• Applied Biological Chemistry
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• v.50 no.4
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• pp.245-252
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• 2007

FTA (fault tree analysis), an analytical method for system failure management, was employed in the management of faults in running PCR analysis. PCR is executed through several processes, in which the process of PCR machine operation was selected for the analysis by FTA. The reason for choosing the simplest process in the PCR analysis was to adopt it as a first trial to test a feasibility of the FTA approach. First, fault events-top event, intermediate event, basic events-were identified by survey on expert knowledge of PCR. Then those events were correlated deductively to build a fault tree in hierarchical structure. The fault tree was evaluated qualitatively and quantitatively, yielding minimal cut sets, structural importance, common cause vulnerability, simulation of probability of occurrence of top event, cut set importance, item importance and sensitivity. The top event was 'errors in the step of PCR machine operation in running PCR analysis'. The major intermediate events were 'failures in instrument' and 'errors in actions in experiment'. The basic events were four events, one event and one event based on human errors, instrument failure and energy source failure, respectively. Those events were combined with Boolean logic gates-AND or OR, constructing a fault tree. In the qualitative evaluation of the tree, the basic events-'errors in preparing the reaction mixture', 'errors in setting temperature and time of PCR machine', 'failure of electrical power during running PCR machine', 'errors in selecting adequate PCR machine'-proved the most critical in the occurrence of the fault of the top event. In the quantitative evaluation, the list of the critical events were not the same as that from the qualitative evaluation. It was because the probability value of PCR machine failure, not on the list above though, increased with used time, and the probability of the events of electricity failure and defective of PCR machine were given zero due to rare likelihood of the events in general. It was concluded that this feasibility study is worth being a means to introduce the novel technique, FTA, to the management of faults in running PCR analysis.