Failure Mode and Effects Analysis

Q Nathan & Nathan Consultants Pvt. Ltd.,

COURSE MATERIAL
ON

Failure Mode and Effect Analysis

(FMEA)

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

Nathan & Nathan Consultants Pvt. Ltd.

Failure Mode and Effects Analysis

Failure Mode and Effect Analysis

FMEA
Origin
US-Space program and defence safety system in 1960s
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

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

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

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 teams thoughts as a process is developed

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Failure Mode and Effects Analysis

POTENTIAL
FAILURE MODE AND EFFECTS ANALYSIS
(PROCESS FMEA)
Item.
Process Responsibility.
FMEA Number..
Model Year(s)/Vehicle(s). Key Date
Page of .
Core Team
FMEA Date (Org)(Rev) Prepared by
Process
Function

Potential
Failure
Mode

Potential
Effect(s)
of Failure

S
E
V

C
l
a
s
s

Potential
Cause(s) /
mechanism (s) of
Failure

O
c
c
u
r

Current
Process
Controls
Prevention

Current
Process
Controls
Detection

D
e
t
e
c
t

R
P
N

Recommende
d Action(s)

Responsibilit
y & Target
Completion
Date

Action Results

Actions
Taken

Nathan & Nathan Consultants Pvt. Ltd.

Sev

O
cc

D
et

RP
N

Failure Mode and Effects Analysis

Process
Function/ Requirements

Potential
Failure
Mode

Potential
Effect(s) of
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

Potential Failure Mode

Potential
Effect(s) of
Failure

Sev

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

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

Severity

Class

Potential Cause(s) /
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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10

Suggested Evaluation Criteria:

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

Effect
Hazardous
without
warning
Hazardous
with warning
Very high

High

Criteria: Severity of Effect

This ranking results when a potential failure
mode results in a final customer and/or
manufacturing /assembly plant defect. The
final customer should always be considered
first .If both occur, use higher of the two
severities
Very high severity ranking when a potential
failure mode affects safe vehicle operation
and/or involves non-compliance with
government regulation without warning
Very high severity ranking when a potential
failure mode affects safe vehicle operation
and/or involves non-compliance with
government regulation with warning.
Vehicle/item inoperable (Loss of primary
function)
Vehicle/item operable, but at reduced level of
performance. Customer very dissatisfied

Criteria: Severity of Effect

This ranking results when a potential
failure mode results in a final customer
and/or a manufacturing/assembly plant
defect. The final customer should always
be considered first. If both occur, use
higher of the two severities.
(Manufacturing/Assembly Effect)
Or may endanger operator ( machine or
assembly) Without warning
Or may endanger operator ( machine or
assembly) With warning
Or 100% of product may have to be scraped,
or, vehicle /item repaired in repair
department with a repair time greater than
one hour.
Or product may have to be sorted and a
portion (less than 100%) scrapped, or
vehicle/Item repaired in repair department
with a repair time between a half hour and an
hour.

Ra

10

Failure Mode and Effects Analysis

Moderate

Low
Very low
Minor
Very minor
None

Vehicle/Item operable but comfort

/Convenience item(s) inoperable. Customer
dissatisfied
Vehicle/Item operable but comfort/convenience
item(s) operable at a reduced level of
performance.
Fit & Finish / Squeak & Rattle item does not
conform. Defect noticed by most customers.
(Greater than 75%)
Fit & Finish/Squeak & Rattle item does not
conform. Defect noticed by 50% of customers
Fit & Finish/Squeak & Rattle item does not
conform. Defect noticed by discriminating
customers.(Less than 25% )
No discernible effect

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Or a portion (less than 100%) of the product

may have to be scraped with no sorting, or
vehicle/item repaired in repair department
with a repair time less than half- hour.
Or 100% of product may have to be
reworked, or vehicle /item repaired off line
but does not go to repair department
Or the product may have to be sorted, with
no scrap, and a portion (less than 100%)
reworked.
Or a portion (less than 100%) of the product
may have to be reworked, with no scrap
online but out of station.
Or a portion (Less than 100%) of the product
may have to be reworked, with no scrap, on
line but in station.
Or slight inconvenience to operation or
operator ,or no effect.

5
4
3
2
1

12

Failure Mode and Effects Analysis

Classification

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

O
c
c
u
r

Classify special process

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

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Failure Mode and Effects Analysis

Potential Cause(s) / Mechanism

(s) of Failure

Occur

Current
Process
Controls

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
Dont 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..

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Failure Mode and Effects Analysis

Potential Cause(s) / Mechanism

(s) of Failure

O
c
c
u
r

Current
Process
Controls

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

Occurrence

D
e
Current
t
Process
e
Controls
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
Dont consider failure detecting measures
while giving ranking (100% inspection)

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Failure Mode and Effects Analysis

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
Very High: Persistent Failures

High: Frequent Failures

Moderate: Occasional Failures

Likely Failure Rates

>=100 per thousand Pieces
50 per thousand Pieces

Ranking
10
9

20 per thousand Pieces

10 per thousand Pieces

5 per thousand Pieces

2 per thousand Pieces

1 per thousand Pieces

0.5 per thousand Pieces

0.1 per thousand Pieces

Low: Relatively few failures

Remote: Failure is Unlikely

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<=0.01per thousand Pieces

17

Failure Mode and Effects Analysis

Current Process Controls

D
e
R
t
P
e
N
c
t

Type of Controls
Level
1
2
3

Type
Prevention of causes

Examples
Mistake proofing

Detection of causes &

SPC, Visual
leading to corrective
control etc.
actions
100% inspection,
Detection of defect
patrol 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

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Detection
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
Dont 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

RP
N

Recommended
Action

Failure Mode and Effects Analysis

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
Criteria
Types
Detection
Suggested Range of Detection Methods
Ranking
A
B
C
Almost
Absolute certainty of
** Connot detect or is not checked
10
Impossible
non-detection
Very Remote Controls will
** Control is achieved with indirect or random
9
probably not detect
checks only
Remote
Controls have poor
** Control is achieved with visual inspection
8
chance of detection
only
Very Low
Controls have poor
** Control is achieved with double visual
7
chance of Detection
inspection only
Low
Controls may detect
**
** Control is achieved with charting methods,
6
such as SPC(statistical Process Control)
Moderate
Controls May Detect
**
Control is based on variable gauging after
parts have left the station, or Go/No Go
5
gauging performed on 100% of the parts after
the parts have left the station.
Moderately
Controls have a good **
**
Error Detection in Subsequent operations, OR
High
chance to Detect
gauging performed on setup And first piece
4
Check (for set up causes only)
High
Controls have a good **
**
Error detection in station or error detection in
chance to Detect
subsequent operations by multiple layers of
3
acceptance : supply,select,install,,connot
accept discrepant part.
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Failure Mode and Effects Analysis

Very High
Very High

Controls almost
certain to Detect

**

Controls certain To
detect

**

Error detection in station (Automatic Gauging

with automatic stop feature). Cannot pass
discrepant part.
Discrepant part cannot be made because item
has been error proofed by process/product
design

2
1

Inspection Types
A-Error Proofed
B- Gauging
C-Manual Inspection

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Process Failure Mode and Effects Analysis

RPN

Recommended Responsibility &

Target
Action
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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Process Failure Mode and Effects Analysis

Recommended Action

Responsibility
& Target
Completion Date

Action
Results

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
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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Process Failure Mode and Effects Analysis

Responsibility & Target

Completion Date

Actions
Taken

Sev

D
O e
RPN
cc
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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Process Failure Mode and Effects Analysis

Action Results
Actions Taken

Sev

Occ

Det

Describe the verification results

Where effectiveness measure is
required, specify the target date
accordingly
After the preventive and corrective
actions have been identified, estimate
and record the resulting severity,
occurance and Detection rankings.
Calculate and record the resulting
RPN

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RPN