SBS - The best value in QMS software

Minor Nonconformance from AIAG Manual - Recommended actions field on our PFMEAs

Sidney Vianna

Post Responsibly
Staff member
Admin
#11
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.
 
Elsmar Forum Sponsor
L

Lars_

#12
  • 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?
 
B

Bill Ryan - 2007

#13
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?
 

Helmut Jilling

Auditor / Consultant
#15
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.
 
B

Bill Ryan - 2007

#16
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).
 
L

Lars_

#17
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.
 
#18
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!
 
Last edited:

Jim Wynne

Staff member
Admin
#19
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.
 

Helmut Jilling

Auditor / Consultant
#20
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.
 
Thread starter Similar threads Forum Replies Date
G Timing allowed by IATF to close a Remote Site Minor Nonconformance IATF 16949 - Automotive Quality Systems Standard 2
A Where are the rules for when a repeat minor nonconformance becomes a major? IATF 16949 - Automotive Quality Systems Standard 36
W Minor Audit Nonconformance Against Determining the scope of QMS IATF 16949 - Automotive Quality Systems Standard 12
E Short Case Studies - Major/Minor Nonconformance, Observation or OK? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 9
R Audit Plan MNC (Minor Nonconformance) ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 10
S Auditor says a Minor Nonconformance will become a Major Nonconformance General Auditing Discussions 8
M Is it necessary to classify nonconformance as minor, major, observations in an IQA? Internal Auditing 18
J Communicating Quality Objectives - Minor Nonconformance AS9100B/ISO9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P Lack of 3rd Shift Internal Audit - Major or Minor NC (Nonconformance)? Internal Auditing 17
S Minor nonconformance seems more opinion ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 18
D Major vs. Minor Nonconformance - TS 16949 3rd Party Audit Question IATF 16949 - Automotive Quality Systems Standard 4
M What happens if a Major or Minor Nonconformance is found during Surveillance Audit ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
M Major/Minor Nonconformity - Nonconformance from last audit found again Nonconformance and Corrective Action 15
D Definition Major vs. Minor Nonconformance (Finding) - Difference and Definition Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 20
Randy Minor Nonconformance turning into a Major - Systemic failure throught an organization General Auditing Discussions 40
Q Nonconformance vs. Nonconformity - I cannot find major and minor, either! Nonconformance and Corrective Action 36
D Minor nonconformance - Not requiring Certificates of Compliance on our supplier PO's Supplier Quality Assurance and other Supplier Issues 7
A Definition Major vs. Minor Nonconformance (Finding) - Internal Audit - Definition & Differences Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 38
M IEC 62304 Software changes - Minor labeling changes on the GUI IEC 62304 - Medical Device Software Life Cycle Processes 3
M Major vs. Minor for Internal Audits? Internal Auditing 10
C Fact or fiction - Repeat minor becomes a major IATF non-conformance IATF 16949 - Automotive Quality Systems Standard 7
Q ISO 14001:2015 accredited but import most product - CB Raised minor NC on Life Cycle Perspective ISO 14001:2015 Specific Discussions 2
J EU ISO 13485:2016 Recertification Audit - Effect of 10 Minor Nonconformances EU Medical Device Regulations 2
Y Informational Change control process - Major vs Minor change - Active class III medical devices ISO 13485:2016 - Medical Device Quality Management Systems 12
S Minor diameter of threaded ring gage General Measurement Device and Calibration Topics 1
D Minor non-conformance for not receiving a CofC from a heat treater Manufacturing and Related Processes 10
supadrai Informational Japan Minor Change Notification Application Form - Found it? Japan Medical Device Regulations 0
P Major Finding Elevation - Do I elevate this minor finding to a major one? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 14
P Received a minor for not having good measureables/goals. Need help with KPIs. IATF 16949 - Automotive Quality Systems Standard 52
P Minor Non-Conformance - Maintenance Records Not Fully Completed ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 24
M "Minor" Address Change Implications on Product Labeling Requirements Misc. Quality Assurance and Business Systems Related Topics 2
Sidney Vianna Top 10 Major and minor NC's during IATF 16949:2016 Audits IATF 16949 - Automotive Quality Systems Standard 8
qualprod Minor non-conformance for not controlling local regulation laws? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 20
K Notified Body - Minor Nonconformances - They have withheld all certificates General Auditing Discussions 3
T Non-addressed Minor Finding elevated to Major Finding Internal Auditing 37
B IATF 16949: Definition Major/Minor Non-conformity IATF 16949 - Automotive Quality Systems Standard 6
T Defining Major vs. Minor Changes to Procedures ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
R Classification of Major & Minor Defects AQL - Acceptable Quality Level 10
Hershal Minor quake in So Cal - 17 March 2014 Coffee Break and Water Cooler Discussions 4
M Is a New Revision Required for Minor Document Changes? Document Control Systems, Procedures, Forms and Templates 15
L Definitions for Minor & Major Nonconformances ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 15
S What constitutes Major and Minor changes in Software Software Quality Assurance 7
F Response to ISO 13485 Audit Minor Nonconformances ISO 13485:2016 - Medical Device Quality Management Systems 6
L Root Cause for Minor Non-conformance regarding Supplier Delegation Nonconformance and Corrective Action 5
M Is a Corrective Action required for each major/minor Tool Repair? Quality Manager and Management Related Issues 7
S Minor Nonconformity for Lack of Job Descriptions in ISO 9001 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 62
M Minor/ Major Change - Japan - When you have to notify the PMDA of a change? Other Medical Device Regulations World-Wide 1
J Major NC downgraded to Minor by Registrar during Re-Visit Nonconformance and Corrective Action 7
M Definition Major vs. Minor Non Conformance Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 14
S Minor NC for Not Having Management Review When Scheduled Management Review Meetings and related Processes 12

Similar threads

Top Bottom