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Verification

(10.6.5)

Validation

(10.6.6)

Figure*! 0.6.1 Process flow of design and development

defines and practices individual responsibilities for interfaces, reporting channels and management rules, according to the interface management lists, flow charts of design work and other management documents.

Design and development for a product, if experienced in the past, may be followed where appropriate (see Sectionl0.5, Product Realization Planning). It is important to clearly define what activities be covered in this section 10.6.

  1. Inputs to Design and Development

At the outset of design and development, inputs to design and development concerning product requirements are clearly identified and documented as requirement specifications, examination policies, technical examinations, etc. and then recorded. These inputs will be used later as criteria for verifying whether they were converted to the intended outputs

The inputs include:

  1. functional and performance requirements;

  2. applicable statutory and regulatory requirements;

  3. relevant information from previous similar designs,; and

  4. other essential requirements for design and development.

The identified inputs are reviewed for adequacy, including that requirements are complete,

unambiguous and not in conflict with each other, etc. Reviews may be performed according to the design and development review (see 10.6.4), as well as peer review meetings and approval process reviews.

Examples of inputs to design and development are listed in Table 10.6.1.

  1. Outputs from Design and Development

The outputs from design and development process such as design drawings and design specifications are generated in a form that enables comparison with the pre-selected inputs by the person(s) other than the original designer(s) and are subject to approval prior to release to the next stage.

Design and development outputs:

  1. meet the input requirements for design and development;

  2. provide appropriate information for purchasing, production and provision of service;

  3. or refer to the product acceptance criteria, inspections/tests acceptance criteria; and

  4. describe specify characteristics of the product that are essential for its safe and proper use.

  1. Review of Design and Development

During the design and development process, activities are needed to confirm design appropriateness effective operation.

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NSRA, Japan

At suitable stages of design and development, systematic reviews are performed in accordance with the arrangements made in the planning stage to evaluate whether the results of design and development can meet the requirements, and to identify any problems and propose necessary actions.

This review corresponds to the Design Review

(DR). It is conducted multilaterally with participation of representatives from relevant groups concerned with the design and development at various stages.

The results of design reviews, items of concerns and any actions taken accordingly are recorded and maintained.

Examples of check items in the DR are listed in Table10.6.2.

Tablei0.6.1 Examples of design and development inputs

1

Fundamental functions of structures, systems and components

2

Performance requirements (capacity, rating and system outputs, etc.)

3

Applicable statutes, standards and codes

4

Conditions of fluids in use (pressure, temperature and chemical properties, etc.)

5

Load conditions (seismic loads, wind loads, thermal loads, etc.)

6

Environmentally possible conditions during construction, operation and maintenance (temperature, humidity, site elevation, direction of wind, radiation dose equivalent, etc.)

7

Interface requirements (mechanical and physical interfaces between structures, systems and components)

8

Requirements relating to materials (compatibility, insulating properties, corrosion resistance, treatment without rules of official quality approval)

9

Requirements relating to mechanical properties (stress, vibration resistance, impact resistance, etc.)

10

Requirements relating to structure (including component basements and piping supports, etc.)

11

Hydraulic requirements (available net positive suction head of pumps, acceptable pressure loss and liquid velocity, etc.)

12

Requirements relating to chemical properties Oimiting conditions of water quality, sampling, etc.)

13

Electrical requirements (power source voltage, electrical circuits, electrical insulation, motors, electromagnetic compatibility, etc.)

14

Requirements relating to components arrangement

15

Requirements relating to operations (including reactor decommissioning)

16

Requirements relating to instrumentation and control (instrumentation and control system for operation, testing and maintenance, types of alarms and instrument systems, spare, measurement ranges and attachment positions, etc.)

17

Requirements relating to protection against illegal intruders

18

Requirements relating to redundancy, diversity and dependency of structures, systems and components for plant safety and reliability (fail safe, etc.)

19

Requirements to assure that structures, systems and components can withstand the events anticipated in the design

20

Requirements relating to tests, inspections and test operations

21

Requirements relating to accessibility, maintainability, easy repairing and in-service inspections

22

Requirements relating to transportation

23

Requirements relating to handling, storage, cleaning and delivery

24

Requirements relating to fire protection, fire resistance and fire extinguishing

25

Requirements relating to injury and accident protection (radiation control, usage restriction of dangerous materials, evacuation provisions from the site, grounding of electrical equipment)

26

Ergonomic considerations (man-machine interfaces, etc.)

27

Limit of radiation dose equivalent for employees and the public

28

Other requirements to prevent hazards to public health and safety

29

Requirements relating to feedback information from past nonconformities

[Source] JEAG4101 2000

NSRA, Japan

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