Calibration and Verification Records - TS 16949 Clause 7.6.2

K

kat.k.

#1
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.
 
Elsmar Forum Sponsor
E

Elynn

#2
Re: calibration/verification records

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

BradM

Staff member
Admin
#3
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.:)
 
#4
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

Involved In Discussions
#5
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.
 
K

kat.k.

#7
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.
 
#8
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

Thaumaturge
Super Moderator
#9
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.
 
Thread starter Similar threads Forum Replies Date
J Calibration/Verification Records (IATF 16949 7.1.5.2.1) IATF 16949 - Automotive Quality Systems Standard 5
E IATF 16949 Cl. 7.1.5.2.1 - Calibration and Verification Records Requirements IATF 16949 - Automotive Quality Systems Standard 1
J IATF 16949 Cl. 7.1.5.2.1 - Gauges (Measuring Jigs) Calibration/Verification Records IATF 16949 - Automotive Quality Systems Standard 6
M Clarification on Calibration/Verification Records 7.1.5.2.1d (IATF 16949) General Measurement Device and Calibration Topics 11
B Calibration/Verification Records - IATF 16949 section 7.1.5.2.1 f) IATF 16949 - Automotive Quality Systems Standard 6
P IATF 16949 Cl. 7.1.5.2.1 "Calibration/Verification Records" Interpretation IATF 16949 - Automotive Quality Systems Standard 12
G TS-16949 7.6.2 ? Calibration/Verification Records - Assessment of the Impact IATF 16949 - Automotive Quality Systems Standard 5
C Calibration/verification records - New gage certificate as calibration evidence General Measurement Device and Calibration Topics 4
S TS 16949 Clause 7.6.2 Calibration Verification Records Records and Data - Quality, Legal and Other Evidence 7
M Calibration or Verification? What terminology to use ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
V Calibration certificate verification Qualification and Validation (including 21 CFR Part 11) 3
G Assigning a calibration tolerance - An x-y coordinate machine - Uncertainty as my verification tolerance General Measurement Device and Calibration Topics 4
D How to set equipment calibration/verification criteria General Measurement Device and Calibration Topics 1
S Calibration and Verification requirement for foreign EASA Part 145 EASA and JAA Aviation Standards and Requirements 7
J Pneumatic & Electrical Torque Tool - Calibration/Verification of 'Power Tools' General Measurement Device and Calibration Topics 2
Q Using Caliper A to verify Caliper B - Verification of Calibration ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
K Verification instead of calibration?(ISO 9001:2008) Calibration Frequency (Interval) 10
K "Verification of Calibration" - CMM arm General Measurement Device and Calibration Topics 6
I Verification or calibration Fluke 8508a with 5720a? TUR not 4:1? Measurement Uncertainty (MU) 1
Q Number of Calibration Verification Points - Calipers, height gages, etc General Measurement Device and Calibration Topics 6
A Calibration/Verification of thermo-hygrometer in storage areas ISO 13485:2016 - Medical Device Quality Management Systems 9
G Is this Calibration or Verification ? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 23
D How Working Standard Calibration result use in Verification of Equipment General Measurement Device and Calibration Topics 7
M Calibration Certification Qualification vs. Verification by Uncertified Staff General Measurement Device and Calibration Topics 6
AshleyE Torque Wrench Calibration/Verification General Measurement Device and Calibration Topics 24
G BRC (British Retail Consortium) - Calibration vs. Verification Food Safety - ISO 22000, HACCP (21 CFR 120) 4
JodiB Balance Calibration Verification question General Measurement Device and Calibration Topics 9
JodiB Log Book for Analytical Balance Calibration Verification General Measurement Device and Calibration Topics 4
Uriel Alejandro How to Record Evidence for Verification/Calibration of Equipment AS9100, IAQG 9100, Nadcap and related Aerospace Standards and Requirements 6
M Establishing Ranges for Weights for Calibration Verification of a Micro-Balance Calibration Frequency (Interval) 1
H Analytical Balance Calibration and Verification General Measurement Device and Calibration Topics 9
D Precision Balance Verification and Calibration Process General Measurement Device and Calibration Topics 3
D Equipment Verification and Calibration Report Standard General Measurement Device and Calibration Topics 9
P Record Retention requirements of Calibration and Verification Service Providers ISO 13485:2016 - Medical Device Quality Management Systems 11
P Is it compulsory to send new measuring equipment for calibration / verification? Calibration Frequency (Interval) 3
D Calibration vs. Verification and Measurement Device Labeling General Measurement Device and Calibration Topics 10
M Basis used for Calibration or Verification of Measuring Equipment ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 8
D For Reference Only or Calibration/Verification - Tape Measures for cutting bar stock ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 26
M Methods for Verification/Calibration of Video (Optical) Extensometer General Measurement Device and Calibration Topics 2
C Updating our Laboratory Calibration / Verification Procedures IATF 16949 - Automotive Quality Systems Standard 5
R Verification vs. Calibration and what to do with the results of each General Measurement Device and Calibration Topics 3
B Difference between Calibration & Verification and How to calibrate Go/No Go gauge? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 4
S Audit and Calibration question - does verification alone meet the requirements? General Auditing Discussions 5
D Calibration vs. Verification - Can we calibrate dial indicators in-house? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
P Internal Calibration or Verification - Personnel Requirements IATF 16949 - Automotive Quality Systems Standard 3
S Verification of calibration certificate Miscellaneous Environmental Standards and EMS Related Discussions 1
R Calibration (Verification) of RF cables General Measurement Device and Calibration Topics 2
M Telescoping Gage - Calibration or Verification General Measurement Device and Calibration Topics 5
L Difference between Calibration, Verification and Adjust (Adjustment) General Measurement Device and Calibration Topics 6
C Verification vs. Calibration of Dial Weight Dynamometer General Measurement Device and Calibration Topics 4
Similar threads


















































Top Bottom