Effective Quality Management System Research Articles

Intelligent Medical Informatics Management System Based on Pattern Recognition and Visual Multimedia: A Deep Learning Perspective

With the continuous development of China’s medical modernization technology, medical devices have been widely used in the prevention, diagnosis and treatment of diseases, and health care. The direct or indirect contact of medical devices with the human body is closely related to diagnosis, treatment and rehabilitation. As a result, the quality and safety problems of medical devices in the development of high-end, high-tech products have also increased. Establishing an effective quality management system for medical device production can effectively control the level of production quality management in medical devices and guarantee the quality of products. Therefore, the management of the quality of medical devices is a major task. The use of digital construction to manage scientific and technological archives can make the management of scientific and technological archives more standardized, automatic and professional. This is also a development trend of hospital science and technology archives management. In this paper, we use pattern recognition technology and multimedia vision technology to study the construction of medical technology management system. The deep learning is integrated to promote the overall performance of the proposed methodology. The simulation results have reflected the robustness.

Approach to cost-of-quality management in pharmaceutical manufacturing

Introduction: The costs related to pharmaceutical production, including quality costs are a substantial and persistent part of the costs of pharmaceutical companies. Moreover, there are a number of activities in pharmaceutical production, originating from regulatory requirements to ensure the quality of pharmaceuticals, which do not contribute to real value; however, they consume time, materials and human resources. One of them is the operation of an effective quality management system in accordance with the requirements of the Good Manufacturing Practice for pharmaceuticals. The adherence to all regulatory requirements related to pharmaceutical production is quite costly and constitutes a substantial part of the budget of pharmaceutical companies. There are, however, opportunities for cost reduction which can increase profit without extra investments, ensuring at the same time regulatory compliance. Materials and Methods: A scientific literature review was performed with regards to cost management in pharmaceutical production. On the grounds of the analysis, personal experience and observation, some factors were identified which could impact the costs of pharmaceutical manufacturers and an approach for their management was developed, aiming to reduce the costs and improve company performance. Results: The costs for materials, equipment, production process, personnel, control and facilities were identified as major sources of production costs in the pharmaceutical industry, which affect the quality costs. The costs were classified by type and specific approaches for cost reduction were proposed; the expected effects of this reduction on the company results were assessed, e.g. reduction of total costs, losses and product unit costs, reduction of the duration of production, reduction of downtime and the time required for preparation and effective use of facilities, as well as quality costs (for assessment, prevention, internal and external issues/failures). Conclusion : The proposed approaches for cost reduction can be used as a manual for cost assessment, as well as for the suitability and prioritization of the relevant approaches for their reduction. They have a major impact on the “good quality” costs, related to assessment and prevention; they also contribute to the reliability of quality assurance, thus reducing the costs for its application for handling of internal and external issues. The proposed approaches have a synergistic effect on quality costs reduction and on the improvement of company performance.

Application of an Effective Quality Management System at the Enterprises for the Production of Reinforced Concrete Products and Structures of the Penza Region

In this article the quality management system at the enterprises on production of reinforced concrete products and designs of the Penza region is considered. The main characteristics of enterprises in this industry, which speak of the need to improve the competitiveness of enterprises of building materials for a stable position in the market. The main factor in the competitiveness of enterprises can be indicators of product quality. The analysis of the quality management system at these enterprises. All types of quality control are considered in detail. The procedures taking place at each stage of quality management at the enterprises for the production of concrete products and structures of the region are described. The General provisions on quality management which are available on them are revealed. Shortcomings of the existing system are specified, proceeding from it recommendations on effective quality management at the enterprises of the region are offered. These recommendations will bring enterprises to a new level of production and ensure the quality and competitiveness of enterprises. The application of the new quality management system is considered on the example of the company LLC “Building materials”, one of the main market participants in the production of concrete products and structures of the Penza region. The calculation of the efficiency of the new quality management system is given..

Critical Analysis of the Applicability of the ISO 9001 Standard in Higher Education Institutions

This paper analyses the applicability of the ISO 9001 standard in higher education institutions (HEIs). The ISO 9001standard, initially developed for application in industry, sets the requirements for implementing a quality management system (QMS) in an organisation. Over the years, the standard has been adapted to the higher education (HE) sector as a model for quality assurance and enhancement. In this study, the standard is analysed based on a framework with the following variables; 1) Importance of the philosophy of the standard in HE, 2) Suitability to HE, 3) Ease of implementation, 4) Effect on quality assurance and enhancement and 5) Effect on quality culture. The mechanisms of how the standard affects quality management are also presented. The analysis shows that ISO 9001 is based on a philosophy that resonates with general approaches to quality assurance in HEIs. The seven principles of the standard provide a good base for an effective QMS. The standard is suitable to HEIs as its provisions can be adapted to the peculiarities of this sector. Although there is some considerable workload exerted by the standard, it can be applied with ease. There is both theoretical and empirical basis for the standard to embolden quality assurance and enhancement in HE. Both academic provision and administrative services can benefit from the standard. The standard can promote and strengthen quality culture in HEIs, more so where staff show deep engagement with the processes of the standard. It is concluded that the ISO 9001 standard provides a framework for a QMS that is applicable to the HE sector.

RESEARCH ON EFFECTIVENESS EVALUATION OF QUALITY MANAGEMENT SYSTEM IN PHARMACEUTICAL COMPANIES

Under the background of increasing competitive pressure at home and abroad, it is an important task for pharmaceutical companies to improve their competitiveness by strengthening internal management. Based on defining the concept of pharmaceutical quality management system and the effectiveness of management system, this paper constructs the evaluation index system and evaluation model of the effectiveness of quality management system, and verifies the feasibility of theoretical research by case analysis, which supports the improvement of management systems such as pharmaceutical companies.

Voluntary behaviour, knowledge sharing and quality management system implementation in pharmaceutical industry: a preliminary study

The implementation of quality management system requires voluntary motivation from each organisation's member to achieve organisational perfection. In practice, quality management system implementations are often based on customer demands as a business to business requirement. Certified companies are often no better than firms that do not yet have quality management system certifications. This study aims to develop and to confirm a model of effective quality management system implementation by using internal motive factors, such as voluntary behaviour, prosocial behaviour, perceived employability, and trust. By conducting a survey to a leading Indonesian pharmaceutical firm as a preliminary study, 49 responds revealed that perceived employability and trust had significant effect to form voluntary behaviour amongst employees. Voluntary behaviour has shown the ability to foster effective quality management system implementation, and the effect could be more promising through the existence of knowledge sharing practice.

Voluntary behaviour, knowledge sharing and quality management system implementation in pharmaceutical industry: a preliminary study

The implementation of quality management system requires voluntary motivation from each organisation's member to achieve organisational perfection. In practice, quality management system implementations are often based on customer demands as a business to business requirement. Certified companies are often no better than firms that do not yet have quality management system certifications. This study aims to develop and to confirm a model of effective quality management system implementation by using internal motive factors, such as voluntary behaviour, prosocial behaviour, perceived employability, and trust. By conducting a survey to a leading Indonesian pharmaceutical firm as a preliminary study, 49 responds revealed that perceived employability and trust had significant effect to form voluntary behaviour amongst employees. Voluntary behaviour has shown the ability to foster effective quality management system implementation, and the effect could be more promising through the existence of knowledge sharing practice.

The Use of Structural Equation Model (SEM) to Evaluate the Effectiveness of ISO 9001 Quality Management System (QMS) on the Performance of Oil and Gas Drilling Companies

The purpose of this paper is to evaluate the effectiveness of ISO9001 through achieving its intended objectives and determine its impact on the performance dimensions of oil and gas drilling companies which are related to operations and HSE. 375 samples were obtained using a structured questionnaire from oil and gas drilling companies operating in OMAN to conduct an empirical study. A structured equation modeling (SEM) through SMART PLS was applied in order to determine the impact of ISO 9001 effectiveness on the performance dimensions of oil and gas drilling companies. The findings of this study reveal as identified in the literature, the dimensions of the ISO 9001 effectiveness which are evaluated by the degree of achievement of the standard’s objectives, namely (continuous improvement, customer focus, prevention of nonconformities, risk-based thinking, leadership & commitment and Competency framework) and reveals its significant contribution to the performance of the oil and gas drilling companies. The operational and HSE performance of the oil and gas drilling companies are directly and significantly influenced by ISO 9001 effectiveness. The findings of this study revealed that the R2 value for the first order constructs which are the six ISO objectives are all above the 0.7, implying that the six constructs significantly explain the second order construct ISO 9001 QMS effectiveness. The R2 for QMS effectiveness is 0.460 which means that, 46% of the variation in performance can be explained by effective quality management systems. The effect size f2 was calculated to assess the effect each latent construct has on Quality Management Systems. It has been revealed in this study that PNC has the highest effect on QMS followed by CI, RBT, L&C, CF and CFW respectively.  From the Q square statistic, it is inferred that QMS 9001 effectiveness has a high (strong) effect of 39% on performance. Finally, the Model fit was assessed based on the SRMR criteria by which it revealed a good fit of the model which was 0.052. These findings will support practitioners and decision makers to focus on quality related problems that might occur in their current or future projects to enhance their organization performance.

P.138 Effects of cannabis use on neural progenitors and neuronal differentiation in humans

An effective and efficient quality management system (QMS) requires a well-equipped toolbox for monitoring processes, determining root cause, and driving continuous improvement. A common approach and lexicon enhance improvement activities as well as communications. Corrective and preventive action, failure investigation, statistical process control, and root cause analysis are critical to success. A well-defined, preplanned inspection management process should also be in the toolbox to present the QMS in the most correct and favorable manner. An ongoing focus on improvement is essential to thrive or even survive in the highly regulated medical device industry. Maintaining acceptable performance levels, meeting quality objectives, and driving continuous improvement require a well-equipped toolbox. There are many approaches, tools, and techniques for improvement. These tools vary in favorability over time. However, they have many similarities. And they are known by an alphabet soup of acronyms such as CAPA, RCA, A3, 5S, 5 whys, Six Sigma, 6Ms, DMAIC, DMADV, DFSS, PDCA, PDSA, TQM, SPC, FMEA, FMECA, FTA, DOE, ANOVA, Cpk, Ppk, C&E Matrix. Medical device manufacturers can benefit by having a rigorous and consistent methodology for problem analysis and improvement. Effective use of these tools can support a culture of data-based decision making. CAPA is the single most important process for improvement and has very specific regulatory requirements.

The Relationship between Management’s Commitment with Job Satisfaction According to Shari’ah-Based QMS (MS1900:2014) at Malaysian Higher Education Institution

Management’s commitment in an organisation plays an important role in ensuring the application of effective quality management system (QMS). This article explores the relationship between management’s commitment of an organisation that implements Shari’ah-based Quality Management System (MS1900:2014) with job satisfaction at Malaysian Higher Education Institution (HEI). The methodology of this study employed a qualitative design via a semi-structured interview conducted on selected respondents. The respondents consist of employees who are directly and actively involved with the implementation of MS1900 standard. The findings of this study show that management’s commitment has apparently influenced job satisfaction among employees at HEI. Therefore, the results of this study can serve as a guide to ensure that the implementation of quality management system based on Shari’ah standards (MS1900) can be applied effectively, blessed and rewarded by Allah SWT.

Fundamentals of ISO 9001:2015

The choice of an effective quality management system is a non-trivial task which requires a special approach. We consider the main changes in the new edition of the international standard for quality management systems ISO 9001: 2015, its impact on the workflow and benefits.

The Quality Management System as a Factor for the Competitiveness of the Bulgarian Pharmaceutical Manufacturers

Introduction: The regulatory requirements for the quality of medicines and the strong competition in the pharmacy sector necessitate the establishment of effective quality management systems (QMS) that both meet regulatory requirements and contribute to enhancing the competitiveness of pharmaceutical manufacturers. The aim of the study is to investigate the attitudes of the Bulgarian pharmaceutical companies’ senior managers to the QMS as a factor of competitiveness. Materials and methods: An analysis of scientific literature on the competitiveness of pharmaceutical manufacturers in Bulgaria was carried out. Semi-structured interviews were conducted with executives and quality managers between May 2017 and August 2018. An online semi-structured interview with 17 closed-ended questions and 5 open questions was sent to 34 companies, with responses received from 21 respondents. Results: The competitive pressure in the pharmaceutical market in Bulgaria, according to the majority of the senior managers of pharmaceutical manufacturers (76%), is stronger in terms of the price of pharmaceuticals compared to quality, unlike the competitive pressure of the world market where the quality is of prime importance. All respondents have indicated that the QMS can significantly influence competitiveness. According to more than half of the respondents (52%), effective QMS contributes to increasing competitiveness, mainly by reducing the number of defective / rejected products, which is related to lowering total costs. Conclusion: Effective QMS has an impact on various business indicators and its contribution is most significant in ensuring quality of the products and activities; reducing costs and increasing profitability; expanding external markets and introducing innovation. Bulgarian manufacturers have a positive attitude towards the effective functioning of the QMS and use it as a means of adding value.

Quality management in biobank. World tendencies and experience of biobank of FSI «NMRC for preventive medicine» of the Ministry of healthcare of Russia.

This paper provides several definitions of the term "biobank"; a list of standards developed by the International Organization for Standardization (ISO) applicable to the activities of biobanks; analyzes the legal and ethical requirements; the Russian legal framework in the field of biobanking, the best international practices and recommendations; describes the experience of the development and implementation of quality management systems according to ISO 9001 in Biobanks established in different countries, and the experience of the Bank of Biological Material of the National Medical Research Center for Preventive Medicine of the Ministry of Healthcare of Russia. The ISO 20387 Biobanking Standard, released in August 2018, combined the knowledge and experience of specialists from around the world and defined the general requirements that must be fulfilled by biobanks and repositories wishing to guarantee their customers the high quality of the preanalytical stage of scientific research, biological samples and associated data. In 2019, the Russian version of this standard is expected. Documents of the quality management system provide the reproducibility of activities on the main storage processes and facilitates the process of incorporating a new employee; conducting internal and external audits; Biobank knowledge management - continuous staff education. The introduction of an effective quality management system into biobank activity warrants the high quality of biological samples, the standardized pre-analytical stage, reliable, regulated long-term storage of biomaterial and related information for use in research purposes today and in future.

Development of conceptual model as a means of forming effective quality management systems for engineering services enterprises

Introduction. Integration of Ukraine into the European Economic Area, membership in the World Trade Organization put forward strict requirements on the quality of goods (services, jobs) to the activities of domestic enterprises, in particular in the field of engineering. The formation of quality management systems (QMS) at engineering services enterprises in the context of the requirements of the international standard ISO 9001: 2015 can become an effective mechanism for ensuring their competitiveness as a decisive factor for commercial success. Along with the obvious advantages of designing and implementing quality management systems according to the requirements of the international standard ISO 9001: 2015 at enterprises, today there are a lot of problems, in particular in the field of engineering, to resolve which companies require methodological developments, practical tools and quality specialists.
 Aim and tasks. The aim of the study is to develop a conceptual model for the formation of the quality management system of an engineering enterprise according to the requirements of international standard ISO 9001: 2015 as a tool to improve its performance and ensure integration with the overall management of the company.
 Research results. The article substantiates the relevance of the formation of quality management systems at the enterprises of engineering services in the context of the requirements of international standard ISO 9001: 2015 and proves that they are an effective mechanism for ensuring their competitiveness as a decisive factor of commercial success. The existing models of quality management as a basis for the development of quality management systems in the leading countries of the world been analyzed. The model of processes of quality management system of the engineering enterprise according to requirements of standard ISO 9001: 2015 has been investigated and the essence of all its components has been revealed. The conceptual model of quality management system formation of an engineering enterprise in the context of the requirements of international standard ISO 9001: 2015 has been developed.
 Conclusions. The developed conceptual model of quality management system formation of the engineering enterprise is an effective methodological tool of quality management that will allow providing its integration into the general management of the company. Further developments are aimed at expert assessment of quality management system processes of engineering services companies in the context of the requirements of international standard ISO 9001: 2015.

Role of Quality Management System in Improving the Quality of EIA

The quality of Environmental Impact Assessment (EIA) very much depends on the efficiency of the management system of the EIA consultant organizations. As per statutory requirements, EIA Consultant Organisations must have an accreditation for carrying out the EIA study in India from the National Accreditation Board for Education and Training (NABET) which is a nodal organization under the Quality Council of India (QCI) as per Gazette Notification dated March 3, 2016. The Quality Management System (QMS) is an integral part of the accreditation process, hence the study provides an analysis of the effectiveness of QMS for Accredited EIA Consultant Organisations (ACOs) in reality. The relationship between QMS and EIA reports is analysed from NABET database for various accredited consultant organizations across the country. The study revealed that the quality management system has a significant impact on the EIA reports. The major factors affecting EIA quality are lack of implementation of a quality system, inadequate knowledge of the system and lack of data interpretation. A regular review of QMS by NABET helps maintain the quality at every step of EIA. It suggests that there is a scope for developing a strategic framework to reach excellence in EIA reports through developing a strategic management system for the betterment of society and environment.

ХАРАКТЕРИСТИКА, ОСОБЕННОСТИ И НАПРАВЛЕНИЯ РАЗВИТИЯ СИСТЕМ МЕНЕДЖМЕНТА КАЧЕСТВА ТРАНСПОРТНЫХ КОМПАНИЙ

For the competent organization and regulation of activities related to the management of the quality of service of transport processes, it is necessary to develop an effective quality management system for transport, the principles of which all participants in the transportation process would follow. This system already exists, but, in order to take into account external and internal changes occurring in market conditions, it should be regularly reviewed and updated to the prevailing market conditions. This article discusses in detail the features of the current quality management system for enterprises operating in the transport sector, using railway transport as an example.

Practical Guidance to Implementing Quality Management Systems in Public Health Laboratories Performing Next-Generation Sequencing: Personnel, Equipment, and Process Management (Phase 1).

Quality standards as part of an effective quality management system (QMS) are the cornerstone for generating high-quality test results. Next-generation sequencing (NGS) has the potential to improve both clinical diagnostics and public health surveillance efforts in multiple areas, including infectious diseases. However, the laboratories adopting NGS methods face significant challenges due to the complex and modular process design. This document summarizes the first phase of quality system guidance developed by the Centers for Disease Control and Prevention (CDC) NGS Quality Workgroup. The quality system essentials of personnel, equipment, and process management (quality control and validation) were prioritized based on a risk assessment using information gathered from participating CDC laboratories. Here, we present a prioritized QMS framework, including procedures and documentation tools, to assist laboratory implementation and maintenance of quality practices for NGS workflows.

Development of an effective product quality management system

The object of research is product quality management. During the research, the analysis method was used to study approaches to product quality management. The paper reveals the theoretical foundations for product quality management. It is shown that in order to control the quality of products, it is necessary to establish relations between subjects and objects of quality, their changes using the method of a systematic approach. This method shows that for the sustainable economic development of a manufacturing enterprise, first it is necessary to study the structure of the management system. After that, it will be possible to propose an improved control system, schematically depicting it. The international standards proposed in the work will allow the manufacturer to be competitive among others. Producers who seek to export their products must implement in their production a system of measures focused on high product requirements. However, the transition to modern equipment should occur without any psychological discomfort for workers. Do not forget that the use of a quality management system in production is quite long and financially costly. The process of enterprise restructuring should be economically justified, since owners must have income from manufacturing products. That is, the implementation of a quality management system should be cost-effective for a manufacturing enterprise. The use of integrated quality control systems in the modern era of innovation is a sign of enterprise competitiveness. In the work, an improved product quality management system is obtained. This is due to the fact that the proposed system has advantages, in particular, modernization of the material and technical base and employee incentives, not only through material rewards, but also through professional qualifications. Thanks to this, it is possible to obtain new quality indicators. Compared with similar outdated quality methods, the proposed model provides such advantages as the introduction of innovative technologies and equipment in production, training in modern technologies for workers, and allows them to compete in the labor market.

(In)effectiveness of quality management systems and models of excellence in practice

This paper presents some tools, used to ensure quality and excellence in organizations. On the way to ensure quality and excellence, which enable efficiency and effectiveness, organizations are assisted by well-known tools, with their common features being discussed. Based on the research, findings on the (non)functioning of these tools are given, with the focus on popular tools, such as ISO 9001, the EFQM model, etc. Results of the survey are used to suggest how to make the quality and excellence tools more useful and direct their usage toward realization of organizational effectiveness.

Implementing a quality management system using good clinical laboratory practice guidelines at KEMRI-CMR to support medical research.

Background: Good Clinical Laboratory Practice (GCLP) is a standard that helps ensure the quality and reliability of research data through principles of Good Laboratory Practice (GLP) and Good Clinical Practice (GCP). The implementation of GCLP includes careful documentation of procedures, competencies and safety measures. Implementation of GCLP is influenced by existing resources and quality systems, thus laboratories in low- and middle-income countries may face additional challenges. Methods: This paper describes implementation of GCLP at the Kenya Medical Research Institute-Center for Microbiology Research (KEMRI-CMR) as part of a quality system to support medical research. This study employed assessment, twinning (institutional mentorship) model, conducting relevant training workshops and Kaizen 5S approaches to implement an effective quality management system using GCLP standard. This was achieved through a collaboration between the KEMRI/Wellcome Trust Research Programme (KWTRP) and KEMRI-CMR. The aim was compliance and continuous monitoring to meet international GCLP standards in a way that could be replicated in other research organizations. Results: Following a baseline assessment in March 2017, training, mentorship and a cycle of quality audit and corrective action using a Kaizen 5S approach (sorting, setting in order, shining, standardizing and sustaining) was established. Laboratory personnel were trained in writing standard operating procedures and analytical plans, microbiological techniques, and good documentation practice. Mid-term and exit assessments demonstrated significant declines in non-conformances across all GCLP elements. KEMRI-CMR achieved GCLP accreditation in May 2018 by Qualogy Ltd (UK). Conclusions: Involving all the laboratory personnel in implementation of quality management system processes is critical to success. An institutional mentorship (twinning) approach shows potential for future collaborations between accredited and non-accredited organizations to accelerate the implementation of high-quality management systems and continuous improvement.