新产品设计和开发控制流程(英文版)

ABCD Co.,LtdQuality management system documentsNew product design and development controlprocedureDocument Number：SOP-ENG-04Version：BPrepared by Checked by Approved by DateNew product design and development control procedur e page：1/12Version HistoryVersion Change description Prepared/Modified Commencement DateA First ReleaseB "CAD file specification and operation procedure" changed to"technical document operation process,specification and control procedure"New product design and development control procedur e page：2/12 1Purpose1.1For effective controlling product design and development wholeprocess,ensure design and development product to meet therequirements of contract,customer,laws and regulations.2Scope2.1Apply to meet the contract,the customer and legal requirements ofnew product design and development.3Definition&Abbreviation3.1BTP report:build/trial/pilot report3.2Technical document:Product design drawing,bill of material andprocess 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,and including arrange engineering trial,organization andmanagement activities etc.4.2SCF:Responsible for trial process procurement and materialorganization.4.3OPE:Responsible for process planning,process and workinstruction preparation and review;Responsible for fixture andgauge preparation;Responsible for staff training and trial planimplementation.4.4QUA:Responsible for validation activities of detection,measurement and test during design and development process;Responsible for preparing inspection instruction,work instructionand test report etc.New product design and development control procedur e page：3/124.5Demand planning dept.:Responsible for productivity prediction andassessment of new product and mold for new product.4.6OFD:Responsible for order confirmation and production planningfor new product.4.7L&W:Responsible for receiving,store and in time delivering ofmaterials.5Work process&content5.1Design and development planning5.1.1Planning 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 development5.2.1Ideation Phase5.2.2Development Phasea)Design import phaseb)Design forming phase5.2.3Launch Phasea)1st shot First trial assembleb)EB Engineering buildingc)AT Assemble triald)MP Mass pilot5.2.4Post-Launch Phasea)Mass production(order confirmation,manufacturing andshipping)b)Continuous improvement and cost downNew product design and development control procedur e page：4/125.3New product set up project5.3.1New product project name5.3.2New product project plana)New product design and development〝Timeline〞b)Human resource assignment〝China Engineering ProjectTeam〞1）Project manager2）Design engineer3）Other dept.engineer,such as QA engineer,IE/PE engineer,procurement engineer.5.3.3Review:Project team members review the above contentintegrity,suitability and feasibility on the new product startmeeting.5.3.4Confirmation:When review is approved,project manager confirmthe approval of new product project.5.3.5New lists of documents in project starting phase,includingTimeline,China Engineering Project Teama)China Engineering Project Team:project name,projectmanager.Project members and responsibilities,tips andnotices.b)Timeline:project activities,every phase planning completiontime.5.4New product design5.4.1Design imported phasea)InputNew product design and development control procedur e page：5/121）Customer’s product function and performancerequirement(product main function module or wholemachine BOS);2）Product design and development required time”Timeline”;3）Product use the standard and the corresponding laws andregulations request,including safety,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〝BOS review and Follow-Up List〞,discussproblems with customer and let customer update as soonas possible.c)Design1）Design requirement:When designing,manufactureconvenience and service maintenance should beconsidered,modular design as much as possible andeach module independently;use standard parts as muchas possible,control cost and quality.Note:Design drawings requirements to meet specific"technical document operational procedures,practices andcontrol procedures."2）Design content5.4.1.c.2.1Overall design scheme:critical module and new moduledesign plan.5.4.1.c.2.2Structure drawing:whole machine/parts explodingdrawing,3D drawing,2D drawing.New product design and development control procedur e page：6/125.4.1.c.2.3Electronic drawing:schematic,wiring diagram,layoutdiagram;5.4.1.c.2.4BOM:whole machine BOM,electronic BOM;5.4.1.c.2.5Packaging design(paper tray,foam etc.),according tosimilar product dimensions weight historical experience,drop test simulation of new product,and based on thesedata to develop matched packaging plan.5.4.1.c.2.6Some necessary design parameters and validatingdata.3）Verified by engineers,project managers confirm designmodule and new module.5.4.2Design forming phasea)Make model machine:Required to achieve customers’allfunctions,and to meet the laws and regulations in force andsafety and environmental protection standards.b)According to product quality control plan and BOS,QUAprepare or modify product testing standard,part testingstandard and Lab experiment standard and other qualitycontrol 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 form〝DFMEA〞,review main content:1)The degree of meet user requirements,as well as therelevant laws,regulations and national standards,publicpractice of compliance.2)Appearance and shape of agreeableness,the rationality ofNew product design and development control procedur e page：7/12the structure,operation convenience,manufacturability,reliability,maintainability,safety and environmentalprotection,etc.3)Product under the intended condition in use andenvironmental work ability,abusing and misusing failureand automatic protection performance.4)Product technology level compared with the performanceof similar products.5)Product economy,standardization and inheritance.6)Key purchased components,raw materials procurementsupply possibility,the feasibility of special partsoutsourcing 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）Other Dept.output of technical document:inspectiondocuments and process document etc.;3）Quotation file: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,quotation document,verification experimentreport,BTP reports etc.5.5New product trial productionNew product design and development control procedur e page：8/125.5.1Mould design and development,seeing“Mould design anddevelopment procedure”.5.5.21st shot sample(first assemble)a)After the completion of the mould design,ENG release trialtechnical document,SCF prepare material as thisdocument.b)QUA responsible for incoming test report.c)Team assemble whole machine according to 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’s requirement and other requirement.e)After test,the prototype should be shipped to US for validationby US team.5.5.3EB(Engineering building)a)First sample is OK,ENG begin to plan engineering samplemachines and trial(10–30units).Plan content:1）ENG:a full set of latest drawings,BOM and BOS;2）QUA:update test standard,provide test report;3）OPE:process document,working instruction;preparefixture and gauge;b)Engineering sample machine review:design is OK or not,sample machine fit requirement or not.c)When related team confirm and approve the plan content,engineering samples begin to be manufactured,QUA testthe machines and provide test report.New product design and development control procedur e page：9/12d)On the basis of prototype test data,team design improvementon the functions that not fit customer’s requirement andagency requirement and release updated technicaldocument.e)Agency engineer deliver parts and whole machine to authoritycertification company and arrange product safety certification.5.5.4AT(Assemble trial)a)ENG make samples of color box,manual,label and screenprinting according to artwork,manual sample,label sketch;b)ENG provide documents to related departments,includingBOS,part and assemble drawings,exploding drawing,BOM,product packaging file;c)According to trial plan,ENG inform SCF before2weeks,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 responsible for operator training,prepare fixture andprocess document;PE responsible for fixture,jig,gauge andto determine the completion time.f)According to requirement,QUA provide test documents(Incoming inspection standard and report,product testingstandard etc.);g)EB trial review:technical documents review,if machine fitdesign,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;New product design and development control procedur e page：10/12i)Data analysis:Team do analysis of trial,to judge if productsatisfy customer requirement,if satisfy all kinds of standards,and make continuous improvement on things not fitrequirement;j)After sale service:According to trial state,make spare parts kit for vulnerable and difficult buying parts,and create spare partskit BOM.k)First sample confirmation(1st Article Samples):After the trial qualified,US Fellowes confirm and approve on first sample,first sample content including complete BTP test report,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);5.5.5MP(manufacture production)a)MP preparation1）ENGa.1According to trial plan,confirm trial quantity(50-200units),date,material and arrival process.a.2Provide updated technical documents to relateddepartments(BOS,part and assemble drawings,exploding drawing,BOM,product packaging file).a.3Provide every one unit machine to OPE and QUA.2）QUAb.1Provide complete test files.New product design and development control procedur e page：11/12b.2Provide critical part confirmation report“FAI”,detailsee"Parts release control procedures".3）OPEc.1IE provide complete process files,WI.c.2Production line monitor responsible forteardown/assemble training(record)and qualitycontrol training etc.4）SCFd.1According to latest updated technical documents,prepare small batch trial production materials.b)After trial production,each department analyze andsummarize trial data,prepare continuous improvementdata.c)What customer require to change immediately,eachdepartment divide the work and cooperate,completevalidation and confirmation of rectification.d)After rectification,team and customer together to confirmrectification content and continuous improvement plan.5.5.6New product trial phase file list:1st ARTICLECHECKLIST&APPROVAL FORM,BTP report,Agency test report andagency certificate etc.5.6Production release confirmation5.6.1Design document confirmation phase(under control):After trialvalidation and customer confirmation,design document releaseB00version on MP phase(previously document should be Aversion except whole machine BOM based on Oracle),whichpresent new product trial phase is over,product into productionNew product design and development control procedur e page：12/12release phase,details see“Technical document controlprocedure”5.6.2Production release phase(order confirmation and produce);When OFD receive new product order,manufacture departmentproduce products according to controlled technical documentprovided by ENG and shipment.5.7Design change5.7.1Design need be changed when customer requirement change,cost down,process/quality improvement etc.,detail see"Engineering Change Control Procedure".6Reference file"Technical Document control procedure""Engineering Change Control Procedure""Mould development management procedure""Technical document operational procedures,practices and control procedure""Parts and components production control procedure"7AccessoryBOS review and Follow-Up ListTimelineDFMEAQuality planBTP Report1st ARTICLE CHECKLIST&APPROVAL FORM。