COSTCO GMP验厂标准

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

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

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, 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

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）