ISO程序文件中英文版04设计和开发控制程序
ISO9000-设计和开发控制程序
设计和开发控制程序设计和开发控制程序1 范围本程序适用于公司产品设计和开发的策划、输入、输出、评审、验证和更改控制，以确保产品设计和开发输出满足输入要求，以使产品达到规定的使用要求或已知的预期用途要求。
2 规范性引用文件无3 职责3.1 运营部3.1.1负责组织公司技术基础标准和产品标准的制定和修订。
3.1.2负责对研发项目（包含课题）进行管理、监督及考核。
3.2 业务部门业务部门包括设计和开发部门。
负责产品的设计和开发，保证设计输出能够满足规定使用要求和已知预期用途的要求。
3.3 相关责任部门配合本程序的实施和执行。
4 管理内容与要求4.1设计开发类别：新产品设计与开发；定型产品、技术改造设计。
4.2 新产品设计和开发，运营部根据各业务部门提报的资料编制项目立项和项目启动通知，交由各部门执行。
4.3各业务部门确定的技术改造项目，根据市场需要确定启动时间。
4.4设计和开发策划4.4.1各业务部门接到运营部下达的项目立项/启动通知后开始启动新研发项目。
4.4.2项目负责人根据项目整体实施计划组织完成产品设计并协调相关工作，必要时可对项目整体实施计划进行调整。
4.4.3设计简化原则a)对定型产品/项目的技术改造设计，其设计文件和技术文件可适当简化和引用，相应的评审、验证和确认也可合并进行；b)新产品的设计与开发，其设计文件或技术要求，与现有产品/项目完全一致时，可直接引用或借用，无需另行编制。
4.5设计和开发输入评审4.5.1项目负责人应组织项目设计人员分析、评审需开发项目的输入资料，以确定与本次设计相关的要求是否明确。
设计输入包括以下内容：a)产品/项目的功能和性能要求；b)适用的法律、法规要求；c)过去类似设计的有关信息，可参照已有的研发项目、客户需求概述、其他技术资料；d)设计和开发所必需的其它要求（如顾客的任何协议，包括口头承诺协议）；e)产品/项目的安全防护功能；f)相关的环境因素和危险源；g)设计和开发所必须的其它要求。
ISO9000有关设计和开发控制的程序文件
ISO9000有关设计和开发控制的程序文件1、目的对设计和开发的全过程进行控制，确保新产品能满足顾客的需求和期望及有关法律、法规的要求。
2、范围适用于本厂新产品的设计开发全过程，包括引进产品的转化、定型产品及生产过程的技术改进等。
3、职责3.1 技质部负责设计、开发全过程的组织、协调、实施工作，进行设计和开发的策划，确定设计开发的组织和技术的接口、输入、输出、验证、评审、设计和开发的更改和确认等。
3.2 厂长负责审批项目建议书、下达设计和开发任务书，设计开发方案、设计开发计划书、设计开发评审、设计开发验证报告，试产报告。
3.3 供销部负责所需物料的采购。
3.4 供销部负责根据市场调研或分析，提供市场信息及新产品动向，负责提交顾客使用新产品后的《客户试用报告》。
3.5 技质部负责新产品的检验和试验。
3.6 生产部负责新产品的加工和生产。
4、程序4.1 设计和开发的策划4.1.1 设计和开发项目的来源A、供销部与顾客签订的新产品合同或技术协议。
根据厂长批准的相应的《产品要求评审表》，技质部部长下达《设计开发任务书》，并将与新产品有关的技术资料归档。
B、供销部根据市场调研或生产部根据技术革新需要或技质部综合各方信息均可提出《项目建议书》，报厂长批准后，技质部部长下达《设计开发任务书》，并组织实施。
4.1.2 技质部部长根据上述项目来源，确定项目负责人，将设计开发策划的输出转化为《设计开发方案》、《设计开发计划书》。
计划书内容包括：A、设计开发的输入、输出、评审、验证、确认等根阶段的划分和主要工作内容；B、各阶段人员职责和权限、进度要求和配合单位；C、资源配置需求，如人员、信息、设备、资金保证等及其他相关内容。
4.1.3 设计开发的输出文件将随着设计开发的进展，在适当时予以修改，应执行《文件控制程序》的有关规定。
4.1.4 设计和开发不同组别可能涉及工厂不同职能或不同层次，也可能工厂外部。
4.1.4.1 对于组别之间重要的涉及开发信息沟通，设计开发人员填写《设计开发信息联络单》，由设计组负责人审批后发给相关组别。
ISO质量认证手册 设计和开发控制程序
1.0 目的对设计和开发全过程进行有效控制，确保产品能满足顾客的需求和期望及有关标准、法规的要求。
2.0 适用范围适用于本公司新产品的设计、开发全过程，包括引进产品的转化、定型产品及生产过程的技术改进等。
3.0 权责3.1 技术质量部负责设计和开发全过程的组织、协调、实施工作，进行设计和开发的策划、确定设计和开发的组织和技术接口、输入、输出、评审、验证、确认和更改等；3.2 总工程师负责审核项目建议书和设计和开发确认报告，负责下达设计和开发任务书，负责批准设计和开发计划、设计和开发评审报告、设计和开发验证报告；3.3 总经理负责批准项目建议书和设计和开发确认报告；3.4 供应综合部负责所需物资的采购；3.5 营销综合部负责根据市场调研或分析，提供市场信息及新产品动向，负责提交顾客使用新产品的《客户确认报告》；3.6 技术质量部负责新产品的检验和试验；3.7 生产综合部负责新产品的加工试制和生产。
4.0 程序4.1 设计和开发的策划4.1.1 设计和开发的项目来源：1）与顾客签订的特殊合同或协议，该类合同或协议顾客只明确了对产品功能和性能上的要求，但未明确产品的具体的质量特性要求（规格），根据相应的《合同评审表》，营销综合部提出《项目建议书》经总经理批准后，连同顾客所附上的相关资料转交技术质量部立项；2）根据市场调研分析或根据顾客的意向与需求，营销综合部提出的《项目建议书》，经总经理批准后连同相关的背景资料转交技术质量部立项；3）综合本公司内外反馈的信息，技术质量部以《项目建议书》提出开发或技术改进的建议，经总经理批准后，转回技术质量部立项；4.1.2 技术质量部根据批准立项的产品设计和开发要求，确定产品设计和开发项目负责人，报送总工程师批准；4.1.3 产品设计和开发项目负责人根据经批准的《项目建议书》，负责主持策划工作，编制《设计和开发计划书》，明确设计和开发各个阶段详细工作内容、要求进度及责任及相应的控制计划等，报总工程师审定；4.1.4 设计和开发计划包括：1）设计和开发过程的各阶段；2）每个设计和开发阶段应进行的评审、验证和确认活动；3）设计和开发过程的职责和权限；4）设计和开发所需的资源（如有一定资格能胜任的人员、适用的软件、试制用设备、试验及验证用仪表以及信息、材料等）；5）进度计划；4.1.5《设计和开发计划书》可根据设计和开发进展的实际情况进行更改，但更改应经过批准；4.1.6 接口管理产品设计和开发项目负责人应对参与设计和开发的各工作组之间的接口进行管理，以确保沟通有效，职责明确：1）组织接口：明确划分工作相互关连的不同小组（部门）有关人员的职责：开发过程由技术质量部协调各小组工作，产品研制过程由生产综合部按开发计划和设计图样安排生产；2）技术接口：对影响设计和开发质量的信息传递应填写联络单，以保证有效的沟通；3）评审：作为设计和开发依据的重要信息，应由项目负责人组织评审，以鉴别信息是否完整、准确，为避免接口遗漏或管理无效，在各阶段应由项目负责人主持进行相应的评审；4.2 设计和开发输入4.2.1 对产品的要求或供需双方达成的技术协议，应予以规定并正式形成《设计和开发任务书》，这些要求包括：1）功能和特性要求；2）应遵守的法律、法规要求；3）从以往类似的设计得出的适用的要求；4）设计和开发必须满足的任何其他要求。
设计和开发控制程序、英语
设计和开发控制程序、英语Designing and Developing Control Programs in EnglishThe field of control systems has become increasingly important in modern technology, with applications spanning a wide range of industries, from manufacturing to transportation, and beyond. As the complexity of these systems continues to grow, the need for efficient and effective control programs has become paramount. In this essay, we will explore the process of designing and developing control programs, with a focus on the use of English as the primary language of communication and implementation.Firstly, it is essential to understand the fundamental principles of control systems. A control system is a collection of components that work together to maintain a desired state or output, often in response to external inputs or disturbances. These systems can be classified into two main categories: open-loop and closed-loop. Open-loop systems operate without feedback, while closed-loop systems use feedback to adjust the control actions and maintain the desired output.The design of a control program begins with a thoroughunderstanding of the system's requirements and constraints. This involves gathering information about the system's inputs, outputs, and the desired behavior. Engineers must also consider factors such as the system's physical limitations, environmental conditions, and any safety or regulatory requirements. Once the system requirements are clearly defined, the next step is to develop a mathematical model of the system's dynamics, which can be used to analyze its behavior and design the appropriate control strategies.One of the key aspects of control program design is the selection of the appropriate control algorithm. There are various control algorithms available, each with its own strengths and weaknesses, and the choice will depend on the specific requirements of the system. Some common control algorithms include proportional-integral-derivative (PID) control, model predictive control (MPC), and fuzzy logic control. Each of these algorithms has its own set of tuning parameters and implementation considerations, and engineers must carefully evaluate the trade-offs to select the most appropriate solution.The implementation of the control program is a critical step in the overall design process. This involves translating the mathematical model and control algorithm into a working software program that can be deployed on the target hardware. This process requires a strong understanding of programming languages, such as C, C++, orPython, as well as the specific hardware and software platforms used in the control system.One of the key challenges in implementing control programs is ensuring that the software is robust, reliable, and efficient. This requires careful attention to code structure, error handling, and performance optimization. Additionally, engineers must consider the integration of the control program with other system components, such as sensors, actuators, and user interfaces, to ensure seamless operation.Throughout the design and development process, clear and effective communication in English is essential. Engineers must be able to document their work, collaborate with team members, and communicate with stakeholders, such as customers, regulatory bodies, and other technical professionals. This requires a strong command of technical English, including the ability to use appropriate terminology, express complex technical concepts, and write clear and concise documentation.In conclusion, the design and development of control programs is a complex and multifaceted process that requires a deep understanding of control system principles, programming skills, and effective communication in English. By mastering these skills, engineers can create innovative and efficient control solutions thatdrive technological progress and improve the lives of people around the world.。
ISO9001-设计开发控制程序
ISO9001-设计开发控制程序ISO9001-设计开发控制程序1、简介1.1 目的本程序的目的是规范和控制设计开发过程，确保产品的质量和符合相关法律法规要求。
1.2 适用范围本程序适用于设计开发部门及相关人员。
1.3 定义（此处与设计开发相关的定义，例如产品设计、产品开发等）2、设计开发流程2.1 需求分析2.1.1 确定设计开发的需求和目标2.1.2 审查现有产品或系统，以确定改进点和问题2.1.3 收集和分析用户需求和反馈意见2.2 概念设计2.2.1 确定产品的整体概念和功能2.2.2 进行初步的绘图和草图设计2.2.3 确定关键技术和材料2.3 详细设计2.3.1 开展详细的设计和建模工作2.3.2 确定产品的规格和特性2.3.3 编写设计文档，包括设计原理、结构、性能等2.4 实施2.4.1 根据详细设计进行产品的制造和组装2.4.2 进行实验验证和测试2.4.3 根据测试结果进行必要的调整和改进2.5 验证和确认2.5.1 进行产品性能和质量方面的验证测试2.5.2 进行用户评估和反馈收集2.5.3 完善设计和确保产品符合相关标准和要求2.6 产品发布2.6.1 完成产品的文档和规格编制2.6.2 进行市场推广和销售2.6.3 开展售后服务和用户支持3、设计开发控制3.1 项目管理3.1.1 制定详细的项目计划和进度表3.1.2 跟踪和控制项目进展，确保按时完成任务3.1.3 分配适当的资源和人员进行设计开发工作3.2 质量控制3.2.1 设立质量目标和指标3.2.2 进行设计阶段的质量检查和验证3.2.3 引入适当的质量管理工具和方法3.3 变更控制3.3.1 建立变更控制流程和机制3.3.2 审核和评估变更请求的合理性和影响3.3.3 实施变更并进行相应的文档更新和通知4、相关附件（列出本文档涉及的相关附件）5、法律名词及注释（列出本文所涉及的法律名词及相应的注释）。
ISO14001文件管理与控制程序(中英文版)
文件管理与控制程序Docume nts man ageme nt and con trol procedure1. 目的Purpose确保环境管理体系文件、适用的外来文件(有关的法律、法规、标准、相关方提供的文件或规范)使用的有效性。
To assure the2. 适用范围scope适用于对环境管理体系相关文件及适用的外来文件的控制。
It is apply to theen vir onment man ageme nt system relati on docume nts and usable exter nal docume nts 'con trol.3. 职责Responsibility3.1环工组：负责环境管理体系文件及适用的外来文件的归口管理；负责监控文件的执行。
The environment team: to man age and be in charge of en vir onment man ageme nt docume nts and exter nal docume nts.3.2各部门in dividual departme nt :确保各相关场所均使用现行文件的有效版本。
To en sure Therelative workplace is using the curre nt effective docume nts.4. 工作程序Work procedure4.1 文件控制范围包括：documents control ' s scopea) 环境管理手册；en vir onment man ageme nt manu al;b) 环境管理体系程序文件；en vir onment man ageme nt system procedure docume nts;c) 环境管理体系作业指导文件；the work in structio n docume nts for en vir onmentman ageme nt system;d) 环境记录表格；en vir onment record form;e) 夕卜来文件。
【ISO9001-2015质量管理体系程序文件】设计和开发控制程序
总经理管理者代表业务部生产部行政部品管部采购部财务部仓务部信息部冲压车间五金车间焊接车间喷粉车间注塑车间针车车间装配车间汽车座椅车间1.目的规定本部门对产品设计开发所要遵循的步骤，以利于产品设计开发规划与管制工作之进行，确保所设计开发之产品能够符合客户和法律法规要求及市场需求。
2.范围本程序适用于公司新产品的设计开发相关规划、输入、输出、审查、验证及确认工作。
3.权责3.1有关产品设计开发任务以“项目管理方式”进行管制，产品设计开发项目小组由指定之项目负责人组成，成员包括设计工程人员/业务人员/模具工程人员/品管人员/制造人员/采购人员等，成员需求视任务之复杂程度、困难程度而定；3.2项目小组所有成员负责每一款产品设计开发项目规划、执行及管制工作。
4.设计开发控制流程4.1有关产品设计开发工作之阶段区分如下:▓策划阶段（项目输入）【阶段代号: C1】▓设计计划阶段（输入，决定输出哪些项目）【阶段代号: C2】▓设计开发阶段（输出图档/模型等，并评审）【阶段代号: C3】▓工程试模阶段（EP 试作/验证）【阶段代号: C4】▓试产阶段（PP 试作/验证/确认）【阶段代号: C5】▓量产阶段（量产/改善）【阶段代号: C6】具体参见下页表格说明。
接上页接上页接上页5.相关文件5.1《文件和资料控制程序》（QB-001）5.2《质量记录控制程序》（QB-002）6.相关表单6.1《产品设计开发联络书》（QD-KF-001）6.2《制造规格单》（QD-YW-001）6.3《设计开发计划书》（QD-KF-002）6.4《设计开发输入（输出）清单》（QD-KF-003）6.5《零件明细表》（QD-KF-016）6.6《委托单》（QD-KF-004）6.7《样车物料采购单》（QD-KF-005）6.8《样车发料（领料）单》（QD-KF-006）6.9《设计开发评审报告》（QD-KF-007）6.10《设计开发验证报告》（QD-KF-008）6.11《模具制造申请表》（QD-KF-009）6.12《零组件确认书》（QD-KF-010）6.13《工艺通知单》（QD-KF-011）6.14《样板间样品情况记录表》（QD-KF-012）6.15《样件发放领用登记表》（QD-KF-013）6.16《设计开发确认书》（QD-KF-014）6.17《设计开发更改申请表》（QD-KF-015）。
ISO文件控制程序（中英文）
ISO文件控制程序（中英文）ISO文件控制程序Document Control Procedure1.0目的Purpose:此文件的目的是按照ISO或其他适用的文件的要求建立一个控制所有文件的程序, 并且保证所有适用的文件的现行版本在使用中。
The purpose of this document is to have an established procedure to control all documents that are required as per ISO and other applicable systems. This procedure will also ensure that current versions of the applicable documents are available at the point of use.2.0范围Scope:适用于所有质量、环境健康与安全管理体系文件和技术文件以及有关的外来文件的控制。
This procedure is applicable to the control of documents and data related to QMS/EHS and external documents relating to products and environment.3.0定义Definition:3.1内部文件和资料：本公司ISO系统文件、资料、表格，它可以是以硬拷贝（指以纸张形式存在）和软拷贝(指以电子文档或各种光盘、软盘、录像带）形式存在。
Internal document and data: documents , data and forms of ISO managingsystem of our company. This could be in the form of hard copy (viz. paper)or in soft copy form (viz. electronic doc. floppy disk or video tape).3.2外来文件和资料：非本公司编制的文件，包括：国家标准、企业行业标准、与公司环境因素有关的法律法规及其他要求、与公司产品有关的法律法规及客户提供检验标准、产品图纸等。
中英对照-产品设计和开发控制程序
Marketing Department is in charge of the communication with the customer before new product development, to ensure the adequacy and effectiveness of customer requirements. Submit the mission after obtaining the document (like technical specification) or drawing required by customer.
After Technical Department receives the documents from Marketing Department, organize to conduct the compliance review for product related requirements like technical requirements, parameters, appearance requirements, delivery, statutory and regulatory requirements. If pass the review, officially confirm it as a contract. "Contract Review Form" is approved by General Manager, after being approved, it could be confirmed as a new product, Marketing Department formally issue the "Design and Development Mission Form of New Product" or "Production Notification", distribute to Technical Department with customer documents together. It goes into design and development stage.
ISO 程序文件 文件与 控制程序
A．公司的文件受控主要采用纸张形式，对于无法用纸张进行受控的文件如工程图纸、软件等，可采用电子文档文件（如PDF文件等）形式进行受控。
B．由文件制定部门以软盘或电子邮件的形式将文件传送至文控中心，并注明文件名称、文件编号、版号、修改号及生效日期等。软件受控时需提交的文件包括源程序、编译后的可执行文件以及相应软件的流程图，其中源程序及可执行文件为电子文档，流程图为纸张文档。
具体的动作方法
品保体系运行之证据(record & form)
5.13.2体系文件的格式。(如附件)
5.13.3文件与资料的编号原则根据《质量体系文件编号原则及格式的规定》
5.13.3.1文件编码的基本组成：
一级文件：质量手册
事业部代码+文件类别
二级文件：程序文件：
事业部代码+文件类别
三级文件：技术标准、工艺标准、检验标准、工作指示、作业指导书、控制计划等文件。
如文件由于丢失等原因不能收回时，丢失者应将情况书面报告管理者代表，
5.7当文件不作为活动依据，只作参考时，执行单位可向文控中心申请并经管理者代表批准后，复印原稿按管理外文件发行,发行同时须加盖“非受控文件”章,管理外文件不再随版本或版次更新而更换。
5.8发往外部的文件（图纸或技术资料）需要更改为pdf格式，且防止打印、复制。
2)客户代码：当业务有新客户进入时，且新客户提出报价要求，则业务及时对新客户进行编号，编号原则为按客户进入的先后顺序，以流水号编码；
3)开发案号：按该客户的开发的产品顺序以流水号登记；
4)版本号：按客户文件版本号执行。
所有受控文件禁止私自复印，如有需要向文控中心申请。
5.15质量记录的管理
中英对照-产品设计和开发控制程序
After Marketing Department primarily confirms the document, drawing and sample required by customer, fill in "Review Form for Contract Requirements", submit to Technical Department with customer documents together.
3．3市场部负责新产品开发前与顾客的沟通，保证顾客要求的充分性、有效性。在取得顾客要求的文件（如技术规范书等）或图样后做出任务提交。
Marketing Department is in charge of the communication with the customer before new product development, to ensure the adequacy and effectiveness of customer requirements. Submit the mission after obtaining the document (like technical specification) or drawing required by customer.
产品开发中与产品有关要求评审按《销售管理制度》4.2.1、42.2执行。.
Implement as clauses 4.2.1 and 4.2.2 of ""Sales Management Institution".
4．1．1市场部门及技术部门与顾客沟通要考虑产品技术要求、工况要求、参数规范、标准、交货期、交付要求、数量、价格、付款方式、标志、包装等方面要素，保证沟通尽可能充分、有效。
ISO9001文件控制程序(中英文)
ISO9001文件管理程序Document Control Procedure文件更改历史记录Amendment History版次Revision更改日期Change Date更改概要Description of Changes更改人Prepared by批准人Approved byPrepared by编制Reviewed by审核Approved by批准ISO9001文件管理程序Document Control Procedure1.0 Purpose目的Define the requirements and responsibilities for Document control.定义出文件控制的要求和权责。
2.0 Scope范围This procedure applies to all QMS documentation, including: quality manual, procedure, WI, external document and form.适用于与质量管理体系有关的所有文件。
包括:手册、程序文件、操作指导书、外来文件及表单。
3.0 Definitions定义3.1 Quality Manual: According to the requirements of International and national standard (such as ISO9001), describe quality management system documentation in Co-active.3.1质量手册：根据相关国际或国家标准(如ISO9001)要求，阐述本公司质量管理体系的文件。
3.2 Procedure: Define the function of QMS requirement allocation bydepartment. Such as document control, management review, internalaudit procedure.3.2程序文件：描述为实施质量管理体系要求所涉及的各职能部门的活动的文件。
ISO9001设计和开发控制程序
文件制修订记录1.0目的：对产品设计和开发的全部过程进行控制，确保产品能满足顾客的需求和期望及有关法律法规的要求。
2.0范围:适用于本公司新产品（研发和改良）的设计和开发，及客户来图来样加工。
3.0权责3.1业务部：负责市场调研分析及客户需求信息的收集。
3.2工程部：负责新产品开发工程标准制定﹑技术资料审查样品制作。
3.3生产部：负责产品生产及相关量产能力的验证。
3.4资材部：负责新材料的供应商开发，设计和开发物料的采购，小批量试产的物料计划和生产计划。
4.0定义：4.1OEM:按顾客提供的图档（3D/2D）进行生产加工。
4.2ODM:按顾客委托设计开发或公司指令进行设计开发。
4.3FMEA:潜在失效模式与后果分析。
4.4.CDA:关键尺寸评估表。
5.0作业内容：5.1新产品设计和开发的策划与输入：5.1.1设计项目来源：客户委托和公司指令。
客户委托：由客户提供产品设计的意向，参考样品（参考机型或资料）、功能要求、外观要求﹑成本要求﹑产品执行标准和法律要求等作为设计和开发策划与输入的信息。
公司指令：公司高层和业务部根据市场反馈信息，行业发展动态与理念（行业展销会上获取新概念），提出对产品结构﹑款式和档次要求，成本要求；结合产品执行标准和法规要求作为设计和开发策划与输入的信息。
5.1.2工程部根据设计和开发的项目需求，指派项目工程师组建小组，填写[新产品立项书]经部门经理审核，总经理批准后实施。
5.1.3项目工程师根据设计输入的信息，进行产品3D图档的设计。
工程师完成初始图档的设计后，同时根据实际的需要输出以下工程资料：a.[新产品初始材料清单]b.[新产品开模清单]c.[新产品初始过程流程图]。
d.[新产品新材料/新工艺清单]e.[新产品增添设备清单]。
5.1.4如项目属OEM来图制造产品，业务部接到顾客图档后交工程部进行立项，工程部按5.1.3条款要求输出相关资料。
5.2新产品设计和开发的控制（评审﹑验证和确认活动）：5.2.1工程部项目小组成员及业务部提案人员，依项目设计输入要求对新产品图档或手板样品进行设计评估﹑验证和确认，并填写[新产品制造可行性评价表]。
汽车行业程序文件中英文版-程序文件目录
汽车行业程序文件中英文版-程序文件目录汽车行业程序文件中英文版程序文件目录一、设计与开发程序1、产品概念设计程序 Product Concept Design Procedure市场调研与需求分析 Market Research and Demand Analysis创意构思与概念生成 Creative Conception and Concept Generation 概念评估与筛选 Concept Evaluation and Screening2、工程设计程序 Engineering Design Procedure详细设计与计算 Detailed Design and Calculation材料选择与规格确定 Material Selection and Specification Determination设计验证与优化 Design Verification and Optimization3、样车制作与测试程序 Prototype Manufacturing and Testing Procedure样车制造工艺规划 Prototype Manufacturing Process Planning样车组装与调试 Prototype Assembly and Debugging性能测试与评估 Performance Testing and Evaluation二、采购与供应链管理程序1、供应商选择与评估程序 Supplier Selection and Evaluation Procedure潜在供应商搜寻 Potential Supplier Searching供应商资质审核 Supplier Qualification Audit实地考察与评估 Onsite Inspection and Evaluation2、采购订单管理程序 Purchase Order Management Procedure采购需求确定 Purchase Requirement Determination订单下达与跟踪 Order Placement and Tracking交货验收与入库 Delivery Acceptance and Warehousing3、供应链风险管理程序 Supply Chain Risk Management Procedure风险识别与评估 Risk Identification and Evaluation风险应对策略制定 Risk Response Strategy Formulation风险监控与预警 Risk Monitoring and Early Warning三、生产制造程序1、生产计划与调度程序 Production Planning and Scheduling Procedure订单分解与排产 Order Decomposition and Production Scheduling资源配置与产能规划 Resource Allocation and Capacity Planning进度跟踪与调整 Progress Tracking and Adjustment2、工艺过程控制程序 Process Control Procedure工艺流程设计与优化 Process Flow Design and Optimization作业指导书制定 Work Instruction Formulation过程检验与质量控制 Process Inspection and Quality Control3、设备管理与维护程序 Equipment Management and Maintenance Procedure设备选型与采购 Equipment Selection and Purchase设备安装与调试 Equipment Installation and Commissioning日常维护与保养 Daily Maintenance and Repair四、质量控制与检验程序1、进料检验程序 Incoming Inspection Procedure原材料检验标准制定 Raw Material Inspection Standard Formulation 抽样方案与检验方法 Sampling Plan and Inspection Method不合格品处理 Nonconforming Product Handling2、过程检验程序 Inprocess Inspection Procedure工序检验点设置 Inspection Point Setting in Processes检验记录与统计分析 Inspection Record and Statistical Analysis质量问题反馈与处理 Quality Problem Feedback and Handling3、成品检验程序 Finished Product Inspection Procedure成品检验标准制定 Finished Product Inspection Standard Formulation 全项目检验与抽样检验 Fullitem Inspection and Sampling Inspection 检验报告与质量证书 Inspection Report and Quality Certificate五、销售与市场推广程序1、市场调研与分析程序 Market Research and Analysis Procedure市场趋势研究 Market Trend Research竞争对手分析 Competitor Analysis消费者行为研究 Consumer Behavior Research2、销售渠道管理程序 Sales Channel Management Procedure经销商选择与合作 Dealer Selection and Cooperation销售渠道拓展与优化 Sales Channel Expansion and Optimization渠道绩效评估与激励 Channel Performance Evaluation and Incentive3、客户关系管理程序 Customer Relationship Management Procedure客户信息收集与管理 Customer Information Collection and Management客户投诉处理与满意度调查 Customer Complaint Handling and Satisfaction Survey客户忠诚度培养 Customer Loyalty Cultivation六、售后服务程序1、售后服务政策制定程序 Aftersales Service Policy Formulation Procedure保修范围与期限确定 Warranty Scope and Period Determination售后服务费用标准制定 Aftersales Service Cost Standard Formulation 服务承诺与条款说明 Service Commitment and Clause Explanation2、维修与保养服务程序 Repair and Maintenance Service Procedure服务预约与接待 Service Reservation and Reception故障诊断与维修方案制定 Fault Diagnosis and Repair Plan Formulation维修作业与质量检验 Repair Work and Quality Inspection3、配件供应与管理程序 Spare Parts Supply and Management Procedure配件库存管理 Spare Parts Inventory Management配件采购与配送 Spare Parts Purchase and Distribution配件质量控制 Spare Parts Quality Control七、人力资源管理程序1、招聘与选拔程序 Recruitment and Selection Procedure岗位需求分析 Job Requirement Analysis招聘渠道选择 Recruitment Channel Selection面试与评估流程 Interview and Evaluation Process2、培训与发展程序 Training and Development Procedure培训需求调查 Training Requirement Survey培训计划制定与实施 Training Plan Formulation and Implementation 培训效果评估与反馈 Training Effect Evaluation and Feedback3、绩效考核与薪酬管理程序 Performance Appraisal and Compensation Management Procedure绩效指标设定 Performance Indicator Setting绩效考核评估 Performance Appraisal Evaluation薪酬计算与发放 Compensation Calculation and Distribution八、财务管理程序1、预算编制与控制程序 Budget Preparation and Control Procedure预算目标设定 Budget Target Setting预算编制流程 Budget Preparation Process预算执行监控与调整 Budget Execution Monitoring and Adjustment2、成本核算与控制程序 Cost Accounting and Control Procedure成本项目分类与核算方法 Cost Item Classification and Accounting Method成本分析与控制措施 Cost Analysis and Control Measures成本降低与优化方案 Cost Reduction and Optimization Plan3、财务报表编制与审计程序 Financial Statement Preparation and Audit Procedure财务数据收集与整理 Financial Data Collection and Arrangement报表编制规范与流程 Statement Preparation Specification and Process 审计配合与整改 Audit Cooperation and Rectification。
ISO程序文件中英文版04设计和开发控制程序
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。
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。
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Author : Checked by : Approved by :1/15 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 Office1. 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 ofdesign 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。
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 OfficeOther Departments shall be responsible for completing job of coordinating and perfecting the Production Assembling DevelopmentProject which is ordered by Director General.4. 工作程序Procedures for work4.1设计方案制定流程Procedures for formulating the “DesignBrief”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 theC.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”, t he C.T.O. or Dept. Director will appoint a project engineer who will be responsible for conducti ng 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 inthe Product Development Proposal :structureVersion :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 Officefeatures 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。