APQP PHASE 4: Product and Process Validation and Production Feedback 产品和工艺验证及生产反馈

1 Introduction 简介

This artical discusses the major features of validating the manufacturing process through an evaluation of a significant production run. During a significant production run, the organization’s product quality planning team should validate that the control plan and process flow chart are being followed and the products meet customer requirements. Additional concerns should be identified for investigation and resolution prior to regular production runs. The inputs and outputs applicable to the process steps in this chapter are as follows:

本篇讨论通过评估重要生产运行来验证制造工艺的主要特征。 在重要的生产运行期间,组织的产品质量计划团队应验证是否遵循控制计划和流程图,并且产品符合客户要求。 在定期生产运行之前,应确定其他问题以进行调查和解决。 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
• 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
• Significant Production Run
  重大生产运行
• Measurement Systems Evaluation
  测量系统评估
• Preliminary Process Capability Study
  初始工艺能力研究
• Production Part Approval
  生产件批准
• Production Validation Testing
  生产验证测试
• Packaging Evaluation
  包装评估
• Production Control Plan
  生产控制计划
• Quality Planning Sign-Off and Management Support
  质量计划签署和管理支持

2 Content 内容

2.1 Significant Production Run 重大生产运行

INPUTS
主要输入
OUTPUTS
主要输出
The significant production run must be conducted using production tooling, production equipment, production environment (including production operators), facility, production gages and production rate. The validation of the effectiveness of the manufacturing process begins with the significant production run (refer to the Chrysler, Ford, and General Motors Production Part Approval Process (PPAP) manual or the appropriate customer-specific requirements for additional details). The minimum quantity for a significant production run is usually set by the customer, but can be exceeded by the organization’s product quality planning team. Output of the significant production run (product) is used for:
重要的生产运行必须使用生产工具、生产设备、生产环境(包括生产操作员)、设施、生产量具和生产率。生产过程有效性的验证从重要的生产运行开始(有关附加细节,请参阅克莱斯勒、福特和通用汽车生产部件批准过程(PPAP)手册或适当的客户特定要求)。重要生产运行的最小数量通常由客户设置,但是可以由组织的产品质量规划团队超过。重要生产运行(产品)的产量用于:
• Preliminary process capability study
  初步工艺能力研究
• Measurement systems analysis
  测量系统分析
• Production rate demonstration
  生产率示范
• Process review
  工艺评审
• Production validation testing
  生产验证测试
• Production part approval
  生产件批准
• Packaging evaluation
  包装评估
• First time capability (FTC)
  试生产能力
• Quality planning sign-off
  质量计划签署
• Sample production parts
  样品生产零件
• Master sample (as required)
  主样本(根据需要)

2.2 Measurement Systems Evaluation 测量系统评估

The specified monitoring and measuring devices and methods should be used to check the control plan identified characteristics to engineering specification and be subjected to measurement system evaluation during or prior to the significant production run. Refer to the Chrysler, Ford, and General Motors Measurement Systems Analysis (MSA) reference manual.

应使用指定的监测和测量装置和方法检查控制计划确定的特性与工程规范,并在重大生产运行期间或之前进行测量系统评估。 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。

2.3 Preliminary Process Capability Study 初始工艺能力研究

characteristics identified in the control plan. The study provides an assessment of the readiness of the process for production. Refer to 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 details concerning the preliminary process capability study. Refer to customer-specific requirements for unique requirements.

控制计划中确定的特征。 该研究评估了生产过程的准备情况。 有关初步过程能力研究的详细信息,请参阅克莱斯勒,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。 有关独特要求,请参阅客户特定要求。

2.4 Production Part Approval 生产件批准

PPAP's purpose is to provide the evidence that all customer engineering design record and specification requirements are properly understood by the organization and that the manufacturing process has the potential to produce product consistently meeting these requirements during an actual production run at the quoted production rate. Refer to the Chrysler, Ford, and General Motors Production Part Approval Process (PPAP) manual.

PPAP的目的是提供依据,证明组织正确理解所有客户工程设计记录和规格要求,并且制造过程有可能在实际生产运行期间以报价生产率生产始终满足这些要求的产品。 请参阅克莱斯勒,福特和通用汽车生产件批准程序(PPAP)手册。

2.5 Production Validation Testing 生产验证测试

Production validation testing refers to engineering tests that validate that products made from production tools and processes meet customer engineering standards including appearance requirements.

生产验证测试是指工程测试,用于验证由生产工具和流程制成的产品是否符合客户工程标准(包括外观要求)。

2.6 Packaging Evaluation 包装评估

All test shipments (when required) and test methods must assess the protection of the product from normal transportation damage and adverse environmental factors. Customer-specified packaging does not preclude the organization’s product quality planning team involvement in evaluating the effectiveness of the packaging.

所有测试货物(如果需要)和测试方法必须评估产品对正常运输损坏和不利环境因素的保护。 客户指定的包装并不妨碍组织的产品质量计划团队参与评估包装的有效性。

2.7 Production Control Plan 生产控制计划

The production production control plan is a written description of the systems for controlling production parts and processes. The production control plan is a living document and should be updated to reflect the addition or deletion of controls based on experience gained by producing parts. (Approval of the authorized customer representative may be required.) The production control plan is a logical extension of the pre-launch control plan. Mass production provides the organization the opportunity to evaluate output, review the control plan and make appropriate changes. Chapter 6 and Appendix A-8 present Control Plan Methodology and a checklist to verify completeness.

生产生产控制计划是用于控制生产零件和过程的系统的书面描述。 生产控制计划是一份活文件,应根据生产零件所获得的经验进行更新,以反映控制的添加或删除。 (可能需要批准授权客户代表。)生产控制计划是发布前控制计划的合理扩展。 批量生产使组织有机会评估输出,审查控制计划并进行适当的更改。 第6章和附录A-8介绍了控制计划方法和检查完整性的清单。

2.8 Quality Planning Sign-Off and Management Support 质量计划签署和管理支持

The organization’s product quality planning team should perform a review at the manufacturing location(s) and coordinate a formal sign-off. The product quality sign-off indicates to management that the appropriate APQP activities have been completed. The sign-off occurs prior to first product shipment and includes a review of the following:

组织的产品质量计划团队应在制造地点进行审查并协调正式签署。 产品质量签核向管理层表明已完成适当的APQP活动。 签收发生在首次发货之前,包括对以下内容的审核:

• Process Flow Charts. Verify that process flow charts exist and are being followed.
  流程图。 验证是否存在并且正在遵循流程图表。
• Control Plans. Verify that control plans exist, are available and are followed at all times for all affected operations.
  控制计划。 验证控制计划是否存在,是否可用并且始终遵循所有受影响的操作。
• Process Instructions. Verify that these documents contain all the special characteristics specified in the control plan and that all PFMEA recommendations have been addressed. Compare the process instructions, PFMEA and process flow chart to the control plan.
  流程说明。 确认这些文档包含控制计划中指定的所有特殊特征,并且已解决所有PFMEA建议。 将过程说明,PFMEA和过程流程图与控制计划进行比较。
• Monitoring and Measuring Devices. Where special gages, fixtures, test equipment or devices are required per the control plan, verify gage repeatability and reproducibility (GR&R) and proper usage. (Refer to the Chrysler, Ford, and General Motors Measurement Systems Analysis (MSA) reference manual for more information.)
  监控和测量设备。 如果控制计划需要特殊的量具,夹具,测试设备或设备,请验证量具的可重复性和再现性(GR&R)以及正确使用。 (有关详细信息,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。)
• Demonstration of Required Capacity. Using production processes, equipment, and personnel.
  所需能力的证明。 使用生产流程,设备和人员。
Upon completion of the sign-off, a review with management should be scheduled to inform management of the program status and gain their support with any open issues. The Product Quality Planning Summary and Approval report shown in Appendix E is an example of the documentation required to support an effective quality planning sign-off.
签字完成后,应安排与管理层进行审查,以便向管理层通报计划状态,并在任何未解决的问题上获得支持。 附录E中显示的产品质量计划摘要和批准报告是支持有效质量计划签核所需文档的示例。