Core Tools - PFMEA - Not having the word ''NONE'' in Recommended Actions

larry hopperrath

Registered Visitor
#1
Good morning everyone!
We recently has a re-certification to QS-9000. One minor non-conformance that was found was for not having the word ''NONE'' on our process FMEA in the section for recommened actions. The wording on the Corrective Action request from our auditor was ''compliance with core tools''. Besided the PFMEA and control plan, I cannot think any other thing that falls under ''core tools''. Can any one else help me think of what else might fall under this?
Larry
 
Elsmar Forum Sponsor
#2
I would never accept a nonconformance without a direct quote from the requirement: "where's the shall?". Just saying ''compliance with core tools'' is insufficient. Have the auditor show you the source of the requirement and the specifically what the requirement is.

In the FMEA Manual, it does say: "If engineering assessment leads to no recommended actions for a specific failure mode/cause/control combination, indicate this by entering "None" in this column." That is probably where the auditor got the "requirement". Now, the next question is: Where does it say you have to follow the FMEA manual to the letter?
 
R

Rob Nix

#3
I absolutely agree with Dave. The FMEA manual is a reference, nothing else. Therefore, whether you choose to put "none" or leave it blank is your choice, as long as it is done consistently and agrees with your own internal procedures. Obviously, it is always better to enter something in any form field to ensure it was considered. But, if the risk of failing to do so does not outweigh the efforts to enforce the requirement to do so, then it is nothing to waste time and effort on.

This topic sounds suspiciously like the "auditor clearinghouse" thread.

And, as far as "core tools" goes, who's to say FMEA is THE core 'risk analysis' tool. There are many techniques to analyze risk, FMEA is just one.

Whew, what's gotten into me today?
 
Q

qualitytrec

#4
Our customer dinged us for that on our last PPAP submission. They said it needed to show that it had been considered and that we decided to have no recomended actions. It was easy enough to fix.
I would argue that the "issue" was not a nonconformance but if anything a concern or OFI.
JMO,
Mark
 
Last edited by a moderator:
#5
One additional thing. In the "General Information" part of the FMEA manual (page 1), it states: "This manual introduces the topic of Potential Failure Mode and Effects Analysis (FMEA) and gives general guidance in the applicaiton of the technique." emphasis mine

Guidelines, not "shalls"
 
K

Kevin H

#6
Reference vs "Shall"

We're continually arguing with one of our customers regarding FMEA's. They are pushing that we use the standard AIAG format. We use an equivalent form that was developed for our needs at a corporate level. Everytime this customer contacts/audits us they complain about the non-AIAG form. Our response is consistently that we developed the forms to address the needs of our business, that they are equivalent to the AIAG forms, and that as expressed in the manual the manual and forms are guidance not a rigid requirement. (By the way, the forms really are equivalent to the AIAG ones- the customer has not been able to find an area in the standard FMEA format that we do not address, but this customer, and especially 1 auditor from the customer wants to see the AIAG form.)

So far, we've been able to "hold the line" and continue to use the forms designed to address our business.
 
T

Tom W

#7
We had the same finding a few years back.

While the manual is a reference manual - if you say you perscribe to it and that you have customers that require you to use it then that is where you have made it a requirement.

Trust me I fought this one and lost. :bonk:
 
B

bgwiehle

#8
There seem to 2 parts to your question:

FMEA format:
larry hopperrath said:
...One minor non-conformance that was found was for not having the word ''NONE'' on our process FMEA in the section for recommened actions. The wording on the Corrective Action request from our auditor was ''compliance with core tools''.
We've never used "none" in our recommended actions column and our customers & auditors have never had a problem with our PFMEA format. We do record improvements and corrective actions in that column so it's not blank. Having "none" entered adds no value to us or our customers.

We use the same column layout as in the FMEA manual but our header is laid out differently. We addressed most of the prescribed items somewhere, but a couple just aren't valid in our PFMEA system;
ie. instead of key date, we use model year or production start, and instead of core team we use responsible engineer - we do have cross-functional meetings, but attendance is more by function.

Core Tools:
larry hopperrath said:
Besided the PFMEA and control plan, I cannot think any other thing that falls under ''core tools''. Can any one else help me think of what else might fall under this?
Larry
Especially under TS16949, "core tools" means all the AIAG manuals: APQP, FMEA, SPC, MSA and PPAP.

B.G. Wiehle
 
T

Tom W

#9
Actually in TS16949 there is no reference to the AIAG manuals - it simply states reference to customer perscribed formats in which the AIAG is one of many.

Seeing no value added to placing none in the column is a mute point when you have customers that perscribe to the AIAG FMEA guidebook then it becomes a requirement. If your organization and ALL of your customers don't care to enforce this requiremnet then that is one thing. But the auditor has the responsibility to audit to these customer specific requirements if they exist. Just to say that you do not think it adds value or that your customers do not care if NONE is in the column does not matter to the auditor if you say you follow the AIAG FMEA (or you have a customer that requires it) guidebook.

While I agree that putting none there might not have benefit to the organization it does tend to show your organizations ability to follow the requirements that your customers perscribe too. Which in the end is what the auditor is there for.
 
B

Bill Ryan - 2007

#10
Just from my experience, I've had the same battles with our customers. I echo what Mark and Tom have posted. Since I began documenting PFMEAs we have moved to a software that automatically enters "NONE" unless overwritten with a Recommended Action. It also wasn't that big a deal to add NONE to all the documents when in Excel format.

I also agree with the other responses that the AIAG manual is a guideline which may or may not be the "best" way for your company to institute/utilize the PFMEA methodology. As long as you have the information your customer "requires", there should be no issues (that probably makes too much sense to be applied in the automotive world :bonk: ).

I also agree with B.G. Wiehle that the "core tools" the auditor reference are, most likely, the AIAG manuals (I've been away from the specific QS requirements for about 4 years now - having gone to TS).
 
Thread starter Similar threads Forum Replies Date
D Automotive Core Tools - Developing PPAP, PFMEA and Control Plan Work Instructions APQP and PPAP 3
A The latest revision number and changes in automotive core tools IATF 16949 - Automotive Quality Systems Standard 1
S I have just purchased the all new Core Tools Software (CTS) from AIAG IATF 16949 - Automotive Quality Systems Standard 37
T Relationship between TS16949 and 5 Core Tools & relationship between 5 Core Tools IATF 16949 - Automotive Quality Systems Standard 5
V Latest revisions of Core Tools Manuals from the AIAG (APQP, PPAP, FMEA, SPC and MSA) IATF 16949 - Automotive Quality Systems Standard 3
D Core Tools Application at a Remote Site IATF 16949 - Automotive Quality Systems Standard 3
M TS16949 Auditor and Core Tools Training Provider Recommendation in Germany Training - Internal, External, Online and Distance Learning 3
S The relationship (correlation) of 5 Core Tools with TS 16949 IATF 16949 - Automotive Quality Systems Standard 9
A APQP and Core Tools Training Requirements APQP and PPAP 11
E Training Our Internal Auditors on the Core Tools Training - Internal, External, Online and Distance Learning 10
V Need Training on Automotive "Core Tools" Training - Internal, External, Online and Distance Learning 11
P AIAG FMEA Core Tools Exam FMEA and Control Plans 4
E Training Documents - Training manuals for the 5 core tools Quality Tools, Improvement and Analysis 1
J The 5 Core Tools Training for Internal Auditors IATF 16949 - Automotive Quality Systems Standard 16
D Core Tools Forms Disk IATF 16949 - Automotive Quality Systems Standard 1
Stijloor AIAG Core Tools Forms Disc Available APQP and PPAP 3
P Can my organization use Core Tools that are not the Most Current Revision? IATF 16949 - Automotive Quality Systems Standard 6
M Seeking Trainer for Core tools training in Ontario, Kitchener Training - Internal, External, Online and Distance Learning 0
J Core Tools Training Evidence for Internal Auditors Internal Auditing 16
Q 'Core' Automotive Quality Tools - Seeking a PPT or PDF presentation IATF 16949 - Automotive Quality Systems Standard 22
R APQP and Core Tools Training how to Determine the Effectiveness of Training Training - Internal, External, Online and Distance Learning 10
S What is considered a "core algorithm"? (From an FDA guidance document) Medical Information Technology, Medical Software and Health Informatics 4
W Core Process Metrics AS9100D for Product Planning? Quotes and sales? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 1
alonFAI Gaps between the Bobbin and the Ferrite Core in a Transformer Manufacturing and Related Processes 1
T What are the Core Concepts of TQM? Quality Manager and Management Related Issues 6
RoxaneB Foundational or Core Competencies - When Stakeholders Disagree Training - Internal, External, Online and Distance Learning 5
Q Kraft Paper / Core Paper MSDS - Plastic Specs IATF 16949 - Automotive Quality Systems Standard 4
S Outsourcing a Core Process ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
D PFMEA and Control Plan Core Team Changes FMEA and Control Plans 4
Q Shortening Core Processes ISO 9001:2008 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
Q Core Process without a Documented Procedure ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
P ISO 9001 - Determining Core Processes - Recommendation of Online Training ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
A Do you have a Turtle Diagram for each Core Process? Turtle Diagram Question AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 49
Q Core Team - Who gets listed as part of the "Core Team" in a control plan FMEA and Control Plans 4
C Creating a Micro QMS - 4 geographical sites and 3 types of core activities ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
C Flow Chart showing Interaction of Core and Support Processes ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 11
Q Is Accounting a Core process? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 36
I Core Processes - Are Core Processes really needed in the quality manual Quality Management System (QMS) Manuals 4
A Core Procedures needed for ISO9001:200x ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 6
D Quality Manual and SOPs for imaging core laboratory Other ISO and International Standards and European Regulations 4
D What are the core processes in a public service agency? Service Industry Specific Topics 4
S Definition Core Procedures and Supporting Procedures - Definitions Definitions, Acronyms, Abbreviations and Interpretations Listed Alphabetically 7
Stijloor North American Automotive Quality Core Tool Certification Program Professional Certifications and Degrees 2
N Should a Process Map have all the Core Processes? Process Maps, Process Mapping and Turtle Diagrams 12
G Examples for Process Orientation - Core Process in Environmental Management System Miscellaneous Environmental Standards and EMS Related Discussions 9
S Example of EMS Process Flow with interaction of core elements - Chemical industry Miscellaneous Environmental Standards and EMS Related Discussions 8
Marc Advanced Micro Devices' new dual-core processors prices revealed After Work and Weekend Discussion Topics 2
S What is core items in ISO9001:2000 ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
Govind Software Reliability Measurement - Telecordia standard GR-282-CORE Reliability Analysis - Predictions, Testing and Standards 4
A Multi-vari analysis - Core diameter oversize Statistical Analysis Tools, Techniques and SPC 3

Similar threads

Top Bottom