Severity Rating CORRECTIVE ACTIONS - Opinions Wanted Please

[Wullie23]

Team,

Really interested to know how industries/organisations prioritise their Corrective Actions in terms of Critical / Major / Minor e.t.c or a 1, 2 or 3 system and then define specific timelines to prioritise the implementation of these actions to prevent recurrence.

Thoughts encouraged and apprieciated.

Thanks

 

[Mikishots]

Team,

Really interested to know how industries/organisations prioritise their Corrective Actions in terms of Critical / Major / Minor e.t.c or a 1, 2 or 3 system and then define specific timelines to prioritise the implementation of these actions to prevent recurrence.

Thoughts encouraged and apprieciated.

Thanks

Where I work, there is no distinction. While this info may be of use for our external auditors (AS9100C, using PEARs and OEIs) for their audits, if the finding is written clearly enough there is no need for ranking.

 

[Jim Wynne]

Team,

Really interested to know how industries/organisations prioritise their Corrective Actions in terms of Critical / Major / Minor e.t.c or a 1, 2 or 3 system and then define specific timelines to prioritise the implementation of these actions to prevent recurrence.

Thoughts encouraged and apprieciated.

Thanks

Without knowing more about the size of your company or its business, I would say that if you have so many corrective actions to do that categorization or rating is required, you have too many corrective actions. This might be because you have too many nonconformities or because you're invoking CA inappropriately. Also, if you have a continually high number of CAs to do, it means that CA probably isn't effective.

Take a step back and try to see what the cause of all the CAs is and what you can do to reduce the number.

 

[CATERAF]

I agree with Jim Wynne - I'd say you have too many CA requests if you need to be prioritising them.

However, if you are in a pressured environment and MUST categorise some infront of others, then I would try to make as few a distinctions as possible. Putting things with a low category just gives the impression that they aren't very important and can be put on the backburner. As the nature of the QMS is to continually improve you don't really want a CA item on the backburner. Perhaps just deal with critical and everything else. Critical should be rare and hence there should still be minimal categorising. Again though, it's not adviseable. Everything in CA is important because it means you have nonconformances that are reoccuring/likely to reoccur. You don't want to dilly dally about dealing with them because the quality of your product/service is affected.

 

[sagai]

I cannot agree better than the replies already posted herein.

The distinction I have seen is slightly different.
It is not about severities, but the way it tend to be solved and as such there are CAs likely to be solved by a one time correction, some others requires comprehensive handling and root cause analysis to identify the corrective actions themselves, other "set of" CAs likely requires also to initiate based on their content preventative actions.
Could be another subset of corrective actions, those are considered as non CAs, due to human error.
Cheers!

 

[phloQS]

In our company we have a small difference between CAs which just belong to one departement and CAs which affect more than one departement. These are actions where the actions have to follow a different workflow. Surveillance has to be tighter. But the way is always the same:
1. identify the nonconformance/ the influence of nonconformance
2. Root-cause analysis
3. Immediate action necessary or not?
4. Proposal for action/ approval for action
5. Implement action
6. Check adequacy of action

Priorisation is time, when CA occurs. FIFO principle.

regards

phloQS

 

[sagai]

How do you check, if the action was effective?

 

[phloQS]

This depends on the nonconformance. Auditing the process where nonconformance occurs is the normal way we check the effectivness. When result of the audit is that there are no more nonconformities the action was effective. If you have a CA for example "Training action is poorly documented in different departements" I would first check the influence on the processes with poor training documentation, than improve the training procedure, train the persons on the new procedure, and after a while check the result: Are there any undocumented trainings yet?- If there are any: the CA was ineffective; If there are not any: CA was effective or there were no training anymore.

regards

phloQS

 

[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/CorrectiveActionArticle.pdf
http://www.qualitydigest.com/inside...rifying-effectiveness-corrective-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