CostcoGMP审核事项和审核标准20200327.docx

COSTCO NONFOOD GMP AUDIT SUPPLIER SEMINAR 2020 供应商研讨会 Prepared by Iris Liu Mar. 27, 2020 WHEN YOU NEED TO BE SURE SG$ Content 内容 What is Costco Factory Capability Audit?什么是CostcoX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 bot/7 quality management systems as we〃 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) 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。授权审核第三方报价，排期，实施审核，要求30天内完成。 Remark: Different qualified third party use same checklist.注意：不 同公正行用的 审核检查表是相同的。 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 SGi Request Document List （Costco QMS GMP Audit） 所需文件/证件清单 E Adobe Acrobat Section Nd Items项目与内容 Available 提快 Document YES NO General Requirements —般要求 □ .1 Brief introduction of factory 工厂商介 0.2 Business license 营业执照 0.3 Organization chart公司组蛆兼■构图 0.4 Factorys plane figure-factory floor plans （公司）~ 区~房平 面匣 Factory profile 工厂概况 0.5 Production process ctiart 主产工序流程匯 □ □ □ 0.6 ISO 9001 certificate or other auality Assurance systems- ISO9QD1 证书 或其他顧■保证系统 □ □ □ 0.7 Relevant product lab test reports or safety certification marksautticrization document, such as UL,ETL,CE,CSA,EU REACH.RoHS.产品霜试或雰全认证标志授权文件，比如 UL.ETL,CE.CSArEU REACH,RoHS. □ □ □ 1.1 Quality manual 质■:手团 1.2 Quality Procedure? B程序 1. Man ag e ment 1.3 Qualrty policy 质■方针 □ □ Commitment and Continual 1.4 iM a nag? me nt review procedure and records 菅壁评审程序记承 I