This paper proposes a method of Fault Tree Analysis (FTA) for control program. If malfunction of control program occurs, industrial product into which program is installed may behave inadequately. As a result, it causes some faults for industrial products, but it also causes damages to the users and environments. This paper proposes following method; prepare FT templates corresponding to the program structure, extract characteristics of control program, and develop FT according to the predefined rules. As a result, we can develop FT mechanically. The proposed FTA method is applied to an analysis of "spin too fast" fault for satellite, and FT is developed. The result of FT is adequate. This result shows that safety of control program installed into industrial products are improved by applying the proposed FTA method for control program.
This paper proposes operational Risk Management (RM) method using Failure Mode and Effects Analysis (FMEA) for drug manufacturing computerlized system (DMCS). The quality of drug must not be influenced by failures and operational mistakes of DMCS. To avoid such situation, DMCS has to be conducted enough risk assessment and taken precautions. We propose operational RM method using FMEA for DMCS. To propose the method, we gathered and compared the FMEA results of DMCS, and develop a list that contains failure modes, failures and countermeasures. To apply this list, we can conduct RM in design phase, find failures, and conduct countermeasures efficiently. Additionally, we can find some failures that have not been found yet.
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