Narrow definition of IMTE or calibration possible?

cjaldous

Starting to get Involved
#1
Has anyone heard of, or worked in an accepted IMTE system that used limitations to reduce the amount of equipment tracking/calibration?

I'm trying to find a way to limit our IMTE requirements/scope. It was recently suggested that ALL IMTE (calibration required or not) be tracked on a list. We currently do this for calibrated equipment, but not for equipment that does not require calibration. Additionally, we do not document the reason that a piece of IMTE does not require calibration.

We are considering trying to limit tracked IMTE to only include equipment requiring calibration, and for IMTE to only require calibration when it is involved in final acceptance testing or when it is determined that the risk of passing bad parts/product before final testing to not acceptable.

I get the feeling that many just calibrate and track "everything" as it's easier than assessing risk for each IMTE.
 
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Ninja

Looking for Reality
Staff member
Moderator
#2
For most calibration or asset tracking software, tracking "all" is far easier and quicker and cheaper than deciding "which ones?".

What roadblocks are you running into that makes you ask? Are you seeing a specific problem? What is it?
 

somashekar

Staff member
Admin
#3
Has anyone heard of, or worked in an accepted IMTE system that used limitations to reduce the amount of equipment tracking/calibration?

I'm trying to find a way to limit our IMTE requirements/scope. It was recently suggested that ALL IMTE (calibration required or not) be tracked on a list. We currently do this for calibrated equipment, but not for equipment that does not require calibration. Additionally, we do not document the reason that a piece of IMTE does not require calibration.

We are considering trying to limit tracked IMTE to only include equipment requiring calibration, and for IMTE to only require calibration when it is involved in final acceptance testing or when it is determined that the risk of passing bad parts/product before final testing to not acceptable.

I get the feeling that many just calibrate and track "everything" as it's easier than assessing risk for each IMTE.
Very good post....
The organization shall determine the monitoring and measurement to be undertaken and the monitoring and measuring equipment needed to provide evidence of conformity of product to determined requirement. <from ISO 13485:2016, Clause 7.6>
This is not a risk based decision, but a thought based decision to be made for all the monitoring and measurement to be undertaken and the monitoring and measuring equipment selected for it, including that for the work environment monitoring and measurement, which has a direct bearing on the conformity of products.
We are considering trying to limit tracked IMTE to only include equipment requiring calibration, and for IMTE to only require calibration when it is involved in final acceptance testing or when it is determined that the risk of passing bad parts/product before final testing to not acceptable.
So here kindly reconsider .....
 

cjaldous

Starting to get Involved
#4
Ninja and Soma thank you for your replies.

Soma, from your reply and the 13485 clause, it seems we could limit our calibration to IMTE that is used to prove conformity to product requirements.

Ninja, let me give an example. If we use a DMM to select a resistor which has a direct effect on the performance of a product, and the performance affected by that resistor selection is eventually tested later in the process, then we can decide to not calibrate the DMM used for resistor selection because we know that the multimeter is x times more accurate than needed, that they rarely drift out of spec for this purpose, and most importantly, because the product requirement affected by that resistor choice is measured later in the process and we are ok with the added risk of non-conforming product at that later testing stage. Does this make sense?

Ultimately we are trying to simplify the amount of equipment tracked to reduce the possibility of past due calibrations and the increased production responsibilities to cover the additional equipment.
 

Ninja

Looking for Reality
Staff member
Moderator
#5
It was recently suggested that ALL IMTE (calibration required or not) be tracked on a list. We currently do this for calibrated equipment, but not for equipment that does not require calibration. Additionally, we do not document the reason that a piece of IMTE does not require calibration.
Tracking assets is a normal part of doing business and protecting from theft.
Tracking calibration due dates is a normal part of maintaining a robust and effective testing environment.
If you're gonna track stuff, why do it twice?
Track ALL assets...and have additional info on stuff that needs calibration in the same dbase.
That's what I was getting at above.

...not documenting the reason why "calibration not required" seems irresponsible. How do you know the reason isn't "we didn't feel like it"?
If we use a DMM to select a resistor which has a direct effect on the performance of a product, and the performance affected by that resistor selection is eventually tested later in the process, then we can decide to not calibrate the DMM used for resistor selection because we know that the multimeter is x times more accurate than needed, that they rarely drift out of spec for this purpose, and most importantly, because the product requirement affected by that resistor choice is measured later in the process and we are ok with the added risk of non-conforming product at that later testing stage. Does this make sense?
To a degree, yes...but to a degree, no.
My mainstay (stated in other threads here as well):
If you care about the measurement enough to make it, calibrate the test equipment.
If you don't care about the measurement enough to calibrate...why are you bothering to test it?

I can understand your reasoning making the cal cycle for the 'in-line' test 4yrs, or 10yrs...and the product end of line test being one year, or two years (based on data)...
I cannot understand why you would go to "calibration not required", and still spend the time and money to test at all for what may, in fact, be a meaningless number.
If you're willing to take the risk, fine...just scrub the in-line test and save yourself the labor cost.
 

Tidge

Trusted Information Resource
#6
This jumped out at me:

Ninja, let me give an example. If we use a DMM to select a resistor which has a direct effect on the performance of a product, and the performance affected by that resistor selection is eventually tested later in the process, then we can decide to not calibrate the DMM used for resistor selection because we know that the multimeter is x times more accurate than needed, that they rarely drift out of spec for this purpose, and most importantly, because the product requirement affected by that resistor choice is measured later in the process and we are ok with the added risk of non-conforming product at that later testing stage. Does this make sense?
I apologize if this comes across as harsh: This situation sounds to me as if the product could use some more engineering. The manufacturing process as described sounds much more like assembly in a test lab for trials than a design that is suitable for manufacturing.

I can imagine certain complicated designs where some other (poorly controlled) element of the design can be compensated with a 'tuned' choice of a resistor, but I'm still thinking that my imaginary designs could be better engineered. Even in such circumstances I agree with @Ninja that "if it is important enough to require the measurement in the DMR, then measurement equipments needs to be calibrated" (my words). I'll suggest something even more annoying (perhaps): you ought to be recording the measurement at the time it is made.
 

dwperron

Trusted Information Resource
#7
Soma, from your reply and the 13485 clause, it seems we could limit our calibration to IMTE that is used to prove conformity to product requirements.


What you are required to track on a list will depend on your industry requirements.
In the 13485 world 7.6 is the operative clause:

The organization shall determine the monitoring and measurement to be undertaken and the
monitoring and measuring equipment needed to provide evidence of conformity of product to
determined requirements.


You are the organization. If you decide that determining conformity is only required at final acceptance test then you can declare that only that equipment requires calibration / traceability. You will most likely be called upon to show how you have come to that conclusion, and this should be documented and records be maintained.
 

cjaldous

Starting to get Involved
#8
This jumped out at me:

I apologize if this comes across as harsh: This situation sounds to me as if the product could use some more engineering. The manufacturing process as described sounds much more like assembly in a test lab for trials than a design that is suitable for manufacturing.

I can imagine certain complicated designs where some other (poorly controlled) element of the design can be compensated with a 'tuned' choice of a resistor, but I'm still thinking that my imaginary designs could be better engineered. Even in such circumstances I agree with @Ninja that "if it is important enough to require the measurement in the DMR, then measurement equipments needs to be calibrated" (my words). I'll suggest something even more annoying (perhaps): you ought to be recording the measurement at the time it is made.
That is a bit harsh, but that's ok. The transducers that we use, and need to equalize on a unit to unit basis, can vary wildly in response. The variance in transducers could be reduced/controlled through sorting, which we would rather not do. Otherwise, there is is no alternative transducer with a better specification because there is no market for a better spec'd unit. This is a very low volume, hand assembled, analog circuit based research device.

Regardless, thank you for your input.

dwperron, I understand and agree. Our records and SOPs were not enough to sway a recent auditor so it's been a struggle. Thank you for responding.
 

Tidge

Trusted Information Resource
#9
That is a bit harsh, but that's ok. The transducers that we use, and need to equalize on a unit to unit basis, can vary wildly in response. The variance in transducers could be reduced/controlled through sorting, which we would rather not do. Otherwise, there is is no alternative transducer with a better specification because there is no market for a better spec'd unit. This is a very low volume, hand assembled, analog circuit based research device.
Design issues aren't germane to the discussion of IMTE calibration, but it is entirely possible that there is an alternate design that meets all the needs of the transducer, and removes the need for sorting/hand-tuning. I understand that with low-volume, there may be no appetite to do better... but design teams should be willing to accept the challenge. Sometimes the answer isn't on the application sheet for the part that has always been used.
 
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