Title: Use of failure mode and effects analysis in improving the safety of iv drug administration
Source: AMERICAN JOURNAL OF HEALTH-SYSTEM PHARMACY
Author: Adachi, W; Lodolce, AE
Abstract: Purpose. Failure mode and effects analysis (FMEA) was used to identify dosing and administration errors associated with i.v. medications and evaluate the effectiveness of subsequent system improvements. Summary. A multidisciplinary medication safety team conducted an FMEA to identify and reduce common medication errors and selected wrong-dose errors for process improvement. In 2002, wrong-dose errors comprised 17% of all medication errors at the hospital (59 of 347 errors). The most common reason for administering the wrong dose was error in programming the i.v. infusion pump (41%). Potential errors (i.e., failures) identified were misinterpretation of the order, removing the wrong medication or wrong concentration of the correct medication, using the wrong diluent or drug to prepare the drip, and entering the wrong concentration or infusion rate on the pump. Errors in programming the i.v. infusion pump was the step in the medication-use process associated with the highest criticality index. Based on the results of the FMEA, two main interventions were performed. First, standard order sets were revised after streamlining the formulary and eliminating the use of unapproved abbreviations. Second, an i.v. pump with enhanced safety features was implemented. One-year follow-up data revealed that the number of medication errors related to dosing (wrong dose or incorrect infusion rate) had decreased slightly (from 59 in 2002 to 46 in 2003); however, a dramatic reduction was noted in the percentage of pump-related errors. In 2003, pump-related errors accounted for 22% of dosing errors, compared with 41% in 2002. Conclusion. Medication errors related to i.v. infusion pumps were reduced by conducting an FMEA and implementing the process changes needed.
Title: Key enablers for the effective implementation of QFD: a critical analysis
Source: INDUSTRIAL MANAGEMENT & DATA SYSTEMS
Author: Al-Mashari, M; Zairi, M; Ginn, D
Abstract: Purpose - This paper presents the concepts and principles of quality function deployment (QFD) as they have been implemented by Ford company. The paper illustrates the essential linkages between external and internal customers to suppliers (i.e. "Voice-Quality-Satisfaction" Chains). Design/methodology/approach - The paper considers some of the details of changes that are occurring to support the "Breakthrough in Quality". One of the key elements of the Ford Motor Company engineering quality improvements program (EQIP) within Europe has been the linking of some seven-quality tool techniques including QFD as the core link. For the purpose of improving QFD, it is both useful and rational to look at ways in which it can be linked to, or integrated with other quality tools. The Ford EQIP training process argues that QFD, within a customer focused engineering (CFE) process is a key tool in linking all other tools, through the QFD process itself. Findings - The paper also looks at discussions on QFD linkages with other quality tools and processes. This sequence of QFD linkages to other single, or dual linked quality tools finishing with some engineering processes is particularly discussed. Among these are Pugh Concept Selection, Taguchi methods, experimentation, failure mode effects analysis (FMEA), value management, quality benchmark deployment (QBD) and benchmarking, process management, statistical process control (SPC), team oriented problem solving - eight disciplines (TOPS 8D), and systems engineering. Research limitations/implications - Although the manifestation of the Ford customer satisfaction process has been reviewed as the CFE QFD process within Ford of Europe, its adoption and awareness is still limited. As a result of this, it is critical to review the research topic of customer satisfaction with a focus on how Ford Motor Company as a whole approaches this key goal through the use of various marketing, sales and marketing research office (MRO) initiatives. Practical implications - It discusses the various arguments and proposals that link together the end user customers voice to the internal customer-supplier chains that act on the customer input and feedback to improve product quality and ultimately deliver higher end user satisfaction. Originality/value - The paper concludes with a discussion of the use of QFD with other quality tools and processes, the role of QFD within total quality management (TQM) processes, and team working.
Title: Constant quality assurance by means of a process overlapping system FMEA
Source: STAHL UND EISEN
Author: Blasius, A; Plitzko, M; Wieland, HJ
Abstract: Contributors from the steel, steel wire, spring and automotive industries have cooperatively drawn up a plan based on the VDA Volume 4, port 2 (1st edition 1996) for the potential Failure Mode and Effects Analysis (FMEA) for coil and parabolic leaf springs. The specific potential effect of failure addressed is "possible premature spring fracture in the vehicle" The most important finding arrived at by the team was that actions taken in such high risk situations must be performed cooperatively by the companies involved.
Title: Bouncing failure analysis (BFA): The unified FTA-FMEA methodology
Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2005 PROCEEDINGS
Author: Bluvband, Z; Polak, R; Grabov, P
Abstract: This paper introduces Bouncing Failure Analysis (BFA) an innovative combination of two traditional and widely used Failure Analysis (FA) techniques: Failure Mode Effect Analysis (FMEA) and Fault Tree Analysis (FTA), presenting the methodology and the procedure able to maximize the advantages and at the same time to minimize the shortcomings of both known methodologies.
Title: Hazard evaluation of The International Fusion Materials Irradiation Facility
Source: FUSION ENGINEERING AND DESIGN
Author: Burgazzi, L
Abstract: The International Fusion Materials Irradiation Facility (IFMIF) is aimed to provide an intense neutron source by a high current deuteron linear accelerator and a high-speed lithium flow target, for testing candidate materials for fusion. Liquid lithium is being circulated through a loop and is kept at a temperature above its freezing point. In the frame of the design phase called Key Element technology Phase (KEP), jointly performed by an international team to verify the most important risk factors, safety assessment of the whole plant has been required in order to identify the hazards associated with the plant operation. This paper discusses the safety assessments that were performed and their outcome: Failure Mode and Effect Analysis (FMEA) approach has been adopted in order to accomplish the task. Main conclusions of the study is that, on account of the safety and preventive measures adopted, potential plant related hazards are confined within the IFMIF security boundaries and great care must be exercised to protect workers and site personnel from operating the plant. The analysis has provided as a result a set of Postulated Initiating Events (PIEs), that is off-normal events, that could result in hazardous consequences for the plant, together with the total frequency and the list of component failures which could induce the PIE: this assures the exhaustive list of major initiating events of accident sequences, helpful to the further accident sequence analysis phase. Finally, for each one of the individuated PIEs, the evaluation of the accident evolution, in terms of effects on the plant and relative countermeasures, has allowed to verify that adequate measures are being taken both to prevent the accident occurrence and to cope with the accident consequences, thus assuring the fulfilment of the safety requirements. (c) 2004 Elsevier B.V. All rights reserved.
Title: The worker exposure failure modes and effects analysis
Source: FUSION SCIENCE AND TECHNOLOGY
Author: Cadwallader, LC
Abstract: The Worker Exposure Failure Modes and Effects Analysis (WE-FMEA) is a new approach to quantitatively evaluate worker risks from possible failures of co-located equipment in the complex environment of a magnetic or inertial fusion experiment. For next-step experiments such as the International Thermonuclear Experimental Reactor (ITER) or the National Ignition Facility (NIF), the systems and equipment will be larger, handle more throughput or power, and will, in general, be more robust than past experiments. These systems and equipment are necessary to operate the machine, but the rooms are congested with equipment, piping, and cables, which poses a new level of hazard for workers who will perform hands-on maintenance. The WE-FMEA systematically analyzes the nearby equipment and the work environment for equipment failure or inherent hazards, and then develops exposure scenarios. Once identified, the exposure scenarios are evaluated for the worker hazards and quantitative worker risk is calculated. Then risk scenarios are quantitatively compared to existing statistical data on worker injuries; high-risk scenarios can be identified and addressed in more detail to determine the proper means to reduce, mitigate, or protect against the hazard. The WE-FMEA approach is described and a cooling system maintenance example is given.
Title: A CIMOSA presentation of an integrated product design review framework
Source: INTERNATIONAL JOURNAL OF COMPUTER INTEGRATED MANUFACTURING
Author: Chin, KS; Lam, J; Chan, JSF; Poon, KK; Yang, JB
Abstract: Integrating subsystems of manufacturing processes, material flow, organization and information to form a manufacturing system is vital to a smooth and responsive operation in the dynamic market. This article presents an integrated system framework for product design optimization in terms of cost, quality and reliability considerations, which are mapped onto the computer integrated manufacture - open system architecture ( CIMOSA). The authors employ quality function deployment ( QFD), value engineering ( VE) and failure modes and effects analysis ( FMEA) as part of a structured and targeted campaign to achieve quality, cost and reliability deployment objectives. The outcome facilitates the product design and development team to consider tradeoffs among the conflicts from customer attributes as well as the inherent fuzziness in the system.
Title: A new FMEA approach based on availability and costs
Source: AMST '05: Advanced Manufacturing Systems and Technology, Proceedings
Author: D'Urso, G; Stancheris, D; Valsecchi, N; Maccarini, G; Bugini, A
Abstract: The paper reports on a new FMEA (Failure Mode and Effects Analysis) technique for the evaluation of operating failures on machine tools. The traditional FMEA methodology focuses the analysis on failure problems and usually does not take into account other parameters, such as availability and costs. This new technique was setup for predicting operating failures during the design process of machine tools, so reducing costs and time to market. This approach is based on a new index depending on machine tool availability and customer costs related to failure time. For the validation and the evaluation of the method, an industrial case was studied; data collected from this analysis proved to be in good agreement with failures detected by the customer. The adopted method showed a higher reliability compared with traditional FMEA results.
Title: Failure mode and effects analysis application to critical care medicine
Source: CRITICAL CARE CLINICS
Author: Duwe, B; Fuchs, BD; Hansen-Flaschen, J
Abstract: In July 2001, the United States joint Commission on Accreditation of Health Care Organizations adopted a new leadership standard that requires department heads in health care organizations to perform at least one Failure Mode and Effects Analysis (FMEA) every year. This proactive approach to error prevention has proven to be highly effective in other industries, notably aerospace, but remains untested in acute care hospitals. For several reasons, the intensive care unit (ICU) potentially is an attractive setting for early adoption of FMEA; however, successful implementation of FMEA in ICUs is likely to require strong, effective leadership and a sustained commitment to prevent errors that may have occurred rarely or never before in the local setting. This article describes FMEA in relation to critical care medicine and reviews some of the attractive features together with several potential pitfalls that are associated with this approach to error prevention in ICUs.
Title: A fuzzy data envelopment analysis approach for fmea
Source: PROGRESS IN NUCLEAR ENERGY
Author: Garcia, PAA; Schirru, R; Melo, PFFE
Abstract: We present a data envelopment analysis approach for determining ranking indices among failure modes in which the typical FMEA parameters are modeled as fuzzy sets. By this approach, inference rules of the IT THEN kind can be bypassed. The proposed approach is applied to a typical PWR auxiliary feedwater system. The results are compared to those obtained by means of the risk priority numbers, pure fuzzy logic concepts, and finally the DEA-APGF (profiling of severity efficiency) approach. The results demonstrate the potential of the combination of fuzzy logic concepts and data envelopment analysis for this class of problems.
Title: An automated failure mode and effect analysis based on high-level design specification with behavior trees
Source: INTEGRATED FORMAL METHODS, PROCEEDINGS
Author: Grunske, L; Lindsay, P; Yatapanage, N; Winter, K
Abstract: Formal methods have significant benefits for developing safety critical systems, in that they allow for correctness proofs, model checking safety and liveness properties, deadlock checking, etc. However, formal methods do not scale very well and demand specialist skills, when developing real-world systems. For these reasons, development and analysis of large-scale safety critical systems will require effective integration of formal and informal methods. In this paper, we use such an integrative approach to automate Failure Modes and Effects Analysis (FMEA), a widely used system safety analysis technique, using a high-level graphical modelling notation (Behavior Trees) and model checking. We inject component failure modes into the Behavior Trees and translate the resulting Behavior Trees to SAL code. This enables us to model check if the system in the presence of these faults satisfies its safety properties, specified by temporal logic formulas. The benefit of this process is tool support that automates the tedious and error-prone aspects of FMEA.
Title: UML based severity analysis methodology
Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2005 PROCEEDINGS
Author: Hassan, A; Goseva-Popstojanova, K; Ammar, H
Abstract: According to the NASA Standard on software safety , risk is a function of the anticipated frequency of occurrence of an undesired event, the potential severity of resulting consequences, and the uncertainties associated with the frequency and severity. The authors in  developed a methodology for risk assessment of software architectures based on the Unified Modeling Language (UML) . The methodology estimates the probability of software components/connectors failures by measuring the complexity/coupling of the UML dynamic specifications . Severity is estimated based on the MIL(-)STD(-)1629A  and using the classical technique of Failure Mode and Effect Analysis (FMEA). In this paper we address the problem of assessing the severity based on UML artifacts and using the cost of failures of software components and connectors as well as failures of system execution scenarios. We propose a severity assessment methodology which is performed combining three different hazard analysis techniques: Functional Failure Analysis (FFA), Failure Mode and Effect Analysis (FMEA), and Fault Tree Analysis (FTA). The methodology integrates these techniques in order to assess the severity of failures of system scenarios and the severity of failures of each architectural element (component/connector) early in the software analysis and design phases. FFA is used as a top-down approach based on system scenarios to identify the system level failures. FMEA is used as a bottom-up appraoch based on the detailed view of the system to identify the possible causes of component/connector failures. Finally, FTA correlates the results of FMEA and FFA. This process of estimating severity can be automated in development environments supporting UML by annotating the hazard analysis results and the cost of failure information in the UML diagrams. We use this methodology for reliability-based risk assessment , performance-based risk assessment , and requirement-based risk assessment of software systems .
Title: Identification of priorities for medication safety in neonatal intensive care
Source: DRUG SAFETY
Author: Kunac, DL; Reith, DM
Abstract: Background: Although neonates are reported to be at greater risk of medication error than infants and older children, little is known about the causes and characteristics of error in this patient group. Failure mode and effects analysis (FMEA) is a technique used in industry to evaluate system safety and identify potential hazards in advance. The aim of this study was to identify and prioritise potential failures in the neonatal intensive care unit (NICU) medication use process through application of FMEA. Methods: Using the FMEA framework and a systems-based approach, an eight-member multidisciplinary panel worked as a team to create a flow diagram of the neonatal unit medication use process. Then by brainstorming, the panel identified all potential failures, their causes and their effects at each step in the process. Each panel member independently rated failures based on occurrence, severity and likelihood of detection to allow calculation of a risk priority score (RPS). Results: The panel identified 72 failures, with 193 associated causes and effects. Vulnerabilities were found to be distributed across the entire process, but multiple failures and associated causes were possible when prescribing the medication and when preparing the drug for administration. The top ranking issue was a perceived lack of awareness of medication safety issues (RPS score 273), due to a lack of medication safety training. The next highest ranking issues were found to occur at the administration stage. Common potential failures related to errors in the dose, timing of administration, infusion pump settings and route of administration. Perceived causes were multiple, but were largely associated with unsafe systems for medication preparation and storage in the unit, variable staff skill level and lack of computerised technology. Conclusion: Interventions to decrease medication-related adverse events in the NICU should aim to increase staff awareness of medication safety issues and focus on medication administration processes.
Title: Safety methods in software process improvement
Source: SOFTWARE PROCESS IMPROVEMENT, PROCEEDINGS
Author: Lauritsen, T; Stalhane, T
Abstract: Even if the application developers produce software in accordance with the customer requirements, they cannot guarantee that the software will behave in a safe way during the lifetime of the software. We define a system as safe if the risks related to its use are judged to be acceptable . Safety must not be confused with security which broadly is defined as keeping the system unavailable for people who should not be able to access it. In this paper we introduce the Failure Mode and Effect Analysis (FMEA) technique into the software development process to improve the safety of business-critical software. In a business environment this means that the system does not behave in such a way that it causes the customer or his users to lose money or important information. We will use the term "business-safe" for this characteristic.
Title: Demand-driven evolution of IT systems in healthcare - A case study for improving interdisciplinary processes
Source: METHODS OF INFORMATION IN MEDICINE
Author: Lenz, R; Buessecker, F; Herlofsen, H; Hinrichs, F; Zeiler, T; Kuhn, KA
Abstract: Objectives. To analyze and to optimize interdisciplinary clinical processes, to introduce an IT-supported model for demand-driven system evolution in healthcare, and to demonstrate the feasibility of the approach for a clinical example and to present an evaluation. Methods: System evolution and change management are viewed as two sides of the same coin, thus formal methods for process analysis and IT system evolution were embedded into a goal-oriented change management model. Based on a process model, a Failure Mode and Effects Analysis (FMEA) and a computer simulation were performed. A tool for rapid application development (RAD) was used to incrementally improve the healthcare information system according to, newly arising needs. Results. Each of the formal methods used contributed to the successful reorganization of the interdisciplinary clinical process. An evaluation demonstrated significant improvements. An integrated IT application was implemented to support the optimized process. Conclusions. Process improvement is feasible and effective when formal methods for process analysis and requirements specification are used in a reasonable and goal-oriented way. It might be necessary to trade off costs and benefits or simplify a given method in the context of a particular project. As the same information is utilized in different tools, it is supposed that the efforts for process analysis, documentation and implementation of adapted applications could be reduced if different tools were integrated and based on a single Coherent reference model for description of clinical processes.
Title: Incorporating uncertainty in diagnostic analysis of mechanical systems
Source: JOURNAL OF MECHANICAL DESIGN
Author: Mocko, GM; Paasch, R
Abstract: The increase in complexity of modern mechanical systems call often lead to systems that are difficult to diagnose and, therefore require a great deal of time and money to return to a normal operating condition. Analyzing mechanical systems during the product development stages call lead to systems optimized in the area of diagnosability and, therefore, to a reduction of life cycle costs for both consumers and manufacturers and all increase in the useable life of the system. A methodology,for diagnostic evaluation of mechanical systems incorporating indication uncertainty is presented. First, Bayes',formula is used in conjunction with information extracted from the Failure Modes and Effects Analysis (FMEA), Fault Tree Analysis (FTA), component reliability, and prior system knowledge to construct the Component-Indication Joint probability Matrix (CIJPM). The CIJPM, which consists of joint probabilities of all mutually exclusive diagnostic events, provides a diagnostic model of the system. The replacement matrix is constructed by applying a predetermined replacement criterion to the CIJPM. Diagnosability, metrics are extracted from a replacement probability matrix, computed by multiplying the transpose of the replacement matrix by the CIJPM. These metrics are useful for comparing alternative designs and addressing diagnostic problems of the system, to the component and indication level. Additionally, the metrics call be used to predict cost associated with fault isolation over the life cycle of the system.
Title: Treatment delivery software for a new clinical grade ultrasound system for thermoradiotherapy
Source: MEDICAL PHYSICS
Author: Novak, P; Moros, EG; Straube, WL; Myerson, RJ
Abstract: A detailed description of a clinical grade Scanning Ultrasound Reflector Linear Array System (SURLAS) applicator was given in a previous paper [Med. Phys. 32, 230-240 (2005)]. In this paper we concentrate on the design, development, and testing of the personal computer (PC) based treatment delivery software that runs the therapy system. The SURLAS requires the coordinated interaction between the therapy applicator and several peripheral devices for its proper and safe operation. One of the most important tasks was the coordination of the input power sequences for the elements of two parallel opposed ultrasound arrays (eight 1.5 cm x 2 cm elements/array, array 1 and 2 operate at 1.9 and 4.9 MHz, respectively) in coordination with the position of a dual-face scanning acoustic reflector. To achieve this, the treatment delivery software can divide the applicator's treatment window in up to 64 sectors (minimum size of 2 cm x 2 cm), and control the power to each sector independently by adjusting the power output levels from the channels of a 16-channel radio-frequency generator. The software coordinates the generator outputs with the position of the reflector as it scans back and forth between the arrays. Individual sector control and dual frequency operation allows the SURLAS to adjust power deposition in three dimensions to superficial targets coupled to its treatment window. The treatment delivery software also monitors and logs several parameters such as temperatures acquired using a 16-channel thermocouple thermometry unit. Safety (in particular to patients) was the paramount concern and design criterion. Failure mode and effects analysis (FMEA) was applied to the applicator as well as to the entire therapy system in order to identify safety issues and rank their relative importance. This analysis led to the implementation of several safety mechanisms and a software structure where each device communicates with the controlling PC independently of the others. In case of a malfunction in any part of the system or a violation of a user-defined safety criterion based on temperature readings, the software terminates treatment immediately and the user is notified. The software development process consisting of problem analysis, design, implementation, and testing is presented in this paper. Once the software was finished and integrated with the hardware, the therapy system was extensively tested. Results demonstrated that the software operates the SURLAS as intended with minimum risk to future patients. (c) 2005 American Association of Physicists in Medicine.
Title: Formal safety analysis of a radio-based railroad crossing using deductive cause-consequence analysis (DCCA)
Source: DEPENDABLE COMPUTING - EDCC-5, PROCEEDINGS
Author: Ortmeier, F; Reif, W; Schellhorn, G
Abstract: In this paper we present the formal safety analysis of a radiobased -railroad crossing. We use deductive cause-consequence analysis (DCCA) as analysis method. DCCA is a novel technique to analyze safety of embedded systems with formal methods. It substitutes error-prone informal reasoning by mathematical proofs. DCCA allows to rigorously prove whether a failure on component level is the cause for system failure or not. DCCA generalizes the two most common safety analysis techniques: failure modes and effects analysis (FMEA) and fault tree analysis (FTA). We apply the method to a real world case study: a radio-based railroad crossing. We illustrate the results of DCCA for this example and compare them to results of other formal safety analysis methods like formal FTA.
Title: Methods of failure and reliability assessment for mechanical heart pumps
Source: ARTIFICIAL ORGANS
Author: Patel, SM; Allaire, PE; Wood, HG; Throckmorton, AL; Tribble, CG; Olsen, DB
Abstract: Artificial blood pumps are today's most promising bridge-to-recovery (BTR), bridge-to-transplant (BTT), and destination therapy solutions for patients suffering from intractable congestive heart failure (CHF). Due to an increased need for effective, reliable, and safe long-term artificial blood pumps, each new design must undergo failure and reliability testing, an important step prior to approval from the United States Food and Drug Administration (FDA), for clinical testing and commercial use. The FDA has established no specific standards or protocols for these testing procedures and there are only limited recommendations provided by the scientific community when testing an overall blood pump system and individual system components. Product development of any medical device must follow a systematic and logical approach. As the most critical aspects of the design phase, failure and reliability assessments aid in the successful evaluation and preparation of medical devices prior to clinical application. The extent of testing, associated costs, and lengthy time durations to execute these experiments justify the need for an early evaluation of failure and reliability. During the design stages of blood pump development, a failure modes and effects analysis (FMEA) should be completed to provide a concise evaluation of the occurrence and frequency of failures and their effects on the overall support system. Following this analysis, testing of any pump typically involves four sequential processes: performance and reliability testing in simple hydraulic or mock circulatory loops, acute and chronic animal experiments, human error analysis, and ultimately, clinical testing. This article presents recommendations for failure and reliability testing based on the National Institutes of Health (NIH), Society for Thoracic Surgeons (STS) and American Society for Artificial Internal Organs (ASAIO), American National Standards Institute (ANSI), the Association for Advancement of Medical Instrumentation (AAMI), and the Bethesda Conference. It further discusses studies that evaluate the failure, reliability, and safety of artificial blood pumps including in vitro and in vivo testing. A descriptive summary of mechanical and human error studies and methods of artificial blood pumps is detailed.
Title: Multiple failure mode and effects analysis - An approach to risk assessment of multiple failures with FMEA
Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2005 PROCEEDINGS
Author: Pickard, K; Muller, P; Bertsche, B
Abstract: By integrating the procedures of the FMEA method (Failure Mode and Effects Analysis) [ 1] and the FTA method (Fault Tree Analysis)  into a combined procedure, the mFMEA (multiple Failure Mode and Effects Analysis), an inclusive reliability analysis of complex, mechatronical systems, is made possible. The advantages of both methods are brought together and integrated into a new procedure. The FMEA along with its risk analysis, risk assessment and measure controlling, paralleling systematically to the product design cycle is only applicable for single failures. The FTA expands the new procedure through a failure analysis with the help of its combination option to network failures according to Boolean logic. The new procedure allows for the consideration of multiple failures while retaining all the characteristics of FMEA. In addition, through the use of failure networks quantitative information can be derived concerning the system's availability, which delivers important information along with the results of the mFMEA.
Title: Strategies to assure the absence of GMO in food products application process in a confectionery firm
Source: FOOD CONTROL
Author: Scipioni, A; Saccarola, G; Arena, F; Alberto, S
Abstract: This article describes the strategies and the instruments applied in the development and implementation of a system aimed at assuring the production of food which is neither made of nor derived from genetically modified raw material in a confectionery firm. It was chosen to develop a specific planning method partially taken from HACCP and FMEA techniques, mainly as far as the systematic and rigorous analysis of risks is concerned (in this case, the contamination of raw material and/or their genetically modified derivatives along the food chain). The result is a management system model that food organizations can use to assure the traceability of all ingredients incorporated into their food products and, in the same time, to guarantee that these ingredients do not contain or consist or derive from genetically modified organisms (GMOs). (C) 2004 Elsevier Ltd. All rights reserved.
Title: Utilization of a failure mode effects analysis (FMEA) to evaluate the safety of ventilator patients in a non-ICU setting
Author: Seckel, MA; Speakman, B; Bradtke, D; O'Brien, G
Title: Linking product functionality to historic failures to improve failure analysis in design
Source: RESEARCH IN ENGINEERING DESIGN
Author: Stone, RB; Tumer, IY; Stock, ME
Abstract: Prior research has shown that similar failure modes occur within products (or components) with similar functionality. To capitalize on this finding, a knowledge base-driven failure analysis tool, the function-failure design method (FFDM), has been developed to allow designers to perform failure mode and effect analysis (FMEA) during conceptual design. The FFDM can offer substantial improvements to the design process since it enhances failure analysis thus giving it the ability to reduce the number of necessary redesigns. The FFDM, however, is only as good as the knowledge base that it draws from, and one fundamental question that arises in using the FFDM is: at what level of detail should functional descriptions of components be encoded? This paper explores two approaches to populating a knowledge base with actual failure occurrence information from Bell 206 helicopters. Results indicate that encoding failure data using more detailed functional models allows for a more robust knowledge base. Interestingly however, when applying FFDM, high level descriptions continue to produce useful results when using the knowledge base generated from the detailed functional models.
Title: The function-failure design method
Source: JOURNAL OF MECHANICAL DESIGN
Author: Stone, RB; Tumer, IY; Van Wie, M
Abstract: To succeed in the product development market today, firms must quickly and accurately satisfy customer needs while designing products that adequately accomplish their desired functions with a minimum number of failures. When failure analysis and prevention are coupled with a product's design from its conception, potentially shorter design times and fewer redesigns are necessary to arrive at a final product design. In this article, we explore the utility of a novel design methodology that allows failure modes and effects analysis (FMEA)-style failure analysis to be conducted during conceptual design. The function-failure design method (FFDM) guides designers towards improved designs by predicting likely failure modes based on intended product functionality.
Title: Failure Modes and Effects Analysis (FMEA) applied to two modern radiotherapy centres
Source: RADIOTHERAPY AND ONCOLOGY
Author: Teixeira, N; Cunha, G; Moreno, L; Pontes, M; Rosa, M; Jacob, K; Cardoso, I; Ferreira, P; Ramalho, M; Carvoeiras, P; Galhos, R
Title: An evaluation of failure modes and effects analysis generation method for conceptual design
Source: INTERNATIONAL JOURNAL OF COMPUTER INTEGRATED MANUFACTURING
Author: Teoh, PC; Case, K
Abstract: Failure modes and effects analysis ( FMEA) is used in the manufacturing industry to improve product quality and productivity. However, the traditional approach has many shortcomings that affect its effectiveness and limit its usefulness, especially in the early stages of design. Automating the FMEA report generation process seems to answer some of these problems, and there has been much past and on-going research in this area. However, most of the work is limited to specific applications. This paper proposes a method for FMEA generation for a generic application using minimum information during the conceptual design stage. Prototype software has been created for the proposed method. It has been evaluated using case studies from the design and manufacture of two-way radios. The evaluation revealed the feasibility of the proposal, as well as some weaknesses that need further improvement. Generally, the capability of the method to generate FMEA report with minimum information is demonstrated.
Title: FMEA used in assessing warranty costs
Source: ANNUAL RELIABILITY AND MAINTAINABILITY SYMPOSIUM, 2005 PROCEEDINGS
Author: Vintr, Z; Vintr, M
Abstract: The article deals with a possibility how to use Failure Mode and Effects Analysis (FMEA) in assessing warranty costs of repairable products. A proposed procedure is especially suitable for products with a new design when credible information gathered by monitoring of comparable products in service and especially in the warranty period is not available. The article describes a procedure that augments FMEA (FMECA) and, in addition to standard analyzed information, at each failure mode it further evaluates an assumed number of a given type of failure during a warranty period, method of its repair, its labor consumption and costs needed for spare parts and material. It also presents a model that based on these data enables to carry out an estimate of warranty costs of a product as a whole. A method presented facilitates to conduct an estimation of warranty costs already in the initial stages of the product life cycle even when information on the behavior of similar products is missing.
Title: Durability testing of a completely implantable electric total artificial heart
Source: ASAIO JOURNAL
Author: Zapanta, CM; Snyder, AJ; Weiss, WJ; Cleary, TJ; Reibson, JD; Rawhouser, MA; Lewis, JP; Pierce, WS; Rosenberg, G
Abstract: In vitro durability testing was conducted on the Penn State/3M electric total artificial heart (ETAH) to determine device durability and to evaluate device failures. A specialized mock circulatory loop was developed for this testing. Customized software continuously acquired data during the test period, and failures were analyzed using FMEA (failure modes and effects analysis) and FMECA (failure modes, effects, and criticality analysis) principles. Redesigns were implemented when appropriate. Reliability growth principles were then applied to calculate the 1 and 2 year reliability. The 1 and 2 year reliability of the Penn State/3M ETAH was shown to be 96.1% and 59.9%, respectively, at 80% confidence.
Title: FMEA-based expert system for electrolysis diagnosis
Source: LIGHT METALS 2005
Author: Berezin, AI; Polyakov, PV; Rodnov, OO; Yasinski, VL; Stont, PD
Abstract: Reduction of nonproductive expenditures at the cost of decreasing of total amount of sick cells is one of the actual targets. Expert diagnostics system is worked out for exposure of sick cells. Diagnostics process consists of the following procedures: Identification of cell "noises" and their classification as symptoms of a sickness with the help of specially trained neuron net; Type definition and calculation of seriousness of sickness according to expert rules with the help of fuzzy logics; Calculation of priority number of risks - PNR - according to FMEA technique (Potential Failure Mode and Effects Analysis) for each symptom, sickness, cell, potroom. Visualization and documentation of diagnostics results using FMEA protocols. Cell parameters and SPC data (Statistic process control) are the input information for the expert system of diagnostics. Diagnostics system is able to define PNR of 20 types of potroom "sickness", which allows: to reduce the number of sick cells; to reduce the frequency of AE; to define the maximum permissible condition of the cell for relining.
Title: Assessing warranty costs for vehicle and its parts
Source: TRANSPORT MEANS 2005, PROCEEDINGS
Author: Vintr, Z; Vintr, M
Abstract: The article deals with a possibility how to use Failure Mode and Effects Analysis (FMEA) in assessing warranty costs of a vehicle and its parts. A proposed procedure is especially suitable for a vehicle or vehicle's parts with a new design when credible information gathered by monitoring of comparable objects in service and especially in the warranty period is not available.
Title: An approach to structuring a technology base via FMEA
Source: PROCEEDINGS OF THE 12TH INTERNATIONAL CONFERENCE ON INDUSTRIAL ENGINEERING AND ENGINEERING MANAGEMENT, VOLS 1 AND 2
Author: Chen, JX; He, H; Zhang, LN; Zhao, XZ
Abstract: This paper addresses an important practical issue in manufacturing enterprise knowledge management: how to structure a practical technology base. Inspired by the FMEA, a popular tool for reliability analysis, it is suggested in the paper that the application of FMEA can be extended to form a technology breakdown system (TBS) which enables us to well structure a technology base to form an intact platform supporting design,manufacturing and service of products and to devise a way to deliver the technology in a useable form. In order to manage mass information during conducting FMEA and TBS, a feasible and practical three-tier model of a technology management information system(TMIS) has been proposed.
Title: Application of fuzzy sets in evaluation of failure likelihood
Source: 18TH INTERNATIONAL CONFERENCE ON SYSTEMS ENGINEERING, PROCEEDINGS
Author: Bukowski, L; Feliks, J
Abstract: Estimation of failure likelihood for technical objects is a very difficult process because the information about the process is often uncertain and imprecise. Assessment of risk related in catastrophic damages is very difficult, particularly in systems where damage causes threat of human life or serious economic losses. Methods like FMEA and FMECA applied to evaluation of risk of designed systems do not give the full information about meaning of results of possible failure. Therefore the risk evaluation method, when risk is a product of failure likelihood and degree of failure, was proposed.
Title: An eco-innovative tool by integrating FMEA and TRIZ methods
Source: FOURTH INTERNATIONAL SYMPOSIUM ON ENVIRONMENTALLY CONSCIOUS DESIGN AND INVERSE MANUFACTURING, PROCEEDINGS
Author: Yen, SB; Chen, JL
Abstract: An Eco-innovative product design tool combining the concept of green design with failure mode and effect analysis (FMEA) is presented in this study. The proposed approach is on the basis of FMEA structure well known in industry and takes the environment, safety and health into consideration. The checklist of eco-failure can guide designers or engineers to find the more serious burdens and the recommended actions those come from the TRIZ contradiction matrix help them to search for feasible solutions. Both of them will much shorten the time for brainstorm and make up for the lack of experiment. An example was also conducted to verify the practicality of the proposed tool.
Title: Electronic prognostics - A case study using global positioning system (GPS)
Source: AUTOTESTCON 2005
Author: Brown, DW; Kalgren, PW; Byington, CS; Orsagh, RF
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 has 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 diagnostic features. The results of the accelerated failure tests accurately predict the remaining useful life of a 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.
Title: High-reliability, modular ocean cable termination
Source: OCEANS 2005, VOLS 1-3
Author: Simpson, R; Heybrock, K; Linden, JP
Abstract: One of the greatest challenges in underwater communications systems is in the area of terminating ocean cable. Cable design is relatively stable and families of cables consist of many similar attributes; however, the needs for terminations on these cables can vary widely and usually result in a custom design to suit a particular customer, connector type and/or application. There exists a need for a reliable way to terminate a cable such that it can withstand the rigors of deployment and long life service in the ocean environment where the mechanical and environmental conditions are hostile and can vary widely. A high-reliability cable termination has been designed, fabricated and tested to support a range of current system needs and can be readily adapted to future applications. The termination, described in this paper, is capable of integrating armored ocean cable with a variety of commercially available connectors and/or splice joints. The termination consists of polyethylene encapsulation of the conductor and armor wires contained in a sealed titanium pressure vessel with separate electrical and optical penetrators (feed-throughs) qualifled to 10,000 psi hydrostatic pressure. In order to ensure reliability and meet the aggressive schedule, the design consisted of reuse, modification and integration of qualified subassemblies to leverage existing qualified technologies, processes and components. The qualification methods employed a requirements-based testing matrix which also mapped testing methods to each of the failure modes identified in the reliability analysis (Failure Mode and Effects Analysis [FMEA]) to a test method designed specifically to address each failure mode. The result is a robust design that can be readily adapted to suit a variety of cables, connectors and system requirements from short-life, shallow-water, transitory systems to long-life, high-voltage, deep-water, stationary systems.
Title: A framework for warranty prediction during product development
Source: PROCEEDINGS OF THE ASME DESIGN ENGINEERING DIVISION 2005, PTS A AND B
Author: Esterman, M; Gerst, P; Stiebitz, PH; Ishii, K
Abstract: This paper describes the challenges faced by companies to manage warranty performance during product development. Understanding and reducing warranty cost often focuses exclusively on the analysis of product failures. However, warranty costs can also be incurred by events such as misaligned customer expectations that do not involve a product failure, per se. Many experts agree that effective management of system reliability and reliability validation during product development is a key to achieve superior time to market and life cycle quality. The paper first surveys the challenges faced by various organizations ranging from consumer electronics to aircraft engines to experimental high-energy physics accelerators. From the survey emerge some key and common issues that these companies face: identification of failure events; reliability modeling and prediction; prototyping and validation testing. The paper then reviews the current state of the art to identify areas for improvements as well as needed integrations in order to develop a comprehensive framework that will be useful to product developers to manage and predict warranty performance during product development. This framework extends and integrates three areas: 1) extend scenario-based FMEA to include the diagnosis and repair of failure events as part of the scenario; 2) use of Bayesian methods to integrate field data, product development data and engineering judgments; 3) generate costs models that allow tradeoff studies between product design, service model design and warranty policies. The paper concludes by presenting a future research agenda.
Title: Global Failure Modes and Effects Analysis: A planning tool for global product development
Source: DETC 2005: ASME INTERNATIONAL DESIGN ENGINEERING TECHNICAL CONFERENCES AND COMPUTERS AND INFORMATION IN ENGINEERING CONFERENCE, 2005, VOL 4
Author: Leung, P; Ishii, K; Abell, J; Benson, J
Abstract: This paper presents an advanced application of Failure Modes and Effect and Analysis (FMEA) to facilitate globally distributed projects. Recent research in global engineering focuses on the enhancement of collaborative media, yet few studies investigate in design methodologies to guide global product development. Global FMEA (GFMEA) is an attempt to coordinate the planning activities of globally distributed projects and to provide a leading indicator in addressing delays and quality problems. Using risk as a quantifiable metric, GFMEA assesses potential global work distribution failure modes with project complexity and proposes mitigation plans according to the selected distributed scenarios. GFMEA synchronizes the visions within the planning team to ensure the company's objectives strategically align with the project goals. This paper begins with a description of the GFMEA development followed by an industry case study to illustrate the concept. The paper concludes with a discussion of GFMEA limitations and usage as well as suggests improvements for the next iteration.