CIPM-MRA review: The CCQM Perspective W.E. May, CCQM President R.I. Wielgosz, CCQM Executive Secretary
Outline o Introduction o CCQM Strategy document (2012-2013) o The sustainability of the CIPM-MRA process o How to present Chem-Bio CMCs? o The CCQM Questionnaire o The next steps www.bipm.org 2
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 www.bipm.org 3
Impact of CCQM Key comparisons (Example I) CCQM-K82: Methane in Air (2013) Methane concentration and growth rate in the Atmosphere 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 This image cannot currently be displayed. Higher profile for Metrology in Climate Change Measurement and Research 4/18 www.bipm.org www.bipm.org 4
Impact of CCQM Key Comparisons (Example II.) Documented degree of equivalence of measurement capabilities EU Korea UK US Germany ERM DA251a 10 DMR 263a Relative Degeres of Equivalence, % ERM DA252a ERM DA253a ERM DA250a RELA 1/05 KS B RELA 1/05 KS A Creatinine 2 SRM 967a II 111 01 01A SRM 967a I 5 Creatinine 1 111 01 02A SRM 909b II 111 01 03A 111 01 04A Comparison of value-assigned 0 CRMs for Creatinine in Serum SRM 909b I -5 CCQM-K80 -10 CENAM KRISS LGC NIM NIST PTB 5
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 www.bipm.org 6
CCQM Strategy document (2012-2013): Chem-Bio CMCs Change in Number of Number of Number of Number of number of NMIs/DIs disseminate their measurement Number of CMCs per analyte-matrix NMI service CMCs per CMCs per CMC Category analytes in capabilities via services described as: Category in combinaisons providers in Category in Category Dec 2012 Dec 2012 in Dec 2012 Dec 2012 Dec 2008 (Dec 2008 to Dec 2012) a) CRMs b) “calibration services” 1: High purity chemicals 445 404 388 16 263 182 2: Inorganic Solutions 361 219 101 15 324 37 “value assignment for proficiency 3: Organic Solutions 473 322 254 16 351 122 testing scheme samples”. 4: Gases 2039 583 213 33 1500 539 5: Water 160 130 45 18 132 28 Currently: 6: pH 79 1 1 19 89 -10 7: Electrolytic Conductivity 38 3 1 16 27 11 51% of CMCs are delivered through CRMs 8: Metal and metal alloys 194 163 42 7 276 -82 24% of CMCs are delivered as both 9: Advanced materials 113 78 40 12 56 57 ‘calibrations’ and CRMs 10: Biological fluids and 382 324 164 16 316 66 25% of CMCs are delivered only as materials ‘calibrations’ 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 0 15: Surfaces, films and 4 1 1 4 0 4 enginered nano materials www.bipm.org 7 Totals 5360 3049 830 *
CCQM Strategy document (2012-2013) 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? Growth Rate = 350 CMCs per year 3) Are all capabilities delivering services? www.bipm.org 8
CCQM Strategy document: Future Key Comparisons (2013-2023) www.bipm.org 9
Core competencies and core comparisons and broad CMC Claims CCQM-K55 Series: Primary Calibrators, Appendix B: Organics 4 Key comparisons cover 100’s of services/CRMs Broad CMC claim Current Model Appendix C: Appendix C: 100’s of CMCs 4 CMCs (per NMI) (per NMI) www.bipm.org 10
The capability vs. service discussion CMC – ‘Capability’ Available CRMs www.bipm.org 11
ANALYSIS OF ANSWERS TO CCQM QUESTIONNAIRE ON THE CMC PROCESS IN THE CIPM-MRA (2014) Number of answers received (including identity of person/NMI 33* replying) Additional partial replies (no name/ no identity) and not analysed 10 Total number of NMIs/Dis that could have answered the ~70 questionnaire *includes 1 laboratory active in CCRI
INFORMATION ON CMCs (Q. 2,4,5) CUSTOMERS ACCREDITATION NMIS/DIS OTHERS BODIES 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 75% 80% 81.3% 76.9% Service Comments 17 9 7 6
ACCEPT CMCs WITH WIDE (FLEXIBLE SCOPE) (Q. 7) COMMENTS 17 YES 24% YES – BUT USEFULNESS MUST BE 47% MAINTAINED 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 24% CMC REVIEW WORK BROAD CMCS MODIFIED KC 24% PARTICIPATION/REPORT OTHER SUGGESTIONS 28%
Outcome of questionnaire o CCQM ad-hoc WG produced 10 recommendations, which can be grouped as: o General use of CMCs o Formatting of CMCs o Sustainability of the CMC process o Transparency of the CMC process www.bipm.org 17
CCQM Discussions on the way forward for Chem-Bio CMCs Shareholder Opinions in CCQM STAY AS WE ARE ‘A database for ‘A database for shareholders to customers and support accreditation stakeholders’ and certificates’ SERVICE BROAD CMCs BASED DATABASE www.bipm.org 18
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