质量体系要求

质量体系要求的培训材料

No.Item项目Requirement要求Procedure程序Date: May 13, 2009

Record记录Remarks备注Factory shouldkeep the relatedrequirements工厂应保存相关的要求1A) At least one quality supervisor understands our requirements and isUnderstand Worldwisemonitoring the overall safety and reliability requirements for Worldwiserequirements理解WW的要products.至少有一个品质管理人员理解WW的要求,并且全面监督WW产求品达到安全和可靠性方面的要求.B) The related purchasing supervisors should understand Worldwiserequirements and be capable to communicate with their suppliers andsubcontractors.相关的采购管理人员应理解WW的要求,有能力与他们的供应商和分包商交流.C) The product engineers should understand Worldwise requirementsor their products are approved by their quality personal whounderstands our requirements.产品工程师应了解WW的要求或他们的产品已经被理解我们要求的质量人员批准.Quality Performance品质执行结果A) Factory should set their quality targets internally. An inspectionacceptance rate should be equal or over 97% and average Majordefective rate equal or lower than 1.5%.工厂应设定内部的质量目标,验货合格率应达到或高于97%,平均的MA缺陷率达到或小于1.5%.B) Factory should also measure their quality performance and reviewperiodically. Provide CAP if they do not meet their target.工厂应定期检查和测量他们的质量执行结果.如果达不到他们的目标要提供改进计划.Review andNeed需要approval records 检查和批准记录A quality statementor target should beNeed需要posted质量声明或目标要张贴.Need需要23New product sign off新产品的放产A) Factory should have a procedure of new product sign off.工厂应有关于新产品放产的流程.B) Factory should have a check list to make sure all requirements are\"pass\" before sign off.工厂应有列表以确保在签样前所有的要求都能达到.C) Certificates or reports should be collected and provided as asupporting documents.证书或报告应收集起来,做为支持文件.Need需要Approval records确认记录Need需要Need需要No.ItemRequirementB) Factory should make sure that they are capable in making productsor components and materials in compliance with the relatedrequirements.工厂确定他们有能力使产品\\配件\\材料符合客人的要求.ProcedureRecordNeed需要RemarksEvaluation reports评估报告5Communicate with thecritical suppliers and allsubcontractors for therelated requirements与主要的供应商和所有的分包商交流相关的要求A) Factory should provide the related requirements to their criticalsuppliers and all subcontractors and make sure they can understand.工厂应提供相应的要求给他们的主要供应商和分包商以确保他们能理解.B) Factory should collect guarantee letter from their critical suppliersand all subcontractors as possible.工厂应尽可能地搜集主要供应商和所有分包商的保证书.A) For safety requirements, factory should collect at least one testingcertificates each requirements for every critical suppliers and allsubcontractors.对于安全的要求,工厂应收集每个主要供应商和所有的分包商每项要求至少一个测试证书.B) For reliability requirements, factory should collect testing certificatesas possible or a guarantee letter.对于可靠性要求,工厂应尽可能收集测试证书或保证书.Need需要Need需要At least one cert.for every relatedrequirements everyNeed需要vendor 每个卖方每个相关的要求至少一个证书Need需要Storagerequirements储存的要求Need需要6Collect certificates fromcritical suppliers and allsubcontractors从主要的供应商和分包商收集证书.7Protect Worldwise'sconsigned materials 保护WW提供的材料A) Factory should have a procedure how to manage our consignedmaterials.工厂应有程序规定如何管理我们指定的材料.B) Facotory should do incoming inspection for our consigned materialsper our requirements 工厂对于我们指定的材料应按我们的要求做进料检验.C) Facotory should inform Worldwise if they found the materials withdamage or unsuitable for use. Collect final decision from Worldwisewhether the materials could be packed or return.如工厂发现材料有损坏或者不能使用,工厂应通知WW.由WW来决定这个材料是否可以使用或退货.Need需要Need需要Keep supportingdocuments保存文件No.8ItemCorrective Action Plan改进计划RequirementProcedureNeed需要RecordRemarksFor all complaints对于所有的投诉.910A) Factory should have a procedure when and how to conduct a CAP.工厂应有程序规定如何执行改进计划.B) CAP should be conducted when they received any documentedcomplaints or Worldwise's shipment inspection failure.当工厂收到投诉或者WW出货验货失败,应执行改进计划.C) CAP should include root cause analysis, correction and correctiveaction. Preventive action should be required as possible. If re-work isrequired, factory should also write down the re-work method.改进计划应包括原因分析,改进措施.A) Factory should have a procedure showing when, where and howProduct quality control 产they control quality.工厂应有程序规定显示什么时候,哪里和如何控制质品质量控制量.B) Factory should have an in-coming materials inspection.工厂应有来料检验.C) Factory should have an effective control method for criticalprocesses.工厂对于特别重要的过程要有有效地控制方法.D) Factory should have their self inspection for finished product beforeWorldwise and our customer's inspection.在WW和我们的客人来验货之前,工厂要对成品先进行自验.E) In-coming and finished product inspections should be conductedaccording to MIL-STD-105E.来料和成品验货应按MIL-STD-105E进行.F) Factory should have the related physical testing equipment for theirinternal testing purpose. Factory should also be capable to conduct therelated physical testing per our product specifications and be able towrite the testing reports per our required format.工厂应有相关的物理测试仪器用来做内部测试,工厂有能力根据WW的规格书进行相应的物理测试,有能力按我们的格式填写测试报告.Design change control设计A) Factory should have a procedure describe any design changes forWorldwise product.工厂应有程序来描述WW产品设计方面的变化.更改控制B) Factory should keep an approval document for any changes. Emailis acceptable but it should be approved by some right personal.工厂应保存关于设计方面的变化的确认文件,邮件可以接受但应有正确的人来批准.C) Factory should provide the related testing reports to make sure thechange is passed Worldwise requirements.工厂应提供相关的测试报告以确保这些变化达到WW的要求.Need需要Need需要Need需要Need需要Need需要Need需要Need需要Need需要Keep approvalNeed需要documents保存确认的文件Need需要No.11ItemRequirementProcedureNeed需要RecordRemarks12A) Factory should have a procedure for the Sharp tools controlSharp tools control systemincluding how they do if loss of any sharp tool.工厂应有利器控制的程序利器的控制系统包括如果利器丢失如何处理.B) Factory should identify the controlled sharp tools.工厂应识别需要控制的利器.C) Factory should check out any loss of sharp tools every working day.工厂在每个工作日要检查是否有利器丢失.D) Factory should fix the sharp tools by string as possible.工厂应用松紧绳固定住利器.E) Factory should have a list of lost sharp tools with date, area andaction taken. The actions for any lost sharp tools should be approvedby an authorized personal.工厂应有丢失的利器的列表,里面要写明丢失的日期,丢失的地方和采取的措施.利器丢失的措施要给授权的人批准.A) Factory should have a procedure showing how to use the metaldetector. No second detection is allowed if the product failed the firstMetal detection金属探测器detection.工厂应有程序规定如何使用金属探测器,如果产品不能通过第一次的探测,将不允许进行第二次的探测.B) Factory should also have a procedure how to calibrate the metaldetector by using a 1.2mm metal ball. 工厂应有程序规定如何用1.2mm金属球来校准金属探测器.C) Factory should calibrate the metal detector twice a day and onceevery turning on.每次打开和一天两次要对金属探测器进行校准.D) Factory should have a procedure how to handle or rework thedefective products.工厂应有程序规定如何处理或返式这些不良品.All Worldwise product specificaitons, quality and testing requirementsshould be under control and no outdated documented were allowed toDocument control文件控制use. Factory should keep all these documents in the easy accessarea.WW的产品规格书/质量/测试要求要进行控制,不能过时的文件不能使用,这些文件必须放在可以拿得到的地方All quality activities should keep records. They include incoming, inprocess and final inspections. Some other related quality activitiesinclude sharp tools control, training and internal audits. These recordsRecord control记录控制should be kept for 1 year.质量活动应保存记录,包括进料,过程和最终验货,还包括其它相关的质量活动如利器控制,内部检查,这些记录要保存一年.Need需要Need需要Need需要Sharp tool list利器列表Need需要Need需要NeedNeed需要Need需要Rework and scrapNeed需要records 返工和报废记录.13Need需要14Need需要15Factory should have a training program for all QC and testingtechnicians who conduct Worldwise products' inspection and testing. AQualified QC Training合格training plan and records are required.工厂应有一个QC和测试技术人员的QC培训.培训计划,这些QC和技术测试人员是负责WW产品的验货和测试.需要提供培训计划和记录.Need需要Need需要No.16ItemNew product Review 新产品的检查RequirementFactory should conduct a new product review in order to make surethey are able to make the product shippment on time and able to meetthe required safety and quality requirements. A design review reportfor every product is required.要对新产品进行检查,以确保能准时出货和达到规定的安全和质量要求,每个产品的设计检查报告需要提供.All critical working environment should be identified and well controlled.A list of requirements of the areas and some effective control methodsare required.识别主要的工作环境并进行很好的控制,需要有主要工作环境的要求列表和一些有效控制方法.All critical processes such as check points should have written wrokinstruction to show the workers how to do correctly.所有重要的过程例如检查点应有书面的作业指导来指导工人如何正确的操作.All critical materials or components should be traceable. A writtenprocedure is required to show how to trace from finished products to thein-coming lots of materials and components. Records are required. Ifno critical materials, at least the finished product itself can show theproduction or pack out date.主要的材料或配件要有可追溯性,一个书面的程序来规定如何进行成品或进料的材料/配件批次来追溯.需要有记录.如果没有重要的材料,至少成品本身要有生产或包装日期.All transportation tools and storage areas must not damage orcontaminate Worldwise products. A procedure or a list of requirementsshould be documented. Periodically audits and records are required.运输工具和储存地方不能损坏或污染WW产品.一个流程或者要求列表要文件化.定期检查和记录是需要的.All critical processes should be identified and effectively controlled. Aninstruction should be provided how to control for every critical process.应识别出主要过程并进行有效控制.应提供指导书如何进行每个主要过程的控制.Factory should have a procedure how to handle all defectives from in-coming, in process, inspection and testing. All check points shouldrecord the defectives. Over 3% defective rate should be analyzed andrecorded.工厂应有程序规定如何处理进料/过程/验货/测试中产生的不良品.每个检查点如有不良都要记录.超过3%的不良率要进行分析和记录.All measuring or testing equipment used on production or producttesting should be calibrated periodically. Reasonable internalcalibration is acceptable. All calibration records should be kept for atleast 3 years.用在产品或产品测试方面的测试设备需要定期校准.合理的内部校准是可以接受的.所有的校准记录需要保存三年.ProcedureNeed需要RecordNeed需要Remarks17Critical workingenvironment主要的工作环境.Work instruction作业指导List of critical areasand theirNeed需要requirements主要区域列表和要求Need需要Post at work areas张贴切在工作区域1819Traceability system可追溯系统Need需要Need需要20Product protection产品保护Need需要List of requirementsfor warehouse andNeed需要transportation仓储和搬运的要求列表.Post at work areas张贴切在工作区域21Critical process control主要过程的控制.Need需要22Defectives control不良品的控制.Need需要CAP is required forhigh defective rateNeed需要更高的不良率需要有改善计划.23Testing equipmentcalibration测试设备的校准.Need需要