National Quality Department

Business Excellence Program (BEX)

Business Process Management System
Training

Failure Mode & Effect Analysis

FMEA
April 2011
Rev 1.0

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 About This Module…

An FMEA is a systematic method for identifying, analyzing,

prioritizing and documenting potential failure modes, their
effects on system, product, process performance and the
possible causes of failure.

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 What We Will Learn…

1. As a Team, how to construct an FMEA and

associated Action Plan

2. How the FMEA process ties to process

mapping

3. The relationship between Failure Mode,

Cause and Effect

4. The different types of FMEAs

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 Sample FMEA
p R
S O D R Actual r i Risk
Failure E C E P Resp. Schedule Compl. p p p p s X
Effects V Causes C Controls T N Action Recommended Person Date Action Taken Date S O D n k prpn
Must PM Schedule
redo Periodic created and
copy 6 Paper Jam 7 Maint. 7 294 Periodic preventive maintence Key Opr 3/1 implemented 2/15 6 3 7 126 3 378
Place sign over copier outlining
Must Existing standard size enlarge/reduce or
redo User notes on reliable mach to clearly indicate Place sign over
copy 6 misset size 6 copier 5 180 standard reduce/enlarge Key Opr 2/20 mach 2/15 6 3 2 36 1 36
Must User Existing
redo misset notes on Place sign to encourage user to Place sign over
copy 6 control 5 copier 4 120 utilize auto settings Key Opr 2/20 mach 2/15 6 2 2 24 1 24
Used
landscape
Must instead of
redo portrait or Tray Place note on ruler re tray
copy 6 vice versa 7 Selection 2 84 selection Key Opr 1/20 Placed Note 1/15 6 2 1 12 1 12

Must align Use Auto

redo marking Feeder / Enlarge marks for 8.5 " paper on
copy 6 not clear 4 align ruler 3 72 ruler Key Opr 1/15 Enlarged marks 1/14 6 2 1 12 1 12
Doc
Must moved Use Auto Place sign over copier re
redo when lid Feeder / "Ensure align prior to copying or
copy 6 closed 5 align ruler 2 60 use auto Feeder" Key Opr 1/15 Displayed Sign 1/14 6 1 1 6 1 6

Must User Auto Place sign over copier to

redo selected select encourage user to use auto tray Place sign over
copy 6 wrong tray 3 function 3 54 select Key Opr 2/25 mach 2/20 6 2 3 36 1 36
Must Periodic
redo Cleaning Place cleaning material near Placed Cleaning
copy 6 Dirty Glass 6 SOP 1 36 copier Maint. 1/15 Matl 1/15 6 1 1 6 1 6

National Quality Depart Datafile/CopyFMEA.xls

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 Why Use FMEAs?

Identify
critical product characteristics and process variables

Prioritize
product and process deficiencies in support of downstream
improvement actions

Help focus
on prevention of product and process problems

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 Benefits of FMEA’s

 Improves the quality, reliability and safety of processes.

 Helps increase customer satisfaction.
 Reduces process development timing and cost.
 Reduces the amount of rework, repair and waste.
 Documents and tracks actions taken.
 Prioritizes deficiencies to focus improvement efforts.

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 Process and FMEA Hierarchies
Process - Level #1

Step #1 Step #2 Step #3

FMEA - Level #1

Process - Level #2

Step #1 Step #2 Step #3 FMEA - Level #2

Process - Level #3

Step #1 Step #2 Step #3 FMEA - Level #3

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 Process FMEA Steps
 Steps Completed Prior to FMEA:
– Charter Team
– Develop and Characterize Process Map
 FMEA Steps:
1. Identify “Heavy Hitter” Process Step
1. Identify Associated y’s (Product Parameters)
1. Identify Failure Mode
1. Identify Failure Effects/Rate Severity
1. Identify Causes/Rate Occurrence
1. Identify Controls (if any)/Rate Detection
1. Calculate RPN
1. Prioritize by RPN Order
1. Determine Actions/Plan
1. Recalculate RPN Based on Plan
1. Take Action
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 Header Accessible from

FMEA Form
View Header/Footer
in Excel

Workbook in Excel

\DataFile\FMEAForm.xls
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 Cause -Failure Mode -Effect
Continuum
Effect (y’s)
Cause Failure
(x’s) Mode

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 The Cause and Effect Diagram
Admin/Service Example
Example
Measurements Materials Manpower
First produced in 1950 by
Professor Kaoru Ishikawa -
Also called the:
 Ishikawa Diagram
 Fish Bone Diagram
Failure Mode
(Defect)
Developed to represent the
relationship between some
“effect and all possible
Failure “causes” influencing it.
Effect
Mother Methods Machines Create using Igrafx:
Nature

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 The Cause and Effect
Diagram Example (cont.)
Measurement
Manpower Material
Reproducibility Repeatability
Inadequate Late
training Linearity
Wrong quantity
Stability
Lack of
experience Defective Calibration

Distractions

Defects
Too hot
Vague
Too humid
Not maintained Out of date

Too cold Inadequate capability Complex

Mother nature
Machines Methods

Datafile/Causeeffecte.igx
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 Copy Machine Example
• Our process is copying
documents on a Xerox model
XC1045 copy machine.
• First we will construct a
process map
• Then we will construct a cause
and effect diagram
• Finally we will complete an
FMEA

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 Process: Making A Copy

Place Set Set Select

Enter size Press Retrieve
Document number of light/dark paper
required button copies
in Copier copies settings source

N Hinges C Copies C Size desired C Darkness C Size desired Cr Button

N Glass clean required Cr Size button desired x Paper
Cr Number
button
Make Copies

Document set Number of Size selected Darkness set Correct Copies Copies
correctly copies selected correctly directly paper tray Right number
Glass clean correctly selected Right contrast
Right
orientation
Right size
Right paper

Legend
C Controllable
Cr Critical
N Noise
P Procedure
x Input

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Step 1: Identify “Heavy Hitter” Process Step
 From the Process Map, identify the process step with the
most likelihood of having failure modes with significant
effects
 Use defect data and/or team knowledge about failure
modes when selecting process steps
 Significant impact to the business? (COPQ, cycle time,
fill rate, ...)
 Use a Cause and Effect Diagram to capture
brainstorming results.
 After completing FMEA Steps #2-7 for all failure modes
associated with this process step, return to this step and
select the next most likely “Heavy Hitter” process step
 Not all process steps will need to be analyzed by the
FMEA
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 Step 2: Identify Associated y’s
 From the Process Map, identify the y’s that are associated with the
process step being investigated
 As the y’s are the indications of a successful completion of the
process step, they are crucial as a basis for determining failure
modes

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 Step 3: Identify Failure Mode
• Brainstorm failure modes for the selected process step :
– Identify the ways in which the process could fail to generate
each of the expected “y’s”
• Eliminate “duplicates” from brainstorm list
• Are the failure modes from the same level of the process?
• Are the failure modes specific?
• Are the failure modes the most likely?
• Do the failure modes provide good coverage of the process
step?
• Have all y’s been considered?

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Step 4: Identify Failure Effects/Rate Severity
 Pick the most likely failure mode and brainstorm the most
important Effects:

– FAILURE EFFECTS are the outcome of the occurrence of the

failure mode on the process. The impact on the customer ---
What does the customer experience as a result of the Failure
Mode?
 Identify each effect as being “Attribute” or “Variable”
 Severity doesn’t change unless the design changes.

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Step 5: Identify Causes/Rate Occurrence
 Identify the most likely causes for each failure mode using a
Cause and Effect Diagram:

– CAUSES are the conditions that bring about the Failure Mode
 Transfer the resulting information to the FMEA form
 Assign an occurrence value (1-10) to the likelihood that each
particular cause will happen and result in the failure mode
 The occurrence score for each cause should be related to the
likelihood of that cause resulting in the failure mode and producing
the specific associated effect

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 Organize Brainstorming Ideas
Materials Manpower
Measurement
Wrong Size Selected wrong
Wrong Paper orientation
Selected Size

Copy Misaligned
Too Humid Document Moved
When Lid was Alignment Marking
Closed Unclear

Mother Method
Nature Machine

What would you add?

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 Step 6: Identify Controls (if any)/Rate
Detection
 Identify the current mechanisms in place which prevent the cause
from occurring, or detect it before the product reaches the
customer. Some examples of controls are SPC, training,
maintenance, inspection/review, SOP etc.
 Assign a detection value (1-10) based on an assessment of the
likelihood that the current control mechanisms will detect the cause
of the failure mode before it reaches the customer.
 Don’t agonize over detectability.

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Step 7: Calculate Risk Priority Number (RPN)

The product of the estimates of severity

occurrence and

detection.

The RPN provides a relative priority for taking action

the bigger the RPN, the more important to address.

RPN = SEVERITY x OCCURRENCE x DETECTION

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 Steps 8 and 9

8: Prioritize by RPN Order

Use the “Sort” command in Excel to order the spreadsheet in
descending order of Risk Priority Number (RPN).

9: Determine Actions/Plan
Based on the causes found, determine actions that will
minimize the effect of each cause, in priority order.

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 Steps 10 and 11
10: Recalculate RPN Based on Plan
 Assuming the actions are carried out successfully, reassign
severity, occurrence and detectability.
 Place these new ratings in the “predicted” columns (ps, po & pd).
 Assign a rating from 1 to 5 for each action that will show the “risk”
associated with each action (5 being the greatest risk). Place the
rating in the “risk” column.

11: Take Action

 Based on the risk mitigation column (Risk * prpn), take the actions
indicated or reassign actions. Then….
 Complete the actions indicated by the times stated!

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 Step 2
ID y’s
Steps 1-11
Step 1 Step 6 Step 9
ID Process Steps
Step 4
Step 11 R
p
S
Failure E
O
C
D R
E P
FMEA Resp. Schedule
Actual
Compl. p p p
r
p
i Risk
s X
Effects V Causes C Controls T N Action Recommended Person Date Action Taken Date S O D n k prpn
Must PM Schedule
redo Periodic created and
copy 6 Paper Jam 7 Maint. 7 294
Periodic preventive maintence Key Opr 3/1 implemented 2/15 6 3 7 126 3 378
Place sign over copier outlining
Must Existing standard size enlarge/reduce or
redo User notes on reliable mach to clearly indicate Place sign over
copy 6 misset size 6 copier 5 180 standard reduce/enlarge Key Opr 2/20 mach 2/15 6 3 2 36 1 36
Must User Existing
redo misset notes on Place sign to encourage user to Place sign over
copy 6 control 5 copier 4 120 utilize auto settings Key Opr 2/20 mach 2/15 6 2 2 24 1 24
Used
landscape
Must instead of
redo portrait or Tray Place note on ruler re tray
copy 6 vice versa 7 Selection 2 84 selection Key Opr 1/20 Placed Note 1/15 6 2 1 12 1 12

Must align Use Auto

redo marking Feeder / Enlarge marks for 8.5 " paper on
copy 6 not clear 4 align ruler 3 72 ruler Key Opr 1/15 Enlarged marks 1/14 6 2 1 12 1 12

Step 10
Step 3 Step 5
6
ID Failure Modes 5 2 60 Step 7 & 8 Key Opr 1/15

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Types of FMEA Process FMEA
• Helps analyze manufacturing and assembly processes
to reduce the occurrence and improve detection of
defects.
• Assists in the development of process control plans.
• Establishes a priority for improvement activities.
• Documents the rationale behind process changes and
helps guide future process improvement plans.
• IS PROACTIVE! Should be started when new
processes are designed or when old processes are
changed.

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 Process FMEA Scoring Definition

Score SEVERITY CRITERIA OCCURRENCE DETECTION

10 Hazardous Without Warning 1 in 2 Very High Absolute Uncertainty
9 Hazardous With Warning 1 in 3 Very High Very Remote
8 Very High 1 in 8 High Remote
7 High 1 in 20 High Very Low
6 Moderate 1 in 80 Moderate Low
5 Low 1
1 in
in 400 Moderate Moderate
4 Very Low 2,000
1 in Moderate Moderately High
3 Minor 15,000
1 in Low High
2 Very Minor 150,000
£1 in Low Very High
1 None 1,500,00 Remote Almost Certain

Note: When completing a Process FMEA, first assume the material is good and
the process is bad. Then assume that the process is good and the material is
bad. Lastly, review the process for safety considerations.

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 Design FMEA
• Helps to identify potential process failure modes early
in the process development cycle.
• Increases the likelihood that all potential failure modes
and their effects on assemblies will be considered.
• Assists in evaluating process design requirements
and test methods.
• Establishes a priority for design improvement.
• Documents the rationale behind design changes and
helps guide future development projects.
• IS PROACTIVE! Should be done when new
processes are designed or existing processes are
changed.

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 Defect FMEA
• Helps identify the root causes of defects.
• Establishes a priority for improvement
activities.
• Documents plan of action.
• Provides methodology to battle initial ground
swell of defects.
• Focuses effort on defects with highest $ impact.
• IS NOT PROACTIVE!

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 Scoring Criteria Use actual
defect quantities

Score SEVERITY CRITERIA OCCURRENCE DETECTION

10 Hazardous Without Warning Very High Absolute Uncertainty
9 Hazardous With Warning Very High Very Remote
8 Very High High Remote
7 High High Very Low
6 Moderate Moderate Low

5 Low Moderate Moderate

4 Very Low Moderate Moderately High

3 Minor Low High
2 Very Minor Low Very High
1 None Remote Almost Certain

Note: To change header information, click on "View" then "Header".

RISK: Optional field used to reflect the probability of completing actions.

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 The Catapult
Analyze the Catapult process using the FMEA tool.
(Remember we want to get the “most bang for the buck”.)

• Break into the Catapult teams

• We have already constructed a process map
• First, we will construct a cause and effect
diagram
• Then we will complete at least two failure modes
for the most critical step(s) of our process
• Appoint a spokesman for your team to debrief
the class on your progress, questions, etc. 25 minutes!
• Complete the FMEA (FMEAform.xls) for the
Catapult process before the third session (We
will use this information for our DOE competition)

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 Catapult Process Map
Assemble Select Catapult Set Catapult
Start Secure to table
Catapult Settings Pins

Pins (2) Clamp Plan or Positions

Arm Tape Measure Prediction Designated
Rubber Band Tape equation
Ball Computer

Arm Aligned Feasible Correct

moves with tape settings settings
smoothly ± 3 inches

Pull Arm to Measure Record

Shoot Stop
Proper Angle distance distance

Operator Tape Measure

Operator Recorder
Consistency Observers
No Parallax Lateral Computer
movement positioned
properly

Correct
angle Ball flys Accurate Correct
straight measurement distance
± 2 inches recorded

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 Complete the Diagram Below
FMEA Exercise

Men
Method Material
Rubber Band Release consistency
Calculation procedure Angle measurement
Ball

Distance

Air Conditioner Arm moves freely Repeatability

Reproducibility
Mother nature
Machine Measure

Datafile/CatapultC&E.IGX

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 When To Update an FMEA?
FMEA Summary

An FMEA should be updated whenever a change is being considered

to a process’s:
 design
 application
 environment
 material
 operation

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 Summary of Product/Process FMEA’s
 What is the tool?
– Spreadsheet
 What will the tool
identify/show?
– All product/process failure
modes, related effects,
causes, & methods of
controlling them
– Risk Priority Number (RPN)
for action based on failure
severity, probability of
occurrence and detection
capability
– Actions/plans to reduce
elements of RPN
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 When do you apply this tool?
– When evaluating product for
robustness (functionality,
produceability, reliability)
– During early stages of defect reduction
efforts to identify causes
– When identifying key process/product
parameters and evaluating methods
for controlling them
 What results can you expect?
– Learn to identify critical product/
process parameters
– Achieve consensus on solutions and
methods of implementation
– Detailed product/process
understanding
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 Keys to Success
 Identify purpose...BE SPECIFIC!

 Understand effects...INVOLVE CUSTOMERS & SUPPLIERS!

 Link to the process map.

 Use to prioritize efforts, allocate resources.

 Use as a risk assessment/prioritization tool based on predicted impact.

 Use to build consensus on prioritization.

 Encourage creativity...TEAMWORK!

 PLAN!

 ASK QUESTIONS!
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 Process FMEA Steps
 Steps Completed Prior to FMEA:
– Charter Team
– Develop and Characterize Process Map
 FMEA Steps:
1. Identify “Heavy Hitter” Process Step
1. Identify Associated y’s (Product Parameters)
1. Identify Failure Mode
1. Identify Failure Effects/Rate Severity
1. Identify Causes/Rate Occurrence
1. Identify Controls (if any)/Rate Detection
1. Calculate RPN
1. Prioritize by RPN Order
1. Determine Actions/Plan
1. Recalculate RPN Based on Plan
1. Take Action
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 What We Have Learned

1. As a Team, how to construct an FMEA and associated

Action Plan

2. How the FMEA process ties to process mapping

3. The relationship between Failure Mode, Cause and Effect

4. The different types of FMEAs

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 FMEA Appendix
FMEA Scoring Criteria, Terminology and
Spreadsheet

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 FMEA Appendix
Key Definitions for FMEA
Severity is an assessment of how serious the effect of the potential failure mode is on the customer.
The customer in this case could be the next operation, subsequent operations, or the end user.

Occurrence is an assessment of the likelihood that a particular cause will happen and result in the
failure mode.
Detectionis an assessment of the likelihood that the current controls (design and process) will detect
the cause of the failure mode, should it occur, thus preventing it from reaching your customer.
The customer in this case could be the next operation, subsequent operations, or the end user.

Current Controls (for both design and process) are the mechanisms which prevent the cause of the
failure mode from occurring, or detect the failure mode, should it occur, before the product
reaches your “customer.” For example, current controls include SPC, inspections, written
procedures, training, preventive maintenance and all other activities that ensure a smooth
running process.
Critical Characteristics are those items which affect customer safety and/or could result in non-
compliance to regulations and thus require controls to ensure 100% compliance. These are
usually process“settings” such as temperature, time, speed, etc.

Significant Characteristics are those items which require SPC and quality planning to ensure
acceptable levels of capability.
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 FMEA Appendix

A.
Terminology
Process or Product Name – Description of Process or Product being analyzed.
B. Responsible – Name of Process Owner.
C. Prepared By - Name of Agent coordinating FMEA study.
D. FMEA Date – Dates of Initial and subsequent FMEA Revisions.
E. Process Step/Part Number – Description of individual item being analyzed.
F. Potential Failure Mode – Description of how the process could potentially fail to meet the
process requirements and/or design intent, i.e. a description of a non-conformance at that
G. Potential Failure Effects – Description of the effects of the Failure Mode upon the customer,
i.e. what the next user of the process or product would experience or notice.
H. SEV (Severity) – An assessment of the seriousness of the effect of the potential failure mode
I. Potential Causes – Description of how the failure could occur, described in terms of something
J. OCC (Occurrence) – Description of how frequently the specific failure cause is expected to
K. Current Controls – Description of process controls that either prevent, to the extent possible,
L. DET (Detection) – An assessment of the probability that the current controls will detect the
potential cause, or the subsequent failure mode.
M. RPN (Risk Priority Number) – The product of the Severity, Occurrence, and Detection
Rankings i.e., RPN = SEV * OCC * DET.
N. Actions Recommended – Actions to reduce any or all of the Occurrence, Severity or Detection
rankings.
O. Responsibility – Person or group responsible for the Recommended Action.
P. Actions Taken – Brief description of actual action and effective date.
Q. New SEVERITY Rating after corrective action.
R. New OCCURENCE Rating after corrective action.
S. New DETECTION Rating after corrective action.
T. Resulting new RPN after corrective action.
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 FMEA Appendix

Suggested PFMEA Severity Evaluation Criteria

  Criteria : Severity of Effect
  This ranking results when a potential failure
  mode results in a final customer and/or a
  manufacturing/assembly plant defect. The final
  customer should always be considered first. If
  both occur, use the higher of the two
 Effect severities.
(Customer Effect)
Criteria : Severity of Effect  
This ranking results when a potential failure mode  
results in a final customer and/or a  
manufacturing/assembly plant defect. The final  
customer should always be considered first. If  
both occur, use the higher of the two severities.  
(Manufacturing / Assembly Effect)  
Ranking

Hazardous Very high severity ranking when a potential Or may endanger operator (machine or 10
Without failure mode affects safe vehicle operation assembly) without warning
warning and/or involves noncompliance with
government regulation without warning

Hazardous Very high severity ranking when a potential Or may endanger operator (machine or 9
With failure mode affects safe vehicle operation assembly) without warning
warning and/or involves noncompliance with
government regulation with warning

Very High Vehicle/item inoperable (loss of primary Or 100% of product may have to be scrapped, 8
function) or vehicle/item repaired in repair department
with a repair time greater than one hour.

High Vehicle/item operable but at a reduced level of Or product may have to be sorted and a 7
performance. Customer very dissatisfied. portion (less than 100%) scrapped, or
vehicle/item repaired in repair department with
repair time between a half – hour and an hour.

Moderate Vehicle/item operable but comfort/convenience Or a portion (less than 100%) of the product 6
item(s) inoperable. Customer dissatisfied may have to scrapped with no sorting, or
vehicle/item repaired in repair department with
a repair time less than a half-hour

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 FMEA Appendix

Suggested PFMEA Severity Evaluation Criteria

Low Vehicle/item operable but Or 100% of product may have 5
comfort/convenience item(s) to be reworked, or vehicle/item
operable at a reduced level of repaired offline but does not go
performance. to repair department.
Very Low Fit and finish/squeak and rattle Or the product may have to be 4
item does not confirm. Defect sorted, with no scrap, and a
noticed by most customers portion (less than 100%)
(greater than 75%) reworked.
Minor Fit and finish/squeak and rattle Or a portion (less than 100%) of 3
item does not confirm. Defect the product may have to be
noticed by 50% of customers reworked, with no scrap, on-
line but out-of-station
Very Fit and finish/squeak and rattle Or a portion (less than 100%) of 2
Minor item does not confirm. Defect the product may have to be
noticed by discriminating reworked, with no scrap, on-line
customers (less than 25%) but in-station.
None No discernible effect Or slight inconvenience to 1
operation or operator, or no
effect
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 FMEA Appendix

Suggested PFMEA Occurrence Evaluation Criteria

Probability Likely Failure Rates * Ranking
Very High : Persistent  100 per thousand pieces 10
Failure
50 per thousand pieces 9
High : Frequent Failures 20 per thousand pieces 8
10 per thousand pieces 7
Moderate : Occasional 5 per thousand pieces 6
Failures
2 per thousand pieces 5
1 per thousand pieces 4
Low : Relatively Few 0.5 per thousand pieces 3
Failures
0.1 per thousand pieces 2
Remote: Failure is Unlikely  0.01 per thousand pieces 1
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 FMEA Appendix

Suggested PFMEA Detection Evaluation Criteria

Detection Criteria Inspection Types Suggested Range of Ranking
Detection Methods
A B C

Almost Absolute certainty of non-     X Cannot detect or is not 10

Impossible detection checked

Very Controls will probably not     X Control is achieved with 9

Remote detect indirect or random checks
only
Remote Controls have poor chance     X Control is achieved with 8
of detection visual inspection only
Very Low Controls have poor chance     X Control is achieved with 7
of detection double visual inspection only

Low Controls may detect   X X Control is achieved with 6

charting methods, such as
SPC {Statistical Process
Moderate Controls may detect   X   Control}
Control is based on variable 5
gauging after parts have left
the station, or Go/No Go
gauging performed on 100%
of the parts after parts have
Moderately Controls have good chance X X   Error detection
left the station in subsequent 4
High to detect operations, OR gauging
performed on setup and first-
piece check(for set – up
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 FMEA Appendix

Suggested PFMEA Detection Evaluation Criteria

High Controls have good X X   Error detection in- 3
chance to detect station, or error
detection in subsequent
operations by multiple
layers of acceptance:
supply, select, install,
verify. Cannot accept
discrepant part.
Very High Controls almost X X   Error detection in- 2
certain to detect station, (automatic
gauging with automatic
stop feature). Cannot
accept discrepant part.

Very High Controls certain to X     Discrepant parts cannot 1

detect be made because item
has been error-proofed
by process/product
design.

Inspection Types:
A: Error-proofed
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Gauging BPMS - FMEA Rev 1.0 46
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 Questions ?

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