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If a supplier cannot provide sufficient material traceability or will not disclose enough information to confirm chemical composition, the dedication process may be difficult to justify. The same is true if the material’ s performance depends on characteristics that are not easily verified without destructive testing or highly specialised equipment. Functional complexity must also be evaluated. A replacement item may require testing under load, at temperature, under pressure, or in dynamic service conditions. The organisation should confirm that appropriate test equipment is available or that qualified third-party testing can be used. Supplier quality controls are equally important. A commercial supplier may not operate under a nuclear quality programme, but it may maintain a robust quality system for another regulated industry. For example, if the commercial grade supplier complies with:
• AS9100D( Aerospace)
• ISO 13485( Medical Devices),
• IATF 16949( Automotive), or
• MIL-STD-11991B( Military Equipment),
All of which are based on ISO 9001 requirements, then additional confidence may be assumed in using that supplier for
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an item to be dedicated. These programmes can provide useful evidence of a supplier’ s process discipline, traceability practices, inspection controls, and corrective-action processes. A site survey may offer additional confidence. The survey should focus on material traceability, record retention, process management, and corrective-action programs.
Option 2: Identify and qualify an equivalent item
The second option is to source an equivalent, though non-identical, item from a supplier qualified to 10CFR50 Appendix B. This approach may reduce the need to dedicate a commercial item, but it requires a detailed equivalency evaluation. The replacement must be evaluated for material, dimensional, quality, and performance equivalency. Material equivalency requires more than confirming that a material appears similar. The alternate material must provide the mechanical and / or chemical properties required by the application and must remain compatible with existing environmental qualifications. This may be particularly important when a historical qualification report identifies a specific material or trade name. A replacement made from a broadly similar material class may
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require reconciliation or requalification if its formulation, physical properties, or environmental behaviour differs from the original. Dimensional equivalency should also be considered and extends beyond the evaluation of basic installation fit. Geometrical differences, no matter how minute, should be evaluated for impacts to a parts loading, mass distribution, or dynamic response of the parent equipment. Are existing seismic qualifications impacted? Even if unimpacted, a demonstration of seismic evaluation should be documented. Quality equivalency concerns the way the item is manufactured, inspected, documented, and controlled. A physically similar item produced under a different quality program or by an alternate business may not support the same quality required of the original. When evaluating the quality of an item from an alternate supplier, a few key items that an organisation should consider are:
• Material traceability
• Documentation availability
• Process controls and correction action programmes; and
• Operating experience and performance record- Is the new supplier affiliated with any past 10 CFR Part 21 reported events?
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