Section 2 Documentation and Exchange of Documents

201. General

1. Documentation in risk-based approval process may comprise, but is not limited to, documents speci- fied in 202. and 203..

2. Documentation that is required to be exchanged between the approval team and the design team in the approval process is summarized in Fig 6.1.

202. From Design Team to Approval team

1. Risk-based design documents:

(1) Design concepts and objectives;

(2) Specification and general description of generic design and detailed design;

(3) Relevant drawings (generic design, system arrangement, structural drawing, production drawing, lines, etc.);

(4) Detail drawings of subsystems;

(5) Description of target system function and required sub function;

(6) Novel characteristics or risk-based characteristics of design (including operational characteristic);

2. Analysis reports of generic design and detailed design:

(1) List of existing prescriptive regulations/rules/standards that are considered to be applied;

(2) Identified hazards reports;

(3) Safeguards included in the design;

(4) Results of risk analysis and risk assessment(including risk models);

(5) Safety critical elements;

(6) Applicable risk control option and consequent reduced level of risk;

(7) References and relative inter/external experts opinions;

(8) Applicable techniques or methods of test, calculation and analysis, simulation relative to the de- sign;

(9) Objectives, scope and boundary conditions of test, calculation and analysis, simulation relative to

the design;

(10) Result report of test, calculation and analysis, simulation relative to the design;

(11) Discussion about assumptions, error and uncertainties;

(12) If necessary, items which require additional further design analysis;

(13) If necessary, cost-benefit assessments

3. Documents relative to construction and operation:

(1) Safety management procedure

203. From Approval team to Design Team

1. Result of generic design preview

2. Preliminary approval criteria and final approval criteria

(1) Documentation of applicability of any regulations, rules or standards as well

(2) Risk analysis and assessment plans;

(3) Plan of test, calculation and analysis, simulation relative to the design;

(4) Documentation requirements and process;

3. Review opinion on design analysis

4. Opinion on preliminary approval review and final approval review

5. List of final approval requirements

6. Preliminary approval certificate and final approval certificate with conditions

7. Survey requirements and safety management system approval opinion

as any deviation;

Fig 6.1 Documentation between design team and approval team