Design fmea procedure pdf

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Design Failure Mode and Effects Analysis must be done in a step-wise fashion since each step builds on the previous one. Here are the 10 steps to a Design FMEA.

STEP 1: Review the design

• Use a blueprint or schematic of the design/product to identify each component and interface.
• List each component in the FMEA table.
• If it feels like the scope is too large, it probably is. This is a good time to break the Design 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 or interface can fail.
• Get an exhaustive list – it can be pared 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 customer or on subsequent components.
• There will likely be more than one effect for each failure.

STEP 4: Assign Severity rankings

• Rate the severity of each effect using customized ranking scales as a guide.

STEP 5: Assign Occurrence rankings

• Determine how frequently the failure is likely to occur.

STEP 6: Assign Detection rankings

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

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 Design 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.