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management notebook.

  1. So that the measurement results will not lose their validity, protective actions must be taken, e.g. an adjustment knob set point is protected from being changed by mistake or the set point is checked, before and after the measurement as being unchanged since calibration.

  2. Measuring devices must be protected from damage and deterioration during their handling, maintenance, and storage by setting protection fences or by a locking control.

When the measurement devices used were not appropriate, e.g., they were outside the calibration standard range, or the calibration period had expired, the validity of the previous measurement results obtained using those devices must be evaluated and recorded. Appropriate actions must be also taken for the equipment and any work which might have been affected, and the results of calibration and its verification must be recorded.

The actions to take, when a measurement device is outside the calibration standard range, include, among others, to identify the measured items obtained by the device the day after they deviated from the calibration standard or after the previous calibration, to conduct comparative evaluation with the required accuracy, and to measure the item again.

  1. When computer software is built in the monitoring equipment or the measurement instruments, it is necessary to confirm that the intended monitoring and measurement can be performed. This confirmation must be undertaken prior to initial use. Reconfirmation must be done as necessary.

  1. Monitoring & Measurement and Internal Audit

The process of "Monitoring & measurement and internal audit" corresponds to the part of C (Check) in the PDCA cycle for product realization.

Figure 10.9.1 shows the PDCA cycle for product realization in the quality management system.

Here, the measurements and analyses of the effectiveness of the quality management system are performed in addition to the inspections and tests of products, through which the aim is to connect with the continuous improvement of the effectiveness of the quality management system.

Thus, the conformity of products and work to their requirements must be demonstrated, the suitability of the quality management system to product realization must be ensured, and the monitoring and measuring processes necessary to improve the effectiveness of the quality management system continuously must be planned and implemented.

Plan

Product realization(Sec.L0.5) Production and service provision (implementation of work) (Sec. 10.8)

Do

Design and development (Sec. 10.6)

Purchasing (Sec. 10.7)

; Production and service provision (implementation of work) (Sec. 10.8)

Figure 10.9.1 PDCA cycle for product realization in the quality management system

NSRA, Japan

10-26

Chapter 10 Quality Assurance (QA)

  1. Monitoring and Measurement of Products (Inspections & Tests)

  1. Equipment and devices, etc., are inspected and tested to verify that their requirements have been met

What kinds of inspections and tests are conducted at which stages are discussed in “Planning of pro duct realization” (Section 10.5).

Table 10.9.1 shows examples of inspections, tests and the stages when they are conducted.

  1. The degree of independence of inspectors and examiners selected must be defined.

The degree of independence indicates the independence level of inspectors and examiners from such workers as the equipment manufacturers; this is determined according to the importance or the complexity or the distinctive characteristics, etc., of the inspections and tests for nuclear safety and it does not discourage workers from confirming their own work.

Table 10.9.2 shows examples of degrees of

independence.

  1. Decisions of acceptance or rejection of products, records of inspection results, and descriptions of the person who formally authorized release (delivery to the next process) should be included in the records. The person who formally authorized release is the person who approved the completion of the inspection and test concerned, including the approval of the acceptance or rejection decision of the products.

Table 10.9.3 shows examples of persons who can formally authorize releases.

  1. Until the inspections and tests developed in planning of product realization are completed, the product concerned must not be installed or operated. However, the installation or the operation of the product is permitted when it is approved by the person who has the authority over the product concerned. Table 10.9.4 shows examples of authorizations.

Table 10.9.1 Examples of inspections, tests and the stages when they are conducted

Examples of inspections and tests

Examples of the stages when conducted

Pre-commissioning tests, Periodic inspections, Periodic licensee's inspections, In-house inspections, Acceptance inspections of purchasing products.

Periodic inspection stage, Factory production stage, Site installation stage, Pre-commissioning stage.

[Source] JEAG4121-2005 exposition

Table 10.9.2 Examples of degrees of independence

No.

Importance for nuclear safety

Independent degree of inspectors

Examples of inspections

1

High

Organizational independence (inspectors of other organizations)

Periodic inspection

2

Intermediate

Organizational independence (inspectors of other organizations) or inspectors other than the person in charge of the work

Periodic licensee's inspection

3

Low

Inspectors other than the person in charge of the work or even the worker him/herself are acceptable.

Periodic licensee's inspection, in-house inspection

[Source] JEAG4121-2005 exposition

Table 10.9.3 Examples of persons who can formally authorize releases

  1. ) For inspection of equipment : The person in charge of inspection.

  2. ) For inspection of systems : The responsible inspector.

iii) For inspection during transition from a periodic inspection to power operation phase : Several persons including the responsible inspector and chief engineer.

[Source] JEAG4121-2005 exposition

10-27

NSRA, Japan