10 CFR 50 Appendix B Audit Preparation for Inspection Companies
A 10 CFR 50 Appendix B audit runs in 6 stages, beginning with the licensee or its designee evaluates the supplier before award — criterion.. U.S. Nuclear Regulatory Commission tests the system by sampling finished work backwards to the records behind it, so preparation means reconciling records to jobs rather than rewriting manuals.
Appendix B sets eighteen quality assurance criteria for activities affecting the safety-related functions of nuclear structures, systems and components. For an inspection service provider two criteria bite hardest. Criterion IX, Control of Special Processes, requires measures assuring that special processes 'including welding, heat treating, and nondestructive testing, are controlled and accomplished by qualified personnel using qualified procedures in accordance with applicable codes, standards, specifications, criteria, and other special requirements.' Criterion X, Inspection, requires inspection by individuals other than those who performed the activity being inspected. Criterion XVII requires records identifying the inspector or data recorder, the type of observation, the results, the acceptability and the action taken on any deficiency. Criterion XVIII requires planned periodic audits by trained personnel without direct responsibility in the area audited. What separates firms that clear an audit from firms that collect findings is not the quality of the documentation but whether it describes what actually happens.
Source: Appendix B to 10 CFR Part 50, 'Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants,' full text from the GPO govinfo CFR annual edition, Title 10 Volume 1, revised as of 1 January 2024 — Introduction and Criteria I through XVIII, quoting Criterion IX, X, XVII and XVIII verbatim. Cross-referenced against 10 CFR Part 21, 'Reporting of Defects and Noncompliance,' same edition, whose definition of 'basic component' at paragraph (4) expressly includes 'safety-related design, analysis, inspection, testing, fabrication, replacement of parts, or consulting services... whether these services are performed by the component supplier or others.' Accessed 21 Aug 2026.
| Stage | What happens | What it tests |
|---|---|---|
| Stage 1 | The licensee or its designee evaluates the supplier before award — Criterion VII requires source evaluation and selection, and control. | Where the paperwork is tested against itself |
| Stage 2 | The supplier submits its QA program manual and procedures for the licensee's review against the eighteen criteria and against whatever. | Where the paperwork is tested against practice |
| Stage 3 | On-site audit by the licensee, its designee, or a joint programme such as NUPIC, performed to written procedures or checklists. | Where the paperwork is tested against practice |
| Stage 4 | Findings are documented and reviewed by management having responsibility in the area audited; the supplier responds with cause determination and. | Where the paperwork is tested against practice |
| Stage 5 | Followup, including reaudit of deficient areas where indicated, then placement on the licensee's Approved Suppliers List for the specific scope. | Where the paperwork is tested against practice |
| Stage 6 | Criterion VII requires the effectiveness of the supplier's quality control to be reassessed at intervals consistent with the importance, complexity. | Where the paperwork is tested against practice |
| Renewal | Appendix B sets no expiry — it is a standing regulatory requirement, not a certificate. What recurs is verification. Criterion XVIII requires a comprehensive system of planned and periodic audits, and Criterion VII requires the licensee to assess the effectiveness of a supplier's quality control 'at intervals consistent with the importance, complexity, and quantity of the product or services.' For NDT service suppliers this normally lands on the joint utility audit cycle — NUPIC runs most vendors on a 33-month schedule — supplemented by annual internal audits. | Diarised from the certificate date, not the last audit |
How long does 10 CFR 50 Appendix B audit preparation take?
Document work — the written practice, procedures and quality manual — takes weeks. What cannot be compressed is documented experience and records history: on-the-job hours accrue in real time, and calibration and certification history cannot be back-filled. Firms that start when the audit is scheduled rather than announced clear it without findings.
What does U.S. Nuclear Regulatory Commission look at first?
Records, not manuals. A manual states intent; records show practice. The usual opening move is to take a completed job and trace it back to the technician's certification, the instrument's calibration, the approved procedure and the report — and see whether all four reconcile.
What are the most common 10 CFR 50 Appendix B findings?
QA manual written to the eighteen criteria in the abstract with no procedure translating Criterion IX into control of NDE special processes at the working level, Independence problem under Criterion X — the technician who performed the examination also signs the verifying inspection, Records failing Criterion XVII because the inspection record does not identify the inspector or data recorder, the type of observation, the acceptability, or the action taken on a deficiency, Sub-tier flowdown gaps under Criteria IV and VII — calibration houses, consumables suppliers or contract technicians procured without the applicable QA and 10 CFR Part 21 requirements imposed. Almost all of them are evidence problems rather than capability problems: the work was done correctly and the proof was not kept, or was kept somewhere the firm could not retrieve during the audit.
Can a consultant attend the 10 CFR 50 Appendix B audit?
Yes, and it changes the outcome. Someone who has sat through the same audit at other firms answers in the auditor's own terms, produces the right record without a search, and stops a clarification turning into a finding. The firm still owns every answer — the consultant does not speak for it.
What happens after a 10 CFR 50 Appendix B finding?
A corrective action with a deadline, and evidence of closure at the next audit. Repeat findings are treated far more seriously than first ones, because they show the corrective-action system itself is not working.
Does 10 CFR 50 Appendix B require a pre-audit or gap assessment?
Not as a requirement, but the arithmetic favours it: a gap assessment finds the same evidence problems the auditor would, without the finding attached, and while there is still time to fix them. Firms entering their first 10 CFR 50 Appendix B audit blind typically collect findings that a sampling exercise would have caught.
What the auditor asks to see
- Quality assurance program description covering all eighteen criteria, with the organisational chart and delegated authorities required by Criterion I
- Documented instructions, procedures and drawings for activities affecting quality, with quantitative or qualitative acceptance criteria (Criterion V)
- Special process procedures for nondestructive testing, with evidence the procedures and the personnel are qualified (Criterion IX)
- Inspection program showing inspection is performed by individuals other than those who performed the work, and identifying any mandatory hold points (Criterion X)
- Procurement documents imposing the applicable regulatory, code and QA requirements on sub-tier suppliers (Criterion IV) and the supplier evaluation and assessment records required by Criterion VII
- Calibration and control records for measuring and test equipment (Criterion XII)
- Nonconformance and corrective action records, with the cause and the action to preclude repetition documented and reported to management for significant conditions adverse to quality (Criteria XV and XVI)
- Inspection and test records identifying the inspector or data recorder, the type of observation, the results, the acceptability and the action taken on deficiencies, plus qualifications of personnel, procedures and equipment (Criterion XVII)
- Internal audit plan, checklists, reports and reaudit records demonstrating a comprehensive system of planned and periodic audits (Criterion XVIII)
Findings to close before the audit
- QA manual written to the eighteen criteria in the abstract with no procedure translating Criterion IX into control of NDE special processes at the working level
- Independence problem under Criterion X — the technician who performed the examination also signs the verifying inspection
- Records failing Criterion XVII because the inspection record does not identify the inspector or data recorder, the type of observation, the acceptability, or the action taken on a deficiency
- Sub-tier flowdown gaps under Criteria IV and VII — calibration houses, consumables suppliers or contract technicians procured without the applicable QA and 10 CFR Part 21 requirements imposed
- Corrective action stopping at the immediate fix, with no documented determination of cause and action to preclude repetition as Criterion XVI requires
- Internal audits performed by someone with direct responsibility in the area audited, or with no checklist, contrary to Criterion XVIII
- Measuring and test equipment used out of calibration with no evaluation of the validity of previous results (Criterion XII)
- Commercial-grade items and services used in safety-related work without a dedication process, so the item never qualifies as a basic component
Related: the 10 CFR 50 Appendix B overview, outsourced ASNT Level III cover, written practice development, NDT procedure development, a programme gap assessment, interim Level III cover.