Академический Документы
Профессиональный Документы
Культура Документы
1 CP/IPA-CN-Q | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
¾1960’s Use of the FMEA was encouraged for space product development and
served well on getting a man on the moon. (Apollo Plan)
60年代 美国的航天工业鼓励在产品开发上采用FMEA概念,并在阿波罗登月计划
上取得成功。
¾1993 GM, Ford, Kreisler compile the FMEA manual, the third edition at Jul, 2001.
1993年 美国三大汽车公司编写了FMEA参考手册,2001年7月第三版
2 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
3 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
What is PFMEA? 什么是PFMEA?
过程FMEA主要是由负责制造的工程师/小组采用的一种分析技术, 用来保证在可能的范
围内已充分考虑到并指明潜在失效模式及与其相关的起因/机理。一个FEMA以其最严密的
形式总结了小组进行过程时的设计思想(包括根据经验和过去的错误,对一些可能失效项
目的分析)。这种系统化的方法体现了工程师在任何制造策划过程中的思维过程,并使之
规范化。
4 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
What is PFMEA? (Continued) 什么是PFMEA?(续)
5 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
What’s the time to do the PFMEA? 什么时候做PFMEA?
Early review and analysis of new or revised processes is promoted to anticipate, resolve, or monitor potential process
concerns during the manufacturing planning stages of a new model or component program.
在新车型或零件项目的制造计划阶段,对新工艺或修订过的工艺进行早期评审和分析能够促进预测,解决或监控潜在过
程问题。
6 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
What’s The Relationship? 关系是什么?
PROBLEM-SOLVING
ENVIRONMENT
C
TEAMWORK! PROBLEM- O C
SOLVING
TOOLS
N U
T S
A T
DESIGN I
FMEA
N
O
PROCESS CONTROL
M M
FMEA PLANS
E E
MANUFACTURING N R
PROCESS FLOW T
SUPPLIER
The customer’s Design FMEA(if available) and the Manufacturing Process Flow Chart serve
as inputs for conducting Process FMEA’s.
The actions identified in the Process FMEA should transferred to the PQP.
客户的设计FMEA(如果有)和制造过程流程图作为输入导入过程FMEA。
过程FMEA中的措施导入PQP中。
7 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
The definition of “Customer” 客户的定义
The definition of “Customer” for a process FMEA should normally be the “End User.” However, the
customer can also be a subsequent or downstream manufacturing or assembly operation, or
government regulations.
客户在PFMEA中的定义可以为最终用户,也可以是下一道制造或装配工序,或者是政府法规。
Your customer expects to receive products, sub-assemblies and/or material with Zero Defects. This
means that we, as a supplier, must examine all influences which can lead to defect parts at the
customer’s doorstep and initiate appropriate actions to ensure Zero Defects will be achieved.
It is Possible! It is Expected!
你们的客户希望接受零缺陷的产品,总成和/或材料。这就意味着你们作为供应商需要考虑所有会导致
缺陷产品到达客户的影响,并且先期开展合适的措施保证零缺陷交付。
这是可能的!这是期望的!
8 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
What is the scope for a P-FMEA? PFMEA的考虑范围是什么?
Material/ Performance per Operation
Performance per Line
Parts Performance per Product
Op 10 Op 20 Op 30
Op 10 Op 20 Complete
Product
Act A Act B
Supplier
Packaging
PFMEA
Shipping
Warehousing
Transportation
Zero Defects Received
By Customer
The entire process flow needs to be examined to ensure that the appropriate action will
be taken which ensures delivery of products with Zero Defects.
PFMEA应考虑整个过程,以保证合适的措施被执行,从而保证零缺陷产品交付顾客。
9 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
What is the scope for a P-FMEA? PFMEA的考虑范围是什么?
The schematic on the previous page shows that we need to understand the
processes and flows of:
在前页的示意图显示,我们制作PFMEA时应包括:
10 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Subsystem C O D Action Results
Responsibility
Potential Potential S l Potential Cause(s)/ c Current Process Current Process e R.
Recommended & Target S O D R.
Failure Effect(s) of e a Mechanism(s) c Controls Controls t P. Actions
Action(s) Completion e c e P.
Function Mode Failure v s of Failure u Prevention Detection e N. Taken
Date v c t N.
Reqmts. s r c
- Special controls
- No Function
11 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
¾Where the process involves numerous operations with different potential modes of
failure, it may be desirable to list the operations as separate elements.
如果过程许多具有不同潜在失效模式的作业,那么可以把这些作业以独立项目列出
。
12 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Potential Failure Mode: 潜在失效模式:
Potential failure mode is defined as the manner in which the process could potentially fail to
meet the process requirements and/or design intent as described in the process function/
requirements column. It is a description of the nonconformance at that specific operation. It can
be a cause associated with a potential failure mode in a subsequent (downstream) operation or
an effect associated with a potential failure in a previous (upstream) operation.
所谓潜在失效模式是指过程可能潜在不满足过程要求和/或设计意图的种类,是对某具体作业不符
合要求的描述。 它可能是引起下一道作业的潜在失效模式的起因,也可能时上一道作业潜在失效
的后果。
Start by comparing similar processes and reviewing customer (end user and subsequent
operation) claims relating to similar components. In addition, a knowledge of the design intent is
necessary. Typical failure modes could be but are not limited to:
在此建议把相似过程的比较和顾客(最终用户和后续作业)对类似零组件的投诉情况的研究作为
出发点。此外,对设计目的了解也很必要。典型的失效模式可能是,但不局限于下列情况:
13 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Potential Failure Mode: 潜在失效模式:
Bent 弯曲 Burred 毛刺
Hole Off – Location 孔位错误 Cracked 断裂
Hole Too Shallow 孔过浅 Hole Missing 孔缺失
Handling Damage 操作不当 Dirty 脏污
Hole Too Deep 孔过深 Surface Too Rough 表面太粗糙
Deformed 变形 Surface Too Smooth 表面太光滑
Open Circuited 开路 Short Circuited 短路
Mislabeled 贴错标签
NOTE: Potential failure modes should be described in “physical” or technical terms, not
as a symptom noticeable by the customer.
注:应用“物理”或“技术”的短语来描述潜在失效模式,而不同于顾客所见的现象
14 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
Describe the effects of the failure in terms of what the customer might notice or experience,
remembering that the customer may be an internal customer as well as the ultimate end user.
State clearly if the failure mode could impact safety or cause noncompliance to regulations. The
customer(s) in this context could be the next operation, subsequent operations or locations, the
dealer, and/or the vehicle owner. Each must be considered when assessing the potential effect
of a failure.
依据顾客可能注意到的经历的情况来描述失效的后果,在这里,顾客可以是内部顾客和最终使用
者。如果该失效模式可能影响的安全或造成违反法规,则要清楚陈述。在本文中的顾客可能是下
一道作业,后续的作业或工位,代理商和/或车主。当评审潜在失效后果时,每一个都必须考虑。
For the end user, the effects should always be stated in terms of product or system performance,
such as:
对最终使用者来说,失效的后果应一律用产品或系统的性能来描述,例如:
15 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Potential Effect(s) of Failure (Continued): 潜在失效后果(续):
Erratic 作业不正
Noise 噪音 Rough 粗糙 Excessive 过度
Operation 常
Unpleasant
Effort 费力 Inoperative 不起作用 异味 Unstable 不稳定
Odor
Operation Intermittent 间歇性工 Poor 外观不
作业减弱 Draft 阻力
Impaired Operation 作 Appearance 良
Vehicle Control 车辆控制减 Rework/ Customer 顾客不
Leaks 泄漏 返工/返修
Impaired 弱 Repairs Dissatisfaction 满意
Scrap 报废
If the customer is the next operation or subsequent operation(s) / location(s), the effects should
be stated in terms of process/ operation performance, such as:
如果客户是下一道作业或后续作业/工位,该后果应该以过程/作业性能来描述。例如:
Cannot Fasten 无法紧固 Does Not Fit 无法安装
Cannot Bore/Tap 无法钻孔/攻丝 Does Not Connect 无法结合
Cannot Mount 无法设置 Does Not Match 无法配合
Cannot Face 无法加工表面 Causes Excessive Tool Wear 导致工具过度磨损
Damages Equipment 损坏设备 Endangers Operator 危害操作者
16 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Severity: 严重度:
¾Severity is the rank associated with the most serious effect for a given failure mode.
严重度是对一个已假定失效模式的最严重影响的评价等级。
¾A reduction in severity ranking index can be effected through a design change to system,
subsystem or component, or a redesign of the process.
要减少严重度的级别数值,只能能通过系统、子系统或零组件的设计变更, 或是对该过程从新
设计来实现。
¾If the customer affected by a failure mode is the manufacturing or assembly plant or the
product user, assessing the severity may lie outside the immediate process engineer’s / team’s
field of experience or knowledge. In these cases, the Design FMEA, design engineer, and/or
subsequent manufacturing or assembly plant process engineer, should be consulted.
如果受失效模式影响的顾客是制造或装配厂或产品使用者,严重度的评价可能超出了本过程工
程师/小组的经验或知识范围。在这种情况下,应与设计FMEA,设计工程师和/或后续制造或装配
厂的过程工程师进行协商,讨论。
¾If the Severity Index rank 9 or 10, special attention must be given, the preventive/corrective
actions should be planed & taken, regardless of RPN
当严重度为9或10,必须特别注意, 应该采取适当的预防和纠正措施,无论RPN为几分。
17 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Suggested PFMEA Severity Evaluation Criteria 推荐的PFMEA严重度评价准则
Effect Criteria: Severity of Effect Criteria: Severity of Effect Ranking
后果 判定准则:后果的严重度 判定准则:后果的严重度 级别
(Customer Effect 客户影响) (Manufacturing/Assembly Effect 制造/装配影响)
Hazardous without Very high severity ranking when a potential failure mode affects safe vehicle Or may endanger operator (machine or assembly) without warning. 10
warning operation and/or involves noncompliance with government regulation without warning. 或可能在无警告的情况下,危害机器或装配操作者。
无警告的严重危害 在无警告的情况下,潜在失效模式严重影响车辆安全运行和/或包含不符合政府法规项
Hazardous with Very high severity ranking when a potential failure mode affects safe vehicle Or may endanger operator (machine or assembly) with warning. 9
warning operation and/or involves noncompliance with government regulation with warning. 或可能在有警告的情况下,危害机器或装配操作者。
有警告的严重危害 在有警告的情况下,潜在失效模式严重影响车辆安全运行和/或包含不符合政府法规项
Very High Vehicle/item inoperable (loss of primary function). Or 100% of product may have to be scrapped, or vehicle/item repaired in repair department 8
很高 车辆/系统无法运行,丧失基本功能 with a repair time greater than one hour.
或者可能100%的产品得报废,或者车辆/系统需在维修部门维修一小时以上
High Vehicle/item operable but at reduced level of performance. Customer very Or product may have to be sorted and a portion (less than 100%) scrapped, or vehicle/item 7
高 dissatisfied. repaired in repair department with a repair time between a half-hour and an hour.
车辆/系统能运行,但舒适性或方便性项目失效 或产品需筛选部分(低于100%)报废,或者车辆/系统需在维修部门维修半个小时到一小时
Moderate Vehicle/item operable, but Comfort/Convenience item(s) inoperable. Customer Or a portion (less than 100%) of the product may have to be scrapped with no sorting, or 6
中等 dissatisfied. vehicle/item repaired in repair department with a repair time less than a half-hour.
车辆/系统能运行,但舒适性或方便性项目失效,顾客感觉不舒适 或部分(低于100%)产品报废(不筛选),或者车辆/系统需在维修部门维修半个小时以内
Low Vehicle/item operable, but Comfort/Convenience item(s) operable at a reduced level Or 100% of product may have to be reworked, or vehicle/item repaired off-line but does not 5
低 of performance. go to repair department.
车辆/系统能运行,但有些书实行或方便性项目性能下降 或产品需要100%返工,或车辆/系统需要离线修理,但不需送往维修部门
Very Low Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by most Or the product may have to be sorted, with no scrap, and a portion (less than 100%) 4
很低 customers (greater than 75%). reworked.
装配和涂装或尖响和卡嗒响等项目不符合要求。大多数客户发现缺陷(大于75%) 或者产品需经筛选,无报废,部分(低于100%)需要返工
Minor Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by 50% of Or a portion (less than 100%) of the product may have to be reworked, with no scrap, on- 3
轻微 customers. line but out-of-station.
装配和涂装或尖响和卡嗒响等项目不符合要求。 50%的客户发现缺陷 或者部分(低于100%)产品需要在线站外返工,无报废
Very Minor Fit & Finish/Squeak & Rattle item does not conform. Defect noticed by discriminating Or a portion (less than 100%) of the product may have to be reworked, with no scrap, on- 2
很轻微 customers (less than 25%). line but in-station.
装配和涂装或尖响和卡嗒响等项目不符合要求。有鉴别力的顾客发现缺陷(低于25%) 或者部分(低于100%)产品需要在线站内返工,无报废
18 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
If a classification is identified in the Process FMEA, notify the design responsible engineer since
this may affect the engineering documents concerning control item identification.
如果在过程FMEA中鉴定了某一分类,应通知负责设计的工程师,因为它可能会影响有关控制项
目标识的工程文件。
Special product or process characteristic symbols and their usage are directed by specific
company policy and are not standardized in this document.
特殊产品或过程特殊特性符号及其使用是由特定公司的政策所规定,在本文件中不另做标准化。
19 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Classification (Special characteristics identified by Bosch):
分类(BOSCH特殊特性标示):
“S” Safety characteristic 影响安全的特性
“G” Regulatory characteristic 影响法规的特性
“SG” Safety and regulatory characteristic 影响安全和法规的特性
“K” A key characteristic is a product characteristic or a production process parameter
that has a significant impact on customer satisfaction and/or internal processes.
对顾客安全和/或内部过程有重要影响的关键产品/过程特性
“OS” Operator safety characteristic 影响操作安全的特性
If the customer does not agree RB symbols, then the characteristics specified by customer are
identified with “/c” in the internal Bosch documents, in additional to the internally determined
characteristics.如果顾客不同意BOSCH标示的符号,则有顾客规定,并在BOSCH内部文件中
标示”/C”,作为内部决定的特性的补充。
Example:
例如:
20 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Classification: 分类:
Supplier Key Product Characteristics identification:
供应商关键产品特性(KPC)的识别:
Drawing, Specification (Major from customer) 图纸,标准(主要来自客户的)
DFMEA, ICL 设计FMEA,重要特性列表
Regulations 法律法规
…
According to the effects to the KPC, the supplier should identify the Key Control
Characteristics & the internal KPC with discussed by Bosch.
供应商根据对关键产品特性(KPC)的影响,与BOSCH协商定义关键过程特性(KCC)以及内部关键
产品特性。
KCC KCC
KPC
KPC KCC
21 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Classification (ICL): 分类(重要特性列表):
Date: 2006-7-5
No. (critical processes) FMEA measuring equipment measurement per- capability P monitoring Cpk definition
System formance C sht.
S, G, A
required
required
required
required
required
required
SG, K, Fu other Q-safeguards method:
OS, Fe (e.g.: deformation by improper fastening test, SPC, material and Cgk ≥ GRR ≤ Ppk Cmk (e.g.: x|s, x|R, inspection chart,
/C Mo S O D RPN structure analysis, etc …) 1,33 10%, ≥ 1,33 ≥ 1,67 original value) (A/B/C/D)
2 L1 = 9.8 ± 0.2 mm K Mo 8 x | s
3 s2 - s1 = 0.6 ± 0.03 mm K Fu 9 x | s
4 e1 ≤ 0.2 mm K Fu 9
5 e2 ≤ 0.2 mm K Fu 9
6 DH ≤ 5.6 mm K Fu 9
packing: BOSCH packaging instruction other: MSDS / N2580: material sheet required additional remarks:
quality assurance HoP1/PUQ1-Haupenthal 2005-12-29 CEO All additional requirements also see N38 A SF 1/2
development
fill in from Bosch fill in from supplier To be filled out only for production use.
legend: PQP = product quality assurance plan, A = relevant for throughput, Fu = critical to function, Fe = critical to manufacturing, Mo = critical to assembly, S = severity, O = occurrence, D = detection, RPN = Risk Priority No., S = characteristic relevant to security, G = characteristic relevant to
SG = relevant to security and characteristic relevant to law, K = important characteristic is a product characteristic or a production process parameter which has an essential importance or meaning for the customer's satisfaction and / or the internal process, OS = characteristic with
safety relevance for associat, /C = from the customer required distinguishing marks are to be noted in the relevant documents (ISO/TS 16949), in addition, with/C, A = material lot, B = heat treatment lot, C = production lot, D = delivery lot
22 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Potential cause of failure is defined as how the failure could occur, described in terms of
something that can be corrected or can be controlled.
潜在失效起因/机理时指失效是怎么发生的,并依据可以被纠正或控制的原则来描述。
List, to the extent possible, every failure cause assignable to each potential failure mode. Many
causes, however, are not mutually exclusive, and to correct or control the cause, a design of
experiments, The causes should be described so that remedial efforts can be aimed at those
causes which are pertinent.
针对每一个潜在失效模式,在尽可能延伸的范围内,列出每个可以想到的失效起因。失效的许多
起因并不是相互独立的,唯一的,要纠正或控制一个起因,需要考虑诸如试验设计之类的方法,
来明确那些来源起因是主要的贡献者,哪些来源起因容易得到控制。应描述这些起因,以便针对
那些相关的因素采取纠正措施。
23 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Potential Cause(s)/ Mechanism(s) of Failure: 潜在失效起因 / 机理:
Potential Cause/ Mechanism of Failure should be physical/mechanical/chemical
Typical failure causes may include, but are not limited to:
引起失效的原因应是:物理的/机械的/化学的
典型的失效起因包括但不限于:
Improper torque - over, Improper weld – current, 焊接不正确—电流,时间,
扭矩不正确—过大,过小
under time, pressure 压力不正确
Improper heat treat – time 热处理不正确—时间,温度
Inaccurate gauging 量具不精确
temperature 有误
Inadequate or no
Inadequate gating/venting 浇口/通气口不正确 润滑不当或无润滑
lubrication
Part missing or miss
零件漏装或错装 Worn locator 定位器老化
located
Worn tool 工具磨损 Chip on locator 定位器有缺口
Broken tool 工具磨损 Improper machine setup 机器设置不正确
Improper programming 不正确的程序设计
Only specific errors or malfunctions (e.g., operator fails to install seal) should be listed;
ambiguous phrases (e.g., operator error, machine malfunction) should not be used.
应明确列出具体的错误或误操作情况(例如:操作者未装密封垫),而不应用一些含糊不清的词
语(如,操作者错误,机器工作不正常)。
24 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Occurrence: 频度:
¾The likelihood of occurrence ranking number has a relative meaning rather than an
absolute value.
频度的可能性分级数字重在其相关含义 而不是具体的数值。
25 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
26 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Current Process Controls: 现行过程控制:
¾Current Process Controls are descriptions of the controls that either prevent to the extent possible the
failure mode or cause/mechanism of failure from occurring, or detect the failure mode or
cause/mechanism of failure should it occur.
现行过程控制是对尽可能阻止失效模式或失效原因/机理的发生,或者探测将发生的失效模式或失效原
因/机理的控制的描述。
¾These controls can be process controls such as error/mistake proofing, statistical process control
(SPC), or can be post-process evaluation.
这些控制可以是防错、统计过程控制或也可以是加工后评价的过程控制。
27 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Detection: 探测度:
¾Detection is the rank associated with the best detection control listed in the process control
column.
探测度是结合了列在过程控制中最佳的探测控制等级。
¾In order to achieve a lower ranking, generally the planned process control has to be improved.
为了取得较低的探测度数值,计划的过程控制需要不断的改进。
¾Do not automatically presume that the detection ranking is low because the occurrence is low
(e.g., when control charts are used)
不要擅自推断:因为频度低,不易探测度数也低(如使用控制图)
¾Random quality checks are unlikely to detect the existence of an isolated defect and should not
influence the detection ranking. Sampling done on a statistical basis is a valid detection control.
随机质量抽查不大可能查明某一孤立缺陷的存在,也不影响不易探测度数值的大小。以统计原
理为基础的抽样检查是一种有效的不易探测度控制方法。
¾The preferred approach is to first use prevention controls when process development.
在设计开发过程中加入预防控制是最好的方法。
28 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Suggested PFMEA Detection Evaluation Criteria:
建议的P-FMEA探测度评价准则: Inspection Types
Detection Criteria Suggested Range of Detection Methods Ranking
检查类型
探测度 评价标准 建议的探测度分级方法 级别
A B C
Almost Impossible Absolute certainly of non-detection Cannot detect or is not Checked
X 10
几乎不可能 确定绝对无法探测 无法探测或没有检查
Control is achieved with indirect or random
Very Remote Controls will probably not detect
X checks only 9
很微小 现行控制方法将不可能探测
仅能以间接的或随机检查来达到控制
Controls have poor chance of
Remote Control is achieved with visual inspection only
detetion X 8
微小 仅能以目视的检查来达到控制
现行控制方法只有很少机会去探测
Controls have poor chance of Control is achieved with double visual
Very Low
detetion X inspection only 7
很小
现行控制方法只有很少机会去探测 仅能以双重目视的检查来达到控制
Control is achieved with charting methods
Low Controls may detect
X X such as SPC (Statistical Process Control) 6
小 现行控制方法可能可以探测
以图表的方式(如SPC)来达到控制
Control is based on variable gauging after
parts have left the station, or Go/No Go
Moderate Controls may detect gauging performed on 100% of the parts after
X X 5
中等 现行控制方法可能可以探测 parts have left the station
在零件离开工位后以计量值量具,或在零件离
开工位后执行100%GO/NO GO检查
Error detection in subsequent operations or
Controls have a good chance to gauging performed on setup and first-piece
Moderately High
detect X X check (for set-up causes only) 4
中上
现行控制方法有好的机会去探测 在后续作业中探测错误,或执行作业前准备和
首件的测定检查
Error detection in-station, or error detection in
subsequent operations by multiple layers of
Controls have a good chance to acceptance: supply, select, install, verify.
High
detect X X Cannot accept discrepant part 3
高
现行控制方法有好的机会去探测 当场侦测,或以多重接受准则在后续作业中探
测错误,如库存,挑选,验证。不接受缺陷零
件
Error detection in-station (automatic gauging
Controls almost certain to detect with automatic stop feature), Cannot pass
Very High
现行控制方法几乎可以确定可以探 X X discrepant part. 2
很高
测 当场侦测错误(有自动停止功能的自动化量具
)缺陷零件不能通过
Discrepant parts cannot be made because
Controls certain to detect item has been error-proofed by
Certain
现行控制方法几乎可以确定可以探 X process/product design. 1
几乎肯定
测 该项目由过程/产品设计了防错法,不会生产
缺陷零件
29 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
RPN = (S)X(O)X(D)
30 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
31 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
¾To reduce the probability of occurrence, process and/or design revisions are required. An
actionoriented study of the process using statistical methods could be implemented with an
ongoing feedback of information to the appropriate operations for continuous improvement and
defect prevention.
为了减小失效发生的可能性,需要修改过程和/或设计。为了持续改进和预防缺陷,可以用统计
学方法通过持续的信息回馈到适当的作业过程,来进行以纠正措施为目标的过程分析。
¾Only a design and/or process revision can bring about a reduction in the severity ranking.
只有修改设计和/或工艺过程,才能减小严重度数;
¾The preferred method to accomplish a reduction in the detection ranking is the use of
error/mistake proofing methods.
使用防错方法来减小探测度的级别是最优先的方法。
32 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?
Follow-Up Actions: 跟踪措施:
The process-responsible engineer is responsible for ensuring that all actions recommended have been
implemented or adequately addressed. The FMEA is a living document and should always reflect the
latest design level as well as the latest relevant actions, including those occurring after start of production.
负责过程的工程师负责确保所有的建议措施已被实施或以妥善地落实。FMEA是一个动态文件,它不仅应
该随时体现最新的设计版本还应该体现最新的相关纠正措施,包括产品正式投产后发生的事件。
The process-responsible engineer has several means of ensuring that concerns are identified and that
recommended actions are implemented. They include, but are not limited to the following:
负责过程的工程师有几种方式来确保已经鉴别了所顾虑的问题以及建议措施的实施,这些方式包括但不仅
限于以下几点:
33 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
Suggested PFMEA Checklist: 建议PFMEA检查表:
34 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
What makes a good PFMEA? 怎样做一个好的PFMEA?
Needless to say, relevant experience certainly contributes to a quality FMEA. The following
steps will set the foundation for a quality FMEA:
必须说相关的经验对一个好的PFMEA贡献很大,以下的步骤是做一个好的PFMEA的基础
¾Assemble a cross-functional team of people involved in all relevant steps … both internal and
external experts as applicable.
组建了解所有步骤的多功能小组,并能主动联系各个部门的代表,如果可能的话可以让内部或外
部 的专家加入。
¾All customer requirements (Drawing, Spec., DFMEA, Assembly status, ICL…) and process
flow are clear.
保证所有的客户要求(图纸,规范,设计FMEA,装配情况,重要特性列表…)和过程流程被清
晰的了解。
¾An PFMEA is a pro-active tool which can predict failure modes, prevent defects. An PFMEA
must be performed as earlier as possible. The PFMEA should be initiated prior to tooling for
production.
过程FMEA是一个预测失效,预防缺陷的前期主动工具,而不是事后被动的一个文件,前期及早
的介入是一个好的过程FMEA的基础,第一版应在工装生产准备之前。
35 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
What makes a good PFMEA (continued)?
怎样做一个好的PFMEA(续)?
¾Conduct the FMEA session. The key is to ask many questions with the focus on “what can go
wrong?” Allow the team to brainstorm freely through every eventuality. Use historical data
(warranty, customer complaints, in-process quality data, scrap or re-work, etc). Keep in mind:
“Zero Defects Received.”
开展一个FMEA 会议,关键是问许多问题“什么会导致失效?”建议团度开展头脑风暴。团队
必须参考历史数据(客户投诉,过程中质量数据,报废和翻修等…) 记住:“零缺陷接受”
¾Review all scores and ensure all actions/recommendations are implemented and verified.
审核所有的分数并保证所有的措施/建议被执行和验证。
¾A quality FMEA is not created in one session. In many cases it requires several team sessions.
It has proven that the “touch and feel” approach contributes to quality FMEA’s, meaning have the
team go look at the production stations, have the parts available, go out and see storage areas.
All of this will generate the questions required for a quality FMEA.
一个好FMEA不是由一个会议产生,已经证明“感觉和触摸”对一个好的FMEA贡献很大,所
以小组应该多看生产、储存区域,零件,这将会使你产生更多的疑问,将有利于一个好的FEMA
。
36 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.
Process Failure Mode & Effects Analysis
Exercise: 练习:
37 Department | 4/27/2006 | © Robert Bosch GmbH reserves all rights even in the event of industrial property rights. We reserve all rights of
disposal such as copying and passing on to third parties.