FMEA

FMEA
• Failure Mode and Effects Analysis (FMEA for
short) is a systematic way to identify and
evaluate the potential failures of a product or
process. It provides a formal process for
eliminating or mitigating the risks of a failure.
It is an on-going process that documents and
tracking problems and changes through the
product development phase.
 FMEA Contd…
• A formal, structured process which is applied
in developing something new to assure that as
many potential problems as are reasonably
possible to predict have been considered,
analyzed, and their causes remedied before
the item under development reaches the
hands of the end user.
 FMEA Contd…
FMEA Applicable to
• product development
• idea development
• organization development
• process development
• software development
 Objective of FMEA
• To identify early in the product or process
design all manner of failures so they can be
eliminated or their impact reduced through
redesign at the earliest possible time.
 Process of FMEA
Step 1:Identify the Adverse Effects of Major
Process Performance Failures:
First, determine the outcomes of a process
failure.
Step 2: Identify the Process Steps Associated
With Each Failure: Walk through the steps in
the process that have failed.
 Process of FMEA Contd…
Step 3: List the Failure Modes
The failure mode is a description of the
malfunction at a process step. The failure
mode can be an effect (output) associated
with a failure in a previous operation or it can
be a cause (input) associated with a failure in
a subsequent operation.
 Process of FMEA Contd…
Step 4: List All the Causes for Each Failure Mode: In
this step, the team looks at all the sources of
process variation that cause the failure mode to
occur.
Step 5: Assign Severity, Occurrence and Detection
Ratings After identifying the cause, designate a
risk priority number—either 2, 5 or 7—for the
severity of the effect, the frequency of the cause
and the ability to detect the issue in the future.
 Process of FMEA Contd…
• The severity rating defines how much the effect
impacts the company. For example, a safety issue that
could result in an injury would receive a high severity
rating of 7 (very severe). If a minor defect in a product
doesn’t impact customer satisfaction, the continuous
improvement (CI) team might designate a 5 (moderate)
or 2 (not severe).
• The occurrence rating is the frequency that a failure
cause occurs. A rating of 2 means it’s not likely the
cause will reoccur, a 5 means there’s a moderate
chance it will repeat, and a 7 means the cause will
likely reoccur.
 Process of FMEA Contd…
• The detection rating determines the
capabilities of current methods or devices in
place to prevent or detect failure modes or
causes. A rating of 2 means the cause is likely
detectable, 5 means it’s moderately
detectable, and 7 means the cause is unlikely
detectable.
 Process of FMEA Contd…
• Step 6: Calculate the Risk Priority Number for
Each Cause Multiply the three ratings
(detection × occurrence × severity = risk
priority number) to establish the risk priority
number for each cause.
• Step 7: List the Current Controls for Each
Cause: If there already a control plan in place
to prevent future failures, then list all of them.
 Process of FMEA Contd…
• Step 8: Determine the Effectiveness of the
Current Controls Check to see whether there
are controls in place and whether they’re
effective and sustainable.
• Step 9: Determine Corrective Actions Start
working on the cause that has the highest risk
priority number and take corrective actions.
• Step 10: Recalculate All Risk Priority Numbers
Reassess the severity, occurrence and
detection ratings and recalculate the risk
priority numbers. If the process is satisfactory,
leave it alone and move on to the next-highest
risk priority. If the process needs further
refinement, keep working on it until it reaches
an acceptable level.
 Types of FMEA
• System – focuses on global system functions.
• Design – focuses on components and
subsystems.
• Process – focuses on manufacturing and
assembly processes.
• Service – focuses on service functions.
• Software – focuses on software functions.