Can you receive a minor nonconformance during a TS audit for the AIAG manual?

We received a nonconformance for not entering 'none' in recommended actions field on our PFMEAs, page 55 of the manual says if there are no recommended actions indicate this by placing none in the columne

Hello Mslet94, welcome to the cove.

"Can you receive a minor nonconformance during a TS audit for the AIAG manual?"

Yes if the PFMEA manual is part of your CORP requirement you can and you did.

If it were only one occurence wherein the "NONE" was not there for a low RPN (risk priority number) the auditor would let this pass granted you correct the document. But I assume there are no "NONES" on all your documents that required no "recommended action" right?
Take it as a learning experience and accept it or be "intrepid" and appeal :notme:

Footnote:
Was this CAR issued today? If so, you can correct this non-conformance on the spot (by updating your PFMEA documents) so that It will not go on record.
Goodluck!

Was this CAR issued today? If so, you can correct this non-conformance on the spot (by updating your PFMEA documents) so that It will not go on record.
Goodluck!Not many auditors would take that route. Correcting the PFMEA document with the word none is not corrective action, since it does nothing to prevent the problem from happening again. That is correction, which is different from corrective action. Without being able to dig deep, the OP seems to be uncertain if the AIAG Manuals are mandatory requirements. Seems to be the root cause of the problem there.

Thank you Sidney and EtobiLad ...both great comments! When we fix things on the spot it doesn’t matter our auditor still gives us a nonconformance and in some cases I completely understand because the purpose is to improve our processes but for an item like this it is hard to complete a full 8D … but hey I have a good start going! Thanks!

Not many auditors would take that route. Correcting the PFMEA document with the word none is not corrective action, since it does nothing to prevent the problem from happening again.

I do agree.. this should be coupled with something like procedure or i.e. create or update a work instruction for person preparing the PFMEA documents or other means to prevent this from happening again.

......
Good luck on your preventive action mslet94.

Can you receive a minor nonconformance during a TS audit for the AIAG manual?

We received a nonconformance for not entering 'none' in recommended actions field on our PFMEAs, page 55 of the manual says if there are no recommended actions indicate this by placing none in the columne

There are two things to consider here:

Were the PFMEA documents in question approved by the customer (as part of a PPAP submission, for example)? If so, the customer has given tacit approval of your methods, whether they realize it or not, and the auditor is off base.
There is some confusion about when AIAG manuals become "requirements." In the case of the FMEA and SPC manuals, to name two examples, the manuals are self-described as guidelines and not rigid requirements. If a customer simply states that a supplier must do PFMEA in accordance with the AIAG manual, what they're saying, whether they realize it or not, is that the methods shown in the manual are guidelines and not rigid, word-for-word requirements.I look at it this way: Whether or not "none" is in the Recommended Actions field affects nothing, and has no bearing on anything worth raising a issue over. It is not evidence of any sort of systemic problem, and no one is hurt by it. No harm, no foul.

I do agree.. this should be coupled with something like procedure or i.e. create or update a work instruction for person preparing the PFMEA documents or other means to prevent this from happening again.

......
Good luck on your preventive action mslet94.

To prevent what from happening again? Why engage in all of this hand-wringing, training and procedure-writing for a "problem" that doesn't really exist? Companies are going broke at this moment because the auto industry is making their suppliers chase their tails in the name of corrective action that doesn't need to be done.

I do agree.. this should be coupled with something like procedure or i.e. create or update a work instruction for person preparing the PFMEA documents or other means to prevent this from happening again.

......
Good luck on your preventive action mslet94.


Aren't there instructions with the AIAG documents on how to fill them out? Why reinvent the wheel? Bring your team together and show them what to do, and where to look in the future as they are completing PFMEA to ensure they do it right. It is called training and this is exactly why you should be assessing competency. (is there someone in charge to review the PFMEA (and every other AIAG document) for conformance prior to saying they are complete?)

To prevent what from happening again? .
The CAR has been issued in this case for mslet94. You can argue this with the auditor(s) as no harm no foul but they still give you a CAR.

Why engage in all of this hand-wringing, training and procedure-writing for a "problem" that doesn't really exist?
Again the CAR was still issued..

Companies are going broke at this moment because the auto industry is making their suppliers chase their tails in the name of corrective action that doesn't need to be done.
No argument here. Appeal!

Steelmaiden, I also agree with not recreating the wheel. If you can show them that efforts where undertaking to train the user. The PFMEA blue book (manual) does tell you the how to's. So training can be a route.

There are two things to consider here:

Were the PFMEA documents in question approved by the customer (as part of a PPAP submission, for example)? If so, the customer has given tacit approval of your methods, whether they realize it or not, and the auditor is off base.
There is some confusion about when AIAG manuals become "requirements." In the case of the FMEA and SPC manuals, to name two examples, the manuals are self-described as guidelines and not rigid requirements. If a customer simply states that a supplier must do PFMEA in accordance with the AIAG manual, what they're saying, whether they realize it or not, is that the methods shown in the manual are guidelines and not rigid, word-for-word requirements.I look at it this way: Whether or not "none" is in the Recommended Actions field affects nothing, and has no bearing on anything worth raising a issue over. It is not evidence of any sort of systemic problem, and no one is hurt by it. No harm, no foul.


I am inclined to agree with Jim's thoughts. I have written NC's when the Detection or Severity scoring is clearly not following the tables, or when there are substantive problems. But to write an NC because they did not write none, is perhaps a bit much. Not adding value. Not many customers are asking for that.

I am inclined to agree with Jim's thoughts. I have written NC's when the Detection or Severity scoring is clearly not following the tables, or when there are substantive problems. But to write an NC because they did not write none, is perhaps a bit much. Not adding value. Not many customers are asking for that.Me too. I agree that the "write up", as stated is one of those tic-tac, mickeymouse, non-value added "findings". However, if you are going to accept it as CAR, writing the word none in the field is not preventing recurrence, thus, and by definition, is not a corrective action.

Were the PFMEA documents in question approved by the customer (as part of a PPAP submission, for example)? If so, the customer has given tacit approval of your methods, whether they realize it or not, and the auditor is off base.

What you wrote about PFMEA is interesting Jim, and it made me curious.
Can the above apply to everything in a PFMEA? I mean, regardless of what it contains – for instance a 10 under “Severity” with “No action” in the end – so would/should/could not the auditor write a NC, as long as the document is accepted by the customer?

I mean, regardless of what it contains – for instance a 10 under “Severity” with “No action” in the end – so would/should/could not the auditor write a NC, as long as the document is accepted by the customer?

Are you implying that you interpret the "blue book" to mean that if there is a Severity of "10" there MUST be a Recommended Action?

Are you implying that you interpret the "blue book" to mean that if there is a Severity of "10" there MUST be a Recommended Action?

A 10 Severity - Action should be considered, though you may not always be able to come up with one outside of a design change.

What you wrote about PFMEA is interesting Jim, and it made me curious.
Can the above apply to everything in a PFMEA? I mean, regardless of what it contains – for instance a 10 under “Severity” with “No action” in the end – so would/should/could not the auditor write a NC, as long as the document is accepted by the customer?


Be careful not to make a "Rule" out of Jim's comment. We were discussing something pretty inconsequential.

I have often written NC's on FMEAs when there are significant errors, or substantive problems. But to write an NC for inconsequential things adds no value. Customers are not asking for that.

When a PPAP submission is made, the Warrant states on the bottom that all requirements have been met, except as noted below. Any deviations and exceptions should be noted. That is the process PPAP has set up to request customer approval of deviations.

If they are noted, and the customer signs off on it, most auditors would accept that customer signature as evidence the customer clearly was ok with the deviation. However, if there are deviations or errors buried on the 50th page of a PPAP, it is not fair to expect a customer signature on the warrant to be construed as acceptance of the deviation/error. If you hide it, I would write that up.

But, I would not write an NC because they didn't write "None" in each field. That is inconsequential.

A 10 Severity - Action should be considered, though you may not always be able to come up with one outside of a design change.

I agree - you need to see if something can be done - if the risk analysis process supports doing something. However, if nothing is to be "done", the entry in the Recommended Action column remains "none" (or whatever verbiage is being used in that column).

Suppose I've got an RPN of 10x1x10=100 (I'm not design responsible). With an Occurrence value of 1 my process doesn't allow me to produce the defect. There also may be no means available for me to Detect the Failure Mode. Why would I spend any more effort or money on reducing the RPN value. (I realize that example is a little simplistic but there are times when, for whatever reasons, there simply is no action to be taken).

Are you implying that you interpret the "blue book" to mean that if there is a Severity of "10" there MUST be a Recommended Action?

Since we got a minor NC because a P-FMEA show severity rankning of 9 without any action notified, and the auditor said there MUST be actions on 9's and 10's on Severity, I got the impression that this was fact. But reading your and hjilling's discussion below, I understand more.

But to write an NC because they did not write none, is perhaps a bit much. Not adding value. Not many customers are asking for that.The FMEA Manual, Recommended Action(s) section, specifically states, "If engineering assessment leads to no recommended actions for a specific failure mode/cause/control combination, indicate this by entering "None" in this column."

If you have a bunch of Recommended Action(s) entries with nothing entered, you will most certainly have earned a non-conformance. Obviously, you are not properly trained in FMEA and this needs to be corrected.

If you have a FMEA with 25 entries and only 1 of those entries has a blank Recommended Action, you are still going to get a non-conformance from your auditor. If the RPN is 500, you have failed to take an appropriate action. If it is 50 you have failed to enter a "none" to make it clear that you do not recommend action. You can argue all you want about "it's only one", "it's obvious that there's no action."

Personally, I agree with you, this is a bit much, not adding value, and I'm certainly not asking for it. However, when your system is darn near perfect, auditors still have to find something to write up so their employers don't lean on them. This is the kind of stuff that they "find". Welcome to the wonderful world of TS16949, core tools manuals, and automotive CSR compliance.

Once again, hjilling, I wish you were my auditor. I'm ready to start manufacturing aircraft parts out of flash paper. If anything ever goes wrong, they'll never be able to trace it to me!

The FMEA Manual, Recommended Action(s) section, specifically states, "If engineering assessment leads to no recommended actions for a specific failure mode/cause/control combination, indicate this by entering "None" in this column."

If you have a bunch of Recommended Action(s) entries with nothing entered, you will most certainly have earned a non-conformance. Obviously, you are not properly trained in FMEA and this needs to be corrected.

If you have a FMEA with 25 entries and only 1 of those entries has a blank Recommended Action, you are still going to get a non-conformance from your auditor. If the RPN is 500, you have failed to take an appropriate action. If it is 50 you have failed to enter a "none" to make it clear that you do not recommend action. You can argue all you want about "it's only one", "it's obvious that there's no action."

Personally, I agree with you, this is a bit much, not adding value, and I'm certainly not asking for it. However, when your system is darn near perfect, auditors still have to find something to write up so there employers don't lean on them. This is the kind of stuff that they "find". Welcome to the wonderful world of TS16949, core tools manuals, and automotive CSR compliance.

Once again, hjilling, I wish you were my auditor. I'm ready to start manufacturing aircraft parts out of flash paper. If anything ever goes wrong, they'll never be able to trace it to me!

I think you make a good point, Icy. Nonetheless, there is still some question as to how the AIAG requirements become "shalls" if the manual clearly states that it consists of guidelines and not requirements. I've reviewed thousands of supplier PFMEAs (usually as parts of PPAP submissions) and whenever I've seen the absence of "none," I've made mention of it, more or less in passing, but I never let it affect my appraisal of the substance of the document. Unless a given condition (A) shows evidence of systemic failure and (B) the failure is likely to cause some sort of trouble down the line, it's best not to make a big deal about it.

The FMEA Manual, Recommended Action(s) section, specifically states, "If engineering assessment leads to no recommended actions for a specific failure mode/cause/control combination, indicate this by entering "None" in this column."

If you have a bunch of Recommended Action(s) entries with nothing entered, you will most certainly have earned a non-conformance. Obviously, you are not properly trained in FMEA and this needs to be corrected.

If you have a FMEA with 25 entries and only 1 of those entries has a blank Recommended Action, you are still going to get a non-conformance from your auditor. If the RPN is 500, you have failed to take an appropriate action. If it is 50 you have failed to enter a "none" to make it clear that you do not recommend action. You can argue all you want about "it's only one", "it's obvious that there's no action."

Personally, I agree with you, this is a bit much, not adding value, and I'm certainly not asking for it. However, when your system is darn near perfect, auditors still have to find something to write up so there employers don't lean on them. This is the kind of stuff that they "find". Welcome to the wonderful world of TS16949, core tools manuals, and automotive CSR compliance.

Once again, hjilling, I wish you were my auditor. I'm ready to start manufacturing aircraft parts out of flash paper. If anything ever goes wrong, they'll never be able to trace it to me!


Well, Icy, seein' how I'm sittin' at an airport with a whole lot of time to kill...I might as well have a little fun with your post....

After a 1000+ audits, I think I've got the FMEA training thing down pretty good. I don't think I need more training. I've passed the FMEA section on the AIAG test a whole bunch of times in the last 11 years. And, I do write lot's of findings on FMEAs, but not silly findings. Now...I'll explain my comment.

Most FMEAs run about 8-12 pages with a hundred or so items. There is ABSOLUTELY ZERO value in writing "NONE" a 100 times, and I have never heard a customer STA/SQE comment about it. Any customer engineer with more than 2 weeks of experience has better things to do. And any auditor who makes a federal case out of it should find better things to do, cuz' he ain't doin' no good as an auditor. I don't personally know a single auditor who has proposed that in my presence. And I would have stopped him if he did.

HOWEVER, IF a supplier tackles additional actions, and decides it is not feasible, there would be value in writing "None" to close it out. I routinely look at high or significant line items to see what if any additional work is done, but we have to apply logic. Shoot, someone has to start, don't they?

Lastly, as an auditor, most guys I know try to provide value to the client, and we don't "feel a need to write something" up. I work for two agencies, and neither of them have ever inferred they expect we will "write something." And, I don't hear auditors say that either.

(Now, I'm sure there are some, but not in the circles I run with. We'd tear up an auditor who expressed such a silly notion.)

At any rate, it's time we all focus on why all of us are doing this - to make more profit and satisfy our customers. Anything else is foolishness.

Nonetheless, there is still some question as to how the AIAG requirements become "shalls" if the manual clearly states that it consists of guidelines and not requirements.It has always been my understanding that the 19 major points (Sections 2.1 through 2.2.18 of the PPAP Manual, specific to this thread Section 2.2.6, PFMEA) rise to the level of "shall" based on TS16949:2002, Section 7.3.6.3, Product Approval Process: "The organization SHALL conform to a product and manufacturing process approval procedure recognized by the customer."

It has always been my understanding that the 19 major points (Sections 2.1 through 2.2.18 of the PPAP Manual, specific to this thread Section 2.2.6, PFMEA) rise to the level of "shall" based on TS16949:2002, Section 7.3.6.3, Product Approval Process: "The organization SHALL conform to a product and manufacturing process approval procedure recognized by the customer."

Yes, but the problem is that if you tell me that I "shall" use an AIAG manual as the baseline, and the AIAG manual explicitly states that it contains guidelines and not requirements, the necessity for following the manual to the letter has not been established. In other words, unless the customer explicitly states that the manual's status as a guideline document is superseded, all bets are off.

Yes, but the problem is that if you tell me that I "shall" use an AIAG manual as the baseline, and the AIAG manual explicitly states that it contains guidelines and not requirements, the necessity for following the manual to the letter has not been established. In other words, unless the customer explicitly states that the manual's status as a guideline document is superseded, all bets are off.I am looking right at Page 1 of the PPAP Manual 4th Edition, Page 1, Purpose, Applicability and Approach. The manual does not state that it is a "guideline". Under Approach, the first sentence states: "The word "shall" indicates mandatory requirements."
Section 2.2.6 states: "The organization shall develop a Process FMEA in accordance with, and compliant to, customer-specified requirements, (e.g. Potential Failure Mode and Effects Analysis reference manual)."

So we are following a Customer Specific Requirements tree:
TS16949:2002 registration required
Customer Specific Requirement: PPAP per AIAG PPAP Manual
Customer Specific Requirement per PPAP: PFMEA per AIAG PFMEA Manual
It is my contention (arrived at based on customer specification and audit, 3rd party registrar audit, and AIAG training) that when the customer specifies that they want a PFMEA compliant with the AIAG PFMEA Manual, the manual has now been elevated from guideline to requirement, regardless of the Foreword's statement that, "This manual provides general guidelines for preparing an FMEA."

It has always been my understanding that the 19 major points (Sections 2.1 through 2.2.18 of the PPAP Manual, specific to this thread Section 2.2.6, PFMEA) rise to the level of "shall" based on TS16949:2002, Section 7.3.6.3, Product Approval Process: "The organization SHALL conform to a product and manufacturing process approval procedure recognized by the customer."


That is pretty much how most of us auditors interpret it. That, and specific TS Customer Specific Requirements specify it, which then makes them requirements.

That is pretty much how most of us auditors interpret it. That, and specific TS Customer Specific Requirements specify it, which then makes them requirements.Bingo!
I know we are arguing quality management system esoterica here but this is where the findings get written when you are running a mature system. These kinds of findings are also so limited in scope that it is a cast-iron B***H to write and implement corrective action. Customer specific requirements for the Big 3 are so huge and detailed it is virtually impossible to dot every single I and cross every single T. However, if you manage to cover all but 3.4 of the 1,000,000 possible places to screw up, you can be sure that your trusty 3rd party auditor will find them and write you 3.4 findings.

Bingo!
I know we are arguing quality management system esoterica here but this is where the findings get written when you are running a mature system. These kinds of findings are also so limited in scope that it is a cast-iron B***H to write and implement corrective action. Customer specific requirements for the Big 3 are so huge and detailed it is virtually impossible to dot every single I and cross every single T. However, if you manage to cover all but 3.4 of the 1,000,000 possible places to screw up, you can be sure that your trusty 3rd party auditor will find them and write you 3.4 findings.


If you are referring to the vast reams of all the customers specs, drawings, etc., I would agree. However, the comment was in reference to the TS specific customer documents, which in most cases is a dozen or two pages. The other requirements are to be determined during the Design and APQP activity.

Good discussion.

While we're on the topic of auditing PPAP documents.

Our PPAP group was awarded a minor nonconformance for approving PFMEA's for not having evidence the supplier is reducing their RPN calculation based their supplier quality assurance manual that states; "Supplier shall focus on reducing the high severity and high PRN items for the to ten percent. This should be reviewed regularly to insure continual improvement.

(1) why is this a PPAP nonconformance?

Thank you for your feedback.

Good discussion.

While we're on the topic of auditing PPAP documents.

Our PPAP group was awarded a minor nonconformance for approving PFMEA's for not having evidence the supplier is reducing their RPN calculation based their supplier quality assurance manual that states; "Supplier shall focus on reducing the high severity and high PRN items for the to ten percent. This should be reviewed regularly to insure continual improvement.

(1) why is this a PPAP nonconformance?

Thank you for your feedback.

Are you saying your organization received a minor NC because a supplier to you did not provide evidence they were reducing their RPN?

As to the standard, that would be reaching pretty far. However, if Your Supplier Manual states that you are to review it regularly, then it would be an NC against your procedure (your manual).

It sounds like a good practice, but you might want to allow yourself some flexibility, maybe based on need or supplier performance.

Yes, I agree. It should be a NC against the manual.

Thanks for your feedback.

All nonconformities are nothing more than symptoms. The auditor might be viewing this "none" as a symptom of a bigger issue. It could be evidence that the manual was not followed, and there could be other areas where instructions were also disregarded. The "fix" might not be to just write in "none", but to look at the entire FMEA process to ensure you are not missing other stuff.

Maybe I'm missing something (and I frequently do) according to the FMEA 3rd Edition;
"If engineering assessment leads to no recommended actions for a specific failure mode/cause/control combination, indicate this by entering "None" in this column"

Page 55 19) Recommended Action(s)

I'm betting there is more to this than we know... such as a customer issued NC, and a resulting corrective action that was not addressed on the FMEA and/or Control Plan

Thank Riogradeguy

but nope no more then what meets the eye, we do review no customer issues related, low RPN because we Poke Yoke to dealth (i work for a japanese company)... we just HAD an auditor who like to find things (dont get me wrong it needed to be corrected) that often time had no value add, we just got a new auditor who is awsome....he really looked at our systems and processes and wrote findings that have really helped us improve our company

We've never had finding from a TS auditor for this particular item, but we did have a "customer" audit (we are a 2nd tier automotive supplier) and and at the time we had A LOT of "none" on our recommended actions and he did not like it. So we started recording our preventative actions in this column. So we kinda killed two birds with one stone; we got rid of the "none"s and we have a record of preventative actions.

(does anyone forsee any problems with this tactic?)

We had a hard time in the beginning trying to find stuff for this column as our company expanded and opened this building. We learned from past mistakes and built this building and machinery learning from what we had done wrong, in the beginning everything was perfect but unforseen problems do arise and that's when we started coming up with preventative actions.

We've never had finding from a TS auditor for this particular item, but we did have a "customer" audit (we are a 2nd tier automotive supplier) and and at the time we had A LOT of "none" on our recommended actions and he did not like it. So we started recording our preventative actions in this column. So we kinda killed two birds with one stone; we got rid of the "none"s and we have a record of preventative actions.

(does anyone forsee any problems with this tactic?)

We had a hard time in the beginning trying to find stuff for this column as our company expanded and opened this building. We learned from past mistakes and built this building and machinery learning from what we had done wrong, in the beginning everything was perfect but unforseen problems do arise and that's when we started coming up with preventative actions.

That's exactly what the "right side" of the document is for - a reduction in Severity (process or product design change), a reduction in Occurence (preventive measure), or a reduction in Detection (improvement of ability to catch nonconformance).
My only question would be - Although not a necessity (but most customers want to see wish to see an improvement), did you improve your RPN score with the Recommended Actions you entered?

Yes, even if the preventative action was on an item that had not previously been covered in the FMEA, it was added and the scores were entered/updated to reflect the preventative action.