Internal Laboratory Scope - Ranges for Measurement Tools Specified?

[Dtwo5]

We do internal lab calibrations on simple measurement tools - micrometers, calipers, indicators, etc.
Our auditor is mandating that listing the range of our calibration capabilities must be included in our scope.
I responded with "show me" and he's referencing guide 25 and QS-9000!!
I've searched all the forums and cannot find anything on this - sample "scopes" do not include the "range" of instruments.
I do not feel any benefit will be gained by listing "micrometers, 0-4", indicators, 0-2", calipers, 0-24" etc" within our lab scope.
Anyone?

 

[Jim Wynne]

We do internal lab calibrations on simple measurement tools - micrometers, calipers, indicators, etc.
Our auditor is mandating that listing the range of our calibration capabilities must be included in our scope.
I responded with "show me" and he's referencing guide 25 and QS-9000!!
I've searched all the forums and cannot find anything on this - sample "scopes" do not include the "range" of instruments.
I do not feel any benefit will be gained by listing "micrometers, 0-4", indicators, 0-2", calipers, 0-24" etc" within our lab scope.
Anyone?

The fact that your auditor is citing obsolete standards is telling. Even if we do use the QS-9000 definition, a lab scope must only describe:

• the specific tests, evaluations and calibrations a supplier laboratory has the ability and competency to perform
• a list of the equipment which it uses to perform the above
• a list of the methods and standards to which it performs the above.

From QS-9000, Third Edition, page 128
In my opinion, your scope could be simply reference "mechanical measuring devices" and not even mention specifically the types of devices, so long as specific information can be gleaned from the required references to standards. In other words, your own documentation (calibration procedures, e.g.) will describe the specifics. If there's no procedure or standard that deals with calibration of micrometers, then micrometers aren't included in the scope by default.

 

[Duke Okes]

While I agree that the scope, per se, does not need to include the ranges, this should be spelled out somewhere. Otherwise, if someone asks you to calibrate something how will you know whether or not you have the capability to do so? This is obviously less difficult for an internal calibration lab, but imagine you were an external lab that got calls asking if you could do something? It would be nice to have a list of capabilities so someone doesn't agree to a contract they can't fulfill.

 

[Dtwo5]

Thanks Jim.

Duke - wow, that's a lot of "what if's".

Quite simply, people don't ask us to calibrate stuff - that is not our business. If we were an 17025 calibration facility, then yes I could see it for the reasons you cited.

Problem is our TS auditor is also "qualified" to audit 17025, so I think he's getting the standards confused.
He is insisting that in order to meet the TS internal lab requirements, we must be 17025 "compliant".

The AIAG ISO/TS 16949:2002 implementation guide, page 137, states:
"Note: Accreditation to ISO/TEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory".

Like I said - I think he is confused.

 

[Jim Wynne]

Thanks Jim.

Duke - wow, that's a lot of "what if's".

Quite simply, people don't ask us to calibrate stuff - that is not our business. If we were an 17025 calibration facility, then yes I could see it for the reasons you cited.

Problem is our TS auditor is also "qualified" to audit 17025, so I think he's getting the standards confused.
He is insisting that in order to meet the TS internal lab requirements, we must be 17025 "compliant".

The AIAG ISO/TS 16949:2002 implementation guide, page 137, states:
"Note: Accreditation to ISO/TEC 17025 may be used to demonstrate supplier in-house laboratory conformity to this requirement but is not mandatory".

Like I said - I think he is confused.

You need to remind the auditor that 16949 is the controlling standard and ask him to tell you specifically where the relevant "shall" is.

 

[BradM]

Jim is correct in his suggestions.

We do internal lab calibrations on simple measurement tools - micrometers, calipers, indicators, etc.

Welcome! You are now in the calibration business!! Stating, eventually someone is going to ask you about how you do your own calibrations. It may be a customer, auditor, etc. I'm not suggesting that you have to undertake some requirement that is not necessary or build some unneeded procedures. You should expend some effort in having proper procedures documenting the fundamentals of your calibration program.

In my opinion, there is benefit in identifying the capabilities of your operation.

Having to do things to comply with a phantom requirement is one thing. Establishing measurement capabilities as good practice is another that you may give some thought to.

 

[Duke Okes]

Thanks Jim. Duke - wow, that's a lot of "what if's".
Quite simply, people don't ask us to calibrate stuff - that is not our business. If we were an 17025 calibration facility, then yes I could see it for the reasons you cited. Like I said - I think he is confused.

So does the lab select the measurement equipment to be used by all people in the organization? If not, then you are being asked by whoever does that selection to calibrate what they select. And suppose someone in the tool room brought in a special gage, dropped it, and asked the lab if they could calibrate it? So whether you're inside or outside doesn't matter relative to knowing what you are able to calibrate vs. what you cannot.

TS does require both internal and external labs to have a lab scope. ISO 17025 doesn't actually talk about a lab scope as a separate document, but uses the term generically to indicate the range of calibration/testing services the lab is competent to perform.

It sounds to me like the quibble between you and your auditor is whether or not the ranges need to be in a particular document. The auditor does not have the right to indicate where something is, as long as you have covered it.

However, you need to think about the range thing from another angle ... intent and control. Who makes the decision on what instruments (types, sizes, etc.) your lab can and cannot calibrate? Is that person always there (e.g., they don't take vacations, they'll never get sick)? If not, having the list of types of gages you calibrate, and the ranges for which you are capable (e.g., based on the size of the calibration standards you have), would be a logical control mechanism. If something needs to be calibrated and it does not fit within the envelope of that list, either the organization has to develop the capability (e.g., get standards, provide any needed training, update calibration instructions) or outsource the calibration to someone who has the capability.

 

[Dtwo5]

We have a calibration program (MS access database software program) and every measurement instrument we have is entered into the system, along with a calibration procedure. Also, our system identifies which gages are sent out because we don't have the capability to calibrate in-house.

If/when a new measurement system is purchased, we find out our ability to calibrate it (we already know) when it is entered into our database. The system requires a calibration procedure to be selected from the existing database when a new gage is entered.

Our auditor is saying the following:
1)TS says your measurement system must be 17025 compliant.
2) Since all labs that are 17025 identify their capability ranges within their scope, then you must as well.
3) We already list the types of gages we can calibrate on our Lab Scope AND the equipment we use to calibrate them.
We already have:
Micrometers
Calipers
Plug Gages
Indicators
Etc, etc, etc
4) Now he wants us to put in:
Micrometers 0-4"
Calipers 0-24"
Indicators 0-2"
etc, etc, etc

 

[Hershal]

If your auditor is saying that the TS 16949 standard requires you to be compliant, then read the standard.....if in fact it DOES say that, then he has a valid point.....

ILAC (and its recognized Regions) require accredited labs to differentiate ranges and uncertainties on the scope.....internally, you may not need to break them down, but if you do not, then the maximum value of uncertainty (the MU taken at most coarse setting) also applies at you smallest setting.....at 20" then, the MU could be larger than the measurement. To truly be compliant to ISO/IEC 17025, you have to meet the same criteria as a commercial lab.....don't feel bad, accredited testing laboratories that have internal cal are in the same situation.

One other point, to be compliant to ISO/IEC 17025, you must have traceable calibrations, which means you must calculate the measurement uncertainty.

Hope this helps.

Hershal