PFMEA's for TE Suppliers - No problems that require a Recommended Action

M

monkey

#1
My company is currently ISO 9001:1994 and upgrading to QS/TE.
Our machining processes are always the same as our product has not changed significantly over the last 40 years. We machine to the print via milling, endmilling, drilling, lathe work, etc. Our processes are stable and there are no problems that require a "Recommended Action." We do however have basic family Design FMEA's for our products. The TE Supplement says that Process FMEA's, generic to a common process, or family of products shall be used when appropriate. What is appropriate? This would be an exercise in futility for us to do, but if registration requires it, we can comply. I'm wondering if I can say that for our company, PFMEA's our NOT appropriate.

THANKS!
 
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D

D.Scott

#2
Just my opinion here as we are not a TE company. We are QS-9000 though.

FMEAs are always appropriate. The clause you refer to allows you to use the same generic FMEA for a family of parts or a generic process when appropriate. This means when all the situations are the same and the generic FMEA fits the circumstances. If you find there is something different about THIS NEW product, it may mean you need to revise your generic FMEA. In any case, a FMEA (generic or otherwise) must be submitted with every PPAP. It may be a case of simply photocopying the generic one and including it but it must be sent.

It is also easy to fall into a trap here. Be sure you go through the steps of reviewing the generic FMEA against the requirements of the product.

I think you are fortunate to have such a stable and predictable process, as most are not. A question just for clarification though. You say your process is stable which indicates you do SPC to establish that. The SPC is obviously done on some characteristic of the product/process. If nothing could ever require a "recommended action", why are you controlling it with SPC and what would you do if it ever did go "out of control"?

Good luck with the transition to QS/TE.

Dave
 
A

Al Dyer

#3
PFMEA is a wonderful thing, it can be used for:

APQP
PPAP
Continuous Improvement
Mistake Proofing
Prioritized Reduction Plans
Internal Audit Guides
Process Control
Preventive Action
Management Review
Key Measurables
MSA

One of the most useful tools in the quality bag of tricks, even if not required by a customer.

Just as a personal issue I tend to lean away from "family" FMEA's. If a company is large enough to have the volume of new parts coming in the door it is large enough to spend a few hours doing a part specific FMEA.

Example:

I receive a complaint on part #123---
I do a corrective action and update the FMEA---
I look at like FMEA's---
I update FMEA's with similar processes---

Bingo, Preventive action.

Simplistic I know, but I think applicable.
:bigwave:
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#4
I would wait for a T&E specialist to answer your question for a definite, however I doubt you'll be able to get out of doing an FMEA. I think Laura is our T&E Expert here.

D. Scott said:

> You say your process is stable which indicates you do SPC
> to establish that. The SPC is obviously done on some
> characteristic of the product/process.

I'm not sure they'll do SPC, nor do I have any idea how monkey has determined the process to be stable. I say this because in most T&E suppliers, volume is not sufficient as I understand it.

This said, the question is: How do you know your process(es) is stable?
 
D

D.Scott

#5
I am the first to agree with Marc - "Wait for a TE specialist to answer for definite".

I was not saying they will need to do SPC, I was saying the indication is they ARE DOING SPC. The SPC Reference Manual from AIAG defines a stable process as "a process that is in statistical control" - the assumption was that if they have a stable process they must be doing SPC.

If there is another way to demonstrate a stable process, I would love to hear about it. It could make my life a lot easier.

Sorry to have mudded the waters. Hope this hasn't made it worse.

Dave
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
I don't think the 'waters have been muddied' at all. I just wanted to point out that T&E is very different from high volume manufacturing of 'parts'.

Monkey will have to elaborate on how s/he knows their processes are stable.

I also don't think a stable process negates the requirement for an FMEA.

> We do however have basic family Design FMEA's for our
> products. The TE Supplement says that Process FMEA's,
> generic to a common process, or family of products shall
> be used when appropriate. What is appropriate?

That "...what is appropriate..." is, of course, the question. If I was auditing you, I would be questioning you with respect to volume, feedback from assembly, etc.

A bigger question is - are you really T&E? You mention milling, etc., but do you make equipment or parts? That is to say, what is the product that goes out the door (that you sell)?
 
J

John Swartz

#7
Insight from a TE Supplier

First let me blow the dust off this topic....

We manufacture production equipment as a TE Supplier to the B3. As for our processes, all we really do is cut, form, and weld sheetmetal and structural steel.

We first developed a process map of our shop processes which are simply fabrication (Cut and form steel) and assembly. (Shipping is a given)

I have had our operations people develop FMEAs for all the equipment (sans welders) and our PFMEA is easily developed from the equipment FMEAs and process map.
 
#8
FMEA's

AIAG has just released "FMEA Manual for TOooling and Equipment" (Machinery FMEA) manual, $9 for members, $27 non-members.

I haven't seen it yet. I just got the notification letter today and placed an order.

Review to follow...
 
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