实施管理程序

1、精选优质文档-倾情为你奉上1 目的/Purpose设想产品制造过程中所有的可能产生的失效模式及后果并指明其相关的起因/机理，找到能够避免或减少这些潜在失效发生的措施，在生产过程中加以重点控制并持续努力改进生产过程，力求防止缺陷的发生。Assume all potential failure mode and effect occurred possibly during manufacturing process and point out the related cause, find out the measures of minimizing occurrence of potentia

2、l failure, focus on controlling during production process and strive continuously to improve production process and try to avoid defects occurring.2 适用范围/Application Scope适用于公司产品制造全过程潜在的失效模式及其后果的分析，及做出相应的防止规定。The procedure is applicable to PFEMA during whole process of products manufacturing, and de

3、velop the corresponding prevention provision.3 术语和定义/Terms and Definition PFMEA：（潜在的失效模式及后果分析）是在产品设计和过程设计阶段，对构成产品的子系统、零件、对构成过程的各个工序逐一进行分析，找出所有潜在的失效模式，并分析其可能的后果，从而预先采取必要的措施，以提高产品的质量和可靠性的一种系统化的活动。PFMEA: Conduct analysis on subsystem, parts of forming products and every working procedures forming the p

4、rocess, find out all potential failure mode and analyze the possible consequence, adopt necessary measures in advance, is kind of systematic activities of improving quality and reliability of products. 头脑风暴法：又称畅谈法、集思法等，是采用会议的方式，利用集体的思考，引导每个参加会议的人围绕某个中心议题，广开言路、激发灵感，在自己的头脑中掀起风暴、毫无顾忌、畅所欲言地发表独立见解的一种创造性思

5、考的方法。 Brain Storm Method: Known as “say ones say” method, collective thinking method, adopt type of meeting, utilize collective thinking, induct every person participating in the meeting to speak frankly surrounding the main point and inspire inspiration, lift up storm in brain, is one kind of creat

6、ive thinking method of “say ones say” without worry.4 程序流程图/Procedures Flow Chart无/Nil5 职责与权限/Responsibility and Authorization5.1 项目小组（APQP）组长由技术部部长指定，由项目组长选择小组成员组成有相关部门人员参加的项目小组。The chief of Technical Dept. designate APQP chief, and APQP chief select team members and form APQP with related personne

7、l.5.2 由APQP组长召集项目组成员编制PFMEA。APQP chief call together members to develop PFMEA.6 工作程序/Working Procedures 6.1 实施的时机及对象产品/Timing and Object Products of Implementation当有新的产品、更改产品和过程发生变更的产品时，在可行性阶段之前或过程中及在工装制造之前须进行过程失效模式和后果分析。When there are new products, modified products and products with changed proces

8、s, must perform PFEMA before feasible stage or during process as well as before tooling manufacturing.我公司将顾客提出要求的产品、或具有与以往产品不同的独特功能的产品，列为PFMEA对象产品。Our company regards the products with customers requirements or possessing unique function different from previous product as object products of PFMEA6.2

9、 实施步骤/Implementation Procedures6.2.1 PFMEA的准备工作/PFMEA Preparation a) 建立FMEA小组/Establish FMEA team 由APQP小组组长负责，召集参与产品制造过程的各部门的主管技术员组建成多功能小组，实施PFMEA。多功能小组在此阶段任务是：APQP team chief take charge, call in the in charge technical staff involving in manufacturing process to establish multi-function team, impl

10、ement PFMEA. The task of multi-function team at this stage is:l 利用过程流程图，确定过程步骤。Utilize process flow chart, determine process procedures.简要描述被分析的过程/工序。Briefly describe the analysis process/working procedures尽可能短的说明该工艺过程/工序的目的。Try to shorten the explanation of process course/purpose of working procedu

11、res如果该过程包括有多项不同的失效模式的工序，则这些工序单独列出。If the process includes various working procedures of failure mode, the working procedures should be listed out separately.l 用“头脑风暴法”列出所有可能的失效模式和/或起因。Utilize “Brain Storm Method” to list out all possible failure mode and / or cause.b) 准备必须的资料Prepare essential materi

12、alsl 过程流程图；Process flow chart;l 过程特性矩阵表；Process characteristic matrix tablel 特殊过程特性明细表；Special process characteristic list l 工程规范；Engineering criterionl 正式PFMEA表格。Formal PFMEA form6.2.2确定潜在过程失效模式/起因 Identify the PFEMA/Causel 将“头脑风暴会议”上得到的信息进行整理，确定哪些属于失效模式，哪些属于起因/机理。Compile the information from “Brai

13、n Storm Meeting”, identify which one belongs to failure mode and which one belongs to cause.l 潜在的过程失效模式是指过程可能发生的不能达到过程功能要求或过程设计意图的问题的表现形式。Potential process failure mode means the representation format of problem when process occurred possibly fails to reach process function requirements or process d

14、esign intention.是对具体工序不符合要求的描述。The description of specific working procedures failing to comply with requirements所谓潜在是指可能发生，也可能不发生。So-called potential means might occur, might not occur 一般情况下，它是按规定的操作规范进行操作时的潜在失效问题，但由于过程设计中对技术与体力的能力考虑不足而造成的失效或因设备、工装设计中的问题而引起制造、装配过程的失效也应包括在PFMEA中。In normal circumstan

15、ce, potential failure occurs while operating under specified operation regulation, however, the failure caused by insufficient consideration of technique and physical capability during process design or failure of manufacturing, assembling process caused by equipments and tooling design should be in

16、cluded in PFMEA. l 失效原因/机理是指使失效模式发生的原因。Failure cause means the cause of failure mode.每一个失效模式的可能原因都应该考虑到。Should consider all possible causes of failure mode.上一道工序的失效模式可能是下一道工序的失效起因；下一道工序的失效模式可能是上一道工序失效模式的后果。The failure mode of previous working procedure might be cause of failure of next working proce

17、dure; the failure mode of next working procedure might be the consequence of failure mode of previous working procedure.误操作（人的误操作，机器的误操作）是失效模式的可能原因之一。Mis-operating (human mis-operating, machine mis-operating) might be one of possible causes of failure mode.6.2.3 列出起因和现行控制/List out Causes and Existin

18、g Controll 在PFMEA表格中填上所有的失效模式。Fill in all failure mode in PFMEA formsl 在PFMEA表格上，对每一个失效模式，列出它的起因。List out the cause of every of failure mode in PFMEA forms.l 现行的过程控制是对尽可能地防止失效模式或其起因/机理的发生或者探测将发生的失效模式或其起因/机理的控制的说明。应考虑二类过程控制：The existing control is the explanation of cause control. The cause control i

19、nclude try to prevent failure mode or occurrence of cause or to detect the failure mode or occurrence of cause. Should consider two kinds of process control:预防：防止失效的起因/机理或失效模式出现，或者降低其出现的机率。Prevention: Prevent the cause of failure or failure mode occurring, or minimize the rate of occurrence.探测：探测出失效

20、的起因/机理或者失效模式，导致采取纠正措施。Detect: Detect cause of failure or failure mode, lead to adopting corrective measures. 如果可能，最好的途径是先采用预防控制。If possible, best approach is to adopt prevention control.6.2.4 分析失效后果/确定严重度(S)Analyze Failure Consequence/ Determine the Severity Rate列出失效模式对所有顾客的影响和后果，包括对过程的影响和对产品功能的影响。L

21、ist out the impact and consequences of failure mode to all customers, including the impact to process and products function.顾客是广义的，包括：Customers are generalized, include:最终顾客Under users直接顾客（下一道工序）Direct customers (Next working procedures)中间顾客（下游工序）Middle customers 严重度是失效模式发生时对顾客的影响后果的严重程度的评价指标。Severi

22、ty rate is referring to the appraisal index of severity to customers impact consequence while failure mode occur.严重度只适用于失效的后果Severity rate is applicable to consequence of failure only.当一个失效模式有若干可能的后果，严重度将列出危害程度最大的那个后果的严重度分数。When there is some possible consequence for failure mode, severity rate will

23、 list out the marks of biggest harm extent. 要减少失效的严重度级别数值，只能通过修改设计或工艺过程来实现。To reduce severity rate figure of failure, can be achieved through modifying design or process course only.严重度的评分采用110分（详见FMEA手册）The grade of severity rate adopts 1-10 score (details are provided in FMEA manual)6.2.5 确定频度（O）/

24、 Determine Frequency (O)频度是指某一失效起因或机理出现的可能性大小的评估。Frequency is referring to evaluation of high and low possibility of cause of failure occurred.频度评估的依据主要参考已有过程或类似过程的统计资料，如过程的Cp (Cpk)值，PPM值，故障率等。The main criterion of frequency evaluation is based on statistic materials of existed process or similar pr

25、ocess, such as Cp (Cpk) value of process, PPM value and failure rate etc.对于无历史资料参考的过程，根据小组的经验，工程判断来估计。For the process without history materials as reference, evaluate based on team experience and engineering judgment.按可能性大小给出110的评定分（详见详见FMEA手册）Mark 1-10 score based on high and low possibility (detai

26、ls are provided in FMEA manual).6.2.6 确定探测方法/探测度（D）Determine the Detecting Method/ Detecting Degree探测度是指零件在离开该制造工序或装配工序之前，采用现行过程控制方法找出失效模式起因机理和可能性大小。Detecting degree is referring to before the parts depart from the manufacturing working procedures or before assembling working procedures, adopt exist

27、ing process control method to find out the cause of failure mode and possibility of failure mode. 以统计原理为基础的抽样检测是有效改善探测度的措施Sampling detecting based on statistic principle is measure of improving detecting degree effectively.增加样本容量和抽样频率都有助于改善探测度。Increase sample capacity and sampling frequency help to

28、improve detecting degree.不能认为100%检查就具有高的探测度，因其成本高，易受测量系统变差的影响。100% inspection does not mean high detecting degree, which is high cost, and affected easily by deviation of measurement system.探测度的评分采用110分（详见FMEA手册）The grade of detecting degree adopts 1-10 score (details are provided in FMEA manual).6.

29、2.7评估RPN值/实施纠正措施Evaluate RPN Value/ Implement Corrective Measures RPN=（S）×（O）×（D）潜在失效模式的综合风险评估Comprehensive risk evaluation of potential failure mode用它来表示过程风险的度量，RPN数值在11000之间Indicate the measurement of process risk, RPN value is in between 1-1000如果RPN100时，过程设计人员必须采取措施If RPN100, process de

30、sign personnel must adopt measures不管RPN值多大，当S（严重度）8时，应引起特别注意，若可行，必须采取措施。Regardless of how big of RPN value, when s (severity rate) 8, should pay special attention, if possible, must adopt measures.在所有情况下，如果失效模式的后果会危害制造/装配人员，就必须采取纠正措施。Under any circumstances, if consequence of failure mode jeopardize

31、s manufacturing/assembling personnel, must adopt corrective measures.l 失效模式的RPN计算完成后，按其大小顺序以及失效模式的严重度来考虑纠正措施，以降低S，O和D。After completing calculation of RPN of failure mode, consider the corrective measures based on big and small sequence as well as severity rate of failure mode, decrease S, O and D.所采

32、取的纠正措施应按照下列优先顺序来实施：Implement corrective measures adopted should based on the following priorities: 1 消除失效模式的起因Eliminate the cause of failure mode2降低失效模式的后果（改变设计或过程）（S）Minimize the consequence of failure mode (Modify design or process) (S)3减少失效模式的发生频率（O）Reduce the occurrence frequency of failure mode

33、4改进失效模式的探测方法（D）Improve the detecting methods of failure mode (D)纠正措施应包括设计（产品/过程）更改、工艺改进、改进探测（检验）方法等内容，并应明确实施的责任人、完成时间及效果确认方法。Corrective measures should include design (products/process) change, process improvement, improvement of detecting (inspection) method, define responsible personnel of impleme

34、ntation, completion time and effectiveness confirmation method.l 简要记下措施的实施情况和日期。当明确了纠正措施后，重新估计S、O、D值，并重新计算出新的RPN。对制定措施，因某种原因（成本过高等）而未实施的，应予以说明。Write down briefly the implementation status and date. After define corrective measures, re-evaluate value of S, O, D and re-calculate new RPN. For the measu

35、res developed, failing to implement due to curtain reasons (high cost), should give explanation.6.2.8完成FMEA分析/Complete FMEA Analysis完成PFMEA表格中各项内容整理，填写。Complete the compilation of every content of PFMEA form and fill in.负责过程的工程师应负责保证所有可行的建议措施已被实施或已妥善落实，并确认这些已反映在生产作业指导文件中。The engineer in charge of th

36、e process should ensure all feasible measures have been implemented or carried out properly, and confirm the measures have been reflected in production working guidance documents.6.3 内容更新/持续改进Content Update/Continuous Improvement当产品要求有变动、生产过程变化、工序不稳定或工序能力不足时，原项目小组成员需要重新讨论并更新PFMEA。PFMEA是一个动态文件，它应体现最新设计及过程改进措施的情况，包括产品正式投产之后的