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.

本篇讨论规划过程的各个要素,在此过程中,设计特征和特征被发展为近似最终形式。即使设计归客户所有或共享,组织也应在产品先期质量策划流程中考虑所有设计因素。这些步骤包括原型构建,以验证产品或服务是否符合客户之声的目标。可行的设计必须允许满足生产产量和时间计划,并与满足工程要求的能力,质量,可靠性,投资成本,重量,单位成本和时间目标保持一致。虽然可行性研究和控制计划主要基于工程图纸和规范要求,但可以从本章描述的分析工具中获得有价值的信息,以进一步定义可能需要特殊产品和过程控制的特征并确定其优先级。

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:

在本篇中,产品质量计划流程旨在确保对工程要求和其他相关技术信息进行全面和严格的审查。在此过程的这个阶段,将进行初步可行性分析,以评估制造过程中可能出现的潜在问题。适用于本章的输入和输出如下:

INPUTS
主要输入
OUTPUTS
主要输出
APQP OUTPUTS
APQP输出
•• Design Goals
  设计目标
• Reliability & Quality goals
  可靠性和质量目标
• Preliminary Bill of Materials
  初始材料清单
• Preliminary Process Flow Chart
  初始工艺流程图
• Preliminary Listing of Special Product and Process Characteristics
  特殊产品和过程特性清单
• Product Assurance Plan
  产品保证计划
• Management Support
  管理者支持
• Design Failure Mode and Effects Analysis (DFMEA)
  设计失效模式和影响分析(DFMEA)
• Design For Manufacturability and Assembly
  可制造性和装配设计
• Design Verification
  设计验证
• Design Reviews
  设计评审
• Prototype Build – Control Plan
  原型构建 - 控制计划
• Engineering Drawings
  工程图纸
• Engineering Specifications
  工程规范
• Material Specifications
  材料规格
• Drawing and Specification Changes
  图纸和规格变更
• New Equipment, Tooling and Facilities Requirements
  新设备、工装和设施的要求
• Special Product and Process Characteristics
  特殊的产品和工艺特点
• Gages/Testing Equipment Requirements
  检具/测试设备要求
• Team Feasibility Commitment & Management Support
  团队可行性承诺和管理支持

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。 还应审查附录A-1中的设计FMEA检查表,以确保考虑了适当的设计特性。

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:

可制造性和装配设计是一个同步工程流程,旨在优化设计功能,可制造性和易装配之间的关系。 第1篇中定义的客户需求和期望范围将决定组织的产品质量计划团队参与此活动的程度。本手册不包括或参考准备可制造性和装配计划设计的正式方法。该组织的产品质量计划团队至少应考虑此处列出的项目:
• Design, concept, function, and sensitivity to manufacturing variation
  设计,概念,功能和对制造变化的敏感性
• Manufacturing and/or assembly process
  制造和/或组装工艺
• Dimensional tolerances
  尺寸公差
• Performance requirements
  性能要求
• Number of components
  组件数量
• Process adjustments
  流程调整
• Material handling
  物料搬运
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.
以上列表可以根据组织的产品质量计划团队的知识,经验,产品/流程,政府法规和服务要求进行扩充。

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.

设计验证可验证产品设计是否满足第1章中描述的活动所产生的客户要求。

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
  设计/功能要求考虑因素
• Formal reliability and confidence goals
  正式的可靠性和信心目标
• Component/subsystem/system duty cycles
  组件/子系统/系统占空比
• Computer simulation and bench test results
  计算机模拟和台架测试结果
• DFMEA(s)
  设计失效模式及后果分析
• Review of the Design for Manufacturability and Assembly effort
  审查可制造性和装配工作的设计
• Design of Experiments (DOE) and assembly build variation results (Refer to Appendix B.)
  实验设计(DOE)和装配体构建变异结果(参见附录B)
• Test failures
  测试失败
• Design verification progress
  设计验证进度
• Design verification
  设计验证
• Product and process validation of components and assemblies through the application of a comprehensive test plan and report.
  通过应用全面的测试计划和报告,对组件和组件进行产品和过程验证
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.
组织的产品质量计划团队不仅限于列出的项目。 该小组应酌情考虑并使用附录B中列出的分析技术。

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:
原型零件的制造为团队和客户提供了一个绝佳的机会,可以评估产品或服务满足客户之声目标的程度。 组织的产品质量计划团队负责审查以下内容的原型:
• Assure that the product or service meets specification and report data as required.
  确保产品或服务符合规范并根据需要报告数据
• Ensure that particular attention has been given to special product and process characteristics.
  确保特别注意特殊产品和工艺特性
• Use data and experience to establish preliminary process parameters and packaging requirements.
  使用数据和经验建立初步的工艺参数和包装要求
• Communicate any concerns, deviations, and/or cost impact to the customer
  向客户传达任何顾虑,偏差和/或成本影响

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.

除了图纸和性能规格外,还应审查材料规格,以了解与物理性能,性能,环境,处理和储存要求相关的特殊特性。 这些特征也应包含在控制计划中。

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.

如果需要更改图纸和规格,团队必须确保及时传达变更并将其正确记录到所有受影响的区域。

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。