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articles:nist_traceability [2018/12/14 12:34] – [What are SI Units?] rrandallarticles:nist_traceability [2023/02/01 18:32] (current) – [What are "International Standards"?] rrandall
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-**[[https://www.nist.gov/document/gmp-13-ensuring-traceability-20180213docx|NIST GMP 13, "Good Measurement Practice +**[[https://www.nist.gov/system/files/documents/2019/06/21/gmp-13-ensuring-traceability-20190621.pdf|NIST GMP 13, "Good Measurement Practice 
 for Ensuring Metrological Traceability”]], sec. 1.1 (3rd para.):** \\ for Ensuring Metrological Traceability”]], sec. 1.1 (3rd para.):** \\
 "//Test numbers issued by NIST should not be used nor required as proof of the adequacy or traceability of a test or measurement. Having a NIST number does not provide evidence that the measurement value provided by another organization has the property of metrological traceability.//" "//Test numbers issued by NIST should not be used nor required as proof of the adequacy or traceability of a test or measurement. Having a NIST number does not provide evidence that the measurement value provided by another organization has the property of metrological traceability.//"
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 And And
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-**[[https://www.nist.gov/document/gmp-13-ensuring-traceability-20180213docx|NIST GMP 13, "Good Measurement Practice  +**[[https://www.nist.gov/system/files/documents/2019/06/21/gmp-13-ensuring-traceability-20190621.pdf|NIST GMP 13, "Good Measurement Practice  
-for Ensuring Metrological Traceability”]], sec. 1.3.3, "Use of, or reference to, official test numbers of a national metrology institute":** \\  +for Ensuring Metrological Traceability”]], sec. 1.6.3, "Use of, or reference to, official test numbers of a national metrology institute.":** \\  
-"//Having an authentic test number does not provide assurance or evidence that the measurement value provided by another organization is traceable. Not only must there be an unbroken chain of comparisons, but each measurement must be accompanied by a statement of uncertainty associated with the value. Test report numbers should not be used nor required as proof of the adequacy or traceability of a test or measurement. National and international standards dealing with test and measurement quality requirements, such as ISO 10012, ISO/IEC 17025 and the ISO 9000 series do not require the use or reporting of specific test numbers to establish traceability.//"+"//Having an authentic test number does not provide assurance or evidence that the measurement value provided by another organization is traceable. Not only must there be an unbroken chain of comparisons, but each measurement must be accompanied by a statement of uncertainty associated with the value. Test report numbers should not be used nor required as proof of the adequacy or traceability of a test or measurement. National and international documentary standards for test and measurement quality requirements, such as ISO 10012, ISO/IEC 17025 and the ISO 9000 series, provide guidance for assessing metrological traceability and do not require the use or reporting of specific test numbers to establish metrological traceability.//"
 </WRAP> </WRAP>
 This is further noted in the: This is further noted in the:
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 a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards __traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information__;//" a. calibrated or verified, or both, at specified intervals, or prior to use, against measurement standards __traceable to international or national measurement standards; when no such standards exist, the basis used for calibration or verification shall be retained as documented information__;//"
 </WRAP> </WRAP>
-Unfortunately, the language in ISO 9001:2015 & AS9100:2016 (Rev. D) is antiquated in stating its requirements for "measurement traceability". In contrast, ISO 17025:2017 is much more modern and technically correct in stating:\\+Unfortunately, the language in ISO 9001:2015 & AS9100:2016 (Rev. D) is extremely antiquated in stating its requirements for "measurement traceability"And, unfortunately, similar antiquated language appears in U.S. Regulations. For example, 21 CFR 820.72 states: 
 + 
 +<WRAP center round box 80%>**TITLE 21--FOOD AND DRUGS** \\ 
 +CHAPTER I--FOOD AND DRUG ADMINISTRATION \\ 
 +DEPARTMENT OF HEALTH AND HUMAN SERVICES \\ 
 +SUBCHAPTER H--MEDICAL DEVICES \\ 
 +PART 820 -- QUALITY SYSTEM REGULATION \\ 
 + 
 +Subpart G--Production and Process Controls \\ 
 + 
 +Sec. 820.72 Inspection, measuring, and test equipment. \\ 
 +(b) (1) Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be __traceable to national or international standards__. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.</WRAP> 
 + 
 +Similar antiquated language appears in [[http://everyspec.com/MIL-STD/MIL-STD-1300-1399/MIL-STD-1309D_87/|MIL-STD-1309D]], (12 February 1992), which doesn't even recognize international standards or offer alternatives where no national measurement standards exist: 
 +<WRAP center round box 80%>**MIL-STD-1309D, "Definitions of Terms for Testing, Measurement and Diagnostics"**\\ 
 +3.1.653 Traceability. The ability to relate individual measurement results to __national standards or nationally accepted measurement systems__ through an unbroken chain of comparisons. 
 +</WRAP> 
 + 
 +In contrast, ISO 17025:2017 is much more modern and technically correct in stating:\\
 <WRAP center round box 80%> <WRAP center round box 80%>
 **ISO 17025:2017, “General requirements for the competence of testing and calibration laboratories”** \\ **ISO 17025:2017, “General requirements for the competence of testing and calibration laboratories”** \\
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 \\ \\
 [[http://www.isobudgets.com/measurement-traceability-complying-iso-17025-requirements/|{{ :articles:measurement-traceability-pyramid-600px.jpg?direct }}]] [[http://www.isobudgets.com/measurement-traceability-complying-iso-17025-requirements/|{{ :articles:measurement-traceability-pyramid-600px.jpg?direct }}]]
 +
 +I describe the above pyramid as "//typical//" because, contrary to the antiquated language of ISO 9001:2015 & AS9100:2016, it is possible to “bypass” the National Metrology Institutes (NMIs) to obtain traceability directly to SI units. Using the example of DC volts, [[https://www.fluke.com|Fluke]], a world leader in the field of metrology, owns a [[https://nvlpubs.nist.gov/nistpubs/jres/095/jresv95n3p219_A1b.pdf|Josephson voltage system]], which they can use to realize the SI Units directly.
 +
 +Also, while not strictly speaking a National Metrology Institute (NMI), the [[https://www.bipm.org|"Bureau International des Poids et Mesures" (BIPM)]] offers [[https://www.bipm.org/en/bipm-services/|calibration & Measurement services]] (with traceability to SI Units) to its [[https://www.bipm.org/en/about-us/member-states/|Member States]]. In that instance, the BIPM would serve as equivalent to a NMI.
 +
 +Transcat has an excellent White Paper on this topic at: [[https://www.transcat.com/calibration-resources/white-papers/what-is-measurement-traceability]].
 ===== What are SI Units? ===== ===== What are SI Units? =====
 {{ :articles:2018-si.png?direct&130|}} {{ :articles:2018-si.png?direct&130|}}
-The "[[https://www.bipm.org/en/measurement-units/|International System of Units]]" (//Système International d'Unités//, with the international abbreviation SI) consists of 7 base units that define 22 derived units. With the exception of the kilogram, the base SI units are all derived from intrinsic (i.e., invariant) constants of nature, such as the speed of light in vacuum and the [[https://en.wikipedia.org/wiki/Boltzmann_constant|Boltzmann constant]] (which serves as the basis for the Kelvin temperature scale). According to Dr. Chris Sutton, "[[https://www.sciencelearn.org.nz/resources/1872-non-si-units|the SI system of units allows for complete coverage of all scientific measurements]]". \\+Adopted by the [[https://en.wikipedia.org/wiki/General_Conference_on_Weights_and_Measures|General Conference on Weights and Measures (CGPM)]] in 1960, the "[[https://www.bipm.org/en/measurement-units/|International System of Units]]" (//Système International d'Unités//, with the international abbreviation SI) consists of 7 base units that define 22 derived units. The base SI units are all derived from intrinsic (i.e., invariant) constants of nature, such as the speed of light in vacuum and the [[https://en.wikipedia.org/wiki/Boltzmann_constant|Boltzmann constant]] (which serves as the basis for the Kelvin temperature scale). According to Dr. Chris Sutton, "[[https://www.sciencelearn.org.nz/resources/1872-non-si-units|the SI system of units allows for complete coverage of all scientific measurements]]". \\
  
 The SI Units are defined in the [[https://www.bipm.org/en/publications/si-brochure/|SI Brochure]], which is published by the [[https://www.bipm.org/en/about-us/|“Bureau International des Poids et Mesures” (BIPM)]], located in France. The SI Units are defined in the [[https://www.bipm.org/en/publications/si-brochure/|SI Brochure]], which is published by the [[https://www.bipm.org/en/about-us/|“Bureau International des Poids et Mesures” (BIPM)]], located in France.
- 
-SI Units are also explained on the NIST web site at: https://www.nist.gov/pml/weights-and-measures/metric-si/si-units 
  
 Because SI units are derived from intrinsic (i.e., invariant) constants of nature, "intrinsic measurement standards" exist. This is acknowledged in ISO 17025:2017, sec. 6.5.2, which provides 3 (three) different methodologies for achieving metrological traceability. And is further clarified in ISO 17025:2017, "Annex A: Metrological traceability". \\ Because SI units are derived from intrinsic (i.e., invariant) constants of nature, "intrinsic measurement standards" exist. This is acknowledged in ISO 17025:2017, sec. 6.5.2, which provides 3 (three) different methodologies for achieving metrological traceability. And is further clarified in ISO 17025:2017, "Annex A: Metrological traceability". \\
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 A.2 Establishing metrological traceability** \\ A.2 Establishing metrological traceability** \\
 //A.2.1 Metrological traceability is established by considering, and then ensuring, the following: \\ //A.2.1 Metrological traceability is established by considering, and then ensuring, the following: \\
-b) a documented unbroken chain of calibrations going back to stated and appropriate references (appropriate references include national or international standards, and __intrinsic standards__);// \\ +b) a documented unbroken chain of calibrations going back to stated and appropriate references (appropriate references include national or international standards, and __intrinsic standards__);// 
----- +
-Source: [[https://ilac.org/?ddownload=840|ILAC-P10:01/2013, "ILAC Policy on the Traceability of Measurement Results"]]" +
 </WRAP> </WRAP>
 +
 +SI Units are also explained on the NIST web site at: https://www.nist.gov/pml/weights-and-measures/metric-si/si-units and in "[[https://www.nist.gov/pml/special-publication-330|NIST Special Publication 330 -  The International System of Units (SI)]]"
 ===== What are "intrinsic" standards? ===== ===== What are "intrinsic" standards? =====
  
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 </WRAP> </WRAP>
  
-Let's use the example of DC volts. [[https://www.fluke.com|Fluke]], a world leader in the field of metrology, owns a [[https://nvlpubs.nist.gov/nistpubs/jres/095/jresv95n3p219_A1b.pdf|Josephson voltage system]], which they can use to realize the SI directly. Even though they don't send an instrument to NIST for calibration, they [[https://www.fluke.com/en-us/learn/blog/electrical/the-volt-makes-a-stop-at-the-fluke-metrology-lab|compare their Josephson voltage system to an identical Josephson Voltage system maintained by NIST]]. +As mentioned earlier, [[https://www.fluke.com|Fluke]] owns a [[https://nvlpubs.nist.gov/nistpubs/jres/095/jresv95n3p219_A1b.pdf|Josephson voltage system]], which they can use to realize the SI Units directly for DC Volts. Even though they don't send an instrument to NIST for calibration, they [[https://www.fluke.com/en-us/learn/blog/electrical/the-volt-makes-a-stop-at-the-fluke-metrology-lab|compare their Josephson voltage system to an identical Josephson Voltage system maintained by NIST]].  
 + 
 +==== Legal Metrology ==== 
 + 
 +Fluke performs this comparison described above because, just as the requirements for “measurement traceability” contained in ISO 9001:2015 & AS9100:2016 (Rev. D) are antiquated, so is U.S. law in this area. U.S. Law has designated NIST as holding the national standards of measurement, and NIST has defined the U.S. legal volt to be produced from its one particular Josephson voltage system, so it is the national standard. However, this is only pertinent to the area of "legal metrology" (Ref.: [[https://www.oiml.org/en/about/legal-metrology|International Organization of Legal Metrology]]).
  
-Fluke performs this comparison because, just as the requirements for “measurement traceability” contained in ISO 9001:2015 & AS9100:2016 (Rev. D) are antiquated, so is U.S. law in this area. U.S. Law has designated that NIST holds the national standards of measurement, and NIST has defined the U.S. legal volt to be produced from its one particular Josephson voltage system, so it is the national standard. 
 ===== What are "International Standards"? ===== ===== What are "International Standards"? =====
-While ISO 9001:2015, AS9100:2016 (Rev. D) and ISO 17025:2017 all mention "International Standards", I am aware of only four (4) "international standards" (as opposed to SI //units//); three of which are listed as examples in the "Bureau International des Poids et Mesures" (BIPM) [[https://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf|JCGM 200:2012, "International vocabulary of metrology – Basic and general concepts and associated terms (VIM)"]] (3rd edition), sec5.2, "international measurement standard". However, there are probably others. Those that I am aware of include: \\+While ISO 9001:2015, AS9100:2016 (Rev. D) and ISO 17025:2017 all mention "International Standards", none of them define what this means. Fortunately, the "Bureau International des Poids et Mesures" (BIPM) [[https://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf|JCGM 200:2012, "International vocabulary of metrology – Basic and general concepts and associated terms (VIM)"]] (3rd edition), defines this term. 
 + 
 +<WRAP center round box 80%> 
 +**International Measurement Standard** \\ 
 +//measurement standard recognized by signatories to an international agreement and intended to serve worldwide// \\
 \\ \\
-**1 - The international prototype of the kilogram** \\+EXAMPLE 1   The international prototype of the kilogram. 
 + 
 +EXAMPLE 2   Chorionic Gonadotrophin, World Health Organization (WHO) 4th international standard 1999, 75/589, 650 International Units per ampoule. 
 + 
 +EXAMPLE 3   VSMOW2 (Vienna Standard Mean Ocean Water) distributed by the International Atomic Energy Agency (IAEA) for differential stable isotope amount-of- substance ratio measurements. 
 + 
 +---- 
 +Source: The "Bureau International des Poids et Mesures" (BIPM) [[https://www.bipm.org/utils/common/documents/jcgm/JCGM_200_2012.pdf|JCGM 200:2012, "International vocabulary of metrology – Basic and general concepts and associated terms (VIM)"]] (3rd edition), sec. 5.2. 
 +</WRAP> 
 + 
 +I am aware of only four (4) "international standards" (as opposed to SI //units//); three of which are listed as examples in the definition shown above. However, there are probably others. Those that I am aware of include: \\ 
 +\\ 
 +**1 - The international prototype of the kilogram (OBSOLETE as of May 20, 2019)** \\
 All of the SI units are based on physical constants of nature EXCEPT the kilogram. The kilogram is the unit of mass; which nominally has the same mass as one litre of water at the freezing point.  All of the SI units are based on physical constants of nature EXCEPT the kilogram. The kilogram is the unit of mass; which nominally has the same mass as one litre of water at the freezing point. 
 The only SI unit "physical artifact" (i.e., not defined by a fundamental, natural constant), the international prototype kilogram (IPK), was certified in 1889, and consists of a cylinder of platinum-iridium. The IPK is maintained by the [[https://www.bipm.org/en/publications/si-brochure/kilogram.html|BIPM]]. The only SI unit "physical artifact" (i.e., not defined by a fundamental, natural constant), the international prototype kilogram (IPK), was certified in 1889, and consists of a cylinder of platinum-iridium. The IPK is maintained by the [[https://www.bipm.org/en/publications/si-brochure/kilogram.html|BIPM]].
  
-<note>Because the IPKs stability has been a matter of significant concern, during November 2018, the world’s measurement experts voted and unanimously approved a revision of the SI that establishes a measurement system entirely based on physical constants of nature. The changes will take effect on [[http://www.worldmetrologyday.org|World Metrology Day]], May 20, 2019. See [[https://www.theverge.com/2018/11/13/18087002/kilogram-new-definition-kg-metric-unit-ipk-measurement|The Kilogram is Dead; Long Live the Kilogram]]</note>+<WRAP center round info 80%> 
 +Because the IPKs stability has been a matter of significant concern, during November 2018, the world’s measurement experts voted and unanimously approved a revision of the SI that establishes a measurement system entirely based on physical constants of nature. The changes took effect on [[http://www.worldmetrologyday.org|World Metrology Day]], May 20, 2019; which commemorates the anniversary of the signing of the Metre Convention in 1875. See [[https://www.theverge.com/2018/11/13/18087002/kilogram-new-definition-kg-metric-unit-ipk-measurement|The Kilogram is Dead; Long Live the Kilogram]] 
 +</WRAP> 
 **2 - Chorionic Gonadotrophin (Biological standard)** \\ **2 - Chorionic Gonadotrophin (Biological standard)** \\
 Defined by the [[http://apps.who.int/iris/bitstream/handle/10665/70154/WHO_BS_09.2107_eng.pdf|World Health Organization (WHO)]] in the 4th international standard 1999, as 75/589, 650 International Units per ampoule. Defined by the [[http://apps.who.int/iris/bitstream/handle/10665/70154/WHO_BS_09.2107_eng.pdf|World Health Organization (WHO)]] in the 4th international standard 1999, as 75/589, 650 International Units per ampoule.
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 **3 & 4 - VSMOW2 (Vienna Standard Mean Ocean Water) & SLAP2 (Standard Light Antarctic Precipitation)** \\ **3 & 4 - VSMOW2 (Vienna Standard Mean Ocean Water) & SLAP2 (Standard Light Antarctic Precipitation)** \\
 Distributed by the [[https://nucleus.iaea.org/rpst/ReferenceProducts/ReferenceMaterials/Stable_Isotopes/2H18O-water-samples/VSMOW2.htm|"International Atomic Energy Agency" (IAEA)]] for differential stable isotope amount-of-substance ratio measurements, the [[http://www-naweb.iaea.org/NAALIHL/docs/ref_mat/InfoSheet-VSMOW2-SLAP2.pdf|VSMOW2 & SLAP2 reference material standards]] are used in producing the triple point of water (see the BIPM "[[https://www.bipm.org/utils/common/pdf/ITS-90/Guide_ITS-90_2_2_TPW-2018.pdf|Guide to the Realization of the ITS-90 - Triple Point of Water]]") with the smallest amount of uncertainty. Distributed by the [[https://nucleus.iaea.org/rpst/ReferenceProducts/ReferenceMaterials/Stable_Isotopes/2H18O-water-samples/VSMOW2.htm|"International Atomic Energy Agency" (IAEA)]] for differential stable isotope amount-of-substance ratio measurements, the [[http://www-naweb.iaea.org/NAALIHL/docs/ref_mat/InfoSheet-VSMOW2-SLAP2.pdf|VSMOW2 & SLAP2 reference material standards]] are used in producing the triple point of water (see the BIPM "[[https://www.bipm.org/utils/common/pdf/ITS-90/Guide_ITS-90_2_2_TPW-2018.pdf|Guide to the Realization of the ITS-90 - Triple Point of Water]]") with the smallest amount of uncertainty.
-===== Conclusion =====+===== Traceability to Organizations, rather than SI Units =====
  
-Specifying that a calibration service provider __must__ supply "NIST Traceable" calibration certifications not only reveals a lack of understanding "metrological traceability", it ignores the reality that many calibrations, from accredited metrology laboratories, may be traceable to SI units through other means (e.g., intrinsic measurement standards).+The US Federal Aviation Administration, "[[https://www.faa.gov/documentLibrary/media/Order/6200.4G.pdf|FAA National Policy - Order 6200.4G]]" (dated 03/08/10) states: 
 + 
 +<WRAP center round box 80%> 
 +**FAA National Policy - Order 6200.4G** \\ 
 +Appendix 2 - Definitions \\ 
 +h. Calibration Standard - a device or instrument used as a basis to calibrate measure, gage, test, inspect, or otherwise examine basic accuracy values. The standard has a higher order of accuracy than the examined item and is __traceable to the National Institute of Standards and Technology (NIST)__.</WRAP> 
 + 
 + 
 +Specifying that a calibration service provider __must__ supply "NIST Traceable" calibration certifications, which this policy essentially requires, not only reveals a lack of understanding "metrological traceability", it ignores the reality that many calibrations, whether from NMIs (e.g., the [[https://www.nrc-cnrc.gc.ca/eng/solutions/advisory/calibration_index.html|NRC]] in Canada, [[http://www.cenam.mx/eng/|CENAM]] in Mexico, [[https://www.ptb.de/cms/en.html|PTB]] in Germany,) or accredited commercial metrology laboratories, may be traceable to SI units through other means (e.g., intrinsic measurement standards).
  
 This is politely pointed out by the [[https://ilac.org|ILAC – International Laboratory Accreditation Cooperation"]]. This is politely pointed out by the [[https://ilac.org|ILAC – International Laboratory Accreditation Cooperation"]].
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 Source: [[https://ilac.org/?ddownload=840|ILAC-P10:01/2013, "ILAC Policy on the Traceability of Measurement Results"]]"  Source: [[https://ilac.org/?ddownload=840|ILAC-P10:01/2013, "ILAC Policy on the Traceability of Measurement Results"]]" 
 </WRAP> </WRAP>
 +===== Conclusion =====
 +
 +Unless required by statute or regulation (i.e., for [[https://www.oiml.org/en/about/legal-metrology|Legal Metrology]]), mandating "NIST traceability" unnecessarily "limits" the sources for metrological traceability, excluding other NMIs and/or accredited commercial metrology laboratories.
 +
 +NIST, for example, is a non-regulatory agency of the United States Department of Commerce. When the US Government was "shut down" during 1995, 2013, 2018, and 2019, NIST operations were suspended. So if your company had measurement standards at NIST awaiting calibration, or if you outsourced calibration to a metrology lab who had its measurement standards at NIST, then the length of time associated with the government "shutdown" was added to the delay in receiving those instruments. These government "shutdowns" create a "ripple effect" throughout industry.
 +
 +To avoid this, standards writing bodies and regulatory agencies should gain a better understanding of "metrological traceability" and allow other NMIs and/or accredited commercial metrology laboratories to be utilized in providing metrological traceability to SI units. In particular, these bodies should promote international consistency of measurements through adopting the recommendations of the [[https://ilac.org/latest_ilac_news/joint-bipm-oiml-iso-and-ilac-declaration-on-metrological-traceability-signed/|"Joint BIPM, OIML, ISO and ILAC Declaration on Metrological Traceability"]].
 +
 +----
  
-Further, mandating "NIST traceability" unnecessarily "limits" the sources for metrological traceability through other NMIs, such as the [[https://www.nrc-cnrc.gc.ca/eng/solutions/advisory/calibration_index.html|NRC]] in Canada, [[http://www.cenam.mx/eng/|CENAM]] in Mexico, [[https://www.ptb.de/cms/en.html|PTB]] in Germany, the [[http://nml.gov.ph|NML]] in the Philippines, or NIM in China. This use of other NMIs may be due to location, but could also be a diligent metrology laboratory seeking out and utilizing the NMI providing the world’s best uncertainty for a particular parameter.+For more information visit: [[https://us.flukecal.com/literature/about-calibration]]