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Joint AESAN/EFSA Workshop ‘Science Supporting Risk Surveillance of Imports’ - 10 February 2010, Seville (Spain)
The importance of harmonised analytical methods
to provide reliable results
Robouch, Piotr
European Commission – Joint Research Centre (JRC) – Institute of Reference Materials
and Measurements (IRMM), Geel (Belgium)
At the previous EFSA Joint Event in Paris, several speakers mentioned the importance of
harmonised analytical methods to provide reliable data in the frame of official control or for
customs inspection of imported goods.
How to guarantee reliable results? A possible demonstration may reside in the participation to
"inter-laboratory comparisons" – more specifically proficiency testing (PT) exercises – meant to
determine the performance of laboratories for specific test/measurements and to monitor
laboratories'' continuing performance. Hence, it is expected from a laboratory having reported
satisfactory results in a PT exercise for a given measurand (i.e. a given analyte in a particular
matrix determined by a specific analytical technique) to report reliable results for similar
samples. Such quality results may either reduce the number of unjustified disputes based on
discrepant analytical results; or properly identify a serious risk to be notified.
The IUPAC "Harmonised protocol for the proficiency testing of analytical chemistry laboratory"
(Thomson et al. Pure Appl. Chem., Vol. 78, No. 1, pp. 145–196, 2006) sets the basic principles
on how to organise a PT and to evaluate PTs. These principles have taken onboard in two
complementary ISO standards: - ISO 17043:2010 "Conformity assessment General
requirements for proficiency testing" (recently published) and – ISO 13528:2005 "Statistical
methods for use in proficiency testing by inter-laboratory comparisons".
Many inter-laboratory comparisons are organised by the Institute of Reference Materials and
Measurements (IRMM). Several PTs are run in the frame of the European Measurement
Evaluation Program (IMEP) or in the frame of the Community Reference Laboratories (CRLs)
mandates to monitor the reliability of the measurement capability throughout the Member States.
Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 1Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected] 1
Joint Research Centre (JRC)
The importance of harmonised harmonised
analytical methods to provide to provide
reliable resultsPiotr Robouch
IRMM - Institute for Reference Materials and MeasurementsGeel - Belgium
http://irmm.jrc.ec.europa.eu/http://www.jrc.ec.europa.eu/
2Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 2Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
What did we hear in Paris?
Harmonisation/improvement of analytical methods
Experience knowledge & confidenceExperience, knowledge & confidence
Setting appropriate contaminants limits
Fair trade
Effective official control & border inspections
Proper monitoring
Appropriate risk analysis/assessment
Rapid and transparent notification
mutual recognition
Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 3Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected] 3
Joint Research Centre (JRC)
6 custom borders
IRMM - Institute for Reference Materials and MeasurementsGeel - Belgium
Taxation = f(sugar content)
http://irmm.jrc.ec.europa.eu/http://www.jrc.ec.europa.eu/
4Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu
The challenge4Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
5Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu
Inter-Laboratory Comparison5Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
(ISO 17043:2010)[…]
6Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 6Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
7Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 7Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
8Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu
Relevant documents8Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
ISO 17043:2010Conformity assessment Conformity assessment General requirements for proficiency testing
ISO 13528:2006Statistical methods for use in proficiency testing by inter-laboratory comparisons
IUPAC- The international harmonized protocol for the proficiency testing
of analytical chemistry laboratories
- Harmonized guidelines for single-laboratory Validation of methods of Analysis
COMMISSION DECISION 657/2002/EC … concerning the performance of analytical methods and the interpretation of results (cf Food)interpretation of results (cf. Food)
9Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 9Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
What can we learn?
10Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 10Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
Mandate:
− Coordinate network of national reference laboratoriesCoordinate network of national reference laboratories
− Organising interlaboratory comparisons
− Setting up EU-wide standards for testingg p g
− Providing scientific and technical assistance to EU Commission
− Training analysts from national laboratories
http://www.irmm.jrc.be/html/CRLs/index.htm
11Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 11Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
Some PTs organised by IRMM
12Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu
Initial assumptions…12Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
Same sample treatment
Validated standard operating procedure (same?)p g p ( )
Qualified staff
Same interpretation of the legislation
comparable measurement results
13Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu
Cd in Crab13Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
(EC) 1881/2006( )
Many people consider as a delicacy:- Hepatopancreas (midgut gland)
… human consumption
Hepatopancreas (midgut gland) Extremely large organ with several functions, including the secretion of digestive enzymes and absorption and storage of digested food. It fills most of storage of digested food. It fills most of the area around the stomach, depending on its contents of food reserves and water.
14Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 14Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
The directors of the national metrology institutes(NMIs) of 38 Member States of the BIPM and(NMIs) of 38 Member States of the BIPM andrepresentatives of two international organizationssigned a Mutual Recognition Arrangement(CIPM MRA) for national measurement standardsand for calibration and measurement certificatesissued by NMIs. A number of other institutes haveissued by NMIs. A number of other institutes have
signed since then.
MRA i t i d fMRA is a response to a growing need for an open,transparent and comprehensive scheme to giveusers reliable quantitative information on theqcomparability of national metrology servicesand to provide the technical basis for wideragreements negotiated for international tradeagreements negotiated for international trade,commerce and regulatory affairs.
15Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 15Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
Where to find the PT you need?
The European Proficiency Testing Information System helps finding a suitable proficiency testing (PT) scheme in your region or worldwide. The database lists more than 1000 schemes, mainly in the fields of chemical and mechanical testing.
htt // ti b d / /i d hthttp://www.eptis.bam.de/en/index.htm
16Piotr Robouch – EFSA WS Sevilla 10/02/2009 piotr robouch@ec europa eu 16Piotr Robouch EFSA WS, Sevilla, 10/02/2009 [email protected]
Thank youThank you
