APQP PHASE 2: Product Design and Development Verification 产品的设计与开发验证
1 Introduction 简介
This artical discusses the elements of the planning process during which design features and characteristics are developed into a near final form. All design factors should be considered by the organization in the Advanced Product Quality Planning process even if the design is owned by the customer or shared. The steps include prototype build to verify that the product or service meets the objectives of the Voice of the Customer. A feasible design must permit meeting production volumes and schedules, and be consistent with the ability to meet engineering requirements, along with quality, reliability, investment cost, weight, unit cost and timing objectives. Although feasibility studies and control plans are primarily based on engineering drawings and specification requirements, valuable information can be derived from the analytical tools described in this chapter to further define and prioritize the characteristics that may need special product and process controls.
In this artical, the Product Quality Planning Process is designed to assure a comprehensive and critical review of engineering requirements and other related technical information. At this stage of the process, a preliminary feasibility analysis will be made to assess the potential problems that could occur during manufacturing. The inputs and outputs applicable to this chapter are as follows:
|•• Design Goals
• Reliability & Quality goals
• Preliminary Bill of Materials
• Preliminary Process Flow Chart
• Preliminary Listing of Special Product and Process Characteristics
• Product Assurance Plan
• Management Support
|• Design Failure Mode and Effects Analysis (DFMEA)
• Design For Manufacturability and Assembly
• Design Verification
• Design Reviews
• Prototype Build – Control Plan
原型构建 - 控制计划
• Engineering Drawings
• Engineering Specifications
• Material Specifications
• Drawing and Specification Changes
|• New Equipment, Tooling and Facilities Requirements
• Special Product and Process Characteristics
• Gages/Testing Equipment Requirements
• Team Feasibility Commitment & Management Support
2 Content 内容
2.1 Design Failure Mode and Effects Analysis (DFMEA) 设计失效模式和影响分析（DFMEA）
The DFMEA is a disciplined analytical technique that assesses the probability of failure as well as the effect of such failure. A DFMEA is a living document continually updated as customer needs and expectations require. The DFMEA is an important input to the APQP process that may include previously selected product and process characteristics. The Chrysler, Ford and General Motors Potential Failure Mode and Effects Analysis (FMEA) reference manual provides guidance for the preparation of a DFMEA. The Design FMEA Checklist in
Appendix A-1 should also be reviewed to assure that the appropriate design characteristics have been considered.
DFMEA是一种训练有素的分析技术，可以评估失败的可能性以及失败的影响。 DFMEA是一份根据客户需求和期望要求不断更新的生动文档。 DFMEA是APQP过程的重要输入，可能包括先前选择的产品和过程特征。 克莱斯勒，福特和通用汽车潜在故障模式和影响分析（FMEA）参考手册为DFMEA的准备提供了指导。 还应审查
2.2 Design For Manufacturability and Assembly 可制造性和装配设计
|Design For Manufacturability and Assembly 可制造性和装配设计|
|Design for Manufacturability and Assembly is a Simultaneous Engineering process designed to optimize the relationship between design function, manufacturability, and ease of assembly. The scope of customer needs and expectations defined in Chapter 1 will determine the extent of the organization's product quality planning team involvement in this activity.
This manual does not include or refer to a formal method of preparing a Design for Manufacturability and Assembly Plan. At a minimum, the items listed here should be considered by the organization’s product quality planning team:
|• Design, concept, function, and sensitivity to manufacturing variation
• Manufacturing and/or assembly process
• Dimensional tolerances
• Performance requirements
• Number of components
• Process adjustments
• Material handling
|The above list may be augmented based on the organization’s product quality planning team's knowledge, experience, the product/process, government regulations, and service requirements.
2.3 Design Verification 设计验证
Design verification verifies that the product design meets the customer requirements derived from the activities described in Chapter 1.
2.4 Design Reviews 设计评审
|Design For Manufacturability and Assembly 可制造性和装配设计|
|Design reviews are regularly scheduled meetings led by the organization's design engineering activity and must include other affected areas. The design review is an effective method to prevent problems and misunderstandings; it also provides a mechanism to monitor progress, report to management, and obtain customer approval as required.
Design reviews are a series of verification activities that are more than an engineering inspection. At a minimum, design reviews should include evaluation of:
设计评审是由组织的设计工程活动主导的定期会议，必须包括其他受影响的区域。 设计评审是预防问题和误解的有效方法; 它还提供了一种机制来监控进度，向管理层报告，并根据需要获得客户批准。设计评审是一系列验证活动，不仅仅是工程检查。 设计评审至少应包括评估：
|• Design/Functional requirement(s) considerations
• Formal reliability and confidence goals
• Component/subsystem/system duty cycles
• Computer simulation and bench test results
• Review of the Design for Manufacturability and Assembly effort
• Design of Experiments (DOE) and assembly build variation results (Refer to Appendix B.)
• Test failures
• Design verification progress
• Design verification
• Product and process validation of components and assemblies through the application of a comprehensive test plan and report.
|The organization’s product quality planning team is not limited to the items listed. The team should consider and use as appropriate, the analytical techniques listed in Appendix B.
2.5 Prototype Build – Control Plan 原型构建-控制计划
Prototype control plans are a description of the dimensional measurements and material and functional tests that will occur during prototype build. The organization’s product quality planning team should ensure that a prototype control plan is prepared. Control plan methodology is described in Chapter 6. A Control Plan Checklist is provided in both Section 6 and Appendix A-8 to assist in the preparation of the prototype control plan.
原型控制计划是对原型构建期间将发生的尺寸测量和材料和功能测试的描述。 组织的产品质量计划团队应确保准备原型控制计划。 控制计划方法在第6章中描述。控制计划清单在第6节和附录A-8中提供，以帮助准备原型控制计划。
|Prototype Build – Control Plan 原型构建-控制计划|
|The manufacture of prototype parts provides an excellent opportunity for the team and the customer to evaluate how well the product or service meets the Voice of the Customer objectives. It is the organization’s product quality planning team's responsibility to review prototypes for the following:
|• Assure that the product or service meets specification and report data as required.
• Ensure that particular attention has been given to special product and process characteristics.
• Use data and experience to establish preliminary process parameters and packaging requirements.
• Communicate any concerns, deviations, and/or cost impact to the customer
2.6 Engineering Drawings 工程图纸
Customer designs do not preclude the organization’s product quality planning team's responsibility to review engineering drawings in the following manner. Engineering drawings may include special (governmental regulatory and safety) characteristics that must be shown on the control plan. When customer engineering drawings are nonexistent, the controlling drawings should be reviewed by the team to determine which characteristics affect fit, function, durability and/or governmental regulatory safety requirements.
客户设计不排除组织的产品质量计划团队有责任以下列方式审查工程图纸。 工程图纸可能包括必须在控制计划中显示的特殊（政府法规和安全）特征。 当客户工程图纸不存在时，团队应审查控制图纸，以确定哪些特征影响适合度，功能，耐久性和/或政府法规安全要求。
Drawings should be reviewed to determine if there is sufficient information for a dimensional layout of the individual parts. Control or datum surfaces/locators should be clearly identified so that appropriate functional gages and equipment can be designed for ongoing controls. Dimensions should be evaluated to assure feasibility and compatibility with industry manufacturing and measuring standards. If appropriate, the team should assure that math data is compatible with the customer's system for effective two-way communications.
应检查图纸以确定是否有足够的信息用于各个零件的尺寸布局。 应清楚地识别控制或基准表面/定位器，以便为正在进行的控制设计合适的功能量具和设备。 应评估尺寸以确保可行性和与工业制造和测量标准的兼容性。 如果合适，团队应确保数学数据与客户的系统兼容，以实现有效的双向通信。
2.7 Engineering Specifications 工程规范
A detailed review and understanding of the controlling specifications will help the organization’s product quality planning team to identify the functional, durability and appearance requirements of the subject component or assembly. Sample size, frequency, and acceptance criteria of these parameters are generally defined in the in-process test section of the Engineering Specification. Otherwise, the sample size and frequency are to be determined by the organization and listed in the control plan. In either case, the organization should determine which characteristics affect meeting functional, durability, and appearance requirements.
对控制规范的详细审查和理解将有助于组织的产品质量规划团队确定主题组件或组件的功能，耐用性和外观要求。 这些参数的样本大小，频率和验收标准通常在工程规范的过程中测试部分中定义。 否则，样本大小和频率将由组织确定并列在控制计划中。 在任何一种情况下，组织都应确定哪些特性会影响满足功能，耐用性和外观要求。
2.8 Material Specifications 材料规格
In addition to drawings and performance specifications, material specifications should be reviewed for special characteristics relating to physical properties, performance, environmental, handling, and storage requirements. These characteristics should also be included in the control plan.
2.9 Drawing and Specification Changes 图纸和规格变更
Where drawing and specification changes are required, the team must ensure that the changes are promptly communicated and properly documented to all affected areas.
2.10 New Equipment, Tooling and Facilities Requirements 新设备、工装和设施的要求
The DFMEA, Product Assurance Plan and/or design reviews may identify new equipment and facilities including meeting capacity requirements. The organization’s product quality planning team should address these requirements by adding the items to the Timing Chart. The team should assure that there is a process to determine that new equipment and tooling is capable and delivered on time. Facilities progress should be monitored to assure completion prior to planned production tryout. Refer to the New Equipment, Tooling and Test Equipment Checklist in Appendix A-3.
DFMEA，产品保证计划和/或设计审查可识别新设备和设施，包括满足容量要求。 组织的产品质量计划团队应通过将项目添加到时序图来满足这些要求。 团队应确保有一个流程来确定新设备和工具是否能够按时交付。 应监测设施进度，以确保在计划生产试运行之前完成。 请参阅附录A-3中的新设备，工具和测试设备清单。
2.11 Special Product and Process Characteristics 特殊的产品和工艺特点
In the Plan and Define Program stage (Chapter 1), the team identified preliminary special product and process characteristics. The organization’s product quality planning team should build on this listing and reach consensus through the evaluation of the technical information. The organization should refer to the appropriate customer-specific requirements for additional details on the use of special product and process characteristics. The consensus is to be documented on the appropriate control plan. The Control Plan Special Characteristics and Data Point Coordinates forms referenced in Chapter 6, Supplements K and L, are recommended methods to document and update special characteristics. The organization can use any form that meets the documentation requirements. Refer to customer-specific requirements for unique approval requirements
在计划和定义计划阶段（第1章），该团队确定了初步的特殊产品和工艺特征。 组织的产品质量计划团队应建立在此列表的基础上，并通过评估技术信息达成共识。 组织应参考适当的客户特定要求，以获取有关特殊产品和过程特征使用的其他详细信息。 应在适当的控制计划上记录共识。 第6章，补充K和L中引用的控制计划特殊特征和数据点坐标表格是记录和更新特殊特征的推荐方法。 组织可以使用任何符合文档要求的表单。 有关独特的批准要求，请参阅客户特定要求
2.12 Gages/Testing Equipment Requirements 检具/测试设备要求
Gages/testing equipment requirements may also be identified at this time. The organization’s product quality planning team should add these requirements to the Timing Chart. Progress should be monitored to assure that required timing is met.
此时也可以识别量具/测试设备要求。 组织的产品质量计划团队应将这些要求添加到时序图中。 应监测进展情况，以确保满足所需的时间安排。
2.13 Team Feasibility Commitment & Management Support 团队可行性承诺和管理支持
The organization’s product quality planning team must assess the feasibility of the proposed design at this time. Customer design ownership does not preclude the organization's obligation to assess design feasibility. The team must be satisfied that the proposed design can be manufactured, assembled, tested, packaged, and delivered in sufficient quantity on schedule at an acceptable cost to the customer. The Design Information Checklist in Appendix A-2 allows the team to review its efforts in this section and make an evaluation of effectiveness. This checklist will also serve as a basis for the open issues discussed in the Team Feasibility Commitment, Appendix D. The team consensus that the proposed design is feasible should be documented along with all open issues that require resolution and presented to management for their support. The Team Feasibility Commitment form shown in Appendix D is an example of the type of written record recommended.
组织的产品质量计划团队必须在此时评估拟议设计的可行性。 客户设计所有权并不排除组织评估设计可行性的义务。 团队必须确信所提议的设计可以按照客户可接受的成本按时完成制造，组装，测试，包装和交付。 附录A-2中的设计信息核对表允许团队在本节中审查其工作并对有效性进行评估。 该清单还将作为团队可行性承诺附录D中讨论的未决问题的基础。团队一致认为拟议设计的可行性应与所有需要解决的未决问题一起记录，并提交给管理层以获得支持。 附录D中显示的团队可行性承诺表是推荐的书面记录类型的示例。