PROCESS FMEA

FAILURE MODE & EFFECT ANALYSIS

PFMEA

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 PROCESS FMEA
Origin
FMEA

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

Common Definitions
Function :

Function of the item being analysed to meet the Design intent.

Includes information regarding the environment in which this
system operates.

Failure Mode:

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

system could potentially fail to meet the design intent. Typical
failure mode may includes, not limited to :

Yield; Fatigue; Material Instability; creep; wear; corrosion;

Cracked Deformed; Leaking.
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 PROCESS FMEA
What is FMEA?
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

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 PROCESS FMEA
Who should do FMEA?
FMEA

1. Cross Functional Team Effort – with a leader

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

When FMEA should be done ?

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

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FMEA PROCESS FMEA
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

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FMEA PROCESS FMEA
QS-9000 requirements

• FMEA shall consider special characteristics

• Aiming defect prevention rather than defect detection
• Use FMEA manual & CFT approach

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.

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FMEA PROCESS FMEA

FOR FMEA FORMAT

CLICK HERE

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EXPLANATIONS PROCESS FMEA
Process Potentia Potential
Function/ Requirements l Failure Effect(s) of
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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 PROCESS FMEA
Potential Failure Mode Potential Sev
EXPLANATIONS

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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 PROCESS FMEA
Potential Effect(s) of Failure Sev Class
EXPLANATIONS

• 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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 PROCESS FMEA
Potential Cause(s)
EXPLANATIONS

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)

FOR SEVIORITY RANKING

CLICK HERE

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EXPLANATIONS PROCESS FMEA

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

• Classify special product

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

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EXPLANATIONS PROCESS FMEA
Current Current
Oc Process Process
Potential Cause(s) / Mechanism (s) of Failure
cur Control Control
prevention detection

• 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.….

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 PROCESS FMEA
Current Current
O
Process Process
Potential Cause(s) / Mechanism (s) of Failure cc
Control Control
ur
Prevention detection
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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 PROCESS FMEA
Current
EXPLANATIONS

Current Proces
Process s FOR
Occurrence Controls Control OCCURANCE
preventi s
on Detecti RANKING
on
• Estimate the probability of
occurrence on a 1-10 scale
• Rate against each causes CLICK HERE
• Use past data as a basis
(cpk/rejection %) for ranking
• Document the basis of
occurrence ranking
• For a new process, if there is no
previous experience, use team
judgement
Don’t consider failure-detecting
measures while giving ranking
(100% inspection.)

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 PROCESS FMEA
D
e
EXPLANATIONS

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

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EXPLANATIONS PROCESS FMEA
Recommended
Detection RPN
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
• 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

FOR DETECTION RANKING

CLICK HERE

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EXPLANATIONS PROCESS FMEA
Responsibil
Recommen ity & Target
RPN
ded 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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EXPLANATIONS PROCESS FMEA
Responsibility
& Target Action
Recommended Action
Completion Results
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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EXPLANATIONS PROCESS FMEA

Actio O D R
Responsibility & Target Se
ns c e P
Completion Date v
Taken c t N

• 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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EXPLANATIONS PROCESS FMEA

Action Results

Se Oc
Actions Taken Det RPN
v c

• 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

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EXPLANATIONS PROCESS FMEA
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
3 Conforming incorporation in assembly / manufacturing
documentation &
4 Reviewing process FMEA & Control plans

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 PROCESS FMEA
PROCESS FMEA QUALITY OBJECTIVES
POINTS TO CONSIDER

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.

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

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.

10 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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 PROCESS FMEA

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