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  17025, Guide 25, A2LA (Cal., Meas., and Test)
  Many Hats

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Author Topic:   Many Hats
qaadrian
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posted 20 July 2001 12:39 PM           Edit/Delete Message   Reply w/Quote
Supervision has just authorized one person to be a quality manager, a work leader over the calibration lab and also the head calibration person (calibrates all types of equipment). Wouldn't this be a case of conflict of interest? What does ISO 17025 say about this? Supervision says that a shortage of manpower forced him to make this decision.

Also, should the QA Manager report to the supervisor over the calibration laboratory? Does 17025 provide any guidance? Thanks.

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Jerry Eldred
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posted 20 July 2001 01:21 PM     Click Here to See the Profile for Jerry Eldred   Click Here to Email Jerry Eldred     Edit/Delete Message   Reply w/Quote
I looked in my "draft" version of ISO 17025, and in 4.1.4 j., NOTE 3 it said that "..in laboratories with a small number of personnel, individuals may have more than one function and it may be impractical to appoint deputies for every function."

I am not a 17025 expert. But it doesn't appear to be an issue. There are probably many companies out there with one man labs (I have run a few of them over the years). And even in mid-size labs, there aren't always enough people around to have a separate person fill each job title.

I think one of the key issues is that there shouldn't be conflicts of interest. You may need to be sure and have an auditor from another area (if you have dedicated QA auditors in a QA dept or equivalent) audit the lab periodically. That would be the external person to assure conformance.

In 4.13.1, it says, "...audits shall be carried out by trained and qualified personnel who are, wherever resources permit, independent of the activity being audited."

The part about "...wherever resources permit..." is the allowance for smaller operations, who don't have resources for separate personnel to be able to audit themselves. The hard line philosophy seems to me to have come from the MIL-STD days when DCAS was really hard lined about believing all contractors were out to steal from the government (some of them were).

But I think times have changed in that it is expected that people have integrity, and we should reasonably guardband when it makes sense. But not in all cases does it actually make sense.

So my layman's take on this is that it is acceptable to wear multiple hats within the lab. The un-acceptable course would be that the lab can't be run by production departments, marketing, finance, or other departments who would have a potential conflict of interest (i.e.: production needs to get product out the door, finance has to keep costs as low as possible, etc.).

Hope this is of some help.

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D.Scott
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From:Wellington, OH USA
Registered: Feb 2001

posted 20 July 2001 01:25 PM     Click Here to See the Profile for D.Scott   Click Here to Email D.Scott     Edit/Delete Message   Reply w/Quote
I don't see a problem unless there is something specific you haven't mentioned. 17025 requires that someone with suitable knowledge and experience be in charge. They must possess the required professional skills to do the job. There is no restriction on what this person can be called (quality manager, head person, work leader etc.) The only requirement is that this person serve as the technical head. If the QM is the work leader and head calibration person, and also cleans up at night, I see no problem.

Maybe some of the others have had some real life audit experience with this and can shed some other light.

Hope this helps.

Dave

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JerryStem
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From:W Chester OH USA
Registered: Apr 2001

posted 20 July 2001 04:07 PM     Click Here to See the Profile for JerryStem   Click Here to Email JerryStem     Edit/Delete Message   Reply w/Quote
I am the Quality Manager here, and also the Calibration Standards Dept. Mgr. (There is also a Service Dept. Mgr.) We do service/calibrations of coating/plating thickness measurement equipment here, the machines (Service) and the calibration standards for them (Standards).

We are Guide 25, working on 17025. Our auditor had no problems with us (there are ~8 employees,including owner and wife/accountant).

I am going thru 17025 right now and do not remember seeing anything different in this area. (Other areas, on the other hand...)

Jerry

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Ryan Wilde
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From:Mineola, NY, USA
Registered: Feb 2001

posted 20 July 2001 09:39 PM     Click Here to See the Profile for Ryan Wilde   Click Here to Email Ryan Wilde     Edit/Delete Message   Reply w/Quote
There are a few "one person cal labs" that are accredited to Guide 25/17025 right now that I know of offhand. Being the person that does everything is not a conflict of interest, although it is a huge task to take onto your shoulders.

As far as the QA Manager reporting to the lab supervisor, that depends. If the QA manager is the person that ensures the quality of calibration results (through spot checks, etc.), then yes, generally that person fills a function under the lab supervisor. If you are speaking of the person that writes and ensures the quality SYSTEM, then the general answer would be no, he/she would generally report directly to upper management. In most cases, QA is a department unto itself. In the case of a rather sizeable aircraft company in the Pacific Northwest, it is the most feared entity in the company, and it reports way up the corporate food chain.

Ryan

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