The Modernization of Quality Assurance Requirements
Authors: Adkins John G. 
Published: February 2010

In 2009 the United States Nuclear Regulatory Commission (NRC) will issue Regulatory Guide 1.28 [1] endorsing the Nuclear Quality Assurance (NQA) Standard, NQA-1-2008 Edition with NQA-1a-2009 Addenda [2] as the appropriate quality assurance (QA) requirements for the design, construction and operation of new and existing U.S. nuclear generating facilities. This endorsement will change the U.S. regulatory QA position from NQA-1-1994 and incorporate 15 years of quality experience, lessons learned, technology enhancements and regulatory changes. This regulatory position change will subsequently be included in a revision to the NRC’s NUREG-0800, Standard Review Plan (SRP) 17.5, Quality Assurance Program Description – Design Certification, Early Site Permit and New License Applicants [3]. The Nuclear Energy Institute’s NEI 06-14A, Quality Assurance Program Description (QAPD) [4], which provides a generic QA template for use by new generation early site permit and combined license applicants for implementing QA regulatory requirements of SRP 17.5 will subsequently be revised to document the new regulatory position for the use of NQA-1a-2009. These new quality requirements will be passed on by the utilities constructing new generating facilities to the both U.S. and international suppliers, thus changing the basis of QA requirements for the nuclear industry. The NQA-1 Standard is a four-part criteria standard that provides quality requirements and acceptance criteria for the implementation of a nuclear facility quality assurance program. Part I describes the basic QA program elements and Part II provides requirements for specialized support and application activities for design, construction and operations. Part III contains guidance that support Parts I and II, and Part IV provides guidance for comparison of NQA-1 with other quality standards. This paper will focus on the background of the quality changes included in the endorsement on NQA-1-2008 with the NQA-1a-2009 Addenda and provide a detailed discussion of the following major changes: • Facility configuration control – measures to ensure changes that may affect the approved facility configuration are recognized and processed. • Engineering interface controls – controls to ensure interfaces for design changes are established among design organizations. • Software design controls – alternate design measures specifically for software design to ensure design input, design processes, verification and change control are appropriately performed. • Software application requirements – controls for the software engineering requirements for the acquisition, development, operation, maintenance, and retirement of software. • Electronic records – controls that address use of electronic media for QA record activities. • Commercial grade items – a composite document of criteria for the identification and dedication of commercial grade items and services. • Clarifications for consistency of basic QA requirements – areas in the Standard where the QA text needed to be return to basic principles and to add clarification to ensure national and international consistent application.