Failure Modes Effect Analysis (FMEA)

A Closer Look

The FMEA Form

Identify failure modes and their effects

Identify causes of the failure modes and controls

Prioritize

Determine and assess actions

Process Steps

FMEA Procedure
1. For each process input (start with high value inputs), determine the ways in which the input can go wrong (failure mode) 2. For each failure mode, determine effects
Select a severity level for each effect

3. Identify potential causes of each failure mode

Select an occurrence level for each cause

4. List current controls for each cause

Select a detection level for each cause
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Process Steps

FMEA Procedure (Cont.)

5. Calculate the Risk Priority Number (RPN)

6. Develop recommended actions, assign responsible persons, and take actions

Give priority to high RPNs MUST look at severities rated a 10

7. Assign the predicted severity, occurrence, and detection levels and compare RPNs

Information Flow

FMEA Inputs and Outputs

Inputs Brainstorming C&E Matrix Process History Procedures Knowledge Experience Outputs List of actions to prevent causes or detect failure modes

FMEA

Assigning Rating Weights

Rating Scales
Severity
1 = Not Severe, 10 = Very Severe

Occurrence
1 = Not Likely, 10 = Very Likely

Detection
1 = Likely to Detect, 10 = Not Likely to Detect

Risk Priority Number (RPN)

Calculating a Composite Score

RPN is the product of the severity, occurrence, and detection scores.

Severity

X Occurrence X

Detection

RPN

Function
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

EXAMPLE: HVAC (heating, ventilation, and air conditioning) system must defog windows and heat or cool cabin to 70 degrees in all operating conditions (-40 degrees to 100 degrees) within 3 to 5 minutes

Failure Mode
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

EXAMPLES: HVAC system does not heat vehicle or defog windows HVAC system takes more than 5 minutes to heat vehicle HVAC system does not heat cabin to 70 degrees in below zero temperatures HVAC system cools cabin to 50 degrees HVAC system activates rear window defogger

Effect(s) of Failure
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

EXAMPLE: Cannot see out of front window Air conditioner makes cab too cold Does not get warm enough Takes too long to heat up

Severity
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

EXAMPLE: Cannot see out of front window severity 9 Air conditioner makes cab too cold severity 5 Does not get warm enough severity 5 Takes too long to heat up severity 4

Cause(s) of Failure
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

EXAMPLE: Incorrect location of vents Incorrect routing of vent hoses (too close to heat source) Inadequate coolant capacity for application

Occurrence
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

EXAMPLE: Incorrect location of vents occurrence 3 Incorrect routing of vent hoses (too close to heat source) occurrence 6 Inadequate coolant capacity for application occurrence 2

Current Design Controls

Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

EXAMPLE: Engineering specifications (P) preventive control Historical data (P) preventive control Functional testing (D) detective control General vehicle durability (D) detective control

Detection
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

RPN (Risk Priority Number)

Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

Risk Priority Number is a multiplication of the severity, occurrence and detection ratings EXAMPLE: Cannot see out of front window severity 9, incorrect vent location 2, Functional testing detection 3, RPN 54

Recommended Actions
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

All critical or significant characteristics must have recommended actions associated with them

Responsibility & Target Completion Date

Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

All recommended actions must have a person assigned responsibility for completion of the action Responsibility should be a name, not a title Person listed as responsible for an action must also be listed as a team member There must be a completion date accompanying each recommended action

Action Results
Item Potential Failure Mode
Function

Potential Effect(s) of Failure

S e v

C l a s s

Potential Cause(s)/ Mechanism(s) Of Failure

O c c u r

Current Design Controls

Prevent Detect

D e t e c

Action Results R P N Recommended Actions Response & Target Complete Date Action Taken S E V O C C D E T R P N

Unless the failure mode has been eliminated, severity should not change Occurrence may or may not be lowered based upon the results of actions Detection may or may not be lowered based upon the results of actions

Fault-tree analysis
A deductive top-down technique. Put the risk or hazard at the root of the tree and identify the system states that could lead to that hazard. Where appropriate, link these with and or or conditions. A goal should be to minimize the number of single causes of system failure.

A coffee shop wants to improve customer satisfaction with the coffee served at their shop

Determine Failure Modes

Step 1: For Each Input, Determine the Potential Failure Modes

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Identify Effects and Severity

Step 2: For Each Failure Mode, Identify Effects and Assign Severity

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Identify Failure Causes and Score

Step 3: Identify Potential Causes of Each Failure Mode and Assign Score

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Step 4: List Current Controls for Each Cause and Assign Score

Identify Controls and Score

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RPNs

Step 5: Calculate RPNs

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Identify Actions and Responsibilities

Step 6: Develop Recommended Actions, Assign Responsible Persons, and Take Actions

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Compare RPNs

Step 7: Assign the Predicted Severity, Occurrence, and Detection Levels and Compare RPNs

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Insulin pump fault tree

Incorrect s ugar le vel meas ur ed

Incorrect ins ulin dos e adminis ter ed

or

Co rrect dos e delivered a t wron g time

Delivery s ys tem failure

or

or

Sens or failure

Su gar comp uta tio n error

Timer failure

Ins ulin comp uta tio n incorrect

Pu mp s ig nals incorrect

or

or

Algo rithm error

Arith metic error

Algo rithm err or

Arith metic error

Example Alarm clock fails

Alarm clock fails

Beeper fails
Button fails

electronics fail

Power fails

Beeper not set

Button read fails

SW fails

IN-CLASS PROBLEM
Most cars have a fuel filter between the fuel tank and the engine. Consider the consequences of a) Anti-function (opposite of filtering) b) Partial function c) Intermittent function d) Excess function

What to Do
Potential Causes of failure should be engineering related such as incorrect material, corrosion, wear and human related such as inexperience, misuse, etc. Current Design Controls are things like inspections, testing, poke yoke, and other design checks that are intended to prevent the problem.