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Chapter 10 Quality Assurance (QA)

Table 10.6.2 Examples of verification items in the design review

  1. Adequacy in requirements selected for design

  2. Appropriateness and rationality of assumptions for design

  3. Adequacy of design methods and compliance with specified quality assurance codes

  4. Proper reflection of design requirements in design output documents and confirmation of document adequacy

  5. Compliance with design procedures

(0 Notification about design interfaces, design requirements and verification requirements to other divisions concerned [Source] JEAG4101-2000

  1. Verification of Design and Development

Verification is a process to ensure that the design and development outputs have met the design and development requirements specified in the inputs. Verification is performed in accordance with the preplanned arrangements. The results of verification and any necessary actions to take are recorded and maintained. Verification is performed by designers or groups other than the original designer(s) who had done the design and development. Personnel in the same division, including the designer’s immediate supervisor may do the verification if they are not directly involved in that design and development process. The supervisor’s approval process is a general form of verification.

There are some other forms of verification.

  1. Alternative calculations.

Adequacy of the original calculations or analyses is verified by comparing those results with the results of alternative calculations or analyses. Adequacy of the assumptions for calculations or analyses, design requirements and computer programs used is also verified as in the original ones.

  1. Comparisons between the original design and the similar design (if possible).

  2. Demonstration tests.

In principle, demonstration tests are done under the most severe conditions among the design requirements. If the tests are performed to verify a particular design requirement, other design requirements are verified separately, for example, by design reviews, analyses or complementary tests, in order to assure validity of the design as a whole.

If the test results show the necessity to modify the subject component, the component is verified to satisfy the predetermined requirements after modifications.

  1. Validation of Design and Development

Design and development validation are performed in accordance with the preplanned arrangements to ensure that the resulting product, or the nuclear facility built, meets the requirements for the pre­specified use.

This validation is completed prior to the delivery of the products or the operation of the nuclear facility. The results of validation and any necessary actions to take are recorded and maintained

Validation of design and development might be practically possible only after the delivery or installation, depending on the characteristics of the product. Therefore, the timing of validation will be coordinated, taking into account costs, time needed, expected effectiveness and significance of validation.

Validation for design and development can be done in the following ways, among others:

  1. factory inspections or inspections on receipt of the product or nuclear facilities (if no test operations or function tests will be done);

  2. factory test operations or function tests of the product or nuclear facilities;

  3. function tests of the product or nuclear facilities upon installation; and

  4. pre-service test operations of the product or nuclear facilities.

  1. Configuration Management of Design and Development

Once approved outputs of design and development may sometimes need changes. Nonconformities in nuclear facilities are often rooted in such changes in design and development Design and development changes are clearly identified, reviewed, verified and validated, as appropriate, in order to prevent such nonconformities. The approval process before changes is important

10-19

NSRA, Japan