Search results for: process capability.

Authors: Je Young Lee, Hee Sung Kim, Kwang Ho Choi, Joonhoo Lim, Sebum Chun, Hyung Keun Lee

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This study is purposed to develop an efficient fault detection method for Global Navigation Satellite Systems (GNSS) applications based on adaptive noise covariance estimation. Due to the dependence on radio frequency signals, GNSS measurements are dominated by systematic errors in receiver’s operating environment. In the proposed method, the pseudorange and carrier-phase measurement noise covariances are obtained at time propagations and measurement updates in process of Carrier-Smoothed Code (CSC) filtering, respectively. The test statistics for fault detection are generated by the estimated measurement noise covariances. To evaluate the fault detection capability, intentional faults were added to the filed-collected measurements. The experiment result shows that the proposed method is efficient in detecting unhealthy measurements and improves GNSS positioning accuracy against fault occurrences.

Keywords: Adaptive estimation, fault detection, GNSS, residual.

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Authors: S. Beyou, B. Grondin-Perez, M. Benne, C. Damour, J.-P. Chabriat

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The industrial process of the sugar cane crystallization produces a residual that still contains a lot of soluble sucrose and the objective of the factory is to improve its extraction. Therefore, there are substantial losses justifying the search for the optimization of the process. Crystallization process studied on the industrial site is based on the “three massecuites process". The third step of this process constitutes the final stage of exhaustion of the sucrose dissolved in the mother liquor. During the process of the third step of crystallization (Ccrystallization), the phase that is studied and whose control is to be improved, is the growing phase (crystal growth phase). The study of this process on the industrial site is a problem in its own. A control scheme is proposed to improve the standard PID control law used in the factory. An auto-tuning PID controller based on instantaneous linearization of a neural network is then proposed.

Keywords: Auto-tuning, PID, Instantaneous linearization, Neural network, Non linear process, C-crystallisation.

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Authors: Cathal Merz, Gareth O’Donnell

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Coil reinforced thin-walled (CRTW) tubes are used in medicine to treat problems affecting blood vessels within the body through minimally invasive procedures. The CRTW tube considered in this research makes up part of such a device and is inserted into the patient via their femoral or brachial arteries and manually navigated to the site in need of treatment. This procedure replaces the requirement to perform open surgery but is limited by reduction of blood vessel lumen diameter and increase in tortuosity of blood vessels deep in the brain. In order to maximize the capability of these procedures, CRTW tube devices are being manufactured with decreasing wall thicknesses in order to deliver treatment deeper into the body and to allow passage of other devices through its inner diameter. This introduces significant stresses to the device materials which have resulted in an observed increase in the breaking of the proximal segment of the device into two separate pieces after it has failed by buckling. As there is currently no international standard for measuring the mechanical properties of these CRTW tube devices, it is difficult to accurately analyze this problem. The aim of the current work is to address this discrepancy in the biomedical device industry by developing a measurement system that can be used to quantify the effect of process and design changes on CRTW tube performance, aiding in the development of better performing, next generation devices. Using materials testing frames, micro-computed tomography (micro-CT) imaging, experiment planning, analysis of variance (ANOVA), T-tests and regression analysis, test methods have been developed for assessing the impact of process and design changes on the device. The major findings of this study have been an insight into the suitability of buckle and three-point bend tests for the measurement of the effect of varying processing factors on the device’s performance, and guidelines for interpreting the output data from the test methods. The findings of this study are of significant interest with respect to verifying and validating key process and design changes associated with the device structure and material condition. Test method integrity evaluation is explored throughout.

Keywords: Buckling, coil reinforced thin-walled tubes, fracture, test method.

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Authors: Oğuzhan Hasançebi, Saeid Kazemzadeh Azad

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Keywords: Structural design optimization, optimal sizing, metaheuristics, self-adaptive step-size search, steel trusses, steel frames.}

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Authors: Falntina Ahmad Alata, Natheer Abu Obeid

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This paper revolves around the concept of affordance. It aims to discover and develop an architectural typology based on the ecological concept of affordance. In order to achieve this aim, an analytical study is conducted and two sources were taken into account: 1- Gibson's definition of the concept of affordance and 2- The researches that are concerned on the affordance categorisation. As a result, this paper concluded 16 typologies of affordances, including the possibilities of mixing them based on both sources. To clarify these typologies and provide further understanding, a wide range of architectural examples are presented and proposed in the paper. To prove this vocabulary’s capability to diagnose and evaluate the affordance of different environments, an experimental study with two processes have been adapted: 1. Diagnostic process: the interpretation of the environments with regards to its affordance by using the new vocabulary (the developed typologies). 2. Evaluating process: the evaluation of the environments that have been interpreted and classified with regards to their affordances. By using the measures of emotional experience (the positive affect ‘PA’ and the negative affect ‘NA’) and the architectural evaluation criteria (beauty, economy and function). The experimental study proves that the typologies are capable of reading the affordance within different environments. Additionally, it explains how these different typologies reflect different interactions based on the previous processes. The data which are concluded from the evaluation of measures explain how different typologies of affordance that have already reflected different environments had different evaluations. In fact, some of them are recommended while the others are not. In other words, the paper draws a roadmap for designers to diagnose, evaluate and analyse the affordance into different architectural environments. After that, it guides them through adapting the best interaction (affordance category), which they intend to adapt into their proposed designs.

Keywords: Affordance theory, affordance categories, architectural environments, architectural evaluation criteria, emotional experience.

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Authors: C. Patrascioiu, M. Jamali

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The paper deals with the simulation of the crude distillation process using the Unisim Design simulator. The necessity of simulating this process is argued both by considerations related to the design of the crude distillation column, but also by considerations related to the design of advanced control systems. In order to use the Unisim Design simulator to simulate the crude distillation process, the identification of the simulators used in Romania and an analysis of the PRO/II, HYSYS, and Aspen HYSYS simulators were carried out. Analysis of the simulators for the crude distillation process has allowed the authors to elaborate the conclusions of the success of the crude modelling. A first aspect developed by the authors is the implementation of specific problems of petroleum liquid-vapors equilibrium using Unisim Design simulator. The second major element of the article is the development of the methodology and the elaboration of the simulation program for the crude distillation process, using Unisim Design resources. The obtained results validate the proposed methodology and will allow dynamic simulation of the process.  

Keywords: Crude oil, distillation, simulation, Unisim Design, simulators.

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Authors: Samiah Alammari, Nassim Ammour

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When providing a massive number of tasks successively to a deep learning process, a good performance of the model requires preserving the previous tasks data to retrain the model for each upcoming classification. Otherwise, the model performs poorly due to the catastrophic forgetting phenomenon. To overcome this shortcoming, we developed a successful continual learning deep model for remote sensing hyperspectral image regions classification. The proposed neural network architecture encapsulates two trainable subnetworks. The first module adapts its weights by minimizing the discrimination error between the land-cover classes during the new task learning, and the second module tries to learn how to replicate the data of the previous tasks by discovering the latent data structure of the new task dataset. We conduct experiments on hyperspectral image (HSI) dataset on Indian Pines. The results confirm the capability of the proposed method.

Keywords: Continual learning, data reconstruction, remote sensing, hyperspectral image segmentation.

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Authors: Wararat Rungworawut, Twittie Senivongse

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Business process model describes process flow of a business and can be seen as the requirement for developing a software application. This paper discusses a BPM2CD guideline which complements the Model Driven Architecture concept by suggesting how to create a platform-independent software model in the form of a UML class diagram from a business process model. An important step is the identification of UML classes from the business process model. A technique for object-oriented analysis called domain analysis is borrowed and key concepts in the business process model will be discovered and proposed as candidate classes for the class diagram. The paper enhances this step by using ontology search to help identify important classes for the business domain. As ontology is a source of knowledge for a particular domain which itself can link to ontologies of related domains, the search can give a refined set of candidate classes for the resulting class diagram.

Keywords: Business Process Model, Model DrivenArchitecture, Ontology, UML Class Diagram.

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Authors: Petia Georgieva, Sebastião Feyo de Azevedo

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This paper is focused on issues of nonlinear dynamic process modeling and model-based predictive control of a fed-batch sugar crystallization process applying the concept of artificial neural networks as computational tools. The control objective is to force the operation into following optimal supersaturation trajectory. It is achieved by manipulating the feed flow rate of sugar liquor/syrup, considered as the control input. A feed forward neural network (FFNN) model of the process is first built as part of the controller structure to predict the process response over a specified (prediction) horizon. The predictions are supplied to an optimization procedure to determine the values of the control action over a specified (control) horizon that minimizes a predefined performance index. The control task is rather challenging due to the strong nonlinearity of the process dynamics and variations in the crystallization kinetics. However, the simulation results demonstrated smooth behavior of the control actions and satisfactory reference tracking.

Keywords: Feed forward neural network, process modelling, model predictive control, crystallization process.

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Authors: Samy E. Oraby, Ayman M. Alaskari

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The importance of machining process in today-s industry requires the establishment of more practical approaches to clearly represent the intimate and severe contact on the tool-chipworkpiece interfaces. Mathematical models are developed using the measured force signals to relate each of the tool-chip friction components on the rake face to the operating cutting parameters in rough turning operation using multilayers coated carbide inserts. Nonlinear modeling proved to have high capability to detect the nonlinear functional variability embedded in the experimental data. While feedrate is found to be the most influential parameter on the friction coefficient and its related force components, both cutting speed and depth of cut are found to have slight influence. Greater deformed chip thickness is found to lower the value of friction coefficient as the sliding length on the tool-chip interface is reduced.

Keywords: Mathematical modeling, Cutting forces, Frictionforces, Friction coefficient and Chip ratio.

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Authors: A. Youseef, F. Liu

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The existing information system (IS) developments methods are not met the requirements to resolve the security related IS problems and they fail to provide a successful integration of security and systems engineering during all development process stages. Hence, the security should be considered during the whole software development process and identified with the requirements specification. This paper aims to propose an integrated security and IS engineering approach in all software development process stages by using i* language. This proposed framework categorizes into three separate parts: modelling business environment part, modelling information technology system part and modelling IS security part. The results show that considering security IS goals in the whole system development process can have a positive influence on system implementation and better meet business expectations.

Keywords: Business Process Modelling (BPM), Information System Security, Software Development Process, Requirement Engineering.

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Authors: Eva Štěpánková

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The decision-making process is theoretically clearly defined. Generally, it includes the problem identification and analysis, data gathering, goals and criteria setting, alternatives development and optimal alternative choice and its implementation. In practice however, various modifications of the theoretical decision-making process can occur. The managers can consider some of the phases to be too complicated or unfeasible and thus they do not carry them out and conversely some of the steps can be overestimated. The aim of the paper is to reveal and characterize the perception of the individual phases of decision-making process by the managers. The research is concerned with managers in the military environment – commanders. Quantitative survey is focused cross-sectionally in the individual levels of management of the Ministry of Defence of the Czech Republic. On the total number of 135 respondents the analysis focuses on which of the decision-making process phases are problematic or not carried out in practice and which are again perceived to be the easiest. Then it is examined the reasons of the findings.

Keywords: Decision making, decision making process, decision problems.

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Authors: Sh. Arzani, H. Kazemi Esfeh, Y. Galeh Zadeh, V. Akbari

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Ethylene dichloride is a colorless liquid with a smell like chloroform. EDC is classified in the simple hydrocarbon group which is obtained from chlorinating ethylene gas. Its chemical formula is C2H2Cl2 which is used as the main mediator in VCM production. Therefore, the purification process of EDC is important in the petrochemical process. In this study, the purification unit of EDC was simulated, and then validation was performed. Finally, the impact of process parameter was studied for the degree of EDC purity. The results showed that by increasing the feed flow, the reflux impure combinations increase and result in an EDC purity decrease.

Keywords: Ethylene dichloride, purification, EDC, simulation.

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Authors: Antônio Carlos da Rocha Costa

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This paper concerns a formal model to help the simulation of agent societies where institutional roles and institutional links can be specified operationally. That is, this paper concerns institutional roles that can be specified in terms of a minimal behavioral capability that an agent should have in order to enact that role and, thus, to perform the set of institutional functions that role is responsible for. Correspondingly, the paper concerns institutional links that can be specified in terms of a minimal interactional capability that two agents should have in order to, while enacting the two institutional roles that are linked by that institutional link, perform for each other the institutional functions supported by that institutional link. The paper proposes a cognitive architecture approach to institutional roles and institutional links, that is, an approach in which a institutional role is seen as an abstract cognitive architecture that should be implemented by any concrete agent (or set of concrete agents) that enacts the institutional role, and in which institutional links are seen as interactions between the two abstract cognitive agents that model the two linked institutional roles. We introduce a cognitive architecture for such purpose, called the Institutional BCC (IBCC) model, which lifts Yoav Shoham-s BCC (Beliefs-Capabilities-Commitments) agent architecture to social contexts. We show how the resulting model can be taken as a means for a cognitive architecture account of institutional roles and institutional links of agent societies. Finally, we present an example of a generic scheme for certain fragments of the social organization of agent societies, where institutional roles and institutional links are given in terms of the model.

Keywords: Simulation of agent societies, institutional roles, cognitive architecture of institutional roles.

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Authors: Seok Hong Min, Tae Kwon Ha

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With the increasing interest on Ti alloys, the extraction process of Ti from its typical ore, TiO₂, has long been and will be important issue. As an intermediate product for the production of pigment or titanium metal sponge, tetrachloride (TiCl₄) is produced by fluidized bed using high TiO₂ feedstock. The purity of TiCl₄ after chlorination is subjected to the quality of the titanium feedstock. Since the impurities in the TiCl₄ product are reported to final products, the purification process of the crude TiCl₄ is required. The purification process includes fractional distillation and chemical treatment, which depends on the nature of the impurities present and the required quality of the final product. In this study, thermodynamic analysis on the impurity effect in the chlorination process, which is the first step of extraction of Ti from TiO₂, has been conducted. All thermodynamic calculations were performed using the FactSage thermodynamical software.

Keywords: Rutile, titanium, chlorination process, impurities, thermodynamic calculation, FactSage.

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Authors: Jens Friedrich, Matthias A. Gebele, Armin Lechler, Alexander Verl

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Chatter vibrations and process instabilities are the most important factors limiting the productivity of the milling process. Chatter can leads to damage of the tool, the part or the machine tool. Therefore, the estimation and prediction of the process stability is very important. The process stability depends on the spindle speed, the depth of cut and the width of cut. In milling, the process conditions are defined in the NC-program. While the spindle speed is directly coded in the NC-program, the depth and width of cut are unknown. This paper presents a new simulation based approach for the prediction of the depth and width of cut of a milling process. The prediction is based on a material removal simulation with an analytically represented tool shape and a multi-dexel approach for the workpiece. The new calculation method allows the direct estimation of the depth and width of cut, which are the influencing parameters of the process stability, instead of the removed volume as existing approaches do. The knowledge can be used to predict the stability of new, unknown parts. Moreover with an additional vibration sensor, the stability lobe diagram of a milling process can be estimated and improved based on the estimated depth and width of cut.

Keywords: Dexel, process stability, material removal, milling.

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Authors: Gonçalo G. Aleixo, Alexandra B. Tenera

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This work will provide a new perspective of exploring innovation thematic. It will reveal that radical and incremental innovations are complementary during the innovation life cycle and accomplished through distinct ways of developing new products. Each new product development process will be constructed according to the nature of each innovation and the state of the product development. This paper proposes the inclusion of the organizational function areas that influence new product's development on the new product development process.

Keywords: Cross-functional, Incremental Innovation, New Product development Process, Radical Innovation

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Authors: M. A. M. El-Bendary, A. E. Abu El-Azm, N. A. El-Fishawy, F. Shawky, F. E. El-Samie

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With increasing utilization of the wireless devices in different fields such as medical devices and industrial fields, the paper presents a method for simplify the Bluetooth packets with throughput enhancing. The paper studies a vital issue in wireless communications, which is the throughput of data over wireless networks. In fact, the Bluetooth and ZigBee are a Wireless Personal Area Network (WPAN). With taking these two systems competition consideration, the paper proposes different schemes for improve the throughput of Bluetooth network over a reliable channel. The proposition depends on the Channel Quality Driven Data Rate (CQDDR) rules, which determines the suitable packet in the transmission process according to the channel conditions. The proposed packet is studied over additive White Gaussian Noise (AWGN) and fading channels. The Experimental results reveal the capability of extension of the PL length by 8, 16, 24 bytes for classic and EDR packets, respectively. Also, the proposed method is suitable for the low throughput Bluetooth.

Keywords: Bluetooth, throughput, adaptive packets, EDRpackets, CQDDR, low latency. Channel condition

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Authors: Marko Popovic

Abstract:

There are three possible effects of Special Theory of Relativity (STR) on a thermodynamic system. Planck and Einstein looked upon this process as isobaric; on the other hand Ott saw it as an adiabatic process. However plenty of logical reasons show that the process is isotherm. Our phenomenological consideration demonstrates that the temperature is invariant with Lorenz transformation. In that case process is isotherm, so volume and pressure are Lorentz covariant. If the process is isotherm the Boyles law is Lorentz invariant. Also equilibrium constant and Gibbs energy, activation energy, enthalpy entropy and extent of the reaction became Lorentz invariant.

Keywords: STR, relativistic temperature transformation, Boyle'slaw, equilibrium constant, Gibbs energy.

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Authors: P. K. Gupta

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The present paper deals with the experimental and computational study of axial collapse of the aluminum metallic shells having combined tube-frusta geometry between two parallel plates. Shells were having bottom two third lengths as frusta and remaining top one third lengths as tube. Shells were compressed to recognize their modes of collapse and associated energy absorption capability. An axisymmetric Finite Element computational model of collapse process is presented and analysed, using a non-linear FE code FORGE2. Six noded isoparametric triangular elements were used to discretize the deforming shell. The material of the shells was idealized as rigid visco-plastic. To validate the computational model experimental and computed results of the deformed shapes and their corresponding load-compression and energy-compression curves were compared. With the help of the obtained results progress of the axisymmetric mode of collapse has been presented, analysed and discussed.

Keywords: Axial compression, crashworthiness, energy absorption, FORGE2, metallic shells.

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Authors: Tomas Cechura, Michal Simon

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The aim of this paper is to create a proposal for determining the costs of logistics processes by using process-oriented calculation methods. The traditional approach is that logistics costs are part of manufacturing overhead which is usually calculated as a percentage surcharge. Therefore in the traditional approach it is not obvious where and in which activities costs were incurred. So it is impossible to trace logistics costs to products. Our point of view is trying to fix or at least improve this issue. Another benefit of applying the process approach is identification of logistics processes which are otherwise part of manufacturing overhead. In the first part this paper describes the development of process-oriented methods over time. The next part shows the possibility of implementing the process-oriented method called Prozesskostenrechnung to logistics processes. The conclusion summarizes advantages and disadvantages of using this method in logistics.

Keywords: Cost, logistics, calculation, process-oriented method.

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Authors: N. P. Yadav, Deepti Verma

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This paper focuses on the mathematical modeling for solidification of Al alloy in a cube mold cavity to study the solidification behavior of casting process. The parametric investigation of solidification process inside the cavity was performed by using computational solidification/melting model coupled with Volume of fluid (VOF) model. The implicit filling algorithm is used in this study to understand the overall process from the filling stage to solidification in a model metal casting process. The model is validated with past studied at same conditions. The solidification process is analyzed by including the effect of pouring velocity as well as natural convection from the wall and geometry of the cavity. These studies show the possibility of various defects during solidification process.

Keywords: Buoyancy driven flow, natural convection driven flow, residual flow, secondary flow, volume of fluid.

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Authors: Päivi J. Tossavainen , Leena Alakoski, Katri Ojasalo

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Building a service-centric business model requires new knowledge and capabilities in companies. This paper enlightens the challenges small and medium sized firms (SMEs) face when developing their service-centric business models. This paper examines the premise for knowledge transfer and capability development required. The objective of this paper is to increase knowledge about SME-s transformation to service-centric business models.This paper reports an action research based case study. The paper provides empirical evidence from three case companies. The empirical data was collected through multiple methods. The findings of the paper are: First, the developed model to analyze the current state in companies. Second, the process of building the service – centric business models. Third, the selection of suitable service development methods. The lack of a holistic understanding on service logic suggests that SMEs need practical and easy to use methods to improve their business

Keywords: service-centric business model, service development, action research, case study

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Authors: Noor Elaiza Abdul Khalid, Noorhayati Mohamed Noor, Zamalia Mahmud, Saadiah Yahya, and Norharyati Md Ariff

Abstract:

Glaucoma diagnosis involves extracting three features of the fundus image; optic cup, optic disc and vernacular. Present manual diagnosis is expensive, tedious and time consuming. A number of researches have been conducted to automate this process. However, the variability between the diagnostic capability of an automated system and ophthalmologist has yet to be established. This paper discusses the efficiency and variability between ophthalmologist opinion and digital technique; threshold. The efficiency and variability measures are based on image quality grading; poor, satisfactory or good. The images are separated into four channels; gray, red, green and blue. A scientific investigation was conducted on three ophthalmologists who graded the images based on the image quality. The images are threshold using multithresholding and graded as done by the ophthalmologist. A comparison of grade from the ophthalmologist and threshold is made. The results show there is a small variability between result of ophthalmologists and digital threshold.

Keywords: Digital Fundus Image, Glaucoma Detection, Multithresholding, Segmentation.

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Authors: Teerapun Saeheaw, Nivit Charoenchai, Wichai Chattinnawat

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Simulation model is an easy way to build up models to represent real life scenarios, to identify bottlenecks and to enhance system performance. Using a valid simulation model may give several advantages in creating better manufacturing design in order to improve the system performances. This paper presents result of implementing a simulation model to design hard disk drive manufacturing process by applying line balancing to improve both productivity and quality of hard disk drive process. The line balance efficiency showed 86% decrease in work in process, output was increased by an average of 80%, average time in the system was decreased 86% and waiting time was decreased 90%.

Keywords: line balancing, arena, hard disk drive process, simulation, work in process (WIP)

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Authors: Kazuhide Sugiyama, Hiroshi Osada

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Lately management strategy that put Industrial Design (ID) in its core is recognized more important, as technology and price alone cannot differentiate a product. The needs to shorten the time to develop a product also shorten the development period of ID, and it necessitates the ID process management. This research analyzes the status of integration process of ID and Engineering Design (ED) of office equipment that requires the collaboration of ID and ED to clarify the issues for the efficiency of the development and to propose solutions.

Keywords: Industrial Design (ID), Engineering Design (ED), Integration process, Office equipment

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Authors: Valeria M. Pequeno, Joao Carlos G. M. Pires

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Data Warehouses (DWs) are repositories which contain the unified history of an enterprise for decision support. The data must be Extracted from information sources, Transformed and integrated to be Loaded (ETL) into the DW, using ETL tools. These tools focus on data movement, where the models are only used as a means to this aim. Under a conceptual viewpoint, the authors want to innovate the ETL process in two ways: 1) to make clear compatibility between models in a declarative fashion, using correspondence assertions and 2) to identify the instances of different sources that represent the same entity in the real-world. This paper presents the overview of the proposed framework to model the ETL process, which is based on the use of a reference model and perspective schemata. This approach provides the designer with a better understanding of the semantic associated with the ETL process.

Keywords: conceptual data model, correspondence assertions, data warehouse, data integration, ETL process, object relational database.

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Authors: C. Adam, G. Henri, T. Levent, J-B Mauro, A-L Mayet

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Energy Efficiency Management is the heart of a worldwide problem. The capability of a multi-agent system as a technology to manage the micro-grid operation has already been proved. This paper deals with the implementation of a decisional pattern applied to a multi-agent system which provides intelligence to a distributed local energy network considered at local consumer level. Development of multi-agent application involves agent specifications, analysis, design, and realization. Furthermore, it can be implemented by following several decisional patterns. The purpose of present article is to suggest a new approach for a decisional pattern involving a multi-agent system to control a distributed local energy network in a decentralized competitive system. The proposed solution is the result of a dichotomous approach based on environment observation. It uses an iterative process to solve automatic learning problems and converges monotonically very fast to system attracting operation point.

Keywords: Energy Efficiency Management, Distributed Smart- Grid, Multi-Agent System, Decisional Decentralized Competitive System.

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Authors: R. Ferdous

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Power, responsibility sharing, and democratic decision-making are the central ethos to co-management. It is assumed that involving local community in the decision-making process can create a sense of ownership and responsibility of that community and motivate the community towards collective action. But this paper demonstrated that the process to involve local community is not simple and straightforward as it is influenced by structural aspects, power relations among the actors, and social embedded institutions. These factors shape the process in that way who will participate, how they will participate and how the local community maneuvers their agency in the decision-making process. To grasp the complexities that materialize in the process of participation and to understand the inclusionary and exclusionary nature of participation, this paper examines the subjective understanding of different stakeholders concerning participation and furthermore observes the enabling or constraining factors that affect the community to exercise their agency.

Keywords: Participation, social embeddedness, power, structure.

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Authors: Takashi Kaminagayoshi, Shigeyuki Haruyama

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To improve the manufacturing efficiency of biologics, such as antibody drugs, a quality engineering framework was designed. Within this framework, critical steps and parameters in the manufacturing process were studied. Identification of these critical steps and critical parameters allows a deeper understanding of manufacturing capabilities, and suggests to process development department process control standards based on actual manufacturing capabilities as part of a PDCA (plan-do-check-act) cycle. This cycle can be applied to each manufacturing process so that it can be standardized, reducing the time needed to establish each new process.

Keywords: Antibody drugs, biologics, manufacturing efficiency, PDCA cycle, quality engineering.

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