Laboratory Scope must include inspection stations out on the shop floor

[JRKH]

Lab Scope

OK. Had our document audit yesterday. Everything is going fairly well. Nothing major. Then we reach 4.10.6.1.

The Auditor informs me that the lab scope must include any inspection station out on the shop floor. That this was the way it was explained to him by the AIAG trainers.

We do have an open area in the shop where inspections are performed. This area is not controlled for temp, or humidity, nor do we do anything but dimensional inspection there.

The definition of Laboratory in Section I of the manual does not include inspection, plus the note at the head of 4.10.6 states that 4.10.6 does not apply to inspection or testing performed outside of a laboratory. The QS-9000 Glossary definition for Labaoratory does include dimensional inspection, but also defines it as a "test facility". To me, a facility indicates an area seperate and controlled.

So to the question: Do I need to create a scope for this or is my auditor off his rocker.

James

 

[Sam]

The standard is quite clear, Lab requirements do not apply to inspection stations.
If I remember correctly, that subject is also addressed in the earlier interpretations.

 

[Ken K]

I agree with Sam. If no testing or calibration is performed in the area, it should not need to be included.

 

[JRKH]

Sam said:

The standard is quite clear, Lab requirements do not apply to inspection stations.
If I remember correctly, that subject is also addressed in the earlier interpretations.

Thanks for your input. I did a search and found this:

http://www.aiag.org - DEAD LINK --> /quality/4.10.6.html

this seems to support my auditor since it includes an "area" in the definition of a laboratory. Any comments?

 

[Al Dyer]

Ask the registrar to assign an auditor that knows what he/she is doing. After that find a new registrar, find a new Management Rep. that can explain the system

 

[D.Scott]

The same document goes on to say -

What isn't a lab? Places where testing occurs as a part of a process, which are within the parameters of that process. In other words, if testing is adequately controlled by in-process testing and inspection, and the items to be tested are not taken out of the process to a "facility," the in-house laboratory requirement does not apply.

I am really not sure where this is going and maybe I am confused but what does the location of a floor inspection area have to do with the lab scope? The scope should cover the intent of the lab, the tests performed, the equipment available etc. I don't know of a requirement to specifically define the location of the lab elements. If your scope includes dimensional inspection, why does it matter?

Dave

 

[JRKH]

D.Scott said:

The same document goes on to say -

What isn't a lab? Places where testing occurs as a part of a process, which are within the parameters of that process. In other words, if testing is adequately controlled by in-process testing and inspection, and the items to be tested are not taken out of the process to a "facility," the in-house laboratory requirement does not apply.

I am really not sure where this is going and maybe I am confused but what does the location of a floor inspection area have to do with the lab scope? The scope should cover the intent of the lab, the tests performed, the equipment available etc. I don't know of a requirement to specifically define the location of the lab elements. If your scope includes dimensional inspection, why does it matter?

Dave

Dave,
I guess I'm on kind of a fishing expedition here, and maybe I'm the one who is confused. I have a lab scope for my calibration lab but didn't think I needed one for "inspection".

As defined, a lab is the: "(suppliers testing facility - chemical, metallurgical, reliability, test validation, e.g. fastener labs)". Since what we do is dimensional inspection, and almost all of this is done during the normal production process, (though not "right at the machine"). I don't equate this "inspection" as "Testing at a Facility".

Maybe I'm wrong, but I always thought of inspection and testing as two different things.
Inspection: Checking dimensions, visual inspections of surfaces etc,
Testing: Destructive ( tensile, shear, fatique etc) and Non-destructive: (hardness testing etc.)

Like I said, maybe I'm the one who is confused.

James

 

[Ken K]

James, who exactly is doing the inspection? Production people, QA, lab personnel?

Is the inspection a function of your lab?

I guess my point is if someone from quality comes through and grabs a part, sets it aside and inspects it, does that area also become part of the lab scope.

That this was the way it was explained to him by the AIAG trainers.

I would really ask your auditor to show you evidence of this "interpretation" from AIAG.

Was this area questioned before? New auditor?

 

[M Greenaway]

Just to add my comments in support of what has been said above. An in-process inspection area is not by definition an inspection or test lab, and as such does not require a 'scope'.

 

[Howard Atkins]

C3 Test Equipment at Work Station (QS-9000, cl. 4.11.2) (01/22/99)
Individuals verifying gages at their in process work station do not have to comply with the
requirements for test laboratory if they are not calibrating equipment at their work station.
If individuals are calibrating equipment, they shall be included in the laboratory organization.

Sanctioned agreements
Any activities that are part of the normal process control are not required to be lab scope.