Lead Auditor Assigned to Effectiveness Check - CAPA

B

brooney

#1
As Lead Internal Auditor I assign CAPAs to auditees for nonconformances. Per procedure I am required to approve the action plan. I am wondering if it is appropriate for auditees to assign the effectiveness check of the implementation of the actions to me (lead auditor). Could this be seen as the lead auditor having bias to close the CAPA record?
 
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howste

Thaumaturge
Super Moderator
#3
Certification body auditors close corrective actions for NCRs that they initiate. It should be fine for internal auditors to do the same.
 
A

AverageJoe

#4
I am a Lead Internal Auditor who posted findings against the Quality organization for deficiencies in the Internal Audit Procedures. Our QAM manages all CA/PA findings but in these instances our Quality Director was assigned the stages for Verification of Implementation and Verification of Effectiveness. In previous findings against the Quality organization I was assigned the stages for these Verifications. Is the assignment for verification of findings against your own organization in conflict with AS9100C 8.2.2 b) "Auditors shall not audit their own work." or 8.5.2 f)? It seems that verifying your own CA/PAs isn't different than auditing your own work.
 
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#5
I am a Lead Internal Auditor who posted findings against the Quality organization for deficiencies in the Internal Audit Procedures. Our QAM manages all CA/PA findings but in these instances our Quality Director was assigned the stages for Vertication of Implementation and Vertication of Effectiveness. In previous findings against the Quality organization I was assigned the stages for these Vertications. Is the assignment for verification of findings against your own organization in conflict with AS9100C 8.2.2 b) "Auditors shall not audit their own work." or 8.5.2 f)? It seems that verifying your own CA/PAs isn't different than auditing your own work.
Average Joe: Welcome! Of course an auditor can audit/verify corrective actions! It's not their work, is it? It's the work others did to address the audit nc.


Vertication? I'm unfamiliar with that term...
 
A

AverageJoe

#6
Thanks, Andy N

In those instances I was not allowed to perform the verifications (nee vertications). Since then I have been assigned to these verifications in subsequent findings.
 
A

AverageJoe

#7
I guess the flip side of my question is "should members of the audited organization be disallowed to verify implementation and effectiveness of CA/PAs found against themselves"? Any Quality Dept. is in the unique position of monitoring compliance to Standards throughout the company but they themselves must also comply with those same Standards.
 

John Broomfield

Staff member
Super Moderator
#8
As Lead Internal Auditor I assign CAPAs to auditees for nonconformances. Per procedure I am required to approve the action plan. I am wondering if it is appropriate for auditees to assign the effectiveness check of the implementation of the actions to me (lead auditor). Could this be seen as the lead auditor having bias to close the CAPA record?
AverageJoe,

Approve the action plan and it may be seen that you compromise your impartiality and objectivity when it comes to verifying the effectiveness of the corrective action.

Your organization's competent problem solving teams should not need handholding by you as the auditor. If they are not competent then you have another nonconformity in need of corrective action.

The action plan should be approved by the manager responsible for the corrective action, not by the auditor.

John
 

John Broomfield

Staff member
Super Moderator
#9
AverageJoe,

...and when you've got the responsible managers approving their team's corrective action plans move them on to verifying the effectiveness of their corrective actions before passing the CAR on to you or your system manager for close-out.

This way you build the strength of your system and the competence of your colleagues instead of having them use you or any other auditor as a crutch.

Too many management systems tend to depend too much on their auditors.

John
 
A

AverageJoe

#10
Thanks for all the feedback but perhaps I need to clarify my posts. I am not part of our Quality Dept, which manages all CA/PA records regardless of which Dept. is the auditee. In my role as an Internal Auditor I am often tasked with auditing the Quality Dept simply because I am from a different Dept of the same company. In the instances I described, I was auditing the Quality Dept's Internal Audit procedures and issued CA/PAs. The Quality Manager typically assigns stage owners for containment, root cause, etc. In these instances the Quality Dept itself verified the implementation and effective of the CA plan they proposed.

Question: Does this situation of Quality verifying their own CA/PAs conflict with AS9100C 8.2.2 "Auditors shall not audit their own work."?

As John notes above, "Approve the action plan and it may be seen that you [for clarification, the QM, not the auditor] compromise your impartiality and objectivity when it comes to verifying the effectiveness of the corrective action."
 
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