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Audit issues help

T

Timmers

#1
:truce:

I don't know if this is the correct area t post these questions or not, but we recently went through a pre audit and I had some issues that i need help with, and since I did not get to speak to the auditor before he left I could not ask him what some of these actually mean. I am new to all of this so if I sound ignorant or dumb please forgive me.

1. No evidence that our gagetracking software is certified to meet with QS9000 3rd edition. I have called the software vendor and they aren't sure what is needed.

2. No evidence that "Master" blocks (grade 3 ) are adequate to calibrate our measuring equipment. Now, we don't manufacture rockets so we don't have a very tight tolerance on our parts
( most parts we have .030" - .120"). So wouldn't a grade three that is used only for checking and calibrating our equipment be adequate?

3. Calibration procedures do not meet with "international" practices. What are international practices?

4. Develop a "drop off" policy and place visual aids at the working stations. What is a drop off policy?

I hope these questions don't sound silly, but if any one has been through this and knows what I am talking about, I could sure use the help.
 
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D

D.Scott

#2
Timmers - First and foremost - call the auditor and get his advice on what he found and what he means by the findings.

It looks to me as though there is a lot missing for us to make a definate statement but I will try to venture a guess. My comments are only my opinion and certainly aren't authorative.

1) Not knowing what software you use and what you use it for, I am not sure where he is going - If you only track your gages, I don't know of a requirement for certification. If you are using a gage R&R program in the software, it should follow the MSA guidelines. It was my understanding that commercial software was exempt from this verification but I may not be on the right line of thought here.

2) Your Master Blocks should be traceable to an NIST standard and you should be able to provide calibration certificates for each. The certificate should have all the requirements covered. The Masters should be able to verify accuracy of the calibrated device in increments suitable for your measurement needs. If you stick with 10:1, you should be ok.

3) Not sure here but he could be referring to ISO Guide 17025.

4) This sounds like an "opportunity for improvement" to establish a policy for handling gages on the floor. It sounds like there is currently no organization of gages and they are out on the floor with no control over who has them and maybe no way to verify the current state of calibration. The "drop off area" would serve as a central point for gage control.

These answers are intended to get you going but check with the auditor on these points. It sounds to me like you did pretty well for a pre-audit if those were the only issues. It should be an easy thing to fix and you are on your way.

Good luck - and welcome to the Cove.

Dave
 
#3
Timmers,
You should contact your auditor and review the NCR's. I can provide a "guess" as to what he may be referring to.

"1. No evidence that our gagetracking software is certified to meet with QS9000 3rd edition. I have called the software vendor and they aren't sure what is needed. "
- Products are not certified to QS9000, Companies are. He may be referring to you supplier development process.

"2. No evidence that "Master" blocks (grade 3 ) are adequate to calibrate our measuring equipment. Now, we don't manufacture rockets so we don't have a very tight tolerance on our parts
( most parts we have .030" - .120"). So wouldn't a grade three that is used only for checking and calibrating our equipment be adequate?"
- For QS he may be referring to 4.11.2.a

3. Calibration procedures do not meet with "international" practices. What are international practices?
- For QS he may be referring to 4.11.2.b.1 2nd para.

4. Develop a "drop off" policy and place visual aids at the working stations. What is a drop off policy?
- Never heard of the term.
 
Q

qualitymanager

#5
M Greenway,

Are you referring to the requirement in ISO/IEC 17025:1999 (clause 5.5.7) which says equipment which may have been mishandled (dropping a gauge seems to me mishandling) has to be taken out of service? (I'm no expert on 17025 - I've only done a 2-day overview of the clauses. I don't have any experience with QS-9000).

Arguing the semantics ("drop off policy") I'd interpret what Timmers says as probably meaning a policy on responsibility for custody of items/equipment.

We'll have to wait on the response from the auditor, I guess.


qualitymanager
 
M

M Greenaway

#6
My aplologies.

I was thinking QS9000 when I replied, however probably meant Ford Q1 (I think its in there).
 
R

Randy Stewart

#7
Drop Off

What is a drop off policy?
Our "Drop Off" policy is that dates are posted throughout the shop when gages are due for calibration and the individuals (employee owned gages) who own the due gages drop them off at QA for calibration.
I could be that simple.
I know I don't have all the information from your planning visit so I say this just from the information you provided.
I would question the professionalism of the auditor if s/he left you with these questions after a planning visit. They may not have given you the corrections needed but they sure could have explained themselves better. You can see by the different answers posted here, from people that have been in the trenches for years, and we still don't really know what the auditor was asking for!
If you are responsible for the calibration and the auditor did not go over their findings with you, then IMHO the auditor has not done their job properly. Contact your registrar / account mgr. and get some resolution.
 
M

M Greenaway

#8
Good points Randy.

The audit findings should be specific.

I would be inclined to 'play the game' and close the first finding based on the fact that there is no requirement in QS9000 for calibration management software to be certified to meet with QS9000 third edition.

For the second finding I would ask the auditor to prove they were inadequate.

The third requirement is only a recommendation in QS9000.

And the fourth finding is utter rubbish as there is no requirement for a 'drop off policy' or mandatory visual aids required by QS9000.

Did the auditor have any specific evidence that the system was not working ? Did you hae loads of uncalibrated gauges in use, where calibrated gauges giving erroneous readings, was there an element of gauge management that your computer system could not handle ?
 
T

Timmers

#9
Thanks everyone. You are being very helpful by bringing up all these questions that I never would have thought about. I am having my dept. manager get a hold of the auditor so we can clear up some of these questions.

Thanks again.
 
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