控制計劃程序文件

1、1. Purpose and objective1. 目的2. Process definitions2.1 Scope2.2 Process responsibility2.3 Involved functional divisions2.4 Definitions2.5 Measurables3.0 Procedure3.1 Control plan for prototypes3.2 Control plan for pre-launch3.3 Control plan for production3.4 Product and process changes,relocation of

2、 production2. 過程定義2.1 范圍2.2 過程職責(zé)2.3 相關(guān)職能部門2.4 定義2.5 評價3.0 流程3.1 樣件 控制計劃3.2 試生產(chǎn) 控制計劃3.3 生產(chǎn) 控制計劃3.4 產(chǎn)品和工藝變更，生產(chǎn) 地的變更3.5 存檔3.5 Archiving4. 備注和注釋5.其他適用文件4. Notes and remarks5. Other applicable docume ntsreviewed / 復(fù)審released / 發(fā)布from / 從date/sig nature日期/簽名During product and process developme nt.在產(chǎn)品和工藝發(fā)展

3、階段，產(chǎn)品制造的每一步生everyin dividualproducti onstep for 產(chǎn)步驟必須以下的方式進行計劃:product manufacture must be planned insuch a way thatadhere neeto all specifiedproduct characteristicsisguara nteedusingcon trolled, econo mical seque nces.all pla nned product ion, assembly and testi ngseque nces for aproduct from recei

4、pt of the確保所有規(guī)定的產(chǎn)品特性在生產(chǎn)過程中受控以及經(jīng)濟的。一個產(chǎn)品從生產(chǎn)材料的驗收到成品交貨給顧客的整個過程的所有計劃的生產(chǎn)、 裝配和檢驗的流程都要與控制計劃中的 清晰可實現(xiàn)的流程圖對應(yīng)。產(chǎn)品描述,裝配,檢驗的流程變更前一定 要先評審、批準product ion materials through todelivery of the finishedproductto the customer are collated in a clearlyman ageable layout in theform of a con trol pla n.cha nges to described

5、product ion,assembly and testi ngseque nces控制計劃是作為貫穿整個生產(chǎn)周期的受控文件，因此要提交給客戶/批準，并作為一個有 序的計劃和規(guī)定的生產(chǎn)流程的有效文件驗證證 明。are on ly in troduced followi ng prior assessme nt and approval.The controlplanismaintainedas acontrolleddocumentthroughouttheentire productionperiod andcanconsequentlybepresented tothecustomer

6、/ to approval authorities as a verification document as objective evidence of a methodically planned andspecified production sequence.本中心質(zhì)量程序囊括的定義適用于世界范圍內(nèi) 所有 Automotive 的部門和工廠。（見 IMS 1 卷 1.3 章 1.3.2 節(jié)）。2.0 Process definitions2.1 ScopeThe definitions contained in this Central Quality Procedure are ap

7、plicable worldwide to all Automotive divisions and factories. (see IMS Volume1_1.3 Organization Chapter 1.3.2).2.0 過程定義2.1 范圍of 2.2 過程職責(zé)或職責(zé)范圍2.2 Process responsibility/fields responsibilityProcess resp on sibilityfor the開發(fā)部門在過程中負責(zé)樣件控制計劃的compilati on,assessme nt,updati ng,releaseanddistributi on of p

8、rototype con trol pla ns (A and B samples) lies with Developme ntProcess resp on sibility for the compilati on,assessme nt,updati ng,releaseanddistributi onofproducti on編寫、評估、更新、發(fā)布和下發(fā)（A和B樣品）。為前期開發(fā)（C樣品）和生產(chǎn)樣品（D 樣品）編寫評估、更新、發(fā)布和下發(fā)的 樣件控制計劃，這些過程職責(zé)取決于制 造工廠的生產(chǎn)計劃部門。controlpla ns forpre-la unch(Csamples)andpro

9、duct ion(Dsamples)modelslies withtheProducti on Pla nning Departme nt of the produc ing pla nt.2.3 Invo Ived fun cti onal divisio ns2.3相關(guān)職能部門Developme nt divisi ons which produce and開發(fā)部門生產(chǎn)并向客戶提供樣品（如.for EEV,EEG,ELT)supply samples or prototypescustomers (e.g. EEV,EEG,ELT)生產(chǎn)計劃部門Product ion Pla nning質(zhì)量

10、管理部門Quality Man ageme ntSupplier Quality Assura nee供應(yīng)商質(zhì)量保證部門2.4定義2.4 Defi nitionsCon trolpla n: see ISO/TS 16949chap. and Annex AProducti on material:Materialwhich is used in the manufacture of products.Prototypes:Prototypes areproductsmanufacturedunder theresp on sibility of Developme nt an

11、d supplied to the customer. Parts, comp onentsandmanu facturi ngmethods do not have to comply with thesubseque ntlyusedproduct ion process. Quality resp on sibilitylies with thedeliveri ngDevelopme nt控制計劃：見 ISO/TS 16949 章，附件A生產(chǎn)材料：用于制造產(chǎn)品的材料樣件：樣件是在開發(fā)部門負責(zé)制作并向 客戶提供的產(chǎn)品。零件、部件和制造方 法不要求與量產(chǎn)相同。質(zhì)量方面的職責(zé)

12、在于負責(zé)交貨的開發(fā)部門。試生產(chǎn)件：試生產(chǎn)件是在生產(chǎn)計劃部門 負責(zé)的條件下制造的產(chǎn)品，其零部件和 組件可以不同于發(fā)布狀態(tài)的零部件和組 件。使用的生產(chǎn)工藝仍然處于優(yōu)化和發(fā) 展的狀態(tài)。員工的作業(yè)資格不完全符 合。質(zhì)量方面的職責(zé)在于工廠或質(zhì)量管Pre-la unchproducts:Pre-la unchproductsareproductsmanu facturedun dertheresp on sibilityofProductio nPla nningfrompartsand批量生產(chǎn)：批量生產(chǎn)時產(chǎn)品制造是在正式發(fā)布的零件與部件條件下，產(chǎn)品制造過程與發(fā)布的正式生產(chǎn)狀態(tài)一致，質(zhì)量 責(zé)任在于生產(chǎn)co

13、mp onents with differi ng release statuses.Theproducti onprocesses used are still in the optimizationand release phase.Employee qualification is not yet completed. Quality resp on sibility lies with the pla nt/QMSeries products:Series productsare productsmanu factured un derthe responsibility of Pro

14、duction made from released parts and components. The used production processes comply with the releasedproducti onstatus.Resp on sibilityfor quality lieswith Producti on.零件類：這個描述了具有相似性能的零 部件，它們是采用相同的工藝步驟制造 的，如前燈的反射鏡生產(chǎn).產(chǎn)品系列：這描述了不同的車輛車型， 如鹵素前大燈，右駕版本或左駕版本只 為右駕/左駕安裝順序。產(chǎn)品記錄：這是具體產(chǎn)品的文件，在這 個文件里，按采用日期的時間順序?qū)λ?/p>

15、 有主要的產(chǎn)品和工藝變更進行記載，還 記載了一致認同的標記產(chǎn)品的標識。這 就確保了產(chǎn)品的可追蹤性。提交等級Part groups: This describes partsPPAP, VDA 2 卷 PPR 工藝manu factured usingiden ticalprocess steps,e.g.Duroplastreflectorproduct ionforof a similar n ature which arediffere nt headlamps etc.Product families:This describesdiffere nt vehicle model-rela

16、ted headlamp types such as Haloge n, right-ha nd drive versi on or haloge n left-ha nd drive versi on for right-ha nd / left-ha nd mounting respectively.Product history:This is aproduct-specific docume ntati on in which all major product and processcha nges are listed inchrono logicalorder with date

17、 ofin troductio nandagreediden tify ingmarkingson theproduct. Thisguara nteesproducttraceability.Submissi on level2.5評價沒有定義3.0過程順序PPAP, VDA Volume 2 PPR process2.5 MeasurablesNone defi ned.3.0 Process seque neeIn aeeordanee with the QM plan （CP531）,根據(jù)質(zhì)量計劃（CP531，控制計劃在產(chǎn)品開controlplans must be produced

18、during發(fā)過程中必須完成。必須區(qū)分：the productdevelopme ntprocess. A樣件的控制計劃disti nction must be made betwee n:試生產(chǎn)的控制計劃Con trol pla n for prototypes量產(chǎn)的控制計劃Con trolpla nforpre-la unchproducts這些不同種類的控制計劃要考慮由產(chǎn)品發(fā)展階段決定的不同類別產(chǎn)品的生產(chǎn)、安裝和測試步Con trol pla n for series products驟。These differe nt con trol pla ns take into一個控制計劃要包

19、括：con siderati ondiffere ntproduct ion,assembly and test steps depending on零件類（如脲醛反射器生產(chǎn)）the product developme nt phase.產(chǎn)品系列（如同一款型的右手驅(qū)動版本和左手驅(qū)動版本的前大燈）A con trol pla n can refer to:這個的條件是在同一地點采用相同的工藝流程Part groups (e.g. Duroplast生產(chǎn)這些產(chǎn)品，還有也要考慮從進貨到交貨的reflector product ion)整個制造過程。Product families (e.g.left

20、-ha nddrive andright-ha nddrive注釋1:headlamps of the same type)就零件類的控制計劃必須保證，如果已有了控The conditionfor this is thatthese制計劃，又新增加的產(chǎn)品要求，控制計劃必須are produced within the framework of相應(yīng)的更新。iden ticalprocesses at the samelocatio nandthat they each take intocon siderati onthe en tiremanu facturi ng控制計劃的簡要結(jié)構(gòu):proc

21、ess fromincominggoods through toA)如產(chǎn)品驗證信息delivery.產(chǎn)品名稱，車型Remark1:AL項目編號和修訂狀態(tài)，并且如果有In the caseof controlplans for part要求的話，客戶的項目編號和發(fā)布狀態(tài)groups, caremust betake n to en suretherequireme ntsforn ewlyadded碼)products are take n intoacco unt.Thecon trolpla nmustbe updated作者和相關(guān)團隊that if a con trol pla n alr

22、eady exists,AL-生產(chǎn)工廠（工廠身份證明 鄧白氏編accordi ngly.Schematic structure of the con trol pla n:A) Product ide ntificati onin formatio nsuch asProduct n ame, vehicle typeAL item nu mber and revisi on status and if required customer item nu mber and release status.AL producti onpla nt,(pla ntide ntificatio n D

23、UNS No.)Author and invo Ived teamRelease(byinvo Ivedorga ni zati on,customer ifrequested)Processdesig nati on(e.g.assembly)Type of control plan (prototype,發(fā)布,（如果要求的話，涉及的部門和客戶）過程設(shè)計（如裝配）控制計劃的類型（樣件，試生產(chǎn)或生產(chǎn)）B）過程流程必須列出和指示：影響所有產(chǎn)品特性的過程和特殊產(chǎn)品特性監(jiān)控所有過程特性C）為了實現(xiàn)所有的性能，必須確定產(chǎn)品和過程控制的方法和行動。這個涉及到：公差范圍測試方法隨機抽樣的大小與頻率控制方法

24、記錄結(jié)果如果不合格事件發(fā)生，采取的行動，即pre-la unch or product ion)反應(yīng)計劃和糾正行動計劃B) Process steps must be listed and in dicated:All product characteristicsin flue needby the process andspecial product characteristicsAll process characteristics to bemon itoredand special processcharacteristicsC) For all characteristics, t

25、he methodsand actions for product and process con trolmust be defi ned. Thisrelates to:Target values with tolera neeTest methodsTestfreque ncieswithran domsample sizeCon trol method注釋1在這個控制計劃里，特殊特性必須用客戶要求的標識標記 ISOTS 16949 7.3,2.3），如果客戶沒有要求，就用“ #”標記（根據(jù)CP586）注釋2如果客戶有要求的話，編寫控制計劃時，必須 采用客戶所要求的形式。注釋3在工藝認可

26、或產(chǎn)品的發(fā)布方面，作為一個原則，客戶要求按3級的方法提交控制計劃。關(guān) 于提交的控制計劃采用何種語言必須與客戶達 成一致。注釋4這個控制計劃不取代每個工藝步驟的工序和檢 驗指導(dǎo)書。然而，它們的內(nèi)容是控制計劃的基 礎(chǔ)。在工序指導(dǎo)書中，工藝規(guī)范轉(zhuǎn)變?yōu)榛谌蜶ecord ing of results務(wù)的相關(guān)工藝步驟的工作指導(dǎo)。檢驗指導(dǎo)書描Actio ns in case of non- 述了每項測試和檢查方法。con forma nee,i.e.reacti onpla n and corrective action pla nRemark 1:3.1樣件的控制計劃In thecon trolpla

27、n,specialcharacteristics must be marked with the symbol requested by the customer (ISOTS 16949 7.3,2.3). If no customer request exists, then the symbol for marking is a # (in accorda nee with ZV586)Remark 2:如果客戶要求有樣件控制計劃，那么客戶的規(guī) 范必須考慮進去。AL標準控制計劃標準包括特定的訂單文件， 具體如下：樣品訂單（需求目錄、零部件清單，樣 件的生產(chǎn)流程）theIf request

28、ed by the customer,樣件測試記錄customersformsmust be used for結(jié)果的記錄draw ing up the con trol pla n.Remark 3:On process acceptanee / release of a product, as a rule customers request submission level 3. An agreement must如果適用于表明開發(fā)狀況/電子器件的軟件狀況如果適用于讓步，盡管不合格仍須交付樣件be reached with the customer regardingthe Ian gua

29、ge to be used for submissi on樣件控制計劃由負責(zé)交貨的開發(fā)部門編制和發(fā)The AL standardfor prototype control試生產(chǎn)控制計劃必須根據(jù)產(chǎn)品和工藝進程不斷地進行調(diào)整，并且必須指定前期開of the con trol pla n.Remark 4:The control plan does not replace the work and inspectioninstructions foreach in dividualprocess step. However,their contents form the basis for the

30、con trol pla n. In work in struct ions, the process stipulati ons are conv erted into task-based work in structi onsfor thereleva nt process step.The in specti onin structio nsdescribethe in dividualtest and in spect ionmethods.3.1 Con trol pla n for prototypesIf the customer requests a prototype co

31、ntrolplan , then the customersstipulatio ns must be take n into acco unt for this.布，女口 ELT編制和發(fā)布燈樣品控制計劃，EEG 編制和發(fā)布電子樣品控制計劃，EEV編制和發(fā) 布安裝樣品控制計劃，ELD/EAP編制和發(fā)布設(shè) 計樣品控制計劃。3.2試生產(chǎn)控制計劃試生產(chǎn)控制計劃的結(jié)構(gòu)必須根據(jù) ISO/TS 1694 的規(guī)范（見附件1）和后來的生產(chǎn)進行編制， 即試生產(chǎn)控制計劃必須根據(jù)規(guī)劃的生產(chǎn)和試驗 步驟編制。需要注意一下幾點：試生產(chǎn)控制計劃必須包括控制行動和臨 時反應(yīng)計劃和試驗步驟的計劃（見附件 1 和 2）。在前期

32、開發(fā)生產(chǎn)過程和安裝過程中實施 不同的控制計劃是允許的。偏離生產(chǎn)的產(chǎn)品和過程控制方法必須予 以規(guī)定。pla ns comprises order-specific docume ntati on with:Sample order (requireme nt catalogue, parts list, product ion steps in prototyp ing)Test sheet for the product sampleDocume ntati on of resultsIf applicable indicationof thedevelopme nt status / sof

33、tware status for electr oni cs.If applicable con cessi on where samples have to be delivered despite non-con forma nee.The prototypecontrolplan is compiledand released by thedeliveri ngdevelopme ntdepartme nt,e.g. lightprototype by ELT, electronicprototypeby EEG, assembly prototype by EEV, desig n p

34、rototype by ELD/EAP.發(fā)產(chǎn)品的提供者（產(chǎn)品開發(fā)史）編寫控制計劃的基礎(chǔ)是FMEAs, QRC的結(jié)果， 圖紙信息，測試規(guī)范，IMS程序，目標和規(guī)范 的執(zhí)行度和過程規(guī)劃的行動。注釋：臨時的生產(chǎn)和測試步驟被定義為偏離生產(chǎn)的生 產(chǎn)和測試步驟（如沒有發(fā)布的生產(chǎn)和測試設(shè) 備）。生產(chǎn)計劃部門負責(zé)編寫控制計劃，它需要協(xié)調(diào)其他部門對控制計劃所起的作用。如：維修部，如預(yù)防性維修，機器、設(shè)備和 工具維修。物流部門，如運輸、儲存和進貨。供應(yīng)商質(zhì)量保證部門，如接受檢查的檢 查計劃質(zhì)量管理部門，如產(chǎn)品審核，前期開發(fā)試驗3.2 Con trol pla n for pre-la unchThe struct

35、ure of the pre-la unch con trolplan must be drawn up in accordanee with the ISO/TS 16949 stipulatio ns (see Annex 1) and subseque nt product ion, i.e. a pre-la unch con trol pla n must be drawn up in analogy with the planned production and test steps. Points to n ote:The pre-launchcontrolplanmustcon

36、 ta incon trolacti onsandreact ionpla nsfortemporaryproduct ionand test steps.(seeAnnex 1 and 2)It is admissible to produce differe nt con trol pla ns for prelaunch producti on processes and assembly processes.前期開發(fā)控制計劃發(fā)布由負責(zé)新產(chǎn)品的質(zhì)量管 理部門經(jīng)理或工廠的質(zhì)量管理經(jīng)理執(zhí)行。3.3生產(chǎn)的控制計劃一旦過程驗證完成，從進貨到貨物發(fā)運整個過 程所有的生產(chǎn)和測試步驟必須按時間順序編寫

37、 和記錄在生產(chǎn)控制計劃里。在生產(chǎn)計劃部門、 質(zhì)量保證部門和其他負責(zé)的職能部門正式發(fā)布 之后，將這些控制計劃整合在一起，并且必須 堅持這些計劃。其發(fā)布由以下部門負責(zé)：工廠質(zhì)量管理經(jīng)理生產(chǎn)計劃經(jīng)理，安裝或前期開發(fā)生產(chǎn) 經(jīng)理The product and process controlmethods which deviate from 3.4 產(chǎn)品和工藝變更，生產(chǎn)變更 product ion must be specified.The pre-launchcontrolplan must這個控制計劃必須記載目前的產(chǎn)品和生產(chǎn)狀becon ti nu ouslyadjusted inaccorda n

38、ee with adva ncing product and process maturity and assig ned to the suppliedpre-la unchproducts (product history)The basis forcompilati onofthecon trolpla nare findingsfromtheFMEAs,QRCs,in formatio nfromthedraw ing.testspecificati ons,IMSprocedures, thetarget andperforma neespecificati onand from t

39、he processpla nning activities.態(tài)。這個計劃包括以下條件下控制計劃的更新：所有工藝變更受產(chǎn)品變化影響的控制計劃注釋：生產(chǎn)轉(zhuǎn)移到新的位置總是形成一個過程變化Remark:Temporary product ion and test steps are defined as productionand test stepsdeviat ing from producti on.(e.g. production and test facilities not yet released).compilati onofthecon trolpla n. Itcoord in

40、 atesthereleva ntcon tributi onsto thecon trolpla nfrom otherdivisi ons, such as:Maintenan ce,e.g.preve ntivemaintenan ce, repairs of mach in es, fixtures and toolsLogistics, e.g.tran sportandstorage, incoming goodsSupplier Quality Assura nee e.g. in specti on pla ns for recei ving in specti onsQual

41、ityMan ageme nt e.g. productaudit, pre-la unch testi ng,Release is performed by the resp on sibleHead of Quality Management for new products / the Quality Manager of a pla nt.3.3 Con trol pla n for product ionOnce process validationis complete,all product ion and test steps from incoming goods to go

42、ods dispatch must bedraw nup and docume nted inchrono logical order in producti on control plans. These control plans are bi ndi ngfollowi ng formal release byProductio nPla nning. Quality Assura neeand the other resp on sible functions and must be strictly adhered to.Release is issued by the resp o

43、n sible:Head of QualityManagement inthe pla nt andHead of Product ion Pla nning. Assembly /Pre-la unchProducti on3.4 Product and process cha nges.relocati on of producti onThe controlplans must document thecurrentproduct and production status.Thisen compassesupdati ng of thecon trol pla n in case of

44、:All process cha nges andProduct changes with repercussions on the con trol pla nRemark:Relocati on ofproduct ionto a newlocation always constitutesa process3.5存檔cha nge.3.5 Archivi ngAll prototype con trol pla ns must be reta ined for at least 3?years in the resp on sible departme nt.Pre-la unch an

45、d product ion con trol pla ns must be reta ined for at least所有樣品控制計劃由負責(zé)的部門必須保留三 年以上。前期開發(fā)和生產(chǎn)控制計劃在停止生產(chǎn)以后由 負責(zé)的部門必須保留15年以上15 years followi ng producti on如果生產(chǎn)變更發(fā)生，所有的控制計劃必須同discontinuation in the responsible時隨之變化，并符合新的變更department.4. 備注和注釋In the case of relocated production, all control plans must be rel

46、ocated at the same time and kept at the new location .4. Notes and remarksIssue 2: Completely revised and 全部修訂第 2 章，調(diào)整 ISO/TS 16949 的相關(guān) adjusted in line with ISO/TS 內(nèi)容16949Ann ex/A nl age 11S0/TS 16949;2002(E)Annex A(normative)Control planAd Fha$w of the cortrol planThe control plan shall cover thre

47、e distinct phases as appropriate.自 Prototype a descript on of lhe dimensional measurements, rnaterial and pertormante 2右諄 thal will occur during buildrig of the prototype. The organization shall have a prototype control plan if required by the customer.bi FTe-iauncti; a descriplion cf lhe dimensiona

48、 measurements, material mnd performance tscs tha： occur afier protose 日 nd before full pnoducbon. P launch 庫 c efined as 3 prod actionin the process of productreaiizafion which be required aftt prototvp* buildcl Prodjction. documentation of productprocea ctiaracteri&bca pra5 controls.怕rid mesureimen

49、t systems thal occur during mass praductonEach 口mrt $hail a control p an but in man :a&es, family contrtH pang may cover a number of aiiniiar part$ pnaduced using a ccmtnon process Control pJsn$ are an output of the quality plsri-A.2 Elements of the contwl planThe organizadon thall develop a control

50、 plan that includes, as a minimum, tlw fbllowing content.a) Genenl data- conirol plan number,i盟ue date, and revision daLe. if any,-cu stem 自 r inform alien (s ee cu alom er requireoiganizatian s nam&sile des gnation.paH numtKf(s).-pari name;dascription, engineering change 曲el.- phase ? vered .-contr

51、ol method.t Reaction plan and corrective actions- ruction p-ari (irdud or reterenc&l,-corrective action.Anhang APrguMiOfi納Mun滬plan (CentrQil Pltn)KI Phawn dfr Prdu ktofit ton kungi)lar)Der RpduktnarikunQ.splan mus-5n gowfiit zutrefand. drat unterschrtidliciiire： PhasF?n furfftei-sna j 內(nèi)疏剤咖一辭n電直活瞪阡色i

52、bung dter Mapu1tngen 聞出牡 der Mj1 efiaJerprc&jrn ur4 Lfiistings- l勢忖 die im P 忙iloleeet常u anfai*sn. Wenn vom Kuncten vtflangL mubs Gh? Of鬧m&aiKr 電i袖n Prodiiklicmslenli.uigsoliri Cur dton 卩piotypenbvu efstlwn.l Varserie einA BescEung cJer MafipruFungeri some der 誕itEria幅rprubungBri md Leislungs- 1&l宿 naeh 汐時 PmlQlyp口血翱 創(chuàng)賊 WOT 曲i* SfilprOCUlktiCMl. V