Auditor Feedback ISO 13485

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
In early August 2022 we had our internal audit which resulted in one CAPA. The observation was our Change Control form was often filled out wrong. Our root cause is that the form doesn't exactly follow the SOP so users are confused. We rewrote the SOP and form to more closely match.

As an effectiveness check we were to audit the next 3 change notices to see if errors continued with this new form/SOP. That CAPA is only 2/3 of the way to that point as changes have been large and few so 2 changes in Sept/October and one going to close next week.

The auditor commented that keeping the CAPA open this long isn't "good practice" and he would write an OFI. He stated we should have just closed it after the 2 CNs in Sept/Oct. We felt with 6-8 Changes/year 3 was a reasonable time to wait to assure the correction was effective.

Has anyone heard of this?
 

blackholequasar

The Cheerful Diabetic
I am curious about the feedback on this one - we recently had our recert audit (9001, not as strict lol) and our auditor mentioned something about that as well. He said that CARs that remain open for months on end means that the system "isn't working", but to me that's not true if you are waiting for objective evidence that your CA and PA are effective! Sometimes we don't see a customer for months on end and have to wait to verify that the issue is corrected in the process update. How can I close the CAR when I'm not able to provide evidence that what we planned is going to work?

Now if it's open for 10 years, I get THAT. But if a time is not defined, I think a 'reasonable' amount of time for CAR/CAPA closure is subjective to the company needs.
 

ChrisM

Quite Involved in Discussions
"The auditor commented that keeping the CAPA open this long isn't "good practice" " Sounds like the personal opinion of the auditor. CAPAs can stay open for as long as necessary to ensure effectiveness. What you could do is "partially close" the CAPA - it is closed except for checking effectiveness. Suppose that you had not raised any change notes between revising your documentation and now. you would still need to check the effectiveness but would not have been able to, in any shape or form. Closing a CAPA fully can sometimes depend on many things, and can take time.
 

Tidge

Trusted Information Resource
We (medical device manufacturer) have had CA open for 6+ months, including some long-ish periods for effectiveness checks. The details that stand out in this case is that the original post does make it sound like this was an effectiveness check with a somewhat undefined endpoint for a rather small sample size (three). If I was the 13485 auditor and somehow felt obligated to issue a 'formal' OFI, those are more likely to be where my focus would be. In my personal experience, when the effectiveness checks for action items would take longer than a month it was because we had a supporting study design and needed the time to collect large-ish data sets.(*1)

It's not lost on me that if this OFI is addressed through the CA/PA system: it is entirely possible that the effectiveness check might be (given current story) something like 'look at the next three CA/PA effectiveness checks', which (in my imagination anyway) could end up with the exact same result.

(*1) I'm not going to Monday morning QB this CA, but I am curious: Was 'Update the SOP and Form' the only Action Item? Was "Check the next three Changes' the only effectiveness check? Without implying any judgement calls, this sounds like a circumstance where the Hawthorne effect could come into play w.r.t. the effectiveness check.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
We (medical device manufacturer) have had CA open for 6+ months, including some long-ish periods for effectiveness checks. The details that stand out in this case is that the original post does make it sound like this was an effectiveness check with a somewhat undefined endpoint for a rather small sample size (three). If I was the 13485 auditor and somehow felt obligated to issue a 'formal' OFI, those are more likely to be where my focus would be. In my personal experience, when the effectiveness checks for action items would take longer than a month it was because we had a supporting study design and needed the time to collect large-ish data sets.(*1)

It's not lost on me that if this OFI is addressed through the CA/PA system: it is entirely possible that the effectiveness check might be (given current story) something like 'look at the next three CA/PA effectiveness checks', which (in my imagination anyway) could end up with the exact same result.

(*1) I'm not going to Monday morning QB this CA, but I am curious: Was 'Update the SOP and Form' the only Action Item? Was "Check the next three Changes' the only effectiveness check? Without implying any judgement calls, this sounds like a circumstance where the Hawthorne effect could come into play w.r.t. the effectiveness check.

We updated the Form and SOP then held instructor-led training for all users of the SOP and form. Then, we had to wait until a sample was available so we could review it.
 
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Tidge

Trusted Information Resource
We updated the Form and SOP then held instructor-led training for all users of the SOP and form. Then, we had to wait until a sample was available so we could review it.

This is similar to what I've seen. We've also done some sort of performance assessment against the updated procedures/forms. It's not the same as the "dummy changes" proposed by JQ, but it would be better than nothing, or (in the eyes of the OFI) "waiting an undetermined time for something".
 

Jim Wynne

Leader
Admin
There could even be isolated cases where orthodox CA isn't even possible, such as if a given NC condition is exclusive to a particular product, and that product is never produced again.
 

Miner

Forum Moderator
Leader
Admin
We have a computer system for 8Ds (external issues) where we will close the 8D once the corrective actions have been implemented, but will enter a date for an effectiveness review, if no date is entered, the default is 90 days. Once that date arrives, email reminders are automatically sent out until a response is entered.
 
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