LTO驗(yàn)廠產(chǎn)品加工部分
1 - Process methodology shall be specified. Key equipment shall be capable of achieving required control
應(yīng)明確規(guī)定加工方法。關(guān)鍵設(shè)備應(yīng)能實(shí)現(xiàn)必要的控制
2 - Production process shall be specified and controlled with objective evidence of statistical control
應(yīng)明確規(guī)定生產(chǎn)流程并以統(tǒng)計(jì)學(xué)控制的客觀依據(jù)進(jìn)行控制
3 - Customer needs understood and used to determine process/ product specification
理解顧客需求并將其用于生產(chǎn)流程/產(chǎn)品規(guī)格的制定
4 - Process and final product specifications are aligned with process capability.
流程與最終產(chǎn)品規(guī)格應(yīng)符合工程能力
5 - Critical process control parameters (CPCPs) are defined with acceptable and non-acceptable limits.
以允許范圍及不允許范圍來(lái)定義關(guān)鍵流程控制參數(shù)(CPCP)
6 - CPCPs are measured and recorded.
應(yīng)對(duì)關(guān)鍵流程控制參數(shù)進(jìn)行測(cè)量與記錄
7 - The volume of product reprocessed is acceptable.
重加工產(chǎn)品的數(shù)量應(yīng)在合理范圍之內(nèi)
8 - Instruments/equipment are used to measure CPCPs & are capable of the required accuracy & precision
測(cè)量關(guān)鍵流程控制參數(shù)的儀器/設(shè)備應(yīng)達(dá)到必要準(zhǔn)確度與精密度
9 - Acceptance criteria are defined for new measuring equipment prior to installation
在安裝之前是否定義了新測(cè)量設(shè)備的驗(yàn)收標(biāo)準(zhǔn)?
10 - Breakdowns & shutdowns monitored to ensure delays/ temperature changes do not impact on quality
對(duì)故障與停工進(jìn)行監(jiān)控以確保延遲/溫度改變不會(huì)影響品質(zhì)
11 - Quality management plans specific to achievement of customer component needs shall be in place
應(yīng)制定品質(zhì)管理計(jì)劃以滿足顧客產(chǎn)品的需求