Journal of Optimization and Supply Chain Management

Journal of Optimization and Supply Chain Management

Risk-based Management of the Equipment Process in The Biochemistry Laboratory of Charles Nicolle Hospital of Tunis

Document Type : Research Paper

Authors
Khaled Lajmi 1
Kahena Bouzid 2
Marwa Hajlaoui 3
1 Biochemistry Laboratory, Charles Nicolle Hospital of Tunis, 1006-Tunis, Tunisia
2 Biochemistry Laboratory, Faculty of Medicine, University of Tunis El Manar, 1006-Tunis, Tunisia
3 Biochemistry Laboratory, Charles Nicolle Hospital of Tunis, Tunis, Higher Institute of Medical Technologies of Tunis, University of Tunis El Manar, Tunis, Tunisia
10.22034/ISS.2026.10519.1088
Abstract
Objective: Medical laboratory results play a critical role in clinical decision-making, making effective risk management essential to ensure analytical quality and patient safety. This study aims to evaluate the application of a risk-based approach to equipment management in a public clinical laboratory using the Failure Mode, Effects, and Criticality Analysis (FMECA) method, in accordance with ISO 15189:2022 requirements.
Methods: A prospective study was conducted in the Biochemistry Laboratory of Charles Nicolle Hospital of Tunis. The equipment management process was described using a flowchart, followed by an FMECA to identify potential failure modes. Risks were evaluated based on severity, occurrence, and detectability, allowing prioritization of failures and definition of appropriate corrective actions.
Results: Ten potential failure modes were identified across equipment acquisition, maintenance, and metrology processes. Four failure modes presented high criticality scores: installation errors, non-conforming equipment qualification, delay or omission of preventive maintenance, and lack of metrological confirmation. These failures posed significant risks to analytical reliability, workflow continuity, and patient safety.





Conclusion: The application of FMECA provided a structured and proactive framework for identifying and prioritizing equipment-related risks in a clinical biochemistry laboratory. Implementing targeted corrective actions, including staff training, preventive maintenance planning, supplier quality control, and calibration traceability, can significantly reduce risk levels. This approach strengthens equipment reliability, improves analytical quality, and enhances patient safety, supporting continuous quality improvement in medical laboratories.
Keywords
risk management
clinical laboratory
quality assurance
Subjects
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Journal of Optimization and Supply Chain Management
Volume 3, Issue 3
Summer 2026
Pages 210-221