To Close the RCCA or Verify Effectivenessof RCCA first?

[yodon]

I tend to have 2 states: resolved (actions complete) and closed (effectiveness verified).

 

[Mike S.]

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:

View attachment 29157​

Guidance. Should. Might. Not shalls. Your doctor analogy doesn't fit.

Despite what you say I am not making any rules. You said "Closing a CAR (Corrective Action Request) most definitely should only happen AFTER verification of implementation AND effectiveness of the actions taken. You stated the absolutes, you created the "rule". You used the ALL CAPITALS for emphasis. Not me.

I took exception. I said "sometimes". (I never say never or always. Well, almost never.)

And sometimes we don't know that a process won't be repeated, it just works out that way, unexpectedly. If we knew it was a one-off we would not do a CA, only correction, as you said.

 

[Mike S.]

I tend to have 2 states: resolved (actions complete) and closed (effectiveness verified).

I could see situations where this would be better than simple open/closed designations.

 

[John Predmore]

I tend to have 2 states: resolved (actions complete) and closed (effectiveness verified).

I also use two dates on my tracker: "Tasks Complete" and "Closed". The first Complete date indicates people are no longer actively working on a project. The last task before Tasks Complete is a plan for Effectiveness Check, so that follow-up date and plan goes on the electronic calendar and the verify task is not overlooked.

The second date shows effectiveness verified. Typically, the effectiveness check is 30 days after Tasks Complete, but it could be longer. Someone asked me once why 30 days, which seems like an arbitrary number. The answer I gave him is that half of new year resolutions are dropped by Feb 1.

Recently I closed a CAR where it didn't make sense to verify once, because of the nature of the problem. I scheduled a string of 25 spot checks on my calendar over six weeks, using a random number generator for date and time. Why 25? That heightened level of verification was warranted, the number 25 was arbitrary, but it felt right to my sense of statistical confidence.

 

[malasuerte]

Correction and Corrective Action should be closed first; then the verification activity.

The Actions are assigned to individuals capable of closing said action. The AR assigned directs them to do something to address an issue/NC/etc. When done that person closes the AR in the system (whatever that may be). This should then trigger the audit team to go verify at some point.

It can be verifying that an uncalibrated tool has been removed and sent to the lab for calibration; or the current revision of software is now in place; or that the CA is effective in preventing recurrence.

But in all cases, the person assigned as done their job based on how they see appropriate; so they close the AR. The audit team goes and validates accordingly.