4.8 Analysis of Preliminary Design Phase
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4.8 Analysis of Preliminary Design Phase

  4.8.1 The scope of this phase is to conduct an analysis of the Preliminary design that has been specified in the previous phases of the process. The Submitter is responsible for facilitating all analyses agreed with the Administration. It is highly recommended to invite Administration representatives to attend the meetings to provide a close dialogue between the Administration and the Submitter in order to ensure that all relevant issues are taken into consideration. However, careful consideration should be given to ensuring that their independence from the design team is maintained. The analysis of the preliminary design is a stepwise process monitored by the Administration that may be terminated in case so-called showstoppers are identified.

  4.8.2 At a minimum, a HazId should be required in order to request for preliminary approval of the preliminary design. The Submitter will be required to arrange a HazId workshop, which is a structured brainstorming with the purpose of identifying all relevant hazards and their consequences and mitigating measures already included in the design. The HazId provides a unique meeting place for designers, engineers, operational and safety personnel as well as Administration representatives to discuss the alternative and/or equivalency and its associated hazards.

  4.8.3 The benefits of including Administration representatives are:

  • .1 the Administration representatives will be able to point to issues relevant for approval that may be discussed;

  • .2 the Administration representatives may have expertise within certain areas of the design under consideration and therefore may be able to contribute by drawing attention to issues that may unintentionally have been left out of discussions; and

  • .3 the amount of questions and misunderstandings will be reduced during the review of the HazId and in the overall approval process.

  4.8.4 Typically, results of the HazId will include the following:

  • .1 identified hazards associated with the alternative and/or equivalency design; and

  • .2 identified potential safeguards already included in the design.

  4.8.5 The results of the HazId should be documented (HazId Report) by the Submitter and submitted to the Administration. A list of the participants in the HazId and their expertise and experience should be submitted to the Administration as well.

  4.8.6 Depending on the scope defined by the Submitter and the Administration, the Preliminary design analysis may include a risk assessment. If so, a coarse risk model should be developed based on the HazId. The scope of the evaluation of risk control options depends on the outcome of the risk evaluation.

  4.8.7 The scope related to the risk assessments at this phase will depend on the degree of novelty of the alternative and/or equivalency and the risk assessment plans defined during the Definition of Approval Basis Phase (see paragraph 4.1.3). Typically, the risk assessments will include the following (which is also documented and submitted to the Administration):

  • .1 ranking of hazards (identification of frequencies and consequences) and selection of hazards for risk model;

  • .2 development of a coarse risk model in order to perform quantitative analyses;

  • .3 description of data analysis, assumptions, uncertainties and sensitivities;

  • .4 assessment of the alternative and/or equivalency design by means of reference design;

  • .5 identification of issues, such as design casualty scenarios, that may require further analyses and testing; and

  • .6 identification of issues that may require special attention with respect to operations, accessibility and inspections.

  4.8.8 The risk model may be developed using one of the well-established methods such as fault tree analyses, event tree analyses, Markov models, Bayesian networks, structural reliability analyses, etc. Description of the proposed qualitative and quantitative methods as well as the objectives, scope and basis of the assessments may be included in the risk assessment plan submitted at the time of Definition of Approval Basis Phase (see paragraph 4.1.3).

  4.8.9 The work performed related to risk assessments will be documented by the Submitter and submitted to the Administration. The risk assessment will be included as the basis for approval, if required.

Parent topic: 4 Process
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