CIPM-MRA review: The CCQM Perspective W.E. May, CCQM President R.I. - - PowerPoint PPT Presentation

CIPM-MRA review: The CCQM Perspective

W.E. May, CCQM President R.I. Wielgosz, CCQM Executive Secretary

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• Introduction
• CCQM Strategy document (2012-2013)
• The sustainability of the CIPM-MRA process
• How to present Chem-Bio CMCs?
• The CCQM Questionnaire
• The next steps

Outline

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Introduction, achievements & issues

Since its establishment in 1993, CCQM Activities have -- without question –

• Allowed NMIs to assess the degree of equivalence of measurement capabilities

maintained by NMIs;

• enabled NMIs to identify “spikes” of excellence within the chem/bio world that have

led to establishment of strategic collaborations for both research and standards development purposes

• Improved the quality of chemical and biological measurements within the worldwide

NMI community

• Which has led to better (more and higher quality) services for end user customers

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Impact of CCQM Key comparisons (Example I)

4/18 Methane concentration and growth rate in the Atmosphere CCQM-K82: Methane in Air (2013) Higher profile for Metrology in Climate Change Measurement and Research

World’s Scale for the second most important greenhouse gas is being adjusted in line with the SI (GGMT 2015) Differences of 2 nmol/mol to 5 nmol/mol reported Comparable to the annual change in atmospheric methane levels

5 Documented degree of equivalence of measurement capabilities

Comparison of value-assigned CRMs for Creatinine in Serum

CENAM KRISS LGC NIM NIST PTB

DMR 263a 111 01 01A 111 01 03A 111 01 04A 111 01 02A ERM DA252a ERM DA251a ERM DA250a ERM DA253a Creatinine 1 Creatinine 2 SRM 909b I SRM 967a I SRM 909b II SRM 967a II RELA 1/05 KS A RELA 1/05 KS B

• 10
• 5

5 10

Relative Degeres of Equivalence, %

CCQM-K80

Impact of CCQM Key Comparisons (Example II.)

EU Korea UK US Germany

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Issues and planned actions

Major Issues Growth in interest/ needs for Comparisons and studies Steady Increase in number of CMCs to review – Continuing with the current approach at the same level of effort is not sustainable !!! Planned Actions Establishing a Strategic Planning Framework for Key Comparisons – Core comparisons and core competencies to deliver services Examining basis and structure for CMCs

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CCQM Strategy document (2012-2013): Chem-Bio CMCs

CMC Category Number of CMCs per Category in Dec 2012 Number of analyte-matrix combinaisons in Dec 2012 Number of analytes in Dec 2012 Number of NMI service providers in Dec 2012 Number of CMCs per Category in Dec 2008 Change in number of CMCs per Category (Dec 2008 to Dec 2012) 1: High purity chemicals 445 404 388 16 263 182 2: Inorganic Solutions 361 219 101 15 324 37 3: Organic Solutions 473 322 254 16 351 122 4: Gases 2039 583 213 33 1500 539 5: Water 160 130 45 18 132 28 6: pH 79 1 1 19 89

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7: Electrolytic Conductivity 38 3 1 16 27 11 8: Metal and metal alloys 194 163 42 7 276

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9: Advanced materials 113 78 40 12 56 57 10: Biological fluids and materials 382 324 164 16 316 66 11: Food 426 384 161 20 241 185 12: Fuels 54 49 29 6 47 7 13: Sediments, soils, ores, an 558 354 137 17 418 140 14: Other materials 34 34 34 2 34 15: Surfaces, films and enginered nano materials 4 1 1 4 4 Totals 5360 3049 830 *

NMIs/DIs disseminate their measurement capabilities via services described as: a) CRMs b) “calibration services” “value assignment for proficiency testing scheme samples”. Currently: 51% of CMCs are delivered through CRMs 24% of CMCs are delivered as both ‘calibrations’ and CRMs 25% of CMCs are delivered only as ‘calibrations’

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CCQM Strategy document (2012-2013)

Growth Rate = 350 CMCs per year CHEM/BIO CMCS in the KCDB 1) Need an effective and efficient programme of comparisons to support current capabilities 2) Do we have the resources to review the growing number of CMCs? 3) Are all capabilities delivering services?

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CCQM Strategy document: Future Key Comparisons (2013-2023)

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Core competencies and core comparisons and broad CMC Claims

CCQM-K55 Series: Primary Calibrators, Organics 4 Key comparisons cover 100’s of services/CRMs Appendix B:

100’s of CMCs

(per NMI) Appendix C:

4 CMCs

(per NMI) Appendix C: Current Model Broad CMC claim

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The capability vs. service discussion

Available CRMs CMC – ‘Capability’

ANALYSIS OF ANSWERS TO CCQM QUESTIONNAIRE ON THE CMC PROCESS IN THE CIPM-MRA (2014)

Number of answers received (including identity of person/NMI replying) 33* Additional partial replies (no name/ no identity) and not analysed 10 Total number of NMIs/Dis that could have answered the questionnaire ~70 *includes 1 laboratory active in CCRI

CUSTOMERS ACCREDITATION BODIES NMIS/DIS OTHERS

Primary Target for CMCs

75.8% 56.3% 50% 59.4%

Easily understood

29.2% 33.3% 53.3% 33.3%

More details needed

4.2% 20% 13.3% 0%

Too complicated

50% 26.7% 20% 33.3%

Wrong Format

20.8% 20% 6.7% 8.3%

Catalogued Measurement Service

75% 80% 81.3% 76.9%

Comments

17 9 7 6

INFORMATION ON CMCs (Q. 2,4,5)

ACCEPT CMCs WITH WIDE (FLEXIBLE SCOPE) (Q. 7)

COMMENTS 17 YES 24% YES – BUT USEFULNESS MUST BE MAINTAINED 47% OTHER 24% STOP CMCs 6%

EFFECT ON EFFICIENCY OF CMC REVIEW PROCESS (Q. 9)

INCREASE NO EFFECT DECREASE

LESS CMCs

67% 17% 17%

ON SITE CCQM PEER REVIEWS AND REPORTS

55% 28% 17%

ACCREDITATION REPORTS MADE AVAIALABLE

66% 31% 3%

LESS RMOs INVITED TO REVIEW CMC

45% 31% 24%

MONITORING OF REJECTION RATES

38% 45% 17%

AUTOMATIC REVIEW INTERVAL

39% 36% 25%

OTHER PROPOSALS TO IMPROVE EFFICINECY OF CMC REVIEW PROCESS (Q. 12)

COMMENTS 21 MODERN IT TOOLS 24% MODIFY WHICH GROUP DOES THE BULK OF THE CMC REVIEW WORK 24% BROAD CMCS MODIFIED KC PARTICIPATION/REPORT 24% OTHER SUGGESTIONS 28%

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Outcome of questionnaire

• CCQM ad-hoc WG produced 10 recommendations, which can be

grouped as:

• General use of CMCs
• Formatting of CMCs
• Sustainability of the CMC process
• Transparency of the CMC process

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CCQM Discussions on the way forward for Chem-Bio CMCs

STAY AS WE ARE BROAD CMCs SERVICE BASED DATABASE Shareholder Opinions in CCQM

‘A database for customers and stakeholders’ ‘A database for shareholders to support accreditation and certificates’