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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
Dr. Atif Shahzad
PROJECT
MANAGEMENT
RISK MANAGEMENT
3
Dr. Atif Shahzad
W hy does it alw ays
seem w e have plenty
of tim e to fix our
problem s, but never
enough tim e to
prevent the problem s
by doing it right the
first tim e?
Dr. Atif Shahzad
Today’s Lecture
5

 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
Dr. Atif Shahzad
Uncertainties that Plague Projects
6

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

External Factors ♦ Will outside influences jeopardize the ♦Contingency


project? ♦Robust design
Project Risk Categories
7

Typical Typical Typical Typical Typical


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

• Embedded training
Reactive to Proactive
Reactive Design Predictive
Quality Transition to Design Quality
...

FROM TO
Requirements: Flow down from
Evolving Requirements
Customer Expectations

Design rework / tweaking Control Critical Design Parameters

Modeling / Simulation with


Build & Test Design / Process Capability
Flow-up

Measurement Statistical Quality Prediction


Dr. Atif Shahzad

“Test in” Quality “Design in” Quality


Project and Project Management
9

 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.
Dr. Atif Shahzad
Reliability
10

 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)
Dr. Atif Shahzad
Reliability
11

 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.
Dr. Atif Shahzad
RISK MANAGEMENT
RISK
What are Risks and Risk
Management?
13

 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
Dr. Atif Shahzad
What is Risk Management?
14

Risk management is a continuous


and iterative decision making
technique designed to improve the
probability of success.
It is a proactive approach that:
 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
Dr. Atif Shahzad

 Repeats this process throughout the project life


Risk Management Considers the Entire
Development and Operations Life of a Project
15

Risk Type Examples


 Technical Performance Risk  Failure to meet a spacecraft technical requirement or specification
during verification
 Cost Risk
 Failure to stay within a cost cap for the project
 Programmatic Risk
 Failure to secure long-term political support
 Schedule Risk  Failure to meet a critical launch window
 Liability Risk  Spacecraft deorbits prematurely causing damage over the debris
footprint
 Regulatory Risk
 Failure to secure proper approvals for launch of nuclear materials
 Operational Risk
 Failure of spacecraft during mission
 Safety Risk
 Hazardous material release while fueling during ground
 Supportability Risk operations
Dr. Atif Shahzad

 Failure to resupply sufficient material to support human presence


as planned
Every NASA Space Flight Project Begins
with a Plan for Risk Management
16

 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
Dr. Atif Shahzad
Other Factors to Consider in
Assessing Risk (but not limited to)…
17

 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
Dr. Atif Shahzad
Failure Mode and Effects Analysis

S C O D R Actions Results
e l Potential Causes/c Current e P Responsibility
18
Item Potential Potential v a
s Mechanisms(s) u
c Controls et N Recommended & Target
Function
Failure
Mode
Effects of
Failure s Failure r c
Prevention/Detection Action(s) Completion Date Actions S e
O DR
c e P
Taken v c t N

What can be done?


What How - Design changes
are the bad
Effects? is it? What did they
- Process changes
How do and what
What are the are the
functions often - Special controls
does outcomes
or requirements?
it - Changes to standards,
happen procedures, or guides
What can go What are ?
wrong?
the Cause(s)?
- No Function
How
- Partially
good is
Degraded
this
Function
method Who is going
- Intermittent How can this
Function at to do it and
be prevented detecting
- Unintended when?
Dr. Atif Shahzad

and detected? it?


Function
Module Summary: Risk
19

 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.
Dr. Atif Shahzad
FAILURE MODE
& EFFECT ANALYSIS
INTRODUCTION
LECTURE # 8
FAILURE MODE
& EFFECT ANALYSIS
21

¤ Providea Basic familiarization with a tool that aids in


quantifying
 Severity
 Occurrences
 Detection of failures
¤ and guides the creation of
 correctiveaction
 process improvement
 and risk mitigation plans
Dr. Atif Shahzad
FAILURE MODE
& EFFECT ANALYSIS
HISTORY
LECTURE # 8
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.
 For all automotive suppliers.

 Now adopted by many other industries.


Dr. Atif Shahzad

 Potential serious & frequent safety issues or loyalty issues.


What is FMEA ?
24

Cause & effect, R oot Cause Analysis,


Fishbone Diagram Etc

Failure M ode Effect Analysis


Dr. Atif Shahzad
What is FMEA ?
25

 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”
Dr. Atif Shahzad
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.
Dr. Atif Shahzad

 Is a living document which ultimately helps prevent, and not react


 to problems.
What is FMEA ?
27

W hat 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.
Dr. Atif Shahzad
When to Use
28

 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
Dr. Atif Shahzad
FAILURE MODE
& EFFECT ANALYSIS
TYPES
LECTURE # 8
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
Dr. Atif Shahzad

involve fabrication, assembly, transactions or services.


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
Dr. Atif Shahzad

involve fabrication, assembly, transactions or services.


FAILURE MODE
& EFFECT ANALYSIS
TEAM
LECTURE # 8
The FMEA Team Roles
33
Cham pion / Sponsor
Provides resources & support
Attends some meetings
Promotes team efforts
Shares authority / power with team
Kicks off team
Implements recommendations

FM EA Core Team Facilitator


Team Leader 4 – 6 M em bers “Watchdog“ of the process
“Watchdog” of the project Keeps team on track
Good leadership skills Ex pertise in P roduct / P rocess FMEA Process expertise
Respected & relaxed Cross functional Encourages / develops
Leads but doesn’t dominate Honest Communication team dynamics
Maintains full team participation Active participation Communicates assertively
Typically lead engineer P ositive attitude Ensures everyone participates
R espects other opinions
P articipates in team decisions

R ecorder
Dr. Atif Shahzad

Keeps documentation of teams efforts


FMEA chart keeper
Coordinates meeting rooms/time
Distributes meeting rooms & agendas
FAILURE MODE
& EFFECT ANALYSIS
TERMINOLOGY
LECTURE # 8
FMEA Term inology
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
Dr. Atif Shahzad

in the failure mode .


You must look at the causes not the symptoms of the failure. Most failure
Modes have more than one Cause.
FMEA Term inology (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.
Dr. Atif Shahzad

Assuming that the cause of the failure did occur, assess the capabilities of the
controls to find the design flaw..
FMEA Term inology (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 R ating.


Reducing the Occurrence R ating.
Dr. Atif Shahzad

Reducing the detection R ating.


FAILURE MODE
& EFFECT ANALYSIS
GETTING STARTED
LECTURE # 8
Getting Started on FMEA
39

W hat M ust be done before FM EA Begins!


Understand your
=QFD

R eady?
Customer
Needs

Develop & Evaluate


Product/Process =Brain Storming
Concepts
Develop and
Create =4 to 6 Consensus Based Multi Drive
an Effective
Level Experts
FMEA Team Determine Action Plan 7
“Effects” of3
= What we The Failure
Define the FMEA are and are
Scope Mode
not working Severity R ating

Determine1
Determine2
Determine
4 Determine5 66
Dr. Atif Shahzad

Product or “Causes” of “Controls” Calculate &


Failure Modes
Process The Failure Assess Risk
of Function
Functions Mode Detection R ating
Occurrence R ating
FAILURE MODE
& EFFECT ANALYSIS
WORKSHEET
LECTURE # 8
FMEA Worksheet
41

Process or Prepared by: Page _____ of ______


Product Name
Person Date (Orig) ___________ Revised __________
Responsible

Process Key Potential Potential S Potential O Current D R Actions S O D R


Step Process Failure Failure e Causes c Controls e P Recommended e c e P
Input Mode Effect v c t N v c t 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)
Dr. Atif Shahzad

Det : How likely can the event be detected in time to do something about it
RPN: Risk Priority Number (multiply Sev, Occ, and Det)
The FMEA Worksheet
42

Resp. & p p p p
Product S O D R
Failure Failure Actions Target S O D R
or E Causes C Controls E P
Mode Effects / Plans Complete E C E P
Process V C T N
Date V C T N

1 2 3 4 5 6 7
Develop
Determine Determine Determine
and
Product or “Effects” of “Controls”
Drive
Process The Failure Detection
Action Plan
Functions Mode Determine Rating
Severity “Causes” of
Determine Rating The Failure Calculate
Failure Mode &
Modes Occurrence Assess
of Function Rating Risk

If an FMEA was created during the Design Phase of the Program, USE IT!
Create an Action Plan for YOUR ROOT CAUSE
Dr. Atif Shahzad

and Re-Evaluate the RPN Accordingly


FAILURE MODE
& EFFECT ANALYSIS
SCORING
LECTURE # 8
Dr. Atif Shahzad

44
None Low Moderate High Extreme

FMEA Scoring

1
2
3
4
5
6
7
8
9
10
Rating
FMEA Scoring Severity
45

Severity of Effect Rating

May endanger machine or operator. Hazardous w ithout warning 10


Extreme

May endanger machine or operator. Hazardous w ith warning 9


Major disruption to production line. Loss of primary function, 100% scrap. Possible jig lock and
8
High

Major loss of Takt Time


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.
6
Moderate

Loss of secondary function performance. Requires repair or Minor Variance


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
Low

Minor Nonconformance, may be reprocessed on-line. 2


Dr. Atif Shahzad

None

No effect 1
FMEA Scoring Occurrence
46

Failure Capability
Likelihood of Occurrence Rate (Cpk) Rating
Very High

1 in 2 < .33 10
Failure is almost inevitable
1 in 3 > .33 9
1 in 8 > .51 8
High

Process is not in statistical control.


Similar processes have experienced problems. 1 in 20 > .67 7
1 in 80 > .83 6
Moderate

Process is in statistical control but with isolated failures.


Previous processes have experienced occasional 1 in 400 > 1.00 5
failures or out-of-control conditions.
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 1 in 150k > 1.50 2


failures associated with almost identical processes.
Dr. Atif Shahzad

Remote

Failure is unlikely. No known failures associated 1 in 1.5M > 1.67 1


with almost identical processes.
FMEA Scoring Detection
47

Likelihood that control will detect failure Rating


Very Low

No known control(s) available to detect failure mode. 10

9
Low

Controls have a remote chance of detecting the failure.


8
7
Moderate

Controls may detect the existence of a failure 6


5
Controls have a good chance of detecting the existence 4
High

of a failure 3
Dr. Atif Shahzad

Very High

The process automatically detects failure. 2


Controls will almost certainly detect the existence of
a failure. 1
FMEA Rankings
Source: The Black Belt Memory Jogger, Six Sigma Academy

Rating

High10
Severity Occurrence Detection
Hazardous without Very high and almost Cannot detect or
warning inevitable detection with very low
probability
Loss of primary High repeated failures Remote or low chance
function of detection

Loss of secondary Moderate failures Low detection


function probability

Minor defect Occasional failures Moderate detection


probability
Dr. Atif Shahzad

No effect Failure Unlikely Almost certain


Low 1 48 detection
FMEA Scoring
49

R P N or
R isk P riority N um ber

The Calculation !

S everity x O ccurrence x D etection= R PN


Dr. Atif Shahzad
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

Resp. & p p p p
Product S O D R
Failure Failure Actions Target S O D R
or E Causes C Controls E P
Mode Effects / Plans Complete E C E P
Process V C T N
Date V C T N
Hole Oversize Unable to Wrong Ball Gage
120
Kit Drill
Drilling Hole Install BP 5 Drill Bit 8 Visual Insp 3 010103 5 1 1 5
Dr. Atif Shahzad

Bits
Fastener Used
Failure Mode and Effects Analysis (FMEA)
is only a tool
to identify potential or actual points of
failure
and identify corrective action.
Dr. Atif Shahzad
FAILURE MODE
& EFFECT ANALYSIS
EXAMPLE
LECTURE # 8
Process for FMEA
53

Process to Change Oil in a Car

3000 miles Drive car Replace


Drain Oil
driven on lift Filter

Fill with Take Car Process


new oil off lift Complete
Dr. Atif Shahzad
How to Complete the FMEA
54

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
Dr. Atif Shahzad
FMEA Worksheet
55

Process or Change Oil in Car Prepared by: Leon Page _1____ of __1____
Product Name
Person Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Responsible

Process Key Potential Potential S Potential O Current D R Actions S O D R


Step Process Failure Failure e Causes c Controls e P Recommended e c e P
Input Mode Effect v c t N v c t N

Fill New Wrong Engine


with Oil— type of wear
new Mech oil
oil anic
No oil Engine
added 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)
Dr. Atif Shahzad

Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
How to Complete a FMEA
56

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)
Dr. Atif Shahzad
Severity (SEV) Rating
57

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 Failure would endanger machine or operator with a warning


Dr. Atif Shahzad

Warning

10 Hazardous Failure would endanger machine or operator without a warning


w/out Warning
FMEA Worksheet
58

Process or Change Oil in Car Prepared by: Leon Page _____ of ______
Product Name
Person Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Responsible

Process Key Potential Potential S Potential O Current D R Actions S O D R


Step Process Failure Failure e Causes c Controls e P Recommended e c e P
Input Mode Effect v c t N v c t N

Fill New Wrong Engine 2


with Oil— type of wear
new Mech oil
oil anic
No oil Engine 1
added Failure 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)
Dr. Atif Shahzad

Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
How to Complete a FMEA
59

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).
Dr. Atif Shahzad
FMEA Occurrence (OCC Rating)
60

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
Dr. Atif Shahzad

9 Very High 1 in 3 Almost certain to occur

10 Very High > 1 in 2


FMEA Worksheet
61

Process or Change Oil in Car Prepared by: Leon Page _____ of ______
Product Name
Person Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Responsible

Process Key Potential Potential S Potential O Current D R Actions S O D R


Step Process Failure Failure e Causes c Controls e P Recommended e c e P
Input Mode Effect v c t N v c t N

Fill New Wrong Engine 2 Mis- 3


with Oil— type of wear labeled
new Mech oil
oil anic
No oil Engine 1 Hurrying 3
added Failure 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)
Dr. Atif Shahzad

Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
How to Complete the FMEA
62

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
Dr. Atif Shahzad
FMEA Detection (DET) Rating
63

DET Detection Criteria

1 Almost Current Controls are almost certain to detect/prevent the failure mode
Certain

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
Dr. Atif Shahzad

9 Very Remote Very remote likelihood that current controls will detect/prevent the failure mode
FMEA Worksheet
64

Process or Change Oil in Car Prepared by: Leon Page _____ of ______
Product Name
Person Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Responsible

Process Key Potential Potential S Potential O Current D RPN Actions S O D R


Step Process Failure Failure e Causes c Controls e Recommended e c e P
Input Mode Effect v c t v c t N
Fill New Wrong Engine 2 Misread oil 3 None 9
with Oil type of wear chart for
new oil from oil vehicle
supplier
No oil Engine 1 Hurrying 3 Engine light 3
added Failure 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)
Dr. Atif Shahzad

Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
How to Complete the FMEA
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 )

Process Key Potentia Potential S Potential O Current D RPN Actions S O D R


Step Process l Failure Failure e Causes c Controls e Recommended e c e P
Input Mode Effect v c t v c t N
Fill New Oil Wrong Engine 2 Misread 3 None 9 54
with from type of wear oil chart
new oil supplier oil for
vehicle
Dr. Atif Shahzad

No oil Engine 1 Hurrying 3 Engine light 3 90


added Failure 0
Action Results
66

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


Dr. Atif Shahzad
FMEA Worksheet
67

Process or Change Oil in Car Prepared by: Leon Page _____ of ______
Product Name
Person Leon Mechanic Date (Orig) __26 Mar 2013___ Revised __________
Responsible

Process Key Potential Potential S Potential O Current D RPN Actions S O D R


Step Process Failure Failure e Causes c Controls e Recommended e c e P
Input Mode Effect v c t v c t N
Fill New Wrong Engine 2 Misread oil 3 None 9 54
with Oil type of wear chart for
new oil from oil vehicle
supplier
No oil Engine 1 Hurrying 3 Engine light 3 90 Oil level 1 3 1 3
added Failure 0 checked by 0 0
partner

Sev - Severity of the failure (what impact will it have on our process?)
Occ – How likely is the event to occur (probability of occurrence)
Dr. Atif Shahzad

Det – How likely can the event be detected in time to do something about it
RPN – Risk Priority Number (multiply Sev, Occ, and Det)
FMEA Example
68

Process or Product Hotel Service at Special Olympics Prepared by: Page _____ of ______
Name:

Person Responsible: Joe Quality Date (Orig) ___________ Revised __________

Process Key Potential Potential S Potential O Current D R Actions S O D R


Step Process Failure Failure e Causes c Controls e P Recommended e c e P
Input Mode Effect v c t N v c t N

Register Service Cannot Complaints 5 Lack of 4 No plan on 3 72


guest Desk Register language training
in time and content;
communicat training and
ion skills, volunteer
support of support
volunteers sufficient
not
sufficient
Provide Guest Lack of Inconvenien 10 Cannot 3 Providing 7 210
Guest Support barrier- ce and provide barrier-free
Services free injury barrier-free facility
facility facility

Provide Food Food Disease or 10 Past shelf 6 No control of 8 240


Meals Service goes bad injury life raw material
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Provide Medical Service Illness 10 No 24 Hour 6 12 hour 3 180


Medical Service not in changes for service service
Service time worse
Source: Quality Digest/ August 2006 Quality Service at the Special Olympics World Games, Tang Xiaofen
Summary
69

 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
Dr. Atif Shahzad
Continuous Improvement
70

 Process improvement not a linear process


 Never really ends
 Journey not a destination

Define

Control Measure

Improve
Dr. Atif Shahzad

Analyze
VARIATION MODE
& EFFECT ANALYSIS
EXAMPLE
LECTURE # 8
What is Robust Design?
Example: We want to pick x to maximize F
Simply doing a trade study to optimize the
F value of F would lead the designer to pick
this point What if I pick
this point
This means instead?
that values
of F as low
as this can
be expected!

x
Dr. Atif Shahzad

Robust design: performance is insensitive to


variations.
What is Robust Design?

 Uncertainties are often present and


practically impossible to avoid in many
real world engineering design problems. Y
Optimal Design

Performance
 For instance, if a design is very sensitive
to small geometric variations, which may Robust Design
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 μoptimal± ΔX μrobust± ΔX X
uncertainty into consideration generally Design Variable
leads to designs that should not be
Dr. Atif Shahzad

labeled as optimal but rather potentially


high risk designs that are likely to perform
badly when put to practical use.
What is Robust Design?

 Robust design is used to


minimize the effect (on Y
Optimal Design
performance parameters, Y) of

Performance
variations in controllable and/or Robust Design
uncontrollable factors (design
variables, X) without eliminating
the sources of variations (e.g.
wind),
 Reliability-based design has μoptimal± ΔX μrobust± ΔX X
been widely applied to ensure that Design Variable
a system performance meets the
Dr. Atif Shahzad

pre-specified target with a required


probability level
VMEA
75

 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
Dr. Atif Shahzad
Challenge
76

“We are what we repeatedly do.


Excellence, therefore, is not an act
but a habit.”
-- Aristotle
Dr. Atif Shahzad
QUESTIONS
THANK YOU FOR YOUR INTEREST

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