今天E4 - MARK监审,CQC审核员给我们开的不符合项,不知道如何整改,希望高手能指点一下,谢谢!
1、The requirement(cop)not followed不遵守(COP)要求
Relevant directives and regulations should be available for the auditors.
有关指令和法规应该被用于审核员。
证据:1)The directive of 72/245/EEC,2006/28/EC,and ECE regulation R10.03 are not available and updated;未收集和更新指令72/245/EEC,2006/28/EC,欧洲经委会和监管R10.03。
2)"Control procedure for regulation collection and update"are laid down,but no requirements specified on how to collect the directive/regulation,the responsible person,the frequency and the update review were described.“控制程序收集和更新"规定了下来,但没有规定如何收集指令/监管,负责的人,频率和更新进行描述
2、The requirement(cop)not followed不遵守(COP)要求
COP tests and checks data should be performed,recorded and available for the auditor COP测试和检查应进行记录数据,并可以进行审核
证据:1)The outsourced COP tests and checks required by The EC directive and regulation R10 were not performed;不执行欧共体的指令和规定R10的要求COP的委外测试和检查;
2)No outsourced COP checks and test data were recorded and available for the auditor.没有委外COP检查和试验数据进行记录,并可以进行审核。
要求分析:1、根本原因;2、临时措施;3、纠正措施 |