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]

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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 Potential Potential S C Potential O Current Current D R Recommende Responsibilit Action Results
Function Failure Effect(s) E l Cause(s) / c Process Process e P d Action(s) y & Target
Mode of Failure V a mechanism (s) of c Controls Controls t N Completion
s Failure u Prevention Detection e Date
s r c
t
Actions O D RP
Sev
Taken cc et N

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Failure Mode and Effects Analysis

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

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

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

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

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 results when a potential
This ranking results when a potential failure
failure mode results in a final customer
mode results in a final customer and/or
and/or a manufacturing/assembly plant Ra
manufacturing /assembly plant defect. The
defect. The final customer should always
final customer should always be considered
be considered first. If both occur, use
first .If both occur, use higher of the two
higher of the two severities.
Effect severities
(Manufacturing/Assembly Effect)
Hazardous Very high severity ranking when a potential Or may endanger operator ( machine or
without failure mode affects safe vehicle operation assembly) Without warning
10
warning and/or involves non-compliance with
government regulation without warning
Hazardous Very high severity ranking when a potential Or may endanger operator ( machine or
with warning failure mode affects safe vehicle operation assembly) With warning
9
and/or involves non-compliance with
government regulation with warning.
Very high Vehicle/item inoperable (Loss of primary Or 100% of product may have to be scraped,
function) or, vehicle /item repaired in repair
8
department with a repair time greater than
one hour.
High Vehicle/item operable, but at reduced level of Or product may have to be sorted and a 7
performance. Customer very dissatisfied portion (less than 100%) scrapped, or
vehicle/Item repaired in repair department
with a repair time between a half hour and an
hour.
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Failure Mode and Effects Analysis

Moderate Vehicle/Item operable but comfort Or a portion (less than 100%) of the product
/Convenience item(s) inoperable. Customer may have to be scraped with no sorting, or
6
dissatisfied vehicle/item repaired in repair department
with a repair time less than half- hour.
Low Vehicle/Item operable but comfort/convenience Or 100% of product may have to be
item(s) operable at a reduced level of reworked, or vehicle /item repaired off line 5
performance. but does not go to repair department
Very low Fit & Finish / Squeak & Rattle item does not Or the product may have to be sorted, with
conform. Defect noticed by most customers. no scrap, and a portion (less than 100%) 4
(Greater than 75%) reworked.
Minor Fit & Finish/Squeak & Rattle item does not Or a portion (less than 100%) of the product
conform. Defect noticed by 50% of customers may have to be reworked, with no scrap 3
online but out of station.
Very minor Fit & Finish/Squeak & Rattle item does not Or a portion (Less than 100%) of the product
conform. Defect noticed by discriminating may have to be reworked, with no scrap, on 2
customers.(Less than 25% ) line but in station.
None No discernible effect Or slight inconvenience to operation or
1
operator ,or no effect.

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Failure Mode and Effects Analysis

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

Potential Cause(s) / Mechanism Current

Occur Process
(s) of Failure 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

O
Potential Cause(s) / Mechanism c Current
c Process
(s) of Failure u Controls
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

D
e
Current
t
Occurrence 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)

Likely Failure Rates

Probability Ranking

10
Very High: Persistent Failures >=100 per thousand Pieces
50 per thousand Pieces 9
20 per thousand Pieces 8
High: Frequent Failures
10 per thousand Pieces 7
5 per thousand Pieces 6
Moderate: Occasional Failures 2 per thousand Pieces 5
1 per thousand Pieces 4

0.5 per thousand Pieces 3

Low: Relatively few failures
0.1 per thousand Pieces 2

Remote: Failure is Unlikely 1

<=0.01per thousand Pieces

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Failure Mode and Effects Analysis

D
e
R
t
Current Process Controls e
P
N
c
t

Type of Controls

Level Type Examples

1 Prevention of causes Mistake proofing
Detection of causes &
SPC, Visual
2 leading to corrective
control etc.
actions
100% inspection,
3 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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Failure Mode and Effects Analysis

RP Recommended
Detection N Action

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

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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)
Inspection
Detection Criteria Types 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 Controls almost ** Error detection in station (Automatic Gauging

certain to Detect with automatic stop feature). Cannot pass 2
discrepant part.
Very High Controls certain To ** Discrepant part cannot be made because item
detect has been error proofed by process/product 1
design

Inspection Types

A-Error Proofed
B- Gauging
C-Manual Inspection

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Process Failure Mode and Effects Analysis

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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Process Failure Mode and Effects Analysis

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
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

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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Process Failure Mode and Effects Analysis

Action Results

Actions Taken Sev Occ Det RPN

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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