Is corrective action mandatory for each internal audit NCR

sunrizenew

Involved In Discussions
in ISO 9001:2015 clause 9.2.2 (e) said
Take appropriate correction and corrective actions without undue delay; so i understand form (and) that we should talk correction and corrective action together for any internal audit NCR


in ISO 9001 Clause 10.2 Nonconformity and corrective action
Evaluate the need for action to eliminate the cause(s) of the nonconformity, (which mean that taking corrective action is as per need.


and in ISO 19011 clause 6.7 Conducting audit follow-up
The conclusions of the audit can, depending on the audit objectives, indicate the need for corrections, or
for corrective, preventive or improvement actions.

So is taking corrective action for each internal audit NCR is mandatory or not?, or taking correction and action against the NCR to resolve the situation is enough, and corrective action will be taken if there is a need or notice that there are trend in NCR
 
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Jim Wynne

Leader
Admin
There's nothing in any of that to indicate that CA is required for all nonconformities. For example, in your first example, it says to "Take appropriate...actions..." (My emphasis)
 

Howard Atkins

Forum Administrator
Leader
Admin
The question is what do you want?
To improve or to meet some "rules"
The internal audit is for you to improve if you do not take it as such this will in the end rebound on you
 

Bev D

Heretical Statistician
Leader
Super Moderator
The answer is the same as your identical post in the Quality Forum Online. NO. The language is clear in each quoted sections that the actions to be taken are optional based on the need.

Since you posted this question twice, I must ask what your position is: do you believe that all nonconformances in an audit require corrective action or do you believe that it is optional based on the need? Or perhaps this is only a language interpretation matter?
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Follow your documentation rules. Where I work a minor NC or lower does not require an investigation or CAPA. Generally, a minor finding is a one-off of a violation of the standard or your SOP resulting in low risk. Auditors when discovering a minor should look at more records to see if this is a one off or systemic problem.
 

Golfman25

Trusted Information Resource
So here is your problem, OP. The standard says you shall take "appropriate" correction and corrective actions without undue delay. Most of us will read the word appropriate and think -- hey I have some discretion to determine what is and isn't appropriate under the circumstances. That's a common sense approach that most normal people would take. However, that requires thinking and thought.

Now, along comes the "lazy auditor" and because you only did a correction and not a corrective action as you deemed appropriate, you get dinged with a non-conformance and all the BS that goes with it. When you ask your auditor/CB who gets to determine what is and isn't "appropriate" they have no answers -- might even say something to the effect that you "should have" done both the correction and corrective action. Your life sucks for a month as you struggle to close out the non-conformance.

So what do you do? The safe play is to do a full 8D type of correction and corrective action report so you cover your behind. On the other hand, that would seem like a lot of wasted energy for the simple things. In other words, ISO sucks. :)
 

Jim Wynne

Leader
Admin
So here is your problem, OP. The standard says you shall take "appropriate" correction and corrective actions without undue delay. Most of us will read the word appropriate and think -- hey I have some discretion to determine what is and isn't appropriate under the circumstances. That's a common sense approach that most normal people would take. However, that requires thinking and thought.

Now, along comes the "lazy auditor" and because you only did a correction and not a corrective action as you deemed appropriate, you get dinged with a non-conformance and all the BS that goes with it. When you ask your auditor/CB who gets to determine what is and isn't "appropriate" they have no answers -- might even say something to the effect that you "should have" done both the correction and corrective action. Your life sucks for a month as you struggle to close out the non-conformance.

So what do you do? The safe play is to do a full 8D type of correction and corrective action report so you cover your behind. On the other hand, that would seem like a lot of wasted energy for the simple things. In other words, ISO sucks. :)
Here we have the confluence of (a) ambiguous requirements and (b) benighted auditors. I agree that it's difficult if not impossible for justice to be done in a case like this, and sometimes the path of least resistance is the best answer.
 

Ed Panek

QA RA Small Med Dev Company
Leader
Super Moderator
Ultimately you know much much more than any auditor about YOUR PRODUCT. You know and have the design development info, the complaints, the production issues, etc etc etc. You have the engineers and the buyers and the production folks and years of history. You arent just reading it 5 minutes ago so have a good argument why you do things a certain way and why (based on risks) its ok to do that.
 
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