PFMEA

PFMEA
*Process Failure
Modes Effects Analysis
PFMEA Training Course
Level 1
Problem Reaction to Problems,

Poor Flow Customer
Identified Firefighting!
Business or
Manufacturing
Process
*The “P” in PFMEA = Potential, Process, or Product

**Level 1 is an “introductory” level course
http://www.biz-pi.com Process Failure Modes Effects Analysis

1
Course Content
– Course Objectives
– What is a PFMEA?
– PFMEA – Important Points
– Benefits
– When should a PFMEA be completed?
– Example
– Review
– Additional Resources

2
Course Objectives
• Upon completion of this course participants

should understand:
• The importance and benefits of PFMEAs
• The basic PFMEA Structure
• The basic PFMEA Application

3
What is a PFMEA?
A *Process Failure Modes Effects Analysis is an

improvement tool used to:
• 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
*The “P” in PFMEA can stand for Potential, Process, or Product

*The PFMEA can be documented in a hard copy or software format
4
What is a PFMEA?
Process (or Product) Failure Modes Effects Analysis
• Example form
Process Failure Mode and Effect Analysis FMEA Number:
Page: of
Team Leader: Process Responsibility: Prepared by:
Core Team: FMEA Date (Orig.) (Rev.)
Action Results
Potential Current Current Responsibility
Occurrence
Occurrence
Process Potential Potential
Detection
Cause(s)/ Process Process Recommended & Target
Detection
Function
Severity
Severity
Failure Effect(s) of Actions
[Process Mechanism(s) Controls Controls Action(s) Completion
Class
Mode Failure Taken
RPN
RPN
Step Name] of Failure Prevention Detection Date

5
Important Points
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 wayFMEA
Process Failure Mode and Effect Analysis
is “failure
Number:
prevention” Page: of
Core
InTeam:
the PFMEA, it would look like this: The details will be explained later in the course Date (Orig.)
FMEA (Rev.)
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Listen to Traffic Preset Traffic
Karen Smith
Drive to Stuck in Late for Rush Radio Station (Det)
7 6 2 84
7 6 None Visual 7 294 Define Alternate 5-15-2000 Highlighted
Work Traffic Work Hour Routes Map (Prev)
– 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
6
Important Points
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

7
PFMEA Benefits
By Preventing errors or problems…

You prevent waste, improve quality and
cycle-times, and reduce costs !
• 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!
8
PFMEA Benefits
The benefit of using PFMEA’s is simple…
Problem Prevention
=
$$ Increased profits! $$

9
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!

10
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!
11
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

12
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

13
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
14
Preferred Approach
Usual Approach
Processes have numerous risks-high cost-rework-poor quality-poor cycle-times, customer
dissatisfaction, bottlenecks, etc. due to errors and other issues
Problem Reaction to Problems,

Poor Flow Customer
Identified Firefighting!
Business or
Manufacturing
Process
Preferred Approach
PFMEAs are performed TO MINIMIZE risks, rework, errors, and defects, thus improving
quality and cycle-times, resulting in lowered costs and customer satisfaction.
Continuous Improvement
Errors addressed Business or

PFMEA and prevented -
Process controls
Manufacturing Customer
Performed
in Place Process

15
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.

16
#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.

17
#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.

18
#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).

19
How to perform a PFMEA
#4: Begin the Analysis with a PFMEA *form

Let’s
Process Failure Mode andstart with the first column in the PFMEA
Effect Analysis tool
FMEA Number:
Page: of
• Column 1 – Process Function, Process Step,Name or #
Team Leader:
Core Team:
Process Responsibility: Prepared by:
FMEA Date (Orig.) (Rev.)
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Drive to
Work
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.

20
Complete the next column in the PFMEA

• Column 2 – Brainstorm and list all the “potential”
failure
FMEA Number:
Team Leader:
modes for this operation. (keep it simple and focused on things
Process Responsibility:
Page:
that
Prepared by:
couldof
Core Team: actually occur, be sure to list any “actual” failures already known) FMEA Date (Orig.) (Rev.)
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Drive to Stuck in
Work Traffic
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
21

• Column 3 – Brainstorm and list all the “effects” of the
failure
Process Failure mode(s
Mode and Effect Analysis )if it actually occurred. The “effects” ofFMEA
a failure,
Number: defect
Page: of
Team Leader: or error could be both the internalProcess
(e.g. Responsibility:
at the next operation) effect and the external effect
Prepared by:
Core Team: (e.g. at the customer) FMEA Date (Orig.) (Rev.)
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Drive to Stuck in Late for

Work Traffic Work
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
22

• 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 of
Page:
Team Leader: problems should be addressed first. Process Responsibility: Prepared by:
Action Results
Potential Occurrence Current Current Responsibility
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Drive to Stuck in Late for

7
Work Traffic Work
• 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.
23

• Column 5 – The “Potential Causes or Mechanisms of Failure” of a failure
can be determined by brainstorming, using data, using cause & effect diagrams,
Page: of
Team Leader: people’s experience and knowledge of the process, and the step byPrepared
Process Responsibility: step by: process
of *Root Cause Analysis
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
7 6 2 84
• 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.

24

• Column 6 – The “Occurrence” ranking helps us understand
Process Failure Mode and Effect Analysis and
FMEA Number:
Team Leader:
quantify how often the failure is occurring or could occur. Prepared
Page:
by:
of
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
7 6 2 84
• 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.

25

• Column 7 – The “Current Process Controls-Prevention” would be any form
of “Preventive Measures” that are currently in place to “Prevent” FMEA
the failure
Number:
Page: of
Team Leader: mode. E.g. procedures, mistake-proofing,
Process Responsibility: alarms, gages, tooling, etc.
Prepared by:
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
7 6 2 84
•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.

26

• Column 8 – The “Current Process Controls-Detection” would be any
form of “Detection Measures” that are currently in place to “Detect” or
identify
Process Failure theAnalysis
Mode and Effect failure mode once it has occurred, this prevents the
FMEA failure
Number:
Page: of
Team Leader:
from being passed on or escaping to the customer.
Process Responsibility: Prepared by:
Action Results
Potential Occurrence Current Current Responsibility
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
7 6 2 84
•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.

27

• Column 9 – The “Detection” ranking helps us understand the
“strength” of our “detection ability” to capture the failure ifFMEA
it happens.
Number:
Page: of
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
7 6 2 84
•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.
28

• 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
Process Failure“Detection” index, the resulting sum = the Risk Priority Number
Mode and Effect Analysis FMEA Number:or the
Page: of
Team Leader: RPN, which helps us to “prioritize” which problems shouldPrepared
Process Responsibility: be by:
addressed first.
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
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

29

• Column 11 – The “Recommended (Improvement) Actions) are defined.
Process FailureThese
Mode andwould be the corrective or improvement actions required to
Effect Analysis either
FMEA Number:improve
Team Leader:
the “prevention” controls, improve the “detection” controls, or to eliminate,
Page:
Prepared by:
of
Core Team: reduce, or mitigate the failure mode. FMEA Date (Orig.) (Rev.)
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
7 6 2 84
•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
30

• Column 12 – The assigned person or team responsible for
implementing and completing the “Recommended Actions” andPage:
FMEA Number:
of
Team Leader:
Core Team:
Completion Due date. Process Responsibility: Prepared by:
FMEA Date (Orig.) (Rev.)
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
7 6 2 84
•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

31

• Column 13 – The “ (Improvement) Actions Taken” are defined. These would be the
Process Failure Mode and Effect
corrective Analysis
or improvement actions completed as recommended from Column FMEA11,Number:
or above
Page: of
Team Leader: and beyond those recommendedProcess to either improve the “prevention” controls,Prepared
Responsibility: improve by: the
Core Team: “detection” controls, or to eliminate, reduce, or mitigate the failure mode.FMEA Date (Orig.) (Rev.)
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
7 6 2 84
•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
32

• Columns 14-17 –
Process Failure Mode and Effect Analysis After the Improvement Actions are completed,FMEA Number:
Page: of
Team Leader: recalculate the “RPN” . Process Responsibility: Prepared by:
Action Results
Occurrence
Occurrence
Detection
Detection
Function
Severity
Severity
Class
Mode Failure Taken
RPN
RPN
Karen Smith
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.

33
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!

34
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

35
Additional Resources
Business Performance Improvement

http://www.biz-pi.com

36

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PFMEA

Problem Reaction to Problems,

*The “P” in PFMEA = Potential, Process, or Product

http://www.biz-pi.com Process Failure Modes Effects Analysis

http://www.biz-pi.com Process Failure Modes Effects Analysis

• Upon completion of this course participants

• The basic PFMEA Structure

• The basic PFMEA Application

http://www.biz-pi.com Process Failure Modes Effects Analysis

A *Process Failure Modes Effects Analysis is an

• 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

*The “P” in PFMEA can stand for Potential, Process, or Product

Process (or Product) Failure Modes Effects Analysis

Mode Failure Taken

http://www.biz-pi.com Process Failure Modes Effects Analysis

Mode Failure Taken

– At each of our workplaces, the details and complexities of the processes

A PFMEA is a “living” process analysis tool

http://www.biz-pi.com Process Failure Modes Effects Analysis

By Preventing errors or problems…

The benefit of using PFMEA’s is simple…

http://www.biz-pi.com Process Failure Modes Effects Analysis

• World Class companies waste approximately 2-3% of their

• Costs of Poor Quality is estimated at 2-3 x the “tangible”

• Example: 100M$ Sales / 10% = $10 Million Dollars!

http://www.biz-pi.com Process Failure Modes Effects Analysis

• When we wait for errors to happen and then try to

– Provides important “documentation” of the process

http://www.biz-pi.com Process Failure Modes Effects Analysis

PFMEA’s are most effective when completed:

http://www.biz-pi.com Process Failure Modes Effects Analysis

PFMEA’s are also VERY effective if completed on current

Problem Reaction to Problems,

Errors addressed Business or

http://www.biz-pi.com Process Failure Modes Effects Analysis

#1: Identify the process or product that requires the PFMEA

http://www.biz-pi.com Process Failure Modes Effects Analysis

#1: Identify the process or product that requires the PFMEA

http://www.biz-pi.com Process Failure Modes Effects Analysis

#2: Identify the team and a Leader/Consultant to

http://www.biz-pi.com Process Failure Modes Effects Analysis

#3: Identify how the success of the PFMEA will be

• Reduction of RPNs (Risk Priority Number)

http://www.biz-pi.com Process Failure Modes Effects Analysis

#4: Begin the Analysis with a PFMEA *form

Mode Failure Taken

We complete the column as follows…

*form – the PFMEA can be created an MS Excel spreadsheet or in a purchased Software.

Complete the next column in the PFMEA

Mode Failure Taken

Let’s complete the next column in the PFMEA tool…

Complete the next column in the PFMEA

Mode Failure Taken

Drive to Stuck in Late for

Complete the next column in the PFMEA

Mode Failure Taken

Drive to Stuck in Late for

• In Column 4 – Using the *Severity Index define the Severity “ranking” on a

Complete the next column in the PFMEA

Mode Failure Taken