Lecture 11 - Six Sigma 1 - FMEA

Six Sigma 1
Failure
Mode
Effects
Analysis
(FMEA)
FMEA – Part
of an Overall
Risk
Management
Framework
2
Number 1 Rule of Risk
Management
All Products Fail!
◼ Determining how they fail, when they will fail,
and why they are failing will allow a designer
to incorporate failure as an acceptable design
constraint.
◼ Failure is ALWAYS a Design
Requirement/Criteria
◼ “All stakeholders need to understand that the
use of a medical device entails some degree
of risk” – ISO 14971
3
Design Failure - When the Product
Fails?
Design failure has a direct effect on customer
perception of product quality. Product failure is
acceptable if customers perceive it as acceptable
such as:
◼ Periodic Maintenance and Calibration

◼ Periodic Replacements (disposable items / spare
parts)
◼ Acceptable End of Life (customer expectations –
e.g. Infusion Pump replacement every 5 years or
after x 1000 hours?) 4
Bath-Tub Reliability Curve
◼ Assuming a part/device is designed correctly, statistically it should follow a
standard reliability bath-tub curve.
• Infant Mortality –
failures don’t
usually affect the
customer, except
DOA
• Useful life – Low
“constant” failure
rate (failures here
are problems!)
• End of Life Wear
Out – failures
here are normally
acceptable
5
Causes of Reliability Curve Failure
Early Failure Chance Failure Wear Out Failure
(Infant Mortality) (Useful Life) (End of Life)
- Poor Quality Control - Design Errors - Stress Concentration

- Poor workmanship - Insufficient Safety - Corrosion
- Insufficient Testing
Margins
- Fatigue
- Substandard Materials
- Undetected Defects
- Creep
- Contamination
- Misapplication
- Abrasive Wear
- Human Error
- Abuse of Equipment
- Wrong Environment
- Incorrect Packaging
- Lack of Preventive
Maintenance - Poor Maintenance
- Acts of God
6
Quiz – Reliability Curve
Based on the Reliability Curve, should

you buy additional insurance on new
electronics products?
A. Buy Insurance
B. Don’t Buy Insurance
C. I don’t know?
7
What is an FMEA?
• FMEA stands for Failure Modes and Effects
Analysis
• Methodology of FMEA:
– To identify ways the product or process
can fail and then plan to prevent those
failures.
– Assess the failures to determine actions
that would eliminate the chance of
occurrence
– Document the potential failures and the
potential effects they could have.
• FMEA is a very useful tool and can be extremely helpful for design and development teams
while evaluating materials, components, and sub-assemblies comprising medical devices.
• But FMEA is more of a reliability tool rather than a risk management system.
• A medical device might never exhibit a failure mode yet still has risks!
Ref: IEC 60812, Analysis techniques for system reliability — Procedures for failure mode and effects analysis (FMEA) 8
FMEA – Quantitative Assessment?
◼ Risk per ISO 14971 is
defined as “the
combination of the
probability of
occurrence of harm and
the severity of that
harm”.
9
Boeing 787 Dreamliner –
FMEA Example
10
Quiz I - Definitions
This definition applies to “overall process
which of the following: comprising a risk
A. Risk Assessment analysis and a risk
B. Risk Management evaluation”
C. Risk Control
D. Risk Estimation
11
Quiz II - Definitions
The following is a
definition of what? “the combination of the
A. Risk probability of occurrence
B. Hazard of harm and the severity
C. Harm of that harm”.
D. Hazardous Situation
12
Quiz III - Definitions
This definition applies to “physical injury or
which of the following:
damage to the health of
A. Risk people, or damage to
B. Hazard property or the
C. Harm environment”
D. Residual Risk
13
Quiz IV - Definitions
The following items are • Electromagnetic Energy
examples of: • Mechanical Energy
A. Risks • Vibration
• Biological
B. Hazards
• Bacteria
C. Harm • Viruses
D. Hazardous Situation • Chemical
14
History of FMEA
• Created by the aerospace industry in the 1960s.
• In 1974 the Navy developed MIL-STD-1629 on FMEA’s.
• Ford began using FMEA in 1972.
• Incorporated by the “Big Three” auto companies in 1988.
• Automotive Industry Action Group (AIAG) and American
Society for Quality(ASQ) standards in 1993.
• Late 1990’s, early 2000’s risk management in medical device
industry
• Latest – Medical device transition from FMEA risk management
as part of Design verification (CFR 820.30) activities to a fully
integrated Risk Management framework (as per ISO
14971:2012).
15
What is a ‘Failure Mode’
16
What is an ‘Effect’
17
What is a ‘Cause’
18
What is a ‘Control’
19
Quiz - Definitions
This definition applies to The manner in which a

which of the following: product (device) or
A. Risks service fails.
B. Hazards
C. Failure Mode
D. Hazardous Situation
20
Types Of FMEA
– Project/Program: Identifies what can go wrong with a
major project
– Design: Identifies what can go wrong with the design of
a product or service. Consideration for System,
Subsystem, Component.
– Process: Identifies what can go wrong in the
manufacturing and assembling of components.
– Use (or Misuse): Identifies what can go wrong with the
end user using your device.
21
FMEA Manufacturing Risks
• Where do Manufacturing ‘Risks’ come from?
22
FMEA Steps
23
Example Risk
Chart
• Are these risk

levels
acceptable?
• Is risk reduction
required?
Source: GHTF: Implementation of risk management

principles
and activities within a Quality Management
System (2005)
24
FMEA Form
25
Risk Priority Numbers, RPN
RPN = SEV x OCC x DET
Effects Causes Controls
• The risk priority number (RPN) is the product of the rankings

for:
– Severity (SEV)
– Probability of Occurrence (OCC)
– Difficulty to Detect (DET)
• High RPN’s are flags to take effort to reduce the calculated risk
• High severity ratings should be given special attention
(regardless of RPN)
26
ISO14971 Risk
Estimation –
Rating
Definitions
27
Example Severity Definitions Medical
Device
Source: Risk Analysis and Design Controls for Medical Devices. Geetha Rao
28
More Detailed - Rating Definitions
29
Worked Example - Automotive
Design FMEA
30
Worked Example - Function
Item Action Results
C O D
Current
Potential Response &
Potential Potential S l c Design e R
Cause(s)/ Recommended Target
Failure Effect(s) of e a c t P S O D R
Controls
Mechanism(s) Actions Complete Action
Mode Failure v s u e N E C E P
Of Failure Date Taken
s r c V C T N
Function Preven Detect
t
• Function should be written in verb-noun context

• Each function must have an associated measurable
• EXAMPLE:
• HVAC system must defog windows and heat or cool
cabin to 70 degrees in all operating conditions (-40
degrees to 100 degrees)
• - within 3 to 5 minutes
• or
• - As specified in functional spec #_______; rev.
date_________
31
Worked Example - Failure Mode
Item Action Results
C O D
Current
Controls
s r c V C T N
Function PreventDetect
• Failure modes should be written in verb-noun context

• There are 5 types of failure modes: complete failure, partial
failure, intermittent failure, over-function, and unintended
function
• EXAMPLES:
• HVAC system does not heat vehicle or defog windows
• HVAC system takes more than 5 minutes to heat vehicle
• HVAC system does heat cabin to 70 degrees in below zero
temperatures
• HVAC system cools cabin to 50 degrees
• HVAC system activates rear window defogger
32
Worked Example - Effect(s) of
Failure
Item Action Results
C O D
Current
Controls
s r c V C T N
Function Prevent Detect
• Effects must be listed in a manner customer would describe them

• Effects must include (as appropriate) safety / regulatory body, end user,
internal customers – manufacturing, assembly, service
• EXAMPLE:
• Cannot see out of front window
• Air conditioner makes cab too cold
• Does not get warm enough
• Takes too long to heat up
33
Worked Example - Severity
Item Action Results
C O D
Current
Controls
s r c V C T N
• Severity values should correspond with AIAG, SAE

• If severity is based upon internally defined criteria or is based upon standard with specification
modifications, a reference to rating tables with explanation for use must be included in FMEA
• EXAMPLE:
• Cannot see out of front window – severity ?
• Air conditioner makes cab too cold – severity ?
• Does not get warm enough – severity 5
• Takes too long to heat up – severity 4
34
Effect Criteria: Severity of Effect Defined Ranking
May endanger operator. Failure mode affects safe vehicle operation and / or
Hazardous:
involves noncompliance with government regulation. Failure will occur WITHOUT 10
Without Warning
Severity
warning.
May endanger operator. Failure mode affects safe vehicle operation and / or
Hazardous: With
involves noncompliance with government regulation. Failure will occur WITH 9
Warning
Definitions
warning.
Major disruption to production line. 100% of product may have to be scrapped.
Very High 8
Vehicle / item inoperable, loss of primary function. Customer very dissatisfied.
(AIAG) High
Minor disruption to production line. Product may have to be sorted and a portion
(less than 100%) scrapped. Vehicle operable, but at a reduced level of 7
performance. Customer dissatisfied.
Minor disruption to production line. A portion (less than 100%) may have to be
Moderate scrapped (no sorting). Vehicle / item operable, but some comfort / convenience 6
item(s) inoperable. Customers experience discomfort.
Minor disruption to production line. 100% of product may have to be reworked.
Low Vehicle / item operable, but some comfort / convenience item(s) operable at 5
reduced level of performance. Customer experiences some dissatisfaction.
Minor disruption to production line. The product may have to be sorted and a
Very Low portion (less than 100%) reworked. Fit / finish / squeak / rattle item does not 4
conform. Defect noticed by most customers.
Minor disruption to production line. A portion (less than 100%) of the product may
Minor have to be reworked on-line but out-of-station. Fit / finish / squeak / rattle item 3
does not conform. Defect noticed by average customers.
Minor disruption to production line. A portion (less than 100%) of the product may
Very Minor have to be reworked on-line but in-station. Fit / finish / squeak / rattle item does 2
not conform. Defect noticed by discriminating customers.
None No effect. 1
35
Severity Definitions - Manufacturing
36
Quiz – Severity Rating
What should the Severity rating be for cannot see
out of front window?
A. Severity of 1-2
B. Severity of 3-4
C. Severity of 5- 6
D. Severity of 7- 8
E. Severity of 9- 10
37
Quiz – Severity Rating
What should the Severity rating be for Air conditioner makes cab too
cold?
A. Severity of 1-2
B. Severity of 3-4
C. Severity of 5- 6
D. Severity of 7- 8
E. Severity of 9- 10
38
Classification: Severity & Occurrence
Item Action Results
C O Current D
Controls Action
Mechanism(s) Actions Complete
s r c V C T N
• Classification should be used to define potential critical and significant characteristics

• Critical characteristics (9 or 10 in severity with 2 or more in occurrence- suggested) must
have associated recommended actions
• Significant characteristics (4 thru 8 in severity with 4 or more in occurrence -
suggested) should have associated recommended actions
• Classification should have defined criteria for application
• EXAMPLE:
• Cannot see out of front window – severity ?
• incorrect vent location – Occurrence ?
• Air conditioner makes cab too cold – Severity = 5
• Incorrect routing of vent hoses (too close to heat source) – Occurrence 6
39
SRL Safety/Regulatory/Legal
Class Column Symbol Table
WFF Warranty/Field Failure
Classification: 10 SRL SRL SRL SRL SRL SRL SRL SRL SRL
Severity & 9 SRL SRL SRL SRL SRL SRL SRL SRL SRL
Occurrence 8 WFF WFF WFF WFF WFF WFF WFF
7 WFF WFF WFF WFF WFF WFF WFF

Severity
1 2 3 4 5 6 7 8 9 10
Occurrence
40
Worked Example - Cause(s) of
Failure
Item Action Results
C O D
Current
Controls
s r c V C T N
• Causes should be limited to design concerns

• Analysis must stay within the defined scope (applicable system and interfaces to
adjacent systems)
• Causes at component level analysis should be identified as part or system characteristic
(a feature that can be controlled at process)
• There is usually more than one cause of failure for each failure mode
• Causes must be identified for a failure mode, not an individual effect
• EXAMPLE:
• Incorrect location of vents
• Incorrect routing of vent hoses (too close to heat source)
• Inadequate coolant capacity for application 41
Worked Example - Occurrence
Item Action Results
C O D
Current
Controls
s r c V C T N
• Occurrence values should correspond with AIAG, SAE

• If occurrence values are based upon internally defined criteria, a reference must be included in
FMEA to rating table with explanation for use
• Occurrence ratings for design FMEA are based upon the likelihood that a cause may occur,
based upon past failures, performance of similar systems in similar applications, or percent
new content
• Occurrence values of 1 must have objective data to provide justification, data or source of
data must be identified in Recommended Actions column
• EXAMPLE:
• Incorrect location of vents – occurrence ?
• Incorrect routing of vent hoses (too close to heat source) – occurrence ?
• Inadequate coolant capacity for application – occurrence 2 42
Occurrence Probability (AIAG)
Probability of Failure Possible Failure Rates Cpk Ranking
Very High:  1 in 2 < 0.33 10
Failure is almost inevitable 1 in 3  0.33 9
High: Generally associated with
1 in 8  0.51 8
processes similar to previous
processes that have often failed 1 in 20  0.67 7
Moderate: Generally associated

1 in 80  0.83 6
with processes similar to
previous processes which have 1 in 400  1.00 5
experienced occasional failures,
1 in 2,000  1.17 4
but not in major proportions
Low: Isolated failures associated

1 in 15,000  1.33 3
with similar processes
Very Low: Only isolated failures
associated with almost identical 1 in 150,000  1.5 2
processes
Remote: Failure is unlikely. No
failures ever associated with  1 in 1,500,000  1.67 1
almost identical processes 43
Quiz – Occurrence Rating
What should the Occurrence rating be for Incorrect location of vents?
A. Occurrence of 1-2
B. Occurrence of 3-4
C. Occurrence of 5- 6
D. Occurrence of 7- 8
E. Occurrence of 9- 10
44
Quiz – Occurrence Rating
What should the Occurrence rating be for Incorrect routing of vent
hoses (too close to the heat source)?
A. Occurrence of 1-2
B. Occurrence of 3-4
C. Occurrence of 5- 6
D. Occurrence of 7- 8
E. Occurrence of 9- 10
45
Worked Example - Current Design
Controls
Item Action Results
C O Current D
Controls Action
Mechanism(s) Actions Complete
s r c V C T N
• Preventive controls are those that help reduce the likelihood that a failure mode or cause will
occur – affects occurrence value
• Detective controls are those that find problems that have been designed into the product –
assigned detection value
• If detective and preventive controls are not listed in separate columns, they must include an
indication of the type of control
• EXAMPLE:
• Engineering specifications (P) – preventive control
• Historical data (P) – preventive control
• Functional testing (D) – detective control
• General vehicle durability (D) – detective control
46
Current Process Controls
• The mechanisms that either prevent to the extent possible the
failure mode from occurring or detect the failure modes should
it occur.
• Consider 3 types of process controls
– prevent the cause/mechanism or failure mode/effect from occurring,
or reduce their rate of occurrence.
– detect the cause/mechanism and lead to corrective actions,
– detect the failure mode.
• Examples
– SPC, Inspections, Monitoring, Training, Preventive Maintenance, etc.
47
Worked Example - Detection
Item Action Results
C O D
Current
Controls
s r c V C T N
• Detection values should correspond with AIAG, SAE

• If detection values are based upon internally defined criteria, a reference must be included in
FMEA to rating table with explanation for use
• Detection is the value assigned to each of the detective controls
• Detection values of 1 must eliminate the potential for failures due to design deficiency
• EXAMPLE:
• Engineering specifications – no detection value
• Historical data – no detection value
• Functional testing – detection 3
• General vehicle durability – detection 5
48
Detection Probabilities (AIAG)
Detection Criteria: Liklihood the existence of a defect will be Ranking
detected by test content before product advances to
next or subsequent process
Almost Impossible Test content detects < 80 % of failures 10
Very Remote Test content must detect 80 % of failures 9
Remote Test content must detect 82.5 % of failures 8
Very Low Test content must detect 85 % of failures 7

Low Test content must detect 87.5 % of failures 6
Moderate Test content must detect 90 % of failures 5
Moderately High Test content must detect 92.5 % of failures 4
High Test content must detect 95 % of failures 3
Very High Test content must detect 97.5 % of failures 2
Almost Certain Test content must detect 99.5 % of failures 1 49

Detection Probabilities (Mfg)
50
Quiz – Detection Rating
What should the Detection rating be for Incorrect routing of vent hoses
(too close to heat source)?
A. Detection of 1-2
B. Detection of 3-4
C. Detection of 5- 6
D. Detection of 7- 8
E. Detection of 9- 10
51
RPN (Risk Priority Number)
Item Action Results
C O D
Current
Controls
s r c V C T N
• Risk Priority Number is a multiplication of the severity, occurrence and detection

ratings
• Lowest detection rating is used to determine RPN
• RPN threshold should not be used as the primary trigger for definition of
recommended actions
• EXAMPLE:
• Cannot see out of front window – severity ?,
• Incorrect vent location – Occurrence ?,
• Functional testing – detection ?
52
Recommended Actions
Item Action Results
C O D
Current
Controls
s r c V C T N
• All critical or significant characteristics must have recommended actions

associated with them
• Recommended actions should be focused on design, and directed toward
mitigating the cause of failure, or eliminating the failure mode
• If recommended actions cannot mitigate or eliminate the potential for failure,
recommended actions must force characteristics to be forwarded to process
FMEA for process mitigation
53
Responsibility & Target
Completion Date
Item Action Results
C O D
Current
Controls
s r c V C T N
• All recommended actions must have a person assigned responsibility for

completion of the action
• Responsibility should be a name, not a title
• Person listed as responsible for an action must also be listed as a team member
• There must be a completion date accompanying each recommended action
54
Action Results
Item Action Results
C O D
Current
Controls
s r c V C T N
• Action taken must detail what actions occurred, and the results of those actions
• Actions must be completed by the target completion date
• Unless the failure mode has been eliminated, severity should not change
• Occurrence may or may not be lowered based upon the results of actions
• Detection may or may not be lowered based upon the results of actions
• If severity, occurrence or detection ratings are not improved, additional
recommended actions must be defined
55
Corrective Action Effectiveness
• Type of Action • Effectiveness %
• Improve or introduce 0
inspection 0-30
• Do it better next time 30-60
• Improve product 30-60
documentation
30-60
• Improve process
30-60
documentation
60-100
• Add to common errors list
60-100
• Education / Training
60-100
• Redesign / Rewrite Test Code
60-100
• Redesign part / subassembly
• Tool / (Avoid or Remove)
• Improve System or Production
Note: Action taken may include multiple Corrective Actions from the above list.
Ref: Stamatis D.H. (2003), Failure Mode and Effect Analysis: FMEA from Theory to Execution 56
ASQ Quality Press. 2nd Edition.
Additional Slides
Medical Device Example
57
Risk Analysis Example
Collagen Meniscus Implant
Menisci play a fundamental role in the knee joint.
The Collagen Meniscus Implant (CMI®) is a biological
and completely absorbable implant made from highly
purified collagen with a porous structure.
It is arthroscopically attached to fill the void resulting

from damaged and lost meniscal tissue and makes
use of the body's own healing ability.
More than 1 million surgical interventions involving
the meniscus are performed annually in the United
States and approximately 400,000 in Europe.
The arthroscopic meniscal resection is one of the
most common surgical procedures performed
worldwide.
58
Risk Management Tables - Collagen
Meniscus Implant
59
Risk Analysis - Collagen Meniscus
Implant
60
Risk Analysis - Collagen Meniscus
Implant
Per Stamatis
(2003),
Effectiveness
Low
61
FMEA – Response to FDA Letter
St. Jude Medical Implantable Electronic Systems Division, Sylmar, CA.
Update in response to FDA-483 (November 7th 2012)
Inspectional observations and Warning Letter (January 10, 2013)
62
Risk Management
Framework and EN ISO
14971:2012 Standard
FMEA
63
Blank FMEA Form
Failure Mode and Effects Analysis
(Project FMEA) FMEA Number:
1 2 3 Page of
System/Component: Design Responsibility: 4 5Prepared by:
FMEA Date (Orig.) (Rev.)
Core Team:
Action Results
Item / O D
Process S Potential Cause(s)/ c e R. Responsibility & O D
Potential Failure Potential Effect(s) of Current Design Current Design Recommended S c e
e Mechanism(s) of c t P. Target Completion
Mode Failure Controls Prevention Controls Detection Action(s) ActionsTaken e c t
v Failure u e N. Date
Function r c v u e
6 r c
1. System/Component: process being analysed

2. Design Responsibility: function updating FMEA over time
3. Prepared By: person currently responsible for FMEA
4. FMEA Date (Orig): original FMEA release date
5. (Rev.): date of latest revision of FMEA
6. Item/Process/Function: specific part of program being analysed and
function
64
Blank FMEA Form
Page of
System/Component: Design Responsibility: Prepared by:
Core Team:
Action Results
Item / O D
Function r c v u e
r c
7 8 9 10 11 12
7. Potential Failure Mode: how component can fail to function

8. Potential Effects: customer impact of failure mode
9. Severity (Sev): magnitude of effect of failure mode
10. Potential Causes: failure point
11. Occurrence (Occur): rates frequency of failure mode
12. Detection (Detec): how well can failure be detected
65
Blank FMEA Form
Page of
System/Component: Design Responsibility: Prepared by:
Core Team:
Action Results
Item / O D
Function r c v u e
r c
13 15 16 17
14
13. Detection (Detec): how well can failure be detected

14. Risk Priority Number: Severity x Occurrence x Detection; (RPN)
15. Recommended Actions: actions which will lower RPN rating
16. Responsibility: individual taking recommended action
17. Actions Taken: system changes lowering RPN
66
Possible Product Failure Modes
67

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Six Sigma 1

◼ Periodic Maintenance and Calibration

- Poor Quality Control - Design Errors - Stress Concentration

Based on the Reliability Curve, should

B. Don’t Buy Insurance

This definition applies to The manner in which a

• Are these risk

Source: GHTF: Implementation of risk management

Effects Causes Controls

• The risk priority number (RPN) is the product of the rankings

• Function should be written in verb-noun context

• Failure modes should be written in verb-noun context

• Effects must be listed in a manner customer would describe them

• Severity values should correspond with AIAG, SAE

• Classification should be used to define potential critical and significant characteristics

Occurrence 8 WFF WFF WFF WFF WFF WFF WFF

7 WFF WFF WFF WFF WFF WFF WFF

6 WFF WFF WFF WFF WFF WFF WFF

5 WFF WFF WFF WFF WFF WFF WFF

4 WFF WFF WFF WFF WFF WFF WFF

• Causes should be limited to design concerns

• Occurrence values should correspond with AIAG, SAE

processes that have often failed 1 in 20  0.67 7

Moderate: Generally associated

Low: Isolated failures associated

• Detection values should correspond with AIAG, SAE

Almost Impossible Test content detects < 80 % of failures 10

Very Remote Test content must detect 80 % of failures 9

Remote Test content must detect 82.5 % of failures 8

Very Low Test content must detect 85 % of failures 7

Moderately High Test content must detect 92.5 % of failures 4

High Test content must detect 95 % of failures 3

Very High Test content must detect 97.5 % of failures 2

Almost Certain Test content must detect 99.5 % of failures 1 49

• Risk Priority Number is a multiplication of the severity, occurrence and detection

• All critical or significant characteristics must have recommended actions

• All recommended actions must have a person assigned responsibility for

It is arthroscopically attached to fill the void resulting

1. System/Component: process being analysed

7. Potential Failure Mode: how component can fail to function

13. Detection (Detec): how well can failure be detected

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