QPA-制程稽核准则

PROCESS AUDIT GUIDELINES
制程稽核准则
1.0 SUGGESTED CONTENT包含的内容
1.1 WORK INSTRUCTIONS作业指导书
Available at each process step
每个步骤是否被执行
Work Instruction under revision control and at current revision level
作业指导书是否有版本管制及当前版本。

Calls out current production part number and revision level
有没有注明产品编号及版本。

Calls out direct materials P/N, description, usage, and designator
有无直接罗列所用材料料号，规格，用量，点位。

Calls out operation machine name & station number, machine program name & revision, fixtures name/part number & revision
有无机器名称/编号，机器程序名/版本，治具名/编号/版本。

Call out tools/gages with part number or name, indirect materials with detailed description, and their working conditions
有无罗列所用工具及计量器名称或编号，以及用到的间接材料（如胶，锡丝）有无具体说明，包括他们工作条件。

Calls out work process/instruction for the station
每一站有无罗列作业步骤及作业指导。

Call out highlights/special notes for the operation
在作业指导书中有没有对相关注意事项做重点标识。

1.2 OPERATOR作业员
Is operator certified for operation
作业员是否有受过相关作业资格培训
If operator is in training, verify adequate supervision
在训新员工上线是否有人做足够的监督检查
Ongoing program for re-certification of operators
对作业员是否有再认证计划.
Is operation staffed per Work Instructions
作业指导书是否规定各操作负责人员.
Is operation being performed per Work Instructions
作业指导书上规定的操作是否都被执行.
Is the operator monitored for his/her performance
作业员的绩效是否被考核
1.3 MATERIALS材料
Production materials for each operation specified in Work Instructions and under A VL control 作业指导书是否有罗列出每站所需用到的生产材料, 并列入管制.
Verify production materials are revision controlled & current
检查生产材料是否有版本管制及目前版本状况
Handling & storage guidelines called out in Work Instruction
作业指导书中是否定义材料处理&存储办法.
Compliance with handling & storage guidelines documented
材料处理&存储办法是否被有效执行
Scrap and nonconforming material is isolated from normal production
废料和不良品是否与良品隔离
Material preparation operations documented and controlled
备料动作有无文件说明并被控制
Controlled by an effective FIFO system
是否有一个有效的先进先出的系统,并被执行
Verify traceability of materials
验证材料的可追溯性
Self audit system to ensure correct material usage
有无自检系统以确保材料的正确使用
Materials are clearly marked/identified on line and storage area
在产线上及存储区的材料是否有清楚的鉴别标识
1.4 EQUIPMENT / TOOLING / FIXTURES仪器/工具/治具
Calibration校准
Preventive maintenance (PM) records and schedules, maintenance log
预防保养履历记录,时间表,保养日志
Hour log maintained between PM’s, replacement, etc.
预防保养，更换等有无做时间记录，按小时数实施
Tooling & fixtures identified by part number and revision
工治具编号与版本
Operating procedure available at each operation
是否有对应于每一操作的作业程序
Cycle count management / hour log for tooling
对工具模具有无做周期循环/小时数管理
ECO/ECN tracking
工程变更单/工程变更通知跟踪
Machine & tool capability studies performed and on file
是否完成仪器工具性能研究并保存相关文件
1.5 ESD CONTROL (IF APPLICABLE)静电管制(如可适用)
Training records for all personnel
对所有相关人员的培训记录
Daily test logs in place
现场测试日报
All ESD systems in good working order and are properly installed and maintained
所有正常控制的静电系统是否被恰当地安装并保养维护
ESD earth ground rod is checked for grounding impedance and recorded on annual basis
是否每年检查ESD接地棒对地阻抗并记录
ESD grounding main system is checked for grounding impedance and recorded on monthly basis 是否每月检测ESD接地系统对地阻抗并记录
Instrument/fixtures/benches are checked for grounding impedance and recorded on weekly basis 是否每周检测并记录仪器设备/治具/椅子等对地阻抗
Wrist/heel strip, and/or conductive shoes are checked and recorded by shift
是否每班检测并记录静电手环或传导鞋。

Wireless wrist strip is not allowed unless used with ionic blower and conductive floor
无线手环是不被允许的，除非在离子吹风机和传导地板环境中使用
All semiconductor materials are in ESD free container, package or bin when/during storage, transfer, and handling
所有半导体材料在存储，运输及搬运中必须用防静电容器，防静电袋等进行静电防护。

People, semiconductor materials, machines, instrument, tools, fixtures, and working benches at ESD sensitive operation stations are grounded
在静电敏感站的人员，半导体材料，机器，工具，治具及工作桌椅必须接地。

1.6 QUALITY CONTROL品质控制
Effective SPC in place and closed loop corrective action is taken when out-of-control occurs
现场是否有做有效的SPC管制，当超出管制点时是否做CLCA。

Control limits of control chart are reviewed on monthly basis
是否每月审查管制图之上下限
Effective Continuous Improvement Process (CIP) in place
现场是否实施有效持续改进过程
Quality acceptance/rejection criteria established for each process step
每段制程是否建立允收/拒收标准
Effective quality inspection and measurement capability in place at each inspection station
在每一个检验站是否有进行有效的品质检验与测量
Evidence that operators receive quality feedback and are responsible for the quality of their work 是否保证作业员可收到品质反馈并改进他们作业品质。

Self audit system in place and effective
是否有自我稽核系统并有效实施
1.7 PRODUCTION PROCESS / FLOW生产制程/流程
Does layout prevent misrouting of product and minimize handling
线体设置是否能保证制程顺畅（产品不滞流）以达成最少的人工处理。

Evaluate physical layout for proper line balance and potential bottlenecks
线体规划有无对其平衡及潜在瓶颈进行评估
Is flow of defective product documented
是否有文件定义不良品的处理流程
Is line stop criteria documented and enforced to prevent excessive buildup of defective product 是否有文件定义停线标准以强迫防止生产额外不良品
Is customer’s process flow documented
是否文件化客户制程流程
1.8 TEST PROCESS测试过程
Verify that test process is documented
检查测试步骤方法是否文件化
Is test equipment and software under revision control
是否有对测试仪器与软件进行版本管制
Test yield and defect data collection system exists, is automated and collects all data
现有的测试单元及不良数据收集系统是否是自动化以及是否能够收集到所有数据
Feedback to the defect source from test yields and defect data for improvement
测试区域是否能及时反馈不良以加以改善
Test process and production flow prevents test escapes or misrouting of product
测试过程以及生产流程是否可以防止测试漏失及保证生产顺畅
1.9 FAILURE ANALYSIS PROCESS不良分析过程
Is process documented
该制程是否文件化
Are production materials and repair materials effectively controlled to prevent misrouting or wrong parts being used
对生产及维修材料进行有效地控制以防止用错料。

Are there proper skills, training, and equipment to support failure analysis
是否有适当的技巧，培训及设备支持不良分析
Age and quantity of debug WIP is controlled
是否对调试工具的使用年限及数量进行控制。

Effective method to prioritize debug activities
使用有效的方法对调试动作优先顺序进行区分
Failure analysis output drives corrective actions
是否能从不良分析之结果得出改善措施
Failure analysis data communicated to 客户on regular basis
是否能定期将不良分析数据传送给客户
Process in place to verify effectiveness of FA and corrective actions
是否有适当的过程来验证不良分析及改善措施的有效性
Process in place to evaluate No Fault Found defects (also CND – Can Not Duplicate)
使用适当的方法评估no fault found不良。

Rework Process rework过程
Procedures for each type of rework operation
确定每种类型返工的流程
Proper tools in place to rework all production materials and components used
在适当地方中使用适当工具rework所有的制造材料和元件
Data collection for all rework performed
收集所有rework数据
Data collection automated / filing computerized
数据收集自动化/ 用计算机进行整理
Data feedback to defect source
将数据反馈到不良源中心
Accept/reject criteria defined and available at rework station
对接收/拒收标准进行定义以及是否可以应用于Rework站
Verification of rework quality
验证rework质量
Documented process flow for rework operations
对rework操作的流程进行文件化
Reworked material marked (physical marking or computer scan)
对已rework材料进行标注(对其本身进行标注或计算机扫描)
Rework history available for all reworked materials
将所有rework材料列入可用的rework档案
Reworked materials go through proper test and inspection re-flow channel
对已rework材料进行适当的测试及回流检验
1.10 PACKAGING / SHIPPING PROCESS 包装/出货过程
Procedure in place at packaging and shipping station
在包装及出货站是否有适当的流程
Procedures are part number specific
该流程是否区分不同的料号
Procedures comply with customer’s Packaging and Shipping spec
该流程应与客户包装与出货规格一致。

1.11 RMA PROCESS FOR RETURNED MATERIAL 对于退回材料的RMA过程
RMA process documented
RMA过程是否文件化
RMA test process flow documented
RMA测试流程是否文件化
System in place to keep line and field returns segregated
是否有适当的系统将产线与市场返回品进行隔离
Closed loop corrective action process in place
是否有适当的CLCA流程
Minimum shippable revision level control and marking system in place
是否有适当的最小装载版本水平控制及标识系统
Data collection for all rework performed
对所有Rework过程的数据进行收集
Data collection filing computerized
使用计算机对收集的数据进行处理
Data feedback to defect source
将数据反馈到不良源中心。