Volume 23, Issue 1 (Spring 2026)
bloodj 2026, 23(1): 22-33 |
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Ethics code: IR.TMI.REC.1404.040
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Rafiee M H, Amini-Kafiabad S. Preventive Risk Assessment of Plasma Warehouse at -25°C Using Failure Mode and Effects Analysis. bloodj 2026; 23 (1) :22-33
URL: http://bloodjournal.ir/article-1-1620-en.html
URL: http://bloodjournal.ir/article-1-1620-en.html
Abstract: (10 Views)
A B S T R A C T
Background and Objectives
Maintaining plasma at -18°C to -20°C is a critical element of the cold chain in Blood Transfusion centers requiring infrastructure that complies with Good Manufacturing Practice (GMP) standards. Evidence suggests that many costly failures stem from latent deficiencies introduced during the facility design phase. This study aimed to apply Failure Mode and Effects Analysis (FMEA) to proactively identify and mitigate risks during the design and construction of a plasma storage facility.
Materials and Methods
This retrospective study was conducted during the design and construction phase of a -25°C plasma warehouse at the headquarter of the Iranian Blood Transfusion Organization. A multidisciplinary team identified potential failure modes by reviewing design documents and conducting brainstorming sessions. For each failure mode, the severity (S), probability of occurrence (O), and detectability (D) were assessed, and a risk priority number (RPN = S × O × D) was calculated. Failure modes with an RPN ≥ 64 were prioritized for preventive and control measures, and re-evaluation was performed after these measures were determined. The nonparametric Wilcoxon test was used to compare changes pre and post intervention changes by SPSS 23 software.
Results
A total of 37 potential failure modes were identified across six categories. The initial RPN ranged from 64 to 200, with a mean of 127.02 ± 49.04 and a median of 120. Following the implementation of the control measures, the mean RPN decreased to 21.13 ± 5.95 and a median of 24. There was a significant redution in the mean score for occurrence and detectability (p<0.001), while the severity scores remained unchanged. The most substantial reductions were observed for deficiencies in requirements documentation (93.33%) and the operator presence system (92.5%). After the intervention, no failure modes had an RPN above the threshold of 64. Sensitivity analysis confirmed the robustness of the results.
Conclusions
The systematic application of FMEA during the design and construction phase of plasma warehouse is an effective and cost-effective tool for preventing critical risks prior to facility operation. Thia approach can serve as a practical model for blood transfusion centers, especially in resource-limited settings.
Background and Objectives
Maintaining plasma at -18°C to -20°C is a critical element of the cold chain in Blood Transfusion centers requiring infrastructure that complies with Good Manufacturing Practice (GMP) standards. Evidence suggests that many costly failures stem from latent deficiencies introduced during the facility design phase. This study aimed to apply Failure Mode and Effects Analysis (FMEA) to proactively identify and mitigate risks during the design and construction of a plasma storage facility.
Materials and Methods
This retrospective study was conducted during the design and construction phase of a -25°C plasma warehouse at the headquarter of the Iranian Blood Transfusion Organization. A multidisciplinary team identified potential failure modes by reviewing design documents and conducting brainstorming sessions. For each failure mode, the severity (S), probability of occurrence (O), and detectability (D) were assessed, and a risk priority number (RPN = S × O × D) was calculated. Failure modes with an RPN ≥ 64 were prioritized for preventive and control measures, and re-evaluation was performed after these measures were determined. The nonparametric Wilcoxon test was used to compare changes pre and post intervention changes by SPSS 23 software.
Results
A total of 37 potential failure modes were identified across six categories. The initial RPN ranged from 64 to 200, with a mean of 127.02 ± 49.04 and a median of 120. Following the implementation of the control measures, the mean RPN decreased to 21.13 ± 5.95 and a median of 24. There was a significant redution in the mean score for occurrence and detectability (p<0.001), while the severity scores remained unchanged. The most substantial reductions were observed for deficiencies in requirements documentation (93.33%) and the operator presence system (92.5%). After the intervention, no failure modes had an RPN above the threshold of 64. Sensitivity analysis confirmed the robustness of the results.
Conclusions
The systematic application of FMEA during the design and construction phase of plasma warehouse is an effective and cost-effective tool for preventing critical risks prior to facility operation. Thia approach can serve as a practical model for blood transfusion centers, especially in resource-limited settings.
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