Section
3 Stage 02: Technology validation
3.1 Introduction
3.1.1 Following the verification of the technology through a technology
appraisal activity, this stage comprises a series of objective tests that must be
completed to confirm that the technology is capable of meeting technical
requirements, as identified in the definition of the technology. Equally, the
findings highlighted in the technology appraisal report must also be considered
during the various qualification activities associated with this stage of the
certification process.
3.2 Preparation of a Technology Qualification Plan
3.2.2 The Technology Qualification Plan (TQP) should list all qualification
activities that are required in order to provide evidence that the technology has
met or exceeded the acceptance criteria for each defined specification as
established in the definition of the technology (see
Ch 3, 2.4 Definition of the technology). In particular, it
should address novel aspects that pose uncertainties and any critical failure mode
or other risks identified during the risk assessment (see
Ch 3, 2.12 Risk assessment).
3.2.3 Each component identified as a red, amber or yellow must be included in
the document indicating how the respective issues of concern can be addressed.
Additionally, if components identified as green are considered critical, these
should also be addressed in the TQP.
3.2.4 As an independent assessor and in keeping with conflict-of-interest
issues, LR (or other external discipline specialists) assessing the technology shall
not be involved in the preparation of the TQP. However, the technology developer is
free to engage any third-party entity in support of its development to provide
expertise concerning intended qualification activities.
3.2.5 As a minimum, a TQP shall consist of two parts, covering the following:
Part A: General
- Title of the technology seeking certification;
- Name and contact details of technology developer (as on the application
form);
- Project reference number, as stated on the Technology Appraisal Report;
- Referenced technology appraisal report number, including version;
- Scope of the certification;
- List of referenced documents previously submitted for design review (e.g.
basis of design, previous test reports, etc.);
- Definition of the technology;
- Summary of technology assessment;
- Summary of risk assessment;
- Summary of system readiness assessment;
- List of external consultants, etc. involved with the development of the TQP
(to ensure there is no conflict of interest);
- Risks (technical & non-technical) to implementation of the TQP;
- Schedule and sequence of tests; and
- Management of change process.
Part B: For each identified qualification activity, the following details
are required:
- Brief description of the qualification activity;
- Impacted components/subsystems, with reference to their unique identifier;
- What specific aspects of the definition of the technology does the
qualification activity target/address;
- Details of the qualification activity procedure;
- Details of acceptance criteria;
- Documents to be submitted prior to testing (e.g. test procedures for
approval);
- Personnel involved with each qualification activity (e.g. responsible,
accountable, consulted, informed);
- Witness points, where LR as an independent assessor is required to be
represented;
- Proposed venues for test (e.g. details of accredited test laboratories); and
- Documentation that will be produced following testing (e.g. test reports,
graphs, etc.).
3.3 Review of technology qualification plan
3.3.1 Following the completion of the TQP, the technology developer is to
submit it for approval. The approval process will consider clear links between the
definition of the technology (see
Ch 3, 2.4 Definition of the technology), the technology and
risk assessments highlighted in the technology appraisal report, and the acceptance
criteria established at the commencement of the technology verification stage. If
any of these are unclear or ambiguous, the technology developer will be notified and
requested to update the TQP to demonstrate the above.
3.3.2 Approval for a TQP is granted in the form a document referred to as a
‘Statement of Feasibility’. Upon issuing this document, the technology developer
shall not modify the TQP without written consent from LR. This is to ensure that
further R&D work conducted by technology developers (or their consultants) does
not influence the design under assessment.
3.4 Execution of technology qualification activities
3.4.1 The execution of the qualification activities should strictly follow the
schedule and sequence stated in the approved TQP. If there is a deviation, LR should
be informed along with the reasons for doing so.
3.4.2 In order to ensure traceability, each test should be linked to a specific
subsystem/component using the unique identifier assigned during the technology
decomposition activity (see
Ch 3, 2.7 Technology decomposition 2.7.6). Additionally, test
reports should also link to specific details of the definition of the technology
(see
Ch 3, 2.4 Definition of the technology) that were
addressed.
3.4.3 If, during the execution of various qualification activities it is
identified that results from a specific test do not conform to the agreed acceptance
criteria, these should be recorded along with the cause and potential reason for
noncompliance. These details may assist in further investigation, including the
possibility of substituting a qualification activity to understand whether the
results received are the same.
3.4.4 A qualification activity can be repeated as often as needed to ensure the
results meet or exceed the acceptance criteria as stated in the approved TQP.
However, no modification to any approved qualification activity shall be made
without approval from LR. Equally, the approved TQP shall not be revised to reflect
any modified test procedure or acceptance criteria without the consent of LR.
3.4.5 Any deviation from the approved TQP should follow a documented management
of change process, including the possibility for updating the TQP and the definition
of the technology appropriately.
3.5 Witnessing of tests
3.5.1 During the development of the TQP, the technology developer should engage
with LR to agree which specific qualification activities require independent
witnessing. These should be introduced into the test-schedule accordingly.
3.5.2 If LR is required to witness any test, arrangements for visits to a
test-site should be planned well ahead of the test date, including the availability
of approved test procedures and any relevant background information. LR accepts
tests reports from accredited test facilities (i.e. test laboratories that have an
ISO 17025 accreditation with a scope for the test being conducted) and hence does
not need to witness tests conducted at these sites.
3.6 Submission of test results
3.6.1 The results from each qualification activity should be reported in
accordance with their respective details as stated in the TQP. It is important that
the outcome of each activity is reported fully and accurately soon after its
completion. This supports project progress and provides an up to date understanding
of the technology’s status.
3.6.2 If anomalies of any description are discovered during testing, these
should be discussed with LR so appropriate decisions can be made concerning further
qualification activities.
3.6.3 Copies of all test results should be introduced into a dossier of
evidence to support the performance review during the final stage of the
certification process.
3.7 Review of test results against acceptance criteria
3.7.1 This activity involves the review of each test result against the
associated acceptance criteria to determine if they have been met or exceeded.
3.7.2 As part of this review, the approved test procedure will be referenced to
determine if it was followed accurately to obtain the submitted results.
3.8 Final review of submitted test results
3.8.1 Upon satisfactory completion of all qualification activities stated in
the TQP, LR will perform a final review of the outcomes from the various
qualification activities. While test results would have been reviewed progressively
soon after tests ( see
Ch 3, 3.6 Submission of test results), the purpose of this
stage is to confirm the following:
- The TQP has been fully implemented;
- All qualification activities have been completed in accordance
with the approved TQP;
- The results from each activity have met the acceptance criteria
as stated in the definition of the technology;
- Any deviation has been suitably reported and an approved
management of change process implemented;
- Any recommendation arising has been suitably addressed; and
- All uncertainties identified during the technology verification
stage have been fully addressed, such that confidence in the CTEs have
increased to a level commensurate with equivalent mature technologies.
3.8.2 As part of this review the following activities will be undertaken:
- A detailed design review of specific subsystems demonstrated during testing;
and
- A critical design review of the entire system/technology against the
definition of the technology.
3.9 Issuance of a technology validation report
3.9.1 This is a deliverable from LR which follows the conclusion of the
technology validation stage and forms the basis of the next stage of the
certification process. It also serves as evidence required by the technology
developer confirming that the technology has completed an independent assessment
process.
3.9.2 The purpose for the technology validation report is the following:
- To confirm that the qualification activities have been carried out in
accordance with the definition of the technology and approved TQP;
- To confirm whether the tests results have met or exceeded their respective
acceptance criteria;
- To confirm whether further analysis or testing may be appropriate for
certain unresolved uncertainties; and
- To confirm any limitations, conditions, or recommendations beyond the scope
of the assessment.
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