Patil Divyashree Kantilal,
Divyani Rajender Patil,
Mahale Devendra S,
Amit Kumar R Dhankani,
Mansi A Dhankani,
S.P. Pawar,
- Student Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’sCollege of Pharmacy Maharashtra India
- Student Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’sCollege of Pharmacy Maharashtra India
- Student Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’sCollege of Pharmacy Maharashtra India
- Assistant Professor Department of Pharmaceutical Quality Assurance, P.S.G.V.P. Mandal’sCollege of Pharmacy Maharashtra India
- Assistant Professor Department of Pharmaceutics, P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
- Principal P.S.G.V.P. Mandal’s College of Pharmacy Maharashtra India
Abstract
This 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.
Keywords: Risk-based approach, Quality Management Systems, ISO 9001:2015, Risk assessment, Software Development Life Cycle (SDLC).
[This article belongs to Research & Reviews: A Journal of Drug Formulation, Development and Production(rrjodfdp)]
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| Volume | 11 |
| Issue | 02 |
| Received | April 12, 2024 |
| Accepted | June 4, 2024 |
| Published | June 20, 2024 |