4.4.1 The submission and approval process for
an alternative and/or equivalency design should be clear, transparent
and well described in order to avoid misinterpretations. In the following
sections, the phases of the process outlined in figure 2 are described taking into
account the roles of the Administration and the Submitter.
4.4.2 The details of the process for an alternative
and/or equivalency design depend also on the design process of the
Submitter. The process shown in figure
2 was based on a design process covering preliminary and final
design, both consecutively analyzed in the approval process. However,
the Submitter may wish to carry out the approval process using a final
design, i.e. without an analysis of a preliminary design. In such
cases both parties may agree to skip the analysis of the Preliminary
Design and adjust accordingly the approval process including the documentation
of analyses. Independent of such details the approval process should
consider among others the definition of the approval basis, the hazard
identification, review of approval basis after HazId and quantitative
risk assessment.
4.4.3 Documentation and the exchange of documents
between the Administration and the Submitter are highlighted in the
description of each phase. Results of assessments need to be fully
documented in a manner readily accessible to a third party. A description
of the documentation requirements for the submission and approval
process is provided in section 6 of this document.