Failure mode and effects analysis drastically reduced potential risks in clinical trial conduct

Abstract

BackgroundFailure mode and effects analysis (FMEA) is a risk management tool to proactively identify and assess the causes and effects of potential failures in a system, thereby preventing them from happening. The objective of this study was to evaluate effectiveness of FMEA applied to an academic clinical trial center in a tertiary care setting.MethodsA multidisciplinary FMEA focus group at the Seoul National University Hospital Clinical Trials Center selected 6 core clinical trial processes, for which potential failure modes were identified and their risk priority number (RPN) was assessed. Remedial action plans for high-risk failure modes (RPN >160) were devised and a follow-up RPN scoring was conducted a year later.ResultsA total of 114 failure modes were identified with an RPN score ranging 3–378, which was mainly driven by the severity score. Fourteen failure modes were of high risk, 11 of which were addressed by remedial actions. Rescoring showed a dramatic improvement attributed to reduction in the occurrence and detection scores by >3 and >2 points, respectively.ConclusionsFMEA is a powerful tool to improve quality in clinical trials. The Seoul National University Hospital Clinical Trials Center is expanding its FMEA capability to other core clinical trial processes.

Failure mode and effect analysis (FMEA) to improve collaborative project-based learning: Case study of a Study and Research Path in mechanical engineering

“…It has been previously pointed out that, because the S score is associated to the nature of the failure mode, there are hardly action plans to reduce it. 60 In our educational process, the only way to reduce the S score of a given failure would be to diminish its weight on assessment, which is in our opinion an artificial way of reducing the risk. On the other hand, the FMEA team decided that class observations and written reports would continue being the main failure-detection methods, but in addition the teacher would hold periodic interviews with the students throughout the semester to detect problems arising from groups’ malfunctioning.…”

Cartilage Tissue Engineering by Extrusion Bioprinting: Process Analysis, Risk Evaluation, and Mitigation Strategies

“…This study applies the FMEA/FMECA to a laboratory experimental procedure. It is a method commonly utilized in healthcare and pharmaceutical systems to assess the risk of failure and identify the most critical areas for improvements [28][29][30]. Although not formally required for non-regulated investigations, FMEA/FMECA offers the great advantage to identify and control errors with the perspective to increase research performance and facilitate clinical translation.…”

Quality Management Tools on the Stage: Old but New Allies for Rigor and Standardization of Extracellular Vesicle Studies

“…Failure Mode and Effect Analysis (FMEA) is a systematic approach for identifying all possible failures in a design, process, product or service ( Tague, 2004 ; Lanati, 2018 ). Recently, FMEA has been successfully applied as a tool for risk assessment in biomedical research, biopharmaceutical manufacturing processes, analytical procedures and clinical trials ( Zimmermann and Hentschel, 2011 ; Lee et al, 2017 ; Mascia et al, 2020 ; Petretta et al, 2021 ). Risk analysis is an extremely valid tool to implement in EV basic and even more applicative studies, for the identification and assessment of causes and consequences, and the definition of suitable controls ( Reiner et al, 2017 ).…”