Calibration of Equipment for Field Installers

[Gman2]

I am about to audit and rebuild our calibration process (I already know it needs it, its been dropped for years, our re-cert date is next spring). The question I have is do we have to control the tools/equipment for the field installers? We manufacture equipment here on site then send either our own installers to install the equipment in factories or we contract out union installers when necessary.

How much will I need to attempt to control out in the field? I know its a vague question, I guess I am hoping everyone will say "don't worry about it" lol.

They could be using tape measures, pressure gages, meters, calipers (maybe) and maybe electronic testing equipment. Im not sure exactly yet because I have not audited it yet but there are at least 100+ people that we send out in the field to install. Controlling their equipment may be a nightmare.

G

 

[Jen Kirley]

I am glad you asked this!

The short answer is yes. I would expect to see suitable controls of all instruments your installers use that could impact the quality of service and/or usability of the thing they installed or fixed.

Of course suitable is meant to be a "weasel word." That is, you determine the risk that the equipment/tools introduce if they are not reading as designed. You identify the conditions that could be causing the equipment to be damaged or fall out of calibration, and you take reasonable steps to address those conditions. For field technicians that might mean one or more protective cases for the equipment.

That is, some means to keep the equipment from getting damaged, a means to prevent unauthorized adjustment by users, identification and evidence of traceable calibration (or defined means to check if not traceable), and record of reviews/actions should the instruments be found out-of-tolerance when calibrated. The essential requirements of 7.6.

I hope this helps!

 

[Reg Morrison]

How much will I need to attempt to control out in the field?

A typical case where you should apply RBT (Risk Based Thinking). It depends on the the usage of the device and it's impact on the proper equipment operation.

If the field technicians have to inspect, measure, test any critical characteristic for the equipment to function properly and reliably, you certainly want them to have IMTE that provides accurate values, thus the need for calibration.

On the other hand, if the checks they do in the field are not critical, you should not need to bother with calibration of such devices. I suspect that the technician-owned devices would be the most difficult to control.

Good luck.

 

[Big Jim]

The requirements from element 7.6 are the same for in house work as it is for field work.

Pay attention to the famous "Where necessary to ensure valid results . . . " If it isn't necessary for valid results, it doesn't need to be calibrated. If it is necessary for valid results it does need to be calibrated.

If calibration is needed, the level of controls are the same.

I suspect it is necessary for valid results.

 

[antonjav]

oh, and do not forget that 7.6 doesn't only mention about calibration... it also requires "... or verification or both".

Hence, the determination of precision and accuracy, like bias and linearity, might also be in order in this particular case...

 

[AndyN]

Before we all fire off on a debate about what we "THINK" needs to be done, it's more appropriate for you to decide based on what the requirements for what your organization says is important when installing/servicing your product. For example - as a past Xerox employee, when installing a copier, the instructions may say that it needs to be so many inches away from a wall. Measure with a tape is going to be satisfactory, right? Calibration needed? Not on your life!

The power outlet should be 115/120V ac. Multi-meter used, calibration? Nope.

The paper guides may need checking to see if the "pinch roller" is within certain limits. Feeler gauge used. Calibration? Hmmmm - maybe just a periodic verification against the micrometer the tech carries, which IS calibrated.

 

[antonjav]

Hi Andy, the verification requirement is not based on "what we think" -- it is explicitly indicated in element 7.6.

Thanks.

 

[antonjav]

Hi Andy, I guess I missed that your example is based from a Xerox standpoint which is installing a copier. And you're correct from that vantage point.

However, for other industries like those in the medical parts/equipment or automotive industries, measuring equipment like multimeters, calipers, or equivalent (provided that the same are referenced in the control plan), calibration and the verification of measurement system effectiveness is a requirement.

Hope that this has helped clarify. Thanks again.

 

[AndyN]

Hi Andy, the verification requirement is not based on "what we think" -- it is explicitly indicated in element 7.6.

Thanks.

Maybe it isn't! The debates here about what is and what isn't needed to be included in a calibration system are legendary. I'd suggest that this is one of THE least well understood requirements. On Linkedin, only recently, there are over 77 comments about whether a lifting sling needed to be considered as calibrated. When someone with a Ph.D in chemistry is quoting Merriam-Webster's dictionary definition for a lifting device as needing control under 7.6 (because the tag fell off), you know people don't understand!

 

[AndyN]

Hi Andy, I guess I missed that your example is based from a Xerox standpoint which is installing a copier. And you're correct from that vantage point.

However, for other industries like those in the medical parts/equipment or automotive industries, measuring equipment like multimeters, calipers, or equivalent (provided that the same are referenced in the control plan), calibration and the verification of measurement system effectiveness is a requirement.

Hope that this has helped clarify. Thanks again.

Since the OP is talking about field related activities (which aren't included in med. device or automotive control plans) I though it was appropriate to keep my example close to the right context. It avoids confusion for readers.