TS16949 - No "For Reference Only" Gages allowed?

[bobdoering]

Since this is in the TS forum, I would still qualify the need of any gages identified in the control plan to be calibrated.

What typically confuses people is what calibration actually means, and what the calibration requirements for each gage is. This confusion either has them send everything out because they do not understand it at all, save some for in house, with varying success depending on the training of the individual(s) doing the calibration, or giving up and putting "for reference only" on it. Of course, the ability to adjust a gage has nothing to do with calibration. All gages should be able to be compared to a standard. The only difference between gages that can or can not be adjusted is the reaction plan if they fail calibration.

If I was to audit, I would look at the control plan, check out the gages for the operation, review the calibration records and associated calibration procedures, look for evaluation of meeting calibration (comparison to a standard, with the identification of the standard's traceability, etc.), verification of linearity and stability, where required. I would inquire of the basis for your calibration frequency. If you can muster that information correctly, you are doing pretty darn good. If you can go the next step and have valid uncertainty data, you are way out in front of the pack. On the other hand, if the gage said 'for reference only", then I would ask to see the gage that is actually used to measure the control plan characteristic, and how the product is protected from being measured with the 'for reference only' gage.

 

[qusys]

Since this is in the TS forum, I would still qualify the need of any gages identified in the control plan to be calibrated.

What typically confuses people is what calibration actually means, and what the calibration requirements for each gage is. This confusion either has them send everything out because they do not understand it at all, save some for in house, with varying success depending on the training of the individual(s) doing the calibration, or giving up and putting "for reference only" on it. Of course, the ability to adjust a gage has nothing to do with calibration. All gages should be able to be compared to a standard. The only difference between gages that can or can not be adjusted is the reaction plan if they fail calibration.

If I was to audit, I would look at the control plan, check out the gages for the operation, review the calibration records and associated calibration procedures, look for evaluation of meeting calibration (comparison to a standard, with the identification of the standard's traceability, etc.), verification of linearity and stability, where required. I would inquire of the basis for your calibration frequency. If you can muster that information correctly, you are doing pretty darn good. If you can go the next step and have valid uncertainty data, you are way out in front of the pack. On the other hand, if the gage said 'for reference only", then I would ask to see the gage that is actually used to measure the control plan characteristic, and how the product is protected from being measured with the 'for reference only' gage.

Agree.
But what about the several tools that are used by techs during maintenance acitivities ( I mean multi-meter,volt-meter, oscilloscopes, torque wrench , sensor on equipment for safety, etc...)? they are not referenced in the control plan , but the organization shall define how to treat them ( if they are critical for form, fir and function, safety etc)

 

[bobdoering]

Agree.
But what about the several tools that are used by techs during maintenance activities ( I mean multi-meter,volt-meter, oscilloscopes, torque wrench , sensor on equipment for safety, etc...)? they are not referenced in the control plan , but the organization shall define how to treat them ( if they are critical for form, fit and function, safety etc)

If they are critical for form, fit and function, safety etc., I would question why they are not on the control plan (as well as the PFMEA). It sounds like they would fall under process controls, if they apply. You have to get pretty far from the process to really make sense of using unverified gaging.

I would also include the gaging used for qualified lab testing, including DV and PV testing as candidates for calibration. Some customers want to see that on the control plans, some do not specify it...but as a qualified TS lab, you can bet it is applicable.

 

[vanputten]

"You have to get pretty far from the process to really make sense of using unverified gaging."

Do you mean one has to get pretty far from the process of determining product conformity to requirements to really make sense of using unverified gaging? I ask this from a purely meet TS 16949 requirements, not from an optimization or best practice standpoint.

 

[bobdoering]

"You have to get pretty far from the process to really make sense of using unverified gaging."

Do you mean one has to get pretty far from the process of determining product conformity to requirements to really make sense of using unverified gaging? I ask this from a purely meet TS 16949 requirements, not from an optimization or best practice standpoint.

What I mean is you have to get pretty far from the process to find gages that have no relationship to the control of the process or product verification so as to not need MSA - MSA being calibration, gager R&R, etc. You will not find a black and white TS 16949 minimum requirement such as "it must be a dimension on the customer print to require calibration" because there are so many different things that may impact the net output that need valid measurement systems to assure it. You can play cat an mouse with your assessor as to what does or does not need calibration...and some folks put more effort into that effort just having a meaningful calibration system. But my position is if you need it to measure the part or control the process it should be on the control plan and it should have valid MSA. It is simply not that hard.

I ask this from a purely meet TS 16949 requirements, not from an optimization or best practice standpoint.

Why should that be divergent?

 

[vanputten]

I don't know why meeting a standards requirements and optimization should or shouldn't be divergent. I was framing my question to avoid getting wrapped up in a philosophical debate on what is optimal.

 

[The Specialist]

I disagree with many contributing to this debate.

There is no regulation that states ‘thou must not categorise instruments/measurement devices as reference only’.

If the organisation has a robust and clear method/procedure for handling/categorising instruments and devices then they are well within their rights to label them as they wish; providing that it is clear as to the intended use and categorisation of the instrument.

In my view, labelling instruments with ‘for information only’ or ‘reference only’ is a good thing for the following reasons:

· Operators are CLEAR as to the allowable use of the equipment
· It is clear on observation of the equipment as to its calibrated/control status
· There can be no fear that the instrument has just lost its ‘label’
· It is clear that the instrument has been included in the impact assessment/criticality review process and has not just been ‘missed’

The only thing that matters, IMO, is that those instruments that require calibration have been identified and scheduled for routine calibration/verification. AND that this decision (to calibrate, or not) was made following proper impact/criticality/risk assessment.

Beyond this; why does anyone care how instruments are categorised or labelled??

 

[The Specialist]

I totally agree, Jan. Dirk is also correct - in principle, however, the vast majority of people who take the route of 'for reference only' markings on measuring equipment or documentation either are uneducated to the ramifications of their choices or are taking the 'silver bullet' approach to (cynically) getting certified.

What?
Nonsense. IMO

There may be many 'valid' reasons for using 'for reference only' tagging on instruments.
Where has the assumption come from that this is being used as a lazy or cynical approach to instrument control?
A totally myopic view.

 

[Stijloor]

What?
Nonsense. IMO

There may be many 'valid' reasons for using 'for reference only' tagging on instruments.
Where has the assumption come from that this is being used as a lazy or cynical approach to instrument control?
A totally myopic view.

How about 45+ years of experience both in Europe and the USA?

Stijloor.

 

[The Specialist]

How about 45+ years of experience both in Europe and the USA?

Stijloor.

Sorry, so 45+ years experience has taught you to make assumptions about other people’s processes and procedures?