QS-9000 Clause 4.11.2.b.1 - Calibration by OEM vs. Accredited Laboratory

  • Thread starter J.R. Strickland
  • Start date
J

J.R. Strickland

#1
Calibration by OEM vs Accredited Laboratory

We have an ongoing (going on 4 years now) argument with our Registrar regarding the use of OEM equipment manufacturers vs accredited labs. The note in Section 4.11.2.b.1 states that "Where a qualified laboratory does not exist for a given piece of equipment, calbration services may be performed by the original equipment manufacturer". Our Registrar has interpreted this to mean we must show evidence that a qualified laboratory does not exist prior to utilizing the original equipment manufacturer for calibration services. This issue really came to light during one of our surveillance audits when the assessor inquired as to the "accreditation" of the calibrator of a particular piece of mechanical measuring equipment. The situation is that the OEM had a local field representative that could drive in from about 50 miles away and perform the cal. The nearest "accredited" lab was on the west coast. Not needing to be a rocket scientist to determine the cost implications and assuming the OEM field representative knows his/her own equipment better than some 3rd party, we took the field rep approach. Our auditor says we should have flown the person in from CA. Our position has been,and continues to be, calibration by the original measurement equipment manufacturer should be acceptable, without searching for a "qualified laboratory".

Any comments, different interpretation approaches from different registrars, other pearls of wisdom would be appreciated.


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W

W. Kindel

#2
Hi!

QS9000 is notorious for using terminology that isn't formally defined anywhere, and this can often be used to your advantage. The term I refer to here is "Qualified": Since QS9000 doesn't define the word anywhere, why not define it yourself in your procedures, to include close geographic proximity as one of the "qualifications" for your calibration service? Since QS9000 claims as one of its objectives the "reduction of waste in the supply chain", it shouldn't be too hard to demonstrate how it's wasteful to fly someone across the continent to perform a function that can be done by a guy 50 miles away. Just my thoughts - anyone else?

W. Kindel
 
K

Ken K

#3
You have brought up a point that is becoming increasingly frustrating for many companies, ours included. Quite simply, auditor/registrar interpretations. We have gone through the same situation regarding our 6 environmental chambers (along with other issues) We actually had to show there were no accredited labs that could calibrate/maintain these chambers. A letter from the manufacturer finally settled it in our favor.
Interpretations are a dangerous thing. Who's to judge which one is correct; yours or the
auditor/registrar? A non-conformance is one thing; a bad interpretation that lead's to a
non-conformance is evil!
Good luck.
 
W

W. Kindel

#4
Hello again!

We're fortunate to be a very small company, one in which the people who's work is being audited are the same ones who must approve the registrar's invoice before it gets paid. It's amazing how agreeable auditors can become when they realize that if they can't prove their point to our satisfaction, they won't get paid for their trouble (not to mention getting reimbursed for their hotel and airfare . . .)

Keep in mind that you're the customer, and sometimes it pays to act like it!

W. Kindel
 
S
#5
J.R.
Refer to page 2 oh the QSR 3rd ed.;
Notes are for guidance only and therefore are not to be audited. You may want to search the IASG sanctioned interpretations for more info on this topic.
 
J

J.R. Strickland

#6
Thanks for everyone's response. I have already taken into consideration most of the input. I must admit though, I haven't considered holding an invoice hostage.

Well, the rest of this issue is even more interesting...We did not like our registrars interpretation and submitted a question to the IASG following the steps as detailed in the 3rd edition interpretations dated February 29, 2000, Paragraph I.B "How to Communicate". The response we received supported our position, our registrar didn't like it and I told them we following the aforementioned defined process and we expected them to comply. They then performed their own investigation which eventually ended up at RAB. RAB's position is that the standard is clear and there is not need in changing their process and will continue to audit registrars to the same "clear" interpretation of the standard which is to calibrate using 1) a qualified internal lab, 2)an accredited lab, or 3) customer recognized government agency. This strict interpretation says that you can not use the OEM if an accredited lab is available, regardless of cost impact. Thereby forcing you to prove that an accredited lab is not available. Perhaps they forgot the goal was to reduce waste in the supply chain.

When will the madness stop?


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B

BigEasy Scientist

#7
Originally posted by J.R. Strickland:
3) customer recognized government agency

[/B]
What are some examples of these agencies?
I'm having problems finding an accredited lab for calibrating scales, and our current lab will not meet the Jan 01 deadline. They do calibrate the state DOT scales. Would this be close enough to 'government agency'
 
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