PCPA (过程审核） 总评： 日期：
GAC FIAT Automobiles Co., Ltd
零件号： 项目： 供应商名称：
零件名称：
供应商质量
工程师：
供应商代码： 供应商工厂：
广汽菲亚特采购部 PROCESS VERIFICATION (VP) PRE-SERIES (PS) RELEASE TO PROD. (DaP) CURRENT PRODUCTION
供应商质量 物料需求数： 物料需求数： 物料需求数： 物料需求数：
供应数： 供应数： 供应数： 供应数：
1文件 2模具/ 设备 3过程 4人力资源与组织架构 5产品验证/ 一日生产 6质量运行 7质量运行 8物流 9持续改进
A
图纸和技术文件
模具状态（质量，产能
与时间进度）
二级供应商的批准
操作工是否经过适当
的培训？
自我验证状态 来料控制 记录控制 可追溯性 经验教训
F-C F-S F F F-S F F F F
B
流程图
设备工装状态（质量，
产能与时间进度）
二级零件批准 管理层参与 综合测试状态 生产批准
与“报告特性”相关的记录控
制
标识 二级供应商的改进活动
F F-S F F-S-C F F F
C
潜在失效模式及后果
分析
工装设备和模具的保存
条件
是否每个工位都易于得到清
晰的最新发布的作业指导书
？
用于控制的资源是否
充足？
匹配试验和Benestare（
工厂批准）状态
过程控制与试验 检验实验设备管理 先进先出 问题解决
F-S F F F-S-C F F F
D
过程控制计划
日常与预防性的维护（
机器/模具/设备）
过程能力（短期、长期、设
备能力指数）
如果是多班次生产，
班次之间有交接班信
息传递吗？
一日生产 出货质量 返工 恰当的搬运与包装 定期再验证
F-S F F-S F F-S F F F
E
项目管理 工装防错 生产开始/重启 健康与安全 加严的前期投产控制计
划
供应商质量工程师的评审 不合格品的管理 适当的工艺流程 体系认证
F F F-S F F
na - Not Applicable
不适用
nv - Not Valuated
未被评估
1 - JOB STOPPER
已造成工作停滞
2 - JOB STOPPER
Risk
有导致工作停滞的风险
3 - 2nd Level
Issue
有问题但不会导致工
作停滞
4 - Planned Activity
according to
Project
项目按计划进行
5 - Implemented
Activity
活动已执行
审核目的：
新项目节点
批量生产
ATTACHED DOCUMENT (附件）
F=Doc. of Supplier（供应商文件）
C=Doc. of Customer （
客
户
文件
）
S= Doc. of SQE（供应商质量工程师文件）
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项 项 项 项 SQE
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na/nv项
目
请说
明具体原因
总评：
Result: %
日期：
Date: 20140826
Fiat Powertrain Technologies
供应商质量工程
师(SQE)：
供应商：
Supplier:
供应商工厂：
Supplier Plant:
产品：
Products:
C553
注意：对供应商缺少必要的关键加工设备和关键工序，以及在采购定点前未实施完成
对评分为1分和2分（红色）的项整改，无论其PSA分数多少，均判定PSA为红色，
不合格。
The PSA rating will be always red(negative) when the suppliers lack of necessary
key equipments and processes or didn't close the red score items before sourcing
date.
[20%,60)% [60%,80%) [80%,100%]供应商质量
Supplier Quality
1文件
Documentation
2模具/设备
Tooling / Equipment
3过程
Process
4人力资源与
组织架构
Human Resources &
Organization
5产品验证/ 一日生产
Product Qualification / One
Day Production
6质量运行
Implementation of Quality
7质量运行
Implementation of Quality
8物流
Logistic
9持续改进
Continuous Improvement
A
图纸和技术规范
Drawings and
Specifications
模具状态
（质量、产能与进度）
Die Status (Quality,
Capacity and Timing)
二级供应商的批准
Tier 2 Approval
操作工是否经过
适当的培训？
Have Operators Been
Properly Trained?
自我验证状态
Self-Qualification Status
来料控制
Incoming Material Controls
记录控制
Controls Recording
可追溯性
Traceability
经验教训
Lessons Learned
2 na na 5 na 5 5 5 5
B
流程图
Flow Chart
设备状态（质量，产能
与时间进度）
Equipment Status
(Quality, Capacity and
Timing)
二级零件批准
Tier 2 Components Approval
管理层参与
Management
Involvement
综合测试状态
Integrative Tests Status
生产批准
Production Approval
与“报告特性”相关
的记录控制
Controls Recording
Regarding Report
Characteristics
标识
Identification
二级供应商的
管理和改进活动
Improvement Activities for
Tier 2 Suppliers
5 na na 5 na na 5 5 na
C
过程潜在失效模式
及后果分析
PFMEA
工装设备和模具
的保存条件
Preservation conditions of
dies， machines and
equipments
是否每个工位都易于得到
清晰的作业指导书？
Are clear operator
instructions available and
updated for each operation?
用于控制的资源
是否充足？
Are the Resources
Dedicated to Controls
Sufficient?
匹配试验和Benestare（工
厂批准）状态
Matchability and Benestare
Status
过程控制与试验
Process Controls and Tests
检验实验设备管理
Control Instruments
Management
先进先出
FIFO
售后保修
Warranty
5 na na na na na na 5 na
D
过程控制计划
Process Control Plan
日常与预防性的维护（
机器/模具/设备）
Ordinary and Preventive
Maintenance
(Machines/Dies/Equipmen
ts)
过程能力（短期、
长期、设备能力指数）
Process Capability
(Ppk, Cpk & Cmk)
如果是多班次生产有,
交接班信息传递吗？
If more than one shift,
does information get
passed across shifts?
一日生产
1DP
出货质量
Outgoing Quality
返工
Re-works
恰当的搬运与包装
Appropriate Handling and
Packaging
定期再验证
Periodic Re-Qualification
5 na na 5 na na na 5 na
E
国际材料数据系统
IMDS
特殊维护是否有效？
Is the Special Maintenance
Effective?
生产重启
Restart of Production
环境，健康与安全（E
HS)
Environment, Health
and Safety (EHS)
加严的前期投产控制计划
Strengthened Pre-Launch
Control Plan
供应商质量工程师的评审
SQE Audit
不合格品的管理
Non-Conforming Products
Management
适当的工艺流程
Appropriate Process Flow
质量与环境质量体系认证
Quality and Environmental
Certifications
5 na na 5 na na 5 5 5
评分
SQE 签名确认 组长签名确认 科长/副科长签名确认
日期 日期 日期
版本Version：00 保存期限Storage life：3年 生效时间Valid time：20121001 表格编号 TABLE NO.： GF_PRO_PU_001_01(1/3)
广汽菲亚特汽车有限公司
GAC-FIAT AUTOMOBILES CO.,LTD
潜在供应商评审
Potential Supplier Assessment(PSA)
Y GR
NA(Not Applicable) 不适用
NV(Not Valuated )未被评估
1 已造成工作停滞
JOB STOPPER
2 有导致工作停滞的风险
JOB STOPPER Risk
3 有问题但不会导致工作停滞
2nd LevelIssue
5 活动已执行
ImplementedActivity
4 项目按计划进行
Planned Activity according to
Project
NA/NV项目请说明具体原因
NA/NV item need detail
description
SAFETY RELATED
重点问题及整改计划
版本Version：00 保存期限Storage life：3年 生效时间Valid time：20121001 表格编号 TABLE NO.： GF_PRO_PU_001_02(2/3)
问题(Question) 评分(Ranking) 确认到的事实(Observation) 整改计划 (Corrective Action) 责任人(Responsible)
日期(Date)
状态
Status
1
2
本报告共？页(? pages) ——1/？——
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项 项 SQE
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评审细则 Guidelines & Observations
审核员备注 （供应商质量管理工程师）
AUDITOR REMARKS (SQE)
供应商介绍/股权结构Supplier
Profile/Ownership Structure：
主要产品Major products:
主要客户OEM Customers:
质量体系Certified Quality
System:
最近质量业绩Quality PPM:
优点Strengths:
不足Weekness:
No. 评分 评审细则 确认到的事实
1A
图纸和技术规范
Drawings and
specifications
是否取得了针对产品开发的必要的技术文件，例如2D/3D数据，标准,建立了图纸的变更清单
Supplier must achieve the necessary technical documents like 2D/3D data, specfications and establish a list
about the change of the drawings.
图纸必须有反映客户某种形式的批准，即：设计工程师签名、批准的设计变更通知等。
The drawings must reflect some form of customer approval; . Design Engineer’s signature, approved
design change order, etc.
供应商必须能证明“客户批准”的图纸与发运的零件相符。
Supplier must be able to show that the “customer approved” drawing agrees with the part being shipped.
应有被检查零件、产品或总成件的技术文件（图纸、技术要求、标准和规范）且应是最新的版本，无论其为
内部生产件还是外部采购件。
The technical documentation (Drawings, Technical Specs., Standards and Norms) for the part, product or
component under examination shall be updated and available, whether the part is produced internally or
purchased from external sources.
供应商必须能证明其对文件的正确管理。审核员应核实供应商有一个列出所有生产使用图纸的清单，以确保
图纸是最新的，避免保留和错用废旧图纸。
The correct management of documents shall be shown. The auditor shall verify the existence of a list with
all the drawings used, in order to ensure they are updated to avoid the retention and use of obsolete
drawings.
图纸中必须标注公差。
Tolerances must be shown on the drawing.
是否系统地收集了必要的客户标准,包括引用标准和嵌套标准
The supplier must acquire all the necessary standards including the quotative standards and nested
standards.
几何尺寸和公差(GD&T)必须与基准关联。
Geometric Dimensioning and Tolerancing (GD&T) must relate back to data.
必须标识出关键产品特性(KPC)，即对零件变差、整车装配、外形或功能有潜在影响的特性。（注：并不是
所有零件都必须有KPC。KPC 的识别和批准由顾客的产品工程师负责）。
Key Product Characteristics (KPC's) must be identified for characteristics that are critical to variation in the
part and potentially impact fit, form or function on the car (Note: it is not necessary that all parts have KPC's;
the customer’s product engineering group is responsible for the identification and approval of KPC's).
如果客户提供的技术文件没有标明重要特性（安全、法律法规、关键等），至少供应商应选定影响精密公差
、配合、功能、表面处理、可靠性、耐久性的特性，或受过程参数影响的特性，和/或影响后续/最终工艺过程
的特性，进行质量控制。
If the technical documentation supplied by the customer does not indicate the existence of significant
characteristics (safety, homologation, key, etc.) at a minimum the supplier should select characteristics that
affect close tolerances, fit, function, finish, reliability, durability or characteristics affected by process
parameters and/or characteristics that affect the successive/final process.
1B
流程图
Flow Chart
是否有经过批准的过程流程图，并且流程图进行了动态更新
The Process Flow Diagram must be approved and updated.
过程流程图必须覆盖从进料区域直至发运道口的整个过程、明确贴标识和产品存储区域。
The Process Flow Diagram must begin at the material receiving area and continue through the entire
process to the shipping dock, identifying Labelling and Product storage areas.
流程图上要有返工或返修操作，以及物料重返工艺过程的流程。在有返工返修后的物料重返正常流程的关键
点，必须使用生产用试验设备对其重新检验并确认其合格通过
Any rework or repair operations must be shown on the Diagram and indicate the flow of material back into
the process. A critical point involves the flow of repaired or reworked material back to the normal process
where production test equipments must re-check and pass the parts.
无论在线检测还是离线检测，流程中必须明确测量和检查区域。如果零件检测会导致产品报废，应在流程图
上标明。
Gauging and Inspection areas must be shown in the process, whether they are on the production line or off-
line. If any of the part inspections or checks result in scrapping the parts, this should be identified on the
chart.
1C
过程潜在失效模
式及后果分析
PFMEA
是否有PFMEA且可接受？RPN是否可接受？是否和DFMEA有继承性？编号与过程流程图是否匹配？是否包
括KPC/PQC/KCC？是否有证据证明它被持续更新？
Is there a PFMEA available and is it acceptable? Are RPNs acceptable, is it consistent with DFMEA,
numbers match Process flow and includes KPC's/PQC's/KCC's? Any evidence that it is a living document?
应将对产品/过程的纠正措施更新到FMEA和控制计划中去
Corrective actions to product/process shall be used to update FMEA's and Control Plans.
供应商必须能描述在PFMEA开发过程中如何考虑影响零件性能的关键设计特性。
The supplier must be able to describe how critical design characteristics that impact part performance were
considered in the PFMEA development.
鉴于许多产品失效可能源于制造过程的问题，供应商在开发PFMEA时必须参考DFMEA。（如：PFMEA的严
重度与DFMEA的严重度有关）
Since many product failures can be the result of problems in the manufacturing process, the supplier must
use the DFMEA as a reference document when developing the PFMEA (. PFMEA severity related to
DFMEA severity).
应进行制造、操作和控制方法的初步分析（利用客户工厂的装配FMEA，DOE，后续过程信息，产品使用信
息等）。至少供应商应分析影响精密公差、配合、功能、表面处理、可靠性和耐久性的特性，和/或受过程参
数影响的特性，和/或影响后续/最终过程的特性
A preliminary analysis on the manufacturing, activities and controls means has to be conducted (using
assembling FMEA c/o customer’s plant, DOE, knowledge of successive processes, knowledge of how the
product is used, etc.). At a minimum the supplier should analyze characteristics that affect close tolerances,
fit, function, finish, reliability, durability, and/or are affected by process parameters and/or characteristics
that affect the successive/final process.
过程/产品FMEA易得并可供客户查阅。
Process/Product FMEA shall be available for review by the customer.
需验证由跨职能小组编制PFMEA，与工艺流程图上的各要素相符，其中严重度、频度、探测度的评分符合现
用质量绩效数据。
Verify that the Process FMEA was generated by a cross-functional team and follows the elements of the
Process Flowchart, with rankings for severity, occurrence and detection appearing consistent with available
quality performance data.
降低RPN的行动应是可见的，并持续进行。
Activities on RPN reduction should be visible and following an ongoing process.
对于产品族的PFEMA，应有定期评审的文件，以证明PFMEA对潜在改进所做的评估。
For Family PFMEA you need to have a periodic reviewed document that shows evidence of PFMEA
evaluation for potential improvement.
应计划/实施旨在恢复初始/最佳条件的活动，并能证明行之有效。
Actions aimed to restore initial/optimal conditions shall be planned/implemented and there shall be evident
the effectiveness of these actions.
1D
过程控制计划
Process
Control Plan
是否有过程控制计划（PCP），并且反映了最新状态
Is there a up to date Process Control Plan (PCP) available.
是否可接受（编号和控制与PFMEA和流程图是否一致，包括KPC/PQC/KCC、恰当的频次和样本容量、最新
的EWO/ODM）？
Is i t acceptable (numbers and contro ls match PFMEA and Process F low Char t , inc ludes
KPC's/PQC's/KCC's, recalls suitable frequencies and sampling sizes, includes latest EWO/ODM)?
PCP必须包括进料、贯穿整个流程直到贴标识、发运。
PCP must include incoming, throughout the process to labelling and shipping.
在投产时期，应有前期生产PCP（加严计划）。
During the launch period there shall be an Early Production PCP (strengthened Plan).
应有一个组织机构通过发展相关文件，以确保控制方法/条件的更新
There shall be an organized structure to guarantee the updating of the control methods/conditions with the
evolution of the referring documents.
在整个文件系统中应该用相应的符号标出重要特性。
Any significant characteristic shall be designated by appropriate symbols throughout the whole
documentation.
每个控制计划或操作指导书应标明产品特性等级。当有要求时，它应与技术规范和/或产品预防性分析（FME
A,DOE等）一致。
The classification of product characteristics shall be indicated on each Control Plan or Operating Instruction.
This shall be compliant with the technical specifications and/or preventive analysis performed on the
product when requested (FMEA, DOE, etc.).
安全/报告特性的过程控制计划和/或法律法规特性的管理应满足7B中所写的要求
The management on PCP of Safety/Report Characteristics and/or Homologation Characteristics shall
comply with it is written in point 7B.
所有外购件也应有符合更新的图纸、安全特性和重要特性等级的控制计划和/或检验指导书。
Control plans and/or Inspection Instructions, compliant with updated drawings, safety and significant
characteristic classifications, shall be available for all purchased parts.
用于实施检测的文件（频次、图纸、指导书等）应按要求置于每个操作工位上。
Documentation used to conduct inspections (cycles, drawings, instructions, etc.) shall be available at each
workstation as required.
对PCP内容进行评审。
Review the content of the PCP.
应确保过程控制计划的内容或书面说明的完备性（特性、控制频次、样本容量、测量、设备记录、反应计划
等）
The adequacy of the contents of PCP or written instructions (characteristic, control frequency, sample size,
measure, equipment recording, reaction rules, etc.) shall be ensured.
对于产品族的PFEMA，应有定期评审的文件，以证明进行了为潜在改进而做的过程控制计划PCP的评估
For Family PFMEA you need to have a periodic reviewed document that shows evidence of PCP review for
potential improvement.
确保利用过程FMEA编制PCP，着重注意KCC/KPC。
Ensure that the Process FMEA was utilized in compilation of the PCP with emphasis placed on KCC's /
KPC's.
寻找能证明控制计划是定期评审的动态文件的证据。
Seek evidence that control plan is a “living” document subject to regular review.
随时间变化而有显著变化的过程/机器参数（如：温度、时间、速度、压力等）必须进行自动或手动系统监测
，且符合规定的公差。
Process/machine parameters subject to significant alterations over time (. temperatures, times, speed,
pressures, etc.) must be systematically monitored, automatically or manually, with respect to set tolerances.
检查对最高PRN控制的证据。
Check the evidence of controls related to highest RPN's.
应定义控制频率、样本容量、检验标准。有必要考虑在初期分析（如：FMEA）中所定义的特性对产品功能
的影响，以及产生特性的过程的稳定性
The control frequencies, size and methodological criteria shall be defined. It is necessary to take into
account the effect of the characteristic on the functionality of the product as defined by preliminary analysis
(. FMEA) and the stability of the process generating the characteristic.
1E –
国际材料数据系
统（对危险或禁
用物质的使用限
制管理） IMDS
(Management
of use limitation
for dangerous
or forbidden
substances)
供应商应有使用限制的参考规定以及在规定中提及标准的最新版本。Supplier shall have the reference set of
rules where are written the use limitationas well as of the updated norms recalled in those set of rules.
供应商必须将使用限制发给它的供应商。
Supplier must have sent the use limitation to its Suppliers.
供应商必须要求其供应商参与申请，并保存收到文件的副本。
Supplier must have asked its Suppliers for the involved applications and must retain copy of the
documentation received.
按广汽菲亚特的要求，供应商应有文件副本。
Supplier shall have copy of the documentation requested by GAC-Fiat Auto.
供应商应在预期时间内回复广汽菲亚特的要求，并保存递送文件的副本。Supplier shall have answered the
requests of GAC-Fiat Auto in the expected time and shall retain copy of the sent documentation.
如果因某一物质被（从规定中）去除而需要调整特定材料/部件，供应商应采取所有措施以确保承担义务，和
零件更改前和更改后的追溯性管理。If specific materials/components need adjustment due to a substance
elimination, Supplier shall carry out all the measures in order to guarantee the compliance with obligations
and shall manage the traceability of components before and after modification.
供应商应通过传送更新的相关零件号的MDS迅速与广汽菲亚特就过程的调整进行沟通。Supplier shall quickly
communicate to GAC-Fiat Auto the adjustment in progress through the sending of updated MDS (Material
Data Sheet) regarding the involved Part Numbers.
供应商在IMDS（国际原材料资料系统）中是否输入供给广汽菲亚特零件号的所有信息？Does Supplier
insetred all data related to GAC-Fiat PN's of its own supplying into IMDS (International Material Data
System)?
供应商应有整套IMDS参考规定。
Supplier shall have the reference set of rules specific for IMDS.
供应商必须在 注册。
Supplier must be registered to site .
供应商应知道广汽菲亚特设有帮助台和服务人员为供应商填写MDS提供帮助。
Supplier shall be aware of the presence of an Help Desk and a reference person in GAC-Fiat Auto as an
help for the filling in of MDS's.，
供应商应该让它的供应商参与输入他们的数据，并保存相关文件。Supplier shall have involved its own
suppliers for the insertion of their data and shall retain the related documentation.
供应商对所有输入到他自己MDS的数据，以及与二级供应商的材料/零件相关的数据负责。Supplier shall be
structured in order to guarantee the MDS insertion for all Fiat PN's within the Benestare and shall have a
method for MDS's quality control for those arrived by tier 2 Suppliers.
每当产品总重有显著变化（>10%）或产品组成有变化（也包括表面处理）时，供应商应更新MDS，IMDS自
动变更修改等级。Supplier shall update the MDS every time a significant variation of total weight of the
product (>10%) occurs or a variation of the composition of the product (also regarding surface treatments)
through an automatic change of modification level into the IMDS.
供应商负责将所有的数据输入他自己的MDS，也包括二级供应商的材料/零件。Supplier is responsible of all
data inserted in its own MDS, also those related to materials/components of Tier 2 Suppliers.
2A
模具状态
Die status
审核者应就时间节点制造和调试)和功能性对模具状态进行核实。
The auditor shall verify die status in terms of (building and try-out) timing and functionality.
审核者应核实模腔数，以及模具寿命与预期需求的一致性。
The auditor shall verify the number of cavities and the consistency of life time with the estimated needs.
审核者应在模具验收时确认所有要求被执行。
The auditor shall verify the implementation of all requirements contained into the tooling sign off.
2B
设备工装状态
Equipment and
Tooling status
是否能制造与预定零部件类似或者同等难易程度的零部件?是否有加工同类产品的实绩？
Does supplier has experience to provide same kind of parts for other OEMs?
审核者应就时间节点（制造）和功能性对设备、工装的状态加以核实
The auditor shall verify equipment and tooling status in terms of (building) timing and functionality.
审核者应核实新专用设备在相关节点的状态
The auditor shall verify special equipments purchased for project status in terms of timing
审核者应核实供应商具备所有必要的设备，以确定最终的制造过程。
The auditor shall verify the presence of all necessary equipments to make definitive the process.
2C
设备工装模具的
储存
Preservation
conditions of
dies,
equipemnts
and toolings
审核者应核实放置工装、设备和模具以及检具的环境，特别注意湿度、保护措施、润滑和标识
The auditor shall verify the environment where are stored the dies, with particular attention to the conditions
of humidity, protection, lubrication and identification.
随着时间的推移，存贮条件是否可以保证工装设备和模具的功能性？
Do the conditions guarantee the functionality through time?
2D
日常和预防性的
维护
(机器/模具/设备
)
Ordinary and
Preventive
Maintenance
(machines/dies/
equipments)
对所有直接与产品有联系的生产设备（包括机加刀具），应制订有计划的预防性或可预见性的维护保养计划
There shall be a programmed, preventive or predictive maintenance plan for all production equipment
directly connected with the product (including machine tooling).
该维护计划应被遵守，所有维护活动应被记录工作日志上（包括日常/特别的维护活动）
This plan shall be complied with, and all interventions performed shall be recorded in a logbook
(ordinary/extraordinary maintenance interventions included).
维护记录应被分析，以识别出某台设备或维护计划的弱点
The records shall be analyzed to identify any weakness in the equipment and/or in the maintenance plan.
对于可能引起停产的机器/工装应有备件
There shall be spare parts ready for those machines/tools that may cause stopping of production.
维护相关的指导性文件是否便于理解和执行
The working instructions for equipments maintenance must be easy to understand and implement
文件准备
模具设备准备
过程安排
人员安排
产品验证质量运行
质量运行
物流准备
持续改进
无论内部/外部的维修，均应该被记录在日志上
All internal/external maintenance must be recorded.
属于顾客的工装、检具等，一定要有永久的标识，同时应包含在维护计划中
Customer owned tooling, gauges, etc., must be permanently identified and included in the maintenance
plan.
2E
特殊维护有效果
吗？
Is the Special
Maintenance
Effective?
应有一支训练有素的维修队伍，内部人员或委外皆可，在整个工作时间需要维修或发生紧急情况时，该维修
队伍是可用的
There shall be a trained maintenance team, internal or external, available for intervention also in case of
emergency during all working time.
特殊维修应有记录
Special maintenance interventions must be recorded.
3A
二级供应商批准
Tier 2 approval
是否存在被批准的供应商清单并且涵盖了所有组装零件？
Does an approved supplier list exist for all components needed for the assembled part?
对于每一类产品或技术是否有合格供应商清单？
Is there a list of qualified suppliers for each commodity or technology?
在APQP或者产品认可期间，供应商清单的变更是否被认可？
Are there been any changes on the supplier list agreed during the APQP or the Part Approval?
应有可系统的适时更新的供应商清单，列明针对每一个具体的图纸，工艺技术，产品或者标准件的一个或多
个合格供应商。
There shall be a systematically updated list indicating one or more qualified suppliers for each specific
drawing, technology, commodity or standard parts.
对于关键供应商（注：在财务、质量或地理位置等方面有重大风险的可能会影响产品正常供应的二级供应商
），要具备在各已获PPAP/Benestare批准的供应商间进行生产切换的灵活性。
For critical supplier there should be a flexibility to switch production between PPAP approved/benestariati
suppliers.
3B
二级零件的批准
Tier 2
components
approval
在使用二级供应商的零件/材料用于被审核的产品前，供应商是如何验证其二级供应商的零件/材料？（是否具
有相关文件，且完整齐备，控制是否实施完成并证明有效？，如果是来自多个模具或者一模多腔，是否有针
对每一个模具或模腔的认可？）
How does the supplier qualify purchased product/material prior to its being used for the product being
audited? (existence of relevant documentation, completion and validity of the controls performed or
certified; if obtained from multiple moulds, dies, or multi-cavity dies, approval shall be given for each mould,
die, cavity).
材料或零件的更改管理是否能够确保可靠？
Is the management of modified material/components guaranteed?
在产品开始生产之前，二级供应商的零件必须已经得到供应商的样件认可，而且样件必须是用实际的生产工
装，在常规的生产条件下完成的。产品认可必须确保样件符合图纸、技术规范的所有要求，并且能够和客户
的制造过程相兼容并能在最终产品上使用。如果是多模、一模多腔的产品，零件必须永久性标注出是哪一个
模具或模腔产出的产品。每一个模具或模腔生产出来的产品都应该分别取样并交样以进行独立尺寸控制。
Before starting production, the sub-supplier shall receive part approval on samples submitted to the
supplier; samples must be produced on the actual production tooling under normal production conditions.
Part approval must ensure that the samples produced meet all of the requirements of the part drawing,
technical specifications, and are compatible with the customer’s processes and use on the final product.
When a part is obtained from multiple moulds, dies or multi-cavity equipment, each mould/die/cavity shall
be identified in a permanent way on the part. A separate sampling shall be provided for each of them, in
order to carry out separate dimensional controls.
对于尺寸相同但有不同特征（颜色, 硬度, 压纹等）的零件也应分别抽样并交样。
The separate sampling is also required for parts of the same size but different characteristics (colour,
hardness, embossing, etc.).
如果批准的方式是偏差认可的，应该视其为暂时性批准，并应指明数量或者有效期限。
If the approval is granted via deviation, this shall be temporary and shall indicate the quantity and/or the
valid time period.
对于可能影响到匹配或功能的产品特性偏差应该需要供应商特定职能部门的书面授权。
Deviation on characteristics that may affect the fit or functionality of the component shall be authorized in
writing by the supplier’s specific function (dept.).
如果适用的话，审核员应该核实标准样件是否存在。
When applicable, the auditor shall verify the existence of any master samples.
审核人员应该核实零件相对于技术标准的符合性。
The auditor shall verify the conformity of the part to the technical specifications.
3C
是否每个工位都
易于得到清晰的
最新发布的作业
指导书？
Are clear
operator
instructions
available and
updated for
each
operation?
针对产品制造的方法和要求，岗位上应该拥有清晰的操作指导书以及相关参数的设置指导说明。在策划和开
发这些指导书的期间，需要让员工特别关注需要检验的工艺要求点。这些文件中的各种不同的步骤应该能够
容易的被识别出来。（例如用分类、颜色、图片/简图/图纸等）以避免可能的误操作。
Workstations shall be provided with clear operator instructions and parameter set-up instructions according
to the needs and method of production. During the planning and development of these instructions, special
attention should be given to operations where inspections occur. Such documents shall be easily
i d e n t i f i a b l e f o r t h e v a r i o u s s t e p s r e l a t e d t o t h e u s a g e ( e . g . c l a s s i f i c a t i o n , c o l o u r s ,
pictures/sketches/drawings, etc.) to avoid any possible mistake.
审核人员应该核实操作员工对自己岗位知识、工作流程和作业指导书的的掌握和运用情况。
The auditor shall verify the knowledge and the application of procedures and job instructions by the
operators.
审核人员应该带着控制计划到现场考察生产线，并就其内容与现场作业指导书作交叉核查。
The auditor walk the line having the CP and cross-checking the control instructions.
评估目视控制的充分性。
Review the adequacy of Visual Controls.
3D
过程能力（短期
、长期、设备能
力指数)
Process
Capability (Ppk,
Cpk & Cmk)
对所有的可测量的重要特征特性，过程能力指数都需要计算：Cm 和Cmk针对设备能力研究，Cp Cpk针对量
产的过程能力研究。在定义所要使用的统计模型时，须考虑过程的具体特征(如存在一个或多个模具/模腔)及
所考察的特性(如是单侧或双侧公差）。
For all important measurable characteristics the process capability indexes must be calculated: Cm and
Cmk for machine capability studies, and Cp and Cpk for ongoing process capability. It is necessary to
consider the process specific characteristics (. presence of one or more moulds/cavities) and the
characteristics under examination (. unilateral, bilateral limits) when defining the statistical model to be
used.
Cm, Cmk, Cp, Cpk可接受的值必须满足客户的要求，包括长短期。(参考GFAC 质量手册)。
Acceptable values shall meet customer requests for Cm, Cmk, Cp, Cpk, short and long term (ref. GFAC
quality manual).
如果能力指数不能满足要求，需要进行100％的产品检验。此外，过程必须改进以满足目标或者开发更为可靠
的生产过程。
If the process should result not capable, 100% product inspection must be performed. Additionally, the
process must be improved to meet the objective or a more capable process must be developed.
能力指数必须是在正常的工艺生产过程中计量取得的。（设备、机器必须是最终运行环境）。
Capability must be determined under the normal production conditions (. machine or equipment installed
in the final environment).
过程能力必须被持续监控以确保其持续的稳定性。这些工作必须使用SPC等技术工具加以实施并且/或者在固
定的时间间隔里按照初始的方法重新计算。
Process capability must be monitored over time to guarantee its ongoing stability. This must be done using
adequate SPC techniques and/or recalculations at fixed intervals by the same initial method.
当产品或过程发生变更、设备进行大修或者设备作了移动之后，设备能力需要重新计算。
Machine capability must be re-calculated when there are any modifications to the product or process, major
maintenance is done on the machine or when the machine is moved.
上述所有的数据，包括纠正特殊原因的偏差的整改计划的实施，都应该以正式的格式记录在案。
All the above data, as well as any corrective actions implemented as a result of the elimination of special
causes of variation, shall be recorded on the relevant forms.
当过程能力指数的结果不能达到设定目标时，必须：
In the event the results of process capability are less than the objective, it shall be provided for:
回顾过程的数据，处理并重新计算控制限；
reviewing periodic data processing and re-calculating control limits;
重新评估取样的频次；
reviewing sampling frequencies;
相应地增加检验；
increasing inspections accordingly;
相应的可追溯的行动记录在案；
availability and traceability of actions recorded in a logbook;
确定措施的效果。
determination of the effectiveness of actions.
当所用的过程类型不能确保在目标/要求的能力下运作时，保持这样的控制是没有必要的，应该替换为更可靠
的100%检验的控制方法并且更新相应文件。
When the type of process utilized does not permit to operate at the objective/required capability, it is
useless to maintain such a control in the plan. It shall be replaced with a more robust 100% control.
Reference documentation shall be updated accordingly.
审核人员应该要求查看所有的Ppk, Cpk and Cmk值，并且核实它们符合技术标准要求。需要的话，审核员可
以用直接取自生产过程的数据来作交叉验证。
The auditor shall request all values of Ppk, Cpk and Cmk and shall verify if they meets specifications. If it is
necessary, the auditor make a crosscheck with the data directly taken from the process.
3E –
生产重启
Restart of
Production
依照要求，应具有一旦发生生产变更或重新启动生产时，关于设备管理的作业指导书。
There shall also be, according to requirements, instructions concerning equipment management in case of
production changes or re-starts (set-up).
在生产开始时，必要的过程参数应加以记录，并须对其加以分析以查验是否有偏移。
Whenever necessary parameter values shall be recorded at the start of production; these should be
analyzed to verify any drift.
生产重启时，应对初期产品做100%确认。
Initial products shall be 100% confirmed when production is restarted.
4A
操作工是否经
过适当的培训？
Have
operators been
properly
trained?
员工须经培训合格才能执行分配的作业（设备的使用、遵循操作指导书、事故预防、产品的搬运和标识、非
正当操作造成的对产品与公司的后果、产品和/或机器失效的反应措施）及新设备/机器的管理与设置。
Personnel shall be qualified to carry out the assigned tasks (use of equipment, compliance with work
instructions, accident prevention, product handling and identification, consequences of non-conformities to
product and the company caused by activities not properly performed, reaction in case of product and/or
machine failures) and the management/setting of new equipment/machines.
培训后须作进一步的资格认证。
Further qualifications shall take place after training.
培训计划的编制应根据需控制的特性的重要程度进行。
Training plans shall be commensurate to the importance of the characteristics controlled.
要就产品及在一些特殊工作岗位可能发生的普遍的和特别的难点对员工进行培训（特别注意标有“安全/报告”
特性的工位）。必须有培训课程完成的记录以及一份能展示每个员工的各种技能的岗位技能矩阵图，这个矩
阵的内容要与工作的天数和每天轮班的次数相一致。
The personnel shall be trained on the product, critical points in general and in particular on the difficulties
which may take place in the specific workstation (particular attention to be given to “Safety/Report”
characteristics). A record of training courses completed, as well as a skills matrix chart identifying the
versatility of the employees shall be available. This matrix shall be consistent with the days of work and
number of shifts per day.
培训计划需定期更新。
A periodic updating of training plan shall be defined.
必须定义管理/更新多职能矩阵表的责任。
The responsibility for the management/updating of the versatility matrix shall be defined.
审核员要核实针对新项目的各种员工培训计划
Auditor should confirm the training plan for the new project
审核员要核实对操作员进行的培训课程的有效性。
The auditor shall verify the effective distribution of training courses to operators.
4B
管理层参与
Management
involvement
管理层有参与质量问题的管理吗？
Is Management involved in quality issues?
最高管理者或者其代理者应评审产品实现过程和支持过程，以确保它们的有效性和效率。
Top management shall review the product realization process and the support process to assure their
effectiveness and efficiency.
负责人不在时,代理人是否明确？
Is an alternate person available if the responsible person is absent?
控制计划的编制是在客户规定的时间期限内完成的吗？
Are Action Plans made within the timing shared with the customer?
控制计划内容的实施是否有明确的责任人且责任人明白自己的职责？
Is responsibility for implementation assigned and do people understand their responsibility?
向下阶段过渡时的的评价活动、负责人及记录方法等是否明确？
Are evaluation meeting, person responsible and record available when the program is implemented to next
stage?
4C
用于控制的资源
是否充足
Are the
Resources
dedicated to
controls
sufficient?
过程中使用的资源是否充足？关键岗位人员须有顶岗计划、检测设备能满足检测需求。
Is the number of resources involved in the processes adequate? Critical operation shall have backup
human resource and inspection instruments/equipments shall be available.
是否按照客户的时间节点制定了相应的项目管理计划，计划是否包括了客户要求的所有项目？例如，客户的
产能要求。
Does the supplier make a project development plan according with the customer timing? The plan must
incldue all the customer requirement such as prodcution capacity.
是否实施了项目的进度管理？
Does the supplier updated the project development plan
如果发生了项目的延迟，是否制定了相关的挽回计划
If the project delay, is there a action for retrieval
是否有一个专门的能胜任的的项目团队？职责是否明确？
Does supplier has a dedicated capable project team? Are their responsiblities clearly defined?
资源是否能保证覆盖所有班次？
Is coverage of all working shifts guaranteed?
4D –
班次交接
If more than
one shift
寻找是否有定义清晰的有效信息交流的证据，尤其是交接班，跨部门等方面的问题信息能快速传达给正确的
人员。
Seek evidence that effective well defined lines of communication are in place, particularly across shifts,
dept's., etc., that problems info quickly reach the correct personnel.
有交接班记录
4E –
环境，健康和安
全（EHS)
Environment,
Health and
Safety (EHS)
应该制定对工作场所的清洁计划以保持可满足产品要求的场所清洁水平。
There shall be a cleannes plan of workplaces in order to maintain the right level according to product
criticality.
是否给员工配备了必要的劳保用品。
Do the staff have necessary labour protection appliance
5S状况
5S status
寻找生产现场潜在的安全隐患。
Auditor should verify the potential safty hazard in the plant
5A
自我验证状态
Self-
Qualification
status
供应商自我验证测试是否完成？
Has been the Self-Qualification procedure completed?
测试结果是否符合要求？
Are the test results positive?
测试结果是否与顾客共享？
Are the test results positive?
如果测试结果不符合要求， 对异常的项目是否有清晰的弥补计划？
If not, are clear the recovery actions related to the underlined anomaly?
5B
综合测试状态
Integrative
Tests Status
用于综合测试样品是否已发运到实验室？
Has been the samples for integrative tests delivered?
是否完成样品的构成品以及交货状态的测量和编号？
Has been the samples and single parts measured and numbered
综合测试的结果是否符合标准要求？
Are the test results positive?
如果综合测试的结果不符合要求， 对异常的项目是否有清晰的弥补计划？
If not, are clear the recovery actions related to the underlined anomaly?
5C
匹配试验和工厂
批准试验状态
Matchability
and Benestare
Status
用于Benestare（工厂批准）和匹配试验的样品是否发运到工厂？
Has been the samples for matchability and Benestare tests delivered?
试验结果是否符合要求？
Are the test results positive?
如果测试结果不符合要求， 对异常的项目是否有清晰的矫正计划？
If not, are clear the recovery actions related to the underlined anomaly?
5D
一日生产
1DP
产能是否被验证？
Has been the productive capacity process verified?
产能是否满足了客户要求？
Is the productive capacity sufficient to meet the customer requests?
针对本次广汽菲亚特审核启动项目，产能是否得到保证
For this PSA audit about GFAC project,the production capacity is sufficient
产能验证是否包括了备用件和可能在一定时间内客户需要增加的数量？
Does the verified productive capacity include the amount for spare parts and possible production increases
requested by the customer for a limited period of time?
5E
加严的前期投产
控制计划
Strengthened
Pre-Launch
Control Plan
审核员应该验证加严的控制计划是否存在，其中应包括提高过程中的控制抽样频率和/或抽样数量，以及设立
用于验证将发运产品的终检站。该终检站应离线（表示应在正常工艺流程之外）。
The auditor shall verify the existence of the Strengthened Pre-Launch Control Plan, characterized by the
presence of "in process" controls with sampling frequencies and/or sampling sizes higher than usual and by
the presence of a final control station off line for the certification of delivering material.
工作现场应该满足生产要求（现场明亮，配置必要的设备等）。
This station shall be in adequate conditions for the right functioning (lighted place, necessary equipment
available, etc.).
审核员应该证实加严的控制计划是否足够， 例如：对PFMEA中RPN最高的过程是否有更加严格的控制，所
有最重要的特性是否被考虑。
The auditor shall verify the adequacy of the Strengthened Pre-Launch Control Plan, for example checking if
at the highest RPN's of Process FMEA correspond more severe controls or checking if all most important
characteristics (Key, Critical, ...) have been taken in account.
审核员应该证实执行加严控制计划的责任人是否被指定， 责任人是否正确验证了所有准备发运的批次。
The auditor shall verify that the responsible for execution of the Plan have been identified and he correctly
certifies all batches ready for shipping.
2D
日常和预防性的
维护
(机器/模具/设备
)
Ordinary and
Preventive
Maintenance
(machines/dies/
equipments)
6A
来料控制
Incoming
Material
Controls
若买入的材料/原材料包含重要特性， 分供方有什么程序可对其过程进行正确管理 （即，控制计划），包括
对检验结果的记录和存档吗？是否有购买未经认可的材料？当不得不从未经认可的供应商处购买时，应首先
知会客户并得到客户的许可。为防止使用不合格零部件或原材料，必须在进料检验和制造过程中通过足够的
抽样计划确保对其进行有效的控制。
For purchased material/raw material with significant characteristics assigned, what is the sub-supplier’s
procedure for the correct management of processes (. control plan), including the recording and filing of
inspection results? When it is necessary to purchase from non-qualified suppliers, with notification of
customer and its approval, effective controls, using an adequate sampling plan, shall be exercised both in
the Incoming Inspection area and during the manufacturing process to prevent/block the use of non-
conforming parts or raw material.
必须有所使用的控制计划且易于获得，当有要求时，相关检验和试验的结果应能得到。
The control plan used shall be available and the related results of inspections and tests shall be accessible
on request.
应就如何保持已实施及已验证的质量检验记录的方法加以规定。
The methodologies for retaining the performed/certified quality checks shall be defined.
所有零部件必须符合客户要求并获得批准。
All components must be approved with customer requirements.
若适用，必须核实是否有存放参考样件。
When applicable, it must be verified the existence of deposited reference samples.
当采用计算机系统对来料、抽样计划以及接受/拒绝标准进行管理时，应该建立备用方法以在计算机系统失效
时使用。
If there is a computerized system to manage incoming products, sampling plans and acceptance/reject
criteria, there shall be available an alternative method in case the system were not operational.
应编制并使用控制计划（包括控制特性，频次，样本数量），并确保针对重要特性的内容的恰当性， 从而能
够进行定期再检验、数据处理和接受标准的升级。
Control plans shall be developed and used (characteristics, frequencies, sample sizes), assuring the
appropriateness of contents referring to significant characteristics, in order to allow periodic re-examination,
data processing and acceptance criteria evolution.
分供方至少必须有质量体系认证的要求，过程评审结果合格，且质量绩效满足产品的重要性/质量目标，才能
在自我认证的状态下进行运作。
Sub-suppliers may operate in self-certification status if they at least have quality system certification
requirements, positive process audit evaluation and quality performances suitable to the importance/product
quality goals.
应制定程序规定在出现不合格品时，如何暂停、重启自我认证状态。
Procedures shall be defined for suspension/re-establishment of the self-certification status when non-
conformities occur.
检验和试验结果应该随时可获得，且当客户要求时，应立即提交给客户。
Results of inspections and tests shall always be available and promptly sent to the customer if required.
在发运文件、产品标识和包装上必须标示自我认证状态的特殊符号。
A specific symbol showing the self-certification status shall appear on the material shipping documents,
product identification sheet, and on package.
应随机抽检来料批次并对检验结果进行统计分析，以便与分供方绩效考察指标进行比较。
Audits on incoming lots shall be done randomly and statistical evaluation of the results shall be made in
order to compare them with the sub-suppliers’ indicators.
应该有一个能对分供方的以下几方面进行干预的机制：
A structure able to intervene on the sub-supplier shall be operating, in terms of:
- 针对新产品/新工艺进行的过程评审；
process auditing for each new product/process;
- 当产品是新产品或者有更改时对控制计划的分析及提交。
analysis and sharing of control plans in case a product is new and/or has been modified.
必须有有效的程序来管理产品和工艺的更改，和/或任何开出的偏差放行。 该活动应通过对产品/零部件变更
的正确管理得以体现。
There shall be adequate procedures for the management of any modification concerning the product,
process and/or any issued deviation. This activity shall be shown through a correct management of
product/component modifications.
除非客户另有规定，凡更改前生产的产品均应被视作不合格品。
Any product produced before a modification shall be considered as non-conforming unless otherwise
provided by the customer.
6B
生产批准
Production
approval
在重新开始生产时，或任何制造过程的调整或更改后，都应该对首件的控制加以定义并实施。
Controls on the first part produced shall be defined and implemented in case of re-start of production, after
any modification, or change of manufacturing process.
应通过以下措施确保产品符合技术规范：
Conformity to specification shall be guaranteed through:
零件的批准应由指定的人员按照特定批准进行。 这一规定应可被获得，正确且完整。
part approval by appointed personnel with specific approval instructions. The instructions shall be available,
correct and complete;
“可以生产”的批准应由适当的负责人在确认了由稳定工艺生产的首批产品符合规范后给出。
OK to produce given by suitable responsible after verification of conformity to specifications of the first parts
realized with steady process;
有产品的相关文件（图表，指导书，等等）；
availability of the related documentation concerning parts (charts, instructions, etc.);
有生产使用的工装、控制和搬运设备；
availability of production tools, control and handling equipment;
当适用时， 在工作站须有批准过的标准样件。
when applicable, availability at working station of approved master sample part.
6C
过程控制和试验
Process
Controls and
Tests
供应商应该有程序规定对工艺过程的监测并在工艺过程发生偏离或退化时及时采取措施。
The supplier shall have a procedure for the detection and immediate action on the process, when process
drift or degradation is evident.
过程和设备参数（温度、压力、电压、电流、负荷、电容、扭矩等）是否根据客户和供应商双方的规范，图
纸和标准的要求而定义？
Have been process and machine parameters defined according to how is prescribed into specs, norms,
drawings both customer and supplier (temperature, pressure, voltage, current, load, capacity, torque, etc.)?
检查过程控制限是否与公差混淆。
Check that process control limits are not confused with tolerances.
控制限应显示持续改善的应用过程。
Control limits have to show continuous improvement process in place.
数据记录的方法必须适合使用的检测手段，且任何控制限的使用必须合理。任何超差或变差的特殊原因都应
调查清楚，记录在案且有切实可行的整改计划支持系统可反馈给操作工。
The method of recording data should be verified as suitable for the checks being performed and any control
limits utilized should be reasonable. Out of control conditions or special causes of variation should be
clearly identified, documented and linked to a robust corrective action support system that is responsive to
the operator.
供应商应有一套操作简单的能辨识已生产的合格产品的系统（批次分隔、控制表单等）。
The supplier shall use a system for the easy identification of conforming products already produced (lot
breaker, control charts, etc.).
供应商应有程序规定当发现不合格品时，追溯检查直至之前最后一个受控的点/产品。
The supplier shall have procedure to inspect parts back to the last ‘in-control’ point/part, when a non-
conformity is found.
应定义并应用针对严重不符合的管理规定， 包括：
There shall be defined and applied rules for the management of major non-conformities including:
- 对不合符的定义；
identification of the non-conformity;
- 根本原因分析；
root cause analyses;
- 临时和长期整改措施；
interim and long term corrective actions;
- (对整改措施的)有效性的验证；
verification of effectiveness;
- 将改善扩展应用到类似过程中去。
对过程的整改措施应该在FMEA 和控制计划中体现。
extension of improvements to similar processes.
评审员必须至少完整检查一个针对某一不符合的相应整改措施的管理。
extension of improvements to similar processes.
6D
出货质量
Outgoing
Quality
必须有行之有效的产品审核计划并将其实施：
There shall exist and be applied an adequate Product Audit Plan:
必须保存历次审核的结果；
results of previous audits shall be available;
如发现缺陷产品，必须有相应的反应计划。
reaction plan if defective parts are discovered shall be available.
6E
SQE 审核
SQE Audit
在来料检验区域从已检合格的批次中抽取一个样品并检验。
In the Incoming Material Area select a sample from previously accepted/approved lots and inspect it.
在制造现场， 审查员应抽取从不同的机器由不同的操作工生产出的产品并观察其检验过程将结果与之前的检
验记录加以核对，并与规范相比较。 如出现不合格品， 应调查并确认根本原因。
In the Manufacture Area, the auditor shall require parts to be selected from different machines and different
operators and witness the execution of the inspections, checking the consistency of the results with the
previous recorded inspections, and comparing them to the specifications. In case of non-conformity, the
results shall be investigated to determine the root cause.
审核员应验证所使用的原材料与客户所批准的材料一致。
The auditor shall verify that the raw material being used is the same as approved by the customer.
在检查完整的工序时， 审核员应审查/检验从至少3台机器设备或过程产出的成品或半成品，并就选定的特性
进行对照审查。
During the examination of the complete sequence of operations, audits/inspections shall be performed by
the auditor on finished or semi-finished products selected from a minimum of three machines/processes
and audit them relevant to selected characteristics.
审核员可自行选择，检查从3台机器设备或过程生产的各15件产品，对应预控制表检查其过程控制的状况。
At the auditor’s option, check 15 pieces from each of the three machine/processes to demonstrate process
control using a pre-control chart.
在发货区，从已检验合格的待发货批次中抽取样品检查其相关特性。
In the Shipping Area select samples from previously accepted/approved lots that are ready to be shipped
and inspect them in connection with their characteristics.
在产品审核过程中，检验员的表现看起来是否受过充分的培训？
During the Product Audit, did the inspection personnel show to be adequately trained?
检验方法的执行是否与检验要求一致且充分？
Are the inspection methods performed in a way that is consistent and adequate with the inspection
requirements?
审核的结果合格吗？
Are the results of the audit conforming?
7A
记录控制
Controls
recording
应对检验和测试结果的记录和归档定义条件和职责。
Conditions and responsibilities shall be defined for the recording and filing of inspection and test results.
应建立有程序文件以定义在标识、贮存、保护、检索、保存期限和记录处置所需的控制。
A d o c u m e n t e d p r o c e d u r e s h a l l b e e s t a b l i s h e d t o d e f i n e t h e c o n t r o l s n e e d e d f o r t h e
identification,storage,protection,retrieval,retention time and disposition of records.
7B
与报告/安全特
性相关的记录控
制
Controls
recording
regarding
Report/Safety
Characteristics
对于具有安全/报告特性和/或有法律法规要求的零件，为了确定相关特性的符合性，对产品应进行直接的控制
和记录。
For parts with Saferty/Report Characteristics and/or subject to homologation, controls directly to the product
shall be provided, performed and recorded, in order to ascertain conformity of the related characteristics.
对这些控制的形式化应在过程控制计划中形成特性的特定过程步骤中加以规定,也应在位于过程控制计划末尾
的用于记录这些控制的附表中得以体现。这些文件应递交给SQE。
The formalization of these controls shall be on the PCP, both on the step in which the characteristic is
generated and at the bottom of the PCP, in a special annex that resume these controls. This document
shall be handed to the SQE.
类似的控制也应在产生这些特性的二级供应商那里实施。
In this formalization shall also be made clear controls performed on characteristics realized at Tier 2 plants.
7C
控制仪器的管理
Control
instruments
management
应有足够数量的检验和测试设备去执行必要的控制（包括人员）。
There shall be a sufficient quantity of inspection and test equipment to carry out the necessary controls
(personnel included).
边界样品对操作者而言是否可利用，且在使用中？
Are boundary samples available to operators and in use?
是否所有的量具都具有操作指导书并放置于显眼位置？
Do all gauges have operator instructions attached and clearly visible?
是否有标准样品用于校验和防错设备验证？
Are Master Parts available to confirm inspection and error proofing devices?
量具和测量设备应具有与图纸、规范和特性重要程度相适应的足够的测量精度。
Gauges and measure equipment shall be of adequate measuring class commensurate to the requirements
of drawings, regulations and importance of the characteristics.
应确保量具、试验设备和参考样品的易于得到、适宜性、标识、效率和正确存贮。
Availability, suitability, identification, efficiency, correct storage of gauges, test equipment and reference
samples shall be ensured.
供应商应有一个书面的且得到正确应用的程序，对量具精确性、重复性、再现性以及稳定性进行评估。
The supplier shall have a written, and properly applied, procedure to audit the capability of the gauges for:
accuracy, repeatability, reproducibility and stability.
应审核量具能力和公差之间的一致性。
The consistency between capability of the gauges and tolerances shall be audited.
应具有量具校验系统，包括校验频率和相关结果的记录。
There shall be a gauge calibration system, including calibration frequency and recording of relevant results.
应确保量具的标识、校准状态和有效日期（通过校准标签、颜色代码等）。
Gauge identification, calibration status and expiration date (via calibration stickers, colour code, etc.) shall
be ensured.
应定义标准，确保在量具校准期间所要求的检验和测试能够持续进行（特别是当仪器被送到外部实验室进行
校准时）。
The criteria adopted to guarantee the continuance of required inspections and tests during the gauge
calibration period shall be defined (especially when the instrument is sent to external laboratories).
应具有量具履历卡，包括启用日期、校验记录（注：包括校验日期和校验原因，可为普通原因或特殊原因，
如量具掉地...）、校验前状态、维护和修理等。
There shall be gauge history cards containing start-up date, interventions of calibration, ‘as found’ condition
， maintenance, repair, etc.
应具有量块和/或参考样品用来进行量具校准，且能够溯源到国家标准。
There shall be gauge blocks and/or reference samples for gauge calibration; traceable to the national
standard.
对于正确校验所用的量块和/或样品，其精度等级的适当性应加以定义（初级、中级工作样品等）。
The appropriateness of the accuracy level of gauge blocks and/or samples required for a correct calibration
shall be defined (primary, secondary work samples, etc.).
须对一旦发现量具失效（失效包含超出校验有效期，或虽在有效期内但实际已超出校验规范等状况）的情形
制定反应计划。
Reaction rules shall be defined in the event that any gauge is found out of calibration.
应该确保对于不符合、不具备能力的量具的标识和隔离。
Identification and segregation of any non-conforming, not capable gauge shall be ensured.
可参考性、测量溯源性和校准有效期应该被显示。
Referability, metrological traceability and calibration expiration date shall be shown.
对于有外观检验项目的零件，应具有边界样品和接受标准用于进行检验。接受标准应由客户或供应商制定。
A boundary sample and acceptance standards shall be available and used for inspection of parts having
appearance items, etc. The acceptance standards shall be developed by either the customer or the
supplier.
当适用时，每一个检验/控制点应有边界样品。
The boundary sample shall be, when applicable, in each inspection/control station.
对边界样品的识别和更改应在特定的图表上予以记录。
The identification and recording of the modifications on the boundary samples shall be recorded on specific
charts.
应具有标准样品的可参考性和追溯性证据。
There shall be evidence of referability and traceability of the master samples.
对边界样品的存贮、搬运和保存条件应进行定义
Storage, handling conditions and preservation of the boundary samples shall be defined.
根据要求，当发生生产变更时（设置），应具有关于量具管理的指导书。
There shall also be, according to requirements, instructions concerning gauge management in case of
production changes (set-up).
根据生产需要和生产方式，量具应具有清楚的作业指导书和参数设置指导书。在这些指导书的策划和开发过
程中，针对涉及检验的操作，须给予特别的关注。这些指导书中应针对不同的步骤而使用相应的形式 (如分类
，颜色，图片/草图/图纸等）使各步骤易于识别，以避免误用。
Gauges shall be provided with clear operator instructions, and parameter set-up instructions according to
the needs and method of production. During the planning and development of these instructions, special
attention should be given to operations where inspections occur. Such documents shall be easily
identifiable for the various steps related to the usage (classification, colours, pictures/sketches/drawings,
etc.) to avoid any possible mistake.
当适用时，每一个检验/控制点应有标准样品。
The master sample shall be, when applicable, in each inspection/control station.
应确认维护和修理活动内容及其执行情况并在特定的图表上予以记录。
The identification and recording of the intervention actions shall be recorded on specific charts.
应有证据证明标准样品的可参考性和可追溯性。
There shall be evidence of referability and traceability of the master samples.
对标准样品的存贮、搬运和保存条件应进行定义。
Storage, handling conditions, and preservation of the master samples shall be defined.
审核员应通过模拟一个或多个不符合产品去验证防错装置的有效性。
The auditor shall verify the effectiveness of mistake proofing by simulating one or more non-conformities.
应有用于验证量具和检验/测试设备操作状况的参考样品。
Reference samples used to verify the operating condition of gauges and inspection/test equipment shall be
available.
参考样品应根据控制计划中规定的频次进行使用。
Reference samples shall be used according to the frequencies set out in the Control Plans.
100%的防错（客观的）控制，要求用自动的方式对零件进行探测和拒收，当防错装置发生故障停机或失效时
，产品应被视作“不合格品”分选出来(默认为阳性，即无论防错装置故障停机或失效时流出的产品实际是否合
格，都应默认为疑似产品加以隔离)。
Error proof (objective) 100% control requires that the detection and rejection of parts are performed in an
automatic way and, when the device breaks down, or goes out of calibration, the parts shall be selected as
"non-conforming" (positivity of consensus).
检验/测试设备（QA机器）参数的设置和修改应设置权限管理。防止员工随意/错误的修改。
There shall be QA machine management procedure to avoid the parameter is changed by operators's
misoperation.
7D
返工
Re-works
对不合格品的返工、返修或润色加工（注：润色加工与返工返修不同，指产品必须经过此道工序方能达到合
格，如“去毛刺”等）应具有正式的指导书。指导书应定义出返修方法、设备、要使用的材料，以及对返工产品
的识别和控制的方法。
Written instructions shall be developed for reworking, repair or touch-up of non-conforming parts. The
instructions should define the method of repair, the equipment, the material to be used, and the methods of
identification and control of the reworked products.
当适用时，对返工/返修品应进行清楚地标识且可追溯。
The reworked/repaired products, when applicable, shall be clearly identified and traceable.
返工/返修品应放在不合格发生点之前以再次返回到正常生产过程中；或至少使用与发现此不符合的相同的量
具或测试设备进行再次检验。
The reworked/repaired products shall be reinserted into the principal flow at the point previous to where the
non-conformity was generated; or at least re-checked with the same gauges or test equipment that
discovered the non-conformity.
7E
不合格品管理
Non-
conforming
Products
Management
是否有不合格产品控制的处理流程和管理规定？不合格品处置的职责、权限是否明确？
Are Non-conforming control procedure available? Is the responsibility clearly defined?
负责产品质量的人员是否有权停止生产，以纠正质量问题？
Can person responsible for quality stop the line to solve quality issues?
不合格产品应使用标记/文件进行充分地识别，并进行适当地隔离（指定区域，最好是封闭的，或者适当的料
箱）。
Non-conforming parts shall be adequately identified via signs/documents and properly segregated (well
delimited areas, better if enclosed, or adequate containers).
对不合格品的管理和相应的职责应在程序上进行定义：
There shall be defined rules for the management of non-conforming products and relevant responsibilities:
标识；
identification
隔离；
segregation
返工/返修；
re-work/repair
再次检验；
re-check
拒收或报废；
reject or scrap
偏差；
deviations
当发现不合格品时，相关的管理程序应被正确地使用（产品的隔离和处置，原因分析，过程纠正，纠正措施
有效性的控制）。
When a non-conformity is discovered, the relevant management procedure shall be correctly applied
(segregation and interventions on product, analysis of the causes, corrections on processes, control of
effectiveness of corrective actions).
供应商是否和客户建立了稳定的沟通渠道并有效运作？当有质量问题发生时，供应商是否对问题围堵和改进
措施方面及时告知客户？
Has a stable communication system been established between supplier and customers and does it work
properly? In case of quality issues, is the supplier able to reply to cutomer's claims in terms of containment
and corrective actions in the right times?
8A
可追溯性
Traceability
涉及安全或要求遵循特别法规的零件,其追溯性必须得到保证。
Traceability shall be guaranteed for safety components and/or for components subject to specific regulation.
当零部件含有"安全/报告"或者需符合法律法规类型的特性时，其检验和试验结果须能追溯到与顾客达成的协
议以及各项国内和国际法规的要求。（参考GFAC 质量手册）。
When the components have characteristics classified as “Safety/Report” or subject to homologation, it shall
be possible to trace back the results of inspections and tests according to what is agreed with the customer
and according to what is required by various national/international regulations (ref. GFAC quality manual).
在包装标签和产品,批号,包装单,数量,工程更改版本, 零部件及内部和外部制程控制之间应有可追溯性联系。
There shall be a traceability link between the packaging label and the product, lot, packing list, quantity,
revision level, components parts and processing controls used both in internal and external processes.
当合同里要求时,对原材料和/或下级供应商零件的批次必须保持可追溯性。
Lot traceability to the raw material and/or sub-supplier components shall be maintained when required by
contract.
向质量部门交验的产品批须有清楚的标识。
There shall be a clear identification of the batches assigned to Quality Department inspections/checks.
储存的物料必须能用报告文件号和批次号来做迅速的识别。
Materials stored in stock shall be rapidly identifiable by means of documentation reporting codes and lot
number.
必须有足够的程序对产品及制程的更改和/或签发的偏差许可加以管理。须通过一个正确管理产品/零部件变更
的案例来验证这点。
There shall be adequate procedures for the management of any modification concerning the product,
process and/or any issued deviation. This activity shall be shown through a correct management of
product/component modifications.
除非客户另有规定， 否则任何在更改前生产的产品都必须视为不合格产品。
Any product produced before a modification shall be considered as non-conforming unless otherwise
provided by the customer.
8B
标识
Identification
在仓库的物料上的标识标签必须是可见的。
The identification tag/label shall be visible for materials in stock.
所有的半成品和/或成品须正确标识(如零件号，批号，数量)，同时，其在制造过程中的已经历的不同阶段(已
完成的工序)也应明确体现出来。
All semi-finished and/or finished products shall be positively identified (. part number, lot code, quantity)
and the progress shall be clearly shown with respect to the different phases of the manufacturing cycle
(operations completed).
应确保检验状态目视化管理规定（例如，有颜色代码的标签）的应用及其适宜性。
The application and appropriateness of the provisions to visualize the inspection status (. color coded
tags) shall be guaranteed.
待检查产品；
product waiting to be inspected
已检查和已接受的产品；
product inspected and accepted
待处置产品；
product waiting for a decision
不合格产品；
non-conforming product
报废产品（隔离/标识，以避免被重新投入到生产过程中）。
waste product (scrap) (segregation/identification in order to avoid any re-insertion into the process).
在不合格材料贮存并等待最终处置的拒收产品区，必须标识且禁止未授权的人员进入。
The rejected product area, where the non-conforming material is stored waiting for its final destination, must
be identified and forbidden to unauthorized personnel.
标识的条件必须与过程的风险及类型相吻合。
Identification conditions shall be commensurate to the risk and type of process.
标识可以针对单个零件，也可以针对产品箱或工作单元，必要时，应能追溯至诸如检验、检具/试验设备、操
作人员、日期、团队等方面的信息。
Identification may be related to every single piece, to the container or the work cell, and shall enable to go
back, as necessary, to the information concerning inspections, gauges/test equipment, operator, date,
team, etc.
标识必须清楚，即使该批次已有部分被使用。
Identification shall be clear, even after the partial use of the lot.
必须保证标识与追溯性要求的一致性.特别是对于具有"安全/报告"特性的产品。
Consistency between identification and traceability requirements shall be guaranteed in particular for
products with Safety/Report characteristics.
每个盒子、箱子、包装等均应有标识。 须定期检查标识与实际产品、数量是否相符。
Each box, container, packaging, etc. shall be identified. Periodic controls shall be carried out to ascertain
that identification and product/quantity correspond.
不合格产品必须有标识，并在相关区域被隔离。
Non-conforming products shall be identified and segregated in the relevant areas.
产品标识/标记必须与客户规范一致，且对于组成总成件的所有零部件，只要其能在售后市场上单独购得的，
则均须加以书面标识。
Product identification/marking shall comply with the customer’s specifications and has to be written, in case
of assemblies, on all components of the assembly, if they are available loose on the spare parts market.
审核员必须确认所有包装都被正确的标识。
The auditor shall ensure all packaging is properly identified.
8C
先进先出
FIFO
必须有一个体系保证先进先出贯穿于整个流程。
There shall be a system guaranteeing FIFO throughout the process flow.
对于容易腐烂/变质的产品是否有过期时间管理？
Is the expiration date for perishable products managed?
产品批次必须以有组织的方式送往下一个操作站点（先进先出，目的地的标识和传输设备的安排）。
Product lots shall be sent to the following operation in an organized manner (FIFO, identification of
destination and arrangement of machinery).
如果供应商依赖信息检索系统来管理先进先出， 那么在该系统出故障时, 应有一套备用的等效的先进先出人
工管理系统。
If there is an Information Retrieval System, in the event of a failure, FIFO shall be managed by means of an
equivalent manual system.
8D
恰当的搬运和包
装
Appropriate
handling and
packaging
每个工位的产品储存区域都必须与要求一致。
Product storage areas at each workstation shall be commensurate to requirements.
包装的设计应能确保单个零件直到其在生产线上被使用时的完整性，即使是重新包装时也应该保证。
Packaging used shall be designed to assure, even in the case of repackaging, the integrity of the single
component until its use in the production cycle.
包装必须按照客户认可的标准（包装规范）来标识。
Packaging shall be identified according to standards agreed with the customer (packaging specifications).
操作指导书必须对有包装损坏状况下的处置作出定义。
Operating instructions shall be defined in case of damaged packaging.
在进行卸货，分段运送,储存操作中,环境条件必须要能保护产品和包装的完整性。
During unloading, staging and storage operations, environmental conditions shall be such as to protect the
integrity of the product and its packaging.
搬动、运输和储存方式（叉车、托盘等）应有效且在安全的条件下进行操作。
Handling, transport and containing means (forklifts, transpallets, etc.) shall be efficient and operated under
safety conditions.
物料须存贮于托盘、料架等之上，且其必须是合适贮存并状况良好：清洁，有恰当维护，安全，符合最大堆
积高度以确保安全和产品的完整性。
Storage shall be done on pallets, shelves, etc.; these shall be suitable and in good conditions: cleaning,
maintenance, safety, complying with the maximum piling to ensure safety and product integrity.
储存/堆存区域必须有足够空间容纳物料，且位置合理便于物料流动，也有足够空间容纳和保护产品，且方便
进入并可安全操作.
Storage/stockpiling areas shall be sufficiently sized to contain the material, located in a logical way with
respect to the flow, adequate to contain and protect the product, with easy access and safe handling.
供应商不能将客户的包装箱/包装材料用于内部流转使用。
The supplier shall not use customer containers/packaging for internal handling.
8E
适当的工艺流程
Appropriate
process flow
工位上要使用的技术文件必须容易拿到,而不需要打断操作作业。
The technical documentation to be used in the workstations shall be easily accessible without disrupting the
working activity.
物流设计必须考虑如何避免漏工序或和相似零件/产品混淆。
Material flow shall be designed to avoid missing of operations or mix of parts with similar products.
对于当前处于未生产状态的生产设备必须加以标识和隔离,以避免对生产中零件/产品的流管理中造成混淆。
Equipment for production of lots/work orders not currently under production shall be properly identified and
isolated to avoid confusion in the flow management of components/products being manufactured.
对照工艺流程图，生产平面布置图和控制计划，就从物料接收到产品发送的全过程，对实际生产区域进行核
查。
Review the actual manufacturing area against the Process Flowchart, general layout and process control
plan considering all processes from Goods Receiving to Dispatch.
生产是否采用单件流，拉动系统似的工艺布置
The process flow whether using an one piece flow and a pull prodcution system.
工作场所应该遵照总体布局图来布置，并提供足够的空间、照明等。
The workplace should be configured as per the general layout and be provided with adequate space,
lighting, etc.
应该指定专门的区域用于量具、报废品和返工品的放置，必要时加锁。
Locations should be designated and, where necessary, secured for the storage of gauges, scrap, reworked
parts, etc.
对于过程控制计划，标准操作书，作业指导书，过程设定手册，SPC记录表等的展示也应该做相应的规定。
Provisions should also be made for display of Process Control Plans, Standard Operation Sheets, Work
Instructions, Process Setting Sheets, SPC Sheets, etc.
9A
经验教训
Lessons
Learned
对目前产品中发现的问题是否有进行管理并做分析? 相关的纠正措施是否也被实施于尚在前期开发中的产品?
Are the issues found on current product managed and analyzed? Are the relevant corrective actions
implemented on the advance products?
9B
二级供应商的管
理和改进活动
Improvement
Activities for
Tier 2 Suppliers
是否有一个针对对二级供应商的改进计划来提高其产品/过程质量？是否有二级供应商问题的跟踪？二级供应
商是否完成未然防止和再发防止？
Does an improvement plan related to tier 2 suppliers exist, in order to improve the quality of their
product/process to prevent defects ? Have tier 2 supplier issues been followed up and closed according to
plan and related FMEA documents been updated for issue prevention?
企业应该有评估二级供应商绩效的方法。是否有制定二级供应商质量监查、评价、指导的方法及规定并按计
划实施？
There should be some methods and plans to assess the adequacy of Tier 2 supplier performances. Audit
and training should be implement according to plan.
9C
售后保修
Warranty
是否有开发相应的分析或预防系统来防止来自客户的投诉？
Are developed analysis/prevention system that allow to prevent and avoid any claim from customer?
对于客户抱怨的响应时间是否及时
Are the response time for the customer timely?
对于抱怨品检测出的问题是否有对其数据进行管理和分析？
Are managed and analyzed the data related to problems detected on the non-conforming
对于客户退还的失效样件是否做相应的分析？
Are the samples returned from customer analyzed?
与这些分析相关的纠正措施是否被实施？
Are Corrective Actions related to those analysis implemented?
相关的纠正措施是否横向展开？
Are corrective actions extend to the other simulated components?
其认可的二级供应商是否参与以上活动并对过程和FMEA进行回顾检讨？这些行动的成效是否传达到新产品
开发中？
Are the qualified tier 2 suppliers involved in the above mentioned activities going back up the processes and
FMEA reviews? Are the results of these activities transferred to the new products in development?
9D
定期再验证
Periodic Re-
Qualification
必须进行定期过程再审核/评审,以确保当初通过过程批准时的表现随着时间推移仍能达到要求。
Periodic process reviews and/or audit shall be performed in order to assure the maintenance over time of
performances achieved during the qualification/approval of the process.
应依据与客户商定的定期再验证的频次，就供应的系统、总成或零部件的定期再验证进行计划。
A periodic re-qualification of the supplied system, assembly or component shall be planned, with
frequencies shared with the customer.
如果客户没有特殊要求，供应商必须自己有一个定期重新认证的计划，频率不少于两年一次。
In case there is not a specific request by the customer, the supplier shall arrange a plan by itself with
frequency not lower than once every two years.
重新认证的过程必须包括所有为取得CCQ而必需进行的对于系统,总成或零部件的自我验证测试, 即当初自我
验证测试计划里的测试项目。
The re-qualification process shall include all the necessary tests for the self qualification of the system,
assembly or component for the achievement of . (Certificate of Quality and Conformity). They are the
tests that are written into the shared Self Qualification Test Plan.
9E
质量体系和环境
体系认证
Quality and
Environmental
certifications
审核员必须要求供应商提供质量体系认证和环境认证证书的复印件(ISO/TS 16949 and ISO 14000 或等同的)
The auditor shall require to supplier copy of its Quality System Certificate and Environmental Management
Certificate (ISO/TS 16949 and ISO 14000 or equivalent).
7C
控制仪器的管理
Control
instruments
management
