2. The Effective Application of FMEA
• Who am I?
• What is FMEA?
• Why do FMEA?
• Application of FMEA
• A Structured Approach
• Effective FMEA
• Use Software for FMEA
• Use an FMEA Facilitator
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3. What is FMEA?
Contrary to popular belief FMEA is actually an acronym for a risk analysis called Failure Modes
& Effects Analysis, and not ‘Five Men Endlessly Arguing’.
“Failure Modes & Effects Analysis is an activity that brings minds together in a
collaborative and pre-emptive way in order to avoid failure of a system!”
FMEA is a systematic procedure that focuses on a system(s) in order to uncover weaknesses,
i.e. what can go wrong, what could possibly cause it and what are the potential effects. FMEA
then focuses on these weaknesses with the objective of making them obsolete, or by reducing
the likelihood of failure (or risk of failure) though the implementation of corrective methods,
which in turn optimises the system.
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4. What is FMEA?
FMEA is a living document and if used correctly records:
• intellectual property
• weaknesses within the system
• quantified risk of system failure
• mistakes made
• solutions to problems
• responsibility for controls methods
Failure are any potential errors or defects within a process, design, or part,
especially ones that affect the ‘customer’, environment and law.
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5. What is FMEA?
• 1949 – US Military (MIL-P-1649)
• 1963 – NASA
• 1965 – Aerospace Industry
• 1975 – Nuclear Industry
• 1977 – Ford Motor Company
• 1980 – DIN 25448
• 1986 – VDA Volume 4
• 1992 – Ford, Chrysler & GM
• 2008 – AIAG
Is universally accepted as an engineering tool
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6. Why do FMEA?
• Cost reduction and increased profits
• Demand for higher quality
• Extended warranty periods
• Product liability
• Quality standard demands
• Retention of knowledge
• Make processes more robust
• Enhanced communication within the business, customer
& suppliers
• Shorter development times
• Functional Safety & Reliability
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8. Application of FMEA
There are two main schools of thought about the
methodology to use and which is most effective?
• Rose with a different name
• Procedure
• Document formats
• Adherence to ISO / TS 16949
• Basis for ISO / TS 26262
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9. Application of FMEA
To get the best out of FMEA you should have:
• Cross functional team
• FMEA Moderator / Facilitator
• Props and documentation
• Structured approach
• FMEA Software
• Management Support!
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12. Effective FMEA
Step 2: Runs in line with other engineering techniques, such as
Function Analysis System Technique (FAST)
How?Why?Effects Causes
Accelerator input circuit
Provides specified voltage stimulus for
the accelerator pedal target point
Capacitor #38
Filter noise
Monolithic integrated low dropout
voltage tracker
Mirrors input voltage to output voltage
Capacitor #39
Filter noise
Diode #6
Protection
Programmed Microcontroller
Provides accelerator target stimulus
PCB circuit track
Maintain electrical continuity
Accelerator input circuit
Conditions accelerator target wiper
signal
Electronic drive control
Sends a timely motor speed target to the
controllers
Mode
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13. Accelerator input circuit
Provides specified voltage stimulus for
the accelerator pedal target point
Capacitor #38
Filter noise
Monolithic integrated low dropout
voltage tracker
Mirrors input voltage to output voltage
Capacitor #39
Filter noise
Diode #6
Protection
Programmed Microcontroller
Provides accelerator target stimulus
PCB circuit track
Maintain electrical continuity
Accelerator input circuit
Conditions accelerator target wiper
signal
Electronic drive control
Sends a timely motor speed target to the
controllers
Effective FMEA
Focus on functions provide guidance for the analysis of
failures, or step 3.
• Loss of Voltage stimulus
• Corrupted Voltage stimulus
• Voltage stimulus when not
required
• Signal stuck at ground
• Signal stuck at specified
voltage
• Signal is corrupted
• Short
• Open
Effects CausesMode
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14. Effective FMEA
Step 3: Efficient construction of effective possible failure
scenarios
Effects Causes
Accelerator input circuit
Loss of voltage stimulus for accellerator
pedal target point
Capacitor #38
Short
Monolithic integrated low dropout voltage
tracker
Output loss when input is high
Diode #6
Shorted to ground
Diode #6
Open
Programmed Microcontroller
Output stuck low
PCB circuit track
Loss of electrical continuity
Accelerator input circuit
Point of target wiper signal stuck at ground
Mode
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15. Effective FMEA
Step 4: Possible failure scenarios are displayed in a fashion that
is consistent with previous steps
Failure Effect(s) S Failure Mode Failure Cause(s)
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16. Effective FMEA
AIAG form can be unintentionally misleading
Mode Causes
Effects
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18. Effective FMEA
Step 4: Ensuring that only the controls that are
currently in fruition are considered when calculating
the risk
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19. Effective FMEA
Step 4: Analysis of the data using RPN is not just 1-
1000, there are 120 values that can result from SxOxD,
which may not reflect criticality.
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20. Effective FMEA
Common sense shall prevail by looking at the risk
assessment results in a different way e.g.:
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Automotive
risk model
21. Effective FMEA
Step 5: Reduction of the risk is displayed in a
Chronological order
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22. Effective FMEA
Create your own descriptions of the risk factors of
Severity (S), Occurrence (O) and Detection (D):
• Reflect what you do as a business
• Reflect the product you make
• Is there a customer mandate?
• Using ‘rule of thumb’ statements & benchmark
examples
• Use AIAG descriptions as guidance*
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23. Use Software for FMEA
Due to the complexities of modern products &
processes, software is essential. Many companies use
MS Excel, but dedicated software can provide a visual
representation of:
• the system analysed
• interfaces between sub-systems, plus inputs and
outputs
• complex relationships between the failures
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24. Use Software for FMEA
In addition to this dedicated software allows the FMEA to:
• be filtered or colour coded according to your own
criteria
• produce additional statistical data and additional quality
documentation as a consequence
• Switch easily between FMEA form layouts
• handles variances
• Supports delegation and tracking of corrective measures
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25. Use an FMEA facilitator
• Experienced FMEA facilitation will ultimately save time
and make meetings more focused & constructive.
• An experienced FMEA facilitation minimises digression
into different types of FMEA.
• An external FMEA facilitator may ask the ‘stupid
questions’ that may have been overlooked as they may
be thinking outside of the box
• An effective FMEA records intellectual capital for the
future developments (semantics)
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Call last week
FMEA guy kick into touch
Est. 2007 / Experience2000 - Europe, Asia, Americas, Scandinavia, Africa
Exposure: Automotive, Aerospace, Medical, Nuclear, Food & Marine
Exposure to products: PCB, Dynamic positioning systems, Cranes, power train, Heaters, Medical devices
Frustrations about not doing FMEA effectively (Time? Bad reputation?)
Before event – aftter fact
Mistake here is that people don’t record potential events because of the “we have already fixed it with controls”
FMEA is a living document that captures the intellectual capital within the business and is therefore a record of mistakes made, solutions to problems discovered and communication within the business.
Discovery of weaknesses within a system are discovered by quantifying risk, which takes into account the current controls. It is widely used in manufacturing industries in various phases of the product life cycle.
1949: US military on the 9th November (MIL-P-1649) to analyse equipment reliability in order to minimise losses of personnel and equipment.
1963: NASA for the Apollo project.
1965: adopted by the aerospace industry.
1975: nuclear power engineering..
1977: 1st deployed within the automotive industry by Ford
1986: VDA: Quality Assurance Prior to Serial Application
1992: formation of QS-9000
subsequently taken up by medicine, telecommunication and non-technological companies.
1996: Verband der Automobileindustrie (VDA) volume 4, part 2, Quality Assurance Prior to Serial Application with the subtitle System FMEA was published.
2000: TS/ISO 16949 standard. This SAE paper served for the revision of the FMEA as the QS-9000 3rd edition.
2008: QS-9000 4th Edition is officially released and is now re-branded as AIAG (Automotive Industry Action Group).
Bad reputation due to being undertaken inefficiently / effectively
Proof of due diligence
Determine HAZARDS
VDA, ISO 9001 ISO/TS 16949
Milestones – different types of FMEA
£1 spent on FMEA can save £1,000 at a later date!
Fits in with existing company norms regardless of the buzz words used to brand the product life cycle
This VDA approach
coerces the FMEA participants to analyse,
Focus
re-analysing previous steps
ultimately ensuring that all potential risks have been considered and dealt with accordingly.
Disciplined approach is now widely employed by many international manufacturing companies as has 5 clear stages
Core and peripheral team members
Structured approach (prioritised)
Without Management > ‘check box exercise’
All singing from the same ‘hymn sheet’
Effort made at the start
The document is the end result
Influential factors
Charles Bytheway 1964 - Higher Order & Lower Order Functions
Why? & How?
Verb noun description
MODE = Way something is done or happens – intended behaviour
Cause / Effect levels
Provides focus & promotes understanding
Why Green?
Captures the thought process of the design
Positives & Negatives
Why red? red represents danger in most cultures (not China)
MALFUNCTIONS
Step 2 offer suggested possible Failure Causes & Effects
Logical layout is more representative of a domino effect
Well market
widely used
Many columns make it daunting
Cause and effect confussion - ambiguous
Severity value relationship confusing i.e. S of the cause??
Keeps being revised and is gradually become more VDA in it’s appearance
living document that needs to be easy to pick up, understand and then modify
Minimises opportunity for erroneous entries
Efficient use of paper (when printed)
Mnemonic E = mc2 . mass–energy equivalence
People feel coerced to fill out the cells and sometimes they do so with controls that they intend, or are going to do.
S=10 x O=1 x D=10
S=1 x O=10 x D=10
>>S=10 x O=10 x D=1
Green is no action
Amber will be dealt with as a continual improvement task, but is not priority
Red deemed to warrant action
Combination of RPN and SxO according to Company Norms
Focus on high D?
Allows you to add Guestimates and recommended actions to one cell i.e. Do not have to move from recommended to action taken columns
S=9/10 is always about injury to end user, laws, HS and regulations etc
AIAG is not always the best
Severity from design
Chair meetings and listen to all
Semantics= The meaning of a word, phrase, sentence, or text
Summarise.. FMEA if done correctly takes time, but will
Cost reduction and increased profits
Demand for higher quality
Extended warranty periods
Product liability
Quality standard demands
Retention of knowledge
Make processes more robust
Enhanced communication within the business, customer & suppliers
Shorter development times
Functional Safety & Reliability