DFMEA (Design FMEA) and PFMEA (Process FMEA) - Who should lead?

C

Carrie11

#1
Hi All

In my "former life" I worked in the automotive industry and in that sector the DFMEA was led by a design engineer and the PFMEA by a process engineer. Obviously quality played a major role in the team in both cases and the team was made up of people from various disciplines.

I now work in the body armour business and a customer requirement is that we create both a DFMEA and PFMEA. My MD has decided that FMEA's are a quality led function and that I should champion this.

My question is "Is this best practice?" I would have thought the best and most knowledgeable person to lead DFMEA is a design engineer and PFMEA a process engineer. Am I wrong or have I just had it easy for a while?!!

Irrespective of this I have to complete both FMEA's in two days......on my own!!!!

Your comments would be appreciated.
 
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Jim Wynne

Staff member
Admin
#2
Re: DFMEA and PFMEA. Who should lead?

Hi All

In my "former life" I worked in the automotive industry and in that sector the DFMEA was led by a design engineer and the PFMEA by a process engineer. Obviously quality played a major role in the team in both cases and the team was made up of people from various disciplines.

I now work in the body armour business and a customer requirement is that we create both a DFMEA and PFMEA. My MD has decided that FMEA's are a quality led function and that I should champion this.

My question is "Is this best practice?" I would have thought the best and most knowledgeable person to lead DFMEA is a design engineer and PFMEA a process engineer. Am I wrong or have I just had it easy for a while?!!

Irrespective of this I have to complete both FMEA's in two days......on my own!!!!

Your comments would be appreciated.
In general, the best person is the one who is (A) familiar with the FMEA process and (B) experienced at running meetings. If you're saying that you have to complete the two FMEAs all by yourself, with no participation from those involved with the design and processes), you might as well not bother--the results aren't likely to be very helpful, especially given the two-day deadline.
 
C

Carrie11

#3
Re: DFMEA and PFMEA. Who should lead?

Thanks Jim

I realise "my" fmea's will be not worth the paper they are written on as I do not know all the ins ands outs of either the process or design. Do you know of any "best practice" guidelines for fmea as my MD won't take my word that
  • it's not a task than be completed in 2 days
  • it needs input from a multi functional team
 

RCW

Quite Involved in Discussions
#4
Re: DFMEA and PFMEA. Who should lead?

I agree with Jim. The most knowledgeable person of the design or process being reviewed is not necessarily the best moderator for the meeting/review process.

In appendix G.4 of ISO 14971:2007 (Medical Device - Risk Management), it references an IEC document (IEC 60812) for more information on FMEAs. I have never seen the document and I don't know if you can get your hands on it. Like most specs, there's a nice price tag attached to it.

Also, just curious, do you have a Risk Management procedure in your quality system? I know my procedure calls out the minimum people / groups who must attend.
 
C

Carrie11

#5
Re: DFMEA and PFMEA. Who should lead?

We do not have risk management detailed in our management process, however, surprisingly, I have also been given responsibility for this...alone!
 

Jim Wynne

Staff member
Admin
#6
Re: DFMEA and PFMEA. Who should lead?

Thanks Jim

I realise "my" fmea's will be not worth the paper they are written on as I do not know all the ins ands outs of either the process or design. Do you know of any "best practice" guidelines for fmea as my MD won't take my word that
  • it's not a task than be completed in 2 days
  • it needs input from a multi functional team
Do you have the AIAG FMEA manual (or SAE J1739)? Here's a quote from page 4 of the 4th edition AIAG manual:
Because the development of an FMEA is a multi-disciplined activity affecting the entire product realization process, its implementation needs to be well planned to be fully effective. The process can take considerable time and a commitment of the required resources is vital. Important to FMEA development is a process owner and senior managment commitment.
Then further down the same page:
An FMEA is developed by a multi-functional (or cross-functional) team. The team size will depend both on the complexity of the design and the size and organzation of the company. Team members need relevant expertise, available time and authority sanctioned by management.
 
G

gholland

#7
Re: DFMEA and PFMEA - Who should lead?

Sounds like you're running into 'check the box' syndrome. You're being asked to fill out a form for the customer that isn't going to be looked at after you draft it.

The dFMEA should be done by the design engineers with Quality doing overwatch to make sure it's done correctly and then the document reviewed by the team including management. The pFMEA should be done by the process/manufacturing engineers in the same fashion.

You cannot, as a QE, be fluent in the design and the manufacture of the device well enough to do the FMEAs. The last FMEAs I did took over a month and had representatives of all disciplines in the meetings. For example the dFMEA took 3-5 people 6 meetings of 2 hours each. The pMFEA took 3-5 people 8 meetings of 2 hours each. Granted the machine for our project was huge but the design was fairly simple.

I would expect a dFMEA for 'body armor' to be very detailed taking into account all sorts of things like environment, ballistics of your threat, moisture and humidity, size of wearer, etc. I can see the team taking many meetings to hammer this out if done correctly.

In medical devices these are supposed to be documents that are used to generate risk mitigations and process/design improvements. They are not supposed to be done at the end of the project. Perhaps other industries are different.

I know that if I was a customer (i.e. the grunt being shot at in the field) I would hope that the process for identifying failures in my body armor was not 1/2 assed. Not a dig at you but, as usual, the 'check the box' theory of project management.

:2cents:
 
M

Murphys Law

#8
Whilst you now have responsibilties for the DFMEA, you should have some knowledge of assessing if the RPN standard of the FMEA is acceptable or not.

Just look at the RPNs and assess it meeting your companies standard or not.

If the RPNs are too high, then get a corrective action or validation plan to reduce them. If still too high to meet your comfort zone, then approach your management for a waiver. It is what it is is. Don't fight it !

I have had to assess DFMEAs without being a designer engineering background but stick to the FMEA basics, and have the design group explain it back to you.
 
Last edited by a moderator:

Stijloor

Staff member
Super Moderator
#9
Whilst you now have responsibilties for the DFMEA, you should have some knowledge of assessing if the RPN standard of the FMEA is acceptable or not.

Just look at the RPNs and assess it meeting your companies standard or not.

If the RPNs are too high, then get a corrective action or validation plan to reduce them. If still too high to meet your comfort zone, then approach your management for a waiver. It is what it is is. Don't fight it !

I have had to assess DFMEAs without being a designer engineering background but stick to the FMEA basics, and have the design group explain it back to you.
RPN "standards" should never be used to prioritize the need for action.

The FMEA 4th Edition states:

The use of an RPN threshold is not a recommended practice for determining the need for actions.
The manual has some excellent explanations why this practice is discouraged.

Stijloor.
 

Jim Wynne

Staff member
Admin
#10
RPN "standards" should never be used to prioritize the need for action.

The FMEA 4th Edition states:

The use of an RPN threshold is not a recommended practice for determining the need for actions.
Stijloor.
The RPN shouldn't be used by itself to prioritize actions. If you can't use the RPN for prioritization at all, there's no sense in having RPNs.

Added in Edit: I now see that Stijloor was using "standards" to mean trigger or threshold values, and thus my response was not to the point he was making. :bonk:
 
Last edited:
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