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 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 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: 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 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: 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: 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.
Abstract: This paper describes the collection and analysis of
data obtained from face-to-face interviews conducted in selected
Libyan industrial companies. The objectives of the interviews are to
enhance understanding, and generate explanations of current issues in
culture and quality management systems in Libyan companies. The
method used in analyzing the questions, as well as the main finding
of each question are explained. The interviews probed areas identify
national and organizational culture, quality management systems,
current methods, effects, barriers and other factors affecting the
success of quality management implementation. Eleven questions are
prepared and been discussed with the interviewees.
Abstract: To solve these problems, we investigated the management system of heating enterprise, including strategic planning based on the balanced scorecard (BSC), quality management in accordance with the standards of the Quality Management System (QMS) ISO 9001 and analysis of the system based on expert judgment using fuzzy inference. To carry out our work we used the theory of fuzzy sets, the QMS in accordance with ISO 9001, BSC, method of construction of business processes according to the notation IDEF0, theory of modeling using Matlab software simulation tools and graphical programming LabVIEW. The results of the work are as follows: We determined possibilities of improving the management of heat-supply plant-based on QMS; after the justification and adaptation of software tool it has been used to automate a series of functions for the management and reduction of resources and for the maintenance of the system up to date; an application for the analysis of the QMS based on fuzzy inference has been created with novel organization of communication software with the application enabling the analysis of relevant data of enterprise management system.
Abstract: The popularity of quality management system models
continues to grow despite the transitional crisis in 2008. Their
development is associated with demands of the new requirements for
entrepreneurs, such as risk analysis projects and more emphasis on
supervision of outsourced processes. In parallel, it is appropriate to
focus attention on the selection of companies aspiring to a quality
management system. This is particularly important in the automotive
supplier industry, where requirements transferred to the levels in the
supply chain should be clear, transparent and fairly satisfied. The
author has carried out a series of researches aimed at finding the
factors that allow for the effective implementation of the quality
management system in automotive companies. The research was
focused on four groups of companies: 1) manufacturing (parts and
assemblies for the purpose of sale or for vehicle manufacturers), 2)
service (repair and maintenance of the car) 3) services for the
transport of goods or people, 4) commercial (auto parts and vehicles).
The identified determinants were divided into two types of criteria:
internal and external, as well as hard and soft. The article presents the
hard – technical factors that an automotive company must meet in
order to achieve the goal of the quality management system
implementation.
Abstract: This paper provides a literature review to document the state of the art with respect to handling “human bias” in decision making within the established quality management systems (QMS) and LEAN theory, in the context of shipbuilding. Previous research shows that in shipbuilding there is a huge deviation from the planned man-hours under the project management to the actual man-hours used because of errors in planning and reworks caused by human bias in the information flows, among others. This reduces the efficiency, and increases operational costs. Thus, the research question is how QMS and LEAN handle biases. The findings show the gap in studying the integration of methods to handle human bias in decision making into QMS and lean, not only within shipbuilding, but in general. Theoretical and practical implications are discussed for researchers and practitioners in the areas of decision making, QMS and LEAN, and future research is suggested.
Abstract: This paper presents the early-warning lights
classification management system for industrial parks promoted by the
Taiwan Environmental Protection Administration (EPA) since 2011,
including the definition of each early-warning light, objectives, action
program and accomplishments. All of the 151 industrial parks in
Taiwan were classified into four early-warning lights, including red,
orange, yellow and green, for carrying out respective pollution
management according to the monitoring data of soil and groundwater
quality, regulatory compliance, and regulatory listing of control site or
remediation site. The Taiwan EPA set up a priority list for high
potential polluted industrial parks and investigated their soil and
groundwater qualities based on the results of the light classification
and pollution potential assessment. In 2011-2013, there were 44
industrial parks selected and carried out different investigation, such as
the early warning groundwater well networks establishment and
pollution investigation/verification for the red and orange-light
industrial parks and the environmental background survey for the
yellow-light industrial parks. Among them, 22 industrial parks were
newly or continuously confirmed that the concentrations of pollutants
exceeded those in soil or groundwater pollution control standards.
Thus, the further investigation, groundwater use restriction, listing of
pollution control site or remediation site, and pollutant isolation
measures were implemented by the local environmental protection and
industry competent authorities; the early warning lights of those
industrial parks were proposed to adjust up to orange or red-light. Up
to the present, the preliminary positive effect of the soil and
groundwater quality management system for industrial parks has been
noticed in several aspects, such as environmental background
information collection, early warning of pollution risk, pollution
investigation and control, information integration and application, and
inter-agency collaboration. Finally, the work and goal of self-initiated
quality management of industrial parks will be carried out on the basis
of the inter-agency collaboration by the classified lights system of
early warning and management as well as the regular announcement of
the status of each industrial park.
Abstract: In the highly competitive and rapidly changing global
marketplace, independent organizations and enterprises often come
together and form a temporary alignment of virtual enterprise in a
supply chain to better provide products or service. As firms adopt the
systems approach implicit in supply chain management, they must
manage the quality from both internal process control and external
control of supplier quality and customer requirements. How to
incorporate quality management of upstream and downstream supply
chain partners into their own quality management system has recently
received a great deal of attention from both academic and practice.
This paper investigate the collaborative feature and the entities-
relationship in a supply chain, and presents an ontology of
collaborative supply chain from an approach of aligning
service-oriented framework with service-dominant logic. This
perspective facilitates the segregation of material flow management
from manufacturing capability management, which provides a
foundation for the coordination and integration of the business process
to measure, analyze, and continually improve the quality of products,
services, and process. Further, this approach characterizes the different
interests of supply chain partners, providing an innovative approach to
analyze the collaborative features of supply chain. Furthermore, this
ontology is the foundation to develop quality management system
which internalizes the quality management in upstream and
downstream supply chain partners and manages the quality in supply
chain systematically.