2022年新产品设计和开发控制流程 .pdf

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：SOP-ENG-04version ：BNew productdesignand developmentcontrolprocedurepage： 1 /12Version HistoryVersionChange descriptionPrepared/ModifiedCommencementDateAFirst ReleaseBCADfile specificationandoperationprocedurechangedto technicaldocumentoperationprocess,specificationandcontrolprocedure名师资料总结 - - -精品资料欢迎下载 - - - - - - - - - - - - - - - - - - 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,ensuredesignanddevelopmentproducttomeettherequirements 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 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,organizationandmanagement activities etc.4.2SCF:Responsiblefortrialprocessprocurementandmaterialorganization.4.3OPE:Responsibleforprocessplanning,processandworkinstructionpreparationandreview;Responsiblefor fixtureandgaugepreparation;Responsiblefor stafftrainingandtrial planimplementation.4.4QUA:Responsibleforvalidationactivitiesofdetection,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., LtdVersionnumber：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: Responsiblefor 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 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,manufacturingandshipping)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 project5.3.1 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:Projectteammembersreviewtheabovecontentintegrity,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)ChinaEngineeringProjectTeam: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 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） Product 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 BOSreviewandFollow-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, 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 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,layoutdiagram;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.2.6Somenecessarydesignparametersandvalidatingdata.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 productqualitycontrolplanand 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 suitability.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 - - - - - - - - - - - - - - - - - - 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) Productundertheintendedconditioninuseandenvironmentalwork 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 procurementsupplypossibility,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, electronic 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 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 developmentcontrolprocedurepage： 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 report.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, 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 report;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 report.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 functionsthat 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 screenprinting 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 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,QUAprovidetestdocuments(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 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 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 sample 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 confirmation;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, 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 developmentcontrolprocedurepage： 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 latest updatedtechnical documents,prepare small batch trial production materials.b) Aftertrialproduction,eachdepartmentanalyzeandsummarizetrialdata,preparecontinuousimprovementdata.c) Whatcustomerrequiretochangeimmediately,eachdepartmentdividetheworkandcooperate,completevalidation and confirmation 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 document 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(orderconfirmationandproduce);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 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 - - - - - - - - -