Chapter 10 Quality Assurance (QA)

1. General

1. Need for qa Activities in Nuclear Power Plants (npPs)

NPPs produce radioactive materials concurrently when generating power and the prevention of accidents caused by these materials, i.e. “safety assurance,” is the top requirement for NPPs. Therefore, strict legal regulations are applied to NPPs. Meanwhile, the electric utilities are obliged legally to supply power stably for which they must establish the NPP reliability.

To achieve the goals of safety and reliability, well- planned systematic activities (plan, do, check and act for necessary improvements) are needed in every stage from design through operation of NPPs; these are known as QA activities. In order to achieve the expected NPP missions, QA must; plan clearly who in the organization does what duties and how; plan implementation of their duties accordingly; check that the duties are implemented as planned; and take actions for improvement as needed.

In Japan, the JEAC4111-2003 “QA standard on nuclear safety for NPPs” became effective in 2003. The utilities are obligated to implement their QA activities, pursuant to this code. Namely, the QA activities are now under government regulation, having changed from voluntary activities to obligatory ones.

2. Addressing qa

(1) Significance of QA

JEAC4111-2003 (pp.31-32) defines QA as follows: “all the activities for providing a product which a customer can use with confidence”. QA is used to address the objective or core activity of quality control activities. Meanwhile, the term QA in international business has a quite different meaning. There, the term QA, was popularized by the IS09000 series, and it is defined as "a part of

quality management which focuses on provision of reliability that the quality requirements are met’ and for which “evidence” is needed to provide the reliability. In other words, QA means that the organization will provide reliability by showing its ability to do so using evidence of it commitment

QA focuses in its international sense on “demonstration” as a means of providing a product in good faith. To assure quality means to prove with evidence that an appropriate quality management system (QMS) is in place and being operated. Consequently, the central activities of QA in the international sense are inspections, auditing, documents, and recording. This is different from the QA concept in Japan, which has been ambiguously understood as a voluntary and overall activity for customer satisfaction; i.e. it is a "natural voluntary activity.”

On the other hand, ISO9001 is not a QMS model, which suppliers present voluntarily to their customers, but a set of QMS requirements having QA at its core that customers (purchasers) request of the suppliers. When applying the ISO9001 to QMS, it is necessary to reconfirm that the QA activity provides the customer with evidence that the supplier is able to meet the needs of the customer.

JEAC4111-2003 deals with QA in which the party concerned must build up and implement a mechanism to meet the legal requirements

ISO9001 in its 2000 version added the requirements of “customer satisfaction” and “continuous improvement” to its earlier QA requirements. In order to realize these added requirements, a new QMS was introduced internationally, since a management system for leading and managing the organization is needed.

(2) Quality management systems in electric utilities and NPP suppliers *¹

For electric utilities, “product” as defined in

Chapter 10

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NSRA, Japan