Auditor wants to know where our calibration procedure came from - TS16949

[Hershal]

My interpretation of the original question is not unlike what I ask when I assess cal labs.....what is the SOURCE of your internal procedure?

If the source is a NA 17-20 series or a T.O. 33K or a relevent ASTM Standard, no sweat, they are well validated.....however, if it is a lab-developed procedure, then it must be validated.

I suspect that is the question here.....so you should have a validated source like the military procedures and reference that in your internal procedure.

Of course, unless you have calibration professionals performing your internal cal, I always recommend outsourcing to accredited labs.

Hope this helps.

Hershal

[apestate]

Hershal

Of course you are talking about evaluating calibration laboratories. While unpleasant, there are certainly different circumstances in most factories, especially the small and mid-size. And of course we're not talking about specific TS-16949 requirements, but about actual practice in calibration laboratories. Proper calibration.

Could you go into more detail on NA 17-20 and T.O. 33k--or other sources of validated calibration procedures that you referenced in your post?

How would you come up with validated procedures for tools like the following:

Sunnen GR series dial bore gages
Sunnen PR bore gaging stand (looks like a toaster or old time radio)
Mitutoyo twin-beam digital readout height stand
TESA-Hite Plus D 600mm digital height stand

Since we're not eligible for GIDEP participation (bleh), and since I don't see anything at NCSL or anywhere, the plan is to develop a procedure based on MIL-PRF-38793B, Performance Specification, Technical Manuals: Calibration Procedures - Preparation. This standard will be the basis of the procedure.

The procedure itself will come from the manufacturer and any other information I can get. As far as validating... I think we'll work toward that when we have something to work WITH. Of course it'll probably never happen because it'll probably be seen as overkill for a tractor/implement parts factory.

In short, could you go into a little more detail about sources for calibration procedures for this sort of gaging?

[Hershal]

The NA 17-20 series and the T.O. 33K series are military procedures.....if you don't have access to GIDEP, it is unlikely that you will have these. ASTM Standards exist for several fairly generic types of calibrations like force and oven surveys, but there are several so the equipment you listed may be covered by some of them, depending on the usage. There may also be ANSI procedures that cover the equipment.

Otherwise you plan to create a procedure seems reasonable. What you can pull directly from the manufacturer or the standard you mentioned can be considered validated. Specific lower level steps (e.g. turn knob to x position) likely do not require validation, unless they are sub-set in a section that is actually developed by the organization.

Hope this helps.

Hershal

[Ken K]

We wrote our own calibration procedures back in 1994 to cover the equipment used in the lab. Our TS (was QS) manual has the following statement which has never been questioned by the auditor. The sources listed below helped us write those procedures.



The verification methods used by the lab have been written to ensure all applicable in-house instruments used for testing are within tolerance and traceable to NIST where applicable. These methods have been written with guidance from the following;

• MIL-STD 45662A - Military Standard Calibration Systems Requirements
• ISO 10012-1 - Quality Assurance Requirements for Measuring Equipment
• ANSI/NCSL Z540-1 - Calibration Laboratories and Measuring and Test Equipment
• Mitutoyo Recommended Practices
• Original equipment suppliers calibration methods / recommendations

[Al Rosen]

There is a copy of Mil-Std-120 in the free files area. It has some cal procedures.

[RESET]

Update:
Our surveillance audit has come and gone. I asked our quality manager several times for more information. I never received any further explanation. Before the audit I went thru every one of our 21 calibration procedures. I did change a couple to correct some things that I thought were incorrect. The question of procedures never came up. This topic has not been discussed here since.

I want to thank you all for your input. I learned a couple things in the process and chasing this caused me to find other potential problems with our system.

[Jim Wynne]

In Reply to Parent Post by RESET

I want to thank you all for your input. I learned a couple things in the process and chasing this caused me to find other potential problems with our system.

Ah, serendipity. The deeper you dig, the more likely you are to fortuitously find things you weren't looking for. It pays to pay attention.