Search results for: EOR process

Authors: Julio Macedo

Abstract:

Several methodologies are now available to conceive the improvements of a process so that it becomes competitive as for example total quality, process reengineering, six sigma, define measure analysis improvement control method. These improvements are of different nature and can be external to the process represented by an optimization model or a discrete simulation model. In addition, the process stakeholders are several and have different desired performances for the process. Hence, the methodologies above do not have a tool to aid in the conception of the required improvements. In order to fill this void we suggest the use of intelligent reference models. A reference model is a set of qualitative differential equations and an objective function that minimizes the gap between the current and the desired performance indexes of the process. The reference models are intelligent so when they receive the current state of the problematic process and the desired performance indexes they generate the required improvements for the problematic process. The reference models are fuzzy cognitive maps added with an objective function and trained using the improvements implemented by the high performance firms. Experiments done in a set of students show the reference models allow them to conceive more improvements than students that do not use these models.

Keywords: continuous improvement, fuzzy cognitive maps, process competitiveness, qualitative simulation, system dynamics

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Authors: Felix Baumann, Aleksandar Milutinovic, Dieter Roller

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Up to this point business process management projects in general and business process modelling projects in particular could not rely on a practical and scientifically validated method to estimate cost and effort. Especially the model development phase is not covered by a cost estimation method or model. Further phases of business process modelling starting with implementation are covered by initial solutions which are discussed in the literature. This article proposes a method of filling this gap by deriving a cost estimation method from available methods in similar domains namely software development or software engineering. Software development is regarded as closely similar to process modelling as we show. After the proposition of this method different ideas for further analysis and validation of the method are proposed. We derive this method from COCOMO II and Function Point which are established methods of effort estimation in the domain of software development. For this we lay out similarities of the software development rocess and the process of process modelling which is a phase of the Business Process Management life-cycle.

Keywords: COCOMO II, busines process modeling, cost estimation method, BPM COCOMO

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Authors: Faisal A. Aburub

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Organizations today need to invest in software in order to run their businesses, and to the organizations’ objectives, the software should be in line with the business process. This research presents an approach for linking process models and system models. Particularly, the new approach aims to synthesize sequence diagram based on role activity diagram (RAD) model. The approach includes four steps namely: Create business process model using RAD, identify computerized activities, identify entities in sequence diagram and identify messages in sequence diagram. The new approach has been validated using the process of student registration in University of Petra as a case study. Further research is required to validate the new approach using different domains.

Keywords: business process modelling, system models, role activity diagrams, sequence diagrams

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Authors: Hyun-Woo Cho

Abstract:

Earlier detection of incipient abnormal operations in terms of plant-wide process management is quite necessary in order to improve product quality and process safety. And generating warning signals or alarms for operating personnel plays an important role in process automation and intelligent plant health monitoring. Various methodologies have been developed and utilized in this area such as expert systems, mathematical model-based approaches, multivariate statistical approaches, and so on. This work presents a nonlinear empirical monitoring methodology based on the real-time analysis of massive process data. Unfortunately, the big data includes measurement noises and unwanted variations unrelated to true process behavior. Thus the elimination of such unnecessary patterns of the data is executed in data processing step to enhance detection speed and accuracy. The performance of the methodology was demonstrated using simulated process data. The case study showed that the detection speed and performance was improved significantly irrespective of the size and the location of abnormal events.

Keywords: detection, monitoring, process data, noise

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Authors: H. Abdolvand, M. Riazat, H. Sohrabi, G. Faraji

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An experimental investigation into the Tube Backward Extrusion (TBE) process on AZ31 magnesium alloy is studied. Microstructures and grain size distribution of the specimens before and after TBE process are investigated by optical microscopy. Tensile and Vickers microhardness tests along extrusion direction were performed at room temperature. It is found that the average grain size is refined remarkably from the initial 33 µm down to 3.5 µm after TBE process. Also, the microhardness increased significantly to 58 HV after the process from an initial value of 36 HV.

Keywords: tube backward extrusion, AZ31, grain size distribution, grain refinement

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Authors: Hyun-Woo Cho

Abstract:

Unexpected operational events or abnormalities of industrial processes have a serious impact on the quality of final product of interest. In terms of statistical process control, fault detection and diagnosis of processes is one of the essential tasks needed to run the process safely. In this work, nonlinear representation of process measurement data is presented and evaluated using a simulation process. The effect of using different representation methods on the diagnosis performance is tested in terms of computational efficiency and data handling. The results have shown that the nonlinear representation technique produced more reliable diagnosis results and outperforms linear methods. The use of data filtering step improved computational speed and diagnosis performance for test data sets. The presented scheme is different from existing ones in that it attempts to extract the fault pattern in the reduced space, not in the original process variable space. Thus this scheme helps to reduce the sensitivity of empirical models to noise.

Keywords: fault diagnosis, nonlinear technique, process data, reduced spaces

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Authors: S. J. Yune, K. H. Park

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The purpose of this study was to examine the validity of the research process for enhancing the humanities competence of the medical students. The research process was developed to be operated as a core subject course of 3 semesters. Among them, the research process for enhancing humanities capacity consisted of humanities and societies (6 teams) and education-psychology (2teams). The subjects of this study were 88-second grade students and 22 professors who participated in the research process. Among them, 13 professors participated in the study of humanities and 37 students. In the validity test, the professors were more likely to have more validity in the research process than the students in all areas of logic (p = .001), influence (p = .037), process (p = .001). The validity of the professor was higher than that of the students. The professors highly evaluated the students' learning outcomes and showed the most frequency to the prize group. As a result of analyzing the agreement between the students and the professors through the Kappa coefficient, the agreement degree of communication and cooperation competence was moderate to .430. Problem-solving ability was .340, which showed a fair degree of agreement. However, other factors showed only a slight degree of agreement of less than .20.

Keywords: research process, medical school, humanities competence, validity verification

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Authors: Shiva Abdoli, Daniel T.Semere

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Several researches have been conducted to study consumption of energy in cutting process. Most of these researches are focusing to measure the consumption and propose consumption reduction methods. In this work, the relation between the cutting parameters and the consumption is investigated in order to establish a generalized energy consumption model that can be used for process and production planning in real production lines. Using the generalized model, the process planning will be carried out by taking into account the energy as a function of the selected process parameters. Similarly, the generalized model can be used in production planning to select the right operational parameters like batch sizes, routing, buffer size, etc. in a production line. The description and derivation of the model as well as a case study are given in this paper to illustrate the applicability and validity of the model.

Keywords: process parameters, cutting process, energy efficiency, Material Removal Rate (MRR)

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Authors: Abbas Al-Refaie

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This paper aims at improving the performance of the tableting process using statistical quality control and fuzzy goal programming. The tableting process was studied. Statistical control tools were used to characterize the existing process for three critical responses including the averages of a tablet’s weight, hardness, and thickness. At initial process factor settings, the estimated process capability index values for the tablet’s averages of weight, hardness, and thickness were 0.58, 3.36, and 0.88, respectively. The L₉ array was utilized to provide experimentation design. Fuzzy goal programming was then employed to find the combination of optimal factor settings. Optimization results showed that the process capability index values for a tablet’s averages of weight, hardness, and thickness were improved to 1.03, 4.42, and 1.42, respectively. Such improvements resulted in significant savings in quality and production costs.

Keywords: fuzzy goal programming, control charts, process capability, tablet optimization

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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: Pisut Painmanakul, Thawatchai Chintateerachai, Supanid Lertlapwasin, Nusara Rojvilavan, Tanun Chalermsinsuwan, Nattawin Chawaloesphonsiya, Onanong Larpparisudthi

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Conventional coagulation, advance oxidation process (AOPs), and the combined process were evaluated and compared for its suitability to treat the stabilized cutting-oil wastewater. The 90% efficiency was obtained from the coagulation at Al2(SO4)3 dosage of 150 mg/L and pH 7. On the other hands, efficiencies of AOPs for 30 minutes oxidation time were 10% for acoustic oxidation, 12% for acoustic oxidation with hydrogen peroxide, 76% for Fenton, and 92% sono-Fenton processes. The highest efficiency for effective oil removal of AOPs required large amount of chemical. Therefore, AOPs were studied as a post-treatment after conventional separation process. The efficiency was considerable as the effluent COD can pass the standard required for industrial wastewater discharge with less chemical and energy consumption.

Keywords: cutting oily-wastewater, advance oxidation process, sono-fenton, combined process

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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: Likewin Thomas, M. V. Manoj Kumar, B. Annappa

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Traditional execution process follows the path of execution drawn by the process analyst without observing the behaviour of resource and other real-time constraints. Identifying process model, predicting the behaviour of resource and recommending the optimal path of execution for a real time process is challenging. The proposed AlfyMiner: αyM iner gives a new dimension in process execution with the novel techniques Process Model Analyser: PMAMiner and Resource behaviour Analyser: RBAMiner for recommending the probable path of execution. PMAMiner discovers next probable activity for currently executing activity in an online process using variant matching technique to identify the set of next probable activity, among which the next probable activity is discovered using decision tree model. RBAMiner identifies the resource suitable for performing the discovered next probable activity and observe the behaviour based on; load and performance using polynomial regression model, and waiting time using queueing theory. Based on the observed behaviour αyM iner recommend the probable path of execution with; next probable activity and the best suitable resource for performing it. Experiments were conducted on process logs of CoSeLoG Project1 and 72% of accuracy is obtained in identifying and recommending next probable activity and the efficiency of resource performance was optimised by 59% by decreasing their load.

Keywords: cross-organization process mining, process behaviour, path of execution, polynomial regression model

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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 work piece. 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: R.T.O. Lacerda, L. Ensslin., S.R. Ensslin, L. Knoff

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This research paper aims to discover research opportunities in business process management and performance measurement from a constructivist view. The nature of this research is exploratory and descriptive and the research method was performed in a qualitative way. The process narrowed down 2142 articles, gathered after a search in scientific databases, and identified 16 articles that were relevant to the research and highly cited. The analysis found that most of the articles uses realistic approach and there is a need to analyze the decision making process in a singular manner. The measurement criteria are identified from scientific literature searching, in most cases, using ordinal scale without any integration process to present the results to the decision maker. Regarding management aspects, most of the articles do not have a structured process to measure the current situation and generate improvements opportunities.

Keywords: performance measurement, BPM, decision, research opportunities

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Authors: Hyun-Woo Cho

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Unexpected events may occur with serious impacts on industrial process. This work utilizes a data representation technique to model and to analyze process data pattern for the purpose of diagnosis. In this work, the use of triangular representation of process data is evaluated using simulation process. Furthermore, the effect of using different pre-treatment techniques based on such as linear or nonlinear reduced spaces was compared. This work extracted the fault pattern in the reduced space, not in the original data space. The results have shown that the non-linear technique based diagnosis method produced more reliable results and outperforms linear method.

Keywords: process monitoring, data analysis, pattern modeling, fault, nonlinear techniques

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Authors: Mohammad Amini, Aliakbar Alijarahi

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This research that is collected and title as ‘ the search of possibility of running six sigma process in IT education center ‘ goals to test possibility of running the six sigma process and using in IT education center system. This process is a good method that is used for reducing process, errors. To evaluate running off six sigma in the IT education center, some variables relevant to this process is selected. These variables are: - The amount of support from organization master boss to process. - The current specialty. - The ability of training system for compensating reduction. - The amount of match between current culture whit six sigma culture . - The amount of current quality by comparing whit quality gain from running six sigma. For evaluation these variables we select four question and to gain the answers, we set a questionnaire from with 28 question and distribute it in our typical society. Since, our working environment is a very competition, and organization needs to decree the errors to minimum, otherwise it lasts their customers. The questionnaire from is given to 55 persons, they were filled and returned by 50 persons, after analyzing the forms these results is gained: - IT education center needs to use and run this system (six sigma) for improving their process qualities. - The most factors need to run the six sigma exist in the IT education center, but there is a need to support.

Keywords: education, customer, self-action, quality, continuous improvement process

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Authors: J. Fernandez de Canete, P. Del Saz Orozco, I. Garcia-Moral, A. Akhrymenka

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Object-oriented modeling is spreading in current simulation of wastewater treatments plants through the use of the individual components of the process and its relations to define the underlying dynamic equations. In this paper, we describe the use of the free-software OpenModelica simulation environment for the object-oriented modeling of an activated sludge process under feedback control. The performance of the controlled system was analyzed both under normal conditions and in the presence of disturbances. The object-oriented described approach represents a valuable tool in teaching provides a practical insight in wastewater process control field.

Keywords: object-oriented programming, activated sludge process, OpenModelica, feedback control

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Authors: Eva Štěpánková

Abstract:

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, concrete organization

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Authors: Hong Lu, Xiong Xiao

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Shaft parts are widely used in machinery industry, however, bending deformation often occurred when this kind of parts is being heat treated. This parts needs to be straightened to meet the requirement of straightness. As for the pressure straightening process, a good straightening stroke algorithm is related to the precision and efficiency of straightening process. In this paper, the relationship between straightening load and deflection during the straightening process is analyzed, and the mathematical model of the straightening process has been established. By the mathematical model, the iterative method is used to solve the straightening stroke. Compared to the traditional straightening stroke algorithm, straightening stroke calculated by this method is much more precise; because it can adapt to the change of material performance parameters. Considering that the straightening method is widely used in the mass production of the shaft parts, knowledge base is used to store the data of the straightening process, and a straightening stroke algorithm based on empirical data is set up. In this paper, the straightening process control model which combine the straightening stroke method based on iteration and straightening stroke algorithm based on empirical data has been set up. Finally, an experiment has been designed to verify the straightening process control model.

Keywords: straightness, straightening stroke, deflection, shaft parts

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Authors: J. J. M. Trienekens, H. L. Romero, L. Cuenca

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While process harmonization is increasingly mentioned and unanimously associated with several benefits, there is a need for more understanding of how it contributes to business process redesign and improvement. This paper presents the application, in an industrial case study, of a conceptual harmonization model on the relationship between drivers and effects of process harmonization. The drivers are called contextual factors which influence harmonization. Assessment of these contextual factors in a particular business domain, clarifies the extent of harmonization that can be achieved, or that should be strived at. The case study shows how the conceptual harmonization model can be made operational and can act as a valuable assessment tool. From both qualitative, as well as some quantitative, assessment results, insights are being discussed on the extent of harmonization that can be achieved, and action plans are being defined for business (process) harmonization.

Keywords: case study, contextual factors, process harmonization, industrial company

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Authors: Anas Hourani, Batool Ahmad

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Software applications play an important role inside any institute. They are employed to manage all processes and store entities-related data in the computer. Therefore, choosing the right software product that meets institute requirements is not an easy decision in view of considering multiple criteria, different points of views, and many standards. As a case study, Mutah University, located in Jordan, is in essential need of customized software, and several companies presented their software products which are very similar in quality. In this regard, an analytic hierarchy process (AHP) and a fuzzy analytic hierarchy process (Fuzzy-AHP) models are proposed in this research to identify the most suitable and best-fit software product that meets the institute requirements. The results indicate that both modules are able to help the decision-makers to make a decision, especially in complex decision problems.

Keywords: analytic hierarchy process, decision modeling, fuzzy analytic hierarchy process, software product

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Authors: J. Skibinski, P. Caban, T. Wejrzanowski, K. J. Kurzydlowski

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In the present study, numerical simulations of heat and mass transfer during gallium nitride growth process in Metal Organic Vapor Phase Epitaxy reactor AIX-200/4RF-S is addressed. Existing knowledge about phenomena occurring in the MOVPE process allows to produce high quality nitride based semiconductors. However, process parameters of MOVPE reactors can vary in certain ranges. Main goal of this study is optimization of the process and improvement of the quality of obtained crystal. In order to investigate this subject a series of computer simulations have been performed. Numerical simulations of heat and mass transfer in GaN epitaxial growth process have been performed to determine growth rate for various mass flow rates and pressures of reagents. According to the fact that it’s impossible to determine experimentally the exact distribution of heat and mass transfer inside the reactor during the process, modeling is the only solution to understand the process precisely. Main heat transfer mechanisms during MOVPE process are convection and radiation. Correlation of modeling results with the experiment allows to determine optimal process parameters for obtaining crystals of highest quality.

Keywords: Finite Volume Method, semiconductors, epitaxial growth, metalorganic vapor phase epitaxy, gallium nitride

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Authors: Kyung Min Park, Cheol Hee Moon

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In this study we are to develop a sealing process using a mixture of a LMPA and an epoxy for the atmospheric OLED sealing process as a substitute for the thin-film process. Electrode lines were formed on the substrates, which were covered with insulating layers and sacrificial layers. A mixture of a LMPA and an epoxy was screen printed between the two electrodes. In order to generate a heat for the melting of the mixture, Joule heating method was used. Were used instantaneous discharge process for generating Joule heating. Experimental conditions such as voltage, time and constituent of the electrode were varied to optimize the heating conditions. As a result, the mixture structure of this study showed a great potential for a low-cost, low-temperature, atmospheric OLED sealing process as a substitute for the thin-film process.

Keywords: organic light emitting diode, encapsulation, low melting point alloy, joule heat

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Authors: Anjian Chen, Joseph C. Chen

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This paper studies a case where the targeted surface roughness of fused deposition modeling (FDM) additive manufacturing process is improved. The process is designing to reduce or eliminate the defects and improve the process capability index Cp and Cpk for an FDM additive manufacturing process. The baseline Cp is 0.274 and Cpk is 0.654. This research utilizes the Taguchi methodology, to eliminate defects and improve the process. The Taguchi method is used to optimize the additive manufacturing process and printing parameters that affect the targeted surface roughness of FDM additive manufacturing. The Taguchi L9 orthogonal array is used to organize the parameters' (four controllable parameters and one non-controllable parameter) effectiveness on the FDM additive manufacturing process. The four controllable parameters are nozzle temperature [°C], layer thickness [mm], nozzle speed [mm/s], and extruder speed [%]. The non-controllable parameter is the environmental temperature [°C]. After the optimization of the parameters, a confirmation print was printed to prove that the results can reduce the amount of defects and improve the process capability index Cp from 0.274 to 1.605 and the Cpk from 0.654 to 1.233 for the FDM additive manufacturing process. The final results confirmed that the Taguchi methodology is sufficient to improve the surface roughness of FDM additive manufacturing process.

Keywords: additive manufacturing, fused deposition modeling, surface roughness, six-sigma, Taguchi method, 3D printing

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Authors: Venkata Venugopal Rao Gudlur

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The Proposed Policies referred to as “SOP”, on the Internet of Things (IoT) based Forensic Investigation into Process Management is the latest revolution to save time and quick solution for investigators. The forensic investigation process has been developed over many years from time to time it has been given the required information with no policies in investigation processes. This research reveals that the current IoT based forensic investigation into Process Management based is more connected to devices which is the latest revolution and policies. All future development in real-time information on gathering monitoring is evolved with smart sensor-based technologies connected directly to IoT. This paper present conceptual framework on process management. The smart devices are leading the way in terms of automated forensic models and frameworks established by different scholars. These models and frameworks were mostly focused on offering a roadmap for performing forensic operations with no policies in place. These initiatives would bring a tremendous benefit to process management and IoT forensic investigators proposing policies. The forensic investigation process may enhance more security and reduced data losses and vulnerabilities.

Keywords: Internet of Things, Process Management, Forensic Investigation, M2M Framework

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Authors: Shamsu Abdullahi, Nazir Yusuf, Hazrina Sofian, Abubakar Zakari, Amina Nura, Salisu Suleiman

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Requirements negotiation process models help in resolving conflicting requirements of the heterogeneous stakeholders in the software development industry. This is to achieve a shared vision of software projects to be developed by the industry. Negotiating stakeholder agreements is a serious and difficult task in the software development process. There are many requirements negotiation process models that effectively negotiate stakeholder agreements that have been proposed by the research community. Other issues in the requirements negotiation research domain include stakeholder communication, decision-making, lack of negotiation interoperability, and managing requirement changes and analysis. This study highlights the current state of the art in the existing software requirements negotiation process models. The study also describes the issues and limitations in the software requirements negotiations process models.

Keywords: requirements, negotiation, stakeholders, agreements

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Authors: Ching-Hua Li, Sheng-Hui Chen

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Sputtering is a popular technique with many advantages for thin film deposition. To fabricate a hydrogenated silicon thin film using sputtering process for solar cell applications, the ion bombardment during sputtering will generate microstructures (voids and columnar structures) to form silicon dihydride bodings as defects. The properties of heterojunction silicon solar cells were studied by using boron grains and silicon-boron targets. Finally, an 11.7% efficiency of solar cell was achieved by using all sputtering process.

Keywords: solar cell, sputtering process, pvd, alloy target

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Authors: Louis Nwachi

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Urban planning systems in most countries still rely on expert-driven, top-down technocratic plan-making processes rather than a public and people-led process. This paper set out to evaluate the need for public participation in the plan-making process and to highlight the factors that affect public participation in the plan-making process. In doing this, it adopted a qualitative approach based on document review and interviews taken from real-world phenomena. A case study strategy using the Metropolitan Area of Abuja, the capital of Nigeria, as the study sample was used in carrying out the research. The research finds that participation is an important tool in the plan-making process and that public engagement in the process contributes to the identification of key urban issues that are unique to the specific local areas, thereby contributing to the establishment of priorities and, in turn, to the mobilization of resources to meet the identified needs. It also finds that the development of a participation model by city authorities encourages public engagement and helps to develop trust between those in authority and the different key stakeholder groups involved in the plan-making process.

Keywords: plan-making, participation, urban planning, city

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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

Procedia PDF Downloads 317