SP-19_失效模式控制程序.doc

萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 1 of 10 修改历史记录修改历史记录 Revision History 修改日期 Prepared or Revised Date 版 本 REV 变更申请号 Apply No 编写 WRITTEN BY 修改 说明 CHANGE REMARKS 2006 4 20B0无谢冰秀体系重建 按照 ISO9001 2000 TS16949 2002 ISO14001 2004三个国际 标准要求建立整合的质量环境管理体系文 件 Establish integrated quality environmental management system according to ISO9001 2000 TS16949 2002 ISO14001 2004 standard 文控审核 Checked by DCC 日期 Date 萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 2 of 10 1 目的目的 PURPOSE 本程序用于识别设计和过程中的潜在问题并通过系统的手段消除潜在问题 以提高产品和过 程质量 This procedure is to establish and maintain the actions needed to identify potential problem in design and process and to eliminate the potential problem in a systematic manner which will improve the product and process quality 2 范围范围 SCOPE 本程序适用于与汽车客户相关的所有新的 修改或现有的产品和过程 This procedure is applicable to all new modify and existing products and processes relating to automotive customer only 对于汽车客户 过程失效模式分析应作为 PPAP 文件的一部分递交给客户 对于非汽车客户 根 据客户要求递交 For Automotive Customer Process FMEA will be provided as a set of document for PPAP submission as for Non Automotive Customer it will be submitted upon customer requisition 3 职责职责 RESPONSIBILITIES 项目工程师负责监控和执行本程序 The Project Engineer will be responsible for the monitoring and execution of the procedure 项目工程师负责控制失效模式分析过程 将失效模式分析和控制计划联系起来并递交给 客户 The Project Engineer will be the central control of the FMEA process linking Failure Mode Effect and Analysis FMEA to the control plans and submission to the customer 项目工程师召集 FMEA 核心团队开展过程失效模式分析 The Project Engineer will gather a FMEA core team for the study of PFMEA FMEA 核心团队可以与 APQP 团队相同 The FMEA core team can be the same for APQP team 4 程序程序 PROCEDURE 4 1接接收收模模具具和和零零件件信信息息 Receive Information for Mould and Parts 项目或客户服务或销售和市场人员接收来自客户的模具设计和零件规格 这些信息的形式 可能是客户图纸 前期的材料清单或规格 Information on the mould design or parts specification is received from the customer by the Project Customer service Sales and Marketing Staff and the information may be in the form of Customer Drawing Pre BOM or specification 萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 3 of 10 4 2召召开开 FMEA会会议议 Conducting FMEA meeting 项目组长指定一个 FMEA 推动者 A FMEA Facilitator will be appointed by the Project Team Leader FMEA 推动者召集核心团队 进行头脑风暴会议 参照 APQP 计划图识别产品和过程的失效 模式 The FMEA Facilitator will activate the FMEA Core Team for a brainstorming session with reference to the APQP planning chart to identify the Potential Failure on the product and process of the operation for producing the product FMEA 核心团队根据过程流程图识别所有需要进行评估的过程 The FMEA Core Team will identify all the process function that required to be assessed based on process flow chart FMEA 核心团队根据可能发生的失效特征定义并列出特殊的操作过程中的每一种失效模 式 The FMEA Core Team will define and list down each potential failure mode for the particular operation based on the characteristics of failure that could occur FMEA 核心团队也应由客户或内部指定的特定的客户特征定义潜在失效模式 The FMEA Core Team will also define the potential failure for the Customer Specific Characteristic is specified by the customer or identified internally FMEA 核心团队应描述失效可能 对客户产生的影响 The FMEA Core Team will describe the effect of the failure that the part might have on the customer FMEA 核心团队应在 FMEA 表格中记录所有的发现 The FMEA Core Team will record all the findings into the Process FMEA form 4 3评估潜在失效评估潜在失效 Assess the Potential Failure FMEA 核心团队应评估潜在失效模式对客户影响的严重性并对影响进行评级 详见附表 A The FMEA Core Team will assess the severity of the effect from the potential failure mode to the customer and assign a ranking based on the effect Refer to Table A for ranking details FMEA 团队应定义失效可能发生的频率并对失效发生比例进行评级 详见附表 B The FMEA Core Team will determine the frequency that the failure will likely to occur and assign a ranking towards this failure rate Refer to Table B for ranking details 对失效的可检测进行评级 详见附表 C Assign a ranking to the level of detection of the failure Refer to Table C for ranking details 计算风险系数 RPN 严重程度等级 X 发生频率等级 X 可检测等级 Calculate the Risk Priority Number RPN value Where RPN Severity Ranking X Occurrence Ranking X Detection Ranking 萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 4 of 10 4 4推荐纠正潜在失效的措施推荐纠正潜在失效的措施 Recommend the Actions to Correct the Potential Failures FMEA 核心团队讨论并推荐风险系数值大于或等于 125 或严重程度级别大于或等于 7 的 失效的纠正措施 The FMEA Core Team will discuss and recommend the corrective actions to be taken on those failures with RPN value greater or equivalent to 125 or Severity level that is greater or equivalent with 7 FMEA 核心团队指派相关人员负责完成推荐措施的执行 The FMEA Core Team will assign personnel to be responsible for the completion of the recommended actions FMEA 核心团队在过程 FMEA 中记录所有的措施 The FMEA Core Team will record all the actions into the PFMEA form FMEA 核心团队发行受控的过程 FMEA 进行试模和验证 The FMEA Core Team will Issue controlled copy of PFMEA for trial and verification 4 5 开开始始试试模模并并验验证证 Conduct trial and verification FMEA 核心团队发出试模申请并安排试模 The FMEA Core Team will raise a Trial Run Requisition to arrange a mold trial FMEA 核心团队在试模过程中对推荐的措施进行验证和评估 The FMEA Core Team will carry out the verification and evaluation on the recommended actions during the mold trial FMEA 核心团队参照客户图纸同时评估过程的认证和确认产品的尺寸 The FMEA Core Team will evaluate the process qualification and confirm the product dimensions with reference to the customer drawing at the same time FMEA 核心团队观察并临时记录试模过程中发现的其它失效类型 The FMEA Core Team will observe and dot down any problems found on the verification or other type of failures during the mold trial 4 6评审和跟踪评审和跟踪 Review and follow up FMEA 核心团队评估试生产过程中发馈的问题 The FMEA Core Team Evaluate the feedback of the problems identified during the production trial FMEA 核心团队重新评估过程 FMEA 中严重程度 发生频率和可检测性的级别 详见附表 A 附表 B 和附表 C The FMEA Core Team will re assess the ranking of Severity Occurrence and Detection of the previous PFMEA Refer to Table A Table B and Table C for ranking details 萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 5 of 10 FMEA 核心团队评审最终的风险系数 如果风险系数仍旧高 需采取进一步的纠正措施 必 要时 再安排试生产 The FMEA Core Team will review the resulting RPN and if the RPN is still remaining high further corrective action need to be taken Request for further production trial if needed FMEA 核心团队对照过程认证结果对过程进行论证 The FMEA Core Team will qualify the process with reference to the Process Qualification results FMEA 团队更新过程过程失效模式分析 The FMEA Core Team will update the PFMEA 如果过程是受控的 FMEA 核心团队批准过程 FMEA 如果过程不受控 不批准过程 FMEA The FMEA Core Team will approve the PFMEA if the process is under control otherwise reject if it is not 递交批准的过程 FMEA 给 APQP 团队以获得客户的批准 适用于需递交 PPAP 的汽车客 户 Submit the approved PFMEA to APQP team to obtain customer approval Applicable to Automotive Customer with PPAP submission 4 7文件和分发过程文件和分发过程 FMEA Document and distribute the PFMEA APQP 团队接收客户的批准或让步接收通知 适用于需递交 PPAP 的汽车客户 分发批准 的 FMEA 给各个部门 必要时 如果过程 FMEA 未获得客户批准 应对结果进行跟踪 The APQP team will receive the customer approval or waiver notice Applicable to Automotive Customer with PPAP submission Then will distribute the approved FMEA to respective section Follow up with the customer closely if there is any rejection for the PFMEA if necessary 4 8 定期评审定期评审 过程变更评审过程变更评审 Periodic review Process Change review 发生任何过程变更时 FMEA 核心团队应评审过程 FMEA The FMEA core team will review the PFMEA if any process changes 产品投产后 每年应定期评审过程 FMEA Periodic review will be made after every one year for active product 如果过程 FMEA 中有 RPN 变更 增加 减小 应更新相关文件 控制计划 作业指导 标准作 业流程 等 Update the relevant document Control Plan work instruction standard operating procedures etc accordingly if there is RPN changes Increase Decrease in the PFMEA 5 0相相关关文文件件 RELATED DOCUMENTS 过程失效模式分析表格 Process FMEA form 附表附表 A 严重程度评级指南严重程度评级指南 Table A Severity Scale Guideline 萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 6 of 10 后果后果 Effect 判定准则 后果的严重度判定准则 后果的严重度 Criteria Severity of Effect Defined 判定准则 后果的严重度判定准则 后果的严重度 Criteria Severity of Effect Defined 评分评分 Ranki ng 无警告的严 重危害 Hazardous Without Warning 失效模式在没有任何预兆的情况 下可能影响到安全行车和 或违反 政府法规 Failure mode affects safe vehicle operation and or involves non compliance with government regulation Failure will occur WITHOUT warning 或可能在无警告的情况下对 机器 或总成 操作者造成危害 May endanger operator WITHOUT warning10 有警告的严 重危害 Hazardous With Warning 失效模式在有预兆的情况下可能 影响到行车安全和 或违反政府法 规 Failure mode affects safe vehicle operation and or involves non compliance with government regulation Failure occurs WITH warning 或可能在有警告的情况下对 机器 或总成 操作者造成危害 May endanger operator WITH warning 9 很高 Very High 汽车 系统不能运行 失去最基本的 功能 客户非常不满意 Vehicle item inoperable loss of primary function Customer very dissatisfied 或 100 的产品可能需要报废 或 者车辆 项目需在返修部门返修 1 个小时以上 Major disruption to production line 100 of product may have to be scrapped Vehicle item repair time is above one hour in repair department 8 高 High汽车 系统能运行 但性能下降 客户 不满意 Vehicle item operable but at a reduced level of performance Customer dissatisfied 或产品需进行分检 一部分 小于 100 需报废 或车辆 项目在返修 部门进行返修的时间在 0 5 1 小时 之间 Minor disruption to production line Product may have to be sorted and a portion less than 100 scrapped Vehicle item repair time is from half hour to one hour in repair department 7 中等 Moderate 汽车 系统能运行 但部分舒适性 方 便性部件不能运行 客户感觉不舒 适 Vehicle item operable but some comfort convenience item s inoperable Customer experience discomfort 或一部分 小于 100 产品可能需 要报废 不需分检或者车辆 项目 需在返修部门返修少于 0 5 小时 Minor disruption to production line A portion less than 100 may have to be scrapped no sorting Vehicle item repair time is less half hour in repair department 6 Low 低汽车 系统能运行 但一些舒适性 方 便性项目性能下降 客户感觉有点 不满意 Minor Vehicle item operable but some 或 100 的产品可能需要返工或者 车辆 项目在线下返修 不需送往 返修部门处理 disruption to production line 100 of product 5 萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 7 of 10 comfort convenience item s operable at reduced level of performance Customer experiences some dissatisfaction may have to be reworked Vehicle item is repaired on site not in repair department 非常低 Very Low 配合 表面处理 尖响 卡嗒响不符合 要求 大部分客户会注意到这个缺 陷 Fit finish squeak rattle item does not conform Defect noticed by most customers 或产品可能需要分检 无需报废 但部分产品 小于 100 需返工 Minor disruption to production line The product may have to be sorted and a portion less than 100 reworked line The product may have to be sorted and a portion less than 100 reworked 4 轻微 Minor配合 表面处理 尖响 卡嗒响不符合 要求 有一半客户会注意到这处缺 陷 Fit finish squeak rattle item does not conform Defect noticed by average customers 或部分 小于 100 产品可能需要 返工 无需报废 在生产线上其它 工位返工 Minor disruption to production line A portion less than 100 of the product may have to be reworked on line but out of station 3 非常轻微 Very Minor 配合 表面处理 尖响 卡嗒响等不符 合要求 少数客户会注意到这个缺 陷 Fit finish squeak rattle item does not conform Defect noticed by discriminating customer 或部分 小于 100 产品可能需要 返工 无需报废 在生产线上原工 位返工 Minor disruption to production line A portion less than 100 of the product may have to be reworked on line but in station 2 无 None无影响 No effectNo effect or very minor no convenience on operator 或对操作 或操作者而言有轻微的不方便或无 影响 1 附表附表 B 发生频度评级指南发生频度评级指南 Table B Occurrence Scale Guideline 失效概率失效概率 Probability of Failure 可能的失效率可能的失效率 Possible Failure RatesPpk 评分评分 Ranking 100 个每 1000 件 0 55 10 非常高非常高 失效几乎不能避免 Very High Failure is almost inevitable 50 个 每 1000 件 0 55 9 高高 High 通常与以前经常发生失效的同类 过程相似 Generally associated 20 个 每 1000 件 0 78 8 萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 8 of 10 with processes similar to previous processes that have often failed 10 个 每 1000 件 0 86 7 5 个 每 1000 件 0 94 6 2 个 每 1000 件 1 00 5 中等中等 通常与以前偶有失效但比例 不高的过程相似 Moderate Generally associated with processes similar to previous processes which have experienced occasional failures but not in major proportions 1 个 每 1000 件 1 10 4 低低 相关的类似过程只有个别的 失效发生 Low Isolated failures associated with similar processes 0 5 个 每 1000 件 1 20 3 非常低非常低 几乎只有在相同的过程中 发生个别失效 Very Low Only isolated failures associated with almost identical processes 0 1 个 每 1000 件 1 30 2 几乎不发生几乎不发生 失效不太可能发生 大多数相同的过程中未发生过失 效 Remote Failure is unlikely No failures ever associated with most identical processes 0 01 个 每 1000 件 1 67 1 附表附表 C 可探测度评级指南可探测度评级指南 Table C Detection Scale Guideline 检验类型检验类型 Inspection Type 可探测度可探测度 Detection 标准标准 Criteria ABC 建议的探测方法建议的探测方法 Suggested Ranged of Detection Methods 评分评分 Ranking 几乎不可能 Almost Impossible 完全确定不可探测 Absolute certainty of non detection X 不能探测或未检查 Cannot detect or is not checked 10 非常极低 Very Remote 控制方法可能无法探 测 Controls will probably not detect X 通过间接或随机检查控制 Control is achieved with indirect or random checks only 9 极低 Remote 控制方法探测到机会 不多 Controls have poor chance of detection X 只是通过目视检查 Control is achieved with visual inspection only 8 萨古拉科技 上海 有限公司 SAK URA TECH SHANGHAI CO LIMITED SPSH 19 失效模式分析失效模式分析 FAILURE MODE EFFECT ANALYSIS FMEA 版本Revision B0 发布Issued April 20th 2006 批准 Approved by页码Page 9 of 10 非常低 Very Low 控制方法探测到的机 会不多 Controls have poor chance of detection X 只是通过目视检查控制 Control is achieved with double visual inspection only 7 低 Low 控制