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Chapter 10 Quality Assurance (QA)

  1. Internal Audit

  1. As for internal auditing, it is important that the top management makes the purpose of the audit clear. Additionally, the information on the results of audits is used as input to the management reviews (Section 10.3), and becomes the data to evaluate the effectiveness of the quality management system. Therefore, it is important that internal audits give the priority to not only the evaluation of the adaptability to the quality management system but also the evaluation of the effectiveness of the quality management system which improves the performance of the organization.

Moreover, the information on the results of the audits makes the audited side “aware of the opportunity for improvement” because the product and work are evaluated objectively. Therefore, it is important that the audited side accepts the audit in good faith and reflects on the comments for continuous improvement of the work.

In addition, internal audits in the electric power company must be done by an independent assessment organization (the auditing section must be independent of the nuclear power department) which is required by IAEA standards.

  1. The internal audits are conducted at the planned intervals to clarify the following items related to the quality management system.

  1. [Whether it is conforming or not ] Determination must be made as to whether the quality management system is conforming: to "Planning of product realization" (Section 10.5);

the requirements of the quality management system standards; and the quality management system requirements established by the organization.

  1. [Whether it is effective or not ] Determination must be made as to whether the quality management system is being effectively implemented and maintained.

  1. The audit program (which may be an annual audit plan) is developed, and then the audit criteria, scope, frequency and methods are defined. The status and importance of the processes and areas to be audited, and the results of the previous audits are considered at that time.

Moreover, to ensure objectivity and impartiality of the audits, they are conducted by auditors other than the staff and the responsible person of the audited activity.

Table 10.9.6 shows examples of the audit criteria, scope, frequency, methods, and selection of auditors.

  1. The responsibilities and requirements for planning and conducting audits, and for reporting results and maintaining records are defined in the in-house standards etc.

Generally, in the auditing procedure, when the auditor detects a non-conformity in the audit, the auditor confirms it to the staff being audited in such a way that the staff is able to accept the evidence of the results of audits and to understand the contents of the non-conformity.

  1. The management responsible for the area being audited confirms the nature of the detected non­

Table 10.9.6 Examples of the audit criteria, scope, frequency, methods, and selection of auditors [Audit standard ] IS09001/JEAC4111, Quality manual of organization concerned.

[ Audit scope] (a) Objects in the organization / divisions headquarters/ OO department OO section, power station / □□ department □□ section

(b) Objects to be audited

  • Quality system audit (conformity to the quality management system requirements)

  • Subject audit (conformity to the quality management system requirements of a certain activity)

[ Audit frequency ] (a) Planned intervals (Conducting audits of all units in a certain period by all means).

(b) As needed (Conducting audits at the time of changes in the quality management system and on finding nonconforming products, etc.).

[ Audit method ] Documentary review and on site review

[Selection of auditors ] Selecting persons not engaged in the work to be audited

[Source ] JEAG4121-2005 exposition

10-29

NSRA, Japan

conformities, and plans and performs the actions to eliminate these detected nonconformities and their causes.

To confirm the status of the implementation of the corrective actions, follow-up activities are generally planned and performed. The timing and the method of the follow-up activities are

determined depending on the significance level of the corrective actions. The verification of the actions taken and the reporting of the verification results are also included in the follow-up activities.

Table 10.9.7 shows examples of follow-up activities depending on the significance level of the corrective actions.

Table 10.9.7 Examples of follow-up activities depending on the significance level of the corrective actions

  1. ) Corrective actions for significant non-conformities

Confirmation of the corrective action plan and implementation status by additional audits

  1. ) Corrective actions for minor non-conformities

Confirmation of the corrective action plan and the implementation status with verbal reports

[Source] JEAG4121-2005 exposition