Issue with CAPA system - Should Over Due CAs warrant a CAPA?

[Maira O.]

Hello,

So we have several CAPA's that are severely past due, and we want to assign a CAPA to address the current problem.

While some people in my company agree that this is good practice to show the FDA that we noticed a gap in our system and we are addressing it, others seem to think that if assigned, that CAPA might cause more harm rather than help us during an FDA audit.

What do you guys think? Should a CAPA be warranted? Or will that just expose us during an FDA audit?

Any comments or suggestions will be greatly appreciated and helpful!

 

[Coury Ferguson]

Re: Issue with CAPA system - Should it warrant a CAPA?

Maira,

My opinion, and I am not an expert in Medical Devices.

CAPA is a major part of the Quality Management System, that is in place. It is one of the greatest tools you can use. But, it must be a thorough CAPA program.

Since your company is under Regulatory Oversight (FDA), in my opinion, if I was the FDA and was reviewing the CAPA program in your company, I would ask questions. Questions like:

1. Delinquent CAPAs, why?

2. Why haven't these CAPAs been elevated to the next level in your company or the supplier for appropriate action?

3. The delinquent CAPAs are a reflection of the company's failure in their CAPA program. Now, what actions are you going to take internally, to eliminate the recurrence?

4. Since, the CAPA program has shown evidence, that the system isn't working, I will write a Major Non-conformance for a complete breakdown of the CAPA program.

Do you feel you would be able to answer these questions and explain the reason why the System failed?

So yes, the CAPA program is very important to a healthy Quality System.

Again, just my opinion on this.

 

[JoShmo]

What's the subject of these CAPAs? (how I hate that term) How were they found?

Many I've seen are written in a way that anyone could tell what needed fixed. Then, the system gets burden-down with so much noise no-one knows which to go after. Classic. Before you worry about what to do, I'm with those who say they can cause more harm than good. Don't foget it's the same as poainting yourself into a corner.

 

[TWA - not the airline]

I agree with Coury that a finding of "CAPA system not working" would be a very serious issue in any inspection. So you'll need to address this very carefully. If your CAPA system has a monitoring of open CAPAs and that has been working and now alerted you to this situation then you could raise a CAPA and after investigation of the issue address the root cause with a CA. In order to restore compliance you could also install a task force with increased resources to timely close out the open CAPAs as a kind of correction. This would show that even though something happened on the way your CAPA system actually is working...
If it is just you who noticed this and there is no formal, documented monitoring of open CAPAs then maybe you could start to address this out of the management review/responsibility or internal audit system (which may or may not feed this back into the CAPA system...). Those systems are not that in-depth visible during an inspection which may be an advantage but also raise more suspicion about your system.
The best way to proceed also depends on what you perceive as the root cause right now. If it is priorities and/or resources then you'll never succeed without the support of management...So maybe you do not only have to consider FDA but also politics...

Hope this helps...

Best,

TWA

 

[Candi1024]

A CAPA to fix CAPAs. That just sounds scary in and of itself.

I don't love the way CAPAs have progressed in the system I work in. The preventative action tends to have too wide of a scope, to the point that we are digging into way too many details to verify that problems don't exist elsewhere. But being that the CAPA is usually raised because of an audit finding, and not actual quality issues, we are wasting time on non-value added activities.

Does it have to be a CAPA in the formal sense? I mean if a tool is broken, you wouldn't use it to fix itself.

 

[TWA - not the airline]

A CAPA to fix CAPAs. That just sounds scary in and of itself.

I don't love the way CAPAs have progressed in the system I work in. The preventative action tends to have too wide of a scope, to the point that we are digging into way too many details to verify that problems don't exist elsewhere. But being that the CAPA is usually raised because of an audit finding, and not actual quality issues, we are wasting time on non-value added activities.

Does it have to be a CAPA in the formal sense? I mean if a tool is broken, you wouldn't use it to fix itself.

Candi, I'm with you and I totally understand what you mean. The CAPA system has become the sacred cow of quality management, sometimes totally blown out of proportion. In my experience this is what happens when quality is not supported by management; if it is, things tend to get addressed much earlier...

 

[RoxaneB]

Personally, I am not a fan of generating a finding because CAPAs are "overdue". These "overdue" CAPAs are not the issue...they are a symptom of something else such as an inefficient and/or ineffective CAPA process.

The first question to be asked, in my opinion, is WHY are they taking so long to close? Some possibilities include (but are not limited to):

• Resources - Are there simply just not enough resources (be it time, money, people, etc.) to properly process, resolve, action and close the CAPAs? Some CAPAs require significant investment (again...time, money, people) and could stay open for a while. If you're waiting for technology to be developed, this could take some time.
• Quantity - If you issue a full-blown CAPA for every issue, it will bog the system down. Develop triggers (based on an analysis of solid data) that will help people determine what is a correction versus a corrective action.
• Failure to adequate resolve the issue - Are they still open because issues keep occurring (i.e., the root cause has not been properly identified/actioned)?
• Management commitment - If leadership isn't committed to reviewing, actioning, supporting and resolving CAPAs, why should anyone else in the organization care?

 

[Tyler C]

Hello,

So we have several CAPA's that are severely past due, and we want to assign a CAPA to address the current systemic problem.

While some people in my company agree that this is good practice to show the FDA that we noticed a gap in our system and we are addressing it, others seem to think that if assigned, that CAPA might cause more harm rather than help us during an FDA audit.

What do you guys think? Should a CAPA be warranted? Or will that just expose us during an FDA audit?

Any comments or suggestions will be greatly appreciated and helpful!

Hi,
I have a few questions. Are there any time frames around your CAPA system, either in your procedure or your key performance indicators?
How is your CAPA set up? Is it for any and every product nonconformity, or process nonconformities?

For example, we have a KPI for our CAPA system, and that is measuring any validation issues. Basically, we can't have a CAPA in our system longer than 3 months unless it is specifically for continual improvement (preventive action). Since this is a KPI, if we do have any longer than 3 months, we have to initiate a CAPA to determine why they have not been resolved. This helps us determine if there is a lack of follow through, a lack of commitment to quality, or if we simply have not determined the root cause yet.

There is not always a corrective action to be taken, such as if we have worked diligently on the root cause and just have not been able to determine it yet.

I do see the value in initiating a CAPA for severely overdue CAPAs. I also understand not wanting to bring attention to it or wanting to 'paint yourself into a corner', but on the other hand, what value is the QMS if it is not effective? I do feel an auditor would understand if you were working on fixing your system as that is a part of continual improvement, but the auditor may not like the fact that you are trying to hide a broken system.

 

[Ninja]

As was mentioned briefly above...what you call the effort of fixing the problem is likely far less important than finding the root cause and fixing it...quickly.

Generating a CA for the CA system not working...then dumping it straight into the non-working system seems a little illogical. Forget about using the broken system, and just fix it by any means necessary.

Worry about terminology after the system is fixed.

"We can't solve problems by using the same kind of thinking we used when we created them."
"Insanity: doing the same thing over and over again and expecting different results."
- Both attributed to Albert Einstein -

 

[Candi1024]

Just for perspective, our goal for CAPAs is under one year.

There are many reasons they go over. The flow of information from the CAPA team to the CAPA engineer to the engineer working on the project is one issue.

Another issue is that the scope is just too broad. This is an exaggeration, but if we found a misspelling in one AI, the scope would include checking all 1400 AI's for spelling issues. And that would be pretty easy compared to most of our scopes.

We also routinely fail effectiveness checks.

If I was working on this, I would do an A3. Unfortunately (or fortunately) I am not a CAPA engineer