cipm-mra review: the ccqm perspective · shareholder opinions in ccqm ‘a database for customers...
TRANSCRIPT
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CIPM-MRA review: The CCQM Perspective
W.E. May, CCQM President R.I. Wielgosz, CCQM Executive Secretary
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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
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
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Documented degree of equivalence of measurement capabilities
Comparison of value-assigned CRMs for Creatinine in Serum
CENA
MKR
ISS LGC
NIM
NIST PT
B
DMR
263a
111
01 0
1A11
1 01
03A
111
01 0
4A11
1 01
02A ER
M D
A252
aER
M D
A251
aER
M D
A250
aER
M D
A253
a
Crea
tinin
e 1
Crea
tinin
e 2
SRM
909
b I
SRM
967
a I
SRM
909
b II
SRM
967
a II
RELA
1/0
5 KS
ARE
LA 1
/05
KS B
-10
-5
0
5
10
Rela
tive D
eger
es o
f Equ
ival
ence
, %
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 1822: Inorganic Solutions 361 219 101 15 324 373: Organic Solutions 473 322 254 16 351 1224: Gases 2039 583 213 33 1500 5395: Water 160 130 45 18 132 286: pH 79 1 1 19 89 -107: Electrolytic Conductivity 38 3 1 16 27 118: Metal and metal alloys 194 163 42 7 276 -829: Advanced materials 113 78 40 12 56 5710: Biological fluids and materials
382 324 164 16 316 66
11: Food 426 384 161 20 241 18512: Fuels 54 49 29 6 47 713: Sediments, soils, ores, an 558 354 137 17 418 14014: Other materials 34 34 34 2 34 015: Surfaces, films and enginered nano materials
4 1 1 4 0 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’
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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
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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)
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ACCEPT CMCs WITH WIDE (FLEXIBLE SCOPE) (Q. 7)
COMMENTS 17 YES 24% YES – BUT USEFULNESS MUST BE MAINTAINED
47%
OTHER 24% STOP CMCs 6%
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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%
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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
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
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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’
CIPM-MRA review: The CCQM PerspectiveOutlineIntroduction, achievements & issuesImpact of CCQM Key comparisons (Example I)Documented degree of equivalence of measurement capabilities �Issues and planned actionsCCQM Strategy document (2012-2013): Chem-Bio CMCsCCQM Strategy document (2012-2013)CCQM Strategy document: Future Key Comparisons (2013-2023)Core competencies and core comparisons and broad CMC ClaimsThe capability vs. service discussionDiapositive numéro 12Diapositive numéro 13Diapositive numéro 14Diapositive numéro 15Diapositive numéro 16Outcome of questionnaireCCQM Discussions on the way forward for Chem-Bio CMCs