How to respond to a Regulator regarding missed corrective action timelines

[ERobyn]

Hi- we were sponsor audited last year- we provided responses to findings and the timelines for corrective action. The problem is that we have input the corrective actions- one of them being upgrading our entire quality management system- but we have done it outside of the timeline. Is there an adequate way to address this? I am Quality Assurance at our site (1 person department)- neither manufacturing or quality control met their promised timelines-

What do I do now (if anything)? Any assistance or advice would be much appreciated.

[Stijloor]

Can someone help?

Thank you!!

Stijloor.

[ScottK]

In Reply to Parent Post by ERobyn

Hi- we were sponsor audited last year- we provided responses to findings and the timelines for corrective action. The problem is that we have input the corrective actions- one of them being upgrading our entire quality management system- but we have done it outside of the timeline. Is there an adequate way to address this? I am Quality Assurance at our site (1 person department)- neither manufacturing or quality control met their promised timelines-

What do I do now (if anything)? Any assistance or advice would be much appreciated.

Upgrading the entire quality management system is a heck of a response!
What did you upgrade to? What was the baseline?
What is the FDA expecting?
What is on the line here?

I would suggest starting by documenting what you did do.
Then identify the gaps still remaining.
Then call a meeting with the stakeholders and top management at the site and show the commitment dates and the current lag and ask for updated commitments.
I would write a report based on that information.

Just give the facts and say this is where we are now, this is where we need to be, it will take us this much more time to get there. Maybe even have top management sign off on a committment statement.
Top management was present at the audit, right?

Keep to the facts and be objective. Don't rationalize or make excuses.

[wppsdx]

it is a deviation???

[somashekar]

In Reply to Parent Post by ERobyn

Hi- we were sponsor audited last year- we provided responses to findings and the timelines for corrective action. The problem is that we have input the corrective actions- one of them being upgrading our entire quality management system- but we have done it outside of the timeline. Is there an adequate way to address this? I am Quality Assurance at our site (1 person department)- neither manufacturing or quality control met their promised timelines-

What do I do now (if anything)? Any assistance or advice would be much appreciated.

Be frank .. show progress .. identify bottleneck and your efforts to overcome it .. demonstrate it .. accept that your timeline was with best efforts foreseen and that you had to overcome some pitfall which has been a learning process in this course.. Show revised timeline and please do not overshoot it......

[Ajit Basrur]

Great responses so far - just one additional point from me is to assure them with a solid CA and PA to prevent it happen again.

[v9991]

In Reply to Parent Post by wppsdx

it is a deviation???

YES it is deviation; for implementation,
an form is provided to request-assess-approve the extension of timelines;
+
system for periodic review of the such time line extension is part of deviation/incident/CAPA review mechanism.

Now for your given instance, have a backup of either a deviation/incident OR have above review mechanism to demonstrate that its one-off case; to prove that there is no impact because of delay.