Hello everyone,

I just got hired on to a company and have been tasked with creating a calibration lab from the ground up. They have not had a need for a real cal lab before, but some customers and other regulations are pushing them to create one and start using it. It will need to be FDA compliant.

From what I know right now (only my third day) I’ll be calibrating lot’s of temperature indicators, thermocouples (J/K), RTD, pressure gauges (air/liquid), vacuum gauges, RPM (converting Hz to RPM), compound pressure sensors, etc…

I’ve been tasked to buy equipment to calibrate with. Mindful, I have to keep it in reason.

Some of the equipment I was looking at are:


Process Calibrators (Fluke 743b or 725)
Temperature Calibrators (Fluke 724)
Pressure (Fluke 718)
Loop Calibrator (Fluke 707)
Power supply
RPM Calibrator
Field (portable) Metrology Well (for thermocouples)

These don’t have to be all Fluke. I am familiar with Fluke more than some others like Omega for instance, but I don’t have to stick with Fluke if others are better.

Looking for suggestions on what equipment to buy.

Thanks!!

Hello everyone,

I just got hired on to a company and have been tasked with creating a calibration lab from the ground up. They have not had a need for a real cal lab before, but some customers and other regulations are pushing them to create one and start using it. It will need to be FDA compliant.

From what I know right now (only my third day) I’ll be calibrating lot’s of temperature indicators, thermocouples (J/K), RTD, pressure gauges (air/liquid), vacuum gauges, RPM (converting Hz to RPM), compound pressure sensors, etc…

I’ve been tasked to buy equipment to calibrate with. Mindful, I have to keep it in reason.

Some of the equipment I was looking at are:


Process Calibrators (Fluke 743b or 725)
Temperature Calibrators (Fluke 724)
Pressure (Fluke 718)
Loop Calibrator (Fluke 707)
Power supply
RPM Calibrator
Field (portable) Metrology Well (for thermocouples)

These don’t have to be all Fluke. I am familiar with Fluke more than some others like Omega for instance, but I don’t have to stick with Fluke if others are better.

Looking for suggestions on what equipment to buy.

Thanks!!


Here is a Manual that I found while looking for something similar. It is the NIST's and it is a template. I didn't see any "Copyright" statement on the Manual. I have split it into two parts, because the file size exceeds the upload limit.

Maybe it may help you.

Hello everyone,

I just got hired on to a company and have been tasked with creating a calibration lab from the ground up. They have not had a need for a real cal lab before, but some customers and other regulations are pushing them to create one and start using it. It will need to be FDA compliant.

From what I know right now (only my third day) I’ll be calibrating lot’s of temperature indicators, thermocouples (J/K), RTD, pressure gauges (air/liquid), vacuum gauges, RPM (converting Hz to RPM), compound pressure sensors, etc…

I’ve been tasked to buy equipment to calibrate with. Mindful, I have to keep it in reason.

Some of the equipment I was looking at are:


Process Calibrators (Fluke 743b or 725)
Temperature Calibrators (Fluke 724)
Pressure (Fluke 718)
Loop Calibrator (Fluke 707)
Power supply
RPM Calibrator
Field (portable) Metrology Well (for thermocouples)

These don’t have to be all Fluke. I am familiar with Fluke more than some others like Omega for instance, but I don’t have to stick with Fluke if others are better.

Looking for suggestions on what equipment to buy.

Thanks!!

What is your background in calibration?

Before you purchase calibration equipment you will need to review process equipment to understand the equipment accuracy you will be calibrating and what accuracy the actual process requires.

Since you are working with process equipment that contain multiple elements such as display modules and thermal couples you will also need to determine total system accuracy which is not the adding together of the display unit accuracy and thermal couple accuracy.

Calibration equipment itself should have a system accuracy at a minimum 4:1 to a preferred 10:1 ratio to the unit under test with calibration certification reflecting actual results traceable to a national or international standard body.

When calibrating pressure gauges the actual calibration standard should have a 1/4 of 1% accuracy over the most accurate process gauge using nitrogen as a calibration media.

What is your background in calibration?

Before you purchase calibration equipment you will need to review process equipment to understand the equipment accuracy you will be calibrating and what accuracy the actual process requires.

Since you are working with process equipment that contain multiple elements such as display modules and thermal couples you will also need to determine total system accuracy which is not the adding together of the display unit accuracy and thermal couple accuracy.

Calibration equipment itself should have a system accuracy at a minimum 4:1 to a preferred 10:1 ratio to the unit under test with calibration certification reflecting actual results traceable to a national or international standard body.

When calibrating pressure gauges the actual calibration standard should have a 1/4 of 1% accuracy over the most accurate process gauge using nitrogen as a calibration media.

I had calibration lab experience and training in the military. I'm new to this type of enviroment.

Most of what I have found out thus far, is the the tolerances on the process is between 1 - 3%.

Look at my response in your other thread.:D Before you buy anything...

You need to make a thorough (and accurate) inventory of the equipment. The labor you will need to do the work is going to need to be sold to management. Also, you will need to evaluate vendors, audit them, etc. Thus, you need to determine what is before you.

As far as standards, look at buying the standards that are critical for your process. Or more simply put, get the most bang for your buck.

Starting off, you may want to qualify some vendors, and have them calibrate the equipment for you. It's going to take you some time to get things going. So assure the equipment is calibrated and tagged properly first.

Then, you can work on setting up your calibration system.:)

Step number one is to join NCSLI www.ncsli.org and get the Recommended Practices (RPs). There is a RP specifically for how to set up a cal lab.

Make sure you control both temp and RH.

Also, get a copy of ANS/ISO/IEC 17025:2005 whether you intend to get accreditation or not as it will help develop a good management structure to maintain control and provide services. If you intend to seek accreditation don't just pick any, shop around a bit first.

If your parent organization has Government contracts, join GIDEP www.gidep.org to have access to military calibration porocedures and avoid validation issues.

Get training in the specific types of calibration you will be doing and make sure it is documented. There are NIST sessions and similar at NCSLI in San Antonio end of July.

Hope this helps.

Hershal, what's the difference between NCSLI and ANSI? (as for becoming members of).

NCSLI is a membership organization of Metrology professionals.....for calibration, this is the better organization.....

Thanks, I'm going to join today.

I also recommend getting training in uncertainty analysis, which you will need going forward. I believe Dilip Shah will have a course at NCSLI in San Antonio and his course has a good reputation, and Dilip will take time to make sure you have a good handle on it. If you can't make that one, I believe IAS will have one sometime in the fall.

At NCSLI, you can also go around and see all the newest and best, including from Fluke/Hart, oh, and you get to touch and play with it also.

Also, if you can get training in 21 CFR Part 11, get it. Operating in the FDA environment it is critical. Also, at NCSLI, join the Healthcare Committee (I forget the Committee number), as these folks deal with the very same issues as you. You can learn and contribute at the same time.

I've been tasked with writing a "statement" or "rationale" on what we choose to calibrate within the factory compared to what we don't calibrate. For instance, right now I am starting to calibrate items when they are referenced in a batch recipe...ie: temp needs to be 180F, RPM's on mixer need to be whatever, need so many gallons of water, etc...

I have no idea where on where to start since this is their first cal lab. I have downloaded some RP's from NCSLI though.

Maybe someone has an example that I can use to get started on ours.

Thanks! :thanx:

I'm not sure if I completely understand what you're asking, so I'll throw some stuff out there, and see if any of it sticks!:tg::lol:

In the end, the process determines what the instrument requirements should be.

Now... this is just a suggestion and not a "have to", so consider it as such. What I have found helpful is to create a instrument record (IR) that establishes the instrument in the system. So the IR would have the make, model, serial number, and maybe even the mfg. specifications and such. Then, there can be a place for process specifications. Finally, a line can be added for calibration tolerance. Then the form can have the appropriate signatures.

Let's take the RPM. So there is an indicator with a sensor, and the mfg. tolerance is say +/15RPM. However, the process that is being used, requires a RPM reading that is within +/-100 RPM. Thus, the decision is to calibrate the instrument to +/-50 RPM. That decision can be based on the process limit, limitations of accuracy/uncertainty ratio, make consistent with other process equipment, or otherwise.

You can also use the IR to document initial validation checks, gauge R&R, and any additional checks you may deem necessary.

The form can be done all electronically, if chosen. But you at least have a written record of the assessment of the instrument, and the rationale for doing what you are doing. You can always change, but it's nice having a history of why you are currently doing what you're doing. That sure beats the "I don't know; we've just always done it that way". Aside from sounding silly, it creates problems sometimes, in that you don't know if what you are doing is being done for a good reason, or just randomly ended up as a matter of practice.:)

Thanks for the reply Brad, it was really helpful. I realize that my question is pretty vague.

The company I work for now has never had a true calibration program. The maintenance guys were tasked with calibrating the instruments. They hired me about a month ago. I have calibration experience from the Navy but never was a calibration tech in a manufacturing enviroment.

So I'm starting the lab from scratch. Just moved into my office/lab yesterday and still don't have furniture yet. We've purchased Gage InSite from IndySoft and are currently going through the validation, which will take care of the electronic records part.

We have a customer audit starting next week, the audtior is a former FDA guy.

So my manager basically want's me to put on paper "the rationale" behind the cal lab. I currently have a writers block on how to proceed. They have given me no further direction other to have it ready by tomorrow! From there they will write or add to the SOP.

I'm currently reviewing RP's from NCSL (RP1, 6 and 9). Also got the ISO 17025.

Hopefully this will give you a little idea where I'm coming from!:bonk:

Thanks for the reply Brad, it was really helpful. I realize that my question is pretty vague.

The company I work for now has never had a true calibration program. The maintenance guys were tasked with calibrating the instruments. They hired me about a month ago. I have calibration experience from the Navy but never was a calibration tech in a manufacturing enviroment.

So I'm starting the lab from scratch. Just moved into my office/lab yesterday and still don't have furniture yet. We've purchased Gage InSite from IndySoft and are currently going through the validation, which will take care of the electronic records part.

We have a customer audit starting next week, the audtior is a former FDA guy.

So my manager basically want's me to put on paper "the rationale" behind the cal lab. I currently have a writers block on how to proceed. They have given me no further direction other to have it ready by tomorrow! From there they will write or add to the SOP.

I'm currently reviewing RP's from NCSL (RP1, 6 and 9). Also got the ISO 17025.

Hopefully this will give you a little idea where I'm coming from!:bonk:

Good explanation.

First thing I would do is get 'all hands on deck' and review the current status of instrumentation in your facility. Assure each has a unique identification number, and assure each instrument is appropriately marked. Of note, you need to do something with past due calibration equipment. Either get it sent off for calibration, quarantine, or as a last resort, establish a plan with quality to extend the calibration interval. I would hesitate to do that, but in your situation, it would be better than processes using past due calibration equipment.

This exercise should yield some records of your current state. From that, sit down with management and draw up an approach/ gap analysis, prioritizing things based on risk analysis. Also, this exercise will assure the correct information goes in your database correct, the first time. There is nothing worse than having incorrect instrument data.:mad:
:tg::bigwave::)

I realize you have a lot to do, and many things you wish to do.:agree1: But to me, first and foremost is getting a handle on your current process, and identifying how to approach it.

So my manager basically wants me to put on paper "the rationale" behind the cal lab.


The most basic rationale behind a metrology lab is to do calibration - which is to ensure the measuring devices read correctly based on comparison to a national standard, and gage R&R - which provides the evidence that you are using the correct gage for the job. Hopefully, you are really doing a metrology lab, and not just a calibration lab. Subsets of that information would include stability, etc.

The national standards are good, but a good reference - even if you are not automotive - is the AIAG MSA book.

Some additional thoughts to add to Bob's comments include control of equipment as opposed to sending it out; and as has been pointed out, correct measurements.

The folks doing that before certainly want correct measurements, but unless they are specifically trained in the science of measurement (Metrology) then they are at an immediate disadvantage. That sounds harsh, but it in truth is reality. Metrology is a science, in fact one of the three oldest recorded sciences in the world, and requires appropriate training and care.

Your role, besides managing the lab and making the measurements, will likely include understanding and helping to control the sources of errors in the measurement. Those errors are the scources of uncertainty.

Hope this helps.