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Interesting Discussion Addressing Human Factors in Corrective Action

pziemlewicz

Involved In Discussions
#1
In a recent AS9100D audit, I received one minor NCN: Need to better document how we're reviewing/addressing human factors within the corrective action process.

Does anyone have a suggestion of something that works? Has someone seen a customer corrective action request form with an area to document this? I understand the objective, but how to better document within our corrective action process leaves me scratching my head.

Thanks in advance!
 
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#2
Did you note a trend in your analysis of corrective actions? There's a "as applicable". Did the auditor consider those? Did your organization? It sounds like the auditor has jumped at a highlighted requirement and made a big deal of it.
 

pziemlewicz

Involved In Discussions
#3
1) I think the was grasping at something to write up.
2) The "trend" might have been that there were some (2-3) longer-open corrective actions in one department. The supervisor had originally replied "operator error / re-trained the operator" and I'd rejected their reply.
 

yodon

Staff member
Super Moderator
#5
I'm not an AS guy but I thought your post was interesting and have some questions. Did the auditor say why the current documentation was deficient? Was a specific requirement cited in the finding? Was the issue over corrective action for a product (component) or for a process thing (what was the original NC that drove the CA)?
 

pziemlewicz

Involved In Discussions
#6
The text from finding is below.

Clause: 10.2.1 Nonconformity and Corrective Action
Statement of Nonconformity: The corrective action form doesn’t contain documented evidence that Human factors are considered during the corrective action process.
Evidence: Corrective Action Form, CAR 1062
 
#7
The text from finding is below.

Clause: 10.2.1 Nonconformity and Corrective Action
Statement of Nonconformity: The corrective action form doesn’t contain documented evidence that Human factors are considered during the corrective action process.
Evidence: Corrective Action Form, CAR 1062
Does it have to? It's an "as applicable", therefore you decide. Are they looking for a check box to say you did/din't consider it? It's all very well for these auditors to drop a finding like this, but they seem to be creating situations. Have you a history of failures due to human factors? Do you have a history of failures due to operator intervention? For example, in a highly automated machining environment, I'd expect human factors to be low down on the list of issues.
 

Sidney Vianna

Post Responsibly
Staff member
Admin
#8

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dsanabria

Quite Involved in Discussions
#9
In a recent AS9100D audit, I received one minor NCN: Need to better document how we're reviewing/addressing human factors within the corrective action process.

Does anyone have a suggestion of something that works? Has someone seen a customer corrective action request form with an area to document this? I understand the objective, but how to better document within our corrective action process leaves me scratching my head.

Thanks in advance!
Time to appeal this NCR...

2. determining the causes of the nonconformity, including, as applicable, those related to human factors;
 
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