PFMEA程序文件

1、FLEXTRONICS DMP-001-F2.01 WORK INSTRUCTION 作业指导书 DOC. No. /DOC. No. /文件编号： DMQAIDMQAI- -001001 REV./REV./版本号： 0101 PRODUCT/ PRODUCT/ 产品： AllAll TITLE / TITLE / 标题： Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式与效果分析 PAGE/PAGE/页数 1 OF 81 OF 8 REVIS ION HIS TOR

2、Y / REVIS ION HIS TORY / 版本记录 REVIS IONREVIS ION 版本 CHANGE DE SCRIPTIONCHANGE DE SCRIPTION 修改内容 ISSUERISSUER 发布者 RELEAS E DATERELEAS E DATE 发行日期 01 New release. (Replace old document QAI-GE-018, WI-QA D-005 and 16-3B) Arking Xu Mar.09.04 REMARKREMARK 备注 APPROVALAPPROVAL DEPARTMENTDEPARTMENT NAMENAME

3、 TITLETITLE 部门 名字 职位 QA(FI) _ Jackie Duan _ Sr. Engineer _ QA(FT) _ Aiping Yuan _ Section Head _ QA(FM) _ PK Tan _ Manager _ PE (FI) _ John H NG _ Manager _ PE (FT) _ Matthew leung _ Manager _ PL&AS (FM)_ SG Chang _ Manager _ MT(FM) _ Penglai Ng _ Manager _ FLEXTRONICS DMP-001-F2 .01 WORK INSTRUCTIO

4、N 作业指导书 DOC. NO. /DOC. NO. /文件编号： DMQAIDMQAI- -001001 REV/REV/版本号: : 0101 PRODUCT / PRODUCT / 产品： AllAll TITLE / TITLE / 标题: : Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式与效果分析 P PAGE/AGE/页数： 2 Of Of 2 1 PURPOSE （目的） The purpose of this work instruction is

5、to provide a method for continuous improvement through the use of PFMEAs. 此作业指导书的目的是为运用制程失效模式及效果分析达到持续改善目的提供方法。 2SCOUPE （范围） This work instruction applies to any manufacturing process at FLEX requirement for failure mode effect analysis or any process at FLEX PFMEA. 适用于客户要求或管理要求而需要做失效模式及效果分析的伟创力 3 D

6、EFINITIONS （定义） 4. REFERENCE （参考文件） 4.1 DMP-010 Corrective and Preventive Action 5. RESPONSIBILITY （职责） 5.1 Quality Engineer: PFMEA Team Leader, holds the PFMEA meeting, prepare and update PFMEA base on team discussion result, apply PFMEA issue. 品质工程师：PFMEA团队之领导者。主导制程失效模式及效果分析 根据团队讨论结果准备和更新报告，申请报告发行

7、。 WORK INSTRUCTION （Doumen） that has a customer （Doumen） where management requires a （斗门）的所有制程。 3.1 3.2 3.3 3.4 3.5 3.6 3.7 3.8 3.9 PFMEA: Process Failure Mode and Effect Analysis. It should describe all the potential failure modes which may occur in process and their corresponding failure effects;

8、evaluate and rank the severity, occurrence and detection of the failures. It should also describe the current control method, recommend corrective action, person responsible responsibility and due date. PFMEA-制程失效模式及效果分析。它应列出制程中所有可能出现的潜在失效模式以及相应的失效结 果，评价和评定其严重度、发生度、检测度的等级分数。同时指出当前的控制方法和建议的改善行动以及 相应的

9、责任者和完成期限。 QE: Quality Engineer QE:品质工程师 SQE: Supplier Quality Engineer SQE:供应商管理品质工程师 PE: Process Engineer PE:工艺工程师 ME: Manufacturing Engineer ME:制造工程师 TE: Test Engineer TE:测试工程师 EE: Equipment Engineer EE:设备工程师 DCC: Document Control center DCC:文件控制中心 RPN: Risk Priority Number RPN:风险优先系数 纠正与预防措施 ,举行制

10、程失效模式及效果分析会议, FLEXTRONICS DMP-001-F2 .01 作业指导书 DOC. NO. /DOC. NO. /文件编号： DMQAIDMQAI- -001001 REV/REV/版本号: : 0101 PRODUCT / PRODUCT / 产品： AllAll TITLE / TITLE / 标题: : Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式与效果分析 PAGE/PAGE/页数： 3 Of Of 3 5.2 Manufacturing

11、 Engineer, Process Engineer, TE, EE, SQE and Production Supervisor are Process PFMEA team member, prepare PFMEA report together with Quality Engineer. 制造工程师，工艺工程师，测试工程师，设备工程师，供应商管理品质工程师和生产主管是制程失效模式 及效果分析之组员，同品质工程师一起准备潜在失效模式及效果分析报告。 5.3 DCC: Control the PFMEA files and keep in DCC. DCC:负责控制及保存制程失效模式及

12、效果分析文件。 6. PROCEDURE (程序) 6.1 Operating Procedure 操作程序 6.1.1 A PFMEA team is made up of the Quality Engineer, Manufacturing Engineer, Process Engineer, TE, EE, SQE and the appropriate Production Supervisor. PFMEA小组由品质工程师，制造工程师，工艺工程师，测试工程师，设备工程师，供应商管理品质工 程师和相应的生产主管组成。 6.1.2 Quality Engineer initiates

13、 a PFMEA during New Product Introduce when required. 在新产品导入时而且需要时，品质工程师应该发起 PFMEA 6.1.3 During the mass production, based on feedback of daily quality report, abnormal notice, CAR, PER and so on. Quality Engineer summarize abnormity from process within 3 month and have a meeting to analyze Failure E

14、ffect, Failure Cause, Current Process Control. 在量产过程中，基于每日品质报告、异常问题通知单、纠正措施报告、问题评估报告等的反馈更新制 程失效模式及效果分析文件。品质工程师三个月进行总结一次，并召开会议对其进行失效影响和原因 当前控制方法加以分析。 6.1.4 Evaluates the RPN number. Determine score of RPN and classify High Risk, Medium Risk and Low Risk per different process and product. Suggest to c

15、lassify High Risk (above 100), Medium Risk (60100), Low Risk (Below 60). 评估RPN数值，可根据不同的制程和产品来决定高风险 ，中风险和低风险的分数。建议对于 RPN值 进行高低分类：高风险(100分以上)，中风险(在60和100分之间)，低风险(在60分以下)。 6.1.5 High risk priority number (RPN) is targeted for reduction through team effort. And determine Recommended Action, Responsibili

16、ty, Target Completion Date and Action Taken, and record them on the Failure Mode and Effect Analysis sheet. Medium risk priority number (RPN) is targeted for optional reduction through team effort. 高风险系数的失效是小组努力降低的目标 ，需要决定所采取的相应纠正行动 ，责任人及完成日期记录在 制程失效模式及效果分析表中。中风险系数的失效是小组可选择降低的目标。 6.1.6 Relative resp

17、onsibility should take recommended action. 相关责任人应对所推荐的纠正行动加以实施。 6.1.7 Follow Up and Review of the PFMEA: The PFMEA is a living document and should always reflect the latest status of relevant actions. So the PFMEA review needs to be organized by QE within the project team at least 3 months and updat

18、ed according to the actual status. Its recommended that PFMEA review meeting can be performed during the CIP (Continual Improvement Program) meeting. PFMEA的跟进及评审：PFEMA 是一种活的且需不断更新的文件从而反映最新的状态。因此 ，各项目 内的品质工程师应每三个月一次组织 PFMEA团队依据最新的情况进行一次评审并对 PFMEA进行相 应的更新。建议在各项目的持续改善会议中对 PFMEA进行评审。 6.2 Rating Factor G

19、uidelines: 评分指南表 6.2.1 The PFMEA Severity Evaluation Criteria. PFMEA 严重度评估标准。 6.2.2 The PFMEA Occurrence Evaluation Criteria. PFMEA 发生率评估标准。 6.2.3 The PFMEA Detection Evaluation Criteria.FLEXTRONICS DMP-001-F2 .01 WORK INSTRUCTION 作业指导书 DOC. NO. /DOC. NO. /文件编号： DMQAIDMQAI- -001001 REV/REV/版本号: : 01

20、01 PRODUCT / PRODUCT / 产品： AllAll TITLE / TITLE / 标题: : Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式与效果分析 PAGE/PAGE/页数： 4 Of Of 4 PFMEA 可检出率评估标准 6.2.1 PFMEA Severity Evaluation Criteria Rating 级另 U Description 描述 Definition 定义 10 Dangerously High 特别高 Failur

21、e w ould be noti ceable to the customer and would drasti cally affect the customers process or product 对客户来说是显而易见的，且会严重影响客户的制程和产品。 9 Extremely high 极高 Failure w ould be readily apparent to the customer, but would have major effects on the customers process or product. 对客户来说是容易见到的，且主要会影响客户的制程和产品。 8 V

22、ery High 很高 Failure w ould create a major nuisance to the customer, the customer cannot overcome it in the process without performance loss 是可弓施客户麻烦的，在制程中客户是不能克服的 ，也就不会有损失. 7 High 高 Failure can be overcome w ith modifications to the customers process or product, but there is major performance loss 在

23、制程中客户是能克服的，但会有重大损失。 6 Moderate 中等 Failure results in a subsystem or partial malfunction of the product. 失效会引起下一站的或部分的帮障。 5 Low 低 Failure creates enough of a performance loss to cause the customer to complain. 失效会造成大的损失并引起客户的抱怨. 4 Very low 很低 Failure can be overcome w ith modifications to the custome

24、rs process or product, but there is minor performance loss 失效能够被克服，但是会引起定的损失. 3 Minor 次要的 Failure w ould create a minor nuisance to the customer, but the customer can overcome it in the process w ithout performance loss 失效会引起客户一些麻烦，但是能够被克服.不会有损失. 2 Very Minor 极次要的 Failure may not be readily apparent

25、 to the customer, but would have minor effects on the customers process or product. 在客户处失效不容易显露出来，但是在客户制程中会有一点影响. 1 None 没有影响的 Failure w ould not be noticeable to the customer and would not affect the customers process or product 在客户处失效不会显露出来，在客户制程中也不会有一点影响. 6.2.2 PFMEA Occurrence Evaluation Criteri

26、a Rating 级另 U Probability 可靠性 Possible Failure Rates 可能失效比率 Cpk 制程能力指数 10 Very High: Failure is almost inevitable 很局:几乎是无法避免的 1 in 2 0.33 8 High Repeated Failures 高的:重复失效的 1 in 8 0.51 7 High Repeated Failures 高的:重复失效的 1 in 20 0.67 6 Moderate: Occasional Failures 中等:偶尔失效的 1 in 80 0.83 5 Moderate: Occ

27、asional Failures 中等:偶尔失效的 1 in 400 1.00 4 Moderate: Occasional Failures 中等:偶尔失效的 1 in 2,000 1.17 3 Low : Relatively few failures w ith similar processes 低的:与相似制程相联系的孤立失效 1 in 15,000 1.33 2 Very Low: Isolated failures with identical processes 很低的：只与几乎相同制程相联系的单独失效 1 in 150,000 1.50 FLEXTRONICS DMP-001

28、-F2 .01 1 Remote: Failure is unlikely 极低的:失效是不太可能的 豆 1 in 1,500,000 2.00 WORK INSTRUCTION 作业指导书 DOC. NO. / DOC. NO. / 文件编号： REV/ REV/ 版本号: : 0101 PRODUCT / PRODUCT / 产品： AllAll DMQAIDMQAI- -001001 TITLE / TITLE / 标题: : Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis

29、PAGE/ PAGE/ 页数: : 制程失效模式与效果分析 5 Of Of 5 6.2.3 PFMEA Detection Evaluation Criteria Ranking 级另 u Detection 检测 Inspection lypes 检查类型 Definition 定义 10 Almost Impossible 几乎不可能 Cannot detection or is not checked 不能察觉或检查出来 9 Very Remote 几乎微乎其微 No Control method know n for check failure now 现在没有已知的控制方法去检测失效

30、. 8 Remote 绝对少的 me possible is remote tnat Control method know n can cneck failure now 现在已知的控制方法检测出失效的可能性是绝对低的 . 7 Very Low 很彳氐的 The possible is very low that Control method know n can check failure now 现在已知的控制方法检测出失效的可能性是很低的 . 6 Low 低的 X The possible is low that Control method know n can check fail

31、ure now 现在已知的控制方法检测出失效的可能性是低的 . 5 Moderate 中等 X The possible is Moderate that Control method known can check failure now 现在已知的控制方法检测出失效的可能性是中等的 4 Moderately High 适度高的 X X The possible is Moderately High that Control method known can check failure no w 现在已知的控制方法检测出失效的可能性是适度高的 3 High 高的 X X The possib

32、le is High that Control method know n can check failure now 现在已知的控制方法检测出失效的可能性是较高的 2 Very High 很高的 X X It is possible that Control method know n can check failure now 现在已知的控制方法检测出失效是很容易的， 1 Certain 几乎可确定的 X It is noticeable that Control method know n can check failure no w 现在已知的控制方法检测出失效的可能性是显而易见的 I

33、nspection Types: A. E rror proofed （防呆） B. Gauging （治具） C. Manual （人工） 6.3 Implementation procedure for the PFMEA: The PFMEA form DMQAI-001-F1.01 is designed for the PFMEA preparation. The following steps need to be implemented by the PFMEA team with reference to the section number in the PFMEA form

34、. PFMEA的实施程序:PFMEA表格用于制程失效模式及效果的分析 .依据PFMEA表格中标识的完成步骤序 号完成如下所列填写。 6.3.1 Part No-Fill the part number in the section 在Part No栏中填入零件的料号。 6.3.2 Project-Fill the Project name in the section 在Project栏中填入项目的名称。 6.3.3 Model-Fill the Product Model in the section 在Model栏中填入产品的型号。 6.3.4 Customer-Fill the cust

35、omer name in the section 在Customer栏中填入客户的名称。 6.3.5 Process-Fill the process name in the section 在Process栏中填入制程工站的名称。 6.3.6 Core Team-Fill major person name taken part in analysing PFMEA in the section 在Core Team栏中填入参加 PFMEA分析成员的名字。 6.3.7 Doc No-Fill PFMEA 于 number in the section. The format should b

36、e: PFMEA-Project Code-XXX FLEXTRONICS DMP-001-F2 .01 （PFMEA Order Number）. For example, “ PFMEAERIC- 005 means the PFMEA is the 5th PFMEA of Ericsson project. WORK INSTRUCTION 作业指导书 DOC. NO. /DOC. NO. /文件编号： DMQAIDMQAI- -001001 REV/REV/版本号: : 0101 PRODUCT / PRODUCT / 产品： AllAll TITLE / TITLE / 标题: :

37、 Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式与效果分析 PAGE/PAGE/页数： 6 Of Of 6 在Doc No栏中填入PFMEA编号，其格式为:PFMEA-四位项目代码-XXX （PFMEA的流水号）. 例如“ PFMEA-ERIC-005 ”是指爱立信项目的第 5份PFMEA。 6.3.8 PFMEA Leader-Fill the person name leading PFMEA in the section 在PFMEA Leader 栏中填入导P

38、FMEA分析人的名字。 6.3.9 Reviewed By- Fill the person name review PFMEA in the section 在Reviewed By 栏中填入审核 PFMEA 人的名字。 6.3.10 Revision- Fill the revision number of PFMEA in the section, for example: 01,02, 03 . 在Revision栏中填入 PFMEA的版本，如 01, 02, 03 6.3.11 FMEA Date- Fill the date of PFMEA revised in the sect

39、ion 在FMEA Date栏中填入修改 PFMEA版本的日期。 6.3.12 Threat Hold RPN: Fill the target score with threat in the section 在Threat Hold RPN 栏中填入需要降低的目标风险系数。 6.3.13 Item- Fill number in the section 在Item栏中填入序号。 6.3.14 Process Description- fill process name in the section 在Process Description 栏中填入具体的制程名称。 6.3.15 Poten

40、tial Failure Mode- Work out each potential failure modes for the analysed process and enter the description of the potential failure mode in the section. 潜在失效模式的分析：针对每种制程，分析出其潜在的失效模式并将其描述在 Potential Failure Mode 中。 6.3.16 Potential Effect of Failure-Analyse the effects of each potential failure in t

41、erms of what the customer might notice or experience, customer can be internal subsequent operation as well as the ultimate end user. The determined effects need to be entered in the section 潜在失效模式的影响分析 ：结合可能对客户的影响 ，对每个潜在的失效模式的影响进行分析 ，客 户既可以是内部下一工位的操作也可以是指最终用户。经确认的失效模式影响需填入 Potential Effect Failure

42、中。 6.3.17 Sev-The severity will be determined based on the effects of the failure. The severity rank is ranged from 1 to 10 points. The detail severity evaluation criteria refer to sheet. The team determined severity rank need to be filled in the section 严重度的评估：严重度主要依据失效模式的影响程度进行评估 .严重度的评定范围从 1分到10

43、分.详细的严重度评估标准参见图表 .经团队确认的严重度填入 Sev中。 6.3.18 Potential Cause of Failure-The potential cause for every failure needs to be determined in terms of something that can be corrected or controlled. The potential cause need to be entered in the section. 潜在失效原因：需要针对每种失效模式分析出可加以控制改善的潜在原因。分析出的潜在原因 需填入 Potential

44、 Cause of Failure 中。 6.3.19 Occ-Occurrence is the likelihood that a specific cause of failure will occur. The occurrence likelihood is ranked from 1 to 10 points. Refer to sheet - Occurrence Evaluation Criteria and fill the team evaluated Occurrence rank in the section 失效原因的发生率评估：发生率是指一种失效原因出现的可能性，发

45、生率的评定范围从 1分至 10分.具体评估标准参见图表 -发生率的评估标准。团队发生率的评估结果填入 Occ中。 6.3.20 Current process controls-The current process controls are the descriptions of the controls that either prevent the possible failure from occurring or detect the cause of failure and lead to corrective action. The current process control

46、 needs to be filled in the section FLEXTRONICS DMP-001-F2 .01 当前的制程控制：当前的制程控制是指用来防止问题发生的预防控制以及检测出失效原因的控 制措施。当前制程的控制措施需填入 Current process controls 中。 WORK INSTRUCTION 作业指导书 DOC. NO. /DOC. NO. /文件编号： DMQAIDMQAI- -001001 REV/REV/版本号: : 0101 PRODUCT / PRODUCT / 产品： AllAll TITLE / TITLE / 标题: : Process F

47、ailure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式与效果分析 PAGE/PAGE/页数： 7 Of Of 7 6.3.21 Det-The detection is the detect possibility for the potential failure based on current process control. The detection possibility is ranked from 1 to 10 points. Refer to sheet Detection

48、 evaluation criteria. The detection rank needs to be entered in the section. 可检出率的评估：可检出率是指在当前制程控制的情况下潜在失效模式可被检测出的可能性 .可 检出率的程度评定范围从 1分至10分.具体评估标准参见图表 -可检出率的评估标准。将可检 出率的评估标准填入 Det栏中。 6.3.22 Risk Priority Number (RPN)-The RPN need to be calculated to determine the priority of the concerns in process

49、for improvement actions. The RPN is Severity (S) x Occurrence (O) x Detection (D). The RPN need to be entered in the section 风险优先级数：计算出风险优先级数来确定制程改善的优先次序 .风险优先级数=严重度x发生 率x可检出度。将计算出的风险优先级数填入 RPN栏中。 6.3.23 Recommended Action-The preventive / corrective actions should be provided for high RPN items. Ge

50、nerally, the recommended actions are needed when the RPN rank is greater than or equal to 100. Another case is: Must action for the item of Severity=9 or 10, no matter the result of RPN. The recommended actions need to be described in the section 建议的行动：针对高风险系数模式需采取预防改善措施予以改善。一般地，高风险优先级数是 指RPN大于或等于100。另外一种情形是：无论RPN值是多大，当严重度是9或10时，必须 采取预防改善措施予以改善。建议的改善行动须填入 Recommended Action 中。 6.3.24 Responsibility & Target Com