10 steps for an effective FMEA

10 steps for an effective FMEA
10 steps for an effective FMEA

10 steps for an effective FMEA

 

All product/design and process FMEAs should follow these 10 steps:

 

(See Table 1 for a sample process FMEA.)

 

  1. Review the process:

 

Gather a team of four to six (be sure to include people with various job responsibilities and levels of experience) and give each member a copy of the product’s blueprint. Also, have the team operate the product so all members can become familiar with the way it works.

 

  1. Brainstorm potential failure modes:

 

Look at each component of the product and identify ways it could potentially fail.

 

  1. List potential effects of each failure mode:

 

List the potential effect of each failure next to the failure. If a failure has more than one effect, write each in a separate row.

 

  1. Assign a severity rating for each effect:

 

Give each effect its own severity rating (from 1 to 10, with 10 being the most severe). If the team

can’t agree on a rating, hold a vote.

 

  1. Assign an occurrence rating for each failure mode:

 

Collect data on the failures of your product’s competition. Using this information, determine how likely it is for a failure to occur and assign an appropriate rating (from 1 to 10, with 10 being the most likely).

 

  1. Assign a detection rating for each failure mode and effect:

 

List all controls currently in place to prevent each effect of a failure from occurring and assign a detection rating for each item (from 1 to 10, with 10 being a low likelihood of detection).

 

  1. Calculate the risk priority number (RPN) for each effect:

 

Multiply the severity rating by the occurrence rating by the detection rating.

 

  1. Prioritize the failure modes for action:

 

Decide which items need to be worked on right away. For example, if you end up with RPNs ranging from 50 to 500, you might want to work first on those with an RPN of 200 or higher.

 

  1. Take action to eliminate or reduce the high risk failure modes:

 

Determine what action to take with each high risk failure and assign a person to implement the action.

  

10. Calculate the resulting RPN as the failure modes are reduced or eliminated:

 

Reassemble the team

after completing the initial corrective actions and calculate a new RPN for each failure. Then you may decide you’ve taken enough action or you want to work on another set of failures.

 

10 steps for an effective FMEA

 

FMEA sample
FMEA sample

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