Category Archive FMEA

Bydoctor

FMEA 成果經驗分享

2010-10-29 病人安全標竿學習 簡報檔

Bydoctor

The Basic Steps of Conducting a Healthcare FMEA

  1. Identify the process to be examined.
  2. Assign FMEA team members, team leader and team facilitator.
  3. Explain the methodology to the team.
  4. Develop either a flowchart or detailed process flow (outline format) of the process under analysis. All steps in the process should be included.
  5. Designate which of the steps in the process constitute “Functions.”
  6. Determine which Functions represent potential “Failure Modes” or points of potential failure.
  7. Determine the worst potential adverse consequence or “Effect” of each of the Failure Modes.
  8. Determine the “Contributory Factors” for each Failure Mode. A One or more Root Cause Analyses may be necessary to complete this step. Note that we advocate the use of the term “Contributory Factor” rather than “Cause.”
  9. Identify any “Controls” in the process. Controls are components of the process which (a) reduce the likelihood of a Contributory Factor or a Failure Mode, (b) reduce the severity of an Effect, or (c) detect the occurrence of a Failure Mode or Contributory Factor before it leads to the adverse outcome (Effect).
  10. Rate the Severity of each Effect (usually on a scale of 1-10, with 10 being the most severe). The impact of Controls that ameliorate the severity of an Effect are reflected in this rating as well.
  11. Rate the Occurrence (likelihood) of each Contributory Factor (usually on a scale of 1-10, with 10 being the most frequent, or “certain to occur”). The impact of Controls that reduce the likelihood of occurrence of a Failure Mode or Contributory Factor are reflected in this rating as well.
  12. Rate the effectiveness of each “Detection Control (usually on a scale of 1-10, with 10 being the lack of a Detection Control, or the presence of a wholly ineffective one, and 1 being a 100% flawless detection system).
  13. Multiply the three ratings by one another for each Contributory Factor and the corresponding Effect and Detection Controls. The range of these products will be from 1 to 1,000. The resultant number is the Risk Priority number (RPN) for that Contributory Factor.
  14. Rank-order the Contributory Factors according to the Risk Priority Numbers.
  15. Use a Pareto Chart with the traditional 80% rule to determine which contributory Factors should be addressed first.
  16. Add to the above listing ALL Contributory Factors which result in an Effect with Severity of 10, irrelevant of RPN.
  17. Develop a plan addressing how the selected Contributory Factors will be addressed, by whom, when, how the improvement will be assessed, etc.
  18. Continue the improvement process.

    參考資料: CCD Health System

    Bydoctor

    What is HFMEA?

    HFMEA® is the acronym (首字母組合詞) for Healthcare Failure Mode and Effects Analysis。
    在美國榮民醫院系統 Veterans Affairs (VA) National Center for Patient Safety (NCPS) 的大力推廣下,已經成為醫療界實行 FMEA 時常採用的代名詞。

    問題是現況下 VA 所建議的 FMEA 實施步驟中的風險分級,捨棄傳統的風險優先數 RPN,改採較簡單之危害指數矩陣及決策樹,當初目的是為了快速推廣到所有並不熟悉 FMEA 的榮民醫院。台灣開始推動 Healthcare FMEA 時,因為 VA 的資訊豐富,所以幾乎以 VA 的版本作為推動的範本,結果造成的印象是 HFMEA = 危害指數矩陣及決策樹,採用 RPN 的是 FMEA。

    VA 的 HFMEA 才等於 Healthcare FMEA 嗎?
    雖然 VA 是應用 FMEA 的先驅,但當 JC 開始在評鑑時要求醫院應該進行預應式風險管理時,雖然沒有明指是 FMEA,但所有資料都在推動 FMEA。為此 VA 還特別請示 JC ,他們修改過的所謂 HFMEA 是否符合 JC 的要求。可見 VA 的 HFMEA 只是醫療界採用的 FMEA 中的一種模式而已。

    HFMEA 是註冊商標 !
    如果你有注意 VA 網站上的資訊,所有引用 HFMEA 的地方一定會加註 Service Mark (SM) 或 Trademark (TM)。為什麼? 因為那是別人的註冊商標,不是他們的,所以說 HFMEA 等於 VA,真的說不通!
    HFMEA 其實是 CCD Health Systems 的註冊商標,他們是提供 RCA, FMEA 等品管軟體服務的公司。根據其網站的資料其 FMEA 的風險分析採用的是 RPN,所以其實 HFMEA 還是採用 RPN 的!

    如果你上美國 JC 或 IHI (Institute for Healthcare Improvement) 的網站,可以發現所有的 FMEA 的例子都是採用 RPN 做風險分析。

    所以狹隘的認為 HFMEA 就等於要用危害指數矩陣及決策樹是一種偏見,請不要再以採用 “RPN” 或 “危害指數矩陣” 來做為是否是 HFMEA 的判別標準了。

    Bydoctor

    FMEA or FEMA

    剛開始學習 FMEA 時,一直有個困擾,為什麼明明是 F-M-E-A,大家都念成 FE-MA ?
    Failure Mode and Effects Analysis 的首字母組合詞是 FMEA,FEMA 其實是 Federal Emergency Management Agency 的首字母組合詞,這樣亂念不會造成混淆嗎?

    到底誰是始作俑者我查不到,但是許多人跟我有一樣的疑惑。

    不論如何,我會堅持念 F-M-E-A。

    “The beginning of wisdom, is the definition of terms” – Socrates