Maturity Models of Quality Management System in High-Tech Industry: a Systematic Literature Review

Author(s):  
Yulia S. Shrayner ◽  
Vladimir V. Yashchenko
2021 ◽  
Vol 16 (1) ◽  
pp. 150-180
Author(s):  
Rafael Augusto de Oliveira Sanches ◽  
Eric de Paula Ferreira ◽  
Fernando Silva Parreiras

Purpose – Aiming to fulfill the need to consolidate and carry out a critical analysis of the studies developed on Organizational Culture and Quality Management Systems, this study aims to understand the relationship between these concepts through a systematic review of the literature. Design/methodology/approach – This study is descriptive and is predominantly classified as a quantitative approach. Using the systematic literature review technique, publications contained in the Materials Science & Engineering Database, Emerald Insight, OneFile (GALE), Taylor & Francis Online - Journals, ScienceDirect Journals (Elsevier), Elsevier (CrossRef), Directory of databases were analyzed Open Access Journals (DOAJ), MEDLINE / PubMed (NLM), Library & Information Science Collection and Springer (CrossRef) and 22 studies that deal with the topics in an integrated manner were used. Findings – The analysis shows that the Cameron and Quinn (2011) and Hofstede (2003) models are the most used. Regarding the business sectors in which studies were carried out, no research relating to the topics studied in utilities companies had been carried out, with most of the studies (38%) carried out in companies in the industrial sector. Originality/value – With regard to aspects of quality management relating to organizational culture, there is a balance between the hard and soft elements in the literature and that most studies put forward the management levels of companies as the target audience for the data source. Keywords - Organizational Culture, Management System, Quality Management System, Systematic Literature Review.


Author(s):  
Silvia Martínez-Perales ◽  
Isabel Ortiz-Marcos ◽  
Jesús Juan Ruiz

AbstractThere is a broad consensus on the importance and advisability of testing laboratories adopting a Quality Management System (QMS) to support their work, no matter they are industrial or research oriented. However, laboratories involved in R&D have specific difficulties to implement a QMS due to the peculiar nature of their activity. This paper analyzes the main challenges and difficulties found by professionals when implementing a QMS in a research testing laboratory, based on the literature review and a questionnaire with 86 laboratories participating performed in collaboration with RedLab (Red de Laboratorios de la Comunidad de Madrid). After this analysis, a set of requirements for the competence of research testing laboratories based on ISO/IEC 17025 and UNE 166002 is defined, and an agile methodology for the fulfilment of these requirements is proposed.


2020 ◽  
Vol 10 (5) ◽  
pp. 1113-1120
Author(s):  
Xiaofei Mao ◽  
Xiaoyi Feng ◽  
Fangjun Cheng ◽  
Penggang Chen

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.


2021 ◽  
Vol 284 ◽  
pp. 04013
Author(s):  
Nikita Rodionov ◽  
Lyudmila Tatarnikova

The concept of a digital twin and its types are discussed in this paper. The essence of the development of digital twins in the SysML language, the use of AnyLogic (simulation software) and the use of MES (Manufacturing Execution Systems) software for communication with production systems are described. The functions of neural technologies that can be integrated into a modern QMS (quality management system) are considered. The use of digital twins in the quality management system allows monitoring inconsistencies in the technological component of production and quickly eliminating them, and also offers solutions to the identified problem. Companies are now finding a competitive advantage in digital technologies, especially digital twins, whose economic benefits are undeniable. The quality management system of enterprises with high-tech industries is more and more moving into the analysis of big data and in interaction with the digital environment. Thus, it is so important to pay attention to technologies directly related to the analysis of the quality of the product and the processes of its creation. As a result of the study, a clear connection between advanced information technologies and the development of the quality management system of enterprises was revealed.


2021 ◽  
pp. 7-20
Author(s):  
И.В. Каблашова ◽  
И.В. Логунова ◽  
К.С. Кривякин ◽  
В.Н. Родионова

Введение. В статье изложены результаты теоретического исследования научных подходов к разработке методологии управления качеством наукоемких процессов в условиях внедрения цифровых стандартов деятельности предприятия. Выявлено, что разработка и внедрение цифровых стандартов является современным решением, которое позволяет обеспечить полноценное использование информационных технологий при выработке и реализации стратегических и оперативных решений с целью постоянного улучшения качества процессов и совершенствования системы управления наукоемким предприятием. Данные изменения предопределяют необходимость переосмысления некоторых положений методологии управления качеством с учетом изменений в деятельности наукоемкого предприятия при внедрении цифровых стандартов. Данные и методы. Проведенные исследования показали, что система управления качеством процессов призвана обеспечивать сбалансированность всех этапов жизненного цикла разработки и реализации новой продукции с учетом требований к качеству входов и выходов, срокам осуществления и оптимальной загрузки всех компонентов производственной мощности наукоемкого предприятия. При исследовании использовались методы эмпирического и методологического анализа, статистические методы, данные научных и аналитических публикаций по рассматриваемой проблеме, ресурсы сети интернет. Полученные результаты. Проведен анализ методологии применения процессного подхода, рекомендованного международной системой менеджмента качества и стандартами ИСО. Обосновано, что в условиях внедрения цифровых стандартов должны быть построены интеграционные модели цепочек процессов, включающих операции, выполняемые структурными подразделениями, расположенными на разных уровнях организационной структуры управления наукоемким предприятием, сформированы новые условия осуществления взаимосвязанных процессов, что обусловливает необходимость разработки новых компетенций для персонала. Сделан вывод, что для эффективной реализации механизма управления качеством процессов необходимо четко идентифицировать ответственность персонала за качество каждого процесса, организовать постоянный мониторинг и диагностику текущих параметров процессов. Ответственность за организацию мониторинга следует идентифицировать линейным руководителям, а ответственность за своевременную корректировку процесса - на непосредственных исполнителей процессов. Предложен методический подход к обеспечению вовлеченности персонала в деятельность по проявлению цифровых инициатив для улучшения качества процессов, что позволит обеспечить повышение эффективности и производительности наукоемкого предприятия с учетом стратегических целей в области управления качеством. Заключение. Сформулированные решения по внедрению изменений в механизме управления качеством процессов при внедрении цифровых стандартов деятельности наукоемкого предприятия определяют необходимость разработки цифровой модели реализации процессов по этапам жизненного цикла создания новой продукции. При этом приоритетными вопросами являются изменение управления цепочками процессов и содержания трудовой деятельности персонала, что непосредственно влияет на эффективность работы наукоемкого предприятия. Introduction. The article presents the results of a theoretical study of scientific approaches to the development of a methodology for quality management of knowledge-intensive processes in the context of the introduction of digital standards of enterprise activity. It is revealed that the development and implementation of digital standards is a modern solution that allows for the full use of information technologies in the development and implementation of strategic and operational decisions in order to continuously improve the quality of processes and improve the management system of a knowledge-intensive enterprise. These changes determine the need to rethink some provisions of the quality management methodology, taking into account changes in the activities of a knowledge-intensive enterprise when implementing digital standards. Data and methods. The conducted research has shown that the process quality management system is designed to ensure a balance of all stages of the life cycle of the development and implementation of new products, taking into account the requirements for the quality of inputs and outputs, the timing of implementation and optimal utilization of all components of the production capacity of a high-tech enterprise. The research used methods of empirical and methodological analysis, statistical methods, data from scientific and analytical publications on the problem under consideration, and Internet resources. The results obtained. The methodology of the process approach application recommended by the international quality management system and ISO standards is analyzed. It is proved that in the conditions of digital standards implementation, integration models of process chains should be built, including operations performed by structural divisions located at different levels of the organizational structure of the management of a knowledge-intensive enterprise, new conditions for the implementation of interrelated processes should be formed, which makes it necessary to develop new competencies for personnel. It is concluded that for the effective implementation of the process quality management mechanism, it is necessary to clearly identify the responsibility of personnel for the quality of each process, to organize constant monitoring and diagnostics of the current process parameters. The responsibility for organizing monitoring should be identified to line managers, and the responsibility for timely process adjustments should be assigned to the direct executors of the processes. A methodological approach is proposed to ensure the involvement of personnel in the development of digital initiatives to improve the quality of processes, which will ensure an increase in the efficiency and productivity of a knowledge-intensive enterprise, taking into account the strategic goals in the field of quality management. Conclusion. The formulated decisions on the implementation of changes in the process quality management mechanism when implementing digital standards for the activities of a high-tech enterprise determine the need to develop a digital model for the implementation of processes at the stages of the life cycle of creating new products. At the same time, the priority issues are changing the management of the process chains and the content of the staff's work, which directly affects the efficiency of the knowledge-intensive enterprise.


2014 ◽  
Vol 903 ◽  
pp. 359-364 ◽  
Author(s):  
Kung Leong Tiong ◽  
Zakuan Norhayati Mohmad ◽  
Muhamad Zameri Mat Saman ◽  
Mohd Shoki Md Arif ◽  
Ahamad Zaidi Bahari

This paper sets out to explore the degree of Quality Management System (QMS) implementation in current Malaysian construction industry. This research test these with a questionnaire based on nine major QMS aspects which are gathered from literature review. Data collected was analyzed using Mean and ANOVA. The findings indicate that QMS are implemented in moderate level with slight differences between mean values from various aspects. Besides, top management level respondents react more positive towards implementation of QMS in all aspects compared to middle management level and lower management respondents. Future research will benefit by using different QMS aspects for further improvement and replication to other industries.


2018 ◽  
Vol 3 (01) ◽  
pp. 45
Author(s):  
Nur Hidayat ◽  
Indah Kusuma Hayati

Recently, the evolvement of globalization era has been the global challenges that cannot be avoided either by private or government sectors, and they are requested to be survived encountering such the condition. The implementation of Quality Management System (QMS) in the operational company is the way how to guarantee the quality of products or services offered to the people. One of the purposes of QMS implementation is to provide a prime satisfaction to the customers. The impact of QMS implementation is expected to increase job performance of the employees. Besides the implementation of Quality Management System (QMS), the impact of global challenges has been increasing the competitive efforts to execute more effective production process. However, it has required manpower protection accordingly. This research aims to find out whether the implementation of quality management system and safety and healthy at work management system have impacted on the job performance of employees. Objects of this research are the employees in the production department at PT Guna Senaputra Sejahtera Plant 1 Bogor. Data analysis technique of this research has applied software Smart PLS (Partial Least Square). PLS has estimated a model of correlation among the latent variables and correlation between latent variables and its indicators. Result of data processing has indicated that the implementation of Quality Management System (QMS) and system of safety and healthy at work have positively and significantly impacted job performance of employees.Keywords : Quality Management System (QMS), Safety and Healthy at Work System ( SHWS / SMK3), and Job Performance of Employees


Sign in / Sign up

Export Citation Format

Share Document