Justification of "Design Excluded" in IATF 16949

[Teamk1]

Going through my audit notes to make some changes and improvements which were identified and I have written "Justify "without design" - section 4.3.1.2 of quality manual". Mind you, the auditor did NOT disagree that we are design excluded. But this is what my manual already reads which sure seems like a straight-forwarded and clear justification to me. Is this not clear enough or detailed enough? What might anyone recommend? Or is it fine and I should leave it as is? Note - it's read this way for years; we had a new auditor this year. Any input would be appreciated. Thank you.

4.3.1.2 Justification:

"Our company" does not design or develop products. All product characteristics are specified by customers or license holders. Our engineering activities are limited to design and development of manufacturing processes, and thus ISO 9001, Section 8.3, and IATF 16949, Section 8.3, shall be applied only where relevant to the design of manufacturing processes.

 

[John C. Abnet]

Not sure

Or is it fine and I should leave it as is? Note - it's read this way for years; we had a new auditor this year. Any input would be appreciated. Thank you.

4.3.1.2 Justification:

"Our company" does not design or develop products. All product characteristics are specified by customers or license holders. Our engineering activities are limited to design and development of manufacturing processes, and thus ISO 9001, Section 8.3, and IATF 16949, Section 8.3, shall be applied only where relevant to the design of manufacturing processes.

Not sure I understand your question @Teamk1 ;
IF you are saying your certification body (3rd party) auditor wrote a nonconformance for the stated justification (that was in place at the time of the audit), then.......change nothing. IF indeed your organization is NOT design responsible (simply "build to print"), then your justification is well written.

Please provide the actual verbiage from the auditor's non conformance report. Thank you.

Be well.

 

[AMIT BALLAL]

@Teamk1 , I would suggest to keep the statement as it is / whatever works in your case. Nothing much required for meeting this particular requirement.

I don't even like the "Design exclusion justification" requirement. If you don't make design, design is excluded by default.

 

[Thee Bouyyy]

But this is what my manual already reads which sure seems like a straight-forwarded and clear justification to me. Is this not clear enough or detailed enough? What might anyone recommend? Or is it fine and I should leave it as is?

Yes, Please leave as it is. This is enough and easy to understand for any one. Don't waste your time on this subject. I don't think so that auditor gave you the non-conformance on this. If so, I wanna see the exact wording of auditor in this case.

 

[Teamk1]

Thanks, all!

During the audit there were occasions where the documentation either was too vague, not what the auditor wanted to see, or maybe even wasn't completely buttoned up. On these occasions the auditor agreed that we met the spirit of the requirement and would not write non-conformances where it made no real sense to do so if I promised to go back and make the improvements or changes.

I had taken a great deal of notes during the audit and am now going back to do the work. This note about justification was one of them. He did NOT write a non-conformance. He could clearly see we are not design responsible and have plenty of evidence to show that, and had the justification in the quality manual. Nevertheless, I had that comment in my notes and while it seems fine to me I wanted to get some other opinions to see if it wasn't good or good as it could be.

The general consensus, then, seems to be it's good and to leave it be. Which is what I will do. Thanks again for the input!

 

[John C. Abnet]

would not write non-conformances where it made no real sense to do so if I promised to go back and make the improvements or changes.

not what the auditor wanted to see,

Unbelievable. You may want to consider filing a formal grievance with the certification body and request a different auditor in the future. These positions by the auditor are not acceptable behavior.

Be well.