Section 1 General

101. General

1. The expected safety performance of the risk-based design is to be quantitatively specified in the form of the evaluation criteria.

2. The approval of the risk-based design requires the development, review, and selection of appropriate evaluation criteria. Before evaluation the alternative and/or equivalent design, the Submitter and the Administration need to agree on established evaluation criteria.

3. Safety objectives and functional requirements available in IMO instruments are to be taken into consideration when developing the evaluation criteria.

102.

Validity of design

1. Validity of design means compatibility with requirements identified by performing risk-based appro- val process.

2. Requirements could be divided into following functional requirements and safety requirements.

When the design is satisfied with both of them, validity of design is proven.

(1) Functional requirements: essential requirements to obtain target system function

(2) Safety requirements: requirements related with maintenance or development of safety(including risk control options and safety systems)

3. These requirements are included in several documents prepared during performing risk-based appro- val process and finally integrated and organized in the document of final approval requirements list.

103.

Safety of design

1. Safety of design means acceptance possibility of an assortment of risk identified through risk-based approval process.

2. Risks are divided into followings according to level and scope of the subjected design.

(1) High-level risk is the integrate risk for entire design and commonly dealt with in the prelimi- nary approval phase.

(2) Low-level risk is local risk for specific components, functions, systems, etc. and commonly dealt

with in final approval phase. If necessary, this can be dealt with in the preliminary approval phase.

3. Safety of design is proven by confirming that identified risks of Par 2 is satisfied with defined risk evaluation criteria.

4. Identified risks and relevant evaluation result are included in documents and specified overall in the design analysis report and design review opinion.

104. Definition of risk evaluation criteria

1. Risk evaluation criteria are defined and revised at the time of definition of preliminary approval ba- sis phase and final approval basis phase respectively. If necessary, already defined risk evaluation criteria may be revised additionally after review of design analysis result and agreement between the approval team and the design team.

2. Following items are to be described in detail where defining risk evaluation criteria.

(1) Type of risks

(2) Risk acceptance criteria

(3) Identification scope of risks

3. The design team calculates various risk levels by performing risk analysis for the design and car-

ries out risk assessment with comparing to the risk acceptance criteria, and then they are to submit the result to approval team. The approval team reviews the risk assessment report submitted by de- sign team and ascertain the suitability of procedures and adequacy of result and may consequently approve the design based on the result.

4. In the definition of the risk assessment, economic criteria is not considered in principle. However, it can be properly consulted when reviewing the adequacy of the risk control measures.

5. Risk acceptance criteria is to be in accordance with Annex 1.