10 Steps To Do FMEA

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Process Failure Mode and Effects Analysis must be done in a step-wise

fashion since each step builds on the previous one.  Here’s an overview of
the 10 steps to a Process FMEA.

STEP 1:  Review the process

 Use a process flowchart to identify each process component.


 List each process component in the FMEA table.
 If it starts feeling like the scope is too big, it probably is.  This is a
good time to break the Process Failure Mode and Effects Analysis
into more manageable chunks.

STEP 2:  Brainstorm potential failure modes

 Review existing documentation and data for clues about all of the
ways each component can failure.
 The list should be exhaustive – it can be paired down and items can
be combined after this initial list is generated.
 There will likely be several potential failures for each component.

STEP 3:  List potential effects of each failure

 The effect is the impact the failure has on the end product or on
subsequent steps in the process.
 There will likely be more than one effect for each failure.

STEP 4:  Assign Severity rankings

 Based on the severity of the consequences of failure.

STEP 5:  Assign Occurrence rankings

 Rate the severity of each effect using customized ranking scales as a


guide.

STEP 6:  Assign Detection rankings

 What are the chances the failure will be detected prior to it occuring.

STEP 7:  Calculate the RPN

 Severity X Occurrence X Detection

STEP 8:  Develop the action plan


 Decide which failures will be worked on based on the Risk Priority
Numbers.  Focus on the highest RPNs.
 Define who will do what by when.

STEP 9:  Take action

 Implement the improvements identified by your Process Failure Mode


and Effects Analysis team.

STEP 10:  Calculate the resulting RPN

 Re-evaluate each of the potential failures once improvements have


been made and determine the impact of the improvements.

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