; Dieter, A; Bertsche, B
Abstract: In today's developments it is important to know the future failure behaviour of the products as soon as possible. In many cases this kind of prediction is not possible and therefore there is a need for at least a qualitative option for a concept comparison, based on which an estimation in regards to the potential failure behaviour or ratio the newly developed product has to the former one. Therefore, a new approach will be shown with which such a consideration will be enabled. This comparison procedure will use already existing data and, although the method is based on FMEA assessment values, the new approach will not use the classic RPN classification, because these classifications cannot be used for such kind of predictions or considerations. For the improvement of its usage, the integration of a so called confidence level will be shown. The procedure and the generation of the confidence level, and in particular the two possible options will be shown with an example and discussed in detail.
Title: FMEA and BBN for robustness analysis in web-based applications
Source: RISK, RELIABILITY AND SOCIETAL SAFETY, VOLS 1-3
Author: Calori, IC; Stalhane, T
Abstract: In this paper we present a general framework for conducting robustness analysis early in the development life cycle of web-based systems. This framework exploits the robustness failure modes and evaluates the impact of modifications that can be applied to reduce the severity of these failures. First, the system is systematically decomposed in its components using Jacobson's analysis. Next, with Failure Modes and Effects Analysis (FMEA) we identify all failure modes, causes and effects. Finally, by using Bayesian Belief Networks (BBNs) we model each subsystem and evaluate failure severities and possible improvements. A more complex model of the system can also be built up by integrating the subsystem models, giving a better understanding of the overall system behavior. We present a practical example and we discuss the benefits of applying this framework and BBN models to analyze the robustness of web-based systems.
Title: Formal support for failure knowledge modeling and diagnostic reasoning using polychromatic sets
Source: 2007 5TH IEEE INTERNATIONAL CONFERENCE ON INDUSTRIAL INFORMATICS, VOLS 1-3
Author: Li, G; Gao, JM; Chen, FM
Abstract: Failure modes and effects analysis (FMEA) is a traditional safety analysis method that has a worldwide recognition across many industries. However, there are documented limitations to the technique, which make it difficult for direct conversion to the diagnosis models. This paper aims to contribute to the reuse of FMEA knowledge through a novel knowledge modeling approach. Taking the structure model into consideration, we define the failure modes as the inherent component properties at different hierarchical levels and propose a formal failure knowledge representation model based on the polychromatic sets theory. It is a structured modeling technique for representing FMEA causal knowledge in unified mathematical language, which in turn provides the framework for organizing the failure modes, the causes and effects more systematically and completely. Using the iterative search process operated on the reasoning matrices, the diagnosis reasoning for more than one top-level failure event can be realized automatically. The research shows this new approach has formed mathematical foundation which can make significant progress in FNMA knowledge formalization.
Title: A decision support system for predicting the reliability of a robotic dispensing system
Source: ICEIS 2007: PROCEEDINGS OF THE NINTH INTERNATIONAL CONFERENCE ON ENTERPRISE INFORMATION SYSTEMS
Author: Sturek, J; Ramakrishnan, S; Nagula, P; Srihari, K
Abstract: Decision Support Systems (DSS) are information systems designed to support individual and collective decision-making. This research presents the development of a DSS to facilitate the prediction of the reliability of a Robotic Dispensing System (RDS). While it is extremely critical for design teams to identify the potential defects in the product before releasing them to the customers, predicting reliability is extremely difficult due to the absence of actual failure data. Design teams often adopt tools such as Failure Mode Effects and Analysis (FMEA) to analyze the various failure modes in the product. There are commercial softwares that facilitate predicting reliability and conducting FMEA. However, there are limited approaches that combine these two critical aspects of product design. The objective of this research is to develop a DSS that would help design teams track the overall system reliability, while concurrently using the data from the alpha testing phase to perform the FMEA. Hence, this DSS is capable of calculating the age-specific reliability value for a Robotic Dispensing System (RDS), in addition to storing the defect information, for the FMEA process. The Risk Priority Number (RPN) calculated using the data gathered serves as the basis for the design team to identify the modifications to the product design. The tool, developed in Microsoft Access(R), would be subsequently utilized to track on-field performance of the RDS. This would facilitate continuous monitoring of the RDS from the customer site, especially during its "infant mortality" period.
Title: Hazard analysis of EUCLIDIAN: An image-guided robotic brachytherapy system
Source: 2007 ANNUAL INTERNATIONAL CONFERENCE OF THE IEEE ENGINEERING IN MEDICINE AND BIOLOGY SOCIETY, VOLS 1-16
Author: Hu, Y; Podder, T; Buzurovic, I; Yan, K; Ng, WS; Yu, Y
Abstract: Robotic assistance can help clinicians to improve the flexibility of needle insertion and accuracy of seed deposition. However, the robotic platform is a safety critical system for its automated operational mode. Thus, it is important to perform Hazard Identification & Safety Insurance Control (HISIC) for securing the safety of a medical robotic system. In this paper, we have performed HISIC for our robotic platform, called Endo-Uro Computer Lattice for Intratumoral Delivery, Implementation, and Ablation with Nanosensing (ECLIDIAN) The definition and requirements of the system are described by Unified Modeling Language (UML). Failure Mode and Effect Analysis (FMEA) are executed for the principles of HISIC, such as hazard identification, safety insurance control, safety critical limit, monitoring and control. FMEA combined with UML can also be implemented to ensure reliability of the human operation. On the basis of safety control index and fuzzy mathematics, safety effective value is outlined to assess the validity of safety insurance control for robotic system. The above principles and methods are feasible and effective for hazard analysis during the development of the robotic system.
Title: Development to high-volume manufacturing: Reducing the risks
Source: CITSA 2007/CCCT 2007: INTERNATIONAL CONFERENCE ON CYBERNETICS AND INFORMATION TECHNOLOGIES, SYSTEMS AND APPLICATIONS : INTERNATIONAL CONFERENCE ON COMPUTING, COMMUNICATIONS AND CONTROL TECHNOLOGIES, VOL III, POST-CONFERENCE ISSUE, PROCEEDINGS
Author: Cudney, E; Drain, D; Lough, KG
Abstract: Process problems that are detected during the development process can be corrected relatively inexpensively. However, process problems that are transferred to manufacturing for high-volume production can be extremely expensive to correct. Failure Modes and Effect Analysis is a tool which identifies potential failure modes, the effect(s) of the failure mode, and quantifies risks. FMEA has not achieved its potential as a fisk-management tool in many industries. This paper discusses common errors in performing Failure Modes and Effects Analysis as well as techniques for improving its use by integrating commonly available statistical methods.
Title: New product introduction of fully buffered DIMM - A process perspective
Source: IPACK 2007: PROCEEDINGS OF THE ASME INTERPACK CONFERENCE 2007, VOL 1
Author: Chennagiri, G; Iyer, S
Abstract: The introduction of new products to the manufacturing environment is a challenging task. The extent of this challenge varies depending on the complexity of the product being introduced. Fully Buffered Dual In-line Memory Modules (FBDIMMs). which have been it recent introduction to file memory? industry, pose several unique challenges that need to be addressed, The objective of this study was to first comprehend file distinguishing features of this product against a generic memory module front an assembly process perspective and address the associated issues Failure Modes and Effects Analysis (FMEA) was conducted to highlight (lie areas of concern from a process and reliability stand point, Processes were developed to mitigate [lie occurrence and severity, rate or the identified failure modes. The assembly of heat sinks oil these modules is a unique aspect and required special tools and fixtures. Various issues that were critical to quality were encountered while assembling the heat sinks, Centering of heat sinks over the module after assembly was also observed to be critical. Misaligned heat sinks Call obstruct the insertion of modules into test and application sockets, A special tool was designed to address this issued Upon installation of the new tool. a capability study was performed to validate the process. Removal of the heat sink for component rework purposes was also a concern. This was mainly due to the adhesion of the Thermal Interface Material (TIM) material used oil the heat sink with the components on the board. The adhesion led to component separation front the board during the removal process and required it special process to miligate this issue. The methods used to address these issues ire reported, The product reliability was validated using thermal cycling. shock and vibration tests. The results of these tests are also reported in the paper.
Title: Reliability analysis for automatic transmission based on AMESim
Source: PROCEEDINGS OF THE INTERNATIONAL CONFERENCE ON MECHANICAL ENGINEERING AND MECHANICS 2007, VOLS 1 AND 2
Author: Xu, JG; Hu, N; Chen, Z
Abstract: This paper presents a qualitative simulation method on reliability analysis, considering that hydraulic control system of automatic transmission (AT) has a complex structure and its failure modes are various, unpredictable and occur randomly. First, by using AMESim, simulation models of hydraulic control systems and planetary gear sets, which worked together in GM 4T65E transmission, are set up. Then failure states of adjustable-displacement oil pump return spring and the No.4 shuttle valve are simulated individually. To cause failure of the adjustable-displacement oil pump return spring, its coefficient of rigidity is set to an infinitesimally positive number. Comparing simulation results of the failed component state with those of normal state, it can be learned that the failed return spring causes the output oil pressure of supply pressure regulation and flow control subsystem to become lower than system requirements. Therefore, AT does not have normal working oil pressure. It causes the shifting actuator to slip. Furthermore, sufficient power can not be produced to enable car to pull away from the curb. Similarly, to cause failure of the No.4 shuttle valve, its coefficient of flow is set to naught. Comparing the simulation results, it can be learned that the failed shuttle valve causes loss of third-gear engagement with the selector in D (Drive) or O/D (Overdrive) position and the engine's braking function with the transmission in first gear (manual low gear). Finally, relationship between failed components and AT's problem is established. After analysis, it can be learned that dynamic simulation using AMESim not only remedies the defect in steady-state simulation, but also opens up an avenue to 'Failure Mode and Effect Analysis' of AT. This becomes the foundation for trouble-shooting overall AT system. The simulation example demonstrates the efficiency of the presented method.
Title: Using an innovative SoC-level FMEA methodology to design in compliance with IEC61508
Source: 2007 DESIGN, AUTOMATION & TEST IN EUROPE CONFERENCE & EXHIBITION, VOLS 1-3
Author: Mariani, R; Boschi, G; Colucci, F
Abstract: This paper proposes an innovative methodology, to perform and validate a Failure Mode and Effects Analysis (FMEA) at System-on-Chip (SoC) level. This is done in compliance with the IEC 61508, an international norm for the functional safety of electronic safety-related systems, of which an overview is given in the paper. The Methodology is based on a theory to decompose a digital circuit in "sensible zones" and a tool that automatically extracts these sensible zones from the RTL description. it includes as well a spreadsheet to compute the metrics required by the IEC norm such Diagnostic Coverage and Safe Failure Fraction. The FMEA results are validated by using another tool suite including a fault injection environment. The paper explains how to take benefits of the information provided by such approach and as example it is described how the methodology has been applied to design memory sub-systems to be used in fault robust microcontrollers for automotive applications. This methodology has been approved by TUV-SUD as the flow to assess and validate the Safe Failure Fraction of a given SoC in adherence to IEC 61508.
Title: Using Failure Mode Effect Analysis to increase electronic systems reliability
Source: 2007 30TH INTERNATIONAL SPRING SEMINAR ON ELECTRONICS TECHNOLOGY
Author: Goel, A; Graves, RJ
Abstract: This paper focuses on improving the reliability of electronic systems in the electronic packaging/manufacturing industry using Failure Mode and Effect Analysis (FMEA). The paper starts with the introduction to reliability and the FMEA. It briefly summarizes the research done in these areas, describes the benefits and limitations of the FMEA, compares various FMEA approaches, defines its scope, and offers suggestions for a multidiscipline and multifunctional team. It presents a FA EA form exclusively designed for the electronic systems industry, and provides a list of failure modes that should be considered while performing FMEA on electronic systems. While anticipating every failure mode is not possible, it formulates an extensive list of potential failure modes.
Title: Interruption cost evaluation for distribution system reliability using analytical and statistical technique
Source: 2007 CONFERENCE PROCEEDINGS IPEC, VOLS 1-3
Author: Wang, SF; Ren, Q; Zhang, YJ
Abstract: To evaluate the interruption cost of distribution system, this paper presents an improved FMEA method to calculate reliability, and a statistical approach to gain Sector Custom Average Damage Function (SCADF). A feeder is firstly divided into line blocks and load blocks according to the isolation devices. Based on these blocks, an equivalent mathematic model is introduced to sum up the elements' data. Load point indexes and system indexes can be evaluated after analyzing the failure mode effect of the distribution network. There has been a survey method for SCADF, whose result is accurate but not universal for different areas. So in this paper, an alternate method is also presented, using the product value which customer created and the electric energy which the process consumed, involving some statistics theory such as regression analysis. The related data can be available easily from the regional government bureau of statistic and the power supply corporation. At last, an actual feeder is illustrated to demonstrate the efficiency of the proposed method.