CIPM-MRA review: The CCQM Perspective

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

2 www.bipm.org

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

3 www.bipm.org

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 4 www.bipm.org

This image cannot currently be displayed.

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

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

6 www.bipm.org

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

7 www.bipm.org

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’

8 www.bipm.org

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?

9 www.bipm.org

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

10 www.bipm.org

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

11 www.bipm.org

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%

17 www.bipm.org

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

18 www.bipm.org

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