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The FMEA Debate

Vote on the proper way to apply effect / severity.

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Side A	Side B
The aggregate approach to applying Effect/Severity After completing a first pass on your PFMEA, ensure you are not overstating risk. You can ensure risk is not overstated by applying an aggregate approach to Severity (Effect of Failure). Since you are protected by your current process controls, there is no need to apply the Effect of Failure beyond your four walls. There will be no field effect of the failure because your Current Process Controls will capture the failure and prevent it from leaving your manufacturing plant.	Applying Effect/Severity withough regard to Process Controls When applying Severity to your Effect of Failure, ask the following question, "What is the Effect if there are no Process Controls?" Severity for your Effect of Failure should be assigned without regard to your Process Controls. Assume the failure will escape your four walls. True, applying Detection via your Current Process Controls ensures the failure won't make it out of the plant, but we are asking what is the effect of the failure, not what is the effect under certain operating conditions.

Side A

Side B

The aggregate approach to applying Effect/Severity
After completing a first pass on your PFMEA, ensure you are not overstating risk. You can ensure risk is not overstated by applying an aggregate approach to Severity (Effect of Failure). Since you are protected by your current process controls, there is no need to apply the Effect of Failure beyond your four walls. There will be no field effect of the failure because your Current Process Controls will capture the failure and prevent it from leaving your manufacturing plant.

Applying Effect/Severity withough regard to Process Controls
When applying Severity to your Effect of Failure, ask the following question, "What is the Effect if there are no Process Controls?" Severity for your Effect of Failure should be assigned without regard to your Process Controls. Assume the failure will escape your four walls. True, applying Detection via your Current Process Controls ensures the failure won't make it out of the plant, but we are asking what is the effect of the failure, not what is the effect under certain operating conditions.

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Side A

Side B

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