Design Failure Mode & Effect Analysis,

Design Review & Design Validation Plan

(DFMEA, DR & DVP)
Dr K C Vora
Deputy Director & Head,
ARAI Academy, ARAI

New Product Development (NPD)

Concept
Phase
Feasibility
studies

Formulate
development
policy

Definition
Phase
Draft
several
scheduling
proposals

Design
Phase
General
design

Jigs, tools &

equipment

Make
tradeoffs

Define system
specifications

Solicit bids
(when using
subcontractors)

Production
process
design

Detailed design

Make prototypes
List
operational
requirements

Production
Phase

Prototype
testing
Qualification
testing

Pilot
production
Pilot evaluation

Full
production
startup
Product launch

Market
stage

House of Quality
QUALITY ELEMENTS
Q-CHARACTERSTIC

CUSTOMER
IMPORTENCE

VOC

CUSTOMER
REQUIRE
MENTS
OR
CR

QUALITY ELEMENTS CONFLICT

IDENTIFICATION TABLE

CUSTOMER
COMPLAINT
DATA
RELATIONSHIP
MATRIX
OR
QFD TABLE- 1
OR
QUALITY TABLE-1
TECHNICAL
BENCHMARKING
PRODUCT PLANNING.

TECHNICAL
STUDY
ITEMS

SUBSYSTEM

DESIGN TARGETS.
RELIABILITY
TARGETS
BOTTLENECK TECHNOLOGY
ISSUES
MECHANISM
- AA

BENCHMARKING
BY CUSTOMER

IMPACTED
COMPONENTS
A , B ,C

QUALITY
PLANNING
CONCEPT
DEVELOPMENTTABLE
BNE ISSUES
COST ISSUE

FUNCTION & SERVICE CONCERNS

FT DIAGRAM

FMEA table
ACTION PLAN TABLE

DFMEA

FMEA
FAILURE MODES & EFFECTS ANALYSIS (FMEA)
is a paper-and-pencil analysis method used in engineering
to document and explore ways that a product design
might fail in real-world use.
Failure Mode & Effects Analysis is an advanced quality
improvement tool.
FMEA is a technique used to identify, prioritize and
eliminate potential failures from the system, design or
process before they reach the customer.
It provides a discipline for documenting this analysis for
future use and continuous process improvement.

History of FMEA
Historically, FMEA was one of the first systematic
techniques for failure analysis developed by the U.S.
Military on 9th November, 1949. FMEA was implemented
in the 1960s and refined in the 70s. It was used by
reliability engineers working in the aerospace industry.
Then the Automotive Industry Action Group formed by
Chrsyler, Ford & GM restructured the FMEA techniques
which found a lot of importance in the automotive
industry.
Since then FMEA has been instrumental in producing
quality goods in the automotive sector.

Types of FMEAs
Design
Analyzes product design before release to
production, with a focus on product function.
Analyzes systems and subsystems in early
concept and design stages.
Process
Used to analyze manufacturing and assembly
processes after they are implemented.

Types of DFMEA
SYSTEM

FMEA
- Chassis system
- Engine system
- Transmission

COMPONENT FMEA
- Piston
- Crankshaft

FMEA Timeline

DFMEA: Starts early in process. It is complete by the time

preliminary drawings are done but before any tooling is initiated.
PFMEA: Starts as soon as the basic manufacturing methods have
been discussed. It is completed prior to finalizing production
plans and releasing for production.

Standards
MIL-STD 1629, Procedures for Performing a Failure Mode and Effect
Analysis
IEC 60812, Procedures for Failure Mode and Effect Analysis (FMEA)
BS 5760-5, Guide to failure modes, effects and criticality analysis
(FMEA and FMECA)
SAE ARP 5580, Recommended Failure Modes and Effects Analysis
(FMEA) Practices for Non-Automobile Applications
SAE J1739, Potential Failure Mode and Effects Analysis in Design
(Design FMEA)
SEMATECH (1992,) Failure Modes and Effects Analysis (FMEA): A
Guide for Continuous Improvement for the Semiconductor Equipment
Industry

Limitations of FMEA
They can only be used to identify single failures

and not combinations of failures

Failures which result from multiple simultaneous
faults are not identified by this
Unless adequately controlled and focused, the
studies can be time consuming
They can be difficult and tedious for complex
multi-layered systems
They are not suitable for quantification of system
reliability

Responsibility and scope of DFMEA

The DFMEA is a team function
All team members must participate
Multi-disciplinary expertise and input is beneficial
Input from all engineering fields is desirable
Representatives from all areas (not just technical
disciplines) are generally included as team members
The DFMEA is not a one meeting activity
The DFMEA will be refined and evolve with the product
Numerous revisions are required to obtain the full benefit of
the DFMEA
The DFMEA must include all systems, sub-systems and
components in the product design

Steps to conduct DFMEA

Form the cross functional team.
Call FMEA Meeting with advance intimation.
Complete the top of the form
Project, year, team members, date, and DFMEA iteration
There will be many iterations
List items and functions
Start with the system, then subsystems and finally components
Document potential failure modes
How could the design potentially fail to meet the design intent?
Consider all types of failure
Document the potential effects of failure
How would design potentially fail to meet the design intent?

Rate the severity of the failure effect

See ranking guidelines
Severity ranking is linked to the effect of the failure
Document potential causes and mechanisms of failure
Failure causes and mechanisms are an indication of design
weaknesses
Potential failure modes are the consequences of the failure causes
A single failure mode may have multiple failure mechanisms
Use group brainstorming sessions to identify possible failure
mechanisms
Dont be afraid to identify as many potential causes as you can
This section of the DFMEA will help guide you in necessary design
changes
The output of the DFMEA will indicate on which item to focus
design efforts

Rate the occurrence

See attached page for ranking guidelines
Things that may help you rate the occurrence
Are any elements of the design related to a previous device
or design?
How significant are the changes from a previous design?
Is the design entirely new?
List the design controls
Design controls are intended to:
Prevent the cause of the failure mode (1st choice solution)
Detect the cause of the failure mode (2nd choice solution)
Detect the failure mode directly (3rd choice solution)

 Applicable design controls include

Predictive code analysis, simulation, and modeling
Tolerance stack-up studies
Prototype test results (acceptance tests, DOEs, limit tests)
Proven designs, parts, and materials

List any critical or special characteristics

Critical characteristics: Severity > 8 and Occurrence >1

Special characteristics: Severity > 6 and Occurrence >2

Detection rate

See attached page for ranking guidelines

Calculate the RPN of each potential failure effect

RPN = (Severity) x (Occurrence) x (Detection)

What are the highest RPN items?

Define recommended actions

What tests and/or analysis can be used to better understand the

problem to guide necessary design changes ?

 Assign action items

Assemble team
Partition work among different team members
Assign completion dates for action items
Agree on next team meeting date
Complete Action Results Section of DFMEA
Note any work not accomplished (and the justification
for incomplete work) in the actions taken section of
the DFMEA.
Why was nothing done?

 Change ratings if action results justify adjustment, but

the rules are:
Severity: May only be reduced through elimination
of the failure effect
Occurrence: May only be reduced through a design
change
Detection: May only be reduced through
improvement and additions in design control (i.e. a
new detection method, better test methodology,
better codes, etc.)
Include test and analysis results with DFMEA to
validate changes.

__ System
__ Subsystem
__ Component
Model Year/Vehicle(s):
Core Team:

Potential
Failure Mode and Effects Analysis
(Design FMEA)
Design Responsibility
Key Date:

FMEA Number:
Page 1 or 1
Prepared by:
FMEA Date (Orig.):

Responsibil Action Results

Potential
Current D
O Current
Potential Potential S C
ity
L Cause(s)/ C Design
Design E R. Recommend
S O D R.
Failure Effect(s) of
&
Target
C
T
P.
ed
AMechanism(s)
Actions E C E P.
Controls
Controls
E
U
E N.
Mode
Failure
S
Action(s) Completion Taken
V C T N.
V S Of Failure R Prevention Detection C
Function
Date

Item

19

The FMEA Form

Identify failure modes

and their effects

Identify causes of the

failure modes
and controls

Prioritize

Determine and assess

actions

FMEA Sequence
Subsystem

Potential Potential S C Potential O Current Controls

failure Effect(s) E L Cause(s) C
mode
of
V A Mechanism C
Failure
S
(s) of
U
S
Failure
R

Function
Requires

What are the

effect(s)?

How bad
is it?

What are the

Functions,
Features or
Requirements?
What can go
wrong?
- No function
- Partial/ over/
degraded
function
- Intermittent
function
- Unintended
function

What are
the
cause(s)?

How often
does it
happen?
How can this
be prevented
and
detected?

D R Recommen Respons
E P
ded
ibility &
T N Action(s)
Target
E
completi
C
on date
T
I
O
N

What can be done?

- Design changes
- Process
changes
- Special controls
- Changes to
standards,
procedures, or
guides

How good is this

method at
detecting it?

Action
results

Act- S O D R
ion E C E .
s V CT P
take
.
n
N
.

FMEA Procedure
List all Function &
requirements
List all conceivable
failure modes
Consider effects, if above
failure mode happens
Look possible causes &
mechanism for
failures mode
Assess the frequency of
occurrence of
failure modes (O)

Re- evaluate
(New RPN )
Define Responsibility
& Time- frame
Recommend
improvements
Calculate the Risk
Priority Number (RPN)
Assess the possibility of
Failure being
detected ( D )

Assess the Severity of effect (s)

Functions & Requirements

Functional Requirements
Customer Requirements
Legal Requirements
Benchmarking Requirements
State of the Art Trend

Function & Function Tree

Function means what the product does, and is normally
considered in a dynamic sense, expressed as
Verb + object - (There could be a number of functions for a
product or its sub assy. Or part.)
Example
Can drive with stability,
Generates electricity,
Propels airplane,
Some time cd be given as static expression by noun +
adjective
Easy handling, good look, quite sound,
Also expressed as adverb
Rotate smoothly
Basic functions are expressed by verb + Object

Motivation
Analyze the vehicle / engine / system / components
and summarize various functions and failure modes.
Conduct DFMEA various components/systems.
These components & systems all had failure modes
and a corresponding Risk Priority Number (RPN) to
be calculated using severity, occurrence & detection
rankings.
The idea is to reduce this RPN value so that the
components/systems are designed more towards
reliability and safety. These reductions are to be done
through design changes.

Famous Failures

Failure Definitions
Failure: (Noun)
1a- Omission of occurrence or performance,
specifically a failing to perform a duty or expected
action
1b- A state of inability to perform a normal function
1c- A fracturing or giving away under stress
2.- A lack of success
3.- A falling short or deficiency

Deterioration or decay

Failure Definitions
Fail: (Noun)
(a) To lose strength: Weaken
To fade or die away
To stop functioning
To fall short
To be absent or inadequate
To be unsuccessful
( b) To miss performing an expected service or function
To be deficient in: Lack
To leave undone: Neglect
To be unsuccessful in passing (like a test)

Failure Categories
Failure Categories

Reliability
Catastrophic
Complete
Critical
Degradation
Dependent
Gradual

Independent
Inherent

Weakness

Intermittent
Major

Minor

Misuse

Non-relevant

Partial
Primary
Random
Relevant
Secondary
Sudden
Wear-out

How We Call a Failure ?

1. Unsuccessful (Not meeting design intent)
2. Deteriorating (Not to standards)
3. Defective (Imperfection, flaw)
4. Decaying (Gradual or sudden decline)
5. Deficient (Impaired or inferior; weak)
6. Incomplete (Inadequate)
7. Non-Functional (Doesnt work)
8. Omission (Overlooked, neglected, missed)

Examples

Unsuccessful: A required function is wrong

Example: Wrong firing sequence in engine

Deteriorating: A measured value does not meet an

established level
Example: Engine power does not qualify to a defined
level
Defective: A part has a physical flaw
Example: Crack in the engine casting
Decaying: A measured value has changed from
an initial baseline level
Example: Head lamp light lux level reduction over
time

Examples

Deficient: A material or product is not capable of

meeting requirements
Example: Strength of con-rod deficient due to selected
material grade.

Incomplete: One or more expected functions or

outputs are missing
Example: Kombi switch does not provide for night light
dipping. (not considered by development)

Non-Functional: The component is not working or

responding to commands
Example: Kombi switch does not function for command for
night light dipping ( considered in dev, but not performing )

Omission: A required characteristic has not been

designed or measured
Example: Water pressure in radiator not considered in design

Failures & Failure Modes

Failures modes
Concept of failure mode is fundamental to FMEA
A failure mode is not a failure in itself, it is a class of
undesirable phenomena that can result in failure.
Failure mode is also not a actual cause of failure.
Wire break, short circuit, adhesion, surface
roughness, leakage,
detachment, slackness,
blockage, deformation, snapping,
cracking, loss are
few examples of failure mode.
CAUSE
Cause of failure mode

FAILURE-MODE

FAILURE
Effect of failure mode

Failures & Failure Modes

CAUSE

CAUSE Wrong oil selection

Wrong gasket
wrong workmanship
Over filling
Wrong breather
Deflection

Leakage
( Oil / Gas )
Oil leakage

FAILURE

FAIURES Engine stalling

Over Heating
Air entrapping
Others

Severity, Occurrence & Detection

Severity
Importance of the effect on customer
requirements
Occurrence
Frequency with which a given cause occurs and
creates failure modes
Detection
The ability of the current control scheme to detect
or prevent a given cause
35

Occurrence (O) Table

Probability of Failure
Very High : Persistent
failures

Possible Failure Rates

> 100 per thousand vehicles/ items
50per thousand vehicles/ items

Ranking
10
9

High : Frequent failures

20 per thousand vehicles/ items

10 per thousand vehicles/ items

5 per thousand vehicles/ items

2 per thousand vehicles/ items

1 per thousand vehicles/ items

Low : Relatively few

failures

0.5 per thousand vehicles/ items

0.1 per thousand vehicles/ items

Remote : Failure is
unlikely

< 0.010 per thousand vehicles/ items

Moderate : Occasional
failures

Severity (S) Table

Effect
Hazardous
without
warning

Criteria : severity of Effect

Ranking
Very high severity ranking when a potential failure mode affects safe
10
vehicle operation and/or involves noncompliance with government
regulation without warning.

Hazardous
with warning

Very high severity ranking when a potential failure mode affects

safe vehicle operation and/or involves noncompliance with
government regulation with warning.

Very High
High

Vehicle/ item inoperable (loss of primary function).

Vehicle/ item operable but at reduced level of performance.
Customer very dissatisfied.

8
7

Moderate

Vehicle/ item operable, but Comfort/ Convenience item(s)

inoperable. Customer dissatisfied.

Low

Vehicle/ item operable, but Comfort/ convenience item(s) operable

at a reduced level of performance. Customer somewhat dissatisfied.

Very Low

Fit & Finish/ Squeak & Rattle item does not conform. Defect noticed
by most customers (greater than 75%).

Minor

Fit & Finish/ Squeak & Rattle item does not conform. Defect noticed
by 50% of customers.

Very Minor

Fit & Finish/ Squeak & rattle item does not conform. Defect noticed
by discriminating customer (less than 25%).

None

No discernible effect.

Detection (D) Table

Detection
Absolute
Uncertainty
Very Remote
Remote
Very Low
Low
Moderate
Moderate High
High
Very High
Almost Certain

Criteria : Likelihood of Detection by Design Control

Design control will not and/or can not detect a potential cause/
mechanism an subsequent failure mode; or there is no Design
control
Very remote chance the Design control will detect a potential
cause/ mechanism and subsequent failure mode.
Remote chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
Very low chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
Low chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
Moderate chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
Moderate high chance the Design control will detect a potential
cause/ mechanism and subsequent failure mode.
High chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
Very high chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
Design control will almost certainly detect a potential cause/
mechanism an subsequent failure mode.

Ranking
10

9
8
7
6
5
4
3
2
1

Risk Priority Number (RPN)

RPN is the product of the severity, occurrence, and
detection scores.

Severity

Occurrence

Detection

RPN

RPN / Risk Priority Number

Top 20% of Failure
Modes by RPN
R
P
N

Failure Modes

Example of Significant / Critical Threshold

Special Characteristics Matrix

S
E
V
E
R
I
T
Y

POTENTIAL CRITICAL
10
CHARACTERISTICS Safety/Regulatory
9
8
POTENTIAL
SIGNIFICANT
7
CHARACTERISTICS
6
Customer Dissatisfaction
5
4
ANOYANCE
ALL OTHER
ZONE
3
CHARACTERISTICS
2 Appropriate actions /
1 controls already in place
1 2 3 4 5 6 7 8 9 10
OCCURRENCE

FMEA Inputs and Outputs

Inputs
a
Brainstorming
Process Map
Process History
Procedures
Knowledge
Experience

Outputs

FMEA

List of actions to prevent

causes or detect failure
modes
History of actions taken

Action
Recommend Action, wherever RPN is high through
- Design Controls
- Design changes
- Process changes
- Special controls changes to
standards/procedures/guidelines

Decide Responsibilities
Decide Target date of completion.

What Next?
Repeat: undertake the next revision of the DFMEA
The DFMEA is an evolving document!
Revise the DFMEA frequently & keep on reducing RPN!
Diligence will eliminate design risk!
Include documentation of your results!

Design Review (DR)

Steps for NPD

PRODUCT CONCEPT
CONCEPTUAL DESIGN

DR1

DR2
DR3
DR4
DR5

OUTLINE DESIGN
DETAILED DESIGN
PROTOTYPE MAKE
TRIL RUN
INITIAL PRODUCTION
MASS PRODUCTION

PRODUCTION
PREPARATION

SUPPLIER
PREPARATION

DR Phase Planning

Participants for Design Review

Design Engineer; System Engineer, System
Experts, Process Engineer; Product Planner,
Manufacturing Engineer, Sourcing Engineer;
Reliability Engineer; Service Engineer;
Contribution by Participants:
Participants should come to the meeting along
with the data worked out and results relevant to
their roles/expertise required under "preparation
list" and leading to "deliverables ".

Preparation for Design Review

Intent & concept definition of project

Application details & translated to Technical requirements
Design Inputs
Customer Requirements - VOC; RWUP translated to technical
requirements
Deliverables- performance & endurance; Reliability goals
Benchmark & competition data
Information of failures /successes of similar products, competitor
product
Metallurgical data
Cost data
Design calculations of performance, endurance, strength
requirements of system/ components
Homologation requirements
Legal regulation
Layout & detail drawings of system
Operational ergonomic requirement data
Assembly build variation analysis.

Deliverables of Design Review

Conformance of design to the intent & concept for
performance, endurance & warranty.
Conformance of design to strength
Conformance to regulations & homologation
Manufacturability aspects
Serviceability aspects
Identification of special/ stranger technology
Use of standard products
Use of standard materials
Identification of patent issues- a) use of present- legal matters;
b) patentable features
Identification of overlapping & interdependent areas between
Interfacing systems
Identification of environmental issues
Operational ergonomic conformance.

Design Validation Plan

(DVP)

Design Validation Plan (DVP)

Design Validation is next step to DFMEA.
Depending upon RPN in DFMEA, the components
are arranged in DVP.
It contains all the information regarding the
acceptance criteria, responsible person or team,
type of test and start & finish dates.

Why Design Validation?

Are we building it right?
Major costs of projects are incurred in early design
stages.
The cost of fixing a design and faulty decisions at later
stages is exponentially greater than at an earlier
stage.
Early Validation/Verification:
reduces risk early in the program
provides feedback to designers before delivery
proves that requirements are met
saves costs
reduces complexity of fault detection

Validation Definition
The documented act of proving that any
procedure, process, equipment, material, activity
or system, actually leads to the expected results.
Design Validation means establishing by
objective evidence that device specifications
conform to user needs and intended uses.

Design, Build & Verify

55

Design Verification Catalogue (DVC)

The Design Verification Catalogue (DVC) allows the System
Engineers to verify that the vehicle / system / sub-system /
component meets the design specifications appearing in
corresponding VDS / SDS / CDS.
DVC serves to,
describe appropriate Design Verification Methods (DVM)
associate one or more verification methods with each
SDS requirement
capture facility and prototype requirements to conduct
planned verifications.
DVC includes the operating conditions, accuracy and
uncertainty of the test.
56

Requirements of
Design Validation
Design validation shall be performed under defined
operating conditions on initial production units, lots or
batches, or their equivalents.
It includes testing of production units under actual or
simulated use conditions.
It includes software validation and risk analysis.
The Validation must be documented in Design
Validation Plan.

Design Validation Process

Validation Plan
Validation Review
Validation Methods
Validation Report

Comparison Between Validation,

Verification & Review

Validation Methods
Testing ( Static as well as Dynamic)
Analysis ( Using software's and simulations)
Inspection Methods(Visual or with Test Rigs)
Compilation of relevant scientific literature
Study of historical evidences of similar design

Examples of validation methods &

activities

Worst case analysis of an assembly.

Fault tree analysis of a process or design.
Failure modes and effects analysis (FMEA).
Package integrity tests.
Testing of materials.
Comparison of a design to previous vehicles having
an established history of successful use.

Conclusion
For design of high performance products / systems /
components, quality tools like DFMEA plays an
important role to achieve desirable performance and
durability requirements. If this is done right from
concept stage, the risk of failures substantially
reduces and lot of time, energy and cost is saved.
Design Review is a continuous process of
conforming that the design to the intent & concept
for performance, endurance & warranty is foolproof.
Design Validation Plan is a systematic plan to
confirm that the design meets the desired target
after verification.