Christian Grøn, DHI

Obligations of a Test Body and an

Analytical Laboratory

Final AdvanceETV Conference, Brussels, May 2012

The organisation and distribution of

work

The workflow

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

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

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

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

Cascading quality assurance and

control

Verificationbody

Test body

Analyticallaboratory

Assessment, quality assurance and control

Quality assurance and control

Results

Results

Accreditationbody

Assessment

Assessment

Test body quality assurance

Location Target taskTest body

internal auditor

Test

responsible

Test body Test plan Review -

Test body

Test system performance

and test body quality

management system

Test system audit -

Test body Test performance Test performance

audit

Test system

control

Analytical

laboratory

Analytical

performance- Review

Test body Test report Review -

Analytical laboratory quality

assurance

Location Target taskLaboratory

staff

Laboratory

internal auditor

Analytical

laboratoryMethod performance Validation -

Analytical

laboratory

Laboratory analytical

system and quality

management

- Test system audit

Analytical

laboratoryAnalytical performance Quality control -

An example – test body operation

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

Thank you for your attention

For more information visit

www.etv-denmark.com

- or contact Christian Grøn

chg@dhigroup.com

‘Verify Once

Accepted Everywhere’