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QS9000系列培训
培 训 安 排
25日 上午 APQP
25日 下午 APQP, Control PLan
26日 上午 PPAP，FMEA
26日 下午 FMEA
时 间
09:00~10:30
10:30~10:50 Tea Break
10:50~12:00
12:00~13:00 Lunch
13:00~14:00
14:00~14:10 Tea Break
14:10~15:30
15:30~15:45 Break
15:45~17:00
培 训 要 求
互相交流
共同进步
积极参与
畅所欲言
产品质量先期策划
ADVANCED PRODUCT QUALITY PLANNING
DTI
德尔福-清华研究所
Introduction, 导 言
产品开发
成本
时间
质量
Proprietary Information,专有信息
Some of the information in the APQP may be considered proprietary and should not be shared with anyone outside the division without first consulting your management.
this includes the sharing of information with your customer
APQP中的某些信息属专有信息，在未事先征得主管许可的情况下，不得向部门以外的人透露。
包括不得向顾客透露这类信息
Customer-Specific Requirements
顾客的特殊要求
Your customer might have specific requirements. Be aware of what they are prior to starting. In addition, the customer might have specific formats or forms you must use. If so, you will need to get their written approval to use an alternate format.
顾客可能有特殊要求，开始APQP之前应首先了解这些特殊要求。此外，顾客可能有特定的表单或格式。在此情况下，只有经过顾客的书面批准方可使用其他格式。
Contents,内容
Introduction, 导言
Organizational Activities, 组织活动
Timing Chart, 五阶段具体要求
Overview, 概要
Tools, 工具
Linking of Tools/Documents, 工具/文件之间的关系
Introduction, 导 言
什么是质量？
Introduction, 导 言
What is Quality?
什么是质量？
quality means that the product or service meets the needs and wants of the customer
质量系指产品或服务能满足顾客的需求
quality means minimizing waste by reducing variation
质量系指通过减少变差，最大限度地减少浪费
Introduction, 导 言
质量策划 与 质量改进
Advanced Product Quality Planning (APQP) defines and establishes the steps necessary to assure quality
产品质量先期策划(APQP)确定了为保证质量所需采取的方法步骤
assures that the product meets customer needs
确保产品满足顾客需求
minimizes waste
最大限度地减少浪费
assures that the project is completed on time
确保项目按时完成
Introduction, 导 言
APQP encourages Simultaneous Engineering via development processes(., use of cross-functional teams)
APQP鼓励开发过程中采用 同步技术 (即运用跨部门小组)
and concentration on Defect Prevention
并且强调 预防缺陷
Introduction, 导 言
How does APQP accomplish this?
APQP如何实现这一目标？
it directs company resources to satisfy the customer
引导公司资源集中用来满足顾客要求
promotes early identification of problems
有助于及早发现问题
anticipates changes to avoid late changes
预先作出更改，以免晚期更改
produces the highest quality at the lowest cost
以最低的成本，生产最优质的产品
APQP provides a logical sequence of steps to follow
APQP提供了一套可供遵循的前后连贯的工作步骤
Introduction, 导 言
Summary of APQP, APQP概要
Organize the cross-functional team and define the scope
组织跨部门小组，确定工作范围
Develop a timing chart (project plan)
编制时间表(项目计划)
Identify the tools and responsibilities needed to carry out the activities in each phase, 确定完成每一阶段任务所需采用的工具和应履行的责任
Revise/adapt as necessary, 必要时进行修改
Implement and assess the plan
执行和评价该计划
Introduction, 导 言
APQP is accomplished through the execution of YOUR own Product Development Procedure.
通过实施贵公司的产品开发程序来实现APQP。
Introduction, 导 言
Responsibilities, 责任
perform all applicable parts of APQP
执行APQP所有适用的部分
the following chart shows what is expected
下图表明了需要进行的工作
Introduction, 导 言
Define the scope, 确定范围 X X X
Plan and define, 计划和确定项目 X
Product design/dev, 产品设计/开发 X
Feasibility, 可行性 X X X
Process design/dev, 过程设计/开发 X X X
Product/process val., 产品/过程验证 X X X
Feedback/Corr Action, 反馈/修正措施 X X X
Control Plans, 控制计划 X X X
Introduction, 导 言
Mfg. Only
制造
Design Resp.
设计责任
Services
服务
Organizational Activities
组织活动
Necessary for Any APQP Program
对任何实施APQP的项目
都是不可或缺的
Who Initiates APQP?
谁发起APQP活动？
you do!
发起人就是你
you are responsible for the planning and implementation of the activities
你负责策划和开展APQP活动
Organizational Activities
组织活动
Organize a Cross-Functional Team
组建跨部门小组
May include but is not limited to:
可能包括，但不局限于：
- engineering，工程 - manufacturing，制造
- quality，质量 - purchasing，采购
- sales，销售 - customers，顾客
- field service，现场服务 - subcontractors，分包商
- material control，材料控制
Organizational Activities
组织活动
Assess the training needs of team members and take action!
评估小组成员的培训需求，并采取相应措施。
Organizational Activities
组织活动
CROSS FUNCTIONAL TEAM
Responsibility
Approval
Support
Inform
Consult
Organizational Activities
组织活动
Define the Scope (you must...)
确定范围(必须要...)
have a project team leader
任命一名项目小组组长
have defined roles and responsibilities of team members
确定小组成员的作用和责任
identify and understand the customers and their expectations
确认和了解顾客及其期望
assess feasibility of program
评估项目可行性
Organizational Activities
组织活动
Define the Scope (continued)
确定范围(续)
identify the costs, timing, and constraints
确定成本、时间安排和限制条件
determine what assistance might be required from the customer
确定需要从顾客那里得到哪些帮助
identify documentation process
确定文件编制过程
Organizational Activities
组织活动
Establish Lines of Communication
建立沟通渠道
with other teams in the company
与公司内部其它小组之间
with customer teams
与顾客小组之间
might include regular meetings
可包括定期会议
Organizational Activities
组织活动
Timing Chart
时间表
Each Program Will Have a Unique Timing Chart
每个项目都应有单独的时间表
Timing Chart, 时间表
After the organizational activities, begin to develop a timing chart
组织工作完成后，应制订时间表
activities，活动
events，事项
responsibilities，责任
timing, including sequences of activities
时间安排，包括活动顺序
Timing Chart, 时间表
The 5-Phase model to be described in this training can be used as a starting point
培训中介绍的5阶段模型可作为一个起点
some of the useful tools will be described in this training
培训中将介绍一些实用工具
the list of tools is not meant to be all-inclusive
工具清单并非详细无遗
Timing Chart, 时间表
APQP
5-phase model
APQP
5阶段模型
* Your customer might use different terminology.
顾客可能使用其它术语
Planning
Product Design & Development
Process Design & Development
Production
Feedback Assessment and Corrective Action
Prototype
Pilot
Launch
Program
Approval
Concept
Initiation
Product & Process
Validation
Timing Chart, 时间表
Note the phases of the timing chart:
注意时间表上的各个阶段
1. Plan and define the program, 计划和确定项目
2. Design and develop the product, 产品设计和开发
3. Design and develop the process, 过程设计和开发
4. Validate the product and process, 产品和过程确认
5. Feedback and Corrective Action, 反馈和纠正措施
Each phase contains several activities and suggested helpful tools
每个阶段都包括若干活动内容和推荐的实用工具。
Phase 1，第一阶段
Plan and
Define Program
计划
和确定项目
Timing Chart， 时间表
Planning
策划
Product Design & Development
产品设计和开发
Process Design & Development
过程设计和开发
Product & Process Validation
产品和过程的确认
Production
生产
Feedback Assessment and Corrective Action
反馈评估和改进措施
Prototype
制作样件
Pilot
试生产
Launch
投入生产
Program
Approval
批准项目
Concept
Initiation
提出概念
顾客需求
设计目标
设计文件
工艺文件
作业指导书
开发：保证转换的充分性和完备性
超越顾客期望
性能达到设计目标
产品特性符合规范
达到工艺文件要求
严格遵循作业指导书
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
Purpose
目的
determine market and customer needs and translate them into an initial product and process design; capture lessons learned
确定市场和顾客需求，并体现在初步产品和过程设计中；汲取以往的经验和教训。
develop a plan for assuring that design goals and reliability goals, as defined and required by the customer, are built into the design
制订计划，确保设计能够实现顾客确定的和要求达到的设计目标与可靠性目标
gain management commitment
取得管理层的支持
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
List of Inputs (may vary according to product, process, or customer needs):
输入清单(不同产品、过程或顾客需要，可所有不同)：
Voice of the Customer 顾客之声
Customer needs: contact your Sales Dept., Product Engineering, Application Engineering, etc., whichever are applicable 顾客需求：与销售部、产品设计部、应用工程部等了解顾客需求的部门取得联系
Marketing needs: consult your Marketing group
市场需求：请市场开发小组提供咨询意见
Business Plan/Marketing Strategy: consult your business unit, operational director, customer management (might be confidential)
业务计划/市场开发战略：请业务部门、经营主管、顾客管理部门提供咨询意见(可能需保密)
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
List of Inputs (may vary according to product, process, or customer needs):
输入清单(不同产品、过程或顾客需要，可所有不同)：
Benchmarking Data (internal and external): . competitive analysis, cost information, reliability, process equipment benchmarks
基准评测(内部和外部)：如竞争力分析、成本信息、可靠性、生产设备基准评测等
Product/Process Assumptions: consult design and manufacturing standards
产品/过程设想：查阅设计和制造标准
List of Inputs (may vary according to product, process, or customer needs):
输入清单(不同产品、过程或顾客需要，可所有不同)：
Lessons learned: systems are being developed to share lessons learned with divisional personnel
经验教训：建立一套系统，使大家能够共享经验教训
Product Reliability Studies: as defined and required by the customer
产品可靠性研究：根据顾客意见和要求进行
Customer Inputs: other information they can provide
顾客输入：他们可提供的其它信息
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
List of Outputs (may vary according to product, process, or customer needs):
输出清单(不同的产品，过程或顾客需求可有所不同)
Design Goals: measurable characteristics and attributes with target values where applicable
设计目标：可测量的产品特性和属性，可能的情况下提出量化指标
Reliability Goals: performance over the life of the product under normal conditions
可靠性目标：产品在正常使用条件下寿命周期内的性能
Quality Goals: measured as Ppk, Cpk, first time quality, ppm, DPTV, scrap reduction
质量目标：可用Ppk、Cpk、初次检验质量、ppm、DPTV和废品降低率等指标确定
List of Outputs (may vary according to product, process, or customer needs):
输出清单(不同的产品，过程或顾客需求可有所不同)
Preliminary Bill of Materials
初步材料清单
Preliminary Process Flowchart
初步过程流程图
Preliminary KPCs, KCCs: must be documented on the control plan, and, maybe also on the process flow diagram (depending on the customer)
初步KPC、KCC清单：必须列入控制计划，有些顾客要求列入过程流程图
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
List of Outputs (may vary according to product, process, or customer needs):
输出清单(不同的产品，过程或顾客需求可有所不同)
Product Assurance Plan
产品保证计划
Management Support: demonstrate that planning requirements are met, and concerns are scheduled for resolution
管理支持：表明策划要求已经达到，而且问题的解决已有计划
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
a plan to assure that the design goals are met
确保设计目标得以实现
might include 可以包括：
Reliability, durability apportionment
可靠性、耐用性指标分解
Function/quality deployment
功能/质量展开
Risk and roadblock assessment
风险和困难评估
Failure modes analysis and action plan
失效模式分析和措施实施计划
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
Product Assurance Plan，产品保证计划
工具
Quality Function Deployment，质量功能展开
Customer
desires
客户要求
Quality Characteristics
质量特性
Quality Char.
质量特性
Subsystem Characteristics
子系统特性
Component Characteristics
零部件特性
Subsystem
Char.
子系统特性
Flow
从上层流向下层
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
Importance
重要性
投诉
用户
竞争力
评价
技术的重要性
目标值
技术竞争力
评价
Customer Needs
用户需求
Product Characteristics
产品特性
Relationships
关系
Requirements Matrix，要求矩阵
strong relationship
强关系
weak relationship
弱关系
Good, solid feel
好，感觉稳定
Easy to reach
容易接近
Easy to see
容易看到
Know when I actuate it
知道何时启动
Actuation
force
启动力
Amt of
travel
行程量
Amt of
reach
接近量
Size
大小
Brightness
亮度
Requirements matrix for an automotive switch，汽车开关要求矩阵
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
Requirements Matrix，要求矩阵
Good, solid feel
好，感觉稳定
Easy to reach
容易接近
Easy to see
容易看到
12 6 9 9 3
Phase 1, Plan and Define Program
第一阶段, 计划和确定项目
strong relationship
强关系 ＝9
weak relationship
弱关系 ＝3
Good, solid feel
好，感觉稳定
Easy to reach
容易接近
Easy to see
容易看到
Know when I actuate it
知道何时启动
Actuation
force
启动力
Amt of
travel
行程量
Amt of
reach
接近量
Size
大小
Brightness
亮度
Requirements matrix for an automotive switch，汽车开关要求矩阵
51 21 36 9 3
Requirements Matrix，要求矩阵
Good, solid feel
好，感觉稳定
Easy to reach
容易接近
Easy to see
容易看到
strong relationship 强关系 ＝9
weak relationship
弱关系 ＝3
Good, solid feel
好，感觉稳定
Easy to reach
容易接近
Easy to see
容易看到
Know when I actuate it
知道何时启动
Actuation
force
启动力
Amt of
travel
行程量
Amt of
reach
接近量
Size
大小
Brightness
亮度
Requirements matrix for an automotive switch，汽车开关要求矩阵
5
4
1
2
顾客需求
设计目标
设计文件
工艺文件
作业指导书
开发：保证转换的充分性和完备性
超越顾客期望
性能达到设计目标
产品特性符合规范
达到工艺文件要求
严格遵循作业指导书
Customer requirements/顾客需求
通常称为“什么(Whats)”的目标的列表，用以反映顾客对某一特殊产品的需要和期望。
第一层顾客需求列表通常是含糊和概括性的。
支持第一层列表的第二层顾客需求列表通常比较详细，但不能直接支持工程人员的行动。
第三层顾客需求列表可以直接支持工程人员的行动。
技术特性设计
确定影响一个或多个顾客需求的技术特性。
每一个技术特性必须影响一个顾客的要求并且用可测量的项目表达。
是顾客呼声的技术表达。
在产品总体设计阶段，考虑技术特性时应注意：
不要使用诸如：方法、成本、价格、可靠性、顾客需要、零件、试验和过程步骤等词语；
不要列出零件、过程，因在该阶段主要考虑产品的设计问题。
质量屋（House of Quality）
③ 设计或技术属性
① 顾客需求
④ 顾客需求与设计或技术属性间的关系
⑤ 属性间的相关关系
② 重要度
⑩ 重要度权重数
⑨ 目标值
⑦ 技术评审
⑥ 顾客评审
竞争能力评审
⑧ 顾客要求优先度
基本原理
基本原理
Phase 2，第二阶段
Timing Chart， 时间表
Planning
策划
Product Design & Development
产品设计和开发
Process Design & Development
过程设计和开发
Product & Process Validation
产品和过程的确认
Production
生产
Feedback Assessment and Corrective Action
反馈评估和改进措施
Prototype
制作样件
Pilot
试生产
Launch
投入生产
Program
Approval
批准项目
Concept
Initiation
提出概念
Product
Design and
Development
产品设计和开发
Purpose
目的
develop the design into near final form
使设计接近定型
verify the design to make sure it meets all requirements
对设计进行验证，以保证达到全部要求
assess production and quality assurance needs
对生产和质量保证需求进行评估
Phase 2, Product Design & Development
第二阶段,产品设计和开发
List of Outputs by Design Group (may vary according to product, process, or customer needs)
由设计部门完成的结果(具体内容可根据产品类型、过程和顾客需求确定)
Design Failure Mode and Effects Analysis
设计失效模式及后果分析
Design for Manufacturability
设计的制造工艺性
Design Verification and Prototype Build
设计验证和样件制造
Phase 2, Product Design & Development
第二阶段,产品设计和开发
List of Outputs by Design Group (may vary according to product, process, or customer needs)
由设计部门完成的结果(具体内容可根据产品类型、过程和顾客需求确定)
Design Verification and Prototype Build
设计验证和样件制造
Design Reviews
设计审查
Engineering Drawings and Changes
工程图纸及其更改
Engineering and Material Specifications
技术要求和材料规格
Phase 2, Product Design & Development
第二阶段,产品设计和开发
List of Outputs by Quality Planning Team
由质量策划小组完成的结果
New Equipment, Tooling, Facilities Reqmts
对新设备、新工具、新设施的要求
KPCs, KCCs
KPC、KCC清单
Prototype Build Control Plan
样件制造控制计划
Gages/Testing Equipment Reqmts
对检测仪表/试验设备的要求
Feasibility Review/Commitment
可行性审查/承诺
Phase 2, Product Design & Development
第二阶段,产品设计和开发
工 具
Design FMEA
设计FMEA
listing of failure modes inherent to the product design
列出产品设计中固有的失效模式
list of the effects and causes of failure
列出失效的后果和产生原因
corrective action prioritized by
按如下各项排序改进措施
severity of effect， 后果的严重程度
likelihood of occurrence， 发生的可能性
ability to detect failure， 探测失效的能力
Phase 2, Product Design & Development
第二阶段,产品设计和开发
工 具
Design Verification
设计验证
verification means checking a design to make sure it meets all the requirements
设计验证是指对设计进行检查，以确保其符合所有要求
differs from validation
与确认的区别：
validation uses production parts in a realistic environment (QS9000 requires validation in the actual environment)
确认是指将生产部件在实际环境中使用(QS9000要求在实际环境中进行确认)
verification is often just a paper/computer check
验证通常仅指案头/计算机检查
Phase 2, Product Design & Development
第二阶段,产品设计和开发
工 具
Design Reviews
设计评审
a review of the design by a cross-functional team to check (among others)
由跨部门小组对下列内容进行评审
design requirements，设计要求
failure modes，失效模式
predicted reliability，可靠性预测
design standards used and DFM efforts
采用的设计标准和DFM措施
test plans and test results，试验计划和结果
verification studies，验证研究
Phase 2, Product Design & Development
第二阶段,产品设计和开发
工 具
KPCs (key product characteristics)，KPC(关键产品特性)
a product characteristic for which reasonably anticipated variation is likely to affect customer satisfaction, safety, or compliance with regulations 是一种产品特性，当其在合理范围内出现变差时，会引起顾客不满，影响安全性或违反某些法规
can be identified by the customer or the cross-functional team 可由顾客或跨部门小组确定
KCCs (key control characteristics)，KCC(主要控制特性)
a process characteristic that must be controlled in order to reduce the variation in a KPC 为减少KPC的变差，必须加以控制的过程特性
Phase 2, Product Design & Development
第二阶段,产品设计和开发
工 具
Prototype Control Plan，样件控制计划
includes dimensional measurements and functional tests on prototype builds
包括尺寸测量和样件功能试验
to verify the prototype product
对样件产品进行验证
to verify the process if production-intent tooling is used
如果使用将来生产用的工装，则对过程进行验证
a good way to find and fix real problems prior to production tooling being made
是一种在生产工具制造之前及时发现和解决实际问题的好办法
Phase 2, Product Design & Development
第二阶段,产品设计和开发
工 具
Feasibility Review/Commitment--make sure Manufacturing is part of this review
可行性评审/承诺 -- 确保产品制造也在评审之列
can quality be met?
能达到质量要求吗？
is there sufficient capacity?
有足够的过程能力吗？
can it be done on schedule?
能按预定计划完成吗？
are costs within reason?
成本是否适中？
Phase 2, Product Design & Development
第二阶段,产品设计和开发
Feasibility must be assessed even if the customer owns the design
即使是顾客提供的设计，也必须对可行性进行评估
质量特性展开
Contact
force
amt of
insertion
spring rate
radius
material
thickness
alloys
inherent
stresses
base metal
thickness
of blade
deflection
F = k x
Phase 2, Product Design & Development
第二阶段,产品设计和开发
Phase 3，第三阶段
Timing Chart， 时间表
Planning
策划
Product Design & Development
产品设计和开发
Process Design & Development
过程设计和开发
Product & Process Validation
产品和过程的确认
Production
生产
Feedback Assessment and Corrective Action
反馈评估和改进措施
Prototype
制作样件
Pilot
试生产
Launch
投入生产
Program
Approval
批准项目
Concept
Initiation
提出概念
Process
Design and
Development
过程设计和开发
Purpose
目的
develop an effective manufacturing system and related control plans
建立有效的加工制造系统，并制订有关的控制计划
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
List of Outputs (may vary according to product, process, or customer needs)
输出列表(根据产品类型、过程和顾客需求而定)
Packaging Standards, 包装标准
Process Flowchart, 过程流程图
Floor Plan Layout, 场地平面布置图
Characteristics Matrix, 特性矩阵
Process Failure Mode and Effects Analysis
过程失效模式及后果分析
Pre-Launch Control Plan, 试生产控制计划
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
List of Outputs (may vary according to product, process, or customer needs)
输出列表(根据产品类型、过程和顾客需求而定)
Process Instructions，作业指导书
Measurement Systems Analysis Plan，测量系统分析计划
Preliminary Process Capability Plan，初始过程能力研究计划
Packaging Specifications，包装规范
Product/Process Quality System Review，产品/过程质量体系评审
Management Support， 管理支持
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
Process Flowchart，过程流程图
lists all steps in making the product
列出产品制造的所有步骤
from receiving to shipping
从来料验收到成品装运
includes different types of activities
包括不同的作业类型
fabricate/assemble，制造/装配
move，搬运
store，存放
inspect，检验
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
Process Flowchart
过程流程图
利用随意贴便条纸绘制流程图
mold part
inspect
set up
fill hopper
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
过程流程图
建议的最终格式
mold part
注塑零部件
fab
加工
move
搬运
store
存放
insp
检验
step
步骤
oper. descr.
作业说明
item#
编号
KPC
item#
编号
KCC
inspect part
for flash
检验零件有无飞边
store part in
container
将零部件放入周转箱内
carry parts
to assy area
将零部件送往装配区
1
no flash
无飞边
pressure
压力
1
1
2
3
4
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
过程流程图
建议的最终格式
mold part
注塑零部件
fab
加工
move
搬运
store
存放
insp
检验
step
步骤
oper. descr.
作业说明
item#
编号
KPC
item#
编号
KCC
inspect part
for flash
检验零件有无飞边
store part in
container
将零部件放入周转箱内
carry parts
to assy area
将零部件送往装配区
1
no flash
无飞边
pressure
压力
1
1
2
3
4
工 具
Characteristics Matrix (Recommended but not required)
特性矩阵(推荐但不要求)
allows us to prioritize which characteristics are important to control
使我们能够优先控制那些重要的特性
Process Steps
加工步骤
Characteristics
特性
look for relationships
寻找相互关系
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
Characteristics Matrix
特性矩阵
No. Process Step Part Char. Process Char.
color durom. tensile stickiness
mix materials
mixing time
21
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
工 具
No. Process Step Part Char. Process Char.
color durom. tensile stickiness
mix materials
mixing time12
21
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
Characteristics Matrix
特性矩阵
工 具
No. Process Step Part Char. Process Char.
color durom. tensile stickiness
mix materials
mixing time 12
21
Temperature 18
Presure 9
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
Characteristics Matrix
特性矩阵
工 具
Process FMEA，过程FMEA
listing of failure modes caused by the process not meeting requirements
列出因过程不符合要求所产生的失效模式
list of the effects and causes of failure
列出失效的后果和产生原因
corrective action prioritized by
按下列各项改进措施的优先顺序
severity of effect，后果的严重程度
likelihood of occurrence，发生的可能性
ability to detect failure，检测失效的能力
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
Pre-Launch Control Plan
试生产控制计划
includes dimensional measurements, attributes, and functional tests on early production parts
包括对早期生产的部件进行尺寸检验、特性和功能
试验
to check the process prior to full production
在正式生产之前检查过程
also includes additional controls to be in place until the process is validated
也包括在过程确认之前所采取的附加控制措施
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
Measurement Systems Analysis Plan
测量系统分析计划
to assure that gages and measurement procedures are capable of detecting changes in process output
确保测量系统具有探测过程输出变化的能力
can also be used to check inspection gages and procedures for sorting conforming vs. nonconforming product
用于判别产品合格，不合格的测量系统也可进行MSA
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
Preliminary Process Capability Study Plan
初始过程能力研究计划
an assessment of the the ability of the process to meet specifications
评估过程能否达到技术要求
measures the process variation
检测过程变差
based on a significant production run on production equipment
以在正式生产装备上进行的有效的生产为基础
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
Packaging Specifications
包装规范
individual packaging must assure that the product characteristics, attributes, etc. do not change during packing, transit, and unpacking
每个包装均必须保证产品特性、属性等在包装、运
输和开包过程中不会改变
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
工 具
Product/Process Quality Systems Review
产品/过程质量体系评审
a review of the procedures and other components of the quality system to make sure the customer does not receive nonconforming parts
对质量体系的过程控制和其它要素进行检查、以免向客
户提供不符合要求的产品
based on similar processes, team experience, and customer input
建立在类似的过程、小组经验和顾客输入的基础上
Phase 3, Process Design & Development
第三阶段, 过程设计和开发
Phase 4，第四阶段
Timing Chart， 时间表
Planning
策划
Product Design & Development
产品设计和开发
Process Design & Development
过程设计和开发
Product & Process Validation
产品和过程的确认
Production
生产
Feedback Assessment and Corrective Action
反馈评估和改进措施
Prototype
制作样件
Pilot
试生产
Launch
投入生产
Program
Approval
批准项目
Concept
Initiation
提出概念
Product
and
Process
Validation
产品和过程确认
Purpose
目的
production trial run
生产试运行
validate the manufacturing process
对制造过程进行确认
develop a control plan for production
制订生产控制计划
Phase 4, Product & Process Validation
第四阶段, 产品和过程确认
List of Outputs
输出清单
Production Trial Run (Internal Pilot Run)，生产试运行(内部试生产)
Measurement Systems Evaluation，测量系统评价
Preliminary Process Capability Study，初始过程能力研究
Production Validation Testing，生产确认试验
Packaging Evaluation， 包装评价
Production Control Plan，生产控制计划
Production Part Approval，生产件批准
Phase 4, Product & Process Validation
第四阶段, 产品和过程确认
工 具
Production Trial Run，生产试运行
must complete total manufacturing system release
整个制造系统都必须全部开通
performed under production conditions, incl. cycle time, environment, operators
在生产条件下运行，包括周期时间、环境和操作人员等
make parts for preliminary process capability and production validation test
制造的零部件用于初始过程能力研究和生产确认试验
assure containment is in place if parts are to be shipped
如果零部件要装运，应确保有相应的限控手段
Phase 4, Product & Process Validation
第四阶段, 产品和过程确认
工 具
Production Validation Test
生产确认试验
refers to engineering tests that validate the products made from production tools and processes meet engineering standards
系指确认由生产工具和过程制造的产品是否符合设计标准的工程试验
Phase 4, Product & Process Validation
第四阶段, 产品和过程确认
工 具
Production Control Plan
生产控制计划
systems for controlling parts and processes
控制零部件和过程的系统
includes receiving inspection, manufacturing processes, assembly, packaging, etc. as applicable
包括原材料验收、制造过程、装配和包装等项内容
used for the production run
用于生产运行
DOES NOT replace written process instructions or procedures
不能取代书面的制造过程指令或程序
Phase 4, Product & Process Validation
第四阶段, 产品和过程确认
工 具
Production Part Approval (PPAP)
生产件批准(PPAP)
warrant，保证书
drawings, checking aids，零部件图纸、检验辅具
sample parts, master sample，样件、标准样件
list of KPCs, KCCs，KPC、KCC清单
dimensional and appearance evaluation
尺寸和外观评价
material tests，材料试验
FMEAs，失效模式及后果分析
control plan, gages, process flowchart
控制计划、检测仪表、过程图
process capability results，过程能力研究结果
Phase 4, Product & Process Validation
第四阶段, 产品和过程确认
Phase 5，第五阶段
Timing Chart， 时间表
Planning
策划
Product Design & Development
产品设计和开发
Process Design & Development
过程设计和开发
Product & Process Validation
产品和过程的确认
Production
生产
Feedback Assessment and Corrective Action
反馈评估和改进措施
Prototype
制作样件
Pilot
试生产
Launch
投入生产
Program
Approval
批准项目
Concept
Initiation
提出概念
Feedback,
Assessment,
Corrective Action
反馈，
评定，
纠正措施
Purpose
目的
monitor the process and customer feedback
监测过程，听取顾客反馈意见
improve the process
改进过程
install methods to work with the customer to correct and solve problems
与顾客合作，共同建立纠正和解决问题的方法
Phase 5, Feedback, Assess., Corrective Action
第五阶段, 反馈，评定，纠正措施
Outputs
输出
Reduced Variation
减少变差
Customer Satisfaction
顾客满意
Delivery and Service
交付和服务
Phase 5, Feedback, Assess., Corrective Action
第五阶段, 反馈，评定，纠正措施
工 具
Reduce Variation
减少偏差
SPC
SPC(统计过程控制)
Statistical Engineering/Problem Solving
统计工程/问题的解决
Robust Design
稳健性设计
Error proofing
差错预防
Design of Experiments
实验设计
Phase 5, Feedback, Assess., Corrective Action
第五阶段, 反馈，评定，纠正措施
工 具
Customer Satisfaction
顾客满意
the product or service must work in the customer’s environment
产品或服务必须适合顾客的实际使用环境
supplier must work with the customer to correct problems and correct deficiencies
供货商必须与顾客合作，共同解决所出现的问题，并弥补产品缺陷
Phase 5, Feedback, Assess., Corrective Action
第五阶段, 反馈，评定，纠正措施
工 具
Delivery and Service (if part of contract)
发货和服务(如果合同中有规定的话)
the supplier and customer must develop a system for servicing and delivering replacement parts
供货商和顾客必须建立一个提供服务和发运更换件的系统
this is a good opportunity to record and act on comments and complaints from the ultimate customer
是记录最终顾客的意见和投诉，并据此采取行动的极好机会
Phase 5, Feedback, Assess., Corrective Action
第五阶段, 反馈，评定，纠正措施
Linking of Tools/Documents
工具/文件联接
Many Tools Are Dependent on Input From Other Tools; Be Sure That Appropriate Documents Are Linked to Each Other
许多工具依赖其它工具的输入；
应确保有关文件相关联
APQP
Customer Needs
Design Char.
Design FMEA
Process Char.
Characteristics Matrix
Process Flowcharts
Internal Needs & Constraints
Process FMEA
Control Plan
Process Capability
Meas. Sys. Analysis
SPC
Process Instructions
DFM
顾客需求
设计目标
设计文件
工艺文件
作业指导书
开发：保证转换的充分性和完备性
超越顾客期望
性能达到设计目标
产品特性符合规范
达到工艺文件要求
严格遵循作业指导书
Checklists
检查表
Checklists Help to Assure That APQP Documents Are Filled Out Completely and Correctly, and Are Linked
检查表可有助于我们确保APQP文件填写完整、正确，并相互关联
Checklist Questions，检查表问题
Design FMEA，设计FMEA
Action and Responsibility must be assigned as appropriate.
必须合理确定措施和责任
1 Was the SFMEA and/or DFMEA prepared using the Chrysler, Ford, and GM Potential Failure Mode and Effects Analysis (FMEA) reference manual? SFMEA和/或DFMEA是根据Chrysler(克莱斯勒)，Ford(福特)和通用汽车公司的潜在失效模式及后果分析(FMEA)参考手册准备的吗？
2 Have historical campaign and warranty data been reviewed?
是否已经查阅过历史资料和保证数据？
3 Have similar part DFMEAs been considered?
是否已经考虑过类似零部件的设计FMEA？
4 Does the SFMEA and/or DFMEA identify Special Characteristics?
SFMEA和/或DFMEA是否确定了具体特性？
5 Have design characteristics that affect high risk priority failure modes been identified?
是否确定了那些影响高危优先失效模式的设计特性？
6 Have appropriate corrective actions been assigned to high risk priority numbers?
对于高危产品是否已采取适当的改进措施？
7 Have appropriate corrective actions been assigned to high severity numbers?
对于缺陷十分严重的产品，是否已采取适当的改进措施？
8 Have risk priorities been revised when corrective actions have been completed and verified?
在采取了改进措施并得到验证后，危险优先顺序排列是否已经修改？
Checklist Questions，检查表问题
Design FMEA，设计FMEA
Checklist Questions，检查表问题
Process Flowchart，过程图
Action and Responsibility must be assigned as appropriate.
必须合理确定有关行动和责任
1 Does the flowchart illustrate the sequence of production and inspection stations?
过程图能说明生产流程和检验位置吗？
2 Were all the appropriate FMEAs (SFMEA, DFMEA) available and used as aids to develop the process flowchart?
是否所有FMEA(SFMEA、DFMEA)均已齐备，并能用来帮助绘制过程图？
3 Is the flowchart keyed to product and process checks in the control plan?
过程图是否能够协助按控制计划对产品和过程进行检查？
4 Does the flowchart describe how the product will move, . roller conveyor, slide containers, etc.?
过程图是否能够说明产品是怎样运送的，如滚道还是滑动集装箱？
5 Has the pull system/optimization been considered for this process?
在确定过程的过程中是否考虑了拉动系统/最优化吗？
6 Have provisions been made to identify and inspect reworked products before being used?
是否已采取措施，在使用前对返工件进行确认和检查？
7 Have potential quality problems due to handling and outside processing been identified and corrected?
是否已确认由于搬运和外部加工所造成的潜在质量问题，并采取了改进措施？
Checklist Questions，检查表问题
Process Flowchart，过程图
Checklist Questions，检查表问题
Process FMEA ，过程FMEA
Action and Responsibility must be assigned as appropriate.
必须合理确定有关行动和责任
1 Was the process FMEA prepared using the Chrysler, Ford, and GM guidelines?
过程FMEA是根据克莱斯勒、福特和通用汽车公司的参考手册准备的吗？
2 Have all operations affecting fit, function, durability, governmental regulations, and safety been identified and listed sequentially? 所有影响装配、使用功能、耐久性、政府法规和安全的作业是否都已确认，并按顺序列出了清单？
3 Were similar part FMEAs considered?
类似零部件的FMEA是否已考虑过？
4 Have historical campaign and warranty data been reviewed?
是否已查阅过历史资料和保证数据？
5 Have appropriate corrective actions been planned or taken for high risk priority numbers?
对于那些危险性最大的零部件，是否已制订纠正计划或采取了纠正行动？
6 Have appropriate corrective actions been planned or taken for high severity numbers?
对于那些缺陷较严重的零部件，是否已制订纠正计划或采取了纠正行动？
7 Were risk priorities numbers revised when corrective action was completed?
采取改进措施后，危险排序是否已经修改？
8 Were high severity numbers revised when a design change was completed?
设计变更后，严重程度排序是否已经调整？
Checklist Questions，检查表问题
Process FMEA ，过程FMEA
9 Do the effects consider the customer in terms of the subsequent operation, assembly, and product?
这些后果会影响顾客今后的使用、组装和产品生产吗？
10 Was warrantly information used as an aid in developing the Process FMEA?
在确定过程FMEA时，是否利用保证信息作为一种辅助手段？
11 Were customer plant problems used as an aid in developing the Process FMEA?
顾客生产出现的问题是否能用来确定过程FMEA？
12 Have the causes been described in terms of something that can be fixed or controlled?
是否已经说明了原因，表明它们是可以解决或加以控制的？
13 Where detection is the major factor, have provisions been made to control the cause prior to the next operation?
如果检验是主要因素，是否已规定在下次进行作业前控制产生缺陷的原因
Checklist Questions，检查表问题
Process FMEA ，过程FMEA
Checklist Questions, 检查表问题
Control Plan, 控制计划
Action and Responsibility must be assigned as appropriate.
必须合理确定有关行动和责任
1 Was the control plan methodology referenced in Section 6 used in preparing the control plan?
在制订控制计划时，是否采用了第6节中提供的控制计划方法？
2 Have all the known customer concerns been identified to facilitate the selection of special product/process characteristics?
在确定特定产品/加工特性时，是否充分考虑了所有顾客意见？
3 Are all special product/process characteristics included in the control plan?
特定产品/加工特性是否全部反映在控制计划中？
4 Were SFMEA, DFMEA, PFMEA used to prepare the control plan?
在制订控制计划时，是否采用了SFMEA、DFMEA、PFMEA方法？
5 Are material specifications requiring inspection identified?
需要检验的材料规范是否已经确定？
6 Does the control plan address incoming material/components through Processing/assembly including packaging?
控制计划是否包括从来料和零配件采购到加工制造、组装和包装等全部工序？
7 Are engineering performance testing requirements identified?
设计性能试验要求是否已经确定？
8 Are gages and test equipment available as required by the control plan?
控制计划中要求提供的检测仪表和试验设备是否齐备？
9 If required, has the customer approved the control plan?
必要时，顾客是否会批准控制计划？
10 Are gage methods compantible between customer and supplier?
顾客和供货商是否能就检测方法达成一致意见？
Checklist Questions, 检查表问题
Control Plan, 控制计划
1
5
2
3
4
5
5
5
6
7
8
9
10
11
13
14
15
16
17
18
19
20
21
22
23
24
25
5
26
27
28
29
31
34
44
35
35
35
5
32
33
34
35
36
38
39
40
41
42
32
43
44
45
46
47
40
40
48
42
42
42
49
50
51
52
53
54
55
56
57
58
59
60
61
62
63
64
65
66
67
68
30
5
70
71
72
73
74
