IATF 16949 - What to do if external auditor won't accept our root cause?

[Ashland78]

When you respond through CARA it is complicated to amend the response (s). Hence, I think that is why they use email.

I have my big audit coming up in 3 weeks. I hear so many complain about the auditors. I appreciate each auditors individual personality, and work with it. Many talk down about who they get. I think it is good to have auditors that have fresh eyes.

Good luck and I am curious to see how this ends up for you.

 

[DariusPlumdon]

When you respond through CARA it is complicated to amend the response (s). Hence, I think that is why they use email.

I have my big audit coming up in 3 weeks. I hear so many complain about the auditors. I appreciate each auditors individual personality, and work with it. Many talk down about who they get. I think it is good to have auditors that have fresh eyes.

Good luck and I am curious to see how this ends up for you.

Thanks. I must stress I am very pro audits, as you say different eyes are good and we all have our own individual personality. I do not need to even like an auditor, but the key thing is they must listen, be fair, be clear, and understand that they raise the finding ... we may address it as they expect, but there may be an equally good or better way

 

[qusys]

We had a few minor NCs raised in our recent IATF16949 external audit; all the findings were fair.

We have responded in full (in the CARA system) with containment plan, 5Y analysis root cause, proof of implementation etc. The same way we have done for the past 10 years plus with no issue.

The external auditor has now responded basically saying that he will not accept our root cause as it is not what he thought the root cause should be!

Any ideas as to how to proceed with this ... as our auditor is not a great listener (that is being very generous) and has already pushed back on this.

To be clear the auditor is not questing the semantics or of our 5Y relationship; they just do not understand or will not accept that the real root cause is correct.

As things stand the only thing I can do is use the root cause they want us to, reverse engineer a fictitious 5Y & 'create' evidence to satisfy and close the audit; which to me defeats the whole ethos and point of a good audit*

*I must stress we have already taken good corrective actions to improve things based on the genuine/real root cause

Hi DariusPlumdon,
I am with you , but it is very difficult to understand why the auditor said that the real cause is not correct despite your effort and work.

Based upon what data and evidences, did he affirm that, given that you as an organization have also checked the proof of test ( with an internal audit, I presume)?
I know that there is also Veto Power as super partes body for final judgement, so if he accepts your actions, Veto Power could block the certification path and refuse the action as escalation. Is this could be a risk for you to pursue?
Just for curiosity: if possible, could you explain the ncn's and clause violated , just to give us only a summary of them without precise details?

 

[Ed Panek]

Auditors can and do overstep their bounds. We have had auditors require us to have ESD grounding straps despite evidence the device is not serviceable and ESD is not relevant. Another required us to send our returned devices to be Ethylene Oxide sterilized prior to our troubleshooting.

Might be a good idea but we can sanitize the device with a chemical agent and be done with it.

Most regulatory companies have an industry engagement group; they are after all for-profit companies. Develop a relation with yours and rather than a nasty confrontation use them to help smooth things out or help explain your root cause and logic. Then they can be an advocate for your auditor.

 

[Randy]

Might be a good idea but we can sanitize the device with a chemical agent and be done with it.

Simple IPA pad or spray could be enough in many cases wouldn't it?

 

[SeanN]

It's now apparent with your clear summary. After advice from several senior auditors, I have no more technical opinion. From a business management standpoint, the primary objective is to ensure a successful audit outcome, as you mentioned, while also addressing the underlying issue in your own way. Perhaps it would be beneficial to expand your action plan slightly to encompass all suspected root causes, thereby satisfying everyone involved. Although this may appear to be somewhat time-consuming, it is unavoidable given your current circumstances. This approach could prove instrumental in resolving issues stemming from multiple root causes and eliminating any potential biases.

 

[Ed Panek]

Simple IPA pad or spray could be enough in many cases wouldn't it?

Yes. The devices are for intact skin only. We clean them with IPA and let them dry for 48 hours.

 

[Golfman25]

Ok I’ll ask. What was the root cause in question? How was it phrased?

for my most recent audit, I had to actually walk the auditor thru the 5 why steps. It was brutal.

 

[Bev D]

for my most recent audit, I had to actually walk the auditor thru the 5 why steps. It was brutal.

Ugh. This behavior drives me crazy. And it’s not just auditors. All sorts of people ‘just know what the cause is’. Even with data and evidence and a demonstration these people will refuse to acknowledge that the cause wasn’t what they knew it was!

 

[cztony]

better to know the NC before to provide suggestion,