Failure Mode and Effects Analysis Modified on 04.12.

2001

Q Nathan & Nathan Consultants Pvt. Ltd.,

TRAINING MATERIAL

ON

Failure Mode and Effect Analysis

(PROCESS FMEA)

No.36, Muktha Building, 8th Main 18th Cross, Malleswaram, Bangalore 560 055
Ph : 080-3440703 / 3440704, Fax : 080-3311622
Email: [email protected]

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Failure Mode and Effects Analysis Modified on 04.12.2001

Failure Mode and Effect Analysis

FMEA

Origin

US-Space program and defence safety system in 1960’s

Common Definitions

Failure:

A ‘Failure’ is that a component, assembly or system which

does not meet the requirements or function in accordance with
design intent. (Ex. Not meeting the specification, heat
treatment failure)

Failure Mode:

A ‘Failure Mode’ is the manner in which a component,

assembly or system failure occurs. (Ex. How the component
could not meet the specifications, hardness high, hardness
low)

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Failure Mode and Effects Analysis Modified on 04.12.2001

What is FMEA?

FMEA is a systemised group of activities to:

1. Recognise and evaluate the potential failure of a product /
process and its effects
2. Identify actions which could eliminate or reduce the chance
of potential failure occurring
3. Document the process

Why FMEA?

1. For a company policy where continuous improvement is

emphasized for its product, process
2. FMEA is a living document

Who should do FMEA?

1. Cross Functional Team Effort – with a leader

2. Team of knowledgeable individuals Ex. Expertise in Mfg.,
Assly., Quality., etc.
3. Team should include representatives of sub-contractors
and/or customers

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Failure Mode and Effects Analysis Modified on 04.12.2001

When FMEA should be done?

1. Essence is timeliness
2. Pro-Active rather than reactive
3. Before process failure mode occurs

Advantages of FMEA

1. Avoids late change crisis

2. Reduces or eliminates chance of implementing corrective
change
3. Excellent technique for preventive action
4. Interactive process which is never ending

Types of FMEA

1. System FMEA – Power transmission system

2. Design FMEA – Axle shaft
3. Process FMEA – Heat treatment

QS-9000 requirements

 Process FMEA shall consider special characteristics

 Aiming defect prevention rather than defect detection
 Use PFMEA manual & CFT approach

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Failure Mode and Effects Analysis Modified on 04.12.2001

Potential – Process FMEA

Potential Means ‘Anticipated’

It is an analytical technique to assure that potential failure

mode and their associated causes have been considered and
addressed

Collection of team’s thoughts as a process is developed

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Failure Mode and Effects Analysis Modified on 04.12.2001

POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA)

Item……………………………………. Process Responsibility…………. FMEA Number……………………..

Model…………………………………. Key Date…………… Page …… of …….
Core Team……………………………… FMEA Date ……………………… Prepared by…………………………

Process Potential Potential SEV Class Potential Occ Current Current D R Recommended Responsibility & Action Results
Function Failure Effect(s) Cause(s) / ur Process Process e P Action(s) Target
Mode of Failure mechanism Control Controls t N Completion Date
(s) of Failure Prevention Detection e
c
t
R
Actions
Sev Occ Det P
Taken
N

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Failure Mode and Effects Analysis Modified on 04.12.2001

Process Potential Potential

Failure Effect(s) of
Function/ Requirements Mode Failure

 Specify the description and

Function of the process
 List out Outputs of the Process

Example
Process function / description
- Manual application of wax
inside door
- Machining of outer diameter

Requirements
- To cover inner door at minimum
thickness to retard corrosion
- Outer diameter, run-out, free
from tool mark

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Failure Mode and Effects Analysis Modified on 04.12.2001

Potential Failure Mode Potential Sev

Effect(s) of
Failure
Two Assumptions are
1. Consider all inputs are acceptable
2. Consider the Design is acceptable
 List the failure modes those are
possible to occur against the
requirements specified in the
previous column.
 Apart from Engg. Specification,
what would a customer consider
objectionable
 CUSTOMER is
- Next opn.
- Subsequent Opn.
- End user
Example
Bent, Diameter oversize, Diameter
undersize, Cracked, Deformed, Open
Circuited, Burred
OD not clear – Is it a failure mode in
machining of casting / forging?

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Failure Mode and Effects Analysis Modified on 04.12.2001

Potential Effect(s) of Failure Sev Class

 List the effects of failure in

- Next operation
- Subsequent operations
- Customer
- End user/ Environment
 Describe the effects using the
terminology specified in Severity
rating table
 For each failure mode, more than
one effect can be listed

Example
- Cannot locate
- Cannot face
- Does not fit
- Does not match
- Scrap, re-work
- Vehicle / item inoperable
- Loss of primary function
- Customer dissatisfaction

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Failure Mode and Effects Analysis Modified on 04.12.2001

Potential Cause(s) /
Severity Class Mechanism (s) of
Failure

 Assess the seriousness of the

effect in a 1-10 scale
 This rating applies to EFFECT
only (i.e. previous column)
 Consider the Design FMEA
 Consult subsequent Mfg./
Assembly plant
 Safety related effects should be
rated in Nos.9 or 10
 While giving ranking consider
only the required criteria (i.e.
next opn. / vehicle)

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Failure Mode and Effects Analysis Modified on 04.12.2001
Suggested Evaluation Criteria:
(The team should agree on an evaluation criteria and ranking system, which is consistent; even if modified for individual process analysis)
Criteria: Severity of Effect Criteria: Severity of Effect
This ranking result when a potential failure This ranking result when a potential failure
mode result in a final customer and / or a mode result in a final customer and / or a
Effect manufacturing / assembly plant defect . the manufacturing / assembly plant defect . the Ranking
final customer should always be considered final customer should always be considered
first. If both occur , use the higher of two first. If both occur , use the higher of two
severities. severities.
Hazardous Very high severity ranking when a potential Or may endanger operator ( machine or assembly )
without failure mode affects safe vehicle operation and /or without warning .
10
warning involves noncompliance with government
regulation without warning.
Hazardous Very high severity ranking when a potential Or may endanger operator ( machine or assembly )
with warning failure mode affects safe vehicle operation and /or with warning
9
involves noncompliance with government
regulation with warning.
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 with a 8
repair with a repair time greater than one hour.
High Vehicle /item operable but at reduced level of Or product may have to be sorted & portion ( less
performance .Customer very dissatisfied . than 100 % ) scrapped or vehicle /item repaired in
7
repair department with a repair with a repair time
between a half-hour & hour .
Moderate Vehicle /item operable but Comfort / convenience Or product (less than 100 % ) may have to
item(s) inoperable customer dissatisfied . scrapped with no sorting , or vehicle /item repaired
6
in repair department with a repair with a repair
time less then half-hour .
Effect Criteria: Severity of Effect Criteria: Severity of Effect Ranking
This ranking result when a potential failure This ranking result when a potential failure
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Failure Mode and Effects Analysis Modified on 04.12.2001

mode result in a final customer and / or a mode result in a final customer and / or a
manufacturing / assembly plant defect . the manufacturing / assembly plant defect . the
final customer should always be considered final customer should always be considered
first. If both occur , use the higher of two first. If both occur , use the higher of two
severities. severities.
Low Vehicle /item operable but comfort /convenience Or 100 % of product may have to reworked, or
item (s) operable at reduced level of performance. vehicle /item repaired off line but does not go to 5
repair department
Very low Fit and finish / squeak and rattle item does not Or the product may have to be sorted ,with no
conform .defect noticed by most scrap and a portion ( less than 100 % ) reworked . 4
customers( greater then 75 % )
Minor Fit and finish / squeak and rattle item does not Or portion ( less then 100 % ) of the product may
conform .defect noticed by 50% of customers have to be reworked with no scrap , online but out 3
of station
Very minor Fit and finish / squeak and rattle item does not Or portion ( less then 100 % ) of the product may
conform .defect noticed by most customers ( less have to be reworked with no scrap , online but in 2
then 25 %) station
None No discernible effect Or slight inconvenience to operation or operator ,
1
or no effect

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Failure Mode and Effects Analysis Modified on 04.12.2001

O
Potential
c
Cause(s) /
Classification Mechanism (s) of
c
u
Failure
r

 Classify special process

characteristics (e.g. critical, key,
major)

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 Failure Mode and Effects Analysis Modified on 04.12.2001

O
Current Current
Potential Cause(s) / Mechanism c
Process Process
c
(s) of Failure Control Control
u
prevention detection
r

 List the first level potential causes

such as
- man
- machine
- tool
- process parameter
- fixture etc.
 List the root causes under the first
level causes using WHY? WHY?
analysis
 Describe the causes in such a way that
can be eliminated or controlled
 Don’t use ambiguous statements such
as
- operator mal-functioning
- fixture problem etc.
 Use the cause and effect diagram, if
required
 consider input materials in last
iteration of cause analysis

Contd.….

Potential Cause(s) / Mechanism O Current Current

c Process Process
(s) of Failure c Control Control
u Prevention detection
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 Failure Mode and Effects Analysis Modified on 04.12.2001
r

Example
Under Man
- Fails to clean
- Fails to assemble
- Fails to tight
- Mis-locate
Under machine
- inadequate lubrication
- excessive vibration
- excessive spindle run-out
Under process
- improper time / temperature
- inadequate gating / venting
Under design
- Symmetric design
- Difficult to assemble
Under Raw Material
- Mixed material
- New source
- Alternate material
- Excessive hardness

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 Failure Mode and Effects Analysis Modified on 04.12.2001

D
Current Current e
Process Process t
Occurrence Control Control e
Prevention Detection c
t

 Estimate the probability of occurrence

on a 1-10 scale
 Rate against each causes
 Use existing or past data as a basis
(Cpk / rejection %) for ranking
 Document the basis of occurrence
ranking
 For a new processes, if there is no
previous experience, use team
judgement
 Don’t consider failure detecting
measures while giving ranking (100%
inspection)

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Failure Mode and Effects Analysis Modified on 04.12.2001

Suggested Evaluation Criteria:

(The team should agree on an evaluation criteria and ranking system, which is consistent, even if modified for individual process
analysis)

Probability of Failure Possible Failure Rates Ranking

> 100 per thousand vehicles / item. 10
Very High: Persistent failures
50 per thousand vehicles / item 9
20 per thousand vehicles / item 8
High: Frequent failures
10 per thousand vehicles / item 7
5 per thousand vehicles / item 6
Moderate: Occasional failures 2 per thousand vehicles / item 5
1 per thousand vehicles / item . 4

Low: Relatively few failures 0.5 per thousand vehicles / item 3

0.1 per thousand vehicles / item 2

Remote: Failure is unlikely < 0.010 per thousand vehicles / item 1

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Failure Mode and Effects Analysis Modified on 04.12.2001

Suggested Evaluation Criteria with Ppk Values.

Probability of Failure Possible Failure Rates Ppk Ranking

> 100 per thousand vehicles / item. < 0.55 10
Very High: Persistent failures
50 per thousand vehicles / item > 0.55 9
20 per thousand vehicles / item > 0.78 8
High: Frequent failures
10 per thousand vehicles / item > 0.86 7
5 per thousand vehicles / item > 0.94 6
Moderate: Occasional failures 2 per thousand vehicles / item > 1.00 5
1 per thousand vehicles / item . > 1.10 4
> 1.2
Low: Relatively few failures 0.5 per thousand vehicles / item 3
> 1.30
0.1 per thousand vehicles / item 2

> 1.67
Remote: Failure is unlikely < 0.010 per thousand vehicles / item 1

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Failure Mode and Effects Analysis Modified on 04.12.2001

D
Current Process Current Process e
R
t
Control Control e
P
N
Prevention Detection c
t

 Type of Controls
Level Type Examples
P- Prevention of
Mistake proofing
Prevention causes
Detection of causes SPC, Visual
D- & leading to control etc. 100%
Detection corrective actions inspection, patrol
Detection of defect inspection

 List the existing controls, which can detect the

causes or failure mode
 While listing, specify the frequency of detection
measures

Examples
- Visual Check, one per shift for film thickness
- SPC chart five pieces in an hour
- On-line monitoring of crimping force
- Auto-control of temperature
- 100% on-line inspection
- Visual monitoring of Ammeter

RP Recommended
Detection N Action

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Failure Mode and Effects Analysis Modified on 04.12.2001

 Assess the probability of controls

listed in the previous column,
which will detect the cause or
failure mode
 While giving ranking, assume the
failure is occurred
 Don’t assume ranking is low
because the occurrence is low
 Random controls should not
influence detection ranking
 One detection ranking can be
assigned to multiple controls

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 Failure Mode and Effects Analysis Modified on 04.12.2001

Suggested Evaluation Criteria

(The team should agree on an evaluation criteria and ranking system which is consistent, even if modified for individual process analysis)

Inspection Types
Detection Criteria: Suggested range of detection methods Ranking
A B C
Almost Impossible Absolute certainty of non- detection . X Can not detect or is not checked
10
Very Remote Control will probably not detect X Control is achieved with indirect or
random checks only 9
Remote Control have poor chance of detection X Control is achieved with visual inspection
only. 8
Very Low Control have poor chance of detection X Control is achieved with double visual
inspection only. 7
Low Controls may detect X X Control is achieved with charting methods,
such as SPC 6
Moderate Controls may detect X Control is based on variable gauging after
parts have left the station, or Go / No Go
5
gauging performed 100 % of the parts after
parts have left the station
Moderately High Controls have a good chance to detect. X X Error detection in subsequent operations,
or gauging performed on set up & first 4
piece check
High Controls have a good chance to detect. X X Error detection in- station , or error
detection in subsequent operations by
multiple layers of acceptable supply , 3
select , install , verify , con not accept
discrepant part
Very High Controls almost certain to detect X X Error detection in station . Can not pass
discrepant part 2
Almost certain Controls almost certain to detect X Discrepant parts can not be made because
item has been error- proofed by process / 1
product design.

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 Failure Mode and Effects Analysis Modified on 04.12.2001

Recommended Responsibility &

RPN Action
Target
Completion Date

 Risk Priority Number is

the multiplication of
severity x occurrence x
detection.
 While calculating RPN,
consider only highest
severity rating of each
failure mode

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Failure Mode and Effects Analysis Modified on 04.12.2001

Responsibility
Action
Recommended Action & Target
Results
Completion Date

 Policy for RPN to take action

- define a target RPN and
anything above that can be
considered for action. For
Ex. It can be 50. Considering

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Failure Mode and Effects Analysis Modified on 04.12.2001

95% of the failures are

attended
- consider only high priority
no. for take action and
review periodically
 As a first priority, take action
on causes to reduce
occurrence ranking
 The next priority is to
consider action on controls to
reduce detection ranking
 severity ranking can be
reduced by
- elimination of failure mode
by change in processes or
design

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Failure Mode and Effects Analysis Modified on 04.12.2001

D
Responsibility & Target Actions
Sev
O e
RPN
Taken cc
Completion Date t

 Specify the responsibility and

target completion date for
every actions identified
 During APQP, the FMEA
completion dates should be
prior to production run

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Action Results

Actions Taken Sev Occ Det RPN

 Describe the verification results

 Where effectiveness measure is
required, specify the target date
accordingly
 After the assessment of the actions
taken, re-assess the values of severity,
occurrence, detection and RPN

Follow up actions
The Process - responsible engineer is responsible for ensuring that all actions recommended have been implemented or
adequately addressed . FMEA is a living document and should always reflect the latest design level as well as the latest
relevant actions.
The Process responsible engineer has several means of ensuring that concerns are identified and that recommended actions
are implemented . they includes but not limited to followings :

1 Ensuring design requirements are achieved

2 Reviewing engineering drawings & specifications

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Failure Mode and Effects Analysis Modified on 04.12.2001

3 Conforming incorporation in assembly / manufacturing documentation &

4 Reviewing process FMEA & Control plans

PROCESS FMEA QUALITY OBJECTIVES

1 PROCESS IMPROVEMENTS: The FMEA drives process improvement as primary objective. With an emphasis on
Error / Mistake proofing solutions

2 HIGH RISK FAILURE MODES: The FMEA address all high-risk failure modes as identified by FMEA team, with
executable action plans. All other failure modes are considered.

3 CONTROL PLANS: The pre launch and production Control Plan consider the failure modes from the process
FMEA.

4 INTEGRATION: The FMEA is integrated and consistent with process flow diagram and the process control plan.
The process FMEA considers the design FMEA, if available as part of its analysis.

5 LESSONS LEARNED: The FMEA considered all major “ lessons learned “ as input to failure mode identification

6 SPECIAL OR KEY CHARACTERISTICS: the FMEA identifies appropriate key characteristics candidates as
input to the key characteristics selection process , if applicable due to company policy.

7 TIMING: The FMEA is completed during the “ Window of opportunity “ where it could most efficiently impact the
product design of product or process.

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8 TEAM: The right people participate as part of the FMEA team through out the analysis and are adequately trained in
FMEA methods

9 DOCUMENTATION: the FMEA is completely filled out “ by the book ” including “ action plan ” and new RPN
values.

TIME USAGE: Time spent by FMEA team as early as possible is an effective & efficient use of time, with a value –added
result. This assumes recommended actions are identified as required and the actions are implemented.

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