before accepting the requirements through communication with the customer or by other means. Oral comments made in inspections by a government regulator are an example of undocumented requirements (in the case of electric utilities a regulator is a customer along with the general public). In such a case, the organization (e.g. the electric utilities) must confirm the instructions before taking actions, by an inquiry or other means, such as the confirmation procedure before the application of laws (the “no action letter system” is institutionalized in Japan).

4. Customer Communication and Customer Satisfaction

Hie organization must formulate and implement effective arrangements for communicating with the customer, in order to facilitate customer satisfaction, concerning product information, enquiries, contracts or order handling, including their amendments, and customer feedback, including their complaints.

For the electric utilities, communication with government regulators on “information on nuclear safety,” ’’requirements for special inspections” or “feedback from the government regulators” are examples. Communication with local governments and local residents and the general public outside the local area is also an important activity for electric utilities operating NPPs and must be voluntarily addressed and implemented by them. The means of communication is not limited; the means and process of communication should be selected as appropriate to the organization in view of its size and the actual local situation. These points must be defined when formulating the product realization planning.

The organization must monitor, through communication with the customer, how the customer rates the organization as to whether they meet the customer requirements. This information helps the organization judge whether or not its own QMS works effectively and whether or not the result is obtained as planned, and eventually it helps to improve the corporate QMS if necessary. Therefore, the way of utilizing such information must also be defined in the planning stage,

The customer for electric utilities operating and

maintaining NPPs is the general public and the regulators representing the public. The utilities must monitor, through communication with the regulators, how the customer rates them on achieving nuclear safety. The information source includes: reviews by the regulators, inspection results, instruction documents and regulators’ comments on routine work.

10.6 Design and Development

The quality of a product depends on design, as is occasionally expressed “Qualities are embedded in design, fit in manufacturing and checked in inspections”. This section elaborates on planning, input, output, review, verification, validation and configuration management concerning the design and development (Figure 10.6.1).

For the nuclear organization, the object of design and development is nuclear facilities and that, specifically speaking, is a series of processes of examining and improving plans and developing specifications for repair and replacement work. The improvement of plans comes from proposals for betterment, corrective actions for nonconformities, and other sources.

1. Planning of Design and Development

In the planning, the following items are specified and issued as the design documents, which will eventually be approved by the managers.

1. Stages of design and development (conceptual design, basic design, detailed design, etc)

2. Review, verification and validation that are appropriate to each design and development stage

3. Responsibilities and authorizations for design and development

These plans are reviewed and updated in accordance with the progress of design and development. Any issues, for example, a delay, must be clearly identified and measures taken accordingly.

Design and development for nuclear facilities involves many designers from multiple divisions. Therefore, it is important to clearly define the interfaces between them and manage them in order to achieve the planned goals as a group. Every division involved in design and development

NSRA, Japan

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Chapter 10 Quality Assurance (QA) Review (10.6.4)			—►	Design & development	—►
Requirements	—►	Input (10.6.2)				Output (10.6.3)	—►	Product /nuclear facility
j		A