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Registrar Nightmare... Document Review and Other Auditor Issues

M

MsHeeler

#61
#61
I'm hoping that he has forgotten about this, but if he hasn't I have a plan. I will mention "external documents" in the control of documents procedure and state that the manuals are kept in document control, and add them to our master list of documents as "external". This should work!

I will have to give a list of findings a little later, they are not too bad and I am fixing them as we go. "I'd like to see this" is one thing I never want to hear again.

So man fires, so little time!
Thanks for your support :biglaugh:
MsHeeler
 
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CarolX

CarolX

Super Moderator
Super Moderator
#62
#62
FWIW - a master list of all documents is NOT a requirement of the standard. We maintain a list of our documents for our QMS, but we do not keep a list of documents of external origin. We do, however, have a process for verification of latest revision of these documents.
 
M

MsHeeler

#63
#63
I think it will be easier to just make an addition to an already existing document, but I see your point. I will need to add something for verifying that they are current.

MsHeeler
 
CarolX

CarolX

Super Moderator
Super Moderator
#64
#64
MsHeeler said:
I think it will be easier to just make an addition to an already existing document, but I see your point. I will need to add something for verifying that they are current.

MsHeeler
Click to expand...
What is important is do what works best for you. I work for a job shop and we have over 5000 customer drawings on file. We would have to hire an army just to "log" these. Our process is to review the print rev to each customer order to verify we have the latest revision.
 
M

MsHeeler

#65
#65
WOW! That sounds fun!!! I will be taking over our drawings, work instructions, quality inspections, etc. after the audit is over. I'm not sure how many there are, but there are a bunch. :truce:

MsHeeler
 
M

MsHeeler

#66
#66
WE PASSED!!!!!

Ok here are the findings.

1. Not all records are stated in Control of Records.

2. Item on production floor not identified

3. No evidence that when measuring device was found to be out of calibration that and evaluation was made to see if products may have been affected.

4. No evidence that new pin gages are certified to a national or international standard.

Note: Beware, if you get a short cert from MSC direct, it is USELESS. MSC told be that it only shows that you got the parts that you ordered! :mad:

BTW - We state that we do not do design, so the auditor wanted to call the head of engineering at our sister company to interview him on product design. Wow! I could have written the auditor more minors than he wrote us! Yes, it was a nightmare. I had to argue points over and over again.

He told me that when he came back, if our Operator Work Instructions were not made a part of the Document Control System, he would write me a MAJOR. We state in Control of Documents that Operator Work Instructions were controlled using appropriate signatures. I argued this point at least 5 times in one day! Then he brought it up again in the closing meeting. I almost went across the table.

This man is an idiot! I could go on 10 more pages!

But I won't
MsHeeler
 
T

Ted Schmitt

#68
#68
:applause:

CONGRATULATIONS !!

Don´t let your guard down now... keep the spirit up and don´t think you guys are "Superman".... there´s plenty of work still to be done as you can see by the audit findings ...
 
C

Cari Spears

Super Moderator
Staff member
Super Moderator
#69
#69
MsHeeler said:
1. Not all records are stated in Control of Records.

2. Item on production floor not identified

3. No evidence that when measuring device was found to be out of calibration that and evaluation was made to see if products may have been affected.

4. No evidence that new pin gages are certified to a national or international standard.
Click to expand...
Congratulations!:applause:

We received the same nonconformance as your number three during our AS9100 registration audit because when we sent a pin gage set out for calibration they replaced two of them.
 
M

MsHeeler

#70
#70
More nightmares from the auditor! :mad:

Pre-Assesment Audit - Closed

We had no quality manual or procedures. He gave us twelve separate noncoformances for not have a procedure.

He just sent me the nonconformances and wants me to put the Procedure and revision dates that answered the nonconformance.

Documentation Audit - Closed

He sent me the "check list" to update the revision dates on the procedures.

Certification Audit - Over, Almost Closed

Just sent for signatures

So what should be my answer for the first two? Should I do it and send him a bill, or just send him a copy of the Master List of Documents?

MsHeeler
 
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