I’ve spent most of my career working with Nuclear Regulation. One of the most complex series of regulations you can imagine. The U.S. Internal Revenue Service probably sent people over to help the AEC/NRC develop these regulations. They cover a wide variety of issues all under the name of safety and security.
One of the smallest parts of the regulation is actually quality assurance. The majority of this regulation sits as an appendix to one of the largest chapters, Appendix B to 10CFR50. This little collection of requirements is a mere 3 pages long. It draws in 10CFR21 as a part of the regulation which is an additional 9 pages. These regulations were written in the 1970’s with few modifications to clarify and/or expand the application of these regulations.
A little History
Appendix B was written primarily to target plants under construction, whereas the NRC was concerned with control of the engineering, procurement, and construction of nuclear power plants. The original authors split into several teams and fairly quickly generated the text that now forms most of Appendix B. In total, the requirements of 10CFR50 Appendix B apply to designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying. They never imagined that it would become so permanent.
10CFR21 requires immediate notification to the NRC of any facility, activity, or basic component that either contains defects or fails to comply with requirements and creates a substantial safety hazard to the facility. In addition, it provides a means for accepting commercially manufactured items for nuclear safety-related applications. This process is referred to as commercial grade item (CGI) dedication.
Like other regulations, standards were developed by independent organizations. ANS developed the first set, sometimes referred to as ANSI N45.2 and daughter standards. However, ASME stepped in after a few years and created a standard that eventually became known as NQA-1. The NQA-1 Committee, which consists of a collection of QA experts and managers from all facets of the industry, meets periodically to update the standard to current technology and known issues. Some of these areas include Software Controls, CGI Dedication, and Maintenance.
The problem is that the regulations were written when few quality standards existed in industry. The NRC’s Appendix B program was a pioneer in demanding quality control, record-keeping, and training of the people performing the work. However, the criteria as written is poorly organized with overlaps and gaps in the requirements. It fails to deal with modern technology in terms of software control, electronic record keeping and document control. These have been left to the cottage industry the has arisen around NQA-1.
ASME issues a new version of NQA-1 every 4 years or so. They are planning to issue a new version in the next few months. The problem is that the NRC just approved the last standard in 2010 and virtually no one has been able to update their programs to reflect that standard. The new standard may well address critical issues, but the ability of the NRC to review and approve and the industry to adopt to the newer standards is not adequate to this continuous modification.
In addition, many of the small suppliers are finding these regulations to be burdensome without actually improving the quality of their products. Many suppliers today comply with ISO-9001 which is an international quality standard. However, the NRC (and ASME) do not recognize that this program provides adequate quality for parts generated under the program. This has created an additional burden to the industry that increases costs without increase quality. For safety-related components, the industry either had to demand that a supplier develop an NQA-1 based program in addition to their ISO programs, or they have to go through a separate dedication process that required testing and more paperwork to validate the part.
It seems to me that it is time, past time in fact, for the NRC to step back and look at the quality requirements in context of international standards (that are used by other nuclear regulators to a high degree of effectiveness) and modify the regulations to reflect these standards. Look at what experts in relevant technologies have done and point to those standards appropriately, stop trying to create independent regulations that are simply increasing costs without improving quality or safety.
Tell me what YOU think is needed?