PFMEA是过程潜在失效模式及影响分析(Process Failure Mode and Effects Analysis)的英文简称，是跨功能小组主要采用的一种分析技术，用以最大限度地保证各种潜在的失效模式及其相关的起因/机理已得到充分的考虑和论述。本文线束工程师之家介绍一下线束行业PFMEA作业指导书（中英文）
1 PURPOSE（目的）文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
The purpose of this work instruction is to provide a method for continuous improvement through the use of PFMEAs. 文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
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。文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
2 SCOUPE（范围）文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
This work instruction applies to any manufacturing process that has a customer requirement for failure mode effect analysis or any process at FLEX (Doumen) where management requires a PFMEA.文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
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所有制程。文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
3 DEFINITIONS（定义） 文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
3.1 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; 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.文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
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责任者和完成期限。文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
3.2 QE: Quality Engineer文章源自线束工程师之家-https://www.suncve.com/pfmea-operation-instructions-for-wire-harness-industry-chinese-and-english/
QE:品质工程师
3.3 SQE: Supplier Quality Engineer
SQE: 供应商管理品质工程师
3.4 PE: Process Engineer
PE: 工艺工程师
3.5 ME: Manufacturing Engineer
ME:制造工程师
3.6 TE: Test Engineer
TE: 测试工程师
3.7 EE: Equipment Engineer
EE: 设备工程师
3.8 DCC: Document Control center
DCC:文件控制中心
3.9 RPN: Risk Priority Number
RPN: 风险优先系数
4. REFERENCE（参考文件）
4.1 DMP-010 Corrective and Preventive Action 纠正与预防措施
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, 举行制程失效模式及效果分析会议，根据团队讨论结果准备和更新报告，申请报告发行。
5.2 Manufacturing 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 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, basedon 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 Effect, 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 Riskper different process and product. Suggest to classify High Risk (above 100), Medium Risk (60~100), 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, Responsibility, 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 responsibility 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 updated according to the actual status. It's 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。
6.2Rating Factor Guidelines:评分指南表
6.2.1 The PFMEA Severity Evaluation Criteria.
PFMEA 严重度评估标准。
6.2.2The PFMEA Occurrence Evaluation Criteria.
PFMEA 发生率评估标准。
6.2.3 The PFMEA Detection Evaluation Criteria.
PFMEA 可检出率评估标准。
6.2.1 PFMEA Severity Evaluation Criteria
Rating
级 别
Description
描 述
Definition
定 义
10
Dangerously High
特别高
Failure would be noticeable to the customer and would drastically 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 would be readily apparent to the customer, but would have major effects on the customer's 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
Very High
很 高
Failure would create a major nuisance to the customer, the customer cannot overcome it in the process without performance loss
是可引起客户麻烦的，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 with modifications to the customer's process or product, but there is major performance loss
在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 with modifications to the customer's 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 would create a minor nuisance to the customer, but the customer can overcome it in the process without 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 to the customer, but would have minor effects on the customer's 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 would 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 Criteria
Rating
级 别
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
很高:几乎是无法避免的
≥ 1 in 2
9
Very High: Failure is almost inevitable
很高:几乎是无法避免的
1 in 3
> 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: Occasional 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 with 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
1
Remote: Failure is unlikely
极低的:失效是不太可能的
≤ 1 in 1,500,000
>2.00
6.2.3 PFMEA Detection Evaluation Criteria
Ranking
级 别
Detection
检 测
Inspection Types
检查类型
Definition定 义
A
B
C
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 known for check failure now
现在没有已知的控制方法去检测失效.
8
Remote
绝对少的
╳
The possible is remote 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绝对低的.
7
Very Low
很低的
╳
The possible is very low 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很低的.
6
Low
低 的
╳
╳
The possible is low 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低的.
5
Moderate
中 等
╳
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
ModeratelyHigh
适度高的
╳
╳
The possible is ModeratelyHigh 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适度高的
3
High
高 的
╳
╳
The possible is High 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较高的
2
Very High
很高的
╳
╳
It is possible that Control method known 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
╳
It is noticeable 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显而易见的
Inspection Types:A. Error – 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.
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。
6.3.1Part 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 customer name in the section
在Customer栏中填入客户的名称。
6.3.5Process--Fill the process name in the section
在Process栏中填入制程工站的名称。
6.3.6Core 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 be: PFMEA-Project Code-XXX (PFMEA Order Number). For example, “PFMEA-ERIC-005” means the PFMEA is the 5th PFMEA of Ericsson project.
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PFMEA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。
6.3.10Revision-- 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 section
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 Potential 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 terms 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 Cause of Failure中。
6.3.19 cc--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 needs to be filled in the section
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。
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 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 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. Generally, 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 Completion Date--Enter the responsibility for the recommended action and the target completion date in the section。
责任者与目标完成日期:确定建议行动的责任者及目标完成日期并填入Responsibility & Target Completion Date栏中。
6.3.25 Action Taken--After the recommended action has been implemented, enter the brief description of the actual action and effective date in the section
采取的改善行动：当建议的改善行动被执行以后, 在Action Taken栏中填入实际采取的改善行动及生效日期。
6.3.26 Action Results: After the implementation of the recommended action, work out the resulting severity,occurrence and detection rankings and fill those rankings in section Sev, Occ, Det. Then, calculate the resulting RPN rank and fill the rank in the section RPN.
行动结果: 当已执行建议的改善行动后,需重新评估失效模式改善后的严重度,发生率以及可检出率，并将其填入Sev, Occ, Det中。然后重新计算RPN并将结果填入RPN中。
7. RECORD（记录）
7.1 DMQAI-001-F1.01 Process Failure Mode and Effect Analysis Keep for 1 years after EOL
DMQAI-001-F1.01制程失效模式及效果分析后保留一年
8. Flow Chart（流程图）
N/A
9. ATTACHMENT（附录）
9.1 See attached PFMEA Format
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