COSTCO QMS及GMP验厂审核标准培训教材

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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。
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
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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). 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。
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AUDIT RESULT审核结果
Score • 100% - 98% • 97% - 85%( no critical or major) 无关键或主要不符 合项 •97% - 85%( with critical or major) 有关键或主要不符 合项 • 84% - 70%(no critical or major) 无关键或主要不符 合项 •84% - 70%(with critical or major) 有关键或主要不符 合项 • 69% - 60% Terms
Actions
CAP Desk Review(Collection of evidence is needed) 不符合项文件审核（需要提交整改证据） CAP Desk Review+ partial re-audit (to review CAP compliance) 文件审核 +现场跟进审核（只评估不符合 项） CAP Desk Review 不符合项文件审核 CAP Desk Review+ partial re-audit (to review CAP compliance) 文件审核 +现场跟进审核（只评估不符合 项） CAP Desk Review+ partial re-audit (to review CAP compliance) 文件审核 +现场跟进审核（只评估不符合 项） CAP Desk Review+ full re-audit 不符合项文件审核+重新现场审核
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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 Risk Management风险管理 Requirements 要求 Verification of Risk Assessment风险评估的验证 Quality Management Systems质量管理体系 Design and Development设计和开发 Incoming Materials / Supplier Chain Management 进料控制/供应链管理 Documentation Requirements 文件要求 Customer Focus, Customer Specifics, Customer Property and Compliance客户关注，规范，财产和符合性 Product Recall and Traceability 产品召回和可追溯性 Internal Audits内审 Business Planning业务应急计划 Sites and Facilities Management工厂和设施管理 Factory Facilities and Environment工厂设施和环境 Factory Equipment and Test Equipment 工厂的设备和测试设备 Foreign Contamination 异物污染 Product Control 产品控制 Warehouse Management仓库管理 Incoming Material Control 进料控制 Process Control 过程控制 Product Testing and Product Claims 产品测试和声明 Finished Products Control 成品控制 Control of Nonconforming Product 不合格品的控制 Personnel Training and Competency 人员培训和能力 Industry Module 工业模块（Toys玩具、 E and E 电子电器、 Softline 纺织）
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。
COSTCO QMS及GMP验厂审核标准培训 教材
2018-07-18
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
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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
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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：
The audit is valid for 1 year from the date of the initial audit. If any non-conforming points are found, we encourage the factory to address those points internally, so as to None for Costco have them corrected by the next required audit. 无 审核有效期为1年。如有任何的不符合项，工厂自行改善。 Any one of either moderate (orange)/minor (yellow) findings - CAP required for review internally 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 Any one of either critical/major (red)/moderate (orange)/minor (yellow) findings - CAP required for review internally prior to partial re-audit which is to be conducted in 3 months. 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 Any one of either moderate (orange)/minor (yellow) findings - CAP required for review internally 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 Any one of either critical/major (red)/moderate (orange)/minor (yellow) findings - CAP required for review internally prior to partial re-audit which is to be conducted in 1-3 months. 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 Findings - CAP required for review internally prior to partial re-audit which is to be conducted 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 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
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B. 1. 2. C. 1. 2. 3. 4. 5. 6. 7. D. 1. 2. 3. E. 1. 2. 3. 4. 5. 6. F. G.
SCORE CONTRIBUTION FOR EACH SECTION 每个模块分数分布
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SCORE CONTRIBUTION FOR EACH SECTION 每个模块分数分布
What is COSTCO FACTORY CAPABILITY AUDIT 什么是COSTCO工厂能力审核
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。