【正文】 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 。 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(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)。 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填寫說明 17. 難檢度 (Detection): 難檢度量在設(shè)計(jì)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(jì)管制。 (P預(yù)防 ,D檢測 )。 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填寫說明 16. 現(xiàn)行設(shè)計(jì)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?yàn)樵擃A(yù)防並未被使用在相同或類似的設(shè)計(jì)上。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)防管制及檢測管制 ,以協(xié)助小組成員明確區(qū)分兩者類型的管制方式。 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。 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)測試，或創(chuàng)造出系統(tǒng)模型計(jì)算程序等。 The likelihood of occurrence ranking number has a relative meaning rather than an absolute value. 藉由設(shè)計(jì)變更或設(shè)計(jì)過程變更 (如設(shè)計(jì)查核表、設(shè)計(jì)審查、設(shè)計(jì)指南 )才是降低發(fā)生率的唯一方法，才是降低發(fā)生率的唯一方法 . Preventing or controlling the causes/mechanisms of the failure mode through a design change or design process change (., design checklist, design review, design guide) is the only way a reduction in the occurrence ranking can be effected. 設(shè)計(jì) FMEA填寫說明 潛在失效原因 /機(jī)制發(fā)生率的評估分為 1到 10級，在確定這個(gè)估計(jì)值時(shí)，需考慮下列問題： Estimate the likelihood of occurrence of potential failure causes/mechanism on a 1 to 10 scale. In determining this estimate, question such as the following should be considered: (a) 相似零件、子系統(tǒng)或子系統(tǒng)的過去服務(wù)歷史資料和相關(guān)經(jīng)驗(yàn) ? What is the service history/field experience with similar ponents, subsystems, or systems? (b) 是否沿用以前使用的零件、子系統(tǒng)或系統(tǒng) ,還是與其相似 ? Is the ponent a carryover or similar to a previous level ponent, subsystem, or system? (續(xù) )(Occurrence(continued)): 設(shè)計(jì) FMEA填寫說明 (c) 與上一版序零件、子系統(tǒng)或系統(tǒng)改變程度的大小 ? How significant are changes from a previous level ponent, subsystem, or system? (d) 零件與上一版序零件 ,更無顯著的差異 ? Is the ponent radically different from a previous level ponent? (e) 零件是否為全新的產(chǎn)品 ? Is the ponent pletely new? (f) 零件的用途是否改變 ? Has the ponent application changed? (g) 作業(yè)環(huán)境是否改變 ? What are the environmental changes? (續(xù) )(Occurrence(continued)): 設(shè)計(jì) FMEA填寫說明 (h) 是否運(yùn)用工程分析去預(yù)估 ,應(yīng)用此零件之發(fā)生度 ? Has an engineering analysis (., reliability) been used to estimate the expected parable occurrence rate for the application? (i) 更無放入預(yù)防管制考量 ? Have preventive controls been put in place? 發(fā)生率評價(jià)等級分?jǐn)?shù)為 FMEA作業(yè)範(fàn)圍內(nèi)的相對評分，並不 一定反映實(shí)際可能的發(fā)生 The occurrence ranking number is a relative 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(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 Note: The ranking value of 1 is reserved for “Remote: Failure is unlikely.” 設(shè)計(jì) 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(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)對於所考慮的失效模式和 /或原因 /機(jī)制是充分 的。 This column may also be used to highlight highpriority failure modes for engineering assessment if the team finds this helpful or if local management requires it. 特殊的產(chǎn)品或製品特性符號及其使用，系由三大汽車公司政策自訂，本手冊並未予以標(biāo)準(zhǔn)化。 Note: 1. It is not remended to modify criteria ranking values of 9 and 10. Failure modes with a rank of severity 1 should not be analyzed further. 2. 高嚴(yán)重度者，更時(shí)可藉由設(shè)計(jì)修改來降低失效的嚴(yán)重度，例如「平胎行駛」可減輕瞬