BRIDGING RISK ASSESSMENT AND RESILIENCE: AN FMEA-BASED APPROACH FOR VACCINE MANUFACTURING SUPPLY CHAINS
Main Article Content
Abstract
The objectives of this research are: 1) to analyze systemic risks within the vaccine supply chain by integrating Failure Mode and Effects Analysis (FMEA); 2) to evaluate the correlation between critical risk levels and current systemic resilience; and 3) to propose and validate resilience-enhancing strategies through a combined framework. Adopting a qualitative methodology, data were synthesized from eight supervisory experts across key functions of a leading vaccine manufacturer, utilizing RPN calculations, resilience gap analysis, Spearman’s Rank Correlation, and the Wilcoxon Signed-Rank Test.
The findings reveal that: 1) Systemic risk assessment identified ten critical vulnerabilities, with "Supply Uncertainty and Lead Time" emerging as the most severe (RPN = 343). 2) The strong negative correlation (ρ = -0.72) between RPN and Resilience Scores highlights a critical vulnerability where operational risks severely compromise systemic resilience, revealing that high-risk areas lack essential robustness and redundancy. 3) The deployment of strategic interventions, such as Multi-Tier Safety Stock and Automatic Logic Validation, yielded statistically significant improvements (P=0.003). These results confirm that this integrated framework effectively bolsters pharmaceutical supply chain security, serving as a strategic blueprint for high-reliability organizations facing volatile environments
Article Details
References
จรียากรณ์ หวังศุภกิจโกศล, กริช วงศ์เจริญ, ณัฐกรานต์ ไชยหาวงศ์ และ ธัญญรัตน์ คำเพราะ. (2568). องค์ประกอบเชิงยืนยันของความยืดหยุ่นของสายการบินในประเทศไทย. วารสารมหาจุฬานาครทรรศน์, 12(2), 115–126.
พรรณวิภา ลาภจิตร และ นุศราพร เกษสมบูรณ์. (2565). การจัดการความเสี่ยงโดยใช้ Failure Mode and Effects Analysis ในลูกโซ่ความเย็นวัคซีนของอำเภอสนม จังหวัดสุรินทร์. วารสารเภสัชกรรมไทย, 14(4).
วรพจน์ เกษอางค์ และ รัฐยา พรหมหิตาทร. (2563). การศึกษาปัจจัยเสี่ยงในการส่งออกสินค้าทางเรือไปทวีปเอเชีย กรณีศึกษา บริษัท เอบีซี จำกัด มหาชน. วารสารวิชาการนอร์ทเทิร์น, 10(1), 167-184.
Alkhatib, S. F., & Momani, R. A. (2023). Supply chain resilience and operational performance: The role of digital technologies in Jordanian manufacturing firms. Administrative Sciences, 13(2), Article 40. https://doi.org/10.3390/ admsci13020040
Atieh Ali, A. A., Sharabati, A.-A. A., Allahham, M., & Nasereddin, A. Y. (2024). The relationship between supply chain resilience and digital supply chain and the impact on sustainability: Supply chain dynamism as a moderator. Sustainability, 16(7), Article 3082. https://doi.org/10.3390/ su16073082
Aven, T. (2016). Risk assessment and risk management: Review of recent advances. In Risk assessment and risk management: Review of recent advances (pp. 1-13).
Godina, R., Pimentel, C., Matos, C., & Ferreira, J. (2021). Failure mode and effects analysis (FMEA) in the context of Industry 4.0: A literature review. IOP Conference Series: Materials Science and Engineering, 1032(1).
Kis, Z., Kontoravdi, C., Shattock, R., Shah, N., & Hallett, J. (2021). The state of play for mRNA vaccines: delivering the new wave of molecular medicines. Nature Reviews Materials, 6(12).
Kök, E., & Yıldız, B. S. (2023). A proactive failure mode and effect analysis in the medical device production process using fuzzy AHP-fuzzy TOPSIS approach. Soft Computing, 27(19).
Olutuase, O. A., Ng, A. K., Olutuase, O. D., & Akbari, M. (2022). Supply chainfragility: A threat to public health in a pandemic. Social Science & Medicine, 313.
Park, S., Seo, J., & Park, S. (2023). An integrated FMEA approach for offshorewind turbine system with uncertainty using intuitionistic fuzzy set and Bayesian Network. Ocean Engineering, 281.
Ullah, I., Khan, S. A., & Khan, I. (2022). A fuzzy FMEA approach for risk analysi and mitigation in the solar PV systems supply chain. Sustainable Energy, Grids and Networks, 32.