work is 80% done”; the quality of work depends on how the work was planned and how carefully the work was prepared. The organization must define, plan, and establish the work processes (work flow, work procedures, information needed, results to achieve, etc.) prior to the outset of the work in order that the organization’s work on manufacturing the products, providing services, or operating safely are implemented to meet the requirements.

When planning the product realization, the following items must be built in, as applicable, in the processes needed for product realization. When establishing the processes, they must be consistent with the requirements of the other processes.

1. Quality objectives and requirements for the product or the work.

2. Items needed to establish the processes, documents, and provision of resources specific to the product or the work.

3. Required activities for verification of the products or the work, their validation, monitoring, inspections and tests, as well as the criteria for acceptance.

4. Record taking needed to prove that the product realization processes and the resulting product meet the requirements (see 10.2.3).

Basic processes for product realization (a series of activities) are:

1. identification of requirements;

2. design and development of the product;

3. purchasing and procurement of resources;

4. production and services;

revaluation of the product and actions (inspections and corrective actions for non­conformities); and

fothers (process validation, identification and traceability, control of customers’ property, preservation of the products, control of monitoring and measuring devices and monitoring, and monitoring and measurement of the processes)

The organization may also apply the requirements given in 10.6, when developing the product realization processes. When manufacturing the product or providing services, the organization must establish more concrete planning for management and ensure that the items in 10.8 are under controlled conditions.

In the safe operation activities of NPPs, work processes needed are generally categorized as: operation management, fuel management, radioactive waste management, radiation control, maintenance management, and urgency (emergency) preparedness. The organization must establish necessary plans and documents for the planning of these processes including the afore-mentioned requirements to be built into the processes as applicable. When implementing these plans, the organization must plan the details of daily work to ensure that the controlled conditions shown in 10.8 are achieved.

2. Relationship with Customer

fllie relationship with the customer in the QMS is important for the organization, from the viewpoint of both providing the products meeting the customer’ s requirements, and satisfying the customer. Communicating and exchanging information with the customer and collecting the customer’ s feedback are needed. The way and timing of such communications should be planned when establishing the product realization planning.

3. Determination and Review of Requirements related to the Product (Work)

The organization must identify relevant requirements for providing the product meeting the customer’s requirements, not only those stipulated in the specifications, but also other implicit requirements, including legal and regulatory requirements concerning the product and implicit expectations by the customer, etc.

Hie organization must review if the requirements identified above are complete, and if the requirements can be met. These actions must be done prior to the organization's commitment of the product supply to the customer, or the commencement of the work concerned, such as submission of tenders, acceptance of contracts or orders, or acceptance of changes to the contracts or orders. Hie review results and the actions taken after the review must be documented and recorded.

If the customer’s requirements are not documented or there are any doubts about them, the organization must confirm and resolve them

10-15

NSRA, Japan