(FMEA Example with Notations )

FMEA Failure Modes & Effects Analysis for Process or Product

Responsible
Occurences

Occurences
Severity

Severity
Detection

Detection
Potential Potential Current

Risk PN

Risk PN
Person
Process Step/ Potential Failure Effects of Causes of Process Actions Actions
Input Mode Failure Failure Controls Recommended Taken
Anti function
for functional Current Design/
•Inputs from Process
Requirements approach Customer Brainstorm
• full causes Controls to
& focus/experience
• partial • man Prevent or
Specifications • end user
• intermittent • material Detect each of
•Inputs from • assembler 0 0
• excess • method the failure
QFD • maker
function • machine mechanisms.
relationships • regulatory
• environment The probability
body
that each control
will effectively 0 0
detect the failure
is assigned a
numeric value.
0 0

0 0
FMEA Selection
SEVERITY
10
Critical Characteristics Rank from 1 = Minor to
10=Very High
9 (Safety/Regulatory)
8
OCCURANCES
7 Significant Characteristics Likelihood of potential cause
6 (Customer Dissatisfaction) occuring. Rank from
5 1= Extremely Unlikely to
10=Certain
4
3
All Other Characteristics
2 (Appropriate Actions/Controls Already in Place) DETECTION
Likelihood of Detection
1 1 = Extremely Unlikely
1 2 3 4 5 6 7 8 9 10 to 10 = Certain

FMEA Example with Definitions

*A FMEA is a two-phase process.

*First the potential failure modes and corrective actions are identified.

*Then after the corrective actions are implemented, the product or process is re-evaluated to determine if the result is
acceptable.

*The Risk Priority Number (RPN) is the product of Severity, Occurrence and Detection.

*These are assessed and engineering judgment is used to determine if the risk is acceptable.

*Recommended Actions are developed to reduce the RPN with priority given to the highest RPN values and
customer defined specific characteristics.

*Once the actions are implemented, the Severity, Occurrence and Detection values are reassessed
and a new RPN is calculated.
-
*This process continues until the risk level is acceptable.

FMEA Example with Definitions