NRC issues OIG-10-A-20, Audit of NRC's Vendor Inspection Program yesterday. If you are in quality assurance or possibly a business looking to enter the nuclear power industry, this report would provide good information on possible changes (recommendations) in the area of quality assurance on safety related parts. The NRC is looking for feedback.
Here is the Executive Summary:
BACKGROUND
The Nuclear Regulatory Commission (NRC) endeavors to protect the public health and safety and the environment by overseeing vendor compliance with NRC's regulations for assuring the integrity of domestic and global parts and services supplied to nuclear power reactors. Vendors manufacture a range of components such as fasteners, pumps, valves, and reactor vessels, as well as provide design, engineering, and construction services. While most vendors do not hold NRC licenses, they are nonetheless bound through contracts with licensees, applicants, or other vendors to comply with NRC's quality assurance regulations contained in Appendix B to Title 10, Code of Federal Regulations
(10 CFR), Part 50 (Appendix B). Vendors are also required to comply with 10 CFR Part 21 (Part 21). NRC conducts reactive and routine inspections of vendors' implementation of Appendix B and Part 21 requirements.
PURPOSE
The audit objective was to assess NRC's regulatory approach for ensuring the integrity of domestic and foreign safety-related parts and services supplied to current or prospective nuclear power reactors.
RESULTS IN BRIEF
Beginning in 2007, the agency proactively enhanced its overall approach to vendor inspections and increased vendor outreach efforts. After the creation of the Office of New Reactors (NRO), two new branches were established to perform additional vendor inspections, including routine inspections. The Office of the Inspector General (OIG) has identified areas that need management attention while NRO continues its ongoing vendor inspection activities. Specifically:
- Improvements to NRO's vendor inspection planning would enhance the process NRC uses to identify and select vendors for routine inspections.
- NRO's planning process for identifying and selecting vendors for routine inspections, and its strategy for guiding the process, is largely an informal one. Simply identifying the number of vendors is challenging, and NRO does not know how many vendors there are or how to identify changes in the vendor universe. Furthermore, NRO's planning for selecting vendors for inspection is based on an approach that relies primarily on professional judgment. Moreover, NRO's overall strategic approach to vendor identification and selection planning is informal as indicated by NRO staff, who have varying views of the purposes of the Vendor Inspection Program and routine vendor inspections.
- NRC has an opportunity to more effectively communicate its regulatory expectations and requirements to vendors.
- NRC relies on nuclear vendors' understanding and implementation of its regulations to assure that safety-related components will perform adequately in service, and that defects are reported. In order for vendors supplying nuclear components and services to be knowledgeable of their obligations under the regulations, NRC must effectively communicate the regulations. NRC has undertaken a number of efforts to communicate regulations to vendors, but some vendors are not aware of all obligations or NRC expectations. NRC's approach to communicating with vendors is not as effective as it could be because it does not have an outreach/ communications plan. When vendors are not knowledgeable of their obligations under NRC regulations, vendors might not report defects or otherwise fully assure that safety-related components will perform adequately in service.
- Commercial-grade dedication and Part 21 regulations and guidance could be clarified.
- Even when vendors are aware of the applicable NRC regulations and other regulatory information, NRC could clarify its expectations and requirements for Part 21 and for the process of obtaining parts from commercial suppliers known as commercial-grade dedication. NRC presumes that adherence to its regulatory requirements on the part of licensees and vendors assures safety. However, nuclear vendors are confused about how to adequately implement Part 21 and commercial-grade dedication due to unclear, insufficient, or conflicting guidance. Consequently, vendors might fail to implement various aspects of their programs in accordance with NRC's regulations, guidance, or expectations. Ultimately, this could lead to vendors (1) supplying parts and services to nuclear power plants that do not meet NRC regulatory requirements or quality assurance expectations, and (2) inadequately reporting defects.
- Calibration laboratory approval guidance could be clarified.
- NRC's guidance for approving accredited commercial-grade calibration laboratories-which calibrate measuring and test equipment used by vendors to evaluate the properties of materials and parts-could be clarified. In response to a request from one of its licensees, NRC allowed a process permitting the licensee to approve calibration laboratories based on the reviews performed by accrediting bodies in lieu of an Appendix B audit or a commercial-grade survey. However, since NRC's guidance documents describing this process are disparate, vendors are confused about, and have difficulty implementing, the process. Consequently, vendors' approval of laboratories may not be in accordance with NRC's expectations, vendors may find themselves unknowingly in violation of Appendix B or NRC commercial-grade dedication requirements, and vendors could find they have used out-of-calibration equipment during the manufacturing process.
- NRC's approach to counterfeit, fraudulent, and substandard items (CFSI) could be strengthened.
- NRC could strengthen its current approach to CFSI. Both the Federal Government and private sector have recognized the increasing prevalence of CFSI in nuclear and other industries. However, NRC's approach has been primarily reactive and based largely on the abilities of one or two individuals to monitor and evaluate the threat. This is because NRC lacks a formal strategy and plan to monitor and evaluate potential CFSI, and consider program changes to address the issue. Consequently, the lack of any formal strategy or framework could result in reactor construction problems with major implications for public health and safety.
RECOMMENDATIONS
This report makes 10 recommendations to help NRC improve its oversight of the nuclear vendors and the parts and services they supply to nuclear power plants. A consolidated list of the recommendations appears in Section IV of this report.
AGENCY COMMENTS
On August 17, 2010, OIG provided a draft report to the Executive Director for Operations. OIG held an exit conference with the agency on
August 31, 2010. During that meeting agency management provided informal comments to the draft report. Also, on September 10, 2010, OIG held an additional meeting with NRC staff to discuss the agency's informal comments to the draft report. On September 14, 2010, OIG provided the agency a revised draft report, and on September 17, 2010, the agency declined to provide any formal comments. The final report incorporates revisions made, where applicable, as a result of meetings with NRC staff.
You can read the full report here: http://www.nrc.gov/reading-rm/doc-collections/insp-gen/2010/oig-10-a-20.pdf