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  1. Document Control

  1. The documents needed in the QMS, that is, needed in implementing the work must be controlled. The organization may determine what documents, from among practical lists, to control and how, based on its own needs and responsibilities so that the organization can respond flexibly to the changes of the actual situation.

  2. For appropriate document control, the control rules must be documented, taking account of the following items, and the pre-determined rules must be followed.

i )Upon generating a document, the person responsible for review and approval is identified and he/she approves the document if its contents are necessary and sufficient.

  1. The documents are inspected on a periodical basis after making the rules (Review). When the document contents do not match the actual situation or become unnecessary, the document is revised or disposed of, as necessary (Revision). The documents of external origin are replaced with the latest version, as needed. When a document is revised, the original responsible organization and the responsible person inspect the revision and approve the revised document (Re-approval).

  2. The revised parts of a document must be recognizable to the users (Identification of document revision). The revised document must be given the revision number and the revision date and ensure the identification of the revised version (Identification of the revised version).

  3. The latest version of the relevant documents must be available to the users whenever needed and wherever needed (mis-use or unintended use of the old version must be prevented). The latest version must be used in principle (there must be some control so that unintended use of the old version is prevented). Intended use of the old version, as requested by the customer, for example, must be carefully controlled (Use of appropriate documents).

  4. The documents must be controlled to maintain their legibility. Therefore, they must be handled

carefully. They must be readily identifiable by giving their title and any identifying numbers (Legibility and identifiability).

  1. For the documents of external origin (contracts with suppliers, drawings, specifications, laws and standards to apply, etc.), the person responsible for their control must be identified, and their distribution and updating must be surely controlled (Use of documents of external origin).

  2. Obsolete documents (older versions, disposed documents) must be removed from the place of document use to prevent any unintended use. When they must be retained for some purpose, they must be placed at a different location from that of the latest ones, and they must be marked clearly as “old version”, “disposed” or “prohibited for use”, etc. as appropriate (Prevention of unintended use of disposed documents).

  1. Record Control

1509001:2000 and JEAC4111-2003 state that the records are taken and maintained to provide evidence of the conformity to the requirements and the effective operation of the QMS. Record control aims at providing and maintaining the evidence that the organization’s work system has functioned, and consequently its work is being implemented as planned. Especially records in the operation and maintenance stages are objective evidence on the operating conditions and the maintenance results of the facility, and are important for its operational management. In view of this, the record control rules must be documented and observed.

(1) Due consideration is required when defining the scope of record making that the QA uses to demonstrate evidence of reliability (good faith) and to ensure that too much is not documented. Hence, it is recommendable to prescribe in advance the scope of records in the relevant documents, such as the design specifications, purchase documents, examination and inspection instructions and operation manuals. The records must be correct, legible, readily identifiable (contents, place, date and time, etc.) and easily retrievable. The environmental conditions of

NSRA, Japan

10- 10

Chapter 10 Quality Assurance (QA)

Records (excerpt from Table 4.2.1-2 in JEAG4121-2005)

retention periods

Records of management review results

up to when the QMS is drastically revised (5years if the QMS is drastically revised in less than 5 years)

Records of and internal audits

Records of education, training, skills, and experience

while the person concerned stays in the organization/ 5 years if the person concerned stays in less than 5 years).

Records of design and development review results and of necessary actions to take if any

[nuclear facilities of the Importance classification Class 1 and 2] up to decommissioning (5 years if decommissioning will be done in less than 5 years),

[nuclear facilities of the Importance classification Class 3 and others] 5 years