AS9100 Rev D - Clause 8.7 Control of Non conforming outputs

#1
Hello All,

I had surveillance audit (for AS9100 Rev D) recently and the auditor is asking for RCA and corrective actions taken for internal defect that is identified during internal QC (peer QC). We didn't conduct RCA for that internal defect, however the defect is corrected and delivered defect free deliverable to customer. And we have objective evidences/records as per clause No 8.7 (AS9100 Rev D).

From my understanding, Clause 8.7 doesn't call for any RCA, but appropriate actions like the non-conforming output should be identified, isolated, corrected and defect free delivery should be delivered to customer and corrective action is mandatory for post shipment defect (if defects detected by customer post delivery). Please correct me if my understanding is wrong

Could you please let me know 'Is it mandatory to conduct Root Cause Analysis for internal defect (identified during internal QC/inspection) as per standard requirements (8.7)'?
 
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John Broomfield

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#2
From my understanding, Clause 8.7 doesn't call for any RCA, but appropriate actions like the non-conforming output should be identified, isolated, corrected and defect free delivery should be delivered to customer and corrective action is mandatory for post shipment defect (if defects detected by customer post delivery). Please correct me if my understanding is wrong

Your system may cause an output of the system to be nonconforming.

Controlling nonconforming materials, services and products (8.7) as you point out is about limiting the impact of the nonconformity on the customer.

Corrective action is specified by a separate clause (10.2) so your problem solvers determine and remove the root causes from the system to stop recurrence of the nonconformity.

Naturally, having discovered a nonconformity in the system’s output you are going to consider the need for corrective action to avoid a repeat of the nonconformity. It’s usually an investment decision.

Normally, corrective action is a separate process from controlling nonconforming output.

Is this what your management system specifies? It looks as if your management system blended both processes or your auditor cited the incorrect clause.
 

Jim Wynne

Leader
Admin
#3
Hello All,

I had surveillance audit (for AS9100 Rev D) recently and the auditor is asking for RCA and corrective actions taken for internal defect that is identified during internal QC (peer QC). We didn't conduct RCA for that internal defect, however the defect is corrected and delivered defect free deliverable to customer. And we have objective evidences/records as per clause No 8.7 (AS9100 Rev D).

From my understanding, Clause 8.7 doesn't call for any RCA, but appropriate actions like the non-conforming output should be identified, isolated, corrected and defect free delivery should be delivered to customer and corrective action is mandatory for post shipment defect (if defects detected by customer post delivery). Please correct me if my understanding is wrong

Could you please let me know 'Is it mandatory to conduct Root Cause Analysis for internal defect (identified during internal QC/inspection) as per standard requirements (8.7)'?
I've removed the poll because this is not a question that lends itself to opinions. Can you post the entirety of the auditor's NC statement?
 

AMIT BALLAL

Super Moderator
#4
@dineshpan , there is a requirement to determine the need for "eliminating root cause (i.e. Corrective action)" as per clause 10.2.b. You should be able to demonstrate why there was no need for corrective action.

There should be a predetermined criteria regarding when you would take a corrective action and when not. For example, if there is a defect with 1 quantity, you might not take a corrective action, but if the defect is in 100 quantity, there might be a need to take a corrective action. This is an example of need of corrective action based on quantity, but it can also include other factors such as the effect of nonconformity, cost, etc.

Although not mandatory, I would suggest determining such a criteria and documenting it in a procedure/work instruction.
 

Sidney Vianna

Post Responsibly
Leader
Admin
#6
Please correct me if my understanding is wrong
Your understanding is correct, but, be aware of the nuance about the potential for the correction to represent a product repair (and not a rework). A repair would have to be approved by the design-responsible organization. So, when you say "defect-free" product, you need to pay close attention to the AS9100 paragraph that reads (in part):

Dispositions of repair for the acceptance of nonconforming products shall only be implemented after approval by an authorized representative of the organization responsible for design or by persons having delegated authority from the design organization
 

Sidney Vianna

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Leader
Admin
#7
:topic:
From my understanding, Clause 8.7 doesn't call for any RCA, but appropriate actions like the non-conforming output should be identified, isolated, corrected and defect free delivery should be delivered to customer and corrective action is mandatory for post shipment defect (if defects detected by customer post delivery). Please correct me if my understanding is wrong
Usage of quotes in posts: Informational - Neat trick to speed up focused replies in the Forum
 
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