QPA 制程稽核准则

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PROCESS AUDIT GUIDELINES

制程稽核准则

SUGGESTED CONTENT包含的内容

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。

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

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

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

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

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