2015 Fiscal Year Final Research Report
A Risk Management Method for Drug Production Systems Using Plural Safety Analysis Methods
| Project/Area Number |
25350564
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| Research Category |
Grant-in-Aid for Scientific Research (C)
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| Allocation Type | Multi-year Fund |
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| Section | 一般 |
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| Research Field |
Medical systems
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| Research Institution | University of Yamanashi |
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Principal Investigator |
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| Research Collaborator |
Nanba REIJI
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| Project Period (FY) |
2013-04-01 – 2016-03-31
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| Keywords | 医薬品製造システム / 制御システム / リスクマネジメント / 故障モード影響解析 / 故障木解析 |
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| Outline of Final Research Achievements |
This research proposed a risk management method that could apply for computerized systems required severe reliability. Specifically, we proposed a Failure Mode and Effects Analysis (FMEA) method that was used for detecting latent failures comprehensively and a Fault Tree Analysis (FTA) method that is used for identifying causes of specific fault. Furthermore, we developed those support tools. As a result of applying those methods and tools, it became that failures that engineers could not find are detected. Finally, we proposed a risk management method combined FMEA and FTA. As a result of applying this method, it became that many latent failures could be found.
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| Free Research Field |
ソフトウェア工学
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