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  Post Number #1  
Old 9th March 2010, 01:41 PM
wes77

 
 
Total Posts: 20
Please Help! Audit Findings - Refusing outside audit findings

If you found a deficiency with a company during an audit regarding CAPAs, the company says it was of an older CAPA system. The issue has been addressed by updating the system.

The company made the statement after the audit report was written, and there was no mentioning of this during the audit.

Can the company decline this finding?

Is the company responsible for addressing past deficiencies retrospective to the changes of the CAPA system?

What is the general consensus of refusing outside audit findings? I have never experienced this before.

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  Post Number #2  
Old 9th March 2010, 01:51 PM
Sidney Vianna's Avatar
Sidney Vianna

 
 
Total Posts: 9,319
Re: Audit findings

Quote:
In Reply to Parent Post by wes77 View Post

If you found a deficiency with a company during an audit regarding CAPAs, the company says it was of an older CAPA system. The issue has been addressed by updating the system.

The company made the statement after the audit report was written, and there was no mentioning of this during the audit.

Can the company decline this finding?

Is the company responsible for addressing past deficiencies retrospective to the changes of the CAPA system?

What is the general consensus of refusing outside audit findings? I have never experienced this before.
Just another example of games that some registrants want to play to get to the certificate as soon as possible. If the non-conformities found earlier were valid, it is inconsequential what “CA/PA” system the organization uses to resolve them.
If we were to accept this excuse rationale as valid, the registrant would soon learn that they can get “away with murder” if they “claim” that new processes, procedures and systems have been recently implemented, conveniently in close proximity with an external audit.
Shameless in my opinion. And, the worse part is to realize that some CB/auditors would accept this
Thank You to Sidney Vianna for your informative Post and/or Attachment!
  Post Number #3  
Old 9th March 2010, 02:03 PM
JRKH's Avatar
JRKH

 
 
Total Posts: 972
Re: Audit findings

Quote:
In Reply to Parent Post by wes77 View Post

If you found a deficiency with a company during an audit regarding CAPAs, the company says it was of an older CAPA system. The issue has been addressed by updating the system.

The company made the statement after the audit report was written, and there was no mentioning of this during the audit.

Can the company decline this finding?

Is the company responsible for addressing past deficiencies retrospective to the changes of the CAPA system?

What is the general consensus of refusing outside audit findings? I have never experienced this before.
Difficult question.
It might depend on when this audit was performed (registration audit of a new system)
The type of audit. (internal or external)
The reason for the audit. etc.

It might also depend on the scope of the problem.
I recall having to deal with such an issue years ago where we had about 1000customer supplied drawings in file cabinets - some used regularly and some rarely if at all. As we prepared for registration, we did not wish to have these drawings questioned as to contract review, current revision etc.
Our solution was to aquire two new file cabinets and move the Old cabinets to another location. Then, if and when an order came in for the part, the drawing could be gotten reviewed and filed in the new system.
Could you imagine the headache if we tried to review all of the drawings just to "retroactively addressing" these drawings due to a substandard process?
(Note - When I left the company about 2 years after registration, fewer than 25% of the drawings from the old files had been moved.)

So anyway - If you are concerned about this response, you might ask for further details.

Peace
James
Thanks to JRKH for your informative Post and/or Attachment!
  Post Number #4  
Old 9th March 2010, 02:30 PM
wes77

 
 
Total Posts: 20
Re: Audit Findings - Refusing outside audit findings

this was a external audit of a sister company in Europe.
  Post Number #5  
Old 9th March 2010, 02:49 PM
Jim Wynne's Avatar
Jim Wynne

 
 
Total Posts: 14,228
Re: Audit Findings - Refusing outside audit findings

Quote:
In Reply to Parent Post by wes77 View Post

If you found a deficiency with a company during an audit regarding CAPAs, the company says it was of an older CAPA system. The issue has been addressed by updating the system.

The company made the statement after the audit report was written, and there was no mentioning of this during the audit.

Can the company decline this finding?

Is the company responsible for addressing past deficiencies retrospective to the changes of the CAPA system?

What is the general consensus of refusing outside audit findings? I have never experienced this before.
Quote:
In Reply to Parent Post by wes77 View Post

this was a external audit of a sister company in Europe.
It's not clear to me what the finding was about. Was there something wrong with the CA system itself, or with a particular NC that wasn't properly addressed? If the former is the case, and the system has been improved such that it conforms to requirements, I might protest the finding (depending on other circumstances not in evidence at this point). If there was a nonconformity that wasn't properly addressed due to the deficiency of the system, and it still hasn't been properly addressed, there's cause for concern.

Whether or not your sister company "accepts" your findings is an internal matter. I assume that your description of the company as a "sister" means that the company and whomever it is that you work for (directly) are subsidiaries of some larger entity, one that has developed a scheme of subsidiaries auditing one another. That scheme should include methods for refereeing when necessary. If it doesn't, you should report the findings (and the auditee's disagreement) to some higher authority for mediation.
Thank You to Jim Wynne for your informative Post and/or Attachment!
  Post Number #6  
Old 9th March 2010, 05:11 PM
Bruser

 
 
Total Posts: 16
Re: Audit Findings - Refusing outside audit findings

Why fight the battle unless someones performance is measured by the number of nonconformances in an audit.

Take the n/c, use the "new CA system" to document it and provide corrective action with implementation dates and submit for closure. Next audit if they are doing what they say it will be evident
Thank You to Bruser for your informative Post and/or Attachment!
  Post Number #7  
Old 9th March 2010, 05:23 PM
LSS Master

 
 
Total Posts: n/a
Re: Audit Findings - Refusing outside audit findings

I agree with Bruser. If the issue is really resolved, it will not reappear during the next audit. If not, it will reappear, especially if you note it in your audit report, which you should review prior to performing the next audit.

The strength of the audit system is its cyclic method. If you miss a n/c during an audit, it will surely appear again during a future audit.
  Post Number #8  
Old 9th March 2010, 07:49 PM
wes77

 
 
Total Posts: 20
Re: Audit Findings - Refusing outside audit findings

THe issue was not verifying effectiveness of CAPA.
The procedure was marginal in describing how to verify effectiveness of CAPA.

In the CAPA shown to me, there was no verification of the CAPA just implementation of the CAPA. It was also not explained to me the CAPA shown was of a older system.

From that, my determination was CAPA system needs improvement since there is no verificaiton of effectiveness.

Is my finding still valid after their comments of CAPA being of an older system?
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