**IMC 1248, Appendix D**

**Training Requirements and Qualification Journal for Byproduct Material Sealed Source Device Reviewers**

1246, APPENDIX B	XVI-2	 Issue Date: 02/11/04

**APPENDIX D**

**TRAINING REQUIREMENTS FOR SEALED SOURCE AND DEVICE REVIEWERS**

A. **Applicability**

The training described below is required for all materials license reviewers

assigned to perform radiological safety reviews of sealed source and device

applications.

B. **Training**

1. Required Initial Training

a. Self Study and on-the job Training

(1) NRC Orientation

(2) Code of Federal Regulations

(3) Office Instructions

(4) Regulatory Guidance

(5) NRC Management Directives

(6) ADAMS

(7) Agreement States Program and Interaction

(8) Directed Review of Selected Licensing Case Work

b. Core Training.  These course establish minimum formal classroom training requirements.  Refer to Section 1248-11 for exceptions to these requirements.

(1) Basic Health Physics Technology Course (H-122)

(2) Licensing & Inspection Course (G-108)

(3) Licensing Practice & Procedures Course (G-109)

c. Specialized Training.  Additional courses may be required in order to gain knowledge necessary for specialized licensing activities.  Management will make this determination on an individual basis.

END

Issue Date:  04/19/13	D1	1248

					TECHNICAL REVIEWER QUALIFICATIONS JOURNAL

				BYPRODUCT MATERIAL SEALED SOURCE AND DEVICE REVIEWERS

Applicability

This NRC Technical Reviewer Qualification Journal implements NRC Manual Chapter 1248, by establishing the minimum training requirements for personnel assigned to perform technical evaluations of byproduct material sealed sources and devices applications submitted to the NRC or to an Agreement State.

The NRC Technical Reviewer Qualification Journal serves as a guideline for the development of a Qualification Journal, and establishes the minimum training requirements consistent with NRC Manual Chapter 1248.  The Qualification Journal must provide traceable documentation to show that minimum requirements are met for each technical reviewer.

The NRC Technical Reviewer Qualification Journal consists of a series of qualification guides and qualification cards.  Each qualification card is used to document task completion, as indicated by the appropriate signature blocks.  The corresponding qualification guide establishes the minimum knowledge levels or areas of study that must be completed for each qualification card.

Most of the qualification guides are divided into sections.  The review sections of the qualification guides will identify references with general application to the technical reviewers qualification.  The technical reviewer should be expected to have a general familiarity with these references.  Other sections of the qualification guides will identify specific references that have direct application to the review discipline.  The technical reviewer should be expected to demonstrate detailed knowledge of these specific references.

In order to ensure that the safety evaluations conducted by the reviewer are technically correct and accurate, to promote consistency between like products reviewed, and to ensure that the public and the applicants are given consistent and accurate information regarding policy, regulations, rules and accepted practices associated with sealed source and device safety evaluations, the management will vest full signature authority only to those reviewers that are qualified to perform all areas of evaluation.

The potential reviewers immediate supervisor will assign appropriate submitted applications on a case by case basis.  This discretionary approach is intended to provide the prospective reviewers management with the ability to tailor the qualification process to match the background, experience, qualifications and training levels of the reviewer.  Limited signature authority may be granted by the management in specific areas to competent reviewers who do not have the required qualifications in all areas.

Issue Date:  04/19/13	D2	1248

Issue Date:  04/19/13	D29	1248

	TECHNICAL REVIEWER QUALIFICATIONS JOURNAL

	BYPRODUCT MATERIAL SEALED SOURCE AND DEVICE REVIEWERS

________________             _________________	_______________

(Name)                                 (Title)	(Branch)

To complete your qualification as a Technical Reviewer of Sealed Sources and Devices you are to complete the enumerated qualification cards.  All sign-offs shall include the original signature of the responsible reviewer and the date.  Maintain these cards in a file along with any background or written material required by the program.  This file will constitute the NRC Sealed Source and Device Technical Reviewers Qualifications Journal. 

Signature When Complete		Date

1. NRC Orientation			            

First Line Supervisor            

2. Code of Federal Regulation	           				______

                                                                      First Line Supervisor

3. Office Instructions  			

First Line Supervisor

4. Regulatory Guidance			

 	First Line Supervisor

5. NRC Management Directives     	

First Line Supervisor

6. ADAMS                         		            

                	First Line Supervisor

7. Agreement States Program		

and Interaction				

                                    	First Line Supervisor

8. Directed Review of Selected

Licensing Case Work			

First Line Supervisor

9. Formal Training				

First Line Supervisor

						Signature When Complete		Date

Recommended as qualified reviewer		            

Second Level Supervisor

or Board Chairman

Qualification Board Acceptance			

Second Level Supervisor

Certification Memo issued				

granting signature authority	        Second Level Supervisor

	Qualification Card 1

	NRC General Orientation

 Initials                                   Date	

A.	Site Orientation

1.	New employee processing

package completed		_____  

Employee

2.	Facility tour and introduction		                            ______

First Line Supervisor

B.	NRC Organization

1.	Review of NRC headquarters

and NMSS organization		                           __	__

Employee

2.	Discussion of NRC organization			_____

First Line Supervisor

	Qualification Card 2

	Code of Federal Regulations

Initials			Date

A.	Familiarization with selected

CFR parts completed	

Employee

B.	Discussion completed on CFR parts 

related to radiation byproduct

material applications in industry

and medicine	

First Line Supervisor

	Qualification Card 3

	Office Instructions

Initials			Date

A.	Familiarization with office policies  	

and procedures	

Employee

B.	Discussion completed on office policies 

and procedures

First Line Supervisor

		                                   Qualification Card 4

		                                  Regulatory Guidance

Initials				   Date

  	Regulatory review completed

1. Regulatory Guides						

	Employee

2. Information Notices

	Employee

3. NUREGs

	Employee

4.   Inspection Manual Chapters	

	Employee

5.   Industry Codes and Standards		

	Employee

6.  Sealed Source and Device Registry

	Employee

7.	Review and discuss with Management

Memorandum of Understanding regarding  

the general concepts and elements of MOU 

NRC has signed with other Agencies 

(i.e. FDA, DOL, DOE, DOT, FBI, etc.)

	Employee

	_____________     		

	First Line Supervisor

						Qualification Card 5

					NRC Management Directives

 Initials	Date

A.        Review of selected portions of the		

NRC Management Directives completed				

		 Employee

B.	Discussion of the application of the 

NRC Management Directives to the

Sealed Source & Device program

		_____________		

		                         First line supervisor

					    	Qualification Card 6

							ADAMS

Initials	Date

A. Review of selected portions of the ADAMS

Users Manual and system access completed				

		  Employee

B. Familiarization with ADAMS station(s) 

and operation

	  ___________			

		                        First line supervisor

						Qualification Card 7

	Agreement States Program and Interaction

     Initial                           Date				 

A. Overall coordinating role of OSTP

Employee

B. OSTP General Policies and procedures	

Employee

First Line Supervisor

	Qualification Card 8

				Directed Review of Selected Licensing Case Work

A. Expected Cases to be reviewed. 

The reviewer is expected to review a variety of cases as outlined below.  The reviewer should have participated in the full review, from start to the issuance of the certificate, and developed deficiency questions as necessary.  The cases will be assigned and selected by the team leader or supervisor to represent the following:

Sources: 4

Irradiators: 1

Radiography: 1

Consumer Products: 6

Gauges: 6

Medical Devices: 2

If new cases are not available, at the discretion of the team leader or supervisor, the reviewer may review previously concluded cases.  The cases will be selected by the team leader or supervisor.

This is a flexible requirement and can be modified to reflect the available applications and staff workload.

 Initial	   Date

Required Case work Completed:

	Employee

	First Line Supervisor

	Qualification Card 9

	 Formal Training

 Initials      		 Date

A.	Mandatory

1.	   Basic Health Physics Technology (H-122)

Reviewers classified as Series 1306 are exempt

from this requirement. 

	Employee

	First Line Supervisor

2.    Licensing & Inspection (G-108) 

	Employee

	First Line Supervisor

4.     Licensing Practice & Procedures (G-109) 

	Employee

	First Line Supervisor

Note: Course selection depends on previous health physics training and on the experience of

 	the reviewer.

B.	Elective Technical Courses

 Initial			 Dates

1.    Safety Aspects of Industrial		

Radiography (H-305) 				__

2.	Irradiator Technology (H-315)				__

3.	Transportation of Radioactive 

Materials (H-308) 			 _	___

4.	Safety Aspects of Well Logging (H-314)			  ________

5. Human Error Analysis/	

        Human Reliability Analysis 	

        for NMSS (P-406)                                              

6.    Root Cause/Incident Investigation

Workshop (G-205)	__________               _______

 7.	Public Outreach Meetings	___________	             _______

 8.	Media Training Workshop	___________	              	_

 9.	Q/A & QC Processes (external) 	___________	            	_

10.	Materials & Failure Analysis (external)	 	____________		_

 11.   Welding Technology and Codes 

        (external)	___________	         		_

12.   NDE:  PT, MT, UT, Eddy Current,		

Fiber Optics, Microscopy, 

Electron Scanning Microscopy etc. 

(external)	___________		   ___	__

	Qualification Guide 1

	NRC Orientation

A.	NRC Orientation

1.  	The qualifying individual should read and complete appropriate following forms for processing into the NRC systems:

a.  	Personnel information

b.  	Health insurance elections

c.  	Retirement plan elections

d.  	Savings elections (e.g. U.S. Savings Bonds, TSP, etc.)

e.  	Fitness for Duty requirements and physical examination

f.   	Any other forms which may be required by NRC Office of 

		     Human Resources

g.  	Payroll forms and time and labor reporting

h.  	Regulatory Information Tracking System (RITS)

2.  	The First Line Supervisor should orient the qualifying individual to the facility as follows:

a.	tour the facility and introduce the qualifying individual to the staff

b.	indicate to the qualifying individual the location of controlled documents, reference material, supplies, office equipment, etc.

B. NRC Organization

1.  	The qualifying individual should review and become familiar with:

a.	     Organizational charts of division, NMSS, regions and headquarters and

    	      overall NRC organization (NUREG 0325)

b.	Role of Headquarters in policy and interpretation of regulations

c.	Role of NRC General Counsel

d.	Role of NRC Inspector General

e.	Role of NRC Public Affairs

f.	Role of NRC Office of Investigations

g.	Role of NRC Office of Enforcement

h.	Physical location of NRC offices and regions

i.	Role of NRC as a regulatory agency

      (1)	10 CFR Part 1 (Organization)

      (2)	Atomic Energy Act of 1954, as amended

      (3)	Energy Reorganization Act of 1974, as amended

      (4)	NRC Enforcement Policy (NUREG1600)

      (5)	Incident Response Plan (NUREGs 0728 and 0845)

      (6)	Energy Policy Act of 1992

2.	The First Line Supervisor should discuss NRC organization and role with the qualifying individual to ensure the qualifying individual has a full understanding of NRC's organization and mission and the role of a Sealed Source and Device Technical Reviewer in the risk informed performance based mission.

	Qualification Guide 2

	Code of Federal Regulations

A. A selection of currently applicable CFR Parts should be made by the First Line Supervisor.  The selection should include the references listed below and be documented.  The qualifying individual should be expected to have a general knowledge of the topics addressed in the references.  This review may be accomplished by self-study, study quizzes, or discussions.

1         10 CFR Part 1	Statement of organization and general information

2.        10 CFR Part 2		Rules of practice for domestic licensing proceedings 	and issuance of orders

3.	10 CFR Part 9		Public records

4.	10 CFR Part 19	          Notices, instructions and reports to workers:                             				inspection and investigations

5.	10 CFR Part 20	          Standards for protection against radiation

6.	10 CFR Part 21	          Reporting of defects and noncompliance

7.	10 CFR Part 25	          Access authorization for licensee personnel

8.	10 CFR Part 26	          Fitness for duty programs

9.	10 CFR Part 30	          Rules of general applicability to domestic licensing of

					by product material

10.	10 CFR Part 31	          General domestic licenses for byproduct material

11.	10 CFR Part 32	          Specific domestic licenses to manufacture or transfer

					certain items containing byproduct material

12.      10 CFR Part 33	         Specific domestic licenses of broad scope for 	byproduct material

13.      10 CFR Part 34	           Licenses for radiography and radiation safety 			         requirements for radiographic operations

14.	10 CFR Part 35	         Medical use of byproduct material

15.      10 CFR Part 36	Licenses and radiation safety requirements for irradiators

16.      10 CFR Part 39	Licenses and radiation safety requirements for 

					well logging

17.	10 CFR Part 71	          Packaging and transportation of radioactive material

18.      10 CFR Part 150.20     Reciprocity

19.      10 CFR Part 170.31     Application Fees

20.      10 CFR Part 171.16     Annual Fees

B. Following completion of the qualifying individual's self study of the listed CFR Parts, a discussion will be held with the qualifying reviewer by the First Line Supervisor to test the qualifying reviewers knowledge of these Parts.  To the extent possible, recent application of various sections, new regulatory initiatives, and current industry issues should be emphasized.

	Qualification Guide 3

	Office Instructions 

A. Office/Division Policies and Procedures

1.	Read the Office/Division Policy and Procedures Manual 

2.	The qualifying individual should review the Office/Division policies and practices on:

 a.	Travel, including Management Directive 14.1 Official Temporary Duty Travel

 b.	Telephone use

 c.	Policies on use of annual leave and sick leave and excused leave, including Management Directive 10.62, Leave Administration.

 d.	Work schedule, including Management Directive 10.42, Hours of Work and Premium Pay

 e.	Use of government equipment including computers (ADAMS) and Management Directive 13.1 Property Management

 f.	Union activities, including Management Directive 10.102, Labor-Management Relations Program for Federal Employees

 g.	Communications outside NRC

 h.	Policies on outside employment and acceptance of gifts

 i.	Participation in political activities

 j.	Routing of mail and procedures for sending mail and materials (via 

	U.S. Mail, Federal Express, etc.), including Management Directive 3.23, Mail Management

 k.	Ordering of documents (e.g. NUREGs)

 l.	NMSS emergency and evacuation procedures

 m.	Employee appraisal system and Individual Development Plan (IDP)

     (1)	Employee trial period (Management Directive 10.14 Employment and Staffing)

     (2)	Employee appraisals (Management Directive 10.67, NonSES Performance Appraisal System)

 o.	Differing Professional Views or Opinions (Management Directive 10.159, General Personnel Management Provisions)

B. The First Line Supervisor should discuss these policies and practices with the qualifying individual to ensure that the qualifying individual has a full and complete understanding.

C. 

	Qualification Guide 4

	Regulatory Guidance

D. A selection of currently applicable regulatory guidance should be identified by the First Line Supervisor.  These references should include those listed below and should****be documented.  The qualifying individual should be expected to have a general knowledge of the topics addressed in the references.  The review may be accomplished by selfstudy, studyquizzes, briefings, or discussions. 

1.	Regulatory Guides (use latest revisions)

6.1		Leak Testing Radioactive Brachytherapy Sources

6.9		Establishing Quality Assurance Programs for the 	Manufacture

   		and Distribution of Sealed Sources and Devices Containing

 		Byproduct Material

8.29		Instruction Concerning Risks from Occupational Radiation 	Exposure

Others as selected by the First Line Supervisor

2.	Information Notices

                  	IN 94-89		Equipment Failures at Irradiator Facilities

  	            	IN 95-44		Ensuring Compatible Use of Drive Cables Incorporating Use of

 				Industrial Nuclear Company Ball - Type Male Connectors

	IN 96-04		Incident Reporting Requirements for Radiography Licensees

 		IN 96-20		Demonstration of Associated Equipment Operability 

  	            IN 96-51		Residual Contamination Remaining in Krypton-85 Handling

 			System after Venting 

 		IN 96-52	Cracked Insertion Rods On Troxler Model 3400 Series Portable Moisture Density Gauges

	IN 96-53		Retrofit to Amersham 660 Posilock Radiography Camera to

 			Correct Inconsistency in 10 CFR Part 34 Compatibility

 		IN 96-54 		Vulnerability of Stainless Steel to Corrosion When Sensitized.

	IN 97-89		Distribution of Sources and Devices Without Authorization

	IN 98-09		Collapse of an ISOCAM II, Dual-Headed Nuclear Medicine

 			Gamma Camera

	IN 99-23			Safety Concerns Related to Repeated Control Unit Failures of

 				the Nucletron Classic Model High-Dose-Rate Remote

 				Afterloading Brachytherapy Devices

	IN 99-27 		Malfunction of Source Retraction Mechanism in Cobalt-60

 			Teletherapy Treatment Units

Others as selected by the First Line Supervisor

3.		NUREG Reports

	NUREG-0325		USNRC Functional Organizational Chart

	NUREG-0403	High Temperature Testing of Smoke Detector Sources

	NUREG-1175		Environmental Assessment of Consumer Products Containing Radioactive Material

 	NUREG-1480		Loss of an Iridium-192 Source and Therapy Mis-Administration at Indiana Regional Cancer Center

  	NUREG-1556		Consolidated Guidance About Materials Licenses 

	Vols. 1 to 20

	NUREG-1600	General Statement of Policy and Procedure for NRC Enforcement Actions

	NUREG-1631		Source Disconnects Resulting From Radiography Drive Cable Failures

	NUREG-1717		Systematic Radiological Assessment of Exemptions for Source and Byproduct Materials

	NUREG/CR-4357	The Feasibility of Detecting the Import of Unauthorized Radioactive Materials in to the USA

  		NUREG/CR-5881	An examination of Source Material Requirements Contained in 10 CFR 40

	NUREG/CR-6074	Investigation of Failed Radioactive Stainless Steel Troxler Gauges Vol.5

	NUREG/CR-6642	Safety Testing of Industrial Radiography Devices

Others as selected by the First Line Supervisor

4.	Inspection Manual Chapters

INSPECTIONS

IMC 0300	Announced and Unannounced Inspections

IMC 0303	Item Reporting

IMC 2800	Materials Inspection Program

INTERACTIONS WITH OTHER FEDERAL AGENCIES

IMC 1007		 Interfacing Activities Between Regional Offices of NRC and

OSHA

INCIDENT RESPONSE

IMC 1300	Incident Response Actions  Responsibility and Authority

IMC 1301	Response to Radioactive Material Incidents That Do Not Require Activation of the NRC Incident Response Plan

IMC 1302	Action Levels for Radiation Exposures and Contamination Associated With Materials Events Involving Members of the Public

IMC 1330	Response to Transportation Accidents Involving Radioactive Materials

IMC 1360	Use of Physician and Scientific Consultants in the Medical Consultant Program

Others as selected by the First Line Supervisor

5.	Industrial Codes and Standards

                     	ANSI N42.16		Gamma Radiography- Specification for Design and Testing of Apparatus

                     	ANSI N42.17A		Performance Specifications for Health Physics

                     	ANSI N43.2		Radiation Safety for X-Ray Diffraction and Fluorescence Analysis Equipment

   	ANSI N43.3		Installations Using Non-Medical and Sealed Gamma-Ray Sources, Energies Up to 10 MEV

                    	ANSI N43.4		Classification of Radioactive Self-Luminous Light Sources

 	  	ANSI N43.6		Sealed Radioactive Source- Classification (ISO 2919)

  	  	ANSI N43.7		Safe Design and Use of Self-Contained Dry Sources Storage Gamma Irradiators (Category I)

  	  	ANSI N43.8		Classification of Industrial Ionizing Radiation Gauging Devices (ISO 7205)

 	  	ANSI N43.9		For Gamma Radiography- Specifications for Design and Testing Apparatus

  	ANSI N43.10		Safe Design and Use of Panoramic, Wet Source Storage Gamma Irradiators ( Category IV) and Dry Source Storage Gamma Irradiators (Category II)

 	  	ANSI N43.15		Safe Design and Use of Self-Contained Wet Sources Storage Gamma Irradiators (Category III)

 	  	ANSI N44.1		Integrity and Test Specifications for Selected Brachytherapy sources

 	  	ANSI N44.2		Leak-Testing Radioactive Brachytherapy Sources

 	  	ANSI N449.1		Procedures for Periodic Inspection of Cobalt and 

Cesium-137 Teletherapy Equipment

  	ANSI N537		Radiological Safety Standards for Design of Radiographic and Flouroscopic Industrial X-Rays Equipment  

 	  	ANSI/ISO/QSC-		Quality management systems - Requirements

	  	Q9001-2000

  	  	ISO 7205		Radionuclide Gauges - Gauges designed for permanent installation

	Others as selected by the First Line Supervisor

6.	Sealed Source and Device Registry

7.	The First Line Supervisor will discuss with the reviewer as minimum the general concepts and elements of MOU NRC has signed with other Agencies (i.e. FDA, DOL, DOE, DOT, FBI, etc.)  That impact the registration or disposal of radiological sources and devices.  Review and discuss the following with Management:

            	1.  FDA	Sealed Source and Device Applications requiring notification and/or 510K approved form

2.  DOE	DOE Technical and Contractual Interfaces and TAPM Qualifications Requirements	

3.  DOT   The First Line Supervisor will discuss with the reviewer the

DOT Technical Regulatory Interfaces

Others as selected by the First Line Supervisor

B. The application of these guidance documents to the Sealed Source and Device review program should be studied in detail by the qualifying individual and covered by the First Line Supervisor in discussions, interviews, or oral quizzes.

	Qualification Guide 5

	NRC Management Directives

A. A selection of currently applicable NRC Management Directive (MD) references should be identified by the First Line Supervisor.  These references should include those listed below and be documented.  The qualifying reviewer should be expected to have a general knowledge of the topics addressed in the references.  This review may be accomplished by selfstudy, studyquizzes, briefings, or discussions.  The selection should include:

1.    NRC MD 3.1		Freedom of Information Act

2.    NRC MD 3.2		Privacy Act

3.    NRC MD 8.3		NRC Incident Investigation Program

4.    NRC MD 8.8		Management of Allegations

5.    NRC MD 9.1		Organization Management

6.    NRC MD 9.29		Regional Offices

7.    NRC MD 10.42		Hours of Work and Premium Pay

8.    NRC MD 10.43		Time and Attendance Reporting

9.    NRC MD 10.67		NonSES Performance Appraisal System

10.  NRC MD 10.101		Employee Grievances

11.  NRC MD 10.130		OSHA

12.  NRC MD 10.131		Standards for Protection Against Ionizing Radiation

13.  NRC MD 10.159		Differing Professional Views or Opinions

14.  NRC MD 14.1			Official Temporary Duty Travel

Others as selected by the First Line Supervisor

	Qualification Guide 6

	ADAMS

A. The use and training for ADAMS will consist of a PDC course in using ADAMS; review of ADAMS USER GUIDE; and knowledge of capturing and retrieving ADAMS documents.

Qualification Guide 7

Agreement States Program and Inspection

A. The First Line Supervisor will discuss with the reviewer in training the role of OSTP office as a single point of entry interface for coordinating the Agreement State Programs and the available course of corrective actions to match problematic Agreement State Programs.

Qualification Guide 8

	Directed Review of Selected Licensing Case Work

A. Compile an Attachment in the following

Format for all the case work completed

1.	Type of Byproduct:

2.	 Applicant:

3.	Type of Device or Source:

4.	    Status:

5.	    Date Completed:

6.	Reviewer:

7.	Total of products reviewed:

Qualification Guide 9

Required Formal Training

The standards for each Training Course are provided in the NRC Technical Training Center Course Catalog and will not be duplicated in the Qualification Guide.

Attachment 1

Revision History for IMC 1248, Appendix D

Issue Date:  04/19/13	Att11	1248