SlideShare a Scribd company logo
1 of 16
Prepared by..
Janaki Patel(140110105033)
Jay Patel(140110105034)
Kevin Patel(140110105035)
Mihir Patel(140110105036)
What is FMEA?
• Failure mode - the way in which something
might fail
• Effects analysis – studying the consequences of
the various failure modes to determine their
severity to the customer.
Simply put FMEA is:
• A process that identifies all the possible types of
failures that could happen to a product and
potential consequences of those failures.
Why do an FMEA?
• Preventing problems is cheaper and easier than
cleaning them up.
• Some things are too risky or costly to incur
mistakes.
Resources Needed
• Commitment of top management
• Knowledgeable individuals
• Individuals attentive to FMEA timelines
• People resources may be internal or external to
the business or a combination of both
FMEA Provides the Potential to:
• Reduce the likelihood of customer complaints
• Reduce the likelihood of campaign changes
• Reduce maintenance and warranty costs
• Reduce the possibility of safety failures
• Reduce the possibility of extended life or
reliability failures
• Reduce the likelihood of product liability claims
Advantages
• Enhance design and manufacturing efficiencies
• Alleviate late change crises
• Minimize exposure to product failures
• Augment business records
• Improve “bottom line” results
• Add to customer satisfaction
Limitation
• Employee training requirements
• Initial impact on product and manufacturing
schedules
• Financial impact required to upgrade design,
manufacturing, and process equipment and
tools
Types of FMEA
Back Ground Task for PFMEA (Process
FMEA)
1. Details of the manufacturing
process/Process flow chart
2. List of critical process parameters
(Temperature, Pressure, etc.)
3. Properties of device material
(brittleness, density etc.)
4. Manufacturing environment details
5. Manufacturing Tool details
6. Batch to batch variation
Back Ground Task for DFMEA
(Design FMEA)
1. Detail design of Device
2. Part/Component list
3. Functions of components
4. Theory/principle for the positioning of different
components at their respective places (pin, sieve etc)
5. Operating environment conditions (Humidity level,
Pressure, Temp etc)
6. Design Specifications (with Tolerances)
7. Details of operating methods (pin movement fidelity,
fatigue effects etc)
8. Critical parameters of design and its dimensions
FMEA Procedure
1. For each process input (start with high value inputs),
determine the ways in which the input can go wrong
(failure mode)
2. For each failure mode, determine effects
▫ Select a severity level for each effect
3. Identify potential causes of each failure mode
▫ Select an occurrence level for each cause
4. List current controls for each cause
▫ Select a detection level for each cause
12
Process Steps
FMEA Procedure (Cont.)
5. Calculate the Risk Priority Number (RPN)
6. Develop recommended actions, assign responsible
persons, and take actions
▫ Give priority to high RPNs
▫ MUST look at severities rated a 10
7. Assign the predicted severity, occurrence, and detection
levels and compare RPNs
13
Process Steps
FMEA Inputs and Outputs
14
FMEA
C&E Matrix
Process Map
Process History
Procedures
Knowledge
Experience
List of actions to prevent
causes or detect failure
modes
History of actions taken
Inputs Outputs
Information
Flow
The FMEA Form
15
Identify failure modes
and their effects
Identify causes of the
failure modes
and controls
Prioritize
Determine and assess
actions
A Closer Look
Preparing FMEA for device manufacturing

More Related Content

What's hot

6 OEE overview
6 OEE overview6 OEE overview
6 OEE overviewWebseology
 
Process Failure Modes & Effects Analysis (PFMEA)
Process Failure Modes & Effects Analysis (PFMEA)Process Failure Modes & Effects Analysis (PFMEA)
Process Failure Modes & Effects Analysis (PFMEA)Anand Subramaniam
 
Poka Yoke - Fundamentals by Praneet Surti
Poka Yoke - Fundamentals by Praneet SurtiPoka Yoke - Fundamentals by Praneet Surti
Poka Yoke - Fundamentals by Praneet SurtiPraneet Surti
 
Overall Equipment Effectiveness
Overall Equipment EffectivenessOverall Equipment Effectiveness
Overall Equipment EffectivenessAnand Subramaniam
 
Manufacturing simulation
Manufacturing simulationManufacturing simulation
Manufacturing simulationsameer agrawal
 
Administración visual (av)
Administración visual (av)Administración visual (av)
Administración visual (av)Cinthia Vazquez
 
Gemba walk: the start of your lean journey
Gemba walk: the start of your lean journeyGemba walk: the start of your lean journey
Gemba walk: the start of your lean journeyboscollkid
 
FAILURE MODE EFFECT ANALYSIS
FAILURE MODE EFFECT ANALYSISFAILURE MODE EFFECT ANALYSIS
FAILURE MODE EFFECT ANALYSISANOOPA NARAYANAN
 
Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)DEEPAK SAHOO
 
Human error as a root cause
Human error as a root causeHuman error as a root cause
Human error as a root causeJignesh Bhadani
 
Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)Abou Ibri
 
Poka yoke error proofing
Poka yoke error proofing Poka yoke error proofing
Poka yoke error proofing ssusercee91d
 

What's hot (20)

Mistake proofing smpl_1
Mistake proofing smpl_1Mistake proofing smpl_1
Mistake proofing smpl_1
 
Failure Mode Effect Analysis - FMEA
Failure Mode Effect Analysis - FMEAFailure Mode Effect Analysis - FMEA
Failure Mode Effect Analysis - FMEA
 
FMEA
FMEAFMEA
FMEA
 
6 OEE overview
6 OEE overview6 OEE overview
6 OEE overview
 
Process Failure Modes & Effects Analysis (PFMEA)
Process Failure Modes & Effects Analysis (PFMEA)Process Failure Modes & Effects Analysis (PFMEA)
Process Failure Modes & Effects Analysis (PFMEA)
 
Poka Yoke - Fundamentals by Praneet Surti
Poka Yoke - Fundamentals by Praneet SurtiPoka Yoke - Fundamentals by Praneet Surti
Poka Yoke - Fundamentals by Praneet Surti
 
Overall Equipment Effectiveness
Overall Equipment EffectivenessOverall Equipment Effectiveness
Overall Equipment Effectiveness
 
Manufacturing simulation
Manufacturing simulationManufacturing simulation
Manufacturing simulation
 
Administración visual (av)
Administración visual (av)Administración visual (av)
Administración visual (av)
 
Process fmea
Process fmea Process fmea
Process fmea
 
9. design of experiment
9. design of experiment9. design of experiment
9. design of experiment
 
Gemba walk: the start of your lean journey
Gemba walk: the start of your lean journeyGemba walk: the start of your lean journey
Gemba walk: the start of your lean journey
 
FAILURE MODE EFFECT ANALYSIS
FAILURE MODE EFFECT ANALYSISFAILURE MODE EFFECT ANALYSIS
FAILURE MODE EFFECT ANALYSIS
 
Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)
 
Dpmo
DpmoDpmo
Dpmo
 
8 Wastes
8 Wastes8 Wastes
8 Wastes
 
Toyotismo
ToyotismoToyotismo
Toyotismo
 
Human error as a root cause
Human error as a root causeHuman error as a root cause
Human error as a root cause
 
Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)Failure Mode Effect Analysis (FMEA)
Failure Mode Effect Analysis (FMEA)
 
Poka yoke error proofing
Poka yoke error proofing Poka yoke error proofing
Poka yoke error proofing
 

Similar to Preparing FMEA for device manufacturing

FMEA failure-mode-and-effect-analysis_Occupational safety and health
FMEA failure-mode-and-effect-analysis_Occupational safety and healthFMEA failure-mode-and-effect-analysis_Occupational safety and health
FMEA failure-mode-and-effect-analysis_Occupational safety and healthJing Jing Cheng
 
fmea-130116034507-phpapp01.pdf
fmea-130116034507-phpapp01.pdffmea-130116034507-phpapp01.pdf
fmea-130116034507-phpapp01.pdfRajendran C
 
Failure mode effect_analysis_fmea
Failure mode effect_analysis_fmeaFailure mode effect_analysis_fmea
Failure mode effect_analysis_fmeaJitesh Gaurav
 
Failure Mode Effect Analysis in Engineering Failures
Failure Mode Effect Analysis in Engineering FailuresFailure Mode Effect Analysis in Engineering Failures
Failure Mode Effect Analysis in Engineering FailuresPadmanabhan Krishnan
 
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)Prashant Rasekar
 
failure modes and effects analysis (fmea)
failure modes and effects analysis (fmea)failure modes and effects analysis (fmea)
failure modes and effects analysis (fmea)palanivendhan
 
Failure mode and effects analysis
Failure mode and effects analysisFailure mode and effects analysis
Failure mode and effects analysisDeep parmar
 
IT 381_Chap_7.ppt
IT 381_Chap_7.pptIT 381_Chap_7.ppt
IT 381_Chap_7.pptRajendran C
 
Failure mode effects analysis, Computer Integrated Manufacturing, Quality fun...
Failure mode effects analysis, Computer Integrated Manufacturing, Quality fun...Failure mode effects analysis, Computer Integrated Manufacturing, Quality fun...
Failure mode effects analysis, Computer Integrated Manufacturing, Quality fun...SUNDHARAVADIVELR1
 
FMEA presentation for research and development
FMEA presentation for research and developmentFMEA presentation for research and development
FMEA presentation for research and developmentbasant11731
 
FMEA análise e odos de falhas e seus efeitos.ppt
FMEA análise e odos de falhas e seus efeitos.pptFMEA análise e odos de falhas e seus efeitos.ppt
FMEA análise e odos de falhas e seus efeitos.pptGleibsonHenrique
 
IT 381_Chap hubybybybybybybytggyguh7h7_7.ppt
IT 381_Chap hubybybybybybybytggyguh7h7_7.pptIT 381_Chap hubybybybybybybytggyguh7h7_7.ppt
IT 381_Chap hubybybybybybybytggyguh7h7_7.pptksujith0034
 
DFMEA DR & DVP 261113 KCV
DFMEA DR & DVP 261113 KCVDFMEA DR & DVP 261113 KCV
DFMEA DR & DVP 261113 KCVKamal Vora
 

Similar to Preparing FMEA for device manufacturing (20)

FMEA failure-mode-and-effect-analysis_Occupational safety and health
FMEA failure-mode-and-effect-analysis_Occupational safety and healthFMEA failure-mode-and-effect-analysis_Occupational safety and health
FMEA failure-mode-and-effect-analysis_Occupational safety and health
 
Mahi2
Mahi2Mahi2
Mahi2
 
Mahi2
Mahi2Mahi2
Mahi2
 
fmea-130116034507-phpapp01.pdf
fmea-130116034507-phpapp01.pdffmea-130116034507-phpapp01.pdf
fmea-130116034507-phpapp01.pdf
 
Failure mode effect_analysis_fmea
Failure mode effect_analysis_fmeaFailure mode effect_analysis_fmea
Failure mode effect_analysis_fmea
 
FMEA
FMEAFMEA
FMEA
 
Failure Mode Effect Analysis in Engineering Failures
Failure Mode Effect Analysis in Engineering FailuresFailure Mode Effect Analysis in Engineering Failures
Failure Mode Effect Analysis in Engineering Failures
 
FMEA.pptx
FMEA.pptxFMEA.pptx
FMEA.pptx
 
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
PFMEA, Risk Reduction and Effectiveness – Advance (AIAG FMEA #4 Edition)
 
failure modes and effects analysis (fmea)
failure modes and effects analysis (fmea)failure modes and effects analysis (fmea)
failure modes and effects analysis (fmea)
 
Failure Mode & Effects Analysis (FMEA)
Failure Mode & Effects Analysis (FMEA)Failure Mode & Effects Analysis (FMEA)
Failure Mode & Effects Analysis (FMEA)
 
Failure mode and effects analysis
Failure mode and effects analysisFailure mode and effects analysis
Failure mode and effects analysis
 
FMEA
FMEAFMEA
FMEA
 
IT 381_Chap_7.ppt
IT 381_Chap_7.pptIT 381_Chap_7.ppt
IT 381_Chap_7.ppt
 
Failure mode effects analysis, Computer Integrated Manufacturing, Quality fun...
Failure mode effects analysis, Computer Integrated Manufacturing, Quality fun...Failure mode effects analysis, Computer Integrated Manufacturing, Quality fun...
Failure mode effects analysis, Computer Integrated Manufacturing, Quality fun...
 
FMEA presentation for research and development
FMEA presentation for research and developmentFMEA presentation for research and development
FMEA presentation for research and development
 
FMEA análise e odos de falhas e seus efeitos.ppt
FMEA análise e odos de falhas e seus efeitos.pptFMEA análise e odos de falhas e seus efeitos.ppt
FMEA análise e odos de falhas e seus efeitos.ppt
 
IT 381_Chap hubybybybybybybytggyguh7h7_7.ppt
IT 381_Chap hubybybybybybybytggyguh7h7_7.pptIT 381_Chap hubybybybybybybytggyguh7h7_7.ppt
IT 381_Chap hubybybybybybybytggyguh7h7_7.ppt
 
DFMEA DR & DVP 261113 KCV
DFMEA DR & DVP 261113 KCVDFMEA DR & DVP 261113 KCV
DFMEA DR & DVP 261113 KCV
 
FMICA ppt
FMICA pptFMICA ppt
FMICA ppt
 

Recently uploaded

result management system report for college project
result management system report for college projectresult management system report for college project
result management system report for college projectTonystark477637
 
Java Programming :Event Handling(Types of Events)
Java Programming :Event Handling(Types of Events)Java Programming :Event Handling(Types of Events)
Java Programming :Event Handling(Types of Events)simmis5
 
(RIA) Call Girls Bhosari ( 7001035870 ) HI-Fi Pune Escorts Service
(RIA) Call Girls Bhosari ( 7001035870 ) HI-Fi Pune Escorts Service(RIA) Call Girls Bhosari ( 7001035870 ) HI-Fi Pune Escorts Service
(RIA) Call Girls Bhosari ( 7001035870 ) HI-Fi Pune Escorts Serviceranjana rawat
 
UNIT - IV - Air Compressors and its Performance
UNIT - IV - Air Compressors and its PerformanceUNIT - IV - Air Compressors and its Performance
UNIT - IV - Air Compressors and its Performancesivaprakash250
 
Structural Analysis and Design of Foundations: A Comprehensive Handbook for S...
Structural Analysis and Design of Foundations: A Comprehensive Handbook for S...Structural Analysis and Design of Foundations: A Comprehensive Handbook for S...
Structural Analysis and Design of Foundations: A Comprehensive Handbook for S...Dr.Costas Sachpazis
 
The Most Attractive Pune Call Girls Manchar 8250192130 Will You Miss This Cha...
The Most Attractive Pune Call Girls Manchar 8250192130 Will You Miss This Cha...The Most Attractive Pune Call Girls Manchar 8250192130 Will You Miss This Cha...
The Most Attractive Pune Call Girls Manchar 8250192130 Will You Miss This Cha...ranjana rawat
 
247267395-1-Symmetric-and-distributed-shared-memory-architectures-ppt (1).ppt
247267395-1-Symmetric-and-distributed-shared-memory-architectures-ppt (1).ppt247267395-1-Symmetric-and-distributed-shared-memory-architectures-ppt (1).ppt
247267395-1-Symmetric-and-distributed-shared-memory-architectures-ppt (1).pptssuser5c9d4b1
 
(SHREYA) Chakan Call Girls Just Call 7001035870 [ Cash on Delivery ] Pune Esc...
(SHREYA) Chakan Call Girls Just Call 7001035870 [ Cash on Delivery ] Pune Esc...(SHREYA) Chakan Call Girls Just Call 7001035870 [ Cash on Delivery ] Pune Esc...
(SHREYA) Chakan Call Girls Just Call 7001035870 [ Cash on Delivery ] Pune Esc...ranjana rawat
 
(PRIYA) Rajgurunagar Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
(PRIYA) Rajgurunagar Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...(PRIYA) Rajgurunagar Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
(PRIYA) Rajgurunagar Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...ranjana rawat
 
UNIT-III FMM. DIMENSIONAL ANALYSIS
UNIT-III FMM.        DIMENSIONAL ANALYSISUNIT-III FMM.        DIMENSIONAL ANALYSIS
UNIT-III FMM. DIMENSIONAL ANALYSISrknatarajan
 
CCS335 _ Neural Networks and Deep Learning Laboratory_Lab Complete Record
CCS335 _ Neural Networks and Deep Learning Laboratory_Lab Complete RecordCCS335 _ Neural Networks and Deep Learning Laboratory_Lab Complete Record
CCS335 _ Neural Networks and Deep Learning Laboratory_Lab Complete RecordAsst.prof M.Gokilavani
 
Processing & Properties of Floor and Wall Tiles.pptx
Processing & Properties of Floor and Wall Tiles.pptxProcessing & Properties of Floor and Wall Tiles.pptx
Processing & Properties of Floor and Wall Tiles.pptxpranjaldaimarysona
 
Call for Papers - African Journal of Biological Sciences, E-ISSN: 2663-2187, ...
Call for Papers - African Journal of Biological Sciences, E-ISSN: 2663-2187, ...Call for Papers - African Journal of Biological Sciences, E-ISSN: 2663-2187, ...
Call for Papers - African Journal of Biological Sciences, E-ISSN: 2663-2187, ...Christo Ananth
 
Booking open Available Pune Call Girls Koregaon Park 6297143586 Call Hot Ind...
Booking open Available Pune Call Girls Koregaon Park  6297143586 Call Hot Ind...Booking open Available Pune Call Girls Koregaon Park  6297143586 Call Hot Ind...
Booking open Available Pune Call Girls Koregaon Park 6297143586 Call Hot Ind...Call Girls in Nagpur High Profile
 
College Call Girls Nashik Nehal 7001305949 Independent Escort Service Nashik
College Call Girls Nashik Nehal 7001305949 Independent Escort Service NashikCollege Call Girls Nashik Nehal 7001305949 Independent Escort Service Nashik
College Call Girls Nashik Nehal 7001305949 Independent Escort Service NashikCall Girls in Nagpur High Profile
 
(ANJALI) Dange Chowk Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
(ANJALI) Dange Chowk Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...(ANJALI) Dange Chowk Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
(ANJALI) Dange Chowk Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...ranjana rawat
 
Coefficient of Thermal Expansion and their Importance.pptx
Coefficient of Thermal Expansion and their Importance.pptxCoefficient of Thermal Expansion and their Importance.pptx
Coefficient of Thermal Expansion and their Importance.pptxAsutosh Ranjan
 
MANUFACTURING PROCESS-II UNIT-2 LATHE MACHINE
MANUFACTURING PROCESS-II UNIT-2 LATHE MACHINEMANUFACTURING PROCESS-II UNIT-2 LATHE MACHINE
MANUFACTURING PROCESS-II UNIT-2 LATHE MACHINESIVASHANKAR N
 
Top Rated Pune Call Girls Budhwar Peth ⟟ 6297143586 ⟟ Call Me For Genuine Se...
Top Rated  Pune Call Girls Budhwar Peth ⟟ 6297143586 ⟟ Call Me For Genuine Se...Top Rated  Pune Call Girls Budhwar Peth ⟟ 6297143586 ⟟ Call Me For Genuine Se...
Top Rated Pune Call Girls Budhwar Peth ⟟ 6297143586 ⟟ Call Me For Genuine Se...Call Girls in Nagpur High Profile
 

Recently uploaded (20)

result management system report for college project
result management system report for college projectresult management system report for college project
result management system report for college project
 
Java Programming :Event Handling(Types of Events)
Java Programming :Event Handling(Types of Events)Java Programming :Event Handling(Types of Events)
Java Programming :Event Handling(Types of Events)
 
(RIA) Call Girls Bhosari ( 7001035870 ) HI-Fi Pune Escorts Service
(RIA) Call Girls Bhosari ( 7001035870 ) HI-Fi Pune Escorts Service(RIA) Call Girls Bhosari ( 7001035870 ) HI-Fi Pune Escorts Service
(RIA) Call Girls Bhosari ( 7001035870 ) HI-Fi Pune Escorts Service
 
UNIT - IV - Air Compressors and its Performance
UNIT - IV - Air Compressors and its PerformanceUNIT - IV - Air Compressors and its Performance
UNIT - IV - Air Compressors and its Performance
 
Structural Analysis and Design of Foundations: A Comprehensive Handbook for S...
Structural Analysis and Design of Foundations: A Comprehensive Handbook for S...Structural Analysis and Design of Foundations: A Comprehensive Handbook for S...
Structural Analysis and Design of Foundations: A Comprehensive Handbook for S...
 
The Most Attractive Pune Call Girls Manchar 8250192130 Will You Miss This Cha...
The Most Attractive Pune Call Girls Manchar 8250192130 Will You Miss This Cha...The Most Attractive Pune Call Girls Manchar 8250192130 Will You Miss This Cha...
The Most Attractive Pune Call Girls Manchar 8250192130 Will You Miss This Cha...
 
247267395-1-Symmetric-and-distributed-shared-memory-architectures-ppt (1).ppt
247267395-1-Symmetric-and-distributed-shared-memory-architectures-ppt (1).ppt247267395-1-Symmetric-and-distributed-shared-memory-architectures-ppt (1).ppt
247267395-1-Symmetric-and-distributed-shared-memory-architectures-ppt (1).ppt
 
(SHREYA) Chakan Call Girls Just Call 7001035870 [ Cash on Delivery ] Pune Esc...
(SHREYA) Chakan Call Girls Just Call 7001035870 [ Cash on Delivery ] Pune Esc...(SHREYA) Chakan Call Girls Just Call 7001035870 [ Cash on Delivery ] Pune Esc...
(SHREYA) Chakan Call Girls Just Call 7001035870 [ Cash on Delivery ] Pune Esc...
 
(PRIYA) Rajgurunagar Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
(PRIYA) Rajgurunagar Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...(PRIYA) Rajgurunagar Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
(PRIYA) Rajgurunagar Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
 
UNIT-III FMM. DIMENSIONAL ANALYSIS
UNIT-III FMM.        DIMENSIONAL ANALYSISUNIT-III FMM.        DIMENSIONAL ANALYSIS
UNIT-III FMM. DIMENSIONAL ANALYSIS
 
Water Industry Process Automation & Control Monthly - April 2024
Water Industry Process Automation & Control Monthly - April 2024Water Industry Process Automation & Control Monthly - April 2024
Water Industry Process Automation & Control Monthly - April 2024
 
CCS335 _ Neural Networks and Deep Learning Laboratory_Lab Complete Record
CCS335 _ Neural Networks and Deep Learning Laboratory_Lab Complete RecordCCS335 _ Neural Networks and Deep Learning Laboratory_Lab Complete Record
CCS335 _ Neural Networks and Deep Learning Laboratory_Lab Complete Record
 
Processing & Properties of Floor and Wall Tiles.pptx
Processing & Properties of Floor and Wall Tiles.pptxProcessing & Properties of Floor and Wall Tiles.pptx
Processing & Properties of Floor and Wall Tiles.pptx
 
Call for Papers - African Journal of Biological Sciences, E-ISSN: 2663-2187, ...
Call for Papers - African Journal of Biological Sciences, E-ISSN: 2663-2187, ...Call for Papers - African Journal of Biological Sciences, E-ISSN: 2663-2187, ...
Call for Papers - African Journal of Biological Sciences, E-ISSN: 2663-2187, ...
 
Booking open Available Pune Call Girls Koregaon Park 6297143586 Call Hot Ind...
Booking open Available Pune Call Girls Koregaon Park  6297143586 Call Hot Ind...Booking open Available Pune Call Girls Koregaon Park  6297143586 Call Hot Ind...
Booking open Available Pune Call Girls Koregaon Park 6297143586 Call Hot Ind...
 
College Call Girls Nashik Nehal 7001305949 Independent Escort Service Nashik
College Call Girls Nashik Nehal 7001305949 Independent Escort Service NashikCollege Call Girls Nashik Nehal 7001305949 Independent Escort Service Nashik
College Call Girls Nashik Nehal 7001305949 Independent Escort Service Nashik
 
(ANJALI) Dange Chowk Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
(ANJALI) Dange Chowk Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...(ANJALI) Dange Chowk Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
(ANJALI) Dange Chowk Call Girls Just Call 7001035870 [ Cash on Delivery ] Pun...
 
Coefficient of Thermal Expansion and their Importance.pptx
Coefficient of Thermal Expansion and their Importance.pptxCoefficient of Thermal Expansion and their Importance.pptx
Coefficient of Thermal Expansion and their Importance.pptx
 
MANUFACTURING PROCESS-II UNIT-2 LATHE MACHINE
MANUFACTURING PROCESS-II UNIT-2 LATHE MACHINEMANUFACTURING PROCESS-II UNIT-2 LATHE MACHINE
MANUFACTURING PROCESS-II UNIT-2 LATHE MACHINE
 
Top Rated Pune Call Girls Budhwar Peth ⟟ 6297143586 ⟟ Call Me For Genuine Se...
Top Rated  Pune Call Girls Budhwar Peth ⟟ 6297143586 ⟟ Call Me For Genuine Se...Top Rated  Pune Call Girls Budhwar Peth ⟟ 6297143586 ⟟ Call Me For Genuine Se...
Top Rated Pune Call Girls Budhwar Peth ⟟ 6297143586 ⟟ Call Me For Genuine Se...
 

Preparing FMEA for device manufacturing

  • 1. Prepared by.. Janaki Patel(140110105033) Jay Patel(140110105034) Kevin Patel(140110105035) Mihir Patel(140110105036)
  • 2. What is FMEA? • Failure mode - the way in which something might fail • Effects analysis – studying the consequences of the various failure modes to determine their severity to the customer.
  • 3. Simply put FMEA is: • A process that identifies all the possible types of failures that could happen to a product and potential consequences of those failures.
  • 4. Why do an FMEA? • Preventing problems is cheaper and easier than cleaning them up. • Some things are too risky or costly to incur mistakes.
  • 5. Resources Needed • Commitment of top management • Knowledgeable individuals • Individuals attentive to FMEA timelines • People resources may be internal or external to the business or a combination of both
  • 6. FMEA Provides the Potential to: • Reduce the likelihood of customer complaints • Reduce the likelihood of campaign changes • Reduce maintenance and warranty costs • Reduce the possibility of safety failures • Reduce the possibility of extended life or reliability failures • Reduce the likelihood of product liability claims
  • 7. Advantages • Enhance design and manufacturing efficiencies • Alleviate late change crises • Minimize exposure to product failures • Augment business records • Improve “bottom line” results • Add to customer satisfaction
  • 8. Limitation • Employee training requirements • Initial impact on product and manufacturing schedules • Financial impact required to upgrade design, manufacturing, and process equipment and tools
  • 10. Back Ground Task for PFMEA (Process FMEA) 1. Details of the manufacturing process/Process flow chart 2. List of critical process parameters (Temperature, Pressure, etc.) 3. Properties of device material (brittleness, density etc.) 4. Manufacturing environment details 5. Manufacturing Tool details 6. Batch to batch variation
  • 11. Back Ground Task for DFMEA (Design FMEA) 1. Detail design of Device 2. Part/Component list 3. Functions of components 4. Theory/principle for the positioning of different components at their respective places (pin, sieve etc) 5. Operating environment conditions (Humidity level, Pressure, Temp etc) 6. Design Specifications (with Tolerances) 7. Details of operating methods (pin movement fidelity, fatigue effects etc) 8. Critical parameters of design and its dimensions
  • 12. FMEA Procedure 1. For each process input (start with high value inputs), determine the ways in which the input can go wrong (failure mode) 2. For each failure mode, determine effects ▫ Select a severity level for each effect 3. Identify potential causes of each failure mode ▫ Select an occurrence level for each cause 4. List current controls for each cause ▫ Select a detection level for each cause 12 Process Steps
  • 13. FMEA Procedure (Cont.) 5. Calculate the Risk Priority Number (RPN) 6. Develop recommended actions, assign responsible persons, and take actions ▫ Give priority to high RPNs ▫ MUST look at severities rated a 10 7. Assign the predicted severity, occurrence, and detection levels and compare RPNs 13 Process Steps
  • 14. FMEA Inputs and Outputs 14 FMEA C&E Matrix Process Map Process History Procedures Knowledge Experience List of actions to prevent causes or detect failure modes History of actions taken Inputs Outputs Information Flow
  • 15. The FMEA Form 15 Identify failure modes and their effects Identify causes of the failure modes and controls Prioritize Determine and assess actions A Closer Look