【文章內(nèi)容簡(jiǎn)介】 quirements Function, fitting measurements Material Environmental aspects Transport (internal/external) Productspecific measure from the process FMEA. 、是否已進(jìn)行了設(shè)計(jì) DFMEA，并確定了改進(jìn)措施？ ?要求 /說明 ?通過跨部門的合作及與顧客和供方的合作必須清楚地了解產(chǎn)品風(fēng)險(xiǎn)，并用合適的措施不斷降低產(chǎn)品風(fēng)險(xiǎn)。對(duì)于復(fù)雜零部件或整套功能系統(tǒng)，使用系統(tǒng) SFMEA（見， ）很有意義。要使用其他類似的分析技術(shù)，可與顧客商定。 ?需考慮要點(diǎn)，例如： ?—顧客要求 /產(chǎn)品建議書 ?—功能，安全性，可靠性，易維修性，重要特性 ?—環(huán)保要求 ?—各有關(guān)部門的參與 ?—試驗(yàn)結(jié)果 ?—通過過程 PFMEA確定的針對(duì)產(chǎn)品特定的措施。 、設(shè)計(jì) DFMEA是否在項(xiàng)目過程中補(bǔ)充更新？已確 定的措施是否已落實(shí)？ ?要求 /說明 ?對(duì)產(chǎn)品的過程的更改必須由項(xiàng)目負(fù)責(zé)人進(jìn)行評(píng)定，在與FMEA小組商討后，必要時(shí)必須進(jìn)行新的分析。在措施落實(shí)后也要對(duì)設(shè)計(jì) DFMEA補(bǔ)充更新（設(shè)計(jì)評(píng)審），使其符合現(xiàn)狀。 ?需考慮要點(diǎn)，例如： ?—顧客要求 ?—重要參數(shù) /重要特性，法規(guī)要求 ?—功能，裝配尺寸 ?—材料 ?—環(huán)保要求 ?—運(yùn)輸（內(nèi)部 /外部） ?—通過過程 PFMEA確定的針對(duì)產(chǎn)品特定的措施。 :Is a quality plan prepared? Requirements/Explanations: The quality plan must contain ponents, subassemblies, assemblies, parts and materials, including the production process from prototype and pilot production phase, which belong to the product. The quality plan is a living document and must be raised/updated for new/amended products. A quality plan (according to DIN EN ISO 8402/) is generally to be raised for the following phases: a) Prototype phase A description of the dimensional, as well as material and functional inspections, which are to be carried out during the construction of the prototype (if required by the customer). b) Pilot production phase/Interface to process development A description of the dimensional, as well as material and functional inspections, which are to be carried out after construction of the prototype and prior to serial production. It must give details, amongst others, about: establishing and marking of significant characteristics raising of an inspection and test plan provision of equipment and fittings timely, planned provision of measuring equipment inspections at appropriate points during the production clarification of acceptance criteria Comment: In addition, see also VDA Volume . ?、是否制訂了質(zhì)量計(jì)劃？ ?要求 /說明 ?質(zhì)量計(jì)劃必須包括該產(chǎn)品自樣件（樣車）階段到批量生產(chǎn)前階段的大總成、組件、小組件、零件、材料及生產(chǎn)過程。質(zhì)量計(jì)劃是一個(gè)動(dòng)態(tài)文件，必須為新產(chǎn)品制訂質(zhì)量計(jì)劃并在產(chǎn)品有更改時(shí)對(duì)其補(bǔ)充更新，使用符合現(xiàn)狀。一般必須為下列階段制訂質(zhì)量計(jì)劃 （根據(jù) DIN EN ISO8402/） ? a)樣件（樣車）階段（ Prototypenphase) ?這是一個(gè)描述在樣件（樣車）制造階段所必須進(jìn)行的尺寸、材料及功能檢驗(yàn)的文件（若顧客要求） ?h）批量生產(chǎn)前階段（ Vorserienphase)/與過程開發(fā)的接口 ?這是一個(gè)描述在樣件（樣車）制造以后，批量生產(chǎn)前所必須進(jìn)行的尺寸、材料及功能檢驗(yàn)的文件。 ?質(zhì)量計(jì)劃必須詳細(xì)說明下列內(nèi)容： ?—確定、標(biāo)識(shí)出重要的特性 ?—制訂檢驗(yàn)和試驗(yàn)流程 ?—配置設(shè)備和裝置 ?—及時(shí)地預(yù)先配備測(cè)量技術(shù) ?—在產(chǎn)品落實(shí)的適當(dāng)時(shí)間點(diǎn)進(jìn)行的檢驗(yàn) ?—澄清驗(yàn)收標(biāo)準(zhǔn)。 ?注：進(jìn)一步的內(nèi)容亦見 :Are the required releases/qualification records at the respective times? Requirements/Explanations: The releases/qualification records of all individual parts, subassemblies and purchased parts are to be proven. The following points, for example, are to be considered: Product trials (. fitting inspections, functional tests, durability checks, environmental simulations) Status of the prototype parts Pilot series model Production/inspection, measuring and test equipment in experimental installation. :Are the required resources available? Requirements/Explanations: The required resources are to taken from the quotation calculation and the preplanning. They must be available, or planned and provided at the respectively appointed time. The required means for this must be included in the project. The following points, for example, are to be considered: Customer requirements Qualified personnel Lost time through absenteeism Through put/Processing time Buildings, premises Experimental installation Prototype construction Tools/Equipment Test/Inspection/Laboratory equipment. 、是否已獲得各階段所要求的認(rèn)可 /合格證明？ ?要求 /說明 ?對(duì)每個(gè)零件、總成和配套件都必須進(jìn)行認(rèn)可 /合格驗(yàn)證 ?需考慮要點(diǎn)，例如： ?—產(chǎn)品試驗(yàn)（例如：裝車試驗(yàn)，功能試驗(yàn)，壽命試驗(yàn)， 環(huán)境模擬試驗(yàn)） ?—樣件狀態(tài) ?—小批量試生產(chǎn)樣件 ?—試制時(shí)的制造設(shè)備和檢驗(yàn)裝置 /檢驗(yàn)器具。 、是否已具備所要求的產(chǎn)品開發(fā)能力？ ?要求 /說明 ?必須從報(bào)價(jià)核算和預(yù)規(guī)劃方案中得出所要求的產(chǎn)品開發(fā)能力。這一產(chǎn)品開發(fā)能力必須具備或相應(yīng)的進(jìn)度表中明確規(guī)劃并能按時(shí)落實(shí)。必須在項(xiàng)目中準(zhǔn)備好所需的資源。 ?需考慮要點(diǎn)，例如： ?—顧客要求 ?—具有素質(zhì)的人員 ?—缺勤時(shí)間 ?—全過程時(shí)間 ?—房屋、場(chǎng)地 ?—試驗(yàn)裝置 ?—樣件（樣車）制造 ?—模具 /設(shè)備 ?—試驗(yàn) /檢驗(yàn) /實(shí)驗(yàn)室裝置 Process Development Element 3:Process Development Planning ? Basic planning for the manufacture of a product to customer requirements, must already have taken place at quotation stage, which must then be put into precise terms and included in a process development plan, after receipt of contract. Technical and personnel resources, already available, must be considered and expansions preplanned. ?When setting all tasks, objectives and deadlines, all interfacing areas are to be included through interdisciplinary cooperation. All tasks and responsibilities are to be clearly established. ? When planning and implementing processes, amendments can bee necessary due to changed customer requirements or special legislative requirements, which also make a reexamination of the planning necessary. ?Questions ?: Are the product requirements available? ?: Is a process development plan available and are the targets maintained? ?: Are the resources for the realization of serial production ?planned? ?:Have the process requirements been determined and considered? ?: Are the necessary personnel and technical preconditions ?for the project process planned/available? ?:Is the process FMEA raised and are improvement measures established? 過程開發(fā) 要素 3：過程開發(fā)的策劃 ? 在報(bào)價(jià)階段就必須根據(jù)顧客要求進(jìn)行產(chǎn)品生產(chǎn)的基礎(chǔ)策劃，接受委托后將其具體化，并制訂出過程開發(fā)計(jì)劃?，F(xiàn)有的技術(shù)能力和人員能力必須予以考慮，擴(kuò)展能力規(guī)模必須預(yù)先計(jì)劃。 ?在細(xì)化各項(xiàng)任務(wù)、目標(biāo)及進(jìn)度表時(shí)，要通過跨部門合作把各接口部門聯(lián)接起來。必須明確規(guī)定各項(xiàng)任務(wù)及職責(zé)。 ?由于顧客要求的更改或特別的法規(guī)要求，生產(chǎn)過程的策劃和落實(shí)可以做相應(yīng)更改，這一更改可能要求對(duì)策劃過程重新考慮。 ?提問： ?、是否已具有對(duì)產(chǎn)品的要求？ ?、是否已具有過程開發(fā)計(jì)劃，是否遵守目標(biāo)值？ ?、是否已策劃了落實(shí)批量生產(chǎn)的資源？ ?、是否了解并考慮到了對(duì)生產(chǎn)過程的要求？ ?、是否已計(jì)劃 /已具備項(xiàng)目開展所需的人員與技術(shù) 的必要條件？ ?、是否已做了過程 PFMEA，并確定了改進(jìn)措施？ Are the product requirements available? ?Requirements/Explanations: ?All requirements of the product to be produced, must be known and included in the planning. ?The following points, for example, are to be conside