As per ISO 13485:2003, a corrective action must establish a procedure to review a corrective action and its effectiveness. I have included this in my procedure by including a re-evaluation/inspection of the action taken, after three months. In certain cases, the action has not been efficient in preventing the re-occurrence of the problem OR the occurrence of new problem. In these cases, do you open another CAPA or add to the existing CAPA till the solution is final?

In these cases, do you open another CAPA or add to the existing CAPA till the solution is final? Since, according your post, the proposed corrective and preventive actions were innefective in solving the problem, I would track the new solution and it's effectiveness as part of the original CAR (or PAR).

As I understand it, if the original solution proved to be ineffective then I would o back and document an alternative solution of the same form. This would be the case if a new problem arises from the proposed action. Thank you. I guess now it’s a matter of finding the space on that same form to document the alternative action.

Are you using a paper system? If so, I would write in a note saying something like "See Attachment 1" or "see re-audit" and attach it. When I say "re-audit" I mean there shold be some kind of record that the re-audit was done, and what happened.

that would be my plan, attach additional pages as required, either blank sheets or cross out the parts where you would have to re-enter the same information.

As per ISO 13485:2003, a corrective action must establish a procedure to review a corrective action and its effectiveness. I have included this in my procedure by including a re-evaluation/inspection of the action taken, after three months. In certain cases, the action has not been efficient in preventing the re-occurrence of the problem OR the occurrence of new problem. In these cases, do you open another CAPA or add to the existing CAPA till the solution is final?

How did you determine the 3 months interval between CA implementation and verifying its effectiveness? Let that time be determined through a fair estimate by the owner of the process and the CAR issuing authority. Companies create difficulties by establishing unrealistic time lines.

It is OK to go through a number of cycles (PDCA) before a CAR is finally closed out. It would be nice to hit paydirt every time, but in my experience, that rarely happens. As long as activities and progress are documented and tracked and given an opportunity for status review by Management, there should not be any problem.

Just my :2cents:

Stijloor.

It is OK to go through a number of cycles (PDCA) before a CAR is finally closed out. It would be nice to hit paydirt every time, but in my experience, that rarely happens. As long as activities and progress are documented and tracked and given an opportunity for status review by Management, there should not be any problem.
Seems like we ought to have a place to record pass 1, pass 2, pass 3, etc on the documentation. The approach would be more realistic that way. :lol:

we have a "follow-up" section for each action item, and for the overall corrective action request. (we do use a database, but it would work for paper systems as well) We just record the results of the follow-up, close if it works, leave open with a suggested follow-up date if it doesn't. Of course there is always the chance that we would add more action items at any time during the process.

I didn't address the follow-up time in my original post, but I always question the effectiveness of saying that we will review every CA at "3 months". I do believe that some things you may be able to assess at 3 months, some maybe 3 days. I just finalized one that we scheduled our final evaluation at 1 year, because of the frequency of use and the past failure rates. Nothing wrong with saying you will check these at 3 months, but you may have better luck scheduling review on a case by case basis.

Seems like we ought to have a place to record pass 1, pass 2, pass 3, etc on the documentation. The approach would be more realistic that way. :lol:

Would be nice....but perhaps too cumbersome....

My concern is (and always has been) that because of unrealistic time lines and the urgency to get the CAR out of people's hair, quick fixes and hurried activities are the norm, resulting in recurrences.

I was more referring to what Dr. Deming calls: "determined effort" not repeats of sloppy work....

Stijloor.