Is unqualified software in a nuclear Power Plant (NPP) or Small Modular Reactor (SMR) a concern for your organization? You are not alone. At Alithya, we regularly hear from NPP / SMR owners and operators; nuclear engineering, procurement and construction vendors; design service providers; system integrators; and original equipment manufacturers. They often express concerns about unqualified digital hardware and software components requiring software validation or software verification. Many also request guidance on independent verification and validation (IV&V services).
The role of software in nuclear and SMR operations
In a modern NPP / SMR, software is integral to every aspect of operation. Digital hardware and software components are used from the plant floor to the control room: in nuclear safety systems, mitigating systems, reactor control and regulating systems, process control systems, and monitoring and surveillance systems.
Today, digital Instrumentation and Control (I&C) components play a key role in operating and maintaining NPPs, thus helping improve operational effectiveness and equipment reliability. Digital I&C components play an even greater role in SMRs. SMRs are designed and built using digital technologies to operate and maintain the plant safely, reliably, cost effectively and in compliance with nuclear regulatory requirements.
Risks of unqualified software
Use of digital hardware and software components for safety-critical and safety-related I&C systems in NPPs / SMRs also has its unique challenges. Software increases complexity of systems and introduces multiple new failure modes. A single software failure in a safety-critical or safety-related system can impact the plant's operations or pose risks to personnel or the environment. Unqualified software in NPPs / SMRs also increases the risk of violating licensing conditions, which may result in the nuclear regulator shutting down the plant.
We must assess all the digital hardware and software components contained in a safety-critical or safety-related system to determine whether they are suitable for use in nuclear applications. This is where software qualification becomes essential to mitigate risks and ensure compliance.
What is software qualification of nuclear safety systems?
Software qualification is the process of assessing the safety, reliability, reviewability and maintainability of the software components to demonstrate that they are suitable for their intended applications in NPPs.
Software qualification evaluates programmable digital devices used in safety-critical and safety-related real-time process control applications. These programmable digital devices may contain software, firmware, or programmable logic (e.g., devices such as application-specific integrated circuit, complex programmable logic device, and field-programmable gate array).
Different types / classes of software components must be qualified:
- Commercial-Off-The-Shelf (COTS) software: Software that is pre-developed and available for use prior to the design process.
- Custom-developed software: Software that is designed and developed for the specific application to meet the project-specific requirements.
- Modifiable-Off-The-Shelf (MOTS) software: Configurable software (e.g., ladder-logic developed programmable logic controllers) that is designed and developed for the specific application to meet the project-specific requirements.
- Software engineering tools: COTS software components that are used for offline configuration, calibration, maintenance, diagnostics, and development of the target application.
Compliance, safety, and cost impacts of poor software
Some of the key risks of neglecting or not performing software qualification in nuclear safety systems are:
- Safety system failures: Use of unqualified or poor-quality power plant software in safety systems can lead to impairment of special safety systems in the plant.
- Regulatory compliance violations: The nuclear industry is one of the most heavily regulated sectors globally. Nuclear facilities must have a valid operating license to run, a requirement that is enforced by independent regulators. Software qualification is a licensing condition for NPPs / SMRs. Failure to meet stringent regulatory requirements (e.g., CSA, NRC, IEEE, NQA-1) can lead to legal penalties, project delays, or worse, the shutdown of the nuclear facility.
- Human error amplification: Software is often relied upon to augment human decision-making. If the reactor software is flawed, it can amplify human mistakes, making them much more dangerous in a critical environment.
- Increased costs: Identifying software quality issues during or after implementation is far more expensive than addressing them early in the development phase. The cost of a failure can include regulatory fines, legal settlements, and costly downtime, not to mention the potential loss of life.
How to perform software qualification
1. Define requirements and scope
- Determine the general requirements for software qualification.
- Define the candidate product scope.
- Identify the software components in scope.
- Describe the applicable functions (including safety functions).
- Describe the applicable system interfaces.
- Identify restrictions or conditions related to use in NPP / SMR applications.
- Determine quality requirements (safety, reliability, reviewability, maintainability).
2. Categorize functions and software
- Categorize the software’s function.
- Determine the software category to enable a graded approach to software qualification
- Examples of categories:
- CSA N290.14:15 → Category I (Safety-Critical), II (Safety-Related), III (Important to Safety), IV (Non-Safety-Related).
- IEC 61508 → SIL 1, SIL 2, SIL 3, SIL 4.
3. Assign qualified personnel
The team must demonstrate expertise in:
- Computer engineering and software quality assurance (SQA) for digital I&C applications in NPPs.
- Nuclear SQA standards, processes, and practices.
4. Perform qualification activities
- Identify and classify digital items (COTS, custom-developed software, MOTS, and engineering tools).
- Perform digital item qualification activities (based on category and complexity).
- Methods for COTS software may include:
- Certification to recognized SQA programs (IEC 61508, CE-1002-STD).
- Proven-in-use arguments.
- Proof through testing.
- Custom and MOTS software must comply with recognized SQA programs.
5. Assess qualification concerns
Review potential issues that could impede safety-related functions.
6. Perform failure analysis
Use industry-standard techniques:
- FMEA (Failure Modes and Effects Analysis)
- HAZOP (Hazard and Operability Analysis)
- STPA (System Theoretic Process Analysis)
7. Produce a software qualification report
The report must:
- Describe the target application
- Identify all digital items, classifications, and categories
- Outline qualification methodology
- Summarize activities, concerns assessment, and failure analysis
- Describe qualification results, operating limits, conditions, and recommendations
8. Maintain software qualification
- Document and assess all changes to digital hardware and software.
- Re-qualify items when changes impact existing qualifications.
Why Alithya is a trusted leader in nuclear software qualification
Software qualification is a challenging and highly specialized process. It is tailored to specific applications and must align with the unique requirements of the nuclear reactor technology and nuclear regulatory standards. Achieving success in software qualification demands a deep expertise and experience across multiple engineering disciplines and a thorough understanding of the nuclear domain.
But you don’t need to lose sleep over software qualification. By leveraging Alithya’s expertise in nuclear regulatory compliance and our extensive nuclear domain experience, we not only successfully perform software qualification services for our clients, but we also provide insights, objective advice, and actionable recommendations to ensure that proposed systems meet their safety and reliability requirements.
Since 1980, Alithya has been providing the nuclear industry with services ranging from electrical, computer, software, and I&C engineering to design engineering, cybersecurity, and digital hardware and software qualification.
Successful performance of software qualification requires the right people, right process, and right technology. We are uniquely positioned to help you navigate the complex landscape of software qualification in nuclear safety environments.
Right people, process, and technology for software qualification success
Right people
- Experience in software qualification: We have a proven record of performing software qualification of 600 COTS digital hardware and software components that are used in safety-critical and safety-related applications anywhere in the plant – from the plant floor to the control room.
- Expertise in nuclear software and cybersecurity standards: For 40+ years, we have helped nuclear operators and suppliers comply with regulatory requirements for computer systems, software, and cybersecurity. We have expertise in multiple nuclear computer system and software standards (e.g., CSA N290.14:15, CE-1001-STD, CE-1002-STD, IEC 61508, IEEE 1012) and cyber security standards (e.g., CSA N290.7:21). Alithya consultants have been the leading authority in software qualification in the Canadian nuclear industry. Our consultants have even co-authored software qualification standards and have been in Technical Sub-Committees of multiple software qualification standards groups.
- Experience in nuclear safety-critical and safety-related systems: Alithya understands the unique challenges and regulatory requirements that shape nuclear safety systems. Our experience spans from the design and development of safety-critical shutdown systems (software category I) and safety-related reactor control systems (software category II) to safety-related monitoring, HMI/SCADA, and balance of plant systems (software category III) for nuclear customers.
- End-to-end engineering services: We have extensive experience acting as both an engineering services vendor and an equipment integrator. This provides our clients with a one-stop option for engineering design projects that require technology/equipment integration and delivery, resulting in cost savings and risk reduction for our clients.
Right process
- Proven methodology: Alithya’s proven, structured, software qualification process is designed to mitigate risks early and ensure full compliance with regulatory standards. Our team is well-versed in industry-leading frameworks for software qualification.
- Independent, objective evaluation: While fully engaged in the qualification and validation process, our team remains independent from your design and development activities. This separation ensures objective, unbiased evaluation—providing you with confidence in your software’s integrity and a clear path to operational safety.
Right technology
Our Engineering Technology Laboratory in the Greater Toronto Area, Ontario, Canada, is qualified to perform for design, development, verification, validation, and qualification of nuclear safety-critical and safety-related digital I&C systems. We will leverage our proven-in-use tools to successfully perform software qualification for your products and systems.
When it comes to reducing risks in nuclear safety systems, there’s no room for error. Alithya is committed to ensuring your computer system and software is not only functional but also safe, reliable, and compliant with the highest industry standards.
Contact us today to learn how Alithya’s software qualification services can ensure that your computer system and software are ready for use in nuclear safety applications.