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检查表 供应商质量审核Checklistsupplier auditBDH261NO. 评价evaluate1.11.21.31.4NO. 评价evaluate2.1记录 /comments2、设计和过程 FMEA/design and process FMEADFMEA的零件编号、修订版本、原始日期和审定日期是否正确?文 件 要 求 /document questionsDFMEA(含有设计职责) /DFMEA(if supplier is design responsible)生产过程中,材料和产品流动是否与过程流程图一致?is there a dated copy of the current floor plan readily available?操 作 要 求 /implementation/process questionsdoes the floor plan identify the following :all required assembly, process and inspectionstations? locations for all raw material, work in process(WIP) and finished product?are process flowcharts dated and current?does the actual material and production flow follow the process flowchart?文 件 要 求 /document questions 记录 /comments1、平面布置图和过程流程图 /Plant Layout and Process Flow Diagram供应商名称 /supplier name 产品型 号 /part no. 审核日期 /audit date是否有最新版平面布置图?平面布置图上是否有所有装配、生产和检测岗位、原材料、半成品、成品的区域划分?流程图是否是最新版本的并标注有日期?第 1 页,共 22 页检查表 供应商质量审核Checklistsupplier auditBDH261供应商名称 /supplier name 产品型 号 /part no. 审核日期 /audit date2.22.32.42.52.6NO. 评价evaluate3.1does the DFMEA have the correct Part#, Revision Level, Orig. Date and Rev. Date?3、控制计划 /Control PlanPFMEAPFMEA是否按图纸的规定包括了所有顾客和内部要求的特殊特性和安全要求?does the PFMEA include all customer and interal Scs and Safety Requirements as defined bycustomer drawings and interal requirements?are there RPN calculations for each failure mode and recommended actions for high RPNs ?Does the PFMEA follow the process flow?文 件 要 求 /document questions是否对每个失效模式的 RPN都进行了计算,并对 RPN值高的采取了建议措施?does the DFMEA include all functional specifications, appearance specifications, SCs andSafety Requirements as defined by customer drawings?是否对每个失效模式的 RPN都进行了计算,并对 RPN值高的采取了建议措施?PFMEA是否与流程图一致?DFMEA是否包括了顾客的所有性能要求、外观标准、特殊特性和安全要求?are there RPN calculations for each failure mode and recommended actions for high RPNs ?Does the Control Plan have the correct Part #, Revision Level, Orig. Date and Rev.Date?控制计划是否有正确的产品编号、修订号、原始日期和修订日期?记录 /comments第 2 页,共 22 页检查表 供应商质量审核Checklistsupplier auditBDH261供应商名称 /supplier name 产品型 号 /part no. 审核日期 /audit date3.23.33.43.53.63.73.8Does the Control Plan include all the customer SCs and Safety Requirements asdefined by customer drawings?Does the Control Plan include the following: Incoming Inspection, In-processInspection 2、 receiving inspection and/or testing(samplingbasedon performance); 3、 2nd or 3rd party assessments or audits ofcoupled withrecords of acceptable quality performance ; 4、 part evaluation by accreditedlaboratory.is inspection and/or test status suitably identified throughout the productionprocess?是否在整个生产过程中都保持了产品适当的检验和 /或试验状态的标识?在所有要求的检验和试验完成或必要的报告收到和验证前,不得将产品放行,除非有可靠追回程序时才可放行?在生产过程中是否提供文件表明:只有通过了检验和 /或试验的材料才能提供给顾客?are there provisions in the process that only material that has passed theinspections and/or test can be provided to the customer?does the supplier assure that no product is dispatched until all activities specified inthe document and /or control plan have been satisfactorily completed ?does the supplier hold product until the required inspections and testshave been completed or necessary reports have been received andverified,except for release under positive recall?操 作 要 求 /implementation/process questions在控制计划和 /或文件化程序中是否具体规定了标识(如:盖章、标签、贮存位置等)?is the identification specified in the control plan and/or documented procedures(e.g.stamp marks, tags, storage location.)第 5 页,共 22 页检查表 供应商质量审核Checklistsupplier auditBDH261供应商名称 /supplier name 产品型 号 /part no. 审核日期 /audit date4.114.124.134.144.154.164.174.18do the records identify the inspection authority responsible for therelease of the product?必须按要求的频次对所有产品进行全忙于检验和功能验证(按顾客的工程材料及性能标准),其结果必须可供顾客评审。is the procedure to re-qualify all reworked/repaired material being followed?记录是否标明负责合格产品放行的授权检验者?供方是否保存了所有检验和试验的记录?does the supplier maintain adequate records of all inspections and tests?检验和试验记录是否清楚的表明产品是否已通过了检验和/或试验?do inspection and test records clearly show whether the product has passedor failed the inspection and/or test?是否按文件和 /或控制计划的要求对产品进行检验 /试验?对返工和返修品是否重新进行了检查?is product inspected/tested as required by documented procedures and /or thecontrol plan?最终检验和试验是否根据文件和 /或控制计划的要求进行?is final inspection and testing conducted in accordance with documented proceduresand/or the control plan?是否进行了作业准备验证,使用的是哪一种(末件比较 /首件检查)?are job setups verified whenever a setup is performed? Which is used( Last-offpart comparison or first part check) ?第 6 页,共 22 页检查表 供应商质量审核Checklistsupplier auditBDH261供应商名称 /supplier name 产品型 号 /part no. 审核日期 /audit dateNO. 评价evaluate5.15.25.35.4记录 /comments6、过程监控与操作指导书 /Process Monitoring & Operator InstructionsA layout inspection and a functional verification(to applicable customerengineering materal and performance standards)shall be performed for allproducts at a established frequency, results shall be available forcustomer review.5、产品规范与图纸 /Product Specifications & Drawings文 件 要 求 /document questionsIs the current revision of the customer specification(s) on hand?Are specifications reflected on supplier drawings and relevant documentscorrectly(eg: control plan ,inspection instruction ,operation instruction)?操 作 要 求 /implementation/process questions 无 /none供方是否保存了工程更改在生产中实施日期的记录?does the supplier maintain a record of the date on which each change isimplemented in production.对新 /旧规范生产的产品如何控制?how to control the products between the new/old specifications.是否有顾客规范的最新修订版?产品规范是否正确地反映在供应商的图纸和相关文件上(如:控制计划、操作指导书、检验指导书)?第 7 页,共 22 页检查表 供应商质量审核Checklistsupplier auditBDH261供应商名称 /supplier name 产品型 号 /part no. 审核日期 /audit dateNO. 评价evaluate6.16.26.36.46.56.66.7每一个生产岗位是否有有效的工作空间和足够的照明,以达到有效的工作环境?是否有一个用以查证操作工已进行了可视样品、量具和操作指导书等的培训的系统?are the statistical techniques used in the process controlling(eg. Control chart)?does each workstation provide adequate lighting and sufficient space to promote effectiveworking conditions?所有超出控制和不良趋势是否都被备注和采取纠正措施?Are trends and out of control situations being noted and corrected?过程控制中是否使用了统计技术(控制图)?新进员工(包括转岗员工)是否进行培训,有无记录。does the organization provide on-the -job training for personnel in any new ormodified job affecting product quality. Are records of training maintained?Is a system in place to verify operator training on gages, visual aids, and operatorinstructions?操作指导书、结构图、检验指导书是否受控并且能追赶溯到生产零件的级别?Operator and process monitoring instructions comply with QS4.9.1操作和过程监控指导书是否满足 QS4.9.1文 件 要 求 /document questions 记录 /commentsOperator Instructions, Set-up Sheets and Inspection instructions are controlled andtraceable to the level parts being produced第 8 页,共 22 页检查表 供应商质量审核Checklistsupplier auditBDH261供应商名称 /supplier name 产品型 号 /part no. 审核日期 /audit date6.86.96.106.116.126.136.14是否在生产、交付的所有阶段都有保持了产品的标识?are the identifications maintained during all stages of production ,delivery?A written detailed lot tracebility system exists through all stages of material flow fromincoming to shipping, including off-line and rework / repair operations.是否有一个书面的详细的批次管理系统存在,管理系统涉及原材料从进料到发运包括离线、返工 /返修的操作。是否按规定的方法确保所有现场的工程文件都为正确的修订版本(规范、 PFMEA、控制计划、结构图、操作指导书、可视辅具)?在生产线上是否都可得到好的样品 /不良样品?它们是否都有状态标识?Are visual aids (including appropriate boundary samples) and operator instructionsreadily accessible by the operators at each station and being followed?试生产的资料是否被收集和保存?Has pilot build data been collected and stored?是否有文件化程序规定对返工 /返修的材料进行重新检查?Is there a procedure to re-qualify all reworked/repaired material?在每个工作岗位,操作工是否能很容易地得到可视辅具(包括合适的临界样品)和操作指导书,并按其进行操作?Is the system being followed to ensure the correct revision level is in place for allengineering documents? (Specifications, PFMEA, Control Plans, Setup Sheets,Operator Instructions, Visual Aids)操 作 要 求 /implementation/process questions第 9 页,共 22 页检查表 供应商质量审核Checklistsupplier auditBDH261供应商名称 /supplier name 产品型 号 /part no. 审核日期 /audit date6.156.166.176.186.1

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