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: This paper presents an analysis of the influences of engagement in the perception of organizational management systems, including their benefits and difficulties through a case study in certain organizations that provide services to the oil and gas industry. The case study proposes to identify components of engagement and its relationship with the perception of the management system, discuss factors that impact the perception of the management system, discuss how to engage and maintain the engagement of people involved.This paper presents an analysis of the influences of engagement in the perception of organizational management systems, including their benefits and difficulties through a case study in certain organizations that provide services to the oil and gas industry. The case study proposes to identify components of engagement and its relationship with the perception of the management system, discuss factors that impact the perception of the management system, discuss how to engage and maintain the engagement of people involved.This paper presents an analysis of the influences of engagement in the perception of organizational management systems, including their benefits and difficulties through a case study in certain organizations that provide services to the oil and gas industry. The case study proposes to identify components of engagement and its relationship with the perception of the management system, discuss factors that impact the perception of the management system, discuss how to engage and maintain the engagement of people involved.
Abstract: At this stage, Georgia is a country which is actively involved in the European integration process, for which the primary priority is effective integration in the European education system. The modern Georgian higher education system is the process of establishing a new sociocultural reality, whose main priorities are determined by the Quality System as a continuous cycle of planning, implementation, checking and acting. Obviously, in this situation, the issue of management of education institutions comes out in the foreground, since the proper planning and implementation of personnel management processes is one of the main determinants of the company's performance. At the same time, one of the most important factors is the psychological comfort of the personnel, ensuring their protection and efficiency of stress management policy.
The purpose of this research is to determine how intensely the relationship is between the psychological comfort of the personnel and the efficiency of the quality system in the institution as the quality assurance mechanisms of educational institutions affect the stability of personnel, prevention and management of the stressful situation. The research was carried out within the framework of the Internal Grant Project «The Role of Organizational Culture in the Process of Settlement of Management of Stress and Conflict, Georgian Reality and European Experience » of the Batumi Navigation Teaching University, based on the analysis of the survey results of target groups. The small-scale research conducted by us has revealed that the introduction of quality assurance system and its active implementation increased the quality of management of Georgian educational institutions, increased the level of universal engagement in internal and external processes and as a result, it has improved the quality of education as well as social and psychological comfort indicators of the society.
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: 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: The successful realization of complex systems is dependent not only on the technology issues and the process for implementing them, but on the management issues as well. Managing the systems development lifecycle requires technical management. Systems engineering management is the technical management. Systems engineering management is accomplished by incorporating many activities. The three major activities are development phasing, systems engineering process and lifecycle integration. Systems engineering management activities are performed across the system development lifecycle. Due to the ever-increasing complexity of systems as well the difficulty of managing and tracking the development activities, new ways to achieve systems engineering management activities are required. This paper presents a systematic approach used as a design management tool applied across systems engineering management roles. In this approach, Transdisciplinary System Development Lifecycle (TSDL) Model has been modified and integrated with Quality Function Deployment. Hereinafter, the name of the systematic approach is the Transdisciplinary Quality System Development Lifecycle (TQSDL) Model. The QFD translates the voice of customers (VOC) into measurable technical characteristics. The modified TSDL model is based on Axiomatic Design developed by Suh which is applicable to all designs: products, processes, systems and organizations. The TQSDL model aims to provide a robust structure and systematic thinking to support the implementation of systems engineering management roles. This approach ensures that the customer requirements are fulfilled as well as satisfies all the systems engineering manager roles and activities.
Abstract: This paper investigates the barriers behind the underutilisation of six sigma in Libyan manufacturing companies (LMCs). A mixed-method methodology is proposed, starting by conducting interviews to collect qualitative data followed by the development of a questionnaire to obtain quantitative data. The focus of this paper is on discussing the findings of the interview stage and how these can be used to further develop the questionnaire stage. The interview results showed that only four key barriers were highlighted as being encountered by LMCs. With a difference in terms of their significance, these factors were identified, and placed in descending order according to their importance, namely: “Lack of top management commitment”, “Lack of training”, “Lack of knowledge about six sigma”, and “Culture effect”. The findings also showed that some barriers which, were found in previous studies of six sigma implementation were not considered as barriers to LMCs but can, in fact, be considered as success factors or enablers for six sigma adoption. These factors were identified as: “sufficiency of time and financial resources”; “customers unsatisfied”; “good communication between all departments in the company”; “we are certain about its results and benefits to our company and unhappy with the current quality system”. These results suggest that LMCs face fewer barriers to adopting six sigma than many well-established global companies operating in other countries and could take advantage of these successful factors by developing and implementing a six sigma framework to improve their product quality and competitiveness.
Abstract: The garment manufacturing industry involves
sequential processes that are subjected to uncontrollable variations.
The industry depends on the skill of labour in handling the varieties
of fabrics and accessories, machines, as well as complicated sewing
operation. Due to these reasons, garment manufacturers have created
systems to monitor and to control the quality of the products on a
regular basis by conducting quality approaches to minimize variation.
With that, the aim of this research has been to ascertain the quality
approaches deployed by Malaysian garment manufacturers in three
key areas - quality systems and tools; quality control and types of
inspection; as well as sampling procedures chosen for garment
inspection. Besides, the focus of this research was to distinguish the
quality approaches adopted by companies that supplied finished
garments to both domestic and international markets. Feedback from
each company representative has been obtained via online survey,
which comprised of five sections and 44 questions on the
organizational profile and the quality approaches employed in the
garment industry. As a result, the response rate was 31%. The results
revealed that almost all companies have established their own
mechanism of process control by conducting a series of quality
inspections for daily production, either it was formally set up or
otherwise. In addition, quality inspection has been the predominant
quality control activity in the garment manufacturing, while the level
of complexity of these activities was substantially dictated by the
customers. Moreover, AQL-based sampling was utilized by
companies dealing with exports, whilst almost all the companies that
only concentrated on the domestic market were comfortable using
their own sampling procedures for garment inspection. Hence, this
research has provided insights into the implementation of a number
of quality approaches that were perceived as important and useful in
the garment manufacturing sector, which is truly labour-intensive.
Abstract: The Figaro AM-1 sensor module which employs TGS
2600 model gas sensor in air quality assessment was used. The
system was coupled with a microprocessor that enables sensor
module to create warning message via telephone. This low cot sensor
system’s performance was compared with a DiagNose II commercial
electronic nose system. Both air quality sensor and electronic nose
system employ metal oxide chemical gas sensors. In the study
experimental setup, data acquisition methods for electronic nose
system, and performance of the low cost air quality system were
evaluated and explained.
Abstract: The main objective of this paper is to identify and
disseminate good practice in quality assurance and enhancement as
well as in teaching and learning at master level. This paper focuses
on the experience of the Erasmus Mundus Master program CIMET
(Color in Informatics and Media Technology). Amongst topics
covered, we discuss the adjustments necessary to a curriculum
designed for excellent international students and their preparation for
a global labor market.
Abstract: Quality control is the crucial step for ISO 9001
Quality System Management Standard for companies. While
measuring the quality level of both raw material and semi
product/product, the calibration of the measuring device is an
essential requirement. Calibration suppliers are in the service sector
and therefore the calibration supplier selection is becoming a worthy
topic for improving service quality.
This study presents the results of a questionnaire about the
selection criteria of a calibration supplier. The questionnaire was
applied to 103 companies and the results are discussed in this paper.
The analysis was made with MINITAB 14.0 statistical programs.
“Competence of documentations" and “technical capability" are
defined as the prerequisites because of the ISO/IEC17025:2005
standard. Also “warranties and complaint policy", “communication",
“service features", “quality" and “performance history" are defined as
very important criteria for calibration supplier selection.
Abstract: The overriding goal of software engineering is to
provide a high quality system, application or a product. To achieve
this goal, software engineers must apply effective methods coupled
with modern tools within the context of a mature software process
[2]. In addition, it is also must to assure that high quality is realized.
Although many quality measures can be collected at the project
levels, the important measures are errors and defects. Deriving a
quality measure for reusable components has proven to be
challenging task now a days. The results obtained from the study are
based on the empirical evidence of reuse practices, as emerged from
the analysis of industrial projects. Both large and small companies,
working in a variety of business domains, and using object-oriented
and procedural development approaches contributed towards this
study. This paper proposes a quality metric that provides benefit at
both project and process level, namely defect removal efficiency
(DRE).
Abstract: Despite the extensive use of eLearning systems, there
is no consensus on a standard framework for evaluating this kind of
quality system. Hence, there is only a minimum set of tools that can
supervise this judgment and gives information about the course
content value. This paper presents two kinds of quality set evaluation
indicators for eLearning courses based on the computational process
of three known metrics, the Euclidian, Hamming and Levenshtein
distances. The “distance" calculus is applied to standard evaluation
templates (i.e. the European Commission Programme procedures vs.
the AFNOR Z 76-001 Standard), determining a reference point in the
evaluation of the e-learning course quality vs. the optimal concept(s).
The case study, based on the results of project(s) developed in the
framework of the European Programme “Leonardo da Vinci", with
Romanian contractors, try to put into evidence the benefits of such a
method.
Abstract: There are various approaches to implement quality
improvements. Organizations aim for a management standard which
is capable of providing customers with quality assurance on their
product/service via continuous process improvement. Carefully
planned steps are necessary to ensure the right quality improvement
methodology (QIM) and business operations are consistent, reliable
and truly meet the customers' needs. This paper traces the evolution
of QIM in Malaysia-s Information Technology (IT) industry in the
past, current and future; and highlights some of the thought of
researchers who contributed to the science and practice of quality,
and identifies leading methodologies in use today. Some of the
misconceptions and mistakes leading to quality system failures will
also be examined and discussed. This paper aims to provide a general
overview of different types of QIMs available for IT businesses in
maximizing business advantages, enhancing product quality,
improving process routines and increasing performance earnings.
Abstract: The link between urban planning and design principles and the built environment of an urban renewal area is of interest to the field of urban studies. During the past decade, there has also been increasing interest in urban planning and design; this interest is motivated by the possibility that design policies associated with the built environment can be used to control, manage, and shape individual activity and behavior. However, direct assessments and design techniques of the links between how urban planning design policies influence individuals are still rare in the field. Recent research efforts in urban design have focused on the idea that land use and design policies can be used to increase the quality of design projects for an urban renewal area-s built environment. The development of appropriate design techniques for the built environment is an essential element of this research. Quality function deployment (QFD) is a powerful tool for improving alternative urban design and quality for urban renewal areas, and for procuring a citizen-driven quality system. In this research, we propose an integrated framework based on QFD and an Analytic Network Process (ANP) approach to determine the Alternative Technical Requirements (ATRs) to be considered in designing an urban renewal planning and design alternative. We also identify the research designs and methodologies that can be used to evaluate the performance of urban built environment projects. An application in an urban renewal built environment planning and design project evaluation is presented to illustrate the proposed framework.