Process/Product

Failure Modes and Effects Analysis

(FMEA)

Process or
Prepared by: Page ____ of ____
Product Name:

Responsible: FMEA Date (Orig) ______________ (Rev) _____________

S O Current Controls D R S O D R
Process Actions
Potential Failure Mode Potential Failure Effects E Potential Causes C E P Resp. Actions Taken E C E P
Step/Input Recommended
V C Prevention Detection T N V C T N
What is the In what ways does the Key What is the impact on the Key What causes the Key Input to What are the existing controls What are the existing controls and What are the actions Whose What are the completed

How Severe is the

effect to the cusotmer?

How often does cause

How well can you detect

or FM occur?

cause or FM?
process step/ Input go wrong? Output Variables (Customer go wrong? and procedures (inspection and procedures (inspection and test) for reducing the Responsible actions taken with the
Input under Requirements) or internal test) that prevent eith the cause that prevent eith the cause or the occurrance of the for the recalculated RPN? Be
investigation? requirements? or the Failure Mode? Should Failure Mode? Should include an Cause, or improving recommended sure to include
include an SOP number. SOP number. detection? Should action? completion month/year
have actions only on
high RPN's or easy
fixes.

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 Worksheet

FMEA
Worksheet

Failure Modes -
Process What can go
Step Key Process Input wrong? Effects Causes Current Controls

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