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Process Failure Modes Effects Analysis http://www.biz-pi.com 1
*Process Failure
Modes Effects Analysis
PFMEA Training Course
Level 1
PFMEA
*The “P” in PFMEA = Potential, Process, or Product
**Level 1 is an “introductory” level course
Process Failure Modes Effects Analysis http://www.biz-pi.com 2
Course Content
– Course Objectives
– What is a PFMEA?
– PFMEA – Important Points
– Benefits
– When should a PFMEA be completed?
– Example
– Review
– Additional Resources
Process Failure Modes Effects Analysis http://www.biz-pi.com 3
Course Objectives
• Upon completion of this course participants
should understand:
• The importance and benefits of PFMEAs
• The basic PFMEA Structure
• The basic PFMEA Application
Process Failure Modes Effects Analysis http://www.biz-pi.com 4
What is a PFMEA?
• Analyze Risks of a business, service, or manufacturing process.
• Prevent potential and/or current defects, problems, or issues
• Analyze the effects, causes and controls of process or product defects
• Manage the improvements required to reduce or eliminate failures
• Improve flow, costs, and quality of a product or process.
• Prioritize improvement actions for management and costs decisions
A *Process Failure Modes Effects Analysis is an improvement tool used to:
*The “P” in PFMEA can stand for Potential, Process, or Product
*The PFMEA can be documented in a hard copy or software format
Process Failure Modes Effects Analysis http://www.biz-pi.com 5
What is a PFMEA?
• Example form
Process (or Product) Failure Modes Effects Analysis
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Process Failure Modes Effects Analysis http://www.biz-pi.com 6
Everything we do is a Process!
Whether it is work, school, play, manufacturing, designing, gardening, etc.
All of our normal daily routines are processes
We reduce, eliminate, and control “failures” in our daily lives in many ways…..for
example: If we wish to avoid getting “stuck in traffic”(failure mode) during morning
rush hour (cause) we may take an alternate route, this in a way is “failure
prevention”
– At each of our workplaces, the details and complexities of the processes
require a more analytical approach to this “failure prevention” a.k.a. PFMEA
In the PFMEA, it would look like this: The details will be explained later in the course
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Important Points
Process Failure Modes Effects Analysis http://www.biz-pi.com 7
A PFMEA is a “living” process analysis tool
(document) used for:
– Defining process or product problems
– Problem-solving and prevention
– Reducing, eliminating and controlling errors
– Continuous Improvement
– Enhancing efficiency (Lean) & quality (Six Sigma)
– Improving team effectiveness
– Analyzing Risks
– Prioritizing improvement activities
Important Points
Process Failure Modes Effects Analysis http://www.biz-pi.com 8
PFMEA Benefits
• You can effectively Prevent
– rework, retest, re-inspection, poor quality, higher costs, etc.
• It costs companies less to prevent problems than to react to
them (Firefighting = Dollars Wasted)
• You can improve Cycle-times
– Time, Labor, and money is more effectively spent on “preventing”
rather than “reacting” to errors
• PFMEAs make teams more effective!
By Preventing errors or problems…
You prevent waste, improve quality and cycle-times, and reduce costs !
Process Failure Modes Effects Analysis http://www.biz-pi.com 9
PFMEA Benefits
The benefit of using PFMEA’s is simple…
Problem Prevention
=
Increased profits! $$ $$
Process Failure Modes Effects Analysis http://www.biz-pi.com 10
PFMEA Benefits
• World Class companies waste approximately 2-3% of their Sales on “poor quality”
…all others greater than 4%!
• Costs of Poor Quality is estimated at 2-3 x the “tangible” numbers ($$)… this means if an average company calculates their COPQ at 5% of sales , it is realistically 10-15%! This is due to all of the “un-captured” waste ($$)!
• Example: 100M$ Sales / 10% = $10 Million Dollars! (this company spent $10M on doing things incorrectly!)
• This waste directly effects profits and job security for all!
Process Failure Modes Effects Analysis http://www.biz-pi.com 11
PFMEA Benefits
• When we wait for errors to happen and then try to correct them, this is known as “firefighting” and is VERY costly!
• When we invest the time and resources to analyze and prevent problems, this is known as Prevention, and is Less Costly.
Problem Prevention
=
Reduced Product and Process Costs! $$ $$
Process Failure Modes Effects Analysis http://www.biz-pi.com 12
What does a PFMEA do for us?
– Provides important “documentation” of the process
• Allows you to meet customer requirements
• Meets “Continuous Improvement” requirements
• Meets many industry standards such as ISO9000, QS9000, AS9100
– Tells us the “effect” a failure could have on the customer
– Tells us which “failures” we should reduce, eliminate and control
• Allows the team to focus on the important few, instead of the trivial
many
– Provides a “Prioritized” list of required improvement actions
• Improves team efficiency when solving issues
• Teams are more focused on “priorities” that impact the business
Process Failure Modes Effects Analysis http://www.biz-pi.com 13
When should it be completed?
PFMEA’s are most effective when completed:
• During the development of a new process, product,
or service
• Prior to “start-up” of a new process, product , or
service
• When evaluating new process equipment or tools
• For any business, transactional, or production
process that is being launched for use
Process Failure Modes Effects Analysis http://www.biz-pi.com 14
Good Reactive Tool
PFMEA’s are also VERY effective if completed on current
processes or products, and should be performed
where there is:
• Poor quality and low yields
• High costs
• Low profit margins
• Excessive or expensive defects
• Processes that are “Not Lean” or that have poor
throughput and cycle-times
• Chronic Supplier problems
Process Failure Modes Effects Analysis http://www.biz-pi.com 15
Preferred Approach
Reaction to Problems,
Firefighting!
PFMEA
Performed
Errors addressed
and prevented -
Process controls
in Place
Usual Approach
Preferred Approach
Problem
Identified
Business or
Manufacturing
Process
Processes have numerous risks-high cost-rework-poor quality-poor cycle-times, customer
dissatisfaction, bottlenecks, etc. due to errors and other issues
Customer
Business or
Manufacturing
Process
Customer
PFMEAs are performed TO MINIMIZE risks, rework, errors, and defects, thus improving
quality and cycle-times, resulting in lowered costs and customer satisfaction.
Poor Flow
Continuous Improvement
Process Failure Modes Effects Analysis http://www.biz-pi.com 16
How do we perform a PFMEA?
#1: Identify the process or product that requires the PFMEA
Analysis …
Recommended:
• New processes being launched
• Business, transaction, service, or manufacturing
process
• Current processes with poor yields, rework, errors,
defects, poor cycle-times, high costs, high customer
dissatisfaction, etc.
Process Failure Modes Effects Analysis http://www.biz-pi.com 17
How do we perform a PFMEA?
#1: Identify the process or product that requires the PFMEA
Analysis …
Recommended:
• New processes being launched
• Business, transaction, service, or manufacturing
process
• Current processes with poor yields, rework, errors,
defects, poor cycle-times, high costs, high customer
dissatisfaction, etc.
Process Failure Modes Effects Analysis http://www.biz-pi.com 18
How do we perform a PFMEA?
#2: Identify the team and a Leader/Consultant to
facilitate completion of the PFMEA…
Recommended:
• Use a Subject Matter Expert with PFMEA application
experience
• Those responsible for the process and have the authority to
make positive changes
• Those most familiar and “close” to the Business or
manufacturing process
• This may include customers, suppliers, engineers,
production personnel, etc.
Process Failure Modes Effects Analysis http://www.biz-pi.com 19
How do we perform a PFMEA?
#3: Identify how the success of the PFMEA will be
measured
Recommended:
• Process metrics: Improved Quality Yields, Costs
Reductions, Reduced Cycle times, Improved Test Yields,
Increased Output/Demand etc.
• Reduction of RPNs (Risk Priority Number)
• RPNs are calculated in the PFMEA and provide a good measure
of the “effectiveness” of improvements to a process or product.
(this will be explained later in the course).
Process Failure Modes Effects Analysis http://www.biz-pi.com 20
#4: Begin the Analysis with a PFMEA *form
Let’s start with the first column in the PFMEA tool
• Column 1 – Process Function, Process Step,Name or #
We complete the column as follows…
•In Column 1 – List the process step name and/or reference number in this
column: Example- Drive to Work
we will use a simple process like “Drive to Work” to help students understand the basics
*form – the PFMEA can be created an MS Excel spreadsheet or in a purchased Software.
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work
Process Failure Modes Effects Analysis http://www.biz-pi.com 21
Complete the next column in the PFMEA
• Column 2 – Brainstorm and list all the “potential” failure
modes for this operation. (keep it simple and focused on things that could
actually occur, be sure to list any “actual” failures already known)
Let’s complete the next column in the PFMEA tool…
•In Column 2 – List all of the potential (but practical) Failure Modes
(errors/defects) : Example- In this case the “Failure Mode” is
“Stuck in Traffic”, in other words, this is the problem we want to prevent
•There could be several failure modes to one process, list each one and
complete the form accordingly
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
PreventionO
ccu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Process Failure Modes Effects Analysis http://www.biz-pi.com 22
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
Complete the next column in the PFMEA
• Column 3 – Brainstorm and list all the “effects” of the
failure mode(s )if it actually occurred. The “effects” of a failure, defect
or error could be both the internal (e.g. at the next operation) effect and the external effect
(e.g. at the customer)
In Column 3 – List all of the potential (internal and external) effects of the
Failure Modes, defects or errors : Example- Customer rejects, poor fit,
rework, cycle-time increase, test failure
This “effects” list will help you determine the “Severity” ranking to be
placed in column 4
How to perform a PFMEA
Process Failure Modes Effects Analysis http://www.biz-pi.com 23
• In Column 4 – Using the *Severity Index define the Severity “ranking” on a
scale of 1-10 :
•Example- Place a number between 1-10 in the column, according to the
“level” of severity the team feels is appropriate for the particular failure’s
“effect” it may have on the next customer.
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7
Complete the next column in the PFMEA
• Column 4 – The “Severity” ranking helps us understand how serious “effect” or the
“impact” of a failure may be if it happens. It allows us to “quantify” the effects of a failure
• The “Severity” index is multiplied with the “Occurrence” index and the “Detection” index, the
resulting sum = the Risk Priority Number or the RPN, which helps us to “prioritize” which
problems should be addressed first.
How to perform a PFMEA
Process Failure Modes Effects Analysis http://www.biz-pi.com 24
• In Column 5 – : List the applicable “Causes” for the particular Failure.
•Example- In the example, we would list that “Rush Hour” would be the cause that
would create the condition where we would experience the “Failure” or getting
“stuck in traffic”. There can be more than one cause for a failure/error, it is important
to perform effective root cause analysis to ensure each cause is properly
addressed.
Complete the next column in the PFMEA
• Column 5 – The “Potential Causes or Mechanisms of Failure” of a failure
can be determined by brainstorming, using data, using cause & effect diagrams,
people’s experience and knowledge of the process, and the step by step process
of *Root Cause Analysis
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
PreventionO
ccu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Process Failure Modes Effects Analysis http://www.biz-pi.com 25
• In Column 4 – Using the *Occurrence Index define the Occurrence “ranking”
on a scale of 1-10 : Example- Place a number between 1-10 in the column,
according to the estimated times the failure mode might occur, or has occurred.
• For example: 1=1 out of 1000, 2=2 out of 400, … 10 =1 out of 2 etc.
Complete the next column in the PFMEA
• Column 6 – The “Occurrence” ranking helps us understand and
quantify how often the failure is occurring or could occur.
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
PreventionO
ccu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Process Failure Modes Effects Analysis http://www.biz-pi.com 26
•In Column 7 – : List the applicable “Causes” for the particular Failure. Example- In
the example, we would list “None”, since there are no current controls in-place to
prevent the failure mode. This also helps illustrate the “need” for prevention
controls.
Complete the next column in the PFMEA
• Column 7 – The “Current Process Controls-Prevention” would be any form
of “Preventive Measures” that are currently in place to “Prevent” the failure
mode. E.g. procedures, mistake-proofing, alarms, gages, tooling, etc.
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
PreventionO
ccu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Process Failure Modes Effects Analysis http://www.biz-pi.com 27
•In Column 8 – : List the applicable “Detections” for the particular Failure. Example-
In the example, we would list “Visual” or “Inspection”, since the failure mode is
identified by a visual inspection.
Complete the next column in the PFMEA
• Column 8 – The “Current Process Controls-Detection” would be any
form of “Detection Measures” that are currently in place to “Detect” or
identify the failure mode once it has occurred, this prevents the failure
from being passed on or escaping to the customer.
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Process Failure Modes Effects Analysis http://www.biz-pi.com 28
•In Column 9 – Using the *Detection Index define the Detection “ranking” on
a scale of 1-10 :
•Example- Place a number between 1-10 in the column, according to the
“level” of detection the team feels is appropriate to “identify” or “to catch” the
failure if it occurred. The higher the number, the “weaker” the detection
capability.
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Complete the next column in the PFMEA
• Column 9 – The “Detection” ranking helps us understand the
“strength” of our “detection ability” to capture the failure if it happens.
Process Failure Modes Effects Analysis http://www.biz-pi.com 29
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
•In Column 9 – You get the RPN number by multiplying the S x O x D=RPN :
Example- 7 x 6 x 7 = 294
How to perform a PFMEA
Complete the next column in the PFMEA
• Column 10 – The “RPN” , or Risk Priority Number ranking, helps us
understand the “priority” of a particular failure based on it’s effect,
number of occurrences, and strength of detection capability.
• The “Severity” index is multiplied with the “Occurrence” index and the
“Detection” index, the resulting sum = the Risk Priority Number or the
RPN, which helps us to “prioritize” which problems should be
addressed first.
Process Failure Modes Effects Analysis http://www.biz-pi.com 30
•In Column 11 – : List the applicable “Recommended Actions” to improve prevention,or to
improve detection for, or to eliminate the particular Failure. Example- In the example, we
would list
•“Listen to Traffic Radio” in the morning - This would be a “detection” measure to avoid
the failure mode.
•“Define Alternate Routes” – This would be a “preventive” measure to avoid the failure
mode
Complete the next column in the PFMEA
• Column 11 – The “Recommended (Improvement) Actions) are defined.
These would be the corrective or improvement actions required to either improve
the “prevention” controls, improve the “detection” controls, or to eliminate,
reduce, or mitigate the failure mode.
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
Prevention
Occu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Process Failure Modes Effects Analysis http://www.biz-pi.com 31
•In Column 11 – : List the assigned person or persons responsible for completing
the “Recommended Actions” to improve prevention,or to improve detection for, or to
eliminate the particular Failure. Example- In the example, Karen Smith 5-15-2000
Complete the next column in the PFMEA
• Column 12 – The assigned person or team responsible for
implementing and completing the “Recommended Actions” and
Completion Due date.
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
PreventionO
ccu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Process Failure Modes Effects Analysis http://www.biz-pi.com 32
•In Column 13 – : List the “Actions Taken” to improve prevention,or to improve
detection for, or to eliminate the particular Failure. Example- In the example, we
would list
•“Preset Traffic stations”-This would be an action to improve “detection” capability
•“Highlight Map” – with alternate routes, This would be an action to improve
“prevention”, to avoid the failure mode
Complete the next column in the PFMEA
• Column 13 – The “ (Improvement) Actions Taken” are defined. These would be the
corrective or improvement actions completed as recommended from Column 11, or above
and beyond those recommended to either improve the “prevention” controls, improve the
“detection” controls, or to eliminate, reduce, or mitigate the failure mode.
How to perform a PFMEA
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
PreventionO
ccu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 6 2 84
Process Failure Modes Effects Analysis http://www.biz-pi.com 33
FMEA Number:
Page: of
Process Responsibility: Prepared by:
FMEA Date (Orig.)
Actions
Taken
Se
ve
rity
Occu
rre
nce
De
tectio
n
RP
N
Process Failure Mode and Effect Analysis
Action ResultsResponsibility
& Target
Completion
Date
Recommended
Action(s)
RP
N
De
tectio
n
Current
Process
Controls
Detection
Current
Process
Controls
PreventionO
ccu
rre
ncePotential
Cause(s)/
Mechanism(s)
of Failure
Cla
ss
Se
ve
rity
Potential
Effect(s) of
Failure
Potential
Failure
Mode
Process
Function [Process
Step Name]
Team Leader:
(Rev.)Core Team:
Drive to
Work Stuck in Traffic
Late for Work
7 Rush
Hour 6 None Visual 294
Listen to Traffic
Radio 7 Define Alternate
Routes
Karen Smith
5-15-2000
Preset Traffic Station (Det)
Highlighted Map (Prev)
7 3 2 42
• The RPN number is recalculated by multiplying the “new” occurrence ranking with
the new detection ranking and the Severity ranking (which did not change thru the
improvement actions), : Example- 7 x 3 x 2 = 42
•Congratulations! You “Lowered” the risks of the failure mode thru the improvement
actions, and reduced the RPN. This gives evidence of the improvement and its
effectiveness. Now the team would move on to the next “highest” RPN.
How to perform a PFMEA
Complete the next column in the PFMEA
• Columns 14-17 – After the Improvement Actions are completed,
recalculate the “RPN” .
Process Failure Modes Effects Analysis http://www.biz-pi.com 34
PFMEA Guidelines
• One Failure Mode may have more than one root
cause!
• Keep “brainstorming” activities realistic!
• Focus on solving the highest RPNs, once the PFMEA
is complete!
• Prevention is greater investment by far than
reaction!
• PFMEA’s can help analyze and solve any
manufacturing, business, or transactional process!
Process Failure Modes Effects Analysis http://www.biz-pi.com 35
Review
You learned:
• The basics of a PFMEA
• Why it is important to use
• How you can prevent problems, reduce costs and improve quality
• How to complete the “basics” of a PFMEA
Process Failure Modes Effects Analysis http://www.biz-pi.com 36
Additional Resources
Business Performance Improvement http://www.biz-pi.com