过程失效模式及后果分析控制程序中英文版本

1、文件名称：过程失效模式及后果分析控制程序Document Title： Control procedure for Process failuremode and effects analysis文件状态DOC. Status文件编号版本修订Doc. No： COP016Issue: 02Rev: 01页号Page 1 of 1311.02.03.04.04.14.24.3.it ' s a kind of a目的 Purpose本程序确定了与产品和过程相关的潜在的失效模式和潜在制造或装配过程失效的机理/起因，评价了潜在失效对顾客产生的后果和影响，阐明了如何采取控制来降低失效产生频度或

2、失效 条件探测度的过程变量和能够避免或减少这些潜在失效发生的措施。This procedure ide ntify mecha nism /cause for pote ntial failure mode and pote ntial assemble process failure releva nt with products and process and evaluate the aftereffect and effect pote ntial failure have on customers and clarify how to con trol to decrease fai

3、lure freque ncy or process variable of detectivity and avoid or decrease these potential failure范围 Scope本程序适用于公司所有新产品/过程或修改过的产品/过程及应用或环境发生变更的原有产品/ 过程的样品试制和批量生产。This procedure can be applied to sample making and producti on in qua ntity of all the new products/ processes or altered products /processe

4、s and origi nal products /processes whose en vir onment cha nge 职责 ResponsibilitiesAPQP小组负责过程失效模式及后果分析（PFMEA）的制定与管理。APQP team are resp on sible to set and man agPFMEA）术语TermsPFMEA指Process Failure Mode and Effects Analysis（过程失效模式及后果分析）的英文简称。由负责制造/装配的工程师/小组主要采用的一种分析技术，用以最大限度地保证各种 潜在的失效模式及其相关的起因/机理已得到充

5、分的考虑和论述。（PFMEA）-abbreviation for“Process Failure Mode and Effects Analysistech no logy engin eer /team who are resp on sible to manu facture and assemble ofte n use . It en sure， sufficie nt con siderati on and discussi on of process failure mode and its cause/mecha nism to the utmost exte nt失效一一在规定

6、条件下（环境、操作、时间），不能完成既定功能或产品参数值和不能维持 在规定的上下限之间，以及在工作范围内导致零组件的破裂卡死等损坏现象。Failure-the phenomenon that can ' t fin-stefnction or parameters of products and can maintain with in upper limit and lower limit and the phe nomenon of damage and stuck of parts and subassembly with in work ing scope严重度（S）指一给定失

7、效模式最严重的影响后果的级别，是单一的FMEA范围内的相对定级结果。严重度数值的降低只有通过设计更改或重新设计才能够实现。Serious ness -he serious degree some failure mode can create .itspondin g'resuoraf somesin gle FMEA item频度（O）指某一特定的起因/机理发生的可能发生，描述出现的可能性的级别数具有4.4OPI001-1/02-01文件名称：过程失效模式及后果分析控制程序Document Title： Control procedure for Process failuremod

8、e and effects analysis文件状态DOC. Status文件编号版本修订Doc. No.： COP016Issue: 02Rev: 01页号Page 2 of 131相对意义，但不是绝对的。Occurrenee -the possibility degree some cause/mechanism may happen .it' s relativ不易探测度（D）指在零部件离开制造工序或装配之前，利用第二种现行过程控制方法找出失效起因/机理过程缺陷或后序发生的失效模式的可能性的评价指标；或者用第三种过程 控制方法找出后序发生的失效模式的可能性的评价指标。Un-det

9、ectivity -it means that we use the second kind of process control method to find out failure， cause / mecha nism , process defect or evaluat ing target of possibility of appeara nee of failure mod in the following procedure . use the third kind of process control method to find out evaluation target

10、 of possibility of appeara nee of failure mode in the followi ng procedure before parts and assembly leave manu facturi ng procedure or being assembled风险优先数（RPN）指严重度数（S）和频度数（O）及不易探测度数（D）三项数字之 乘积。Risk priority nu mber -the product of serious ness , Occurre nee and un-detectivity顾客一一一般是指最终使用者”但也可以是随后或

11、下游的制造或装配工序，维修工序或 政府法规。Customer it means“ final user“ gen erally ,it also can be lateurranufassembli ngprocedure ,repairi ng procedure or gover nment code培训和资格：过程失效模式及后果分析人员应经过PFMEA、APQP及相关知识的培训。Training and qualification :Personnel to analyze Process failure mode and its effects should be trai ned P

12、FMEA、APQP and releva nt kno wledge 程序内容 procedure content当顾客和公司有需求和要求时，APQP小组依产品质量先期策划程序在生产之前，在可行 性阶段或之前进行过程失效模式及后果分析，经 APQP小组长核准。如顾客有要求时，过程 失效模式及后果分析（PFMEA）必须提交顾客评审和批准；过程失效模式及后果分析（PFMEA ）制作的依据是工艺技术、产前会议总结、客户要求、市场投诉等制作修改。APQP team an alyze Process failure mode and its effects in accorda nee with <

13、;pla nning procedure for product quality > before produc ing ,duri ng or before feasibility phase whe n customers or company have requirements and needs .and ask for team leader' s approval . when custorequireme nts. Process Failure Mode and Effects An alysis （PFMEA） should be sent to custome

14、rs for exam ining and appro ving. PDMEA was made and modified based on process tech no logy, summary for preproducti on review , customersrequireme nts, market complai nts and so on.6.1.1针对新产品，APQP小组将建立和制订其单独的过程失效模式及后果分析（ PFMEA）;针对 常规产品（即：老产品、旧产品），APQP小组根据其系列分类、相同的工艺流程/过程和相同 的产品/过程特性（特别是其相同的产品/过程特殊特

15、性）建立和制定其通用的过程失效模式及 后果分析（PFMEA ）。e bunot a4.54.64.75.06.06.1mersOPI001-1/02-016.1.36.1.4hen文件名称：过程失效模式及后果分析控制程序Document Title： Control procedure for Process failuremode and effects analysis文件状态DOC. Status文件编号版本修订Doc. No.: COP016Issue: 02Rev: 01页号Page 3 of 131APQP team set up Process failure mode and

16、effects an alysis for new products particularly and set up com mon PFMEA for conven ti onal products in accorda nee with its sort, the same products / the same process characteristics and the same tech no logy procedure /processAPQP小组应列出产品生产过程流程图的清单，过程失效模式及后果分析（PFMEA）从产品整个过程的流程图开始，该产品的流程图应确定与每一工序相关的

17、产品/过程特性。APQP小组并将用于该产品过程失效模式及后果分析（PFMEA）准备工作的流程图纸的复印件附在 该产品过程FMEA分析表之后，以作为进行该产品过程FMEA分析之依据。APQP team should make a list for flow chart of product producti on processes .an alyze process failure mode and effects from flow chart . flow chart should identify product /process characteristics of each proc

18、edure . APQP team attach flow chart used to prepare for process failure mode and effects an alysis on FMEA an alysis form of that productsAPQP小组在进行过程失效模式及后果分析（PFMEA ）前可根据该产品的过程流程图先进行 过程的初步风险分析和评估，。该风险分析和评估必须考虑从单个部件到总成的所有制造工 序，过程失效模式及后果分析（PFMEA ）应包括从进料检验到出货的所有过程的特殊特性。 并分析产品在制造过程中的每一个工序步骤操作评定过程的风险（如：高

19、、中、低风险）；对评定为高风险（即：RPN> 100和/或严重度8的工序/项目和特殊特性应优先采取纠正与 预防措施；当顾客有要求或公司认为0需要的中等风险，也应对其采取纠正与预防措施。在确定了潜在的失效模式之后，应采取纠正/预防措施来消除潜在失效模式或不断减少它们发生的 可能性。当纠正预防措施实施验证有效后，过程的风险（即 RPN值）就会恢复正常（RPN < 80）。届时，须修改过程失效模式及后果分析（PFMEA）中的风险系数（RPN值）APQP team can an alyze and evaluate risk of process in accorda nee with f

20、low chart of that products before process failure mode and effects an alysis .we should con sider all the manu facturi ng procedure during this risk analysis . PFMEA should include special characteristics of all processes from incoming material in specti on to delivery. we an alyze operati on of eac

21、h procedure in manu facturi ng process and evaluate the risk （eg. high, media n, low risk）,for the procedure/items and special characteristics with high risk first（ie.NRP80 or Seriousness>8,corrective and preventive action also should be took, for the procedure/items and special characteristics w

22、ith media n risk w customers required or our compa ny con sider it is n ecessary, corrective and preve ntive action also should be took. When ide ntified pote ntial process failure mode, corrective and preve ntive measures should be took to eliminate or reduce the possibility of appearanee. When the

23、 effective of corrective and preventive verified, the risk of process（RPN） will get right （RPNw 80） ,then the RNP of 二FMEA should be modified._在进行过程失效模式及后果分析（PFMEA ）时，应假定所设计的产品能够满足设计要求，文件名称：过程失效模式及后果分析控制程序Document Title： Control procedure for Process failuremode and effects analysis文件状态 DOC. Status文

24、件编号版本修订Doc. No： COP016Issue: 02Rev: 01页号Page 4 of 1316.1.56.1.66.26.36.4因为设计缺陷和薄弱环节所产生的潜在失效模式可包括在过程失效模式及后果分析（PFMEA）中。Assume products we desig n can meet desig ning requireme nts whe n an alyze process failure mod and effects because pote ntial failure mode that desig n defect and weak sect ion creat

25、e can be in cluded in PFMEA过程失效模式及后果分析（PFMEA）并不是依靠改变产品设计来克服过程中的缺陷和薄弱 环节的，但它的确要考虑与计划的制造或装配过程有关的产品设计特性，以最大限度的保证 产品能满足顾客的要求和期望。PFMEA doesn' t depe nd on alterati on of products n to over（d®sig defect and weak sect ion but it will con sider product desig n characteristics releva nt with manu fa

26、cturi ng and assembli ng process to en sure products meet customers ' requireme nts and expectati ons to the utmost exte nt 公司必须对每一过程中所涉及到的产品和/或过程的特殊特性进行过程失效模式及后果分析， 并寻找最佳改善方法努力改进过程，以防止发生缺陷和预防潜在失效发生，而不是依靠检测 找出缺陷和失效。Our compa ny should an alyze Process failure mode and effects about special characteristics of products and process in every process and find out the best way to improve process to avoid de