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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.

FAILURE MODE AND EFFECTS ANALYSIS


(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.

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.

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.

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.

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.

RELATIONSHIP OF CAUSE, FAILURE


MODE & EFFECT

Cause

Failure
Mode

Effect

FMEA through Cause & Effect Diagram


Causes

Causes

Causes

Prevent
or Detect

Failure
Mode

Effect

Causes

Causes

Causes

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.

STEPS IN FMEA PROCESS

6. Calculate risk priority number ( RPN) for each


potential
failure mode.
7. Determine recommended actions to reduce RPNs.
8. Establish time frame for corrective actions.
9. Take corrective actions.
10. Put all controls in place.

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.

BEST TO WORST RATINGS FOR FMEA


CALCULATIONS
Rating
Degree of Severity
Likelihood of Occurrence
Ability to detect
1

Customer will not at all observe


the adverse effect

Very remote possibility

Sure that the potential failure


will be detected & prevented
before reaching the next
customer

Customer will experience


slight discomfort

Low failure with supporting


documents

Almost sure that the potential


failure will be detected before
reachig the next customer

Customer will experience


annoyance because of slight
degradation of performance

Low failure without supporting


documents

Less chances that the


potential failure will reach the
next customer undetected

Customer dissatisfied due to


reduced performance

Occasional failures

Some controls may detect


the potential from reaching the
next customer

Customer is uncomfortable

Moderate failure rate with


supporting documents

Moderate chances that the


potential failure will reach the
next customer

BEST TO WORST RATINGS FOR FMEA


CALCULATIONS
Rating
Degree of Severity
Likelihood of Occurrence
Ability to detect
6

Warranty repairs

Modearate failure rate without


supporting documents

Controls are not likely to detect


or prevent the potential failure
from reaching the next
customer

High degree of customer


dissatisfaction

High failure rate with supporting


documents

Less chances that the potential


failure will be detected or
prevented before reaching
the next customer

Vey high degree of customer


dissatisfaction

High failure rate with supporting


documents

Very less chances that the


potential failure will be detected
or prevented before reaching
the next customer

Negative impact on the


customer

Failure is almost certain

Existing controls will not detect


the potential failure

10

Negative impact on the


customer, people & society

Assured failure

Existing controls will not detect


the potential failure

FMEA Form: ( Column 1 to 9 )


Rank severity
on 1 to 10
scale

1
Process
Part No.

Rank occurrence
on a 1 to 10
scale

2
3
Potential failure mode Potential failure effect

Rank how well


cause/failure
can be detected
on 1 to 10 scale

List how the cause


is presently
being controlled

4
SEV

5
Potential causes

6
OCC

7
Current Controls

8
DET

9
RPN

1
2
3
4
5

List failure
modes for each
step

List effects
of each
failure mode

List causes
for each failure
mode

RPN=
SEV*OCC*DET

FMEA Form contd: ( column 10 to 15 )


Designates people
responsible for
corrective action

10
11
Actions Recommended Responsibility

List actions
recommended
on RPN pareto

RPN is recalculated
on completion of
corrective action

12
SEV

13
OCC

14
DET

15
RPN

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