组织是否应当定义所有的过程，并且加以文件化？
Should an organization define and document all its processes?
产品设计或过程变更在实施之前，是否得到客户的文件化批准或者签署文件化豁免书？
Has written customer approval or waiver been obtained and documented prior to a design or process change being implemented into production?
对于所有设备，是否有做设备过程能力研究并文件化记录？
Has a machine process capability study been done and documented on all pieces of equipment?
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