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.
So what?
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?
In a recent conversation discussing pricing, a NQA-1 supplier quipped, “the pipe is the same pipe and the welder is the same welder but the stack of paper is vastly different!”
And the cost is considerably higher. Somehow we have to get a grip on what really matters here.
The real problem is that the cost of the paper is someone else’s paycheck, and they’ll go to great lengths to protect it.
Yes,
That is my observation. It’s a great deal like to complexity surrounding the IRS. Someone makes a great deal of money around complex and difficult to interpret (and comply with) regulations.
The fact that the NRC doesn’t recognize 3rd party certifications means more money for independent auditors. Other requirements mean that it is difficult to qualify as an auditor unless you work for a large company. Keeps the pool small and high priced.
Hi Margaret:
A very well written piece. I worked in a Quality Assurance department at a nuclear power plant from construction through full power operation for 20+ years in California. Spent my last 5 year of my career working in a training department implementing the CFR’s & INPO standards for the training and qualification of plant engineers, QA/QC and licensed operators. Also became the spokesperson for the implementation of management objectives relating to quality initiatives which was way fun.
My only comment would be that ‘quality’ still begins with the worker – not at some regulatory agency in Washington. A quick example. Back in the 1980’s our quality assurance group found that only about 10% of plant employees could even identify what the difference was between quality assurance and quality control. After a significant effort to train the workforce was accomplished the number jumped to over 70%. Two things became quite evident.
1. Employee knowledge and workforce practices improved and;
2. The number of formalized corrective actions needed significantly decreased.
There is of course a roll for nuclear standards however, I doubt seriously there is much difference in the END RESULTS between 10CFR50, NQA, ASME, INPO, ISO or any other quality standard implemented. There literary are only a couple of ways to manufacture wire, service/repair a valve or weld S.S. pipe.
As a well seasoned utility employee I was given the opportunity to travel around the U.S. bench-marking other nuclear plants before I retired. What is significantly more IMPORTANT than the applicable quality standard in place at each facility is the attitude of the management team in place. Based on my 20+ years as a Certified Quality Engineer, achieving quality objectives really does start at the top of the management structure.
Great article.
Thomas D. Garven
Lake Havasu City, AZ
Tom,
Thank you for such a thoughtful comment.
I agree 100% quality starts at the top. It is recognizing this basic premise as well as the fact that much has changed since the mid-70’s in terms of viable and effective quality programs that should allow the NRC to make its regulations more effective and less costly. I would gladly work with the NRC to make that happen!