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.

Background : Measurement of blood glucose is a basic part of patient care. Increasingly, blood glucose measurement has become a part of self-care. Devices featuring convenience and quickness are used to measure blood glucose and are used in settings often unsupervised by knowledgeable health care personnel. In this context, a validation test of a handy blood sugar measuring instrument(made by R. co. Ltd) will provide health care professionals and consumers with some assurances that the devices that they are using or purchasing are capable of producing valid results. Method : In this study, we fulfilled requirements from the ICH Q2 guidelines for assurance of accuracy, precision, linearity and range. From the two subjects, blood glucose was measured repeatedly at post-prandial 1h/2h/3h/4h, 12 times each , by two investigators and with two instruments. Then, we compared the results of a handy blood sugar measuring instrument with those of a chemistry analyzer, Hitachi 7070 auto-analyzer, in a core laboratory in Clinical Trial Center, Seoul National University Hospital. Results : Mean accuracy, intra-assay precision and intermediate precision were 92.6%, 2.3%(min. 1.07%, max. 4.51%), 1.73%(min. 0%, max. 5.65%) each. In scatter plot of the results of a handy blood sugar measuring instrument and Hitachi 7070 auto-analyzer, linearity was apparent and the correlation coefficient(r), r 2 was 0.986 and 0.972 each. Conclusions : Mean accuracy was not satisfactory regarding the criteria for quality control of blood glucose measurement(within ±5%) in SNUH. The intermediate precision was also not satisfactory regarding the criteria for Quality Control (less than 5%).

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