QUALITY ASSURANCE/ QUALITY CONTROL AS APPLIED TO RADIOLOGICAL CONTROL AND RECORDS

1. QUALITY ASSURANCE/ QUALITY CONTROL ASAPPLIED TO RADIOLOGICALCONTROL AND RECORDS HPT001.022

2. Enabling Objectives • Define QA/QC • Describe NQAP Principal Objective • Describe QA/QC Programs & Features • Identify QA Program for RadCon • Describe NQAP Expectations & Responsibilities • Identify Levels of Procedure Use & Characteristics of Each

3. Enabling Objectives • Identify Labels for Hard Copy Documents • Identify Organizations Responsible for Controlling Documents & Records • Describe Criteria for Lifetime Quality Assurance Records • Define Quality Assurance Record • Describe Safeguards Information

4. Quality Assurance • Quality AssurancePlanned and systematic actions necessary to provide adequate confidence that a structure, system, or component will perform satisfactorily in service.

5. Quality Control • Quality Control Component of Quality AssurancePhysical characteristics of a material, structure, or system which provide a means to control the quality of the material, structure, or system to predetermined requirements.

6. Applicable Documents

7. Regulations & Guidelines • Regulation:10 CFR 50, Appendix B • Guidelines:NRC Regulatory Guide 1.33, “Quality Assurance Program Requirements”

8. NQAP • TVA Nuclear Quality Assurance Plan (NQAP)Defines & describes the nuclear quality assurance (QA) requirements for the Tennessee Valley Authority & establishes responsibilities for their implementation.

9. NQAP Principal Objective • Provide confidence that activities affecting quality during design, construction, operation, and maintenance are accomplished in a manner to achieve compliance with preestablished quality objectives and acceptance criteria.

10. Programs & Featuresfor which NQAP Applies • Radiological Control • Emergency Preparedness • Nuclear Plant Security • Radioactive Material Shipment • Special Nuclear Material Management • Fire Protection • Radwaste Management Systems, etc. • Chemistry

11. Elements of NQAP • List of Safety-Related Items/Systems • Graded Approach to NQAP Requirements • Assignment of Responsibilities • Preparation of Nuclear Procurement System Documents • Training of Personnel

12. Elements of NQAP • Provisions for Special Controls, Processes, Test Equipment, Tools & Skills • Measures to Control Cleanliness of Facilities, Material & Equipment • Prompt Corrective Actions • Control of Adequate Records

13. Augmented QA Program • “Radiological Control & Radioactive Material Shipment Augmented Quality Assurance Program,” (RC&RMS) (SPP-5.9)Applies to all TVA organizations that implement portions of the RC&RMS programs.

14. RC&RMS Programs • RC&RMS Programs not Regulated by10 CFR 50Dosimetry Processing (15CFR285–NVLAP)Radioactive Materials Shipment (10CFR71)Personnel Exposure Data (Privacy Act)Land Use Survey Data (Privacy Act) (For Radiological Environmental Monitoring Program)

15. Management Controls • Ensure that the Program Activities:1. Meet Regulatory Requirements & TVA Policy2. Are Performed as Required3. Satisfactory Completion Verified & Documented4. Accomplished by Approved Procedures & Instructions.

16. QA Records Retention • Radiation Exposure History:75 years from time of creation and Concurrence from OGC • Facility Radiological Control Program:75 years from time monitoring no longer provided, Licensed material no longer present, and Concurrence from OGC

17. Contents of QA RecordHistory Files • Instrument Calibration Records • Radiological Surveys • RWPs • Program Bases & Documentation • Environmental & Effluent Measurements • Radioactive Material Shipment & Disposal • Source & Byproduct Material • Miscellaneous Records

18. Miscellaneous Records • Rad Engineering/Exposure Optimization • Management/Audit Reports • ALARA Job Reviews/Pre Job Briefings • Radiological & Environmental Trend Data • Correspondence with NRC • Regulatory Inspection/Audit Data • Self-Assessments • QA Evaluations, Audits & Assessments • Evaluations of TEDE for Respirator Use

19. QA Responsibilities • Chief Nuclear Officer & Exec. VP, TVAN:Establish Management Policies & Requirements • Nuclear Assurance: Maintain NQAP & Verify Implementation. • Line Management: Establish Quality Requirements in Procedures & Instructions and Ensure Achievement.

20. QA Responsibilities • Each Organization: Designate Individual to be Responsible to Assure QA Requirements Fully Implemented. • Each Employee: 1. Expected to do Job Right First Time2. Comply with Requirements of NQAP & its Implementing Documents.

21. Document Control • SPP-2.0, “Procedures and Document Control” • SPP-2.2, “Administration of Site Technical Procedures” • SPP-2.3, “Document Control”

22. Procedure Use Classifications • Continuous Use • Reference Use • Information Use • Multiple Use

23. Continuous Use Procedures Characteristics: • Consequences of improper action could have direct impact on nuclear safety. • Activity difficult or complex & independent of frequency performed. • Activity infrequently performed with some degree of complexity.

24. Continuous Use Procedures Present & Directly Referred to: • Each step performed exactly as written • Each step read before performing • Sign-offs performed before proceeding • Sign-offs performed at step completion • If reader used, each step acknowledged by reader before proceeding

25. Reference Use Procedures Characteristics: • Work consists of small segments that can be easily accomplished from memory. • Consequences of improper actions are not immediate. • Activity infrequently performed or has some degree of complexity

26. Reference Use Procedures Available at Job for referral: • Referenced periodically to verify each segment of procedure performed • User responsible for results when not referring to procedure • When required, appropriate sign-offs completed to verify that each segment performed

27. Information Use Procedures Characteristics: • Performed frequently or not complex • Can easily be performed from memory • Within knowledge & skills of performers

28. Information Use Procedures • Procedure should be reviewed periodically, such as:1. Before performance2. During continuing training3. Following revisions • User responsible for results obtained when not referring to procedure

29. Multiple Usage Procedures • Procedures in which different sections require different levels of use. • Procedure identified as multiple use • Classification of individual sections identified on cover sheet or in procedure

30. Document Control Program • Ensures latest revisions of controlled documents identified and available • Electronic documents available upon release by appropriate organization • Transmittal/Receipt acknowledgement required for hard-copy documents • Information-only copies may be distributed with transmittal but no receipt acknowledgement required

31. Controlled Copy Document Identifications • “Controlled” – To ensure latest revision • “WORK INSTRUCTION___” - Work plan or work instruction requiring revision level • “Information Only” – Reference only—Cannot be used for quality or safety related activities • “SUPERSEDED” or “SUPERSEDED BY___” No longer current or superseded

32. Controlled Copy Document Identifications • “VOID” or “CANCELLED” – Document no longer valid • “VFU” (Verified for Use) – Verified as current by document user • “INACTIVE DOCUMENT” – Document changed to inactive by revision—Reactivated by subsequent revision • “ADMINISTRATIVE HOLD” – Technical or other difficulties preclude use

33. Document ControlResponsibilities • Management Services1. Maintain Controlled Document List2. Determine documents to be controlled • TVAN Organizations – Generate or revise documents per applicable requirements of TVAN standards, procedures, instructions • TVAN Managers & Supervisors – Monitor & enforce procedure use

34. Document ControlResponsibilities • Procedure Performer:1. Ensure latest revision being used2. Understand activity and procedural requirements3. Adhere to procedure requirements • Document User – Ensure documents used are correct revision level for a given activity

35. Records Management • SPP-2.4, “Records Management” & NQAP • QA Records must be:1. Identified2. Reviewed3. Authenticated4. Retained5. Retrievable • QA Records are auditable

36. Lifetime QA Records Significant Value in: • Demonstrating for safe operation • Maintaining , reworking, repairing, replacing, or modifying an item • Determining cause of accident or malfunction of an item Provide baseline data for in-service inspection

37. Definitions • Nonpermanent Quality Assurance Record- A nonpermanent QA record which does not qualify as a Lifetime QA record • Electronic Document Management System (Electronic Vault) – TVA Repository for official records in electronic format • Quality Assurance Record – Furnishes documentary evidence of quality of items or activities

38. Definitions • Nonquality Assurance Record – Required to be retained, but not QA record • Permanent Record – Determined to have significant value to warrant preservation • Record – Any document maintained for informational value • Records Administrator – Individual charged with ensuring records are identified and organized

39. Records Requirements • Legible • Technically Accurate • Complete • Retrievable • Traceable • Secure • Pages Accountable

40. Safeguards Information (SGI) • Information not otherwise classified as National Security Information or Restricted data that specifically identifies licensees:1. Security measures for physical protection of special nuclear material of of more than moderate significance2. Security measures for physical protection & location of certain plant equipment vital to safety

41. Safeguards Information (SGI) Four Most Common Violations of SGI: • Leaving SGI Unattended • SGI Containers Unsecured • Leaving SGI on Personal Computer (PC) Hard Drive • Improper Mailing Procedure

42. Sensitive Security Information • Information that is the property of TVA and has been determined sensitive by the originator • Distribution on Need to Know basis only

43. Sensitive Security Information • Any commercial, financial, attorney/client, law enforcement, security, attorney work product, strategic business, privacy or other whose disclosure could:1. Be Illegal2. Be Prejudicial to TVA or Private Co.3. Violate Privacy of an Individual4. Not be available in Civil Discovery

44. Records Responsibilities • TVA Enterprise Document Management (EDM) Division – Establish & maintain administrative control over TVA records • TVAN Organizations – Identify records administrator & advise Management Svs. • Each Site – Maintain records list with:Classification, Retention, Location, and Responsible Organization

45. Records Responsibilities • Each Organization – Maintain list of all records generated and ensure completeness and accuracy of records • Originating Organizations – Maintain accountability for storage of records and protect QA records from damage, loss, misplacement, or destruction

46. Computer Software Control • SPP-2.6, “Computer Software Control” – Describes processes necessary to control computer software applications within TVAN • Software Quality Assurance – Controls and actions which provide assurance that computer software performs as intended.

47. Computer Control Responsibilities • Corporate Document Control Records Management (DCRM) – Document Control for computer applications software • Application Owner – Ensures application software & software documentation meets requirements

48. Computer Control Responsibilities • Application Developer1. Develops/Modifying software2. Preparing/Revising software documentation3. Prepare software design description4. Perform & Document validation & operability testing

49. Summary • Nuclear Quality Assurance Plan (NQAP) • Radiological Control & Radioactive Material Shipment Augmented Quality Assurance Program (RC&RMS) • Document Control • Records Management • Computer Software Control