Implementation Of Quality System Research Articles

Models of quality costs by A. Feigenbaum, J. Juran, F. Crosby in the concept of the development of quality economics

Aim. Consider the specifics and features of quality cost models by A. Feigenbaum, J. Juran, F. Crosby in the context of increasing the efficiency of cost management.Objectives. Describe Joseph M. Juran's model (Juran's Spiral); classify quality costs by J. Juran — A. Feigenbaum; describe the classification of costs by F. Crosby.Methods. This work uses general scientific research methods: deduction, induction, generalization, comparative analysis, synthesis (unification), study and theoretical analysis.Results. In the modern economy, product quality plays a critical role, influencing the competitiveness and stability of the country's economic system, which makes quality management not just a formality, but a strategic necessity. Active implementation and development of quality systems is considered by enterprises as a means to improve reputation, increase market share and strengthen customer loyalty, and such systems help reduce costs by preventing defects and optimizing processes.Conclusions. An analysis of quality cost models was carried out as one of the key methods in increasing the economic efficiency of the organization. In modern quality management practice, special attention is paid not only to the identification and assessment of quality costs, but also to their role in the process of making managerial and technical decisions. This is especially true when planning the production activities of an enterprise. Quality cost analysis is becoming an important tool to help management formulate economically sound decisions.

Integracion y usos de los sistemas de gestion ISO 9001, 14001 y 45001 en el sector industrial

The objective of this work is to understand the development of the integration of standards in management systems in industry segments and identify common points and differences, observing the way in which the different technical regulations implemented interact. The main questions have to do with the form of implementation, scope of the level of national certification in the process of integration of management systems. The methodology used is descriptive, based on a bibliographic review in electronic databases such as WOS, Science Direct, Scopus and similar, by searching for keywords and already published concepts. Marked differences were found in the various management systems along with operational similarities that demonstrate that the benefits in the implementation of quality, environment and safety systems are decisive for organizational growth and competitiveness, with a broader scope considering integration. As the main contribution to identifying the verifiable gap in the management of the systems and the future productive bets regarding the benefits they can offer to the organization.

Algorithm of management actions for the formation and implementation of a resilient health care quality system.

Aim: Development of an algorithm of management actions for the formation of a resilient system of quality of medical care in health care institutions of obstetric and gynecological profile and formalization of its closed structural and logical scheme. Materials and Methods: A set of theoretical approaches of social medicine and methods of business process reengineering is used, taking into account the dominant ones: systemic and integrated approach and alarm and process approaches; the concept of resilience; quality of medical care; reproductive health care using business ecosystem methods. Results: The algorithm of management actions for the formation of a resilient system of quality of medical care in obstetric and gynecological health care institutions, which is formalized in nine stages: analysis of needs and identification of problems; substantiation of performance requirements; development of a health care quality strategy; involvement of stakeholders; formation of a system of relative indicators; development of an action plan; implementation of a set of measures; monitoring and evaluation; improving the quality of health care. Conclusions: The results made it possible: construction of a closed structural and logical scheme of management actions, taking into account the combination of factors of influence, harmonized with the main functions of the resilient system, which determine the peculiarities of its functioning; justification of the boundaries of managerial and social responsibility of management entities according to the binary components of the medical and social justification of the process of improving the quality of medical care.

Results of the expert survey assessing the efficiency level of the national regulatory system in the field of medicines turnover

The aim. The aim of the research is to analyze the efficiency level of the national regulatory system in the field of medicines circulation using self-diagnostic tools, which will allow identifying reserves for its optimization and further improvement. 
 Materials and methods. The research materials consisted of the results of a survey conducted among government officials of national regulatory authorities in the field of medicines circulation. The research utilized methods of sociological survey, descriptive statistics, graphical analysis, data grouping, and generalization techniques. The research includes the development of a questionnaire based on the World Health Organization's "Global Benchmarking Tool" methodology, adapted to the national healthcare system. The questionnaire consisted of 2 questions to determine respondent characteristics and 104 statements about the functioning of the national regulatory system in the field of drug circulation. 
 Results. According to 75 % of the surveyed officials in Ukraine, an effective regulatory system operates in the field of drug circulation. Based on the number of affirmative answers, all statements were divided into 4 groups: high, sufficient, moderate, and low. Thus, the quality management system of national regulatory authorities was evaluated at a high level, while the funding system of national regulatory authorities received the lowest ratings. The grouping allowed us to identify weaknesses in the activity of the national regulatory system in the field of drug circulation, such as the lack of funds in budgets for staff training and overall insufficient funding for national regulators, including insufficient funding from international donors, lack of clarity and comprehensiveness in the regulatory framework for the pharmaceutical sector, etc. 
 Conclusions. In accordance with the aim of the article, we conducted research on the efficiency level of the national regulatory system in the field of drug circulation, which revealed that the most mature and effective direction of its activity today is the development and implementation of quality systems in national regulatory authorities

Public health implementation of pathogen genomics: the role for accreditation and application of ISO standards.

Pathogen genomics has transitioned rapidly from the research setting into a powerful tool now routinely used in public health microbiology, for surveillance, outbreak investigations and disease control. As these investigations can have significant public health, treatment and legal impacts, we must ensure the accuracy of these results through validation of testing processes. For laboratories working in this space, it is important to approach this work with a quality and accreditation framework in mind, working towards implementation of quality systems and test validation that meet international regulatory standards. Here we outline the key international standards and processes that lead toward accreditation for pathogen genomics.

Business Relationship in Business Process Management and Management with the Literature Review Method

In an increasingly globalized and digitized environment, businesses face various challenges. Rising costs, intense competition, rapidly evolving technology, increasingly demanding and privileged consumers, and the demands of a socially changing society. In this respect, the effectiveness and efficiency of the operation of the business organization are realized. This article addresses the following fundamental scientific questions at a theoretical level: How important is Business Process Management (BPM) concerning Quality Management (QM)? Is BPM the QM axis? The relationship between business process management and quality management needs to be studied more interdisciplinary. This study aims to build this relationship. The research methods used are literature review and critical analysis of scientific sources. Academic papers and other sources published within two years (2021–2022) were analyzed to look for research findings on the relationship between BPM and QM. The results show confusion and overlap between different QM and BPM paradigms. The BPM paradigm can be considered an integral part of almost every primary quality management paradigm. BPM is like a horizontal domain that encompasses different quality management paradigms. The conclusions drawn are helpful for organizations implementing quality systems. Integrating BPM into quality management systems and tools creates the conditions for an organization to develop effectively and efficiently. A limitation of this study is the paucity of quantitative studies on scholarly sources. In the future, it may be helpful to conduct systematic literature reviews that include quantitative analyzes of scientific studies.

Organizational change and evidence-based practices in support services for people with intellectual and developmental disabilities

SummaryThe impact on support services for persons with intellectual and developmental disabilities of the socioeconomic movements and theoretical reformulations of the last decades has generated the necessity, in order to guarantee their sustainability, to carry out processes of profound change in their organizational culture, intervening in the elements that compose it. Among them are professional practices as the best way to intervene in culture, with the use of comparative analysis between an organization's current practices and those expected with culture change. In this line, the organizational self-assessment tool "Organizational Effectiveness and Efficiency Scale" (OEES) is applied in a study with 24 organizations, which uses a collaborative assessment approach in the service of a set of evidence-based practices identified as standards in key aspects that guide culture change, specifically, a person-centered approach, participative structures, use of information systems and data management, implementation of quality systems and participative and transformational leadership. The results obtained show that a large majority of organizations have significant discrepancies between their current practices and evidence-based practices. The descriptive analysis allows affirming the usefulness of the scale for an organizational diagnosis and identification of strategies to guide transformational change.

A Performance Quality Index to Assess Professional Conduct of Contractors at Sustainable Construction Projects in Saudi Arabia

The quality performance of contractors in sustainable construction projects is a major concern for the industry. Over the past decade, studies on measurements, factors, and indicators for assessment of the professional conduct of construction companies are to be found in the sustainable construction management literature. There is adequate evidence over the last decade that an increasing number of construction professionals have adopted the measurement of the professional conduct of contractors as a tool to support their future decisions. The method of the Analytical Hierarchy (AHP) process has been deployed to identify the major factors and sub-factors involved in sustainable construction in Saudi Arabia. Using several governing factors, including quality of document submittals (QDS), quality system implementation (QSI), and quality of construction works (QCW), a working framework was developed by using the pair-wise comparison method. The results show that proper accountability and keen consideration of factors that could hinder sustainable construction by contractors contribute to the development of a better perspective on quality issues. After a critical analysis, a Performance Quality Index was developed, and a benchmark value was obtained. The benchmark value of PQI will assist project managers and owners in the sustainable construction sector as a reference for future improvement in the quality performance of contractors.

Design and Implementation of Beef Product Quality and Safety Traceability System Based on Blockchain Technology

Design and Implementation of Beef Product Quality and Safety Traceability System Based on Blockchain Technology

Impact of Quality System on Financial, Innovation, and Operational Performance of Business Projects in Pakistan SME’s.

Quality practices are globally recognized efforts in a relationship to the entities’ financial, Innovational and operational performances in an organization’s project implementation. They help them to determine their levels of satisfaction in all aspects of projects and their systematic approaches adopted. This research work took place to find out the Impact of Quality systems on SMEs’ Business Project Performance: case study for Pakistan. The population for this research was all the small and medium enterprises established in Pakistan. That were sampled with random sampling technique. This research work took place to have investigative descriptive method in design with deductive reasoning approaches. The data was collected with close ended questionnaire and it was analyzed on SPSS 22.0 version. The main findings determined the correlation between quality system and organizational project implementation process with regards to its financial, Innovational and operational performance with some high positive attributions.

Stability of Some Biochemical Parameters in Sheep and Goat Serum Stored at -20℃.

In Veterinary Medicine biochemicalinvestigation of serumis widely used to aid diagnosis and treatment. However, delays usually happen between sampling and analysis. As a result, the serum is stored in refrigerators.In this regard, information on the effects of temperature and storage duration on the stability of the analyte is incomplete in general and its effect in sheep and goat serum is not described. Therefore, the objective of this study was to examine the stability of selected biochemical analytes from sheep and goat serum following storage at -20℃ for 2 months. Serum from 20 apparently healthy male 2-2.5 year-old sheep and goats was obtained and aliquots of serum from each sample were kept in three tubes. The first tube is for baseline (T0), which is done within an hour, while the other two (T1 and T2) are stored at -20℃ for 1 and 2 months, respectively. Total protein, albumin, urea, total cholesterol, and triglycerides were assayed. The results revealed that storage temperature and duration for up to 2 months had no significant effect on any analytes except for urea in goats. The changes in terms of total observed error (TEo) for total protein; albumin and urea were greater than the acceptable values in both animals. Thus, further studies are required to assure alteration of analyte at various storage temperatures and duration. In addition, implementation of quality systems to achieve quality targets for analytes with greater TEo as compared to the established TEa is needed.

Webinar and survey on quality management principles within the Australian and New Zealand ACPSEM Workforce.

Healthcare relies upon the accurate and safe delivery of patient care. This is only achievable when systems are developed to ensure high quality, robust outcomes, for instance quality management systems. The concept of quality management can take on a different meaning depending on the context in which it is found. To add complication, the amount of education required for quality management will vary depending on one's exposure to the implementation of quality systems. In part to address these issues, the Australasian College of Physical Scientists and Engineers in Medicine (ACPSEM) Queensland Branch held a quality management webinar for members and non-members across Australia and New Zealand. The purpose of the webinar was to educate and facilitate discussion regarding the application of quality management principles for the ACPSEM profession. In conjunction, a pre- and post-webinar survey was conducted to gain an insight into existing knowledge and attitudes within the professions governed by the ACPSEM and students undertaking related studies. This paper authored by the webinar speakers reintroduces the quality management principles that were discussed in webinar, exemplifies the importance of quality management skills within the ACPSEM professions and presents the results of the surveys, promoting the need for more educational resources on quality management tools.

A Study of the Utility of Vertical Quality Audits in a Blood Transfusion Centre as a Quality Improvement Tool: Comparison and Differences between Vertical and Horizontal Audits.

Introduction: Blood transfusion services is the important part of the modern healthcare system without which efficient medical care is not possible. Blood bank quality audits become an important assessment tool to check the efficiency of the quality system in terms of realization of quality policy, fulfilment of designed targets and implementation of quality system documents. Aim:To study the utility of vertical quality audits as a quality improvement tool, to compare vertical and horizontal audits and explore the differences between them. Methods and materials: The study duration was three years and two months, from November 2018 to December 2021. We conducted an observational prospective study of vertical and horizontal quality audits in a transfusion centre of our tertiary care hospital as per ISO 9001:2000 and National Accreditation Board for Hospitals & Healthcare Providers (NABH) guideline. Results:The most common non-conformities in vertical audit were related to documentation (80%). The donor area was the most common area of blood bank from where non-conformities were observed in vertical audit (60%). The most commonly observed non-conformities in horizontal audit were related to procedural or technical aspects (42.8%). The donor area was the most common area of blood bank from where non-conformities were observed in horizontal audit (57.14%). Conclusions:Quality audits verify compliance and therefore, they are driving continuous quality improvement in a blood bank. Vertical audit is a retrospective process and helps to identify near miss events and errors performed by blood bank staff. Horizontal audits are cumbersome to conduct as compared to vertical audits.

The Importance of Implementing Quality Systems in the Economic Development of the Constanta Metropolitan Area

The Importance of Implementing Quality Systems in the Economic Development of the Constanta Metropolitan Area

GENETIC DIVERSITY AND PARENTAGE ANALYSIS FOR DNA MARKER-BASED FOREST REPRODUCTIVE MATERIAL TRACEABILITY SYSTEM IN LITHUANIA

Scots pine is economically and ecologically important forest tree species in Lithuania. According to the Regulation of Forest Planting and Restoration of Lithuania (2018) and the Regulations on Forest Reproductive Material (FRM) (2017) forests must be planted and replanted with the target tree species, using high quality seeds and seedlings from a given provenance. EU Council Directive (1999/105/EC) indicates that EU Member States are responsible for the regulation, requirements and implementation of FRM quality and traceability system. The existing FRM control system in Lithuania is based on the control actions of the supporting documents regarding the origin of FRM. However, this FRM traceability system is limited and, in some cases, cannot ensure that FRM used for reforestation/afforestation originates from the declared place of origin or belongs to a certain seed or plant lot. In this study we aimed to assess and compare genetic diversity of scots pine seed orchard clones with seeds, and to test DNA based parentage analysis methods with Jonava scots pine seed orchard clones and seeds. Up to now DNA markers based FRM traceability system in Lithuania has not been tested and implemented. Thus, our first results based on 12 nuclear microsatellite markers indicated that genetic diversity among Jonava seed orchard clones and collected seeds were moderately high and comparable with other studies on scots pine in Europe. The test of the maternity analysis software CERVUS has showed very positive results in maternity assignments. Therefore, selected microsatellite markers in combination with accurate sampling design and specific DNA analysis methods should be improved and can be used for FRM traceability system based on DNA “fingerprints”.

Impact of ISO: 17020 for Quality Assurance System in Construction Sector

The objective of the paper is to analyze the various factors and loop holes that have a significant impact on effectiveness of quality and quality assurance system and to suggest recommendations to increase the quality performance of the construction projects. The paper also highlights the difference in Quality Assurance system of projects wherein ISO: 17020 is not implemented and the project wherein it is implemented. In the current paper, National Council for Cement and Building Materials, India monitored 30 construction projects were selected with a construction cost between five to thirty Crores covering 15 project with ISO:17020 procedures and 15 project without ISO:17020 procedures. The data was collected from these projects on various quality and management related aspects. These projects cover structures such as school buildings, community hall, hostel block, convention centers etc. The study was conducted for construction projects of different government bodies. This analysis has been mainly done covering the factors playing key role in quality of a structure during construction such as client’s commitment towards quality, quality of material, documentation, work practices, personnel etc. Based on the data analysis, quality assurance system for these projects were categorized as Excellent, Good, Average and Poor in Quality Grading based on the various factors that directly or indirectly affects the quality and smooth functioning of project during and post construction. The difference in implementation of quality system with and without ISO: 17020 is highlighted in the paper.

The Use of Digital Technologies for the Purpose of Improving Methodological Approaches to the Creation of a Pharmaceutical Quality System at Enterprises for the Production of Medicines

Introduction. The article is devoted to the aspects of improving methodological approaches to the creation of a pharmaceutical quality system (PQS) at enterprises for the production of medicines, taking into account the possibility of using tools and means of digitalization. The relevance of the study is associated with the enduring importance of comprehensive high quality assurance in the development, production and release of medicines into circulation. The implementation of PQS requires numerous transformations of management and production processes, which can be facilitated by tools and elements of digitalization.Aim. To consider the potential and specific areas of application of digital technologies to improve the methodology and practice of developing and implementing PQS.Materials and methods. The state in the subject area was assessed on the basis of the results of economic and statistical analysis and forecasting of the implementation of PQS at Russian pharmaceutical enterprises that have positive and comparatively long experience in this area: the companies LLC "OZON" and JSC "AKRIKHIN". The assessment was carried out by calculating the integral indicator of the effectiveness of the functioning of PQS, which is a set of weighted key performance indicators (KPI) for quality.Results and discussion. The importance of the introduction of PQS for the development of pharmaceutical enterprises and the presence of numerous difficulties in the implementation of PQS, which necessitates the improvement of methodological approaches in the subject area, are stated. It has been proven that even at those enterprises where PQS has been introduced with varying degrees of success, the use of digitalization tools would contribute to a faster, more systematic and high-quality implementation of PQS. Among the key areas of application of digital tools, the authors propose monitoring of quality indicators (using neural network cards) and the use of blockchain platforms and smart contracts to register the release of drugs of appropriate quality.Conclusion. Digital tools contribute to complex improvement in many areas of socio-economic activity. Their active use at pharmaceutical enterprises is intended to contribute to ensuring the proper implementation and uninterrupted functioning of pharmaceutical quality systems, through constant monitoring of the quality of manufactured products and registration of manufactured batches in high-precision information storage systems.

Quality Management System at NPLI: Transition of ISO/IEC 17025 From 2005 to 2017 and Implementation of ISO 17034: 2016

ISO/IEC 17025 is the single most popular and well adopted international standard which is applicable for any testing and calibration laboratories irrespective of size of the laboratories. Similarly, ISO 17034 is also very important international standard for development/production of reference materials (RMs) by competent producers. CSIR-National Physical Laboratory of India (NPLI) was one of the 38 National Metrology Institutes (NMIs) those who signed International Committee for Weights and Measures Mutual Recognition Arrangement (CIPM MRA) during 21st General Conference on Weights and Measures (CGPM) meeting in Paris, France on 14th October, 1999. NPLI has been maintaining quality system based on ISO/IEC 17025 for more than two decades to fulfil the requirements of CIPM MRA. NPLI has participated in 130 international inter-comparisons so far; some of them were also piloted by NPLI. NPLI has also undergone International Peer Reviews through Asia Pacific Metrology Programme (APMP) to register 236 Calibration and Measurement Capabilities (CMCs) on various parameters in International Bureau of Weights and Measures Key Comparison Database (BIPM KCDB). However, NPLI for the first time implemented uniform quality system based on ISO 17034 in 2020. In this direction, NPLI for the first time prepared integrated Quality Manual to make policies, objectives and procedures addressing all the requirements of both the standards. Presently, 28 Sub-Divisions of NPLI follow quality system. Some of the Sub-Divisions are involved only in calibration/testing activities maintain only ISO/IEC 17025: 2017. Similarly, some of the Sub-Divisions are involved only in development/production of RMs/certified reference materials (CRMs) (Bharatiya Nirdeshak Dravya, BND®–Indian Reference Material) maintain only ISO 17034. On the other hand, few Sub-Divisions are involved both in calibration/testing as well as BND activities and accordingly follow both the standards. It is an extraordinary challenge for implementation and monitoring of quality system in such a big organization like NPLI. In this article, authors have highlighted preparation process of integrated quality manual based on ISO/IEC 17025: 2017 and ISO 17034: 2016 including policies, objectives & procedures adopted and its implementation process at NPLI. In November, 2020, NPLI has undergone on-site peer review of quality system of 23 Sub-Divisions through APMP.

Health boards' governance of quality and risk: quality improvement agenda for the board

PurposeThis study explores key governance, leadership and management activities that have impact on quality, risk and safety within Australian healthcare organisations.Design/methodology/approachCurrent non-executive directors (n = 12) of public and private health boards were interviewed about contemporary approaches to fiduciary and corporate responsibilities for quality assurance and improvement outcomes in the context of risk and safety management for patient care. Verbatim transcripts were subjected to thematic analysis triangulated with Leximancer-based text mining.FindingsBoards operate in a strong legislative, healthcare standards and normative environment of quality and risk management. Support and influence that create a positive quality and risk management culture within the organisation, actions that disseminate quality and risk broadly and at depth for all levels, and implementation and sustained development of quality and risk systems that report on and contain risk were critical tasks for boards and their directors.Practical implicationsFindings from this study may provide health directors with key quality and risk management agenda points to expand or deepen the impact of governance around health facilities' quality and risk management.Originality/valueThis study has identified key governance activities and responsibilities where boards demonstrate that they add value in terms of potential improvement to hospital and health service quality care outcomes. The demonstrable influence identified makes an important contribution to our understanding of healthcare governance.

Design and Implementation of Quality and Safety Traceability System for Reusable Medical Devices Disinfection Based on RFID Technology

Focusing on the requirements of visual traceability for reprocessing of reused medical devices under the background of deep integration of intelligent medical treatment, a quality and safety traceability system for disinfection of reused medical devices is developed. The multi-dimensional data of the reprocessing chain of reusable medical devices are acquired in real time by the RFID mobile terminal handset and stored temporarily. The data package is formatted based on LoRa protocol and uploaded to the management and control platform in multi-threaded transmission mode for in-depth analysis and traceability. The corresponding prototype system is developed. The first-line operation and maintenance test results show that the prototype system has strong cooperation, strong operation robustness, and obvious advantages in the identification rate and other layers of sterile equipment package.