PFMEA程序文件

1、FLEXTRONICS DMP-001-F2.01 WORK INSTRUCTION 作業(yè)指導(dǎo)書 DOC. No. /DOC. No. /文件編號： DMQAIDMQAI- -001001 REV./REV./版本號： 0101 PRODUCT/ PRODUCT/ 產(chǎn)品： AllAll TITLE / TITLE / 標(biāo)題： Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式與效果分析 PAGE/PAGE/頁數(shù) 1 OF 81 OF 8 REVIS ION HIS TOR

2、Y / REVIS ION HIS TORY / 版本記錄 REVIS IONREVIS ION 版本 CHANGE DE SCRIPTIONCHANGE DE SCRIPTION 修改內(nèi)容 ISSUERISSUER 發(fā)布者 RELEAS E DATERELEAS E DATE 發(fā)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 備注 APPROVALAPPROVAL DEPARTMENTDEPARTMENT NAMENAME

3、 TITLETITLE 部門 名字 職位 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 作業(yè)指導(dǎo)書 DOC. NO. /DOC. NO. /文件編號： DMQAIDMQAI- -001001 REV/REV/版本號: : 0101 PRODUCT / PRODUCT / 產(chǎn)品： AllAll TITLE / TITLE / 標(biāo)題: : Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式與效果分析 P PAGE/AGE/頁數(shù)： 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. 此作業(yè)指導(dǎo)書的目的是為運用制程失效模式及效果分析達(dá)到持續(xù)改善目的提供方法。 2SCOUPE （范圍） This work instruction applies to any manufacturing process at FLEX requirement for failure mode effect analysis or any process at FLEX PFMEA. 適用于客戶要求或管理要求而需要做失效模式及效果分析的偉創(chuàng)力 3 D

6、EFINITIONS （定義） 4. REFERENCE （參考文件） 4.1 DMP-010 Corrective and Preventive Action 5. RESPONSIBILITY （職責(zé)） 5.1 Quality Engineer: PFMEA Team Leader, holds the PFMEA meeting, prepare and update PFMEA base on team discussion result, apply PFMEA issue. 品質(zhì)工程師：PFMEA團(tuán)隊之領(lǐng)導(dǎo)者。主導(dǎo)制程失效模式及效果分析 根據(jù)團(tuán)隊討論結(jié)果準(zhǔn)備和更新報告，申請報告發(fā)行

7、。 WORK INSTRUCTION （Doumen） that has a customer （Doumen） where management requires a （斗門）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。它應(yīng)列出制程中所有可能出現(xiàn)的潛在失效模式以及相應(yīng)的失效結(jié) 果，評價和評定其嚴(yán)重度、發(fā)生度、檢測度的等級分?jǐn)?shù)。同時指出當(dāng)前的控制方法和建議的改善行動以及 相應(yīng)的

9、責(zé)任者和完成期限。 QE: Quality Engineer QE:品質(zhì)工程師 SQE: Supplier Quality Engineer SQE:供應(yīng)商管理品質(zhì)工程師 PE: Process Engineer PE:工藝工程師 ME: Manufacturing Engineer ME:制造工程師 TE: Test Engineer TE:測試工程師 EE: Equipment Engineer EE:設(shè)備工程師 DCC: Document Control center DCC:文件控制中心 RPN: Risk Priority Number RPN:風(fēng)險優(yōu)先系數(shù) 糾正與預(yù)防措施 ,舉行制

10、程失效模式及效果分析會議, FLEXTRONICS DMP-001-F2 .01 作業(yè)指導(dǎo)書 DOC. NO. /DOC. NO. /文件編號： DMQAIDMQAI- -001001 REV/REV/版本號: : 0101 PRODUCT / PRODUCT / 產(chǎn)品： AllAll TITLE / TITLE / 標(biāo)題: : Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式與效果分析 PAGE/PAGE/頁數(shù)： 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. 制造工程師，工藝工程師，測試工程師，設(shè)備工程師，供應(yīng)商管理品質(zhì)工程師和生產(chǎn)主管是制程失效模式 及效果分析之組員，同品質(zhì)工程師一起準(zhǔn)備潛在失效模式及效果分析報告。 5.3 DCC: Control the PFMEA files and keep in DCC. DCC:負(fù)責(zé)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小組由品質(zhì)工程師，制造工程師，工藝工程師，測試工程師，設(shè)備工程師，供應(yīng)商管理品質(zhì)工 程師和相應(yīng)的生產(chǎn)主管組成。 6.1.2 Quality Engineer initiates

13、 a PFMEA during New Product Introduce when required. 在新產(chǎn)品導(dǎo)入時而且需要時，品質(zhì)工程師應(yīng)該發(fā)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. 在量產(chǎn)過程中，基于每日品質(zhì)報告、異常問題通知單、糾正措施報告、問題評估報告等的反饋更新制 程失效模式及效果分析文件。品質(zhì)工程師三個月進(jìn)行總結(jié)一次，并召開會議對其進(jìn)行失效影響和原因 當(dāng)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). 評估RPN數(shù)值，可根據(jù)不同的制程和產(chǎn)品來決定高風(fēng)險 ，中風(fēng)險和低風(fēng)險的分?jǐn)?shù)。建議對于 RPN值 進(jìn)行高低分類：高風(fēng)險(100分以上)，中風(fēng)險(在60和100分之間)，低風(fēng)險(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. 高風(fēng)險系數(shù)的失效是小組努力降低的目標(biāo) ，需要決定所采取的相應(yīng)糾正行動 ，責(zé)任人及完成日期記錄在 制程失效模式及效果分析表中。中風(fēng)險系數(shù)的失效是小組可選擇降低的目標(biāo)。 6.1.6 Relative resp

17、onsibility should take recommended action. 相關(guān)責(zé)任人應(yīng)對所推薦的糾正行動加以實施。 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的跟進(jìn)及評審：PFEMA 是一種活的且需不斷更新的文件從而反映最新的狀態(tài)。因此 ，各項目 內(nèi)的品質(zhì)工程師應(yīng)每三個月一次組織 PFMEA團(tuán)隊依據(jù)最新的情況進(jìn)行一次評審并對 PFMEA進(jìn)行相 應(yīng)的更新。建議在各項目的持續(xù)改善會議中對 PFMEA進(jìn)行評審。 6.2 Rating Factor G

19、uidelines: 評分指南表 6.2.1 The PFMEA Severity Evaluation Criteria. PFMEA 嚴(yán)重度評估標(biāo)準(zhǔn)。 6.2.2 The PFMEA Occurrence Evaluation Criteria. PFMEA 發(fā)生率評估標(biāo)準(zhǔn)。 6.2.3 The PFMEA Detection Evaluation Criteria.FLEXTRONICS DMP-001-F2 .01 WORK INSTRUCTION 作業(yè)指導(dǎo)書 DOC. NO. /DOC. NO. /文件編號： DMQAIDMQAI- -001001 REV/REV/版本號: : 01

20、01 PRODUCT / PRODUCT / 產(chǎn)品： AllAll TITLE / TITLE / 標(biāo)題: : Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式與效果分析 PAGE/PAGE/頁數(shù)： 4 Of Of 4 PFMEA 可檢出率評估標(biāo)準(zhǔn) 6.2.1 PFMEA Severity Evaluation Criteria Rating 級另 U Description 描述 Definition 定義 10 Dangerously High 特別高 Failur

21、e w ould be noti ceable to the customer and would drasti cally affect the customers process or product 對客戶來說是顯而易見的，且會嚴(yán)重影響客戶的制程和產(chǎn)品。 9 Extremely high 極高 Failure w ould be readily apparent to the customer, but would have major effects on the customers process or product. 對客戶來說是容易見到的，且主要會影響客戶的制程和產(chǎn)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 是可弓施客戶麻煩的，在制程中客戶是不能克服的 ，也就不會有損失. 7 High 高 Failure can be overcome w ith modifications to the customers process or product, but there is major performance loss 在

23、制程中客戶是能克服的，但會有重大損失。 6 Moderate 中等 Failure results in a subsystem or partial malfunction of the product. 失效會引起下一站的或部分的幫障。 5 Low 低 Failure creates enough of a performance loss to cause the customer to complain. 失效會造成大的損失并引起客戶的抱怨. 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 失效能夠被克服，但是會引起定的損失. 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 失效會引起客戶一些麻煩，但是能夠被克服.不會有損失. 2 Very Minor 極次要的 Failure may not be readily apparent

25、 to the customer, but would have minor effects on the customers process or product. 在客戶處失效不容易顯露出來，但是在客戶制程中會有一點影響. 1 None 沒有影響的 Failure w ould not be noticeable to the customer and would not affect the customers process or product 在客戶處失效不會顯露出來，在客戶制程中也不會有一點影響. 6.2.2 PFMEA Occurrence Evaluation Criteri

26、a Rating 級另 U Probability 可靠性 Possible Failure Rates 可能失效比率 Cpk 制程能力指數(shù) 10 Very High: Failure is almost inevitable 很局:幾乎是無法避免的 1 in 2 0.33 8 High Repeated Failures 高的:重復(fù)失效的 1 in 8 0.51 7 High Repeated Failures 高的:重復(fù)失效的 1 in 20 0.67 6 Moderate: Occasional Failures 中等:偶爾失效的 1 in 80 0.83 5 Moderate: Occ

27、asional Failures 中等:偶爾失效的 1 in 400 1.00 4 Moderate: Occasional Failures 中等:偶爾失效的 1 in 2,000 1.17 3 Low : Relatively few failures w ith similar processes 低的:與相似制程相聯(lián)系的孤立失效 1 in 15,000 1.33 2 Very Low: Isolated failures with identical processes 很低的：只與幾乎相同制程相聯(lián)系的單獨失效 1 in 150,000 1.50 FLEXTRONICS DMP-001

28、-F2 .01 1 Remote: Failure is unlikely 極低的:失效是不太可能的 豆 1 in 1,500,000 2.00 WORK INSTRUCTION 作業(yè)指導(dǎo)書 DOC. NO. / DOC. NO. / 文件編號： REV/ REV/ 版本號: : 0101 PRODUCT / PRODUCT / 產(chǎn)品： AllAll DMQAIDMQAI- -001001 TITLE / TITLE / 標(biāo)題: : Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis

29、PAGE/ PAGE/ 頁數(shù): : 制程失效模式與效果分析 5 Of Of 5 6.2.3 PFMEA Detection Evaluation Criteria Ranking 級另 u Detection 檢測 Inspection lypes 檢查類型 Definition 定義 10 Almost Impossible 幾乎不可能 Cannot detection or is not checked 不能察覺或檢查出來 9 Very Remote 幾乎微乎其微 No Control method know n for check failure now 現(xiàn)在沒有已知的控制方法去檢測失效

30、. 8 Remote 絕對少的 me possible is remote tnat Control method know n can cneck failure now 現(xiàn)在已知的控制方法檢測出失效的可能性是絕對低的 . 7 Very Low 很彳氐的 The possible is very low that Control method know n can check failure now 現(xiàn)在已知的控制方法檢測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 現(xiàn)在已知的控制方法檢測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 現(xiàn)在已知的控制方法檢測出失效的可能性是中等的 4 Moderately High 適度高的 X X The possible is Moderately High that Control method known can check failure no w 現(xiàn)在已知的控制方法檢測出失效的可能性是適度高的 3 High 高的 X X The possib

32、le is High that Control method know n can check failure now 現(xiàn)在已知的控制方法檢測出失效的可能性是較高的 2 Very High 很高的 X X It is possible that Control method know n can check failure now 現(xiàn)在已知的控制方法檢測出失效是很容易的， 1 Certain 幾乎可確定的 X It is noticeable that Control method know n can check failure no w 現(xiàn)在已知的控制方法檢測出失效的可能性是顯而易見的 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的實施程序:PFMEA表格用于制程失效模式及效果的分析 .依據(jù)PFMEA表格中標(biāo)識的完成步驟序 號完成如下所列填寫。 6.3.1 Part No-Fill the part number in the section 在Part No欄中填入零件的料號。 6.3.2 Project-Fill the Project name in the section 在Project欄中填入項目的名稱。 6.3.3 Model-Fill the Product Model in the section 在Model欄中填入產(chǎn)品的型號。 6.3.4 Customer-Fill the cust

35、omer name in the section 在Customer欄中填入客戶的名稱。 6.3.5 Process-Fill the process name in the section 在Process欄中填入制程工站的名稱。 6.3.6 Core Team-Fill major person name taken part in analysing PFMEA in the section 在Core Team欄中填入?yún)⒓?PFMEA分析成員的名字。 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 作業(yè)指導(dǎo)書 DOC. NO. /DOC. NO. /文件編號： DMQAIDMQAI- -001001 REV/REV/版本號: : 0101 PRODUCT / PRODUCT / 產(chǎn)品： AllAll TITLE / TITLE / 標(biāo)題: :

37、 Process Failure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式與效果分析 PAGE/PAGE/頁數(shù)： 6 Of Of 6 在Doc No欄中填入PFMEA編號，其格式為:PFMEA-四位項目代碼-XXX （PFMEA的流水號）. 例如“ PFMEA-ERIC-005 ”是指愛立信項目的第 5份PFMEA。 6.3.8 PFMEA Leader-Fill the person name leading PFMEA in the section 在PFMEA Leader 欄中填入導(dǎo)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 欄中填入審核 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欄中填入 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欄中填入修改 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 欄中填入需要降低的目標(biāo)風(fēng)險系數(shù)。 6.3.13 Item- Fill number in the section 在Item欄中填入序號。 6.3.14 Process Description- fill process name in the section 在Process Description 欄中填入具體的制程名稱。 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. 潛在失效模式的分析：針對每種制程，分析出其潛在的失效模式并將其描述在 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 潛在失效模式的影響分析 ：結(jié)合可能對客戶的影響 ，對每個潛在的失效模式的影響進(jìn)行分析 ，客 戶既可以是內(nèi)部下一工位的操作也可以是指最終用戶。經(jīng)確認(rèn)的失效模式影響需填入 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 嚴(yán)重度的評估：嚴(yán)重度主要依據(jù)失效模式的影響程度進(jìn)行評估 .嚴(yán)重度的評定范圍從 1分到10

43、分.詳細(xì)的嚴(yán)重度評估標(biāo)準(zhǔn)參見圖表 .經(jīng)團(tuán)隊確認(rèn)的嚴(yán)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. 潛在失效原因：需要針對每種失效模式分析出可加以控制改善的潛在原因。分析出的潛在原因 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 失效原因的發(fā)生率評估：發(fā)生率是指一種失效原因出現(xiàn)的可能性，發(fā)

45、生率的評定范圍從 1分至 10分.具體評估標(biāo)準(zhǔn)參見圖表 -發(fā)生率的評估標(biāo)準(zhǔn)。團(tuán)隊發(fā)生率的評估結(jié)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 當(dāng)前的制程控制：當(dāng)前的制程控制是指用來防止問題發(fā)生的預(yù)防控制以及檢測出失效原因的控 制措施。當(dāng)前制程的控制措施需填入 Current process controls 中。 WORK INSTRUCTION 作業(yè)指導(dǎo)書 DOC. NO. /DOC. NO. /文件編號： DMQAIDMQAI- -001001 REV/REV/版本號: : 0101 PRODUCT / PRODUCT / 產(chǎn)品： AllAll TITLE / TITLE / 標(biāo)題: : Process F

47、ailure Mode and Effect AnalysisProcess Failure Mode and Effect Analysis 制程失效模式與效果分析 PAGE/PAGE/頁數(shù)： 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. 可檢出率的評估：可檢出率是指在當(dāng)前制程控制的情況下潛在失效模式可被檢測出的可能性 .可 檢出率的程度評定范圍從 1分至10分.具體評估標(biāo)準(zhǔn)參見圖表 -可檢出率的評估標(biāo)準(zhǔn)。將可檢 出率的評估標(biāo)準(zhǔn)填入 Det欄中。 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 風(fēng)險優(yōu)先級數(shù)：計算出風(fēng)險優(yōu)先級數(shù)來確定制程改善的優(yōu)先次序 .風(fēng)險優(yōu)先級數(shù)=嚴(yán)重度x發(fā)生 率x可檢出度。將計算出的風(fēng)險優(yōu)先級數(shù)填入 RPN欄中。 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 建議的行動：針對高風(fēng)險系數(shù)模式需采取預(yù)防改善措施予以改善。一般地，高風(fēng)險優(yōu)先級數(shù)是 指RPN大于或等于100。另外一種情形是：無論RPN值是多大，當(dāng)嚴(yán)重度是9或10時，必須 采取預(yù)防改善措施予以改善。建議的改善行動須填入 Recommended Action 中。 6.3.24 Responsibility & Target Com