Failure Mode and Effect Analysis

Lecture 2-3
Design FMEA

Customer Defined

FMEA

The definition of "customer" for a

Design FMEA can be the . . . .
END USER
NEXT ENGINEERING
GROUP
MANUFACTURING
REPAIR CENTER
2

Living Document

FMEA

The Design FMEA is a living document and

should be initiated at or by the design concept
finalization, be continually updated as
changes occur throughout the phases of
product development, and be fundamentally
completed along with the final drawings.

Drawings

What is DFMEA?

FMEA

A Design FMEA is an analytical

technique utilized by product or
process designers as a means to
ensure that, to the extent
possible, potential failure modes
and their associated causes
have been considered and
addressed.
4

Design FMEA

FMEA

The Design FMEA supports the design

process in reducing risk of failures by:
Aiding in the objective evaluation of design
requirements and design alternatives
Increasing the probability that potential
failure modes and their effects on system
operation have been considered in the
design / development process.
Providing additional information to aid in
the planning of thorough and efficient
design test and development programs.
5

DFMEA Assumptions

FMEA

V The Design FMEA addresses design intent and

assumes the design will be manufactured to this
intent.
V Potential failure modes / causes which can occur
during the manufacturing or assembly process
are not included in a Design FMEA. Their
identification, effect, and control are covered by
the Process FMEA.
V The Design FMEA does not rely on process
controls to overcome potential weaknesses in the
design, but it does take the technical and

physical limits of the manufacturing

process into consideration.
6

DFMEA Phases

FMEA

Planning Phase
Timing: early in the design process
Purpose: quick visibility of most obvious weak points

Development Phase
Timing: design and preliminary component specs are
available
Purpose: expansion of planning phase

Verification and Introduction Phase

Timing: completion of engineering model and start of
Customer testing
Purpose: final failure modes and risk assessment prior
to production

Time Phase

FMEA

CONCEPT

The FMEA
ENG PROTOTYPE
develops in
complexity and
detail as the
DEVELOPMENT
product
progresses
through the
design phases
8

Technique - Listed Items

FMEA

HARDWARE
BOTTOM-UP
TOP-DOWN
FUNCTIONAL BLOCK
RELIABILITY BLOCK
9

System Breakdown Concept

System

FMEA

A composite of subsystems whose functions

are integrated to achieve a mission or specific
output

Subsystem composite of assemblies whose functions are

integrated to achieve a specific activity
necessary for achieving a mission
Assembly

a composite of subsystems

Component a composite of piece parts

Piece Part

least fabricated item, not further reducible

Interface

the interactions point(s) necessary to produce

the necessary effects between system elements
(interfaces transfer energy/information, maintain
mechanical integrity, etc.
10

Functional vs. Geographic

FMEA

Functional

Cooling system
Propulsion system
Braking system
Steering system

Geographic

Engine compartment
Passenger compartment
Dashboard / Control Panel
Rear end
etc.

Interface components
If an engine-driven
belt powers both a
water pump and a
power steering
system, be sure to
include it as part of
one, or as a separate
interface element.

11

System Breakdown Example

SYSTEM

AUTOMOBILE

SUBSYSTEM

ASSEMBLY

FMEA
SUBASSEMBLY

COOLING

RADIATOR
WATER PUMP
COOLANT
HOSES, CLAMPS
THERMOSTAT

PROPULSION

FUEL

STORAGE
DELIVERY

AIR

CARBURATOR

SPARK / IGNITION

BATTERY
GENERATOR
PLUGS
COIL
DISTRIBUTOR

ENGINE

ETC . . . .

TRANSMISSION

ETC . . . .
12

Functional FMEAs

FMEA

Focus on the functions that a product, process, or

service is to perform rather than on the
characteristics of the specific implementation. When
developing a functional FMEA, a functional block
diagram is used to identify the top-level failure modes
for each functional block on the diagram.

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Functional Block

FMEA

FUNCTIONAL BLOCK
MOUNTING DECK,
COVER

BASE DECK

STAMPED
COVER

COVER SEAL

TAPE SEAL

Much of a complex product can be

analyzed by looking at functional blocks
rather than individual items
14

Reliability Block

FMEA

R EL IAB IL IT Y B L O C K

HEA D
P RE AM P
F IL T ER
A M P (A G C )
S L IM M IN G
A to D
D EC O D E
CO NTRO L
B UF F ER

HO S T

15

Detailed FMEAs

FMEA

Focus on the characteristics of specific

implementations to ensure that designs
comply with requirements for failures that can
cause loss of end-item function, single-point
failures, and fault detection and isolation.

16

Technique - Hardware

FMEA

HARDWARE

FMEA follows
the hardware
BOM from the
bottom-up, or
the top-down

UNIT ASSY
BASE FINAL
ASSY
MOTOR ASSY

MOTOR POLE
ASSY

MOTOR POLE
SPACER

MACHINE
SCREW

MOUNTING
BRACKET

MAGNET

MOTOR POLE
Handbook pg. 14

17

Interface FMEAs

FMEA

Focus on the interconnections between

system elements so that the failures
between them can be determined and
recorded and compliance to
requirements can be verified..

18

DFMEA Form

FMEA

19

Worksheet

FMEA

FMEA WORKSHEET

PRODUCT:

TYPE: DESIGN PROCESS OTHER____________

ITEM:

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

ENGR

POTENTIAL
CAUSES

PG

VERIFICATION OR
CURRENT CONTROL

RPN

20

10

DFMEA Steps - Teams

FMEA

PRODUCT:

FMEA NO.

PROCESS/OPERATION:

Oklahoma City
FUNCTION

SEVERITY
POTENTIAL
FAILURE MODE

POTENTIAL
EFFECTS OF

OCCURRENCE

FAILURE

1.

PAGE

PLANNING REFERENCE:

DESIGN (OR PROCESS) FMEA

POTENTIAL
CAUSE(S) OF

DATE:

DETECTION

CURRENT
CONTROLS

RPN = S x O x D

RPN

ACTION
PRIORITY

CORRECTIVE
ACTION

RESPONSIBILITY
& DATE DUE

ACTION
TAKEN

RESULTING
S

FAILURE

DESIGN ENGINEER

OF

BY:

3.

RPN

ENGINEER WITH
PROGRAM TEAM

(MANUF ENGINEER)

DESIGN ENGINEER, MANUFACTURING

2.

ENGINEER, QUALITY ENGINEER,

RELIABILITY ENGINEER
21

Ground Rules

FMEA

1. Do not consider all conceivable failure

modes
2. Initially write the failure mode as loss of
function
3. Decide on the approach - function or
hardware
4. Develop each column of the FMEA
independently.

22

11

Function

FMEA

FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

PG

VERIFICATION OR
CURRENT CONTROL

RPN

Common problems
Not all functions are identified
The description is not exact or concise
The description is not in direct language

23

Potential Failure Mode

FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

FMEA

PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

VERIFICATION OR
CURRENT CONTROL

PG

RPN

The manner in which the item (product,

component, system) could potentially fail to
meet the design intent.
Assume that the failure mode could occur but
may not necessarily occur.
Potential failure modes should be described
in physical or technical terms, not as a
symptom noticeable by the customer
24

12

Effects of Failure
FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

FMEA
PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

PG

VERIFICATION OR
CURRENT CONTROL

RPN

Describe in terms of what the customer might

notice or experience
State clearly if safety or compliance to
regulations is an issue.
Keep in mind the hierarchical relationships
between parts, subsystems and systems.

25

Severity of Effect
FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

FMEA
PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

VERIFICATION OR
CURRENT CONTROL

PG

RPN

An assessment of the seriousness of the

effect.
Only applies to the effect
If several effects exist for a failure mode,
choose the worst case severity.
Rank on a scale of 1-10

26

13

Severity of Effect

Design

FMEA

SEVERITY EVALUATION CRITERIA

Severity of EFFECT

Ranking

Unreasonable to expect that the minor nature of this failure would cause any
real effect on the overall performance

Improbable, minor

Low
The failure is insignificant and the user is only minimally affected
The product is fully functioanl and the failure is viewed as a nuisance item

2
3

Moderate
Failure causes customer dissatisfaction in the form of annoyance
Failure notices by customer requires correction
Customer notices slight performance degradation

4
5
6

High
Loss of some product function but not of system performance

Product inoperable or fails to meet performance criteria

Extreme
Potentailly hazardous affect. possibly safety-related
Product safety of liability hazard

9
10
27

Severity Another Example

FMEA

28

14

Potential Causes
FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

FMEA
PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

PG

VERIFICATION OR
CURRENT CONTROL

RPN

For each potential failure mode, list all

possible causes
Goal is to get to root cause, or to a
reasonable place to break the cause-effect
chain.
Rotate columns is necessary. If the team
starts finding causes of causes, promote the
original cause to potential failure mode.
29

Testing the Relationships

FMEA

Use the following to see if you got the

relationships in the proper sequence:

IF cause THEN failure mode

HOW DO I KNOW? effect

30

15

Cause-Effect Model

FMEA

FAILURE
MODE

LIKELY EFFECTS

LIKELY CAUSES
TRIGGER

PREVENTIVE

ACTIONS

CONTINGENT
- ADAPTIVE
- CORRECTIVE

31

Occurrence

FMEA

FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

VERIFICATION OR
CURRENT CONTROL

PG

RPN

The likelihood that a specific cause will occur

and result in the failure mode.
Rank on a scale of 1 - 10

32

16

Occurrence of Cause

FMEA

Design

OCCURRENCE EVALUATION CRITERIA

Probability the CAUSE will occur

Possible
Failure Rate
(DPPM)

Ranking

Remote
Failure is unlikely. No known failures associated with almost identical designs

<1 in 10
(<1)

Very Low
Only isolated failures associated with similar designs

< 1 in 20,000
(<50)

<1 in 4,000
(<250)

1 in 1,000
1 in 400
1 in 80

4
5
6

1 in 40
1 in 20

7
8

1 in 8
1 in 2

9
10

Low
Occassional failures associated with similar designs
Moderate
Previous designs have experienced problemsor occassiona lfactory out-of control
conditions

High
Similar designs have experience problems which have led to stop-ship conditions
Extreme
Failure almost inevitable

33

Occurrence Another Example

FMEA

34

17

Engineering Verification
FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

FMEA

PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

PG

VERIFICATION OR
CURRENT CONTROL

RPN

The activities that will assure the design

adequacy for the failure mode / cause
If the design FMEA is done very early, it may
not be possible to determine the engineering
verification

35

Effectiveness
FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

FMEA
PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

VERIFICATION OR
CURRENT CONTROL

PG

RPN

The ability of the proposed design control to

detect the potential cause.
Rank on a scale of 1 - 10

36

18

Effectiveness of Design Verification

FMEA

EFFECTIVENESS EVALUATION CRITERIA

Effectiveness of the Verification Activity

Ranking

Very Effective
Design evaluation controls will detect a design weakness prior to production release

1
2

High
Controls will have a good chance of detecting design weakness
Will be detectable after release but before build

3
4

M oderate
Controls may detect design weakness before initial shipment
Will be detected prior to shipment to customer

5
6

Low
Controls not likely to detect design weakness and must wait for larger volume

7
8

Very Low
Controls will probably not detect falure
Controls cannot ir will not detect failure

9
10
37

Effectiveness (Detection)

FMEA

38

19

Risk Priority Number

FMEA WORKSHEET
TYPE: DESIGN PROCESS OTHER___________________

FUNCTION

POTENTIAL
FAILURE MODE

EFFECTS OF
FAILURE

FMEA

PRODUCT:
ITEM:

ENGR

POTENTIAL
CAUSES

PG

VERIFICATION OR
CURRENT CONTROL

RPN

Occurrence
x Severity
x Effectiveness
RPN = O x S x E
39

Action Priority

FMEA

Final ranking (or risk assessment)

in order of importance
Priority
A
B
C
D

RPN range
OVER 200
100-199
26-99
1-25

40

20

FMEA

Ef
fec
tiv
en
es
s
RP
N

Oc
cu
rre
nc

Fa
ilu

Se
ve
rit

re
M

od

Shortcomings of RPN Method

96

96

SAME RESULT
Handbook pg. 29

41

FMEA

Ef
fec
tiv
en
es
s
RP
N

Oc
cu
re
nc

y
Se
ve
rit

Fa
ilu

re
M

od

Shortcomings of RPN Method

96

96

FOCUS ON SEVERITY
42

21

Another Scoring Approach

FMEA

SEVERITY

FMEA Area Chart*

10
9
8
7
6
5
4
3
2
1

HIGH PRIORITY

MEDIUM
PRIORITY

LOW PRIORITY

1 2 3 4 5 6 7 8 9 10
OCCURRENCE
* Failure Modes and Effects Analysis, Paul Paladay, PT Publications, 1995

Actions

43

FMEA

A well-developed Design FMEA

will be of limited value without
positive and effective corrective
actions.
The design must be improved
based on the results of the
FMEA study.
44

22

Specifications

FMEA

What problems do we
encounter with specifications?
Component misspecification due to
communication problems
Unenforceable specs - cant be verified with
present technology
Improper specs - standard conditions can
be a trap! OR specs for past products no
longer sufficient for new ones

45

FMEA Homework 2

FMEA

Complete a design FMEA for the product shown on

the next page
Use the forms provided on the web page, or create
forms of your own. If your company already has
FMEA forms, you may use them for this exercise.
Concentrate on the function / failure mode / effect
and cause columns. Make up something (within
reason) for the engineering verification and scoring.
Each person is to submit an FMEA.
Submit the FMEA to me attached to e-mail.
Assignment is due 4/2/2004.
46

23

FMEA Homework 2

FMEA

1. Evaluate the design of a pressure-sensitive

adhesive label attached to an instrument case.
2. The case contains sensitive electronic
components that cannot be exposed to
contamination from particles or vapors,
including possible contamination from the
pressure-sensitive adhesive.

ADHESIVE

3. The hole is used for final adjustment and is ADHESIVE-FREE

covered with a pressure-sensitive label. To
AREA
keep the inside of the case from being exposed
to possible contamination from the adhesive,
the label was designed with a no-adhesive area.
4. The final adjustment of the components is
intended for the factory only and must not be
done by the consumer.
5. Remember that you are product designers
and not process engineers at this point,
however, the process engineer on your team
says that a manufacturing constraint exists, the
labels must be attached by hand by an operator
on an assembly line.
6. List any process concerns that you will want
to consider as part of a later process FMEA.

RECESSED AREA

TOP VIEW SHOWING LABEL IN PLACE

47

Design FMEA Form

FMEA

PRODUCT:

FMEA NO.

PART / SYSTEM:

DES IGN FMEA

SEVERITY

P AR T OR
S YS TEM
FUNCTION(S)

POTENTIAL
FAILURE MODE

PAGE

DRAWING REFERENCE:

EFFECTS OF
FAILURE -LOCAL,
NEXT LEVEL, END
USER

EFFECTIVENES

OCCURRENCE
S

POTENTIAL
CAUSES OF
FAILURE

DATE:

DESIGN
VERIFICATION
ACTIVITES

OF

BY:

RPN = S x O x E
E R PN
ACTIO
N

RECOMMEN.
CORRECTIVE
ACTIONS

RESPONSIB
& DUE
DATE

R ES U LTIN G
ACTIONS
TAKEN

E RP N

48

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