ML24047A151

RCP 901.5 Assuring the Technical Quality of Inspections 02/01/2024

ML24047A151
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Issue date:	02/01/2024
From:	Huda Akhavannik NRC/NMSS/DMSST
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RCP-901.5 Rev 0 11/29/2023 Page 1 of 32 RCP-901.5 Rev 0 11/29/2023 Page 1 of 32 State of Connecticut Department of Energy and Environmental Protection Radioactive Materials Program RCP-901.5 Procedures for Assuring the Technical Quality of Inspections and Inspection Reports Prepared By: ______________________________________________Date:

Reviewed By:

Date:

Approved By:

Date:

RCP-901.5 Rev 0 11/29/2023 Page 2 of 32 RCP-901.5 Rev 0 11/29/2023 Page 2 of 32 Revision Date Description of Changes

RCP-901.5 Rev 0 11/29/2023 Page 3 of 32 RCP-901.5 Rev 0 11/29/2023 Page 3 of 32 TABLE OF CONTENTS SECTION TITLE PAGE TABLE OF CONTENTS 1.0 PURPOSE... 4 2.0 SCOPE 2.1 Applicability 4

3.0 REFERENCES

5 4.0 DEFINITIONS AND ABBREVIATIONS. 5 5.0 GENERAL.. 6 5.1 Equipment 5.2 Precautions and Limitations 5.3 5.4 5.5 5.6 Responsibilities Prerequisites Records Attachments 6.0 PROCEDURE. 7 ATTACHMENTS Inspection Report Quality Assurance (QA) Checklist. 30

RCP-901.5 Rev 0 11/29/2023 Page 4 of 32 RCP-901.5 Rev 0 11/29/2023 Page 4 of 32 1.0 PURPOSE 1.1 The purpose of this procedure is to provide an outline and checklists to inspectors in order to conduct inspections of radioactive materials licensees compatible with the NRC. The purpose of this Radioactive Materials Program Procedure is to provide guidance to ensure the technical quality of inspections and that inspection reports are consistent with the NRCs criteria for secondary reviews of inspections and inspection reports (See STP SA-102 Reviewing the Common Performance Indicator, Technical Quality of Inspections).

1.2 Objectives 1.2.1 To ensure that inspections of licensed activities focus on health, safety, and security issues in accordance with NRC Inspection Manual Chapter 2800, Materials Inspection Program.

1.2.2 To ensure that inspection findings are well-founded and well-documented in reports.

1.2.3 To verify that inspections are complete and reviewed by a second qualified inspector for technical quality.

1.2.4 To determine that procedures are in place and used to help identify incident root causes and poor licensee performance.

1.2.5 To confirm that follow-up inspections address previously identified open items and/or past violations.

1.2.6 To verify that inspection findings lead to appropriate and prompt regulatory action.

1.2.7 To confirm that supervisors conduct annual accompaniments of each inspector to assess performance and assure application of appropriate and consistent policies and guides.

RCP-901.5 Rev 0 11/29/2023 Page 5 of 32 RCP-901.5 Rev 0 11/29/2023 Page 5 of 32 1.2.8 To determine that inspection guides are consistent with NRC guidance, and that they are being used consistently by inspectors to assure uniform and complete inspection practices.

2.0 SCOPE 2.1 Applicability 2.1.1 This procedure applies to the technical quality of reports drafted by qualified inspectors.

2.1.2 This procedure describes quality assurance actions and applicable responsibilities.

3.0 REFERENCES

3.1 Sections 22a-153-1 to 22a-153-150, inclusive, of the Regulations of Connecticut State Agencies 3.2 Sections 22a-148 through 22a-165(h) of Chapter 446a - Radiation and Radioactive Materials of the Connecticut General Statutes 3.3 NRC Inspection Manual Chapter 2800, Materials Inspection Program 3.4 NUREG 1556 Series 3.5 NRC Inspection Procedures (IP) 8700 Series 3.6 IMC 0620, "Inspection Documents and Records 4.0 DEFINITIONS & ABBREVIATIONS 4.1 IP - Inspection Procedure 4.2 NMED - Nuclear Materials Events Database 4.3 NOV - Notice of Violation

RCP-901.5 Rev 0 11/29/2023 Page 6 of 32 RCP-901.5 Rev 0 11/29/2023 Page 6 of 32 4.4 NOW - Notice of Warning 4.5 NRC - Nuclear Regulatory Commission 4.6 QA - Quality Assurance 4.7 RCPD - Radiation Control Program Director 4.8 SRCP - Supervising Radiation Control Physicist 4.9 RSO - Radiation Safety Officer 5.0 GENERAL 5.1 EQUIPMENT 5.2 PRECAUTIONS AND LIMITATIONS 5.3 RESPONSIBILITIES 5.3.1 Inspector 5.3.1.1 All Department qualified inspectors are required to prepare inspection reports in accordance with the guidance provided in this procedure. See Section 6.0.

5.3.1.2 Each inspection should be performed in accordance with IMC 2800, the NRC Inspection Procedure for that license type and applicable NUREG 1556 Appendix audits and checklists. The checklists from the applicable NUREG Volumes provide for an objective evaluation of individual inspection tasks.

5.3.1.3 Each inspection of a license holder shall be documented. As a minimum a Department Form 591M Safety Inspection and Compliance Inspection (see Attachment 1 of RCP-901.4 Documentation of Inspection Reports) may be used for inspections without issues. A narrative inspection report as described in Section 6.0 of RCP-901.4 is required for a notice of violation or other enforcement or escalated enforcement actions.

RCP-901.5 Rev 0 11/29/2023 Page 7 of 32 RCP-901.5 Rev 0 11/29/2023 Page 7 of 32 5.3.1.4 Each inspection report must be reviewed by a second qualified inspector for quality assurance purposes. The review is to assure compliance with this and other procedures of the Radioactive Materials Program and documented using Attachment 1 Inspection Report Quality Assurance (QA) Checklist.

5.3.2 Supervising Radiation Control Physicist (SRCP) 5.3.2.1 The SRCP must also review and approve each inspection report in a timely manner before final filing.

5.3.3 Radiation Control Program Director (RCPD) 5.3.3.1 The Radiation Control Program Director (RCPD) or designee must annually complete an inspection accompaniment with each of the Radiological Health Specialists qualified as inspectors. These are documented using Appendix B of NRC States Agreement Procedure SA-102 Reviewing the Common Performance Indicator, Technical Quality of Inspections. See Section 6.13 of this procedure.

5.4 PREREQUISITES 5.5 RECORDS 5.6 ATTACHMENTS

- Inspection Report Quality Assurance (QA) Checklist 6.0 PROCEDURE 6.1 Inspection Report Writing 6.1.1 Inspectors have the primary responsibility for ensuring that observations and findings are accurately reported, that referenced material is correctly characterized, and that the scope and depth of conclusions are adequately

RCP-901.5 Rev 0 11/29/2023 Page 8 of 32 RCP-901.5 Rev 0 11/29/2023 Page 8 of 32 supported by documented observations and findings. Advice and recommendations are not to be included in inspection reports.

6.1.2 Inspectors are responsible for ensuring that the content and tone of the report, as issued, is consistent with the content and tone of the exit meeting presentation.

6.1.3 When the report differs significantly from the exit meeting, the individual conducting the inspection should discuss those differences with the licensee before the report is issued.

6.1.4 Inspectors must ensure that inspection reports follow the general format given in this procedure based on the type of inspection. Further guidance on inspection quality and performance is found in RCP 901.1 Scheduling of Inspections, RCP-901.2 Inspection Preparations, 901.3 Performance-Based Inspections. Audits to aid in the quality of inspection performance are found in in the applicable NUREG 1556 Safety Audit Appendices.

6.2 Secondary Report Review and Concurrence 6.2.1 Before issuance, each inspection report must be reviewed by a different member of the Radioactive Materials Program qualified to conduct similar inspections. This secondary report review is designed to better ensure the quality of all inspections and their reports. This secondary review is documented on Attachment 1, Inspection Report Quality Assurance (QA) Checklist.

6.2.2 The secondary report reviewer should establish that conclusions are logically drawn and sufficiently supported by observations and findings and that the observations, findings, and conclusions are consistent with Radioactive Materials Program and other Department policies and requirements.

6.2.3 The secondary report reviewer should ensure that assessments made in the inspection report represent the requirements of the Radioactive Materials Program and established Department policy rather than the personal views

RCP-901.5 Rev 0 11/29/2023 Page 9 of 32 RCP-901.5 Rev 0 11/29/2023 Page 9 of 32 of an individual inspector. This is documented on Attachment 1 Inspection Report Quality Assurance (QA) Checklist.

6.2.4 The Department will maintain Attachment 1 Inspection Report Quality Assurance (QA) Checklist used for secondary report review with the original inspection report to provide a record of inspectors' and reviewers' concurrences. They should address how to ensure continued inspector concurrence when substantive changes are made to the report as originally submitted, and how to treat disagreements that occur during the review process. At a minimum, substantial changes should be discussed with the inspector or inspectors involved to ensure continued concurrence, and disagreements that cannot be adequately resolved should be documented.

6.3 Inspection Report Content and Form 6.3.1 Cover Letter.

6.3.2 The purpose of the cover letter is to transmit the inspection report results to licensee senior management representative and/or RSO.

6.3.3 Inspection reports are transmitted using a cover letter with DEEP letterhead and summarizes the results of the inspection findings.

6.3.4 When the inspection findings reveal the licensees program is adequate to provide for the security of licensed radioactive materials and the protection of workers and the public, then a Department Form 591M Safety Inspection and Compliance Inspection (Attachment 1 of RCP-901.4 Documentation of Inspection Results) or Attachment 4 of RCP-901.4 Clear Inspection Report follows the cover letter.

6.3.4.1 The Clear Inspection Report is transmitted only with the cover letter and other elements of the inspection report.

6.3.5 When the inspection findings reveal a violation, a Notice of Violation or Notice of Warning follows the cover letter (see RCP 901.4 Documentation of Inspection Results).

RCP-901.5 Rev 0 11/29/2023 Page 10 of 32 RCP-901.5 Rev 0 11/29/2023 Page 10 of 32 6.3.6 The cover letter is written to transmit the inspection report to the licensees management, and to deliver the big picture message regarding the inspection. Because it is the highest-level document, it does not need to (and normally will not) detail all the items inspected, and the inspection procedures used. It will note the areas covered by the inspection.

6.3.7 The tone of the cover letter must have a correct balance. The Department focuses on performance issues. If a licensee performed some activity 100 times, and succeeded 99 times, the inspector will be most interested in the single failure. But that does not mean that the cover letter will make it appear that the licensee rarely succeeded. The safety and regulatory significance of any licensee failure will be a primary consideration, above and beyond the numerical frequency of failure compared to success. When identifying problem(s) in a cover letter, the nexus to safety and security will also be provided.

6.3.8 The cover letter must always be consistent with the inspection report. In addition, it must be consistent with the information that the inspector conveyed to the licensee managers at the exit meeting. If the inspectors understanding of the facts, or the perspective on the nature or significance of the findings changes after the exit meeting, the Department shall call the licensee and re-exit. There should never be any surprises in a cover letter to anyone who was present at the exit meeting.

6.3.9 The cover letter for any type of violation should not contain recommendations. A Notice of Warning is required to identify actions that licensees can take to come into compliance. However, care must be taken to avoid consulting. If the licensee is not meeting safety or regulatory requirements, the statements should clearly state those facts. If the Department believes that a licensee cannot ensure the safety of its activities, then an order or some similar official action may be appropriate in accordance with RCP 902.1 Enforcement, Escalated Enforcement and Administrative Action.

6.3.9.1 Cover Letter Content. Cover letter content varies somewhat depending on whether the inspection resulted in findings or not.

In general, every cover letter has the same basic structure, as follows:

RCP-901.5 Rev 0 11/29/2023 Page 11 of 32 RCP-901.5 Rev 0 11/29/2023 Page 11 of 32 6.3.9.1.1 Addresses, Date, and Salutation. At the top of the first page, the cover letter begins with the Department seal and address, followed by the date on which the report cover letter is signed and the report issued. In the upper left-hand corner above the principals addressees name, include the Nuclear Materials Events Database (NMED) number, if applicable.

6.3.9.1.2 Subject Line. The subject line of the letter should state the facility name (if it is not apparent from the Addressee line) and inspection subject. The words NOTICE OF VIOLATION or NOTICE OF WARNING should be included if such a notice accompanies the inspection report. The entire subject line should be capitalized.

6.3.9.1.3 Introductory Paragraphs. The first two paragraphs of the cover letter should give a brief introduction, including the type of inspection report.

6.3.9.1.4 Body. The body of the letter should discuss the most important topics first.

6.3.9.1.5 Closing. The final paragraph consists of standard legal language that varies depending on whether enforcement action is involved.

6.3.9.2 Inspection Report Details 6.3.9.2.1 The detailed discussion in the report provides the information which forms the bases upon which the other sections of an inspection report are developed.

6.3.9.2.1.1 In most cases, the detailed discussion will be organized into one or more sections, each addressing an area of inspection.

RCP-901.5 Rev 0 11/29/2023 Page 12 of 32 RCP-901.5 Rev 0 11/29/2023 Page 12 of 32 6.3.9.2.1.2 Each area will in turn be divided into three parts: scope, observations and findings, and conclusions.

6.3.9.2.1.3 Generic issues, if any, must be discussed in detail (see below).

6.3.9.2.1.4 Violations, if any, must be described in detail and with bases (see below).

6.3.9.2.2 Scope. Scope is the extent of, or the area dealt with, in the inspection. Elements documented in an inspection should cover all relevant areas of the inspections scope. The Scope portion of each area inspected will describe what was inspected. In most cases, the approach that can be used in writing the scope should be consistent with the NRC Inspection Procedure (IP) which was used in performing that portion. Much of the writeup can be extracted from the Purpose section(s) of the applicable NRC IP. When describing the Scope, it is acceptable to state either what the inspector(s) did, or what the inspection accomplished.

6.3.9.2.3 Observations and Findings. The observations and findings are the foundation of every inspection report.

They derive out of performing inspections according to the applicable NRC inspection procedure(s).

6.3.9.2.3.1 There should always be a readily-identifiable connection between the stated Scope and the reported observations and findings. Thus, if the Scope was the review of personnel dosimetry records, the observations and findings will not be about packaging and shipping.

6.3.9.2.3.2 Observations and findings will be descriptive and will be relatively detailed compared to the other parts of the report documentation

RCP-901.5 Rev 0 11/29/2023 Page 13 of 32 RCP-901.5 Rev 0 11/29/2023 Page 13 of 32 package. The amount of detail will be as much as is needed to make clear what was found, and whether it was significant. The inspector should say what was observed or found in an unequivocal manner. If an inspector was looking to see if contamination was well controlled - and it was - the report should state: Contamination was well controlled not Contamination appeared to be well controlled. If too small a sample was examined to reach an unequivocal conclusion, the qualifier should state what specifically was inspected. For example, the report should state that, Contamination was well controlled in the areas examined by the inspectors.

6.3.9.2.3.3 If the inspector identifies no findings during an inspection (other than minor findings), the report should state No findings of significance were identified. A sample letter for an inspection with no items of nonconformance is found in RCP-901.4 Documentation of Inspection Results as Clear Inspection Report.

6.3.9.2.4 Generic Issues. Findings that are likely to have generic concerns e.g., product defects and software problems should include details such as the manufacturers name and model number for components, specifications, and other names and technical data that identify the item of concern. A generic issue is a well-defined, discrete, radiological safety or environmental (with respect to radiological health and safety) matter of which safety/risk significance has been adequately determined.

6.3.9.2.4.1 Generic issues have the potential to affect public health and safety, or the environment

RCP-901.5 Rev 0 11/29/2023 Page 14 of 32 RCP-901.5 Rev 0 11/29/2023 Page 14 of 32 (with respect to radiological health and safety);

6.3.9.2.4.2 The generic issue applies to two or more facilities and/or licensees; 6.3.9.2.4.3 The issue is not being addressed using other regulatory programs and processes; existing regulations, policies or guidance; 6.3.9.2.4.4 The issue can be resolved by new or revised regulation, policy, or guidance; 6.3.9.2.4.5 Resolution of the issue may involve review, analysis, or action by the affected licensees or holders of other regulatory approvals.

6.3.9.2.4.6 Upon discovery of a generic concern during an inspection of a licensees facility, the Department will notify affected Connecticut licensees of the issue. The Department will notify the NRC of the discovery of the generic concern and resolution, if applicable.

6.3.9.2.5 Violations. In the case of a finding that results in a Notice of Violation, it is critical that enough detailed information be given so that the reader can understand what the requirement was, and how it was not met. See Sections 6.4 through 6.12 of this procedure for important information about violations and other findings. After the details of what occurred are provided, two specific concluding statements should be constructed.

6.3.9.2.5.1 The first statement will define what the requirement was, including any related regulation. For example, 10 CFR 20.1801 requires that licensees shall secure from unauthorized access or removal licensed

RCP-901.5 Rev 0 11/29/2023 Page 15 of 32 RCP-901.5 Rev 0 11/29/2023 Page 15 of 32 materials that are stored in controlled or unrestricted areas.

6.3.9.2.5.2 The second statement will describe (or refer to a preceding description) how the requirement was violated. For example, Contrary to this requirement, the licensee failed to secure the radiographic exposure device (manufacturer model and serial numbers.) that contained the sealed source of iridium-192 (manufacturer model and serial numbers, activity, and date of activity) in storage, as described above, is considered a violation of 10 CFR 20.1801. Additional actions or responses by the licensee, if any, should be included to fully describe the violation.

6.3.9.2.6 Conclusions. The Conclusions are statements describing the quality of licensee performance in the area inspected. The report will discuss whether the licensee succeeded or failed, whether performance was good (or some other descriptor), and whether violations were identified. Every statement in a Conclusion section should have a basis (proof that it is correct) written in the observations and findings.

6.3.9.2.7 Exit Meeting Summary. The final section of each inspection report briefly summarizes the exit meeting, which is also described in the first paragraph of the cover letter and identifies the most senior licensee manager who attended the meeting, and includes the following information:

6.3.9.2.7.1 Absence of Proprietary Information. At the exit meeting, the inspectors should verify that information which the inspector reviews during the meeting and intends to include in the report is not proprietary. If the licensee does not

RCP-901.5 Rev 0 11/29/2023 Page 16 of 32 RCP-901.5 Rev 0 11/29/2023 Page 16 of 32 identify any material as proprietary, the exit meeting summary or some other element of the inspection report should include a sentence to that effect.

6.3.9.2.7.2 Subsequent Contacts or Changes in Department Position. The inspector should briefly discuss any contact with the licensee management after the exit meeting to discuss new information relevant to an inspection finding. In addition, if the Department's position on an inspection finding changes after the exit meeting, that change should be discussed with the licensee before the report is issued.

6.3.9.2.7.3 Characterization of Licensee Response.

Licensee responses should not be included in the summary except in cases where the licensee disagrees with the inspection findings. In that case, the summary should state that the licensee took exception to the findings.

6.3.9.2.7.4 Oral Statements and Regulatory Commitments. If at the exit meeting or at any other time during the inspection, the licensee makes an oral statement that it will take a specific action in response to a non-compliance, the statement may be documented in the body of the report. Details of statements made at the exit meeting should not be included in the exit meeting summary. Such statements should only be characterized in the report if the statements represent licensee commitments in response to a non-compliance in order to eliminate the need for a subsequent licensee response. However, the report cover letter must include a provision for the licensee to respond if the commitment documented in the report does not accurately reflect the licensees corrective actions or

RCP-901.5 Rev 0 11/29/2023 Page 17 of 32 RCP-901.5 Rev 0 11/29/2023 Page 17 of 32 positions. Otherwise, licensee commitments are documented by licensee correspondence, after which the inspector may reference the correspondence in the inspection report.

Because regulatory commitments are a sensitive area, the inspector should ensure that any reporting of licensee statements are paraphrased accurately, and contain appropriate reference to any applicable licensee document.

6.3.9.2.8 Report Attachments. The attachments discussed below are included at the end of the inspection report if applicable to the inspection. The attachments may be combined into a single attachment entitled "Supplementary Information."

6.3.9.2.9 Key Points of Contact. The inspector lists, by name and title, those individuals who furnished relevant information or were key points of contact during the inspection (except in cases where there is a need to protect the identity of an individual). The list need not be exhaustive; a list of 5-10 individuals is sufficient.

The alphabetized list includes the most senior licensee manager present at the exit meeting and Department technical personnel who were involved in the inspection if they are not listed as inspectors on the cover page.

6.3.9.2.10 List of Items Opened, Closed, and Discussed (Optional). The report should include a quick-reference list of items opened and closed. Open items that were discussed (but not closed) should also be included in this list, along with a reference to the sections in the report in which the items are discussed.

6.3.9.2.11 List of Documents Reviewed. A list of the appropriate key documents and records reviewed during an inspection that are significant to any finding

RCP-901.5 Rev 0 11/29/2023 Page 18 of 32 RCP-901.5 Rev 0 11/29/2023 Page 18 of 32 must be publicly available. Therefore, if a list is not otherwise made public, the report should include a listing of all the documents and records reviewed during the inspection that are not identified in the body of the report. (See IMC 0620, "Inspection Documents and Records.) "Reviewed" in this context means to examine critically or deliberately.

The list does not include records that were only superficially reviewed. Lists consisting of more than six condition reports, documents reviewed, procedures, etc., should normally be removed from the body of the report and included as an attachment to facilitate reading.

6.3.9.2.12 List of Acronyms, as appropriate. Reports whose details section exceeds 20 pages should include a list of acronyms. For reports in which a relatively small number of acronyms have been used, the list is optional. In all cases, however, acronyms should be spelled out when first used in inspection report text.

6.4 Notice of Violation and Notice of Warning.

6.4.1.1 Licensees are officially notified that they have failed to meet regulatory requirements when Department issues a Notice of Violation (NOV) or a Notice of Warning (NOW) for minor violations. NOVs and NOWs may be sent with an inspection report or in a separate letter which refers to an inspection report that was distributed previously. An NOV should not be sent to the licensee in advance of the inspection report. An example of a Notice of Violation or Warning Letter is Attachment 3 of RCP 901.4 Documentation of Inspection Reports. Letters are generated in ICM/SIMS.

6.4.1.2 Every NOV / NOW must be clear, so that there is little doubt that the licensee (or other reader) can understand the basis for the violation. The licensee may not agree with our basis, but they must understand our position.

RCP-901.5 Rev 0 11/29/2023 Page 19 of 32 RCP-901.5 Rev 0 11/29/2023 Page 19 of 32 6.4.1.3 Every NOV / NOW must clearly state what requirement was not met, including the date and revision number of any applicable documents related to the inspection. A clear statement of what happened (including when, if the timing is important) must be provided. The NOV / NOW should also provide the length of time the licensee was in non-compliance.

6.4.1.4 For more information on Notices of Warning, see Section 6.6. Minor Violations.

6.5 Significance of Observations 6.5.1.1 This section discusses the significance of observations including violations, items of noncompliance, and enforcement actions. The guidance provided in this section is for informational purposes.

6.5.1.2 Thresholds of Significance. When conducting inspections, the Department inspector reviews a selection of procedures, events, and operations; he or she cannot hope to monitor all the activities in progress, nor to document every minor discrepancy that occurs. As part of maintaining a focus on safety, inspectors continually use Department requirements, inspection procedures, industry standards, and their own training and insight to make judgments about which issues are worth pursuing and which are not.

6.5.1.3 To communicate effectively, inspection reports must give evidence of that judgment and prioritization, discussing significant safety issues in appropriate detail, treating less significant issues succinctly, and avoiding excess verbiage. To maintain some consistency in how minor issues are treated, report writers must recognize certain "thresholds of significance." They must use similar criteria in deciding whether an issue is significant and will need

RCP-901.5 Rev 0 11/29/2023 Page 20 of 32 RCP-901.5 Rev 0 11/29/2023 Page 20 of 32 documentation, and if the issue is important enough to track or follow up, etc.

6.6 Minor Violations.

6.6.1 Minor violations are those that are defined in CGS Sec 22a-6s. Minor violations do not warrant enforcement actions and are not of safety significance as it relates to the licensees radiation safety program. Minor violations must be documented in a Notice of Warning. Minor violations may or may not be documented in a narrative inspection report.

6.6.1.1 The Notice of Warning must include the elements described in RCP 901.4 Documentation of Inspection Results - Section 6.3.6.

6.7 Violations Identified as Part of Licensee Self-Assessments.

6.7.1 Under certain circumstances, minor or non-escalated violations may not be documented in the inspection report. This is generally justified when the violation has been identified and corrected as part of a licensee self-assessment effort. As a matter of policy, Department enforcement seeks to encourage licensee self-assessment efforts, and seeks to avoid the negative impact that can result from a redundant Department emphasis on problems which the licensee's responsible action has already identified and corrected.

6.7.1.1 For example, suppose that while evaluating the licensee's quality assurance efforts in the fire protection area, an inspector reviews relevant audits and surveillances conducted over the previous year. The review reveals that the audits have been probing and thorough; the findings are well-developed and technically sound, and include six noncompliance issues, four of which might be classified as non-escalated violations.

6.7.1.2 In such a case, the inspector should follow up on the non-compliances and other audit findings to ensure that root causes have been appropriately identified and assessed, that appropriate and comprehensive corrective actions have been taken, and that no new examples of the

RCP-901.5 Rev 0 11/29/2023 Page 21 of 32 RCP-901.5 Rev 0 11/29/2023 Page 21 of 32 violations exist. Provided that no new problems are revealed by this follow-up, the inspector is normally not expected to cite the four violations individually, nor to report the details of those violations in the inspection report. Instead, the Department report findings and conclusions should assess the adequacy of the licensee's quality assurance efforts, including a clear reference to the name, dates, and general subject matter of the audit or self-assessment.

NOTE: This expectation only applies to Severity Level IV violations. Even when identified through a licensee self-assessment, violations that could be categorized at Severity Level III or above must be documented in the inspection report and given appropriate follow-up.

6.7.1.3 In some instances, reasons exist to document one or more of the violations found in a licensee audit or self-assessment. For example, if the report concludes that the licensee's self-assessment was especially negative, one or more examples should be given to support that conclusion.

6.7.1.4 In addition, the inspector may decide to document one or more of the violations found in a licensee self-assessment due to the technical significance or generic implications of the particular item. Technical details surrounding the violation may provide useful insight on equipment or system reliability, or on some aspect of human performance. In some cases, the inspector may decide to pursue additional follow-up of a particular licensee finding because of related licensee problems, previous Department observations or violations involving the same or a related topic, or emerging government or industry sensitivity in the given technical area.

6.7.1.5 If, for any of these reasons, the inspector decides to discuss in the inspection report a particular licensee self-assessment finding or audit finding, and that finding involves a violation, then the violation must be clearly dispositioned in the report. The violation may be dispositioned as a minor violation documented with a

RCP-901.5 Rev 0 11/29/2023 Page 22 of 32 RCP-901.5 Rev 0 11/29/2023 Page 22 of 32 Notice of Warning (NOW) unless any one of the following circumstances results in a non-escalated violation with an NOV:

6.7.1.5.1 The licensee or non-licensee identified the violation.

6.7.1.5.2 The licensee or non-licensee corrected or committed to correcting the violation within a reasonable period of time by specific corrective action committed to by the end of the inspection, including immediate corrective action and comprehensive action to prevent recurrence.

6.7.1.5.3 The violation is not repetitive as a result of inadequate corrective action.

6.7.1.5.4 The violation is not willful.

6.8 Thresholds of Significance for Non-Enforcement-Related Issues.

6.8.1 Inspectors must also make judgments about the relative significance of non-enforcement-related findings. As with enforcement issues, the judgment of individual inspectors will differ; questions on the relative significance of an issue should be discussed with other inspectors and with Department managers.

6.9 Determining the Significance of Negative Findings.

6.9.1 The following questions should be used to determine whether or not a finding should be documented in the inspection report. If the answer to any one of these questions is "yes," the finding should be documented in the inspection report. If the answers to all questions are "no," the finding normally should not be documented.

RCP-901.5 Rev 0 11/29/2023 Page 23 of 32 RCP-901.5 Rev 0 11/29/2023 Page 23 of 32

• Does the finding have any actual impact (or any significant potential for impact) on safety?

• Is this finding illustrative of a programmatic licensee problem that could have a safety or regulatory impact?

• Does this finding provide insights on an equipment, system, or human performance problem?

• Could the finding be viewed as the possible precursor to a significant event?

• If the licensee takes no action on this matter, will the condition worsen (i.e., will the safety significance increase)?

• If this finding recurs, will its recurrence result in more significant or additional safety concerns?

• Will this information be useful in assessing the long-term performance of this licensee program or functional area?

• Does this finding have generic significance?

6.10 Determining the Significance of Neutral or Positive Findings.

6.10.1 For neutral or positive findings or for licensee improvements, similar thresholds of significance should apply. The inspector should ask questions similar to those below. If the answer to any one of these questions is "yes,"

the finding should be documented in the inspection report. If the answers to all questions are "no," the finding normally should not be documented.

• Does the licensee improvement have an actual positive impact (or a significant potential for positive impact) on safety?

• Will the licensees efforts to impact change in this area be likely to result in programmatic improvements to safety or regulatory performance?

RCP-901.5 Rev 0 11/29/2023 Page 24 of 32 RCP-901.5 Rev 0 11/29/2023 Page 24 of 32

• Will this upgrade be likely to result in improved equipment or system reliability or improved human performance? Does this information provide useful equipment, system, or human performance insights?

• Does this licensee action significantly reduce the probability of a particular event?

• Will this information be useful in assessing the long-term performance of this licensee program or functional area?

• Does this finding have a generic significance?

6.11 Findings Previously Covered in Licensee Self-Assessments.

6.11.1 This decision should be treated similarly to the corresponding decision for enforcement issues. In general, little benefit exists in the Departments re-emphasis of issues already covered in licensee self-assessments, unless there is some problem with the licensee's actions.

6.11.2 In some instances, however, the technical significance or generic implications of an issue merit ensuring that it is discussed and preserved as a matter of public record.

6.11.3 If the licensee self-assessment that initially discussed the issue is already in the licensee files, the inspection report may simply refer to the discussion in the licensee self-assessment. If more detail is needed, or if the licensee self-assessment is not in the licensee files, the inspector may wish to discuss the issue in the inspection report narrative.

6.12 Documenting Noncompliance 6.12.1.1 Types of Noncompliance. The manner of documenting a noncompliance in the inspection report depends on how that noncompliance will be dispositioned. A noncompliance may be addressed as a non-escalated violation, as an escalated enforcement action or as a Minor Violation.

RCP-901.5 Rev 0 11/29/2023 Page 25 of 32 RCP-901.5 Rev 0 11/29/2023 Page 25 of 32 6.12.1.2 Note that a noncompliance may not be documented simply as a "weakness," "licensee failure," or a similar informal characterization. If the report narrative describes a condition or event in a manner that suggests to the reader that a violation may have occurred, then the finding must be clearly dispositioned as a violation, an apparent violation, or an NCV. If a violation does not exist (e.g., no requirement exists in this area), it may be appropriate to clarify the finding by stating that "this condition [or event]

does not constitute a violation of Department requirements."

6.12.1.3 Non-Escalated Enforcement Actions. Most violations of moderate significance (i.e., more than minor concerns) fall into this category. If at the time of issuing the inspection report a violation has been identified, the inspection report will cite it as a "non-escalated" enforcement action.

6.12.1.4 Potential Escalated Enforcement Actions. When an issue is being considered for escalated enforcement action, the inspection report narrative should refer to the potential noncompliance as an "apparent violation." The report details should not include any speculation on the severity level of such violations nor on expected Department enforcement sanctions. Potential escalated actions, by their nature, require further Department deliberation (and, usually, additional licensee input) to determine the appropriate severity level and Department action.

6.12.1.5 Similarly, report narratives that discuss apparent violations should be carefully constructed to avoid making explicit conclusions (i.e., final judgments) about the safety significance of the issue. The report should include any available details that demonstrate safety significance, or that would help in making such a decision and should also describe any corrective actions taken or planned by the licensee. However, since a potential escalated enforcement action automatically entails further evaluative steps,

RCP-901.5 Rev 0 11/29/2023 Page 26 of 32 RCP-901.5 Rev 0 11/29/2023 Page 26 of 32 neither the inspection report details nor the accompanying cover letter should present a final judgment on the issue.

6.12.1.6 Minor Violations. Minor violations should not normally be documented in inspection reports. However, to the extent that documentation is necessary, the standard language should be used: This failure constitutes a violation of minor significance and is not subject to formal enforcement action. A Notice of Warning pursuant to CGS Sec 22a-6s must be provided to the licensee for minor violations.

6.12.1.7 Supporting Details and Discussions of Safety Significance. The discussion of noncompliance issues must be sufficiently detailed to substantiate any Department safety and regulatory concerns and to support any enforcement sanction the Department may choose to issue. At a minimum, for a violation, the report should state:

• What requirement was violated;

• How the violation occurred;

• When the violation occurred, and how long it existed;

• Who identified it, and when;

• Any actual or potential safety consequence;

• The root cause (if identified);

• Whether the violation appears isolated or programmatic;

• What corrective actions have been taken or planned; and

RCP-901.5 Rev 0 11/29/2023 Page 27 of 32 RCP-901.5 Rev 0 11/29/2023 Page 27 of 32

• Who was involved with the violation (i.e.,

management involvement or low-level individual).

6.12.1.8 The degree of detail necessary to support an enforcement action is a function of the significance and complexity of the noncompliance. Although supporting details clearly assist in determining the safety significance of the noncompliance, inspectors should be cautious in making direct statements regarding safety significance in the inspection report details.

6.12.1.9 Violation severity levels are based on the degree of safety significance involved. In assessing the significance of a noncompliance, the Department considers four specific issues: (1) actual safety consequences; (2) potential safety consequences, including the consideration of risk information; (3) potential for impacting the Department's ability to perform its regulatory function; and (4) any willful aspects of the violation.

6.12.1.10 As a result, if an inspection report refers to a noncompliance as being "of low safety significance" (meaning, in a general sense, that the noncompliance did not result in any actual adverse impact on equipment or personnel), the writer may have inadvertently made it difficult for the Department to subsequently decide that the potential for an adverse impact or the regulatory significance of the noncompliance warrants issuance of a Severity Level III violation. Therefore, before characterizing a violation as being of low safety significance, the inspector should also address the potential consequences and regulatory consequences of the violation in addition to the absence of an actual adverse consequence.

6.12.1.11 Noncompliance Involving Willfulness. Inspection reports should neither speculate nor reach conclusions

RCP-901.5 Rev 0 11/29/2023 Page 28 of 32 RCP-901.5 Rev 0 11/29/2023 Page 28 of 32 about the intent behind a violation, such as whether it was deliberate, willful, or due to careless disregard. The Enforcement Division will make determination of willfulness for escalated enforcement violations referred for civil penalties. As with any observation, the report discussion should include relevant details on the circumstances of the violation without making a conclusion about the intent of the violator. EXAMPLE:

"The radiographer failed to activate his alarming ratemeter, although he had informed the inspectors earlier that he had been properly trained on the use of the device;" not, "The radiographer deliberately failed to activate his alarming ratemeter.

6.13 Supervisory Accompaniments 6.13.1.1 At least annually, the Radiation Control Program Director (RCPD) or a designee will accompany each Department materials license inspector on at least one inspection. This will allow the RCPD to determine whether the inspector is following Department guidelines and good practices as established in Inspection Manual Chapter 2800 Materials Inspection Program.

6.13.1.2 In order to ensure the inspection meets Department criteria, the RCPD or designee will use SA-102 Appendix B, Inspector Accompaniment Summary Sheet to document the inspection.

6.13.1.3 The review of the inspection will be discussed with the inspector. This will ensure that any deficiencies may be identified in a timely manner.

6.13.1.4 The inspection reports for the accompaniment inspection along with any associated correspondence will be placed in a file at the RCPDs office.

6.13.1.5 Additionally, the RCPD or designee will utilize SA-102 Attachment B-1 along with the relevant inspection

RCP-901.5 Rev 0 11/29/2023 Page 29 of 32 RCP-901.5 Rev 0 11/29/2023 Page 29 of 32 guidance from the applicable NRC Inspection Procedure when reviewing inspections and inspection reports to determine the adequacy of the inspection. The checklist provides for an objective evaluation of individual inspection tasks. Performance of each individual inspection task i.e., inspector instrumentation, inspection procedure used, effective licensee communication etc.,

are evaluated to determine the completeness of inspection preparation, performance and inspection report generation.

RCP-901.5 Rev 0 11/29/2023 Page 30 of 32 RCP-901.5 Rev 0 11/29/2023 Page 30 of 32 ATTACHMENT 1 INSPECTION REPORT QUALITY ASSURANCE (QA)

CHECKLIST INSPECTION REPORT QUALITY ASSURANCE (QA) CHECKLIST License Number:

License type:

Inspector:

Inspections Date(s):

Inspection Type:

Initial Routine Reactive Special Reduced Inspection Area Evaluation Comments Inspection report issued within 30 days Satisfactory Unsatisfactory Department Form 591M issued (Clear Inspections)

Satisfactory Unsatisfactory N/A Report Details Satisfactory Unsatisfactory Observations and Findings Satisfactory Unsatisfactory

RCP-901.5 Rev 0 11/29/2023 Page 31 of 32 RCP-901.5 Rev 0 11/29/2023 Page 31 of 32 Conclusions Satisfactory Unsatisfactory Documenting Noncompliance Satisfactory Unsatisfactory N/A Report Review and Concurrence List all items reviewed (note any non-concurrences)

RCP-901.5 Rev 0 11/29/2023 Page 32 of 32 RCP-901.5 Rev 0 11/29/2023 Page 32 of 32 Inspector:

Signature:

Reviewed and Approved By:

Signature: