SBS - The best value in QMS software

Traceability - NIST Policy on Traceability, Section II.B.4

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#1
I have created this thread in response to a suggestion by Jane_Ackerman. Thanks for the idea, as this is a great topic to explore.

Her note in the pressure gage thread:

Hershal,
If the calibration provider is indeed accredited, and you have their cert and scope on file, why would the NIST numbers they provide, not be valid to prove their traceability?

Isn't that part of the "credibility" of being "accredited" (ie: aren't they audited for that by their AB)?

(May need to be a separate forum topic)

Jane


My response follows.....

According to the NIST Policy on Traceability, Section II.B.4, the "NIST numbers" are job numbers.....

"Test report numbers issued by NIST are used solely for administrative purposes. Although they often uniquely identify documents that bear evidence of traceability, test report numbers themselves do not address the issues listed in II.B.1 above, and should not be considered as the sole evidence of traceability."

NCSLI also has a position on the numbers.....

"Test report numbers issued by the National Institute of Standards and Technology (NIST) of the United States Department of Commerce are intended to be used solely for administrative purposes. Although they are often used to uniquely identify documents which bear evidence of traceability, test report numbers should not be used nor required as proof of the adequacy or traceability of a test or measurement."

All of which means that NIST numbers may be used as a COMPONENT of the traceability path, but then it MUST be tied to a SPECIFIC calibration at a specific time/place, under specific conditions, for a specific customer.

To use the NIST numbers then means you will need a copy of the individual report that goes with that specific calibration of the instrument. And if the report does not document the specific calibration of the specific instrument, then it is not valid for traceability, any more than a generic calibration procedure is.

Hope this helps.

Hershal
 
Elsmar Forum Sponsor

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#2
I neglected to answer that the AB should have checked the traceability path.....and documented it adequately.

Hershal
 
J

jane_ackerman - 2010

#3
Hershal said:
To use the NIST numbers then means you will need a copy of the individual report that goes with that specific calibration of the instrument. And if the report does not document the specific calibration of the specific instrument, then it is not valid for traceability, any more than a generic calibration procedure is.

Hershal
I just want to make sure I have a clear understanding (and personally, I am concerned about TS16949 compliance).
In advance, please pardon my :mad: ... I'm anticipating answers that I don't want to hear.

I send thread gages to an A2LA Accredited Company (Company A) for calibration. I have their A2LA Cert and Scope on file.

Company A's cert for my thread gage calibration lists the Manufacturer, Description, Gage ID, Serial Number, Last Cal Date, Next Cal Due Date, Uncertainty and NIST Numbers of the standards they used to calibrate my threads.
There are also some general statements at the bottom claiming traceability to Grand Masters certified by NIST and that the calibration was performed in compliance with ANSI/NCSL Z540-1, ANSI/ASME B1.2, ANSI/ASME B1.22M and ISO 10012-14

My interpretation of what you stated, is that this is not acceptable and I should be asking Company A to provide certs showing that each of their standards used, were calibrated by Company B (whoever calibrated their standards).

:mad: If this is correct, then what about the standards that Company C used to calibrate Company B's equipment?
Do I need to track down Company C, D & E etc? And how do I know that these standards are within the calibration scope for these companies unless I obtain copies of those too?:mad:

Where does it stop? :frust:


Hershal said:
I neglected to answer that the AB should have checked the traceability path.....and documented it adequately.
Hershal
Why then, do "we" need to duplicate the work that the AB does during their registration/accreditation audit? ... and if their AB finds an issue, then my guess is, they would not receive their accreditation in the first place?


*big deep breath* .... ok, I'm done.
I hope I'm wrong so I can go eat some crow after I pull my foot out of my mouth.
 
Last edited by a moderator:

Hershal

Metrologist-Auditor
Staff member
Super Moderator
#4
No sweat on the frustration aspect.....it is similar from here.....

At the end user (lack of a better term) you should not have to do anyhing more if you have the cert and scope from the lab and the cal cert has the logo.

The lab on the other hand gets to jump through hoops.....as does the accrediting body.....

The unpleasant reality is that in certain specific areas of calibration, NIST will ONLY give the NIST numbers.....which means they only provide job numbers, thus short-changing the labs (in my opinion of course).....

You have complied with the part you need to do.....labs and ABs have a constant challenge though.....one way a lab MIGHT handle it is to go to another NMI (National Measurement Institute) such as NRC (Canada) or CENAM (Mexico), both of whom do excellent work, are equally acceptable - oh, and they provide an ACTUAL traceability path!

In this case I provided the information.....and hopefully an outlet for some steam.....

Hershal
 
J

jane_ackerman - 2010

#5
WHEW!!!!! Thanks for that info. I thought my job just quadrupled (or more).
 
Thread starter Similar threads Forum Replies Date
G Traceability - Checklist from NIST General Measurement Device and Calibration Topics 4
Raffy ISO 13485 NIST Traceability requirements for calibration of test equipment ISO 13485:2016 - Medical Device Quality Management Systems 3
A Is NIST traceability required if a Refractometer calibration is done in-house? Calibration Frequency (Interval) 6
D Since NIST # can not be used to verify Traceability - What an Auditor should do AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 8
M Pipette Calibration & ISO 8655 - No NIST Standard(s) Traceability ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 5
S ISO 17025 requirements not enough to prove NIST Traceability? ISO 17025 related Discussions 10
S NIST Traceability Numbers: Dense people, needle in a haystack General Measurement Device and Calibration Topics 16
C Steps to NIST - Measurement Traceability for a Certified Operator Class General Measurement Device and Calibration Topics 4
Jerry Eldred Presentation About NIST Traceability General Measurement Device and Calibration Topics 8
J NIST Traceability: OEM Products - New electronics measurement device General Measurement Device and Calibration Topics 5
R Outside Calibration - Accredited, certified - Is NIST traceability guaranteed? General Measurement Device and Calibration Topics 8
S NIST Traceability - Calibrating a grid w/ laser interferonmeters and microscopes General Measurement Device and Calibration Topics 4
Marc NIST Traceability Numbers - Confused Yet? General Measurement Device and Calibration Topics 5
S Traceability of requirements to design and risk Design and Development of Products and Processes 3
T ISO 9001 8.5.2. - Identification and traceability to Identify Outputs - Services ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 2
S IATF 16949 - Partial traceability of Aftermarket products IATF 16949 - Automotive Quality Systems Standard 5
R DHR question: Traceability of components ISO 13485:2016 - Medical Device Quality Management Systems 2
A Does AS9100 require traceability to operators performing the work? AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Traceability of component parts - Bolts, screws and washers ISO 13485:2016 - Medical Device Quality Management Systems 3
R Traceability on Unmarked Parts - AS9100 requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 7
T Non conformance product identification and traceability 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 4
B Traceability of Thermoelement Batches ISO 17025 related Discussions 7
G ISO 17025:2017 Uninterrupted chain of traceability for test laboratories ISO 17025 related Discussions 6
J What is the minimum standard for automotive component traceability? Manufacturing and Related Processes 2
A Validation of Calibration Methods and Traceability - ISO 17025 ISO 17025 related Discussions 3
shimonv Design input/output traceability for mechanical parts ISO 13485:2016 - Medical Device Quality Management Systems 13
K Identification and Traceability with an ERP system - Barcode Labels? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 3
B PED 2014/68/EU - Is this Traceability audit finding correct? Other ISO and International Standards and European Regulations 4
N FDA Traceability Requirements - Component lots ISO 13485:2016 - Medical Device Quality Management Systems 2
Stefan Mundt ISO 9001:2015 - 8.5.2 Identification and Traceability Manufacturing and Related Processes 14
S How to maintain a design traceability matrix ISO 13485:2016 - Medical Device Quality Management Systems 2
N Requirements for the identification and traceability of demo product for sales force US Food and Drug Administration (FDA) 1
MrTetris Traceability in Medical Sofware Development Process IEC 62304 - Medical Device Software Life Cycle Processes 3
M Medical Device Traceability ISO 13485:2016 - Medical Device Quality Management Systems 9
G Where to list chain of traceability? ISO 17025 related Discussions 6
A AS5553B Counterfeit Prevention - Traceability requirements AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 10
T In house Calibration? Measurement equipment traceability requirements - ISO9001 General Measurement Device and Calibration Topics 12
R ISO 9001:2015 Clause 7.1.5.2 - Is Measurement traceability applicable? ISO 9000, ISO 9001, and ISO 9004 Quality Management Systems Standards 1
M Medical Device Traceability Matrix - Examples EU Medical Device Regulations 8
DeeDeeM IATF16949, clause 8.5.2.1 Identification and traceability-supplemental IATF 16949 - Automotive Quality Systems Standard 1
DeeDeeM IATF 16949 - Clause 8.5.2 Identification and Traceability IATF 16949 - Automotive Quality Systems Standard 7
D IATF 16949 - 8.5.2.1 Traceability Plan - Does anyone have an example? IATF 16949 - Automotive Quality Systems Standard 4
A UDI - Traceability of Products Other US Medical Device Regulations 1
B AS9100 Rev D - Traceability of Consumables AS9100, IAQG, NADCAP and Aerospace related Standards and Requirements 4
J Customer Identification and Traceability in Manufacturing Plans Manufacturing and Related Processes 5
S Traceability and the initiation of GMP Activities 21 CFR Part 820 - US FDA Quality System Regulations (QSR) 6
N Calibration Traceability - Fluke 753 dpc with thermocouple Calibrated by Fluke ISO 17025 related Discussions 4
T Policy or Good Guidance for a Traceability Decision Tree (Serial and Batch Numbers) Misc. Quality Assurance and Business Systems Related Topics 4
J How to understand IATF 16949 Clause 8.5.2.1 - Traceability IATF 16949 - Automotive Quality Systems Standard 5
A Aluminum Die Casting Product Traceability Manufacturing and Related Processes 10

Similar threads

Top Bottom