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The review of the design and development changes includes evaluation of possible impacts of the changes on other constituent parts, other products and nuclear facilities already delivered.

The review results of the changes and any necessary actions to take are recorded and maintained.

  1. Purchasing

Purchasing management ensures the quality of nuclear facilities, and hence nuclear safety, since most resources of nuclear business depend on purchasing.

Key points of purchasing management are:

  1. evaluating and selecting competent suppliers who can supply products to be purchased;

  2. identifying the requirements for products to be purchased;

  3. conveying the requirements to the suppliers; and

  4. validating the conformity of the products to the requirements at the appropriate time by appropriate methods

An example of work flow of purchasing is shown in Figurel 0.7.1.

  1. Purchasing Process

Hie purchasing process is established to ensure that purchased products conform to the specified requirements for purchasing. In defining the following items, the impacts of the purchased products on the subsequent product realization processes and the final products, or on nuclear safety, are considered:

  1. method and criteria for selection, evaluation and re-evaluation of the supplier;

  2. the level of rigorousness in fulfilling the purchased product requirements s; and

  3. methods of verification and evaluation criteria.

Suppliers are evaluated and selected based on their competence to supply the product in accordance with the requirements. This competence means primarily technical and manufacturing capabilities including quality control. Competence in quality assurance is included in evaluations, if needed.

The inclusion of quality assurance in competence evaluation criteria is judged on the same basis as

above.

Example evaluation items include the following:

  1. to confirm technical and manufacturing capabilities (manufacturing facilities and workers, etc.) by documentary examinations or by factory observation checks;

  2. to confirm performances in past deliveries and uses of the products delivered (or similar products) for nuclear facilities;

  3. to test or inspect samples of the products to be delivered (or similar products); and

  4. to validate the quality assurance capability by documentary examinations or factory observation checks. Depending on the quality grade, a certificate by a third-party organization for quality management on, for example, IS09001 may suffice as the checks.

Concerning the re-evaluation criteria, the timing and methods are determined and executed with due consideration given to the order frequencies, suppliers’ QA activities, etc.

  1. Communication with Suppliers

It is important to establish and follow communication schemes with suppliers so that the qualities of products and services delivered are properly maintained. Good communication ensures sure information transfer and facilitates finding out and resolving of work issues, building of a safety culture, advancing compliance awareness, etc. (including information dissemination to everybody’ s awareness about the significance of compliance).

How to establish good communication, including the frequency and depth (i.e. detail), are arranged by referring to the specificity, complexity and purchasing frequency of the products or services to be purchased. Following are some examples of communication with suppliers:

  1. exchange of technical information;

  2. review and liaison meetings at different managerial and practical levels on quality and safety;

  3. face-to-face meetings with suppliers;

  4. campaigns regarding quality and safety;

  5. review meetings with suppliers about the goods to be purchased; and

  6. information dissemination by regular morning meetings, etc. to realize mutual understanding.

NSRA, Japan

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Chapter 10 Quality Assurance (QA)

Figure!0.7.1 Work flow in purchasing (an example when the ordering party is a manufacturer)

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NSRA, Japan