Too many NC's/ Deviations and CAPAs galore

theantchamp

Registered
All, I am in a pharma company where we open a deviation for just about everything. I am new to this place but it seems due to the lack of QA knowledge and expierence we tend to say yes to opening a lot of deviations (we dont have nonconformances). Each deviation takes a lot of work to investigate, find root cause and close. We cant close a deviation as is even if its just to document or if it needs a simple correction.

In the pharma world, to minimize the number of open issues can we simply comment and close? And specifically how do you handle software issues where for example a piece of software freezes, the operator restarts and its good to go. Does that merit a deviation? If not are there work arounds? Im just not used to seeing so many open issues.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
"where for example a piece of software freezes, the operator restarts and its good to go "

Did your original validation of this software include "freezing" and restarting (fault recovery)?
 

yodon

Leader
Super Moderator
The question @Jim Wynne posed does need to be answered before too much discussion but I will comment on:

where for example a piece of software freezes, the operator restarts and its good to go.

(I would bet money that your validation didn't include software freezes!)

I think you first have to look at the effects of the freeze. Does that mean the operator has to re-enter a bunch of data (increased likelihood of data entry error?). Might there be any lingering effects from the freeze (corrupted database records, bogus audit trail records, etc.). If you have ruled all that out (with certainty!) then I think it would be reasonable for the operator to just note what happened and move on. I think you can let the level of risk drive the level of response.

Circling back to the validation point. Frequent freezes may well mean that the software isn't suited for its intended purpose! Is this vendor-supplied software or internally developed software? If the former, have you contacted the vendor to see if there is a resolution? If the latter, have you contacted your development team to investigate? I'd worry as much about the (apparent) trend here as the individual instances.
 

theantchamp

Registered
Could you explain what you mean by "deviation"? Why is a deviation necessary if there is no nonconformity?
So its a bit confusing here. Here the term nonconformance doesn't exist. So everything falls under a deviation or CAPA. But a deviation here requires an investigation, root cause analysis, action plan, effectivity...sounds like a capa to me.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
I also wonder about the "culture" (I hate using this term but it fits here) in a pharmaceutical company where operators are taking it upon themselves to troubleshoot failure modes midstream and blazing onwards. Also, hearing a pharma company lacks QA competency is alarming. Was everyone replaced recently?

FDA expects processes to be validated, controlled, released, documented, and trained on. It's key to say the process is consistent always and if it's not, it's corrected via processes that are also documented and controlled.

Ok, off the soapbox.
 

normhowe

Involved In Discussions
Jim Wynne, the definition of 'deviation' depends on the company in Pharma, but typically includes nonconformances and any time someone doesn't follow an SOP as written.

When I've seen massive numbers of deviations, NCs, or CAPAs in companies, the first thing I want to know is how many repeats are we seeing. What trends are we seeing? Certain processes? Certain departments? Are we finding true root causes? Are evaluations of effectiveness truly effective?
My guess is that the system for correcting system errors needs correcting.
 

Ajit Basrur

Leader
Admin
All, I am in a pharma company where we open a deviation for just about everything. I am new to this place but it seems due to the lack of QA knowledge and expierence we tend to say yes to opening a lot of deviations (we dont have nonconformances). Each deviation takes a lot of work to investigate, find root cause and close. We cant close a deviation as is even if its just to document or if it needs a simple correction.

In the pharma world, to minimize the number of open issues can we simply comment and close? And specifically how do you handle software issues where for example a piece of software freezes, the operator restarts and its good to go. Does that merit a deviation? If not are there work arounds? Im just not used to seeing so many open issues.

There is plenty room for improvement. Additionally, I believe when you say, "Deviations", do you categorize under "Planned" and "Unplanned" as its typically done in the Pharma space?

I would suggest revisiting your existing procedures and work instructions, putting a risk-based approach, having a process to record incidents, nonconformance and all that good stuff that goes as part of the quality system requirements.
 
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