BACKGROUND: Failure modes and effects analysis (FMEA) is a risk management tool used by the manufacturing industry but now being applied in laboratories. STUDY DESIGN AND METHODS: Teams from six South Korean blood banks used this tool to map their manual and automated blood grouping processes and determine the risk priority numbers (RPNs) as a total measure of error risk. RESULTS: The RPNs determined by each of the teams consistently showed that the use of automation dramatically reduced the RPN compared to manual processes. In addition, FMEA showed where the major risks occur in each of the manual processes and where attention should be prioritized to improve the process. Despite no previous experience with FMEA, the teams found the technique relatively easy to use and the subjectivity associated with assigning risk numbers did not affect the validity of the data. CONCLUSION: FMEA should become a routine technique for improving processes in laboratories.
BACKGROUND: Failure modes and effects analysis (FMEA) is a risk management tool used by the manufacturing industry but now being applied in laboratories. STUDY DESIGN AND METHODS: Teams from six South Korean blood banks used this tool to map their manual and automated blood grouping processes and determine the risk priority numbers (RPNs) as a total measure of error risk. RESULTS: The RPNs determined by each of the teams consistently showed that the use of automation dramatically reduced the RPN compared to manual processes. In addition, FMEA showed where the major risks occur in each of the manual processes and where attention should be prioritized to improve the process. Despite no previous experience with FMEA, the teams found the technique relatively easy to use and the subjectivity associated with assigning risk numbers did not affect the validity of the data. CONCLUSION: FMEA should become a routine technique for improving processes in laboratories.