DFMEA DR & DVP 261113 KCV

1. Design Failure Mode & Effect Analysis,
Design Review & Design Validation Plan
(DFMEA, DR & DVP)
Dr K C Vora
Deputy Director & Head,
ARAI Academy, ARAI

2. New Product Development (NPD)
Concept
Phase
Definition
Phase
Design
Phase
Production
Phase
Feasibility
studies
Formulate
development
policy
List
operational
requirements
Draft
several
scheduling
proposals
Make
tradeoffs
Define system
specifications
Solicit bids
(when using
subcontractors)
General
design
Detailed design
Make prototypes
Prototype
testing
Qualification
testing
Production
process
design
Jigs, tools &
equipment
Pilot
production
Pilot evaluation
Full
production
startup
Product launch
Market
stage

3. RELATIONSHIP
MATRIX
OR
QFD TABLE- 1
OR
QUALITY TABLE-1
CUSTOMER
REQUIRE
MENTS
OR
CR

DESIGN TARGETS.
TECHNICAL
BENCHMARKING
SERVICE CONCERNS
CONCEPT
DEVELOPMENTTABLE
COST ISSUE
BNE ISSUES
BENCHMARKING
BY CUSTOMER CUSTOMER
COMPLAINT
DATA CUSTOMER
IMPORTENCE
QUALITY ELEMENTS
Q-CHARACTERSTIC
QUALITY ELEMENTS CONFLICT
IDENTIFICATION TABLE
QUALITY
PLANNING
PRODUCT PLANNING.
RELIABILITY
TARGETS
TECHNICAL
STUDY
ITEMS
BOTTLENECK TECHNOLOGY
ISSUES
SUBSYSTEM
MECHANISM
- AA
IMPACTED
COMPONENTS
A , B ,C
FMEA table
FUNCTION &
FT DIAGRAM
ACTION PLAN TABLE
VOC
House of Quality

4. DFMEA

5. • 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.
FMEA

6. • 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 1960’s and refined in the 70’s. 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.

History of FMEA

7. 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.

8. • SYSTEM FMEA
- Chassis system
- Engine system
- Transmission

• COMPONENT FMEA
- Piston
- Crankshaft
Types of DFMEA

9. 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.
FMEA Timeline

10. 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”

Standards

11. • 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
Limitations of FMEA

12. 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

13. •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?

Steps to conduct DFMEA

14. • 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
–Don’t 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

15. • 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 (1
st
choice solution)
•Detect the cause of the failure mode (2
nd
choice solution)
•Detect the failure mode directly (3
rd
choice solution)

16. –Applicable design controls include
•Predictive code analysis, simulation, and modeling
•Tolerance “stack-up” studies
•Prototype test results (acceptance tests, DOE’s, 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 ?

17. • 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?

18. –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.

19. 19
Potential
Failure Mode and Effects Analysis
(Design FMEA) __ System
__ Subsystem
__ Component

Model Year/Vehicle(s):
Core Team: Design Responsibility
Key Date:
FMEA Number:
Page 1 or 1
Prepared by:
FMEA Date (Orig.):
Item
Function
Potential
Failure
Mode
Potential
Effect(s) of
Failure
Potential
Cause(s)/
Mechanism(s)
Of Failure
Current
Design
Controls
Prevention
Current
Design
Controls
Detection
Recommend
ed
Action(s)
Responsibil
ity
& Target
Completion
Date
Actions
Taken
Action Results
S
E
V
C
L
A
S
S O
C
C
U
R
D
E
T
E
C
R.
P.
N.
S
E
V
O
C
C
D
E
T
R.
P.
N.

20. The FMEA Form
Identify failure modes
and their effects
Identify causes of the
failure modes
and controls
Prioritize
Determine and assess
actions

21. Subsystem






Function
Requires 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 Controls D
E
T
E
C
T
I
O
N R
P
N
Recommen
ded
Action(s)
Respons
ibility &
Target
completi
on date
Action
results
Act-
ion
s
take
n
S
E
V
O
C
C
D
E
T
R
.
P
.
N
.






















What are the
Functions,
Features or
Require-
ments?
What can go
wrong?
- No function
- Partial/ over/
degraded
function
- Intermittent
function
- Unintended
function
What are the
effect(s)?
How bad
is it?
What are
the
cause(s)?
How often
does it
happen?
How can this
be prevented
and
detected?
How good is this
method at
detecting it?
What can be done?
- Design changes
- Process
changes
- Special controls
- Changes to
standards,
procedures, or
guides
FMEA Sequence

22. Recommend
improvements
Look possible causes &
mechanism for
failures mode
Consider effects, if above
failure mode happens
Assess the frequency of
occurrence of
failure modes (O)
Assess the possibility of
Failure being
detected ( D )
Assess the Severity of effect (s)
List all conceivable
failure modes
Calculate the Risk
Priority Number (RPN)
Re- evaluate
(New RPN )
Define Responsibility
& Time- frame
FMEA Procedure
List all Function &
requirements

23. Functions & Requirements
•Functional Requirements
•Customer Requirements
•Legal Requirements
•Benchmarking Requirements
•State of the Art Trend

24. 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

25. • 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.

Motivation

26. Famous Failures

27. 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

28. 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)

29. 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

30. 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 (Doesn’t work)
8. Omission (Overlooked, neglected, missed)

31. 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

32. 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

33. 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

34. CAUSE
Leakage
( Oil / Gas )
FAILURE
CAUSE -
• Wrong oil selection
• Wrong gasket
• wrong workmanship
• Over filling
• Wrong breather
• Deflection

Oil leakage • FAIURES -
• Engine stalling
• Over Heating
• Air entrapping
• Others


Failures & Failure Modes

35. Severity, Occurrence & Detection
35
•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

36. Probability of Failure Possible Failure Rates Ranking
Very High : Persistent
failures
> 100 per thousand vehicles/ items 10
50per thousand vehicles/ items 9
High : Frequent failures 20 per thousand vehicles/ items 8
10 per thousand vehicles/ items 7
Moderate : Occasional
failures
5 per thousand vehicles/ items 6
2 per thousand vehicles/ items 5
1 per thousand vehicles/ items 4
Low : Relatively few
failures
0.5 per thousand vehicles/ items 3
0.1 per thousand vehicles/ items 2
Remote : Failure is
unlikely
< 0.010 per thousand vehicles/ items 1
Occurrence (O) Table

37. Effect Criteria : severity of Effect Ranking
Hazardous
without
warning
Very high severity ranking when a potential failure mode affects safe
vehicle operation and/or involves noncompliance with government
regulation without warning.
10
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.
9
Very High Vehicle/ item inoperable (loss of primary function). 8
High Vehicle/ item operable but at reduced level of performance.
Customer very dissatisfied.
7
Moderate Vehicle/ item operable, but Comfort/ Convenience item(s)
inoperable. Customer dissatisfied.
6
Low Vehicle/ item operable, but Comfort/ convenience item(s) operable
at a reduced level of performance. Customer somewhat dissatisfied.
5
Very Low Fit & Finish/ Squeak & Rattle item does not conform. Defect noticed
by most customers (greater than 75%).
4
Minor Fit & Finish/ Squeak & Rattle item does not conform. Defect noticed
by 50% of customers.
3
Very Minor Fit & Finish/ Squeak & rattle item does not conform. Defect noticed
by discriminating customer (less than 25%).
2
None No discernible effect. 1
Severity (S) Table

38. Detection Criteria : Likelihood of Detection by Design Control Ranking
Absolute
Uncertainty
Design control will not and/or can not detect a potential cause/
mechanism an subsequent failure mode; or there is no Design
control
10
Very Remote Very remote chance the Design control will detect a potential
cause/ mechanism and subsequent failure mode.
9
Remote Remote chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
8
Very Low Very low chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
7
Low Low chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
6
Moderate Moderate chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
5
Moderate High Moderate high chance the Design control will detect a potential
cause/ mechanism and subsequent failure mode.
4
High High chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
3
Very High Very high chance the Design control will detect a potential cause/
mechanism and subsequent failure mode.
2
Almost Certain Design control will almost certainly detect a potential cause/
mechanism an subsequent failure mode.
1
Detection (D) Table

39. Risk Priority Number (RPN)
RPN is the product of the severity, occurrence, and
detection scores.
Severity Occurrence Detection RPN X X =

40. RPN / Risk Priority Number
Top 20% of Failure
Modes by RPN
R
P
N
Failure Modes

41. Example of Significant / Critical Threshold
10
9
8
7
6
5
4
3
2
1
1 2 3 4 5 6 7 8 9 10
S
E
V
E
R
I
T
Y
O C C U R R E N C E
POTENTIAL CRITICAL
CHARACTERISTICS
Safety/Regulatory
POTENTIAL
SIGNIFICANT
CHARACTERISTICS
Customer Dissatisfaction
ALL OTHER
CHARACTERISTICS
Appropriate actions /
controls already in place
Special Characteristics Matrix
ANOYANCE
ZONE

42. FMEA Inputs and Outputs
FMEA

a
Brainstorming
Process Map
Process History
Procedures
Knowledge
Experience


List of actions to prevent
causes or detect failure
modes

History of actions taken
Inputs Outputs

43. 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.

44. 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!

What Next?

45. Design Review (DR)

46. Steps for NPD
PRODUCT CONCEPT
CONCEPTUAL DESIGN
OUTLINE DESIGN
DETAILED DESIGN
PROTOTYPE MAKE
TRIL RUN
INITIAL PRODUCTION
MASS PRODUCTION
PRODUCTION
PREPARATION
SUPPLIER
PREPARATION
DR1
DR2
DR3
DR4
DR5
?

47. DR Phase Planning

48. 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 ".
Participants for Design Review

49. •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.
Preparation for Design Review

50. 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.
Deliverables of Design Review

51. Design Validation Plan
(DVP)

52. 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.

53. 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

54. 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.

55. 55



Design, Build & Verify

56. 56
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.

57. 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.

58. Design Validation Process
•Validation Plan
•Validation Review
•Validation Methods
•Validation Report

59. Comparison Between Validation,
Verification & Review

60. 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

61. 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.

62. 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.
Conclusion