Need Help With IATF 16949 Audit NC

[Kirby]

I'm retired but trying to help a friend - her company received a minor NC in a recent audit (IATF) - written against 9.2.2.2 , QMS Audit. The finding was "Evidence of applying the process approach during the audit of measuring devices, gauging, annual layouts and Molding, Service, and Assembly (all shifts) did not exist" . I was hoping that you might be able to offer some general insight into how she could respond.

 

[Golfman25]

I'm retired but trying to help a friend - her company received a minor NC in a recent audit (IATF) - written against 9.2.2.2 , QMS Audit. The finding was "Evidence of applying the process approach during the audit of measuring devices, gauging, annual layouts and Molding, Service, and Assembly (all shifts) did not exist" . I was hoping that you might be able to offer some general insight into how she could respond.

First, you may want to put this in it's own post. You'll probably get more on topic responses that way.

Second, that sounds like a complicated way of saying they didn't do an internal audit of calibration, etc.? I little more detail would be helpful.

 

[Jim Wynne]

First, you may want to put this in it's own post. You'll probably get more on topic responses that way.

Second, that sounds like a complicated way of saying they didn't do an internal audit of calibration, etc.? I little more detail would be helpful.

Post moved to its own thread.

 

[qusys]

I'm retired but trying to help a friend - her company received a minor NC in a recent audit (IATF) - written against 9.2.2.2 , QMS Audit. The finding was "Evidence of applying the process approach during the audit of measuring devices, gauging, annual layouts and Molding, Service, and Assembly (all shifts) did not exist" . I was hoping that you might be able to offer some general insight into how she could respond.

In my opinion, the organization that has received this ncn ( minor, major?) shall put in place a corrective action plan with a root cause analysis ( 5 why's methods for example). It also requested an contiamnete action . Besides, the organization shall ask itself if the corrective action can be extented to other similar process as well. Clearly, we need more data to undestand this ncn. In my opinion, I could think that no all shifts ( day and nights) have been covered in the audit program.

 

[Mikey324]

It sounds like a structured audit approach that clearly shows your Plan, Do, Check, and Act would be helpful.

Maybe start each internal audit with looking at what the targets and objectives are (what was planned)
Your audit notes and random sampling, looking at if everything is being done Work Instructions, drawings, etc (What's actually being done)
Are they meeting the targets and objectives? Who is looking at it? How is it being monitored (How is it checked)
Are action plans in place for anything not performing as planned? (Act)

I structured our report in that way. Keeps notes organized and shows the PDCA of it all.

 

[malasuerte]

So this is saying that your friend's org could not provide evidence that they followed "the process approach" when auditing xyx.

While this is a poorly written NC as it is currently written; they were unable to show evidence apparently. What evidence is there to show that they did NOT follow the process approach? You would need to speak with the auditor who performed that audit and ask them how they performed the audit.

However, If they are accepting the NC, then they need to respond with a root cause and a CAPA.

At a minimum, the audit report should reflect that the auditor used the "process approach". You may need to refresh auditors on PA. Who knows.

 

[octavio tarango]

I'm retired but trying to help a friend - her company received a minor NC in a recent audit (IATF) - written against 9.2.2.2 , QMS Audit. The finding was "Evidence of applying the process approach during the audit of measuring devices, gauging, annual layouts and Molding, Service, and Assembly (all shifts) did not exist" . I was hoping that you might be able to offer some general insight into how she could respond.

You can evidence that you use the process aproach during the audit process, including in your audit notes, the reference of the inputs , outputs and performance of KPI's of the processes audited. Your notes should include the findings of conformance and non conformance, and also you can refers to the clauses audited.
A probable root cause could be a lack of knowledge in audit process (but you will need a 5 why analysis to confirm), ISO 19011 offers good guidance in the subject may be you can add as action plan a training on it. For a systemic action you can add in your work instruction for Internal Audits the guidelines to perform an internal audit including the information that I mentioned in the begining.

hope this bring some help.

 

[DariusPlumdon]

I realise this reply is 5 weeks after the original post, but a similar issue has come up for me.
The best reply I have seen is 'this is a poorly written NC'. I would suggest before you look at containment, 5Y or anything else get your friend to go back to the auditor and either rewrite the finding (unlikely) or explain in writing exactly what they mean.
The auditor can't advise how to address the finding, but from personal experience I know that understanding what any auditor means is key to responding appropriately and not wasting time & effort is taking an action that the auditor thinks misses the point of their finding.
Good luck!

 

[Jim Wynne]

In all cases where an audit NC is concerned, the entire text of the NC statement should be posted.

 

[baldev]

Standard clause 9.1.1.1 Monitoring and measurement of manufacturing processes
Statement of nonconformity
Process of Verifcation of Implementation of Control plan and PFMEA is not effective

how to close this Nc