Calibrating the monitoring device but not the unit

imecoli

Registered
So, this is new to me, we are building out a facility and we were told for validations we would be doing a "Family approach" where we only conduct an IOPQ on one unit and if is passes it sets precedent for all other units with the same model number. If that wasn't strange enough, I was just asked about not calibrating the units, only the monitoring device and using that for justification. this would demonstrate that the unit is within spec. I am concerned that the controller probe will not be calibrated and in the event of opposite temperature drifts in the probes we may potentially approach OOT conditions.

Hs anyone done this? I am not comfortable with this but am I being obtuse?
 

imecoli

Registered
This is coming from someone from {a different company} , he said this is how they handled equipment there.
 
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dwperron

Trusted Information Resource
If you perform an IOPQ on one unit and it fails would they then reject the total "family"?
I think not.....

A question. What is the monitoring device being used for if not for calibrating the units?
 

Ninja

Looking for Reality
Trusted Information Resource
Howdy,
I removed the specific company name in Post#3... just to be safe.
 

imecoli

Registered
If you perform an IOPQ on one unit and it fails would they then reject the total "family"?
I think not.....

A question. What is the monitoring device being used for if not for calibrating the units?

I made sure if the unit fails it invalidates the whole "family approach"
The monitoring will be our Siemens EMS.
 

Miner

Forum Moderator
Leader
Admin
An MSA, which includes a bias/linearity study (i.e., calibration) includes the entire measurement system, not just a portion of the system. In your case the system includes the probes for the very reason that you cited.

A company that I used to work at performed 100% leak testing on the product. The entire measurement system consisted of a mass spectrometer, 3-4 feet of tubing, a robot controlled nozzle and tested at a speed of ~ 1 inch/second. During calibration, they connected a calibrated leak directly to the mass spec, eliminating the tubing and nozzle and tested statically. If you tested the entire system dynamically on the same calibrated leak the results were an order of magnitude different.

Calibrate the entire system.
 

Enghabashy

Quite Involved in Discussions
So, this is new to me, we are building out a facility and we were told for validations we would be doing a "Family approach" where we only conduct an IOPQ on one unit and if is passes it sets precedent for all other units with the same model number. If that wasn't strange enough, I was just asked about not calibrating the units, only the monitoring device and using that for justification. this would demonstrate that the unit is within spec. I am concerned that the controller probe will not be calibrated and in the event of opposite temperature drifts in the probes we may potentially approach OOT conditions.

Hs anyone done this? I am not comfortable with this but am I being obtuse?
As ISO IEC 17025 requirements for verification & calibration , we shall maintain & perform Calibration & intermediate checks plans which covering Re-Calibration date ( it's shall considering the calibration results & uncertainty results as written in the calibration certificates ) , & the mandatory also to plan the interval for internal checks by using another comparison tool ( as example another device ,verification checks blocks gauges, another micrometers , ---etc, " , you can use MSA techniques also as tool of verifications,
The Req. as ISO 17025 /6.4.10 :When intermediate checks are necessary to maintain confidence in the performance of the equipment, these checks shall be carried out according to a procedure.

-the another Req.: 6.4.13 Records shall be retained for equipment--- :e) calibration dates, results of calibrations, adjustments, acceptance criteria, and the due date of the next calibration or the calibration interval;-- e) interlaboratory comparisons;
-other Req.: 7.7 Ensuring the validity of results ; e) intermediate checks on measuring equipment;/7.7.1 inter Lab. comparison
 
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