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{{#Wiki_filter:OFFICE OF NUCLEAR REACTOR REGULATION REGULATORY AUDIT TOPICS REGARDING HUMAN FACTORS ENGINEERING; OPERATOR TRAINING AND REQUALIFICATION; AND CONDUCT OF OPERATIONS DESCRIBED IN OPERATING LICENSE APPLICATION CONSTRUCTION PERMIT NO. CPMIF-001 SHINE MEDICAL TECHNOLOGIES, LLC SHINE MEDICAL ISOTOPE PRODUCTION FACILITY DOCKET NO. 50-608 By {{letter dated|date=July 17, 2019|text=letter dated July 17, 2019}} (Agencywide Documents Access and Management System (ADAMS) Accession No. ML19211C044), as supplemented by letters dated November 14, 2019 (ADAMS Accession No. ML19337A275), March 27, 2020 (ADAMS Accession No. ML20105A295), August 28, 2020 (ADAMS Accession No. ML20255A027),
{{#Wiki_filter:}}
November 13, 2020 (ADAMS Accession No. ML20325A026), December 10, 2020 (ADAMS Accession No. ML20357A084), December 15, 2020 (ADAMS Accession No. ML21011A264),
and March 23, 2021 (ADAMS Accession No. ML21095A235), SHINE Medical Technologies, LLC (SHINE) submitted to the U.S. Nuclear Regulatory Commission (NRC) an operating license application for its proposed SHINE Medical Isotope Production Facility in accordance with the requirements contained in Title 10 of the Code of Federal Regulations Part 50, Domestic Licensing of Production and Utilization Facilities.
During the NRC staffs review of the SHINE operating license application, questions have arisen related to SHINEs human factors engineering (HFE) program; operator training and requalification; and conduct of operations for which additional information is needed to determine that there is reasonable assurance of adequate protection of public health and safety and that applicable regulatory requirements are met. The topics below identify areas where additional information is needed for the NRC staff to continue its review and may become formal requests for additional information following the May 18 - 19, 2021, regulatory audit.
Regulatory Basis and Applicable Guidance Documents The SHINE HFE program, as described in the SHINE operating license application, is being evaluated using the following regulations and guidance:
* Section 50.34, Contents of applications; technical information, paragraph (a) of 10 CFR states, in part, that [e]ach application for a construction permit shall include a preliminary safety analysis report. Specifically, Section 50.34(a)(3) states, in part, that the minimum information to be included in a preliminary safety analysis report shall consist of the preliminary design of the facility, including the principal design criteria for the facility. The requirements in 10 CFR 50.34(b)(1) and (2) state, in part, that an operating license application should include all current information, which has been Enclosure 2
 
developed since the issuance of the construction permit, as well [a] description and analysis of the structures, systems, and components of the facility, with emphasis upon performance requirements, the bases, with technical justification therefor, upon which such requirements have been established, and the evaluations required to show that safety functions will be accomplished. The description shall be sufficient to permit understanding of the system designs and their relationship to safety evaluations. As part of presenting its design bases, in SHINE final safety analysis report (FSAR) Table 3.1-3, SHINE Design Criteria, SHINE establishes the following Principle Design Criteria (PDC) that is relevant to its HFE program:
PDC 6 - Control Room A control room is provided from which actions can be taken to operate the irradiation units safely under normal conditions and to perform required operator actions under postulated accident conditions.
* SHINE FSAR Chapter 7, Instrumentation and Control Systems, Section 7.1.5, states, in part, that SHINE uses HFE principles to facilitate the safe performance of operations and to ensure that the implementation of operator interfaces is standardized across vendors.
* NUREG-0700, Human-System Interface Design Review Guidelines, Revision 2, issued May 2002 (ADAMS Accession No. ML021700337)
* NUREG-0711, Human Factors Engineering Program Review Model, Revision 3, issued November 2012 (ADAMS Accession No. ML12324A013)
The SHINE operator training and requalification program, as described in the SHINE operating license application, is being evaluated using the following regulations and applicable guidance:
* Section 50.34(b)(8), of 10 CFR requires that the FSAR include a description and plans for implementation of an operator requalification program
* Section 50.54, Conditions of licenses, of 10 CFR paragraphs (i) through (m)(1), covers applicable requirements for operators licensed pursuant to 10 CFR Part 55, Operators' Licenses, and for establishing a requalification program
* Section 55.59, Requalification, of 10 CFR covers the elements of a requalification program
* NUREG-1478, Operator Licensing Examiner Standards for Research and Test Reactors, Revision 2, dated June 30, 2007 (ADAMS Accession No. ML072000059)
The SHINE conduct of operations, as described in the SHINE operating license application is being evaluated using the following regulations:
* Section 19.12, Instruction to workers, of 10 CFR which provides instructions to all workers who in the course of employment are likely to receive in a year an occupational dose in excess of 100 millirem (1 millisievert)
* Section 50.34(b)(6)(i), of 10 CFR requires that an applicant describe its organizational structure, allocations or responsibilities and authorities, and personnel qualifications requirements.
The NRC staffs review of the SHINE HFE program; operator training and requalification program; and conduct of operations is also based on the following:
* NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, issued February 1996 (ADAMS Accession No. ML042430055)
* NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Standard Review Plan and Acceptance Criteria, issued February 1996 (ADAMS Accession No. ML042430048)
* Final Interim Staff Guidance Augmenting NUREG-1537, Part 1, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors: Format and Content, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A069)
* Final Interim Staff Guidance Augmenting NUREG-1537, Part 2, Guidelines for Preparing and Reviewing Applications for the Licensing of Non-Power Reactors:
Standard Review Plan and Acceptance Criteria, for Licensing Radioisotope Production Facilities and Aqueous Homogeneous Reactors, dated October 17, 2012 (ADAMS Accession No. ML12156A075)
Audit Topics Human Factors Engineering Subtopic 1: Accident Analysis Audit Topic 1 The human role, as well as the manner in which SHINE considered it from a HFE perspective needs to be clarified. Explain the human role in safe operation of the SHINE facility in a consolidated manner. Currently, aspects of this are spread out across the FSAR (e.g., PDC 6, Sections 7.6.1.1, 7.6.2.2.3, 13a2.2, 13.b.2.3, 7.6, 13b.1.2, 13b.1.2.4, target solution vessel reactivity protection system (TRPS) Criterion 51, engineered safety features actuation system (ESFAS) Criterion 52, etc.). Furthermore, there appears to be inconsistency for some characterizations of this role (e.g., preventative and/or mitigative functions, functions allocated to operators to safety systems, only defense-in-depth credit given, etc.).
Audit Topic 2 It is unclear to NRC staff if the roles of licensed operators and field operators are preventative, mitigative, both, or neither in nature for the operation of the Radioisotope Production Facility (RPF)? Characterize the roles of licensed operators and field operators during RPF operations.
For example, SHINE documentation appears to imply that the role of specific administrative
 
controls (SACs) is both preventative and mitigative in nature (e.g., SHINE Safety Analysis Summary Report scenario IDs 13b.2.4-S, 13b.3-A, FRI-2, FRI-6, and CRI-1, as well as FSAR Section 13b.1.2).
Audit Topic 3 The table below contains a sampling of accident sequences of interest to inform HFE discussions of SHINEs accident analysis. In particular, the NRC staff requests that SHINE be prepared to discuss the human role in the four bolded accident scenarios below (i.e., 13a2.1.4-A, 13a2.1.12-O, 13b.2.7-A, and FRI-2). The NRC staff requests that SHINE identify and discuss other sequences from the table below where the importance of human action is considered to be highest, and also to describe SHINEs basis for that determination.
There may be sequences beyond those identified below that SHINE or the NRC staff determine also merit discussion.
13a2.1.2-D          13a2.1.4-A          13a2.1.4-H          13a2.1.7-E          13a2.1.12-A 13a2.1.12-C          13a2.1.12-D          13a2.1.12-E        13a2.1.12-O          13b.2.4-A 13b.2.4-C            13b.2.7-A          13b.2.5-E          13b.2.5-O            13b.2.5-P 13b.2.5-U          13b.2.5-AD              SE-5              SE-6                  SE-8 CRI-2                CRI-3              FRI-2              FRI-6 Subtopic 2: Control Console and Display Instruments-Related Review Questions Audit Topic 4 The minimum staffing model described in FSAR Section 12.1.3 consists of one senior licensed operator present in the facility, one senior licensed operator or licensed operator present in the control room, and one additional designated person present at the facility able to carry out prescribed written instructions. It is not clear that this model provide assurance that defense-in-depth actions would reliably occur during periods of high facility activity. Discuss how SHINEs minimum staffing model supports the case that operators can reliably fulfil a defense-in-depth role at the facility. Additionally, explain what analyses were used to determine the number and qualifications of operations personnel necessary to support the full range of plant conditions and tasks (including operational tasks under normal, abnormal, and emergency conditions).
Audit Topic 5 FSAR Section 7.6 states, in part that the main control board, [process integrated control system] PICS and [neutron driver assembly system] NDAS operator workstations, and supervisor workstation are not credited with performing safety functions and only assist operators in  diverse actuations to the safety systems. With regard to the diverse actuations of safety systems, what demonstrates that such diverse means could be used to actuate safety systems in a time frame adequate to effectively mitigate an event where a safety system has failed? The NRC staff seeks to understand how SHINEs combination of human system interfaces (HSI), procedures, operator training, etc. will allow SHINE operators to reasonably fulfill the diverse actuations function. Stated differently, it is one thing to provide the pushbuttons to manually initiate a protective action, but it is another matter to show that an operator will correctly interpret indications that such action is required, apply relevant procedural
 
guidance, select the appropriate manual controls, and input a manual actuation prior to facility safety being challenged.
Audit Topic 6 Explain whether operator action will be used to provide diversity to safety systems in the event that a common-cause failure of safety systems occurs.
Audit Topic 7 FSAR Section 7.4.2.2.14 states that changes to the TRPS design throughout the lifecycle process include human factors considerations. FSAR Section 7.5.2.2.14 states that changes to the ESFAS design throughout the lifecycle process include human factors considerations. How will it be ensured that HFE guidelines will be applied to future HSI modifications such that the ability of the operator to reliably implement defense-in-depth actions is maintained over the life of the facility? It is unclear to the NRC staff how SHINE intends to maintain the application of the HFE guidelines after initial installation of instrumentation and control systems. Subsequent modifications to the TRPS and ESFAS could affect the HSI for safety systems such that there may not be assurance that manual actions for defense-in-depth could be implemented effectively.
Audit Topic 8 The procedure categories listed by FSAR Section 12.3 and the categories of procedures described within the referenced standard (American National Standards institute/American Nuclear Society (ANSI/ANS)-15.1-2007) do not explicitly include those related to the emergency or abnormal operating conditions under which the need to manually actuate the TRPS or ESFAS safety systems would be expected to occur. Explain what will ensure that operators will have the procedural guidance necessary to implement defense-in-depth actions.
Audit Topic 9 TRPS Criterion 51 and ESFAS Criterion 52 both state that human factors shall be considered at the initial stages and throughout the design process to ensure that the functions allocated in whole or in part to the operator(s) can be successfully accomplished to meet design goals. It is unclear what is being referred to by the functions allocated in whole or in part to the operator(s) can be successfully accomplished to meet design goals. What functions are allocated to operators for these systems, how was this determined, and how will it be verified that they can be accomplished? The NRC staff seeks to understand how SHINE analyzed the functions allocated to operators, the tasks assigned to them, and how the design of SHINE safety systems and related HSI will facilitate the performance of such tasks.
Audit Topic 10 The SHINE HFE program states that after installation of equipment, the HFE checklist should be used to document the verification activities. What process exists for the tracking and resolution of any identified discrepancies (e.g., a corrective action program)? There appears to be a process for checking HFE criteria during equipment installation, but there does not appear to be any mechanism for tracking and resolving any issues that might be identified.
 
Audit Topic 11 The SHINE HFE Design Guidelines document references ISA-RP60.3-1985 (Human Engineering for Control Centers) for certain criteria associated with Control Panel General Design. What is the basis for using this reference in lieu of a newer standard?
Audit Topic 12 For operations that must be performed using controls and indications at the main control board, will the workstation control panels be capable of being swiveled around such that any required parameters can still be viewed while standing on the front side of the workstation?
Audit Topic 13 For facility operations that require manual operations, has the effect of workload on operator performance been considered? The rationale behind this question is that manual operations are more demanding for the operators and can present an increased opportunity for errors.
Based upon that, the NRC staff seeks to better understand how this aspect of operations was considered.
Audit Topic 14 Do alarms received in the facility control room (i.e., via operator PICS workstations, main control board, criticality accident alarm system, and fire detection) make an audible sound? This does not appear to be mentioned in the FSAR. It also does not appear to be addressed by either the TECRPT-2020-0018 design guidelines or as part of the FRM 1200-09-03-01 HFE checklist.
This is a concern because of the potential for the operator to not be alerted to the receipt of important alarms. Additionally, are alarms presented on the main control board, or just on the operator PICS workstation? This is unclear as FSAR Section 7.6.2.2.8 describes that alarm indication is provided on both the operator workstations and the main control board, however there do not appear to be other discussions regarding alarms on the main control board elsewhere.
Subtopic 3: Administrative Controls Audit Topic 15 The NRC staff cannot identify any programmatic measures that verify and validate the ability of procedures to provide clear, correct guidance when administrative controls are involved. The description provided in FSAR Section 12.3 of the procedure program does not appear to account for the verification and validation of procedures. Explain how procedures will be verified and validated such that they can be expected to reliably implement SACs prior to use.
Stated differently, how will SHINE ensure that facility procedures will be implemented and that the SAC procedural controls can be relied upon to work as written? Will these procedures be validated? This information is requested to establish that the administrative controls will be both reliable and effective. This is important because the reliability of the SACs appears to be linked to the validity of certain assumptions made within the accident analysis.
 
Audit Topic 16 Non-licensed operators (e.g., hot cell operators) appear to have responsibilities for implementing SACs. What training will non-licensed operators have to ensure that they can implement SACs reliably? The NRC staff notes that SHINEs operator training and requalification program, as described in FSAR Section 12.10, does not account for the training and qualification of non-licensed facility personnel on management measures. Explain how non-licensed operators will be trained and qualified such that they can be expected to reliably implement SACs.
Audit Topic 17 Discuss the operator response(s) expected in reaction to a criticality accident alarm. This alarm plays an important role in warning operators of unsafe facility conditions. The NRC staff seeks to better understand what the implications of this alarm being received would be for SHINE operators and what their response is expected to entail.
Operator Training and Requalification Program Audit Topic 18 The regulation, 10 CFR 50.34(b)(8), states, in relevant part, that the FSAR supporting an application for an operating license shall include a description and plans for implementation of an operator requalification program. The operator requalification program must as a minimum, meet the requirements for those programs contained in 10 CFR 55.59. The regulation, 10 CFR 55.59(c), states, in relevant part, that a facility licensee shall have a requalification program reviewed and approved by the Commission. The regulation, 10 CFR 50.54(i-1), states in relevant part, that an operator requalification program shall be in effect within 3 months after the issuance of an operating license.
While SHINE has provided a description of the areas covered by the requalification program, its application for an operating license does not provide a program for approval or discuss implementation in sufficient detail. This information is necessary for the NRC staff to determine that SHINE would possess or have reasonable assurance of a requalification program that addresses the elements required by regulation.
Provide a separate, written requalification program that describes, in detail, how SHINE will address each applicable requirement contained under 10 CFR 55.59(c), as identified below.
Include a discussion of any procedure(s) that will be developed and maintained in order to implement specific sections of the requalification program.
: a. The regulation, 10 CFR 50.34(b)(8), requires plans for implementation of the requalification program following issuance of the operating license.
Describe how SHINE intends to implement the provisions of the requalification program.
: b. The regulation, 10 CFR 55.59(c)(2), requires the requalification program to include preplanned lectures on a regular and continuing basis.
Describe, in detail, how SHINE intends to implement the requirement to deliver lectures, to include: planning, schedule/frequency, and specific topics/subject matter. Lecture
 
topics shall be consistent with those provided in 10 CFR 55.59(c)(2) and consider the guidance on topics for production facilities provided in Section 12.10b of the interim staff guidance (ISG) to NUREG-1537.
: c. The regulation, 10 CFR 55.59(c)(3)(i), requires the requalification program to include on-the-job training such that each licensed operator manipulates the controls during the terms of the license.
Describe, in detail, how SHINE intends to implement the requirement to ensure licensed operators perform manipulations, to include: applicability of each item listed in 10 CFR 55.59(c)(3)(i)(A) through (AA), the frequency on which the manipulations shall be performed, how many manipulations related to the items are required, and any additional manipulations or items that may be appropriate based on facility design as provided by the guidance for production facilities provided in Section 12.10b of the ISG to NUREG-1537.
: d. The regulation, 10 CFR 55.59(c)(3)(ii), requires the requalification program to include on-the-job training such that each licensed operator knows the operating procedures and understands operation of apparatuses and mechanisms associated with the control manipulations discussed in 10 CFR 55.59(c)(3)(i).
Describe, in detail, how SHINE intends to implement the requirement for ensuring licensed operators maintain knowledge and understanding of operating procedures and operation of equipment.
: e. The regulation, 10 CFR 55.59(c)(3)(iii), requires the requalification program to include on-the-job training such that each licensed operator maintains cognizance of facility design changes, procedure changes, and facility license changes.
Describe how SHINE intends to implement the requirement for ensuring licensed operators will be updated and trained on all aforementioned changes.
: f. The regulation, 10 CFR 55.59(c)(3)(iv), requires the requalification program to include on-the-job training such that each licensed operator reviews the contents of all abnormal and emergency procedures on a regularly scheduled basis.
Describe how SHINE intends to implement the requirement for ensuring licensed operators review abnormal and emergency procedures, including frequency of review.
: g. The regulations, 10 CFR 55.59(c)(4)(i) through (c)(4)(iv), require the requalification program to include evaluations for licensed operators, to include: comprehensive written examinations and annual operating tests to determine where retraining is necessary, written examinations for evaluating knowledge of abnormal and emergency procedures, systematic observation and evaluation by supervisors of performance and competency, and accelerated requalification if evaluations indicate the need.
Describe, in detail, how SHINE intends to implement the requirements for ensuring licensed operators are evaluated, to include: criteria for acceptable performance, applicability of items in 10 CFR 55.41, Written examination: Operators, and 10 CFR 55.43, Written examination: Senior operators, to be included in the written
 
examination, and applicability of items in 10 CFR 55.45, Operating tests, paragraphs (a)(2) through (a)(13) to be sampled during the operating test.
: h. The regulation, 10 CFR 55.59(c)(5), requires the requalification program to maintain certain records for each participating licensed operator.
Describe how SHINE intends to implement the requirements for ensuring records for each licensed operator are maintained, to include: what records will be retained, how records will be maintained, and the retention period for each.
Audit Topic 19: Fitness for duty The regulation, 10 CFR 55.53, Conditions of licenses, paragraphs (j) and (k), provides requirements for licensed operators related to drug and alcohol use and participation in an established drug and alcohol testing program.
Describe, in detail, the drug and alcohol testing program that will be implemented or utilized for licensed operators.
Audit Topic 20: Operator Licensing The regulation, 10 CFR 55.53(e), requires, in order to maintain active status, a licensed operator to actively perform the functions for a specified number of hours per calendar quarter.
The regulation, 10 CFR 55.53(f), requires, in order to restore active status, a licensed operator to perform a minimum amount of hours of licensed duties under the direction of another operator. While SHINEs application states that the requalification program describes the essential training required to maintain a license in active status, it does not discuss operator proficiency in sufficient detail.
Describe, in detail, how SHINE intends to implement this requirement to ensure operators can remain proficient and regain proficiency, including: an illustrative list of activities or duties, in addition to various examples of control manipulations, that are considered actively performing the functions of an operator or senior operator.
Audit Topic 21: Operator Manipulations The regulation, 10 CFR 50.54(i), states, in relevant part, the licensee may not permit the manipulation of the controls of any facility by anyone who is not a licensed operator or senior operator as provided in 10 CFR Part 55. The regulation, 10 CFR 50.2, Definitions, provides two definitions: 1) Controls when used with respect to nuclear reactors means apparatus and mechanisms, the manipulation of which directly affects the reactivity or power level of the reactor; and, 2) Controls when used with respect to any other facility means apparatus and mechanisms, the manipulation of which could affect the chemical, physical, metallurgical, or nuclear process of the facility in such a manner as to affect the protection of health and safety against radiation. The regulation, 10 CFR 50.5, Deliberate misconduct, paragraph (j), states, in relevant part, that apparatus and mechanisms other than controls, the operation of which may affect reactivity shall be manipulated only with the knowledge and consent of an operator or senior operator present at the controls.
 
Describe, in detail, the manipulations of the controls, mechanisms, or other apparatus that will be performed by or with the knowledge of operators and senior operators, to include:
system/action and affected parameter (e.g. reactivity, chemical process, nuclear process).
Audit Topic 22: Operator Present at Controls The regulation, 10 CFR 50.54(k), states, in relevant part, that an operator or senior operator shall be present at the controls at all times during the operation of the facility.
Discuss staffing for all combinations of anticipated conditions locally and in the control room, giving consideration for the number of irradiation units and potential for unique or different conditions present across all units at any given time, to include: operation, shutdown, secured, draining, filling, processing.
Audit Topic 23: Senior Operator Present The regulation, 10 CFR 50.54(m)(1), requires, in relevant part, a senior operator to be present at the facility or readily available on call at all times during its operation, and shall be present at the facility during initial start-up and approach to power, recovery from an unplanned or unscheduled shut-down or significant reduction in power, and refueling, or as otherwise prescribed in the facility license.
Discuss how SHINE will implement the requirement to have a senior operator present, including any unique facility considerations.
Discuss whether the unexpected absence of any minimum staffing positions, as described in technical specification (TS) 5.1.3, applies to the licensed operators present at the facility or if it applies only to the additional designated person at the facility able to carry out prescribed written instruction (see: TS 5.1.3.c).
Audit Topic 24: Change in Operator Status The regulation, 10 CFR 50.74, Notification of change in operator or senior operator status, requires that each licensee shall notify the NRC within 30 days of a change in the status of a licensed operator or senior operator: (a) Permanent reassignment from the position for which the licensee has certified the need for a licensed operator or senior operator under § 55.31(a)(3) of this chapter; (b) Termination of any operator or senior operator; (c) Permanent disability or illness as described in § 55.25 of this chapter.
Discuss how SHINE will implement the requirement to notify the NRC for a change in operator status.
Audit Topic 25: Operator Training Regulations in 10 CFR 55.40, Implementation, 10 CFR 55.41, 10 CFR 55.43, 10 CFR 55.45, and 10 CFR 55.46, Simulation facilities, outline the requirements for written examinations and operating tests for licensed operators and senior operators. For written examinations, the knowledge, skills, and abilities will be identified, in part, from learning objectives derived from a systematic analysis of licensed operator or senior operator duties performed by each facility licensee and contained in its training program and from information in the FSAR, system description manuals and operating procedures, facility license and license amendments,
 
licensee event reports, and other materials requested from the facility licensee by the Commission. For operating tests, the content will be identified, in part, from learning objectives derived from a systematic analysis of licensed operator or senior operator duties performed by each facility licensee and contained in its training program and from information in the FSAR, system description manuals and operating procedures, facility license and license amendments, licensee event reports, and other materials requested from the facility licensee by the Commission.
While SHINE has provided a description of the areas covered by the initial training program, its application for an operating license does not discuss operator training in sufficient detail. This information is necessary for the NRC staff to understand and aid in the development of operator licensing examinations and to determine that SHINE would possess or have reasonable assurance of an initial training program for operators and senior operators that addresses the elements required by regulation.
Provide additional detailed information on the initial training program, including training on the general and specific areas identified for written examinations and operating tests in 10 CFR Part 55, ANSI/ANS-15.4-2016, Selection and Training of Personnel Research Reactors, NUREG-1478, and any training on additional areas based on the SHINE design.
This information should include or cover a complete list of subjects/topics, plans/outline for instruction, applicable references (including those for fundamentals and theory), and intent on use of the facility or simulator for operating tests.
NRC staff note: Several regulations in 10 CFR Part 55 reference a facility licensees training program - 10 CFR 55.13, General exemptions, paragraph (a)(2),
10 CFR 55.41(a), 10 CFR 55.43(a), 10 CFR 55.45(a) - however, unless the licensee is using a systems approach to training, there is no requirement to submit the program for approval. This is consistent with 10 CFR 50.120, Training and qualification of nuclear power plant personnel.
While there is no specific regulatory requirement for a plan/program; however, the Part 50 licensee is required to provide candidates for an operator or senior operator license that meet requirements of 10 CFR Part 55. The NRC staff should verify that the initial operator qualification and operator training programs cover the same training areas as required by the regulations, license, and requalification program. The NRC staff should verify that the programs will support the certifications made by the facility licensee as required by 10 CFR 55.31, How to apply, paragraphs (a)(4) and (a)(5). Training should cover the areas that are applicable in the requalification program, as specified for the written exam in 10 CFR 55.41(b) and 55.43(b), and as specified for the operating test in 10 CFR 55.45. As applicants will also be tested in other subject areas applicable to the regulations and license, there may be overlap with TS or other program that specifies a training requirement, e.g. radiation protection, emergency response, quality assurance.
Audit Topic 26 The requirements in 10 CFR 55.59(a)(2) state: Each licensee shall [p]ass a comprehensive requalification written examination and an annual operating test. The guidance for examinations provided in ANSI/ANS-15.4-2016, Section 5.4 states, in part: Written, operating, and oral examinations for initial licensing shall be administered by or under the direction of the responsible authority. The examinations should be designed and weighted for the appropriate license level. Section 5 of the SHINE training program does not mention who will be developing, administering, and grading these tests. Describe how SHINE will make sure that
 
the person who develops, administers, and grades these tests is not indefinitely exempt from the requirements of taking a written examination and operating test him/herself.
Audit Topic 27 The requirements in 10 CFR 55.59(c)(6) state: The requirements of this section may be met by requalification programs conducted by persons other than the facility licensee if the requalification programs are similar to the program described in paragraphs (c) (1) through (5) of this section and the alternative program has been approved by the Commission. The SHINE training program does not include descriptions of how it will meet the requirements of 10 CFR 55.59(c)(6). What provisions has SHINE developed for an alternative training program?
Conduct of Operations Subtopic 1: Organization Audit Topic 28 FSAR Section 12.1.4.2 states, in part, that [t]he design and implementation of the radiation protection training program complies with the requirements of 10 CFR 19.12. However, SHINE does not describe how this is accomplished. Discuss in greater detail how SHINEs radiation protection training program will meet the requirements of 10 CFR 19.12.
Audit Topic 29 Figure 12.1-1 provides the SHINE Operational Organization Chart. In this chart, the Shift Supervisor is shown to report to the Operations Manager. However, there does not appear to be communication lines shown between the Shift Supervisor and the Radiation Protection Manager, as shown in Figure 1 of ANSI/ANS-15.1-2007. Clarify if this communication line exists between the Shift Supervisor and the Radiation Protection Manager.
Subtopic 2: Review and Audit Activities Audit Topic 30 FSAR Section 12.2.1 states, in part, that [t]he qualifications for the review and audit committee members shall include a broad spectrum of technical, operational, and managerial expertise.
Non-SHINE employees may be appointed as committee members, at the discretion of the COO
[Chief Operating Officer]. Can SHINE provide any additional detail on the types of technical, operations, and managerial expertise that will be represented on the audit committee?
Additionally, what circumstances would a non-SHINE individual be appointed as a committee member?
Audit Topic 31 FSAR Section 12.2.2 describes the charter and rules for the SHINE review and audit committee.
This section states, in part, that approval of minutes shall happen in a timely manner. Can SHINE define what constitutes a timely manner? The acceptance criteria in Section 12.2 of NUREG-1537, Part 2 state that [m]inutes of committee meetings should be approved and distributed within 3 months after the meeting.}}

Revision as of 11:43, 8 September 2021

Shine - Hfe Audit Topics
ML21137A340
Person / Time
Site: SHINE Medical Technologies
Issue date: 05/25/2021
From: Steven Lynch
NRC/NRR/DANU/UNPL
To: Piefer G
SHINE Medical Technologies
Lynch S
Shared Package
ML21137A338 List:
References
Download: ML21137A340 (12)
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