Test Equipment at Work Station - Are Operator Daily Checks part of Laboratory Scope?

D

Deb Weissler

According to the latest sanctioned interpretations, C3 states: "... if individuals are calibrating equipment (at their work stations) they shall be included in the laboratory organization." We currently have a series of leak testers that the repair mechanics calibrate daily using known leak orifice masters. The masters are calibrated on a scheduled basis by the Metrology Lab, but the mechanics themselves are not associated with that lab. Is the calibration they are doing subject to the laboratory scope requirements of QS-9000?

[This message has been edited by Deb Weissler (edited 22 March 2000).]
 

Marc

Fully vaccinated are you?
Leader
I wouldn't think a daily check qualifies as a lab function since metrology is doing the actual calibration. The folks doing the daily check at their bench do not adjust the equipment, do they? As I understand what you are saying is they just do a check and if out of the allowable 'tolerance' they call metrology in. Correct?
 
D

Deb Weissler

No, actually they ARE performing calibration adjustments using a calibrated orifice. There is a switch on the front of the leak tester that is normally set at "operate". However if the calibration has shifted when verification is done, the mechanic has a key to allow him to calibrate the settings. Metrology only maintains calibration control on the leak orifices, not on the leak testers themselves.
 

Marc

Fully vaccinated are you?
Leader
I'm moving this to the measurement and calibration forum - maybe we can get some answers there.
 
S

Sam

The basic requirements of 4.10.6 are;
- scope
- qualified people
- procedures
- process control (as Appropriate)
- Test & Cal Methods
- Stat. Methods (as appropriate)

You probably already do or have this info.
My question would be, Why do you have to adjust the equipment every day.

Also,
Marc, question for you,
Is there a difference between "Calibration and adjust" and "verification and Adjust".
During our recent registration audit I "opened mouth and inserted foot" and told the auditor that we do not do calibration I was then informed that I needed to write a procedure to address IM&TE verification activities.
Comments please
 

Jerry Eldred

Forum Moderator
Super Moderator
I'm afraid, painful though it may be, that I am going to have to go with the consensus on this one.

If a unit of lesser and unknown accuracy is being compared with a unit of greater known accuracy (paraphrase, to my best recollection), and it is being adjusted when needed to assure it meets quantitative operating specs, it is a calibration. I believe it would be called a verification if there is no adjustment.

It would still seem to fall under the scope of the lab. I would be hard pressed to exclude it. If I were auditing, I would probably hit on it also.

I would go a little further and say to make sure there is a written procedure, make sure there are documented as received (pre-adjustment) readings, technicians skill levels are documented, and so forth.

Although I have spent much of my life on the bench, I fully understand and adhere to the reasons for this documentation. It need not be any more complicated than necessary to be sure you accomplish what is needed. But certainly there needs to be some method to institutionalize processes.

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B

Batman

I think Jerry is correct. I heve clients distinguish between "calibration" and "standardize" where "calibration" is lab type stuff, maintaining tests and adjustments on measurement equipment that are appropriate to a lab. "Standardize" is what the work station folks do to verify the gage is correct just prior to use. They do not make adjustments. If some gages do require calculations to correct for readings, that is covered in work station procedures. If you have work station gages being adjusted at the work station, it should be clear in work instructions the limits of adjustment allowed. Otherwise this could be interpreted as a "lab area."
 
D

Deb Weissler

Thanks for all your comments! I think that in this particular application "calibration" is a misnomer, and we do need to define the level at which adjustments after verification are allowed by the mechanics. All of our work instructions use the term "calibration" which may get us into trouble with an auditor. Looks like we have some terminology revisions to do!
 
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