TARGET质量验厂2016版新标准最终定名为VFA(Vendor Factory Assessment)。
我们先来看看审核点的分布情况:
除却特殊行业的特殊标准外,小编为您整理了通用标准中的9个致命违规点:
1)审核点3:
Are there documents and records to support the manufacturing control plan is being executed? 是否有文件和记录来证明生产控制计划的执行?
2)审核点7:
Is there a documented process requiring client approval when changing materials, components, design, or manufacturing processes? 是否有成文的流程,要求当产品的原材料、零部件、设计、生产程序等方面需要改变时,工厂必须得到客户的确认方能生产?
3)审核点11:
Does the factory have a process to ensure incoming raw materials and/or subassemblies conform to US Safety and Regulatory requirements? 工厂是否有流程来确保来料及/或分包商能满足美国安全及法规要求?
4)审核点15:
Does the factory compare first production units to client approval samples and/or specifications? 工厂是否有将首件与客户确认样及/或规格说明进行比对?
5)审核点20:
Are quality processes effectively executed on all production shifts? 是否所有生产班次均有执行有效的质量控制?
6)审核点35:
Does the factory have a process for control of non conforming materials to effectively identify, segregate, and disposition non conforming product? 工厂是否有行之有效的程序文件对不合格的材料及产品进行管控?包括有效鉴别、存放和处理?
7)审核点40:
Does the factory execute a corrective action process with investigation and resolution for nonconforming products? 工厂是否有内部纠错系统,分析不合格产品的产生原因和制定相应解决方案?
8)审核点51:
Are raw materials and finished goods appropriately stored to avoid damage and deterioration? 原料及成品是否有得到妥善保存,以避免受损及变质?
9)审核点57:
Is there a documented process to show that clients are notified immediately on issues of product safety or regulatory non-compliance? 工厂是否有标准操作程序文件明确规定,如出现产品安全或法规不符合的情况,工厂必须立即通知相关客户?