Tesco 验厂技术审核指引
声明:以下信息供所有申请者参考,这只是基于客户要求的审核指引概要,它是为贵方关于审核的准备而设计,并不意味着贵方仅需要为审核员提供以下信息,审核员在审核过程中可根据实际 情况要求审核更多的文件/信息。
1. Audit Type: 审核类型
a. QMS +COC (focus on QMS part) 质量管理系统+社会责任, 但是主要关注质量管理体系部 分。
b. Announced Audit 通知审核
2. Audit Scope: 审核范围
Facilities to be accessed 审核厂区范围 :
All facilities in the factory to be accessed for quality control, health and safety, environmental issues verification. 工厂所有区域的评估,包含质量控制,健康安全,环境等。
Records to be accessed 审核记录要求:
The factory should provide at lease one year records, including working hour/wage records.
工厂需要提供过于一年的包括工资工时在内的相关记录
3. Audit Contents: 审核内容
• Site Audit 现场审核:
① Raw materials control and inspection 材料控制和检验
② Packaging control and inspection 包材控制和检验
③ Manufacturing process control 制造过程控制
④ Inspection/Test/Analysis 检验/测试/分析
⑤ Packing, storage and despatch 包装,储存和发货
⑥ Staff, Premises and Equipment 员工,厂房和设备
• Document Audit
① Quality Management 质量管理体系
② Customer Focus 客户导向
③ Product Development 产品开发
④ Risk Assessment 风险评估
⑤ Incidents and Product Recall 意外事故和产品召回
⑥ Purchasing 采购
⑦ Personnel and Training 员工和培训
⑧ Internal audit 内审
⑨ Pest Prevention and Control 虫害的预防和控制
⑩ Planned Maintenance 设备维护保养
⑪ Calibration, Testing and Inspection 校准,测试和检验
• Environmental and Ethics 环境和道德规范
① Environmental 环境
② Ethics including child labor, forced labor, discrimination, discipline, freedom association, working hours and wages, health & safety 道德规范包括童工,强迫劳动, 歧视,惩戒,自由结社,工作时间,工资,健康与安全
4. Main Audit Method : 审核的主要方法
a. Management staff interview 管理人员访谈
b. On site inspection 现场审核
c. Document review 文件审核
d. Workers interview,focus on warehouse persons, 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。
5. Main Documents List : 主要文件清单
Article |
Documents | Dept. |
工厂概况 Factory Profile | -公司简介/营业执照/工厂平面图/ 组织架构图/ 生产工艺流程图 Profile/Business liecense/floor plans/organization chart/process flow chart | |
客户关注 Focus on client | -开发设计流程/开发设计完整个案(1~3 个)/设计变更 R&S process/R&D cases(1-3) including input, output, review, verification and validation and change -潜在危害风险评估(物理异物如金属, 玻璃等/化学/微生物方面的危害) HACCP risk assessment(such as physical, chemical, microbe risk) -客户订单: 规格质量要求/客户签板 P/O from client including client’s quality requirements/ approved samples by client. -客户满意度调查/客户投诉处理,产品紧急事故处理程序(包括召回程序) Customer feedback/complaint, product incident process, recall procedure |
设计部 业务 品保 R&D Sales QC |
供应商方面 Supplier Management | -供应商评审程序/采购控制程序 Supplier and purchase control procedure -合格供应商清单 Approved supplier list - 供 应 商 评 审 记 录 / 供 应 商 持 续 监 控 记 录 Supplier assessment records, supplier performance monitoring records and -向供应商发出的订单/规格质量要求/签板 Purchase order, supplier samples |
采购部 Purchas e |
-ISO 9000/ ISO/TS16949 证书及最近一次内审报告/外审报告/管理评审报告 Quality system certificate/external and internal audit report/management review report |
质量管理 系统方面 Quality system | -质量手册/ 程序文件/ 文件更改收发记录/ 仪器设备清单及内外校记录报告 Quality manual/procedures/document issue and return records/production and test equipments list and calibration records and maintenance records. -QC/QA 组织架构/职责/质量培训记录/与生产工艺流程相对应的质量控制图 QC dept. chart/responsibilities/training records/quality system process chart -FMEA/HACCP 危害分析程序及记录 (潜在失效模式有效分析/产品风险评 估及控制) HACCP Risk assessment procedure and records -CAP(CAPAR)不良控制/不良分析纠正预防/持续 Non-conformance disposal, root cause analysis, corrective actions and preventative actions records. -UL/ CE/ EMC/RoHS 相关的产品测试化验报告/ 其它相应有效的安全证书 UL/ CE/ EMC/RoHS etc safety, reliability, laws conformance test reports | 品保 QC |
来料检验 Incoming inspection | -来料质量控制: 各种来料检验标准(抽样计划,接受标准,检验测试项目和缺陷 分类等)IQC procedure, criteria, specification including non-conformance classification, sample plan, AQL -IQC 来料(各类物料)检验报告/ 不良品退货及让步接收记录 IQC records, non-conformance disposal records -来料中免检产品的质量保证书/ 测试报告 (符合 EN71/ASTM F963, RoHS 等) External test reports or guarantee for free inspection materials. |
来料仓 IQC |
制造过程 与检验 Production control and IPQC | -制造过程质量控制:IPQC 检验标准(抽样计划,接受标准,检验测试项目和缺陷 分类等) IPQC inspection process, criteria, specification including items and non-conformance classification, sample plan etc. -产前会议记录/首件检验记录/巡检,全检,抽检验记录/不良及不良处理(修理/返 工/重新检验)记录 Process start up process and records/first piece inspection records/IPQC patrol inspection records/QC inspection records/Non-conformance disposal records including re-work and re-inspection records. -组装线工具利器 (刀片,断针等) 收发控制记录/ 金属探测记录(如必要要) Assembling line tools control records including blade, needles, etc / Metal detection records. --设备清单/设备维修保养记录 Equipment list and maintenance records. |
生产线 和品保 Producti on and QC |
终检 包装/储存 Finished goods inspection / packing/ storage | -最终产品(成品)质量控制: FQC/OQC/QA 检验标准(抽样计划,接受标准,检验 测试项目和缺陷分类等) FQC/OQC/QA inspection process, criteria, specification including inspection items and non-conformance classification, etc. -FQC/OQC/QA 检验记录/ 及不良及不良处理(修理/返工/重新检验)记录 FQC/OQC/QA inspection records, non-conformance disposal records including re-work, re-inspection records. -包装工段工具利器 (刀片,断针等) 收发控制记录/ 金属探测记录 重量/数量检查记录 Metal tools issue and return records at the packing line/ metal detection records, quantities and weight check records. -可追溯性: 出货跟踪统计/批次标识(如日期标或特定的批次标识) |
包装段 FQC 成品仓 Packing line; QC; Finished goods warehou se |
Traceability: shipping records, batch identification and records. | |||
雇佣条件 Employmen t | -ICTI/SA8000/OHSAS18001/ISO14001/FSC 等证书 ICTI/SA8000/OHSAS18001/ISO14001/FSC certification -社会责任手册/员工手册 Social manual / Employee manual -厂纪/ 厂规/ 招聘规定及程序/ 宿舍规定/ 保安条例 Factory rules/Recruitment program/Dormitory rules/Security guards rules -员工花名册/入厂登记 (全部)/ 劳动合同 (全部) Employee rosters/registration/contracts -员工体检记录/ 请假记录/ 辞工记录/违规处理记录/员工(可包括厂规/生产/ 消防安全等)培训记录 Health examination records/leave records/resignation records/discipline records/factory rules and safety training records -工卡考勤表 (近 12 个月)/ 工资表 (近 12 个月)/ 银行转帐凭证清单/各类保险 缴付凭证 (最近 2 次) 及参保人员清单/各种福利记录(如有薪年假,婚产假记 录 ) 12 months’ attendance records and payrolls/bank transfer records/insurance payment records/benefits records |
人事 财务 HR Finance | |
/安全 /卫生 /环保 Fire safety Safety Hygiene Environmen t | -建筑消防验收/ 卫生许可/ 卫生健康和消防安全政策/规章制度 Fire safety certificate/hygiene certification/H&S policy and program -卫生健康和消防安全培训记录/ 消防演习记录/工伤及用药记录 Training records for H&S/ fire drill records/ accident records -环保评估及许可/监测报告/记录/环保方针政策/化学品清单及 MSDS /废弃物转移处理资质/单据记录 Environmental policy, program, environmental certificate, chemical list, MSDS, hazardous waste disposal records. |
行政 厂务 Admin logistics |
6. Criteria 判断标准:
QMS part grade 质量体系部分的等级:
Green 绿色 | Pass 通过 | Meets the full requirements of the clause. 完全符合要求 |
Amber 橙色 | Minor 轻微不符合 | A good functional system, needs slight improvement 基本符合要求,需要一些改进 |
Red 红色 | Major 严重不符合 | Does not meet the requirements of the clause / system not in place. Corrective action is required before producing for Tesco. 不符合要求,开始 Tesco 产品生产前必须要有纠正措 施 |
E&E part grade 社会责任和环保部分等级:
Green 绿色 | Pass 通过 | Site appears to meet requirement 符合要求 |
Amber | Improvement required | Factory does not fully comply and should take |
橙色 | 需要改进 | action to improve 没有完全符合要求,需要改进 |
Red 红色 | Unacceptable 不可接受 | Factory does not comply and MUST take action to improve 不符合要求,需要改进 |