10 CFR 50 Appendix B is the NRC regulation that sets 18 quality assurance criteria for nuclear power plants and fuel reprocessing plants. An Appendix B audit checks that a QA program meets each criterion and that the work follows the program. Appendix B is US federal regulation, so this checklist quotes it directly, from the current eCFR text. The questions, records and findings under each quote are ours.
Confirm the scope before you start. If you are a supplier, your purchase documents say which parts of Appendix B apply to you. If you hold or are applying for a license, your QA program description and its commitments set the scope. Design control only applies if design is in your scope. Mark anything outside it as not applicable and write down why.
Who Appendix B applies to
Appendix B places the obligation on license applicants and holders. Suppliers come under it through the purchase documents. In the regulation’s own words:
The introduction lists each license type. It opens with construction permits, and later says which activities the criteria cover:
“Every applicant for a construction permit is required by the provisions of § 50.34 or § 53.1309 of this chapter to include in its Preliminary Safety Analysis Report a description of the quality assurance program to be applied to the design, fabrication, construction, and testing of the structures, systems, and components of the facility. … The pertinent requirements of this appendix apply to all activities affecting the safety-related functions of those structures, systems, and components; these activities include designing, purchasing, fabricating, handling, shipping, storing, cleaning, erecting, installing, inspecting, testing, operating, maintaining, repairing, refueling, and modifying.” 10 CFR 50, App. B, Introduction
Criterion I lets the license holder delegate QA work but not responsibility. Criterion IV is how the requirements reach suppliers:
“The applicant may delegate to others, such as contractors, agents, or consultants, the work of establishing and executing the quality assurance program, or any part thereof, but shall retain responsibility for the quality assurance program.” 10 CFR 50, App. B, Criterion I
“To the extent necessary, procurement documents shall require contractors or subcontractors to provide a quality assurance program consistent with the pertinent provisions of this appendix.” 10 CFR 50, App. B, Criterion IV
The definition the 18 criteria rest on:
“As used in this appendix, “quality assurance” comprises all those planned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service.” 10 CFR 50, App. B, Introduction
The current text was last amended on 30 March 2026 (91 FR 15787). It now refers to applicants under Part 53 as well as Parts 50 and 52.
Before the audit
If you only have time for one of these, do the job trace. Following one real order from purchase order to shipment turns up the same gaps an auditor will find, in roughly the order they will find them.
The checklist, criterion by criterion
Organization
Criterion I
“The persons and organizations performing quality assurance functions shall have sufficient authority and organizational freedom to identify quality problems; to initiate, recommend, or provide solutions; and to verify implementation of solutions.”
10 CFR 50, Appendix B, Criterion I
The auditor checks that responsibilities are written down, and that the people doing quality assurance work have the authority and independence the criterion asks for.
Questions to answer
Records to have ready
- Organization chart
- Written responsibilities and authorities
- Delegation agreements with contractors
- Reporting lines for QA staff
Common finding
A QA lead who reports to the project manager responsible for cost and schedule, with nothing written to protect their independence.
Quality Assurance Program
Criterion II
“This program shall be documented by written policies, procedures, or instructions and shall be carried out throughout plant life in accordance with those policies, procedures, or instructions. … The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety. … The program shall provide for indoctrination and training of personnel performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained.”
10 CFR 50, Appendix B, Criterion II
The auditor checks that the QA program is written down, covers the right structures, systems and components, controls them in line with their importance to safety, and trains the people who do the work.
Questions to answer
Records to have ready
- QA program description or manual
- List of covered structures, systems and components
- Training and qualification records
- Management review records
Common finding
Training records that show a course was attended, with nothing to show the person is proficient in the task they now do.
Design Control
Criterion III
“The design control measures shall provide for verifying or checking the adequacy of design, such as by the performance of design reviews, by the use of alternate or simplified calculational methods, or by the performance of a suitable testing program. The verifying or checking process shall be performed by individuals or groups other than those who performed the original design, but who may be from the same organization.”
10 CFR 50, Appendix B, Criterion III
If design is in your scope, the auditor checks that requirements reach the design documents, that designs are verified by someone other than the designer, and that changes get the same control as the original.
Questions to answer
Records to have ready
- Design input and basis documents
- Design verification records
- Design interface agreements
- Design and field change records
Common finding
A design verified by the engineer who did the calculation, signed again as checker.
Procurement Document Control
Criterion IV
“Measures shall be established to assure that applicable regulatory requirements, design bases or functional design criteria, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the applicant or by its contractors or subcontractors. To the extent necessary, procurement documents shall require contractors or subcontractors to provide a quality assurance program consistent with the pertinent provisions of this appendix.”
10 CFR 50, Appendix B, Criterion IV
The auditor checks that your purchase documents carry the regulatory, design and quality requirements to your suppliers, including a QA program where the work needs one.
Questions to answer
Records to have ready
- A sample of purchase orders with their quality clauses
- Quality review records for those purchase orders
- Supplier QA program requirements in the order
Common finding
A purchase order for a safety-related part that never says Appendix B, or any QA program, applies.
Instructions, Procedures, and Drawings
Criterion V
“Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accomplished in accordance with these instructions, procedures, or drawings. Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.”
10 CFR 50, Appendix B, Criterion V
The auditor checks that quality-affecting work is done to written instructions, and that those instructions say how to tell whether the work was done right.
Questions to answer
Records to have ready
- Procedure index
- Work instructions and drawings for a sample job
- Acceptance criteria in those documents
Common finding
A procedure that says to check a dimension but gives no tolerance, so each inspector picks their own.
Document Control
Criterion VI
“These measures shall assure that documents, including changes, are reviewed for adequacy and approved for release by authorized personnel and are distributed to and used at the location where the prescribed activity is performed. Changes to documents shall be reviewed and approved by the same organizations that performed the original review and approval unless the applicant designates another responsible organization.”
10 CFR 50, Appendix B, Criterion VI
The auditor checks that documents are reviewed and approved before release, that changes go back through the same review, and that the current version is where the work happens.
Questions to answer
Records to have ready
- Controlled document list
- Approval records for a sample of documents
- Change records for a recently revised document
Common finding
A superseded revision of a procedure still in use at the workstation.
Control of Purchased Material, Equipment, and Services
Criterion VII
“These measures shall include provisions, as appropriate, for source evaluation and selection, objective evidence of quality furnished by the contractor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. … The effectiveness of the control of quality by contractors and subcontractors shall be assessed by the applicant or designee at intervals consistent with the importance, complexity, and quantity of the product or services.”
10 CFR 50, Appendix B, Criterion VII
The auditor checks how you select suppliers, how you verify what they deliver, and how often you check that their quality control is working.
Questions to answer
Records to have ready
- Approved supplier list with scope
- Supplier evaluations and audit reports
- Receiving inspection records
- Certificates of conformance and material test reports
Common finding
Material installed before the certificate of conformance arrived, with the paperwork added afterwards.
Identification and Control of Materials, Parts, and Components
Criterion VIII
“These measures shall assure that identification of the item is maintained by heat number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, erection, installation, and use of the item. These identification and control measures shall be designed to prevent the use of incorrect or defective material, parts, and components.”
10 CFR 50, Appendix B, Criterion VIII
The auditor checks that every item can be identified, on the item or by traceable records, all the way through fabrication, installation and use.
Questions to answer
Records to have ready
- Traveler or routing for a sample job
- Heat and serial number traceability records
- Marking procedure
Common finding
A part machined from bar stock with the heat number left on the offcut.
Control of Special Processes
Criterion IX
“Measures shall be established to assure 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.”
10 CFR 50, Appendix B, Criterion IX
The auditor checks that welding, heat treating, nondestructive testing and other special processes use qualified procedures and qualified people, as the applicable codes require.
Questions to answer
Records to have ready
- Welding procedure specifications and qualification records
- Welder and NDE personnel qualifications
- Heat treatment procedures and charts
Common finding
An NDE examination performed by a technician whose certification for that method had expired.
Inspection
Criterion X
“Such inspection shall be performed by individuals other than those who performed the activity being inspected. … If mandatory inspection hold points, which require witnessing or inspecting by the applicant’s designated representative and beyond which work shall not proceed without the consent of its designated representative are required, the specific hold points shall be indicated in appropriate documents.”
10 CFR 50, Appendix B, Criterion X
The auditor checks that inspections are planned and done by people other than those who did the work, and that mandatory hold points are respected.
Questions to answer
Records to have ready
- Inspection plans with hold and witness points
- Inspection reports
- Hold point release records
Common finding
Work that proceeded past a mandatory hold point before the customer’s representative released it.
Test Control
Criterion XI
“Test procedures shall include provisions for assuring that all prerequisites for the given test have been met, that adequate test instrumentation is available and used, and that the test is performed under suitable environmental conditions. Test results shall be documented and evaluated to assure that test requirements have been satisfied.”
10 CFR 50, Appendix B, Criterion XI
The auditor checks that required tests are done to written procedures with their prerequisites met, and that results are documented and evaluated.
Questions to answer
Records to have ready
- Test procedures
- Test records
- Results evaluations
- Prerequisite checklists
Common finding
A test record with readings but no evaluation showing they met the acceptance limits.
Control of Measuring and Test Equipment
Criterion XII
“Measures shall be established to assure that tools, gages, instruments, and other measuring and testing devices used in activities affecting quality are properly controlled, calibrated, and adjusted at specified periods to maintain accuracy within necessary limits.”
10 CFR 50, Appendix B, Criterion XII
The auditor checks that tools, gages and instruments used for quality-affecting work are controlled, calibrated and adjusted at set intervals.
Questions to answer
Records to have ready
- Measuring and test equipment register
- Calibration certificates and intervals
- Out-of-tolerance evaluations
Common finding
A torque wrench used on safety-related work three weeks past its calibration due date.
Handling, Storage and Shipping
Criterion XIII
“Measures shall be established to control the handling, storage, shipping, cleaning and preservation of material and equipment in accordance with work and inspection instructions to prevent damage or deterioration. When necessary for particular products, special protective environments, such as inert gas atmosphere, specific moisture content levels, and temperature levels, shall be specified and provided.”
10 CFR 50, Appendix B, Criterion XIII
The auditor checks that material and equipment are handled, stored, cleaned, preserved and shipped to prevent damage or deterioration.
Questions to answer
Records to have ready
- Handling and storage instructions
- Storage condition records
- Packaging and shipping records
Common finding
Items requiring a controlled environment stored in an unheated area with no condition records.
Inspection, Test, and Operating Status
Criterion XIV
“Measures shall be established to indicate, by the use of markings such as stamps, tags, labels, routing cards, or other suitable means, the status of inspections and tests performed upon individual items of the nuclear power plant or fuel reprocessing plant. These measures shall provide for the identification of items which have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent bypassing of such inspections and tests.”
10 CFR 50, Appendix B, Criterion XIV
The auditor checks that anyone can see which inspections and tests an item has passed, so nothing skips a required inspection.
Questions to answer
Records to have ready
- Status tags and stamps
- Travelers or routing cards showing status
- Procedure for status markings
Common finding
An untagged item in the shipping area with no record showing it passed final inspection.
Nonconforming Materials, Parts, or Components
Criterion XV
“These measures shall include, as appropriate, procedures for identification, documentation, segregation, disposition, and notification to affected organizations. Nonconforming items shall be reviewed and accepted, rejected, repaired or reworked in accordance with documented procedures.”
10 CFR 50, Appendix B, Criterion XV
The auditor checks that nonconforming items are identified, documented, segregated and dispositioned, and that affected organizations are told.
Questions to answer
Records to have ready
- Nonconformance log
- Closed nonconformance reports with dispositions
- Customer notifications and approvals
Common finding
A repair disposition carried out without notifying the customer, though the contract required it.
Corrective Action
Criterion XVI
“In the case of significant conditions adverse to quality, the measures shall assure that the cause of the condition is determined and corrective action taken to preclude repetition. The identification of the significant condition adverse to quality, the cause of the condition, and the corrective action taken shall be documented and reported to appropriate levels of management.”
10 CFR 50, Appendix B, Criterion XVI
The auditor checks that problems are found and corrected promptly, and that significant ones get a cause, an action to stop them recurring, and a report to management.
Questions to answer
Records to have ready
- Corrective action log
- Significance criteria
- Cause analyses for significant conditions
- Management reports
Common finding
A significant condition closed by fixing the item, with no cause analysis and no report to management.
Quality Assurance Records
Criterion XVII
“Inspection and test records shall, as a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. Records shall be identifiable and retrievable. Consistent with applicable regulatory requirements, the applicant shall establish requirements concerning record retention, such as duration, location, and assigned responsibility.”
10 CFR 50, Appendix B, Criterion XVII
The auditor checks that records prove what was done, that inspection and test records carry the details the criterion lists, and that records can be found and are kept as required.
Questions to answer
Records to have ready
- Records retention schedule
- Sample inspection and test records
- A complete record package for a past order
Common finding
Inspection records that give a pass result but don’t identify who did the inspection.
Audits
Criterion XVIII
“A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with the written procedures or check lists by appropriately trained personnel not having direct responsibilities in the areas being audited. … Followup action, including reaudit of deficient areas, shall be taken where indicated.”
10 CFR 50, Appendix B, Criterion XVIII
The auditor checks that you run planned, periodic audits of the whole QA program, using written checklists and trained auditors who are independent of the area.
Questions to answer
Records to have ready
- Audit schedule
- Audit procedures and checklists
- Auditor training records
- Audit reports and follow-up
Common finding
An audit finding closed without the reaudit the audit procedure called for.
Appendix B and NQA-1
Many programs meet Appendix B by following ASME NQA-1. The 18 criteria and the 18 NQA-1 Part I requirements line up one for one. For design and construction, NRC Regulatory Guide 1.28, Revision 6 endorses, with clarifications, Parts I and II of NQA-1-2017, NQA-1-2019 and NQA-1-2022. If your program follows NQA-1, use the NQA-1 audit checklist alongside this one.
Questions about Appendix B audits
Who does 10 CFR 50 Appendix B apply to?
Appendix B applies to applicants for, and holders of, NRC licenses and approvals for nuclear power plants and fuel reprocessing plants, including construction permits, operating licenses, combined licenses, early site permits, design approvals, design certifications and manufacturing licenses. The current text refers to applicants under Part 53 as well as Parts 50 and 52. Suppliers come under it through purchase documents: Criterion IV says that, “To the extent necessary, procurement documents shall require contractors or subcontractors to provide a quality assurance program consistent with the pertinent provisions of this appendix.”
What does an Appendix B audit check?
An Appendix B audit checks that the QA program meets each of the 18 criteria and that the work follows it: organization, the QA program, design control, procurement document control, instructions and procedures, document control, purchased material and services, identification of items, special processes, inspection, test control, measuring and test equipment, handling and storage, inspection and test status, nonconforming items, corrective action, QA records and audits.
How often are Appendix B audits required?
Appendix B does not set an interval. Criterion XVIII says: “A comprehensive system of planned and periodic audits shall be carried out to verify compliance with all aspects of the quality assurance program and to determine the effectiveness of the program.” The interval comes from your QA program description and the commitments it makes, so check those.
What is the difference between Appendix B and NQA-1?
Appendix B is the NRC regulation: 18 criteria a QA program must meet. ASME NQA-1 is a consensus standard many programs use to meet those criteria in practice. The 18 NQA-1 Part I requirement titles line up one for one with the 18 criteria, and NRC Regulatory Guide 1.28, Revision 6 endorses Parts I and II of NQA-1-2017, NQA-1-2019 and NQA-1-2022 for design and construction.
Do suppliers have to meet Appendix B?
If the purchase documents require it. Appendix B places the obligation on the license applicant or holder, which can delegate QA work to contractors but keeps responsibility for it. Criterion IV requires procurement documents, to the extent necessary, to require suppliers to have a QA program consistent with the appendix. Your purchase order says what applies to you.
What records should I have ready for an Appendix B audit?
Have your QA program description, organization chart, training records, controlled document list, approved supplier list and sample purchase orders, travelers and inspection and test records for a completed job, the calibration register and certificates, the nonconformance and corrective action logs, audit schedules and reports, and your records retention schedule.
How do I prepare for an Appendix B audit?
Confirm what the purchase documents or license commitments require. Read each criterion on this checklist alongside your own procedures, answer the questions honestly, and pull the records listed. Then trace one completed job from purchase order to shipment and check every record on the way. Close what you find before the audit date.
Find your gaps before the auditor does. The free readiness assessment scores your program against the 18 NQA-1 requirements, which line up with the 18 Appendix B criteria, and lists the gaps. In Forged, each record on this checklist is filed against the job it belongs to, so the record package for an order is in one place when the purchaser asks for it.
References
- U.S. Nuclear Regulatory Commission. 10 CFR Part 50, Appendix B: Quality Assurance Criteria for Nuclear Power Plants and Fuel Reprocessing Plants. eCFR, current as of 1 October 2026; last amended 91 FR 15787, 30 March 2026.
- U.S. Nuclear Regulatory Commission. Regulatory Guide 1.28, Revision 6: Quality Assurance Program Criteria (Design and Construction). Federal Register notice, 11 September 2023.
Forged Operations builds quality management software for nuclear suppliers and operators. Score your program for free at forgedops.com/assessment, or email [email protected].
This checklist is a preparation aid. Regulation quotes are from 10 CFR 50 Appendix B as published on eCFR, current as of 1 October 2026. Check the current text before relying on it. Latest version: forgedops.com/10-cfr-50-appendix-b-audit-checklist/