Design and Process

Failure Mode
and
Effect Analysis
(DFMEA & PFMEA)

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What is Failure Mode Effects nalysis (FMEA)?
• FMEA is a structured method to systematically identify
and correct potential product or process failures before
they occur, to
– eliminate the causes of the potential failure modes,
and/or
– reduce a severity of the failure.
• The benefits of doing an FMEA on an existing or new
process are:
– Identifying ways the process can fail
– Prioritizing these failures for corrective and
preventive action or redesign before the failures occur
– Higher system reliability once countermeasures are
implemented

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 Information gained from FMEA
1. Listing of potential failure modes and
failure causes. These could help guide the
system testing and inspection techniques.
2. Further designation (criticality) of
potential failures that could affect
overall system performance.
3. Detection and control measures for each
failure mode.
4. Management information.
5. Input for further analysis

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 Definitions
Failure mode:
 Is any event which causes a functional failure,
e.g., hose leak.
Failure Effect
 Describe what happens when a failure mode
occurs, e.g. hose leak results in oil spills.
Cause
Why it fails (or may fail)
e.g. poor hose manufacturing, improper pressure
Causes occur with some likelihood or probability

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 Types Of FMEA
• Project/Program:
– Identifies what can go wrong with a major project
• Design:
– Identifies what can go wrong with the design of a
product or service. Consideration for System,
Subsystem, Component.
• Process:
– Identifies what can go wrong with a process
• Service:
– Identifies what can go wrong with a service function
• Application:
– Identifies what can go wrong with customers using
your product or service
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 Design or Process FMEA
• Every product or process has modes of failure.
• The effects represent the impact of the
failures.
• An FMEA is a tool to:
– Identify the relative risks designed into a product
or process,
– Initiate action plan to reduce those risks with the
highest potential impact,
– Track the results of the action plan in terms of risk
reduction.
• FMEAs help us focus on and understand the
impact of potential process or product risks.
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 Design FMEA
• The primary objective of DFMEA is to
uncover potential failures associated with
the product.
• Could use:
– Product malfunction
– Shortened product life
– Safety hazards while using the product.
• DFMEA should be used throughout the
design product – from preliminary design
until the product goes to production

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 Process FMEA
• The primary objective of PFMEA is to
uncover potential failures that can:
– Impact Product Quality
– Reduce Process reliability
– Cause Customer dissatisfaction
– Create Safety or Environmental.
• Ideally, PFMEAs should be conducted prior
to start-up of a new process, but they
could be conducted on existing processes
as well.

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 Risk Priority Number (RPN)
• Risk Priority Numbers (RPNs) are numerical assessments
of risk.
• RPN values range from 1 to 1000. To use RPNs, the
analyst evaluates each failure mode and determines the
Severity, Occurrence, and Detection level in each case.
• All three of these parameters are based on a 1-10 scale.
– Score of 10 indicates the most severe, most likely to
occur, and least likely to be detected failure mode.
• The calculation of RPN is then defined as:

RPN = SEV x OCC x DET

Effects Causes Controls

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 Severity Rating Scale Example
Rating Description
10 Dangerously High
9 Extremely High
8 Very High
7 High
6 Moderate
5 Low
4 Very Low
3 Minor
2 Very Minor
1 None
Definition
Failure could injure the customer or an employee
Failure would create noncompliance with federal regulations
Failure renders the unit inoperable or unfit for use
Failure causes a high degree of customer dissatisfaction
Failure results in a subsystem or partial malfunction of the
product
Failure creates enough of a performance loss to cause the
customer to complain
Failure can be overcome with modifications to the customer’s
process or product, but there is minor performance loss
Failure would create a minor nuisance to the customer, but the
customer can overcome it in the process or product without
performance loss.
Failure would not be readily apparent to the customer, but
would have minor effects on the customer’s process or
product
Failure would not be noticeable to the customer and would not
affect the customer’s process or product.
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 Occurrence Rating Scale Example
Rating Description Potential Failure Rate

10 Very High – More than one occurrence per day or a probability of more than three
Failure is almost occurrences in 10 events (Cpk < 0.33).
inevitable
9 One occurrence every three to four days or a probability of three
occurrences in 10 events (Cpk approximately equal to 0.33).
8 High – Repeated One occurrence per week or a probability of 5 occurrences in 100 events
failures (Cpk approximately equal to 0.67).
7 One occurrence every month or one occurrence in 100 events (Cpk
approximately equal to 0.83)
6 Moderate – One occurrence every three months or three occurrences in 1,000 events
Occasional failures (Cpk approximately equal to 1.00)
5 One occurrence every six months to one year or one occurrence in 10,000
events (Cpk approximately equal to 1.17)
4 One occurrence per year or six occurrences in 100,000 events (Cpk
approximately equal to 1.33)
3 Low – Relatively One occurrence every one to three years or six occurrences in 10 million
few failures events (Cpk approximately equal to 1.67)
2 One occurrence every three to five years or two occurrences in one billion
events (Cpk approximately equal to 2.00)
1 Remote – Failure is One occurrence in greater than five years or less than two occurrences in
unlikely one billion events (Cpk greater than 2.00)
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 Detection Rating Scale Example
Rating Description
10 Absolute
Uncertainty
9 Very Remote
8 Remote
7 Very Low
6 Low
5 Moderate
4 Moderately High
3 High
2 Very High
1 Almost Certain
Definition
The product is not inspected or the defect caused by failure is not
detectable.
Product is sampled, inspected and released based on Acceptable
Quality Level (AQL) sampling plans.
Product is accepted based on new defectives in a sample.
Product is 100% manually inspected in the process.
Product is 100% manually inspected using go/no go or other mistake-
proofing gages
Some Statistical Process Control (SPC) is used in process and product
is final inspected off-line
SPC is used and there is immediate reaction to out-of-control
conditions
An effective SPC program is in place with process capabilities (Cpk)
greater than 1.33
All product is 100% automatically inspected.
The defect is obvious or there is 100% automatic inspection with
regular calibration and preventive maintenance of the inspection
equipment.
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 Risk Priority Number (RPN)

Traditional Strategy for Addressing Failure Modes:

1. Reduce the severity
2. Reduce the occurrence
3. Improve the detection
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 FMEA-risk priority number
The Problem with Risk Priority Numbers
Shortcomings of RPN Method

A 8 4 3 96

B 4 8 3 96

Same
FOCUS ON SEVERITY
Result
10 steps to complete
FMEA
1. Review the process
2. Brainstorm potential failure modes
3. List potential effects of each failure mode
4. Assign severity rating
1 – 10 scale; 1(lowest) – 10 (highest)
5. Assign occurrence rating
1 – 10 scale; 1(lowest) – 10 (highest)
6. Assign detection rating
1 – 10 scale; 1(most likely to detect) – 10 (least likely to detect)
7. Calculate the risk priority number (RPN) for each failure mode
Multiply severity x occurrence x detection = RPN or Criticality
8. Prioritize the failure modes for action
Perform a Root Cause Analysis for the most critical failure
modes
9. Take action to eliminate or reduce the high-risk modes
10. Recalculate the resulting risk priority number
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FMEA Worksheet for Fire Extinguisher

Kamel

Kamel
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FMEA Worksheet

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