COSTCO GMP验厂标准

COSTCO FACTORY CAPABILITY AUDIT SUPPLIER SEMINAR 2015 供应商研讨会Prepared by Iris LiuSep. 14, 2015Content 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 managementsystems 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 Costcofactories 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 announced audits. 所有审核是通知性审核。

2.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。

）3.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, productionpersons, 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A.Management Commitment and Continual Improvement管理承诺和持续改善1. Management Commitment管理承诺2.Analysis and Continual Improvement 分析和持续改善B. Risk Management风险管理1.Requirements 要求2.Verification of Risk Assessment风险评估的验证C. Quality Management Systems质量管理体系1.Design and Development设计和开发2.Incoming Materials / Supplier Chain Management 进料控制/供应链管理3.Documentation Requirements 文件要求4.Customer Focus, Customer Specifics, Customer Property and Compliance客户关注，规范，财产和符合性5.Product Recall and Traceability 产品召回和可追溯性6.Internal Audits内审7.Business Planning业务应急计划D. Sites and Facilities Management工厂和设施管理1.Factory Facilities and Environment工厂设施和环境2.Factory Equipment and Test Equipment 工厂的设备和测试设备3.Foreign Contamination 异物污染E. Product Control 产品控制1.Warehouse Management仓库管理2.Incoming Material Control 进料控制3.Process Control 过程控制4.Product Testing and Product Claims 产品测试和声明5.Finished Products Control 成品控制6.Control of Nonconforming Product 不合格品的控制F. Personnel Training and Competency 人员培训和能力G. Industry Module 工业模块（Toys玩具、 E and E 电子电器、 Softline 纺织）数分布数分布AUDIT RESULT审核结果Score Terms Actions• 100% - 98% The audit is valid for 1 year from the date of the initial audit. If any non-conformingpoints are found, we encourage the factory to address those points internally, so as tohave them corrected by the next required audit.审核有效期为1年。

如有任何的不符合项，工厂自行改善。

None for Costco无•97% - 85%( no critical or major)无关键或主要不符合项Any one of either moderate (orange)/minor (yellow) findings - CAP required for reviewinternally and audit is valid for 1 year只有中等（橙色）或次要（黄色）不符合项，后续需要文件审核关闭不符合项，审核有效期为1年CAP Desk Review(Collection of evidence isneeded)不符合项文件审核（需要提交整改证据）•97% - 85%( with critical or major) 有关键或主要不符合项Any one of either critical/major (red)/moderate (orange)/minor (yellow) findings - CAPrequired for review internally prior to partial re-audit which is to be conducted in 3months.如有关键或主要不符合项（红色），在现场跟进审核前需要做文件审核（30天内完成）， 3个月完成CAP Desk Review+ partial re-audit (toreview CAP compliance)文件审核+现场跟进审核（只评估不符合项）•84% - 70%(no critical or major) 无关键或主要不符合项Any one of either moderate (orange)/minor (yellow) findings - CAP required for reviewinternally and audit is valid for 6 months只有中等（橙色）或次要（黄色）不符合项，后续需要文件审核关闭不符合项，审核有效期为6个月CAP Desk Review不符合项文件审核•84% - 70%(with critical or major) 有关键或主要不符合项Any one of either critical/major (red)/moderate (orange)/minor (yellow) findings - CAPrequired for review internally prior to partial re-audit which is to be conducted in 1-3months.如有关键或主要不符合项（红色），在现场跟进审核前需要做文件审核（30天内完成），1-3个月完成CAP Desk Review+ partial re-audit (toreview CAP compliance)文件审核+现场跟进审核（只评估不符合项）• 69% - 60% Findings - CAP required for review internally prior to partial re-audit which is to beconducted in 1-3 months.如有不符合项，在现场跟进审核前需要做文件审核（30天内完成）， 1-3个月完成CAP Desk Review+ partial re-audit (toreview CAP compliance)文件审核+现场跟进审核（只评估不符合项）• Less than 60% CAP to be submitted to for review internally prior to full re-audit within 1-3 months 后续需要文件审核关闭NC（30天内完成），然后安排重新审核， 1-3个月完成CAP Desk Review+ full re-audit不符合项文件审核+重新现场审核AUDIT RESULT审核结果The audit is not pass/fail. The audit is for continuous improvement and the score to is to help guide the factory to make the changes. 审核不是通过/不通过。