质量体系整改条例.xls

CORRECTIVE ACTIONS AND IMPROVEMENT PLAN CAP Supplier Name MV Sports HK Ltd Supplier ID30000603Audit Date Factory NameCixi City Kewei Toys Co Ltd Factory ID 36121589 Audit TypeFactory Location 406 426 Xida Street Guanhaiwei Town Cixi City Zhejiang China Audit CompanyBV Product CategorySporting Goods Plastic bottle Scooter and other plastic Acc Auditor NameJamie Zhang Audit Clause No Action Required Agreed Completion Date DD MM YYYY Evidence required for sign off Vertified by Audit Company Sign off by Walmart 1 0 1Non compliance The lighting in inspection area plastic injection molding workshop assembly and packing areas were sufficient but in blow plastic injection area was insufficient 83 lux 吹塑车间照 明不充分 Action Required Sufficient lights should be added and no less than 300 lux for production finishing relevant implementation records should be well kept For example all the blades should better be fastened to worktable for safety the materials and products should store away from the broken glass windows 30 12月 11 Evidence required Improved sharp tools control procedure and relevant implementation records 利器 控制程序的改进和相关的数据 1 1 1Non compliance The factory did not have written procedures for scheduled equipment cleaning and repairs and no records were maintained 工厂没有书面的文件系统和程序计划安排设备的情 节和维修 Action Required The factory should have system and procedures for scheduled equipment cleaning and repairs all schedules and actions should be recorded and maintained 30 12月 11 Evidence required Written scheduled and relevant records for equipment cleaning and repairs 设备清 洁和维修的书面计划和相关的数据 1 1 3Non compliance The factory did not have schedules for machines equipments and tools maintenance and calibration All the machines equipments and tools were not labeled with date of last maintenance calibration and schedule 工厂没有机器 设备和 工具没有维护和校准的计划和标识 Action Required Establishing proper maintenance and calibration schedule for machines equipments and tools label the date of last maintenance calibration and schedule for them 30 12月 11 Evidence required The maintenance and calibration schedule for machines equipments and tools including blow plastic molding machine and all testing equipments photos of maintenance and calibration labels 维修和 校准机器 设备和工具包括吹塑机和检测 设备的安排表 维修和校准标签的照片 1 1 6Non compliance The inventory of major machines e g plastic injection molding machines was kept but no updated inventory of moulds were available 有较大机器 例如注塑机 的库存清单 但模型的库 存清单没有保持更新 Action Required The factory should have proper documentation and updated inventory of all machines tools spare parts and equipments for example the updated inventory of moulds should be also available 30 12月 11 Evidence required Updated inventory of moulds 更新的模型 库存清单 1 1 7Non compliance Normally the major maintenance and repair on machines would be sub contracted the internal maintenance team only could conduct some simple maintenance e g cleaning 通常这些机 器的保养和维修分包给别的公司 内部一般就都做做类似保洁 工作 Action Required The factory should have sufficient maintenance team that has suitable skills to perform necessary repair and calibration on machines 工厂需要拥有一定技术水平的保养 维修 校准团队 30 12月 11 Evidence required Records to show the factory have sufficient maintenance team with suitable skills 证明工厂有一定技术水平的保养维 修团队的数据 2 0 1Non compliance Only simple quality inspection and control was conducted in the factory no written quality policy and detailed procedures were established 没有书面的质量方针和详细的流程 Action Required Appropriate Quality Management System including quality policy and procedures including Quality Manuel should establish issue and properly communicated to all departments these procedures should be easy to understand and access 30 12月 11 Evidence required QM quality policy and relevant improved quality procedures relevant communication records to all departments 质量管理 质量方针和质量 改进的相关改善 各部门相交流的数据 2 0 2Non compliance No written quality policies and objectives were available in the factory 没有合适的书面质量控制方针 Action Required Appropriate quality policies and objectives should be established and they should tabe appropriate method such as training and posting to ensure all factory workers including supervisors are aware and fully understand these policies and procedures 30 12月 11 Evidence required Written quality policies and objectives relevant training and communication records 书面的质量政策和目标 相关的 培训和交流数据 2 0 3Non compliance The factory did not have documented customer complaint system and documented recall program 工厂没有建立客户投诉 系统和产品召回体系 Action Required The products recall customer complaint handling program and records should be established and well kept to support application 30 12月 11 Evidence required Written products recall customer complaint handling procedures and relevant application records 书面的产品召 回 客户投诉程序和相关数据 2 0 5Non compliance Meetings to solve Quality issues and concerns would be conducted but there was no documented plan 没有解决质量问 题的书面计划 Action Required Documented records should be kept to show the plans for solving Quality issues and concerns were performed 30 12月 11 Evidence required Records of discussion for solving Quality issues concerns 商讨解决质量问题的数 据 2 0 6Non compliance The factory would conduct some risk control e g harmful substance test for materials But they did not have complete systems and written procedures to control these risks 工厂没有 完整的系统和书面程序来控制那些对人体的危害 Action Required The factory should have system and procedure in place to control the risk of physical chemical and biological contamination that may damage the product and personnel as well relevant records should be kept for verification 30 12月 11 Evidence required Written physical chemical and biological contamination control procedure and relevant records 书面的物理 化学 生物 污染控制程序和数据 2 0 7Non compliance The factory claimed they would conduct risk Audit to identify hazards from chemicals raw materials process equipments and tools during sample making but no documentation for this process was available 工厂承诺有风险评估 但是没有合适的 书面的文件 Action Required Factory should conduct risk Audit to identify hazards from chemicals raw materials process equipments and tools Relevant risk Audit records to identify these hazards should be kept for review 30 12月 11 Evidence required Risk Audit records o identify hazards from chemicals raw materials process equipments and tools 识别危险化学品 原材料 工艺设备和工具的风险审计记录 2 0 8Non compliance The factory was not accredited with any of the international national or customer quality standards association 工厂没有任 何可接受的质量标准认证证书 Action Required The factory should be accredited with some international national or customer quality standards association e g ISO 9001 etc 30 1月 12 Evidence required Relevant accreditation certificates plan for international national or customer quality standards association e g ISO 9001 etc 相关的合格的证书 国际 国内 或客 人认可的质量标准认证证书 例如 ISO9001 3 0 1Non compliance The factory would take some measures to ensure raw materials conform to required specification before use but no relevant inspection instruction and records were available 工厂没有相关 的检查指导和数据显示原谅是否与要求的一致 Action Required The factory should take adequate measures to ensure raw materials conform to required specifications before use relevant inspection instruction should be established and the inspection records including sample size and detailed measuring data should be kept fully 30 12月 11 Evidence required Written inspection instruction and relevant materials inspection records 书面的检验 指导和相关材料的检验数据 3 0 2Non compliance The factory claimed they would conduct first in first out FIFO but most of the materials were not identified to ensure properly FIFO 大多数原料没有实施FIFO体系 Action Required Proper first in first out FIFO system on materials should be practiced and all the materials should be well identified with necessary information e g lot number purchase date 30 12月 11 Evidence required Written FIFO procedure and photo of materials label 书面的FIFO程序文件和材 料标签的照片 3 0 3Non compliance The factory would conduct quality inspection on incoming raw materials accessories and components but did not have written instruction and record of inspections conducted 没有 书面的指导和数据显示对进仓原物料 元件和配件的质量检验 程序 Action Required The factory should have procedures instructions guidelines and documented records for quality inspection on incoming raw materials accessories and components 30 12月 11 Evidence required Written procedures instructions guidelines and documented records for incoming materials quality inspection 来料 质量检验的书面程序 说明 指南和数据 文件 3 0 5Non compliance Per on site observation most of the raw materials were not labeled some materials e g packaging plastic and accessories were stored on the floor directly 大多数原料没有 标识 例如放在地上的包装材料 塑料和部件 Action Required All the materials should be well labeled with purchasing date or lot number supplier name quantity materials name and quality status etc to ensure properly traceability and all the materials should be stored off the floor 30 12月 11 Evidence required Photo of improved materials packaging plastic and accessories storage and identification 改善后材料 包装 塑料和部 件 储存标识的照片 3 0 6Non compliance Only few reference samples were available to check on raw material no documented records and instruction were available to ensure incoming raw materials conform to specifications 没 有文件数据和指导来确保来料符合规格 Action Required The factory should have documented process and reference samples to ensure incoming raw materials conform to specifications 30 12月 11 Evidence required Photo reference samples and records of inspection procedure 参考样品的照片和 检验数据 3 0 9Non compliance The warehouse had well ventilated but the lighting condition in some warehouses were insufficient e g plastic warehouse was 26 lux finished cartons warehouse was 34 lux 仓库照明不充分 例如塑料仓库只有26lux 纸盒仓库只有34lux 不能少于 150lux Action Required The factory should provide sufficient lighting for the storage area no less than 150 lux the suggestion action is add lighting equipments 30 12月 11 Evidence required Photos of improved illumination in plastic warehouse and finished cartons warehouse with corresponding light meter reading indicated 塑料仓库和外箱仓库光 测仪改善后的读数照片 3 0 10Non compliance Most the materials components accessories were not identified with tags labels some materials e g packaging plastic and accessories were stored on the floor directly 材料 部件 配件没有明确的标识 例如堆放在地上的包装材料 塑 料和配件 Action Required All the materials should be properly stacked and identified with tags or labels and be off the floor the label should better be identified by factory and with necessary tracing information e g materials name lot number quantities receipt date quality status inspect by etc 30 12月 11 Evidence required Photos of improved materials label and storage method for materials 改善后的材 料标签和材料的存储方法的照片 3 0 12Non compliance The factory did not have documented supplier selection nor approval process 工厂没有书面的供应商的选用和认可流程 Action Required The factory should have documented supplier selection and approval process the assessment and selection records for all the suppliers should be kept for verification 30 12月 11 Evidence required Assessment and selection procedure and relevant records for all the suppliers 评 估和选择程序 所有供应商的相关数据 3 0 13Non compliance The factory did not track evaluate or document supplier s reliability 工厂没有跟踪及评估供应商的可信度并记录在案 Action Required The factory should track evaluate and document material supplier s reliability performance 30 12月 11 Evidence required Records of supplier s reliability performance tracking and evaluation 供应 商可信度的评估和跟踪数据 4 0 2Non compliance No adequately documented quality procedures were available for example no quality manual written procedures and SOP were established 工厂没有足够的质量程序文件 例如 没有质 量手册 书面的程序文件和设置SOP Action Required The factory should have documented Quality procedures QP at each stage of operation For example quality manual written procedures and SOP should be established 30 12月 11 Evidence required Documented Quality procedures QP at each stage of operation 每个阶段质量程 序的操作文件 4 0 3Non compliance The factory claimed they would conduct Pre production meeting prior to start of production but no relevant records or written procedure were available 工厂承诺在生产前会进行产前会议 但没有任何可用的数据和程序文件显示 Action Required The factory should conduct Pre production meeting prior to start of production all production quality supervisors and Technicians and Merchandisers should be present during pre production meeting Relevant records should be kept for verification 30 12月 11 Evidence required Pre production meeting procedure and relevant meeting and present records 产 前会议程序和相关的会议及出席记录 4 0 4Non compliance The factory claimed the critical quality and safety checks were be reviewed and identified during Pre production meeting but no relevant records were available 工厂承诺重要问题和安全建厂 会在产前会议中讨论 但没有任何可用的数据 Action Required The factory should conduct Pre production meeting prior to start of production relevant records such as critical quality and safety checks identification and actions for improvement should be kept for verification 30 12月 11 Evidence required Pre production meeting procedure and relevant records 产前会议程序和相关数据 4 0 5Non compliance The factory did not conduct pilot run 工厂没有试生产 Action Required The factory should conduct pilot run and keep fully records the product quality against specification sheet should be reviewed and relevant document results with corrective actions prior to production were documented 30 12月 11 Evidence required Pilot run procedure and relevant records 试生产程序和相关数据 4 0 6Non compliance No adequately in house lab testing equipments and relevant testing records were available 没有实施内部实验室测试 Action Required The factory should purchase appropriately testing equipments and perform more in house lab testing performed on current production relevant records should be kept for verification 30 12月 11 Evidence required Adding in house lab testing equipments and relevant testing records on current production 当前生产的实验室测试设备 和相关的测试记录 4 0 7Non compliance The factory QC only compared first piece samples with specification sheet the results were not documented 工厂QC只 比对部分样品 并且没有详细说明和结果 Action Required The factory QC should compare first piece samples against approval sample specification sheet relevant results should be recorded and communicated to supervisor other departments 30 12月 11 Evidence required First piece samples inspection records on every production stage 每一个生产阶段首 件样品的检验记录 4 0 8Non compliance The factory did not have approved samples first piece samples reference samples and work instructions provided to workers as guidelines 工厂没有足够的核准样品 首件样品 参考样品和工 作指导提供给工人做适当的指引 Action Required Adequate approved samples first piece samples reference samples and work instructions should be provided to workers with proper guidelines on every production stage and these samples should be identified with properly comments e g sample name approval personnel name and date etc 30 12月 11 Evidence required Photos of approved samples first piece samples or reference samples in workshops 车间内检验过的样品 首件样 品或者参考样品的照片 4 0 10Non compliance In line inspections were performed by QC s but were not being recorded QC执行巡检但没有记录 Action Required In line inspections IPQC should be performed and recorded by QC at every operation process 30 12月 11 Evidence required Written IPQC procedure and relevant inspection records 书面的IPQC程序和相 关的检验数据 4 0 12Non compliance The factory claimed the QC inspects as per customer standards but no relevant records were available to support application 工厂承诺QC按照客户标准检验 但没有相关的数据 来提供支持 Action Required The factory QC should conduct inspections based on AQL level standards which was higher than or based on those set by customer relevant inspection records should be kept to support application 30 12月 11 Evidence required Records of production inspeciton per standard AQL or as per customer standards 按照AQL标准或者客人标准检 验产品的记录 4 0 13Non compliance The factory claimed they would performs 100 functionality check on final products but no relevant records were kept 工厂 承诺对最终产品实施100 的功能检查 但是没有保持相关记录 Action Required The factory should perform 100 functionality check on final products relevant testing records should be kept for verification 30 12月 11 Evidence required Records of functionality check 功能性检 验的数据 4 0 14Non compliance Factory did not use corrective actions root cause analysis method 工厂没有使用纠正措施和根本原因分析方法 Action Required The factory should use corrective actions root cause analysis method For example the problems should be analyzed root cause analysis and documented with planned results that clearly defines responsibilities actions for improvement and deadlines relevant records should be kept for verification 30 12月 11 Evidence required Written CAPA procedure and relevant CAPA records for quality issues 书面的CAPA程序和质量问题的 CAPA数据 4 0 15Non compliance Some guidelines from clients were placed at the office room instead of in packing area to ensure packaging was correct for product 有些办公室使用的客人的指导方针来包装而不是用正确 的包装方式 Action Required The factory should have guidelines in place to ensure packaging was correct for product these guildlines should be well defined and placed at the using area 30 12月 11 Evidence required Photo of packaging guildelines used in packing area 在包装区域使用的包装指导 照片 5 0 1Non compliance The factory was not appropriately equipped with lab test equipments below 59 of various product related in house tests and no relevant testing records were kept 工厂没有内部 实验室测试设备 也没有任何记录 Action Required The factory should equip sufficient test instruments such as sharp point tester sharp edge tester impact Tester etc the minimum requirements was performed more than 60 of various product related in house tests at the factory And all necessary test records should be kept 30 1月 12 Evidence required Photos of added in house lab testing equipments and relevant testing records 实验室测试设备的照片和相关测试的数据 5 0 2Non compliance All gauges and test equipments e g vernier caliper did not have valid and updated calibrations 所有量规和测试设备不是有 效校准的 Action Required All the gauges and test equipments e g vernier caliper should h