供应商质量审核检查表

检查表——供应商质量审核, Checklist——supplier audit,供应商名称/supplier name 产品型 号/part no.审核日期/audit dateBDH261,1、平面布置图和过程流程图/Plant Layout and Process Flow Diagram,1.1是否有最新版平面布置图？is there a dated copy of the current floor plan readily available?,1.2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？does the floor plan identify the following :all required assembly, process and inspection stations? locations for all raw material, work in process(WIP) and finished product?,1.3流程图是否是最新版本的并标注有日期？are process flowcharts dated and current?,操 作 要 求/implementation/process questions,1.4生产过程中，材料和产品流动是否与过程流程图一致？does the actual material and production flow follow the process flowchart?,2、设计和过程FMEA/design and process FMEA, DFMEA（含有设计职责）/DFMEA(if supplier is design responsible),2.1DFMEA的零件编号、修订版本、原始日期和审定日期是否正确？does the DFMEA have the correct Part, Revision Level, Orig. Date and Rev. Date?,2.2DFMEA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？does the DFMEA include all functional specifications, appearance specifications, SCs and Safety Requirements as defined by customer drawings?,2.3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？are there RPN calculations for each failure mode and recommended actions for high RPNs ?,PFMEA,2.4PFMEA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 by customer drawings and interal requirements?,2.5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？are there RPN calculations for each failure mode and recommended actions for high RPNs ?,2.6PFMEA是否与流程图一致？Does the PFMEA follow the process flow?,3、控制计划/Control Plan,3.1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？Does the Control Plan have the correct Part , Revision Level, Orig. Date and Rev. Date?,3.2控制计划是否是否与流程图一致？Does the control plan follow the process flowchart?,3.3控制计划内是否包括了：进料检验、过程检验和控制、出厂检验以及返工/返修要求？Does the Control Plan include the following: Incoming Inspection, In-process Inspection & Controls, Final inspection and rework/repair Requirements?,3.4控制计划是否按顾客图纸的要求包括了所有顾客的特殊特性和产品安全要求？Does the Control Plan include all the customer SCs and Safety Requirements as defined by customer drawings?,3.5PFMEA中视别的潜在失效模式是否通过控制计划进行得到控制？Are appropriate potential failure modes, as identified in the PFMEA, addressed through the control plan? ,3.6控制计划中是否包括了检验和试验的要求？（包括数量、频次、以及规范要求）,Does Control Plan include both gage and test requirements?,(including quantity, frequency, and required specifications?),3.7所有控制计划中要求的控制（包括SPC）是否在生产过程中得到实施？Are all controls (including SPC), identified on the Control Plan, being used in the production process?,3.8所有控制是否得到定期验证以确保达到预期的结果？Are all controls verified on a periodic basis to ensure desired results?,4、 检验和试验/Inspection and Testing,4.1接受准则不是零缺陷的计数数据，供方是否将接受准则形成文件并由顾客批准？for attribute data with acceptance criteria other than zero defects, does the supplier document acceptance criteria and have customer approval?,4.2是否只有被检查和验证过的产品才能够被投入生产？how does the supplier assure that incoming product has been inspected or otherwise verified to meet requirements, prior to release for production? ,4.3没有验证而用于生产的的原材料是否被明确标识并作好记录？is positive identification provided and recorded for material used in production but not verified?,4.4检验指导书中是否包括抽样计划、检验频次以及检测内容和规范要求（包括进料、过程、最终）,does the inspection instructions include samling quantity, frequency, inspection items and required specifications(incoming\process\out-going).,4.5来料接受计划必须包括以下一种或多种方法：1、进行统计数据接收与评价；2、进货检验和/或试验（根据性能的抽样）；3、当有可接收质量性能的记录时，由第二方或第三方评审或审核。the acceptance plan must include one or more of the following: 1、 receipt and evaluation of statistical data; 2、 receiving inspection and/or testing(sampling basedon performance); 3、 2nd or 3rd party assessments or audits ofcoupled with records of acceptable quality performance ; 4、part evaluation by accredited laboratory.,4.6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？does the supplier hold product until the required inspections and tests have been completed or necessary reports have been received and verified,except for release under positive recall?,4.7供方是否只在文件或控制计划中所有要求的各项活动已圆满完成后，产品才发出？does the supplier assure that no product is dispatched until all activities specified in the document and /or control plan have been satisfactorily completed ?,4.8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.),4.9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 the inspections and/or test can be provided to the customer?,4.1 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？is inspection and/or test status suitably identified throughout the production process?,4.11是否按文件和/或控制计划的要求对产品进行检验/试验？is product inspected/tested as required by documented procedures and /or the control plan?,4.12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 procedures and/or the control plan?,4.13对返工和返修品是否重新进行了检查？is the procedure to re-qualify all reworked/repaired material being followed?,4.14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-off part comparison or first part check）? ,4.15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?,4.16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 passed or failed the inspection and/or test?,4.17记录是否标明负责合格产品放行的授权检验者？do the records identify the inspection authority responsible for the release of the product?,4.18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。A layout inspection and a functional verification(to applicable customer engineering materal and performance standards)shall be performed for all products at a established frequency, results shall be available for customer review. ,5、产品规范与图纸/Product Specifications & Drawings,5.1是否有顾客规范的最新修订版？Is the current revision of the customer specification(s) on hand?,5.2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）？Are specifications reflected on supplier drawings and relevant documents correctly(eg: control plan ,inspection instruction ,operation instruction)?,5.3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 is implemented in production.,5.4对新/旧规范生产的产品如何控制？how to control the products between the new/old specifications.,操 作 要 求/implementation/process questions——无/none,6、过程监控与操作指导书/Process Monitoring & Operator Instructions,6.1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？does each workstation provide adequate lighting and sufficient space to promote effective working conditions?,6.2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？Is a system in place to verify operator training on gages, visual aids, and operator instructions?,6.3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 or modified job affecting product quality. Are records of training maintained?,6.4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 Instructions, Set-up Sheets and Inspection instructions are controlled and traceable to the level parts being produced,6.5操作和过程监控指导书是否满足QS4.9.1,Operator and process monitoring instructions comply with QS4.9.1,6.6过程控制中是否使用了统计技术（控制图）？are the statistical techniques used in the process controlling(eg. Control chart)?,6.7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?,6.8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）？Is the system being followed to ensure the correct revision level is in place for all engineering documents? (Specifications, PFMEA, Control Plans, Setup Sheets, Operator Instructions, Visual Aids),6.9试生产的资料是否被收集和保存？Has pilot build data been collected and stored?,6.1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?,6.11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。A written detailed lot tracebility system exists through all stages of material flow from incoming to shipping, including off-line and rework / repair operations. ,6.12 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?,6.13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？Are visual aids (including appropriate boundary samples) and operator instructions readily accessible by the operators at each station and being followed?,6.14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 all "Master Good / Master Bad" samples available on line? Are they signed ? ,6.15操作指导书是否清晰、易读、能看得见的？The instructions are legible and visible to the operator.,6.16现场是否有返工和返修指导书并按其实施？Are rework and repair procedures in place and being followed?,6.17在生产现场是否划分出合格品、不合格品、待检品的区域，并加以标识。is there an identified area for conforming \nonconforming \awaiting inspecting material/product, segregated from the manufacturing area?,6.18类似产品是否针对防止混入采取措施。is there action to prevent the similar products from mixing. ,6.19检测点的设置是否能有效地阻止不合格品的发运？are inspection point locations effective in preventing shipment of nonconforming products?,6.2批次可追溯性管理已被证明在使用并有效。The lot traceability is demonstrated to be in place and effective.,6.21零件标识是否存在，并至少包括供应商编号，产品编号和生产日期。Part identification is based on PS-4480 with, at a minumum, includesSupplier Code, p/n and run date.,6.22批次数量大小不超过8小时或一天的生产产量中的较小者,Lot size is designated as not to exceed 8 hours or 1 day's production, whichever is smaller.,6.23在工作现场，可追溯性标识是否得到维持并进行记录？are the identification of traceability maitained and recorded on the site ?,7、 Handling and storage,7.1材料包括精密的零部件的搬运和贮存要求是否被评审？Have the handling and storage requirements of material, including delicate components, been reviewed? ,7.2当零件或材料有特殊的搬运要求时，程序或作业指导书中是否清楚地说明了搬运的方法？When special handling of parts or material is required, the procedures or work instructions clearly indicate the handling method.,7.3供方是否使用合适的贮存场地以防止产品损坏或变质？are storage areas appropriate for preventing damage or deterioration of the product?,7.4供方是否以适宜的时间间隔检查库存品状况，以便及时发现变质情况？is the condition of product in stock assessed at appropriate intervals to detect deterioration?,7.5材料的贮存是否充分地避免了环境的影响？Is the storage of material adequate to protect it from environmental factors?,7.6零部件的贮存地点是否得到管理和监控？Is the storage location for components organized & monitored?,7.7是否建立了一些控制方法以消除产品被污染或相似的产品被混合？Have controls been established to eliminate the potential for an operation to contaminate or mix similar products?,8、包装与发运规范/Parts Packaging/Shipping Specifications,8.1下列文件是否存在？The following documentation exists and is included in the plan:,Packaging requirements / instructions/包装指导书,Labeling requirements / instructions/标签指导书,Shipping requirements / instructions/发运指导书,8.2包装是否按顾客要求已进行了测试，包括按实际或模拟路线和条件发运后的包装进行测试？Evidence exists that the packaging has been tested (as required by the using plant) including test packs shipped over actual or simulated shipping route and conditions,8.3在最终检验和试验后，供方是否采取保护产品质量的措施，合同要求时，这种保护应延续到交付的目的地？does the supplier arrange for the protection of the quality of product after final inspection and test ,and when contractually specified does it extend to include delivery to destination? ,8.4供方是否建立支持百分之百按期装运的系统以满足顾客生产的要求？has the supplier established a system to support 100% on-time shipments to meet customer production requirements?,8.5如果未能保持百分之百按期装运，供方是否实施纠正措施以改进交付能力并与顾客就交付问题进行信息沟通？if the supplier’s delivery performqnce is not 100% to schedule, is there evidence of implemented corrective actions, and of communicatin regarding delivery problem information to the customer?,8.6是否有含有第二条路线以及承运商的应急计划。A contingency plan exists which includes secondary routes and carriers, as well as, logistics for expited shipments,8.7包装和标签是否符合顾客的最新要求？Packaging and labeling conforms to the latest customer standard,8.8检查包装损坏或被污染的检查计划,Inspection plan which identifies damaged or contaminated containers for removal from service,8.9所有运输容器、方法和标准包装已经过顾客材料部门主管的批准。All shipping containers, methods and standard packs have been approved by the using plant's Materials Mgr.,8.1发运必须遵守先进先出的库存管理系统。Shipments must conform to FIFO inventory control system,9、异常处理,9.1如果发生顾客抱怨，是否有一个保护顾客利益的程序文件？Are there procedures in place to protect customer in the event of 'Customer Complaint'?,9.2那些文件是否能确保完全隔离所有可疑品：包括顾客处的、公司内的、在运输途中的或在仓库中的？Do these procedures ensure complete isolation of suspect material, at both customer and supplier locations? At transportation and storage locations? ,9.3问题的解决办法是否采用8D或其它方法（如：顾客的要求方法、7-步法、5-步法）,Does the problem solving system incorporate the 8-D, or like processes (I.E. Customer specific methods; 7-Step, 5 Phase, etc.)?,9.4是否建立并实施了关于不合格/可疑的材料/产品的标识、记录、评价、隔离和处置的程序文件？are procedures established and implemented to address nonconforming/ suspect material or product regarding: identification, documentation, evaluation, segregation(when practical), disposition?,9.5是否对所有不合格的、可疑的材料或产品和隔离区提供可视标识？is visual identification of any nonconforming material or product and quarantine areas evident?,9.6是否清楚地定义出评审和处置不合格/可疑产品的职责与权限？are there clear definitions for responsibilities for review and disposition of nonconforming and suspect product?,9.7是否对不合格品进行量化和分析，建立优先减少计划并跟踪计划的实施进展情况？is nonconforming product quantified and analyzed and is a prioritized reduction plan in place?,9.8是否所有不合格都被记录并进行收集和缺陷分析？are all nonconformances products recorded, collected and defect analyzed? ,9.9在工作场所是否易于得到返工指导书，并为相关人员所使用？are the repair/rework instructions accessible and utilized by the appropriate personnel?,9.1是否记录了让步接受和返修产品的实际状况？are accepted nonconformities and repairs documented to record the actual condition of the product?,9.11供方是否确保在收到顾客授权之后才发运不合格的材料？does the supplier ensure that customer authorization is received prior to shipping nonconforming material? ,9.12发运的经授权的不合格材料是否在每个包装箱上都有适当的记录？is material shipped on an authorization properly identified on each shipping container?,10、预防性维护计划/Preventive Maintenance Plans,10.1生产的设备、工装、量具，是否有清单？Is there a list of tooling, equipment and fixtures used for product?,10.2所有工装、量具和主要设备是否都有包括在预防性维护计划中。All tooling, gages, and capital equipment are included in the PM programs,10.3所有设备、工装和量具是否与清单相一致？Is all equipment, gauging and tooling the same as will be used in production? ,10.4所有工装、量具和主要设备是否都被清晰地标识？Are all tools, equipment and fixtures clearly identified ？10.5所有设备和工装都存在文件化的预防维护计划？A documented Preventive Maintenance plan exists for all equipment and tooling,10.6The PM plan includes:/预防性维护计划包括：,Setup the maintenance items for machines, tools and other equipment/制定机器、工装和其它设备的维护项目。A schedule of planned maintenance including maintaining period/包括时间周期的维护计划表。A schedule of planned maintenance including responsible party/维护计划表包括责任部门。Maintenance instructions based on manufacturers recommendation or part performance/建立在制造商的建议和零件性能基础上的维护指导书,10.7标识关键设备并制定应急计划以防止由于设备的故障对顾客造成损失。Key equipment has been identified and contingency plans are in place that will protect the customer form loss of production due to failure of this equipment,10.8是否有关键设备备件清单，是否存有关键生产设备的零配件。is there a key equipment replacement parts list and is the replacement parts for key equipment is available?,10.9预防性维护系统是否得到实施？Is the preventive maintenance system being followed?,10.1是否能对易损件充分保证其可得性？Is there an adequate supply of perishable tooling available in house?,10.11所有好的样品和坏的样品是否都被列入了预防维护计划？ Are all "Master Good / Master Bad" samples on the Preventative Maintenance schedule? ,11、检测量具的评价/Gage & Check Fixture Evaluation,11.1所有用于计量性数据测量的检测设备是否都进行了R&R分析并是可接受的(<30%)?,Were gage R&R's performed and acceptable (<30%) on all variable data measuring instruments?,11.2所有用于计数性数据测量的检测设备是否都进行了R&R分析并是可接受的(按AIAG测量系统分析手册)?,Were gage R&R's performed and acceptable (ref. AIAG "Measurement Systems Analysis" manual) on all attribute measuring instruments?,11.3 是否存在一个系统,用以确保所有检测量量具和设备都得到校正和标识?,Is a system in place to ensure all gages and test equipments are identified and calibrated?,11.4是否有检验测量和试验设备的清单，以及其校正计划？are there a list of all gages and test equipments ,a plan about the calibration?,11.5对所有样件是否有一个管理系统？are there a management system to all masters?,11.6是否所有的检测量具和设备都得到了适宜的校正并可追溯到一个已知的标准?,Are all gages and test equipments properly calibrated and traceable to a known standard?,11.7是否所有的检测量具和设备都有正确的标识?,are all gages and test equipments correctly identified?,11.8从校正记录上是否显示出上下两次校正日期?,The calibration records indicate last/next caliration date?,12、产能验证/Line Speed & Capacity Verified,12.1对每台设备是否进行了设备过程能力研究并形成文件？Has a machine process capability study been done and documented on all pieces of equipment?,12.2是否至少每月一次地将生产产能与顾客订单进行比较？Is there a plan in place to compare your capacity against customer releases at least monthly?,12.3是否已确定出装配过程的最高的三个瓶颈？Have the top three bottlenecks in the assembly process been identified?,12.4是否制定了应急计划以防止设备出现故障时能维持两天的生产？Have contingency plans been established to support production for 2 days in the event of equipment breakdown?,12.5产能是否能足够满足顾客的最大生产要求？Is capacity sufficient to meet the quoted peak production demands?,13、工程标准/Enginering Standards Identified,13.1所有应用工程标准的现行受控清单是否存在？A current, controlled list of all applicable engineering standards exists,13.2及时评审、分发和执行所有顾客工程标准/规范的更改的程序是否存在？"..a procedure to ensure the timely review, distribution, and implementation of all customer engineering standards/specificationsand changes." is in place QS4.5.2.1,13.3所有更改的执行日期的记录是否存在？A record of implementation dates for all changes exists and is current.,13.4更改是否包括对所有相关文件的更改？Implementation includes updates to all appropriate documents,14、产品和过程特殊特性/Special Product and Process Characteristics Identified,14.1是否有产品和过程的特殊特性清单？A list of special product and process characteristics has been developed,14.2特殊特性是否在控制计划、结构图和指导书是标明？Special Product characteristics are noted on the: control plan ; set-up sheets ; operation instructions,14.3特殊特性（工序）的控制是否有明确的规定？are controls of special characteristics (processes) is defined ?,14.4是否按规定的要求对特殊特性（工序）进行控制？are the special characteristics(processes) controlled with the defined requirements,14.5所有要求进行SPC控制的特性的SPC参数是否可得到？所有要求的过程能力是否被满足？Is SPC Data available for all required SPC-controlled characteristics，and is the required process capacity meet?