To Close the RCCA or Verify Effectivenessof RCCA first?

[Roberts2600]

I would like to better understand which action should come first in the RCCA process. Should the RCCA be closed and then verified for effectiveness, or should effectiveness be verified first and then close the RCCA? What is the best order/method for completing this? Can anyone show a general flow of how you do it?

 

[Sidney Vianna]

Closing a CAR (Corrective Action Request) most definitely should only happen AFTER verification of implementation AND effectiveness of the actions taken.

 

[Mike S.]

I have to disagree with Sidney.

While what he proposes may be the optimal scenario, in my world it is not always practical. Sometimes verification of effectiveness cannot take place for months or a year or more, as it may be that long until the process is repeated, and I do not keep CARs open that long. If I can't verify effectiveness in a reasonable time, I will close the CAR and if the problem reoccurs I will open a new CAR which references the original one for context.

 

[Sidney Vianna]

and I do not keep CARs open that long.

Why?

 

[Mike S.]

Why?

There is no point in it, IMO. Sometimes a process is never repeated, sometimes it is a year later. All this time you have to track it, it is a CAR showing as open on reports and it generates questions from auditors. More trouble than it's worth. If the process is repeated in a year and the CA was ineffective I can open a new one and reference the original and I have lost nothing.

I am not in violation of any AS/ISO requirement doing it this way.

Why do you insist on keeping them open?

 

[Roberts2600]

The management team wants to close the CAR, essentially taking it off the tracker log and then verifying the effectiveness afterward. This seems like a bad idea to me because we will lose track of it, and the verification of effectiveness won't be completed. How do you track them once closed to ensure you complete the verification of effectiveness?

 

[Zero_yield]

Interesting points above. I think some of it comes down the structure of your deviation management system.

We have an electronic system that allows us to attach child records to investigations. So the process is:

Investigate, document root cause, document CAPA and effectiveness check plan, close parent record =>
Perform CAPAs, close CAPA record=>
Perform effectiveness check, close effectiveness check record.

Because there's connections between each child and the parent, you can close the investigation and CAPA but still have a record open to keep accountability for performing the effectiveness check.

 

[Sidney Vianna]

Why do you insist on keeping them open?

First of all, you are making a rule for the rare cases where the verification of effectiveness cannot be done in a timely basis.
Secondly for one-offs, there is NO CORRECTIVE action possible, since the process won't happen again. At most you do correction and move on.

This has been discussed here many, many times. If you want to close a CAR without evidence of effectiveness of the actions taken, be my guest. I don't care. My original response in this thread was meant to answer the TYPICAL case of potentially recurring issues and I would NEVER promote a policy simply because there could be a few exceptions.

As to the external audit card, any organization would be in much higher risks of a write up if their policy is to consider CAR's closed BEFORE or WITHOUT verification of implementation AND EFFECTIVENESS.

 

[Roberts2600]

We don't have an automated system here, but I do like the concept you mentioned Zero_yeild, of how your system works. That seems like a practical approach to this issue. We currently use a paper system and spreadsheets, which is challenging to manage at best.

Sidney Vianna, if the CAPs are verified as being completed, would/could you close the CAR at that point and then wait for the effectiveness verification to take place? It seems if you had the CAPs verified as completed, you would stand less of a risk from an auditor writing you up. What are your thoughts?

 

[Sidney Vianna]

if the CAPs are verified as being completed, would/could you close the CAR at that point and then wait for the effectiveness verification to take place? It seems if you had the CAPs verified as completed, you would stand less of a risk from an auditor writing you up. What are your thoughts?

A CAR, by definition, is an exercise in the prevention of recurrence of a problem. In my mind, the goal is not to have an artificially clean log, an audit-ready record, etc....the goal MUST be a process you assure yourself, as best as you can, the problem has been put to rest, before you take the eyes off that ball.

You go to a doctor with some symptoms and he prescribes some drug. Shouldn't he be interested to know the problem is gone, before he deems the treatment effective?

The following is an excerpt from the ISO/TS 9002:2016 guidance document:

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