An extraction of failure modes for drug manufacturing computerized system

This paper shows common failure modes that drug manufacturing computerized system (DMCS) has. Since drugs are manufactured in facilities controlled by DMCS in these days, DMCS´s functions and performance must be adequate and safe. Failure Mode and Effects Analysis (FMEA) is used to investigate the safety. To conduct FMEA effectively, it is important to enumerate all failure modes. But it is difficult because of the differences of ability of each engineer. To solve this problem, we grouped failure modes in existing FMEA results by type. And we develop a list that consists of common failure modes, failures and countermeasures. Using this list, we can conduct FMEA exhaustively.