QCA.G8C00-过程失效模式及效应分析控制程序y.doc

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REV.BTITLEControl Program for PFMEA文件总页数TOTAL PAGES 11文件版次章节编号修改码核准文号ECN NO.生效日期EFF.DATE 变 更 历 程 REVISION HISTORY起稿者INITIATOR A B1-97-8 1 0JS-07080JS-080692007-10-082008-04-24增加附件四，并重新修改原版文件中的部分内容。修改7.2.3和7.4条，删除附件四：PFMEA重要性级别评估准则。 慕 蔚 慕 蔚项 目签 字日 期项 目签 字日 期受控号：拟 制慕 蔚2006-12-26电镀部成 军2007-02-09受控章：品管部骆菊芬2007-02-03集成电路塑料封装研究中心李习周2007-02-02制造一部王晓春2007-02-06品质保证部赵立权2007-02-01制造二部冯学贵2007-02-04设备部钟耕波2007-02-09生管部郑建琴2007-02-12动力部牛旺春2007-02-08批 准： 郭小伟采购部陈世贵2007-02-12发展规划部常文瑛2007-02-08销售部胡超先2007-02-07财务部蒲鸿鸣2007-02-12测试部闫普庆2007-02-02标准化慕 蔚2007-02-13日 期：2007-02-13章节 1-9 7-8版次/修改码 A/1 B/0页数 1-12 2-111 目的Purpose通过对产品制造初期做合适的失效模式分析，用来预先评价产品生产时，对过程、检验及客户造成的潜在失效模式、失效后果与相对应的失效原因分析，及早寻求解决的方法，以减少失效发生机率与其影响，进行产品设计的技术要求或顾客的要求。 The program is to predict the possible problem in the process of manufacturing and instantly solve the problem.2 范围Scope适用于华天科技股份有限公司的现有产品及新产品生产，包括原物料进料、储存管理、过程变更等的控制。Apply to raw material input, store management and process change of Tianshui Huatian Technology Co., Ltd.3 引用文件Reference Document无 N4 定义Definition4.1 失效Failure过程能力不能达到产品生产时制定的规格或质量标准，造成系统失去原有效力。If the production process capability can not meet specifications and quality standards， the system will lose their effectiveness4.2 失效模式Failure Mode造成系统失效的所有相关类似的机制的统称。 It is the general name of failed system mechanism.4.3 失效效应Failure effects失效发生时，失效模式对产品功能或客户的影响。Failure modes have an effect on goods function or customer when it happened.4.4 失效模式及效应分析(FMEAFAILURE MODE AND EFFECTS ANALYSIS)利用制程的辅助分析工具，协助早期鉴别与评估产品或过程的潜在失效模式与其影响，并建立预防补救措施以消除或降低失效的发生频度（几率）Depending on the systematic aided-analysis instrument, we establish the preventive measures to avoid the happening of the failure modes or reduce the frequency of the failure modes.4.5 过程失效模式及效应分析(PFMEAPOTENTIAL FAILURE MODE AND EFFECTS ANALYSIS)：在产品制造初期，应用FMEA方法辅助分析产品制造时潜在失效模式与失效效应。过程FMEA应从一般过程的流程图开始。Depending on the way of FEMA, in the primary stage of products manufacturing, we have a potential failure mode and effects analysis.4.6 潜在失效模式Potential Failure Mode是指过程有可能不能满足过程功能/要求栏中所描述的过程要求和/或设计意图。It is the process that can not meet the process function or design purpose. 4.7 潜在失效的后果Potential Failure Consequence 是指失效模式对顾客产生的影响。It is failure modes that have an effect on the customer.4.8 严重度(S) Severity Level是一给定失效模式最严重的影响后果的级别。It is the worst level of the failure modes.4.9 级别Level是指对那些可能需要附加的设计或过程控制部件、子系统或系统的产品特殊性的分级（如关键、主要、次要）。It is the level depending on the importance of the added design, process-control parts, sub-system and specialty.4.7 4.10 失效的潜在起因/机理Potential Failure Cause or Mechanism是指失效是怎样发生的，并依据可以纠正或可以控制的原则予以描述。It is how failure happened and gives how to solve the failure.4.11 频度(O) Frequency 是指某一特定的起因/机理发生的可能性。描述出现的可能性的级别数具有相对意义,而不是绝对的。通过设计更改或过程更改来预防或控制失效模式的起因/机理是可能导致发生频度数降低的唯一途径。It is the possibility of life failure in a given mechanism.4.12 现行过程控制 Current Design Control尽可能地防止失效模式或起因/机理的发生或者探测将发生的失效模式或起因/机理的控制说明。这些控制可以是诸如防失误/防错、统计过程控制（SPC）或过程后的评价，等。评价可以在目标工序或后续工序进行。Try our best to prevent the failure mode or detect the occurrence of the failure mode .These controls can help prevent errors, statistical process control (SPC) or post-process evaluation, and so on. Evaluation process can process in the target or following procedures.有两类过程控制可以考虑：Two kinds of design control should be considered as follows:预防：防止失效的起因/机理或失效模式出现，或者降低其出现的几率。Prevention: avoid the happening of failure mechanism or reduce the frequency of the failure mode.探测：探测出失效的起因/机理或失效模式，导致采取纠正措施。Probe: depending on the way of analysis or physics to probe the cause or mechanism of the failure modes. 4.13 探测度(D) Probe Degree 是与过程控制栏中所列的最佳探测控制相关联的定级数。探测度是一个在某一FMEA范围内的相对级别。为了获得一个较低的定级，通常计划的过程控制必须予以改进。It is related to the best process control degree. The probe degree is a relative level in the field of FMEA. 4.14 风险顺序数（RPN）是严重度（S）、频度（O）和探测度（D）的乘积。RPN =严重度（S）频度（O）探测度（D）在单一FMEA范围内，此值可用于所担心的过程中的问题进行排序。It is the multiply of severity, frequency and probe.Risk Priority Number(RPN)=（S）（O）（D）In the field of the single FMEA, the value can be given which should be put priority during the process.4.15 失效模式及效应分析(FMEAFAILURE MODE AND EFFECTS ANALYSIS)采用系统化的辅助分析工具，协助早期鉴别与评估产品或制程的潜在失效模式与其影响，并建立预防补救措施以消除或降低失效的频度 (发生)。Depending on the systematic aided-analysis instrument, we establish the preventive measures to avoid the happening of the failure modes or reduce the frequency of the failure modes.4.16 过程失效模式及效应分析(PFMEAPOTENTIAL FAILURE MODE AND EFFECTS ANALYSIS)在产品制造初期，应用FMEA方法辅助分析产品制造时的潜在失效模式与效应分析。In the primary stage of products manufacturing, we use FMEA to help analyze the potential failure mode and effects during the manufacturing.5 职责Responsibility5.1 制造部门Manufacturing Department技术副部长负责进行产品PFMEA初期准备工作及PFMEA会议召开。The deputy minister is in charge of preparing PFMEA and holding such a meeting.5.2 相关单位Other Sectors生管部、集成电路塑料封装研究中心、品管部、业务部门等。Manufacturing Management Department, IC Plastic Packaging Research Center, QC Department and Sales Department.6 PFMEA流程图N Define SystemDefine Production Flowchart and Equipment ArrangementOrganize a Meeting PFMEA Fill in Potential PFMEA Form RPN Benchmark Implement Preventive & Remedy Measures Discuss the Result of Measures RPN BenchmarkEnd the PFMEA CaseImplement the Preventive & Remedy MeasuresCollect the FilesN7 内容Content7.1 PFMEA实施时机 When to implement PFMEA7.1.1 产品变更；When product changes7.1.2 过程变更；When process changes7.1.3 过程不稳定；When process is not stable7.1.4 过程能力不足。When process capability is not enough当有上述状况应实施过程失效模式及效应分析。7.2 失效的分类Failure Types7.2.1 外观或尺寸规格不符；Physical dimension does not agree.7.2.2 功能规格不符，如散热能力不够、电讯品质太差；Function does not agree.7.2.3 品质规格不符，如金(铜)线偏移率与金(铜)线拉力或推球不足等现象； Quality criteria disagrees, such as poor pulling or pushing force.7.2.4 制程不符，良率偏低。Processing procedure disagrees and low yield.7.3 过程FMEA进行的时机When to implement FMEA过程FMEA是一份动态文件,应从一般过程的流程开始。The PFMEA is a dynamic document and should begin with an ordinary flow.7.3.1 在可行性阶段或之前进行；Pre-feasibility or during feasibility7.3.2 在生产用工装到位之前进行；Before eqpt. preparation 7.3.3 从单个部件到总装的所有的制造工序进行。All procedures7.4 PFMEA编号：PFMEA NumberingPFMEA编号共9码，前4码为产品代码，中间3码为制程代码，后2码为流水码，格式如下： PFMEA numbering is made up of 9 digits; the first four digits stand for part number, the middle 3 digits stand for processing procedure and the last 2 digits stand for serial number as follows: P B G AG R D0 1Serial no.Proc codePart code（can bypass when there is no PKG type）制 程Processing procedure制程代码Processing procedure code制 程Processing procedure制程代码Processing procedure code全制程All processing proceduresALL植 球Ball-mountingBMT减 薄GrindingGRD产品分离SingulationSIN划 片SawingSAW测 试TestingTST上 芯Die-bondingDBD包 装PackingPAK压 焊Wire-bondingWBD材 料MaterialMAT塑 封Epoxy M/CENC电 镀PlatingSDP打 印MarkingMRK切 筋TrimDBC贮 存StoreSTP运 输TransportTNS进 料IncomingFID切 割DicingINC7.5 PFMEA分析流程：请参照PFMEA流程图。 The PFMEA analysis flow should depend on its counterpart of PFMEA.7.5.1 建立PFMEA分组Establish PFMEA branch team.7.5.1.1 按照过程在不同的区域或相关的工序，建立PFMEA分组。 Each procedure should establish its own PFMEA branch team.7.5.1.2 分组负责人的资格The person-in-charge qualifications a) 大专以上或相当于在工程师,在本岗位工作满3年以上； Above college educational background or work on the post at least 3 years.b) 人力资源部聘任为二级工程师者；He or she is designated as a Class-B engineer by Personnel Resources department.c) 经过培训、掌握集成电路塑料封装知识和技能，具有较强的工艺分析能力。The person should master the skills of IC and be good at analysis.7.5.2 制定PFMEA表格中的内容PFMEA Form Content对选定的一个或几个项目形成PFMEA分组后,分组负责人召开会议,制定出 PFMEA表格的下述内容：Form Contents as follows: a) 项目/功能；Item/function b) 潜在失效模式；Potential Failure Modes c) 失效模式后果；Failure Mode consequences d) 失效的潜在原因。Failure Reasons7.5.3 召集会议讨论：Convene a meeting制造部门的技术副部长应召集相关单位开会进行过程失效模式及效应分析，评价潜在失效模式的严重程度、级别、频度和不可探测度，分析失效原因并制定相应改善措施。The deputy minister of manufacturing department convenes such a PFMEA meeting to assess and analyse the severity,class, frequency, detect degree of Failure Modes and then adopt the corrective measures. 7.5.3.1 潜在失效模式分析Potential Failure Modes and Analysis与会者可根据以往工程经验与理论判断，从而探讨可能的潜在失效模式。The participants analyses the possible failure modes depending on experience and theory analysis.7.5.3.2 潜在失效效应分析Failure Analysis与会者须依据列出的所有失效模式讨论其可能造成的失效效应。The participants analyse the failure effects.7.5.3.3 严重度（S）评估Severity Assessment 与会者须根据每一个失效模式发生时，评估失效效应的严重度，严重度的量化数字可依据PFMEA严重度等级评估准则(附件一)记录其量化的数字。 The participants should assess the severity of failure effects.The assessment criteria refers to attachment one to record the quantification digit.7.5.3.4 重要级别Importance Class 与会者需指定合适的分级以有效反映：The participants need appoint the proper classification to effectively reflect importance class.a) 客户特别指定或会造成产品致命损伤； Customer points out that products may cause fatal damage.b) 项目中的组件或失效模式需要特别的制程管制； Project components or failure modes require special process controlc) 偏差在合格范围，不会影响产品质量。The deviation is in the field and dose not affect the goods quality.7.5.3.5 失效原因分析Failure Reason Analysis与会者须对失效模式及失效效应的所有组合分析其最有可能发生的原因。The participants should analyse the failure reason of failure modes and failure effects.7.5.3.6 失效原因/机构发生频度数（O）评估Failure Reason or Frequency Assessment与会者须根据每一个失效模式，分析其在产品寿命周期中发生度数的大小。发生频度数的量化数字可依据PFMEA频度数等级评估准则(附件二)记录其量化的数字。The participants should analyse the frequency in the life cycle time. The frequency quantification digits should refer to the Class Assessment Criteria in the attachment two.7.5.3.7 现行过程控制措施Current Process control measures与会者应针对失效模式的频度、失效原因/机构的探测度（检出率）与失效效应严重度提出目前的制程控制措施是否能够降低发生率、失效效应严重度与提高探测度。Participants should refer to the frequency of failure modes, failure causes / organizations detection systems (detection rate) and the severity of failure effects to analyse whether the control measure can reduce the incidence of failure effects and improve the detection of degree of severity.7.5.3.8 探测度（D）评估Detection degrees assessment与会者须针对每一个失效模式探讨发生时的探测出的可能性，其中查出探测度的量化数字可以依PFMEA探测度评估准则(附件三)。Depending on each failure modes,the participants search the possibility of each detection degree.7.5.3.9 风险顺序数（RPN）评估Risky Priority Number与会者须根据各失效模式/机制的严重度、频度及探测度乘积计算风险顺序数。即：The participants calculate RPN by the multiply of Failure modes severity,frequency and detection degree.风险顺序数（RPN）=严重度(S)频度(O)探测度(D)。The RPN is the multiply of Severity,Frequency and Detection degree.判定准则：RPN100为高风险；RPN在 60-100为中风险；RPN60为低风险。Criteria: When RPN100, it is high risk. When RPN is between 60 and 100, it is moderate risk. When RPN is 60, it is low risk.7.5.3.10 建议的措施Proposed Measurea) 对高风险的失效模式采取纠正措施消除起因或改进预防和探测方法。 As for the high risk of failure modes, we should take corrective measures to eliminate the causes or methods to improve the prevention and detection.b) 一般实践中，当严重度是9或10时，必须予以特别注意，以确保现行的设计控制或预防/纠正措施针对了这种风险，不管RPN值是多大。在所有的已确定潜在失效模式的后果可能会给制造/装配人员造成危害的情况下，都应考虑预防/纠正措施，以便通过消除或控制起因来避免失效模式的产生。 In general practice, when the severity is 9 or 10, the required special attention to ensure that the existing design control or preventive / corrective measures for this risk.Meanwhile, we should consider preventive / corrective measures to eliminate or control by the causes of the production to avoid failure modes.c) 若风险优先数低于基准值，则可进入结案动作。与会者应尽可能建议有效的纠正预防措施，并决定实施纠正预防措施的负责人及目标完成日期。 If the risk priority number is lower than the baseline, we can enter the closed action.The participants should put forward effective corrective and preventive measures and decide who will be in charge of implementing the corrective and remedy measures and when to finish the implementation. 7.5.4 纠正预防措施实施结果跟踪Track the result of the corrective and remedy measures项目小组或PFMEA分组对纠正措施进行跟踪。PFMEA project team or branch team should track the corrective measures.7.5.5 纠正措施实施后，由分组组长负责，重新评审风险顺序数。 After the implementation of corrective measures, the group leader should be responsible for re-assessment of risk priority number.当风险顺序数低于标准值时，此纠正预防措施为有效。若风险顺序数仍高于标准值，则须讨论新的补救预防措施继续进行产品制程的修正。When the risk priority number is less than the standard value, it indicates that the corrective and preventive measures are effective.When the risk priority number is higher than the standard value, it necessary to discuss the new remedial preventive measures .7.5.6 项目组长或PFMEA分组组长负责递交PFMEA相关资料交技术部门统一管理并进行下一轮PFMEA。 Project leader or group leader should be responsible for submitting PFMEA PFMEA information technology departments under a unified management and delivery for the next round PFMEA若所有失效模式的风险顺序数均低于高风险值或经过纠正预防措施后均低于高风险值，则此制程失效模式及效应分析可进行结案，而且产品制造必须将PFMEA之有效的纠正预防措施拟定在相关之作业规范。 When the RPN of failure mode is lower than the number of high-risk value or corrected RPN is lower than the high-risk value ,it indicates that this process failure mode and effect analysis can be closed. And the PFMEA effective corrective and preventive meas