*Process Failure Modes Effects Analysis · What is a PFMEA? •Example form Process (or Product) Failure Modes Effects Analysis FMEA Number: Page: of Process Responsibility: Prepared

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


Course Content

– Course Objectives

– What is a PFMEA?

– PFMEA – Important Points

– Benefits

– When should a PFMEA be completed?

– Example

– Review

– Additional Resources


Course Objectives

• Upon completion of this course participants

should understand:

• The importance and benefits of PFMEAs

• The basic PFMEA Structure

• The basic PFMEA Application


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


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

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ve

rity

Occu

rre

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tectio

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RP

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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:


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


FMEA Date (Orig.)

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Current

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Detection

Current

Process

Controls

Prevention

Occu

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ncePotential

Cause(s)/

Mechanism(s)

of Failure

Cla

ss

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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


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


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 !


PFMEA Benefits

The benefit of using PFMEA’s is simple…

Problem Prevention

=

Increased profits! $$ $$


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!


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! $$ $$


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


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


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


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


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.



#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.



#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.



#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).


#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


FMEA Date (Orig.)

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& Target

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Current

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Controls

Detection

Current

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Controls

Prevention

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ncePotential

Cause(s)/

Mechanism(s)

of Failure

Cla

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to

Work


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


FMEA Number:

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FMEA Date (Orig.)

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PreventionO

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of Failure

Cla

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to



FMEA Number:

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of Failure

Cla

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work


• 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



• 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:

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of Failure

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7


• 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.



• 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.


• 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


FMEA Number:

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FMEA Date (Orig.)

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of Failure

Cla

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



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.


• Column 6 – The “Occurrence” ranking helps us understand and

quantify how often the failure is occurring or could occur.


FMEA Number:

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of Failure

Cla

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Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



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.


• 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.


FMEA Number:

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of Failure

Cla

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



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.


• 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.


FMEA Number:

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FMEA Date (Orig.)

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Current

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Prevention

Occu

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Mechanism(s)

of Failure

Cla

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



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.


FMEA Number:

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Current

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Prevention

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of Failure

Cla

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



7 6 2 84


• Column 9 – The “Detection” ranking helps us understand the

“strength” of our “detection ability” to capture the failure if it happens.


FMEA Number:

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of Failure

Cla

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Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



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



• 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.


•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


• 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.


FMEA Number:

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FMEA Date (Orig.)

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of Failure

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Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



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


• Column 12 – The assigned person or team responsible for

implementing and completing the “Recommended Actions” and

Completion Due date.


FMEA Number:

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of Failure

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Effect(s) of

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Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



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


• 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.


FMEA Number:

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of Failure

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Potential

Effect(s) of

Failure

Potential

Failure

Mode

Process

Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



7 6 2 84


FMEA Number:

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of Failure

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Effect(s) of

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Potential

Failure

Mode

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Function [Process

Step Name]

Team Leader:

(Rev.)Core Team:

Drive to


Late for Work

7 Rush


Listen to Traffic


Routes

Karen Smith

5-15-2000



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.



• Columns 14-17 – After the Improvement Actions are completed,

recalculate the “RPN” .


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!


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


Additional Resources

Business Performance Improvement http://www.biz-pi.com

Documents

*Process Failure Modes Effects Analysis · What is a PFMEA? •Example form Process (or Product) Failure Modes Effects Analysis FMEA Number: Page: of Process Responsibility: Prepared