Abstract: 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.
Abstract: The evolution of quality management by companies was strongly enabled by, among others, ISO 9001 certification, which is considered a crucial requirement for several customers. Likewise, performance measurement provides useful insights for companies to identify the reflection of their decision-making process on their improvement. One of the most used performance measurement models is the balanced scorecard (BSC), which uses four perspectives to address a firm’s performance: financial, internal process, customer satisfaction, and learning and growth. Since ISO 9001 certified firms are likely to measure their performance through BSC approach, it is important to verify whether the certificate influences the firm performance or not. Therefore, this paper aims to verify the impact of ISO 9001:2015 on Brazilian firms’ performance based on the BSC perspective. Hence, nine certified companies located in the Southeast region of Brazil were studied through a multiple case study approach. Within this study, it was possible to identify the positive impact of ISO 9001 on firms’ overall performance, and four Critical Success Factors (CSFs) were identified as relevant on the linkage among ISO 9001 and firms’ performance: employee involvement, top management, process management, and customer focus. Due to the COVID-19 pandemic, the number of interviews was limited to the quality manager specialist, and the sample was limited since several companies were closed during the period of the study. This study presents an in-depth analysis of how the relationship between ISO 9001 certification and firms’ performance in a developing country is.
Abstract: The profusion of studies relating to the concept of organizational learning shows the importance that has been given to this concept in the management sciences. A few years ago, companies leaned towards ISO 9001 certification; this requires the implementation of the quality management system (QMS). In order for this objective to be achieved, companies must have a set of skills, which pushes them to develop learning through continuous training. The results of empirical research have shown that implementation of the QMS in the company promotes the development of learning. It should also be noted that several types of learning are developed in this sense. Given the nature of skills development is normative in the context of the quality demarche, companies are obliged to qualify and improve the skills of their human resources. Continuous training is the keystone to develop the necessary learning. To carry out continuous training, companies need to be able to identify their real needs by developing training plans based on well-defined engineering. The training process goes obviously through several stages. Initially, training has a general aspect, that is to say, it focuses on topics and actions of a general nature. Subsequently, this is done in a more targeted and more precise way to accompany the evolution of the QMS and also to make the changes decided each time (change of working method, change of practices, change of objectives, change of mentality, etc.). To answer our problematic we opted for the method of qualitative research. It should be noted that the case study method crosses several data collection techniques to explain and understand a phenomenon. Three cases of companies were studied as part of this research work using different data collection techniques related to this method.
Abstract: The accreditation process of engineering degree programmes is based on various reports evaluated by the relevant governing bodies of the institution of higher education. One of the aforementioned reports for the accreditation process is a self-assessment report which is to be completed by the applying institution. This paper seeks to emphasise the importance of analysis of internal quality management systems and self-examination processes in the engineering accreditation processes. A description of how the programme fulfils the criteria should be given. Relevant stakeholders all need to contribute in the writing and structuring of the self-assessment report. The last step is to gather evidence in the form of supporting documentation. In conclusion, the paper also identifies learning outcomes in a case study in seeking accreditation from an international relevant professional body.
Abstract: The purpose of the article is to describe project objective structure (POS) concept that was developed on research activities and experiences about project management, Balanced Scorecard (BSC) and European Foundation Quality Management Excellence Model (EFQM Excellence Model). Furthermore, this paper tries to define a balanced, systematic, and integrated measurement approach to meet project objectives and project strategic goals based on a process-oriented model. In this paper, POS is suggested in order to measure project performance in the project life cycle. After using the POS model, the project manager can ensure in order to achieve the project objectives on the project charter. This concept can help project managers to implement integrated and balanced monitoring and control project work.
Abstract: Organizations support their operations and decision making on the data they have at their disposal, so the quality of these data is remarkably important and Data Quality (DQ) is currently a relevant issue, the literature being unanimous in pointing out that poor DQ can result in large costs for organizations. The literature review identified and described 24 Critical Success Factors (CSF) for Data Quality Management (DQM) that were presented to a panel of experts, who ordered them according to their degree of importance, using the Delphi method with the Q-sort technique, based on an online questionnaire. The study shows that the five most important CSF for DQM are: definition of appropriate policies and standards, control of inputs, definition of a strategic plan for DQ, organizational culture focused on quality of the data and obtaining top management commitment and support.
Abstract: The impact of lean management on environmental sustainability is the research line that receives the most attention from academicians. Therefore, the social dimension of sustainable development has so far received less attention. This paper aims to evaluate the impact of intra-plant lean manufacturing practices on social sustainability indicators extracted from the Global Reporting Initiative (GRI) parameters. The method is two-phased, including MCDM approach to uncover the most relevant practices regarding social performance and Interpretive Structural Modeling (ISM) method to reveal the structural relationship among lean practices. Professionals from the academic and industrial fields answered the questionnaires. From the results of this paper, it is possible to verify that practices such as “Safety Improvement Programs”, “Total Quality Management” and “Cross-functional Workforce” are the ones which have the most positive influence on the set of GRI social indicators.
Abstract: The purpose of this paper is to analyze and apprehend, through four case studies, the interest of the project of the implementation of the quality management system (QMS) at four Moroccan small and medium-sized enterprises (SMEs). This project could generate significant organizational change to improve the functioning of the organization. In fact, quality is becoming a necessity in the current business world. It is considered to be a major component in companies’ competitive strategies. It should be noted that quality management is characterized by a set of methods and techniques that can be used to solve malfunctions and reorganize companies. It is useful to point out that the choice of the adoption of the quality approach could be influenced by the circumstances of the business context, it could also be derived from its strategic vision; this means that this choice can be characterized as either a strategic aspect or a reactive aspect. This would probably have a major impact on the functioning of the QMS and also on the perception of the quality issue by company managers and their employees.
Abstract: Currently, LLC «Lukoil-Kaliningradmorneft» is implementing a comprehensive program for the development of offshore fields of the Kaliningrad region. This is largely associated with the depletion of the resource base of land in the region, as well as the positive results of geological investigation surrounding the Baltic Sea area and the data on the volume of hydrocarbon recovery from a single offshore field are working on the Kaliningrad region – D-6 «Kravtsovskoye».The article analyzes the main stages of the LLC «Lukoil-Kaliningradmorneft»’s development program for the development of the hydrocarbon resources of the region's shelf and suggests an optimization algorithm that allows managing a multi-criteria process of development of shelf deposits. The algorithm is formed on the basis of the problem of sequential decision making, which is a section of dynamic programming. Application of the algorithm during the consolidation of the initial data, the elaboration of project documentation, the further exploration and development of offshore fields will allow to optimize the complex of technical and technological solutions and increase the economic efficiency of the field development project implemented by LLC «Lukoil-Kaliningradmorneft».
Abstract: Any industrial company needs to determine the amount of variation that exists within its measurement process and guarantee the reliability of their data, studying the performance of their measurement system, in terms of linearity, bias, repeatability and reproducibility and stability. This issue is critical for automotive industry suppliers, who are required to be certified by the 16949:2016 standard (replaces the ISO/TS 16949) of International Automotive Task Force, defining the requirements of a quality management system for companies in the automotive industry. Measurement System Analysis (MSA) is one of the mandatory tools. Frequently, the measurement system in companies is not connected to the equipment and do not incorporate the methods proposed by the Automotive Industry Action Group (AIAG). To address these constraints, an R&D project is in progress, whose objective is to develop a web and cloud-based MSA tool. This MSA tool incorporates Industry 4.0 concepts, such as, Internet of Things (IoT) protocols to assure the connection with the measuring equipment, cloud computing, artificial intelligence, statistical tools, and advanced mathematical algorithms. This paper presents the preliminary findings of the project. The web and cloud-based MSA tool is innovative because it implements all statistical tests proposed in the MSA-4 reference manual from AIAG as well as other emerging methods and techniques. As it is integrated with the measuring devices, it reduces the manual input of data and therefore the errors. The tool ensures traceability of all performed tests and can be used in quality laboratories and in the production lines. Besides, it monitors MSAs over time, allowing both the analysis of deviations from the variation of the measurements performed and the management of measurement equipment and calibrations. To develop the MSA tool a ten-step approach was implemented. Firstly, it was performed a benchmarking analysis of the current competitors and commercial solutions linked to MSA, concerning Industry 4.0 paradigm. Next, an analysis of the size of the target market for the MSA tool was done. Afterwards, data flow and traceability requirements were analysed in order to implement an IoT data network that interconnects with the equipment, preferably via wireless. The MSA web solution was designed under UI/UX principles and an API in python language was developed to perform the algorithms and the statistical analysis. Continuous validation of the tool by companies is being performed to assure real time management of the ‘big data’. The main results of this R&D project are: MSA Tool, web and cloud-based; Python API; New Algorithms to the market; and Style Guide of UI/UX of the tool. The MSA tool proposed adds value to the state of the art as it ensures an effective response to the new challenges of measurement systems, which are increasingly critical in production processes. Although the automotive industry has triggered the development of this innovative MSA tool, other industries would also benefit from it. Currently, companies from molds and plastics, chemical and food industry are already validating it.
Abstract: The sustainable measures on air quality management are recognized as one of the most serious environmental concerns in the mining region. The mining operations emit various types of pollutants which have significant impacts on the environment. This study presents a stochastic control strategy by developing the air pollution control model to achieve a cost-effective solution. The optimization method is formulated to predict the cost of treatment using linear programming with an objective function and multi-constraints. The constraints mainly focus on two factors which are: production of metal should not exceed the available resources, and air quality should meet the standard criteria of the pollutant. The applicability of this model is explored through a case study of an open pit metal mine, Utah, USA. This method simultaneously uses meteorological data as a dispersion transfer function to support the practical local conditions. The probabilistic analysis and the uncertainties in the meteorological conditions are accomplished by Monte Carlo simulation. Reasonable results have been obtained to select the optimized treatment technology for PM2.5, PM10, NOx, and SO2. Additional comparison analysis shows that baghouse is the least cost option as compared to electrostatic precipitator and wet scrubbers for particulate matter, whereas non-selective catalytical reduction and dry-flue gas desulfurization are suitable for NOx and SO2 reduction respectively. Thus, this model can aid planners to reduce these pollutants at a marginal cost by suggesting control pollution devices, while accounting for dynamic meteorological conditions and mining activities.
Abstract: Increasing quality requirements make reliable and effective quality management indispensable. This includes the complaint handling in which the 8D method is widely used. The 8D report as a written documentation of the 8D method is one of the key quality documents as it internally secures the quality standards and acts as a communication medium to the customer. In practice, however, the 8D report is mostly faulty and of poor quality. There is no quality control of 8D reports today. This paper describes the use of natural language processing for the automated evaluation of 8D reports. Based on semantic analysis and text-mining algorithms the presented system is able to uncover content and formal quality deficiencies and thus increases the quality of the complaint processing in the long term.
Abstract: The objective of this study provides an insight into enterprises, who need to carry on their sustainability in harmony with the changing competition conditions, technology and laws, regarding the ISO 9001:2015. In the study, ISO 9001:2015, which is planned to be put in force and exists as a draft, was studied and its differences from the previous standard, ISO 9001:2008, were determined. To find out the differences, a survey was conducted among enterprises that implement a quality system. According to the findings obtained at the end of the study, it was observed that the enterprises attach importance to quality and follow the developments about quality management system, and they find the changes in the new draft document necessary.
Abstract: Small and Middle Enterprises (SME) have a specific mission, characteristics, and behavior in global business competitive environments. They must respect policy, rules, requirements and standards in all their inherent and outer processes of supply - customer chains and networks. Paper aims and purposes are to introduce computational assistance, which enables us the using of prevailing operation system MS Office (SmartArt...) for mathematical models, using DYVELOP (Dynamic Vector Logistics of Processes) method. It is providing for SMS´s global environment the capability and profit to achieve its commitment regarding the effectiveness of the quality management system in customer requirements meeting and also the continual improvement of the organization’s and SME´s processes overall performance and efficiency, as well as its societal security via continual planning improvement. DYVELOP model´s maps - the Blazons are able mathematically - graphically express the relationships among entities, actors, and processes, including the discovering and modeling of the cycling cases and their phases. The blazons need live PowerPoint presentation for better comprehension of this paper mission – added value analysis. The crisis management of SMEs is obliged to use the cycles for successful coping of crisis situations. Several times cycling of these cases is a necessary condition for the encompassment of the both the emergency event and the mitigation of organization´s damages. Uninterrupted and continuous cycling process is a good indicator and controlling actor of SME continuity and its sustainable development advanced possibilities.
Abstract: The confirmatory of Total Quality Management (TQM) implementation is most vital in quality management. This paper focuses on employees' perceptions towards TQM implementation in a local automotive company supplier. The objectives of this study are first and foremost to determine the perception of TQM implementation among the staff, and secondly to ascertain the correlation between the variables, and lastly to identify the relative influence of the 10 TQM variables on the cost of poor quality (COPQ). The TQM implementation is perceived to be moderate. All correlation is found to be significant and five variables having positively moderate to high correlation. Out of 10 variables, quality system improvement, reward and recognition and customer focus influence the perceived COPQ. This study extended a discussion on these three variables contribution to TQM in general and the human resource development in the organization. A significant recommendation to lowering costs of internal error, such as trouble shooting and scraps are also discussed. Certain components of further research that would add value to this study have also been suggested and perhaps could be implemented at policy-level initiatives.
Abstract: Indian manufacturing firms operating in rapidly changing and highly competitive market, over the last few decades, have embraced organization-wide transformation to achieve cultural and operational excellence. In recent years, numerous approaches have been proposed to improve business and manufacturing performance. Lean practices in particular, Total Productive Management (TPM) and Total Quality Management (TQM) have received considerable attention, as they being adopted and adapted for raising the performance standard of Indian manufacturing firms to world class levels. The complementary nature of TPM and TQM is being practiced in many companies to achieve synergy. Specifically, this research investigates whether joint TPM-TQM implementation contribute to higher business performance when compared to individual implementation. Data from 160 manufacturing firms were analyzed that demonstrate synergetic implementation of both TPM-TQM practices over a reasonable period of time, contributed in delivering better business performance as compared to individual implementation strategy.
Abstract: Quality management systems (QMSs) in the construction industry are often implemented to ensure that sufficient effort is made by companies to achieve the required levels of quality for clients. Attainment of these quality levels can result in greater customer satisfaction, which is fundamental to ensure long-term competitiveness for construction companies. However, the construction sector is still lagging behind other industries in terms of its successful adoption of QMSs, due to the relative lack of acceptance of the benefits of these systems among industry stakeholders, as well as from other barriers related to implementing them. Thus, there is a critical need to undertake a detailed and comprehensive exploration of adoption of QMSs in the construction sector. This paper comprehensively investigates in the construction sector setting, the impacts of all the salient factors surrounding successful implementation of QMSs in building organizations, especially those of external factors. This study is part of an ongoing PhD project, which aims to develop a new framework that integrates both internal and external factors affecting QMS implementation. To achieve the paper aim and objectives, interviews will be conducted to define the external factors influencing the adoption of QMSs, and to obtain holistic critical success factors (CSFs) for implementing these systems. In the next stage of data collection, a questionnaire survey will be developed to investigate the prime barriers facing the adoption of QMSs, the CSFs for their implementation, and the external factors affecting the adoption of these systems. Following the survey, case studies will be undertaken to validate and explain in greater detail the real effects of these factors on QMSs adoption. Specifically, this paper evaluates the effects of the external factors in terms of their impact on implementation success within the selected case studies. Using findings drawn from analyzing the data obtained from these various approaches, specific recommendations for the successful implementation of QMSs will be presented, and an operational framework will be developed. Finally, through a focus group, the findings of the study and the new developed framework will be validated. Ultimately, this framework will be made available to the construction industry to facilitate the greater adoption and implementation of QMSs. In addition, deployment of the applicable recommendations suggested by the study will be shared with the construction industry to more effectively help construction companies to implement QMSs, and overcome the barriers experienced by businesses, thus promoting the achievement of higher levels of quality and customer satisfaction.
Abstract: In the present case study we examined the development and testing methods of systems that contain safety-critical elements in different industrial fields. Consequentially, we observed the classical object-oriented development and testing environment, as both medical technology and automobile industry approaches the development of safety critical elements that way. Subsequently, we examined model-based development. We introduce the quality parameters that define development and testing. While taking modern agile methodology (scrum) into consideration, we examined whether and to what extent the methodologies we found fit into this environment.
Abstract: The purpose of this research is to study the management system of information technology which supports the education of five private universities in Thailand, according to the case studies which have been developing their qualities and standards of management and education by service provision of information technology to support the excellence performance. The concept to connect information technology with a suitable system has been created by information technology administrators for development, as a system that can be used throughout the organizations to help reach the utmost benefits of using all resources. Hence, the researcher as a person who has been performing these duties within higher education is interested to do this research by selecting the Control Objective for Information and Related Technology 5 (COBIT 5) for the Malcolm Baldrige National Quality Award (MBNQA) of America, or the National Award which applies the concept of Total Quality Management (TQM) to the organization evaluation. Such evaluation is called the Education Criteria for Performance Excellence (EdPEx) focuses on studying and comparing education quality development for excellent performance using COBIT 5 in terms of information technology to study the problems and obstacles of the investigation process for an information technology system, which is considered as an instrument to drive all organizations to reach the excellence performance of the information technology, and to be the model of evaluation and analysis of the process to be in accordance with the strategic plans of the information technology in the universities. This research is conducted in the form of descriptive and survey research according to the case studies. The data collection were carried out by using questionnaires through the administrators working related to the information technology field, and the research documents related to the change management as the main study. The research can be concluded that the performance based on the APO domain process (ALIGN, PLAN AND ORGANISE) of the COBIT 5 standard frame, which emphasizes concordant governance and management of strategic plans for the organizations, could reach only 95%. This might be because of some restrictions such as organizational cultures; therefore, the researcher has studied and analyzed the management of information technology in universities as a whole, under the organizational structures, to reach the performance in accordance with the overall APO domain which would affect the determined strategic plans to be able to develop based on the excellence performance of information technology, and to apply the risk management system at the organizational level into every performance process which would develop the work effectiveness for the resources management of information technology to reach the utmost benefits.
Abstract: Construction waste has been gradually increased as a result of upsizing construction projects which are occurred within the lifecycle of buildings. Since waste management is a major priority and has profound impacts on the volume of waste generated in construction stage, the majority of efforts have been attempted to reuse, recycle and reduce waste. However, there is still room to study on lack of sufficient knowledge about waste management in construction industry. This paper intends to provide an insight into the effect of project management knowledge areas on waste management solely on construction stage. To this end, a survey among Iranian building construction industry contractors was conducted to identify the effectiveness of project management knowledge areas on three jobsite key factors including ‘Site activity’, ‘Training’, and ‘Awareness’. As a result, four management disciplines were identified as most influential ones on amount of construction waste. These disciplines were Project Cost Management, Quality Management, Human Resource Management, and Integration Management. Based on the research findings, a new model was presented to develop effective construction waste strategies.