Corrective Action Notification - Registration Audit

#1
Hello All,

Lurker not normally a poster but I'd like a few opinions here... We are currently going through an ISO 13485 Registration Audit. We are currently ISO 9001 certified but plan to expand further into Medical Device. Our QMS is young. We have only been certified to ISO 9001 since 2019 and prior to that didn't have the best documented processes and procedures. We've grown since then but are still learning. We received a nonconformance for the following and I'm trying to understand if this really should be a nonconformance?

Classification Justification : Management did have an understanding of why delivery performance was not met (updating of due dates), but documented evidence was weak. No customer complaints for OTD.

Standard/Requirement: 8.5.2

Nonconformity Description: The corrective action process was not effectively maintained.

Objective Evidence Observed:
There was insufficient documented corrective actions for Quality Objectives not being met - On Time Delivery.
 
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yodon

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Super Moderator
#2
Trying to unwind this.
  • You have some quality objective for On Time Delivery
  • You did not meet that quality objective
  • You had 0 customer complaints for late delivery
  • You opened a CAPA to address the issue
Is that close?

I don't see anything in the standard that says you HAVE to open a CAPA if quality objectives are not met. You should, of course, determine IF there are actions to be taken in the Management Review. For example, you may have missed OTD by 1 day for one shipment. If you had 100% OTD quality objective (I'd first say that's unachievable and you need to review it) and this one shipment caused you to fail to meet it, there really shouldn't be a need to open a CAPA. Or maybe you missed a bunch of delivery dates but the reason was due to COVID. You probably wouldn't change anything for that! And you had 0 complaints! Your Management Review outputs should provide the rationale for not taking actions.

Do your internal procedures require you to open a CAPA if a quality objective is not met? We do sometimes shoot ourselves in the foot.
 
#3
That is pretty close. My apology for not laying it out clearly. Everything “Clarification/Justificstion” and below is from the CAN notification from our auditor.
We did not meet our quality objective based on our current data which management explained can be sometimes wrong. We discuss with customers due dates and get approval to push them out but do not actually update the date in the system. The auditor wrote a finding for not issuing a corrective action for not meeting an objective. Our procedures do not require a CAR for not meeting an objective.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#4
The auditor wrote a finding for not issuing a corrective action for not meeting an objective. Our procedures do not require a CAR for not meeting an objective.
The auditor is misguided, as there is no reasonable expectation that failure to achieve a quality objective must be treated via a corrective action process. This issue has been discussed a number of times here, e.g., Is a Corrective Action Expected if a Quality Objective is not in compliance?

Certainly, management must react when objectives are not met, as part of running the business, but, chances are, a formal corrective action is not the tool for the issue at hand.
 
#5
The auditor is misguided, as there is no reasonable expectation that failure to achieve a quality objective must be treated via a corrective action process. This issue has been discussed a number of times here, e.g.,

Certainly, management must react when objectives are not met, as part of running the business, but, chances are, a formal corrective action is not the tool for the issue at hand.
Thank you for the response and the link! I appreciate it.
 

John C. Abnet

Teacher, sensei, kennari
Leader
Super Moderator
#6
You've gotten some wise counsel from @yodon and @Sidney Vianna @qualitytf .

Somewhat redundant to what has already been said...it appears that auditor problem statement can be distilled down to "documented evidence was weak". I would recommend revisiting with the auditor and asking specifically what clause of the standard is being violated? To simply reference 8.5.2 is too broad. Exactly what is the opposite (standard requirement ) of "documented evidence was weak" . There is none.

Reminder: No one here is privy to the exact situation, and the auditor's observation of "documented evidence was weak", etc... may indeed be a good observation. This may be an opportunity for improvement your organization should consider. HOWEVER, that in itself does not make it a non conformance as already stated by others above.

Hope this helps.
Be well.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
#7
Im going to take a slightly different approach. All auditors have different styles as they audit. I know this may be counter to the intent of a QMS but I try to make sure we have prepared for a requirements we may not be able to provide a record of. In the event, the auditor is a "Check a box here " type auditor it may be helpful to just provide why there is no evidence of something. Or, in some cases, generate a CAPA record so it can be used during the audit (Dont hate on me please).

I guess my question is: Did you have any CAPA records to present during the audit?
 
#8
Thank you everyone for your responses. I prepared my approach all last night to speak with the auditor and today when we started he stated that he decided that the CAN was not appropriate before I had a chance to even say anything. So good news for us there.

We're now down to 1 minor finding (deserved) and a day left.
 
#9
Im going to take a slightly different approach. All auditors have different styles as they audit. I know this may be counter to the intent of a QMS but I try to make sure we have prepared for a requirements we may not be able to provide a record of. In the event, the auditor is a "Check a box here " type auditor it may be helpful to just provide why there is no evidence of something. Or, in some cases, generate a CAPA record so it can be used during the audit (Dont hate on me please).

I guess my question is: Did you have any CAPA records to present during the audit?

Yes we had multiple examples of CAPA to show for the 2021 year.
 
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