Previous Minor now turned into major - single lapse problem

As a result of our recertification audit, the same non-conformity was detected as last years minor, which turned it into a major. However it was a single case (human error), so only detected in 1 case out of .... hundreds.
So now, a second major was created: In accordance with Rules clause 5.11.5: "In cases where the accepted corrective action plan for a minor nonconformity is found to be not effectively implemented, a new major nonconformity shall be issued against the corrective action process (see IATF 16949, section 10.2) and the previous minor non-conformity reissued as a major nonconformity."

Containment and systemic actions for the 1st major I'll manage, but I'm really struggling to define root cause and containment action for this second major.
Does anyone have any experience and/or suggestion of what to do with this?

 

Yes, here we go:
MAJOR 1: (Minor - single lapse, problem was not found on other Control Plans or PFMEA's):
Special characteristics notation not fully effective:
For the Control Plan & PFMEA nrXXXX the special characteristics notation is not compatible - special characteristics diameter is identified on the control form in production but not on the Control Plan or PFMEA - this was already NC1 from 2020 - now Major.

> we did establish a system to treat this NC from 2020 and it is in use. Only now, 1 person did not use the correct method for 1 part-FMEA and -CP. Since we can't use the human error as a rootcause we're thinking more to go towards a problem in with the multidisciplinary approach and validation (I must be honest and say that it's not perfect).

MAJOR 2: in accordance with Rules clause 5.11.5: " In cases where ...... the previous minor non-conformity reissued as a major nonconformity.":
Corrective actions NC1 from 2020 audit not effectively solved.
Also, during the audit it was established that root cause analysis for NC's from internal audits is almost non existent.

> I am not really OK with this last sentence. The auditor rushed through the file and did not see everything well (we only do rootcauseanalysis for NC's, not for OFI's).

But now, how to define rootcause and containment?

 

Thanks Andy for your reply.
1. Yes we did a 5Why with the people involved. And we do use this in our problem solving, but not on in a structured way for everything (yes for customer complaints and internal defects, less OK for internal audit-NC's).

2. Internal audits are reported with NC's and OFI's. We decided (and mentioned in our procedure) to only do rootcauseanalysis for NC's.

I agree that we should improve this validation of CA / internal audit process. We will focus on this.

In the meantime I talked to the auditor. He reassured me that I should not worry about rootcause of these 2 majors, since it's just a single-lapse documentation-error. There is no risk for the customer (since the production documentation and -controls were OK), so there are not really any containment actions for these single documentations errors.
I just need to confirm that all members of the multisisciplinary are aware of this problem in top-documentation (p-FMEA and CP) and that implemenation of modifications and correction is ongoing.

 

So the question is why wasn't the control plan and/or PFMEA updated? Or was this a new one? Seems to me the person doing the paperwork was "not competent" ie; inadequately trained and supervised, and didn't understand the correlation between the SC and the docs. Your containment might be to review any other docs they created to ensure no future issues.

Now what chaps me, is that it sounds like you where actually doing everything you should have when you actually produced parts -- actually controlling and monitoring the special characteristic. The major, while required, seems non value added to me. Good luck.