6.1.1 The approval process for an alternative
and/or equivalency is different from a conventional approval process,
and therefore the documentation process needs to be clear, transparent
and well described to avoid misinterpretations. As illustrated in figure 2, documentation may comprise,
but is not limited to, the following:
6.1.1.1 From Submitter to Approval Authority:
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.1 design documents:
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.1 description of the alternative and/or equivalency
design, including design basis;
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.2 functional description;
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.3 identification of interfaces between the design
and other systems/operations (compliant with regulations);
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.4 preliminary general arrangement drawings;
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.5 preliminary detail drawings of subsystems (if
available);
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.6 list of codes and standards that are considered
to be applied;
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.7 risk assessment plans;
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.8 testing and analysis plans; and
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.9 further design basis documents, as necessary;
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.2 analysis reports for assessment of preliminary
design:
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.1 identified hazards;
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.2 safeguards included in the design;
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.3 evaluation criteria applied;
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.4 issues that may require further analyses and
testing;
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.5 description of analysis method applied, including
the details of workshop conducted; If analysis for preliminary design
includes a risk analysis;
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.6 frequencies and consequences associated with
the hazards and resulting risks;
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.7 risk models;
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.8 data references, expert judgments, assumptions,
uncertainties and sensitivities;
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.9 cost-benefit assessments;
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.10 selected risk reducing measures;
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.11 design casualty scenarios;
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.12 issues that may require further analyses and
testing; and
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.13 information on the participated experts in
the analysis;
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.3 issues that may require special attention with
respect to operations, accessibility and inspections;
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.4 description of final design (including revisions
to "preliminary design description" submittals);
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.5 analysis reports for assessment of final design
– including information regarding:
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.6 analyses and testing reports – including
information regarding:
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.1 statements of relevant codes and standards
applied, and deviations made to their application;
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.2 selection of appropriate evaluation criteria
used to assess the design;
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.3 design calculations;
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.4 analyses reports (including objectives, scope,
assumptions, results, conclusions and recommendations);
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.5 test reports, including descriptions of modeling/test
set-up, as well as test objectives, scope, results, analyses, conclusions
and recommendations; and
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.6 error and uncertainty assessments; and
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.7 design specifications:
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.1 underlying analyses, testing and calculations
that define the basis for design; and
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.2 additional documents and drawings – including
final general arrangement drawing and final detailed drawings of subsystems.
6.1.1.2 From Administration to Submitter:
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.1 description of approval requirements and process;
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.2 preliminary approval statement with conditions
(if analysis of preliminary design is performed);
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.3 description of detailed requirements;
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.4 statement of approval of design specifications;
and
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.5 certificate with conditions.
6.1.1.3 Documentation that is required to be exchanged
between the Administration and the Submitter in the approval process
is summarized in figure 3, and this chapter of the Guidelines outlines
requirements pertaining to this documentation.
6.1.1.4 The document requirements described in
this section are considered as minimum. According to the complexity
and features of subjected design development, slight modifications
of the requirements could be required. In this case, the modifications
should be conducted on the basis of the agreement between the Administration
and the Submitter.