A presentation from the final AdvanceETV conference in Brussels May 22-24 providing a summary of the tasks of testbodies and analytical laboratories under the EU Environmental Technology Verification pilot programme.

1. Obligations of a Test Body and an
Analytical Laboratory
Christian Grøn, DHI
Final AdvanceETV Conference, Brussels, May 2012

2. The organisation and distribution of
work

3. The workflow

4. Definition of required test and quality
• Verification body to define:
– Requirements on test data and data quality
• The definition must include:
– Overall test design
– Scale (pilot and/or field)
– Performance parameters to be measured
– Operational parameters to be measured
– Methods of reference analysis if relevant, including sampling,
measurement and calculation methods
– Baseline selection
– Data management
– Quality assurance, perhaps with audit
– Test report contents
• Existing data to be assessed for definition of additional tests needed to ID
what remains to be done

5. Selection and contracting of verification
and test body and of analytical lab
• Proposer responsibility, with respect to all three bodies
• Freedom of selection with requirements fulfilled:
– GVP Part C requirements, ISO 9001 and ISO 17025 based
– For analytical laboratories additionally ISO 17025 accreditation
– For verification bodies additionally ISO 17020 accreditation
• For test and analysis:
– Defined test and quality requirements must be met
– Coordination with the verification body
– Same requirements for proposer inhouse test and analysis, but may
be assured by independent test body
• Real trust is based upon experience – not upon paper work

6. Test lab requirements and tasks
• GVP Part C requirements, ISO 9001 and ISO 17025 based
• Organisation
– Personnel
– Methods, equipment and facilities
– Documentation
– Complaint management
– Management supervision
• Have staff independent of verification and analysis staff
• Do:
– Design test plan
– Test
o Test site selection – may be with proposer or byer – in operation
– Assure and control test quality, perhaps audit
– Assure analytical quality
– Report results

7. Analytical lab requirements and tasks
• GVP Part C requirements and ISO 17025 accreditation
– be accredited to applying ISO 17025 for methods within the relevant
area of analysis
• Have staff independent of verification and test staff
• Do:
– Plan analyses and select methods
– Analyse
– Assure and control analytical quality
– Report data with methods applied and obtained uncertainty
• Documentation of uncertainty through interlaboratory
comparisons, certified reference material analysis and in house
quality control sample analysis

8. Cascading quality assurance and
control
Verification
Assessment, quality
body
assurance and control
Assessment Test body
Quality assurance
Results and control
Results
Accreditation Analytical
body laboratory
Assessment

9. Test body quality assurance
Test body Test
Location Target task
internal auditor responsible
Test body Test plan Review -
Test system performance
Test body and test body quality Test system audit -
management system
Test performance Test system
Test body Test performance
audit control
Analytical Analytical
- Review
laboratory performance
Test body Test report Review -

10. Analytical laboratory quality
assurance
Laboratory Laboratory
Location Target task
staff internal auditor
Analytical
Method performance Validation -
laboratory
Laboratory analytical
Analytical
system and quality - Test system audit
laboratory
management
Analytical
Analytical performance Quality control -
laboratory

11. An example – test body operation

12. Conclusions
• Requirements and tasks are weldefined for test bodies and laboratories
• Quality assurance and control are of high priority
• Interdisciplinary competences are required – from technology application
to analysis
• ETV is an art in itself – it must be learned – and distinguished from
development and ad hoc testing
• Network creation may be needed – as test bodies and analytical
laboratories are not EU ETV technical group participants

13. Thank you for your attention
For more information visit
www.etv-denmark.com
- or contact Christian Grøn
chg@dhigroup.com
‘Verify Once
Accepted Everywhere’