Disparities versus Similarities: WHO GPPQCL and ISO/IEC 17025:2017 International Standards for Quality Management Systems in Pharmaceutical Laboratories

Medicines regulatory authorities expect pharmaceutical companies and contract research organizations to seek ways to certify that their laboratory control measurements are reliable. Establishing and maintaining laboratory quality standards are essential in ensuring the accuracy of test results. ‘ISO/IEC 17025:2017’ and ‘WHO Good Practices for Pharmaceutical Quality Control Laboratories (GPPQCL)’ are two quality standards commonly employed in developing laboratory quality systems. A review was conducted on the two standards to elaborate on areas on convergence and divergence. The goal was to understand how differences in each standard's requirements may influence laboratories' choices as to which document is easier to adopt for quality systems. A qualitative review method compared similar items in the two standards while mapping out areas where there were specific differences in the requirements of the two documents. The review also provided a detailed description of the clauses and parts covering management and technical requirements in these laboratory standards. The review showed that both documents share requirements for over ten critical areas covering objectives, infrastructure, management systems, and laboratory processes. There were, however, differences in standard expectations where GPPQCL emphasizes system procedures for planning and future budgets that will ensure continuity. Conversely, ISO 17025 was more focused on the risk management approach to establish laboratory quality systems. Elements in the two documents form common standard requirements to assure the validity of laboratory test results that promote mutual recognition. The ISO standard currently has more global patronage than GPPQCL.

Proposals for the Thermal Regulation of Buildings in Algeria: An Energy Label for Social Housing

Despite the international commitment of Algeria towards the development of energy efficiency and renewable energy in the country, the internal energy demand has been continuously growing during the last decade due to the substantial increase of population and of living conditions, which in turn has led to an unprecedented expansion of the residential building sector. The RTB (Thermal Building Regulation) is the technical document that establishes the calculation framework for the thermal performance of buildings in Algeria, setting up minimum obligatory targets for the thermal performance of new buildings. An update of this regulation is due in the coming years and this paper discusses some proposals in this regard, with the aim to improve the energy efficiency of the building sector, particularly with regard to social housing. In particular, it proposes a methodology for drafting an energy performance label of new Algerian residential buildings, moving from the results of the thermal compliance verification and sizing of technical systems as defined in the RTB. Such an energy performance label – whose calculation method is briefly described in the paper – aims to raise citizens' awareness of the benefits of energy efficiency. It can represent the first step in a process of integrating technical installations into the calculation of the energy performance of buildings in Algeria.

The Client-Supplier Relationship in Managing Innovation: Delineating Defence Industry First Mover Challenges within the Government Contract Competition

All companies are confronted with the need to innovate in order to meet market demands. In so doing they are challenged with the dilemma of whether to aim to be first into the market with a new innovative product, or to deliberately wait and learn from a pioneers’ mistakes; potentially avoiding higher risks. It is therefore important to critically understand from a first mover advantage and disadvantage perspective the decision-making implications of defence industry transformation onset by an innovative paradigm shift. This paper will argue that the type of industry characteristics matter, especially when considering what role the clients play in the innovation process and what their level of influence is. Through investigation of qualitative case study research, this inquiry will focus on first mover advantages and first mover disadvantages with a view to establish practical and value-added academic findings by focusing on specific industries where the clients play an active role in cooperation with the supplier innovation. The resulting findings will help managers to mitigate risk in innovative technology introduction. A selection from several defence industry innovations is specifically chosen because of the client–supplier relationship that typically differs from traditional first mover research. In this instance, case studies will be used referencing vertical-take-off-and-landing defence equipment innovations. 

Comparison of Composite Programming and Compromise Programming for Aircraft Selection Problem Using Multiple Criteria Decision Making Analysis Method

In this paper, the comparison of composite programming and compromise programming for the aircraft selection problem is discussed using the multiple criteria decision analysis method. The decision making process requires the prior definition and fulfillment of certain factors, especially when it comes to complex areas such as aircraft selection problems. The proposed technique gives more efficient results by extending the composite programming and compromise programming, which are widely used in modeling multiple criteria decisions. The proposed model is applied to a practical decision problem for evaluating and selecting aircraft problems.A selection of aircraft was made based on the proposed approach developed in the field of multiple criteria decision making. The model presented is solved by using the following methods: composite programming, and compromise programming. The importance values of the weight coefficients of the criteria are calculated using the mean weight method. The evaluation and ranking of aircraft are carried out using the composite programming and compromise programming methods. In order to determine the stability of the model and the ability to apply the developed composite programming and compromise programming approach, the paper analyzes its sensitivity, which involves changing the value of the coefficient λ and q in the first part. The second part of the sensitivity analysis relates to the application of different multiple criteria decision making methods, composite programming and compromise programming. In addition, in the third part of the sensitivity analysis, the Spearman correlation coefficient of the ranks obtained was calculated which confirms the applicability of all the proposed approaches.

Combination of Tensile Strength and Elongation of Reverse Rolled TaNbHfZrTi Refractory High Entropy Alloy

The refractory high entropy alloys are potential materials for high-temperature applications because of their ability to retain high strength up to 1600°C. However, their practical applications were limited due to poor elongation at room temperature. Therefore, decreasing the average valence electron concentrations (VEC) is an effective design strategy to improve the intrinsic ductility of refractory high entropy alloys. In this work, the high-entropy alloy TaNbHfZrTi was processed at room temperature by each step reverse rolling up to a 90% reduction in thickness. Subsequently, the reverse rolled 90% samples were utilized for annealing treatment at 800°C and 1000°C for 1 h to understand phase stability, microstructure, texture, and mechanical properties. The reverse rolled 90% condition contains body-centered cubic (BCC) single-phase; upon annealing at 800 °C, the formation of secondary phase BCC-2 prevailed. The partial recrystallization and complete recrystallization microstructures were developed for annealed at 800°C and 1000°C, respectively. The reverse rolled condition and 1000°C annealed temperature exhibit extraordinary room temperature tensile properties with high ultimate tensile strength (UTS) without compromising loss of ductility called “strength-ductility” trade-off. The reverse-rolled 90% and annealing treatment carried out at temperature about 1000°C for 1 h consist of UTS 1430 MPa and 1556 MPa with an appreciable amount of 21% and 20% elongation, respectively. The development of hierarchical microstructure prevailed for the annealed 1000°C which led to the simultaneous increase in tensile strength and elongation.

Neural Network Supervisory Proportional-Integral-Derivative Control of the Pressurized Water Reactor Core Power Load Following Operation

This work presents the particle swarm optimization trained neural network (PSO-NN) supervisory proportional integral derivative (PID) control method to monitor the pressurized water reactor (PWR) core power for safe operation. The proposed control approach is implemented on the transfer function of the PWR core, which is computed from the state-space model. The PWR core state-space model is designed from the neutronics, thermal-hydraulics, and reactivity models using perturbation around the equilibrium value. The proposed control approach computes the control rod speed to maneuver the core power to track the reference in a closed-loop scheme. The particle swarm optimization (PSO) algorithm is used to train the neural network (NN) and to tune the PID simultaneously. The controller performance is examined using integral absolute error, integral time absolute error, integral square error, and integral time square error functions, and the stability of the system is analyzed by using the Bode diagram. The simulation results indicated that the controller shows satisfactory performance to control and track the load power effectively and smoothly as compared to the PSO-PID control technique. This study will give benefit to design a supervisory controller for nuclear engineering research fields for control application.

Educational Experiences in Engineering in the COVID-19 Era and Their Comparative Analysis: Spain, March-June 2020

In March 2020, in Spain, a sanitary and unexpected crisis caused by COVID-19 was declared. All of a sudden, all degrees, classes and evaluation tests and projects had to be transformed into online activities. However, the chaotic situation generated by a complex operation like that, executed without any well-established procedure, led to very different experiences and, finally, results. In this paper, we are describing three experiences in two different Universities in Madrid. On the one hand, the Technical University of Madrid, a public university with little experience in online education was considered. On the other hand, Alfonso X el Sabio University, a private university with more than five years of experience in online teaching was involved. All analyzed subjects were related to computer engineering. Professors and students answered a survey and personal interviews were also carried out. Besides, the professors’ workload and the students’ academic results were also compared. From the comparative analysis of all these experiences, we are extracting the most successful strategies, methodologies, and activities. The recommendations in this paper will be useful for courses during the next months when the sanitary situation is still affecting an educational organization. While, at the same time, they will be considered as input for the upcoming digitalization process of higher education.

Energy Management System with Temperature Rise Prevention on Hybrid Ships

Marine shipping has now become one of the major worldwide contributors to pollution and greenhouse gas emissions. Hybrid ships technology based on multiple energy sources has taken a great scope of research to get rid of ship emissions and cut down fuel expenses. Insufficiency between power generated and the demand load to withstand the transient behavior on ships during severe climate conditions will lead to a blackout. Thus, an efficient energy management system (EMS) is a mandatory scope for achieving higher system efficiency while enhancing the lifetime of the onboard storage systems is another salient EMS scope. Considering energy storage system conditions, both the battery state of charge (SOC) and temperature represent important parameters to prevent any malfunction of the storage system that eventually degrades the whole system. In this paper, a two battery packs ratio fuzzy logic control model is proposed. The overall aim is to control the charging/discharging current while including both the battery SOC and temperature in the energy management system. The full designs of the proposed controllers are described and simulated using Matlab. The results prove the successfulness of the proposed controller in stabilizing the system voltage during both loading and unloading while keeping the energy storage system in a healthy condition.

Software Product Quality Evaluation Model with Multiple Criteria Decision Making Analysis

This paper presents a software product quality evaluation model based on the ISO/IEC 25010 quality model. The evaluation characteristics and sub characteristics were identified from the ISO/IEC 25010 quality model. The multidimensional structure of the quality model is based on characteristics such as functional suitability, performance efficiency, compatibility, usability, reliability, security, maintainability, and portability, and associated sub characteristics. Random numbers are generated to establish the decision maker’s importance weights for each sub characteristics. Also, random numbers are generated to establish the decision matrix of the decision maker’s final scores for each software product against each sub characteristics. Thus, objective criteria importance weights and index scores for datasets were obtained from the random numbers. In the proposed model, five different software product quality evaluation datasets under three different weight vectors were applied to multiple criteria decision analysis method, preference analysis for reference ideal solution (PARIS) for comparison, and sensitivity analysis procedure. This study contributes to provide a better understanding of the application of MCDMA methods and ISO/IEC 25010 quality model guidelines in software product quality evaluation process.

Incorporating Lexical-Semantic Knowledge into Convolutional Neural Network Framework for Pediatric Disease Diagnosis

The utilization of electronic medical record (EMR) data to establish the disease diagnosis model has become an important research content of biomedical informatics. Deep learning can automatically extract features from the massive data, which brings about breakthroughs in the study of EMR data. The challenge is that deep learning lacks semantic knowledge, which leads to impracticability in medical science. This research proposes a method of incorporating lexical-semantic knowledge from abundant entities into a convolutional neural network (CNN) framework for pediatric disease diagnosis. Firstly, medical terms are vectorized into Lexical Semantic Vectors (LSV), which are concatenated with the embedded word vectors of word2vec to enrich the feature representation. Secondly, the semantic distribution of medical terms serves as Semantic Decision Guide (SDG) for the optimization of deep learning models. The study evaluates the performance of LSV-SDG-CNN model on four kinds of Chinese EMR datasets. Additionally, CNN, LSV-CNN, and SDG-CNN are designed as baseline models for comparison. The experimental results show that LSV-SDG-CNN model outperforms baseline models on four kinds of Chinese EMR datasets. The best configuration of the model yielded an F1 score of 86.20%. The results clearly demonstrate that CNN has been effectively guided and optimized by lexical-semantic knowledge, and LSV-SDG-CNN model improves the disease classification accuracy with a clear margin.

An Approach to Capture, Evaluate and Handle Complexity of Engineering Change Occurrences in New Product Development

This paper represents the conception that complex problems do not necessary need similar complex solutions in order to cope with the complexity. Furthermore, a simple solution based on established methods can provide a sufficient way dealing with the complexity. To verify this conception, the presented paper focuses on the field of change management as a part of new product development process in automotive sector. In the field of complexity management, dealing with increasing complexity is essential, while, only non-flexible rigid processes that are not designed to handle complexity are available. The basic methodology of this paper can be divided in four main sections: 1) analyzing the complexity of the change management, 2) literature review in order to identify potential solutions and methods, 3) capturing and implementing expertise of experts from change management filed of an automobile manufacturing company and 4) systematical comparison of the identified methods from literature and connecting these with defined requirements of the complexity of the change management in order to develop a solution. As a practical outcome, this paper provides a method to capture the complexity of engineering changes (EC) and includes it within the EC evaluation process, following case-related process guidance to cope with the complexity. Furthermore, this approach supports the conception that dealing with complexity is possible while utilizing rather simple and established methods by combining them in to a powerful tool.

Geometric Simplification Method of Building Energy Model Based on Building Performance Simulation

In the design stage of a new building, the energy model of this building is often required for the analysis of the performance on energy efficiency. In practice, a certain degree of geometric simplification should be done in the establishment of building energy models, since the detailed geometric features of a real building are hard to be described perfectly in most energy simulation engine, such as ESP-r, eQuest or EnergyPlus. Actually, the detailed description is not necessary when the result with extremely high accuracy is not demanded. Therefore, this paper analyzed the relationship between the error of the simulation result from building energy models and the geometric simplification of the models. Finally, the following two parameters are selected as the indices to characterize the geometric feature of in building energy simulation: the southward projected area and total side surface area of the building. Based on the parameterization method, the simplification from an arbitrary column building to a typical shape (a cuboid) building can be made for energy modeling. The result in this study indicates that no more than 7% prediction error of annual cooling/heating load will be caused by the geometric simplification for those buildings with the ratio of southward projection length to total perimeter of the bottom of 0.25~0.35, which means this method is applicable for building performance simulation.

Nascent Federalism in Nepal: An Observational Review in Its Evolution

Nepal practiced a centralized unitary governing system for long and has gone through the federal system after the promulgation of the new constitution on 20 September 2015. There is a big paradigm shift in terms of governance after it. Now, there are three levels of governments, one federal government in the center, seven provincial governments and 753 local governments. Federalism refers to a political governing system with multiple tiers of government working together with coordination. It is preferred for self and shared rule. Though it has opened the door for rights of the people, political stability, state restructuring, and sustainable peace and development, there are many prospects and challenges for its proper implementation. This research analyzes the discourses of federalism implementation in Nepal with special reference to one of seven provinces, Gandaki. Federalism is a new phenomenon in Nepali politics and informed debates on it are required for its right evolution. This research will add value in this regard. Moreover, tracking its evolution and the exploration of the attitudes and behaviors of key actors and stakeholders in a new experiment of a new governing system is also important. The administrative and political system of Gandaki province in terms of service delivery and development will critically be examined. Besides demonstrating the performances of the provincial government and assembly, it will analyze the inter-governmental relation of Gandaki with the other two tiers of government. For this research, people from provincial and local governments (elected representatives and government employees), provincial assembly members, academicians, civil society leaders and journalists are being interviewed. The interview findings will be analyzed by supplementing with published documents. Just going into the federal structure is not the solution. As in the case of other provincial governments, Gandaki also had to start from scratch. It gradually took a shape of government and has been functioning sluggishly. The provincial government has many challenges ahead, which has badly hindered its plans and actions. Additionally, fundamental laws, infrastructures and human resources are found to be insufficient at the sub-national level. Lack of clarity in the jurisdiction is another main challenge. The Nepali Constitution assumes cooperation, coexistence and coordination as the fundamental principles of federalism which, unfortunately, appear to be lacking among the three tiers of government despite their efforts. Though the devolution of power to sub-national governments is essential for the successful implementation of federalism, it has apparently been delayed due to the centralized mentality of bureaucracy as well as a political leader. This research will highlight the reasons for the delay in the implementation of federalism. There might be multiple underlying reasons for the slow pace of implementation of federalism and identifying them is very tough. Moreover, the federal spirit is found to be absent in the main players of today's political system, which is a big irony. So, there are some doubts about whether the federal system in Nepal is just a keepsake or a substantive achievement.

Comparison of Conventional Control and Robust Control on Double-Pipe Heat Exchanger

Heat exchanger is a device used to mix liquids having different temperatures. In this case, the temperature control becomes a critical objective. This research work presents the temperature control of the double-pipe heat exchanger (multi-input multi-output (MIMO) system), which is modeled as first-order coupled hyperbolic partial differential equations (PDEs), using conventional and advanced control techniques, and develops appropriate robust control strategy to meet stability requirements and performance objectives. We designed the proportional–integral–derivative (PID) controller and H-infinity controller for a heat exchanger (HE) system. Frequency characteristics of sensitivity functions and open-loop and closed-loop time responses are simulated using MATLAB software and the stability of the system is analyzed using Kalman's test. The simulation results have demonstrated that the H-infinity controller is more efficient than PID in terms of robustness and performance.

Scenario and Decision Analysis for Solar Energy in Egypt by 2035 Using Dynamic Bayesian Network

Bayesian networks are now considered to be a promising tool in the field of energy with different applications. In this study, the aim was to indicate the states of a previous constructed Bayesian network related to the solar energy in Egypt and the factors affecting its market share, depending on the followed data distribution type for each factor, and using either the Z-distribution approach or the Chebyshev’s inequality theorem. Later on, the separate and the conditional probabilities of the states of each factor in the Bayesian network were derived, either from the collected and scrapped historical data or from estimations and past studies. Results showed that we could use the constructed model for scenario and decision analysis concerning forecasting the total percentage of the market share of the solar energy in Egypt by 2035 and using it as a stable renewable source for generating any type of energy needed. Also, it proved that whenever the use of the solar energy increases, the total costs decreases. Furthermore, we have identified different scenarios, such as the best, worst, 50/50, and most likely one, in terms of the expected changes in the percentage of the solar energy market share. The best scenario showed an 85% probability that the market share of the solar energy in Egypt will exceed 10% of the total energy market, while the worst scenario showed only a 24% probability that the market share of the solar energy in Egypt will exceed 10% of the total energy market. Furthermore, we applied policy analysis to check the effect of changing the controllable (decision) variable’s states acting as different scenarios, to show how it would affect the target nodes in the model. Additionally, the best environmental and economical scenarios were developed to show how other factors are expected to be, in order to affect the model positively. Additional evidence and derived probabilities were added for the weather dynamic nodes whose states depend on time, during the process of converting the Bayesian network into a dynamic Bayesian network.

Gaits Stability Analysis for a Pneumatic Quadruped Robot Using Reinforcement Learning

Deep reinforcement learning (deep RL) algorithms leverage the symbolic power of complex controllers by automating it by mapping sensory inputs to low-level actions. Deep RL eliminates the complex robot dynamics with minimal engineering. Deep RL provides high-risk involvement by directly implementing it in real-world scenarios and also high sensitivity towards hyperparameters. Tuning of hyperparameters on a pneumatic quadruped robot becomes very expensive through trial-and-error learning. This paper presents an automated learning control for a pneumatic quadruped robot using sample efficient deep Q learning, enabling minimal tuning and very few trials to learn the neural network. Long training hours may degrade the pneumatic cylinder due to jerk actions originated through stochastic weights. We applied this method to the pneumatic quadruped robot, which resulted in a hopping gait. In our process, we eliminated the use of a simulator and acquired a stable gait. This approach evolves so that the resultant gait matures more sturdy towards any stochastic changes in the environment. We further show that our algorithm performed very well as compared to programmed gait using robot dynamics.

Review of Innovation Management Frameworks and Assessment Tools

Research studies are highly fragmented when an Innovation Management Framework is being discussed. With the aim to identify an Innovation Management Framework/Assessment Tool suitable for Small & Medium Enterprises (SMEs) in the service industry, this researcher critically reviewed existing innovation management frameworks and assessment models/tools and discovered a number of literature gaps. It is established that the existing literature lacks generally agreed innovation management dimensions, commonly accepted knowledge creation through empirical studies on innovation management in SMEs, effective innovation management performance measurements, suitable innovation management framework in SMEs, and studies on innovation management in the service industry, in particular in retail SMEs. As such, there is a dire need to develop an appropriate firm-level innovation management framework suitable for SMEs in the service industry for future research projects and further studies. In addition, this researcher also discussed the significance of establishing such an innovation management framework.

A Comparative Analysis of Multiple Criteria Decision Making Analysis Methods for Strategic, Tactical, and Operational Decisions in Military Fighter Aircraft Selection

This paper considers a comparative analysis of multiple criteria decision making analysis methods for strategic, tactical, and operational decisions in military fighter aircraft selection for the air force fleet planning. The evaluation criteria governing the decision analysis process are determined from the literature for the three existing military combat aircraft. Military fighter aircraft selection problem is structured using "preference analysis for reference ideal solution (PARIS)” approach in multiple criteria decision analysis (MCDMA). Systematic comparisons were made with existing MCDMA methods (PARIS, and TOPSIS) to verify the stability and accuracy of the results obtained. The proposed integrated MCDMA systematic approach is expected to address the issues encountered in the aircraft selection process. The comparative analysis results show that the proposed method is an effective and accurate tool that can help analysts make better strategic, tactical, and operational decisions.

Trainer Aircraft Selection Using Preference Analysis for Reference Ideal Solution (PARIS)

This article presents a multiple criteria evaluation for a trainer aircraft selection problem using "preference analysis for reference ideal solution (PARIS)” approach. The available relevant literature points to the use of multiple criteria decision making analysis (MCDMA) methods for the problem of trainer aircraft selection, which often involves conflicting multiple criteria. Therefore, this MCDMA study aims to propose a robust systematic integrated framework focusing on the trainer aircraft selection problem. For this purpose, an integrated preference analysis approach based the mean weight and entropy weight procedures with PARIS, and TOPSIS was used for a MCDMA compensating solution. In this study, six trainer aircraft alternatives were evaluated according to six technical decision criteria, and data were collected from the current relevant literature. As a result, the King Air C90GTi alternative was identified as the most suitable trainer aircraft alternative. In order to verify the stability and accuracy of the results obtained, comparisons were made with existing MCDMA methods during the sensitivity and validity analysis process.The results of the application were further validated by applying the comparative analysis-based PARIS, and TOPSIS method. The proposed integrated MCDMA systematic structure is also expected to address the issues encountered in the aircraft selection process. Finally, the analysis results obtained show that the proposed MCDMA method is an effective and accurate tool that can help analysts make better decisions.

Aircraft Selection Using Multiple Criteria Decision Making Analysis Method with Different Data Normalization Techniques

This paper presents an original application of multiple criteria decision making analysis theory to the evaluation of aircraft selection problem. The selection of an optimal, efficient and reliable fleet, network and operations planning policy is one of the most important factors in aircraft selection problem. Given that decision making in aircraft selection involves the consideration of a number of opposite criteria and possible solutions, such a selection can be considered as a multiple criteria decision making analysis problem. This study presents a new integrated approach to decision making by considering the multiple criteria utility theory and the maximal regret minimization theory methods as well as aircraft technical, economical, and environmental aspects. Multiple criteria decision making analysis method uses different normalization techniques to allow criteria to be aggregated with qualitative and quantitative data of the decision problem. Therefore, selecting a suitable normalization technique for the model is also a challenge to provide data aggregation for the aircraft selection problem. To compare the impact of different normalization techniques on the decision problem, the vector, linear (sum), linear (max), and linear (max-min) data normalization techniques were identified to evaluate aircraft selection problem. As a logical implication of the proposed approach, it enhances the decision making process through enabling the decision maker to: (i) use higher level knowledge regarding the selection of criteria weights and the proposed technique, (ii) estimate the ranking of an alternative, under different data normalization techniques and integrated criteria weights after a posteriori analysis of the final rankings of alternatives. A set of commercial passenger aircraft were considered in order to illustrate the proposed approach. The obtained results of the proposed approach were compared using Spearman's rho tests. An analysis of the final rank stability with respect to the changes in criteria weights was also performed so as to assess the sensitivity of the alternative rankings obtained by the application of different data normalization techniques and the proposed approach.