Notified Body changed the submission deadlines for NC, CAPA Plans

[bimeri]

We are working with a European NB, and they published the new deadlines for findings and the CAPA Plan. But the deadline is so short, it really does not make sense to me. For example:

• A CAPA plan has to be submitted within 10 working days after the last audit day.
• Major Nonconformity needs to be effectively solved and submitted within 2 months.

Have you faced this kind of situation? Is it okay to complain about it to the NB?

 

[yodon]

I can't comment on what they can do / what deadlines they can set; but what you describe doesn't seem unreasonable.

For the CAPA, you just need a PLAN in place within 10 working days.

For the Major NC, they believe that you have a serious issues with compliance and 2 months to address the NC seems reasonable.

 

[Bev D]

I essentially agree with Yodon.

Two considerations:

I will know that getting to a true root cause and implementing an effective Corrective Action that prevents recurrence for a Physics problem is impossible to time out. But external audits are typically focused on people/behavior systems so this isn’t as difficult - although ‘effective’ may be very tough to judge. Example: I once had a major finding for a lack of an effective risk assessment process for a change that affected the product. How do you prove effectiveness of something like that? It came in stages: first and easiest we developed and agreed on a process (~1 month). Second we trained and implemented the process(1 month), third we assessed the process for improvements - what was working and wasn’t (1 year) then we finally we compared failures before and after the new process. This took 3+ years.

The other concern is what they consider a “major” and where are NCs classified as minor and major?

 

[EmiliaBedelia]

Are you working under MDD or MDR?

NBs are getting pretty strict about MDD. I suspect they are coming under a lot of scrutiny with CAs nowadays to make sure that they are not letting things slip with the extended transition period. They may have gotten a finding on their side that is making them tighten the timelines.

I agree with the above comments... my NB defines Major as a "Nonconformity that affects the capability of the management system to achieve the intended results". If your NB doesn't think your QMS is effective they have grounds to suspend or terminate your certification, so it's not a problem they can let you sit on for a long time. Getting to the root cause and making long term fixes may take longer, but you need to be able to move quickly to at least resolve the immediate issue.

If you have a plan that will take longer to execute, maybe your NB will accept a slightly longer timeline to make the fix (eg, if you have to do some physical testing or something like that that has an actual logistical limitation), but you will have to make that case with your specific situation.

 

[bimeri]

Under MDR. And yes I agree with the above comments as well.

 

[Jen Kirley]

For what it's worth, all major NCs I have issued as a registration auditor had a 10 day response time, while minors had a 30 day response time. Yes, this is about the root cause analysis and plan only.

 

[Ed Panek]

A major NC is treated like all hands on deck where I work. They are rare so that's reasonable.

 

[Philip B]

I agree with the comments above. Ten days to send a plan and two months to resolve a major NC seems entirely reasonable to me.