FICCI CE

Failure Mode &

Effect Analysis
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Failure Mode and Effects Analysis (FMEA)

FMEA is a structured analysis for identifying ways & methods in which

the product or processes can fail and then plan to prevent those
failures. FMEA is a proactive tool for reducing defects and non-
conformities.
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FMEA

FMEA is a structured approach in :-

• Identifying ways in which a product / process can fail to meet critical
customer requirements.
• Estimating the risk of causes with regard to these failures.
• Evaluating control plan for preventing these failures.
• Prioritizing the actions for improving the process.

FMEA is an extremely important tool for each phase of Six Sigma

strategy viz. Measure, Analyze, Improve, Control.
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Advantages of FMEA

• For improving the reliability and safety of the products.

• For improving customer satisfaction.
• Tracking actions to reduce non-conformities.
• New product development.
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Definition of terms

Failure Mode : It is a manner in which a part or a process can

fail to meet specifications. It is usually associated with defect or
non-conformities.

Examples : Missing part, Oversized, Undersized, Incorrect

price, Offspec parts.
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Definition of terms

Cause : Causes are sources of variation which are associated with key
process inputs. Cause can be best defined as a deficiency which
results in a failure mode.

Examples : Instructions not followed, Lack of experience, Incorrect

documentation, Poor handling etc.
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Definition of terms

Effect : Effect is the impact on the customer (both internal & external) if
the failure mode is not prevented or corrected.

Examples : Customer dissatisfaction, Frequent product breakdowns,

Customer downtime.
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Relationship of cause, failure mode & effect

Failure
Cause Effect
Mode
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FMEA through Cause & Effect Diagram

Causes Causes Causes

Prevent
or Detect

Failure
Mode

Effect

Causes Causes Causes

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Steps in FMEA process

1. Develop a process map and identify process steps.

2. List key process outputs for satisfying internal and

external customer requirements.

3. List key process inputs for each process steps.

4. List ways the process inputs can vary (causes) and

identify associated failure modes and effects.

5. Assign severity occurrence and detection rating for each cause.

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Steps in FMEA process…contd.

6. Calculate risk priority number ( RPN) for each potential

failure mode.

7. Determine recommended actions to reduce RPN’s.

8. Establish time frame for corrective actions.

9. Take corrective actions.

10. Put all controls in place.

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Ranking terms used in FMEA calculations

Scale:1(Best) to 10 ( Worst)

• Severity (SEV) : Severity indicates how severe is the impact of the effect
on the customer.

• Occurrence (OCC) : This indicates the likelihood of the cause of the

failure mode to occur.

• Detection (DET) : This indicates the likelihood of the current system to

detect the cause or failure mode if it occurs.

• Risk priority number : This number is used to place priority to items for
better quality planning.

RPN = SEV X OCC X DET

See next slides for specimen best to worst ratings on a 10 point scale.
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Best to Worst ratings for FMEA calculations

Rating Degree of Severity Likelihood of Occurrence Ability to detect

1 Customer will not at all observe Very remote possibility Sure that the potential failure
the adverse effect will be detected & prevented
before reaching the next
customer

2 Customer will experience Low failure with supporting Almost sure that the potential
slight discomfort documents failure will be detected before
reachig the next customer

3 Customer will experience Low failure without supporting Less chances that the
annoyance because of slight documents potential failure will reach the
degradation of performance next customer undetected

4 Customer dissatisfied due to Occasional failures Some controls may detect

reduced performance the potential from reaching the
next customer

5 Customer is uncomfortable Moderate failure rate with Moderate chances that the
supporting documents potential failure will reach the
next customer
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Best to Worst ratings for FMEA calculations

Rating Degree of Severity Likelihood of Occurrence Ability to detect

6 Warranty repairs Modearate failure rate without Controls are not likely to detect
supporting documents or prevent the potential failure
from reaching the next
customer

7 High degree of customer High failure rate with supporting Less chances that the potential
dissatisfaction documents failure will be detected or
prevented before reaching
the next customer

8 Vey high degree of customer High failure rate with supporting Very less chances that the
dissatisfaction documents potential failure will be detected
or prevented before reaching
the next customer

9 Negative impact on the Failure is almost certain Existing controls will not detect
customer the potential failure

10 Negative impact on the Assured failure Existing controls will not detect
customer, people & society the potential failure
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FMEA Form: ( Column 1 to 9 ) CE

Rank severity Rank how well

Rank occurrence List how the cause
on 1 to 10 cause/failure
on a 1 to 10 is presently
scale can be detected
scale being controlled
on 1 to 10 scale

1 2 3 4 5 6 7 8 9
Process Potential failure mode Potential failure effect SEV Potential causes OCC Current Controls DET RPN
Part No.

1
2
3
4
5

List failure List effects List causes

RPN=
modes for each of each for each failure
SEV*OCC*DET
step failure mode mode
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FMEA Form contd: ( column 10 to 15 )

Designates people RPN is recalculated
responsible for on completion of
corrective action corrective action

10 11 12 13 14 15
Actions Recommended Responsibility SEV OCC DET RPN

List actions
recommended
on RPN pareto