Auditor has rejected our in-house gage verification - Calibration in 17025:2005

A

amanbhai

#1
Hi everybody,
External calibration has not been aranged since last year. Our equipment has been verified through our inhouse verification plan. (External calibration date has been overdue for almost six months) but auditor has rejected our verification.
Could we verify our equipment in house?
Can guru provide some insight on this subject?
 
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Marcelo

Inactive Registered Visitor
#2
Re: Auditor has rejected our verification - Calibration in 17025:2005

You can verify your equipment in house, but that doesn´t mean you can calibrate them. In thory, you can only "calibrate" if your lab is a calibration lab accreditated to ISO 17025. If not, i think the only thing you can do are intermediate checks, which are not considered officla calibrations. I think your "inhouse verification plan" seems more like intermediate checks.
 
D

D.Scott

#3
Re: Auditor has rejected our verification - Calibration in 17025:2005

Hi everybody,
External calibration has not been arranged since last year. Our equipment has been verified through our in-house verification plan. (External calibration date has been overdue for almost six months) but auditor has rejected our verification.
Could we verify our equipment in house?
Can guru provide some insight on this subject?
You are allowed to verify your equipment in-house. The equipment must be verified against a standard traceable to NIST.

You say you have an in-house verification plan. Is the plan documented? Does it meet the requirements? Is there a system to identify the calibration status of the equipment? Is the equipment uniquely identified?

You say the external calibration is overdue. Is this shown by a label on the equipment or on the calibration certificate? Does your verification plan include placing a calibration label on the equipment which supersedes the other label?

Let's say you buy a gage which is calibrated by the OEM. It arrives with a cal. cert and has a sticker on it showing the next cal. due date (let's say it is due in 6 months). If you now enter the gage into your calibration system, the rules established in your system would now control the calibration status. Your system states this gage is due for calibration in 1 year. You would remove the OEM sticker and replace it with your internal sticker showing the due date. One year later you would pull the gage and verify it against an NIST traceable standard and put it back in use with a new sticker showing it was due in another year. The alternative would be to send it out for calibration and use their sticker to show the status.

For the purpose of meeting the requirements of the standard, calibration and verification become synonymous. The calibration status is the same in both cases. You don't need to have stickers that say "verified" and/or "calibrated". The tricky part is to determine what will work for your purposes. Can you rely on in-house verification or do you need to send it to the experts? This decision can be defined in your in-house calibration system.

If you follow a documented calibration system that meets the requirements of the standard, the auditor should be ok with it. If you have no documentation or no traceable standards I can see where he would have a problem.

If I didn't manage to address your question, please elaborate a little more on what the auditor said and we will see if we can help.

Dave
 
B

Benjamin28

#4
Re: Auditor has rejected our verification - Calibration in 17025:2005

Mmatunes is correct, you can certainly continue doing an intermediate verification...but I would think of this as more of an operational check. You will still need to continue with your external calibration by a certified lab or develop an internal calibration function that has all the bells and whistles.

What standard are you being held to, does it give any guidance to the requirements for calibration of measurement equipment?
 
J

John Nabors - 2009

#5
Re: Auditor has rejected our verification - Calibration in 17025:2005

You are allowed to verify your equipment in-house. The equipment must be verified against a standard traceable to NIST.
Seeing as amanbhai is in Canada, would he want his traceability to be to the US NIST? Would someone who unlike me actually knows the answer to that question please respond?

Regards -John
 
M

Mr Niceguy

#6
Re: Auditor has rejected our verification - Calibration in 17025:2005

You don't say whether you are a testing organisation accredited to 17025:2005, or a calibration laboratory accredited to 17025 that is subcontracting some activities. It makes a slight difference because the standard in clause 5.6.2.2.1 allows a relaxation of a requirement for testing labs to prove traceability when the contribution to combined uncertainty is very small. Naturally the in-house checks and uncertainty assessment must be verified and documented for the auditor.
 
M

Mr Niceguy

#7
Re: Auditor has rejected our verification - Calibration in 17025:2005

Seeing as amanbhai is in Canada, would he want his traceability to be to the US NIST? Would someone who unlike me actually knows the answer to that question please respond?

Regards -John
All the major western primary standards bodies , NIST, NPL UK, TNO etc recognise each other, have collaborative agreements, exchange primary standards where possible, even audit each other sometimes. It shouldn't make any difference. I am in the UK and I have gas flow meters traceable to the Swedish body and particle size reference material traceable to NIST.
 

BradM

Staff member
Admin
#8
Re: Auditor has rejected our verification - Calibration in 17025:2005

Some good posts here, everybody.

Towards your subject, Dave seems to have a pretty comprehensive post.

Which auditor is this? Do you have some type of certification? What section or non-conformity did they cite?

What industry are you in? What are your customer requirements?

What do you tell yourself you will do in your procedures?

It is really naive to accurately suggest to you a proper course of action until I know what you are required to do.

If you have no mandatory requirements on the part of your industry and your customer, the only other thing you have to comply with is what you tell yourself you will do through your own procedures.

Verification is a very open-ended word, that can cover a plethora of activities. Without knowing the details surrounding the verification, it's difficult to assess if it's adequate, or where it may be deficient.

Personally, I would not ever leave on an overdue calibration sticker on a piece of equipment. I would proceduralize handling matters so you can take the sticker off. Overdue calibration stickers are big red flags that are easy for anyone to see, and instantly requires an explanation.
 
S

SilverHawk

#9
Inhouse laboratory is not a mandatory requirement to be accredited to ISO 17025 according to ISO/TS 16949 Clause 7.6.3.1 (See Note).

If your equipment's measurement capabilities is made known thru the linerity and bias computation, the equipemnt is still good an dmay not required any calibartion.

After all, the ISO 17025 clause 5.10.4.4 mentioned that acalibration certificate (or calibration label) shall not contain any recommendation on the calibration interval except where this has been agreed with the customer.
 
K

Ken K

#10
You can verify your equipment in house, but that doesn´t mean you can calibrate them. In thory, you can only "calibrate" if your lab is a calibration lab accreditated to ISO 17025. If not, i think the only thing you can do are intermediate checks, which are not considered officla calibrations. I think your "inhouse verification plan" seems more like intermediate checks.
That's not correct. Our registrar uses the following procedure:


"Testing laboratories that perform calibrations only for themselves do not
need to be accredited as a calibration laboratory. Calibration laboratories
that perform specific calibrations only for themselves to support their
accredited services do not need to be accredited for those calibrations. For
the purpose of assuring traceability, an accredited laboratory may calibrate its
own equipment if the appropriate requirements of LAB and ISO/IEC 17025
have been met. The laboratory shall demonstrate competency to perform
the calibrations it undertakes."

Depends on how much work you wish to do.
 
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