Severity Rating CORRECTIVE ACTIONS - Opinions Wanted Please

[CATERAF]

Well ideally the nonconformance shouldn't occur again... thus, some CAs can take a while to be deemed as effective because you have to wait to determine if the nonconformance resurfaces. Say, for example, that you felt that the nonconformance is likely to occur everytime you do X procedure. If you thought you might do X procedure 20 times in 2 months, that is sufficient to determine if the nonconformance occurs again. Then you'd just be checking the outcomes from those 20 procedures. If it passes all, you know the CA was effective.

Other nonconformances are less clear cut and may just be reduced, and as long as you can find a way to show/measure that, then that counts as checking if it's effective.

Audits are another way to check too because you're measuring how well something is working. Thus, your audit should tell you there are zero nonconformities and you know it was effective.

"Insect Warface" posted the following methods for looking at Non-conforming product control.

N/C Product Control:

• Scrap & Defect rates/cost
• Physical inventory accuracy (useful if misplaced parts are becoming problematic)
• Cost of Poor Quality (this can be anything related to detrimental performance which affects your product quality)

These two websites have a little bit of information too if that helps:
http://www.iqps.net/iqps/pdf/Correct...ionArticle.pdf
http://www.qualitydigest.com/inside/...e-action.html#

[sagai]

My apology for hanging on this subject.

When result of the audit is that there are no more nonconformities the action was effective.

It raises one question in my mind that how is it possible to ensure that the audit is comprehensive enough and it blindly checks the origin of all the earlier non conformities without knowing exactly the nature of those ...
Moreover if there is a non conformity as part of the upcoming audit, how do you evaluate its relation the the effectiveness of the earlier CAs without considering all the CAs raised in history for that area before ...
I have my doubts about this approach.

"Training action is poorly documented in different departements"

I am wondering if it is a non conformity to raise?

Many thanks, Cheers

[phloQS]

In Reply to Parent Post by sagai

My apology for hanging on this subject.

It raises one question in my mind that how is it possible to ensure that the audit is comprehensive enough and it blindly checks the origin of all the earlier non conformities without knowing exactly the nature of those ...
Moreover if there is a non conformity as part of the upcoming audit, how do you evaluate its relation the the effectiveness of the earlier CAs without considering all the CAs raised in history for that area before ...

I am sorry, but I do not understand what your question is. Could you explainwhat you exactly mean, maybe with an example.
The documentation of training can be requested by differnet standards.
6.6.2 of DIN EN ISO 13485 states that training has to be performed and to be documented in an adequate way.
If such a thing is not done by our company, there is a nonconformance to a standard which leads into a CA.

regards

phloQS

[sagai]

e) maintain appropriate records of education, training, skills and experience

I wonder if the DIN release of ISO13485 would say more than this ...

Subjective adjectives and adverbs mostly coming from people reading the standards, not from regulators I guess.


The problem I had originally was about that if we are not checking the closed CAPA items as part of the upcoming audit, than the effectiveness check of those only incidentally could occur rather than a deliberate manner; whereas the conclusion if zero nonconformity registered during the audit than it misleadingly ends up with the conclusion that the CAPA resolutions were effective.

Cheers!

[Jim Wynne]

In Reply to Parent Post by sagai

I wonder if the DIN release of ISO13485 would say more than this ...

Subjective adjectives and adverbs mostly coming from people reading the standards, not from regulators I guess.


The problem I had originally was about that if we are not checking the closed CAPA items as part of the upcoming audit, than the effectiveness check of those only incidentally could occur rather than a deliberate manner; whereas the conclusion if zero nonconformity registered during the audit than it misleadingly ends up with the conclusion that the CAPA resolutions were effective.

Cheers!

Unless you're 100% sure that you've neutralized the cause of something there's no way to conclude that a given CA is effective. Just because some symptom doesn't occur doesn't necessarily mean that the cause has been eliminated or neutralized. It only means that the the symptom hasn't occurred. That's evidence of effectiveness, but not proof.

The whole key to determining effectiveness is understanding causes, not understanding manifestations of causes. When CAs fail, it's almost always because root causes haven't been properly identified or addressed.

[sagai]

I am trying to stipulate some thoughts for finding the way out from the CAPA effectiveness check kind of black hole ...
So there is no way out?
Many thanks

[Jim Wynne]

In Reply to Parent Post by sagai

I am trying to stipulate some thoughts for finding the way out from the CAPA effectiveness check kind of black hole ...
So there is no way out?
Many thanks

The way out is understanding the cause(s). If you can't find even a potential cause, there's no point in doing CA because there's nothing to correct. In some cases, even when the cause has been identified, CA isn't feasible because the cure is worse than the disease--it might cost more to permanently fix something than the problem costs.

[CATERAF]

In Reply to Parent Post by sagai

The problem I had originally was about that if we are not checking the closed CAPA items as part of the upcoming audit, than the effectiveness check of those only incidentally could occur rather than a deliberate manner; whereas the conclusion if zero nonconformity registered during the audit than it misleadingly ends up with the conclusion that the CAPA resolutions were effective.
Cheers!

As part of your CA though you could decide on a time period that is sufficient to know whether the CA was effective or not. If you have an audit but there isn't sufficient time to determine if the CA was effective you wouldn't close the CA. You could either come back and run another internal audit on just the involved procedures, or find other means to measure the CA effectiveness rather than just an audit.

Alternatively you could just wait until the next scheduled audit, but I don't recommend this because the next audit is likely to be far away and the CA is therefore not being regularly checked.