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Effective FMEA for Product Safety

Failure Mode & Effect Analysis (FMEA) is a process that identifies potential failures in a design, manufacturing or production process. It determines the effects of failures and identifies actions to address issues with high risks. An FMEA involves identifying failure modes and their causes and effects. It determines the severity, occurrence, and detection rating of each failure and calculates a Risk Priority Number. The FMEA process aims to prevent problems and reduce costs by identifying and addressing high risk failures.

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164 views16 pages

Effective FMEA for Product Safety

Failure Mode & Effect Analysis (FMEA) is a process that identifies potential failures in a design, manufacturing or production process. It determines the effects of failures and identifies actions to address issues with high risks. An FMEA involves identifying failure modes and their causes and effects. It determines the severity, occurrence, and detection rating of each failure and calculates a Risk Priority Number. The FMEA process aims to prevent problems and reduce costs by identifying and addressing high risk failures.

Uploaded by

Owais
Copyright
© © All Rights Reserved
We take content rights seriously. If you suspect this is your content, claim it here.
Available Formats
Download as PPTX, PDF, TXT or read online on Scribd

Failure Mode & Effect Analysis

Haroon Chughtai
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
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
Process Steps

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
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
FMEA Inputs and Outputs
Information
Flow

Inputs Outputs

C&E Matrix List of actions to prevent


Process Map causes or detect failure
Process History modes
Procedures
Knowledge FMEA History of actions taken
Experience
The FMEA Form
A Closer Look

Identify failure modes Determine and assess


Identify causes of the Prioritize
and their effects actions
failure modes
and controls

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