Internal Audit - Issuance of Corrective Actions

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N

noboxwine

#12
Script Ohio

C Emmons said:
You are just mad because the WON the game this weekend!!

Cindy: Don't forget about the reigning, undefeated National Champions ! On the banks of the Olentangy----not the streets of Ann Arbor.

Go Bucks ! :thedeal: :smokin:
 
R

Randy Stewart

#13
Go Bucks !
Oh no, I blind side attack from a guy who willingly jumps into freezing water and has a phobia about boxes and winos!!!! Have to figure he'd be behind a school whose mascot is a NUT!!!

Aren't rivalries great!
 
C

CINDY

#14
Cindy,

Who tracks the Corrective Actions? And wouldn't that be the most logical person to issue them.

I am the LA and issue our Corrective Actions. Everyone has to go through me to get a number if not audit generated. That is the only way I can track them and monitor closing of CA.

Cindy (From the looks of just this post, it looks like I am answering myself. I need HELP)
 
J

jmiruzzi

#15
Hello everyone,
Thanks for the comments, even the football comments. I went to the Univ of Mich also and I am anxious for them to be Notre Dame this weekend!

From reading the comments, looks like a consenus could be that the audit team found the corrective action (the nonconformity), have identified it on the audit report, and should submit the Corrective Action report as well to the auditee management for response.
The process we have would force the CA to be responded to and the audit team to follow up on to ensure compliance. That is what we had done in the past, but made a change to have the auditee management submit the report based on the audit findings based on how we interpreted the new standard.
This question came about in an audit that was performed where the audit team noted the CA concerns on the audit report, but did not submit a separate CA report. The auditee management did not either and it was finger pointing of who should have issued it as nothing was done to address the issue becuase the auditee management was "waiting for the CA to be issued"

There are cases, however when the management may read the audit report and find something additional they may want to also issue a CA report on that the audit team did not. I think they should keep that power to do so.

Does that opinion sound correct to everyone out there? I am looking to be able to present some of the comments from this forum to our quality team in our meeting later this week.
Thank You,
Jennifer
 
#16
This question came about in an audit that was performed where the audit team noted the CA concerns on the audit report, but did not submit a separate CA report. The auditee management did not either and it was finger pointing of who should have issued it as nothing was done to address the issue becuase the auditee management was "waiting for the CA to be issued"
This is a problem, and it sounds like a real issue. I like having the auditors (or the lead auditor) issue the CAR. I think there is less chance of it getting dropped. It is still the auditee management's responsibility to have an effective corrective action. I would have the audit team verify the CA when completed, and the CA is closed upon verification.

There are cases, however when the management may read the audit report and find something additional they may want to also issue a CA report on that the audit team did not. I think they should keep that power to do so.
Absolutely, but add that they don't have to wait until the audit to do so, also they might not need a CA to implement a change.
 

howste

Thaumaturge
Super Moderator
#17
jmiruzzi said:
I went to the Univ of Mich also and I am anxious for them to be Notre Dame this weekend!
Uh oh, was that a Freudian slip?

I agree with db - I think the best group to initiate a corrective action is the one that will actually initiate it! If the auditee management isn't motivated to initiate it, the auditors should. Dropped balls in the audit process are no fun for anyone, whether you play for Univ of Mich or Notre Dame. :p
 

Kevin Mader

One of THE Original Covers!
Staff member
Admin
#18
Hello Jennifer,

It sounds to me like your organization is in need of some Internal Audit(or) Training. The training should cover the various responsibilities and view points of the three parties to the audit.

The party at fault in your explanation is the Auditor, specifically, the Lead Auditor on that audit. It is the auditor’s responsibility (the Lead Auditor) to determine if enough objective evidence exists for the issuance of a request for corrective action. In this case, they stated the need for Corrective Action as part of the Audit Report, which might be correct with regard to how you structured your audit program. Traditionally, requests are treated separately, but in the case of Medical Device manufacturers, this is often not the case.

I disagree with allowing management (the client) the ability to issue corrective actions as part of the audit process. If they want to issue a request for CA outside of the audit process, that’s their prerogative, but they weren’t part of the auditing process whereby they lack the intimacy of details, conditions, and quite possibly, independence (the Client is sometimes the Auditee as well) at the time of the audit. I think that if you review a few resources on auditing, you’ll find that they’ll state that the responsibility for issuing CA requests rests with the Auditor.

I also get the impression that your audit program might be dysfunctional in that it might be used as a weapon of war. “CAR Wars” might pop up whereby the finger-pointing may take on a whole new look of ‘ugly’. An auditor one day may be an auditee another, and folks might be looking to get even rather than improve the QMS.

As I stated before, it looks like your organization does not understand well enough the audit process (i.e. parties, responsibilities, purpose, etc.). This is fundamental to a well running audit program. If nobody there is a resident authority, then you may need to get some outside resource in or attend some classes.

Keep posting here, though. There are many good auditors amongst the Covers who can offer good guidance.

Regards,

Kevin
 
J

jmiruzzi

#19
Thank You everyone for your assistance.
Our quality team met this morning and will re-inforce the role of the audit team and Lead Auditor responsibility of identifying Corrective Actions.
We appreciate your help and opinions.

Jennifer
 
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