SUPPLIER:________________________________DATE:________________________________ LOCATION:___________________________________________DUNS:________________________________ PART NO./DESCRIPTION:_______________________________AUDITOR:_____________________________ GENERAL 通则Yes/No COMMENTS
1)Is there a production released drawing? Is it balloned ? 生产用图纸
是否已发布? 是否清楚?
2)Have customer requirements been defined in measurable terms?
客户要求是否已转化为可测量的术语?
3)Are "Special Characteristics" identified on the part print, material
specification or engineering specification? 特殊特性是否在图纸,材
料规范或工程规范中确认?
4)Is the KPC / QCI identified, at the generating operation, on the PFD
(DP268)? 是否在PFD(DP268)中标识出KPC/QCI?
5)Are process characteristics (parameters) identified at operations that
affect "special characteristics" (KPCs and/or QCIs)? 在操作中影响
特殊特性(KPC和/或QCIs)的过程特性(参数)是否已确认?
6)Is the control plan, process flow diagram, and pfmea linked (process
step 10 is same on pcp and pfmea) 是否控制计划, 过程流程图,
PFMEA 相互联系?
7)Has a line side review been performed? 是否进行在线检查?
8)Is there an early containment plan? 是否有早期遏制计划?
SUPPLIER INPUT FORM / CCP 供应商输入表格/控制计划Yes/
No
COMMENTS
1)Have process verification activities (modeling, simulation, trial runs,
etc.) taken place? 是否进行过程验证(模型, 模拟, 试生产, 等.)
2)Has FTQ been implemented for KPCs / QCIs? Are FTQ alarm limits
identified on the PFD (DP268) and the CCP? Are reaction levels for FTQ defined. 是否针对KPC/QCI执行FTQ?是否在PFD 和控制计划中确认FTQ警戒限制?是否定义了关于FTQ 的反应等级?
3)Does the process that generates the KPC / QCI demonstrate
stability (X-bar and R charts)? KPC/QCI在过程中是否稳定(X-bar 和R图)
4)Does the process that generates the KPC / QCI demonstrate
process capability? What is the Ppk / Cpk value?
Note: If the process does not meet the Delphi requirement, an action plan to improve the process must be initiated. Ppk/Cpk值是否表明工艺能力足够?注释:如果过程没有达到Delphi要求, 必须开始提高过程的行动计划.
5)Is the measurement method for the KPC / QCI / KCC / QCC on the
CCP? 控制计划中是否有关于KPC/QCI/KCC/QCC的测量方法?
6)Has a GR&R been performed for the measurement/ verification
system? Has the measurement system been calibrated? 是否已对测量/验证系统进行GR&R分析?是否已对测量系统进行校验?
7)Has the sampling plan for the KPC / QCI / functional verification
been identified on the CCP? Does it make sense (does it address the primary family of variation)? 关于KPC / QCI /功能性验证的抽样计划是否已在控制计划中确认?是否合格(是否涵盖基本变差)?
8)Is error-proofing for the KPC / QCI identified on the CCP? 关于
KPC / QCI 的防错是否已在控制计划中确认?
9)Is lot control identified on the CCP? Does the lot size and frequency
make sense (does it allow easy access to the last known "good"
check)? 在CCP中是否有批次控制?批次的大小和频率是否合理(它是否可以快速找到最近的好品)?
COMPREHENSIVE CONTROL PLAN 完整的控制计划Yes/
No
COMMENTS
1)If Prototype Supplier, has Prototype Control Plan been developed &
does it contain dimensional measurements & functional tests. 如果样件供应商有样件控制计划,它是否包含尺寸测量和功能测试?
2)Have both Pre-Launch & Production Control Plans been developed?
是否有用于前期生产和正式生产的控制计划?
3)Do Control Plans include receiving inspection, manufacturing
processes, packaging, labeling, & dock audits? ( Dock to Dock) (控制计划是否包括来料检验, 制造过程, 包装, 标识和发货前的检
查?(Dock to Dock)
4)Is the length of time that the Pre-launch Control Plan will be effective
specified? Exit criteria established? 前生产所需的时间是否确定?是否已建立退出标准?
5)Was an internal, multi-disciplinary team used to develop and review
the Control Plans at the supplier? 供应商是否有一个由内部多个部门的人员组成的团队来编制和审核控制计划?
6)Do the Control Plans provide a control method & frequency for every
dimension/ feature that is on the print/specification? 产品图纸/规范
上的每一个尺寸/特性在控制计划中是否都有相应的控制方法和控制
频率?
7)Does the control plan sampling frequency assure lot compliance? 控
制计划抽样频率是否确保和批次一致?
8)Was Control Plan developed using CVM(Supplier Input Form),
PFMEA & PFD? 控制计划是否运用CVM(SIF), PFMEA和PFD?
9)Are Job Set-ups ( e.g. Initial set-up, material change over) included
in control plan? 控制计划是否包括调试(例如:初始开机,物料调换)?
10)Is Functional Gaging used where possible? 如果适用,是否使用功能
性检具?
11)Have appropriate Error Proofing techniques been implemented with
methods (masters) & frequency to verify functionality and listed in
control plan? 是否有适当的防错,包括方法(例如标准样件)和频率,来
验证功能性并在控制计划中体现?
12)Are the Sample Size & Frequency of Control Methods specified
appropriate based on the process capability? Production rate?
Number of cavities or dies? Standard pack? 控制方法中的抽样大
小和频率是否基于过程能力,生产率,模穴数和标准包装?
13)Is FTQ for part at acceptable level? Is Gate Chart being used to
depict pareto of FTQ analysis & to document action plans? 是否
FTQ在一个可接受的水平?门图是否用于FTQ的柏拉图分析和记录行
动计划?
FIRST TIME QUALITY 一次下线合格率Yes/
COMMENTS
No
1)Did the AQE confirm that the alarm limits were established based on
current process rejects data? AQE检查警戒限制的建立是否基于目
前过程不合格品的数据和资料?
2)Did the AQE review that the alarm limits were communicated to
operators? AQE检查警戒限制是否已经与操作人员进行了沟通和交
流?
3)Did the AQE confirm that the reaction plan was established by
defect and evidence of implementation is available? AQE确认反应
计划是否已针对缺陷建立并有相关执行的证据?
4)Did the AQE review that the operator has sufficient tools and skills in
order to identify product discrepancies? AQE检查操作人员是否有
足够的工具和技能以确认产品异常?
5)Did the AQE confirm that the rejected parts were removed from cell
station on a defined frequency? AQE确认不合格品是否以确定的频
次从工作站被移走?
6)Did the AQE confirm that the FTQ trend chart is in PPM ‘s by cell
and shift? AQE确认FTQ趋势图是否用PPM计量并按班次,工作站别
分开?
.
7)Did the AQE confirm that is there an evidence of an improvement
plan developed? AQE确认是否有发展改善计划的证据?
8)Did the AQE verify that a corrective action has being implemented? AQE验
证纠正措施是否已执行?
9)Did the AQE confirm that the recorded data is up-dated to reflect the
corrective actions effect? AQE确认记录的数据是否已更新并反映纠
正措施的效果?
10)Did the AQE verify If corrective actions were effective when new
alarm limits were established? AQE验证当纠正措施有效时是否建
立新的警戒限制?
11)Did the AQE review if lessons learned were incorporated into
existing documents as applicable? AQE检查员所得到的经验教训是
否已综合到现存的文件中?
ERROR PROOFING 防错Yes/
No COMMENTS
1)Is the reason and function for the error proofing device understood? 防错装
置的原因和功能是否已被理解?
2)Are all the components of the masters identified to ensure that they
will not be mixed with good product? 是否所有的标样已被识别以确
保不会混入好品中?
3)Are error proofing devices registered? See Delphi Error proofing
Registration form.(Best Practice) 是防错装置是否已注册?见Delphi
Error proofing Registration form.
4)Are the error proofing devices setup in the "Fail Safe" mode, to
reject parts unless they are proven good. 防错装置是否被设置为"失
效安全"模式, 假如产品是次品要拒收?
5)Does the error proofing device give the operator a warning or stops
the process? 防错装置是否提醒操作人员或停止操作?
6)Are the error proofing devices checks as part of a layered audit? 分
层审核时是否对防错装置进行分层检查?
7)Has a line side review been done on the error proofing devices? 在
线检查时是否对防错装置进行检查?
8)Is there a master list of error proofing devices, documenting location,
type of device, audit frequencies, etc? 是否有一个防错装置清单标
明位置,装置类型,检查频率等?
LOT CONTROL 批量控制Yes/
No COMMENTS
1)Has each lot been validated per the performance specifications and
control plan requirements? 根据性能规范和控制计划的要求, 是否每批产品性能已进行有效性验证?
2)Is there structural integrity in the functional areas (e.g. porosity,
hardness, embrittlement, etc)? 功能方面是否有结构的要求(如:气孔,硬度,脆变等)?
3)Is there dimensional integrity in the functional areas? 功能区是否有
尺寸的要求?
4)Is there visual integrity in the functional areas? 功能方面是否有目视
检查的要求?
5)When KCCs or QCCs are out of control , are all parts contained
during the period when the process is out of control? 当KCC和QCC 过程失控,是否对这期间所有的产品进行遏制?
6)Are inspection samples being taken from each variation stream in
the process? 是否有针对各种变化因素的检验样品?
7)Is there additional risk in using this lot because the operators who
are normally involved in processing the material were not present
during the manufacturing of this lot? 通常进行操作的操作人员的缺席是否会增加该批次产品生产的风险?
8)Have all preventative maintenance activities for all processes
required to manufacture this lot been completed? 是否进行了预防性保养?
9)Are lots identified to allow for recall of all nonconforming and
suspect material? 是否可以依据确定的批次召回所有的不合格品和可疑品?
10)Are standard lot quantities called out in the Comprehensive Control
Plan? 在全面的控制计划中是否规定了标准批次的数量?
11)Were all the Key & Quality Control Characteristics for the lot within
the required specifications? 是否每一批次的关键/质量控制特性均符合规范?