PFMEA

Three Parts:
• Process Flow Diagram (PFD)
• Process Failure Mode and Effects
Analysis (PFMEA)
• Process Control Plan (PCP)
 What Is an FMEA?
• A structured approach to:
oIdentify the ways in which a product or process can
fail
oEstimate the risk associated with specific causes
oPrioritize the actions that should be taken to reduce
the risk
• A Process FMEA will:
oCapture the entire process and the key inputs (Xs)
oIdentify ways the product or process can fail
because of these Xs
oFacilitate the documentation of a plan to prevent
those failures
Applications For FMEA
 Design:
Used to analyze product designs before they are released to
production. A DFMEA should always be completed well in
advance of a prototype build. Focuses on product function.
 Process:
Used to analyze manufacturing, assembly, or any other
processes. Focuses on process inputs. This is the topic for this
module.
 Project:
Documents and addresses failures that could happen during
a major
program
 Key Source Material For An FMEA
PAPERWORK TURN STEAM ON
LOAD DMF LOAD DICY LOAD 2MI 1
TO DICY TANK

BILL OF MATERIALS SCALE ACCURACY

LOAD ACCURACY LOAD ACCURACY
LOAD ACCURACY
Process Map
ISO PROCEDURES PREHEATING
CLEANLINESS ENVIRONMENT
ENVIRONMENT
(HUMIDITY)
REWORK (HUMIDITY)
RAW MATERIAL RAW MATERIAL
RAW MATERIAL
MIXER SPEED
MIXER SPEED

FMEA
 The FMEA Form - The Analysis Section
The FMEA Form
The Analysis Section
Process Potential Potential S O D R Action
Potential Current Section
Step/ Failure Failure E C E P
Causes Controls
Input Mode Effects V C T N 
What is the 0 0
How can 0 0

Effect on the this be If risk is

Outputs? 0 0
found?
0 0 too high,
What can what can
go wrong 0 What are 0 0 0
be done?
with the the
0 0 0 0
Process Potential
Step? 0 Causes? 0 0 0

What is
the How How often is the How well can Estimated
Process serious is cause likely to we detect a risk is “Sev”
Step such an occur and result cause before it x “Occ” x
Effect? in a Failure creates a “Det”
Mode? Failure Mode
and Effect?
 Definition Of Terms – Failure Mode

Failure Mode: The way in which a specific process input

fails
 If it is not detected and either corrected or removed, it
may cause a negative “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
 Note 1: Just because a dimension is out of spec (a Failure
Mode), it does not imply with 100% certainty that the product
will not function (an effect)
 Note 2: Just because the process is improperly setup (a failure
cause), it does not imply with 100% certainty that the
dimension will be out of spec (a Failure Mode)
 Definition Of Terms – Effect And Cause

 Effect: The adverse impact on customer requirements.

Generally has an external customer focus, but can also include
downstream processes.
oA product or process that does not perform satisfactorily
to design
 Cause: Whatever causes the Failure Mode to occur.
How a specific part of the process (operation or component)
can cause a Failure Mode.
oA worn spindle (cause) may cause a dimension to be out of
tolerance (mode) which may cause the part to not fit
(effect)
Definition Of Terms – Severity, Occurrence, And Detection

 Severity: An assessment of how serious the Failure Effect

(due to the Failure Mode) is to the customer
 Occurrence: An assessment of the likelihood that a
particular Cause will happen and result in the Failure Mode
 Detection: An assessment of the likelihood that the
current controls will detect the Cause of the Failure Mode or
the Failure Mode itself, should it occur, thus preventing the
Failure Effect from reaching your customer. The customer in
this case could be the next operation, subsequent
operations, or the end user
 Definition Of Terms – Current Controls

 Current Controls: Systematized methods/devices in

place to prevent or detect failure Modes or Causes (before
causing effects)
 Prevention-based controls may include Mistake
Proofing, automated controls, setup verifications,
Preventive Maintenance, and
Control Charts
 Detection-based controls may include audits, checklists,
inspection, laboratory testing, and Control Charts
 Rating Definitions Typical Scales

Rating Severity
Severity Occurrence
Occurrence Detection
Detection
High 10 Hazardous without Very high and Cannot detect
warning almost inevitable

Loss of primary function High repeated Low chance of

failures detection

Loss of secondary Moderate failures Moderate chance of

function detection

Minor effect Occasional failures Good chance of

detection

No effect Failure unlikely Almost certain

Low 1 detection

Note : Determine if your company has rating scales and rules.

In some companies, rating a “10” on severity may have legal
consequences.
 Risk Priority Number (RPN)

 A key output of an FMEA is the “Risk Priority Number”

 The RPN is a calculated number based on information you
provide regarding:
 The likelihood of potential causes of Failure Modes
 The seriousness of the resulting effects
 The current ability of the process to detect the causes of
the Failure Modes before they cause an effect to reach a
customer
 It is calculated as the product of three (3) ratings, each one
related to the severity, frequency, and detect ability
RPN = Severity x Occurrence x Detection
Regardless of RPN, high severity scores should be given special
attention.
 Risk Priority Numbers (2)

 The Risk Priority Number need not be limited to

Severity, Occurrence, and Detection.
Some examples:
 Add an “Impact” score to estimate the overall impact of
the Failure Mode on the process (10 = high, 1 = low)
 Add an “EHS” rating to a project FMEA to incorporate
possible environmental impact (10 = high, 1 = low)
 Add an “EOC” or Ease Of Completion (10 = easy, 1=
hard) to help prioritize/focus projects
 Comments On Detection Scores

Low Det Score High Det Score

Virtually Virtually
certain no
Prevention Prevention

Cause Failure Mode Effect

(Defect)

 High detection scores imply that we will not easily catch the existence of a
Failure Cause until after the resulting Failure Mode creates a Failure Effect.
Usually, this means that we detect the effect at the end of the line or, even worse,
our customer finds it.
 A very low detection score generally implies that you catch the cause before it
creates the Failure Mode.
 FMEA Model

Cause Mode
Mode Effect
Effect
Faculty inverter
Agitator too Extractable too
High particle slow high
count
Pits Internal opens on
printed circuit in
Temp controller clean room
out
Temp too high Conversion rate
Drill not of calibration too low
properly
Hole not drilled Part will not
sharpened assemble straight
Part not
Hole not drilled Part will not
clamped
square in fixture assemble straight
Hole not drilled Part will not
Drill not
assemble to proper
properly
diameter
 Linking Failure Modes To Effects Note:
The Last Three (3) Examples On Prior Slide

Failure Mode 1 Effect 1

Failure Mode 2 Effect 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.
 A Second Look At The Analysis Section
File: FMEA_Form.XLS

Process/Product - FMEA
Failure Modes and Effects Analysis

Process or
Product Prepared by: Page ____ of ____
Name:
Responsible: FMEA Date (Orig) ______________ (Rev) _____________

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

FM occur?
What is the What is the In what ways What is the impact

to the customer?
What causes the What are the existing

cause or FM?
Sev x Occ x Det
How well can you detect
How often does cause or
How Severe is the effect
process step Key does the Key on the Key Output Key Input to go controls and procedures
Process Input go wrong? Variables (Customer wrong? (inspection and test) that
Input? Requirements) or prevent either the cause
internal or the Failure Mode?
requirements? Should include an SOP
number.

0
 The FMEA Form
The Action Section

Analysis S O R
R Actions D
Section Actions E
P Responsibility Taken C E P
 N
Recommended V C T N
Original RPN

Revised SEV

Revised OCC

Revised DET

Revised RPN
What are the actions for Who is What are the
reducing the Severity or Responsible completed actions
Occurrence, or for the taken with the
improving Detection? recommended recalculated RPN?
Should have actions action? Be sure to include
only on high RPNs or completion
easy fixes. month/year.
 9 Strategies To Complete An FMEA

1. For each Process Input, determine the ways in which the

Process Step can go wrong (Failure Modes)
2. For each Failure Mode associated with the inputs,
determine Effects
3. Identify potential Causes of each Failure Mode
4. List the Current Controls for each Cause
5. Assign Severity, Occurrence, and Detection ratings to each
Cause
6. Calculate RPN
7. Determine Recommended Actions to reduce High RPNs
8. Take appropriate actions and document
9. Recalculate RPNs
 Definition of FMEA
A FMEA is an analytical tool that uses a
disciplined technique to identify and help
eliminate product and process potential failure
modes.
• By ID of potential failures
• Assessing the risks caused by failure modes and Identify
corrective actions
• Prioritizing corrective actions
• Carry out corrective actions
Most COMMON Types of FMEA's

Design (Potential) Failure Modes and

Effects Analysis-DFMEA
•Focus is on potential design- related
failures and their causes.

Process (Potential) Failures Modes and

Effects Analysis-PFMEA
•Focuses is on potential process failures and
their causes.
 PFMEA's
• Focus is on potential process –related
failures and their causes.
oMain drive is to understand the process through
the identification of as many potential failures as
possible.
• e.g. Incorrect material used

• PFMEA typically assumes that the

design is sound.
• Development of Recommended
Actions is targeted at eliminating the
Root Cause of the potential failures.
 PFMEA
Three Parts:
• Process Flow Diagram (PFD)
• Process Failure Mode and Effects
Analysis (PFMEA)
• Process Control Plan (PCP)
 Information Flow

Customer Requirements:
SOR, Vehicle Tech Specs,
System Technical Specs
Product Definition:
Key Product Characteristics, DFMEA

Process Definition:
Process Flow Diagram (PFD),
Product and Process Characteristics
Failure Mode Analysis:
PFMEA

Control Strategy:
Control Plan,
Error proofing
Manufacturing:
Work Instructions & Process Monitoring
 DFMEA/PFMEA Information
Interrelationships

Boundary (Block) Process Flow

Diagram, P- Diagram, Diagram
Etc.

DFMEA PFMEA
Design FMEA Process FMEA

Process Control
Design Verification Plan
Plan & Report
(DVP&R)
 PFD Feeds PFMEA
Identify the Function(s)
• Function is a description of what the Process does
to meet the requirements
 Related to process specification and product
characteristics
 Comes from the PFD operation description
column
• Functions can be described as:
 Do this operation…
 To this part or material…
 With this tooling or equipment…
PFD Feeds PFMEA
Linkage to PFMEA
PFMEA Example continued..
 Sources and Types of Manufacturing Variation

Source of Variation Types of Variation Typical Process Controls

Operator Skill, Training, instructions, visual aids, feedback
Operator Ergonomic Factors layout, motion analysis, human factors

Incoming raw material, purchased Supplier management, internal controls, error

Component / Material parts, previous operations proofing

Machine capability, adjustment, wear Equipment specifications, closed-loop machine

Equipment / Machine over time controls, preventive maintenance

Temperature, humidity, dust, noise Climate control, air filtration, clean room, sound
Environment insulation

Industrial Engineering techniques,

Methods & Systems Sequence, procedure, layout Lean Flow analysis

Process specification, first / last piece check,

Set Up automated controls
Initial set up or adjustment
(for stable processes)

Wear over time, breakage, Predictive maintenance, detection error-

Tool tool-to-tool differences proofing, tooling specifications

Repair, replacement, reassembly, Instructions, error-proofing, machine

Maintenance adjustment qualification, production trial run

Position tolerance, adjustment, wear Predictive maintenance, prevention and

Fixture / Pallet over time detection error-proofing
 Process Control Plan
• PCP will be based on the previous activities in PFD
and PFMEA.
• Review the PFMEA information developed &
supplied and use to identify:
o Specific controls that may be needed due to
the information added
o Identify which controls are Product or Process
• Note any Special Characteristics
• Identify evaluation methods, frequency and Control
Methods
• Note Reaction Plans (particularly related to NC
parts)
 Process Control Plan Example
Form 818-1 (Rev 12Apr02)

Prototype Pre-Launch Production CONTROL PLAN Control Plan No:

Part Number/Latest Change Level Key Contact/Phone Date (Orig.) Date (Rev.)

Customer Part Number Core Team Customer Engineering Approval/Date (If Req'd.)

Part Name/Description Supplier/Plant Approval/Date Customer Quality Approval/Date (If Req'd.)

Supplier/Plant Supplier Code Other Approval/Date (If Req'd.) Other Approval/Date (If Req'd.)

Characteristics Methods
Part/ Machine, Device, Special
Process Name / Sample Reaction
Process Jig, Tools for Char. Product / Process Evaluation
Operation Description No. Product Process Specification / Measurement Control Method Plan
Number Mfg. Class.
Tolerance Technique Size Frequency
Weld beads Tube welds meet Pull test 1 pc. Per shift. Hydraulic pull test Quarantine
300 Initiate weld sequence Robotic Arm per design pull test with failure using test instruction TI21-01 material
/ controller. specification. in parent material. fixture 20-1. since last
TIG welders. Process monitoring
form PMF-20-01 good pull
Perform TIG weld of test.
frame parts.
Good welds, yes Weld appearance Operator 100% Each Visual inspection OWI Remove part
no visible meets visual evaluation to piece. #20-01. and send to
defects. standard. Visual Std repair.
TB20-VS1
Weld voltage yes 24 Volts AC Machine 100% Each weld Closed-loop machineScrap part &
+/- 2.0 volts Control cycle. control. Re-start
welder.
Weld voltage yes 24 Volts AC Visual Once Shift start Set-up OWI #20-02 & Scrap current
+/- 2.0 volts each or Form PMF-20-02 part.
change- Periodic maintenance Shut down.
over or per PM-WI #20. Notify
maint. maintenance.
event.
Inert gas flow yes 5 cubic feet / min. Visual twice Per shift. Operator cleans gas Notify
rate +/- 0.5 cfm cup twice per shift maintenance.
PM-WI-20. Process
monitoring form PMF-
20-01

Inert gas flow yes 5 cubic feet / min. Visual of Once Shift start Set-up OWI #20-02 & Quarantine
rate +/- 0.5 cfm verification each or Form PMF-20-02. material
of Flow change- Equipment Calibration since last
Meter over or Procedure #368 good pull
maint. test.
event Notify
maintenance.
 Process Control Plan Example
Characteristics Methods
Part/ Machine, Special
Process Name / Product / Process Evaluation Sample Reaction
Process Device, Jig, Char.
Operation Description No. Product Process Class. Specification / Measurement Control Method Plan
Number Tools for Mfg.
Tolerance Technique Size Frequency
.
Initiate weld sequence / Robotic Arm
Close and latch curtain TIG welders
300

Weld beads per Tube welds meet Pull test using 1 pc. Per shift. Hydraulic pull test Quarantine
300. Initiate weld sequence / Robotic Arm design pull test with failure test fixture instruction TI41-01 material
Perform TIG weld of TIG welders specification. in parent material. 20-1. since last
frame parts. and controllers. Process monitoring
form PM-20-010 good pull
test.
Good welds, no yes Weld appearance Operator 100% Each Visual inspection OWI Remove
visible defects. meets visual evaluation to piece. #20-010. part and
standard. Visual Std send to
TB20-VS1. repair.
Initiate weld sequence / Weld voltage yes 24 Volts AC Machine 100% Each weld Closed-loop machine Scrap part
Confirm Weld voltage +/- 2.0 volts Control cycle. control. & Re-start
welder
Weld voltage yes 24 Volts AC Visual Once Shift start Set-up OWI #20-02 & Scrap
+/- 2.0 volts each or change- Form PM-20-02 current
over or Periodic maintenance part.
maint. per PM-WI #20. Shut down.
event Notify
Inert gas flow yes 5 cubic feet / min. Visual twice Per shift. Operator cleans gas maintenanc
Notify
rate +/- 0.5 cfm cup twice per shift e.
maintenan
Initiate weld sequence /
Confirm Inert Gas flow PM-WI-2500. Process ce.
rate monitoring form PMF-
20-10
Inert gas flow yes 5 cubic feet / min. Visual Once Shift start Set-up OWI #20-02 & Quarantine
rate +/- 0.5 cfm verification of each or change- Form PM-00-02. material
Flow Meter over or Equipment Calibration since last
maint. Procedure #368 good pull
event test. Notify
Initiate weld sequence / maintenan
Scrap part &
Weld wire feed yes 300 mm / minute Machine 100% Each weld Closed-loop machine ce.
Confirm Wire feed rate rate +/- 10 mm / min. Control cycle. control. Re-start
welder
Weld wire feed yes 300 mm / minute Operator 100% Shift start Set-up OWI #20-020 & Scrap current
rate +/- 10 mm / min. setup check or change- Form PM-20-020 part.
and over or Predictive maintenance Shut down.
verification maint. pinch roller replace @ Notify
event 180 days. maintenance.
What Must be done before FMEA Begins!

Getting Started on FMEA

Understand your
=QFD

Ready?
Customer
Needs

Develop & Evaluate

Product/Process =Brain Storming
Concepts

Create =4 to 6 Consensus Based Multi Develop and

an Effective
Level Experts Drive 7
FMEA Team Determine
“Effects” of3 Action Plan
= What we The Failure
Define the FMEA are and are
Scope Mode
not working Severity Rating

Determine 4 Determine5 66
Determine2
Determine1
Product or “Causes” of “Controls” Calculate &
Failure Modes The Failure
Process Assess Risk
of Function Mode
Functions Detection Rating
Occurrence Rating

33
 The FMEA Worksheet
Resp. & p p p p
Product S O D R
Failure Failure Actions Target S O D R
or E Causes C Controls E P
Mode Effects / Plans Complete E C E P
Process V C T N
Date V C T N

1 2 3 4 5 6 7
Develop
Determine Determine Determine
and
Product or “Effects” of “Controls”
Drive
Process The Failure Detection
Action Plan
Functions Mode Determine Rating
Severity “Causes” of
Determine Rating The Failure Calculate
Failure Mode &
Modes Occurrence Assess
of Function Rating Risk

If an FMEA was created during the Design Phase of the Program, USE IT!
Create an Action Plan for YOUR ROOT CAUSE
and Re-Evaluate the RPN Accordingly

34
FMEA Scoring
Severity
Severity of Effect Rating
May endanger machine or operator. Hazardous without warning 10
Extreme

May endanger machine or operator. Hazardous with warning 9

Major disruption to production line. Loss of primary function, 100% scrap. Possible jig lock and
8
High

Major loss of Takt Time

Reduced primary function performance. Product requires repair or Major Variance.
Noticeable loss of Takt Time 7
Medium disruption of production. Possible scrap. Noticeable loss of takt time.
6
Moderate

Loss of secondary function performance. Requires repair or Minor Variance

Minor disruption to production. Product must be repaired.
Reduced secondary function performance. 5
Minor defect, product repaired or "Use-As-Is" disposition. 4
Fit & Finish item. Minor defect, may be reprocessed on-line. 3
Low

Minor Nonconformance, may be reprocessed on-line. 2

None

No effect 1

35
Occurrence FMEA Scoring Failure Capability
Likelihood of Occurrence Rate (Cpk) Rating
Very High

1 in 2 < .33 10
Failure is almost inevitable
1 in 3 > .33 9
1 in 8 > .51 8
High

Process is not in statistical control.

Similar processes have experienced problems.
1 in 20 > .67 7
1 in 80 > .83 6
Moderate

Process is in statistical control but with isolated failures.

Previous processes have experienced occasional 1 in 400 > 1.00 5
failures or out-of-control conditions.
1 in 2000 > 1.17 4
Process is in statistical control. 1 in 15k > 1.33 3
Low

Process is in statistical control. Only isolated 2

failures associated with almost identical processes. 1 in 150k > 1.50
Remote

Failure is unlikely. No known failures associated 1 in 1.5M > 1.67 1

with almost identical processes.

36
Detection FMEA Scoring
Likelihood that control will detect failure Rating
Very Low

No known control(s) available to detect failure mode. 10

9
Low

Controls have a remote chance of detecting the failure.

8
7
Moderate

Controls may detect the existence of a failure 6

5
Controls have a good chance of detecting the existence 4
High

of a failure
3
Very High

The process automatically detects failure. 2

Controls will almost certainly detect the existence of
a failure. 1
37
 FMEA Scoring
RPN or Risk Priority Number

The Calculation !

Severity x Occurrence x Detection= RPN

38
 Failure Modes & Effect
Analysis
(FMEA) Part or Process Improvement
 FMEA is a technique utilized to define, identify, and eliminate known or
potential failures or errors from a product or a process.
 Identify each candidate Part or Process, list likely failure mode, causes,
and current controls
 Prioritize risk by using a ranking scale for severity, occurrence, and
detection
 Mitigate risk – Can controls be added to reduce risk? Recalculate RPN.
 Characteristics with high Risk Priority Numbers should be selected for
Improvement and Action Plans Created
 Recalculate RPN After Completion of Action Plans to Validate
Improvements
Resp. & p p p p
Product S O D R
Failure Failure Actions Target S O D R
or E Causes C Controls E P
Mode Effects / Plans Complete E C E P
Process V C T N
Date V C T N

120
Hole Oversize Unable to Wrong Ball Gage Kit Drill
Drilling Hole Install BP 5 Drill Bit 8 Visual Insp 3 Bits
010103 5 1 1 5
Fastener Used

39