SQP验厂清单
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Document No.: SQP-D02 Issue Date: 25 Nov 2011 Issue No.: 00 Page 1 of 1©2011 Intertek, All Rights ReservedThe Intertek Group is the owner of the copyright in the material and intellectual know-how presented. No parts in this material maybe reproduced, adapted or distributed outside of your company without the written consent of the Intertek Group other than to the extent necessary to view the material.SQP Document List1. Organization chart2. Responsibility and/or job description,3. Quality System Procedures (e.g., quality policy, objectives, manual and procedures for theQuality Management System and other processes)4. Management review records5. Internal audit documents (audit plan, report, etc.)6. Supplier Control documents (supplier approval procedure / criteria, list of approval supplier list, supplier evaluation records, on-going performance monitoring, etc.)7. Document control procedure and records (including record keeping)8. Product specifications/requirements9. Inspection Instructions, acceptance criteria and inspection & testing reports (including thestages of IQC, In-process and Final inspection)10. Work instructions / workmanship standards for each manufacturing process11. Production schedules/records12. Procedure for defining and reporting of “incident”13. Product recall procedure14. Customer complaints records15. Corrective action reports (related to incident, internal audit, complaint, etc)16. Test records on Traceability system17. Equipment maintenance documents (plan, procedure, record, etc)18. Calibration of monitoring & measuring devices (plan, procedures, records, etc)19. Cleaning schedule and procedure20. List of Approved Chemicals with Corresponding Brands / Manufacturers21. Pest control documents (list of trained pest control staff, contract with external pest controlagency, pest control inspection record, bait documentation, etc)22. Record / plan for “Risk Assessment” of the entire manufacturing processes23. Risk assessment records of final product24. Product testing procedure/program25. Laboratory test reports (including lead and heavy metals content in paints, coatings and non-paint components, hardware, labels, final product, etc).26. Monitoring records of foreign body detectors (e.g. metal detection records, daily sensitivitychecking records of metal detectors…etc)27. Broken needle procedure & records (if applicable)28. Pre-production meetings records29. Process Control Plan30. Training (procedure, training needs & records)SQP文件清单1. 组织架构图2. 责任和 / 或职责描述3. 质量体系程序 (包括:质量政策、目标、质量管理体系手册和程序,以及其它流程)4. 管理层审查记录5. 内部审核文件 (审核计划、报告等)6. 供应商监管文件 (供应商核准程序 / 标准、已核准的供应商清单、供应商评估记录、持续表现监督等)7. 文件监管程序和记录 (包括记录保管)8. 产品规格 / 要求9. 检验要求说明、可接受的标准、检验和测试报告 (包括IQC的阶段、过程中和最终检验)10. 工作要求说明 / 每项生产工序的工艺技术标准11. 生产日程安排 / 记录12. “事故”的界定和报告程序13. 产品召回程序14. 客户投诉记录15. 整改行动报告 (关于事故、内部审核、投诉等)16. 追溯系统中的测试报告17. 设备维护文件 (计划、程序、记录等)18. 监督和测试设备的校准 (计划、程序、记录等)19. 清理日程安排和程序20. 已核准的化学品清单,附带相应的品牌 / 生产商21. 有害物管控文件 (受过培训的管控人员的名单、外部有害物管控机构的联系方式、有害物管控检查记录、投饵记录,等)22. 整个生产流程的“风险评估”记录 / 计划23. 最终产品的风险评估记录24. 产品测试步骤 / 程序25. 实验室测试报告 (包括涂料、涂层和非涂料部件中的铅和重金属、硬件、标签、最终产品,等)26. 夹杂物监控记录 (如:金属探测记录、金属探测器的日常敏感物检查记录,等)27. 断针处理程序 (如适用的话)28. 生产前会议记录29. 程序控制计划30. 培训 (程序、培训需求和记录)Supplier Qualification Program (SQP) Assessment CriteriaSection 1 - Management Commitment and Continual ImprovementAssesses the degree to which a company’s management is committed to providing adequate assessment resources, effective communication, systems of review that identify actions taken and opportunities for improvement.Section 2 - Risk Management SystemsThe company shall have management systems for assuring product safety, legality and quality. (Applies basic risk assessment principles)♦Legislative and Safety Requirements - the company must be aware of and make reference to up-to-date legislation, product standards, codes of practice and developments in science or technology that may impact the risk concerning their products and packaging in the countries of intended sales.♦Risk Assessment - the company shall have risk management plan for product and production processes, based on a risk assessment system which is systematic, comprehensive, thorough, fully implemented and maintained.♦Risk Assessment Verification - the company shall conduct the verification of risk assessment by competent person. Section 3 - Quality Management SystemsThe company shall develop, document and implement an effective quality management system, and address the following areas: ♦Policy Statement♦Control of Document - All documents, records and data impacting the management of product safety, legality and quality are present and effectively controlled♦Control of Records♦Specifications♦Responsibility and Authority - clearly defined and documented organizational structure♦Internal Audit♦Purchasing, Supplier & Sub-contractor Approval and Performance Monitoring♦Customer Property - customer property (including intellectual property) should be subject to controls♦Corrective and Preventive Action - procedures to record, investigate, analyse and correct cause(s) of non-conforming products or failure(s) to meet standards, specifications and procedures♦Identification & Traceability - a system to identify and trace product lots including raw materials, components and packaging materials for all phases of the production process (receipt of materials to product dispatch) ♦Incident, Product Withdrawal and Product Recall - a plan and system to effectively manage product withdrawal and product recall processes♦Business Continuity Planning - plan for identifying methods that ensure business continuity in the event of major incidents/threats to a business.Supplier Qualification Program (SQP) Assessment Criteria♦Customer Focus♦Complaint HandlingSection 4 - Site and Facilities ManagementThe site and the facilities must be maintained and managed so as to prevent or minimize contamination and assure the production of safe and legal finished products. Areas of focus include:♦Site Location and Perimeter♦Factory Layout, Product Flow and Segregation♦Staff Facilities - such facilities must be designed and operated so that they sufficiently minimise all risk of product contamination♦Cleaning and Hygiene Practices♦Waste/Waste Disposal - systems for the collection, collation and disposal of waste material♦Pest Control - controls and practices for minimizing the risk of pest infestationSection 5 – Product ControlThe company shall demonstrate effective control of its products to ensure safety, legality and quality including the following areas: ♦Reference Samples (pre-production and production) - procedures in place for the selection, handling, storage, approval and use of reference samples♦Chemical Control - chemical composition of products and chemicals used in the manufacture or processing of products shall be identified, monitored and recorded as required by legislation in the country of sale and / or manufacture ♦Product Packaging Materials♦Control of non-conforming materials - non-conforming materials, components and products shall be clearly identified, labelled, quarantined, investigated and documented♦Special Handling - handling requirements shall be in place for specific materials♦Product Transport, Storage and Distribution♦Stock Control and Product Release – procedures shall be in place to prevent release of finished product unless all agreed procedures have been followedSection 6 – Product Testing and Product Claims♦Product Testing – the company shall have a suitable, sufficient and validated testing program to ensure the safe, legal production of products that meet required quality standards.♦Product Claims – the company shall validate any declared product information or claims made regarding its products and monitor compliance with such claims necessary.Supplier Qualification Program (SQP) Assessment CriteriaSection 7 – Process ControlThe company shall demonstrate effective control of all operations undertaken, to ensure product safety, legality and quality – as well as ensure that the processes and equipment employed are capable of producing consistently safe and legal product with the desired quality characteristics. The following areas shall be addressed:Generic Hardline♦Control of Operations - ensure processes and equipment employed are capable of producing consistently safe and legal product with the desired quality characteristics♦Control of Incoming Components and Raw Materials♦In-Process and Final Inspections - to assure delivery of safe, legal product of the required quality♦Foreign Body Detection and Control♦Calibration and Control of Measuring and Monitoring Devices (for purposes of monitoring product safety, quality and legality) - shall be identified and calibrated to a recognized national or international standard♦Equipment & Tooling Maintenance♦Final Product Packing and ControlGarments♦Sample Preparation, Pattern & Marker♦Pre-production Activity♦Control of Incoming Components and Raw Materials♦Spreading, Cutting and Bundling♦Knitting♦Embroidery / Appliqué♦Printing♦Fusing♦Sewing♦Linking♦Washing♦Mending and Stitching♦Attachment♦Finishing and Pressing♦Final Inspections - to assure delivery of safe, legal product of the required quality♦Metal Detection and Control♦Final Packing♦Final Audit♦Calibration and Control of Measuring and Monitoring Devices (for purposes of monitoring product safety, quality and legality) - shall be identified and calibrated to a recognized national or international standardSupplier Qualification Program (SQP) Assessment CriteriaToys♦Pre-production Activity♦Control of Incoming Components and Raw Materials♦Molding (Injection molding, Blow molding, Insert molding, Roto cast molding, Diecast molding, Vacuum Forming, etc) ♦Die Cutting for Fabric/Rigid Plastic/PVC Sheet or Laminates, etc.♦Forming and Stamping♦Decoration (Spray Decoration, Coating, Tempo, Hand Painting, Printing)♦Sonic Welding Process♦Gluing Process♦Assembly (Manual/Automated)♦Cutting♦Sewing / Hair Rooting♦Attachment (e.g., eyes, noses, buttons, snaps or other metal press fasteners)♦Stuffing♦Metal Detection and Control♦Final Inspections - to assure delivery of safe, legal product of the required quality♦Final Product Packing and Control♦Calibration and Control of Measuring and Monitoring Devices (for purposes of monitoring product safety, quality and legality) - shall be identified and calibrated to a recognized national or international standardFootwear♦Footwear Manufacturing - Sample Development Activity♦Pre-production Activity (Footwear)♦Shoe Sole Bonding Test Process♦Wear Test Process♦Control of Incoming Components and Raw Materials (Footwear)♦Cutting♦Preparation / Secondary Processing♦Stitching♦Injection Molding♦Bottoming♦Assembly Operation – Lasting♦Autoclave Process (Vulcanizing)♦Finishing♦Final Inspections (Footwear)Supplier Qualification Program (SQP) Assessment Criteria♦Metal Detection and Control♦Final Packing♦Storage♦'Lasts' Management♦Equipment & Tooling Maintenance (Footwear)♦Calibration and Control of Measuring and Monitoring Devices (for purposes of monitoring product safety, quality and legality) - shall be identified and calibrated to a recognized national or international standardSection 8 – Personnel Training and CompetencyThe company shall ensure that personnel performing work affecting product safety, legality and quality are demonstrably competent to carry out their activity, as a result of training, work experience and / or qualification.Americas Asia EMEAElma Isakovic Samuel Lau Catherine BeareTel: +1 732 394 5367 Tel: +852 3760 6334 Tel: +44 78 7237 9094elma.isakovic@ u@ catherine.beare@。
SQP1、产品可追溯性模拟演练报告2、量测设备清单,校正报告3、质量方针的合法性和安全性4、质量方针每个人能回答出来5、质量方针和目标评审记录6、生产工艺流程图7、管代任命书8、主要人员任命书9、关键岗位人员及后备人员任命书10、利器管控负责人任命书11、内审和管理评审要做的很细12、虫害控制:外包协议、资质、杀虫记录13、工厂玻璃分布统计表、定期检查记录14、生产、仓库每月卫生评分表15、厂区卫生检查记录16、洗手间用品配置、卫生检查记录17、客户满意度调查表,客户满意度分析18、客户投诉清单,纠正预防措施报告19、产品召回模拟演练报告20、突发事件处理记录表21、质量目标分解及月统计表,产品交期统计表22、客户样品清单23、岗位说明书24、环境方针与标准25、不良品统计表,不良品趋势分析26、产前会议记录27、试产报告28、法律法规行业清单29、新员工培训计划、培训记录、考核试卷30、员工绩效考核方案31、化学品清单(CSA编号)32、危费转移五联单、危费品放置环境避雨、防火33、产品风险评估(重点)34、生产过程危害因素、工艺风险评估,风险评估要划分到负责人;(重点)35、机器设备清单、设备点检表、设备保养表36、供应商采购合同,调查表,供应商每月评定一次37、成品、原料第三方测试报告38、利器管制39、玻璃制品、易碎品管制40、检验区域、包装区域、仓库光线照明度要求41、包装区、仓库安装防爆灯管42、设备停用做停用标识43、样品测试记录44、每款产品做测试计划(分打样、产前、试产、量产阶段)(重点)45、每款产品做控制计划(重点)46、车间温湿度监控47、QC组织架构图、联系电话48、应急计划(停电、机台关键零配件清单、储存台账)49、厂区蜘蛛网、虫蝇清理、门窗卫生清理50、包装区域人员戴手套,头发戴帽子51、员工不能佩戴首饰52、客供物料提供客供物料清单53、供应商合同中明确“产品召回处置办法”54、要求工厂装灭蚊灯、老鼠笼55、客户样品收发记录56、包材避光,产品不能靠墙,物料堆积限高;窗户关闭,所有物料不能放地上。
一、档案1 收集全厂现有员工有效身份证复印件(正反两面均需复印)和一寸照片2张,确认是否有虚假、借用他人或过期身份证。
2 确定验厂人员名单,将参加验厂人员的相关信息整理填入咨询师提供的花名册中。
9月份之前进厂但现在已经离职的人员全部做离职记录,9月之后进厂现在已经离职的人员不要列进花名册中。
3 所有离职人员在花名册上的“离职日期”一栏填入离职日期,并填写离职申请单。
4 确认花名册,检查并完善花名册中的所有信息。
5 根据最终确认的花名册确认每位员工的《人事档案表》、《劳动合同》及《厂牌》是否符合验厂要求,如不符合要求,则重新制作《人事档案表》、《劳动合同》及《厂牌》。
]6 打印《人事档案表》并给员工签名,签名必须是员工本人签字且签写的姓名应与身份证复印件上的名字保持一致,一定不能代签、不能用铅笔签字,应使用黑色的水笔签名;《人事档案表》只需员工在“员工签名”一栏签字以及“是否愿意加班”一栏填写“是”或“愿意”。
7 打印《劳动合同》并给员工签名,签名必须是员工本人签字且签写的姓名应与身份证复印件上的名字保持一致,一定不能代签、不能用铅笔、圆珠笔签字,应使用黑色的水笔签名;《劳动合同》只需员工在最后一页的“乙方签名”一栏签字,除此以外其他内容可不必填写;在“甲方签名”一栏盖法人章及公司公章。
8 提供正确的卡号以便完成系统考勤。
9 根据近期人员的请假情况(8-10名)填写请假条并给员工签名。
二、工时1 完成2010年9月至12月的工作时间计划表,并按照实际情况排班。
2 待花名册最终确认OK后,完成所有验厂人员9月份开始到验厂当日的考勤数据(其中周日固定休息),确保7天中有一天休息。
3 完成所有验厂人员8-10月份的工资,检查OK后打印成册。
4 按照打印出的工资表制作银行转账单。
5 按照银行转账单修改转账凭证。
6 将离职人员的工资表单独打印,补签名并填写日期(离职当日)。
7 制作验厂人员验厂前一个月发工资的验厂工资条并在验厂前将其发给员工查阅。
质量管理系统部分(品质部/生产制造部/采购/设计)工厂概况营业执照/工厂平面图/组织架构图(品管品管)/生产工艺流程图(品管品管)/设备清单/设备维修保养记录客户关注(设计部/业务/品保)-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)-客户订单:规格质量要求/客户签板-客户满意度调查/客户投诉处理,产品紧急事故处理程序(包括召回程序包括召回程序)供应商方面(采购部)-供应商清单(主要原料,来料及包装等/各一至二个厂名即可)-供应商评审记录/合格供应商统计/供应商来料状况统计-向供应商发出的订单/规格质量要求/签板质量管理系统方面(品保)-ISO9000证书及最近一次内审/外审报告/管理评审报告-质量手册/程序文件/文件更改收发记录/仪器设备内外校记录报告/QC/QA职责/员工质量培训记录-HACCP危害分析程序及记录(产品风险评估及控制)-不良控制/纠正预防/持续改善-UL/CE/EMC/相关的产品测试化验报告/其它相应有效的安全来料检验(来料仓/IQC)-来料中免检产品的质量保证书/测试报告-各种来料检验标准及缺陷分类/IQC来料检验报告来料检验报告/不良品退货及让步接收记录制造过程与检验(生产线)-首件检验记录/IPQC验货标准/巡检及不良处理记录-组装线工具利器(刀片,断针等)收发控制记录/金属探测记录/重量/数量检查记录终检包装/储存(包装段/FQC/成品仓)-FQC/OQC验货标准及记录/不良处理记录-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-可追溯性:出货跟踪统计/批次标识/日期标识社会责任部分(行政人事部/财务部)雇佣条件(人事/财务)-厂纪/厂规/招聘规定及程序/宿舍规定/保安条例-员工花名册/入厂登记(全部)/劳动合同(全部)-员工体检记录/请假记录/辞工记录/违规处理记录/员工培训记录-工卡考勤表(近12个月)/工资表(近12个月)/各类保险缴付凭证(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)消防/安全/卫生/环保(行政/厂务)-建筑消防许可/卫生许可/环保评估及许可-消防安全与卫生政策/环保政策与实施记录-消防安全卫生培训记录/消防演习记录/工伤用药记录。
QMS现场审核检查清单及记录模板一、引言QMS(Quality Management System)现场审核是评估公司质量管理体系是否符合相关标准要求的重要环节。
为了确保现场审核的准确性和一致性,制定了本文档,包含了QMS现场审核检查清单及记录模板。
二、审核前准备1. 确定审核范围及目标在进行现场审核之前,需明确审核的范围,并设定明确的目标以保证审核的焦点和准确性。
2. 编制审核计划制定详细的审核计划,包括审核日期、时间、地点、参与人员等信息,并确保所有相关人员都知晓审核计划。
三、现场审核检查清单根据标准要求及公司的实际情况,编制现场审核检查清单。
清单的内容应全面覆盖质量管理体系的各个方面,确保全面、全面地评估质量管理体系的健康程度。
下面是一个现场审核检查清单的样例:1. 审核对象:(填写审核对象的名称)2. 审核范围:(填写审核范围的具体内容)3. 标准要求一:(填写标准要求一的具体内容)- 审核问题1:(填写问题描述)- 审核问题2:(填写问题描述)- 审核问题3:(填写问题描述)...- 审核问题N:(填写问题描述)4. 标准要求二:(填写标准要求二的具体内容)- 审核问题1:(填写问题描述)- 审核问题2:(填写问题描述)- 审核问题3:(填写问题描述)...- 审核问题N:(填写问题描述)(根据需要,继续添加其他标准要求和对应的审核问题)四、现场审核记录模板在现场审核过程中,需要记录下每一个问题的审核情况以及相关的整改措施和结果。
以下是现场审核记录的模板示例:1. 审核对象:(填写审核对象的名称)2. 审核日期:(填写审核日期)3. 审核人员:(填写审核人员的姓名)审核问题一:- 问题描述:(填写问题描述)- 整改措施:(填写整改措施)- 整改结果:(填写整改结果)审核问题二:- 问题描述:(填写问题描述)- 整改措施:(填写整改措施)- 整改结果:(填写整改结果)(根据需要,继续添加其他审核问题及对应的记录)五、审核结论与报告根据现场审核的结果,制定审核结论并编写审核报告,包括审核的主要发现、问题的整改情况、建议等内容。
QMS现场审核检查清单及记录模板1条款审核记录审核注解4质量管理体系4.1 总要求1总经理/厂长介绍该组织概况、机构、产品、规模、销售业绩等2该组织识别了质量管理体系的主要过程和互相作用有:管理职责、资源管理、产品实现、测量分析和改进,详细过程见手册页的流程图体系覆盖的产品范围:×××3该组织识别了外包过程,或无外包过程,外包过程主要包括:委外培训、委外运输、计量器具委外检修、零部件外协加工等,按7.4进行控制4删减了×××过程4.2文件要求4.2.1总则查文件清单,该组织质量管理体系文件有:质量手册(含质量方针和质量目标)程序文件有×个,含标化要求6个程序三三级文件×个,如管理制度×个,工艺规程×个,作业指导书×个,验证规范×个,国家标准×个,行业标准×个等;质量记录×种4.2.2质量手册查质量手册编号QM-01-2005 批准人:王刚实施日期:2005.12.1其内容包括:质量方针,2006~2008年质量目标,删减条款为7.3,有删减的说明,删减合理适宜,对×个程序文件的内容进行了引用,QMS过程之间的相互作用—见生产工艺流程图(手册页)其过程及相互作用的表述完整并查文件清单,该组织质量管理体系能全面履盖标准4.2.3 文件控制1有程序文件,如《文件控制程序》,QP-423-2005 ,经×××批准,于×××实施。
基本符合标准要求2出示了公司受控文件清单,内容有名称、编号、版次、编制、审批、实施日期、备注等,从文件受控清单中抽查文件可识别文件的修改状态,如A版/0次修改,或A版/1次修改3查三份作业文件(标准/规范/作业指导书….)记录审批人和日期4查文件的发放和回收记录,记录是否发到使用部门、接受人、日期、及发放人5查文件更改记录,有批准人×××,批准日期×××,更改人×××,更改日期×××6查作废文件管理记录,作废文件保留是否有标识、是否专人保存,现场未发现作废文件7查外来文件清单:a顾客来文,b与产品有关的法律法规(国家标准、行业标准和主管部门的强制规定)8抽3个使用文件的现场,有:a现行有效版本的文件,b有控制编号9查上述2-3份文件,记录文件本身保持是否清晰、易于识别4.2.4 记录控制1有程序文件,如《记录控制程序》,QP-424-2005 ,包括记录的标识、贮存、保护、检索、保存期限和处理,从记录清单中可体现,经×××批准,于×××实施。
《SQP验厂清单》第一篇:sqp验厂清单sqp文件清单1.组织架构图2.责任和/或职责描述3.质量体系程序(包括:质量政策、目标、质量管理体系手册和程序,以及其它流程)4.管理层审查记录5.内部审核文件(审核计划、报告等)6.供应商监管文件(供应商核准程序/标准、已核准的供应商清单、供应商评估记录、持续表现监督等)7.文件监管程序和记录(包括记录保管)8.产品规格/要求9.检验要求说明、可接受的标准、检验和测试报告(包括iqc的阶段、过程中和最终检验)10.工作要求说明/每项生产工序的工艺技术标准11.生产日程安排/记录12.“事故”的界定和报告程序13.产品召回程序14.客户投诉记录15.整改行动报告(关于事故、内部审核、投诉等)16.追溯系统中的测试报告17.设备维护文件(计划、程序、记录等)18.监督和测试设备的校准(计划、程序、记录等)19.清理日程安排和程序20.已核准的化学品清单,附带相应的品牌/生产商21.有害物管控文件(受过培训的管控人员的名单、外部有害物管控机构的联系方式、有害物管控检查记录、投饵记录,等)22.整个生产流程的“风险评估”记录/计划23.最终产品的风险评估记录24.产品测试步骤/程序25.实验室测试报告(包括涂料、涂层和非涂料部件中的铅和重金属、硬件、标签、最终产品,等)26.夹杂物监控记录(如:金属探测记录、金属探测器的日常敏感物检查记录,等)27.断针处理程序(如适用的话)28.生产前会议记录29.程序控制计划30.培训(程序、培训需求和记录)第二篇:sqp验厂清单sqp文件清单1.组织架构图2.责任和/或职责描述3.质量体系程序(包括:质量政策、目标、质量管理体系手册和程序,以及其它流程)4.管理层审查记录5.内部审核文件(审核计划、报告等)6.供应商监管文件(供应商核准程序/标准、已核准的供应商清单、供应商评估记录、持续表现监督等)7.文件监管程序和记录(包括记录保管)8.产品规格/要求9.检验要求说明、可接受的标准、检验和测试报告(包括iqc的阶段、过程中和最终检验)10.工作要求说明/每项生产工序的工艺技术标准11.生产日程安排/记录12.“事故”的界定和报告程序13.产品召回程序14.客户投诉记录15.整改行动报告(关于事故、内部审核、投诉等)16.追溯系统中的测试报告17.设备维护文件(计划、程序、记录等)18.监督和测试设备的校准(计划、程序、记录等)19.清理日程安排和程序20.已核准的化学品清单,附带相应的品牌/生产商21.有害物管控文件(受过培训的管控人员的名单、外部有害物管控机构的联系方式、有害物管控检查记录、投饵记录,等)22.整个生产流程的“风险评估”记录/计划23.最终产品的风险评估记录24.产品测试步骤/程序25.实验室测试报告(包括涂料、涂层和非涂料部件中的铅和重金属、硬件、标签、最终产品,等)26.夹杂物监控记录(如:金属探测记录、金属探测器的日常敏感物检查记录,等)27.断针处理程序(如适用的话)28.生产前会议记录29.程序控制计划30.培训(程序、培训需求和记录)sqp验厂评估标准编辑:中国验厂网本站原创日期:xx-12-1316:49:16导读。
1. Senior management commitment and continual improvementCL-SQP QuestionsQuestionRisk Weighting1.1Does the company's management define product safety and quality objectives?(产品安全及质量目标的定义)Moderate 1.2Is the review of the management systems carried out at least annually?(管理系统的审核)Minor 1.3Does the company's management provide the following overall resources required toimplement and improve the quality management system and risk assessment plan,and to address legal, product safety, and product quality matters?1.3.1 personnel1.3.2 infrastructure (e.g., building, equipment, transport…etc)1.3.3 work environment1.3.4 financial supportModerate1.4Does the company have a process in place to identify opportunities forimprovements?Minor2 Risk Management2.1Legislative and Safety RequirementsCL-SQP QuestionsQuestionRisk Weighting2.1.1Is the company aware of relevant legislation, mandatory standards andindustry/customer codes of practice applicable to the product in the countries ofintended sale?(相关法律、强制标准、行业准则)Moderate2.1.2Does the company have a process in place for ensuring it is kept informed of changesto relevant legislation, standards etc?Moderate 2.2Risk Assessment (Documentation)CL-SQP QuestionsQuestionRisk Weighting2.2.1Does the company establish a product risk assessment for each product or a groupof similar products, e.g., FMEA?(产品风险评估)Moderate 2.2.2Does the product risk assessment determine the following?2.2.2.1 Possible Hazard/Risk Identification (e.g., Chemical, Physical, Regulatory);2.2.2.2 Risk level for each identified hazard/risk (e.g., Severe, High, Moderate,Slight);2.2.2.3 Whether the risk is acceptable considering the probability or likelihood andthe severity and potential consequences of the effects on consumer safety (e.g., NotAcceptable, Review & Approve, Acceptable)Moderate2.2.3Does the company conduct a process risk assessment of hazards potentiallyintroduced during the production, packaging or storage processes?(过程风险评估)Moderate2.2.4Does the process risk assessment identify the following?2.2.4.1 A list of potential risk or hazards in the production process2.2.4.2 Control points to manage the identified risk to acceptable level2.2.4.3 Accept / reject limits defined for each control2.2.4.4 Corrective action to be taken where a CCP is out of control2.2.4.5 Responsibility of Control Points2.2.4.6 Records of monitoring & reviews ModerateSupplier Qualification Program (SQP) 'Generic Hardlines' 1-day Checklist3 Management System3.2General Documentation Requirements3.10Business Continuity PlanningThe company shall have procedures in place to identify methods of ensuring business continuity in the case of major incidents/threats to a business.4. Site Standards and Facilities5. Product Control5.6 Product Transport, Storage and Distribution5.8 Product ClaimsThe company shall have procedures in place to validate any declared product information or6. Product Conformity Assessment7. Process ControlCopyright © 2010 Intertek, All Rights Reserved11。
SQP Audit 验厂注意事项采购部:1.建立新供应商评鉴2.建立合格供应商清单3.工厂需对合格供应商需定期依CQDS进行再次评分,并区分成ABC 三种等级4.以上做法需写入供应商管理程序文件中,并有C级厂商辅导或更换的做法5.需對所採購的化學品进行MSDS蒐集,并要求供应商签署有物质禁用协议仓库部:1.进料仓库需规划,允收、待验、待退区域,要有标示2.成品倉庫需要安装灭蚊灯3.所有進料物料需要有物料季度管制标签,并要IQC需在标签上面盖章表示品质合格,方可入库4.各项货架、货品放置需离墙壁50cm的距离,仓库边的窗户需有防晒遮阳。
5.化学品仓的二次容器、MSDS、灭火器、劳保用品需齐备,仓管对于物料的酸硷性要能识别,不能酸硷物料混放。
6.要有温湿度计及每日的温湿度点检记录。
生产部:1.各制程需设置,红色的不良品放置箱,并在箱上有明确标示。
2.各制程需有独立的良品区域与不良品区域,并且标示清楚。
3.所有物料半成品不可放置地面,最低要求需用纸皮垫底。
4.生产部各制程半成品需有半成品标示标签。
5.需有生活用具(包括:茶杯、雨傘、飲水機等)放置區,且生活用具不得靠近生產線。
6.生产的各种有参数控制的设备,需有参数控制校对表,并贴在机台控制区域,以便核对于查询。
7.生产的共种设备上的设备保养表,需由机修人员进行保养的确认,并要每日都需要进行日常维修保养,并保留记录。
8.各種機器需保持清洁,尤其是与产品接触到的生产区域。
9.特别注意尖锐利器管理,所有刀片需使用没有褶痕的刀片,所有刀片、剪刀需進行编号、并绑在生产工位,并做好分到到具体使用人员的分发回收记录。
所有尖锐利器需有每日的收发记录,并有专人管理发放,发放记录一定要记录到发放到单个使用者。
10.生产部成品包装线需对所有人员的穿著注意,需带手套、头套、并且不能配戴首饰,请要求所有包装人员佩戴帽子。
11.生产部成品包装线,需配置灭蚊灯,并做好维修保养记录表。
SQP
文件清单
1. 组织架构图
2. 责任和/ 或职责描述
3. 质量体系程序(包括:质量政策、目标、质量管理体系手册和程序,以及其它流程)
4. 管理层审查记录
5. 内部审核文件(审核计划、报告等)
6. 供应商监管文件(供应商核准程序/ 标准、已核准的供应商清单、供应商评估记录、持续表现监督等)
7. 文件监管程序和记录(包括记录保管)
8. 产品规格/ 要求
9. 检验要求说明、可接受的标准、检验和测试报告(包括IQC的阶段、过程中和最终检验)
10. 工作要求说明/ 每项生产工序的工艺技术标准
11. 生产日程安排/ 记录
12. “事故”的界定和报告程序
13. 产品召回程序
14. 客户投诉记录
15. 整改行动报告(关于事故、内部审核、投诉等)
16. 追溯系统中的测试报告
17. 设备维护文件(计划、程序、记录等)
18. 监督和测试设备的校准(计划、程序、记录等)
19. 清理日程安排和程序
20. 已核准的化学品清单,附带相应的品牌/ 生产商
21. 有害物管控文件(受过培训的管控人员的名单、外部有害物管控机构的联系方式、有害物管控检查记录、投饵记录,等)
22. 整个生产流程的“风险评估”记录/ 计划
23. 最终产品的风险评估记录
24. 产品测试步骤/ 程序
25. 实验室测试报告(包括涂料、涂层和非涂料部件中的铅和重金属、硬件、标签、最终产品,等)
26. 夹杂物监控记录(如:金属探测记录、金属探测器的日常敏感物检查记录,等)
27. 断针处理程序(如适用的话)
28. 生产前会议记录
29. 程序控制计划
30. 培训(程序、培训需求和记录)。