scholarly journals AUTOMATED INFORMATION SYSTEMS AS ELEMENTS OF THE PHARMACEUTICAL ENTERPRISE QUALITY MANAGEMENT SYSTEM

2020 ◽  
pp. 65-71
Author(s):  
Sergii Medushevskiy ◽  
Keyword(s):  
Information Technology ◽  
Information Systems ◽  
Quality Management ◽  
Management System ◽  
Information Technologies ◽  
Management Practices ◽  
Quality Management System ◽  
International Standards ◽  
Information Support ◽  
Pharmaceutical Enterprise

Urgency of the research. With the development of information technology and new management practices, there has been a convergence and often a merger of quality management and information technology practices. At present, concepts based on the integration of quality management systems and automated information systems are becoming increasingly important.Actual scientific researches and issues analysis.In the process of researching specialized scientific and technical litera-ture, modern trends and problems of introduction of information technologies in the quality management system were analyzed.Uninvestigated parts of general matters defining. An unsolved problem is to ensure the quality of use of automated infor-mation systems at a pharmaceutical enterprise integrated into an enterprise quality management system based on the requirements of the international GMP standard and the Guidelines ST-N MOH 42-4.0: 2016 “Medicines. Good manufacturing practice".The research objective. The purpose is to systematically analyze the methodological foundations of quality assurance, through the introduction and use of AIS, aimed at creating favorable conditions for improving the efficiency of the quality management system in the pharmaceutical industry.The statement of basic materials. The issues of construction and improvement of quality management system based on existing technologies for automated production are considered. The structure of the computer quality management system and the mechanisms of its information support are determined. The methods of integration of specialized software systems are alsoanalyzed and the concept of integration of them into the quality management system is proposed.Conclusions.Based on the critical analysis, a number of unresolved problems related to the development, implementation and use of automated information systems based on international standards were separated, as well as the scientific hypothesis of the effective implementation and use of automated information systems integrated into the quality management system of the pharmaceutical enterprise was put forward.

The Use of Information Systems in a Modern Cytopathology Laboratory

2015 ◽  
pp. 208-236 ◽  
Author(s):  
Stavros Archondakis
Keyword(s):  
Quality Improvement ◽  
Information Systems ◽  
Quality Management ◽  
Diagnostic Accuracy ◽  
Management System ◽  
Information Technologies ◽  
Quality Management System ◽  
Image Capture ◽  
Management Concepts ◽  
New Applications

Over the last decade, cytopathology laboratories wishing to achieve an automated and seamless workflow process, to diminish turnaround times, and to improve their diagnostic accuracy have successfully adopted information technologies and automation. New types of cameras and microscopes connected to computers made possible image capture and transmission (telecytology). New innovative information technologies, including e-health and telemedical applications, constitute a valuable tool for interlaboratory collaboration and quality improvement. New applications are expected to enhance the opportunities for improvement in the field of cytological data management and sharing. In this chapter, the authors emphasize quality management concepts applied to cytopathology laboratories and the application of innovative information technologies in a modern cytopathology laboratory wishing to establish an effective quality management system and meet all current requirements concerning all aspects of its routine workflow (personnel, premises, environmental conditions, equipment, information systems and materials, pre-examination processes, examination processes, and the post-examination phase).

scholarly journals Assessment of the competitiveness of industrial companies and methods for assessing the quality of construction products

2020 ◽  
Vol 164 ◽  
pp. 09027
Author(s):  
Olga Safonova ◽  
Lyudmila Tatarnikova
Keyword(s):  
Quality Management ◽  
Product Quality ◽  
Management System ◽  
Building Materials ◽  
Quality Management System ◽  
Iso 9000 ◽  
International Standards ◽  
Specific Method ◽  
Product Management

The model of a quality management system based on international standards ISO 9000 series is recognized in all the world. The aim of the article is to show the competitive advantages of a construction company in the modern market by improving its quality and product management system. We consider the implementation of the provisions of international standards ISO 9000 series as an effective solution to the problem. Quality improvement is a continuous work aimed at improving the technical level of product quality, quality of its manufacture, improving production elements and the quality system itself. The authors of the article give a specific method for improving the enterprise quality management system with a developed sequence. A risk-based approach to creating an enterprise quality management system was also considered. The main research methods in assessing the technical condition of certain building materials are differential, integrated and mixed methods. The authors show the calculation procedure using these methods, as well as the main results of their application. Then, the article provides a methodology for calculating the level of product quality, which is evaluated by a set of indicators, which do not include economic indicators.

DEVELOPMENT OF A PROCESS MODEL OF HUMAN RESOURCES MANAGEMENT IN THE QUALITY MANAGEMENT SYSTEM OF THE ORGANIZATION

2020 ◽  
pp. 43-50
Author(s):  
T. P. Mozhaeva
Keyword(s):  
Quality Management ◽  
Human Resources ◽  
Management System ◽  
Process Model ◽  
Swot Analysis ◽  
Quality Management System ◽  
Human Resources Management ◽  
International Standards ◽  
Dual Nature ◽  
Resources Management

The article describes an approach to the development of a model of human resources management in the quality management system (QMS) of the organization on the basis of their dual nature and process approach in the interpretation of international standards ISO 9000:2015.The analysis of scientific views on the specifics of human resources. The ambiguity of the nature of human resources and in this regard the heterogeneity of personnel processes. The expediency of design of personnel processes on the basis of integration of such tools as methodology IDEF0, functional cost analysis (FSA), PDCA cycle is proved. In the context of risk-based thinking, an algorithm of personnel risk management based on SWOT analysis and statistical justification of the results is proposed. The application of the proposed approach will ensure the correct modeling of human resources management processes in the QMS.

scholarly journals Development of Quality Management System Under ISO 9001:2015 and Joint Inspection Group (JIG) for Aviation Fuelling Service

2017 ◽  
Vol 8 (3) ◽  
pp. 50-59 ◽  
Author(s):  
Kanon Ruamchat ◽  
Natcha Thawesaengskulthai ◽  
Chaipong Pongpanich
Keyword(s):  
Quality Improvement ◽  
Quality Management ◽  
Management System ◽  
Distribution Systems ◽  
Management Practices ◽  
Quality Management System ◽  
Aviation Fuel ◽  
Iso 9001 ◽  
Fuel Quality ◽  
Petroleum Company

Abstract The Joint Inspection Group (JIG) standard for aviation fuel quality management assists in the operational process and maintenance of aviation fuel from its point of origin and through distribution systems to airports. Currently, problems arise as the JIG standard and quality management in aviation fuel are isolated and have independent procedures. Merging the JIG standards with ISO 9001:2015 can override original JIG’s philosophy by connecting all quality assessment, and management parties involved, throughout the supply chain. This integration can harmonize auditing tasks, focusing on risk/opportunity, and continue quality improvement focus. This paper proposes a development of quality management system (QMS) under ISO 9001:2015 for aviation fuelling service in a systematic way. The content and critical success factors of ISO 9001:2015 and JIG standards were studied. The beneficial synergies, similarities, and logical linkages between both standards are identified. This QMS was developed in the largest petroleum company in Thailand and 60 selected experts were surveyed, with a response rate of 88.3%, for their agreement on integrated criteria. Two external quality auditors, who have ISO 9001 and JIG expertise, were interviewed to modify our initial proposed QMS. The final QMS was implemented in the into-plane fuelling services as the first phase of this implementation. Results of framework implementation are discussed in a case study. There are mutual benefits resulting from the integration of JIG and ISO 9001:2015 standards. This QMS provides a unified process for quality management practices, and enhances the effectiveness of risk evaluation as well as the opportunity for continued quality improvement. It facilitates the identification of ISO 9001:2015 requirements and establishes relationships between the roles of JIG standard and the clauses of ISO 9001:2015. The first experience from five airports as the pilot study of proposed QMS implementation minimized conflicts and duplications between JIG and ISO 9001:2015 standards, reduced the number of into-plane fuelling service incidents reported, such as oil spill, machine stoppage, re-inspections, and recall costs.

scholarly journals Mogućnosti korištenja audita sustava upravljanja kvalitetom za unaprjeđenje učinkovitosti javne uprave

2017 ◽  
Vol 7 (1) ◽  
pp. 54
Author(s):  
Ivana Čandrlić - Dankoš
Keyword(s):  
Quality Control ◽  
Quality Management ◽  
Public Administration ◽  
Management System ◽  
Quality Management System ◽  
International Competitiveness ◽  
International Standards ◽  
Iso 9001 ◽  
Business Practices ◽  
The Republic

According to the international requirements of ISO 9001:2015, the conducting of the audit of the quality control system is a key prerequisite for checking the compliance of the system with the international standards requirements and the requirements of the organization's quality management system that applies them. The results of conducted internal audits contain information related to irregularities (noncompliance with the required norms), and recommendations for improvement, all of it aimed towards improving the existing business practices. Simultaneously, the analysis of the position of the Republic of Croatia on international competitiveness charts shows a significant lag in relation to the countries of Central and Eastern Europe. The analysis of the comparison of the Republic of Croatia with other countries based on the analysis of international competitiveness shows lagging in all segments of competitiveness. Consequently, in line with the recommendations of the European Commission as part of the convergence program of national reforms in the Republic of Croatia, the weakness of the system is also reflected in the (non) efficiency of the public sector that needs to be improved. The work of local and regional self-government units (hereinafter referred to as management) in the Republic of Croatia is supervised by State administration bodies, institutions responsible for conducting business of legal and/or natural persons, assemblies in towns and counties, and within municipalities the municipal council as well as internal audit units and internal auditors if the management has implemented a quality management system according to one of the international standards. The question arises about the possibility of using audits as a form of quality management control as a strategic tool for improving the work of the administration, or more precisely the increasing of the efficiency of the system and raising the level of competitiveness. This paper gives a brief overview of the efficiency of the Croatian public administration presented through international competitiveness charts, an overview of the forms of work management oversight, with special emphasis on monitoring specificities according to the international standard ISO 9001:2015 and the Quality Control and Auditing Guidelines standard methodology and the ISO / IEC 19011: 2012. Professional and scientific literature regarding the experiences and the role of internal auditing in public administration has been consulted. The concluding remarks analyze the possibilities of using internal audits as the basis for improving the quality of the management system.

scholarly journals Software support of production restructuring in quality management system of car service enterprise

2019 ◽  
pp. 48-56
Author(s):  
L. А. Tarandushka ◽  
N. L. Kostian
Keyword(s):  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Visual Development ◽  
Object Oriented Programming ◽  
Information Support ◽  
Development Environment ◽  
Software Complex ◽  
Management Quality ◽  
Complex Indicators

The paper describes automation means of the quality management system’s functions for the purpose of optimization an autoservice enterprises (AE) activity. Activity of an enterprise can be explored at regional level, within the scope of an independent enterprise or structural unit and at the level of the certain select technological process. There is a relation between the levels. An important task is a modeling of enterprises activity at all levels. This research is performed at the enterprise PJSC “CHERKASSY-AUTO” in Cherkasy (Ukraine). This enterprise is included in “UkrAUTO” corporation. One of directions of an enterprise activity optimization is restructuring. For information support of the restructuring, a database model of the visual area in the UML notation has been created. The database consists of fourteen tables. The complex indicators of quality of services rendered at the enterprise are calculated. The location of the enterprise, quality estimation of completed services and their nomenclature were taken into account. The algorithms of selection optimal organization form of an enterprise are built for the subsystem of management quality system. The algorithms are implemented in visual development environment Delphi 7.0., supporting the concept of object-oriented programming. Technology of using a developed software package is described step by step. Saving of the results of the survey of AE customers is additionally provided. The modules of Delphi project contain the subprograms, in which are used the method AHP of Saaty and graph theory methods. The results of subsystem approbation indicate the efficiency of developed algorithms. The developed software complex gives an opportunity to get the forecast of the most frequently performed services, it can function both separately at the car service enterprises, and within the Intelligent Quality Management System (MIS) of AE.

scholarly journals ІНТЕГРАЦІЯ ВИМОГ СТАНДАРТІВ НАТО СЕРІЇ AQAP 2000 У СИСТЕМУ УПРАВЛІННЯ ЯКІСТЮ ПІДПРИЄМСТВА З ВИРОБНИЦТВА ВІЙСЬКОВОЇ ТЕХНІКИ

2020 ◽  
pp. 102-108
Author(s):  
Ольга Володимирівна Нємченко ◽  
Альона Юріївна Кисилевська ◽  
Віталій Леонідович Костенко
Keyword(s):  
Quality Assurance ◽  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
International Standards ◽  
Iso 9001 ◽  
Management Systems ◽  
Quality Management Systems ◽  
Government Quality

In recent years, the security and defense sector of Ukraine has been undergoing reforms aimed at gaining the country's membership in the NATO North Atlantic Treaty Organization. One of the many aspects of these reforms is the introduction of some specific standards, in particular, the AQAP 2000 series standards in the quality management systems of military equipment enterprises. In the case of implementation of several international standards at the enterprise, there is a need to create integrated quality management systems. The article presents options for implementing two or more standards in the QMS of the enterprise, analyzes their disadvantages and advantages. The main requirements of the AQAP 2110 standard, which should be integrated with the requirements of the ISO 9001 standard in the context of the PDCA cycle ("Plan-Do-Check-Act"), are considered. The stages of the implementation of integrated QMS are described. The scheme of deliveries of products to the customer in which there is a certification of the quality management system of the manufacturer (supplier) by the external body on conformity assessment, control over the quality of production by military representation, and the government quality assurance GQA has resulted. Government quality assurance GQA means that the authorized national body carries out the process of assessing the conformity of the quality management system of the manufacturer (supplier) to the requirements of ISO 9001 and NATO standards AQAP 2000, which allows the customer to gain confidence in the quality of defense products. A special requirement is to draw up a Quality Plan, which defines the activities, processes, resources, responsibilities of the manufacturer, etc., to convince the customer and the GQA representative that the company can manufacture and supply products of appropriate quality and on time, because in case of defective products or failure to deliver is lost time for a replacement or waiting, and this is a constant risk to the country's combat readiness. Requirements for the content and design of the Quality Plan are given in the standard AQAP 2105. In addition to the above, the following specific requirements of AQAP 2110 are analyzed as the operation of the metrological support system at the enterprise according to DSTU ISO 10012, product configuration management with software according to ACMP 2100, risk management, etc.

scholarly journals Qualification of Customised Medical Implants Produced by Ti6Al4V(ELI) Additive Manufacturing

2020 ◽  
Vol 321 ◽  
pp. 03012
Author(s):  
W B du Preez ◽  
G J Booysen
Keyword(s):  
Additive Manufacturing ◽  
Quality Management ◽  
Management System ◽  
Quality Management System ◽  
Titanium Implants ◽  
International Standards ◽  
Patient Specific ◽  
Medical Implants ◽  
Design Development ◽  
Custom Made

Although many cases of medical implants produced through additive manufacturing (AM) in Ti6Al4V have been reported in literature, most of these processes had not been qualified. To enable certification and commercialisation of medical implants and devices an ISO 13485:2016 quality management system was successfully implemented in the Centre for Rapid Prototyping and Manufacturing (CRPM) at the Central University of Technology, Free State in South Africa. This certification covers qualification of both design, development and production of patient specific custom made titanium implants, as well as preoperative models, jigs and cutting guides in nylon by means of AM and supports commercialisation. With this quality management system as framework for ensuring the reliability and repeatability of the AM performed at the CRPM, the generation of data to validate the individual processes in the AM process chain was pursued. Sufficient research data has been produced and published to prove that medical implants produced through AM can fully comply with the international standards for material, physical, chemical and mechanical properties. In this paper the research performed towards the qualification of AM of Ti6Al4V medical implants is discussed. Examples are given of internationally leading work on utilising these implants in maxillofacial and orthopaedic surgeries.

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