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Should Internal Audit CAPAs be kept separate from "normal" CAPAs?

L

Lesley1707

#1
Hi Guys,

not sure if I am posting on the correct forum but I shall continue anyway. We had a Stage 1 audit for ISO13485 recently and the auditor gave us 1 Major NC, the only major :), for internal audit CAPAs not being linked to normal CAPAS. When we perform internal audits our CAPAs are attached to the audit form and are uniquley identified. I am really confused as this is what I have always done in previous lives! Is there something I am missing / not understanding?

Any advice from you good people would be appreciated!
 
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Ronen E

Problem Solver
Staff member
Moderator
#2
Hi Guys,

not sure if I am posting on the correct forum but I shall continue anyway. We had a Stage 1 audit for ISO13485 recently and the auditor gave us 1 Major NC, the only major :), for internal audit CAPAs not being linked to normal CAPAS. When we perform internal audits our CAPAs are attached to the audit form and are uniquley identified. I am really confused as this is what I have always done in previous lives! Is there something I am missing / not understanding?

Any advice from you good people would be appreciated!
Hi,

Have you asked the auditor to "show you the Shall"...?

In my understanding, if your documented procedure defines that this is how you handle NCs found in internal audits, and the internal-audit-CA(PA) are handled according to ISO 13485:2003 8.2.2, there's no reason to issue a major NC. The wisdom of this specific arrangement can be debated, but by face value it doesn't contradict the standard.

Cheers,
Ronen.
 

insect warfare

QA=Question Authority
Trusted Information Resource
#3
Hi Guys,

not sure if I am posting on the correct forum but I shall continue anyway. We had a Stage 1 audit for ISO13485 recently and the auditor gave us 1 Major NC, the only major :), for internal audit CAPAs not being linked to normal CAPAS. When we perform internal audits our CAPAs are attached to the audit form and are uniquley identified. I am really confused as this is what I have always done in previous lives! Is there something I am missing / not understanding?

Any advice from you good people would be appreciated!
Correct me if I'm wrong, but if this is a Stage 1 audit, shouldn't this be an "area of concern" instead of a "Major NC"? I thought the whole purpose of Stage 1 was to assess readiness for a Stage 2, so there would be no point in classifying NC's if Stage 2 was not even allowed to proceed based on the results of Stage 1. They would all equally be "areas of concern" that would require addressing anyway.

:2cents:

Brian :rolleyes:
 
L

Laura Halper

#4
Lesley,
Without seeing the actual NC wording, it sounds like the issue is that your company has two separate CAPA programs (one for problems identified during internal audits and one for problems identified from all other sources). Without some linkage between them, the existence of the internal audit CAPA's may not be evident.

Sp as Ronen pointed out, it is important that your CAPA Procedure clearly explain how you handle CAPA's from internal audits, and how you handle CAPA's from all other sources. If you keep two separate CAPA logs, then this should also be stated in the Procedure. Your Procedure could provide the linkage between the two systems.
 
J

jinggu

#5
I don't think having two CAPA systems is a problem. My company set out using two spreadsheets tracking CAPAs opened through different sources, being internal and external audit. Later on, we merged two into a universal system. Unless you have tons of CAPA opened which let's hope is not the case. As long as they are uniquely identified and tracked, it's really up to your organization. Just my two cents!
Jing
 
L

lyang

#6
Hi Guys,

not sure if I am posting on the correct forum but I shall continue anyway. We had a Stage 1 audit for ISO13485 recently and the auditor gave us 1 Major NC, the only major :), for internal audit CAPAs not being linked to normal CAPAS. When we perform internal audits our CAPAs are attached to the audit form and are uniquley identified. I am really confused as this is what I have always done in previous lives! Is there something I am missing / not understanding?

Any advice from you good people would be appreciated!
If you are a medical device company, it's recommended not to link Internal Audits to CAPA. This is coming from Ex-FDA Investigator. By linking your Internal Audit CAPA to your CAPA program, by law, FDA Investigator can request Internal Audit Report of the said CAPA. This is why many large medical device manufacturer seperate the two system.

To your question, in my opinion, I don't see how that is a major. Maybe if you explain the above, it may help you build credibility that what you are doing is correct. My company do not link Internal Audit CAPA with our general CAPA program for this very reason.

Just remember if the police ask if they can enter your house, you can say no...once you say yes, they can look at anything and everything without a warrant. This same rules applies to Internal Audit.

My two cents.
 
K

kgott

#7
Hi Guys,

not sure if I am posting on the correct forum but I shall continue anyway. We had a Stage 1 audit for ISO13485 recently and the auditor gave us 1 Major NC, the only major :), for internal audit CAPAs not being linked to normal CAPAS. When we perform internal audits our CAPAs are attached to the audit form and are uniquley identified. I am really confused as this is what I have always done in previous lives! Is there something I am missing / not understanding?

Any advice from you good people would be appreciated!
While I agree with the replies above about it not being a requirement of the standard to combine internal and external CAPAs, I don't see that there is a problem in doing as the auditor (should) suggests.

Unless you have a good reason for doing so, of what value is the silo approach to your business by keeping them seperate?
 
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