How to address a QMS Entry Error

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#1
A review of NCR from 2017 indicated the person responsible for QA/RA prior to me incorrectly used the NCR process for a supplier issue that should have used the SCAR process. A risk review indicated that although the wrong process was used, the result was that the correct process was ultimately utilized.

How should I adjust (Should I adjust?) our QMS to correct this?

  1. Obsolete the NCR and correct the records with a memo
  2. Leave the NCR there and rev it to note it was placed there incorrectly
  3. Do nothing and just explain it during an audit
  4. Something else?
 
Last edited:
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Tagin

Trusted Information Resource
#2
  1. Obsolete the NCR and correct the records with a memo
  2. Leave the NCR there and rev it to note it was placed there incorrectly
  3. Do nothing and just explain it during an audit
  4. Something else?
From 9001 perspective, I vote for #2 with a signed memo, where the memo notes who/when found the discrepancy, the risk review that followed (including review of NC/SCAR QMS process doc for flaws/lack of clarity/etc.), the result of the review, and the reason no further action needs to be taken. Could be just a couple of paragraphs.
 
#3
And to add a little something to Tagin's remarks. The optics of option 3 are always bad for the auditee. The argument being: if you have an explanation, why did you not not document it?
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#4
A review of NCR from 2017 indicated the person responsible for QA/RA prior to me incorrectly used the NCR process for a supplier issue that should have used the SCAR process. A risk review indicated that although the wrong process was used, the result was that the correct process was ultimately utilized.

How should I adjust (Should I adjust?) our QMS to correct this?

  1. Obsolete the NCR and correct the records with a memo
  2. Leave the NCR there and rev it to note it was placed there incorrectly
  3. Do nothing and just explain it during an audit
  4. Something else?
In my opinion, it really depends on how you use the data that comes out of these reports. If their results are blended together for analysis, #2 may work. If, however, your supplier management process wants clean SCAR data, then #1.

It really is up to your organization and the question of "so what?" What is the risk/impact of leaving it where it is?
 

Tagin

Trusted Information Resource
#5
From 9001 perspective, I vote for #2 with a signed memo, where the memo notes who/when found the discrepancy, the risk review that followed (including review of NC/SCAR QMS process doc for flaws/lack of clarity/etc.), the result of the review, and the reason no further action needs to be taken. Could be just a couple of paragraphs.
I'm having second thoughts about my recommendation: technically, you have found a process nonconformance; therefore, shouldn't you raise a new NC against that, and record any corrections to the original NC, the risk review, etc. on that new NC?

If you choose just to update/memo the original NC instead, an auditor could say "well, its good that you fixed this issue on this one old NC, but did you then check other NCs to see if there is a pattern of incorrect NC uses, and why did you not record this error itself as an NC?"

So, just wanted to mention that doubt in my mind. But how much effort does this issue really merit? As @RoxaneB noted, the question is "so what"?

Edit: Also there is perhaps the option to revise the QMS process to allow NCRs to lead to SCARs, which kinda sorta removes the old NC as an issue (even though it occurred prior to the process revision). Is there any benefit to adding that flexibility or would it just make for unclean process overlap?
 

RoxaneB

Change Agent and Data Storyteller
Super Moderator
#6
Edit: Also there is perhaps the option to revise the QMS process to allow NCRs to lead to SCARs, which kinda sorta removes the old NC as an issue (even though it occurred prior to the process revision). Is there any benefit to adding that flexibility or would it just make for unclean process overlap?
Tagin raises a good point that I was hesitant to bring up (i.e., it's off-topic from the original ask, in my opinion), but I'm also all for having posters challenge their own organizations' existing systems.

My experience comes from the world where a nonconformance is a nonconformance is a nonconformance. In a 'Lord of the Rings' approach, we employed a "one system to rule them all" process. There were sections on the form to indicate if the nonconformance was directed internally or externally, if it was process/product/audit/supplier related, etc.

We even indicated if only a correction was needed or if it was a full-blow corrective action - we had defined (and regularly reviewed and updated based on data) triggers to guide our organization on the appropriate path to follow. Appropriate sections for the determined action were provided.

If the answer to "so what?" is minimal or negligent, it could be worthwhile to look at merging the systems. If, however, they are vastly different, continuing to maintain two separate systems may work best for your organization.
 

Ed Panek

QA RA Small Med Dev Company
Staff member
Super Moderator
#7
Thanks for all the feedback. An employee of mine also noted that the NCR is referenced within other documentation including Management Review, so removing it like a tooth could create serious gaps elsewhere. It infected our QMS for 4 years and trying to remove it will create more findings elsewhere.

I think we are going to rev it and reference where the paper trail follows. Open an investigation into this NC and follow that per our QMS procedures.
 

Tidge

Trusted Information Resource
#8
My gut feel is that the NCR shouldn't be moved, but that a new (process non-conformance) should be opened specifically:
  • to come to a consensus about what should be done in this specific instance,
  • create a record of this (new) NCR, in case the problem is a systematic one that requires a more systematic corrective action.
 
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