Limited Calibration requirements in ISO 13485 - Temperature controller

G

Gary Garrison

#1
Hi Everyone,

Thanks in advance for any response.

Here's the scenario: We have a temperature controller on an extruder system that is calibrated at its typical operating temperature, 100 degrees below and 100 degrees above. The controller's maximum temperature input is several hundred degrees above our highest point and several hundred below the lowest. The controller is not marked for limited calibration.

An ISO auditor objects to this situation. The audtor maintains that any instrument not calibrated to its full range and capabilities must be marked limited calibration. If it wasn't me who had to fix this, I may not object to such an obervation. However, could someone get me out of this?

Of the 5,000 pieces of equipment we manage, more than half are calibrated more with respect to their role in the process than to the mfr's full range. Some special made fixtures are calibrated according to the wishes of the Mfg Engineer who built it.

The auditors are using Clause 7.6 section c. as their basis. Has anyone dealt with this before? How did it go?

Thanks

Gary

Excerpt from BS EN ISO 13485:2003, Sec. 7.6

7.6 Control of monitoring and measuring devices



The organization shall determine the monitoring and measurement to be

undertaken and the monitoring and measuring devices needed to provide

evidence of conformity of product to determined requirements (see

7.2.1).



The organization shall establish documented procedures to ensure that

monitoring and measurement can be carried out and are camed out in a

manner that is consistent with the monitoring and measurement

requirements.



Where necessary to ensure valid results. measuring equipment shall



a) be calibrated or verified at specified intervals. or prior to use,

against measurement standards traceable to international or national

measurement standards; where no such standards exist, the basis used for

calibration or verification shall be recorded;



b) be adjusted or re-adjusted as necessary;

c) be identified to enable the calibration status to be determined;

d) be safeguarded from adjustments that would invalidate the measurement

result;

e) be protected from damage and deterioration during handling,

maintenance and storage.

In addition, the organization shall assess and record the validity of

the previous measuring results when the equipment is found not to

conform to requirements. The organization shall take appropriate action

on the equipment and any product affected. Records of the results of

calibration and verification shall be maintained (see 4.2.4).
 
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BradM

Staff member
Admin
#2
Hello there, Gary!

Let me state that I am not an expert in 13485. Thus, these are general comments.

In a way, the auditor has a point, and in another way, they don't.

Did they cite this as a general observation? IMO, I would agree with that. Given the text you cited, I wouldn't think it strong enough for a nonconformity.

In general, instruments should be calibrated for their capability. However, it is entirely possible, practical, and realistic to calibrate a device across the range of use. However, it should be clearly noted on the equipment (In My Humble Opinion).

Say someone came in while you weren't there and wanted to perform an operation at a higher temperature. How are they to know what's it range is? What about if someone grabs a device and start making measurements with it? I realize about procedures, training and the like; I have just found it easiest for me to assure instruments are marked for the purpose they were calibrated for.

Basically, we usually make it a habit to put the calibrated range (limited range) on devices. This is to assure someone has adequate knowledge of how to properly use the equipment.
 
G

Gert Sorensen

#3
Here's the scenario: We have a temperature controller on an extruder system that is calibrated at its typical operating temperature, 100 degrees below and 100 degrees above. The controller's maximum temperature input is several hundred degrees above our highest point and several hundred below the lowest. The controller is not marked for limited calibration.
First: This one of the things that make say "Show me the shall" !!
Second: Is there only one temperature controller on the extruder?

There is no requirement to calibrate a given measurering instrument to its full scale. There can be several reasons for not doing this, and extrusion is a typical example of why you should not do it. I have yet to hear of a compound that will melt at 10, 20 or 50 degrees celsius, and even though the temperature controller can measure this it would be a complete waste of time. If you are using +/- 100 degrees celsius then you have probably covered the entire scope that the extruder will be used in. If you are using +/- 100 degrees Fahrenheit then it will still be OK, provided that the compound that are to be used on this specific extruder is to be processed within that specific range.
To give another example: If you are using a loadcell to measure how much of a given substance is removed from a container during a process, then you can safely choose not to calibrate the load cell in the interval where it only measures the weight of the container, ie. if the container weighs 40 lbs and holds 100 lbs, then you should start your calibration at 40 pounds and calibrate up to the maximum expected load of 140 lbs. You should not care that the loadcell may be used up to e.g. 500 lbs. That is irrelevant to your use.

But if the measuring equipment can be expected to be used for measuring outside of the range, for instance due to ignorance, then you should of course consider this when determining your calibration needs.

:bigwave:
 
R

Rob Udo

#4
Gary,

The difference between ISO 9001 and ISO 13485 requirements regarding calibration is the requirement for a documented procedure in ISO 13485. The practical implementation is identiacal to ISO 9001.

Basically it is enough to calibrate equipment for the range it is used.

But I agree with Gert if he says: "But if the measuring equipment can be expected to be used for measuring outside of the range, for instance due to ignorance, then you should of course consider this when determining your calibration needs."

I would recommend to label the equipment with the range calibrated. It will prevent you from potential problems in the future. It is about communicating the limitations of the equipment to the user. It could be seen as a risk management issue (as required by 7.1 from ISO 13485) to reduce the change of potential misuse of the equipment outside its calibrated range.

Rob Udo.
 
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