FMEA

(Failure Modes and Effects Analysis)

What is FMEA?
FMEA (Failure Modes And Effects Analysis)

Is way to identify and evaluate possible product or process failures and the risks
associated with these failures.

Use this information, action can be planned to reduce or eliminate that risk.

Uncover process problems that may result in:

Safety hazards
Defects in product or service production process
Reduced process efficiency

Ask, How can people, materials, equipment, methods, and environment cause
process problems?
FMEA Benefits

FMEA Benefits
To identify and prioritize parts of the product or process that need further improvement
To improve the quality, reliability, and safety of products and services
To increase customer satisfaction
To document and track actions taken to reduce risk
When to do a FMEA
When the process is complex enough to require it

When a process is created, improved, or redesigned

When existing processes are used in new ways or in new environments

Example of FMEA Worksheet
Worksheet
Process/Product: FMEA Date: (Original)
FMEA Team: (Revised)
Black Belt: Page: of

FMEA Process Action Results

Responsibility

Occurrence
Occurrence

Detection

Detection
Severity

Severity
Item/Process Potential Potential And Target
Potential Current Recommended Action

RPN

RPN
Step Effect(s) Of Cause(s) Of Completion
Failure Mode Controls Action Taken
Failure Failure Date

Total Risk Priority Number Resulting Risk Priority Number

Steps for Completing a FMEA
1. Create detailed process map for process FMEA, identify CTQs (Critical to Quality) and
product components for design FMEA.

2. Assemble team of experts and schedule time for FMEA.

(Average time is 4-6 hrs)
3. List product Item or process step.

4. Utilize 6 Ms (*) of detailed process map or product design to identify potential failure
modes. What can go wrong with this input?

5. List the effect(s) of the failure.

6. Assign a severity rating to each effect identified.

7. List all possible causes of failure. Ask the 5 whys to help dig deeper into the causes.

Note: 6Ms: Machines, Methods, Materials, Measurements, Mother Nature (Environment),

Manpower
Steps for Completing a FMEA (Contd)

8. Assign an occurrence rating for each cause of failure.

9. List current control to prevent each cause of failure.

10. Assign detection rating to each control

11. Calculate risk priority number (RPN) for each cause. (Severity x Occurrence x
Detection)

12. Continue steps 3 to 11 until all failure modes have been identified.

13. Utilize RPN scores to prioritize action items, and assign responsibility, target date
for completion.

14. Compute post RPN to validate Improvements.

FMEA: Severity Rating Scale
Severity The Consequences Of A Failure Should It Occur
Rating Criteria A Failure Could:
Bad
10 Injure a customer or employee

9 Be illegal

8 Render the product or service unfit for use

7 Cause extreme customer dissatisfaction

6 Result in partial malfunction

5 Cause a loss of performance which is likely to result in a complaint

4 Cause minor performance loss

3 Cause a minor nuisance, but be overcome with no performance loss

2 Be unnoticed and have only minor effect on performance

1 Be unnoticed and not affect the performance

Good
FMEA: Occurrence Rating Scale
Occurrence The Likelihood Or Frequency Of Failure
Rating Time Period Probability
Bad
10 More than once per day > 30%
9 Once every 3-4 days < 30%
8 Once per week < 5%
7 Once per month < 1%
6 Once every 3 months
< .03%
Once every 6 months
5 < 1 Per 10,000
4 Once per year < 6 Per 100,000
3 Once every 1-3 years < 6 Per Million

2 Once every 3-6 years < 3 Per 10 Million

Once every 6-100 years < 2 Per Billion

1
Good
 FMEA: Detection Rating Scale
Detection The Likelihood Of A Failure Being Detected Before Its Effect Is Realized

Bad Rating Definition

10 Defect caused by failure is not detectable

9 Occasional units are checked for defect

8 Units are systematically sampled and inspected

7 All units are manually inspected

6 Units are manually inspected with mistake-proofing modifications

5 Process is monitored (SPC) and manually inspected

4 SPC is used with an immediate reaction to out-of-control conditions

3 SPC as above with 100% inspection surrounding out-of-control conditions

2 All units are automatically inspected

1 Defect is obvious and can be kept from affecting the customer

Good
 FMEA: Calculating Risk Priority Number (RPN)
Severity Scale
Rating Criteria A Failure Could: RPN = Severity x Occurrence x Detection
Bad 10
9
8
7 Injure a customer or employee
Be illegal
6 Render product or service unfit for use
Cause extreme customer dissatisfaction
5
Result in partial malfunction
Cause a loss of performance which Occurrence Scale
4 is likely to result in a complaint
Cause minor performance loss
3 Cause a minor nuisance, but be
Rating Time Period Probability
overcome with no performance loss
10 More than once per day > 30%
Be unnoticed and have only minor
2
30%
effect on performance
Be unnoticed and not affect the
9 Once every 3-4 days
5%
performance
Good 1 8 Once per week
Detection Scale
7 Once per month 1%
6 Once every 3 months .03% Rating Definition
10 Defect caused by failure is not detectable
5 Once every 6 months 1 Per 10,000
9 Occasional units are checked for defect
4 Once per year 6 Per 100,000
8 Units are systematically sampled and inspected
3 Once every 1-3 years 6 Per Million
7 All units are manually inspected
2 Once every 3-6 years 3 Per 10 Million
6 Units are manually inspected with mistake-proofing
1 Once every 6-100 years 2 Per Billion
modifications
5 Process is monitored (SPC) and manually inspected
4 SPC is used with an immediate reaction to out-of-control
conditions
3 SPC as above with 100% inspection surrounding out -of-control
conditions
2 All units are automatically inspected
1 Defect is obvious and can be kept from affecting the customer
FMEA Tips
Use brainstorming and/or data analysis methods to identify key
failure modes
Critical process or project steps
High cost and/or customer impact
High probability (problems we see often)

Remember: Numbers are judgments

Identify proactive/preventive steps as well as inspection and

damage-control steps

Error proofing
Robust Design
Use to help prioritize future improvement efforts