Quality systems are designed to provide traceability, control of product, and control of processes, regardless of the regulatory agency or standard responsible for enforcement. These are critical features of any quality system, and nowhere are they more vital than in the nuclear sector. This blog specifically discusses equipment maintenance and supplier quality in nuclear facilities.
Safety and Quality in the Nuclear Industry
Nuclear facilities are the most tightly regulated industry today, have the most complex processes to implement, and the most costly compliance and quality management requirements. From auditable procedural controls and reporting requirements to procedures for producing and managing nuclear materials and facilities, managers in this industry face daily challenges in reaching the goals and objectives mandated for safety and quality.
Supplier Quality Management for the Nuclear Industry
Today, effective Quality Management systems like Solumina from iBASEt can provide the essential functionality to achieve these conditions. As purchased goods come into a facility, Quality Management systems not only provide flexibility in setting criteria for inspection, but also create the inspection orders and definitions that establish the criteria and tests. Such systems can be used to set up sampling with severity switching, so that as supplier quality improves over time and they become a “trusted supplier” on a particular process or part, the level of inspection is adjusted accordingly.
In a similar vein, these systems can provide a process for proof-in verification, that is more all-encompassing than First Article Inspection (FAI). In FAI, the first item received from a supplier or produced on a production line is inspected. With Production Process Validation (PPV), a single item or multiple parts, full product validation, or delta can be specified. PPV can be specified for suppliers as well as manufactured product being built in-house.
Those in the nuclear industry may want to do a 100-percent verification of everything that comes in for top-quality-level parts (those that will be used in the reactor), or parts that are designated as Mark quality for the NNSA. Parts that will be used but won’t be kept to that high standard can be specified to come from a broader range of vendors and have fewer testing requirements (e.g., for areas outside the containment facility at a nuclear power plant, or development areas at a manufacturing plant).
Tracing the Supply Chain in the Nuclear Industry
In the nuclear industry, not every part is critical to safety and regulatory compliance, but those that are critical need to be traceable back to the supplier. Manufacturers need to be able to answer critical questions like:
“How was the part built?”
“Were the tools calibrated properly?”
“Were the personnel certified to perform the work?”
“Was there proper inspection and oversight when components were received and put on the shelf?”
Answering these questions allows the inventory system to verify that parts meet a specified quality level based on their intended use.
Ensuring Regulatory Compliance with Traceability
Tracing the part back to the supplier entails knowing all the sub-vendors involved, and that it has been inspected to meet all necessary criteria. Complex discrete manufacturers in the nuclear industry must ensure hardness testing or tensile strength for a material, and chemical analysis for steel or concrete composition, for example. With this information, the nuclear manufacturing organization can prove to the Nuclear Regulatory Commission (NRC) or National Nuclear Security Administration (NNSA) that the part actually meets the requirement. Traceability is key, for once inside and used in manufacturing or for maintenance activity, the last thing you need to worry about is, “Do these parts meet requirements?”
Tracking, Correcting and Preventing Failures with Solumina by iBASEt
In the instance of any failures, the ability to track them through non-conformance and into a preventive or corrective action that takes account of the bigger picture is imperative. With Solumina software by iBASEt, follow up with random or scheduled audits for review can be completed seamlessly. This includes assessing suppliers or internal processes, looking for counterfeits, ensuring that process changes are working, and parts are meeting the rigorous quality standards needed to operate safely.
In the end, all this work is part of the quality picture in the nuclear sector. Each piece has to be in place, and Solumina assures that they are.
A Solumina Applications Specialist.
Experienced in simplifying the complexity, regulatory compliance, traceability, and integration of medical device, aircraft, space, defense, nuclear, and heavy industrial manufacturing around the world.