Nonconformities and CAPA

#1
Hello,

In my company, we are reviewing our QMS, and as part of it, I have been asked to review our Nonconformity and CAPA Process.

We work in compliance with ISO 13485 and the 21 CFR 820.

The habit in the company is to escalate every NC to CAPA with the result that we are unable to manage the amount of CAPA.

I have suggested the Quality Manager to design the Nonconformance and CAPA Process based on the risk and to take a decision based on the risk on whether or not an NC should be escalated to a CAPA, but he said that this is not in conformance with the ISO standard. I am confused in my previous company we certainly didn't raise a CAPA for each NC. Could you please share your experience?

Thanks for your help in advance
 
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Ninja

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#2
escalate every NC to CAPA with the result that we are unable to manage the amount of CAPA
...curiosity... how many NC's do you have per day/week/month?

We averaged 2 per quarter. I doubt that would have overwhelmed anything...
 

Tagin

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#3
I have suggested the Quality Manager to design the Nonconformance and CAPA Process based on the risk and to take a decision based on the risk on whether or not an NC should be escalated to a CAPA, but he said that this is not in conformance with the ISO standard. I am confused in my previous company we certainly didn't raise a CAPA for each NC. Could you please share your experience?
I'd say you are correct. Specifically, the decision process you are citing is:
8.5.2c - evaluating the need for action to ensure that nonconformities do not recur;
You could argue that by skipping that step, your Quality Manager is not conforming to the ISO standard. :)
 
#4
Hello,

In my company, we are reviewing our QMS, and as part of it, I have been asked to review our Nonconformity and CAPA Process.

We work in compliance with ISO 13485 and the 21 CFR 820.

The habit in the company is to escalate every NC to CAPA with the result that we are unable to manage the amount of CAPA.

I have suggested the Quality Manager to design the Nonconformance and CAPA Process based on the risk and to take a decision based on the risk on whether or not an NC should be escalated to a CAPA, but he said that this is not in conformance with the ISO standard. I am confused in my previous company we certainly didn't raise a CAPA for each NC. Could you please share your experience?

Thanks for your help in advance
ire88.... You are correct.
See that the ISO 13485 standard tell you .. The evaluation of nonconformity shall include a determination of the need for an investigation (CAPA process)
For this determination, you will use the risk based decision. The the CAPA process will take on , which is a subsequent process.
You have to determine if you want to put the NC through the CAPA process based on the data analysis of the NC, the education, experience of the organization.
 

Mike S.

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#7
...curiosity... how many NC's do you have per day/week/month?

We averaged 2 per quarter. I doubt that would have overwhelmed anything...

2 nonconformances per quarter???? As in per 3 months? :oops: IMO that is remarkably low.

Lemme just say that in over 30 years working in manufacturing I have never worked for a company that was within an order of magnitude of that number, nor can I think of a company I ever worked with (i.e. supplier) that was anywhere near that low.
 

Ninja

Looking for Reality
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#8
Looking at the wording above from others, let me re-word mine to match:

We averaged 2 NC's that were rated significant enough to start a CA...not including waivers where it was considered before-the-fact whether a digression from process was worthwhile.
 

QuinnM

Involved In Discussions
#10
Hi ire88,

In our CAPA process, for all CAPA opened we perform a risk analysis during the request phase. If the risk is low, then the CAPA is allowed to be closed with corrections as needed. In this event we do not proceed to the investigation of determine root cause, establishing corrective actions, or performing an effectiveness check. We verify the correction is completed and the CAPA is closed when the risk is determined to be low.

Quinn
 
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