APQP PHASE 3: Process Design and Development Verification 过程设计和开发验证

1 Introduction 简介

This chapter discusses the major features of developing a manufacturing system and its related control plans to achieve quality products. The tasks to be accomplished at this step of the product quality planning process depend upon the successful completion of the prior stages contained in the first two sections. This next step is designed to ensure the comprehensive development of an effective manufacturing system. The manufacturing system must assure that customer requirements, needs and expectations are met. The inputs and outputs applicable to the process step in this chapter are as follows:

组织的产品质量计划团队必须评估本章讨论开发制造系统的主要特征及其相关控制计划,以实现优质产品。 在产品质量计划过程的这一步骤中要完成的任务取决于前两个部分中包含的前几个阶段的成功完成。 下一步旨在确保有效制造系统的全面发展。 制造系统必须确保满足客户的要求,需求和期望。 适用于本章过程步骤的输入和输出如下:

INPUTS
主要输入
OUTPUTS
主要输出
• 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
• Packaging Standards & Specifications
  包装标准及规格
• Product/Process Quality System Review
  产品/过程质量体系审核
• Process Flow Chart
  工艺流程图
• Floor Plan Layout
  平面布置
• Characteristics Matrix
  特征矩阵
• Process Failure Mode and Effects Analysis (PFMEA)
  过程失效模式及影响分析(PFMEA)
Pre-Launch Control Plan
  启动前控制计
Process Instructions
  过程指令
• Measurement Systems Analysis Plan
  测量系统分析计划
• Preliminary Process Capability Study Plan
  初步工艺能力研究计划
Management Support
  管理支持

2 Content 内容

2.1 Packaging Standards & Specifications 包装标准及规格

The customer will usually have packaging requirements that should be incorporated into any packaging specifications for the product. If none are provided, the packaging design should ensure product integrity at point of use. The organization’s product quality planning team should ensure that individual product packaging (including interior partitions) is designed and developed. Customer packaging standards or generic packaging requirements should be used when appropriate. In all cases the packaging design should assure that the product performance and characteristics will remain unchanged during packing, transit, and unpacking. The packaging should have compatibility with all identified material handling equipment including robots.
客户通常会将包装要求纳入产品的任何包装规格中。 如果没有提供,包装设计应确保产品在使用时的完整性。 组织的产品质量计划团队应确保设计和开发单个产品包装(包括内部隔板)。 应酌情使用客户包装标准或通用包装要求。 在所有情况下,包装设计应确保产品性能和特性在包装,运输和拆包过程中保持不变。 包装应与所有已识别的材料处理设备(包括机器人)兼容。

2.2 Product/Process Quality System Review 产品/过程质量体系审核

The organization’s product quality planning team should review the manufacturing site(s) Quality Management System. Any additional controls and/or procedural changes required to produce the product should be updated, documented and included in the manufacturing control plan. This is an opportunity for the organization’s product quality planning team to improve the existing quality system based on customer input, team expertise, and previous experience. The Product/Process Quality Checklist provided in Appendix A-4 can be used by the organization’s product quality planning team to verify completeness.

组织的产品质量计划团队应审查制造现场的质量管理体系。 生产产品所需的任何其他控制和/或程序变更应更新,记录并包含在制造控制计划中。 这是组织产品质量计划团队根据客户意见,团队专业知识和以往经验改进现有质量体系的机会。 附录A-4中提供的产品/过程质量检查表可供组织的产品质量计划团队用于验证完整性。

2.3 Process Flow Chart 工艺流程图

The process flow chart is a schematic representation of the current or proposed process flow. It can be used to analyze sources of variations of machines, materials, methods, and manpower from the beginning to end of a manufacturing or assembly process. It is used to emphasize the impact of sources of variation on the process. The flow chart helps to analyze the total process rather than individual steps in the process. The flow chart assists the organization’s product quality planning team to focus on the process when conducting the PFMEA and designing the Control Plan. The Process Flow Chart Checklist in Appendix A-6 can be used by the organization’s product quality planning team to verify completeness.

过程流程图是当前或建议的过程流程的示意图。 它可用于分析从制造或组装过程的开始到结束的机器,材料,方法和人力的变化来源。 它用于强调变异来源对过程的影响。 流程图有助于分析整个过程,而不是过程中的各个步骤。 该流程图帮助组织的产品质量计划团队在进行PFMEA和设计控制计划时专注于流程。 组织的产品质量计划团队可以使用附录A-6中的流程图清单来验证完整性。

2.4 Floor Plan Layout 平面布置

The floor plan should be developed and reviewed to determine the acceptability of important control items, such as inspection points, control chart location, applicability of visual aids, interim repair stations, and storage areas to contain non-conforming material. All material flow should be keyed to the process flow chart and control plan. The Floor Plan Checklist in Appendix A-5 can be used by the organization’s product quality planning team to verify completeness. The floor plan layout should be developed in such a manner to optimize the material travel, handling and value-added use of floor space and should facilitate the synchronous flow of materials through the process.

应制定和审查平面图,以确定重要控制项目的可接受性,例如检查点,控制图位置,视觉辅助设备的适用性,临时维修站以及包含不合格材料的存储区域。 所有物料流应与工艺流程图和控制计划相关联。 附录A-5中的平面图清单可供组织的产品质量计划团队用于验证完整性。 平面布局应以这样的方式进行,以优化材料的行程,处理和增加地面空间的使用,并应促进材料在整个过程中的同步流动。

2.5 Characteristics Matrix 特征矩阵

A characteristics matrix is a recommended analytical technique for displaying the relationship between process parameters and manufacturing stations. See Analytical Techniques in Appendix B for further detail.

特征矩阵是推荐的分析技术,用于显示过程参数和制造站之间的关系。 有关更多详细信息,请参阅附录B中的分析技术。

2.6 Process Failure Mode and Effects Analysis (PFMEA) 过程失效模式及影响分析(PFMEA)

A PFMEA should be conducted during product quality planning and before beginning production. It is a disciplined review and analysis of a new or revised process and is conducted to anticipate, resolve, or monitor potential process problems for a new or revised product program. For further information on the creation and maintenance of PFMEAs refer to Chrysler, Ford and General Motors Potential Failure Mode and Effects Analysis (FMEA) reference manual. The Process FMEA Checklist in Appendix A-7 can be used by the organization’s product quality planning team to verify completeness.

PFMEA应在产品质量计划期间和开始生产之前进行。 它是对新的或修订过程的严格审查和分析,用于预测,解决或监控新的或修订的产品计划的潜在过程问题。 有关PFMEA的创建和维护的更多信息,请参阅克莱斯勒,福特和通用汽车潜在故障模式和影响分析(FMEA)参考手册。 组织的产品质量计划团队可以使用附录A-7中的过程FMEA核对表来验证完整性。

2.7 Pre-Launch Control Plan 启动前控制计划

Pre-Launch Control Plan 启动前控制计划
Pre-launch control plans are a description of the dimensional measurements and material and functional tests that will occur after prototype and before full production. The pre-launch control plan should include additional product/process controls to be implemented until the production process is validated. The purpose of the pre-launch control plan is to contain potential non-conformities during or prior to initial production runs. Examples of enhancements in the pre-launch control plan are:
启动前控制计划是对原型之后和完全生产之前发生的尺寸测量和材料及功能测试的描述。 启动前控制计划应包括要在生产过程验证之前实施的其他产品/过程控制。 预发布控制计划的目的是在初始生产运行期间或之前包含潜在的不合格。 发布前控制计划中的增强功能示例如下:
• More frequent inspection
  更频繁的检查
• More in-process and final check points
  更多的过程中和最终检查点
• Robust statistical evaluations
  强大的统计评估
• Enhanced audits
  增强审计
• Identification of error-proofing devices
  识别防错设备

For further information on the creation and maintenance of control plans refer to Chapter 6. The Control Plan Checklist in Appendix A-8 can be used by the organization’s product quality planning team to verify completeness.

有关控制计划的创建和维护的更多信息,请参阅第6章。组织的产品质量计划团队可以使用附录A-8中的控制计划核对表来验证完整性。

2.8 Process Instructions 过程指令

Process Instructions 过程指令
The organization’s product quality planning team should ensure that process instructions provide sufficient understanding and detail for all personnel who have direct responsibility for the operation of the processes. These instructions should be developed from the following sources:
组织的产品质量计划团队应确保流程说明为所有直接负责流程操作的人员提供充分的理解和详细信息。 这些说明应从以下来源开发:
• FMEAs
  失效模式与影响分析
• Control plan(s)
  控制计划
• Engineering drawings, performance specifications, material specifications, visual standards and industry standards
  工程图纸,性能规格,材料规格,视觉标准和行业标准
• Process flow chart
  工艺流程图
• Floor plan layout
  平面规划布局
• Characteristics matrix
  特征矩阵
• Packaging Standards and Specifications
  包装标准和规格
• Process parameters
  工艺参数
• Organization expertise and knowledge of the processes and products
  组织产品和工艺的专业技术和知识
• Handling requirements
  搬运需求
• Operators of the process
  操作流程

The process instructions for standard operating procedures should be posted and should include set-up parameters such as: machine speeds, feeds, cycle times, and tooling, and should be accessible to the operators and supervisors. Additional information for process instruction preparation may be found in appropriate customer-specific requirements.

应公布标准操作程序的过程说明,并应包括设置参数,例如:机器速度,进给,循环时间和工具,操作员和主管应该可以访问。 有关过程指令准备的其他信息可以在适当的客户特定要求中找到。

2.9 Measurement Systems Analysis Plan 测量系统分析计划

The organization’s product quality planning team should ensure that a plan to accomplish the required measurement systems analysis is developed, including checking aids. This plan should include, at a minimum, a laboratory scope appropriate for the required measurements and tests, the responsibility to ensure gage linearity, accuracy, repeatability, reproducibility, and correlation for duplicate gages. Refer to the Chrysler, Ford, and General Motors Measurement Systems Analysis (MSA) reference manual.

组织的产品质量计划团队应确保制定完成所需测量系统分析的计划,包括检查辅助工具。 该计划至少应包括适合所需测量和测试的实验室范围,确保重复量具的量具线性,准确性,可重复性,再现性和相关性。 请参阅克莱斯勒,福特和通用汽车测量系统分析(MSA)参考手册。

2.10 Preliminary Process Capability Study Plan 初步工艺能力研究计划

The organization’s product quality planning team should ensure the development of a preliminary process capability plan. The characteristics identified in the control plan will serve as the basis for the preliminary process capability study plan. Reference the Chrysler, Ford, and General Motors Production Part Approval Process (PPAP) manual and Chrysler, Ford, and General Motors Statistical Process Control (SPC) reference manual for further definition.

组织的产品质量计划团队应确保制定初步过程能力计划。 控制计划中确定的特征将作为初步过程能力研究计划的基础。 参考克莱斯勒,福特和通用汽车生产件批准程序(PPAP)手册以及克莱斯勒,福特和通用汽车统计过程控制(SPC)参考手册,以获得进一步的定义。

2.11 Management Support 管理支持

The organization’s product quality planning team should schedule a formal review designed to reinforce management commitment at the conclusion of the process design and development phase. This review is critical to keeping upper management informed as well as gaining assistance to assist in resolution of any open issues. Management support includes the confirmation of the planning and providing the resources and staffing to meet the required capacity.

组织的产品质量计划团队应安排正式审核,旨在加强流程设计和开发阶段结束时的管理承诺。 该审查对于保持高层管理人员的了解以及获得帮助以协助解决任何未解决的问题至关重要。 管理支持包括确认计划,提供资源和人员配置,以满足所需的能力。