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Designing a Dynamic Quality Management System: Monitoring, Early Warning, and Rapid Response to Quality Risks in the Digital Era
Osokina A. V., Shatilova O. V., Danyliuk V. O.

Osokina, Alla V., Shatilova, Olena V., and Danyliuk, Viacheslav O. (2026) “Designing a Dynamic Quality Management System: Monitoring, Early Warning, and Rapid Response to Quality Risks in the Digital Era.” Business Inform 1:531–542.
https://doi.org/10.32983/2222-4459-2026-1-531-542

Section: Management and Marketing

Article is written in Ukrainian
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UDC 65.012.32:004.9

Abstract:
The aim of the study is to formulate the conceptual foundations for designing the architecture of a dynamic quality management system (DQMS) and to develop a multi-level model for its construction, which integrates data monitoring, early warning mechanisms, and controlled rapid response, ensuring continuous improvement and adaptability of the system. The article presents an analysis of the concept of dynamism in quality management systems based on the requirements of ISO 9001:2015, ISO 9004:2018, and ISO 31000:2018, and carries out a comparative analysis of risk management approaches, on the basis of which the key prerequisites for integrating the quality management system (QMS) of business organizations into the digital environment are identified. The hypothesis is put forward that the core of the DQMS shapes approaches based on early warning systems (EWS), business continuity (BC), and a closed-loop corrective and preventive action system (closed-loop CAPA), while digital tools include the Internet of Things (IoT) and comprehensive enterprise management information systems (ERP/CRM), artificial intelligence and machine learning (AI/ML) ensure loop controllability. The novelty of the study lies in transforming this core into principles, modules, and implementation steps through the creation of a multi-level model for constructing a DQMS. Consequently, the dynamism of the QMS is defined as the ability to adapt processes based on risk signals. Risk focus is compared across process, strategic, and organizational levels, and five prerequisites for integration are identified. The DQMS architecture is formulated as a linkage between the PDCA cycle, monitoring loop, and EWS parameters. A multi-level model has been developed that integrates context, data, EWS, CAPA, and BC, transitioning quality management from control to prevention. The theoretical significance of the study lies in refining the concept of DQMS and its principles as a mechanism for data-driven improvement. The practical significance of this work lies in using the DQMS model as a «roadmap» for configuring monitoring, early warning, and response in business organizations. The value of the study is determined by integrating PDCA, EWS, BC, and CAPA into a recurring management cycle, as well as by highlighting the role of decision-making culture and staff responsibility in the QMS. A limitation is the theoretical nature of the work. Future research prospects involve the empirical validation of the model, the development of QMS maturity metrics, and the evaluation of economic impact.

Keywords: dynamic quality management system, risk-based thinking, Quality 4.0, digital tools.

Fig.: 3. Tabl.: 2. Bibl.: 19.

Osokina Alla V. – Candidate of Sciences (Economics), Associate Professor, Associate Professor, Department of Management, Kyiv National Economic University named after Vadym Hetman (54/1 Beresteiskyi Ave., Kyiv, 03057, Ukraine)
Email: [email protected]
Shatilova Olena V. – Candidate of Sciences (Economics), Associate Professor, Associate Professor, Department of Management, Kyiv National Economic University named after Vadym Hetman (54/1 Beresteiskyi Ave., Kyiv, 03057, Ukraine)
Email: [email protected]
Danyliuk Viacheslav O. – Candidate of Sciences (Economics), Associate Professor, Associate Professor, Department of Management, Kyiv National Economic University named after Vadym Hetman (54/1 Beresteiskyi Ave., Kyiv, 03057, Ukraine)
Email: [email protected]

List of references in article

Carvalho A. V. & Lima T. M. (2022). Quality 4.0 and cognitive engineering applied to quality management systems: A framework. Applied System Innovation, 6(5), Article 115. https://doi.org/10.3390/asi5060115
DP «UkrNDNTs» (2015). Systemy upravlinnia yakistiu. Vymohy: DSTU ISO 9001:2015 (ISO 9001:2015, IDT). Chynnyi vid 31.12.2015. Kyiv: DP «UkrNDNTs».
DP «UkrNDNTs» (2018). Menedzhment ryzykiv. Pryntsypy ta nastanovy: DSTU ISO 31000:2018 (ISO 31000:2018, IDT). Chynnyi vid 29.11.2018. Kyiv: DP «UkrNDNTs».
DP «UkrNDNTs» (2021). Bezpeka ta stabilnist. Systemy upravlinnia neperervnistiu biznesu. Vymohy: DSTU EN ISO 22301:2021 (EN ISO 22301:2019, IDT; ISO 22301:2019, IDT). Chynnyi vid 20.12.2021. Kyiv: DP «UkrNDNTs».
DP «UkrNDNTs» (2018). Upravlinnia yakistiu. Yakist orhanizatsii. Nastanovy shchodo dosiahnennia staloho uspikhu: DSTU ISO 9004:2018 (ISO 9004:2018, IDT). Chynnyi vid 12.12.2018 [Quality management. Quality of an organization. Guidance to achieve sustained success: DSTU ISO 9004:2018 (ISO 9004:2018, IDT). Effective from 12.12.2018]. Kyiv: DP «UkrNDNTs».
Hafid A., Sebtaoui F. E. & Mouchtachi A. (2025). An overview of the transformation towards Quality 4.0: Technological needs, challenges, and benefits. Engineering Proceedings, 1(112), Article 18. https://doi.org/10.3390/engproc2025112018
Inshutiyimana S., Rana K. R., Abdullahi F. A. & Aleu M. M. (2025). Artificial intelligence for pharmaceutical quality assurance in Kenya. IET Collaborative Intelligent Manufacturing, 7, Article e70033. https://doi.org/10.1049/cim2.70033
Komkowski T., Antony J., Garza-Reyes J. A., Tortorella G. L. & Pongboonchai-Empl T. (2023). A systematic review of the integration of Industry 4.0 with quality-related operational excellence methodologies. Quality Management Journal, 1(30), 3–15. https://doi.org/10.1080/10686967.2022.2144783
Kovalchuk I. & Orlova-Kurylova O. (2025). Tsyfrova transformatsiia upravlinnia yakistiu na pidpryiemstvi zasobamy shtuchnoho intelektu [Digital transformation of quality management at the enterprise by means of artificial intelligence]. Vcheni zapysky Universytetu «KROK», 3 (79), 294–300. https://doi.org/10.31732/2663-2209-2025-79-294-300
Kupper D., Knizek C., Ryeson D. & Nocker J. (2019). Quality 4.0 takes more than technology. Boston Consulting Group. https://www.bcg.com/publications/2019/quality-4.0-takes-more-than-technology
Martins Y. S., Silva C. E. S. & Gaudencio J. H. D. (2021). From theory to practice: A risk management model for SMEs in the context of ISO 9001. Production, 31. https://doi.org/10.1590/0103-6513.20210036
Martins Y. S., Sanches da Silva C. E., Sampaio P. A. da C. A. & Catalani Gabriel L. (2022). ISO 9001:2015 and risk-based thinking: Scientific research insights. Total Quality Management & Business Excellence, 11–12(33), 1326–1343. https://doi.org/10.1080/14783363.2021.1954898
Matias-Correia R., Dias A. R., Cruz-Correia R., Domingues P. & Sampaio P. (2024). Suitability of ISO 9001:2015 standard in the digital transformation context: Literature review. Proceedings of the 6th International Conference on Quality Engineering and Management (ICQEM 2024) (pp. 206–223). Braga. https://publicacoes.riqual.org/wp-content/uploads/2024/06/icqem_24_206_223.pdf
Sobakar M. (2025). Osoblyvosti systemy upravlinnia ryzykamy v period voiennoho stanu [Features of the risk management system during the period of martial law]. Ukrainskyi zhurnal prykladnoi ekonomiky ta tekhniky, 2(10), 278–283. https://doi.org/10.36887/2415-8453-2025-2-54
Sokhan I. V., Zapadenko V. O. & Luzan Ye. S. (2025). Adaptatsiia systemy upravlinnia yakistiu do novykh vyklykiv tsyfrovoi transformatsii [Adaptation of the quality management system to new challenges of digital transformation]. Aktualni pytannia ekonomichnykh nauk, 15. https://doi.org/10.5281/zenodo.17151692
Sony M., Antony J. & Douglas J. A. (2020). Essential ingredients for the implementation of Quality 4.0: A narrative review of literature and future directions for research. The TQM Journal, 4(32), 779–793. https://doi.org/10.1108/TQM-12-2019-0275
Sulistiyowati W., Suef M. & Singgih M. L. (2025). Integrating ISO 31000 with POAC: A novel framework for risk management in quality improvement projects. Journal of Information Systems Engineering and Management, 34s(10), 184–201. https://doi.org/10.52783/jisem.v10i34s.5787
Yarmus D. V. (2025). Ryzyk-menedzhment v umovakh voiennoho stanu: adaptatsiia modelei upravlinnia [Risk management under martial law: adaptation of management models]. Visnyk Khersonskoho natsionalnoho tekhnichnoho universytetu, 2 (93), 337–343. https://doi.org/10.35546/kntu2078-4481.2025.2.1.45
Zuo E., Du X., Aysa A., Lv X., Muhammat M., Zhao Y. & Ubul K. (2022). Anomaly score-based risk early warning system for rapidly controlling food safety risk. Foods, 14(11). https://doi.org/10.3390/foods11142076

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