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

• Determine how frequently each failure is likely to occur and rate each using customized ranking scales as a guide.

STEP 6:  Assign Detection rankings

• What are the chances the failure will be detected prior to it occurring.

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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