LTO验厂产品加工部分
2018-03-02
LTO验厂产品加工部分
1 - Process methodology shall be specified. Key equipment shall be capable of achieving required control
应明确规定加工方法。关键设备应能实现必要的控制
2 - Production process shall be specified and controlled with objective evidence of statistical control
应明确规定生产流程并以统计学控制的客观依据进行控制
3 - Customer needs understood and used to determine process/ product specification
理解顾客需求并将其用于生产流程/产品规格的制定
4 - Process and final product specifications are aligned with process capability.
流程与最终产品规格应符合工程能力
5 - Critical process control parameters (CPCPs) are defined with acceptable and non-acceptable limits.
以允许范围及不允许范围来定义关键流程控制参数（CPCP）
6 - CPCPs are measured and recorded.
应对关键流程控制参数进行测量与记录
7 - The volume of product reprocessed is acceptable.
重加工产品的数量应在合理范围之内
8 - Instruments/equipment are used to measure CPCPs & are capable of the required accuracy & precision
测量关键流程控制参数的仪器/设备应达到必要准确度与精密度
9 - Acceptance criteria are defined for new measuring equipment prior to installation
在安装之前是否定义了新测量设备的验收标准？
10 - Breakdowns & shutdowns monitored to ensure delays/ temperature changes do not impact on quality
对故障与停工进行监控以确保延迟/温度改变不会影响品质
11 - Quality management plans specific to achievement of customer component needs shall be in place
应制定品质管理计划以满足顾客产品的需求
