Whose responsibility is it to issue Corrective Action Requests?

sowmya

Involved - Posts
#1
I am going back to basics. during internal audit program, the auditor finds non conformities. he gives audit observation report mentioning NCs, positive observations and opportunity for improvements. Whose responsibility is to give non conformance report (8D report mentioning problem statement) to auditee?

1. Auditor, 2. Audit co ordinator (Quality system), 3. Auditee himself can create NCR based on the observation report.

looks silly?. let me know your views.

Thanks
Sowmya
 
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somashekar

Staff member
Super Moderator
#2
Re: Whose responsibility is it to issue Corrective Action Requests??

Hi Sowmya.
Auditor.
An internal auditor who is trained must know how to draft a NC statement and add to it the evidence or audit trail fact based examples that confirmed the NC. His training could also make him competent to attach the NC to a perticular ISO standard clause, though not essential for an internal audit. The MR can pitch in to assist the auditor.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#3
Re: Whose responsibility is it to issue Corrective Action Requests??

I'll agree with somashekar (I usually do!) but point out some more room in the situation...

While I agree that the auditor "should" be responsible, he/she can be "responsible" for it while delegating it to someone else...like the auditee who knows more about the non-conforming process.

In my experience it is often the document that is wrong, not the process. Thus I would delegate the CA to the auditee or process owner.
The auditor is in the best position to make sure it gets done correctly, but the process owner is in the best position to know what "correctly" means.

Note that "should" is often a dangerous word...all that really matters is that the NC gets addressed. "Who" and "how" are secondary points.
 

Kales Veggie

People: The Vital Few
#4
I am going back to basics. during internal audit program, the auditor finds non conformities. he gives audit observation report mentioning NCs, positive observations and opportunity for improvements. Whose responsibility is to give non conformance report (8D report mentioning problem statement) to auditee?

1. Auditor, 2. Audit co ordinator (Quality system), 3. Auditee himself can create NCR based on the observation report.

looks silly?. let me know your views.

Thanks
Sowmya
I would say usually the auditor. Some of my clients make the audit program manager responsible.

The standard does not have a requirement for this. So, it is up to the organization and what works best for them.

Note: an 8D report is often too complicated and requires too many resources to complete. The standard calls for "appropriate to the effects".
 
M

Mueller Time

#5
Nothing silly about it. Everyone's system will be a little different.

In our current system the NCR is written by the auditor, then reviewed by the Lead Auditor or MR. The Lead Auditor or MR then issues CAR to auditee. Our system is set up that way because our auditors are new and we still need a little more oversight. That may change as they become more experienced (my past systems had more experienced auditors and they completed CA requests).

I'm personally not comfortable with the auditee creating their own NCRs.

The secret is to set up a system that works for you. As things change so can the system. We review our CAR and Internal Audit system twice a year just to look for changes/improvements like these.
 

Ninja

Looking for Reality
Staff member
Super Moderator
#6
<snip>...

I'm personally not comfortable with the auditee creating their own NCRs.

<snip>
don't know if that was directed at my post or not...doesn't really matter.

I'll simply draw the distinction between the auditee creating an NCR (probably a bad move) and the auditee creating the CA (which works fine).

The NCR is a natural outcome of the audit...from the auditor.
The response (correcting what the NCR points out) can be from just about anywhere.

But as was said already, it is up to the company what works best for them.
 
G

gbcqc

#7
Nothing silly about it. Everyone's system will be a little different.

In our current system the NCR is written by the auditor, then reviewed by the Lead Auditor or MR. The Lead Auditor or MR then issues CAR to auditee. Our system is set up that way because our auditors are new and we still need a little more oversight. That may change as they become more experienced (my past systems had more experienced auditors and they completed CA requests).

I'm personally not comfortable with the auditee creating their own NCRs.

In our system the MR will type up and issue the CAR, but the auditor is responsible for tracking and follow-up to the corrective action. The same is with internal CARs that were not from an audit. If someone wants to issue a CAR to another department, they have to bring the evidence to the QA Mgr. The QA Mgr. then issues the CAR, but the person who requested the CAR is responsible for the tracking, follow-up and closing of the CAR with the oversight of the QA Mgr.
 

sowmya

Involved - Posts
#8
Thanks to all for your views/ opinions / best practices.

I also agree that Auditor is responsible for creating the NCR.

In reality, conducting internal audit is the responsibility of the MR and Quality system co ordinator (QSC). For auditor, the auditing profile is an add on activity rather than only activity. so, for conducting the audit itself the QSC has to followup. the observation report format is detailed (with evidence details, with clause reference etc.,). Auditor fills up observations and send it to auditee. (again with follow up). The QSC has to follow up auditor again for NCR. Auditor says, the observation report itself is very clear, it is just cut and paste in the NCR report (problem description). Anyway, auditee has to type RC and CA.

in the whole thing, neither auditor is worried nor auditee is worried. it has become QSC responsibility to close the audit pendings and action items. I just started the thread out of frustration.

Anyway, i have discussed this with MR. we have finalized to create a software. The software should be capable of generating the NCR reports from observation sheet. Also to track the pending actions.

Thanks again
Sowmya
 
G

Gmzita

#9
Primarily, I agree that the Auditor should write up the NCR or Improvement.

However, in some of our Internal Audits, the Auditor will write up "observations" instead of an actual NCR or Improvement. In this case, we perform a Management Review on the Internal Audit and determine what further action needs to be taken on the listed "observations". If Management determines that a NCR or Improvement action is needed, then the Quality Manager will draw it up and issue it.
 
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