The recognition and management of risk in donation process and blood product is critical to ensure donor and patient safety. To achieve this goal, the failure mode and effects analysis (FMEA) is a convenient method; moreover it was used to prevent the occurrence of adverse events and look at what could go strong at each step. This study aimed to utilize FMEA in central blood bank in Khartoum to evaluate the potential risk and adverse event that may occur during the donation process. According to the severity, occurrence and the detection of each failure mode, the risk priority number (RPN) was calculated to determine which of the failures should take priority to find a solution and applying corrective action to reduce the failure risk. The statistical package for social sciences (SPSS) version 11 was used as descriptive and analytical statistics tool. The FMEA technique provides a systematic method for finding vulnerabilities in a process before they result in an error, and in this study a satisfactory outcome was reached.
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