Why metrology in chemistry?

1. Why metrology in chemistry? • Industry, Society and Trade need comparable measurement results • Taking away Technical Barriers to Trade in internal, regional and global markets (WTO) • Food safety, diagnostic markers, therapeuticals • Sanitary and Phyto-Sanitary measures • Regulations • Accreditation (ISO 17025, 15189, Guide 34) • Environmental control, security, fraud, forensics, anti-doping

2. What is metrology in chemistry? • Establishing global comparability of measurement results • Comparability through traceability to long term stable, accurate and reproduceble measurement standards in a coherent system of units: the International System of Units SI • If not yet possible to the SI, traceability to other internationally agreed references (e.g. WHO units) • Traceability through primary methods and other methods of “higher order” • Comparability by Key Comparisons • Traceability through value assignment and CRM’s

4. Consultative Committee for Amount of Substance – CCQM - Metrology in Chemistry • Established by the CIPM in 1993 • Over 35 member and observer organizations • Yearly meetings of CCQM plenary, attended by some 60 representatives • 7 working groups, meeting twice a year and attended by some 200 experts from NMI’s and other expert institutes

5. Consultative Committee for Amount of Substance – CCQM - Metrology in Chemistry Aim • To establish worldwide comparability, through • Traceability to SI, or if not (yet) possible to other internationally agreed references, by • Development of primary methods, databases and • Primary pure reference materials and validation of traceable methods • To contribute to the establishment of a globally recognized system of national measurement standards and facilities and the implementation of the CIPM MRA • To advise the CIPM and the BIPM on metrology in chemistry

6. CCQM CCQM Working Groups chair • Key Comparisons and CMC Quality NRC-INMS • Organic Analysis NIST • Inorganic Analysis LGC • Gas Analysis NMi-VSL • Electro-chemical Analysis SMU • Surface Analysis BAM • Bio-Analysis LGC

7. Comparability (draft VIM April 2004) • Property of measurement results enabling them to be compared because they are metrologically traceable to the same stated metrological reference (this does not mean that the quantity values compared are necessarily of the same order of magnitude)

8. Metrological Traceability(draft VIM April 2004) • Property of a measurement result relating the result to a stated metrological reference through an unbroken chain of calibrations of a measuring system or comparisons each contributing to the stated measurement uncertainty • Traceability to the SI (unit of the SI) • If not (yet) feasible to SI, traceability to other internationally agreed references (e.g. WHO units)

9. Primary methods and methods of “higher order” • Establishing traceability requires complete understanding and definition of the measurand in its matrix environment • Being able to write down the measurement equation • Validation of the whole measurement process from sample preparation, sample treatment to calibration, recovery corr. and final measurement • Measurement uncertainty calculation

10. CCQM Metrology in Chemistry Areas defined in overall framework (1) • Health (clinical diagnostic markers) • Food (pesticides, toxins, drinking water) • Environment (water, air, global warming, contaminants in soil) • Advanced materials (semiconductors, alloys, plastics) • Commodities (oil, cement, precious metals, alcohol content)

11. CCQM Metrology in Chemistry Areas defined in overall framework (2) • Forensics (drugs, explosives, breath analysis, DNA) • Pharmaceuticals • Bio-technology (GMO’s, DNA profiling, diagnostics) • General analytical applications (purity, pH, isotopic standards) • Surface analysis

16. Subsequent CCQM-K6 % Difference from CCQM-K6 KCRV K6 cholesterol in serum results are plotted as % differences from KCRVs Subsequent results are plotted relative to NIST results in K6S and are offset by average (NIST-KCRV) result from K6 (NIST Ref Pt)

17. The CIPM Mutual Recognition Arrangement • Mutual recognition of national measurement standards and of calibration and measurement certificates issued by NMI’s (and other designated institutes) • Now signed by a large and increasing number of NMI’s and other designated institutes, of about 75 Member States and Associate Economies and 2 international organizations (IAEA and EC [IRMM and JRC Ispra]) • The signatories represent some 170 NMI’s and other designated institutes operating under the CIPM MRA (Appendix A)

18. The CIPM Mutual Recognition Arrangement • Based on results of key-, supplementary- and bilateral comparisons (Appendix B) • Quality system in place in conformity with ISO/IEC 17025 and ISO Guide 34 • Quality system assessment by RMO review, accreditation and/or on-site peer review • Regional and inter-regional review of claimed calibration and measurement capabilities

19. Appendix C of the CIPM MRA • Published are the calibration and measurement services of the (designated) NMI’s and other institutes, which are normally delivered to the customers * Analysing/measurement/calibration capabilities and/or * CRM’s delivered/sold to customers (Appendix C) • Key Comparison Data Base – KCDB onwww.bipm.org/kcdb

20. CCQM comparability through traceability • Key comparisons • Key Comparison Reference Value (KCRV) often based on gravimetry or (weighted) mean/median value • Assessing competence • Assessing capabilities • Verifying the degree of equivalence • Comparability • Comparability through Traceability

22. Certified Reference Materials • Calibration • Validation - Recovery factor (calibration) • Most of available CRMs NOT the top of the chain • Primary reference when traceability to SI can not (yet) be realized • Primary role of pure reference materials • Matrix problems • Limited availability

23. Primary Reference Materials (PRM’s, SRM’s, some CRM’s) Criteria • Completely defined and characterized; stability, homogeneity, etc. • Value assignment based on application of primary methods and other methods of higher order • Complete uncertainty budget • Quality assurance on basis ISO 17025 and ISO Guide 34

24. The role of National Metrology Institutes • Delivering internationally recognized traceability by being able to assign reliable values to samples • Having available measurement/calibration capabilities, fit-for-purpose for the country • Capable to analyse, characterize and assign values to in-house RM’s from clients/users • Able to characterize and assign values to CRM’s to be delivered/sold to clients

25. The role of National Metrology Institutes • Delivering traceability to CRM producers and Proficiency Testing organizers • Promoting the establishment of a national infrastructure of ISO 34 accredited CRM producers • Networking and cooperating internationally

26. Designated institutes • Many NMI’s do currently not have broad expertise in metrology in chemistry • Trade, industry and society need to be served in an effective and efficient way at short notice • Designate other national institutes and laboratories with special expertise as a NMI for certain quantities and measurement ranges, so they can participate in the CIPM MRA • (e.g. university lab., national health lab, food lab, environmental lab)

27. Economic and Social Impact • NIST studies calculate: • The benefit-cost ratio (bcr) expressed as the potential industry investments versus NIST costs for performing the work • The social rate of return (srr) expressed as the financial benefit for a group of enterprises over a period of time as a percentage of the corresponding NIST financial investment

28. Economic and Social Impact • Typical numbers obtained for NIST projects carried out in support of a wide variety of industries show: • bcr, varying between 3 and 113 • srr, varying between 32% (thermocouple calibration) and 1056% (sulfur in fossil fuel) • Industry savings include lower transaction costs, lower regulatory compliance costs, energy conservation, increased research and development efficiency, increased product quality and enabling new markets

29. Economic and Social Impact • Mayo Clinic and NIST studies show that 3% measurement error in cholesterol measurements lead to 5% false diagnoses, leading to unnecessary treatment or dramatic non-treatment • Same applies for measurement errors in Cardiac Troponin-I analysis, a heart attack marker • Avoiding unnecessary measurements could potentially save the US 10 to 30 billion US$ p.a. • In Germany savings would be > 1.5 billion €

30. Economic and Social Impact • UK studies show that measurements as a whole deliver a significant impact on the economy of the UK of 5 billion GBP per annum in terms of Total Factor Productivity • Annual government budget of 38 million GBP to NPL creates a leverage factor of 130, which is considered as an excellent return of government investments • Canadian studies demonstrate benefit-cost ratio of 13:1

31. Economic and Social Impact • European Union studies show that the EU spends at least 83 billion euros per annum (1% of EU GDP) on measurement activity • Generating 230 billion euros of directly estimable benefits (benefit-cost ratio 3:1 or each euro invested generates 3 euros; other social benefits in terms of health, safety, environment not yet taken into account) • Measurement research and development programmes show a bcr between 5 and 111, with an average of 16, which is equivalent to projects in the USA

32. Economic and Social Impact • EU report states that metrology is a public good, which in the absence of public funding would be underprovided by the market • Building European wide metrological infrastructure is essential for further development of the single market and continuing efforts in health, safety, protection of the environment and the fight against fraud • Sectors discussed are nano-engineering, automobile industry, pharmaceuticals, natural gas, IVD industry, pollution control

33. Economic and Social Impact • Major conclusions are: • NMI’s deliver considerable spillover benefits in international competitiviness and commercial innovation processes • NMI’s generate significant non-economic benefits • Consequent financing should be given to metrology in emerging technologies (nano-technology, chemistry, biotechnology, etc.) • Clear economic rationale for public funding

34. Trade and food safety • Metrology in support of export, often food products • For example poor metrological, testing and quality infrastructure led in 1999 to the EU ban of Nile perch, creating a loss of 100 million US dollars per annum and an increase in unemployment of 150 000 jobs • Metrology to protect own society against dangerous, unsafe and toxic products, including imported products • E.g.,imported fertilizers and agricultural or animal products containing toxic elements or dangerous diseases (grains, fruits, meat, fish, etc.)

35. The KPMG study for the BIPM • Key findings of the study are: • CIPM MRA results in a notional saving of more than 75000 euros per annum in the costs of establishing and maintaining one mutual recognition with one other NMI • Total notional savings to the community of NMI’s more than 400 million euros per annum • The CIPM MRA confers significant benefits to signatory nations

36. The KPMG study for the BIPM • OECD International Trade by Commodities Statistics: • A set of 28 CIPM MRA and OECD signatory nations, including all major trading and industrialized nations in the world, have a total export value in 2000 of 4.2x10¹² euros • It is not unlikely that 10% benefit can be obtained by taking away technical barriers to trade • Even when only 0.1% net benefit is generated by the effects of the CIPM MRA, this means 4.2 billion