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Asking an Auditor's Advice on different systems at different laboratories

C

crendfrey

#1
Greetings all,
I am thanking you all now in advance for helping me through what is coming next for me. I am also begging forgiveness for the long winded questions and explanations.
The Story:
My employer in his infinite wisdom has purchased another calibration lab which effectively doubles the size of my company. (job security for me)
This company was at one time 17025 accredited by a not so reputable AB.
I was hoping to have site specific accreditation by March 2008.
No such luck.
In order to keep a very large customer, who is willing to use some of the work a rounds I seem to have pulled out of my hat, requires accreditation sooner.
They will accept scheduling for accreditation in 90 days. Full accreditation by no later than Feb. 1st.
Its not that the system is a mess, it is just there seems to be no rational system at all.:mg:
I have decided to impose our existing system on them. I feel I am unable to administer 2 different systems in now 5 states.
My first hot issue is traceable certificates for calibration standards.
All standards must be certified by State labs in order to comply with various state weights and measures regulations.
I have a state lab that I use for the original company which I trust implicitly.
For the new company to get to that lab will require a 6 hour drive time to deliver and again to pick up. Not very cost effective.
A state lab less than an hour away has a “conditional” approval through the MAP program.
Now comes the questions for a sage 17025 auditor/assessor……..
Is this acceptable? Given my time constraints, it would be most convenient if it is.
By the same token I do not want to have to do ANYTHING multiple times. I personally have a problem with the word “Conditional” however in the interest of time and cost……. Will it fly?

PS. Many more questions will be coming at you all about FDA and Pharmacopeias,(they seem to have strange definitions of uncertainty) but first things first.
 
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Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#4
My understanding (after Google searching the subject) is that the conditional approval is specific to a certain condition or tool, which must still be corrected. Think of it as a "fix it ticket" for a brake light out on a car.

Your ability to use the lab under conditional approval status is a question for the registrar, IMHO. It might be okay if you are not using what is under this temporary status.

Is there a courier service you can use?
 
C

crendfrey

#5
Mark, I have avoided calling the state for explanation so as not to raise a red flag during the transition of the company. There are many residual issues to be overcome. Some regarding the previous owners relationship with the powers that be with the state.
Hopefully “ conditional” has nothing to do with mass calibration.

The time constraints for accreditation have me grasping at straws for quick and appropriate solutions.

Jennifer,

The problem with a courier is I must transport more than 50,000 pounds of weights for calibration.
This is very costly even using our own vehicles and of course paying the man to do it.

Thanks guys,

I do have a call into my AB to get the official answer.
I was just hoping to have some more information before I started opening all of these cans of worms……:bonk:
 

Jen Kirley

Quality and Auditing Expert
Staff member
Admin
#6
The problem with a courier is I must transport more than 50,000 pounds of weights for calibration.
This is very costly even using our own vehicles and of course paying the man to do it.
I see. That is a lot of stuff.

Does this calibration lab make house calls? I know of one around here that does.
 

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#7
First, the state lab question.....generally, state labs come under what is known as legal metrology, per OIML.....so that may not be much of an issue, just need to make sure the traceability is good, and a few other minor points.....

Secondly, don't sign with ANY of the four recognized ABs in the U.S. till you get a quote from all four and talk to their staff.....IAS, NVLAP, A2LA, and ACLASS.....discuss schedules and how to best work with your systems and approaches.....

Hope this helps.....
 
C

crendfrey

#8
Greetings and thank you Hershal,

The other two companies are already accredited by ACLASS. We at this point have a good working relationship. I believe we will also have them do the new company as I already understand and comply with their requirements to their satisfaction. I have found their auditors reasonable people with, so far, excellent input on ways to improve. Demanding but fair, to us, anyway.

My concern is this “conditional certification of traceability” from NIST.
If they (the state lab) had a cert that said “demonstrated” instead of “Conditionally demonstrated” there would be no question in my mind.
I guess I will just have to call NIST and ask what it means.
 
C

crendfrey

#9
Update…..

Well the news is all good for me.

Conditional approval is for volume only.
I spoke with NIST about approvals, we are good to go.(I think)

This eliminates a logistical nightmare for me….:biglaugh:

First batch of 2600 pounds will be on the way Monday!
 
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