Internal Audit Findings and Issuance Problem

M

Muhd Firdaus

#1
Dear All,

i have conducted internal audit for QA Department and want to issue NCR
for them due to the followings:

1)One Corrective Action Request has not been closed after the due date,
7 days from the date of issuance
2)One Corrective action Request has been replied by the process owner.
However,thre is no indication to show that the contermeasure given
has been verified for its effectiveness by QA Department as to close the CAR.

3) One Corrective Action Request already replied and closed. However ,the status of the report not updated into CAR REGISTER.


i am not sure which clause in ISO9001:2008 that i can use to issue my findings to QA Department. Kindly assist
 
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#2
Why do you want to cite an ISO 9001 requirement (other than your system has not matured enough to the point that you can simply rely on your QMS procedures as requirements)? A better suggestion would be to cite the actual requirement from your corrective action procedure - there should be supplemental controls already documented for closing CAR's and such. If no such controls are present there, then the problem would lie in the corrective action procedure itself, and (just to bake your noodle even further) the resulting NCR may not even end up the responsibility of QA, but rather the person in charge of managing the corrective action process (which may or may not be QA depending on your system in place).

I would also check what you have in place for control of records, and training/evaluation to see if there are any glaring omissions or gaps in those processes as well. If your system has matured enough, your QMS procedures should act as the primary source of your requirements, with ISO requirements being only secondary in nature, otherwise you are only operating in the spirit of "conformance" and not "continual improvement".

Brian :rolleyes:
 
S

SuperGirl

#3
Why do you want to cite an ISO 9001 requirement (other than your system has not matured enough to the point that you can simply rely on your QMS procedures as requirements)? A better suggestion would be to cite the actual requirement from your corrective action procedure - there should be supplemental controls already documented for closing CAR's and such.
I second this.
 
#4
I am not sure I would issue against the standard.

1) The late CAR. Where did the "due date" come from? Since that came from your own documentation, I would use that as the requirement/standard. If you have to write to the standard, you would be looking at 8.2.2 "The management responsible for the area being audited shall ensure that any necessary corrections and corrective actions are taken without undue delay..."

2) The CAR countermeasure not being verified. This one is a little stronger to the standard, also in 8.2.2 "Follow-up activities shall include the verification of the actions taken... " However, it could be argued that the internal audit was the follow-up activity. Again your local documentation may be more specific on closing out CARs

3) The CAR register not being updated. ISO 9001 does not mandate a CAR register. Again, somewhere in your local documentation it should mandate the register and look there for the requirement for updating it. If you have to go back to the standard, I would look at 4.2.4

I always recommend writing to the lowest possible documentation level. I also highly recommend quoting the actual "shall" that is being violated.

Hope that helps.
 
#5
Dear All,

i have conducted internal audit for QA Department and want to issue NCR
for them due to the followings:

1)One Corrective Action Request has not been closed after the due date,
7 days from the date of issuance
2)One Corrective action Request has been replied by the process owner.
However,thre is no indication to show that the contermeasure given
has been verified for its effectiveness by QA Department as to close the CAR.

3) One Corrective Action Request already replied and closed. However ,the status of the report not updated into CAR REGISTER.


i am not sure which clause in ISO9001:2008 that i can use to issue my findings to QA Department. Kindly assist
Why do you have to cite an ISO clause? Will it make any difference to the finding? Will it matter to anyone else?
 
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