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A Risk Management Method for Drug Production Systems Using Plural Safety Analysis Methods

Research Project

Project/Area Number 25350564
Research Category

Grant-in-Aid for Scientific Research (C)

Allocation TypeMulti-year Fund
Section一般
Research Field Medical systems
Research InstitutionUniversity of Yamanashi

Principal Investigator

TAKAHASHI Masakazu  山梨大学, 総合研究部, 教授 (20403446)

Research Collaborator Nanba REIJI  
Project Period (FY) 2013-04-01 – 2016-03-31
Project Status Completed (Fiscal Year 2015)
Budget Amount *help
¥2,990,000 (Direct Cost: ¥2,300,000、Indirect Cost: ¥690,000)
Fiscal Year 2015: ¥910,000 (Direct Cost: ¥700,000、Indirect Cost: ¥210,000)
Fiscal Year 2014: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
Fiscal Year 2013: ¥1,040,000 (Direct Cost: ¥800,000、Indirect Cost: ¥240,000)
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 / 組込みソフトウェア / 医薬品製造 / ソフトウェア / コンピュータ化システムバリデーション
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.

Report

(4 results)
  • 2015 Annual Research Report   Final Research Report ( PDF )
  • 2014 Research-status Report
  • 2013 Research-status Report
  • Research Products

    (17 results)

All 2015 2014 2013 Other

All Journal Article (10 results) (of which Peer Reviewed: 8 results,  Acknowledgement Compliant: 5 results,  Open Access: 3 results) Presentation (5 results) (of which Int'l Joint Research: 1 results) Remarks (2 results)

  • [Journal Article] A Study of Fault Tree Analysis for Control Program in Space System2015

    • Author(s)
      Masakazu Takahashi, Riki Kosaka, Reiji Nanba
    • Journal Title

      Proc. of SII2015

      Volume: NA

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] 肘掛け付き支援具を用いた椅子からの立ち上がり動作の評価2015

    • Author(s)
      高橋正和、難波礼治、他3名
    • Journal Title

      日本福祉工学会誌

      Volume: 17/2

    • NAID

      40020681282

    • Related Report
      2015 Annual Research Report
    • Peer Reviewed / Acknowledgement Compliant
  • [Journal Article] ソフトウェア故障木解析手法の研究2015

    • Author(s)
      高橋正和、小坂力、難波礼治
    • Journal Title

      第189回情報処理学会ソフトウェア工学研究報告

      Volume: 17

    • Related Report
      2015 Annual Research Report
    • Acknowledgement Compliant
  • [Journal Article] Methods for Holding Effective Events that Gererate Interests in Science and Technology among Elementary School2014

    • Author(s)
      Reiji Nanba, Yoshinori Aramaki, Shigeru Isogai, Masakazu Takahashi
    • Journal Title

      Scientific Journal of Education Technology

      Volume: Vol.4, Issue 4 Pages: 47-56

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Open Access
  • [Journal Article] A Proposal of Fault Tree Analysis for Control Programs2014

    • Author(s)
      Masakazu Takahashi, Reiji Nanba
    • Journal Title

      Proc. of SICE2014

      Volume: 1 Pages: 1719-1724

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant
  • [Journal Article] A Study of Improvement in the Standing-up Action of Elderly People by Using the Seating2014

    • Author(s)
      Masakazu Takahashi, Reiji Nanba 他6名
    • Journal Title

      Proc. of SICE2014

      Volume: 1 Pages: 494-499

    • Related Report
      2014 Research-status Report
    • Peer Reviewed / Open Access / Acknowledgement Compliant
  • [Journal Article] A Study of Computerized System Validation Method for PLC Based System2014

    • Author(s)
      Masakazu Takahashi, Reiji Nanba
    • Journal Title

      International Journal of Engineering and Innovative Technology

      Volume: Vol.3, Issue 8 Pages: 61-72

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] An Analysis for Arm Force When Elderly People Stand up from Chair Using Support Tool2014

    • Author(s)
      Masakazu Takahashi, Kenichi Sakoda, Reiji Nanba
    • Journal Title

      Journal of Computer Science, Technology and Application

      Volume: 未定

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Journal Article] 組込みソフトウェア向け故障木解析手法2013

    • Author(s)
      高橋正和
    • Journal Title

      ソフトウェア工学研究会誌

      Volume: 2013-SE-182(26) Pages: 1-6

    • Related Report
      2013 Research-status Report
  • [Journal Article] An analysis of elderly people’s standing-up action from chair -Contribution of arm force-2013

    • Author(s)
      Masakazu Takahashi, kenichi Sakoda, Reiji Nanba
    • Journal Title

      SICE2013

      Volume: Proc. of SICE2013 Pages: 282-287

    • Related Report
      2013 Research-status Report
    • Peer Reviewed
  • [Presentation] A Study of Fault Tree Analysis for Control Program in Space System2015

    • Author(s)
      高橋正和
    • Organizer
      SII2015
    • Place of Presentation
      名城大学(愛知県・名古屋市)
    • Year and Date
      2015-12-11
    • Related Report
      2015 Annual Research Report
    • Int'l Joint Research
  • [Presentation] ソフトウェア故障木解析手法の研究2015

    • Author(s)
      高橋正和
    • Organizer
      第189回情報処理学会ソフトウェア工学研究会報告
    • Place of Presentation
      教育文化会館(北海道・札幌市)
    • Year and Date
      2015-07-22
    • Related Report
      2015 Annual Research Report
  • [Presentation] A Proposal of Fault Tree Analysis for Control Programs2014

    • Author(s)
      Masakazu Takahasi
    • Organizer
      SICE2014
    • Place of Presentation
      札幌、北海道大学
    • Year and Date
      2014-09-09 – 2014-09-12
    • Related Report
      2014 Research-status Report
  • [Presentation] A Study of Improvement in the Standing-up Action of Elderly People by Using the Seating2014

    • Author(s)
      Masakazu Takahashi
    • Organizer
      SICE2014
    • Place of Presentation
      札幌、北海道大学
    • Year and Date
      2014-09-09 – 2014-09-12
    • Related Report
      2014 Research-status Report
  • [Presentation] 組込みソフトウェア向け故障木解析手法2013

    • Author(s)
      高橋正和
    • Organizer
      情報処理学会 第182回 ソフトウェア工学研究会
    • Place of Presentation
      石川県金沢市ITビジネスプラザ武蔵
    • Related Report
      2013 Research-status Report
  • [Remarks] 山梨大学研究者総覧

    • URL

      http://erdb.yamanashi.ac.jp/rdb/A_DispDetail.Scholar?fid=0&id=83FDD3CAFCAE43A0

    • Related Report
      2015 Annual Research Report
  • [Remarks] 山梨大学研究者総覧

    • URL

      http://sangaku.yamanashi.ac.jp/SearchResearcher/contents/83FDD3CAFCAE43A0.html

    • Related Report
      2014 Research-status Report

URL: 

Published: 2014-07-25   Modified: 2019-07-29  

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