4.19.1 Throughout the process, continuous communication
between the Administration and the Submitter is important. As seen
from the discussions in this section the process requires the Administration
and the Submitter to work together on a number of occasions:
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.1 design preview: In order to decide whether
the alternative and/or equivalency requires observance of the approval
process as outlined in this document or whether a conventional process
can be followed, the Administration and the Submitter will need to
meet and discuss the preliminary design developed by the Submitter;
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.2 definition of approval basis: In order to define
the approval basis, the Administration and the Submitter will need
to meet one or several times to discuss the concept, applicable codes/standards/rules/etc.,
plans for risk assessments (including decision of which evaluation
criteria to utilize) and plans for testing and engineering analyses.
The definition of evaluation criteria may require additional meetings
with the Administration to discuss and evaluate the selected criteria;
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.3 monitoring of analysis of Preliminary design:
the Administration may participate in the HazId for all alternative
and/or equivalency designs. Furthermore, if a risk assessment and
an identification of risk control options are agreed at this stage
between the Administration and the Submitter, the Administration may
monitor the activities of the Submitter;
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.4 review of analysis of Preliminary design: The
Administration reviews the results of the analyses for the Preliminary
design;
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.5 approval of Preliminary design: The preliminary
approval will be given with a set of conditions that are to be met
to achieve full approval. The Administration and the Submitter need
to arrange a meeting to discuss the steps forward in the process;
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.6 update of approval basis: In order to consider
the results of the analyses performed for the preliminary design and
the information provided by the specific design in the further risk
analysis process, the approval basis is updated;
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.7 review of analysis of Final design: The Administration
reviews and eventually evaluates the necessary risk assessments necessary
to satisfy the conditions outlined in the approval for the preliminary
design;
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.8 definition of detailed requirements: There
may be a need to arrange a meeting to discuss the final design and
results from the risk assessments and to further detail or revise
the conditions given together for the approval of the final design;
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.9 review of approval tests and analyses: The
Submitter submits the required documentation and evidence of the testing
and analyses to the Administration. Whether or not a meeting is required
depends on the complexity of the testing and analyses; and
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.10 final Approval: The approval certificate may
be issued with some additional conditions assigned, such as additional
survey scope and frequency, condition monitoring, or requirements
related to maintenance and inspection. There should be a meeting between
the Administration and the Submitter when issuing the approval certificate.
During this phase, there may be a need for additional documents and
drawings to be submitted to the Administration.