4.7.1 Following the Preliminary design preview
phase, the next phase is for the Administration to define the approval
basis with respect to scope of analysis and evaluation criteria. In
order to accomplish this, the Administration and the Submitter may
have to meet one or several times to discuss the alternative and/or
equivalency, its purpose and objectives, deviations from conventional
approaches, relevant rules and regulations, possible deviations from
or lack of rules and regulations, requirements that may not be covered
by the rules, proposed operations and potential impact on other systems,
components, etc. During this time, the alternative and/or equivalency
will have to be well understood.
4.7.2 The Submitter and the Administration may
also discuss plans for hazard identification, risk assessments and
plans for testing and analyses. The scope and extent of the analysis
(either qualitative or quantitative analysis or both) to be performed
in the Analysis of Preliminary design phase (see paragraph 4.5) is
agreed between the Submitter and the Administration considering the
requirements of the Submitter with respect to the soundness of the
preliminary approval.
4.7.3 A risk assessment plan should be developed
to identify appropriate types of assessment techniques by Submitter.
The plan should clearly state the proposed evaluation criteria and
the basis for the criteria.
4.7.4 A testing and analysis plan should be developed
to identify appropriate types of test and engineering analyses by
Submitter. This plan is only a preliminary plan, as it will most likely
be revised following the results of the analysis for the preliminary
design phase.
4.7.5 The work performed within this phase will
result in a document issued by the Administration describing the requirements
and the formal process for achieving preliminary approval.