2022年新产品设计和开发控制流程 .pdf

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1、ABCD Co., LtdQualitymanagementsystemdocumentsNew productdesign and developmentcontrolprocedureDocumentNumber： SOP-ENG-04Version：BPrepared byChecked byApproved byDate名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 1 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber

2、：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 1 /12Version HistoryVersionChange descriptionPrepared/ModifiedCommencementDateAFirst ReleaseBCADfile specificationandoperationprocedurechangedto technicaldocumentoperationprocess,specificationandcontrolprocedure名师资料总结 - - -精品

3、资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 2 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 2 /121Purpose1.1For effectivecontrollingproductdesignanddevelopmentwholeprocess,ensuredesignanddevelopme

4、ntproducttomeettherequirements of contract, customer, laws and regulations.2Scope2.1Apply to meet the contract, the customer and legal requirementsofnew product design and development.3Definition& Abbreviation3.1BTP report: build/trial/pilot report3.2Technical document:Productdesign drawing,bill of

5、materialandprocess document, work instruction, technical standard and reporting,and some external files.4Responsibility& Authority4.1ENG: Responsible for new product planning, design, development,review and confirming new product change such as design issues,andincludingarrangeengineeringtrial,organ

6、izationandmanagement activities etc.4.2SCF:Responsiblefortrialprocessprocurementandmaterialorganization.4.3OPE:Responsibleforprocessplanning,processandworkinstructionpreparationandreview;Responsiblefor fixtureandgaugepreparation;Responsiblefor stafftrainingandtrial planimplementation.4.4QUA:Responsi

7、bleforvalidationactivitiesofdetection,measurementand test during designand developmentprocess;Responsiblefor preparinginspectioninstruction,work instructionand test report etc.名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 3 页，共 13 页 - - - - - - - - - ABCD Co., LtdVe

8、rsionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 3 /124.5Demand planning dept.: Responsible for productivity prediction andassessment of new product and mold for new product.4.6OFD: Responsiblefor order confirmationand productionplanningfor new product.4.7L&W: Re

9、sponsiblefor receiving,storeand in timedeliveringofmaterials.5Work process& content5.1Design and development planning5.1.1 Planning contenta) Design and development stage planb) Quality planc) Verification assessment activities related to all stagesd) File list related to all stages5.2Four stages of

10、 new product design and development5.2.1 Ideation Phase5.2.2 Development Phasea) Design import phaseb) Design forming phase5.2.3 Launch Phasea) 1stshot First trial assembleb) EB Engineering buildingc) AT Assemble triald) MP Mass pilot5.2.4 Post-Launch Phasea) Massproduction(orderconfirmation,manufac

11、turingandshipping)b) Continuous improvement and cost down名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 4 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 4 /125.3New product set up projec

12、t5.3.1 New product project name5.3.2 New product project plana) New product design and development Timeline b) Humanresourceassignment ChinaEngineeringProjectTeam1） Project manager2） Design engineer3） Otherdept.engineer,suchasQAengineer,IE/PEengineer,procurementengineer.5.3.3 Review:Projectteammembe

13、rsreviewtheabovecontentintegrity,suitabilityandfeasibilityon thenewproductstartmeeting.5.3.4 Confirmation: When review is approved, project manager confirmthe approval of new product project.5.3.5 Newlistsof documentsin projectstartingphase,includingTimeline, China Engineering Project Teama)ChinaEng

14、ineeringProjectTeam:projectname,projectmanager.Projectmembersandresponsibilities,tipsandnotices.b) Timeline: project activities, every phase planning completiontime.5.4New product design5.4.1 Design imported phasea) Input名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第

15、 5 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 5 /121） Customers productfunctionandperformancerequirement(productmainfunctionmoduleorwholemachine BOS);2） Product design and development required time ”Timeline ”;3） Pr

16、oduct use the standard and the correspondinglaws andregulationsrequest,includingsafety,environmentalprotection etc.4） Design drawings and other technical file specifications;5） The similar historical design information and data;b) Input review: project team review input content, mainly aboutBOS BOSr

17、eviewandFollow-UpList ,discussproblems with customer and let customer update as soonas possible.c) Design1） Designrequirement:Whendesigning,manufactureconvenienceandservicemaintenanceshouldbeconsidered,modulardesignas much as possibleandeach module independently;use standard parts as muchas possible

18、, control cost and quality.Note:Designdrawingsrequirementstomeetspecifictechnicaldocumentoperationalprocedures,practicesandcontrol procedures.2） Design content5.4.1.c.2.1Overall design scheme:critical module and new moduledesign plan.5.4.1.c.2.2Structuredrawing:wholemachine/partsexplodingdrawing,3D

19、drawing, 2D drawing.名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 6 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 6 /125.4.1.c.2.3Electronicdrawing:schematic,wiringdiagram,layoutdiagra

20、m;5.4.1.c.2.4BOM: whole machineBOM, electronicBOM;5.4.1.c.2.5Packagingdesign (paper tray, foam etc.), accordingtosimilar product dimensionsweight historicalexperience,drop test simulationof new product, and based on thesedata to develop matchedpackagingplan.5.4.1.c.2.6Somenecessarydesignparametersan

21、dvalidatingdata.3） Verified by engineers,project managersconfirm designmodule and new module.5.4.2 Design forming phasea)Makemodelmachine:Requiredto achievecustomers allfunctions, and to meet the laws and regulations in force andsafety and environmental protection standards.b)Accordingto productqual

22、itycontrolplanand BOS,QUAprepareormodifyproducttestingstandard,parttestingstandardandLabexperimentstandardandotherqualitycontrol document.c)Design validation and change: For the design phase, a designchange should go through the actual operation and assemblyto assess their availability and suitabili

23、ty.d) Team design review formDFMEA , review main content:1) The degreeof meet user requirements,as well as therelevant laws, regulations and national standards, publicpractice of compliance.2) Appearance and shape of agreeableness, the rationality of名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - -

24、 - - - 名师精心整理 - - - - - - - 第 7 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 7 /12the structure,operationconvenience,manufacturability,reliability,maintainability,safetyandenvironmentalprotection, etc.3) Productundert

25、heintendedconditioninuseandenvironmentalwork ability, abusing and misusingfailureand automatic protection performance.4)Product technology level compared with the performanceof similar products.5)Product economy, standardization and inheritance.6) Key purchasedcomponents,raw materials procurementsup

26、plypossibility,thefeasibilityofspecialpartsoutsourcing processing.7) Main parameters can be checked and tested.8) The accuracy of the design and calculation.e) Contents of design output the full set of technical documents:1） ENG output of technical document:structure, electronicdrawing, BOM, electro

27、nic BOM, BOS;2） OtherDept.outputoftechnicaldocument:inspectiondocuments and process document etc.;3） Quotationfile: tooling quotation,product price, transportquotation;4） Technical document of approval process, see technicaldocument control procedure.5） New product design phase file list: A full set

28、 of technicaldocument,quotationdocument,verificationexperimentreport, BTP reports etc.5.5New product trial production名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 8 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand develo

29、pmentcontrolprocedurepage： 8 /125.5.1Moulddesignand development,seeing“Moulddesignanddevelopment procedure ”.5.5.2 1stshot sample (first assemble)a) After the completionof the mould design, ENG release trialtechnicaldocument,SCFpreparematerialasthisdocument.b) QUA responsible for incoming test repor

30、t.c) Team assemblewhole machine accordingto the full set oftechnical document, QUA test the machine and give testreport.d) On the basis of prototype test data, team provides specificsolution and design improvement on the functions that notfit customer srequirement and other requirement.e) After test

31、, the prototype should be shipped to US for validationby US team.5.5.3 EB (Engineering building)a) First sample is OK, ENG begin to plan engineeringsamplemachines and trial (10 30 units). Plan content:1） ENG: a full set of latest drawings, BOM and BOS;2） QUA: update test standard, provide test repor

32、t;3）OPE:processdocument,workinginstruction;preparefixture and gauge;b) Engineeringsamplemachinereview:design is OK or not,sample machine fit requirement or not.c) When related team confirmand approvethe plan content,engineering samples begin to be manufactured,QUA testthe machines and provide test r

33、eport.名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 9 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 9 /12d) On the basis of prototype test data, team design improvementon the functions

34、that not fit customer s requirementandagencyrequirementandreleaseupdatedtechnicaldocument.e)Agency engineer deliver parts and whole machine to authoritycertification company and arrange product safety certification.5.5.4 AT (Assemble trial)a)ENG make samples of color box, manual, label and screenpri

35、nting according to artwork, manual sample, label sketch;b)ENG providedocumentsto relateddepartments,includingBOS, part and assemble drawings, exploding drawing, BOM,product packaging file;c)According to trial plan, ENG inform SCF before 2 weeks, SCFarrange trial material into warehouse, for specific

36、 purchasingpart, notify supplier in advance refer to manufacture lead time;d)OFD responsible for arranging trial time;e)OPE responsiblefor operatortraining,preparefixtureandprocess document; PE responsiblefor fixture, jig, gauge andto determine the completion time.f)Accordingtorequirement,QUAprovide

37、testdocuments(Incominginspectionstandardandreport,producttestingstandard etc.);g)EB trial review:technicaldocumentsreview, if machinefitdesign, and if design can keep consistent on line;h)EB trial: line execution, ENG and QUA ensure product qualitytogether, after trial QUA do function test life test

38、 and so on,and provide trial product test report;名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 10 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 10 /12i)Data analysis: Team do analysis

39、of trial, to judge if productsatisfy customer requirement, if satisfy all kinds of standards,andmakecontinuousimprovementonthingsnotfitrequirement;j)After sale service: According to trial state, make spare parts kitfor vulnerable and difficult buying parts, and create spare partskit BOM.k)First samp

40、le confirmation(1st Article Samples): After the trialqualified, US Fellowes confirm and approve on first sample,firstsamplecontentincludingcompleteBTPtestreport,packaging and labels etc.l)Customer feedback1） BOS confirmation;2） Color, manual and label packaging file confirmation;3） Spare part kit co

41、nfirmation;4） Order confirmation(by OFD);5.5.5 MP (manufacture production)a) MP preparation1） ENGa.1 Accordingto trial plan, confirm trial quantity(50-200units), date, material and arrival process.a.2Provideupdatedtechnicaldocumentstorelateddepartments(BOS,partandassembledrawings,exploding drawing,

42、BOM, product packaging file).a.3 Provide every one unit machine to OPE and QUA.2） QUAb.1 Provide complete test files.名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 11 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand devel

43、opmentcontrolprocedurepage： 11 /12b.2 Provide critical part confirmationreport “FAI”,detailsee Parts release control procedures .3） OPEc.1 IE provide complete process files, WI.c.2Productionlinemonitorresponsibleforteardown/assembletraining(record)andqualitycontrol training etc.4） SCFd.1 Accordingto

44、 latest updatedtechnical documents,prepare small batch trial production materials.b) Aftertrialproduction,eachdepartmentanalyzeandsummarizetrialdata,preparecontinuousimprovementdata.c) Whatcustomerrequiretochangeimmediately,eachdepartmentdividetheworkandcooperate,completevalidation and confirmation

45、of rectification.d) Afterrectification,teamandcustomertogetherto confirmrectification content and continuous improvement plan.5.5.6 Newproducttrialphasefilelist:1stARTICLECHECKLIST&APPROVALFORM,BTP report, Agency test report andagency certificate etc.5.6Production release confirmation5.6.1 Design do

46、cument confirmationphase(undercontrol): After trialvalidation and customer confirmation,design document releaseB00 versionon MP phase(previouslydocumentshouldbe Aversion except whole machineBOM based on Oracle), whichpresent new product trial phase is over, product into production名师资料总结 - - -精品资料欢迎下

47、载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 12 页，共 13 页 - - - - - - - - - ABCD Co., LtdVersionnumber：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 12 /12releasephase,detailssee“Technical documentcontrolprocedure ”5.6.2 Productionreleasephase(orderconfirma

48、tionandproduce);When OFD receive new product order, manufacturedepartmentproduceproductsaccordingto controlledtechnicaldocumentprovided by ENG and shipment.5.7Design change5.7.1 Design need be changed when customer requirementchange,costdown,process/qualityimprovementetc.,detailseeEngineering Change

49、 Control Procedure.6ReferencefileTechnical Document control procedureEngineering Change Control ProcedureMould development management procedureTechnicaldocumentoperationalprocedures,practicesandcontrolprocedureParts and components production control procedure7AccessoryBOS review and Follow-Up ListTimelineDFMEAQuality planBTP Report1stARTICLE CHECKLIST&APPROVALFORM名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 名师精心整理 - - - - - - - 第 13 页，共 13 页 - - - - - - - - -