FMEA Severity Scores Between Two Sister divisions?

[mengmirez]

Hello to all the Elmar Covers

I wonder if you guys can leand me your expertise, I recently moved to medical device company after working several years in Aerospace industry. My question is, is it a common practice in medical device industry for sister divisions to duplicate FMEA since both have the same identical process and product produced? Is it common to keep the severity the same for both companies while the rest of the fmea numbers updated?
I never seen such scenario before while working in Aerospace.

Thanks

Omengramirez

 

[Bev D]

IF the product is the same and the process is the ‘same’ then the severity of any failure modes should be the same. I can see that different locations could very well have different probabilities of occurence and different MSA effectiveness (detection) as most processes and measurement systems are never exactly the same.

Why does this bother you? Other than the fact that you’ve never seen it. Can you give us some concrete examples that you question?

 

[John C. Abnet]

...in addition to the counsel/questions provided by @Bev D , remember, that SEVERITY (assuming it was stated / ranked correctly ) can only be changed if...
- design changes
- application changes

Bolt is used to hold on wheel....severity may be quite high.
Bolt (same bolt) is used to hold in radio....severity is quite low.

Hope this helps.
Be well.

 

[mengmirez]

IF the product is the same and the process is the ‘same’ then the severity of any failure modes should be the same. I can see that different locations could very well have different probabilities of occurence and different MSA effectiveness (detection) as most processes and measurement systems are never exactly the same.

Why does this bother you? Other than the fact that you’ve never seen it. Can you give us some concrete examples that you question?

@Bev D. Thanks for the input.It doesn’t bother me,it is more of a question of curiosity. Since I have not seen such practice. My understanding of FMEA scoring for Severity, Occurance and Detection is that, It is going to be subjective to the level of expertise of the group who performed the FMEA. So seeing Severity having exact same numbers is unusual for me since the group of expert on one division will not be the same group of expert from another division.

 

[John C. Abnet]

If the product is used in the identical application, then there is no reason the severity would not be identical at both locations since severity is defined as the EFFECT for a given failure mode (as perceived by the customer).

Hope this helps.
Be well.

 

[mengmirez]

If the product is used in the identical application, then there is no reason the severity would not be identical at both locations since severity is defined as the EFFECT for a given failure mode (as perceived by the customer).

Hope this helps.
Be well.

Thanks for the input. I forgot to mentioned on my previous post that It just a Process FMEA and not the risk management standard ISO14971. Thanks again.

 

[Bev D]

@Bev D. My understanding of FMEA scoring for Severity, Occurance and Detection is that, It is going to be subjective to the level of expertise of the group who performed the FMEA. So seeing Severity having exact same numbers is unusual for me since the group of expert on one division will not be the same group of expert from another division.

Even if you assemble the most senior people into a group it does not make them experts. If there are sister divisions using the same processes there should be sharing and collaboration. The laws of physics do not have any geographical or ‘cultural’ uniqueness.

Severity should not be a subjective decision at all. It is a matter of physics and understanding the effects of any given failure mode.

Occurence and Detection should also not be subjective although I know that some engineers and managers want it to be so that they can manipulate the results - or not do the work necessary. Occurrence should come from the development/validation process experiments. Detection should come from the actual MSA studies. (It’s OK that initial subjective ratings may be used - although I prefer no rating at all to use as a place holder - but the final numbers are supposed to come from actual testing)

Most modern FMEA in both automotive and medical devices and other industries have removed detection from the “RPN” Calculation and only use it as a mitigation / control.