This document provides an overview of failure mode and effects analysis (FMEA). It defines key terms like failure mode and effects analysis. It explains that FMEA is a process to identify all possible product failures and their consequences. The document notes that FMEA helps prevent problems, reduce costs, and improve customer satisfaction. It outlines the resources, process, types of FMEA, advantages, and limitations of FMEA.

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

9. Types of FMEA

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