Conducting the VOE after closing the CAPA?

[Javier Guan]

Hello Cove team!
I will appreciate your point of view regarding conducting the verification of effectiveness (VOE) after closing the CAPA. I've seen few companies doing this to prevent CAPAs open forever. This practice lacks of rationale from my perspective, but I will appreciate others sharing more info and experience regarding this.

Thank you, J

 

[Bev D]

We have discussed this many times here…the short answer is:
1. There is no such thing as a CA that is open ‘too long’
2. Verification of effectiveness is a CRITICAL ESSENTIAL part of a CA, so NO you shouldn’t close a CA then verify it’s effectiveness.
3. If you need to track activity then have dates and milestones for individual steps and track the progress with your knowledge of it…
4. There is no such thing as a CAPA…

 

[Sidney Vianna]

What Bev said.

I wonder if this atrocious term CAPA is also used outside of the US in the Life Sciences field. Seems to me it has been promoted (?) by the FDA.

 

[Tidge]

What Bev said.

I wonder if this atrocious term CAPA is also used outside of the US in the Life Sciences field. Seems to me it has been promoted (?) by the FDA.

You aren't wrong with respect to Medical Devices. In particular, the FDA has long used (during inspections) the QSIT to drive a LOT of what folks consider to be "the truth about CAPA" (including "CAPA" as a term).

The MDSAP Audit Model is much better about applying terms in a formal manner. If I have a complaint about the approach to CA/PA from the MDSAP perspective it is that it is practically impossible to tell the difference between "Corrective Actions OR Preventive Actions" and "Corrective Actions AND Preventive Actions." The inability to distinguish between the requirements/approach for a CA versus a PA is only going to reinforce the use of the term "CAPA".

I do believe that there is a true value in differentiating between a corrective action and preventive action, however in my medical device company we don't treat them differently (as a result of 3rd party audit findings), which has had the (predictable?) result that we almost never start (formal) preventive actions.

 

[Sidney Vianna]

I do believe that there is a true value in differentiating between a corrective action and preventive action, however in my medical device company we don't treat them differently (as a result of 3rd party audit findings), which has had the (predictable?) result that we almost never start (formal) preventive actions.

Until ISO 9001:2015 came about and dropped the PA construct in favor the RISK BASED THINKING “thing”, we used to have weekly Armageddon threads here at The Cove on this issue of “formal” preventive actions nonsense.

The ISO TC210 managed to release 13485:2016 not aligned with the HLS (now HS) framework and kept PA alive and kicking; actually more kicking than alive. Sooner or later, 13485 will be revised in line with the HS and it is unlikely they will maintain this PA stupidity as currently is. And, the FDA (apparently now in the 13485 bandwagon) will HAVE TO repent for this CAPA crap and realign with XXI century wokenissm.

 

[Wearerofmanyhats]

my consensus: CAPA? sounds like a lot of CRAPA to me

 

[Johnnymo62]

Back in the day, I tanked a phone interview when I was asked about my experience with CAPA and had no idea what the person was talking about. Unfortunately, no explanation was forthcoming, or I could have talked about the many corrective actions and preventative actions I worked on.

 

[yodon]

I wonder if this atrocious term CAPA is also used outside of the US in the Life Sciences field. Seems to me it has been promoted (?) by the FDA.

A little late to the party but this post warranted a follow-up. Since as long as I've been watching things (20+ years), the top reason for FDA 483s is related to CAPAs. Clearly, this should be an indication of a system in need of attention. I don't think it's necessarily going to help, but the MDIC has a "Case for Quality" initiative which includes some efforts towards improving CAPAs.

Not sure if it's being "promoted" by the FDA but it's certainly driving a lot of effort!

conducting the verification of effectiveness (VOE) after closing the CAPA.

As has been alluded to previously, this would, well, drive a 483 if you were to do it and then be inspected. Measuring effectiveness may well take a long time but auditors and inspectors do seem to focus on timelines. Certainly, companies let CAPAs linger on for inappropriate reasons and I think that's turned into a focal point for auditors and inspectors. We will drive the CAPA to "completion" (all actions are completed and closure is pending verification of effectiveness). Having this completion date (in a reasonable timeframe) has played well with auditors / inspectors but it also shows we're serious about timeliness. We then set the date for and the methods by which effectiveness is assessed. Assuming we are good on those target dates, everybody is generally happy.

 

[Mike S.]

I guess I'll be the oddball here and say I sometimes close a CA before verification of effectiveness is complete. Sometimes it might be a year or more before we run a process again, to me that is "too long" to leave a CA open. If the problem were to reoccur, showing the CA to be ineffective, we open a new CA and reference the old one and try again. So what?

 

[FRA 2 FDA]

I track average aging of CAPAs (yes our system calls them that) through implementation. This ensures that there is some urgency and visibility to how long we are taking to act. Once in monitoring/verification stage, they can linger as long as it takes. I don't worry about this. The CAPA report clearly states what the monitoring period/#of units, whatever is. If an auditor or upper management asked me why a CAPA had been open for so long, all I have to do is open the report and point to that defined period of monitoring. Can't argue with that. Of course, if someone were to just leave one hanging indefinitely after the defined monitoring had been reached, I'd be initiating the secret next phase- harassing.