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Guidance for New Vendors By John Nakoski, U.S. Nuclear Regulatory Commission. 1. What factors do the vendors new to the nuclear power industry need to take into consideration to determine if they should qualify their quality assurance program for supplying products and services to the nuclear power industry Also please describe briefl y any guidance for such vendors totally unfamiliar with the nuclear power industry. I think from the NRC perspective, we see this as a business decision. A vendor new to the industry needs to understand the requirements for quality assurance in this industry. The NRC’s quality assurance requirements are outlined in Appendix B to 10 CFR Part 50. Our quality assurance requirements are typically more stringent than other industries. There is an added cost to meeting these requirements, and a new vendor needs to consider how best to factor that cost into its business decision. In addition to the quality assurance requirements, the NRC has regulations in place that require reporting of defects and non-compliance. These requirements are provided in 10 CFR Part 21. In terms of becoming qualified, a new vendor would need to have as a customer, an NRC licensee or an applicant with an approved quality assurance program. The NRC licensee or applicant could then conduct an audit of the new vendor’s quality assurance program to assess whether it complies with NRC requirements. If the results of the audit indicate the new vendor is in compliance, then the vendor can be added to the licensee’s or applicant’s approved suppliers list. Alternatively, if the new vendor is supplying parts or services to a vendor that is already on an NRC licensee’s or applicant’s approved suppliers list, the existing vendor can audit the new vendor and qualify the Responses to questions by Newal Agnihotri, Editor of Nuclear Plant Journal. John Nakoski John A. Nakoski, Chief, Quality and Vendor Branch 2, Division of new vendor’s quality assurance program. Basically, an NRC licensee or an industry approved vendor would need to conduct an audit of the new vendors quality assurance program to assess whether it complies with NRC requirements. So, most of the burden for qualifying new vendors falls to the licensees, applicants or potential applicants. The Nuclear Utilities Procurement Issues Committee (NUPIC) has taken on the NRC licensees’ and applicants’ role of conducting these audits of the suppliers to the commercial nuclear industry in the US. Of course at the NRC, we have our regulatory oversight role. We inspect those organizations that provide basic services or basic components to the commercial nuclear industry. NUPIC is an organization that is comprised of essentially all the commercial US nuclear utilities and several international utilities. It’s an organization that shares resources to conduct audits required by Appendix B to 10 CFR Part 50 to provide reasonable assurance that vendors have an effective quality assurance program and that they comply with 10CFR Part 21. We’ve interacted with NUPIC for many years. We have been observing its processes and the implementations of its audits at selected vendors throughout the years. We have also been observing Construction Inspection and Operational Programs, Offi ce of New Reactors, U.S. Nuclear Regulatory Commission Together with Juan Peralta, Mr. Nakoski is responsible for developing and implementing the NRC’s programs for the oversight of vendors support related to new reactor construction and quality assurance programs for the design, licensing, and construction of new reactors. Mr. Nakoski has 25 years of experience in the nuclear energy arena, primarily with the NRC. He is a 1983 graduate from Penn State with a B.S. in Nuclear Engineering. its periodic meetings where it discusses vendor and supply chain issues. 2. Briefl y describe how USNRC implements its vendor inspection program. The NRC’s vendor inspection program for new reactors is implemented following guidance documented in our inspection manual chapter (IMC) 2507. For the current operating reactors, IMC 2700 describes the vendor inspection program. These IMCs lay out the basic requirements that we follow to oversee any organization that provides safetyrelated parts or services to the nuclear power industry. Under the IMCs, we have inspection procedures that provide directions to the inspectors that they follow in planning for and conducting inspections. The inspection procedures provide guidance on reviewing vendor quality assurance, commercial grade dedication, and 10 CFR Part 21 programs. In addition, our vendor inspection program includes oversight of organizations that conduct audits of vendors - organizations such as NUPIC. For new reactors, our current plan is to conduct about 10 vendor inspections and several NUPIC audit observations each year. We may perform more if necessary and have the resources available. While 52 http://subscribe.npjonline.com http://www.NPJOnline.com Nuclear Plant Journal, September-October 2008
our vendor inspections provide us with direct insights into the performance of vendors, our observation of NUPIC audits of vendors gives us a sense of the quality of the industry’s oversight of vendors, and provides us the ability to provide feedback on how the oversight process can be enhanced. All of our vendor oversight activities, our inspections and NUPIC audit observations, are documented in publicly available inspection reports. These reports are available from the NRC website in our electronic reading room under ADAMS. We also make them available through our Quality Assurance website (http://www.nrc.gov/reactors/ new-licensing/quality-assurance/vendorinsp.html). 3. What is the best website link that a new vendor can click on to fi nd simple guidance for the quality assurance process required for qualifying to supply nuclear products and services to the nuclear power industry The NRC maintains information on its website that new vendors would find useful regarding the programs and requirements we follow when inspecting vendors. The website is located at: http://www.nrc.gov/reactors/new-licensing/quality-assurance.html. To get this website from the NRC’s main public (www.NRC.gov), click on the “Nuclear Reactor” tab, then drop down to “New Reactor Licensing, there is a link below “Under How We Regulate” called “Quality Assurance for Nuclear Power Plants” and there is a link to “Regulations and Standard Review Plan”, “Vendor Inspections”, Inspections for New Reactor Licensing” and “Nuclear Procurement Issues Committee and Industry Interface.” Also, presentations we’ve made during various conferences over the past several years can be found under the “Nuclear Procurement Issues Committee (NUPIC) and Industry Interface ” link. We have a variety of information on the website and encourage new and existing vendors, or anyone interested in this area, to explore the site. 4. Where is the new reactor licensing procedure defi ned Is this 10 CFR Part 52 What are the provisions for quality assurance in this code of federal regulation 10 CFR Part 52 provides the regulatory framework for new reactor licensing. It points back to 10 CFR Part 50, for the technical and quality assurance requirements. It does point back to and specify that applicants are required to do safety-related activities under quality assurance programs that meet 10 CFR Part 50, Appendix B requirements. Additional guidance for preparing new reactor applications is provided in Regulatory Guide 1.206, “Combined License Applications for Nuclear Power Plants.” When preparing license applications under 10 CFR Part 52, the information applicants use is required to be gathered under an Appendix B quality assurance process. The application itself is developed to satisfy the completeness and accuracy requirements of 10 CFR 50.9 and applications need to be submitted under oath and affirmation. 5. How do you gather the list of vendors who are supplying products and services to the nuclear power plants to ensure that these vendors are qualifi ed for the supplies For new reactor construction, we have requested information from the industry through a regulatory issues summary, 2007-08, “Updated Licensing Submittal Information to Support the Design-Centered Licensing Review Approach.” So far we have received some responses from applicants and the major vendors supplying the designs. In addition, through our interface with NUPIC, we have a list of vendors that have been qualified by the current fleet of operating reactors and are supplying basic components to the currently operating fleet of power reactors. Using this information to give us confidence in the quality of products provided to nuclear power plants, the NRC conducts inspections of a sample of the vendors that have been approved by licensees and oversees the audits conducted by NUPIC of these vendors. 6. If a vendor in China wants to be certifi ed, will NRC go to China It is important to recognize that the NRC is not in the process of certifying or approving vendors to supply products and services to the nuclear power industry. We inspect vendors for compliance with our regulations. Also, in today’s manufacturing arena, many of the vendors of major components are located overseas. So, if a vendor in China was selected by a licensee or applicant and put on an approved suppliers list for the construction of a new reactor, our plan is to include that vendor in the population of vendors that we may inspect. If we had concerns with the quality of the vendor regardless of where they are, domestically or internationally, that would factor into our decision on whether we should inspect a particular vendor. If we received indications from our interactions with the applicants, through NUPIC, from peer regulators in other countries, or as a result of observations of construction inspection activities by the regional staff that problems with quality existed, we would factor that into our decision. So the short answer to the question would be yes, if we determined that it was necessary or consistent with our program guidelines. I would add that over the last 18 months, we have been building an extensive interface program with our peer regulators across the globe. As one example, we recently conducted coordinated inspections with our fellow regulators in Japan and Korea at specific vendors in those countries. 7. What organizations other than USNRC are involved in establishing guidelines for quality for new reactor construction activities Other organizations involved in establishing guidance on quality assurance requirements include: 1. Nuclear Utilities Procurement Issues Committee (NUPIC) 2. Nuclear Energy Institute (NEI) 3. American Society of Mechanical Engineers (ASME) 4. Nuclear Industry Assessment Committee (NIAC) 5. American Society of Quality (ASQ) 6. Electric Power Research Institute (EPRI) Contact: John, A. Nakoski, U.S. Nuclear Regulatory Commission, MS T-7F3, Washington DC 20555; telephone: (301) 415-1068, email: John.Nakoski@nrc.gov. Nuclear Plant Journal, September-October 2008 http://www.NPJOnline.com http://requestinfo.npjonline.com 53
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