AS9100D Non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f - Corrective Action

ImLost

Starting to get Involved
#1
We hired an outside auditor to complete our internal audits; they gave us a non-conformance for 10.2.1 b 2 and 10.2.1. b 3 e and f.

We've added a drop down to in our CAR program to select possible Human Factors related, but I dont know how to implement the other 2.

Any suggestions?
 

ImLost

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#3
Its very vague;
Finding: The process for corrective action is not fully effective
Objective Evidence: The corrective action system does not address Human Factors, updating the risk and opportunities determined during planning, and make changes to the QMS.
Claue: 10.2.1
 

Pjservan

Involved In Discussions
#4
If you have a procedure, then state how these items are covered or addressed. If no procedure I have seen companies address this by including this as part of their form/system. The Human Factors as you described and the other two as a part of the closure of CAR where it is a question whether R/O or QMS changes/updates are needed to further address the CAR.
 

ImLost

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#5
The Human Factors as you described and the other two as a part of the closure of CAR where it is a question whether R/O or QMS changes/updates are needed to further address the CAR.
Thank you - We do have a procedure; I didn't want to unnecessarily bog down an already busy form with additional boxes, drop downs, etc.
We added the human factors box, but now I am wondering if we really need it (as we would have to select a HF with each non-conformance, right?)
 
#6
I think adding notes to your CA form is probably the most helpful. How many people actually refer to the procedure after a while? That can lead to a miss or forgetfulness. You always have the form in front of you during the CA process. Just check the box that you considered the requirement and move on.
 

ImLost

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#7
VERY good point @Golfman25!

So now - to play into that - it has to be considered, but does there need to always been an answer - would it be too simple to put buttons for YES and NO (as in were R/O considered)?
 

Pjservan

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#8
The requirement on human factors in corrective actions is: "determining the causes of the nonconformity, including, as applicable, those related to human factors;..." so agree, a Y/N question could work.
 

John Predmore

Involved In Discussions
#9
I dont know how to implement the other 2
There are four clauses referenced. You said you already added Human factors to your CAR. AS9100 says
10.2.1 b. evaluate the need for action to eliminate the cause(s) of the nonconformity, in order that it does not recur or occur elsewhere, by: [... ]
- 2. determining the causes of the nonconformity, including, as applicable, those related to human factors;
- 3. determining if similar nonconformities exist, or could potentially occur;
- e. update risks and opportunities determined during planning, if necessary;
- f. make changes to the quality management system, if necessary;

I suggest you add comment fields to your CAR form whether
(b3) this problem/failure reads across to other lots, product lines or departments (use words that make sense in your factory).
(e) your risk document was/was-not updated based on this incident (if not, why?)
(f) QMS changes were made (if so, what? if not necessary, why?)
 
#10
If you have a procedure, then state how these items are covered or addressed. If no procedure I have seen companies address this by including this as part of their form/system. The Human Factors as you described and the other two as a part of the closure of CAR where it is a question whether R/O or QMS changes/updates are needed to further address the CAR.
Keep in mind that AS9100D requires a written procedure for corrective actions.

10.2.1 ends with: The organization shall maintain documented information that defines the nonconformity and corrective action management processes.
 

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