PSO_Guidelines(中英文).doc

process sign-off过程放行审核pso1st editionpso guidelines / worksheetsprocess sign-off checklist过程放行审核检查表suppliermfg. locationsupplier codepart no.part namedate of reviewchange leveldate of re-visitdocumentedacceptableunacceptableafter re-visit1part no. description & change level品名，描述和更改水平（版本号）2process flow diagram & manuf. floor plan过程流程图和生产场地计划3design fmea & process fmeadfmea和pfmea4error & mistake proofing防错措施/技术5problem solving methods问题解决方法6incoming & outgoing materials 进料/出货检验/认证计划qualification/certification plan7test sample size & frequency测试/试验样本及频率8parts packaging & shipping specifictions产品包装和装运规范9part handling plan产品搬运计划10engineering standards identified工程标准11preventive maintenance plans预防性维护计划12product quality plan (pqp)产品质量计划（pqp）13gage & test equipment evaluation量具及测量设备分析14tooling, equipment & gages identified模具，设备及治具定义15special product & process characteristics identified特殊产品/过程特性定义16control plan控制计划17evidence of product specifications产品规格的证据18process monitoring & operating instructions过程监控及操作指导19line speed demonstration产线速率20initial process study初始过程分析team process sign-offcorrective action requiredyesnodaterevisit requiredyesnodatesign-offengineeringsdesourcing/purchsupplier qa mgrsupplier plant managerdatesignaturerevisitdatesignatureaiegfm-0028; process sign off form rev1page 26 out of 26 run rate summary节拍生产汇总suppliermfg. locationsupplier codepart no.part namedate of reviewchange leveldate of re-visitsupplier quoted production rates# / hr# / day# / weekstatus (accept./non accept.)planned usagedailyweeklypreparationplanned run dategoal (net good parts)planned hours to run/ hrplanned shifts/ shiftplanned downtime/ dayreason for planned downtimeactual (net good parts)observationactual hoursfrom/ hrto/ shiftactual shift/ daydowntime hourstotal units produced (+)total rejects (-)total net parts (=)resultpassexplain:failopensign-offsdesupplier representativenamephone #datesignaturere-visitdatesignatureprocess sign-offchecklist element & instructions条款说明documentation文件化1) part number, description and change level品名，描述及更改水平verify the following documents have the correct part number, description, and change level entered or cross referenced.验证下列文件是否具有正确的品名，描述及版本号a procedure must be in place to assure correct part number and revision level.有程序确保只使用正确的品名及更改水平号where the product identity is not inherently obvious, the supplier must employ an internal numbering system and provide a cross reference which enables users to identify the motorola part number and revision which corresponds to the suppliers numbering and revision system.对于产品品名标识不是固有且明显的，供应商必须采用内部命名系统来提供参照号码以使得使用者能根据供应商的命名及版本系统来识别mot的品名及版本号责任部门：研发、销售 design and process fmeas as applicable.dfmea及pfmea control plan.控制计划 setup sheets, gages, operator instruction sheets, shipping audit sheets, and inspection instructions, and/or equivalent type of documents , where applicable. 设置规程，治具及操作者指导，装运检查单，检验作业指导，及其它适用文件 check order entry process for correct part no.检查订单录入系统品名的正确性documentation reviewed:已审核文件1) compliant 符合的内容2) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化2) process flow diagram and manufacturing floor plan过程流程图及生产场地计划the process flow diagram must represent the entire manufacturing process from receiving through shipping operations and should include the following: 过程流程图必须代表整个生产过程，从材料接受直至装运操作，且包括如下： processing sequence, method, and equipment used at each station including inspection and repair/rework stations. 每道工序包括检查和返修/返工工序的作业次序、方法及设备。 number of operators needed per station including inspection and repair/rework stations. 每道工序包括检查和返修/返工工序需要的操作者数量 it should include both main-line assembly processes as well as all off-line processes that supply it. 包括主线装配工序及辅线装配工序the manufacturing floor plan should show the layout of the facility and illustrate station-by-station the overall flow of the manufacturing process.生产场地计划应包括生产设施的分布且应一道工序接一道工序地列出所有生产工序a list of sub-suppliers must be available that identifies the “extended enterprise” detailing the suppliers component, and raw material sources. 要有分供应商名单作为“延伸企业”，更出每个元件及原材料的供应源。责任部门：生产、工程、研发 process flow diagram过程流程图 manufacturing floor plan生产场地计划 sub-supplier source list分供方名单 verify sub-source approval from applicable material standards.分供方材料认定note: equipment used can be included in the flow, manufacturing floor plan and/or control plan.设备可以放入流程图，生产场地计划及/或控制计划中* sub-tier supplier supplier to do the checklist themselves with the supplier.分供应商-mot供应商应制定自己的检查单来审核分供应商documentation reviewed:已审核文件3) compliant 符合的内容4) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化3) design fmea and process fmea dfmea及pfmeadesign (as applicable) and process fmeas must be completed for each unique product or process and must be approved by the supplier quality engineer. this should be a team effort. 对每一个特殊产品都必须有dfmea（适用时）和pfmea且必须得到mot sqe的认可the process fmea (pfmea) must reflect the entire manufacturing process from receiving through shipping. pfmea必须反映从收料到装运出货全过程all pfmea concerns must have descriptions of current controls and recommended actions. all concerns and controls must be included in the control plan.所有pfmea存在的问题点都必须有目前的控制描述及建议的措施。所有问题点及控制都必须包括在控制计划内the dfmea and pfmea are living documents and must be traceable to the engineering change levels and processing changes. (as per motorolas supplier spec. provided).dfmea和pfmea都是不断更新的文件，必须能追溯到工程变更及过程变更（按mot的供应商管理文件）责任部门：生产、工程、研发、品控 dfmea (as applicable) if motorola own this is not applicable dfmea （适用时）-如果是mot设计，则不适用 pfmea - a review of the previous defects & include the lesson learnt in the pfmea pfmea，之前发生的不良评审及经验教训等documentation reviewed:已审核文件5) compliant 符合的内容6) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when) process sign-offchecklist element & instructions条款说明documentation文件化4) error and mistake proofing 防措examples of “error proofing” and “mistake proofing” approaches used to improve the production process must be reviewed and verified during the supplier plant visit.必须展示改进生产过程的“防错”及“防疏忽”案例 the error proofing approach should be used to identify potential process and/or design faults, and eliminate the possibility the error would produce a defect.防错方法应该用于识别可能的工艺及/或设计缺陷，去除错误可能生产缺陷的可能性 the mistake proofing approach should be used to develop methods to clearly identify errors that may occur, and prevent them from becoming non-conformances.防疏忽方法应该用于明确识别错误并阻止错误变成不良品责任部门：生产、工程、研发、品控 list of error proofing and mistake proofing.防错及防疏忽措施清单 error and mistake proofing studies. (for each station, process where applicable)防错及防疏忽研究（对适用的每一工位和过程）* to review all defects including escaping defects for error proofing.要评审所有的缺陷包括遗漏的缺陷documentation reviewed:已审核文件7) compliant 符合的内容8) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化5) problem solving methods问题解决方法evidence of problem solving techniques must be provided describing how these techniques were used in developing the production process. name, titles, and location must identify individuals who participated in the problem solving process.有问题解决技术的证明描述如何运用这些技术来改进生产过程。必须注明参加问题解决过程的人员名单、职位及地点责任部门：生产、工程、研发、品控 doe 7/8 step corrective action 8d root-cause-analysis根源分析 drill deep/wide挖掘更深更广 statistical tools统计工具 charting (spc)图表documentation reviewed:已审核文件9) compliant 符合的内容10) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化6) incoming and outgoing material qualification/certification plan 进料/出厂检验/验证计划review the incoming and outgoing material qualification/certification plan plus associated documents and records the plan must be verified during the pso plant visit.进料及出厂检验/验证计划、相关文件和记录 the plan must describe operations and procedures used by incoming and outgoing inspection to qualify and certify incoming material and outgoing product.计划必须描述进料/出厂检验/验证操作及程序 the plan must include incoming and outgoing acceptance sampling plans, both attribute and variable. 计划必须包括进料/出厂可接受抽样计划，包括计量型和计数型 all parts require lot control and traceability, which must be described in detail. this control system must provide records of traceability for all material from the point of usage, or final product, back through all the manufacturing processes. the lot control and traceability system must be verified. special controls are required for rework or repair materials to provide traceability to the rework or repair process. the plan must address containment of defective materials. the plan shall identify processes performed by sub-suppliers or any outside processor and must include records indicating inspections/test results, which relate to the appropriate lot code. (review how they manage their sub-tier suppliers, see pso for their sub suppliers) components or raw material used in the assembly/manufacture of parts for motorola must have full approval status, and verification of the date must be on file.责任部门：生产、工程、研发、品控、采购 incoming and outgoing inspection procedures.进料和出厂检验程序 sampling plans.抽样计划 receiving and shipping reports收料及装运报告 routing cards路线卡 material standards材料标准 inspection test reports检验测试试验报告 supplier dimensional and material certifications供应商尺寸及材料验证所有产品都必须有批控制和可追溯性，必须详细描述。这个控制系统必须提供所有在用材料或最终产品经过所有生产工序的追溯性记录对于返修或返工产品必须采取特殊的控制措施并有追溯性记录计划必须提及缺陷材料的遏制措施计划应明确分供应商或其它外部加工者采用的工艺且包括检验/试验结果，这些都与批号对应。（mot审核时会检查供应商是如何管理分供应商的）所有用于mot产品生产装配的元件/材料都必须有完全的认可，认可验证日期必须有记录6) incoming and outgoing material qualification/certification plandocumentation reviewed:已审核文件11) compliant 符合的内容12) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化7) test sample size and frequency测试/试验样本大小及频率products covered under a performance standard that specifies test sample size and test frequencies must be compliant to specific testing requirements outlined in the apqp reference manual and included in a design verification plan and report (dvp&r) test plan and control plan.产品的测试/试验样本大小及频率必须符合apqp参考手册的测试/试验要求且须包含在设计验证计划/报告（dvp&p）和控制计划中inspection, test, operation instructions, and control plan procedures must include documented sample sizes and test frequencies. 检验，试验，操作指导和控制计划流程必须包含文件化的样本大小和测试/试验频率责任部门：研发、品控 dvp&r inspection test reports检验试验报告 operation instructions操作指导书 control plan控制计划 incoming and outgoing material sampling plans进料和出厂检验抽样计划 applicable performance process and material engineering standards适用的过程性能标准和材料工程标准documentation reviewed:已审核文件13) compliant 符合的内容14) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化8) parts packaging and shipping specifications 产品包装和装运规格the parts packaging and shipping plan must include the types of containers (expendable or returnable) that will be used to ship product to motorolas user facility. the plan must include:产品包装和装运计划必须包括用于装运产品至mot使用设施的包装容器的类型（可降解或可回收），计划必须包括： specific container information (returnable and/or expandable, container dimensions, container material, # of pieces per container, weight of full/empty container, # of containers per pallet, etc.). see motorola packaging spec. shipping and labeling instructions, and packaging requirements. specific information on data required to be shipped, where the data is to be placed and if any special marking on containers is required identifying location of data. if returnable containers are to be used, a returnable container management system must be developed which includes: inventory control to track the number of containers on hand and in transit. inspection plan, which identifies damaged containers for removal from service. a backup plan to cover a shortage of returnable. bar coded labels must be to motorolas bar code spec.责任部门：生产、工程、研发、品控 parts packaging and shipping plan.产品包装和装运计划 shipping instructions (including: transmittal of container style, type, etc.; data requirements and where data is to be placed, special labeling or marking of containers, etc.装运指导（包含容器类型转换、型号等、所需数据、数据放置点、特别的标识 returnable container backup plan.可回收容器备料计划 bar coded labeling instructions条形码 管理指导 packaging approval process包装认可程序特定包装容器信息（可回收和/或可降解、容器尺寸、容器材料、每单位容器可装纳产品数量、满箱/空箱重量、每托盘可装箱数等），参mot包装标准。装运和标签指导书，包装要求特定信息如装运需附上的数据、数据放置地点、是否需要对数据所在包装进行特殊标记如果使用了可回收容器，则需制定可回收容器管理系统，包括：库存控制以追溯手中及途中的容器数量检验计划，包括将受损容器从服务中取出可回收容器短缺的备料计划条形码必须符合mot要求documentation reviewed:已审核文件15) compliant 符合的内容16) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化9) parts handling plan产品搬运计划parts handling plan must include the following:产品搬运计划包括如下： documented procedure detailing the internal material handling operations.文件化的程序详细规定内部材料搬运操作 the types of containers used throughout the manufacturing process including any external processing.整个生产流程包括任何外部流程用到的容器类型 the method by which material is tracked and transferred from one point to another, such as routing cards.材料的追踪及转移，比如路线卡 when production operators require special handling methods, appropriate instructions should be included in the operating instructions.如果生产操作工要求有特殊的操作方法，则必须在操作指导书上明确指出。责任部门：生产、工程、研发、品控 material handling procedures 材料搬运程序 material flow 材料流程 routing cards/sheets路线卡/表 packaging instructions包装指导 operating instructions操作指导 do they have bonepiles & how they control the process of rework/repair & on hold inventory. 是否有产品堆积？如何控制返修/返工？如何控制隔离的库存品？documentation reviewed:已审核文件17) compliant 符合的内容18) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化10) engineering standards identifiedall applicable engineering standards with the latest change level must be identified, listed, and available.必须是最新版本的工程标准all critical product and process characteristics that describe material, processes, performance, reliability, quality, and/or design requirements should be included in the control plan.控制计划中应包含所有描述材料、过程、性能、可靠性、质量和/或设计要求的关键产品和过程特性a system must be in place to obtain revisions to the standards and to notify all applicable departments of specification changes as they occur. 必须存在一个系统来取得最新版本的标准并将最新变更通知到所有适用部门责任部门：研发 list of engineering standards, (see motorola spec index of manufacturers requirements and reference specifications).工程标准清单（参mot的供应商要求和参考标准） an end customer spec as noted on the motorola drawing and/or specification mot图纸和/或规格书中的最终用户规格 industry standard and/or specification for materials, finishes, durability requirements, etc. 工业标准和/或材料、表面处理、耐久性要求等规格 pcn no authorized process changes. pcn：非授权过程变更documentation reviewed:已审核文件19) compliant 符合的内容20) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化11)preventive maintenance plans 预防性维护计划a preventive maintenance (pm) plan must exist for all equipment and tooling. as a minimum the pm plan must include:必须有预防性维护计划（pm）适用于所有设备和工具。pm至少须包括： set-up and approval procedures for all processes and adjustment for machines, tools, and other equipment. 包括所有机器、工具和其它设备过程控制和调试的设置和确认程序 plan schedules, frequencies, and instructions for the periodic maintenance of equipment or machinery, tools, dies, patterns, fixtures, etc., for each item of process equipment and tooling.每一过程设备和工模具期间维护的计划日程、频度和操作指导 perishable tools and supplies, etc. shall have life expectancy and utilization parameters identified including maintenance frequency and responsibility.易损工具器件等应该有目标生命期和利用率参数以确定维护频率和责任责任部门：工程 pm plan pm计划 pm schedule pm日程安排 pm instructions pm作业指导 way of communicating and showing evidence of pm on a regular basis 交流方式并以正常方式展现pm证据 check for any equipment downtime or defects caused by unplanned downtime (was pm frequency/pm checklist adequate).非计划停机的设备停机或故障统计和分析（pm频率/pm检查表）documentation reviewed:已审核文件21) compliant 符合的内容22) needs improvement需要改进的部分（包括行动计划，谁及何时完成等）(include action, who & when)process sign-offchecklist element & instructions条款说明documentation文件化12) product quality plan (pqp)产品质量计划the product quality plan must transl