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Chapter 10 Quality Assurance (QA)

incorporated their QA plans in operational safety programs, which are reviewed by the government Compliance with the QA plan is checked during government-implemented nuclear safety inspections.

  1. Features of JEAC4111-2003

JEAC4111-2003 is prescribed based on IS09001:2000 and has the following features*3.

  1. Compatibility with the IAEA standards

Three items have been taken from the IAEA standards and added to the JEAC4111-2003 for compatibility: grading; independence of inspection and test personnel; and design verification by a person (or persons) other than the original designer (s).

  1. Definitions

JEAC4111-2003 specifies the definitions of terminologies specific to NPPs, which differ from the ISO definitions, as in the following: “nuclear safety” is a product; “the general public” is a customer (regulators are regarded to represent them); and “plant owner" (or "licensee” or “the representative of the licensee”) is the top management. JEAC4111-2003 is addressed basically to electric utilities.

  1. Other items of IS09001:2000 customized to

NPPQA

JEAC4111-2003 customizes IS09001:2000 so that it is straightforward and easily understandable by personnel working on the activities for safe operation and maintenance of NPPs. Such customizations include the following substitutions: “No exceptions are allowed in the quality manual,” for“Some exceptions are allowed in the quality manual”; “Nuclear facilities” for “infrastructures”; “Work planning” for “product realization planning”; “Work implementation” for “production and service provision”; “Properties external to the organization” for “customer properties"; “Preservation of procured commodities produced” for “preservation of product”; “Achievement of nuclear safety” for “customer satisfaction”; “Inspections and tests” for “monitoring and measurement of product”; and “Nonconformity management" for “control of

(*3) JEAG4121-2005, ’’2.2 Difference in applying the JEAC4111-2003 and the IS0900E2000

nonconforming product”.

JEAC4111-2003 and JEAG4121-2005 are being revised in 2008 in a periodical revising step and will be published in 2009 as revised, incorporating the following items.

  1. IS09001-2008 to be published in October 2008 will be reflected in the JEA revisions. There are no big changes, but “References” in the earlier versions are replaced by “Notices” and some new ones are added.

  2. Revised IAEA code (GS-R-3) and guides (GS-G-3.1 and GS-G-3.2) will be reflected. The IAEA documents have adopted many parts of ISO9001. Few changes are needed in the JEAC4111 requirements. But the JEAG4121 revision will incorporate the extended descriptions of safety culture made in the IAEA documents.

  3. JEAC4111 will be reviewed for necessary revisions for conformity to relevant ordinances and/or decrees of the Japanese government (Adoption of RCA and acquisition of technical information from suppliers).

  4. JEAG4121 will be revised to clarify those items being misunderstood due to customization of the ISO9001 to nuclear QA, to promote understanding, and to assure practical application.

  1. Quality Management System (qms)

NPPs are expected to supply power stably following the principle of safety first and to contribute to improvement of the environment, economy and society in general. To ensure safety and reliability of NPPs, qualities of all relevant tasks must be managed and maintained at appropriate levels.

At the beginning, the terms of “quality”, “customer” and “product”, which are elements of QMS, need to be clearly defined. The ISO defines quality as the “degree to which a set of inherent characteristics fulfills customer requirements”. Quality is not limited to products and services but applied to activities, schedules, organization, personnel and work management as well. When applied to the QA of NPPs, it is equivalent to asking whether or not the product (safe operation activities and tasks at nuclear facilities) with its quality

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NSRA, Japan

(nuclear safety) is accepted by, and merits the good faith of, the customer (society and the general public) as expected.

Meanwhile, IS09001:2000 defines QMS as a “system which establishes the quality policy and quality goals, and leads and manages the organization in order to achieve the goals”. The QMS at NPPs, then, is to establish a system by which the organization continually improves itself under the leadership of top management in order to implement appropriately the safe operation activities

of the NPPs, not only to comply with the legal requirements. Figure 10.2.1 shows a PDCA (Plan- Do-Check-Action) cycle for the QMS. Repeating this cycle leads to continual QMS improvement

For NPPs, there are four basic processes as shown in Figure 10.2.2: “operation and management activities”, “resource management”, “planning and implementation of work (product realization)” and “evaluation and improvement”.

Figure 10.2.1 PDCA cycle on quality management system

NSRA, Japan

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Chapter 10 Quality Assurance (QA)

Management activities

Management commitment

Nuclear safety focus

Quality policy and quality objectives

Quality management system planning

Responsibility, authority and communication

Management review

Evaluation and improvement

Preventive action

Corrective action

Resource management

Nuclear installations

Work environment

Continual

improvement

Human resources (Education)

Internal audits

Analysis of data

Procurement

Design and development

Work (product realization) planning and implementation

Planning

-Identification and review of >| requirements

-External communication

Work

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-Operation management

I

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-Fuel management

-Radioactive Waste (RW) management

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-Radiation management

-Maintenance management

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-Emergency measures