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Intertek Costco Non Foods GMP FQA Audit Document Request List Aug2018

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Costco Non-Foods GMP/FQA Audit Document List
所需文件/证件清单
Section
Items & Description 项目与内容
No.
Available 提供
YES
NO
N/A
General Requirements 一般要求
Factory profile
工厂概况
0.1
Brief introduction of factory 工厂简介
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0.2
Business license 营业执照
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0.3
Organization chart 公司组织架构图
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0.4
Factory’s plane figure-factory floor plans (公司)厂区/厂房平面图
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0.5
Production process chart 生产工序流程图
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ISO 9001 certificate or other Quality Assurance systems. ISO9001证书
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0.6
或其他质量保证系统
Relevant product lab test reports or safety certification marks' authorization
0.7
1. Management
Commitment
and Continual
Improvement 管
理承诺和持续改
善
2. Risk
Management
System 风险管
理体系
权文件, 比如 UL, ETL, CE, CSA, EU REACH, RoHS.
Quality Manual 质量手册
□
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1.2
Quality Procedures 质量程序
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1.3
Quality policy 质量方针
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1.4
Management review procedure and records 管理评审程序记录
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1.5
Quality objectives and monitoring records, such as on-time delivery, outgoing
quality, complaint rate, etc. 质量目标 (比如:准时交货率、出厂质量、投诉率等
) 和监控记录
□
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1.6
CAP for internal and external audits 内部和外部审核不符合项的改善
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1.7
Order review records 订单评审记录
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2.1
External documents (legislation, mandatory standards and Industry / customer
standards) list and control records 外来文件(法规、强制标准和工业/客户标准)
清单和管控记录
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2.2
Product & Process Risk Assessment procedure and records 产品及生產過程风险评
估程序和
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2.3
记录
Product & Process Risk Assessment action and validation 产品及生產過程风险评估
措施和验证
□
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证
Customer
satisfaction investigation and action records 客户满意度调查
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3.2
Customer Property Safeguard Policy 客户财产保护政策
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3.3
Specifications for raw materials, Semi-finished Products and finished products 原料
、半成品、成品规格说明书
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Monitoring procedure and records of suppliers/subcontractor 供应商/分
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3.5
Purchase orders and purchase contracts 采购单、采购合同
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3.6
Traceability procedure and test records 追溯程序和测试记录
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3.7
Incident Management Procedure 事故管理程序
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3.8
Procedure for notification to customer 客户告知程序
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3.9
Recall procedure and mock records 召回程序和模拟记录
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□
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3.4
August 2018
产 品测试或安全认证标志授
1.1
3.1
3. Management
Systems 管理体
系
document, such as UL, ETL, CE, CSA, EU REACH, RoHS.
和改善措施记录
包商评审程序及记录
Page 1 of 6
Costco Non-Foods GMP/FQA Audit Document List
所需文件/证件清单
Section
N/A
□
□
□
3.11
Corrective action procedure and records 纠正措施程序和记录
□
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3.12
Protection of customer property Procedure or Policy and records 客户财产(
包括软件、文化和产品)保护程序或政策
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3.13
Document control procedure 文件控制程序和记录
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3.14
Internal audit procedure, plan and records 内部审核程序、计划、记录
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3.15
Records of corrective actions and preventative actions for internal audit
内审纠正与预防措施记录
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4.1
Segregation procedure (when needed) 隔离程序(需要时)
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4.2
Factory drinking, smoking policy 工厂饮食、抽烟政策
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4.3
Personal wearing policy 员工穿戴规定
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Sanitation schedule, cleaning procedures and records 清洁计划, 清洁
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Chemicals handling instruction, list with MSDS and control records 化学
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Cleaning services outsourced contract (when available) and service
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Cleaning procedures 清洁程序和记录
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Pest control procedure, risk, control plan and inspection records 虫害控
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Training record for the internal or external pest control personnel 内部
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Foreign materials control procedure and records 异物(玻璃, 利器,
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4.6
4.7
4.8
4.9
4.10
4.11
程序和记录
品操作指引、清单、MSDS和控制记录
records 清洁服务外包合同(当有时)和服务记录
制程序、风险、控制计划和检查记录
External sub-contract pest service provider Contract (when
Available) 与外部分包虫害服务机构的虫害控制合同(当有时)
虫害控制人员培训记录
化学品,虫害)控制程序和记录
4.12
Metal detector calibration procedure and records, use procedure and products
test records 验针机校准程序和记录,使用程序和产品测试记录
4.13
Broken needle control procedure and records 断针控制程序和记录
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Wood pallet control policy and inspection records 木制栈板控制政策和
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Reference samples and information/specification 参考样品程序及其信息
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5.2
List of approved chemicals with corresponding Brands /
Manufacturers 批准的化学品和相应品牌/生产商清单
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□
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5.3
Design Change Notification (DCN) or Engineering Change Notification (ECN) 设
计变更通知或工程变更通知
□
□
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5.4
Updated SVHC list and test report/ COC for incoming materials, components,
final products 最新SVHC清单, 进料、配件、成品的测试报 告或符合性声明
Materials/chemical/ final goods storing control procedure 原料、化学品
□
□
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4.14
5.1
5.5
August 2018
NO
Complaint handling procedure and records 客户投诉处理程序和记录
4.5
5. Product
Control 产品控
制
Available 提供
YES
3.10
4.4
4. Sites and
Facilities
Management 工
厂和设施管理
Items 项目与内容
No.
检查记录
或规格说明书
、成品存储控制程序
Page 2 of 6
Costco Non-Foods GMP/FQA Audit Document List
所需文件/证件清单
Section
6. Product
Testing and
Product Claims
产品测试和产品
声明
Available 提供
YES
NO
N/A
5.6
Packaging specification 包装规格说明书
□
□
□
5.7
Non-conforming materials and products control procedure and records
不合格品控制程序和记录
□
□
□
5.8
Procedure for identify, handle, approval, storage, and retention of reference
samples, and relevant information and specification. 參考樣品的識別, 處理, 核
准, 儲存 及 保留期限的程序。與及相關的產品信息及規格。
□
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FQC/OQC inspection sampling, defect classification, inspection and test standard
and records 终检抽样、缺陷分级、检验和测试标准及记录
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□
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Release Procedure and records 产品放行程序和记录
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6.3
Product claims 产品声明
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7.1
Pre-production meeting Procedure 产前会议程序
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Pre-production meeting records and the corresponding CAP 产前会议记
□
□
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6.1
6.2
7.2
7. Process
Control 过程控制
Items 项目与内容
No.
录及相应的纠正改善措施
7.3
IQC sampling, defect classification, test standard, specifications and records
来料抽样、缺陷分级、测试标准和规格书及检验报告
□
□
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7.4
Inspection Work Instructions for Goods returned from sub-contractors and
inspection records 分包产品检验指导书和检验记录
□
□
□
7.5
Heavy metals content (e.g. Lead) report for paints, coatings and non- paint
components (hardware, labels, etc.) 油漆,涂层,没有油漆的部件
(金属,标签等)重金属含量(比如铅)报告
□
□
□
Inspection/test equipment calibration schedule, calibration working instruction
and reports 检测设备校准计划,校准作业指导书,内外校报告
□
□
□
Equipment operation instructions, maintenance plan and records 设备
□
□
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Products Packing Control Procedure 包装控制程序
□
□
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Package label, bar code and outer carton verification records 包装标签
□
□
□
□
□
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7.6
7.7
7.8
7.9
操作指引、维护计划和记录
、条形码和外箱验证记录
IPQC sampling, defect classification, inspection standard and records
7.10
制程抽样、缺陷分级、检验测试标准和记录
Industry Module 工业模块
(Select the one which is applicable for the products manufactured in the audited factory)
(选适合工厂所生产的产品的类别)
7.11
Shade checking records for fabric 面料色差检验记录
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7.12
List of Approved light sources per client 客户批准的光源清单
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Fabric and Trims and accessories inspection procedure and records 面
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7.14
Shade matching procedure 色差匹配程序
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7.15
First sample inspection records 首件检验记录
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□
7.16
Fabric shrinkage test 缩水测试记录
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□
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7.17
Fabric relaxation procedure and records松布程序和记录
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7.18
Cutting pieces inspection procedure and records 裁片检验程序和记录
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□
7.19
Cut panel replacement 裁片替换程序
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7.13
August 2018
料和辅料检验程序和记录
Page 3 of 6
Costco Non-Foods GMP/FQA Audit Document List
所需文件/证件清单
Section
Fusing quality monitoring procedure and records 粘衬质量监控程序和记录
Available 提供
YES
NO
N/A
□
□
□
□
□
□
□
□
□
□
□
□
7.24
Laundry management, including approved sample, working instruction, inspection
records, etc. 水洗管理,包括样板,作业指导书, 检验记录等
□
□
□
7.25
Water testing records 水测试报告
□
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□
7.26
Embroidery management, including approved sample, working instruction,
inspection records, etc. 绣花管理, 包括样板, 作业指导书, 检验记录等
□
□
□
□
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7.20
7.21
7.22
7.23
Apparel_Home
Textile_Soft
Toys服装、家纺
及毛绒玩具
Items 项目与内容
No.
7.27
7.28
7.29
7.30
Sewing WI and Measurement inspection records 车缝作业指导书和测量
检查记录
Knitting machines Instruction 针织机器指引
Labels and hangtags management procedure and records 标签和吊牌
管理系统及控制记录
Pressing management, including pressing standard, inspection
records, etc. 熨烫管理,包括作业指导书,检验记录等
Snap and fastener attachment processes 按扣、钉钮管理
Defective/overrun product handling procedure and records 次等品和余
量产品处理程序及处理记录
Attachments components ( example, snaps, buttons) test working instruction
and records 附着物(比如纽扣)的测试作业指导书和记录
Test report for fabric or apparel by in house lab or 3rd party lab,
7.32
including heavy metal test, fabric composition, color, tensile, tear test etc. 布料
或服装的测试报告(内部或第三方实验室测试),包括重金属 含量,成分
,颜色,拉力,撕裂测试等
Test certificates for flammability for filled products 填充产品可燃性测试 报告
7.33
Law Labels 法律标登记资料和标签
□
□
7.34
Filling management WI and records 填充管理作业指导书和记录
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□
□
7.35
Work instruction for cleaning agent application 清洁剂使用作业指导书
□
□
□
7.36
Incoming fibers test records 纤维检验记录
□
□
□
7.37
Incoming yarn test records 纱线检验记录
□
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□
7.38
Blending oils heavy metal test report 混合油重金属测试报告
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□
□
□
□
□
□
□
□
7.41
Other WI, Inspection records, etc. for yarn exist processes (such as Carding, Sizing,
Weaving, etc.) 存在的其他纱线工序(比如: 梳棉,上浆, 织造等)作业指导书
,检验记录等
□
□
□
7.42
WI, Inspection records, etc. for Fabric Pre-Treatment and Production 布料预处理
和生产作业指导书,检验记录等
□
□
□
7.11
Authorization document for National or International safety certification marks
国家或国际的安全认证商标授权使用文件
□
□
□
7.31
Integrated_Texti
le 整合纺织
(Including
"Apparel_Home
Textile"包括"服
装及家纺")
August 2018
7.39
7.40
Yarn conditioning Working Instruction and records 纱线调整作业指导书和记录
Mixing & Blow room (blend ratio and records, WI for blow room
Machine, etc.)混纱和飞纱(混合比例和记录,设备作业指导书,等)
Page 4 of 6
Costco Non-Foods GMP/FQA Audit Document List
所需文件/证件清单
Section
E&E 电子电器
Footwear 鞋類
Furniture 家具
General
Hardlines 普通
消费品
August 2018
Items 项目与内容
No.
Available 提供
YES
NO
N/A
7.12
RoHS related materials, such as BOM, test report, claims
RoHS相关的资料,如BOM,测试报告,声明等.
□
□
□
7.13
Inspection reports showing functionality of electronic components
电子配件的功能性检测报告
□
□
□
7.14
Other WI, Inspection records, etc. for exist processes(such as Molding, Coating,
SMT, hand soldering, etc.) 存在的其他工序(比如: 注塑、喷涂、SMT, 手工焊等
)作业指导书,检验记录等
□
□
□
7.15
ESD procedure 防靜電程序
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□
□
7.16
Hi-pot check 打高压检查
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7.11
Inspection criteria for glue/adhesive/paints and Inspection records 胶水/
粘合剂/染料检验标准和记录
□
□
□
7.12
Fitting checking procedure and records 试穿检查程序和记录
□
□
□
7.13
Paper patterns checking 纸板检查记录
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□
7.14
Cutting procedure, cutting pieces inspection procedure and records 裁切程序、
裁片检验程序和记录
□
□
□
7.15
Other WI, Inspection records, etc. for exist processes (such as Vulcanizing,
Injection, Printing, Stitching, Eyeleting, Lasting, etc) 存在的 其他工序(比如: 硫化
、注塑、印刷、车缝、打鞋眼、成型等)作业指导 书,检验记录等。
□
□
□
7.16
Mold-prevention measures Procedure 防霉措施程序
□
□
□
7.11
Fumigation Certificates for Wood 木材熏蒸证书
□
□
□
7.12
Fire Resistant test certificates 阻燃测试证书
□
□
□
7.13
Natural materials - wood and leather, the species (such as basswood, maple, etc.),
the grade and COO (Country of Origin) traceability 天然原料 (木头, 皮革等),级别
和原产地的追溯资料
□
□
□
7.14
CARB related materials 相关资料
□
□
□
7.15
Moisture content of the wood 木材湿度测试记录
□
□
□
7.16
Other WI, Inspection records, etc. for exist processes (such as Cutting, Drilling,
Sanding, Sewing, Coating, Stuffing, etc) 存在的其他工序(比如: 切割、钻孔、
打磨、车缝、喷涂、填充等)作业指导书,检验记录等。
□
□
□
7.17
Cutting procedure, cutting pieces inspection procedure and records 裁切程序、
裁片检验程序和记录
□
□
□
7.18
Cut panel replacement 裁片替换程序
□
□
□
7.11
Phthalates test report 邻苯二甲酸盐测试报告
□
□
□
7.12
WI, Inspection records, etc for exist processes(such as Fabric relaxation,
Embroidery, Cutting, Drilling, Polishing, Sewing, Coating, Molding, etc.) 存在的工
序(比如: 松布、绣花、切割、钻孔、抛光、车缝
、喷涂、注塑等)作业指导书,检验记录等。
□
□
□
7.11
Phthalates test report邻苯二甲酸盐测试报告
□
□
□
7.12
Chemical analysis for raw materials (Glue/adhesive/dyes etc.), management
procedures and records 原材料(胶水/粘合剂/油漆等)的化 学分析报告、管理
程序和记录
□
□
□
Page 5 of 6
Costco Non-Foods GMP/FQA Audit Document List
所需文件/证件清单
Section
Toys (except
soft toys) 玩具 (
除了毛绒玩具)
No.
NO
N/A
Fire Resistant test certificates 阻燃测试证书
□
□
□
7.14
RoHS related materials, such as BOM, test report, claims RoHS 相关的资料,如
BOM, 测试报告,声明等.
□
□
□
7.15
Natural materials‘ <Wood and leather, the species (such as basswood, maple, etc.),
the grade and COO (Country of Origin) traceability 天然原 料(木头,皮革等),级别
和原产地的追溯资料
□
□
□
7.16
CARB related materials 相关资料
□
□
□
7.17
Fumigation Certificates for Wood 木材熏蒸证书
□
□
□
7.18
Moisture content of the wood 木材湿度测试记录
□
□
□
7.19
WI, Inspection records, etc. for exist processes (such as Fabric relaxation, Cutting,
Sewing, Buttoning, Embroidery, Cutting, Drilling, Coating, Molding, etc) 存在的工
序(比如: 松布、裁剪、车缝、钉钮、绣 花、切割、钻孔、喷涂、注塑等)
作业指导书,检验记录等。
□
□
□
□
□
□
□
□
□
Training procedure, training plan for QC, operators, machine maintenance
employees, test employees, calibration operator, internal auditor, risk assessment
member, cleaning personnel, chemical
handling employees, etc, training material, training records 培训程序,
□
□
□
Training evaluation records 培训效果评估记录
□
□
□
7.21
8.1
8.2
August 2018
Available 提供
YES
7.13
7.20
8. Personnel
Training and
Competency 人
员培训和能力
Items 项目与内容
Common factory internal test:
Toys - pull test, drop test, XRF, flammability test, small part, finger entrapment
Inflatable - leakage, pull test, bite test Plush - flammability, pull test
Utensils - conditioning test, washing test
Cookware - corrosion, washing, scratch resistant 产品内部测试 普通工厂内部
测试:
玩具-拉力测、跌落测试、X射线荧光、燃烧测试、小部件、夹手指测试
膨胀产品-泄露、拉力、咬力 毛绒燃烧、拉力
餐具-条件测试、水洗测试 炊具防腐、水洗、耐划伤
Defective/overrun product handling Procedure and records 次等品和余 量产品
处理程序及处理记录
年度计划 (检验人员,操作人员,设备保养人员,测试人员,计量员,内 审员,
风险评估人员,清洁人员、化学品使用人员等), 培训教材,培训 记录
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