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Informational Family or Baseline PFMEA Rules

tonyfan

Starting to get Involved
#1
Can anyone help me to understand the proper use of a family or baseline PFMEA? I'm in a very heated debate on the proper use of a family or baseline PFMEA with my Quality Engineer and Quality Manager. We had an internal auditor (3rd party) tell us it's ok to submit a "family process FMEA" that includes every process under the roof of the facility for any given part, weldment, or assembly, even if the part(s) do not go through that process.

Example: PPAP submission part process is to receive material, cut, form, wash, paint (outsourced), inspect, pack & ship. The "family PFMEA" being submitted includes receive material, cut, form, machine, spot weld, engrave, weld, wash, gravimetric, paint (internal), inspect, pack, ship.
We have been issued corrective actions during our registrar audits in the past for the PFMEA not lining up with the flow, and control plan. My concern is that this could potentially set us up for yet another corrective action for the same issue.

We are an ISO 9001:2015 and IATF 16949 certified facility. Any and all input is greatly appreciated.
 

try2makeit

Quite Involved in Discussions
#2
Your Part PFMEA should align with your Process flow and CP of the Part. Your Master PFMEA should contain have all processes. If you have Processes showing in your PFMEA that are not applicable to the Part you will have issues at a 3rd party audit or even from your Customer when you submit the documentation.
 

tonyfan

Starting to get Involved
#3
Thank you try2makeit for your input. I agree, they all need to align. QE is submitting his Master PFMEA, but calling it a family or baseline PFMEA. My problem remains that he feels no need to change since the internal auditor agreed that it is ok to submit as such. Rationale used by auditor was that as long as they can see that they are controlling (with the control plan) the potential failures noted on the PFMEA, they are ok to include all process, not just those the part(s) pass thru.
I was hoping for a reference to something written that I could show that they are going down the wrong path if they follow his lead.
 

tonyfan

Starting to get Involved
#5
Thank you Golfman25. May I ask, in your PFMEA submission do you include just the steps or processes that your part(s) go through, or do you include all processes and just modify those that are actually being used?
 

try2makeit

Quite Involved in Discussions
#6
8.3.5.2 Manufacturing process design output (IATF)
The organization shall document the manufacturing process design output in a manner that enables verification against the manufacturing process design inputs.
e - manufacturing process flow charts/layout, including linkage of product, process and tooling.
g - manufacturing process FMEA
I had the IATF bible open on that page...
 

tonyfan

Starting to get Involved
#7
Thanks again try2makeit. I've been showing and explaining this to them. I think I'm just stuck where I'm at until our 3rd party or a customer issues yet another corrective action. :censor: I think I could have had better success if the internal auditor hadn't given them the green light like he did.
 
#8
In the past I have done much the same - made a 'parent' PFMEA which includes all processes (internal and outsourced, and don't forget rework/salvage) and then edited it for PPAP submission, to show ONLY the process steps which are applicable to the part in question.

The only flaw that I find in this approach is that when you make a change to the 'parent' document, it may not be reflected in any previous 'daughter' documents which are related to it. The reverse is also true - if you have ongoing customer issues across several parts for the same failure mode at the same process step, the 'parent' document may require revision (if it is a systemic issue, rather than something specific and unique to a given part).

I believe that there is software available which captures this, however I am not really familiar with any of it - I prefer using Excel as it is much simpler to use, and (kinda) user friendly.
 

tonyfan

Starting to get Involved
#9
Thank you Ron. I hope with all of the feedback I've received, I can maybe come at them from yet another angle and get them to understand my concerns.
Thanks again to everyone that has contributed.
 
#10
What we do is modify the master for each part. That way we have a "clean" PFMEA for submission and the master is kept updated.
So we are a stamper. There are several stamping "processes" we lay out -- blanking, forming, piercing, trimming, etc. But not every part goes thru every one of those processes. So we cut them out and only include the relevant stamping steps. But some parts get plated or painted or other processes. For those we keep in the FMEA in order to match the boxes in our process flow, but just note that they are not applicable.

As per Ron's concern regarding subsequent changes, we treat every submitted (daughter) FMEA as "obsolete" when printed. The parent FMEA is kept up to date with changes. If we need a new one for a previous part, we just cut and paste again. We did this because managing 100s of FMEAs was unworkable and we couldn't keep up with revisions when something changed.
 
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