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Internal Audit NCRS and CAPAs

P

palebluedot

#1
Hello!

I am working as a "Quality Systems Associate", but performing all the duties of a normal quality manager. I am running our QMS in conformance with the ISO 13485 standard, and I'm pretty new to it all (been in my position 4 months).

We recently conducted our internal audit near the end of October, and I just received the list of NCRs. The audit report also lists suggested corrective actions for each NCR. My question is:
Do I need to actually open a separate CAPA report for each NCR found during our internal audit (there were 19)?

That seems pretty unnecessary for some of these NCRs, which have been corrected with something as simple as labeling some materials with "Do Not Use". However, if I do not write up a CAPA report for each non-conformance, how do I show proof that the corrective actions have been put in place?

Any help is much appreciated!:thanx:
 
Elsmar Forum Sponsor
#2
Hello!

I am working as a "Quality Systems Associate", but performing all the duties of a normal quality manager. I am running our QMS in conformance with the ISO 13485 standard, and I'm pretty new to it all (been in my position 4 months).

We recently conducted our internal audit near the end of October, and I just received the list of NCRs. The audit report also lists suggested corrective actions for each NCR. My question is:
Do I need to actually open a separate CAPA report for each NCR found during our internal audit (there were 19)?

That seems pretty unnecessary for some of these NCRs, which have been corrected with something as simple as labeling some materials with "Do Not Use". However, if I do not write up a CAPA report for each non-conformance, how do I show proof that the corrective actions have been put in place?

Any help is much appreciated!:thanx:
Welcome - Can I ask why such a delay? To answer your question, you can bundle ncs into a few corrective actions. Depends on the content. If the auditors were competent they might have combined ncs anyway...
 
P

palebluedot

#3
We are a subsidiary of a larger German company, and due to my inexperience we had our QMR from that company fly out to do our internal audit. He then flew back to Germany, where he also has multiple other job responsibilities beyond his QMR duties, and he fell behind in completing the audit report. (It's also holiday season in Germany, and they have had a lot of days off recently).

A lot of these NCRs are just such simple fixes, I don't see why they need an entire CAPA report and investigation done.

Also, one of our NCRs was for an insufficient CAPA procedure, and lack of an official CAPA report. Per the CAPA suggestion from the auditor, I have written a new CAPA procedure, and created a CAPA report template (8D Report). Do I really need to now open a CAPA report saying I have created the CAPA procedure and report template?
 
I

isoalchemist

#4
It depends on how you have written your system. My preference is to generate a CAPA for each distinct NC found in the report (i.e. you can bundle similar ones if they exist). IMHO NC's in an audit report (internal or external) should be treated at a higher level than NC off the floor (which may just be a "Fix It").

Yes, write up the CAPA for the CAPA system. The interesting part is not the procedure, but understanding the root cause of why it was insufficient in the first place.
 
#5
We are a subsidiary of a larger German company, and due to my inexperience we had our QMR from that company fly out to do our internal audit. He then flew back to Germany, where he also has multiple other job responsibilities beyond his QMR duties, and he fell behind in completing the audit report. (It's also holiday season in Germany, and they have had a lot of days off recently).

A lot of these NCRs are just such simple fixes, I don't see why they need an entire CAPA report and investigation done.

Also, one of our NCRs was for an insufficient CAPA procedure, and lack of an official CAPA report. Per the CAPA suggestion from the auditor, I have written a new CAPA procedure, and created a CAPA report template (8D Report). Do I really need to now open a CAPA report saying I have created the CAPA procedure and report template?
This one internal audit in the year? If so, oh dear...

I'd bundle them. Not seeing the actual nc statements, which is important to know they are "valuable" and not a bunch of nitpicky things (which given the number - 19, could well be). I'd be more worried that this is one audit a year. Added to this, if the findings are somewhat "minor" in nature (not grade), you might be better to run your own audits and if you have to (politics etc) allow the guy from Germany to come over, do that as well.
 

John Broomfield

Staff member
Super Moderator
#6
Hello!

I am working as a "Quality Systems Associate", but performing all the duties of a normal quality manager. I am running our QMS in conformance with the ISO 13485 standard, and I'm pretty new to it all (been in my position 4 months).

We recently conducted our internal audit near the end of October, and I just received the list of NCRs. The audit report also lists suggested corrective actions for each NCR. My question is:
Do I need to actually open a separate CAPA report for each NCR found during our internal audit (there were 19)?

That seems pretty unnecessary for some of these NCRs, which have been corrected with something as simple as labeling some materials with "Do Not Use". However, if I do not write up a CAPA report for each non-conformance, how do I show proof that the corrective actions have been put in place?

Any help is much appreciated!:thanx:
palebluedot,

In the six weeks that have elapsed since the audit, the managers responsible may already have taken action.

Follow-up to confirm the actions they have taken since the audit to fix the nonconformities and, where necessary, to remove the root causes.

Then update your corrective action records accordingly.

In future, of course, you will be careful for your office not to be seen as the cause of delay or condoning delay in corrective action.

John
 
P

palebluedot

#7
Many of the corrective actions have already been successfully implemented, as I had taken notes during the internal audit and got to work on fixing many of the problems while I was waiting for the official audit report. Luckily, none of the NCs that were found affected the customer, so we do not have any customer's awaiting a CAPA report. Most of the NCRs were for things like document control, due to overall sloppiness with all of the managers in the past.
One of our NCRs was for having test materials in our quarantine stock. It is our policy that anything in quarantine must have accompanying paperwork that describes why it was quarantined. Since the test materials were samples we requested, and were not being used in production, we did not have any paperwork for these materials. The auditor gave us an NCR for Control of Nonconforming Product, and declared the material's "inspection status was not clear". As a result, I added control of test materials to the relevant document, and labeled the sample materials as "Sample - For Testing Only - Do Not Use", and relocated these materials to our usable stock.
This was a very simple fix, which is why it seems strange to me that it would need an entire CAPA report written out for it. But according to everyones responses, I would need to write a report for this anyway, correct?

I apologize if this seems obvious to everyone, but it's my first time in this situation.
 
#8
CAPA is - outside of a regulated environment - an overblown requirement. It treats all audit nonconformities the same and, in fact, if you draw a parallel with product non-conformity, sometimes you simply disposition the thing, shrug your shoulders and get on with life. The idea of doing some in-depth, root cause analysis on everything is bizarre and, IMHO totally unnecessary. Some audit findings can be treated as they say in the Forrest Gump movie; "Sh*t Happens"...
 

John Broomfield

Staff member
Super Moderator
#9
palebluedot,

The situation you describe is made strange to you by your own management system not by the standard.

Create a place to record the fixes made to your management system where investment in root cause removal is unwarranted by the cost/risk. These records are important for future verifications of the effectiveness of your evaluations of the need for corrective action.

Usually the corrective action procedure covers such corrections as well as the removal of root causes.

John
 
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