Engineering Management

1. Dr.AtifShahzad
_____________________Dr. Atif Shahzad
BE, MECHANICAL ENGINEERING
UNIVERSITY OF ENGINEERING & TECHNOLOGY, TAXILA, PAKISTAN, 2000
MCS, SOFTWARE ENGINEERING
SZABIST,, ISLAMABAD, PAKISTAN, 2003
MS, AUTOMATION & PRODUCTION SYSTEMS
ECOLE CENTRALE DE NANTES, NANTES, FRANCE, 2007
PhD, AUTOMATION & APPLIED INFORMATICS
UNIVERSITE DE NANTES, NANTES, FRANCE, 2011
EMAIL: atifshahzad@Gmail.com
TEL: +92-333-5219846, +92-51-5179755
LINKEDIN: pk.linkedin.com/in/dratifshahzad

2. PROJECT
MANAGEMENT
RISK MANAGEMENT

3. Dr.AtifShahzad
3

4. Dr.AtifShahzad
Why does it always
seem we have plenty
of time to fix our
problems, but never
enough time to
prevent the problems
by doing it right the
first time?

5. Dr.AtifShahzad
Today’s Lecture
 Introduction
¤ FMEA History
¤ What is FMEA ?
 Definitions
 What it Can Do For You?
 Types of FMEA
 Team Members Roles
 FMEA Terminology
 Getting Started with an FMEA
¤ The Worksheet
¤ FMEA Scoring
5

6. Dr.AtifShahzad
Uncertainties that Plague Projects
Uncertainties Offsets
Mission Objectives
♦ Will the baseline system satisfy the needs &
objectives?
♦ Are they the best ones?
♦ Thorough study
♦ Analyses
♦ Cost & schedule credibility
Technical Factors
♦ Can baseline technology achieve the
objectives?
♦ Can the specified technology be attained?
♦ Are all the requirements known?
♦ Technology development plan
♦ Paper studies
♦ Design reviews
♦ Establish performance margins
♦ Engineering model test and
prototyping
♦ Test & evaluation
Internal Factors
♦ Can the plan and strategy meet the
objectives?
♦Resources
•Manpower skills
•Time
•Facilities
♦Program strategy
♦Budget allocations
♦Contingency planning
External Factors ♦ Will outside influences jeopardize the
project?
♦Contingency
♦Robust design
6

7. Dr.AtifShahzad
Project Risk Categories
7
Typical
Technical
Risk Sources
Typical
Programmatic
Risk Sources
Typical
Supportability
Risk Sources
Typical
Cost
Risk Sources
Typical
Schedule
Risk Sources
• Physical properties
• Material properties
• Radiation properties
• Testing/Modeling
• Integration/Interface
• Software Design
• Safety
• Requirement changes
• Fault detection
• Operating environment
• Proven/Unproven
technology
• System complexity
• Unique/Special
Resources
• COTS performance
• Embedded training
• Material availability
• Personnel availability
• Personnel skills
• Safety
• Security
• Environmental impact
• Communication
problems
• Labor strikes
• Requirement changes
• Stakeholder advocacy
• Contractor stability
• Funding continuity and
profile
• Regulatory changes
• Reliability and
maintainability
• Training
• Operations and
support
• Manpower
considerations
• Facility considerations
• Interoperability
considerations
• System safety
• Technical data
• Sensitivity to technical
risk
• Sensitivity to
programmatic risk
• Sensitivity to
supportability risk
• Sensitivity to schedule
risk
• Labor rates
• Estimating error
• Sensitivity to technical
risk
• Sensitivity to
programmatic risk
• Sensitivity to
supportability risk
• Sensitivity to cost risk
• Degree of currency
• Number of critical path
items
• Estimating error

8. Dr.AtifShahzad
Reactive Design
Quality Transition to
...
Predictive
Design Quality
Requirements: Flow down from
Customer Expectations
FROM TO
“Test in” Quality
Evolving Requirements
Modeling / Simulation with
Design / Process Capability
Flow-up
Statistical Quality Prediction
“Design in” Quality
Build & Test
Measurement
Design rework / tweaking Control Critical Design Parameters
Reactive to Proactive

9. Dr.AtifShahzad
Project and Project Management
 Project is a temporary sequence of unique, complex, and connected
activities having one goal or purpose and that must be completed by
specific time, within budget, and according to specification.
 Project Management is the process of scoping, planning, staffing,
organizing, directing, and controlling the development of an acceptable
system at a minimum cost within a specified time frame.
9

10. Dr.AtifShahzad
Reliability
 Reliability is the probability that the system-of-
interest will not fail for a given period of time under
specified operating conditions
¤ Reliability is an inherent system design characteristic
¤ Reliability plays a key role in determining the system’s cost-effectiveness
¤ Ref: NASA Systems Engineering Handbook (1995 version)
10

11. Dr.AtifShahzad
 Reliability engineering is a specialty discipline within the systems
engineering process. Reflected in key activities:
¤ Design - including design features that ensure the system can perform
in the predicted physical environment throughout the mission.
¤ Trade studies - reliability as a figure of merit. Often traded with
cost.
¤ Modeling - reliability prediction models, reflecting environmental
considerations and applicable experience from previous projects.
¤ Test - making independent predictions of system reliability for test
planning/program; sets environmental test requirements and
specifications for hardware qualification.
11
Reliability

12. RISK MANAGEMENT
RISK

13. Dr.AtifShahzad
What are Risks and Risk
Management?
 Risks are potential events that have negative impacts on safety or
project technical performance, cost or schedule
 Risks are an inevitable fact of life – risks can be reduced but never
eliminated
 Risk Management comprises purposeful thought to the sources,
magnitude, and mitigation of risk, and actions directed toward its
balanced reduction
 The same tools and perspectives that are used to discover, manage and
reduce risks can be used to discover, manage and increase project
opportunities - opportunity management
13

14. Dr.AtifShahzad
What is Risk Management?
 Seeks or identifies risks
 Assesses the likelihood and impact of these risks
 Develops mitigation options for all identified risks
 Identifies the most significant risks and chooses which mitigation options to
implement
 Tracks progress to confirm that cumulative project risk is indeed declining
 Communicates and documents the project risk status
 Repeats this process throughout the project life
14
Risk management is a continuous
and iterative decision making
technique designed to improve the
probability of success.
It is a proactive approach that:

15. Dr.AtifShahzad
Risk Management Considers the Entire
Development and Operations Life of a Project
Risk Type
 Technical Performance Risk
 Cost Risk
 Programmatic Risk
 Schedule Risk
 Liability Risk
 Regulatory Risk
 Operational Risk
 Safety Risk
 Supportability Risk
15
Examples
 Failure to meet a spacecraft technical requirement or specification
during verification
 Failure to stay within a cost cap for the project
 Failure to secure long-term political support
 Failure to meet a critical launch window
 Spacecraft deorbits prematurely causing damage over the debris
footprint
 Failure to secure proper approvals for launch of nuclear materials
 Failure of spacecraft during mission
 Hazardous material release while fueling during ground
operations
 Failure to resupply sufficient material to support human presence
as planned

16. Dr.AtifShahzad
Every NASA Space Flight Project Begins
with a Plan for Risk Management
 This plan reflects the project’s risk management philosophy:
¤ Priority (criticality to long-term strategic plans)
¤ National significance
¤ Mission lifetime (primary baseline mission)
¤ Estimated project life cycle cost
¤ Launch constraints
¤ In-flight maintenance feasibility
¤ Alternative research opportunities or re-flight opportunities
 The risk management philosophy is reflected in a number of ways:
¤ Whether single point failures are allowed
¤ Whether the system is monitored continuously during operations
¤ How much slack is in the development schedule
¤ How technical resource margins (i.e., mass, power, etc.) are allocated throughout the
development
16

17. Dr.AtifShahzad
Other Factors to Consider in
Assessing Risk (but not limited to)…
 Complexity of management and technical interfaces
 Design and test margins
 Mission criticality
 Availability and allocation of resources such as mass, power, volume, data volume,
data rates, and computing resources
 Scheduling and manpower limitations
 Ability to adjust to cost and funding profile constraints
 Mission operations
 Data handling, i.e., acquisition, archiving, distribution and analysis
 Launch system characteristics
 Available facilities
17

18. Dr.AtifShahzad
18
Failure Mode and Effects Analysis
Item Potential Potential
S
e
v
C
l
a
s
s
O
c
c
u
r
Current
D
e
t
e
c
R
P
N
Responsibility
Actions Results
Failure Effects of Recommended & Target
Function Mode Failure
Potential Causes/
Mechanisms(s)
Failure
Controls
Action(s) Completion Date D
e
t
O
c
c
R
P
N
Actions
Taken
S
e
v
What are the
functions
or requirements?
What can go
wrong?
- No Function
- Partially
Degraded
Function
- Intermittent
Function
- Unintended
Function
What
are the
Effects?
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
Prevention/Detection
Who is going
to do it and
when?
What did they
do and what
are the
outcomes

19. Dr.AtifShahzad
Module Summary: Risk
 Risk is inevitable, so risks can be reduced but not eliminated.
 Risk management is a proactive systematic approach to assessing
risks, generating alternatives and reducing cumulative project risk.
 Fault Tree Analysis is both a design and a diagnostic tool that
estimates failure probabilities of initiators to estimate the failure
of the pre-determined, undesirable, ‘top’ event.
 Failure Mode Effects Analysis is a design tool for identifying risk in
the system design, with the intent of mitigating those risks with
design changes.
19

20. FAILURE MODE
& EFFECT ANALYSIS
INTRODUCTION
LECTURE # 8

21. Dr.AtifShahzad
FAILURE MODE
& EFFECT ANALYSIS
¤ Provide a Basic familiarization with a tool that aids in
quantifying
 Severity
 Occurrences
 Detection of failures
¤ and guides the creation of
 corrective action
 process improvement
 and risk mitigation plans
21

22. FAILURE MODE
& EFFECT ANALYSIS
HISTORY
LECTURE # 8

23. Dr.AtifShahzad
FMEA History
23
This “type” of thinking has been around for
hundreds of years. It was first formalized in
the aerospace industry during the Apollo
program in the 1960’s.
 Initial automotive adoption in the 1970’s.
 Potential serious & frequent safety issues.
 Required by QS-9000 & Advanced Product Quality Planning Process
in 1994.
 Now adopted by many other industries.
 For all automotive suppliers.
 Potential serious & frequent safety issues or loyalty issues.

24. Dr.AtifShahzad
What is FMEA ?
24
Cause & effect, Root Cause Analysis,
Fishbone Diagram Etc
Failure Mode Effect Analysis

25. Dr.AtifShahzad
What is FMEA ?
 INCOSE Handbook definition of FMECA:
¤ “Means of recording and determining the following:
 What functions the equipment is required to perform
 How those functions could fail
 Possible causes of the failures
 Effects the failures would have on the equipment or system
 The criticality of the failures”
25

26. Dr.AtifShahzad
What is FMEA ?
26
Definition: FMEA is an Engineering “Reliability Tool” That:
 Helps define, identify, prioritize, and eliminate known and/or
potential failures of the system, design, or manufacturing process
before they reach the customer. The goal is to eliminate the Failure
Modes and reduce their risks.
 Provides structure for a Cross Functional Critique of a design or a
Process
 Facilitates inter-departmental dialog.
 Is a mental discipline “great” engineering teams go through, when
critiquing what might go wrong with the product or process.
 Is a living document which ultimately helps prevent, and not react
 to problems.

27. Dr.AtifShahzad
What is FMEA ?
27
What it can do for you!
1. Identifies Design or process related Failure Modes before they happen.
2. Determines the Effect & Severity of these failure modes.
3. Identifies the Causes and probability of Occurrence of the Failure Modes.
4. Identifies the Controls and their Effectiveness.
5. Quantifies and prioritizes the Risks associated with the Failure Modes.
6. Develops & documents Action Plans that will occur to reduce risk.

28. Dr.AtifShahzad
When to Use
 Early stages (Define) to understand process and identify problem
areas
 Analyze data (Analyze) to help identify root causes
 Determine best solutions (Improve) with lowest risk
 Close out stage (Control) to document improvement and identify
actions needed to continue to reduce risk
28

29. FAILURE MODE
& EFFECT ANALYSIS
TYPES
LECTURE # 8

30. Dr.AtifShahzad
Types of FMEAs ?
30
System/Concept “S/CFMEA”- (Driven by System functions) A system is
a organized set of parts or subsystems to accomplish one or more
functions. System FMEAs are typically very early, before specific hardware
has been determined.
Design “DFMEA”- (Driven by part or component functions) A Design /
Part is a unit of physical hardware that is considered a single replaceable
part with respect to repair. Design FMEAs are typically done later in the
development process when specific hardware has been determined.
Process “PFMEA”- (Driven by process functions & part
characteristics) A Process is a sequence of tasks that is organized
to produce a product or provide a service. A Process FMEA can
involve fabrication, assembly, transactions or services.

31. Dr.AtifShahzad
Types of FMEAs ?
31
System/Concept “S/CFMEA”- (Driven by System functions) A system
is a organized set of parts or subsystems to accomplish one or more
functions. System FMEAs are typically very early, before specific hardware
has been determined.
Design “DFMEA”- (Driven by part or component functions) A Design /
Part is a unit of physical hardware that is considered a single
replaceable part with respect to repair. Design FMEAs are typically done
later in the development process when specific hardware has been
determined.
Process “PFMEA”- (Driven by process functions & part
characteristics) A Process is a sequence of tasks that is organized
to produce a product or provide a service. A Process FMEA can
involve fabrication, assembly, transactions or services.

32. FAILURE MODE
& EFFECT ANALYSIS
TEAM
LECTURE # 8

33. Dr.AtifShahzad
The FMEA Team Roles
33
FMEA Core Team
4 – 6 Members
Expertise in Product / Process
Cross functional
Honest Communication
Active participation
Positive attitude
Respects other opinions
Participates in team decisions
Champion / Sponsor
Provides resources & support
Attends some meetings
Promotes team efforts
Shares authority / power with team
Kicks off team
Implements recommendations
Recorder
Keeps documentation of teams efforts
FMEA chart keeper
Coordinates meeting rooms/time
Distributes meeting rooms & agendas
Facilitator
“Watchdog“ of the process
Keeps team on track
FMEA Process expertise
Encourages / develops
team dynamics
Communicates assertively
Ensures everyone participates
Team Leader
“Watchdog” of the project
Good leadership skills
Respected & relaxed
Leads but doesn’t dominate
Maintains full team participation
Typically lead engineer

34. FAILURE MODE
& EFFECT ANALYSIS
TERMINOLOGY
LECTURE # 8

35. Dr.AtifShahzad
FMEA Terminology
35
1.) Failure Modes: (Specific loss of a function) is a concise
description of how a part , system, or manufacturing process may
potentially fail to perform its functions.
2.) Failure Mode“Effect”: A description of the consequence or
Ramification of a system or part failure. A typical failure mode may
have several “effects” depending on which customer you consider.
3.) Severity Rating: (Seriousness of the Effect) Severity is the
numerical rating of the impact on customers.
 When multiple effects exist for a given failure mode, enter the worst
case severity on the worksheet to calculate risk.
4.) Failure Mode“Causes”: A description of the design or process
deficiency (global cause or root level cause) that results
in the failure mode .
You must look at the causes not the symptoms of the failure. Most failure
Modes have more than one Cause.

36. Dr.AtifShahzad
FMEA Terminology (continued)
36
5.) Occurrence Rating: Is an estimate number of frequencies or
cumulative number of failures (based on experience) that will occur
(in our design concept) for a given cause over the intended “life of
the design”.
6.) Failure Mode“Controls”: The mechanisms, methods, tests,
procedures, or controls that we have in place to PREVENT the Cause
of the Failure Mode or DETECT the Failure Mode or Cause should it
occur .
Design Controls prevent or detect the Failure Mode prior to engineering
release
7.) Detection Rating: A numerical rating of the probability that a given
set of controls WILL DISCOVER a specific Cause of Failure Mode to
prevent bad parts leaving the facility or getting to the ultimate customer.
Assuming that the cause of the failure did occur, assess the capabilities of the
controls to find the design flaw..

37. Dr.AtifShahzad
FMEA Terminology (continued)
37
8.) Risk Priority Number (RPN): Is the product of Severity,
Occurrence, & Detection. Risk= RPN= S x O x D
Often the RPN’s are sorted from high to low for consideration in the action planning
step (Caution, RPN’s can be misleading- you must look for patterns).
9.) Action Planning: A thoroughly thought out and well developed
FMEA With High Risk Patterns that is not followed with corrective
actions has little or no value, other than having a chart for an audit
Action plans should be taken very seriously.
If ignored, you have probably wasted much of your valuable time.
Based on the FMEA analysis, strategies to reduce risk are focused on:
Reducing the Severity Rating.
Reducing the Occurrence Rating.
Reducing the detection Rating.

38. FAILURE MODE
& EFFECT ANALYSIS
GETTING STARTED
LECTURE # 8

39. Dr.AtifShahzad
Getting Started on FMEA
39
Determine
“Controls”
Detection Rating
Determine
“Effects” of
The Failure
Mode
Severity Rating
What Must be done before FMEA Begins!
Determine
“Causes” of
The Failure
Mode
Occurrence Rating
Determine
Product or
Process
Functions
Determine
Failure Modes
of Function
Understand your
Customer
Needs
Develop & Evaluate
Product/Process
Concepts
Create
an Effective
FMEA Team
Develop and
Drive
Action Plan
Ready?
1
3
2 4 6
=QFD
=Brain Storming
=4 to 6 Consensus Based Multi
Level Experts
= What we
are and are
not working
Define the FMEA
Scope
5
Calculate &
Assess Risk
6
7

40. FAILURE MODE
& EFFECT ANALYSIS
WORKSHEET
LECTURE # 8

41. Dr.AtifShahzad
FMEA Worksheet
41
Process or
Product Name
Prepared by: Page _____ of ______
Person
Responsible
Date (Orig) ___________ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Sev : Severity of the failure (what impact will it have on our process?)
Occ : How likely is the event to occur (probability of occurrence)
Det : How likely can the event be detected in time to do something about it
RPN: Risk Priority Number (multiply Sev, Occ, and Det)

42. Dr.AtifShahzad
The FMEA Worksheet
42
Product
or
Process
Failure
Mode
Failure
Effects
S
E
V
Causes
O
C
C
Controls
D
E
T
R
P
N
Actions
/ Plans
Resp. &
Target
Complete
Date
p
S
E
V
p
O
C
C
p
D
E
T
p
R
P
N
1 62 3 4 5 7
Determine
Product or
Process
Functions
Determine
Failure
Modes
of Function
Determine
“Effects” of
The Failure
Mode
Severity
Rating
Determine
“Causes” of
The Failure
Mode
Occurrence
Rating
Determine
“Controls”
Detection
Rating
Calculate
&
Assess
Risk
Develop
and
Drive
Action Plan
If an FMEA was created during the Design Phase of the Program, USE IT!
Create an Action Plan for YOUR ROOT CAUSE
and Re-Evaluate the RPN Accordingly

43. FAILURE MODE
& EFFECT ANALYSIS
SCORING
LECTURE # 8

44. Dr.AtifShahzad
FMEA Scoring
44
Rating
10
9
8
7
6
5
4
3
2
None
1
ExtremeHighModerateLow

45. Dr.AtifShahzad
FMEA Scoring
45
Severity
Severity of Effect Rating
May endanger machine or operator. Hazardous without warning 10
May endanger machine or operator. Hazardous with warning 9
Major disruption to production line. Loss of primary function, 100% scrap. Possible jig lock and
Major loss of Takt Time 8
Reduced primary function performance. Product requires repair or Major Variance.
Noticeable loss of Takt Time 7
Medium disruption of production. Possible scrap. Noticeable loss of takt time.
Loss of secondary function performance. Requires repair or Minor Variance 6
Minor disruption to production. Product must be repaired.
Reduced secondary function performance. 5
Minor defect, product repaired or "Use-As-Is" disposition. 4
Fit & Finish item. Minor defect, may be reprocessed on-line. 3
Minor Nonconformance, may be reprocessed on-line. 2
None
No effect 1
ExtremeHighModerateLow

46. Dr.AtifShahzad
FMEA Scoring
46
Occurrence
Likelihood of Occurrence
Failure
Rate
Capability
(Cpk) Rating
1 in 2 < .33 10
1 in 3 > .33 9
1 in 8 > .51 8
1 in 20 > .67 7
1 in 80 > .83 6
1 in 400 > 1.00 5
1 in 2000 > 1.17 4
Process is in statistical control. 1 in 15k > 1.33 3
Low
Process is in statistical control. Only isolated
failures associated with almost identical processes.
1 in 150k > 1.50 2
Remote
Failure is unlikely. No known failures associated
with almost identical processes.
1 in 1.5M > 1.67 1
Failure is almost inevitable
Process is not in statistical control.
Similar processes have experienced problems.
Process is in statistical control but with isolated failures.
Previous processes have experienced occasional
failures or out-of-control conditions.
VeryHighHighModerate

47. Dr.AtifShahzad
FMEA Scoring
47
Detection
Likelihood that control will detect failure Rating
VeryLow
No known control(s) available to detect failure mode. 10
9
8
7
6
5
4
3
2
1
The process automatically detects failure.
Controls will almost certainly detect the existence of
a failure.
Controls have a good chance of detecting the existence
of a failure
LowModerateHighVeryHigh
Controls have a remote chance of detecting the failure.
Controls may detect the existence of a failure

48. Dr.AtifShahzad
FMEA Rankings
Severity Occurrence Detection
Hazardous without
warning
Very high and almost
inevitable
Cannot detect or
detection with very low
probability
Loss of primary
function
High repeated failures Remote or low chance
of detection
Loss of secondary
function
Moderate failures Low detection
probability
Minor defect Occasional failures Moderate detection
probability
No effect Failure Unlikely Almost certain
detection48
Rating
10
1
High
Low
Source: The Black Belt Memory Jogger, Six Sigma Academy

49. Dr.AtifShahzad
FMEA Scoring
49
RPN or
Risk Priority Number
Severity x Occurrence x Detection= RPN
The Calculation !

50. Dr.AtifShahzad
Failure Modes & Effect Analysis
50
(FMEA) Part or Process Improvement
 FMEA is a technique utilized to define, identify, and eliminate known or potential failures or
errors from a product or a process.
 Identify each candidate Part or Process, list likely failure mode, causes, and current
controls
 Prioritize risk by using a ranking scale for severity, occurrence, and detection
 Mitigate risk – Can controls be added to reduce risk? Recalculate RPN.
 Characteristics with high Risk Priority Numbers should be selected for Improvement
and Action Plans Created
 Recalculate RPN After Completion of Action Plans to Validate Improvements
Product
or
Process
Failure
Mode
Failure
Effects
S
E
V
Causes
O
C
C
Controls
D
E
T
R
P
N
Actions
/ Plans
Resp. &
Target
Complete
Date
p
S
E
V
p
O
C
C
p
D
E
T
p
R
P
N
Hole
Drilling
Oversize
Hole
Unable to
Install BP
Fastener
Wrong
Drill Bit
Used
Ball Gage
Visual Insp5 8 3
120
Kit Drill
Bits
010103 5 11 5

51. Dr.AtifShahzad
Failure Mode and Effects Analysis (FMEA)
is only a tool
to identify potential or actual points of
failure
and identify corrective action.

52. FAILURE MODE
& EFFECT ANALYSIS
EXAMPLE
LECTURE # 8

53. Dr.AtifShahzad
Process for FMEA
Process to Change Oil in a Car
53
3000 miles
driven
Drive car
on lift
Fill with
new oil
Drain Oil Replace
Filter
Take Car
off lift
Process
Complete

54. Dr.AtifShahzad
How to Complete the FMEA
Step 1. Complete header information
Step 2. Identify steps in the process
Step 3. Brainstorm potential ways the area of study could theoretically fail
(failure modes)
Suggestion: Use Affinity Diagram as a brainstorming tool
54

55. Dr.AtifShahzad
FMEA Worksheet
55
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _1____ of __1____
Person
Responsible
Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new
oil
New
Oil—
Mech
anic
Wrong
type of
oil
Engine
wear
No oil
added
Engine
Failure
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

56. Dr.AtifShahzad
How to Complete a FMEA
Step 4
 For each failure mode, determine impact or effect on
the product or operation using criteria table (next slide)
 Rate this impact in the column labeled SEV (severity)
56

57. Dr.AtifShahzad
Severity (SEV) Rating
SEV Severity Product/Process Criteria
1 None No effect
2 Very Minor Defect would be noticed by most discriminating customers. A portion of the product may have to be
reworked on line but out of station
3 Minor Defect would be noticed by average customers. A portion of the product (<100%) may have to be
reworked on line but out of station
4 Very Low Defect would be noticed by most customers. 100% of the product may have to be sorted and a portion
(<100%) reworked
5 Low Comfort/convenience item(s) would be operable at a reduced level of performance. 100% of the
product may have to be reworked
6 Moderate Comfort/convenience item(s) would be inoperable. A portion (<100%) of the product may have to be
scrapped
7 High Product would be operable with reduced primary function. Product may have to be sorted and a
portion (<100%) scrapped.
8 Very High Product would experience complete loss of primary function. 100% of the product may have to be
scrapped
9 Hazardous
Warning
Failure would endanger machine or operator with a warning
10 Hazardous
w/out Warning
Failure would endanger machine or operator without a warning
57

58. Dr.AtifShahzad
FMEA Worksheet
58
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person
Responsible
Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new
oil
New
Oil—
Mech
anic
Wrong
type of
oil
Engine
wear
2
No oil
added
Engine
Failure
1
0
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

59. Dr.AtifShahzad
How to Complete a FMEA
Step 5
 For each potential failure mode identify one or more
potential causes (Could use Affinity Diagram again to
brainstorm ideas)
 Rate the probability of each potential cause occurring
based on criteria table (next slide)
 Place the rating in the column labeled OCC
(occurrence).
59

60. Dr.AtifShahzad
FMEA Occurrence (OCC Rating)
OCC Occurrence Criteria
1 Remote 1 in 1,500,000 Very unlikely to occur
2 Low 1 in 150,000
3 Low 1 in 15,000 Unlikely to occur
4 Moderate 1 in 2,000
5 Moderate 1 in 400 Moderate chance to occur
6 Moderate 1 in 80
7 High 1 in 20 High probability that the event will occur
8 High 1 in 8
9 Very High 1 in 3 Almost certain to occur
10 Very High > 1 in 2
60

61. Dr.AtifShahzad
FMEA Worksheet
61
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person
Responsible
Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new
oil
New
Oil—
Mech
anic
Wrong
type of
oil
Engine
wear
2 Mis-
labeled
3
No oil
added
Engine
Failure
1
0
Hurrying 3
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

62. Dr.AtifShahzad
How to Complete the FMEA
Step 6
 Identify current controls or detection
 Rate ability of each current control to prevent or detect
the failure mode once it occurs using criteria table (next
slide)
 Place rating in Det column
62

63. Dr.AtifShahzad
FMEA Detection (DET) Rating
DET Detection Criteria
1 Almost
Certain
Current Controls are almost certain to detect/prevent the failure mode
2 Very High Very high likelihood that current controls will detect/prevent the failure mode
3 High High Likelihood that current controls will detect/prevent the failure mode
4 Mod. High Moderately High likelihood that current controls will detect/prevent the failure mode
5 Moderate High Likelihood that current controls will detect/prevent the failure mode
6 Low Low likelihood that current controls will detect/prevent failure mode
7 Very Low Very Low likelihood that current controls will detect /prevent the failure mode
8 Remote Remote likelihood that current controls will detect/prevent the failure mode
9 Very Remote Very remote likelihood that current controls will detect/prevent the failure mode
63

64. Dr.AtifShahzad
FMEA Worksheet
64
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person
Responsible
Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
RPN Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new oil
New
Oil
from
supplier
Wrong
type of
oil
Engine
wear
2 Misread oil
chart for
vehicle
3 None 9
No oil
added
Engine
Failure
1
0
Hurrying 3 Engine light 3
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

65. Dr.AtifShahzad
How to Complete the FMEA
Process
Step
Key
Process
Input
Potentia
l Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
RPN Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new oil
New Oil
from
supplier
Wrong
type of
oil
Engine
wear
2 Misread
oil chart
for
vehicle
3 None 9 54
No oil
added
Engine
Failure
1
0
Hurrying 3 Engine light 3 90
65
Step 7
Multiply SEV, OCC and DET ratings and place the value in the RPN (risk priority
number) column. The largest RPN numbers should get the greatest focus. For those
RPN numbers which warrant corrective action, recommended actions and the person
responsible for implementation should be listed.
SEV * OCC * DET = RPN ( 2 * 3 * 9 = 54 )

66. Dr.AtifShahzad
Action Results
Step 8
 After corrective action has been taken, place
summary of the results in the ‘Actions
Recommended’ block
 Assign new value for:
¤ Severity
¤ Occurrence
¤ Detection
 Calculate new RPN number
66

67. Dr.AtifShahzad
FMEA Worksheet
67
Process or
Product Name
Change Oil in Car Prepared by: Leon Page _____ of ______
Person
Responsible
Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
RPN Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Fill
with
new oil
New
Oil
from
supplier
Wrong
type of
oil
Engine
wear
2 Misread oil
chart for
vehicle
3 None 9 54
No oil
added
Engine
Failure
1
0
Hurrying 3 Engine light 3 90 Oil level
checked by
partner
1
0
3 1 3
0
Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)

68. Dr.AtifShahzad
FMEA Example
68
Source: Quality Digest/ August 2006 Quality Service at the Special Olympics World Games, Tang Xiaofen
Process or Product
Name:
Hotel Service at Special Olympics Prepared by: Page _____ of ______
Person Responsible: Joe Quality Date (Orig) ___________ Revised __________
Process
Step
Key
Process
Input
Potential
Failure
Mode
Potential
Failure
Effect
S
e
v
Potential
Causes
O
c
c
Current
Controls
D
e
t
R
P
N
Actions
Recommended
S
e
v
O
c
c
D
e
t
R
P
N
Register
guest
Service
Desk
Cannot
Register
in time
Complaints 5 Lack of
language
and
communicat
ion skills,
support of
volunteers
not
sufficient
4 No plan on
training
content;
training and
volunteer
support
sufficient
3 72
Provide
Guest
Services
Guest
Support
Lack of
barrier-
free
facility
Inconvenien
ce and
injury
10 Cannot
provide
barrier-free
facility
3 Providing
barrier-free
facility
7 210
Provide
Meals
Food
Service
Food
goes bad
Disease or
injury
10 Past shelf
life
6 No control of
raw material
8 240
Provide
Medical
Service
Medical
Service
Service
not in
time
Illness
changes for
worse
10 No 24 Hour
service
6 12 hour
service
3 180

69. Dr.AtifShahzad
Summary
 FMEA identifies risk in our processes
¤ Impact/Severity
¤ Probability of Occurrence
¤ Detection
 Helps identify what can go wrong and what we should fix
 Can be used in multiple stages of process improvement
69

70. Dr.AtifShahzad
Continuous Improvement
 Process improvement not a linear process
 Never really ends
 Journey not a destination
70
Define
Measure
Analyze
Improve
Control

71. VARIATION MODE
& EFFECT ANALYSIS
EXAMPLE
LECTURE # 8

72. Dr.AtifShahzad
What is Robust Design?
Robust design: performance is insensitive to
variations.
Simply doing a trade study to optimize the
value of F would lead the designer to pick
this point
Example: We want to pick x to maximize F
F
x
This means
that values
of F as low
as this can
be expected!
What if I pick
this point
instead?

73. Dr.AtifShahzad
X
Y
μoptimal± ΔX μrobust± ΔX
Optimal Design
Robust Design
Performance
Design Variable
 Uncertainties are often present and
practically impossible to avoid in many
real world engineering design problems.
 For instance, if a design is very sensitive
to small geometric variations, which may
arise either due to manufacturing
processes, and/or in-service degradation
due to erosion processes and foreign
object damage, and/or drifts in operating
conditions, it may not be desirable to use
this design.
 Hence optimization without taking
uncertainty into consideration generally
leads to designs that should not be
labeled as optimal but rather potentially
high risk designs that are likely to perform
badly when put to practical use.
What is Robust Design?

74. Dr.AtifShahzad
 Robust design is used to
minimize the effect (on
performance parameters, Y) of
variations in controllable and/or
uncontrollable factors (design
variables, X) without eliminating
the sources of variations (e.g.
wind),
 Reliability-based design has
been widely applied to ensure that
a system performance meets the
pre-specified target with a required
probability level
X
Y
μoptimal± ΔX μrobust± ΔX
Optimal Design
Robust Design
Performance
Design Variable
What is Robust Design?

75. Dr.AtifShahzad
VMEA
 Many Failures are caused by Variations ( e.g. Strength, loads etc)
 Deductive method of identifying and managing sources of variation
 Casual breakdown of Key product characteristics ( Cause and Effect diagram)
 Sensitivity Assessment of sensitivity coefficients of variation sources affecting the
targeted KPI
 Variation Size assessment via SD calculations Gauss approximation
 Variation Risk Assessment and Prioritization through spread of variation
calculations
 Safety factor of Design is then calculated as ratio between low quintile of
Design parameters and median of design parameters
75

76. Dr.AtifShahzad
Challenge
“We are what we repeatedly do.
Excellence, therefore, is not an act
but a habit.”
-- Aristotle
76

77. QUESTIONS

78. THANK YOU FOR YOUR INTEREST