【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(jì) FMEA填寫說(shuō)明 建議評(píng)估標(biāo)準(zhǔn) (Suggested Evaluation Criteria): 小組成員對(duì)評(píng)估標(biāo)準(zhǔn)及系統(tǒng)等級(jí)應(yīng)更一致的共識(shí)，即使是個(gè)別產(chǎn)品分析更所修訂，亦應(yīng)更一致的共識(shí) The team should agree on an evaluation criteria and ranking system, that is consistent, even if modified for individual product analysis. 註：等級(jí) Note: The ranking value of 1 is reserved for “Remote: Failure is unlikely.” 設(shè)計(jì) FMEA填寫說(shuō)明 建議的 DFMEA發(fā)生率評(píng)估標(biāo)準(zhǔn) 失效的機(jī)率 可能的失效率 等級(jí) 極高：失效幾乎不可避免 ≧ 100 每一千輛車 /項(xiàng)目 10 50 每一千輛車 /項(xiàng)目 9 高：一再重複失效 20 每一千輛車 /項(xiàng)目 8 10 每一千輛車 /項(xiàng)目 7 中等：偶爾發(fā)生失效 5 每一千輛車 /項(xiàng)目 6 2 每一千輛車 /項(xiàng)目 5 1 每一千輛車 /項(xiàng)目 4 低：相對(duì)較少失效 每一千輛車 /項(xiàng)目 3 每一千輛車 /項(xiàng)目 2 極低：不太可能出現(xiàn)失效 ≦ 每一千輛車 /項(xiàng)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(jì)確認(rèn) /驗(yàn)證 (DV)或其他已完成或提出的活動(dòng)，這些 活動(dòng)將保證該設(shè)計(jì)對(duì)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(jì)審查、失效 /安全設(shè)計(jì)，如：壓力閥、數(shù) 學(xué)計(jì)算、線上 /實(shí)驗(yàn)室測(cè)試、可行性評(píng)估、原型測(cè)試、路試、車隊(duì) 測(cè)試 ) ，都是針對(duì)相同的或類似設(shè)計(jì)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(jì) FMEA填寫說(shuō)明 (續(xù) )(Current Design Controls(continued)): 小組應(yīng)隨時(shí)均著眼於改進(jìn)設(shè)計(jì)管制；例如：於實(shí)驗(yàn)室中創(chuàng)造出系統(tǒng)測(cè)試，或創(chuàng)造出系統(tǒng)模型計(jì)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(jì)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(jì) FMEA填寫說(shuō)明 16. 現(xiàn)行設(shè)計(jì)管制 (續(xù) )(Current Design Controls(continued)): (2)檢測(cè)：檢測(cè)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(jì)管制區(qū)分 為兩個(gè)欄位 ,分別是預(yù)防管制及檢測(cè)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(jì) FMEA填寫說(shuō)明 16. 現(xiàn)行設(shè)計(jì)管制 (續(xù) )(Current Design Controls(continued)): ※ 在範(fàn)例中並沒(méi)更使用到預(yù)防管制欄位 ,因?yàn)樵擃A(yù)防並未被使用在相同或類似的設(shè)計(jì)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(cè) )。 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(jì)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(jì) FMEA填寫說(shuō)明 17. 難檢度 (Detection): 難檢度量在設(shè)計(jì)管制中，能否容易檢測(cè)管制的等級(jí)劃分，為了達(dá)到較低等級(jí)，基本上需改善所規(guī)劃的設(shè)計(jì)管制。 (如：確認(rèn)，和 /或驗(yàn)證活動(dòng) ) 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(píng)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(jì) FMEA填寫說(shuō)明 建議評(píng)估標(biāo)準(zhǔn) (Suggested Evaluation Criteria) 小組成員應(yīng)對(duì)評(píng)估標(biāo)準(zhǔn)及等級(jí)系統(tǒng)更一致的共識(shí)，即使是個(gè)別產(chǎn)品分析更所修訂，亦應(yīng)更一致的共識(shí)。 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(jì)開(kāi)發(fā)過(guò)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(cǎi)用表 。 Detection should be estimated using Table 4 as guideline. 備註：等級(jí) 1是幾乎肯定 Note: The ranking value of 1 is reserved for “almost certain.” 設(shè)計(jì) FMEA填寫說(shuō)明 表 DFMEA難檢度評(píng)估標(biāo)準(zhǔn) 難檢度 標(biāo)準(zhǔn) :設(shè)計(jì)管制檢測(cè)的可能性 等級(jí) 絕對(duì)不確定 設(shè)計(jì)管制不會(huì)也 /或不能檢驗(yàn)出潛在原因 /失效機(jī)制和後續(xù)失效模式 ,或者根本就沒(méi)有設(shè)計(jì)管制 10 極微小 設(shè)計(jì)管制檢測(cè)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(jì)管制檢測(cè)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(jì)管制檢測(cè)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(jì)管制檢測(cè)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(jì)管制檢測(cè)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(jì)管制檢測(cè)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(jì)管制檢測(cè)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(jì)管制檢測(cè)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(jì)管制一定可以檢測(cè)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