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Electronic Supplemental Material

Accreditation and Quality Assurancevol. 12, 2007

Springer Verlag

Metrology, essential to Trade, Industry and Society

Robert KaarlsSecretary CIPM, President CCQM

Klaverwydenstraat 132381 VX Zoeterwoude, The Netherlands

Tel +31 71 580 22 31Fax +31 71 580 47 77

Presented at the 3rd International Conference on Metrology, November 2006, Tel Aviv, Israel

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Need for global metrological infrastructure • Global trade, globalized industry, world

wide travelling of people, health care, food safety and pollution control and possible climate change require reliable, traceable and comparable measurements

• Of high economic and societal interest• Taking away Technical Barriers to Trade• Securing good quality of life• In compliance with WTO TBT and SPS

Agreements and other regional and national regulations

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Need for global metrological infrastructure • Non-reliable and non-comparable measurement and

test results means non-acceptance by the consignee• A not internationally recognized national

measurement system leads to technical barriers to trade by non-compliance with technical and sanitary/phytosanitary requirements

• Sectors affected by the lack of a reliable measurement system are many, like: food, health care, environment, electronics and optical, transport, navigation, air and space, energy, ionizing radiation, information technology and telecommunications sector

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Why Metrology ?

• Aiming global comparability of measurement and test results

• Measurement results traceable to the same long term stable references, the SI

• Globally credible, recognised and accepted measurement results with stated measurement uncertainty, fit for purpose

• Once measured/tested, everywhere accepted

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The expanding need on Metrology

• Industrial production (components and parts produced at another time somewhere else on the globe must fit together)

• Worldwide services (e.g. banking, maintenance)

• Innovation • Trade (fair trade, internal markets) • Trade agreements (WTO Technical Barriers to

Trade and Sanitary and Phyto-Sanitary measures)

• Accreditation agreements• Metrological agreements• Once measured/tested, everywhere accepted

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The expanding need on Metrology

• Society- environment, pollution control and climate change - health care and protection- food (safety and nutritional value)- drugs and pharmaceutics- anti-doping- biological activity, micro-biology- “soft/perceptive” metrology (smell, taste, blends, color, glance, form, etc.)

• Regulators• Forensics• Security• One measurement system, less errors

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Sustainable competitiveness and innovation

Growing metrological demands

•Global trade (in commodities >12 trillon US$ of which 80% affected by standards and regulation; compliance costs ~10% of production costs)

•Globally spread industrial and service activities

•Men travelling all around the globe

•New sources of energy (bio, hydrogen, nuclear)

•Nano technology, bio technology, advanced materials

•Information and communications technology

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Demanding Metrological TraceabilitySeveral (regulatory) driving forces• Trade requirements WTO TBT and WTO SPS• Compliance with regulations (a.o. in-vitro

diagnostics, food safety, pollution control)• Labeling (vitamins, amino and sorbic acids, fat,

GMO’s, caffeine, additives, pigments)• Tariff classification/customs (butter fat, sugars,

caffeine, fat in milk, protein in meat)• EU TRACE project (origin of food products)• EU REACH legislation • Accreditation and certification• Avoidance of market distortions in a single

market• International trade agreements (WTO and

bilateral)

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Health CareClinical chemistry and laboratory medicine

- In Vitro Diagnostic measurements (IVD Directive driven JCTLM: higher order CRMs and methods, PT schemes and reference laboratories)

- therapeutic measurements (WHO standards and units)

- global market >25 billion US$

Pharmaceuticals (US Pharmacopeia, European Council - European Directorate for the Quality of Medicines, a.o.)

- global market >250 billion US$

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In vitro diagnostic measurements and its 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 €

Source: NIST/Mayo Clinic and EU study report

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Demanding Metrological Traceability

Sanitary and Phyto-Sanitary measuresQuality and product safety with respect to food

safety, animal and plant health• FAO/WHO Codex Alimentarius Commission (food

safety)

• Office International des Epizooties – OIE (animal health)

• FAO International Plant Protection Convention - IPPC (plant health)

• Food producing companies (suppliers declaration of conformity, e.g. based on Hazard Analysis and Critical Control Points – HACCP, ISO 9001, ISO 14001)

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Food safety measurements

• Regular reports of food exports refused by importing countries due to not acceptance of test reports or due to differences in test results- honey and beef from Argentine- wine and fish from Chile- fish from Kenya, Tanzania, Uganda, Norway- medicines, dietary supplements from China- GMO modified products: soya, rice from USA- chicken from Thailand- etc. The CIPM MRA is essential, assuring reliable comparability and traceability

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Assessing the quality of results of measurements : IMEP-16

13.6

16.3

19.0

21.7

24.5

27.2

29.9

32.6

35.3

38.1

40.8

-50

-40

-30

-20

-10

0

10

20

30

40

50

Pb amount content

Results from all participants with indication of the results of the OIVV members

IMEP- 16: Pb in wineCertified value : 27.18 ± 0.25 µg·L

-1 [U =k ·u c (k =2)]

5 'less than' values11 values

below -50%

28 valuesabove 50%

OIVV members

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14

BIPM-CCQM pilot study 12

0.066

0.088

0.110

0.132

0.154

0.176

0.198

c

1

0-9

mo

l·g

-1

CCQM-P12 : Pb in wine

IRMM certified value(corresponds to IMEP-16 certified value)

Results from BAM, Germany; CENAM, Mexico; CSIR-NML, South-Africa; EMPA, Switzerland; IRMM, European Commission; KRISS, Korea; LGC, United Kingdom; LNE, France; NARL, Australia; NIMC, Japan; NIST, United States of America; NRCCRM, China; PTB, Germany; VNIIM, Russian Federation

±50%

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OIV using a reference value, demonstrated to be equivalent at global level

13.6

16.3

19.0

21.7

24.5

27.2

29.9

32.6

35.3

38.1

40.8

-50

-40

-30

-20

-10

0

10

20

30

40

50

Pb amount content

IMEP- 16: Pb in wine

Certified value : 27.18 ± 0.25 µg·L-1

[U =k ·u c (k=2)]

5 'less than' values

11 valuesbelow -50%

28 valuesabove 50%

IMEP-160.066

0.088

0.110

0.132

0.154

0.176

0.198

-50

-40

-30

-20

-10

0

10

20

30

40

50

CCQM-P12

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Developing countries dependence on metrology

Technical Barriers to Trade by doubts and non-compliance with legislations, specifications and Sanitary and Phyto-Sanitary measures (e.g. HACCP)

Lack of internationally recognized metrological and accreditation infrastructure

Refusal of exported products (food, medicins, etc.)

40% of GDP export of fish and agricultural products

40% of GDP export raw materials (oil, metals, etc.)

Vulnerability for bad imported products

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Climate change, environmental and pollution control

- ozone and greenhouse gases (WMO GAW)

- Volatile Organic Components (WMO GAW)

- Radiation (WMO World Radiation Centre)

- ocean temperature and salinity measurements (UNESCO)

- river and coastel waters (where all our waste, including medicines and personal care products, ends up in living organisms, like whale, dolphin, fish, oysters, shrimp etc. showing changes in genes and proteins)

- air quality (transport, industrial production, heating)

- soil and sediments (industry, agriculture, etc)

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Other sector specific metrology needs

Energy sector

- oil, bio diesel

- hydrogen fuel cells - nuclear fission

Forensics (International Association of Forensic Sciences, European Network of Forensic

Science Institutes) - DNA, RNA- drugs, poisons, explosives, chemical and

biological traces, finger printing, shell bursts by bullets, etc

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Other sector specific metrology needs

Security

- bio-metric data, like iris and other facial scans, finger prints

- airport screening techniques based on ionizing radiation, electromagnetic radiation, heat radiation, optical and acoustical measurements, whole body scanning and imaging

- luggage and container screening based on ionizing and other electromagnetic radiation techniques, disease and drugs testers and chemical traces detection

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Nano metrology, an interdisciplinary areaMicro/nano scale manufacturing (nanolithography)

Nano structures materials (carbon nano tubes)

New composite materials (nanoscale particles)

Nano-electronics, -photonics, -magnetics

Energy conversion (nanorod polymer solar cells)

Nano scale instrumentation (chip based and single electron)

Health care, therapeutics and diagnostics (peptide nanotubes, puncturing cell walls, DNA/RNA strands)

Nano scale processes (e.g. nano particle water filtration)

Already an 1x1012 US$ per year market

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Nano particles, challenges and dangers

Measurement of protein “signatures”, indicators of diseases

Therapeutic possibilities

Infiltrating very easily in other structures, including the human body

Causing impurities and damages

Immediate study of detection and measurement methods and of the toxicity needed

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Material properties

Electromagnetic properties (magnetic and dielectric)

Thermo-electric properties

Thermodynamic/thermophysical properties (conductivity, heat transfer, phase analysis, expansion, heat capacity, emissivity, diffusivity)

Optical properties (reflectivity, whiteness, glance)

Acoustic properties

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Material properties

Mechanical properties (hardness, modulus, strength, toughness, fatigue, creep, friction, corrosion, lubrication)

Properties of fluids and gases (viscosity, density, caloric value)

Structural properties (composites, aerosols, gels, grain and particle size, particle size distribution, porosity, defects, shape)

CIPM Ad Hoc Working Group on (engineering) Materials Metrology (VAMAS and ANMET) reporting in October 2007

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Metrological issues to be solved• Clear definition of measurands, e.g. defined

molecules in a defined matrix environment• Clear understanding of method dependent

results• Understanding the complete measurement

equation• Validation of methods, performance criteria

based• Measurement uncertainty• Uncertainty sample preparation often

substantial

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Metrological issues to be solved• Understanding of the potency of available

methods (answer to the question: how far and how long does the light shine?)

• Development of new measurement technologies

• Commutability of CRM’s• Availability of sufficient and right CRMs • Linking PT schemes to the CCQM

comparisons• Desirable deliverables by the NMIs and

other designated institutes

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Chemical measurements

Bio technology and micro biology (genomics, proteomics, metabolomics, etc.)

-DNA and RNA

-proteins

-cells

-GMOs

Certified Reference Materials (enormous lack of)

NMIs to develop more “chemical calibration capabilities” for assigning values to natural samples from customers (industries, PT providers, testing laboratories)

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Chemical measurements

Further issues to be addressed:

- very low concentration levels

- development of new (primary and other higher order) techniques and methods needed

- lab-on-a-chip, on-the-spot and point-of-care measurements

- high purity reference materials needed, purity analysis

- sample preparation often largest source of measurement uncertainty

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Information technology

Directly after analogue sensor follows microprocessor, signal processing, data transfer, computation and display

Remote monitoring and calibrations

“intelligent, self learning devices”, applying corrections

Reliability of hardware and software difficult to understand and to verify (unsatisfactory “black” box testing)

Multi point network, steering completely automated large manufacturing plants; multi point access for measurements

Controlling human well being (health status, climate predictions)

Now computer aided software for testing whole system

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Establishing worldwide comparability through traceability

• Inter-Governmental Treaty of the “Metre Convention”, established in 1875

• Member States (51) and Associate countries and economies (31) (October 2006)

• 10 Consultative Committees• International Bureau (BIPM) in Sèvres,France• Coordinating and representing the National

Metrology Institutes (NMI’s) globally

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Metre Convention1875

General Conference on Weights and Measures

( CGPM )

meets every four years and consistsof delegates from Member States

International Committee for Weights and Measures

( CIPM )

consists of eighteen individuals elected by the CGPM

It is charged with supervision of the BIPM and affairs of the Metre Convention

The CIPM meets annually at the BIPM

DiplomaticTreaty

Associate Statesand Economies

of the CGPM

Governmentsof

Member States

Internationalorganizations

Consultative Committees( CCs )

Ten CCs each chaired by a member of CIPM;to advise the CIPM; act on technical matters and

take important role in CIPM MRA; compriserepresentatives of NMIs and other experts.

Nationalmetrologyinstitutes( NMIs )

CIPMMRA

Bureau International des Poids et Mesures( BIPM )

International centre for metrology

Laboratories and offices at Sèvreswith an international staff of about seventy

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METROLOGY and REGULATIONS

New regulations addressing traceability and measurement uncertainty

-Air flight safety regulations

-Transmission frequencies and maximum permissible levels of electromagnetic radiation

-Regulations requiring traceability in clinical measurements

-Regulations concerning food safety, nutrional content and labeling

-Regulations dealing with maximum permissible levels of pollution and requirements for water and air quality

-Regulations concerning registration and transport of chemicals

-Legal metrology (fair trade, consumer protection, public safety)

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METROLOGY and ACCREDITATION

BIPM – OIML – ILAC Common Statement and Declaration on the Relevance of their International Agreements on Metrology to Trade, Legislation and Standardisation

CIPM – ILAC Statement by the CIPM and the ILAC on the Roles and Responsibilities of NMIs and NABs

Accreditation of laboratories, CRM producers, PT providers, inspection and certification bodies

CIPM MRA and ILAC Arrangement fully complementary

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METROLOGY and STANDARDISATION

ISO REMCO (Certified Reference Materials)

ISO CASCO (conformity assessment, laboratory accreditation)

ISO TC 212 (clinical chemistry and laboratory medicine)

Many other ISO and IEC committees

Cooperation in the Joint Committee on coordination of assistance to Developing Countries in Metrology, Accreditation and Standardisation (JCDCMAS) together with BIPM, OIML, ILAC, IAF, IEC, ISO, ITU-T, UNIDO and observers from International Trade Centre (ITC of UNCTAD/WTO) and IMEKO

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Inter-governmental/international organisations

Organisations with clear interest in metrology

MoU with WHO, WMO, ILAC, JCTLM (IFCC and ILAC)

IAEA, Codex Alimentarius Commission/IAM, CIE, IAU, ITU, ICRU, IUGG, IUPAC, IUPAP, WADA, Pharmacopeia, IAFSI/ENFSI, a.o.

Approaches to WTO (Technical Barriers to Trade Committee) and World Customs Organisation (WCO)

CIPM Consultative Committees open for observership from and cooperation with these inter-governmental and international organisations

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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 (some 180), acting as NMI’s for certain quantities and measurement ranges, of about 75 (September 2006) Member States and Associate Economies and 2 international organizations (IAEA and EU – JRC IRMM and JRC Ispra) (See Appendix A)(soon also to be signed by the WMO)

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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 international RMO review, accreditation and/or on-site peer review

• Regional and inter-regional review of claimed calibration and measurement capabilities

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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 on www.bipm.org/kcdb

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A MAJOR USER

“The use of NMIs is formally recognized in the top Boeing Commercial procedure for calibration. It specifically identifies the CIPM MRA...and so the KCDB serves the function of the accreditation scopes in the process for approved suppliers (in this case NMIs).

One access to the KCDB at Boeing is on the metrology sites page which is referenced across Boeing in various pages and a search for BIPM internal to Boeing will bring back the KCDB newsletter.”

Source: Derek Porter, Technical Principal, Puget Sound Metrology, Boeing Commercial Group

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EU IVD Directive requires traceability• Implementation of EU-IVD Directive

(98/79/EC)• EC-IVD Directive, Annex I, Essential

requirements A.3• '...The traceability of values assigned to

calibratorsand/or control materials must be assured throughavailable reference measurement procedures and/oravailable reference materials of a higher order.'

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Joint Committee on Traceability in Laboratory Medicine - JCTLM

Principal promotors• CIPM/BIPM• IFCC• ILACSupported by• WHO• Other stakeholders

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Relevant ISO Standards • ISO 17511 In vitro diagnostic medical devices

- Measurement of quantities in biological samples - Metrological traceability of values assigned to calibrators and control materials

• ISO 15193 Presentation of reference measurement procedures

• ISO 15194 Description of reference materials• ISO 15195 Reference Measurement Laboratories• ISO 18153 Metrological traceability of values for

catalytic concentration of enzymes assigned to calibrators and control materials

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The JCTLM and its database as a result of the CIPM MRA www.bipm.org/en/committees/jc/jctlm/jctlm-db/Publishing lists of reliable “higher order” reference

materials and measurement procedures under the aegis of the Metre Convention and its CIPM MRA

Traceable to the SI (list I) and, if not (yet) SI traceable, e.g. WHO International Standards and International Units (list II)

List of reliable measurement services, deliverable by potential reference laboratories (based on ISO 15195 accreditation, or other comparable schemes, and regularly good results in inter-laboratory comparisons)

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CCQM support to the Food sector

• Pesticide residues in fruit products (juices)• Butyric acid in milk (marker for milk fat

content; customs tariff issue) • Growth hormones in meat• Antibiotics and trace contaminants in fish

• Vitamins and Minerals (A, E, Folates in baby food and dietary supplements)

• Proximates in milk products (product standards) (still under consideration)

• Dietary supplements (green tea)• Nitrates, nitrites (Inorganic Analysis)• Humidity and micro-biological issues, etc.

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FAPAS Round 0738: Sn in tomato puree

0

50

100

150

200

250

300

350

0 10 20 30 40 50

ascending results

Sn

ug

/g

IDMS reference value

Mean result

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Change in Sn performance using reference instead of consensus value

Effect on Rating Number of Labs. Percent

'Acceptable' >> 'Unacceptable'

17 37

'Unacceptable' >> 'Acceptable'

9 20

No change to rating 20 43

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PT schemes

More than 800 PT schemes in 19 countries (source : EPTIS)

In some emerging fields, the number of parameters and matrices covered by PT schemes is much higher than the number of parameters and matrices covered by CRMsExample : Water analysis

PT schemesParameters : 250(pesticides : 40%)

CRMsParameters : 40(metals : 65%)

PT schemes and CRMs are complementary but the traceability of PT schemes values is questionable

Source: C. Rivier, LNE, France, CCQM IAWG workshop Berlin, 2005

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Establishing a national network of credible, reliable, recognized dissemination of traceability • Top level cooperating under the Metre Convention

- NMI’s and other designated institutes

• Second level of accredited calibration laboratories and CRM producers under the ILAC Arrangement- traceable to NMI’s and other designated institutes under the CIPM MRA- able to assign values to “in-house” reference materials- delivering Certified Reference Materials

• Third level of “field” laboratories

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ILAC Arrangement International recognition of calibration,

measurement and test results Accreditation of second level calibration and

reference laboratories (ISO/IEC 17025 or ISO 15195)

Accreditation of CRM producers (ISO/IEC 17025 and ISO Guide 34)

Accreditation of Proficiency Testing providers (G 13)

Accreditation of “field” laboratories (ISO/IEC 17025 or ISO 15189)

CIPM MRA and ILAC Arrangement fully complementary

CIPM MRA CMC = ILAC Arrangement BMC