Introducing FACILEX® ATOMIC nuclear quality assurance software for small modular reactors, fusion and advanced fission.
Introducing FACILEX® ATOMIC nuclear quality assurance software for small modular reactors, fusion and advanced fission.
FACILEX® ATOMIC connects 21 configurable software applications through the Plan-Do-Check-Act cycle so requirements, work, evidence, learning and corrective action never become disconnected.
Advanced reactor organizations rarely lack documents.
Requirements, technical decisions, assigned work, supporting evidence and management approval must remain connected across the full lifecycle.
FACILEX® ATOMIC provides that connective tissue through an integrated nuclear quality assurance and operational governance platform. Each application supports a defined nuclear or fusion business process, while the suite preserves the relationships among changes, conditions, SSCs, documents, qualifications, suppliers, readiness gates and operating experience.
The result is a defensible management system that shows not only what was decided, but why it was decided, who authorized it, what evidence supported it and whether the outcome was effective.
FACILEX® ATOMIC integrates 21 configurable nuclear quality assurance, regulatory compliance and operational governance applications within a Plan-Do-Check-Act (PDCA) lifecycle. From requirements, design basis and change control through controlled work, audits, operating experience and corrective action, FACILEX® ATOMIC preserves the relationships among processes, records, decisions and evidence throughout the nuclear lifecycle.
START WHERE THE BUSINESS PAIN IS GREATEST
The Big 3 create the backbone of closed-loop governance
FACILEX® ATOMIC Change Control, Corrective Action Program and Action Item Management can be deployed independently, but together they create a closed-loop governance system that ensures technical changes, adverse conditions and routine follow-up items receive the appropriate level of control, accountability and verification.
Control technical and configuration changes across nuclear structures, systems and components (SSCs), documents, software, procedures and training.
Turn adverse conditions into controlled corrective actions with defined accountability, follow-up, progress tracking and closure.
Capture, assign and manage commitments and follow-up actions while maintaining visibility across projects, corrective actions and nuclear business processes.
THE FACILEX® ATOMIC ADVANTAGE
FACILEX® ATOMIC combines governed business processes, controlled information and enterprise integration in a configurable nuclear operational assurance platform that works with specialized enterprise and engineering systems rather than attempting to replace them.
States, actions, approvals, risk tools, checklists and business rules are configured through the user interface by trained end users.
Preserve revisions, approvals, relationships, applicability and audit history while giving authorized users fast access to the correct information.
Connect FACILEX® processes to SAP, Maximo, Microsoft platforms, engineering tools, document systems and analytics without duplicating their core functions.
When critical information is spread across email, spreadsheets, shared drives and disconnected applications, every audit, readiness review and management decision becomes a data-reconciliation exercise.
FACILEX® ATOMIC creates a connected nuclear compliance environment where the evidence trail is created as the work is performed.
In one connected nuclear compliance environment, leaders can see:
Bring one current process, procedure or pain point. Gateway will map it to the FACILEX® ATOMIC lifecycle, show how the applications connect and identify a practical first deployment that can provide value quickly.
Your highest priority use case
Change Control, CAP, readiness, design basis, supplier assurance or another urgent need.
Your current systems
Where FACILEX® should integrate – and where SAP, Maximo or specialized tools remain authoritative.
A credible first deployment
A focused path that solves a recognizable problem and demonstrates suite-wide potential.
FACILEX® ATOMIC is the nuclear and fusion edition of the FACILEX® suite: twenty-one configurable applications, built on the Microsoft platform, that govern the lifecycles, approvals, evidence and configuration context a nuclear organization is required to control.
Every application has been configured to address the regulatory frameworks that actually apply:
For fusion and DOE-affiliated facilities:
The vocabulary, the classifications and the determination records are the ones that regulators, auditors and new nuclear-experienced hires already expect.
Three markets, one platform:
This matters as much as what it does. Your systems of record stay where they are. SAP and Maximo keep your equipment master. Your EDMS keeps your controlled documents. Your LMS keeps course delivery. Your work management system keeps clearances and schedules. CAFTA, SAPHIRE and RiskSpectrum keep your probabilistic risk assessment, and your I&C vendors keep their design tooling.
FACILEX® ATOMIC integrates with your systems of record and owns the compliance layer above them. That is a shorter procurement conversation and a much shorter argument with your IT organization.
Point tools fail in nuclear for a specific and repeatable reason: the regulations do not treat programs as independent. They require that decisions made in one program propagate into every other program that carries their consequences. Three structural patterns run through the entire portfolio.
Audit findings, event reportability determinations, inbound operating experience, promoted action items, degraded conditions requiring operability determination, supplier corrective actions and design basis discrepancies all funnel into one Corrective Action Program with traceable closure and verified effectiveness. Auditors and inspectors check that integration specifically. In a collection of point tools it does not exist.
The chain runs: a hazard is identified, a control is credited, the control is specified and classified, the classification generates required treatment, and that treatment propagates into equipment data, procurement, surveillance, procedures, training, qualification, change screening and readiness verification. Both frameworks name this explicitly — “special treatment” under NEI 18-04 and 10 CFR 50.69, “management measures” under 10 CFR 70 Subpart H. When the chain breaks it breaks silently, and the finding arrives years later.
Startup, restart, mode change and return to service all ask the same question: given everything that has been done, is it safe and compliant to operate? Every input to that answer — condition reports, surveillance currency, impairments and compensatory measures, procedure approvals, training currency, permits, test results, open items — already lives in the portfolio. Computing readiness instead of assembling it is the single largest recurring saving in the suite, and it is the one capability no point tool can offer at any price.
The change lifecycle, in three applications
Permitted, executed, authorized to run. One change object, three sequential decisions, three auditable records.
Change Control, the Corrective Action Program and Action Item Management appear first: they carry the highest regulatory weight and the highest transaction volume in any nuclear organization, and they are where every implementation should begin. The remaining eighteen follow alphabetically.
Built on Microsoft 365 Ecosystem
FACILEX® ATOMIC runs on the platform your organization already licenses, governs and audits. Word and Excel for protocols, checklists and analysis worksheets. SharePoint Subscription Edition for controlled content. Power BI and Excel for reporting. Teams and Outlook for notification and approval. Full mobile access on tablets and phones for field execution — pre-job briefs, readiness walkdowns, audits, surveillances and impairment verification performed where the work is.
FACILEX® Connect
Deployment options
Subscription Software as a Service on Microsoft Azure, client-dedicated Azure hosting, or on-premises deployment under a prepaid licensing model. Subscription delivers the fastest route to production and removes on-premises software, hardware and support cost. Comprehensive user training is included with every deployment; administrator training with a dedicated training site is available on subscription.
FACILEX® solutions are available on multiple platforms and in all Microsoft-supported languages.
Screening, evaluation and authorization for every change — 50.59, 50.54, USQ and standard-design departures in one governed pipeline.
THE CHALLENGE
In nuclear the question is never only “is this change safe?” It is “may we make this change at all without asking the regulator first?” A single modification can require a 50.59 evaluation, a 50.54(q) emergency plan screen, a 50.54(p) security screen, a 50.54(a)(3) QA program screen and fire protection change control — simultaneously. Most organizations run those gates as separate, disconnected processes. “We screened it under 50.59 but nobody caught the emergency plan impact” is one of the most familiar findings in the industry.
WHY IT MATTERS NOW
LIFECYCLE
Initiation ▸ Applicability ▸ Screening ▸ Evaluation ▸ Approval / LAR ▸ Implementation ▸ Closure
CAPABILITIES Configurable screening gates by jurisdiction, license type and facility · temporary modifications, equivalency and like-for-like determinations · setpoint and method-of-evaluation change tracking · automatic 50.71(e) UFSAR update queue · qualification-gated preparer and reviewer assignment · complete determination history retained as a QA record
REGULATORY ANCHORS 10 CFR 50.59 · NEI 96-07 (RG 1.187) · 10 CFR 50.90 · 50.54(a)(3), (p), (q) · 10 CFR 50.48 · 10 CFR 52.63 / 52.98 · 10 CFR 50.71(e) · 10 CFR 830.203 (USQ)
CONNECTS WITH Hands executed work to Project Delivery Assurance, document consequences to Design Basis Information, affected procedures to Procedure Management, retraining to Training & Qualification, and authorization to operate to Operational Readiness Reviews.
If your change process cannot prove which screens were performed and why, you are one inspection away from finding out.
Condition reporting, graded cause analysis, extent of condition and verified effectiveness — the program a regulator samples first.
THE CHALLENGE
The Corrective Action Program is not a quality back office. It is the plant’s central nervous system and the front door to regulatory oversight. Inspectors sample condition reports continuously, and Problem Identification & Resolution is a standing inspection area. A low condition report volume is not evidence of a clean plant — it is read as a weak safety culture. Your CAP has to make low-threshold reporting cheap, and it has to survive the volume that follows.
WHY IT MATTERS NOW
LIFECYCLE
Identification ▸ Immediate action ▸ Screening ▸ Cause analysis ▸ Corrective action ▸ Effectiveness review ▸ Closure
CAPABILITIES CAQ / SCAQ classification · trend coding and recurring-condition analytics · operability and reportability capture · extent of condition and extent of cause · action to preclude recurrence · due-date governance and escalation · supplier corrective action requests · fleet-wide search
REGULATORY ANCHORS 10 CFR 50 Appendix B Criterion XVI · NQA-1 Requirement 16 · NRC Reactor Oversight Process (PI&R) · NRC Inspection Manual 9900 (operability)
CONNECTS WITH Receives from Audits and Assessments, Event Reporting, Operating Experience, Action Item Management, Design Basis Information and Supplier & Contractor Assurance. Escalates to Change Control when the fix is a modification.
Every regulator conversation you will ever have begins in your corrective action program. Make it the strongest thing you own.
The disciplined, auditable home for everything below the CAP threshold — with a documented path into it.
THE CHALLENGE
Not every issue belongs in the corrective action program, and no plant wants a condition report for a slow printer. But an off-CAP tracker that quietly holds conditions which should have been screened is one of the more serious findings a licensee can collect, and there is enforcement history to prove it. The answer is not to ban the bucket — every organization needs one. The answer is to make the bucket defensible.
WHY IT MATTERS NOW
LIFECYCLE
Creation ▸ CAP screening ▸ Assignment ▸ Active ▸ Verification ▸ Closure
CAPABILITIES Configurable threshold screening rules · promotion to CAP with retained lineage · classification by department, facility, owner and urgency · resolution depth from a single step to dozens · recurring and scheduled actions · aggregated “my responsibilities” view spanning every application in the suite
REGULATORY ANCHORS CAP threshold discipline (PI&R inspection area) · 10 CFR 50 Appendix B Criterion XVI interface
CONNECTS WITH Promotes into the Corrective Action Program and receives follow-up items from every other application in the portfolio.
A low-level action register is either your best evidence of a questioning organization or your worst inspection finding. The only difference is whether the screening was written down.
Audits, surveillances, self-assessments and supplier audits — planned, staffed, evidenced and closed.
THE CHALLENGE
Nuclear is the most audit-intensive industry there is. Appendix B Criterion XVIII and NQA-1 Requirement 18 require planned, scheduled audits of the entire quality assurance program with documented findings, management review and verified corrective action closure. That is before NUPIC supplier audits, independent assessments, self-assessments, readiness assessments and preparation for the inspections you do not schedule yourself.
WHY IT MATTERS NOW
LIFECYCLE
Plan ▸ Team & independence ▸ Prepare ▸ Execute ▸ Classify findings ▸ Report ▸ CAP transfer ▸ Effectiveness
CAPABILITIES Master protocol and template library · risk-based supplier audit frequency and scorecards · sampling plans and evidence requests · factual accuracy review · recurring-finding trending · multi-site aggregated reporting
REGULATORY ANCHORS 10 CFR 50 Appendix B Criterion XVIII · NQA-1 Requirement 18 · NUPIC joint audits · 10 CFR Part 21 interface · ISO 9001 (graded programs)
CONNECTS WITH Sends findings to the Corrective Action Program, draws qualification context from Supplier & Contractor Assurance, supplies evidence to Licensing & Regulatory, and feeds Operational Readiness Reviews.
An audit program you cannot schedule, staff and close on demand is not a program. It is a stack of reports.
What is defeated right now, what compensates for it, who verified it this shift, and how much time is left.
THE CHALLENGE
Your corrective action program tracks a condition toward resolution. Your change process authorizes a temporary modification once. Neither answers the question a shift supervisor asks every twelve hours: what is impaired at this moment, and what is holding the plant safe while it is? Today that answer lives in four or five disconnected logs owned by four or five different departments.
WHY IT MATTERS NOW
LIFECYCLE
Request ▸ Authorization ▸ Compensatory measures ▸ Shift verification ▸ Restoration ▸ Closure
CAPABILITIES LCO completion time tracking with escalation · fire protection impairment register · temporary modification and bypass log · per-shift verification records · expiring-clock dashboard · aggregate exposure by system, unit and site
REGULATORY ANCHORS Technical Specification LCO 3.0.4 and Action Statements · 10 CFR 50.48 / NFPA 805 · 10 CFR 73.55 · 10 CFR 50.54(q) · 10 CFR 830 Subpart B (Technical Safety Requirements)
CONNECTS WITH Change Control authorizes the bypass; the Corrective Action Program documents the condition; Licensing & Regulatory issues permits that create compensatory measures; Operational Readiness Reviews requires the register clear before startup.
Nobody plans to run out of completion time. They run out of visibility first.
Every control the safety case relies on — specified, classified, and carrying its obligations downstream.
THE CHALLENGE
Your hazard analysis credits a safety function in a sentence. Turning that sentence into a specified, classified, obligation-bearing object is where safety cases quietly fail. The analysis says the trip protects the plant. Nobody can produce the setpoint basis, the margin that remains after twenty years of small changes, or the list of programs now required to treat that component differently from every other component.
WHY IT MATTERS NOW
LIFECYCLE
Credit from analysis ▸ Specify ▸ Classify ▸ Generate treatment ▸ Verify ▸ Maintain through change
CAPABILITIES Credited function register · setpoint methodology and uncertainty records · safety classification schemes by regulatory framework · special treatment and management measures generation · SIL and PFD calculation · downstream obligation propagation with live compliance gap view
REGULATORY ANCHORS 10 CFR 70 Subpart H (IROFS) · NEI 18-04 / RG 1.233 · 10 CFR 50.69 · RG 1.105 · ANSI/ISA-67.04.01 · TSTF-493 · IEEE 603 / IEEE 7-4.3.2 · IEC 61508 / 61511 / 61513 / 61226
CONNECTS WITH Hazard & Safety Case credits the function; SSC Data Integration carries the classification; Procedure Management, Training & Qualification, Supplier & Contractor Assurance and Change Control inherit the obligations. Your I&C vendors keep the design tooling.
A credited control with no specification, no margin record and no downstream obligations is not a control. It is an assumption.
The controlled register of what your design basis is, whether it is complete, and whether it still matches the plant.
THE CHALLENGE
Configuration management is the discipline of keeping three things consistent: what the plant must do, what the documents say it is, and what it actually is. They drift. The industry has already run this experiment — the design basis crisis of the late 1990s, the 50.54(f) letters that followed, and a decade of design basis reconstitution at extraordinary cost. Nobody who lived through it wants to price the sequel.
WHY IT MATTERS NOW
LIFECYCLE
Requirement ▸ Required-document register ▸ Currency & review ▸ Change-driven update ▸ Discrepancy resolution ▸ Retention
CAPABILITIES Required-document register with currency status · design basis to SSC and requirement linkage · review clocks and obsolete-version control · update-to-closure tracking driven by approved changes · lifetime and non-permanent retention classification · discrepancy workflow into the CAP
REGULATORY ANCHORS 10 CFR 50.2 (design bases) · Appendix B Criteria III, VI and XVII · NQA-1 Requirements 3, 6 and 17 · 10 CFR 50.49 · 50.71(c) and (e) · 50.75(g) · DOE-STD-1073
CONNECTS WITH Change Control authorizes the change; this application tracks its document consequences. Feeds Credited Controls & Safety Functions, Procedure Management and Operational Readiness Reviews.
Design basis reconstitution is the most expensive project you will ever run — and the most avoidable.
Reportability screening, notification clocks and event investigation — with the determination record that proves the call.
THE CHALLENGE
When something happens, the clock starts before the investigation does. 10 CFR 50.72 notifications run on 1-, 4- and 8-hour clocks. Licensee Event Reports are due in sixty days. Part 21 evaluations carry their own screening and timing. Missed notification timeliness is a recurring violation category — not because licensees do not care, but because the clock started while people were still deciding whether it had.
WHY IT MATTERS NOW
LIFECYCLE
Notification ▸ Classification & clock ▸ Reportability screening ▸ Investigation ▸ Regulatory submission ▸ CAP transfer ▸ Closure
CAPABILITIES Configurable event taxonomies and clock rules · on-call escalation · reportability determination records · LER and submittal assembly · actual versus potential severity assessment · operating experience export · extensive trending and graphical reporting
REGULATORY ANCHORS 10 CFR 50.72 · 10 CFR 50.73 · 10 CFR Part 21 · 10 CFR 20.2202 / 20.2203 · 10 CFR 50.9 · INPO / WANO event reporting
CONNECTS WITH Cause analysis lives in the Corrective Action Program; transferable lessons flow to Operating Experience; supplier-origin defects route to Supplier & Contractor Assurance.
The hour you spend deciding whether the clock has started is an hour off the clock.
HAZOP, What-If, FMEA, FFMEA and checklist analysis — with every credited assumption traceable to the program that implements it.
THE CHALLENGE
Both nuclear and fusion have sophisticated safety analysis and chronically weak linkage between that analysis and the programs carrying its assumptions. The analysis is rarely wrong. What fails is the chain: the hazard was identified, the control was credited, and then nobody propagated the obligation into procurement, procedures, surveillance and training. That break is silent, and it is the finding.
WHY IT MATTERS NOW
LIFECYCLE
Scope & nodes ▸ Hazard identification ▸ Consequence & likelihood ▸ Credit controls ▸ Classify ▸ Propagate obligations ▸ Revalidate
CAPABILITIES Multi-method analysis: HAZOP, What-If, checklist, FMEA, FFMEA and LOPA · project, drawing and node hierarchy · IROFS and credited control designation · LBE register with Frequency–Consequence plotting · recommendation and follow-up tracking · assumption register with validation status · equipment-to-analysis coverage search
REGULATORY ANCHORS 10 CFR 70 Subpart H / NUREG-1520 · NEI 18-04 / RG 1.233 · 10 CFR 50.69 · DOE-STD-3009 and DOE-STD-1027 · Appendix R / NFPA 805 · ANSI/ANS-8 series · NUREG-0711
CONNECTS WITH Credited Controls & Safety Functions specifies what this application credits. Feeds Design Basis Information, Integrated Risk Register and Operational Readiness Reviews.
The safety case is not the document. It is the chain from hazard to control to program — and it breaks without a sound.
Every risk you are monitoring, every risk you have accepted, and what the accumulation looks like in aggregate.
THE CHALLENGE
Individually justified acceptances are how facilities get hurt. A corrective action deferred to the next outage. A temporary modification that has been in place three years. A startup punch item accepted with justification. A design basis discrepancy pending resolution. A degraded-but-operable condition. Each one is defensible on its own. Davis-Besse was the sum of them, and the accumulation was visible to nobody because it lived in six different systems.
WHY IT MATTERS NOW
LIFECYCLE
Identification ▸ Evaluation ▸ Treat or accept ▸ Monitor ▸ Revalidate ▸ Close or escalate
CAPABILITIES Risk and vulnerability register with configurable ranking · accepted-risk tracking with revalidation clocks · aggregation by system, unit, site and fleet · parent-child risk relationships · aging analytics · tight integration with Power BI and Excel for executive reporting
REGULATORY ANCHORS 10 CFR 50.69 (RISC categorization) · 10 CFR Part 54 (aging management) · INPO AP-913 · 10 CFR 73.54 (critical digital assets) · ISO 31000 · DOE O 413.3B
CONNECTS WITH Draws accepted positions from the Corrective Action Program, Bypass & Impairment Control, Operational Readiness Reviews, Design Basis Information and Supplier & Contractor Assurance. Feeds your enterprise risk function rather than replacing it, and does not perform probabilistic risk assessment.
Nobody decides to accept too much risk. They accept it one defensible item at a time.
Radiological, industrial and plant-risk hazards in one analysis — and one pre-job brief the crew actually uses.
THE CHALLENGE
Work hazard analysis in nuclear runs on three axes and usually three systems. Radiation protection owns ALARA planning and the Radiation Work Permit. Safety owns the industrial hazards. Operations owns the online risk assessment. The crew gets briefed from three documents and everyone hopes nothing fell between them.
WHY IT MATTERS NOW
LIFECYCLE
Work scoping ▸ Hazard identification ▸ Radiological & risk screening ▸ Controls & permits ▸ Pre-job brief ▸ Post-job feedback
CAPABILITIES Job step and hazard libraries · dose and stay-time estimation · risk-significance flags drawn from SSC data · control and PPE selection · permit linkage · mobile field execution on tablets and phones · post-job lessons capture
REGULATORY ANCHORS 10 CFR 20.1101(b) (ALARA) · 10 CFR 50.65(a)(4) · OSHA 1910 / 1926 · 10 CFR 851 · DOE Integrated Safety Management · ANSI Z136 (laser safety)
CONNECTS WITH Permits issue from Licensing & Regulatory and your radiation protection system; credited hazards inform Credited Controls & Safety Functions; post-job findings feed Operating Experience and the CAP.
Three hazard analyses in three systems is not defense in depth. It is three chances to miss something.
Licenses, permits, commitments and conditions — decomposed into obligations with owners, clocks and evidence.
THE CHALLENGE
A license is not a document. It is several hundred individual obligations, each with an owner, a monitoring requirement, a reporting frequency and a renewal date. A commitment made in an RAI response twenty years ago is still binding. Reorganizations orphan them. Environmental permit conditions sit in a different department entirely. Almost nobody holds the consolidated list, which is why licensing basis reviews keep finding surprises.
WHY IT MATTERS NOW
LIFECYCLE
Obligation capture ▸ Decomposition ▸ Ownership ▸ Monitoring & evidence ▸ Reporting ▸ Renewal or amendment
CAPABILITIES Condition-level obligation register · commitment extraction and traceability · permit issuance with multi-hazard consolidation · automatic compensatory measure generation · renewal and reporting calendars · evidence collection scheduling · regulator correspondence linkage
REGULATORY ANCHORS 10 CFR 50.4 · 10 CFR 50.54(f) commitments · 10 CFR 20 Appendix B / 50.36a · 40 CFR 61 Subpart H · CWA §316(a) and (b) · 10 CFR Part 71 / 49 CFR · 10 CFR Part 72 · Agreement State byproduct licenses · NUREG-0612 · NFPA 805
CONNECTS WITH Change Control tests every change against license conditions; Bypass & Impairment Control receives the compensatory measures permits create; Audits and Assessments supplies evidence; Transmittals & Vendor Data delivers correspondence and returns extracted commitments.
Every commitment you cannot find is still binding. That is the entire problem.
Inbound screening with documented applicability determinations, and outbound lessons that genuinely transfer.
THE CHALLENGE
In process safety, lessons learned is what you publish after your own incident. In nuclear, operating experience is a two-way program and the inbound half is the larger obligation — SOERs, SERs, NRC Information Notices, Bulletins, Generic Letters and Regulatory Issue Summaries, Part 21 vendor notifications and other licensees’ event reports, every one requiring screening for applicability to your facility with a documented determination. Backlogged screening and thin applicability determinations are recurring findings.
WHY IT MATTERS NOW
LIFECYCLE
Receive ▸ Register ▸ Applicability screening ▸ Determination ▸ CAP actions ▸ Communicate ▸ Trend & close
CAPABILITIES Inbound registry with source taxonomy · applicability determination records · response obligation tracking · cross-unit and cross-fleet screening · searchable lessons library with point-of-use delivery · outbound submission assembly · import from Office, third-party and ERP sources
REGULATORY ANCHORS INPO / WANO SOER and SER · NRC generic communications (IN, Bulletin, GL, RIS) · 10 CFR 50.54(f) · 10 CFR Part 21 · 10 CFR 851 (DOE lessons learned)
CONNECTS WITH Feeds the Corrective Action Program; response obligations become entries in Licensing & Regulatory; internal events arrive from Event Reporting.
Somebody has already had your next event. The only question is whether you read about it in time.
Readiness as a computed answer rather than a binder — for every startup, restart, mode change and return to service.
THE CHALLENGE
Readiness reviews are evidence-gathering exercises. Someone spends weeks assembling proof: open significant condition reports, surveillance currency, cleared impairments, approved procedures, trained operators, closed permits, accepted test results, justified punch-list deferrals. The evidence already exists inside your systems. Assembling it by hand is the entire cost — and it recurs every single time.
WHY IT MATTERS NOW
LIFECYCLE
Scope & grading ▸ Prerequisites ▸ Evidence collection ▸ Independent verification ▸ Open item disposition ▸ Authorization ▸ Post-startup closure
CAPABILITIES Graded readiness templates from short-form to full ORR · prerequisite checklists with live status · evidence attachment and linkage · multi-signature and independent verification · open item and punch-list management with deferral control · ITAAC hierarchy and closure tracking · conditional authorization with expiry · field execution on tablets
REGULATORY ANCHORS Appendix B Criterion XI · NQA-1 Requirement 11 · RG 1.68 · 10 CFR 52.99 and §103(g) · Technical Specification LCO 3.0.4 · DOE O 425.1 / DOE-STD-3006
CONNECTS WITH Project Delivery Assurance executes the work; Change Control authorizes the change; this application authorizes operation. It consumes state from nearly every other application in the portfolio.
You already have the evidence. What you do not have is the three weeks it takes to find it.
Reorganizations, staffing changes and departures — screened as safety questions, because that is what they are.
THE CHALLENGE
In nuclear, your organization is partly described in your licensing basis. Technical Specification Section 5.0 names positions and shift staffing. UFSAR Chapter 13 describes conduct of operations. Your quality assurance program description defines structure and independence. Changing any of it can require a 50.59 screen, a 50.54(a)(3) submittal or a license amendment — and almost no software treats an organization chart as a controlled object.
WHY IT MATTERS NOW
LIFECYCLE
Proposal ▸ Licensing basis screening ▸ Qualification gap analysis ▸ Transition plan ▸ Communication ▸ Implementation ▸ Closure
CAPABILITIES Position-centric organization model · position-to-credential matrix · vacancy and qualification gap alerts · obligation ownership by position · transitional condition management · temporary assignment and acting-role controls · screening determination records
REGULATORY ANCHORS Appendix B Criterion I · NQA-1 Requirement 1 · 10 CFR 50.54(a)(3) and (m) · 10 CFR 50.74 · Technical Specification Section 5.0 · UFSAR Chapter 13 / 50.59 · 10 CFR Part 26 · IAEA GSR Part 2 · DOE O 426.2
CONNECTS WITH Shares the screening engine with Change Control, the credential matrix with Training & Qualification, and obligation ownership with Licensing & Regulatory. Your HR system keeps the employee record.
Every reorganization is a change to something described in your license. Very few are screened like one.
The master list, the review clocks, the change screening and the traceability from requirement to procedure step.
THE CHALLENGE
Appendix B Criterion V requires that activities affecting quality be prescribed by procedures and accomplished in accordance with them. Technical Specification 5.4 and RG 1.33 Appendix A effectively hand the regulator a master list of procedures you must maintain. And in nuclear a procedure is not merely a work instruction — it is the implementing artifact for a commitment you made in writing.
WHY IT MATTERS NOW
LIFECYCLE
Initiation ▸ Draft / revise ▸ Review ▸ Change screening ▸ Approve ▸ Validate ▸ Release ▸ Periodic review
CAPABILITIES Master required-procedure register · requirement and commitment linkage · continuous-use versus reference-use designation · review clock management · validation records · full revision and version audit trail · training impact flags · integration with your document vault and Office tools
REGULATORY ANCHORS Appendix B Criteria V and VI · NQA-1 Requirements 5 and 6 · Technical Specification 5.4 · RG 1.33 Appendix A (ANSI N18.7) · 10 CFR 50.155 · 10 CFR 50.59 · DOE O 422.1 / DOE-STD-1029
CONNECTS WITH Change Control screens the revision; Design Basis Information holds the governing requirement; Training & Qualification receives the impact; Operational Readiness Reviews verifies approval before startup.
Procedure adherence findings do not start with the crew. They start with a procedure nobody realised had to change.
Design control, ITAAC evidence, commissioning and turnover — the execution layer for new build and modifications.
THE CHALLENGE
Every SMR and fusion company is a construction project wearing a company’s clothing. Design control under Appendix B Criterion III has to hold across thousands of design inputs, reviews and verifications on a design that is still maturing. For Part 52 licensees, hundreds of ITAAC each need documented, independently verifiable evidence before fuel load. Schedule is the dominant commercial risk, and evidence assembly is the hidden cost buried inside it.
WHY IT MATTERS NOW
LIFECYCLE
Initiation ▸ Scoping ▸ Design & review ▸ Approval ▸ Implementation ▸ Testing ▸ Turnover ▸ Close-out
CAPABILITIES Project and modification hierarchy · design input and verification records · ITAAC register with evidence and closure states · design review gate management · punch list and open item tracking · turnover package assembly · integration with Microsoft Project and your scheduling tools · contractor and supplier linkage
REGULATORY ANCHORS Appendix B Criteria III and XI · NQA-1 Requirements 3 and 11 · 10 CFR 52.99 and §103(g) · 10 CFR 50.59 interface · RG 1.68
CONNECTS WITH Change Control grants permission to change; Operational Readiness Reviews grants authorization to operate; Supplier & Contractor Assurance and Transmittals & Vendor Data supply the certified records that make closure possible.
On a first-of-a-kind build, evidence you cannot produce is indistinguishable from work you did not do.
Your equipment master, enriched with the safety classification that should travel with every record.
THE CHALLENGE
Your equipment data lives in SAP or Maximo and it should stay there. But in nuclear an asset is not a tag number and a description — it is a set of classification attributes that determine how every program must treat it. When that context does not travel, a condition report on a Q-List component gets handled the same way as one on a parking lot light.
WHY IT MATTERS NOW
LIFECYCLE
Extract ▸ Map ▸ Classify & enrich ▸ Publish ▸ Reconcile ▸ Maintain
CAPABILITIES Connectors to SAP, Maximo and PLM platforms · classification attribute model · facility, system and unit hierarchy navigation · equipment-to-object linkage across every application · reconciliation and discrepancy reporting · graphical asset structure navigator
REGULATORY ANCHORS Q-List and Appendix B scope · 10 CFR 50.65 (Maintenance Rule) · 10 CFR 50.49 (EQ) · 10 CFR 50.69 (RISC) · seismic category · Master Equipment List convention
CONNECTS WITH Supplies classification to every application in the portfolio and receives classification decisions from Credited Controls & Safety Functions.
Safety classification is the most important attribute your equipment record carries. It should never be the one nobody can see.
Approved Suppliers List, qualification scope, audit currency and Commercial Grade Dedication — the industry’s tightest bottleneck.
THE CHALLENGE
There are not enough NQA-1 suppliers to build the SMR fleet. Everyone is qualifying commercial vendors and dedicating their output, and Appendix B Criteria IV and VII require documented evaluation, qualification and periodic re-audit for every one of them. Supply chain quality is not a procurement inconvenience. It is the choke point of the entire industry, and it is where first-of-a-kind schedules go to die.
WHY IT MATTERS NOW
LIFECYCLE
Prequalification ▸ Evaluation & audit ▸ Approval & scope ▸ Procurement control ▸ Receipt & dedication ▸ Performance ▸ Re-audit
CAPABILITIES ASL with scope and expiry control · risk-based audit scheduling and supplier scorecards · CGD workflow with critical characteristics · supplier corrective action requests · Part 21 flowdown and notification screening · contractor qualification verification · links to projects, changes and corrective actions
REGULATORY ANCHORS Appendix B Criteria IV and VII · NQA-1 Requirements 4 and 7 · 10 CFR Part 21 · NUPIC · 10 CFR Part 26 interface · industry CFSI guidance
CONNECTS WITH Audits and Assessments performs the supplier audits; Transmittals & Vendor Data collects the required documentation; Credited Controls & Safety Functions defines what dedication has to protect.
You cannot buy your way out of a supply chain that has not been qualified. You can only document your way through it.
Not whether they took the course. Whether they are qualified, right now, to be assigned this work.
THE CHALLENGE
Your learning management system knows who completed what. Every other program in your organization needs a different answer at the moment of assignment: is this person currently qualified to lead this audit, perform this cause analysis, enter this confined space, prepare this 50.59 evaluation or stand this watch? That is a qualification register question, and an LMS was never built to answer it.
WHY IT MATTERS NOW
LIFECYCLE
Requirement ▸ Assignment ▸ Delivery (your LMS) ▸ Verification ▸ Qualification granted ▸ Currency ▸ Requalification
CAPABILITIES Position-to-credential matrix · qualification register with scope and expiry · LMS completion ingestion · currency dashboards and expiry forecasting · training plan creation and progress tracking · follow-up action items · specific and aggregated reporting
REGULATORY ANCHORS Appendix B Criterion II · NQA-1 Requirement 2 · 10 CFR 50.120 (SAT) · 10 CFR Part 55 and 55.59 · 10 CFR 19.12 · 10 CFR Part 26 · Part 73 Appendix B · INPO accreditation · DOE O 426.2 · 10 CFR 850
CONNECTS WITH Shares the credential matrix with Organizational Change Control and gates assignment in Audits and Assessments, Licensing & Regulatory, the Corrective Action Program and Operational Readiness Reviews.
A completed course is a record. A current qualification is a control.
What you owed, what arrived, what went out — and who was authorized to receive it.
THE CHALLENGE
Every purchase order carries a list of documents the supplier owes: drawings, calculations, Certificates of Conformance, Certified Material Test Reports, weld and NDE records, test reports and vendor manuals. Those are quality assurance records under Criterion XVII, many with lifetime retention, and they are the evidence base for your environmental qualification and seismic files. Items arrive and get installed. The records show up months later, or never.
WHY IT MATTERS NOW
LIFECYCLE
Requirement (SDRL) ▸ Outbound screening ▸ Transmit ▸ Receive ▸ Completeness & authenticity ▸ Acceptance ▸ Retention
CAPABILITIES SDRL register per purchase order · inbound and outbound transmittal records with full provenance · export control and information classification screening gates · recipient authorization checks · CMTR and Certificate of Conformance tracking · retention classification · turnover package assembly · EPC platform integration
REGULATORY ANCHORS Appendix B Criteria IV, VII and XVII · NQA-1 Requirements 4, 7 and 17 · 10 CFR Part 21 · 10 CFR Part 810 / Part 110 · 10 CFR 73.21 and 73.22 · 10 CFR 2.390 · 10 CFR 50.49
CONNECTS WITH Supplier & Contractor Assurance defines who may supply; Project Delivery Assurance consumes the turnover records; Licensing & Regulatory receives regulator correspondence and the commitments extracted from it.
An unqualified supplier and a supplier whose paperwork never arrived look identical in an audit.
Nobody deploys twenty-one applications at once. Three adoption paths account for almost every FACILEX® ATOMIC programme, and each one delivers a defensible capability inside a single quarter.
Operating plant
Start with the Corrective Action Program and Action Item Management, then Change Control. Those three carry the highest transaction volume and the greatest inspection exposure in the plant. Audits and Assessments and Operating Experience follow naturally, because both feed the CAP you have just strengthened. Bypass & Impairment Control is usually the first capability that operations staff ask for once they see the register.
New build and pre-operational
Start with Project Delivery Assurance and Operational Readiness Reviews — ITAAC evidence and closure is the schedule risk that dominates every Part 52 programme, and readiness authorization is what it feeds. Design Basis Information and Transmittals & Vendor Data follow immediately, because the certified records arriving from your supply chain this year are the evidence base for everything afterwards. Supplier & Contractor Assurance is often first in practice, since qualification is the constraint.
Fusion and DOE-affiliated facilities
Start with Hazard & Safety Case and Operational Readiness Reviews. The DOE framework already specifies both — HAZOP, What-If and FMEA methods behind the Documented Safety Analysis, and Order 425.1 with DOE-STD-3006 for readiness verification — so you are implementing a required process rather than importing a foreign one. Procedure Management and Training & Qualification follow as the organization crosses from research practice into controlled operations, which is the transition every fusion company is making right now. Build them before tritium introduction, not after.
Whichever path you take, the applications you deploy later inherit the classifications, obligations and evidence the earlier ones already hold. The suite gets more valuable with each addition — which is the opposite of how a shelf of point tools behaves.
