【正文】 ve rating within the scope of the FMEA and may not reflect the actual likelihood of occurrence. (續(xù) )(Occurrence(continued)): 設(shè)計 FMEA填寫說明 建議評估標(biāo)準(zhǔn) (Suggested Evaluation Criteria): 小組成員對評估標(biāo)準(zhǔn)及系統(tǒng)等級應(yīng)更一致的共識，即使是個別產(chǎn)品分析更所修訂，亦應(yīng)更一致的共識 The team should agree on an evaluation criteria and ranking system, that is consistent, even if modified for individual product analysis. 註：等級 Note: The ranking value of 1 is reserved for “Remote: Failure is unlikely.” 設(shè)計 FMEA填寫說明 建議的 DFMEA發(fā)生率評估標(biāo)準(zhǔn) 失效的機(jī)率 可能的失效率 等級 極高：失效幾乎不可避免 ≧ 100 每一千輛車 /項目 10 50 每一千輛車 /項目 9 高：一再重複失效 20 每一千輛車 /項目 8 10 每一千輛車 /項目 7 中等：偶爾發(fā)生失效 5 每一千輛車 /項目 6 2 每一千輛車 /項目 5 1 每一千輛車 /項目 4 低：相對較少失效 每一千輛車 /項目 3 每一千輛車 /項目 2 極低：不太可能出現(xiàn)失效 ≦ 每一千輛車 /項目 1 Suggested DFMEA Occurrence Evaluation Criteria Probability of Failure Possible Failure Rates Ranking Very high: Persistent failures ≧ 100 per thousand vehicle/items 10 50 per thousand vehicle/items 9 High: Frequent failures 20 per thousand vehicle/items 8 10 per thousand vehicle/items 7 Moderate: Occasional failures 5 per thousand vehicle/items 6 2 per thousand vehicle/items 5 1 per thousand vehicle/items 4 Low: Relatively few failure per thousand vehicle/items 3 per thousand vehicle/items 2 Remote: Failure is unlikely ≦ per thousand vehicle/items 1 (Current Design Controls): 列舉預(yù)防、設(shè)計確認(rèn) /驗證 (DV)或其他已完成或提出的活動，這些 活動將保證該設(shè)計對於所考慮的失效模式和 /或原因 /機(jī)制是充分 的?，F(xiàn)行管制 (如：設(shè)計審查、失效 /安全設(shè)計，如：壓力閥、數(shù) 學(xué)計算、線上 /實(shí)驗室測試、可行性評估、原型測試、路試、車隊 測試 ) ，都是針對相同的或類似設(shè)計所使用的管制方法。 List the prevention, design validation/verification (DV), or other activities that have been pleted or mitted to and that will assure the design adequacy for the failure mode and/or cause/mechanism under consideration. Current controls (., design reviews, fail/safe designs such as a pressure relief valve, mathematical studies, rig/lab testing, feasibility review, prototype tests, road testing, fleet testing) are those that have been or are being used with the same or similar designs. 設(shè)計 FMEA填寫說明 (續(xù) )(Current Design Controls(continued)): 小組應(yīng)隨時均著眼於改進(jìn)設(shè)計管制；例如：於實(shí)驗室中創(chuàng)造出系統(tǒng)測試，或創(chuàng)造出系統(tǒng)模型計算程序等。 The team should always be focused on improving design controls。 for example, creating new system tests in the lab, or creating new system modeling algorithms, etc. 有兩種設(shè)計管制的類型可供考量 (舊版為三種 ) There are two types of design controls to consider: (1) 預(yù)防：預(yù)防失效原因 /機(jī)制或失效模式發(fā)生，或降低發(fā)生的機(jī)率。 Prevention: Prevent the cause/mechanism of failure or the failure mode from occurring, or reduce their rate of occurrence. 設(shè)計 FMEA填寫說明 16. 現(xiàn)行設(shè)計管制 (續(xù) )(Current Design Controls(continued)): (2)檢測：檢測失效原因 /機(jī)制或失效模式，可藉由分析的方法或物理的方法在大批量生產(chǎn)前查出。比較好的方式是第一種方式 Detection: Detect the cause/mechanism of failure or the failure mode, either by analytical or physical methods, before the item is released to production. The preferred approach is to first use prevention controls, if possible. DFMEA之現(xiàn)行設(shè)計管制區(qū)分 為兩個欄位 ,分別是預(yù)防管制及檢測管制 ,以協(xié)助小組成員明確區(qū)分兩者類型的管制方式。更助於目視分辨決定所考量的管制方式。 The Design FMEA form in this manual has two columns for the design controls (., separate columns for Prevention Controls and Detection Controls) to assist the team in clearly distinguishing between these two types of design controls. This allows for a quick visual determination that both types of design controls have been considered. 設(shè)計 FMEA填寫說明 16. 現(xiàn)行設(shè)計管制 (續(xù) )(Current Design Controls(continued)): ※ 在範(fàn)例中並沒更使用到預(yù)防管制欄位 ,因為該預(yù)防並未被使用在相同或類似的設(shè)計上。 In the example included here, it is clear that the team has not identified any prevention controls. This could be due to prevention controls not having been used on the same or similar designs. ※ 如果某一欄位被使用到 ,則其字首“ P ”” D ”應(yīng)該分別註記。 (P預(yù)防 ,D檢測 )。 If a onecolumn (for design controls) form is used, then the following prefixes should be used. For prevention controls, place a ?P? before each prevention control listed. For detection controls, place a ?D? before each detection control listed. ※ 一旦設(shè)計管制欄位已經(jīng)鑑定 ,應(yīng)審查所更預(yù)防管制 ,以決定是否任何發(fā)生率需要修訂。 Once the design controls have been identified, review all prevention controls to determine if any occurrence rankings need to be revised. 設(shè)計 FMEA填寫說明 17. 難檢度 (Detection): 難檢度量在設(shè)計管制中，能否容易檢測管制的等級劃分，為了達(dá)到較低等級，基本上需改善所規(guī)劃的設(shè)計管制。 (如：確認(rèn)，和 /或驗證活動 ) Detection is the rank associated with the best detection control listed in the design control. In order to achieve a lower raking, generally the planned design control (., validation, and/or verification activities) has to be improved. 備註：在訂出難檢度評分後，小組應(yīng)再審查發(fā)生率，以確定發(fā)生率是否仍然恰當(dāng)。 Note: After making the detection ranking, the team should review the occurrence ranking and ensure that the occurrence ranking is still appropriate. 設(shè)計 FMEA填寫說明 建議評估標(biāo)準(zhǔn) (Suggested Evaluation Criteria) 小組成員應(yīng)對評估標(biāo)準(zhǔn)及等級系統(tǒng)更一致的共識，即使是個別產(chǎn)品分析更所修訂，亦應(yīng)更一致的共識。 The team should agree on an evaluation criteria and ranking system that is consistent, even if modified for individual product analysis. 難檢度管制盡可能及早在設(shè)計開發(fā)過程中導(dǎo)入。 It is best to have detection controls in place as early as possible in the design development process. 難檢度應(yīng)採用表 。 Detection should be estimated using Table 4 as guideline. 備註：等級 1是幾乎肯定 Note: The ranking value of 1 is reserved for “almost certain.” 設(shè)計 FMEA填寫說明 表 DFMEA難檢度評估標(biāo)準(zhǔn) 難檢度 標(biāo)準(zhǔn) :設(shè)計管制檢測的可能性 等級 絕對不確定 設(shè)計管制不會也 /或不能檢驗出潛在原因 /失效機(jī)制和後續(xù)失效模式 ,或者根本就沒有設(shè)計管制 10 極微小 設(shè)計管制檢測出潛在原因 /失效機(jī)制或後續(xù)失效模式的機(jī)率及其微小 9 微小 設(shè)計管制檢測出潛在原因 /失效機(jī)制和故障失效模式的機(jī)率微小 8 極低 設(shè)計管制檢測出潛在原因 /失效機(jī)制和故障失效模式的機(jī)率極低 7 低 設(shè)計管制檢測出潛在原因 /失效機(jī)制和故障失效模式的機(jī)率低 6 中等 設(shè)計管制檢測出潛在原因 /失效機(jī)制和故障失效模式的機(jī)率中等 5 中高 設(shè)計管制檢測出潛在原因 /失效機(jī)制和故障失效模式的機(jī)率中高 4 高 設(shè)計管制檢測出潛在原因 /失效機(jī)制和故障失效模式的機(jī)率高 3 極高 設(shè)計管制檢測出潛在原因 /失效機(jī)制和故障失效模式的機(jī)率極高 2 幾乎肯定 設(shè)計管制一定可以檢測出潛在原因 /失效機(jī)制和後續(xù)失效模式 1 Table4. Suggested DFMEA Detection Evaluation Criteria Detection Criteria: Likelihood of Detection by Design C