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(SQDP) Supplier Quality Development Program

PFMEA – Process Failure Mode and Effect Analysis


过程失效模式及后果分析
By CP/IPA-CN-Q

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Process Failure Mode & Effects Analysis

History of FMEA FMEA的历史


¾1940’s FMEA formally introduced in the military standard 1629.
40年代 FMEA被正式引入美国军用标准1629。

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。

¾Late of 1970’s FEMA introduced to America automobile industry as a tool for


design review.
70年代后期 美国汽车工业引用作为设计评审的一种工具

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

¾1994 SAE issued SAE J-1739, FMEA stand


1994年 美国汽车工程学会SAE发布了SAE J-1739-潜在失效模式及后果分析标准

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Process Failure Mode & Effects Analysis

What’s the type of the FEMA? FMEA的种类?


¾Product FMEA (System, Design FMEA)
产品FMEA (系统,设计FMEA)
¾Process FMEA
过程FMEA

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Process Failure Mode & Effects Analysis
What is PFMEA? 什么是PFMEA?

PFMEA stands for: Process Failure Mode and Effect Analysis.


PFMEA – 过程失效模式及后果分析

An Process FMEA is an analytical technique used by a Manufacturing/ Assembly-


responsible Engineer/Team as a means to ensure that, to the extent possible, potential
failure modes and their associated causes / mechanisms have been considered and
addressed. In its most rigorous form, an FMEA is a summary of the team’s thoughts
(including an analysis of items that could go wrong based on experience) as a process is
developed. This systematic approach parallels and formalizes the mental discipline that
an engineer normally goes through in any manufacturing planning process.

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。

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Process Failure Mode & Effects Analysis
What is PFMEA? (Continued) 什么是PFMEA?(续)

ƒAn FMEA must be performed as earlier as possible.


过程FMEA必须尽可能早的介入项目开发中。

ƒAn FMEA is a pro-active tool which can predict failure modes.


过程FMEA是一个可以预测失效模式的前期主动的工具。

ƒWhen executed properly, this method will prevent defects.


当正确执行时,过程FEMA可以预防缺陷。

What is an “FMEA”? In short it is …


Evaluating every possible failure of
every process step, and identifying
how to minimize impacts.
MULTI-DISCIPLIN
简短的说过程FEMA就是对有的过程步骤,评估其所有 TEAMWORK IS
ESSENTIAL FOR A
可能的失效,并且识别如何减少其影响 ROBUST PROCESS!
多功能小组的团队合作是过程
健全的基础

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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。

The Process FMEA is a living document and should be initiated:


ƒBefore or at the feasibility stage,
ƒPrior to tooling for production, and
ƒTake into account all manufacturing operations, from individual components to assemblies.
过程FMEA是一份动态文件,第一版应
ƒ在过程可行性分析阶段或之前开始
ƒ在生产工装准备之前
ƒ而且要考虑从单个零件到总成的所有制造工序

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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

ƒThe customer’s Design FMEA(if available) and the Manufacturing Process Flow Chart serve
as inputs for conducting Process FMEA’s.
ƒThe actions identified in the Process FMEA should transferred to the PQP.
ƒ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。
ƒ过程FMEA中的措施导入PQP中。

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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。

The Key Criteria for Bosch is:


BOSCH的关键评价标准是:

“Zero Defects Delivery”


“零缺陷交付”

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!

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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。

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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:

ƒIncoming parts/material inspection ƒ进货检验,零件/材料


ƒProduction processes ƒ制造过程
ƒInspection processes ƒ检验过程
ƒInternal transportation ƒ内部运输
ƒInternal storage ƒ内部储存
ƒScrap/defect process ƒ废品处置
ƒRepair/re-work process ƒ返工工序
ƒMaintenance and PM process and system ƒ维修及预防性维修体系
ƒLabeling/marking/numbering ƒ标示
ƒPackaging ƒ包装
ƒExternal storage ƒ外部运输
ƒExternal shipping ƒ外部储存
ƒEtc. ƒ其他
Remember: Zero Defects Delivery!
记住:零缺陷交付

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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

What can be done?

How - Design changes


What are the bad is
Effect(s)? it? - Process changes

- Special controls

What are the - Changes to


Functions, Standards,
Features or Procedures, or
Requirements Guides
? What are the How often does it
Causes(s)? happen?

What can go wrong?

- No Function

- Partial / Over / How can this be


Degraded Function prevented and
detected?
- Intermittant Function How good is this
method at
- Unintended Function detecting it?

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Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?

Process Function/ Requirements: 过程功能/要求:

¾Enter a simple description of the process or operation being analyzed (e.g.,


turning, drilling, tapping, welding, assembling).
简单描述将被分析过程或作业(如车、钻、攻丝、焊接、装备)。

¾In addition, it is recommended to record the associated process/operation number


for the step being analyzed.
建议记录下该被分析的步骤的相关过程/作业编号。

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

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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:

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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

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Process Failure Mode & Effects Analysis

How to do the PFMEA? 如何做PFMEA?

Potential Effect(s) of Failure: 潜在失效后果:


Potential effects of failure are defined as the effects of the failure mode on the customer(s).
潜在失效后果是指失效模式对顾客的影响。

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:

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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

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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。

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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

None No discernible effect. Or slight inconvenience to operation or operator, or no effect. 1


无 没有明显的影响 对操作或操作者带来轻微影响或无影响。

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Process Failure Mode & Effects Analysis

How to do the PFMEA? 如何做PFMEA?


Classification: 分类:
This column may be used to classify any special product or process characteristics (e.g., critical,
key, major, significant) for components, subsystems, or systems that may require additional
process controls.
本栏目是用来对需要附加过程控制的零部件,子系统或系统的一些特殊过程特性(如关键,主
要,重要,重点等)进行分类。本栏目另可用来在工程评审强调其高风险的失效模式。

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。

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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:

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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:
ƒDrawing, Specification (Major from customer) 图纸,标准(主要来自客户的)
ƒDFMEA, ICL 设计FMEA,重要特性列表
ƒRegulations 法律法规
ƒ…

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

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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

Important Characteristics List (ICL) Drawing date: 2004-11-22


ECR level: 44W5449N14
ATP-No. :

Part number: F00VC09023 Supplier: used for production

HoP1/PUQ page 1/1 used for pre-production


Determination of Critical Parts Sample Category: (acc. N12AL16)
(acc. RB-NormN12AL13)
Description: Nozzle Spring Supplier-No.: A-sample B-sample C-samples
R R0 others:
part-, function - information / critical functions: Process Process PQP Two-day-
Audit FMEA prod.

End Product: claimed


planned
finished
actions, agreements with the supplier
Pos.- important characteristics Process- remarks inspection specification / capability of process machine S Process control / process mon. batch-
custom. Interface

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)

1 Inner diameter Di= 3.2 ± 0.1mm K Fu 9 x | s

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

7 load loss ≤ 1.0% K Fu 9

packing: BOSCH packaging instruction other: MSDS / N2580: material sheet required additional remarks:

Bosch: name date supplier: name date


project purchasing Q-manager Tolerances in length and width see N38 A SF 1/2

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

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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 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。

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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)。

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Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?

Occurrence: 频度:

¾Occurrence is the likelihood that a specific cause/mechanism of failure will occur.


频度是指具体的失效起因/机理发生的可能性。

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。

¾Preventing or controlling the causes/mechanisms of failure through a design or


process change is the only way a reduction in the occurrence ranking can be effected.
通过设计更改或设计过程更改来预防或控制该失效模式的起因/机理是降低频度级别
数的唯一途径。

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Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?

Suggested PFMEA Occurrence Evaluation Criteria:


建议的P-FMEA频度评价准则:

Probability Likely Failure Rates ppm Cpk Ranking


可能性 可能的失效率 级别
Very High: Persistent failures 1/10 100,000 - 10
很高:持续性发生的失效 1/20 50,000 - 9
High: Frequent failures 1/50 20,000 - 8
高:反复发生的失效 1/100 10,000 - 7
Moderate: Occasional failures 1/200 5,000 0.94 6
中等:偶尔发生的失效 1/1000 1,000 1.10 5
1/2000 500 1.17 4
Low: Relatively few failures 1/15000 67 1.33 3
低:很少有关的相似失效 1/150000 6.7 1.50 2
Remote: Failure is unlikely < 1/1500000 < 0.67 > 1.67 1
极低:失效不大可能发生

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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。

¾There are two types of process controls to consider:


有两种类型的过程控制要考虑,即:
Prevention: Prevent the cause/mechanism of failure or the failure mode from occurring, or reduce
their rate of occurrence.
预防:预防失效起因/机理或失效模式的出现,或减少它们的出现率。
Detection: Detect the cause/mechanism of failure or the failure mode, and lead to corrective
action(s).
探测:探测失效或失效的起因/机理,并引导至纠正措施。

¾The preferred approach is to first use prevention controls, if possible.


如有可能,优先选用预防控制方法,让预防控制方法作为过程意图的一部分,因为其将影响最初的频
度。

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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。

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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

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

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

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Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?

Risk Priority Number: 风险顺序数:


The risk priority number is the product of the severity (S), occurrence (O), and
detection (D) rankings.
风险顺序数(RPN)是严重度数(S),频度数(O)和不易探测度数(D)的乘积。

RPN = (S)X(O)X(D)

When RPN > 125, preventive/corrective action(s) must be given


RPN > 125 必须采取预防/纠正措施。

In general practice when the severity is a 9 or 10, special attention must be


given, regardless of the RPN.
在一般实践中,不管RPN的结果如何,当严重度(S)高时(为9或10时),就应予特别
注意。

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Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?

Risk Priority Number: 风险顺序数:

Exercise: How to evaluated the (S) (O) (D).


练习:如何评价严重度,频度,探测度。

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Process Failure Mode & Effects Analysis
How to do the PFMEA? 如何做PFMEA?

Recommended Action(s): 建议措施:


Actions such as, but not limited to, the following should be considered:
建议措施应考虑(但不限于)以下措施:

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。

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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:

¾Ensuring that process/product requirements are achieved,


确保达到过程/产品要求
¾Reviewing engineering drawings, process/product specifications,
and process flow,
评审产品图纸,过程/产品规范和过程流程图
¾Confirming the incorporation of changes in assembly/manufacturing
documentation, and,
确认在装配/制造文件的结合和一致性;并
¾Reviewing Control Plans and operation instructions.
评审控制计划和操作知道书

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Suggested PFMEA Checklist: 建议PFMEA检查表:

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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。

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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

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Process Failure Mode & Effects Analysis

Exercise: 练习:

Insert a supplier’s process flow chart


插入一个供应商的过程流程图

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