Design FMEA for non-design manufacturer



Design PFMEA for non-design manufacturer

We are an injection molding company molding automotive parts on transferred tools from 1 of the 2 big Tier 1 suppliers.

I am a bit in a struggle here with what my Qa Manager stated. My mgr. stated that for liability reason we won't be submitting Design PFMEA's to the customer. Plus the mgr is afraid that we will need to do all the extra stuff like validation of the design etc. if we want to submit a good Desigh PFMEA.

The customer on the other hand reuested me for apart of the common Process PFMEA, also to submit Design PFMEAs on the tools and workcell (with automation).

I see the Design PFMEA for these as a tool to assess the design of tools and work cell, to check their itemized functions for possile failure modes in the end part and manufacturing process.

Is there anybody in the field that dealt with the same experience?
I do want to keep the customer and my company happy...


Fully vaccinated are you?
My experience has been if you didn't design it you didn't submit a design FMEA. However, my experience has been where one of the big 3 did the design so it was a non-issue.

Any thoughts from others?

Geoff Cotton

Quite Involved in Discussions
We won't let FMEA's off site !!!!

If a customer wishes to view them they are more than welcome to come and take a look but they will not be allowed to take a copy away.

We make extensive use of FMEA and contained within them is very detailed information about our designs and manufacturing processes which if it got into the 'wrong hands' could damage our business.




The old guy is strugling again to understand here.

We also do injection molding for automotive and have on occasion used "hand-me-down" tooling. The point is though whether or not you design the mold, you should still be validating the process design. I am lost trying to figure why you couldn't submit a DFMEA/DPFMEA.

Even in instances where you have design responsibility, the design validation can still be done in partnership with your customer. Most of the "extra stuff" is probably already being done and if it isn't, you could be making a big mistake. It is a lot less expensive to do the work up front than to try to go back and fix it later.

If you are automotive, you are required via PPAP to submit a FMEA. It sounds like Geoff isn't QS because he doesn't send them but you would still be required even if your process were proprietary. You would simply leave the proprietary information off the FMEA. You can meet the requirements without giving the store away.

Marc is absolutely right. If you don't have design responsibility, you don't need a DFMEA. The interpretation of needing a DFMEA for a process is reflected in the latest version of 16949.



Geoff Cotton

Quite Involved in Discussions
We are QS, and we normally submit to level I.

If we are forced to submit to level III we only send the 'front page' of the FMEA. This page only contains an outline of the process and issue numbers etc.

Had no problems with this approach todate.



I have to agree and disgree with what's been written here.

Being an injection molder using transferred tools, I feel that we still need to use the form of a Design PFMEA to assess the condition of the tools. Assess each of its supposed function, and document the failure modes.

We have been struggling a lot with tools that were designed by a previous molder, that are sometimes beyond their time.
Getting PO's from the customer has been a struggle, basicaly because they want to see more documentation on reasons why you want to refurbish their tooling.
In these cases a Design PFMEA would be in its place where you assess all its current functions, adjust occurence ratings to current conditions.

Also what in case you 'design' an automation workcell to get the customer's parts produced. Again, you are not designing the part, you design a workcell, that can affect the quality of part, therefore a Design PFMEA would be in its place, to assess all the supposed functions and their failure mode upfront. Just to prove out why a certain set-up of the work cell was been chosen.

FMEAs are supposed to be living documents, so in case if you did not design the tool, and therefore are not the originator of the tool design PFMEA, you will have to take care of the the updates on the fmea when the tool is transferred to you.

I feel that we have to look at the broader aspect of the word 'design', not just in the context of ISO or QS. You are always 'designing' something, not?


Marc, I agree. But when our customer (big 3) accepts the design responsibility they do send us a copy of the DFMEA for our records.


DFMEA VS PFMEA semantics

According to QS-9000 "Design" refers to product. A supplier is design responsible if "it has the authority to establish a new, or change an existing product specification for any product shipped to a customer".

Therefore, If I do not have design authority, I am not responsible for Design FMEA.

When I design tooling, molds, cells, work flow, etc. I am not changing the product specification. I am designing a process to produce parts to the design specification. Thus any FMEA I create is a PFMEA.

my 2c worth.



Fully vaccinated are you?
Sam said:

Marc, I agree. But when our customer (big 3) accepts the design responsibility they do send us a copy of the DFMEA for our records.

Yes. Technically this is the way it should (is supposed to) work. My experience has been that getting the DFMEA from one of the big 3 was near impossible and in most cases totally impossible. You are lucky in that you are able to obtain a copy of the DFMEA from one of the big 3.



For what it's worth:

We supply the automotive companies as well. Recently, DaimlerChrysler and Ford have begun to make us supply DFMEAs, DVP&Rs, PVP&Rs in our normal PPAP documentation at sign-off(these documents are generally outside our sphere of influence or control, having to do with design and validation). We weren't even familiar with DVP&R and PVP&R forms/tools. We're still somewhat confused what it all means at our level.

We are supposed to take these docs. and reference compliance in our PFMEAs. We are not design responsible. We have very little success getting any of the big three to supply the design side documents (it's happened once in 7 years with a higher end vehicle).

PFMEAs could be a very good and worthwhile tool, especially after you learn the ins and outs of it. But AIAG/QS is so involved with changing the rules every 2-3 years it becomes a paperwork upkeep battle just to grandfather fmeas only several years old, and bring them up to the current version levels (to p/d, new ratings requirements and definitions, etc.).

If auto companies can make PFMEAs any more complicated and removed from their original intent as a tool, I believe it will happen.
Top Bottom