Our company used to have an in-house calibration lab and tech. The lab and tech have since left the company and basically started their own company. They have been continuing doing our calibrations but our procedure has been structured around an in-house tech that goes around and gets equipment and updates our databases as he goes. I am wondering how to redo our procedure to say most, it not all calibrations will now be done by an independant lab. They do not have access to work instructions they used to use since they are no longer with the company but have "unoffical" docs they work from.

The other small thing I am concerned about is they have yet to receive the 17025 cert and "hope to have it by summer". I dont want to be caught with my pants down since I am in process of being moved into ISO Administrator. Just trying to find short and sweet "the tech does calibrations next door now instead of upstairs."

How have you qualified and added this company/person to the Approved Supplier Llist?

I doubt it. They basically left company and were just told "keep doing what you were doing just not here." I was not involved with any talks being I am not that high on totem pole but if I am going to be responsible for the ISO docs I want to know things like this from now on.

Well, I would say it depends. Are you in an industry/ regulatory situation that requires 17025? If yes, you cannot use them until they get it.

I think Phil brought up my thought process. This new organization needs to be qualified to perform your calibration work. Now, in one instance, I don't think you'll have an issue in verifying their competence in doing your work. However, they are on their own, and there are several business decisions that go along with it. For example, what shape are their standards, do they have an adequate recall schedule, document control, etc.

I realize you probably know these folks, and they are 'great people'. However, they own their own business now, and don't have the allegiance to your organization they did before. You need to assure they will take care of business, and provide competent calibration for you. In addition, make sure it is documented very clearly they are contractors. I might even require them to provide liability insurance.

Also, whatever requirements you have of them (17025, etc.) you better put in writing, and have a deadline. If you are going to do that, you should have another vendor lined up in case they don't pan out.

As far as your procedures, if you put a specific reference to who was going to do the work in each one of them, eventually you will need to revise them. If it was me, I would put something a little more flexible in there for future business needs!;)

I think the catch 22 I see coming is that I can't change the procedure to say we aren't doing calibrations in house because these people don't want to be held liable because they aren't certified yet, which they want so they can expand their new buisness. My company has alot of FCC regs to follow and I am thinking I need to rewrite the procedure to be more flexible as to who does our calibrations. I do agree that this company needs to be added to an approved vendor list because if we fall into non-compliance they will say they have nothing to do with it since they don't work for our company. If we are hacing pizza day they always seem to still think they work here though. :cool:

I think the catch 22 I see coming is that I can't change the procedure to say we aren't doing calibrations in house because these people don't want to be held liable because they aren't certified yet, which they want so they can expand their new buisness. My company has alot of FCC regs to follow and I am thinking I need to rewrite the procedure to be more flexible as to who does our calibrations. I do agree that this company needs to be added to an approved vendor list because if we fall into non-compliance they will say they have nothing to do with it since they don't work for our company.

OK... be careful, Stan. I'm a little concerned for your situation. Now, I'm not talking about quality here (that's another situation). It needs to be very, very clear they are not employees. Not only liability issues, but if it is not clear enough (1099 is a must) and they don't pay their self-employment taxes, you could end up in a situation on that. Just make sure it's very clear. Make sure these contractors understand their responsibility in their new endeavor.

Why not revise your procedures to state that something like: calibrations shall be performed against internal procedure XXXX by competent calibration personnel. Alternatively, calibrations can be performed by a qualified calibration source... or something to that effect. Whose procedures are they performing work against?

If we are having pizza day they always seem to still think they work here though. :cool:

Hey... they need to be bringing you pizza, not the other way around!:tg:

Thanks for the advice. I don't know all the details but the people are not employees of my company anymore but are being handled as an outside vendor. The work instructions they are using are ours but they wrote them so I think someone said it was ok for them to use "un-offical docs" for testing purposes. It can be a whole can of worms the more I delve into it thats why I am trying to get a plan of attack if it blows up. Your suggestion for wording is what I was thinking to remove "in-house tech" to "an approved outside lab" and such. Thanks for the help. This is the biggest step I have had in my career and if I end up as THE man for ISO for the company I want to show them I am worthy.

I'm curious if your cal lab was accredited when it was in-house?


The other small thing I am concerned about is they have yet to receive the 17025 cert and "hope to have it by summer". I dont want to be caught with my pants down since I am in process of being moved into ISO Administrator. Just trying to find short and sweet "the tech does calibrations next door now instead of upstairs."

Personally, I like your shorts:cool: I think after reading your posts your way past the point of being caught with your pants down. Seems like some deep doo-doo to me.

I have moved these post to this forum since the questions and replies address calibration specifically.

No we were not "an accredited 17025" lab. The in-house calibration was moved in-house by new owner to cut costs from outside labs. The 1st ISO audit we had after it was transitioned we had a major non-conformance due to un-traceability of test equipment and no gold standards. Our tech was basically using a meter to test a scope then the scope to test the meter so we had no standards. That was corrected and policies and procdures put in place and 9 months later we passed ISO with flying colors now 2 years after getting everything in line and under control everything is headding back out the door for calibration. Long long story on they who's and why's but I don't want to get into company business here but I have been slowing over time been put in charge of the calibration system for the company, kind of like putting a frog in a pot of water and slowly heating up the water till it is boiling and before he knows it you got frog soup.

Sorry to jump in late on this but I am a little confused.

You say your internal calibrations are being done by this "new business" but they are using your procedures and won't accept responsibility for their work because they aren't certified yet.

I understand they are no longer employees but are they doing the work in your building? Are they using your standards? Are they maintaining the calibration records of your company? If they are not taking the work off site and they are not providing certificates of calibration, are they not just contract workers in your facility?

Do you still send your standards to an accredited lab for calibration and maintain records of traceability to NIST?

My point here is to suggest that even though the personnel performing the calibrations are contracted, you are still complying with the calibration and internal lab requirements of the standard (both ISO 9001 and TS 16949).

You would, of course, need to demonstrate the competence of the contract workers. Presumably the use of temporary contract workers is already covered somewhere in a procedure or policy.

Just a thought.

Dave

They are not doing work in our building, they actually have building next door. They are using our standards updating our cal cert records (word doc form) & forwarding them to us for entry in our system.

They send gold standard equipment out for calibration to keep traceability to NIST standards.

I think as long as our procedure states an ourside source is doing calibration in some wording will cover us. I am just trying to figure out now what to remove and update in the procedure relating to in-house calibration, which has decreased drasticly.

Everyone has given me some great advice I think I know which way to head now.

It appears to be a very informal situation that your management have caused to happen. As such, until they fully understand the risk (not simply of another 'major') of not having confidence in what this supplier is doing (it even applies when they were in-house, of course) they are unlikely to allow you or anyone to change much. I'd be finding the data to identify the risks ($$$ or your local currency) that are faced by doing calibrations like this. The accreditation is a nice to have, but management who make these types of decisions are clearly not worried by a certificate.

But then, they may not see much of a risk in their decisions, either...........

StanH,

You have several potential solutions to your challenges......

First, keep them as an external provider and treat them as such. Have them sign a contract so if they use your procedures and records, they "rent" them (likely just give a discount, but works out the same). Otherwise, since you mentioned FCC, have them join GIDEP to obtain procedures.

Second, call it an internal "contract staffed" lab, which means you still own the space, standards, procedures and so on, but they provide the people and experience.

In the contract you have them sign, make sure you put in a requirement that they obtain accreditation from an ILAC signatory body (don't just say something like "A2LA or NVLAP") and then even help them shop all five ABs here in the U.S. prior to selecting one.

WATCH TRACEABILITY!!!!!!! That is a hang-up.....for the calibrations they provide, they must provide you or have quickly available the measurement uncertainty of that calibration or type of calibration. If you do not have uncertainty available you do NOT have traceability! Also, the traceability chain requires documentation showing the next link up. In other words, an unbroken chain of comparisons to National or international standards with stated uncertainties at each step. Oh, and the traceability chain (not knowing your equipment) may/may not run through NIST; perhaps someone like NRC (Canada).

Validation of procedures could be an issue, if they wrote the procedures. Validate them, don't wait and see, get the evidence of validation on file so you have it before you need it.

Records are always an issue, so check the records yourself and have your internal auditor check them since they are basically running your lab, in spite of the terms considered thus far.

Hope this helps.

They are not doing work in our building, they actually have building next door. They are using our standards updating our cal cert records (word doc form) & forwarding them to us for entry in our system.

They send gold standard equipment out for calibration to keep traceability to NIST standards.

I think as long as our procedure states an ourside source is doing calibration in some wording will cover us. I am just trying to figure out now what to remove and update in the procedure relating to in-house calibration, which has decreased drasticly.

Everyone has given me some great advice I think I know which way to head now.

If they were former employees, and were competent to do this work, and continue to use your standards and such, it might make sense to class them as contract employees and seek a solution in that fashion. Nowadays, employees, temps, independent employees...there are all sorts of payroll approaches. Who knows, pretty soon GM might have just independent assembly contractors working onsite.