Failure Mode Effects Analysis

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The Breakthrough Strategy

Define Measure Characterize Analyze
BB Works with Management
1 2 3 4 5 6 7 Select Output Characteristic and identify key process input and output variables Define Performance Standards Validate Measurement System Establish Product Capability Define Performance Objectives Identify Variation Sources Screen Potential Causes Discover Variable Relationships Establish Operating Tolerances

Improve Optimize Control

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10 Validate Measurement System 11 Determine Process Capability 12 Implement Process Controls

2

Measurement Phase
Project Definition: Problem Description Project Metrics Process Exploration: Process Flow Diagram C&E Matrix, PFMEA, Fishbone Data collection system Measurement System(s) Analysis (MSA): Attribute / Variable Gage Studies Capability Assessment (on each Y) Capability (Cpk, Ppk, s Level, DPU, RTY) Graphical & Statistical Tools Project Summary Conclusion(s) Issues and barriers Next steps Completed Local Project Review
Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Breakthrough Strategy
Process Map
PAPERWORK TURN STEAM ON TO DICY TANK LOAD DMF LOAD DICY LOAD 2MI 1
1 2 3 4 5 6 7 8 9 10 11 Low Capacity From Unit Excessive Downtime Material Losses Corrosion of Equipment Poor Reactor Performance 8 4 4 4 7 7 1 1 3 5 2 5 3 1

Cause and Effects Matrix

LOAD ACCURACY ENVIRONMENT (HUMIDITY) RAW MATERIAL MIXER SPEED

BILL OF MATERIALS ISO PROCEDURES REWORK

SCALE ACCURACY PREHEATING

LOAD ACCURACY CLEANLINESS RAW MATERIAL

LOAD ACCURACY ENVIRONMENT (HUMIDITY) RAW MATERIAL MIXER SPEED

INPUTS

Process Step Process Inputs

Heavies in Product Lights in Product Moisture in Product Acidity in Product

OUTPUTS
10 9 9 5 6 4 4 2 6 6 4 3 6 6 6 3 3 3 2 6 7 6 2 2 8 8 8 5 2 2

Total 335 157 149 148 148 144 140 138 137 134 132 125

139 9 7 73 74 131 144 100 16 111 39 34

Day Tanks Analysis 10 Reactor Cat./HF Ratio Reactor Rxr Temperature Lights Removal Condenser Leak Lights Removal Reboiler Leak Purification Low Stages 8 Final StorageContainers 3 NeutralizationpH Value Catalyst Stripper Pluggage Drying Decomposition 2 Drier Water Carryover Drier Molecular Sieve

FMEA
Process Step/Part N um ber Potential Failure M ode Potential Failure Effects S E V Potential C auses O C C C urrent C ontrols D PN E R T A ctions R ecom m ended R esp.

Initial Assessment of Capabilities and Control Plans

Process Whitefilm Process Step Coating Input Dosage Coating Height Coating width Coating length Vacuum Output Process Specification (Target, LSL, USL) 22.5, 22, 23 24,23,25 Cpk Mean - Sigma 1.22 1.54 Measurement Technique UIL-1700 Micrometer %R&R P/T Sample Size Sample Frequency 1/hr 1/hr Control Method Auto-timer Coating & pump speed 25% 31%/0.47 35 pts per panel

C O AT IN G& I M AG IN G

D IR T YP H O T O M AS K

M IC R O C R AC K IN G , D E LA M IN A TI O N ,S T R E AK S

LO WF R E Q U E N C YO FC LE AN IN G 8 8

S O P ,V IS U ALIN S P E C T IO N 7

I N C R E AS EF R E Q U E N C Y M G 448 T OO N C EE VE R Y20 P A N E LS I M P R O VEC LE AN IN G M E TH O D P U R C H AS EO F F-LIN E C LE A N IN GS YS T E M T E S TO N -LIN EM AS K R E P LAC E M E N T P F

M G

P F

14,12,16 36,34,38 35" Hg

1.78 1.43

Laser Measuring Device Laser Measuring Device Vacuum Gauge

1/hr 1/hr 1/hr Monitor

Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Where Does Risk Come From?

Unclear Customer Expectations Job Assignment Variation Vague Workmanship Standards Machine Reliability Measurement Variation (Online and QC) Potential Safety Hazards Poor control plans & SOPs Poor Process Capability

Cumulative Risk
Raw Material Variation

Poorly developed Specification Limits

D. H. Stamatis, FMEA:FMEA from Theory to Practice, Quality Press, 1995

Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Type of FMEAs
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. 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. Project: Documents and addresses failures that could happen during a major program. Software: Documents and addresses failure modes associated with software functions.
Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Definition - FMEA
A structured approach to: identifying the ways in which a process can fail estimating the risk associated with specific causes prioritizing the actions that should be taken to reduce the risk evaluating the current control plan

Primary Directive: Identify ways the process can fail and eliminate or reduce the risk of failure in order to protect the customer
In short a process FMEA will: ultimately capture the entire process identify ways the process failed because of these X's and facilitates the documentation of a plan to prevent those failures
Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Role of Process FMEA

Key tool for the 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 Used to analyzes new manufacturing processes Used to identify deficiencies in the Process Control Plan Can establish and prioritize actions Evaluates the risk of process changes Identifies potential variables to consider in Multi-Vari and DOE studies Guides the development of new manufacturing processes Helps set the stage for breakthrough
Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

FMEA Inputs and Outputs

Inputs
Process map P-Diagram Design specification C&E matrix Process history Process technical procedures

Outputs
List of actions to prevent causes or to detect failure modes History of actions taken and future activity Control Plan Reliability and Robustness check list
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FMEA Team
Team approach is necessary Responsible Black Belt typically leads the team Document should be owned by the process owner Recommended representatives:
Design Manufacturing operators / supervisors Quality Reliability Materials Testing Supplier

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Terminology

(All Process Data Files / FMEA_CP)

Failure Mode : a description of a non-conformance at a particular process step (also know as a shop floor defect). Failure Effect : the effect a particular failure mode will have on the customer (attempt to quantify with respect to Y's). Severity (of failure effect, scale of 1 to 10) : an assessment of the seriousness of the failure effect on the customer. The customer can be the end customer and / or the next process operation.

Failure Cause :
something which can be corrected or controlled (X) that describes how the failure mode could have occurred. Occurrence (of failure cause, scale of 1 - 10) : an assessment of the frequency with which the failure cause occurs. How often does this X fail in a specific way? Detection (of failure cause or failure mode, scale of 1 - 10) : an assessment of the likelihood (or probability) that your current controls will detect 1) when the X fails or 2) when the failure mode occurs.

Risk Priority Number :

= Severity X Occurrence X Detection. used to prioritize recommended actions. Special consideration should be given to high Severity ratings even if Occurrence and Detection are low.

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Definition of Terms - 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 thats wrong is considered a Failure Mode.

Continuous Process Examples

Temperature Too High Heat transfer too fast Agitator too slow

Discrete
Pits Internal Contamination

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Definition of Terms - Effect

Effect - The impact on customer requirements. Generally external customer focus, but can also include downstream processes.
Continuous Process Failure Mode/Effect Examples:
Temperature too high: Melt Viscosity Variable Heat transfer too fast: Conversion rate too low Agitator too slow: Extractables too high

Discrete Process Failure Mode/Effect

Pits: Internal opens on printed circuit Internal Contamination: Short between layers in a multilayer printed circuit board
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Definition of Terms - 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.
Continuous Process Failure Mode/Cause Examples:
Temperature Too High: Thermocouple out of calibration Heat transfer too fast: Dowtherm temp too high Agitator too slow: Faulty inverter

Discrete Process Failure Mode/Cause Examples

Pits: High particle count in clean room Internal Contamination: Flaking paint
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Definition of Terms - Current Controls

Current Controls systematized methods/devices in place to prevent or detect failure modes or Causes (before causing effects). Prevention consists of fool proofing, automated control and set-up verifications Controls consist of audits, checklists, Inspection, laboratory testing, training, SOPs, preventive maintenance, etc. Which is more important to process improvement, prevention or detection? Continuous Process Cause/Current Controls Examples Thermocouple out of calibration: Calibration schedule Dowtherm temp too high: Computer Control of primary Dowtherm supply Faulty inverter: Inverter infra-red inspection schedule and sign-off Discrete Process Cause/Current Controls High particle count in clean room: SPC on particle count Flaking paint: Evaluation of paint samples to determine source of flakes.
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Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

FMEA Model
Cause

Failure Mode (Defect)

Material or process input

Effect

Process Step

Controls
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External customer or downstream process step

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FMEA Model
Prevention
Cause

Detection

Which is best case? Which is worst case?

Detection
Failure Mode (Defect)

Detection
Effect

Material or process input

Process Step

Controls
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External customer or downstream process step

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Linking Failure Modes to Effects

Failure Mode 1 Failure Mode 2

Effect 1

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

What is the Effect What can on the go wrong Outputs? with the Process step?
What is the Process Step

How 0 Bad?
0

How can this be found?

How Often?

How 0 well?
0 0 0 0 0

What are the Causes?

What can be done?

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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
Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Causes

Controls
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Risk Priority Number

Risk Priority Number is not sacred Scaling for Severity, Occurrence and Detection can be locally
developed. Other categories can be added. For example, one Black Belt added an Impact score to the RPN calculation to estimate the overall impact of the Failure Mode on the process.

Severity (of Effect)

Occurrence (of Cause)

Importance of effect on customer requirements - could also be concerned with safety and other risks if failure occurs (1=Not Severe, 10=Very Severe)
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) 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
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Detection (capability of Current Controls)

Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Example Rating Scale

Rating 10 9 8 7 6 5 4 3 2 1 Severity of Effect Hazardous without warning Hazardous with warning Very High High Moderate Low Very Low Minor Very Minor None Low Very Low Remote: Failure is unlikely Likelihood of Occurrence Very high: Failure is almost inevitable Ability to Detect Almost Impossible Very Remote Remote Very Low Low Moderate Moderately High High Very High Almost Certain
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High: Repeated failures

Moderate: Occasional failures

Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

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.

Occ 1 1 1 1 10 10

Sev 1 1 10 10 1 1

Det 1 10 1 10 1 10

Result

Actions

10
10

10
10

1
10
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Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Dynamics of the RPN

Occ Sev Det Result Actions

1
1 1 1 10 10 10 10

1
1 10 10 1 1 10 10

1
10 1 10 1 10 1 10

Ideal Situation
Assured Mastery Failure does not reach user Failure reaches user Freq. fails, detectable, costly Freq. fails, reaches user Freq. fails w/major impact Big Trouble!

No Action
No Action No Action Yes Yes Yes Yes Yes!

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FMEA Form - Initial Assessment

Process Step/Input What is the process step/ Input under investigation?

Potential Failure Mode

Potential Failure Effects

S E V
How Severe is the effect to the cusotmer?

Potential Causes

O C C
How often does cause or FM occur?

Current Controls

D E T
How well can you detect cause or FM?

R P N

Actions Recommended What are the actions for reducing the occurrance of the Cause, or improving detection? Should have actions only on high RPN's or easy fixes.

In what ways does the Key What is the impact on the Input go wrong? Key Output Variables (Customer Requirements) or internal requirements?

What causes the Key Input to go wrong?

What are the existing controls and procedures (inspection and test) that prevent eith the cause or the Failure Mode? Should include an SOP number.

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FMEA Form - Long Term History

Current Controls

D E T
How well can you detect cause or FM?

R P N

Actions Recommended

Resp.

Actions Taken

S E V

O C C

D E T

R P N

What are the existing controls and procedures (inspection and test) that prevent either the cause or the Failure Mode? Should include an SOP number.

What are the actions Whose What are the completed for reducing the Responsible actions taken with the occurrence of the for the recalculated RPN? Be Cause, or improving recommended sure to include detection? Should action? completion month/year have actions only on high RPN's or easy fixes. 0 0

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Methodology
Make sure to address safety issues. Assume incoming material is perfect and process is not. Assume process is perfect and incoming material is not. Two major approaches: Starting with the Cause & Effect Matrix Starting with FMEA directly from the Process Map We will explain the approach using the C&E matrix, though both approaches are very similar Spreadsheet tools have been prepared to assist you in the preparation of the FMEA Ford uses FMEA Plus as a standardized software package
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Starting with C&E Matrix

Advantage The Cause & Effect Matrix assists the team in defining the important issues that the FMEA should address by helping to prioritize: Important customer requirements Process inputs that could potentially impact these requirements Prioritizing the Key Process Inputs according to their impact on the Output variables (We want to focus on Inputs that highly impact a large number of Outputs first) The C&E Matrix will assist in prioritizing the Key quantitative output that can be used in the determination of the specific severity ratings for the next stage of the FMEA process.
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FMEA - Step by Step

STEP 1 For each Process Input, determine the ways in which the Process Step can go wrong (These are Failure Modes) STEP 2 For each Failure Mode associated with the inputs, determine Effects STEP 3 Identify potential Causes of each Failure Mode STEP 4 List the Current Controls for each Cause STEP 5 Assign Severity, Occurrence and Detection ratings to each Cause STEP 6 Calculate RPN STEP 7 Determine Recommended Actions to reduce High RPNs STEP 8 Take appropriate Actions and Document STEP 9 Recalculate RPNs

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Process Map to be Used in Example

INPUTS
Bun Burger Condiments Cooking time Cooking Temp Packaging Procedure

Burger Assembly

OUTPUTS
Appearance Taste Smell Freshness Consistency Temperature

Cook Burger

Assemble

Wrap

Store

Sell

Burger Cook Temp Cook Time

Burger Bun Condiments Assy. Procedure

Assem. Burger Wrapper Wrap Procedure

Heat Lamp Store Time

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C&E Matrix Example

This is the C&E Matrix for the previous Map with the Key Inputs Paretod by the Total Score.
Rating of Importance to Customer 7 1 10 2 8 3 10 4 7 5 8 6 7 8 9 10 11 12 13 14 15

Process Inputs 1 3 4 7 6 8 9 2 10 Storage time Bun Burger Cook Time Cook temp Assembly Procedure Heat Lamp Temp Wrapper Wrap Procedure

Temperature

Consistency

Appearance

Freshness

Smell

Taste

Total 368 343 339 287 269 225 219 168 118
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9 4 3 7 7 9 1 5 5

8 9 7 7 6 1 1 1 1

4 4 6 1 1 1 1 1 1

9 9 8 4 4 4 8 6 5

9 9 8 8 8 8 6 1 1

5 5 8 8 7 6 9 6 1

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FMEA Worksheet
Before we move to the example lets 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 Step Key Process Input
What can go wrong?

Effects

Causes

Current Controls

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FMEA - Step 1
For each critical (high value) Process Step/Input, determine the ways in which the Process Step/input can go wrong (These are Failure Modes) The first two Key Process Input Variables on the C&E Matrix are storage time and bun quality
Failure Modes Process Step
Receiving Assembly

Key Process Input

Storage time Bun

What can go wrong?

Effects

Causes

Current Controls

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FMEA - Step 1 (Contd)

For each critical (high value) Process Input, determine the ways in which the input can go wrong (These are Failure Modes)

Failure Modes Process Step

Receiving Assembly

Key Process Input

Storage time Bun

What can go wrong? Too long over exposed

Effects

Causes

Current Controls

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FMEA - Step 2
For each Failure Mode associated with the inputs, determine Effects
These effects are internal requirements for the next process as well as customer effects.
Failure Modes Process Step
Receiving

Key Process Input

Sorage time

What can go wrong?

Effects
Stale product

Causes

Current Controls

Too long

Assembly

Bun

Dry

Poor quality sandwich

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FMEA - Step 3
Identify potential Causes of each Failure Mode
In most cases, there will be more than one Cause for a Failure Mode. Well keep it simple for this exercise.
Failure Modes Process Step
Receiving

Key Process Input

Storage time

What can go wrong?

Effects
Stale product

Causes
Poor stock rotation

Current Controls

Too long

Assembly

Bun

Dry

Poor quality sandwich

over exposure to air

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FMEA - Step 4
List the Current Controls for each Cause
For each Cause we list how we are either preventing or detecting it. We would like to place a procedure number wherever we have an SOP.

Failure Modes Process Step

Receiving

Key Process Input

Storage time

What can go wrong?

Effects
Stale product

Causes
Poor stock rotation

Current Controls
None

Too long

Assembly

Bun

Dry

Poor quality sandwich

Over exposure to air

None

This is how the FMEA identifies initial holes in the Current Control Plan. Process teams can start working on these holes right away.
Visteon Corporation BB Mod #5 FMEA Rev 1.0 3/02

Not uncommon!

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FMEA - Step 5
Assign Severity, Occurrence and Detection ratings to each Cause
We are now ready to assign appropriate criteria. The team then starts scoring each cause to compute an RPN number.
Process Step/Input Potential Failure Mode Potential Failure Effects S E V Potential Causes O C C Current Controls D E T R P N

Storage Bun

Too long Dry

Stale product Poor quality sandwich

5 7

Poor Stock Rotation over exposed to air

5 5

None None

10 10

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FMEA - Steps 6 and 7

Calculate the RPNs and determine Recommended Actions to reduce High RPNs
Which issues may we want to address first?
Process Step/Input Potential Failure Mode Potential Failure Effects S E V Potential Causes O C C Current Controls D E T R P N

Storage Bun

Too long Dry

Stale product Poor quality sandwich

5 7

Poor Stock Rotation Over exposed to air

5 5

None None

10 250 10 350

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FMEA - Step 7 (Contd)

Determine Recommended Actions to reduce High RPNs
Now fill in recommended actions for top RPNs.
O Potential Causes C C Current Controls D E T R P N Actions Recommended S Resp. Actions Taken E V O C C D E T R P N

Poor Stock Rotation Over exposure

5 5

None None

10 10

250 350

Implement FIFO System

Eng.

2-27-02

10

Actions are recommended for only the high RPNs. The key is FOCUS!
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FMEA - Steps 8 and 9

Take appropriate Actions and Document and Recalculate RPNs
O Potential Causes C C Current Controls D E T R P N Actions Recommended S Resp. Actions Taken E V O C C D E T R P N

Poor Stock Rotation

None

10

250

Implement FIFO System

Eng.

2-27-02

10

50

We have recorded when the action was taken and the impact on the RPN. Notice that this is a nice way to track past activities. The FMEA should grow as new recommended actions are identified, completed and recorded.
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Approaches to FMEAs
Approach One (C&E Matrix Focus) Start with Key Inputs with the highest scores from the C&E Matrix analysis Fill out the FMEA worksheet for those Inputs Calculate RPNs and develop recommended actions for the highest RPNs Complete the Process FMEA for other Inputs over time Approach Two (Customer Focused): Fill out the Failure Mode and Effects columns of the worksheet. Copy to FMEA form and rate Severity. For High Severity Ratings, List Causes and rate Occurrence for each Cause For the highest Severity * Occurrence Ratings, evaluate Current Controls For Highest RPNs develop recommended actions Approach Three (Comprehensive) Good approach for small processes Fill out the FMEA worksheet beginning with the first process step and ending with the last Score SEV, OCC and DET for all causes Develop recommended actions for highest RPNs Approach Four (Super Focused) Pick the top Pareto defect item (Fiber Breakouts) or Failure Mode (Variability in Temperature) Focus the FMEA process on only that defect or Failure Mode Purpose: To Kill that Failure Mode
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