Calibration and Verification Records - TS 16949 Clause 7.6.2

[kat.k.]

TS16949 says - records of calibration/verificatin must - then it lists what the records must have.

But anytime you state - you "verify" gages at specified intervals in your procedures or tell the auditor you do, do you have to show records of this verification?

Thank you
kat.k.

 

[Elynn]

Re: calibration/verification records

Verification records comes with procedures.... Procedures must be validated....

 

[BradM]

Re: calibration/verification records

I'm by no means in the TS16949 field but it would appear that you answered your own question

If the standard says:

TS16949 says - records of calibration/verification must - then it lists what the records must have.

Then you would need to document and verification performed:

But anytime you state - you "verify" gages at specified intervals in your procedures or tell the auditor you do, do you have to show records of this verification?

Thank you
kat.k.

So yes, I think you should be keeping records of some kind of the verification. It will give you a record of the performance of that device, and how the verifications are doing.

 

[AndyN]

Re: calibration/verification records

Brad is correct. Keeping records is also a requirement to demonstrate that what's being done is efective. So, even if it's a quick check, writing down the result will do two things for you - at least:-

Show the thing was in spec.
Show that the frequency of checks is still finding the thing is within limits

That way you can decide how often to do it, and maybe reduce the frequency.

 

[AgnieszkaSz]

I suggest that you use ISO10012 "Measurement management systems - Requirements for measurement processes and measuring equipment" as a guidance. In clause 7.1.4, the contents of records of metrological information shall contain:
- the description and unique identification of the equipment (manufacturer, type, serial no. etc);
- the date of metrological confirmation;
- the result of metrological confirmation;
- the assigned interval for metrological confirmation;
- the identification of metrological confirmation procedure;
- the maximum permissible error(s);
- the relevant environmental condition and statement about any corrections necessary;
- the uncertainties involved in calibrating the equipment;
- details of any maintenence, as adjustment, modification or repairs carried out;
- any limitations of use;
- identification of person(s) performing the metrological confirmation;
- identification of person responsible for the correctnes of recorded information;
- unique identification of of any calibration certificates or reports and other relevant documents;
- evidence of traceability of calibration results;
- the metrological requirements for the intended use;
- the calibration results obtained after, and, when required, before any adjustment, modification or repair.

Uff. Awful lot, isn't it? Mind, this is the full set of contents that would be required in a laboratory. Just choose what is reasonable in your conditions. I must admit that I like ISO10012, it has helped me a lot.

 

[kat.k.]

Re: calibration/verification records

I agree. Thanks for your help.

 

[kat.k.]

Thank you for this information. Is this standard for labs holding the ISO 17025 certification only or for internal labs also?

Thanks again
kat.k.

 

[AndyN]

Thank you for this information. Is this standard for labs holding the ISO 17025 certification only or for internal labs also?

Thanks again
kat.k.

I can be used for internal labs. Whether you intend to be accredited by an 3rd party is another matter, of course.

 

[howste]

TS16949 says - records of calibration/verificatin must - then it lists what the records must have.

But anytime you state - you "verify" gages at specified intervals in your procedures or tell the auditor you do, do you have to show records of this verification?

Thank you
kat.k.

I believe there may be a little more to this question than meets the eye. What if you have a micrometer on an annual calibration cycle, but you verify it daily before use? Are you required to maintain this full list of information for both the annual calibration and each day's verification?

(These are not listed in the same order as TS 16949)
1) equipment identification, including the measurement standard against which the equipment is calibrated
2) statements of conformity to specification after calibration/verification
3) any out-of-specification readings as received for calibration/verification
4) revisions following engineering changes
5) an assessment of the impact of out-of-specification condition
6) notification to the customer if suspect product or material has been shipped

I would suggest that items 1 & 2 need to be included in all records, including both the annual calibration and the daily verification. The annual calibrations would probably include the actual as-found/as-left readings (numerical data) and the standards used for calibration. The daily verifications could be as simple as pass/fail and the standard(s) against which they were verified. Items 3-6 would only be needed in applicable situations such as when the gage is found out-of-tolerance, or when modifications to gaging are made.