FAILUREMODES AND EFFECTS ANALYSIS (FMEA) – AN ASSESSMENT TOOL FOR RISK MANAGEMENT IN CLINICAL LABORATORIES
Abstract:
The present paper aims to be an example of the clinical laboratory risk assessment, though it
does not include all the possible risks. This paper presents the evaluation technique FMEA (failure
modes and effects analysis) as a tool for risk management and quality improvement of the clinical
laboratory analyses. The purpose of FMEA is to aid the clinical laboratory in raising awareness and in
identification of the possible hazardous situations of a testing system. Once the hazardous event has
been identified, the risk can be estimated, analyzed and treated. Using the standard CLSI EP18-A
guidelines, the table FMEA has been laid and, thus the errors from the pre-analytical process,
especially, have been ranked according to criticality
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