Search results for: Safety instrumented system; Safety integrity level; Failure modes

Authors: Dengpan Wu, Dan Liu

Abstract:

In view of the present cloud security problem has increasingly become one of the major obstacles hindering the development of the cloud computing, put forward a kind of memory based on Xen cloud environment security isolation technology implementation. And based on Xen virtual machine monitor system, analysis of the model of memory virtualization is implemented, using Xen memory virtualization system mechanism of super calls and grant table, based on the virtual machine manager internal implementation of access control module (ACM) to design the security isolation system memory. Experiments show that, the system can effectively isolate different customer domain OS between illegal access to memory data.

Keywords: Cloud security, memory isolation, Xen, virtual machine.

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Authors: É. Kónya, E. Szabó, I. Bata-Vidács, T. Deák, M. Ottucsák, N. Adányi, A. Székács

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Spice paprika is a major spice commodity in the European Union (EU), produced locally and imported from non-EU countries, reported not only for chemical and microbiological contamination, but also for fraud. The effective interaction between producers’ quality management practices and government and EU activities is described on the example of spice paprika production and control in Hungary, a country of leading spice paprika producer and per capita consumer in Europe. To demonstrate the importance of various contamination factors in the Hungarian production and EU trade of spice paprika, several aspects concerning food safety of this commodity are presented. Alerts in the Rapid Alert System for Food and Feed (RASFF) of the EU between 2005 and 2013, as well as Hungarian state inspection results on spice paprika in 2004 are discussed, and quality non-compliance claims regarding spice paprika among EU member states are summarized in by means of network analysis. Quality assurance measures established along the spice paprika production technology chain at the leading Hungarian spice paprika manufacturer, Kalocsai Fűszerpaprika Zrt. are surveyed with main critical control points identified. The structure and operation of the Hungarian state food safety inspection system is described. Concerted performance of the latter two quality management systems illustrates the effective interaction between internal (manufacturer) and external (state) quality control measures.

Keywords: Spice paprika, quality control, reporting mechanisms, RASFF, vulnerable points, HACCP, BRC Global Standard.

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Authors: K. P. Jain, J. F. J. Pruyn, J. J. Hopman

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In May 2009, the International Maritime Organization (IMO) adopted the Hong Kong International Convention for the Safe and Environmentally Sound Recycling of Ships to address the growing concerns about the environmental, occupational health and safety risks related to ship recycling. The aim of the Hong Kong Convention is to provide a legally binding instrument which ensures that the process of ship recycling does not pose risks to human health, safety and to the environment. In this paper, critical analysis of the Hong Kong Convention has been carried out in order to study the effectiveness of the Convention to meet its objectives. The Convention has been studied in detail including its background, main features, major stakeholders, strengths and weaknesses. The Convention, though having several deficiencies, is a major breakthrough in not only recognizing but also dealing with the ill-practices associated with ship recycling.

Keywords: Hong Kong Convention, IMO, Ship breaking, Ship recycling.

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Authors: Ali Farhaninejad, Rizal Zahari, Ehsan Rasooliyazdi

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Increasing energy absorption is a significant parameter in vehicle design. Absorbing more energy results in decreasing occupant damage. Limitation of the deflection in a side impact results in decreased energy absorption (SEA) and increased peak load (PL). Hence a high crash force jeopardizes passenger safety and vehicle integrity. The aims of this paper are to determine suitable dimensions and material of a square beam subjected to side impact, in order to maximize SEA and minimize PL. To achieve this novel goal, the geometric parameters of a square beam are optimized using the response surface method (RSM).multi-objective optimization is performed, and the optimum design for different response features is obtained.

Keywords: Crashworthiness, side impact, energy absorption, multi-objective optimization, Square beam, SEA

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Authors: H. S. Huang, J. C. Jao, K. L. Yen, C. T. Tsai

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The purpose of this article applies the monthly final energy yield and failure data of 202 PV systems installed in Taiwan to analyze the PV operational performance and system availability. This data is collected by Industrial Technology Research Institute through manual records. Bad data detection and failure data estimation approaches are proposed to guarantee the quality of the received information. The performance ratio value and system availability are then calculated and compared with those of other countries. It is indicated that the average performance ratio of Taiwan-s PV systems is 0.74 and the availability is 95.7%. These results are similar with those of Germany, Switzerland, Italy and Japan.

Keywords: availability, performance ratio, PV system, Taiwan

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Authors: Jiho Park, Yong-Gyu Lee, Gilwon Yoon

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Data security in u-Health system can be an important issue because wireless network is vulnerable to hacking. However, it is not easy to implement a proper security algorithm in an embedded u-health monitoring because of hardware constraints such as low performance, power consumption and limited memory size and etc. To secure data that contain personal and biosignal information, we implemented several security algorithms such as Blowfish, data encryption standard (DES), advanced encryption standard (AES) and Rivest Cipher 4 (RC4) for our u-Health monitoring system and the results were successful. Under the same experimental conditions, we compared these algorithms. RC4 had the fastest execution time. Memory usage was the most efficient for DES. However, considering performance and safety capability, however, we concluded that AES was the most appropriate algorithm for a personal u-Health monitoring system.

Keywords: biosignal, data encryption, security measures, u-health

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Authors: F. Kovács, K. Kádár, G. Hosszú, Á. T. Balogh, T. Zsedrovits, N. Kersner, A. Nagy, Gy. Jeney

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The paper presents a novel screening method to indicate congenital heart diseases (CHD), which otherwise could remain undetected because of their low level. Therefore, not belonging to the high-risk population, the pregnancies are not subject to the regular fetal monitoring with ultrasound echocardiography. Based on the fact that CHD is a morphological defect of the heart causing turbulent blood flow, the turbulence appears as a murmur, which can be detected by fetal phonocardiography (fPCG). The proposed method applies measurements on the maternal abdomen and from the recorded sound signal a sophisticated processing determines the fetal heart murmur. The paper describes the problems and the additional advantages of the fPCG method including the possibility of measurements at home and its combination with the prescribed regular cardiotocographic (CTG) monitoring. The proposed screening process implemented on a telemedicine system provides an enhanced safety against hidden cardiac diseases.

Keywords: Cardiac murmurs, fetal phonocardiography, screening of CHDs, telemedicine system.

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Authors: B. Cynthia Sherin, E. A. Mary Anita

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Vehicular Ad-hoc Network (VANET) is an emerging and very promising technology that has great demand on the access capability of the existing wireless technology. VANETs help improve traffic safety and efficiency. Each vehicle can exchange their information to inform the other vehicles about the current status of the traffic flow or a dangerous situation such as an accident. To achieve these, a reliable and efficient Medium Access Control (MAC) protocol with minimal transmission collisions is required. High speed nodes, absence of infrastructure, variations in topology and their QoS requirements makes it difficult for designing a MAC protocol in vehicular networks. There are several MAC protocols proposed for VANETs to ensure that all the vehicles could send safety messages without collisions by reducing the end-to-end delay and packet loss ratio. This paper gives an overview of the several proposed MAC protocols for VANETs along with their benefits and limitations and presents an overall classification based on their characteristics.

Keywords: MAC Protocols, QoS, VANET, V2V, V2I.

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Authors: J. R. Wang, S. W. Chen, Y. Chiang, W. S. Hsu, J. H. Yang, Y. S. Tseng, C. Shih

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In this research, the HABIT analysis methodology was established for Maanshan nuclear power plant (NPP). The Final Safety Analysis Report (FSAR), reports, and other data were used in this study. To evaluate the control room habitability under the CO₂ storage burst, the HABIT methodology was used to perform this analysis. The HABIT result was below the R.G. 1.78 failure criteria. This indicates that Maanshan NPP habitability can be maintained. Additionally, the sensitivity study of the parameters (wind speed, atmospheric stability classification, air temperature, and control room intake flow rate) was also performed in this research.

Keywords: PWR, HABIT, habitability, Maanshan.

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Authors: Y. Chiang, W. Y. Li, J. R. Wang, S. W. Chen, W. S. Hsu, J. H. Yang, Y. S. Tseng, C. Shih

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In this research, the HABIT code was used to estimate the concentration under the CO₂ and H₂SO₄ storage burst conditions for Kuosheng nuclear power plant (NPP). The Final Safety Analysis Report (FSAR) and reports were used in this research. In addition, to evaluate the control room habitability for these cases, the HABIT analysis results were compared with the R.G. 1.78 failure criteria. The comparison results show that the HABIT results are below the criteria. Additionally, some sensitivity studies (stability classification, wind speed and control room intake rate) were performed in this study.

Keywords: BWR, HABIT, habitability, KUOSHENG.

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Authors: Biao Ma, Jikai Liu, Man Chen, Jianpeng Wu, Liyong Wang, Changsong Zheng

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Proposing an appropriate control strategy is an effective and practical way to address the overheat problems of the wet multi-plate clutch in Direct Shift Gearbox under the long-time creeping condition. To do so, the temperature variation of the wet multi-plate clutch is investigated firstly by establishing a thermal resistance model for the gearbox cooling system. To calculate the generated heat flux and predict the clutch temperature precisely, the friction torque model is optimized by introducing an improved friction coefficient, which is related to the pressure, the relative speed and the temperature. After that, the heat transfer model and the reasonable friction torque model are employed by the vehicle powertrain model to construct a comprehensive co-simulation model for the Direct Shift Gearbox (DSG) vehicle. A creeping control strategy is then proposed and, to evaluate the vehicle performance, the safety temperature (250 ℃) is particularly adopted as an important metric. During the creeping process, the temperature of two clutches is always under the safety value (250 ℃), which demonstrates the effectiveness of the proposed control strategy in avoiding the thermal failures of clutches.

Keywords: Creeping control strategy, direct shift gearbox, temperature variation, wet clutch.

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Authors: M. Mansouri, P. Jaklitsch, E. Teiniker

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SQL injection on web applications is a very popular kind of attack. There are mechanisms such as intrusion detection systems in order to detect this attack. These strategies often rely on techniques implemented at high layers of the application but do not consider the low level of system calls. The problem of only considering the high level perspective is that an attacker can circumvent the detection tools using certain techniques such as URL encoding. One technique currently used for detecting low-level attacks on privileged processes is the tracing of system calls. System calls act as a single gate to the Operating System (OS) kernel; they allow catching the critical data at an appropriate level of detail. Our basic assumption is that any type of application, be it a system service, utility program or Web application, “speaks” the language of system calls when having a conversation with the OS kernel. At this level we can see the actual attack while it is happening. We conduct an experiment in order to demonstrate the suitability of system call analysis for detecting SQL injection. We are able to detect the attack. Therefore we conclude that system calls are not only powerful in detecting low-level attacks but that they also enable us to detect highlevel attacks such as SQL injection.

Keywords: Linux system calls, Web attack detection, Interception.

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Authors: Devdutt, M. L. Aggarwal

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The development of vehicles having best ride comfort and safety of travelling passengers is of great interest for automotive manufacturers. The effect of transmitted vibrations from car body to passenger seat is required to be controlled for achieving the same. The application of magneto-rheological (MR) shock absorber in suspension system has been considered to achieve significant benefits in this regard. This paper introduces a secondary suspension controlled semi-active quarter car system using MR shock absorber for effective vibration control. Fuzzy logic control system is used for design of controller for actual damping force generation by MR shock absorber. Performance evaluations are done related to passenger seat acceleration and displacement in time and frequency domains, in order to see the effectiveness of the proposed semi-active suspension system. Simulation results show that the semi-active suspension system provides better results compared to passive suspension system in terms of passenger ride comfort improvement.

Keywords: Fuzzy logic control, MR shock absorber, Quarter car model, Semi-active suspension system.

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Authors: Izian Abd. Karim, Kachalla Mohammed, Nora Farah A. A. Aziz, Law Teik Hua

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The economic use and ease of construction of profiled deck composite slab is marred with the complex and un-economic strength verification required for the serviceability and general safety considerations. Beside these, albeit factors such as shear span length, deck geometries and mechanical frictions greatly influence the longitudinal shear strength, that determines the ultimate strength of profiled deck composite slab, and number of methods available for its determination; partial shear and slope-intercept are the two methods according to Euro-code 4 provision. However, the complexity associated with shear behavior of profiled deck composite slab, the use of these methods in determining the load carrying capacities of such slab yields different and conflicting values. This couple with the time and cost constraint associated with the strength verification is a source of concern that draws more attentions nowadays, the issue is critical. Treating some of these known shear strength influencing factors as random variables, the load carrying capacity violation of profiled deck composite slab from the use of the two-methods defined according to Euro-code 4 are determined using reliability approach, and comparatively studied. The study reveals safety values from the use of m-k method shows good standing compared with that from the partial shear method.

Keywords: Composite slab, first order reliability method, longitudinal shear, partial shear connection, slope-intercept.

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Authors: L. Fauziana, M. F. Siti Atiqah, Z. A. Ahmad Noor Syukri

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The aim of the study was to identify seat belt wearing factor among road users in Malaysia. Evidence-based approach through in-depth crash investigation was utilised to determine the intended objectives. The objective was scoped into crashes investigated by Malaysian Institute of Road Safety Research (MIROS) involving passenger vehicles within 2007 and 2010. Crash information of a total of 99 crash cases involving 240 vehicles and 864 occupants were obtained during the study period. Statistical test and logistic regression analysis have been performed. Results of the analysis revealed that gender, seat position and age were associated with seat belt wearing compliance in Malaysia. Males are 97.6% more likely to wear seat belt compared to females (95% CI 1.317 to 2.964). By seat position, the finding indicates that frontal occupants were 82 times more likely to be wearing seat belt (95% CI 30.199 to 225.342) as compared to rear occupants. It is also important to note that the odds of seat belt wearing increased by about 2.64% (95% CI 1.0176 to 1.0353) for every one year increase in age. This study is essential in understanding the Malaysian tendency in belting up while being occupied in a vehicle. The factors highlighted in this study should be emphasized in road safety education in order to increase seat belt wearing rate in this country and ultimately in preventing deaths due to road crashes.

Keywords: crash investigation, risk compensation, road safety, seat belt wearing, statistical analysis.

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Authors: M. Nassereddine, J. Rizk, A. Hellany, M. Nagrial

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The High Voltage (HV) transmission mains into the community necessitate earthing design to ensure safety compliance of the system. Concrete poles are widely used within HV transmission mains; which could have an impact on the earth grid impedance and input impedance of the system from the fault point of view. This paper provides information on concrete pole earthing to enhance the split factor of the system; further, it discusses the deployment of concrete structures in high soil resistivity area to reduce the earth grid system of the plant. This paper introduces the cut off soil resistivity SC ρ when replacing timber poles with concrete ones.

Keywords: Concrete Poles, Earth Grid, EPR, High Voltage, Soil Resistivity.

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Authors: Hadi Adibi-Asl, Alireza Doosthosseini, Amir Taghavipour

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This paper studies the design of an adaptive control strategy to tune an active steering system for better drivability and maneuverability. In the first step, adaptive control strategy is applied to estimate the uncertain parameters on-line (e.g. cornering stiffness), then the estimated parameters are fed into the pole placement controller to generate corrective feedback gain to improve the steering system dynamic’s characteristics. The simulations are evaluated for three types of road conditions (dry, wet, and icy), and the performance of the adaptive pole placement control (APPC) are compared with pole placement control (PPC) and a passive system. The results show that the APPC strategy significantly improves the yaw rate and side slip angle of a bicycle plant model.

Keywords: Adaptive control, active steering, pole placement, vehicle dynamics.

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Authors: J. R. Wang, J. H. Yang, Y. Chiang, H. C. Chen, C. Shih, S. W. Chen, S. C. Chiang, T. Y. Yu

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In this study of ultimate response guideline (URG), Kuosheng BWR/6 nuclear power plant (NPP) TRACE model was established. The reactor depressurization, low pressure water injection, and containment venting are the main actions of URG. This research focuses to evaluate the efficiency of URG under Fukushima-like conditions. Additionally, the sensitivity study of URG was also performed in this research. The analysis results of TRACE present that URG can keep the peak cladding temperature (PCT) below 1088.7 K (the failure criteria) under Fukushima-like conditions. It implied that Kuosheng NPP was at the safe situation.

Keywords: BWR, TRACE, safety analysis, URG.

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Authors: Dongliang Wang, Jun Han, Dianfu Ma, Xianqi Zhao

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Avionics software is safe-critical embedded software and its architecture is evolving from traditional federated architectures to Integrated Modular Avionics (IMA) to improve resource usability. ARINC 653 (Avionics Application Standard Software Interface) is a software specification for space and time partitioning in Safety-critical avionics Real-time operating systems. Arinc653 uses two-level scheduling strategies, but current modeling tools only apply to simple problems of Arinc653 two-level scheduling, which only contain time property. In avionics industry, we are always manually allocating tasks and calculating the timing table of a real-time system to ensure it-s running as we design. In this paper we represent an automatically generating strategy which applies to the two scheduling problems with dependent constraints in Arinc653 partition run-time environment. It provides the functionality of automatic generation from the task and partition models to scheduling policy through allocating the tasks to the partitions while following the constraints, and then we design a simulating mechanism to check whether our policy is schedulable or not

Keywords: Arinc653, scheduling, task allocation, simulation.

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Authors: Abdurrahman Arslanyilmaz, Salman Al Matouq, Durmus V. Doner

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Level 3 autonomous vehicles are able to take full responsibility over the control of the vehicle unless a system boundary is reached or a system failure occurs, in which case, the driver is expected to take-over the control of the vehicle. While this happens, the driver is often not aware of the traffic situation or is engaged in a secondary task. Factors affecting the duration and quality of take-overs in these situations have included secondary task type and nature, traffic density, take-over request (TOR) time, and TOR warning type and modality. However, to the best of the authors’ knowledge, no prior study examined time buffer for TORs when a system failure occurs immediately before intersections. The first objective of this study is to investigate the effect of time buffer (3 and 7 seconds) on the duration and quality of take-overs when a system failure occurs just prior to intersections. In addition, eye-tracking has become one of the most popular methods to report what individuals view, in what order, for how long, and how often, and it has been utilized in driving simulations with various objectives. However, to the extent of authors’ knowledge, none has compared drivers’ eye gaze behavior in the two different time buffers in order to examine drivers’ attention and comprehension of salient information. The second objective is to understand the driver’s attentional focus on comprehension of salient traffic-related information presented on different parts of the dashboard and on the roads.

Keywords: Autonomous vehicles, driving simulation, eye gaze, attention, comprehension, take-over duration, take-over quality, time buffer.

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Authors: Badr M. Alshammari, T. Guesmi

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In this paper, the concept of a non-dominated sorting multi-objective particle swarm optimization with local search (NSPSO-LS) is presented for the optimal design of multimachine power system stabilizers (PSSs). The controller design is formulated as an optimization problem in order to shift the system electromechanical modes in a pre-specified region in the s-plan. A composite set of objective functions comprising the damping factor and the damping ratio of the undamped and lightly damped electromechanical modes is considered. The performance of the proposed optimization algorithm is verified for the 3-machine 9-bus system. Simulation results based on eigenvalue analysis and nonlinear time-domain simulation show the potential and superiority of the NSPSO-LS algorithm in tuning PSSs over a wide range of loading conditions and large disturbance compared to the classic PSO technique and genetic algorithms.

Keywords: Multi-objective optimization, particle swarm optimization, power system stabilizer, low frequency oscillations.

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Authors: Manikanta Prasad Banda, Che Hua Yang

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Anti-symmetric wave propagation along the particle motion of the wedge waves is known as anti-symmetric flexural (ASF) modes which travel along the wedge tips of the mid-plane apex with a small truncation. This paper investigates the characteristics of the ASF modes propagation with the wedge tip crack. The simulation and experimental results obtained by a three-dimensional (3-D) finite element model explained the contact acoustic non-linear (CAN) behavior in explicit dynamics in ABAQUS and the ultrasonic non-destructive testing (NDT) method is used for defect detection. The effect of various parameters on its high and low-level conversion modes are known for complex reflections and transmissions involved with direct reflections and transmissions. The results are used to predict the location of crack through complex transmission and reflection coefficients.

Keywords: ASF mode, crack detection, finite elements method, laser ultrasound technique, wedge waves.

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Authors: Atul Dev, Pankaj Jha

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Dr. Genichi Taguchi looked at quality in a broader term and gave an excellent definition of quality in terms of loss to society. However the scope of this definition is limited to the losses imparted by a poor quality product to the customer only and are considered during the useful life of the product and further in a certain situation this loss can even be zero. In this paper, it has been proposed that the scope of quality of a product shall be further enhanced by considering the losses imparted by a poor quality product to society at large, due to associated environmental and safety related factors, over the complete life cycle of the product. Moreover, though these losses can be further minimized with the use of techno-safety interventions, the net losses to society however can never be made zero. This paper proposes an entirely new approach towards defining product quality and is based on Taguchi’s definition of quality.

Keywords: Existing concept, goal post philosophy, life cycle, proposed concept, quality loss function.

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Authors: Essam Al-Daoud

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A potentially serious problem with current payment systems is that their underlying hard problems from number theory may be solved by either a quantum computer or unanticipated future advances in algorithms and hardware. A new quantum payment system is proposed in this paper. The suggested system makes use of fundamental principles of quantum mechanics to ensure the unconditional security without prior arrangements between customers and vendors. More specifically, the new system uses Greenberger-Home-Zeilinger (GHZ) states and Quantum Key Distribution to authenticate the vendors and guarantee the transaction integrity.

Keywords: Bell state, GHZ state, Quantum key distribution, Quantum payment system.

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Authors: Kahil Amar, Meziani Faroudja, Khelil Nacim

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The principal objective of this study is the evaluation of the seismic performance of reinforced concrete frame structures, taking into account of the behavior laws, reflecting the real behavior of materials, using CASTEM2000 software. A finite element model used is based in modified Takeda model with Timoshenko elements for columns and beams. This model is validated on a Vecchio experimental reinforced concrete (RC) frame model. Then, a study focused on the behavior of a RC frame with three-level and three-story in order to visualize the positioning the plastic hinge (plastic rotation), determined from the curvature distribution along the elements. The results obtained show that the beams of the 1^st and 2^nd level developed a very large plastic rotations, or these rotations exceed the values corresponding to CP (Collapse prevention with cp q_CP = 0.02 rad), against those developed at the 3^rd level, are between IO and LS (Immediate occupancy and life Safety with q_IO = 0.005 rad and rad q_LS = 0.01 respectively), so the beams of first and second levels submit a very significant damage.

Keywords: Seismic performance, performance level, pushover analysis, plastic rotation, plastic hinge.

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Authors: Victor Abioye Akinbinu

Abstract:

This work is intended to study the post-failure characteristic behaviour of rocks and the techniques of controlling the post-failure regime based on the mechanism of rocks deformation process. It is impossible to determine the post-failure regime of rocks using conventional laboratory testing equipment. This is because most testing machines are soft and therefore no information can be obtained after the peak load. Stress-strain deformation tests were conducted using both conventional and unconventional method (i.e. the closed loop servo-controlled testing machine) in accordance to ISRM standard. Normalised pre-failure curves were constructed to show the stages in the deformation process. The first type contains the Class I and progress to Class II with low strength soft brittle rocks. The second type shows entirely Class II characteristic behaviour. The third type is extremely brittle under axial loading, resulted in explosive failure, so its class could not be determined. The difficulty in obtaining the post-failure curves increases as the total volumetric strain approaches a positive value. The author’s use of normalised pre-failure curves enables identification of additional type of deformation process with very brittle response under axial loading. Testing the third type without confinement could cause equipment damage. Identification of the deformation process with the rock classes using conventional test could guide the personnel conducting tests using closed-loop servo-controlled system, to avoid equipment damage when testing rocks with third type deformation process so that testing is performed safely. It has also improved our understanding on total specimen failure and brittleness of rocks (e.g. brittle for Class II and less brittle or ductile for Class I).

Keywords: Closed-loop servo-controlled system, conventional testing equipment, deformation process, post-failure, pre-failure normalised curves, rock classes.

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Authors: A. Tashakori, M. Ektesabi

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Electric vehicle (EV) is one of the effective solutions to control emission of greenhouses gases in the world. It is of interest for future transportation due to its sustainability and efficiency by automotive manufacturers. Various electrical motors have been used for propulsion system of electric vehicles in last decades. In this paper brushed DC motor, Induction motor (IM), switched reluctance motor (SRM) and brushless DC motor (BLDC) are simulated and compared. BLDC motor is recommended for high performance electric vehicles. PWM switching technique is implemented for speed control of BLDC motor. Behavior of different modes of PWM speed controller of BLDC motor are simulated in MATLAB/SIMULINK. BLDC motor characteristics are compared and discussed for various PWM switching modes under normal and inverter fault conditions. Comparisons and discussions are verified through simulation results.

Keywords: BLDC motor, PWM switching technique, in-wheel technology, electric vehicle.

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Authors: Atul Khurana, Rajul Rastogi, Hans-Joachim Gamperl

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The pharmaceutical companies are getting more inclined towards patient support programs (PSPs) which assist patients and/or healthcare professionals (HCPs) in more desirable disease management and cost-effective treatment. The utmost objective of these programs is patient care. The PSPs may include financial assistance to patients, medicine compliance programs, access to HCPs via phone or online chat centers, etc. The PSP has a crucial role in terms of customer acquisition and retention strategies. During the conduct of these programs, Marketing Authorisation Holder (MAH) may receive information related to concerned medicinal products, which is usually reported by patients or involved HCPs. This information may include suspected adverse reaction(s) during/after administration of medicinal products. Hence, the MAH should design PSP to comply with regulatory reporting requirements and avoid non-compliance during PV inspection. The emergence of wireless health devices is lowering the burden on patients to manually incorporate safety data, and building a significant option for patients to observe major swings in reference to drug safety. Therefore, to enhance the adoption of these programs, MAH not only needs to aware patients about advantages of the program, but also recognizes the importance of time of patients and commitments made in a constructive manner. It is indispensable that strengthening the public health is considered as the topmost priority in such programs, and the MAH is compliant to Pharmacovigilance (PV) requirements along with regulatory obligations.

Keywords: Drug safety, good pharmacovigilance practice, patient support program, pharmacovigilance.

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Authors: S. Lemoussu, J. C. Chaudemar, R. A. Vingerhoeds

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The aeronautics sector is currently living an unprecedented growth largely due to innovative projects. In several cases, such innovative developments are being carried out by Small and Medium sized-Enterprises (SMEs). For instance, in Europe, a handful of SMEs are leading projects like airships, large civil drones, or flying cars. These SMEs have all limited resources, must make strategic decisions, take considerable financial risks and in the same time must take into account the constraints of safety, cost, time and performance as any commercial organization in this industry. Moreover, today, no international regulations fully exist for the development and certification of this kind of projects. The absence of such a precise and sufficiently detailed regulatory framework requires a very close contact with regulatory instances. But, SMEs do not always have sufficient resources and internal knowledge to handle this complexity and to discuss these issues. This poses additional challenges for those SMEs that have system integration responsibilities and that must provide all the necessary means of compliance to demonstrate their ability to design, produce, and operate airships with the expected level of safety and reliability. The final objective of our research is thus to provide a methodological framework supporting SMEs in their development taking into account recent innovation and institutional rules of the sector. We aim to provide a contribution to the problematic by developing a specific Model-Based Systems Engineering (MBSE) approach. Airspace regulation, aeronautics standards and international norms on systems engineering are taken on board to be formalized in a set of models. This paper presents the on-going research project combining Systems Engineering and Project Management process modeling and taking into account the metamodeling problematic.

Keywords: Aeronautics, certification, process modeling, project management, SME, systems engineering.

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Authors: P. Naderi, S.M.T. Bathaee, R. Hoseinnezhad, R. Chini

Abstract:

Using electrical machine in conventional vehicles, also called hybrid vehicles, has become a promising control scheme that enables some manners for fuel economy and driver assist for better stability. In this paper, vehicle stability control, fuel economy and Driving/Regeneration braking for a 4WD hybrid vehicle is investigated by using an electrical machine on each non-driven wheels. In front wheels driven vehicles, fuel economy and regenerative braking can be obtained by summing torques applied on rear wheels. On the other hand, unequal torques applied to rear wheels provides enhanced safety and path correction in steering. In this paper, a model with fourteen degrees of freedom is considered for vehicle body, tires and, suspension systems. Thereafter, powertrain subsystems are modeled. Considering an electrical machine on each rear wheel, a fuzzy controller is designed for each driving, braking, and stability conditions. Another fuzzy controller recognizes the vehicle requirements between the driving/regeneration and stability modes. Intelligent vehicle control to multi objective operation and forward simulation are the paper advantages. For reaching to these aims, power management control and yaw moment control will be done by three fuzzy controllers. Also, the above mentioned goals are weighted by another fuzzy sub-controller base on vehicle dynamic. Finally, Simulations performed in MATLAB/SIMULINK environment show that the proposed structure can enhance the vehicle performance in different modes effectively.

Keywords: Hybrid, pitch, roll, regeneration, yaw.

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