COSTCO QMS及GMP验厂审核标准培训教材.pptx

COSTCO QMS及GMP验厂审核标准培训教材2018-07-18Content 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2014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）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.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。Document list is prepared for on site audit and forfactory preparation审核前会发给工厂文件清单准备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：All audits are announced audits. 所有审核是通知性审核。All areas under the same business license of the audited factory will be covered.原则上同一营 业执照下的所有范围都应该覆盖。（即使工厂有几个厂区和不同的生产线。）No certificate will be issued for the Costco Factory Capability audit program. Costco 工厂能力审核不出具证书。MAIN AUDIT METHODS主要审核方式Management staff interview管理人员访谈On-site inspection现场审核Document review文件审核Workers interview, focus on warehouse person, inspectors, production persons, etc. 工人访谈, 主要关注仓库人员，检验人员，生产人员等。Section of Checklist检查表模块Management Commitment and Continual Improvement管理承诺和持续改善Management Commitment管理承诺Analysis and Continual Improvement 分析和持续改善Risk Management风险管理Requirements 要求Verification of Risk Assessment