6.6.1.1 For alternative and/or equivalent designs
(unless the regulation challenges are deemed insignificant or of negligible
impact in terms of safety), a HazId will always be required, as it
fulfills the requirement that the basic risk assessment should address
the parameters of the submitted design known to this point and evaluate
where further scrutiny is justified and necessary.
6.6.1.2 The Submitter should consider:
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.1 statements of main conclusions from initial
meetings, including key elements of risk that may be examined further;
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.2 description of HazId procedure applied;
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.3 documentation in support of any assumptions
made;
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.4 documentation of existing safeguards and control
measures;
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.5 plans and means for proposed safeguards and
control measures;
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.6 levels of agreement within the team and the
qualifications and experience of the participated members;
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.7 points of discussion and further examination,
including further analysis and applicable techniques;
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.8 needs for further in-depth examination of historical
evidence/expert judgment or calculations; and
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.9 sources of information.
6.6.1.3 When receiving the HazId report and monitoring
the session(s), the Administration may consider:
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.1 whether safety issues have been comprehensively
covered (whereas commercial risks in this context are beyond the scope
of the Administration);
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.2 whether all relevant, conceivable scenarios
have been considered, ranked and prioritized;
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.3 whether the composition of the HazId team ensures
that all relevant areas of expertise are represented and heard in
the process, both from a scientific, theoretical, operational and
practical standpoint;
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.4 whether the qualifications and experience of
the participants are verifiable upon request;
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.5 whether existing and proposed safeguards and
control measures are adequate and viable. (The adequate reduction
of risk to acceptable level, or plans to perform such reduction in
the Final design process, is a condition of preliminary approval.);
and
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.6 whether identified significant hazards can
be adequately analysed and reduced by means of the planned detailed
risk analysis processes.
6.6.1.4 The Administration reserves the right
to request further participants if certain areas of expertise or experience
have not been adequately covered by the team composition as described
(an Administration representative may participate to ensure that potential
comments from the Administration to the Submitter are covered to the
maximum extent possible).
6.6.1.5 The HazId further serves to clarify and
rank all identified hazards. As mentioned above, the HazId is a meticulous,
formalized brainstorming process, documenting any contributory factors
impacting on safety critical elements. The documentation derived from
the process is submitted to the Administration.
6.6.1.6 If the expert group does not agree on
the prioritization of scenarios (or at any other stage where expert
judgment is applied), the level of disagreement may be reflected and
documented where the scope would be to achieve a "good" level of consensus
within the expert group performing the task.