COSTCO GMP验厂标准课件.pdfVIP

COSTCO FACTORY CAPABILITY AUDIT SUPPLIER SEMINAR 2015 供应商研讨会 Prepared by Iris Liu Sep. 14, 2015 Content 内容  What is Costco Factory Capability Audit? 什么是Costco工厂能力审核  Audit section 审核模块  Audit result Audit process 审核结果和流程  Special checkpoints except QMS除了QMS 以外的特别检查点  Identified frequent NC经常出现的不符合项 2 What is COSTCO FACTORY CAPABILITY AUDIT 什么是COSTCO工厂能力审核  Costco Factory Capability Audit combines both quality management systems as well as good manufacturing practices Since on Dec. 8, 2014(before that, it was QMS audit). Costco工厂能力审核自去年12月8 日起 是结合了质量管理体系和良好生产规范要求的审核 （在此之前，只是质量管 理体系审核）  SGS is authorized for Costco Capability Audit since 2006. All Costco factories will be audited by a 3rd party. Factory or supplier apply audit from Costco. The 3rd party lab assignment is random. Assigned third party quote, arrange schedule, conduct audit within 30 work days. SGS 自2006年起被授权Costco工厂能力审核。所有Costco的工厂都要经过第三 方审核。Costco协调员会随意指定公证行进行审核。工厂或中间商直接向 Costco 申请审核. 第三方报价，排期，实施审核，要求30天内完成。 Remark: Different qualified third party use itself audit checklist, it is different from the other qualified third party. All in all, these checklists are accredited by Costco. 注意：不同公正行用的审核检查表是不同的。但都已被Costco 认 可。 3 Document list is prepared for on site audit and for factory preparation审核前会发给工厂文件清单准备 4 Audit type and on site MANDAY 审核类型和现场人日 Audit Type审核类型：  Initial 初审 （2 mandays）  Desktop review文审(NA, 3次机会)  Partial re-audit部分重审（现场跟进）(1 manday)  Full Re-audit重审 （2 mandays）  Annual年审 （2 mandays） Remark注意： 1. All audits are