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Patil Divyashree Kantilal, Divyani Rajender Patil, Mahale Devendra S, Amit Kumar R Dhankani, Mansi A Dhankani, S.P. Pawar
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- Student, Student, Student, Assistant Professor, Assistant Professor, Principal Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’sCollege of Pharmacy, Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’sCollege of Pharmacy, Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’sCollege of Pharmacy, Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’sCollege of Pharmacy, Department of Pharmaceutics, P.S.G.V.P. Mandal’s College of Pharmacy, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra, Maharashtra, Maharashtra, Maharashtra, Maharashtra, Maharashtra India, India, India, India, India, India
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Abstract
nThis review investigates the implementation of a risk-based approach within Quality Management Systems (QMS) as stipulated by ISO 9001:2015 regulations. It scrutinizes the challenges organizations encounter when transitioning to ISO 9001-2015 requirements, particularly focusing on the alignment of conceptual frameworks and processes among stakeholders. A key objective of this review is to propose a refined definition of “quality risk” and “risk-based thinking in QMS” to address the idiosyncratic characteristics of their application.
The transition to ISO 9001:2015 necessitates a fundamental shift in how organizations perceive and manage risks within their quality management frameworks. Central to this shift is the recognition that risk management is an integral part of achieving quality objectives and organizational success. However, achieving this integration poses significant challenges, including the need to redefine traditional notions of quality risk and risk-based thinking.
To address these challenges, organizations must adopt a proactive approach to risk management, wherein potential risks are identified, assessed, and mitigated throughout the entire product or service lifecycle. This necessitates the adoption of robust risk assessment methodologies that encompass both qualitative and quantitative approaches. By integrating these methodologies with the Software Development Life Cycle (SDLC), organizations can ensure that risk management becomes an inherent part of their development processes.
Furthermore, adaptability and flexibility are paramount in navigating the complexities of risk management within QMS. Organizational resistance to change, resource constraints, and cultural barriers often impede effective risk management practices. Overcoming these challenges requires a concerted effort to foster a risk-aware culture that encourages continuous improvement and innovation.
Looking to the future, this review identifies emerging trends in risk management within QMS, including the integration of artificial intelligence and machine learning algorithms for predictive risk analysis, and the heightened focus on cybersecurity risk management in an increasingly digitalized world. By embracing these trends and continually refining their risk management practices, organizations can enhance their resilience and competitiveness in today’s dynamic business environment.
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Keywords: Risk-based approach, Quality Management Systems, ISO 9001:2015, Risk assessment, Software Development Life Cycle (SDLC).
n[if 424 equals=”Regular Issue”][This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production(rrjodfdp)]
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References
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1. Abernathy, C. (2016). Embracing the quality risk management process as a means to a strong quality culture. Retrieved from: https://www.outsourcedpharma.com/doc/embracing-the-quality-risk-managementprocess-as-a-means-to-a-strong-quality-culture-0001.
2. Batova, I. B. (2015). Classification of risks and their causes. International Student Scientific Bulletin. Retrieved from: https://www.eduherald.ru/pdf/2015/1/25.pdf
3. Rick Stevenson July 21, 2022 6 Types of Risk Assessment Methodologies https://drata.com/blog/risk-assessment-methodologies#heading-risk-assessment-methodologies
4. Akimov, V.A. (2004). Risks in nature, technosphere, society, and economy. Moscow, Russia: Business Express. Balabanov, I.T. (1997). Risk management. Moscow, Russia: Unity
5. Cagnin, F., Oliveira, M. C., & Cauchick Miguel, P. A. (2019). Assessment of ISO 9001: 2015 implementation: Focus on risk management approach requirements compliance in an automotive company. Total Quality Management & Business Excellence. DOI: https://doi.org/10.1080/14783363.2019.1677151
6. Ramler, Rudolf &Felderer, Michael. (2015). A Process for Risk-Based Test Strategy Development and Its Industrial Evaluation. 10.1007/978-3-319-26844-6_26.
7. Jones, Roger & Preston, Benjamin. (2011). Adaptation and risk management. Wiley interdisciplinary reviews: Climate Change. 2. 296 – 308. 10.1002/wcc.97.
8. Ta-Chun Wen, Hsiang-Yu Chung, Kuei-Hu Chang, Zong-Sian Li, A flexible risk assessment approach integrating subjective and objective weights under uncertainty, Engineering Applications of Artificial Intelligence, Volume 103, 2021, 104310, ISSN 0952-1976, https://doi.org/10.1016/j.engappai.2021.104310.
9. Common Challenges in Risk Management 2022 https://diro.io/common-challenges-in-risk-management/
10. M.Salman Khan The Future Emerging Trends in Risk Management – Key Highlights for 2024 & Beyond Published Dec 21, 2023 https://www.linkedin.com/pulse/future-emerging-trends-risk-management-key-highlights-m-salman-khan–3vxif#:~:text=The%20future%20of%20risk%20management%20is%20shaped%20by%20emerging%20trends,key%20pillars%20in%20this%20transformation.
11. Itkin, B. (2016). Risk and risk-based thinking: Whether we can control the first with the second? Standards and Quality, 10(952), 68-73.
12. Hutchins, G. (2014). Risk management – The future of quality management (translated by Rakhmanov V.) Retrieved from: https://1cert.ru/stati/upravlenie-riskami-budushchee-menedzhmenta-kachestva.
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Research & Reviews: A Journal of Drug Formulation, Development and Production
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| Volume | 11 | |
| [if 424 equals=”Regular Issue”]Issue[/if 424][if 424 equals=”Special Issue”]Special Issue[/if 424] [if 424 equals=”Conference”][/if 424] | 02 | |
| Received | April 12, 2024 | |
| Accepted | June 4, 2024 | |
| Published | June 20, 2024 |
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