FMEA

1. FMEA –Failure Mode and Effect Analysis
FMEA is the analysis of potential failure of a product or process that affects the function
partially or completely
Types of FMEA
• DFMEA – Design
• PFMEA – Process
• Others (Concepts, Systems, Service, etc,.)
Design FMEA
• Design FMEA aids in the design process by identifying known and upcoming
Failure modes and then ranking failures according to relative impact on the product.
• Hence Design FMEA focuses on relative impact of the failure mode on the product
Process FMEA
• Process identifies potential process failure modes by ranking failures and helping to establish
Priorities according to the relative impact on the internal or external customer.
• Hence Process FMEA focuses on relative impact of the failure mode on internal or external
Customer.

2. • Severity - Classification of failure by severity of the effects
• Occurrence - How often they occur
• Deduction - How easily can they deducted
RPN (Risk priority number) = Severity X Occurrence X Deduction
Cause
Failure mode Effect
Control
Process
Calculate
RPN
Re-calculate
RPN
Recommended
action, if need.
• The RPN gives us a relative risk ranking.
• The higher the RPN, the higher the potential risk.
• An organization may decide any RPN above a maximum target of 200 presents
an unacceptable risk and must be reduced.
• Severity will not change, when recalculating RPN.
Define
S, O, D

3. 1) Specifying possibilities
• Functions
• Possible feature modes
• Root causes
• Effects
• Deduction / Prevention
Stages of FMEA documentation
2) Quantifying Risk
• Severity of effect
• Occurrence of failure (probability of cause)
• Deduction (effectiveness of control to prevent cause)
• RPN (Risk priority number)
3) Correcting high causes
• Prioritizing work
• Detailing action
• Assigning action responsibility
• Check point on completion
4) Re-evaluating Risk
• Recalculation of RPN

4. FAILURE MODE AND EFFECTS ANALYSIS
Item:
Responsibility:
FMEA
number:
Model: Prepared by: Page :
Core
Team:
FMEA Date
(Orig):
Rev:
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
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility
and Target
Completion
Date
Action Results
Actions
Taken
S
e
v
O
c
c
D
e
t
R
P
N

5. FAILURE MODE AND EFFECTS ANALYSIS
Item: Drill Hole Responsibility: AAA FMEA number: 123456
Model: Current Prepared by: BBB Page : 1 of 1
Core Team: AAA (Engineering), BBB (Production), CCC (Quality)
FMEA Date
(Orig): 1/1/2021
Rev: 1
Process
Function
Potential
Failure
Mode
Potential
Effect(s) of
Failure
S
e
v
C
l
a
s
s
Potential
Cause(s)/
Mechanis
m(s) of
Failure
O
c
c
u
r
Current
Process
Controls
D
e
t
e
c
R
P
N
Recommended
Action(s)
Responsibility
and Target
Completion Date
Action Results
Actions Taken
S
e
v
O
c
c
D
e
t
R
P
N
Drill Blind
Hole
Hole too
deep
Break
through
bottom of
plate
7
Improper
machine
set up
3
Operator training
and instructions
3 63 0
Hole not
deep
enough
Incomplete
thread
form
5
Improper
machine
set up
3
Operator training
and instructions
3 45 0
hole
missing
Tool life 5
Broken
Drill
5 None 9 225
Install Tool
Detectors
BBB 3/1/2021 5 5 1 25
0 0
0 0

9. Benefits of FMEA
• Prevent failures before they happen.
• Identifies where to focus
• Improves the quality, reliability, and safety of the process
• Reduces process development time, cost
• Documents and tracks risk reduction activities
• Helps to identify critical-to-quality characteristics
• Provides historical records; establishes baseline
• Helps increase customer satisfaction and safety