FMEA Dilemma and

Countermeasures

Gary Jing, PhD

ASQ World Conference – Session W06 – May 2, 2018

Learning Objectives

• This session is intended for experienced

people to discuss / exchange how to better
handle the FMEA activities to get the best
out of it, by addressing challenges and
difficulties.
– Interactions are encouraged & appreciated
• It’s not intended to teach basics to
beginners who have no experience.

5/2/18 2018 WCQI W06 FMEA Gary Jing 2

Agenda

• Speaker’s Connection to the Topic

• The Challenges and Dilemma
• Which Parts being Difficult
• Tips to Deal With the Dilemma
• Integration with Related Activities
• An Unique Practice
• Takeaways
• Appendix - More Discussions on Confusing Points

5/2/18 2018 WCQI W06 FMEA Gary Jing 3

 Gary Jing’s Background
Ø ASQ Fellow, MBA, PhD in IE, CQM / CQE
Ø Founding MBB @ Seagate TCO (1998 - 2005)
Ø Sr. Mgr., Global LS / Founding MBB @ Entegris (2005 - 2009)
Ø Global LSS Leader / MBB @ TE – ADC (2009 - 2015)
Ø CI Director / MBB @ CommScope (2015 - Present)

Ø US Delegation to ISO TC176 for ISO 9000 Revision

Ø Editorial Review Board of Six Sigma Forum Magazine
Ø IQPC/PEX LSS Award Judge Panel
Ø Development of ASQ BB Certification Program (participant)
Ø Delphi panel expert for SME/AME/Shingo Lean Certification Program

Ø Isixsigma DFSS Award (2011), Finalist of IQPC MBB of The Year (2008)
Ø Two patents in disc drive modeling from his Sigma work
Ø Series publications on Lean Sigma
Ø More details on http://www.linkedin.com/in/ggaryjing.

5/2/18 2018 WCQI W06 FMEA Gary Jing 4

Foreword

• FMEA concept and practice can be applied

to almost anything.
• Most common ones are on design and
production (process), which splits into:
– Pre (production) release – easier to change
design.
– Post release – harder to change design.
– Practice will be different b/w the 2 stages.
– This session focuses on the Pre.

5/2/18 2018 WCQI W06 FMEA Gary Jing 5

Foreword

• The mechanism of FMEA is quite

straightforward, yet to do it well isn’t easy.

So, what are the challenges?

Gary Jing, FMEA Dilemma, Six Sigma Forum Magazine, May, 2014

5/2/18 2018 WCQI W06 FMEA Gary Jing 6

What are the Biggest Challenges?
Scenario 1: Cowboy under OSHA

5/2/18 2018 WCQI W06 FMEA Gary Jing 7

Example: Functions Identified for a Marker Cap

20 “functions” identified.
- Too much for FMEA.
- Focus on NUD (new, unique,
difficult) ones instead.

5/2/18 2018 WCQI W06 FMEA Gary Jing 8

A Fundamental Limitation of FMEA & RCA

The cost aspect needed for business decision

is usually not considered in FMEA (or RCA).

Inc
Impact / Return / Reward

Hi
re
as
ing
De
Med
sir
ab
ilit
y

Low

Low Med Hi

Difficulty / Effort / Cost

5/2/18 2018 WCQI W06 FMEA Gary Jing 9

What are the Biggest Challenges?
Scenario 2: Everything is fine.

5/2/18 2018 WCQI W06 FMEA Gary Jing 10

 So, What are the Biggest Challenges
in doing FMEA?

Effectiveness & Efficiency

• The quality of FMEA is hard to evaluate.

• No guaranty (or magic wand)
• With huge investment and no guaranty on results,
people have the tendency to cut corner.

5/2/18 2018 WCQI W06 FMEA Gary Jing 11

 Typical Ways to Boost FMEA Quality

• Experience - Ultimate pursuit

• Formality (& structure) - Less effective

• Right Focus - More effective

• Quantity - Trade efficiency

Will be elaborated in the remaining sections.

5/2/18 2018 WCQI W06 FMEA Gary Jing 12

Different Industries have Different Expectations on
FMEA.

• More serious and formal in highly regulated

industries
– Medical Device, Aerospace, Automotive, etc.
– Can be used as legal documents.
• Less formal in Telecom
– Ad hoc in many cases.
• Less formal in Six Sigma activities
– May be customized or use less formal form, e.g.
Potential Problem Analysis (PPA).

5/2/18 2018 WCQI W06 FMEA Gary Jing 13

Agenda

• Speaker’s Connection to the Topic

• The Challenges and Dilemma
• Which Parts being Difficult
• Tips to Deal With the Dilemma
• Integration with Related Activities
• An Unique Practice
• Takeaways
• Appendix - More Discussions on Confusing Points

5/2/18 2018 WCQI W06 FMEA Gary Jing 14

Which Parts of FMEA are Difficult?

• Types of Failure Mode (FM)

• Types of Control
– Prevention or Detection?
• Is it a Cause or Effect?
– Cause – effect shifting
• Is it a process issue or design issue?
– Some FMs may belong to both
– Many process issues can be addressed by design
• Interaction between (sub-)structures (IBS)
– IBS induced issues are hard to capture
5/2/18 2018 WCQI W06 FMEA Gary Jing 15
Which Parts of FMEA are Difficult?

• Types of Failure Mode (FM)

– Failing to meet the specification
• Complete failure
• Too little (partial, uneven or not complete)
• Too much (over)
• Intermittent
• Failure over time
– Incorrect or inappropriate requirements
• Wrong, missing, hidden, unstated, assumed)
– Unintended use, application, or environment
– Does harm to others

5/2/18 2018 WCQI W06 FMEA Gary Jing 16

Which Parts of FMEA are Difficult?

• Is it a Cause or Effect?
– Chain of Causation
– Cause–effect shifting
Is Electrical Fault a
Cause, FM or Effect?
- It depends, on what
level you are looking at:
- At car level, it’s a
cause;
- At sub-assembly level
is a FM;
- At component level,
it’s an effect.

5/2/18 2018 WCQI W06 FMEA Gary Jing 17

Which Parts of FMEA are Difficult?

• Types of Control
– Prevention or Detection?
– One of most confusing items, hard to do it right.
– Prevention: Focus on preventing failure to occur,
affect Occurrence (O).
– Detection: Focus on preventing effect to occur,
affect Detection (D).
– Different sets for design and process, no overlap.

5/2/18 2018 WCQI W06 FMEA Gary Jing 18

Prevention vs. Detection Controls

DFMEA PFMEA
• Prevention Controls typically occur prior to • Prevention Controls occur
finalizing the design and reduce the risk of prior to manufacturing the
failures during Product Validation Testing product
- Engineering analysis and evaluation: Anti- - Equipment setup
overstress feature requirements
- Tolerance Stack-Up or Statistical Analysis, - Poka-yoke
- Finite Element Analysis • Detection Controls occur
• Detection Controls detect the failure mode, after manufacturing the
typically during Product Validation testing, product but prior to
prior to releasing design for customer orders shipping product to
- Examples include Reliability testing and
customers
Performance testing conducted as part of - Product testing
product validation testing
- Inspection

5/2/18 2018 WCQI W06 FMEA Gary Jing 19

Agenda

• Speaker’s Connection to the Topic

• The Challenges and Dilemma
• Which Parts being Difficult
• Tips to Deal With the Dilemma
• Integration with Related Activities
• An Unique Practice
• Takeaways
• Appendix - More Discussions on Confusing Points

5/2/18 2018 WCQI W06 FMEA Gary Jing 20

Poll

Are all of the FMEA columns equally important?

Options: Yes / No
Which ones are most important?
Options:
• RPN
• Detection
• Function
• Failure mode
• Action
• Others
5/2/18 2018 WCQI W06 FMEA Gary Jing 21
Tips on FMEA Efficiency & Effectiveness

Are all of the FMEA columns equally important?

Which ones are most important?
1. The most important column in FMEA is
potential failure mode (concerns)
– To identify potential failures as thoroughly &
completely as possible.
2. The 2nd most important is the
countermeasures (actions) identified
– To keep risk of FMs at acceptable level.
– Be conscious on cost.

5/2/18 2018 WCQI W06 FMEA Gary Jing 22

Tips on FMEA Efficiency & Effectiveness

3. The 3rd is the risk priority number (RPN)

– To assess the risk, establish priorities and guide
responses.
– Always highly subjective due to lack of data.
– Frequently mistaken as most important in FMEA.
– AIAG is moving away from using it.

4. Everything else is in supporting functions

– To help make better informed decisions in the
process.

5/2/18 2018 WCQI W06 FMEA Gary Jing 23

Redirect Team’s Brain Power to Boost FMEA
Efficiency & Effectiveness

Focusing team resource on NUD and the

top 2 most important columns can boost
efficiency & effectiveness of FMEA.

• The top 2 most important columns (failure

mode & countermeasures) can benefit from
team the most.
• An experienced lead person or a small
subset group can handle the rest well.

5/2/18 2018 WCQI W06 FMEA Gary Jing 24

Redirect Team’s Brain Power to Boost FMEA
Efficiency & Effectiveness

• We can let the whole group focus on

brainstorming for the top 2, and let an
experienced lead person take care of the
rest along with a small sub team.
• Focusing on NUD (new, unique, difficult),
easing on ECO (easy, common, old) items,
can gain efficiency.

5/2/18 2018 WCQI W06 FMEA Gary Jing 25

Agenda

• Speaker’s Connection to the Topic

• The Challenges and Dilemma
• Which Parts being Difficult
• Tips to Deal With the Dilemma
• Integration with Related Activities
• An Unique Practice
• Takeaways
• Appendix - More Discussions on Confusing Points

5/2/18 2018 WCQI W06 FMEA Gary Jing 26

Integration with Related Activities

• How is FMEA activity connected with

others that have similar intent? e.g.
– Six Sigma
– Product Development Process (PDP)
– Dynamic Control Plan (DCP)
• It’ll be much more effective & efficient if
systematically integrate FMEA with
activities with similar intent.

5/2/18 2018 WCQI W06 FMEA Gary Jing 27

Integration with Related Activities

• Six Sigma connection

– Lean Design for Six Sigma (LDFSS), e.g.
– VOC / requirement management, e.g.
• Failing to meet requirements is a/the primary
mode of failure.
• How to make sure you identified hidden /
latent / implied requirements?
à LDFSS VOC section.

5/2/18 2018 WCQI W06 FMEA Gary Jing 28

 How is FMEA Integrated with Relevant Activities
- Product Development Stage AIAG is moving
V
V
to this direction
in joint effort
V
V S
S
S
W V
S S

Process/Product
S
V
S
V
V V V
V V V

Failure Modes and Effects Analysis

V V V
W V V
V
S V
W S S V

(FMEA)
W S
V V W V S V V

with VDA.
HOWs: Measurable Technical Requirements Customer
Assessment
Image Quality General Features Ease of Use Similar to 35
Customer Importance

Konica
Q
Viewfinding indicator graphics

Our Camera Co.

X
Fuji
Y
Store Brands
High appearance rating

A
Impact force resistance

OTU Camera Example

Flash re-charge time

Carrying mechanism
Maximize part re-use
External dimensions

min. of 27 pictures
Surface roughness
Snap load resistance

Process or
Viewfinder Area
Body contouring

Camera weight
Winding force
Color Saturation

Flash power

Prepared by:
Label clarity
Flash force

Snap force

35 mm film

Product Name:
Low Grain
Contrast
Density

UMC

0 1 2 3 4 5

Direction of Improvement K K K J K I K I K K J K K K K K I K K J K K K I
16.0
Responsible: FMEA Date (Orig) ______________ (Rev) _____________
Clear Pictures
Good Image Quality

F F F F F F A QX
Y
V
Low Graininess 11.0 F F A Q XY
V
W
Pictures can't be
5.0 F F F H F H A QXY
"washed out"

S Can't mis-fire when I

S S put it away in my 4.0 F H H F A QXY
V S pocket or purse
W V
Unique Features

S Has to be durable if
S 12.0
WHATs for One-Time-Use Camera (VOC Input Data)

I drop it F H H G A YX Q
V
W
V S
Low purchase price 15.0 F F H H G F H Q XY A
Process S O D R
W

V
V
V
W S
S
Must fit in my shirt
pocket
2.0 F G F H G G A X Q Y Step/Part E C E P
Want to take
6.0
V
V
V
W
W
W
pictures in any light
Has to be really
14.0
F G G H A XQ Y
Number Potential Failure Mode Potential Failure Effects V Potential Causes C Current Controls T N
easy to use H F F F F H F F F F H H G AQXY

Spin Draw Fiber Breakouts Undersized package, High SD Dirty Spinneret Visual Detection of Wraps and
V
W V Easy to wind 1.0 F F G G A YX
Q
V
Easy to use

S
2 8 broken Filaments 9 144
Large view finder

W S
W
W
W
V that helps me get
pictures centered
10.0 G F G F H F AX Y Q Process panel-hours lost
S W
easily

Has to be light &

13.0 H G F H F F F F A X YQ
Filament motion Visual Sight-glass
easy to carry
Regular 35 mm Camera performance

Prefer 35 mm format 8.0 H H H H F F Q

A
Y
X
W S V Has to be close to
9.0
5 2 8 80
W my 35mm in picture
quality
F F F F F F A XY
Q

Has to take a 3.0

minimum of 27
I don't want it to
7.0
H H F A Y
X
Q
Polymer defects Fuzzball Light
8 2 9 144
look cheap G H G H F F F F F G F F A X QY

How Much

Organizational Difficulty

Q Konica 5
0
Assessment

Fuji
Y 4
Technical

Store Brands
A 3
Our Camera Co.
X
2

0
78.

27.
29

29

29

36

16
34
14
24
28
17
14
13
19
14
37
19
29
22
19
22
57

33

Weighted Importance

Relative Importance

VOC / Concept DFMEA

Requirements Generation
Prototype Design for “X”

Functional Architectural Schematic

Ream of
Paper
Load / Store
Paper
Pick Paper
Increment and
Hold Paper
Deliver and
Store Paper
(The important functions and flows)

Delivered
Print
Design Review
Jetted
Ink Display
Process Status
Input Data Status Indication
Data

Ink Level Display Ink

Indication Level
Process/Product
Failure Modes and Effects Analysis
Material flow
Jet Ink (FMEA)
Power flow
Ink Store Ink
Signal flow
Process or
Vapors Prepared by:
Product Name:
Supply Responsible: FMEA Date (Orig) ______________ (Rev) _____________
110/220V AC
Power

Capture Hot Process

Remove Heat Filter Flow S O D R
Vapor Gases Step/Part
Heat E C E P
Number Potential Failure Mode Potential Failure Effects V Potential Causes C Current Controls T N
From Dave Cutherall, Design Edge,
Kristin Wood, Univ. of Texas, Spin Draw Fiber Breakouts Undersized package, High SD Dirty Spinneret Visual Detection of Wraps and
Kevin Otto, PDSS Consulting Process panel-hours lost 2 8 broken Filaments 9 144

Process Map
Cool air Filament motion Visual Sight-glass
5 2 8 80

Functional Analysis
Polymer defects Fuzzball Light
8 2 9 144

/ NUD-New, Pugh Analysis PFMEA

Unique, Difficult

5/2/18 2018 WCQI W06 FMEA Gary Jing 29

How is PFMEA Integrated with Relevant Activities
- Post Production Release

5/2/18 2018 WCQI W06 FMEA Gary Jing 30

Agenda

• Speaker’s Connection to the Topic

• The Challenges and Dilemma
• Which Parts being Difficult
• Tips to Deal With the Dilemma
• Integration with Related Activities
• An Unique Practice
• Takeaways
• Appendix - More Discussions on Confusing Points

5/2/18 2018 WCQI W06 FMEA Gary Jing 31

3-Day DFMA / FMEA Joint Event
- An Unique Practice

• Addresses a host of manufacturing related

concerns together, including: Many of them
have similar
– Design review intent in different
– Design for “X” angles, to identify
and eliminate
– Modularity / part reuse problems in the
– Lean manufacturing & assembly future, thus it’s
better to join
– Field installation & maintenance force.
– FMEA (Design, Process, Application)
• Typically done right after the 1st major
prototype acquired.

5/2/18 2018 WCQI W06 FMEA Gary Jing 32

 Activities & Schedule of Joint Event

Pre Day 1 Day 1 Day 2 Day 2 Day 3 Day 3 Post

Event Morning Afternoon Morning Afternoon Morning Afternoon Event

Stage 0 Lead
Prep & optionally
pre-draft
Kick-off QFD &
FMEA
Stage 1 VOC
Review updates,
Teardown
Current prototype,
Design touch & feel.

Stage 2 Whole team Breakout to

Brainstorm / brainstorm, document
prioritize concerns on
Document concerns, FMEA,
Concerns quickly
assess risk.
Stage 3 Multiple Breakout to Breakout to
Generate rounds of Consolidate further
ideations on ideas & review develop
Better top concerns counter ideas
Solution measures

Stage 4 Breakout to Finalize

Finalizing review QFD improve
ments &
FMEA

5/2/18 2018 WCQI W06 FMEA Gary Jing 33

Take-aways

• What are the constant struggles with FMEA?

– Efficiency and effectiveness.
• The most important columns in FMEA are?
– Failure Mode & Countermeasures (Actions).
• Everything else is in?
– Secondary supporting role, to help making better
informed decisions.
• Focusing the group resource on the?
– Most important items can significantly improve the
efficiency and effectiveness of FMEA.
 Questions?
Gary Jing - http://www.linkedin.com/in/ggaryjing
 Appendix
More Discussions on Confusing Points
More Discussions on Confusing Points

• What’s the primary intent / ultimate goal of

FMEA?
– To prevent future problems.
• Choices of actions should build around this goal.
– Not for investigation / problem solving.
• FMEA format isn’t suited to show complicated
cause-effect relationships.
– Additional or variation on goals are possible.

5/2/18 2018 WCQI W06 FMEA Gary Jing 37

More Discussions on Confusing Points

• What’s in the Scope

– ASQ critical assumption for PFMEA
• All components coming into the process step are
defect-free. – Defective part out of scope.
– My view
• Anything that may jeopardize your goal is in
scope, incl. defective incoming material.
• Failures & solutions not limited to current design.
– May lead to new design, components or process.
• If FMEA doesn’t lead to design change during
development stage, it’s not as effective as it can.

5/2/18 2018 WCQI W06 FMEA Gary Jing 38

More Discussions on Confusing Points

• Expectation / “standard” on outputs

– There is no perfect FMEA or outputs for any
subjective analyses
– Different people doing the same subjective
analysis will get different results
• Which is ok à Delphi Theory – Things will
converge through iterations.
àUse your judgment to decide the best practice
for you.

5/2/18 2018 WCQI W06 FMEA Gary Jing 39

More Discussions on Confusing Points

• Could same FM have multiple effects with

different Severity (S), O and/or D?
– Possible to any of them.
• A FM may have multiple causes and/or effects.
• A cause or effect may associate to multiple FMs.
– To simplify the analysis, a popular practice is to
focus on the most server effect per FM.
• There is a chance to miss an effect with lower
severity yet higher RPN.
• That’s a risk to take to trade for efficiency.

5/2/18 2018 WCQI W06 FMEA Gary Jing 40

More Discussions on Confusing Points

• Can recommended actions lower Severity?

– A frequently debated item.
– Two schools of thought w/ opposite views.
– Ultimately what’s affected is Criticality = SxO.
– More common to keep S unchanged, only
change O, to keep things simple and avoid
confusing debate.

5/2/18 2018 WCQI W06 FMEA Gary Jing 41

More Discussions on Confusing Points

• What training style / format is more effective

– Standalone training w/ hypothetical example /
exercise (e.g. ASQ)?
– Learn through doing real projects?
• FMEA is evolving
– AIAG joining VDA* is proposing dramatic changes
• Emphasize structural analysis (similar to LDFSS)
• Eliminate RPN
– Industries will follow suit in the near future.
* VDA - German Association of the Automotive Industry

5/2/18 2018 WCQI W06 FMEA Gary Jing 42

AIAG/VDA to Emphasize Structural Analysis

AIAG moving toward VDA practice.

5/2/18 2018 WCQI W06 FMEA Gary Jing 43

AIAG/VDA to Replace RPN by Action Priority (AP)

Using more sophisticated Guidance Table to guide AP,

replacing single threshold for RPN.
5/2/18 2018 WCQI W06 FMEA Gary Jing 44