Engineering purchased a new Caliper - 7.6 - Initial Calibration Required?

Q

QACen

#1
Hello - Engineering purchased a new caliper. It has the new certificate of inspection from the manufacturer but it is not necessarily calibrated. If Engineering verifies the equipment as uses the Certificate of Inspection from the manufacturer as evidence, is that acceptable? It is one of those moments where it is immediately needed and to calibrate the equipment would take 4 weeks.

Thoughts?
Thanks for your wisdom and incite!
 
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BradM

Staff member
Admin
#2
Re: 7.6 - Initial Calibration Required?

Hello there!

In my opinion, most of the certificates of inspection are usually not worth the paper they are written on. There is no date, no traceability to the specific instrument, and usually is some general reference to a lot of instruments. Sometimes they may make 1000 of them, test three, and if they pass, they're all good! :D

Saying all that to suggest one needs to be leery about those certificates, and inspect the information on them carefully.

Performing a verification in-house is another matter. If you can verify with traceable blocks and demonstrate there is no (or insignificant error) before and after use, then (IMHO) that would satisfy in demonstrating it's confidence.

You posted this in a 13485 forum. Is this used in Medical Device arena? Would this be considered a GMP piece of equipment? If so, I would not use it if your procedures state that it is to be calibrated. Or, do you have an alternated method specified in your procedures to perform a verification like you suggest? Also, do you have a procedure for using equipment "at risk"?
 

insect warfare

QA=Question Authority
Trusted Information Resource
#3
Re: 7.6 - Initial Calibration Required?

I tend to agree with Brad on the worth of manufacturer's certs...the manufacturer may not even be 17025 certified, or the information on the cert is not NIST-traceable. I usually look for this information right off the bat, and even if I find it, I usually err on the side of caution anyway and ensure calibration / verification is done by a more reputable organization.

I don't know the exact requirements for medical devices or for this company, but the idea of performing in-house verification appears to be a viable solution, provided all requirements were met, plus it would save you those 4 weeks lost through outsourcing. Check the applicable standard plus your internal procedures, and see if this is acceptable.
 
S

sitapaty

#4
Re: 7.6 - Initial Calibration Required?

Why should you suspect a brand new M.T.I?.A good guarantee for accuracy is to buy from a reputed brand.As for as the auditors are concerned The certificate from manufacturer should be acceptable for a certain period.
Sitapaty
 

BradM

Staff member
Admin
#5
Re: 7.6 - Initial Calibration Required?

Hi there! Thanks for contributing! :bigwave:

Why should you suspect a brand new M.T.I?.A good guarantee for accuracy is to buy from a reputed brand.
To an extent, yes; you're correct. However, even a new piece of equipment should be initially verified prior to use to assure something hasn't changed. I have seen instruments shipped international that accumulated some error by the time I received them to use.

My experience (so... it's probably not worth a lot :D) is to perform a verification (calibration, etc.) prior to use. It is worth the confidence gained.

As for as the auditors are concerned The certificate from manufacturer should be acceptable for a certain period.
Sitapaty
Again, I would agree with you to an extent. If it is a legitimate certificate of calibration, I would accept for a certain period. Along with other information, it would contain standards, tolerance assessment, and a direct link to that specific instrument.

I have seen "certificates" that were useful, and certificates that were essentially useless. Useless in that they provided no confidence for that particular instrument, and to me, appeared to be more of a sales job than anything.
 
Q

QACen

#6
Thank you for the comments to my question. Your answers definitely confirmed my doubts about accepting an Engineer's decision to accept the manufacturer's certification of inspection (not calibration). We are in the middle of revising our SOP to further elaborate the verification process. It lacked verbage to actually document the verification. You definitely gave me ideas and further guidance for wording.

Thanks a million! :bigwave:
 

Jim Wynne

Staff member
Admin
#7
Thank you for the comments to my question. Your answers definitely confirmed my doubts about accepting an Engineer's decision to accept the manufacturer's certification of inspection (not calibration). We are in the middle of revising our SOP to further elaborate the verification process. It lacked verbage to actually document the verification. You definitely gave me ideas and further guidance for wording.

Thanks a million! :bigwave:
You earlier mentioned having to wait several weeks for calibration, but it doesn't have to be like that. Buy a set of gage blocks and do it yourself. Even if it's just for a initial verification (which is still calibration) for new devices, the set of blocks is something that should always be on hand when calipers and micrometers are being used.
 
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