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1、精选优质文档-倾情为你奉上1. 目的Purpose 为确保产品设计开发过程中，能有效的管理各个主要活动之输入与输出，以确保产品能符合客户或市场需求。In order to ensure all major activity input and output in the product design and development process can be effectively managed and ensure all products can comply with customer and market requirements. 2. 范围Scope 凡本公司所设计开发及客户委
2、托开发之产品，包括新产品、系列品均属之。This Procedure is applicable to all the products designed and developed by the Company or developed under the commission of the customer, including new products and product series. 3. 权责Responsibilities 作业内容Description 审查Review 核准Approval1设计和开发策划Design and development planning项目小
3、组Project team副总（含）以上主管Deputy or Vice general manager (inclusive) and above2设计和开发输入Design and development input项目小组Project team业务/客户Business/customer3设计和开发控制Design and development review项目小组Project team研发部经理R&D manager4设计和开发输出Design and development output项目小组Project team研发部经理R&D manager5产品量试Product b
4、atch run项目小组Project team 研发部经理R&D manager4. 定义Definitions 4.1项目小组：系指由业务、PM、研发、品管、生管、采购、制造、生技单位之担当人员所组成之设计开发项目小组。Project team: It refers to the design and development project team consisting of the responsible persons of such departments as business, PM, R&D, QC, production management, purchase, manu
5、facture and production technology. 4.2新 产 品：系指设计开发之新系列产品。New products: The new series of products designed and developed. 4.3系 列 品：系指同系列产品，唯产品结构、功能型式或外观形式需作适当变化始符合客户（或市场）需求而进行设计之产品。Product series: i.e. the same series of products designed that cannot meet the customer (market) requirement unless the
6、 product structure, functional type or profile is changed properly. 5. 作业内容Content 5.1新产品New product 5.1.1设计和开发策划：Design and development planning: 5.1.1.1业务部门对产品信息收集的方式，可由搜集产品、策略性产品、市场需求信息、国内外展览、相关的研讨会或各种相关刊物等取得，确定客户（或市场）之要求（适当时含客户规格、样品等）.The business department shall collect product information by
7、means of collected products, strategic products, market demand information, domestic and foreign exhibitions, related seminars or various magazines etc and confirm customer (market) requirements (including customer specifications and samples etc where proper). 5.1.1.2 PM组织成立项目小组针对产品信息数据进行产品开发可行性评估，分
8、析本公司既有技术能力及产品之市场性并填写开发可行性评估表，是否进行产品开发策划，由副总（含）以上主管裁定并指定PM及业务担当开立新产品开发申请表。PM/业务根据开发策划阶段达成的对产品要求制订产品规格书.The PM shall organize and establish project team to evaluate the product development feasibility as per product information and data, analyze the existing technical capacity and product marketabilit
9、y of the Company and fill in Development Feasibility Assessment Sheet; for the planning of whether to have product development planning, it is the responsibility of the deputy general manager (inclusive) or above to determine and the business personnel shall prepare New Product Development Applicati
10、on Form. PM/business personnel shall establish Product Specifications according to the product requirements reached by PM and the business personnel on the development planning stage. 5.1.1.3研发部收到新产品开发申请表后研发部经理指派研发部工程师承担产品设计任务。研发部工程师依据由项目负责人(PM)提出的开发计划书，产品规格书作为产品设计开发阶段之依据，并经副总（含）以上主管核准。After the R&D
11、 department receives the New Product Development Application Form, the R&D manager shall appoint R&D engineer to assume product design task. The R&D engineer shall take the Development Plan prepared and Product Specifications by the project manager (PM) as the basis for product design and developmen
12、t, which shall be reviewed and approved by the deputy general manager (inclusive) or above. 5.1.1.4产品开发策划无需进行时，开发可行性评估表并同产品信息数据一律由PM管理保存。When product development planning is unnecessary, the Development Feasibility Assessment Sheet shall be managed and kept by the PM together will all product inform
13、ation and data. 5.1.1.5 对于ODM、OEM产品,产品规格书的内容必须与客户要求一致。For ODM and OEM products, the content of Product Specifications must be consistent with customer requirements. 5.1.2设计和开发输入：Design and development input: 5.1.2.1 项目负责人提交产品计划书和产品规格书给业务或客户确认，确认依此进行开发和设计。The PM shall submit Product Plan and Product
14、Specifications to the business department or the customer for confirmation, and the development and design shall be conducted according to such confirmed documents. 5.1.2.2 PM需复制一份开发可行性评估表、开发计划书、产品规格书及可供研发参考之产品信息数据给予研发部做为该产品开发和设计的依据。The PM shall copy the Development Feasibility Assessment Sheet, Dev
15、elopment Scheme, Product Specifications and the product information and data for R&D reference to the R&D department for its reference during product development and design. 5.1.2.3 PM应适时跟进和更新开发计划书中开发计划及完成状态,定期发放以指导开发进程。The PM shall in proper time follow and update the development plan and completio
16、n state as provided in the Development Plan and regularly issue it to direct the development progress. 5.1.3 设计和开发的控制5.1.3.1设计和开发评审 Design and development review 项目负责人制作设计评审表，并召集项目小组人员进行产品设计评审，以及产品失效模式的风险评估；由主管经理核准。 The PM shall make Design Review Form and convoke the project team personnel to have
17、product design and product failure mode risk assessment review, which shall be approved by the director/manager. 5.1.3.2设计和开发验证： Design and development validation: 5.1.3.2.1设计和开发验证的目的在验证产品规格与产品规格书符合。 The purpose of design and development shall be consistent with the specification of the product bein
18、g validated and the Product Specifications. 5.1.3.2.2研发部工程师安排制作样品, 依测试项目进行产品验证测试，并作成样品测试报告，并召集项目小组人员进行审查，由开发部经理（含）以上主管核准。验证不合格者，研发部工程师进行相关设计修正。 The R&D engineer shall arrange the making of samples and validate and test products as per test items, make Sample Test Report, and convoke the project team
19、 personnel to have a review, which shall be approved by the R&D manager (inclusive) or above. In the case where the validation proves the design is nonconforming, the R&D engineer shall have related design correction. 5.1.4设计和开发确认Design and development confirmation 5.1.4.1设计验证完成后，项目负责人召集项目小组人员进行设计确认
20、会议，报告设计验证结果，进行设计确认作业，由开发部经理（含）以上主管核准确认。 After the design validation is completed, the PM shall convoke the project team personnel to have a design confirmation meeting and report the design validation result, have design confirmation, which shall be reviewed and approved by the R&D manager (inclusiv
21、e) or above.5.1.4.2 PM/业务担当汇整客户需求之工程文件、产品规格书、测试报告、试作样品等相关文件数据，送交客户进行设计确认，文件数据并予以签回由研发部管理保存。The PM/business personnel shall collect and summarize the related documents and data such as engineering documents, Product Specifications, test report and trial-made samples required by the customer and then
22、submit them to the customer for design confirmation. Then the documents and data are signed and returned to the R&D department for management and keeping. 5.1.4.3产品设计开发案若为自行设计开发，则不进行客户确认作业。If the product design and development scheme is self designed and developed, no customer confirmation is needed
23、. 5.1.4.4项目负责人制作设计确认审查表，并召集项目小组人员进行设计确认审查，由主管经理核准。The PM shall make Design Confirmation Review Form and convoke the project team personnel to have product design review, which shall be approved by the director/manager.5.1.5设计和开发输出：Design and development output: 5.1.5.1研发部工程师依开发计划书及产品规格书进行产品结构、电子、软件程
24、序、包装设计。The R&D engineer shall design the product structure, electronics, software program and packing as per the Development Plan and Product Specifications. 5.1.5.2产品的结构设计应作成结构设计图面（零件规格图、半成品组合图、成品组合图、mock up working samples,电子设计应作成电子原理图、电子Layout图）The structure design of products shall be made into
25、structural design drawings (part specification drawings, semi-finished product constitutional diagram and mock up working samples. Electronic design shall be made into electronic schematic diagram or electronic layout diagram). 5.1.5.3产品的结构、电子设计完成后，由研发部主管与项目负责人及配合工程师进行产品结构、电子设计检讨。检讨结果如未能符合产品规格时，研发部工
26、程师应修正或重新设计并再行检讨。 After the product structure and electronic design is completed, the director of the R&D department and the PM shall cooperate with the engineer to check and review the product structural and electronic design. When the result does not comply with the product specifications, the R&D
27、engineer shall correct or redesign it and then review it a second time. 5.1.5.4产品结构设计确认后，机构设计工程师须作出相关零件2D图,要否开模由副总（含）以上主管核准,如需开模机构设计工程师依零件规格图完成必要之塑料、五金、铝挤、橡胶等等模具委外开发制作，并完成首套治工具制作，以利产品试作。After product structural design is confirmed, the mechanism design engineer shall make corresponding 2D drawing; t
28、he deputy general manager (inclusive) or above shall review and approve die opening. If die opening is needed, the mechanism design engineer shall complete the outsourced development and making of the dies for plastics, hardware, aluminum extrusion and rubber etc, and complete the making of the firs
29、t set of jigs and tools for the convenience of product trial production. 5.1.5.5工程师制作相关BOM COST 及Tooling cost。The engineer shall make related BOM cost and tooling cost. 5.1.5.6研发部对于新的零件物料须请相关供货商进行样品制作及送样。The R&D department shall ask the related vendor to make samples and send proofing for the new pa
30、rt materials. 5.1.5.7项目负责人及配合工程师进行零件组装制样及产品功能测试、除错，并修正及确认相关文件以及完成首件样品制作，并输出机构BOM表、电子BOM表、零件规格图、半成品组合图、成品组合图、治工具规格图、电子原理图、电子Layout图、电子测试规范、作业标准书，经研发部经理核准。The PM shall cooperate with the engineer for part assembly, sample making and product function test and debugging and correct and confirm related d
31、ocuments and complete the making of the first sample and output structural BOM, electronic BOM, part specification drawing, semi-finished product constitutional diagram, finished product constitutional diagram, jig and tool specification drawing, electronic schematic diagram, electronic layout drawi
32、ng, electronic testing specifications and work standard and then submit them to the R&D manager for review and approval. 5.1.5.8设计和开发的输出应满足设计和开发输入的要求。Design and development output shall meet design and development input requirements. 5.1.5.9 产品的设计中的材料选择应符合ROHS要求。The materials determined to be used i
33、n the product design shall be compliant with RoHS Directive requirement.5.1.6产品量试：具体参照试产管理办法Product batch run: The specific reference to the trial production management process;5.1.6.1一般量试之数量应有一定基本量（基本量100 PCS），以取得制程信息，但可视产品复杂性而弹性更动。Generally the quantity for batch run shall be certain basic quantit
34、y (100 PCS) in order to obtain production information, which can be changed due to product complicity and flexibility. 5.1.6.2研发部对生技课、制造课做量试技术数据转移并依数据进行产品量试。The R&D department shall transfer the batch run technical data of the production technology section and the production section and have product
35、 batch run according to the data. 5.1.6.3量试之进行，由项目负责人主导安排，发出经副总（含）以上主管核准的量试（产）通知单，并召开量试前会议，要求相关部门配合及作量试前之准备。For batch run, the PM shall arrange it, send the Batch Run (Production) Notice approved by the deputy general manager (inclusive) or above, convoke pre-batch run meeting and require the relate
36、d department for support and preparation for the batch run. 5.1.6.4量试之进行，须以正常物料流程、正式量产加工治具及测试治具进行，产出之产品并可依业务部门需求，开始出货。Batch run must be conducted with normal materials flow, formal batch production and processing jigs and tools and testing jigs. And the manufactured products can be shipped as per th
37、e request of the business department. 5.1.6.5于量试结束，项目负责人须与项目小组人员召开量试后会议，对量试结果、不良分析及测试治具、加工治具之易制性进行检讨，确认产品制程条件及生产文件符合量产需求，并作成试作、量试（产）报告书。When the batch production ends, the PM must convoke the project team personnel to have after-batch run meeting, check batch run result, defect analysis and testing
38、jigs, processing tools and jigs for their making easiness, confirm product production process conditions and production documents comply with batch production demand and prepare Trial Production, Batch Run (Production) Report. 5.1.6.6于量试阶段中所发生之问题点，由研发部负责整合分析，提出改善对策、计划，或依工程变更管理程序进行工程设计变更，改善设计并重行量试。Fo
39、r the problem points occurring on the batch run stage, the R&D department shall be responsible for the integration and analysis, put forward improvement countermeasures, plan or have engineering design change as per Engineering Change Management Procedures, improve design and have batch run again. 5
40、.1.6.7量试通过后,项目负责人将机种转移文件目录相关技术文件数据转移给DCC.至此, 此产品设计开发案结束。After the batch run passes, the PM shall transfer the related technical documents and data such as Catalogue of Machine Type Transfer Documents to the DCC, then the product design development is finished. 5.2 系列品Product series 为因应产品市场（或客户）系列多样化
41、、市场需求快速变化或策略性产品之要求等问题之考虑，对各项产品之设计开发，并非全新架构之设计，仅对现有产品功能、结构或外观形式作部份变化而进行之产品设计开发，则依5.1.1项进行产品企画后，其后续各阶段作业项目可视产品特性，以弹性方式进行。In order to meet the requirements of product market (or customer) series diversity, market demand rapid change or strategic products etc, the design and development of every product
42、 are not the design of new structure but the product design and development changing partially the existing product function, structure or appearance, which shall be disposed flexibly according to product feature on every stage following after the product planning in 5.1.1. 5.3 设计变更Design change5.3.
43、1产品设计开发作业进行中，因市场异动、客户要求等因素，对产品设计、材料规格等有变更建议，以致需对产品规格作适当修改，产品规格则进行设计变更作业In the case where product design and development need to be changed in design or materials specification etc due to market variation, customer requirement etc and thus product specifications shall be changed properly, then the pr
44、oduct specifications can have design change. 5.3.2 设计确认阶段（含）前：Before (on) design confirmation stage: 5.3.2.1业务担当开立工程变更申请单（E C R），由项目负责人针对产品规格变更事项进行检讨，经副总（含）以上主管裁示接受要求与否，裁示不同意则取消申请，依原计划进行。The business personnel shall establish ECR; the PM shall analyze and review product specifications change; the de
45、puty general manager (inclusive) or above shall determine to accept or not; if the change is not approved, the application shall be cancelled and the original plan shall continue. 5.3.2.2工程变更申请单（E C R）经核准后，项目小组依产品规格变更幅度及实际需求，得以设计规划阶段、产品设计阶段或产品试作阶段为起点，重新进行产品之设计开发，并适时修正开发计划时程表及更新产品规格书。After the ECR is
46、 approved, the project team shall, according to product specifications change extent and actual demand and taking the design planning stage, product design stage or product trail production stage as starting point, conduct the product design and development a second time and correct the development
47、plan schedule and update Product Specifications in proper time. 5.3.2.3研发工程师针对产品规格变更之内容、方式，直接进行相关文件数据作业修正。The R&D engineer shall correct the related documents and data directly as per product specifications change content and mode. 5.3.3产品量试阶段（含）后之产品规格变更，则依工程变更管理程序行之。 The product specifications chan
48、ge after product batch run stage (inclusive) shall be conducted as Engineering Change Management Procedures. 5.4相关模具须依模具管理程序进行模具承认验收作业。 The related dies shall have die acceptance inspection as per Die Management Procedures. 5.5新零件物料须依零件样品承认作业规范进行零件样品承认作业。New part materials shall have part sample acceptance inspection as Part Sample Acceptance Inspection Regulations. 5.6本程序在设计确认阶段（含）前之各项技术资料均不对内发行，产品量试、量产阶段之各项技术数据与文件发行则依据工程技术资料管理规定行之。The technical data before or on the design confirmation stage herein will n