ISO程序文件中英文版04设计和开发控制程序.doc

Version：B/1 Revised Version： B/0 Revision
Effective Date：

File Name：设计和开发控制程序Design and Development Procedure
Edited by：ISO Office

1. 目的：对产品设计开发全过程进行控制，确保设计和开发的新产品满足规定的要求。
Purpose：Control the whole process of product design and development to ensure that the design and development of new product meet the stated requirements.
2. 适用范围：适用于产品设计和开发的全过程。
Applicable Scope：Apply to the whole process of product design and development.
3. 职责Responsibility：
3.1董事总经理负责设计开发项目的立项设计输入及试产交接会的组织和批准工作。
The Director General shall be responsible for approving the establishment of design and development project, design input and organizing the meeting for hand-over of pre-production .
3.2技术总监领导负责产品的设计开发全过程的组织协调及审批工作。
The C.T.O will organize and coordinate the overall process of design and development of product, take charge of audit and approval as well.
3.3项目工程师负责统筹产品的设计开发、型式试验及组织设计开发过程中产品的装配测试工作。
The project engineer shall be in charge of coordinating the design and development and type-test of product, organize the work related to assembly and test during the process of design and development.
3.4 生产技术部负责配合执行产品测试及试验工作，组织产品试产，组织生产装配工艺文件和检验文件的编制及审核工作。
The Production Technique Dept. shall provide cooperation for test and inspection, organize the pre-production, in addition, prepare and approve the production and assembly technology and inspection documents.
3.5品保部负责编制检验标准/规程，参与新产品样品的验证及试产过程中各阶段的检验测试工作。
The QC Dept. will draft the test criterion/ instruction, involve in verification for the sample of new product, also the test and inspection at every stage of pre-production.
3.6采购部负责协调设计开发过程中所需物资的采购工作。
The Purchasing Department will involve in ordering of material needed in the process of design and development .
3.7 生产技术部负责设计开发过程的样品试制和工艺协作。
The Production Technique Dept. shall be responsible for building prototypes in the design and development process also the collaboration of technology.
3.8其他各部门负责完成董事总经理交办的产品配套性开发项目的协作和完善工作。
Other Departments shall be responsible for completing job of coordinating and perfecting the Production Assembling Development Project which is ordered by Director General.
4. 工作程序Procedures for work
4.1设计方案制定流程 Procedures for formulating the “Design Brief”
4.1.1市场部或其它部门人员通过整理市场调查，提出产品开发建议，编写“产品开发建议书”，报董事总经
理审批.
Marketing Dept. or other party may, through the collation of market intelligence, evolve a product concept .When
this happens, a “Product Development Proposal” is submitted to the Director General for approval.
4.1.2董事总经理根据公司人力资源情况，以及通过对竞争对手的产品分析，审批“产品开发建议”；必要时，召集技术总监、营运总监、市场总监、及其它各部门主管进行会议分析讨论，以确认“产品开发建议书”的可行性，决定是否批准开发建议书。
The Director General shall approve the “Production Development Proposal” according to the actual human resource and the competitor analysis; if necessary, convene a meeting with C.T.O., C.O.O., Chief Officer of Marketing and Directors of other department to consult on the viability of the “Production Development Proposal” and decide whether to approve it.
4.1.3董事总经理根据国内外市场发展趋势审批“产品开发建议书”，并抄送技术总监或指定开发部门主管。
If the “Product Development Proposal” is approved by the Director General, a copy of it will be forwarded to the C.T.O. or appointed Development Dept. Director.
4.1.4技术总监或部门主管收到“产品开发建议书”后，委派一名产品项目工程师，对“产品开发建议书”的要求，进行可行性分析，并编写“产品开发可行性报告”报请技术总监或部门主管审核、董事总经理批准。
“产品开发可行性报告”应提出以下数据和资料。
Upon receipt of “Product Development Proposal”, the C.T.O. or Dept. Director will appoint a project engineer who will be responsible for conducting a feasibility study of the “Product Development Proposal”, and the “Development Feasibility Report” is required subsequently, which is to be checked by C.T.O. or Dept. Director, and approved by the Director General.
The object of the “Development Feasibility Report” is to provide data on the following:
4.1.4.1 开发该产品的技术可行性：各结构特点和技术指标。
The Technical possibility of developing the product described in the Product Development Proposal：structure features and technical parameters.
4.1.4.2开发进度和时间
The general time frames involved in the development process.
4.1.4.3开发成本统计，包括人员，经费等其他资源。
A general estimate of the resources required for the development of the proposed product including personnel, financial and other resources.
4.1.5如果依据“产品开发建议书”的要求所作“产品开发可行性报告”结论表明该产品开发可行，则由董事总经理负责组织制定“设计方案”草案下发至各相关部门主管，该“设计方案”应包括开发部开发该产品的所有细节和所需的资料。
Based on the “Product Development Proposal” and the findings of the “Development Feasibility Report” were the later to report that the former was feasible, the Director General must organize the formulation of the draft “Design Brief”, and issue to involved heads of department. The “Design Brief” should include all manner of details and information necessary for the product development department to design a product.
4.1.5.1产品的操作规范 Product performance criteria
4.1.5.2 产品的功能特性 Product functional features
4.1.5.3 产品的物理（外观）特性Product physical (appearance) features
4.1.5.4 经费标准和开发预算Economic and financial criteria and development budgets
4.1.5.5 开发进度和期限Development time scales and deadlines
4.1.6 “设计方案”经由董事总经理召集技术总监，市场总监、营运总监、生产技术部主管和成套工程部主管在内的各部门主管，进行会议讨论，确认后，形成书面文件，报技术总监或部门主管审核，董事总经理批准后实施。
The draft “Design Brief” should be made available to C.T.O., Chief Marketing Dept., Chief Operation Officer, manager of Production Technique Dept. and head of commercial contracts department, the Director General shall consult with these parties before finalizing the “Design Brief”. The written “Design Brief” will be audited by the C.T.O or Dept. Director and issued to the Director General for approval before performance.
4.1.7. 如涉“设计方案”的内容的任何一项更改，均应报请技术总监或部门主管审核，董事总经理批准后，并重新发放。
Any subsequent changes to the contents of the “Design Brief” must come in the format of the publication of a new revision to the “Design Brief”, as long as C.T.O. or Dept. Director check it before submitting it to Director General for approval.
4.2 产品开发程序 Procedures for product development stage
4.2.1 开发部收到“设计方案”后，技术总监或部门主管应编制“产品开发任务书”发放至项目组组长。
Upon the receipt of the “Design Brief” the C.T.O. or Dept. Director must formulate and issue a “Development Project Instruction” to the appointed Project Team Leader. The “Development Project Instruction” includes the following information but is not limited to them:
4.2.1.1 产品开发项目组成员（对项目组长负责并报告工作）。
The members of the product development team who will report to the project team leader.
4.2.1.2 项目工程师根据开发和图纸的编号规则确定项目或产品名称，以将当前项目和其他正在进行的开发项目的零件和图纸区别开来。
The Project Engineer shall determine the project or product name according to the numbering regulations of development and drawings, and distinguishes the component and drawings of current project and other developing projects
4.2.1.3 产品的技术参数和功能（参照设计方案和其他相关资料）。
Technical parameters and functions of the product (refer to the “Design Brief” and other relevant data)
4.2.1.4 项目所需经费和产品成本预算
Financial and economic objectives of the product as well as of the whole project itself.
4.2.1.5 分项目（如有）需要的特别开发和设计验证程序
Sub-projects (if any) requiring special research and design verification processes.
4.2.1.6 “设计建议书”的明细表，产品样本，产品技术条件，型式试验样品、操作使用说明书及产品成本预算等其他文件。
A list of “Design Proposal”, Product Prototypes, product technical condition, Type-Test prototypes, other Documentations such as operations Manual etc.(refer to section), projected product costs.
4.2.2对“产品开发任务书”，所含的任何特定项目的更改均应由技术总监或部门主管修改，并重新发放。更改的内容可能涉及以下几方面：
Changes to the “Development Project Instructions” pertaining to any particular Project must come in the form of revisions, and may be issued by the C.T.O or Dept. Director in response to but not limited to the following:
4.2.2.1 “设计方案”的更改Changes in the “Design Brief”
4.2.2.2 开发过程中相关标准或对现有标准解释的更改。
Changes in relevant standard or interpretation of existing standards during the development stage
4.2.2.3 执行开发项目所需的资源或技术的更改或开发小组成员的变动
Changes in the structure of the development team or the available resource or technology necessary for the execution of the development project
4.2.2.4 开发过程中产生的新技术或形成的新资料，导致原任务书的作废。
When new knowledge or information arises in the development process, the original instructions will be obsolete.
4.2.3 项目组长根据技术总监或部门主管下达的“产品开发任务书”编制 “产品开发计划”，报请技术总监或部门主管审批。
“产品开发计划”应包括：
The project team leader shall draft the “Product Development Plan” according to the “Product Development Order”, and then convey to C.T.O. or Dept. Director for approval.
This plan must include:
4.2.3.1 产品开发各阶段的任务，每个阶段的参与人员，每个阶段的工作，预期目标及完成时间。
开发阶段一般应包括起草设计建议书，具体的技术设计，试制样品，和样品检验阶段。必要时，开发阶段还将包括其他工作或分项目的开发。
Tasks in each phrase of product development, involved staff in each phrase, work in each phrase, anticipated goal and accomplish time
The development phases should generally include a draft Design Proposal, a technical detailing stage, prototyping stage and a stage involving the testing of the prototype. Other sub-phases and sub-projects may be included as when necessary.
4.2.3.2 详细列出每个阶段要求配备的资源和设备
Specify the resources and facilities required at each stage of the plan.
4.2.3.3 每个阶段可能涉及的外部支援(外部顾问或公司内部其他部门人员)
External supports which may possibly involved in each phrase (external consultants or staff from other departments in the company)
4.2.3.4 项目小组每个成员的具体职责
Specific Responsibilities of each member in project team
4.2.3.5 成品，部件装配或个别零件等的检验计划，以充分验证设计的完整性。
The inspection plan of finished product, sub-assemblies, or other individual components, will verify satisfactorily the soundness of the design.
4.2.4对“项目开发计划”所包含的任何内容的更改应采用新版本，并经技术总监或部门主管批准后由项目组长发放，更改的内容可能涉及以下几方面：
Changes to the “Project Development Plan” pertaining to any particular project must come in the form of revisions to be approved by the C.T.O or Dept. Director and may be issued by the project team leader in response to but not limited to the following situations:
4.2.4.1 产品开发任务书的修改 Revision of the “Development Project Instructions”

4.2.4.2 开发过程中相关标准或对现有标准解释的更改。
Changes in the relevant standard or the interpretation of existing standards during the development stage
4.2.4.3 执行开发项目所需的资源或技术的更改或开发小组成员的变动
Changes on the structure of the development team or the available resources or technology
4.2.4.4开发过程中产生的新技术或形成的新资料，导致原计划书的作废。
When new knowledge or information arises in the duration of or due to the development process itself, the original plan will be obsolete.
4.3 样品设计程序 Procedures for generating the prototype design
4.3.1开发小组应编制“设计建议书”和“设计评审报告”，并报部门主管审核及技术总监批准。“设计建议书”包括图纸起草，样机制作和实物制作等。“设计评审报告”包括参与评审人员，评审的具体内容记录及评审结论等。
The development team proceeds to generate the “Design Audit Report” together with the “Design Proposal”, which will be submitted to Dept. Director for reviewing and C.T.O. for approving. “Design Proposal” includes a set of draft drawings and draft data sheets, simulation moulds, mock-up samples. While, the “Design Audit Report” includes involved parties, detailed audit contents and conclusion, etc.
4.3.2技术总监参照“设计方案”确认“设计建议书”是否满足要求，“设计评审报告”的结论是否充分，必要时对建议书和报告提出针对性的更改意见或要求。
The CTO will decide if the “Design Proposal” meets the conditions stated in the “Design Brief”, and make the assessment on whether the conclusion of “Design Audit Report” is sufficient, and approve of the pertinent proposal and or request for a revision of the Design Proposal and report as may be the case.
4.3.3项目开发小组根据技术总监的审批意见，开展具体的设计开发工作：
Once the approval has been made by the C.T.O, the development team proceeds to detailed product development. This includes generating of the following:
4.3.3.1 绘制具体的零件图，含所有零件的部装，总装图，产品标识和包装要求。
Detailed component drawings, sub-assembly drawings and main assembly drawings of all the components, labeling and packaging of the product.
4.3.3.2 列出具体的资料清单包括技术材料清单，含技术条件，产品材料明细表，装配和校验指导书。
Data sheet in detail including technical data sheet, including technical condition, material list, and assembly and calibration instructions.
4.3.4技术总监负责组织具体产品技术图纸的评审及最终审批确认
The C.T.O will be responsible for organizing an audit of the detailed engineering drawings. He will have final approving authority for drawings.
4.4. 样品制作The Prototypes and Samples
4.4.1技术图纸设计完成后，经由部门主管审核，技术总监或其授权人批准后，统一记录于“技术图纸发放登记表”中，方可发放至相关部门。
The finished development drawings must be audited by Dept. Director and approved by the C.T.O, or person empowered, fill in the “Technical Drawing Issuance Record” before they may be issued to departments concerned.
4.4.2采购部依技术资料要求，协助开发部开展样品零部件的采购工作。
The procurement department will be responsible for acquiring the components necessary to build the prototypes with as required by the technical data.
4.4.3 开发小组负责样品制作，必要时，组织相关部门或人员参与协助。
The development team is responsible for building the product prototype, or for organizing other department members to assist in the prototype building process if necessary.
4.4.4当样品试制过程中需对零部件图纸作部分改动时，由项目开发组填写“技术图纸修改通知单”，详细注明修改原因和内容，随图纸一起报请技术总监批准后方为有效。
If minor drawing modifications are deemed to be necessary during the prototype building stage, the development team must write a “Drawing Change Request”, indicating the causes and change content, which have to be approved by the C.T.O before becoming effective.
4.4.5当样品试制过程中，需对产品作部分改动时，应重新评审“设计建议书”，更改“设计评审报告”并报请技术总监审批。但出现产品的重大更改时，须报请董事总经理批准。（产品重大更改指该设计更改将导致最后成品与设计方案的要求不符）
If major product modifications are found to be necessary during the prototype building stage, the “Design Proposal” must be reviewed, and a revised “Design Audit Report” must be completed and submitted to the C.T.O for approval. The major modification is to be approved by the Director General (A design modification will be deemed as “major” when the modification affects the end product’s compliance with the “Design Brief”.)
4.5 检验 Testing
4.5.1 检验贯穿于样品试制的全过程。包括零部件检查，成品及半成品的检验。
Testing may occur at any stage of building prototypes，including all testing of components, finished product and semi-finished products.
4.5.2零部件的检查由品保部根据技术图纸进行,并将检验结果提交开发组及技术总监确认并归档.
The inspection of components must be taken by the QC Dept. under technical drawings; the outcome must be submitted to development team, before the C.T.O. checks and approves it.
4.5.3样品的最终检验 Final test for sample
4.5.3.1内部检验由开发组根据 “设计方案”和“设计建议书”的参数要求，填写“样品试验计划”，经技术总监审核，董事总经理批准后，组织品保及相关人员进行，并将检验结果记录于“样品测试记录”中。
The development team shall write the “Sample Test Plan” in accordance with the parameters given in the “Design Brief” and “Design Proposal”, which is to be checked by the C.T.O and approved by the Director General, before the QC proceeds to in-house test. The outcome of test must be recorded in the “Sample Test Record”.
4.5.3.2必要时，对部分项目可安排外送检验确认。对外送检验样品，由开发组填写“样品试验计划”，报技术总监审核，董事总经理批准后执行。
Where necessary, external testing may be carried out on the prototypes. When this happens, the development team shall fill in the “Sample Test Plan” which to be checked by the C.T.O and approved by the Director General.
4.5.3.3样品内外检验结果均应报请技术总监审批，以确认试验结果的有效性和改善对策。
The test outcome from both the external and in-house audit must be submitted to C.T.O for audit, and the validity of test result and fu