Conducting the VOE after closing the CAPA?

Javier Guan

Javier Guan

Quality Manager
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

Bev D

Heretical Statistician
Leader
Super Moderator
We have discussed this many times here…the short answer is:
1. There is no such thing 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

Sidney Vianna

Post Responsibly
Leader
Admin
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.
 
T

Tidge

Trusted Information Resource
Sidney Vianna said:
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.
Click to expand...

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

Sidney Vianna

Post Responsibly
Leader
Admin
Tidge said:
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.
Click to expand...
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.
 
Johnnymo62

Johnnymo62

Haste Makes Waste
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.
 
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