Interesting Discussion Using "Not A Calibrated Device" or "No Calibration Required" stickers

J

jrcook5

#21
The short answer is, not required. Do you want your R&D devices calibrated? Of course but, following the strict interpertation of the ISO 9001 standard, you are not demonstrating product conformance with R&D test equipment. It makes sense to still calibrate but not under the constraints of the standard.
 
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D

David Hartman

#22
jrcook5 said:
The short answer is, not required. Do you want your R&D devices calibrated? Of course but, following the strict interpertation of the ISO 9001 standard, you are not demonstrating product conformance with R&D test equipment. It makes sense to still calibrate but not under the constraints of the standard.
I beg to differ. Clause 7.3.6 defines the steps for design validation to ensure "that the resulting product is capable of meeting the requirements for the specified application or intended use...". This sounds like demonstrating product conformance to me.
 

Al Rosen

Staff member
Super Moderator
#23
jrcook5 said:
The short answer is, not required. Do you want your R&D devices calibrated? Of course but, following the strict interpertation of the ISO 9001 standard, you are not demonstrating product conformance with R&D test equipment. It makes sense to still calibrate but not under the constraints of the standard.
What are the constraints of the standard you are referring to? How can you be certain of product conformance if the devices used to establish their performance are questionable?
 

Jim Wynne

Staff member
Admin
#24
Al Rosen said:
What are the constraints of the standard you are referring to?
jrcook5 seems to be promoting a pedantic, legalistic interpretation of the standard that narrowly defines "product" conformance as applicable only to finished products, or products being manufactured.
Al Rosen said:
How can you be certain of product conformance if the devices used to establish their performance are questionable?
Exactly. The suggestion seems to be that it's OK to use non-calibrated devices to set the requirements, but calibrated devices must be used to verify them. :confused: Product conformance (fitness for a specific use) and fitness for manufacture are determined (or should be) before any actual manufacturing takes place, so it makes no sense whatsoever that measurement devices used in the development process wouldn't fall under the requirements of the standard.
 

Helmut Jilling

Auditor / Consultant
#25
jrcook5 said:
I think the discussion around what to calibrate must include the standard if any we are trying to comply with. I have argued with QA mgrs. and process engineers for years over what devices to calibrate. If we are talking about ISO 9001-1994 element 4.11 the must control list is limited to "imt&e used by the supplier to demonstrate conformance of product to the specified requirements." This is not to say we might not find it useful to calibrate other devices, it just says they don't have to be controlled to the level required by the standard. I just wish ISO would have continued to use this definition instead of the ambiguous "affect product quality" that they use in 4.11.2.b. Even so, I think the intent was to require control of IMT&E that is used to demonstrate conformance to the "specified requirements." I would be very interested to hear what others have to say about this issue.
Maybe the new ISO standard used the broader term "affect product quality" because they recognized and wanted to infer that other gages ought to be calibrated as well? It makes sense.
 
J

jrcook5

#26
JSW05 said:
jrcook5 seems to be promoting a pedantic, legalistic interpretation of the standard that narrowly defines "product" conformance as applicable only to finished products, or products being manufactured.
PEDANTIC...I had to look that one up. We are talking about conforming to the requirements aren't we? ISO 9001 and 13485 are the standards that apply. The auditors, that come in here including the FDA, are very often "pedantic" in there enforcement of the standards and regulations. By the way, I am in the metrology department where being "pedantic" is actually a huge complement. I am not advocating not calibrating R&D devices, all I'm saying is, do you want to include devices in your calibration system that when found out of tolerance require corrective action per ISO that may be overkill based on the usage of the device. The final products are not affected because they are inspected downstream with the controlled calibrated devices.
 

Jim Wynne

Staff member
Admin
#27
jrcook5 said:
do you want to include devices in your calibration system that when found out of tolerance require corrective action per ISO that may be overkill based on the usage of the device.
CA shouldn't be done because ISO requires it; it should be done whenever it has a reasonable chance of fixing a problem or improving a process. I want to include in the calibration system all devices with the potential to affect product quality, and that includes devices used in product development
jrcook5 said:
The final products are not affected because they are inspected downstream with the controlled calibrated devices.
So you believe that use of calibrated inspection equipment in-process somehow prevents defects? Or is your only concern that defectives don't get shipped?
 

Al Rosen

Staff member
Super Moderator
#28
jrcook5 said:
I am not advocating not calibrating R&D devices, all I'm saying is, do you want to include devices in your calibration system that when found out of tolerance require corrective action per ISO that may be overkill based on the usage of the device. The final products are not affected because they are inspected downstream with the controlled calibrated devices.
Quality System standards and regulations do not require corrective action when devices are found OOT, only an evaluation to determine whether product was affected and if CA is required.
 

Helmut Jilling

Auditor / Consultant
#29
jrcook5 said:
JSW05 said:
jrcook5 seems to be promoting a pedantic, legalistic interpretation of the standard that narrowly defines "product" conformance as applicable only to finished products, or products being manufactured.

PEDANTIC...I had to look that one up. We are talking about conforming to the requirements aren't we? ISO 9001 and 13485 are the standards that apply. The auditors, that come in here including the FDA, are very often "pedantic" in there enforcement of the standards and regulations. By the way, I am in the metrology department where being "pedantic" is actually a huge complement. I am not advocating not calibrating R&D devices, all I'm saying is, do you want to include devices in your calibration system that when found out of tolerance require corrective action per ISO that may be overkill based on the usage of the device. The final products are not affected because they are inspected downstream with the controlled calibrated devices.
You might be right, but I think we are missing the greater point. ISO is not here so you can be a slave and be complaint. You are supposed to be compliant because these are GOOD requirements!

Therefore, why do we calibrate gages? Only so final product can be correct? Or, do we do it to ensure that when we go to the trouble of taking a measurement, that we can rely on the results as being accurate? If that is the case, then the only gages that have to be calibrated are those we wish to ensure are accurate. Then they can be calibrated to an accuracy level that is accurate, at a frequency that meets our needs.

If we are going to be pedantic, let's be pedantic to that objective!

We don't do this stuff for ISO or the auditor, we do it for us.
 
R

Randy Stewart

#30
Moderation is all things.

Calibration can be taken too far, application is the key. Is it a gauge that requires ISO 17025 calibration, or does it need to be verified before use?
Here's a couple items that must be taken into consideration: Tolerances & Uncertainty of Measurment. If my tolerances are so great that my UM doesn't matter, why bother calibrating when verification works.
Saves time and money.
Now with that being said, has anyone noticed how old the cal date is on some of the gas pumps? I used one the other day that was over 2 years old, sure had me wondering.:confused:
 
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