Laboratory Scope - Need some advice regarding our Laboratory Scope

S

S Roepstorff

#1
I am new to this forumg but need some advice regarding the
laboratory scope.
I am asked to write the laboratory scope as part of QS9000, as I am
responsible for our material laboratory.
How detailed are the scope supposed to be?
Does it need to cover all specific test carried out in the laboratory?
Does anybody have a example of a laboratory scope I could see, to get an idea of
the format needed.
Kind regards,

S¿ren Roepstorff
Denmar
 
Elsmar Forum Sponsor
S

Systems Guy

#3
I too have recently been asked to create a Lab Scope.
I am new here but I've ploughed my way through the 'old threads' and have sent a couple of emails out asking if anyone has a Lab scope e.g. they could send me - to no avail.
If anyone does have a helpful example that they could send me, I'd be real greatful.

Thanks for any help!
 
B

Bill M

#4
The best information for a lab scope is from the glossary in QS-9000. Three requirements: a list of the types of testing or calibration done, a list of the equipment used for those tests and calibrations and a list of the methods and standards used. The confusing part is that most make these lists part of a controlled document although the glossary says the lab scope is a record. The second confusing thing is "What is a lab?" IMHO a lab scope could be a cover page you would provide with the lab data to show your facility is competent enough to do the test asked of it. Even one page A2LA or calibration certificates cover most of what is needed for a lab scope. You can keep it to a page or two. Also make sure that the lab has personnel adequately qualified for any of the tests listed in your lab scope, otherwise you should not claim your lab is capable of those tests.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#5
Originally posted by Bill M:

...The second confusing thing is "What is a lab?"
Anything not done as a part of the production process. If you calibrate a device in-house some registrars call that a lab function and as such - you guessed it - you have a lab! Even if that cal is done in the Q manager's office.... That said, I will agree it is still confusing.
 

Marc

Hunkered Down for the Duration
Staff member
Admin
#6
Fri, 17 Mar 2000 11:37:42 -0500 (EST)
From: Greg Gogates <[email protected]>
To: [email protected]
Subject: Laboratory Scope RE4
Sender: [email protected]

Date: Wed, 15 Mar 2000 14:31:40 -0500
From: Steven R Stahley [email protected]
To: Greg Gogates <[email protected]>
Subject: Re: Laboratory Scope

As the chairman of the AIAG Cal Lab Work Group I can not tell you what your QS auditor will want to see as I have seen a very broad range of interpretations for lab scope. I would recommend you try to adopt the ILAC model as closely as it makes sense, refer to the ILAC document on lab scope on their web site www.ilac.org, as this will be the direction I believe you will need to go in the future.

Steven Stahley
Manager, Corporate Metrology
Cummins Engine
 
D

Daniel M. Miller

#8
My company is a design and manfacturer of multi-feature variable gaging system. We build anything from stand alone bench gages to fully automated PLC type, in-line machines for dimensional measurement. We integrate technologies such as LVDT, capactiance, eddy-current, laser, temperature sensors, weigh scales, force gages, etc. We do not manfacture gaging such as ring gages, plug gages, flush pin, or dog-house style gages. We have been removed from the bid-list of one major automotive plant because we are not ISO/IEC Guide 25 / 17025 accredited. I have written the buyer at this facility a letter stating that I will only use an accreditated laboratory for the calibration and certification of the gage setting master used on their equipment. They are unwilling to change their decision at this point. I do not beleive that the intent of QS9000 calibration services 4.11.2.b.1 was written for an organization ssuch as mine. The question is, where do I find clarification on who is required and who is not required to hold the ISO/IEC Guide 25 / 17025 accreditation?
 
D

D.Scott

#9
I don't think you will find anything that says you must be accredited. You are, unfortunately, in the same boat as a lot of us who are required by our customer to meet their mandates. If you want to do business with them, you have to "bite the bullet" and comply with their requirements. Sorry to be the bearer of bad tidings.
Dave
 
J

J.R. Strickland

#10
In response to the confusing question "What is a lab?" Here is my take on the definition which I believe is fully supported by the text of the standard...

The key here is to answer the question..."What is the primary purpose of
the lab?" The QS-9000 glossary defines a laboratory as "...a test facility that may include chemical, metallurgical, dimensional, physical, electrical,reliability testing or test validation." The operative words in this definition are TEST FACILITY. If the primary purpose of the lab is to produce a test or inspection result (this would include calibration), it is a lab and requires a scope as defined in the standard. If the primary purpose of the lab is for engineers and scientists to play, tinker, and design a new product, it probably doesn't meet the
definition even if it may have a couple pieces of measuring equipment they use as an aid in their development. With this in mind, a scope of operations would not be required. Again, the operative words are TEST FACILITY. This certainly does not exclude a development "lab" from following other resident procedures such as calibration, safety, ESD, chemical handling, housekeeping, cleanliness, etc. that may be established.

This position is further supported by looking at the context of the 4.10.6 requirement...Inspection and Testing. 4.10.6.1 starts right off by saying,"The laboratory (supplier's testing facility..." The clear intent of this element is to ensure that when accept/reject decisions are made about a product's integrity or quality, the test data or inspection results used in that decision are from a reliable and credible source.

We have used this approach without any argument from any of our assessors for 4 years now. It is a common sense approach and has not even been debated. (Except for Incoming Inspection...which our registrar
stated was a lab and we didn't agree. In the end, we applied the logic stated above and agreed. The primary purpose of Incoming Inspection is to produce a test or inspection result.)

Hope this helps.
 
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