FMEA

FMEA How to Plan and Organize

N b 14 2006 November 14, 2006
Minnesota ASQ
Jim McLinn CRE, Fellow ASQ
Slide 1
FMEA
N k d FMEA Naked FMEAs
What is it?
Wh d FMEA? Why do an FMEA?
What is it good for? What is it good for?
How to do an FMEA
When to do an FMEA
Slide 2
FMEA
History History
1960s NASA began a version
1974 US Military and Mil Std 1629
1978 FDA issued Hazard Analysis
1988 - Ford issued a new document for
suppliers
1990 Chemical and Gas industry
1994 ISO recommended Design and
P FMEA Process FMEAs
1996 FDA issued recommendation on
FMEA
Slide 3
FMEAs
FMEA
Source of Documents Source of Documents
Mil Std 1629
IEC 812
ARP 5580
RADC TR83-72
AIAG & SAE J1739
VDI Z138 (German) ( )
British Standards
Other forms exist
Slide 4
Other forms exist
FMEA
Th FMEAA d The FMEA Agenda
FMEAs can be done for a product design
or a wide variety of business processes or a wide variety of business processes.
The intent is to improve the design or
process by finding potential problems and
avoiding them.
Slide 5
FMEA
Key FMEA Terms
Failure Mode
The manner in which a part or assembly could potentially fail to meet its
requirements or fail to function. It is what you may reject the part for.
Effects
The potential non-conformance stated in the terms of the next assembly or at the
system (top level) performance (usually from the customers perspective). y ( p ) p ( y p p )
Causes
Thepotential reason(s) behind a failure mode, usually stated as an indication of a
specific design or process weakness. This starts the chain of events leading to p g p g
the Effect.
Analysis
ByusinganFMEA model youwill anticipatefailuremodesdetermineand By using an FMEA model, you will anticipate failure modes,determine and
assess risk to the customer, product or process, and then act to neutralize the
risk or reduce it to acceptable levels
RPN
Slide 6
RPN
Risk Priority Number which helps prioritize the findings of the FMEA
FMEA
Benefits of Using FMEAs
Improves time to get reliable products to
market
Can reduce or prevent recalls (Sony
recalled96millionbatteriesin2006) recalled 9.6 million batteries in 2006)
Identifiesdownstreammaintenance Identifies downstream maintenance
considerations early
May aid in complaint investigation and
meaningful corrective actions of a process
Slide 7
Many others exist
FMEA
TeamFormation Challenges Team Formation Challenges
1. Team Formation
All people must participate with no dominant stars
Should be small: 5 - 8 People are best
Multi-Disciplinedshouldbepresent Multi Disciplined should be present
Product/Process Knowledge is key
Responsibility Level - Must have the authority to
get things done g g
Customer Oriented Driven to prevent problems
for customers
See Sept 2006 Quality Progress but watch
for errors in article
Slide 8
FMEA
Additional Considerations
2 Organization of a Team 2. Organization of a Team
Team Sponsor ( need not be present)
TeamLeader (must bepresent andmoveteamalong) Team Leader (must be present and move team along)
Support Groups
Design Engineering
Electrical, Software or Mechanical people , p p
Manufacturing or Operations
Test Engineering
Reliability Engineering y g g
Field Service or repair
Scribe
C h f ili Coach or facilitator
Slide 9
FMEA
Design vs. Process FMEAs
Design FMEA
Engineer designs to fulfill customer requirements g g q
Failure Mode= Failure to function
Cause = Design weakness
Detection = ReallyverificationandValidation(catch Detection = Really verification and Validation (catch
design weakness before release to
manufacturing)
Process FMEA
Engineering design process to meet specification g g g p p
Failure Mode= Reject (Out of specification)
Cause = Process weakness
Detection = Controlsinplaceonprocesstoprevent
Slide 10
Detection = Controls in place on process to prevent
rejects from reaching the customer.
FMEA When to do Design & Process FMEAs
Project Phases
Phase 1: Phase 2: Phase 3: Phase 5: Phase 4:
Concept
Development
Product
Planning
Design &
Development
Release
& Ramp
Test &
Validation
Initial Design Complete
Design FMEA g
Process FMEA
Apply learning from previous projects
Slide 11
FMEA
Some Related Tools
Function A
Function B
Function C
Functional Block Diagrams Functional Block Diagrams
Fault Tree Analysis
Flow Diagrams Flow Diagrams
Process Mapping
Many other tools exist Many other tools exist
Slide 12
FMEA
Functional Block Diagrams
Is a tool to describe the operation of
i f i t a piece of equipment or process.
Allows all team members to develop a
shared understanding of the operation or g p
process to be improved.
Developsaconcisestartingpoint and Develops a concise starting point and
ending point for analysis of the system.
Slide 13
FMEA
FBD Example: Smoke Detector
Smoke Chamber circuit - ionizes smoke which
cases increase in voltage corresponding to signal to
be sent to control box
Indicator light - shines
when battery test button is
depressed or when alarm is
activated
Vents to smoke
chamber circuit
+
Battery - supplies voltage
to entire system
Control Box - controls
Wire - for
sending signal to
control box
Test Button
Activateshorn
Siren - receives voltage and
in turn produces sound.
Horn
Control wire - sends
voltagewiretosiren
voltage to siren system
units
Activates horn
How the Smoke Detector works: Smoke enters the vent and goes into the smoke chamber 2) The
chamber detects the presence of certain traces of smoke 3) If enough smoke is present chamber sends
signal tocontrol box 4) control boxthendrawsmost of voltageinentiresystemtosiren5)Voltagefrom
Horn
voltage wire to siren
Slide 14
signal to control box 4) control box then draws most of voltage in entire system to siren 5)Voltage from
battery in turn activates obnoxious siren sound
FMEA
FBD Example: Smoke Detector
Inputs Process Outputs
Smoke enters chamber
Light is activated
Presence of smoke
Smoke enters assembly
Successful capture
Smoke passes detector
Ion chamber generates
Voltage goes to control
box
Ion chamber generates
voltage
Control box sends
voltage to Noise Maker
Loud Noise
Alarm Sounds
Slide 15
Loud Noise
FMEA
Fault Tree
What ?
A logical connection diagram that shows a series of related
events which lead to potential root cause(s) of a failure.
When ?
Aspart of adesignreview As part of a design review
When developing a new process
To analyze a failure y
Why?
To minimize high risk or weak linksin a design
To reduce/eliminate process weaknesses
To understand root cause(s) of a failure in a multiple
connection or interaction environment.
Slide 16
co ect o o teact o e v o e t.
FMEA
Smoke Detector Fault Tree
Smoke Detector
Fails to Detect
Smoke
Partial Block Diagram
Smoke does
not enter
chamber
Smoke does
not enter the
assembly
Smoke not
detected in
chamber
Vent is
blocked
Dust
Detector
broken
Slide 17
Paint Dust Insects
Incorrect
installation
Mechanical
shock
Electrical
overstress
Temperature
extreme
Dead or low
battery
FMEA
FMEAs - Failure Modes & Effects Analysis
What ? - Answered
When ? Answered
Wh A d Why - Answered
Time for a short example !! Time for a short example !!
Slide 18
FMEA
FMEAs - Failure Modes & Effects Analysis
Sample DFMEAForm Sample DFMEA Form
Slide 19
FMEA FMEA Fault Tree to Failure Modes & Cause(s)
Smoke does
not enter the
assembly
Vent is
blocked
Multiple
Level Option
Ties to FTA
Levels
blocked
Levels
Paint Dust Insects
Incorrect
installation
Each of the lowest level entries in the Fault Tree are
potential Causes for the Failure Modes
Slide 20
p
There should be at least one Cause for each Failure Mode branch
FMEA
FMEA Effects and Fault Detection
Next we complete the Effects and Fault Detection
columns together.
Slide 21
FMEA
FMEA Severity
Next complete the Severity column Next complete the Severity column.
Severity may ranked from 1 to 10 or as a 1 to
i ( b ) 5 for simple systems (Big number most severe).
OR
1- Failure Mode is of such a minor nature that special equipment or 1- Failure Mode is of such a minor nature that special equipment or
knowledge is required to identify. This is NO IMPACT to System.
2 - Failure Mode will result in a slight system impact and / or a slight
deterioration of systemperformance deterioration of system performance.
3 - Failure Mode will result in noticeable system deterioration and may be
described as a limp along.
4 Fail re Mode ill res lt in a non f nction of a critical s stemitem 4 - Failure Mode will result in a non-function of a critical system item.
5 - Failure Mode will result in a safety problem or non-compliance with
government regulation.
Slide 22
FMEA
FMEA Detection or Verification
Detectability can be ranked from 1 to 10 or 1 Detectability can be ranked from 1 to 10 or 1
to 5(Big number is least likely to be identified in
Product Development) Product Development).
OR
1 - Very high probability that the Failure Mode will be identified. Verification
or Validation (V&V) or other activity will almost certainly identify the
existence of the (potential) defect.
2 - High probability that the Failure Mode will be identified. V&V or other
activities have a good chance of identifying the existence of the defect.
3 - Moderate probability that the Failure Mode will be identified. V&V or
other activities are moderately likely to identify the existence of the defect.
4 - Low probability that the Failure Mode will be identified. V&V or other
activities are not likely to identify the defect.
5 - Very low probability that the Failure Mode will be identified. V&V or
Slide 23
y p y
other activities will not or cannot identify the existence of a defect.
FMEA
FMEA Occurrence
Occurrence may be ranked from 1 to 10 or 1
to 5 as always big numbers are bad
Ranking:
1 more then 10 Years between fails
2 5 to 10 years OR 2 5 to 10 years OR
3 2 to 5 years 1 - Less then 0.1%
4 1 to 2 years 2 - 0.1% to 1%
The Scale Factor may be
changed as long as it is
applied consistently e g one
5 to 1year 3 1% to 10%
6 Quarterly 4 10% to 50%
7 Monthly 5 More then 50%
applied consistently, e.g., one
minute might be a 10 and
twenty four hours might be
a 1
y
8 Weekly
9 Daily
10 Every few hours
a 1.
Rule of Thumb: A 1 should
be at least the expected life
Slide 24
10 Every few hours
p
of the product.
FMEA
FMEA Risk Priority Number
Calculate the Risk Priority and find top 20% Calculate the Risk Priority and find top 20%
RPN is the product of S*D*O.
Top 20% are big impact items to improve
Also include all safety items to prevent or mitigate
Look at any remaining top Severity items
Slide 25
FMEA
FMEA Recommended Actions
Fill out the Recommended Actions based on: Fill out the Recommended Actions based on:
Safety Issue = Yes
RPN ranking (start with the top 20%) RPN ranking (start with the top 20%)
When should we do more than 20%?
Easy fixes that require minimal resources
Others that the team feels are important
Slide 26
FMEA
FMEA Who & When
Slide 27
FMEA
FMEA Audit
Key to closing out actions and making something happen
Slide 28
FMEA
FMEA Suggestions
Take advantage of existing data
Use field experience and talk to service or
repair people
Facilitate proper brainstorming Learn how!
Avoid jumping to solutions ACommon
i i i Engineering Mistake
Dont get bogged down in arguments
A Recommended Action might be another
FMEA or a study
Slide 29
FMEA
Keep Metricsof the FMEA For p
Example look at Statistics:
Total number of entries Total number of entries
Total number of Safety items
Make a RPN Histogram
IdentifyEntriesrequiringwork Identify Entries requiring work
Do man-load time estimates of
meetings g
Create a Parking lot if necessary
Slide 30
FMEA
Congratulations,
you have covered
th FMEA ti the FMEA portion;
now it is time to
address the address the
MANAGEMENT of
the FMEA
Slide 31
FMEA
Ways to Improve FMEAs Ways to Improve FMEAs
Make sure there is management buy-in
Spend lots of time with group in FMEA p g p
Plan, Plan, Plan
Comewithformsfilledout Come with forms filled out
Identify purpose, limits, goals and customers.
D fi ll t f t Define all terms up front.
Set aside enough time.
Slide 32
Do the follow up
FMEA
Train the Team Train the Team
Be sure to include training time for team
Have drawings and aides at hand.
R t ti f 2 t 3 h d Run team meetings for 2 to 3 hours and
then stop.
Come prepared to all meetings Come prepared to all meetings
Let the team work the issues
Slide 33
FMEA
Watch Your Words Watch Your Words
Use a complete sentence to express a complete idea.
Need a complete thought, so no stand alone words in a
section section
Avoid vague words such as:
Bad, Poor & Wrongg
Too, Low & No
Broken, Dead & Failed
Insufficient unacceptable or similar words Insufficient, unacceptable or similar words
Slide 34
FMEA
Dont get Confused: g
Write out whole progression if
necessary
Root Cause
Mechanism
D f t Defect
Growth
Failure Failure
Failure Mode
Next level impact p
Top level Effects
Slide 35
FMEA
Other types of FMEAs
Process FMEAs are common
Maintenance or service FMEAs are done
F i l it h H d Focus on single item such as Hazards
FMEA covering something new
Functional level FMEAs Functional level FMEAs
Try each one, but remember they might have different y , y g
formats or requirements.
Slide 36
FMEA
Get the relationships Correct Get the relationships Correct
Severity is the numerical equivalent of Effects
Occurrence speaks to likelihood of Cause
V ifi ti t lk b t d f V&V t t Verification talks about adequacy of V&V tests.
For a process FMEA, Detection talks about adequacy
of Current Controls. of Current Controls.
NEVER, NEVER, NEVER depend upon the customer
to find or detect problems.
Slide 37
FMEA
Team Dynamics
Use the 30, 60 , 5 Rule
Dont allow arguments or hidden agendas
Encourage discussion for a short time and
then either: then either:
Come to a conclusion
Create an action to get information
U th ki l t Use the parking lot
Slide 38
FMEA
FMEA Myths FMEA Myths
It takes a lot of time
Just a pile of paperwork in the end
C ti ti t t h Corrective actions cost too much
Difficult to implement FMEAs because of
roadblocks roadblocks
Design Engineers job, not others
No body really cares anyway
Not cost effective
Still cant prevent safety problems
Slide 39
FMEA
I C l i In Conclusion
Come Prepared
Keep it simple
Keep it focused
Keep it short
Keep it moving
Follow up on action items p
Practice your team leader skills
Collect Lessons Learned
Slide 40
Collect Lessons Learned