LEAN SIX SIGMA GREEN BELT

OPEN ELECTIVE – AU 1590

ANALYZE PHASE

FMEA -
FAILURE MODES AND
EFFECTS ANALYSIS
Objectives

 Provide insight to the uses of FMEA

 Identification of risk sources
 Define the different types of FMEA
 To learn the steps in developing a Process FMEA
 Create an FMEA
 Definition - FMEA

 A structured approach to:

◦ identifying the ways in which a product or process can
fail
◦ estimating the risk associated with specific causes
◦ prioritizing the actions that should be taken to reduce
the risk
◦ evaluating the design validation plan (Product) or the
current control plan (Process)
 Primary Directive: Identify ways the product or
process can fail and eliminate or reduce the risk of
failure
Where do Risks Come From?
Potential
Poor control
Safety
Unclear Customer plans & SOP’s
Hazards
Expectations Poor Process
Capability

Cumulative Risk
Raw Material
Vague Variation
Workmanship
Standards
Poorly developed
Machine Specification
Reliability Measurement
Limits
Variation (Online
and QC)
D. H. Stamatis, FMEA:FMEA from
Theory to Practice, Quality Press, 1995
 History

 First used in the 1960’s in the aerospace industry

during the Apollo missions
 In 1974 the Navy developed MIL-STD-1629
regarding the use of FMEA
 In the late 1970’s, automotive applications driven by
liability costs
Types of FMEA

 System - used to analyze systems and sub-systems

in the early concept and design stages
◦ Focuses on potential failure modes associated with the
functions of a system caused by the design
 Design - used to analyze product designs before
they are released to production
◦ Focuses on Product Function
 Process - used to analyze manufacturing and
assembly processes
◦ Focuses on Process Inputs
Role of Process FMEA

 Key tool of process team to improve the process in

a preemptive manner (before failures occur)
 Used to prioritize resources to insure process
improvement efforts are beneficial to customer
 Used to document completion of projects
 Should be a dynamic document, continually
reviewed, amended, updated
Purposes of Process FMEA

 Analyzes new processes

 Identifies deficiencies in the process control plan
 Establishes the priority of actions
 Evaluates the risk of process changes
 Identifies potential variables to consider in Multi-Vari
and DOE studies
 Guides the development of new processes
 Helps set the stage for breakthrough
FMEA Inputs and Outputs

 Inputs
◦ Process map
◦ C&E matrix
◦ Process history
◦ Process technical procedures
 Outputs
◦ List of actions to prevent causes or to detect failure
modes
◦ History of actions taken
FMEA Team

 Team approach is necessary

 Responsible Project Leader leads the team
 Recommended representatives:
◦ Design
◦ Practitioners / Operators / Supervisors
◦ Quality
◦ Reliability
◦ Maintenance
◦ Materials
◦ Testing
◦ Supplier
Definition of Terms

 Failure Mode
 Effect
 Cause
 Current Controls
 Severity, Occurrence, Detection
 Risk Priority Number (RPN)
Failure Mode

 Failure Mode - the way in which a specific process input

fails - if not detected and either corrected or removed, will
cause Effect to occur
 Can be associated with a defect (in discrete
manufacturing) or a process input variable that goes
outside of specification
◦ Anything that an operator can see that’s wrong is considered a Failure
Mode
 Examples
◦ Reactor temperature too high
◦ Incorrect PO number
◦ Surface contamination
◦ Dropped call (customer service)
◦ Paint too thin
Effect

 Effect - impact on customer requirements

◦ Generally external customer focus, but can also include
downstream processes
 Examples
◦ Reactor temperature too high: Off-spec material
◦ Incorrect PO number: Accounts receivable traceability errors
◦ Surface contamination: Poor adhesion
◦ Dropped call: Customer dissatisfaction
◦ Paint too thin: Poor coverage
Cause

 Cause
◦ Sources of process variation that causes the Failure Mode to
occur
◦ Identification of Causes should start with Failure Modes
associated with the highest severity ratings
 Examples
◦ Reactor temperature too high: Thermocouple out of
calibration
◦ Incorrect PO number: Typographical error
◦ Surface contamination: Overhead hoist systems
◦ Dropped call: Insufficient number of CS representatives
◦ Paint too thin: High solvent content
Current Controls

 Current Controls
◦ Systematized methods/devices in place to prevent or detect
failure modes or Causes (before causing effects)
◦ Prevention consists of mistake proofing (Poka Yoke), automated
control and set-up verifications
◦ Controls consists of audits, checklists, inspection, laboratory
testing, training, SOP’s, preventive maintenance, etc.
 Which is more important to process improvement,
prevention or detection?
FMEA Model

Cause

Failure Mode
(Defect)
Material or
process input Effect

Process Step
External customer
or downstream
process step
Controls
The Dynamic Nature of the FMEA

Why Armies of Knights Lose Battles

Window of Consideration
Loss Loss Loss Loss Loss
of of of of of
Nail Shoe Horse Rider Battle

Cause Failure Mode Effect

 FMEA Model

Prevention
Cause Detection

Detection
Failure Mode
(Defect) Detection
Material or
process input Effect

Process Step
External customer
or downstream
process step
Controls Which is best case? Which
is worst case?
Linking Failure Modes to Effects

Failure Mode 1
Effect 1
Failure Mode 2

Effect 1
Failure Mode 1
Effect 2

Failure Mode 1
Effect 1
Failure Mode 2

Note that the relationship between the Failure Mode and the
Effect is not always 1-to-1
Risk Priority Number (RPN)
 The output of an FMEA is the Risk Priority Number
 The RPN is a calculated number based on
information you provide regarding
 the potential failure modes,
 the effects, and
 the current ability of the process to detect the failures before reaching
the customer
 It is calculated as the product of three quantitative
ratings, each one related to the effects, causes, and
controls:

RPN = Severity X Occurrence X Detection

Effects Causes Controls
Risk Priority Number

 Risk Priority Number is not sacred

 Scaling for Severity, Occurrence and Detection
must be developed specifically for particular
processes or projects
 Other categories can be added
◦ For example, one engineer added an Impact score to
the RPN calculation to estimate the overall impact of
the Failure Mode on the process
Definition of RPN Terms

 Severity (of Effect)- importance of effect on

customer requirements - could also be concerned
with safety and other risks if failure occurs (1=Not
Severe, 10=Very Severe)
 Occurrence (of Cause)- frequency with which a
given Cause occurs and creates Failure Mode. Can
sometimes refer to the frequency of a Failure Mode
(1=Not Likely, 10=Very Likely)
 Detection (capability of Current Controls) - ability of
current control scheme to detect or prevent:
◦ the causes before creating failure mode
◦ the failure modes before causing effect
◦ 1=Likely to Detect, 10=Not Likely at all to Detect
Example Rating Scale
Severity Occurrence Detectability
May cause death or require The problem will not be apparent
10
evacuation of the community Very high: until the customer uses the product
May cause lost time injury and/or Happens nearly every batch The problem will not be apparent
9 un-repairable damage to the until the customer receives the
reactor product

8 May require first aid

High: Expensive sampling and analysis
Near miss personal injury may Occurs in 50 - 75% of batches is needed to detect
7
result
Reactor may become fouled
6
requiring extensive repairs Moderate:
Reactor may become fouled Happens in 25 - 50% of batches Moderately priced sampling and
5
requiring extensive cleaning analysis is needed to detect

4 Product may require some rework

Trained perso nnel can tell there is a pro blem with

Product will need additional
3 no special equipment but, the batch will require
filtration Low: rewo rk

Minor impact on color, all other Happens in < 25% of batches Trained perso nnel can tell there is a pro blem with
2 no special equipment early eno ugh to fix the batch
parameters unaffected
Remote: Happens less than once Untrained personnel can tell there
1 No effect
a year is a problem
FMEA Model
Because the Detection score is a little difficult to understand, we
will do a quick exercise. Give a Detection score for each of the
boxes below:

Det = ___
Det = ___
Prevention
Detection
Cause Det = __
Det = ___
Detection
Failure Mode
(Defect)
Detection
Material or
process input Effect

Process Step
External customer
or downstream
process step
Controls
Quiz!
Take 5 minutes to fill in the results (internal and
external) and what action should be taken. Take
another 10 minutes with your group to discuss. Be
prepared to present results.

Sev Occ Det Result Action

1 1 1
1 1 10
10 1 1
10 1 10
1 10 1
1 10 10
10 10 1
10 10 10
FMEA Scoring

 There are a wide variety of scoring “anchors”, both

quantitative or qualitative
 Two types of scales are 1-5 or 1-10
 The 1-5 scale make it easier for the teams to decide
on scores
 The 1-10 scale allows for better precision in
estimates and a wide variation in scores

The 1-10 scale is generally considered

to be the best option
 FMEA Form - Initial Assessment

S O D R
Process Actions
Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls E P
Step/Input Recommended
V C T N

How often does cause

How Severe is the
effect to the

How well can you

or FM occur?
cusotmer?

detect cause or FM?

What is the In what ways does the Key What is the impact on the Key What causes the Key Input to What are the existing controls and What are the actions
process step/ Input go wrong? Output Variables (Customer go wrong? procedures (inspection and test) for reducing the
Input under Requirements) or internal that prevent eith the cause or the occurrance of the
investigation? requirements? Failure Mode? Should include an Cause, or improving
SOP number. detection? Should
have actions only on
high RPN's or easy
fixes.

0
FMEA Form - Long Term History

D R S O D R
Actions
Current Controls E P Resp. Actions Taken E C E P
Recommended
T N V C T N

How well can you

detect cause or FM?
What are the existing controls and What are the actions Whose What are the completed
procedures (inspection and test) for reducing the Responsible actions taken with the
that prevent eith the cause or the occurrance of the for the recalculated RPN? Be
Failure Mode? Should include an Cause, or improving recommended sure to include
SOP number. detection? Should action? completion month/year
have actions only on
high RPN's or easy
fixes.

0 0

0 0

0 0

0 0
Philosophical Approach

 Focus on Safety Issues

 Assume incoming material is perfect and process is
not good
 Assume process is perfect and incoming material is
not good
Methodology

 Two major approaches:

◦ Starting with Cause & Effect Matrix
◦ Starting with FMEA directly from the Process Map
 We will explain the approach using a Process Map,
though both approaches are very similar
 Spreadsheet tools have been prepared to assist
you in the preparation of the FMEA
 Process Mapping Examples
Manufacturing
Inputs Types Outputs Inputs Types Outputs

Pump rate C • CTA level Feed quality U Wax

Mixing U Feed Tank • Init level % water in feed U Separation • Viscosity
CTA level U Preparation • % water in Pressure C • Hardness
% water in CTA U Maintain CTA CTA Temperature C Flash • Drop point
Init level U level Reflux ratio C Distillation
CTA/H2O azeo dist Recycle
Init quality U Maintain initiator Water flowrate C
• Composition
Init lot U level Steam C
• Amt to waste
Amt recycle U Cooling water C
treatment
• Amt to flare
• Amt to
burners
Previous grade U • Prod rate Wax feed rate C
Temperature C Polymerization • Conversion Wax temp C
Pressure C Blending req’d U Finishing • Appearance
Feed rates C React initiator, • CTA-to-olefin Wax properties U
• Pellet size
Feed quality U olefin, and CTA in ratio Water flowrate C Final wash • Viscosity
% water in CTA U CSTR • Temp profile Air flowrate C Pelletize • Hardness
Mixer speed C • Cooling H2O Nozzle hole size
• Drop point
Reactor fouling U flowrate U
• % Moisture
Operator U (fouling) Nozzle plugging
Ambient temp U U C = Controllable Input
Cooling water C Trans line temp C
Steam C Ambient temp U U = Uncontrollable Input
Ambient humid U
Steam C
FMEA - Step by Step

 For each Process Input, determine the ways in which the input
can go wrong (Failure Modes)
 For each Failure Mode associated with the inputs, determine
Effects of the Failures on the customer
◦ Remember the internal customers!
 Identify potential Causes of each Failure Mode
 List the Current Controls for each Cause or Failure Mode
 Create Severity, Occurrence, and Detection rating scales
 Assign Severity, Occurrence and Detection ratings to each
Cause
 Calculate RPN’s for each Cause
 Determine Recommended Actions to reduce high RPN’s
 Take appropriate actions and recalculate RPN’s
FMEA Worksheet
Before we move to the example let’s look at an FMEA worksheet
The information on this sheet is transferred directly to the FMEA form
The purpose of this worksheet is to focus the team on the FMEA inputs
and not on scoring
The scoring should be done after the basic inputs have been made
Failure Modes -
Process What can go
Step Key Process Input wrong? Effects Causes Current Controls

LS FMEAFORM.XLS
How can input vary?
We’ll first list Temperature for the Polymerization process step and then
identify the ways it can go wrong.

Failure Modes -
Process Key Process What can go Current
Step Input wrong? Effects Causes Controls
Temperature
Polymerization Temperature
out-of-control
Temperature
too high

Temperature
too low
What Happens?

These effects are internal requirements for the next process and/or
to the final customer

Failure Modes -
Process Key Process What can go Current
Step Input wrong? Effects Causes Controls
Temperature Reactor
Polymerization Temperature
out-of-control Vents
Temperature Off-Spec
too high Material

Reactor
Fouling

Temperature Off-Spec
too low Material
Why?

In most cases, there will be more than one Cause for a Failure Mode
but we’ll keep it simple for this exercise

Failure Modes -
Process Key Process What can go Current
Step Input wrong? Effects Causes Controls
Temperature Reactor Operator Error
Polymerization Temperature
out-of-control Vents during rxn light-off
Temperature Off-Spec Cooling Water
too high Material Failure

Operator Error

Reactor Cooling Water

Fouling Failure

Operator Error

Temperature Off-Spec Thermocouple

too low Material Failure
Current Controls?
For each Failure Mode/Cause we list how we are either preventing the
Cause or detecting the Failure Mode
We will list the procedure number where we have a SOP
We need to be considerate of “holes” in the current controls
column…..in this example, there are controls on the input variable

Failure Modes -
Process Key Process What can go Current
Step Input wrong? Effects Causes Controls
Temperature Reactor Operator Error MPS 9-21 /
Polymerization Temperature
out-of-control Vents during rxn light-off DCS Program
Temperature Off-Spec Cooling Water
DCS Program
too high Material Failure
MPS 9-15 / DCS /
Operator Error
Lab Verification
Reactor Cooling Water
DCS Program
Fouling Failure
MPS 9-15 /
Operator Error
DCS Program
Temperature Off-Spec Thermocouple DCS Program /
too low Material Failure Lab Verification
Rating Scale
Example Rating Scale

Rating Severity of Effect Likelihood of Occurrence Ability to Detect

10 Hazardous without warning Can not detect

Very high:
Failure is almost inevitable
9 Hazardous with warning Very remote chance of detection

8 Loss of primary function Remote chance of detection

High:
Reduced primary function Repeated failures
7 Very low chance of detection
performance

6 Loss of secondary function Low chance of detection

Moderate:
Reduced secondary function Occasional failures
5 Moderate chance of detection
performance
Minor defect noticed by most
4 Moderately high chance of detection
customers
Minor defect noticed by some
3 High chance of detection
customers Low:
Minor defect noticed by Relatively few failures
2 Very high chance of detection
discriminating customers

1 No effect Remote: Failure is unlikely Almost certain detection

Assign RPN

 We are now ready to transfer the worksheet input to

the FMEA form
 Copy and paste the worksheet columns into the
appropriate FMEA form columns
 The team then starts scoring each row to compute
the RPN values
 Notes:
◦ You will only use one Severity value
◦ Determine which Effect has the highest associated Severity and
use that SEV value for ALL causes for the related Failure Mode
RPN Component Value

Potential S O D R
Process Potential Current
Failure E Potential Causes C E P
Step/Input Failure Mode Controls
Effects V C T N

Polymerization/ Temperature Reactor Operator Error MPS 9-21/

10 3 2
Temperature out-of-control Vents during rxn light-off DCS Program

Temperature Off-Spec Cooling Water

7 1 DCS Program 2
too high Material Failure

MPS 9-15/DCS/
7 Operator Error 1 2
Lab Verification

Reactor Cooling Water

5 1 DCS Program 2
Fouling Failure

MPS 9-15/
5 Operator Error 1 2
DCS Program

Temperature Off-Spec Thermocouple DCS Program/

7 1 2
too low Material Failure Lab Verification
Calculate RPNs
• Multiply the Severity, Occurrence, and Detection values for each line in
the FMEA. The Excel form automatically calculates the RPN for you.
• Then sort all lines by RPN.

Potential S O D R
Process Potential Current
Failure E Potential Causes C E P
Step/Input Failure Mode Controls
Effects V C T N

Polymerization/ Temperature Reactor Operator Error MPS 9-21/

10 3 2 60
Temperature out-of-control Vents during rxn light-off DCS Program

Temperature Off-Spec Cooling Water

7 1 DCS Program 2 14
too high Material Failure

MPS 9-15/DCS/
7 Operator Error 1 2 14
Lab Verification

Reactor Cooling Water

5 1 DCS Program 2 10
Fouling Failure

MPS 9-15/
5 Operator Error 1 2 10
DCS Program

Temperature Off-Spec Thermocouple DCS Program/

7 1 2 14
too low Material Failure Lab Verification
RPN Review

 Once you calculate the RPN for each Failure Mode

/ Cause / Controls combination, review the results
and look for insights
◦ Do the gut check - does the Pareto of items make sense?
◦ If not, maybe the ratings given are varying
 Determine potential next steps:
◦ Data collection
◦ Experiments
◦ Process improvements
◦ Process control implementations
Take Action
Now fill in recommended actions for top RPNs

R
Process Potential Failure
P Actions Recommended Resp.
Step/Input Mode
N
CTA Feed / ID options for maintaining
% water varies 490 TDG
% water constant % water.
Polymerization/
Reactor fouls 441 Multi-vari study to ID causes. FPS
Reactor Fouling
Polymerization/ Feed rates
294 ID operator best practices. GMR
Feed Rates too low
CTA Feed /
% water varies 280
% water

Actions are recommended for only the high RPN’s

The key is FOCUS!
Recalculate RPNs

R S O D R
Process Potential Failure
P Actions Recommended Resp. Actions Taken E C E P
Step/Input Mode
N V C T N
CTA Feed / ID options for maintaining Pump installed.
% water varies 490 TDG 7 4 3 84
% water constant % water. Monitoring % water.
Polymerization/ Multi-vari study
Reactor fouls 441 Multi-vari study to ID causes. FPS
Reactor Fouling underway.
Polymerization/ Feed rates
294 ID operator best practices. GMR MPS changes ID'd.
Feed Rates too low
CTA Feed /
% water varies 280
% water

We have recorded the action taken and the impact on the

RPN.
Notice that this is a nice way to track past activities.
The FMEA should be re-evaluated by the group as new
recommended actions are identified, completed and
recorded.
 Overview

S O D R
Process Actions
Potential Failure Mode Potential Failure Effects E Potential Causes C Current Controls E P
Step/Input Recommended
V C T N

How How How

Bad?
0 Often?
0 well?
0 0

What 0 0 0 0
What is
What can go What are How can
the Effect 0 0 0 0 What
is the wrong the these be
on the can be
Input with the 0
Causes? 0
found or 0 0
Outputs? done?
? Input? 0 0 prevented? 0 0
Summary

 Provided insight to the uses of FMEA

 Identified sources of risk
 Defined the different types of FMEA
 Introduced the steps in developing a Process FMEA
 Practiced creating a FMEA