Anatech - Linking Theory and Practice.

ANATECH performs QA system audits, fabrication audits/technical surveillance visits, process qualification audits, and document/records audits at the supplier’s and sub-supplier’s plant(s) and office(s), acting either as our client’s representative or as part of an audit team. Our audits place strong emphasis on the characteristics that are most critical to fuel performance and safety. In fact, with our extensive fuel design and modeling experience, ANATECH is unique in the industry in providing our clients with an audit team that has the broadest experience currently available.  Our audit team has over 80 combined years of first-hand experience in fuel and core-component performance and design, and fabrication and inspection.  This extensive experience uniquely qualifies ANATECH to provide QA support to our clients.

While we audit suppliers to determine whether they follow their own specifications, processes and procedures, major emphasis is placed on whether fabrication and inspection procedures and activities are adequate to produce reliable fuel and core components. Emphasis is also placed on ensuring that the personnel performing the work are suitably trained and qualified to the latest revisions of operating procedures and instructions.   Examples of ANATECH’s audit/surveillance services are provided below.

It is important to note that our audit and surveillance activities are not limited to the fuel supplier, but are performed at the component and material sub-suppliers as well. ANATECH views oversight of the complete supply chain as vital to ensuring that robust fuel and core component performance is achieved.

Fabrication Audits/Technical Surveillances

ANATECH stresses performance-based auditing. This means that our audits emphasize witnessing actual fabrication and inspection activities. The activities audited are compared to operating documents, drawings and specifications and our extensive knowledge of the industry’s best practices. An overall assessment of the adequacy and capability of the processes and documentation can then be made. Documents such as procedures, drawings and specifications are reviewed to ensure that they are consistent with requirements.  Activities related to the fabrication and inspection of the components are reviewed in the supplier’s facility for conformance to contract and supplier requirements. Chemical, dimensional, gage control, and NDT laboratories and standards may be reviewed as well. Audit activities also address operator and inspector training.

Outside of the fabrication campaign, ANATECH is also able to perform technical reviews and evaluations of suppliers. This can include an assessment of the capability of a particular supplier, as well as the comparison of one supplier or a specific facility with another.

QA System Audits

ANATECH reviews the QA systems of fuel and component suppliers on a regular basis as part of supplier qualification activities or as part of an on-site QA System Audit. The documentation required by the regulatory requirements (e.g., 10 CFR 50, Appendix B, NQA-1, ISO 9001, etc.) and our client’s contract is reviewed as part of the audit. These requirements may address the quality-related elements contained in the regulations, from the supplier’s organization to their internal audit practices.

Documents such as the QA Manual and QA Procedures are generally included within the scope of the audit. If a fabrication audit is also performed, some or all of these documents may then be reviewed to ensure that they are utilized in the prescribed manner. The principle objectives of these audits are to ensure that management controls are sufficient to ensure that the product will meet the contract requirements; the supplier is meeting its QA obligations; and, the QA program is in conformance with company policies, contract commitments and regulatory requirements.

Suppliers’ QA systems and their implementation are evaluated, along with other vital intangible parameters. These parameters form part of the assessment of a supplier’s capability to design and manufacture high-quality, reliable fuel and core components. ANATECH also performs audits of supplier QA systems to support other purposes. These audits typically address not only the adequacy of a supplier’s documented QA program but also the effectiveness of its implementation.

Process Qualification Audits

Manufacturing and inspection processes are normally qualified by performing a relatively short, statistically designed production campaign, within and beyond the proposed process limits. The product is then inspected thoroughly to determine whether it meets the specified level of product quality. As the process matures, subsequent changes to the process may require requalification.

This practice, standard at all suppliers, must be audited to ensure that the effort accurately reflects the operational process conditions and is statistically appropriate.  This is achieved through an audit of the qualification process and Qualification Plans.  The qualification activities are then audited to assure that the product was properly manufactured, inspected and characterized. Finally, the results of the qualification program (in the form of Qualification Reports) are also reviewed to ensure the product meets the specification and drawing requirements.

Document/Records Audits

ANATECH provides support to our clients by reviewing specific documents such as reports, manuals, procedures or other records when a full audit or surveillance campaign is not appropriate. In addition, once the fabrication program is complete, our client may wish to have a review performed of the completed records packages, material certifications or test results for its fuel and/or core components (including starting materials). These activities can be conducted either at ANATECH’s offices or at the client’s or supplier’s facility.

As part of our oversight activities of fuel and component suppliers, ANATECH’s audit team has reviewed the state of readiness of suppliers prior to beginning manufacturing. The goal of such a review is to establish that the manufacturer has, in-place, the necessary operational and QA systems in order to assure that the components being produced meet the necessary quality and performance requirements as well as the customer’s expectations. In addition, as part of our supplier assessments, ANATECH’s audit team has reviewed the Quality Culture of suppliers and their staff. The goal of this review is to assure that the overall Quality message is appropriately disseminated and understood at all levels of the staff. This is necessary to ensure that everybody understands that importance of Quality.

Critical evaluation of a supplier’s QA program is an important facet of any fuel procurement, especially one that may result in a transition between suppliers. ANATECH assists our clients in meeting this objective by providing drafts of QA sections of bid specifications and QA articles for draft contracts. We also review the documents prepared by our client. Assistance is provided in the evaluation of the QA aspects of the proposals and in the negotiations of the QA articles of the final contract. Emphasis is placed on the effectiveness of the supplier’s QA program, the completeness of the supplier’s QA obligations and on ensuring our client’s rights in implementing all aspects of their QA program in the supplier’s facilities.  As noted above, ANATECH also has the capability to evaluate the manufacturing and inspection practices of potential suppliers.

An effective audit must be based on intimate knowledge of nuclear fuel technologies combined with detailed knowledge of fuel and core component performance. Consideration of the economics of time and manpower dictates that the emphasis of audits be placed on those aspects of design and production that most affect fuel performance. ANATECH provides unparalleled training and guidance to our client’s personnel to assist in the identification of critical areas necessary for comprehensive audits. These training programs cover a wide range of activities, from component design to fabrication and inspection technology. ANATECH also provides training in the specifics of auditing these activities.

Root Cause Investigation Support

As significant events and problem occur at the fuel suppliers, and their sub-suppliers, a Root Cause Investigation is frequently performed. The goal of the investigation is to perform a detailed review of the problem, and to propose adequate Corrective and Preventive Actions that both addresses the immediate issue as well as implementing the changes necessary to prevent recurrence. Ultimately a Root Cause Investigation Report is issued to document the results and conclusions of the investigation. ANATECH provides support to our clients in performing a thorough independent review of the report and the associated documents, as well as the proposed actions. Our goal is to assure that the vendor has correctly identified the root cause of the event and that the proposed actions fully address the technical and human performance issues that were the initial cause of the event. ANATECH can also review the implementation of the Corrective and Preventive actions to assure they are effective in addressing the problem and preventing recurrence.

Supply Chain Review

As sub-suppliers can have a direct impact on the in-reactor performance of the fuel, it is critical that the utility have a thorough understanding of the entire supply chain (i.e., key materials, processes, products). It is critical to note that many of the final in-reactor properties of the finished components are fixed at the sub-suppliers, long before they are delivered to the fuel and component vendors. As such, ANATECH has the capability to perform all of the previously described audit and surveillance activities at the component, materials and service suppliers that form the supply chain for the fuel and component vendors.

ANATECH’s Audit Team has provided QA services to customers throughout the world. In the course of our work, we have had the opportunity to review the specifications, standards, and manufacturing and inspection practices of all the US fuel suppliers, most of the non-US fuel suppliers and several component suppliers. The following are just some of the facilities we have visited: