hpt001.022 rev. 1 page 1 of 17 tp-1 tvan technical training health physics (radcon) initial training...

HPT001.022Rev. 1 of 17

TP-1 TVAN Technical TrainingHealth Physics (RADCON) Initial Training Program

QUALITY ASSURANCE/ QUALITY ASSURANCE/ QUALITY CONTROL ASQUALITY CONTROL AS

APPLIED TO APPLIED TO RADIOLOGICALRADIOLOGICAL

CONTROL AND RECORDSCONTROL AND RECORDS

HPT001.022HPT001.022

HPT001.022Rev. 1 of 49


Enabling ObjectivesEnabling ObjectivesDefine QA/QCDefine QA/QCDescribe NQAP Principal ObjectiveDescribe NQAP Principal ObjectiveDescribe QA/QC Programs & Describe QA/QC Programs &

FeaturesFeaturesIdentify QA Program for RadConIdentify QA Program for RadConDescribe NQAP Expectations & Describe NQAP Expectations &

ResponsibilitiesResponsibilitiesIdentify Levels of Procedure Use Identify Levels of Procedure Use

& Characteristics of Each& Characteristics of Each

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Enabling ObjectivesEnabling Objectives

Identify Labels for Hard Copy Identify Labels for Hard Copy DocumentsDocuments

Identify Organizations Responsible Identify Organizations Responsible for Controlling Documents & Recordsfor Controlling Documents & Records

Describe Criteria for Describe Criteria for Lifetime Quality Lifetime Quality Assurance RecordsAssurance Records

Define Quality Assurance RecordDefine Quality Assurance RecordDescribe Safeguards InformationDescribe Safeguards Information

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Quality AssuranceQuality Assurance

Quality AssuranceQuality Assurance

Planned and systematic actions Planned and systematic actions necessary to provide adequate necessary to provide adequate confidence that a structure, confidence that a structure, system, or component will system, or component will perform satisfactorilyperform satisfactorily in service. in service.

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Quality ControlQuality Control

Quality Control Quality Control

Component of Quality AssuranceComponent of Quality Assurance

Physical characteristicsPhysical characteristics of a of a material, structure, or system material, structure, or system which provide a means to control which provide a means to control the quality of the material, the quality of the material, structure, or system to structure, or system to predetermined requirements.predetermined requirements.

HPT001.022Rev. 1 of 49


Applicable DocumentsApplicable Documents

10 CFR 20

NRC Reg Guide 1.33

TVA NQAP

SPP-1.4 SPP-2.0

SPP-2.2 SPP-2.3

SPP-2.4 SPP-2.6

SPP-5.9

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Regulations & GuidelinesRegulations & GuidelinesRegulation:Regulation:

10 CFR 50, Appendix B10 CFR 50, Appendix B

Guidelines:Guidelines:

NRC Regulatory Guide 1.33, “Quality NRC Regulatory Guide 1.33, “Quality

Assurance Program Requirements”Assurance Program Requirements”

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NQAPNQAP

TVA Nuclear Quality TVA Nuclear Quality Assurance Plan (NQAP)Assurance Plan (NQAP)

Defines & describes the nuclear Defines & describes the nuclear quality assurance (QA) quality assurance (QA) requirements for the Tennessee requirements for the Tennessee Valley Authority & establishes Valley Authority & establishes responsibilities for their responsibilities for their implementation.implementation.

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NQAP Principal ObjectiveNQAP Principal ObjectiveProvide confidence that Provide confidence that

activities affecting quality during activities affecting quality during design, construction, operation, design, construction, operation, and maintenance are and maintenance are accomplished in a manner to accomplished in a manner to achieve compliance with achieve compliance with preestablished quality objectives preestablished quality objectives and acceptance criteria.and acceptance criteria.

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Programs & FeaturesPrograms & Featuresfor which NQAP Appliesfor which NQAP Applies

Radiological ControlRadiological Control Emergency PreparednessEmergency Preparedness Nuclear Plant SecurityNuclear Plant Security Radioactive Material ShipmentRadioactive Material Shipment Special Nuclear Material ManagementSpecial Nuclear Material Management Fire ProtectionFire Protection Radwaste Management Systems, etc.Radwaste Management Systems, etc. ChemistryChemistry

HPT001.022Rev. 1 of 49


Elements of NQAPElements of NQAP

List of Safety-Related List of Safety-Related Items/SystemsItems/Systems

Graded Approach to NQAP Graded Approach to NQAP RequirementsRequirements

Assignment of ResponsibilitiesAssignment of ResponsibilitiesPreparation of Nuclear Preparation of Nuclear

Procurement System DocumentsProcurement System DocumentsTraining of PersonnelTraining of Personnel

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Elements of NQAPElements of NQAP

Provisions for Special Controls, Provisions for Special Controls, Processes, Test Equipment, Processes, Test Equipment, Tools & SkillsTools & Skills

Measures to Control Cleanliness Measures to Control Cleanliness of Facilities, Material & of Facilities, Material & EquipmentEquipment

Prompt Corrective ActionsPrompt Corrective ActionsControl of Adequate RecordsControl of Adequate Records

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Augmented QA ProgramAugmented QA Program““Radiological Control & Radiological Control &

Radioactive Material Shipment Radioactive Material Shipment Augmented Quality Assurance Augmented Quality Assurance Program,” (RC&RMS) (SPP-5.9)Program,” (RC&RMS) (SPP-5.9)

Applies to all TVA organizations Applies to all TVA organizations that implement portions of the that implement portions of the RC&RMS programs.RC&RMS programs.

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RC&RMS ProgramsRC&RMS ProgramsRC&RMS Programs RC&RMS Programs notnot Regulated by Regulated by

10 CFR 5010 CFR 50

Dosimetry Processing (15CFR285–NVLAP)Dosimetry Processing (15CFR285–NVLAP)Radioactive Materials Shipment (10CFR71)Radioactive Materials Shipment (10CFR71)Personnel Exposure Data (Privacy Act)Personnel Exposure Data (Privacy Act)Land Use Survey Data (Privacy Act)Land Use Survey Data (Privacy Act)

(For Radiological Environmental (For Radiological Environmental Monitoring Program) Monitoring Program)

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Management ControlsManagement ControlsEnsure that the Program Activities:Ensure that the Program Activities:

1. Meet Regulatory Requirements &1. Meet Regulatory Requirements &TVA PolicyTVA Policy

2. Are Performed as Required2. Are Performed as Required3. Satisfactory Completion Verified 3. Satisfactory Completion Verified & &

DocumentedDocumented4. Accomplished by Approved4. Accomplished by Approved

Procedures & Instructions.Procedures & Instructions.

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QA Records RetentionQA Records Retention

Radiation Exposure History:Radiation Exposure History:75 years from time of creation 75 years from time of creation and and Concurrence from OGCConcurrence from OGC

Facility Radiological Control Program:Facility Radiological Control Program:75 years from time monitoring no 75 years from time monitoring no longer provided, Licensed material no longer provided, Licensed material no longer present, longer present, andand Concurrence from Concurrence from OGCOGC

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Contents of QA RecordContents of QA RecordHistory FilesHistory Files

Instrument Calibration RecordsInstrument Calibration RecordsRadiological SurveysRadiological SurveysRWPsRWPsProgram Bases & DocumentationProgram Bases & DocumentationEnvironmental & Effluent MeasurementsEnvironmental & Effluent MeasurementsRadioactive Material Shipment & Radioactive Material Shipment &

DisposalDisposalSource & Byproduct MaterialSource & Byproduct MaterialMiscellaneous RecordsMiscellaneous Records

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Miscellaneous RecordsMiscellaneous Records Rad Engineering/Exposure OptimizationRad Engineering/Exposure Optimization Management/Audit ReportsManagement/Audit Reports ALARA Job Reviews/Pre Job BriefingsALARA Job Reviews/Pre Job Briefings Radiological & Environmental Trend Radiological & Environmental Trend

DataData Correspondence with NRCCorrespondence with NRC Regulatory Inspection/Audit DataRegulatory Inspection/Audit Data Self-AssessmentsSelf-Assessments QA Evaluations, Audits & AssessmentsQA Evaluations, Audits & Assessments Evaluations of TEDE for Respirator UseEvaluations of TEDE for Respirator Use

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QA ResponsibilitiesQA Responsibilities

Chief Nuclear Officer & Exec. VP, TVAN:Chief Nuclear Officer & Exec. VP, TVAN:Establish Management Policies & Establish Management Policies & RequirementsRequirements

Nuclear Assurance: Maintain NQAP & Nuclear Assurance: Maintain NQAP & Verify Implementation.Verify Implementation.

Line Management: Establish Quality Line Management: Establish Quality Requirements in Procedures & Requirements in Procedures & Instructions and Ensure Achievement.Instructions and Ensure Achievement.

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QA ResponsibilitiesQA Responsibilities

Each Organization: Designate Each Organization: Designate Individual to be Responsible to Assure Individual to be Responsible to Assure QA Requirements Fully Implemented.QA Requirements Fully Implemented.

Each Employee: Each Employee: 1. Expected to do Job Right First Time1. Expected to do Job Right First Time2. Comply with Requirements of 2. Comply with Requirements of NQAP &NQAP &

its Implementing Documents.its Implementing Documents.

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Document ControlDocument Control

SPP-2.0, “Procedures and SPP-2.0, “Procedures and Document Control”Document Control”

SPP-2.2, “Administration of Site SPP-2.2, “Administration of Site Technical Procedures”Technical Procedures”

SPP-2.3, “Document Control”SPP-2.3, “Document Control”

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Procedure Use Procedure Use ClassificationsClassifications

Continuous UseContinuous Use

Reference UseReference Use

Information UseInformation Use

Multiple UseMultiple Use

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Continuous Use Continuous Use ProceduresProcedures

Characteristics:Characteristics:

Consequences of improper action could Consequences of improper action could have direct impact on nuclear safety.have direct impact on nuclear safety.

Activity difficult or complex & Activity difficult or complex & independent of frequency performed.independent of frequency performed.

Activity infrequently performed with Activity infrequently performed with some degree of complexity.some degree of complexity.

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Continuous Use Continuous Use ProceduresProcedures

Present & Directly Referred to:Present & Directly Referred to:Each step performed exactly as writtenEach step performed exactly as writtenEach step read before performingEach step read before performingSign-offs performed before proceedingSign-offs performed before proceedingSign-offs performed at step completionSign-offs performed at step completion If reader used, each step acknowledged If reader used, each step acknowledged

by reader before proceedingby reader before proceeding

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Reference Use ProceduresReference Use Procedures

Characteristics:Characteristics:Work consists of small segments that Work consists of small segments that

can be easily accomplished from can be easily accomplished from memory.memory.

Consequences of improper actions Consequences of improper actions are not immediate.are not immediate.

Activity infrequently performed or Activity infrequently performed or has some degree of complexityhas some degree of complexity

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Reference Use ProceduresReference Use Procedures

Available at Job for referral: Available at Job for referral: Referenced periodically to verify each Referenced periodically to verify each

segment of procedure performedsegment of procedure performedUser responsible for results when not User responsible for results when not

referring to procedurereferring to procedureWhen required, appropriate sign-offs When required, appropriate sign-offs

completed to verify that each segment completed to verify that each segment performedperformed

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Information Use Information Use ProceduresProcedures

Characteristics:Characteristics:Performed frequently or not complexPerformed frequently or not complexCan easily be performed from Can easily be performed from

memorymemoryWithin knowledge & skills of Within knowledge & skills of

performersperformers

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Information Use Information Use ProceduresProcedures

Procedure should be reviewed Procedure should be reviewed periodically, such as:periodically, such as:1. Before performance1. Before performance2. During continuing training2. During continuing training3. Following revisions3. Following revisions

User responsible for results obtained User responsible for results obtained when not referring to procedurewhen not referring to procedure

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Multiple Usage Multiple Usage ProceduresProcedures

Procedures in which different sections Procedures in which different sections require different levels of use.require different levels of use.

Procedure identified as multiple useProcedure identified as multiple use

Classification of individual sections Classification of individual sections identified on cover sheet or in identified on cover sheet or in procedureprocedure

HPT001.022Rev. 1 of 49


Document Control Document Control ProgramProgram

Ensures latest revisions of controlled Ensures latest revisions of controlled documents identified and availabledocuments identified and available

Electronic documents available upon Electronic documents available upon release by appropriate organizationrelease by appropriate organization

Transmittal/Receipt acknowledgement Transmittal/Receipt acknowledgement required for hard-copy documentsrequired for hard-copy documents

Information-only copies may be Information-only copies may be distributed with transmittal but no distributed with transmittal but no receipt acknowledgement requiredreceipt acknowledgement required

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Controlled Copy Controlled Copy Document IdentificationsDocument Identifications

““Controlled” – To ensure latest revision Controlled” – To ensure latest revision ““WORK INSTRUCTION___” - Work plan or WORK INSTRUCTION___” - Work plan or

work instruction requiring revision levelwork instruction requiring revision level““Information Only” – Reference only—Information Only” – Reference only—

Cannot be used for quality or safety Cannot be used for quality or safety related activitiesrelated activities

““SUPERSEDED” or “SUPERSEDED BY___” SUPERSEDED” or “SUPERSEDED BY___” No longer current or supersededNo longer current or superseded

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Controlled Copy Controlled Copy Document IdentificationsDocument Identifications

““VOID” or “CANCELLED” – Document VOID” or “CANCELLED” – Document no longer validno longer valid

““VFU” VFU” (Verified for Use) (Verified for Use) – Verified – Verified as current by document useras current by document user

““INACTIVE DOCUMENT” – Document INACTIVE DOCUMENT” – Document changed to inactive by revision—changed to inactive by revision—Reactivated by subsequent revisionReactivated by subsequent revision

““ADMINISTRATIVE HOLD” – Technical ADMINISTRATIVE HOLD” – Technical or other difficulties preclude useor other difficulties preclude use

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Document ControlDocument ControlResponsibilitiesResponsibilities

Management ServicesManagement Services1. Maintain Controlled Document List1. Maintain Controlled Document List2. Determine documents to be controlled2. Determine documents to be controlled

TVAN Organizations – Generate or revise TVAN Organizations – Generate or revise documents per applicable requirements documents per applicable requirements of TVAN standards, procedures, of TVAN standards, procedures, instructionsinstructions

TVAN Managers & Supervisors – Monitor TVAN Managers & Supervisors – Monitor & enforce procedure use& enforce procedure use

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Document ControlDocument ControlResponsibilitiesResponsibilities

Procedure Performer:Procedure Performer:1. Ensure latest revision being used1. Ensure latest revision being used2. Understand activity and procedural2. Understand activity and procedural

requirementsrequirements3. Adhere to procedure requirements3. Adhere to procedure requirements

Document User – Ensure documents Document User – Ensure documents used are correct revision level for a used are correct revision level for a given activitygiven activity

HPT001.022Rev. 1 of 49


Records ManagementRecords Management

SPP-2.4, “Records Management” & SPP-2.4, “Records Management” & NQAPNQAP

QA Records must be:QA Records must be:1. Identified1. Identified2. Reviewed2. Reviewed3. Authenticated3. Authenticated4. Retained4. Retained5. Retrievable5. Retrievable

QA Records are auditableQA Records are auditable

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Lifetime QA RecordsLifetime QA Records

Significant Value in:Significant Value in:Demonstrating for safe operationDemonstrating for safe operationMaintaining , reworking, repairing, Maintaining , reworking, repairing,

replacing, or modifying an itemreplacing, or modifying an itemDetermining cause of accident or Determining cause of accident or

malfunction of an itemmalfunction of an item

Provide baseline data for in-service Provide baseline data for in-service inspectioninspection

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DefinitionsDefinitions

Nonpermanent Quality Assurance Nonpermanent Quality Assurance Record- A nonpermanent QA record Record- A nonpermanent QA record which does not qualify as a Lifetime QA which does not qualify as a Lifetime QA recordrecord

Electronic Document Management Electronic Document Management System (Electronic Vault) – TVA System (Electronic Vault) – TVA Repository for official records in Repository for official records in electronic formatelectronic format

Quality Assurance Record – Furnishes Quality Assurance Record – Furnishes documentary evidence of quality of documentary evidence of quality of items or activitiesitems or activities

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DefinitionsDefinitionsNonquality Assurance Record – Required Nonquality Assurance Record – Required

to be retained, but not QA recordto be retained, but not QA recordPermanent Record – Determined to Permanent Record – Determined to

have significant value to warrant have significant value to warrant preservationpreservation

Record – Any document maintained for Record – Any document maintained for informational valueinformational value

Records Administrator – Individual Records Administrator – Individual charged with ensuring records are charged with ensuring records are identified and organizedidentified and organized

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Records RequirementsRecords Requirements

LegibleLegibleTechnically AccurateTechnically AccurateCompleteCompleteRetrievableRetrievableTraceableTraceableSecureSecurePages AccountablePages Accountable

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Safeguards Information Safeguards Information (SGI)(SGI)

Information not otherwise classified as Information not otherwise classified as National Security Information or Restricted National Security Information or Restricted data that specifically identifies licensees:data that specifically identifies licensees:1. Security measures for physical 1. Security measures for physical

protection of special nuclear material ofprotection of special nuclear material ofof more than moderate significanceof more than moderate significance

2. Security measures for physical2. Security measures for physicalprotection & location of certain plantprotection & location of certain plantequipment vital to safetyequipment vital to safety

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Safeguards Information Safeguards Information (SGI)(SGI)

Four Most Common Violations Four Most Common Violations of SGI:of SGI:

Leaving SGI UnattendedLeaving SGI UnattendedSGI Containers UnsecuredSGI Containers UnsecuredLeaving SGI on Personal Computer Leaving SGI on Personal Computer

(PC) Hard Drive(PC) Hard Drive Improper Mailing ProcedureImproper Mailing Procedure

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Sensitive Security Sensitive Security InformationInformation

Information that is the property of Information that is the property of TVA and has been determined TVA and has been determined sensitive by the originatorsensitive by the originator

Distribution on Need to Know basis Distribution on Need to Know basis onlyonly

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Sensitive Security Sensitive Security InformationInformation

Any commercial, financial, Any commercial, financial, attorney/client, law enforcement, attorney/client, law enforcement, security, attorney work product, security, attorney work product, strategic business, privacy or other strategic business, privacy or other whose disclosure could:whose disclosure could:1. Be Illegal1. Be Illegal2. Be Prejudicial to TVA or Private Co.2. Be Prejudicial to TVA or Private Co.3. Violate Privacy of an Individual3. Violate Privacy of an Individual4. Not be available in Civil Discovery4. Not be available in Civil Discovery

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Records ResponsibilitiesRecords ResponsibilitiesTVA Enterprise Document Management TVA Enterprise Document Management

(EDM) Division – Establish & maintain (EDM) Division – Establish & maintain administrative control over TVA recordsadministrative control over TVA records

TVAN Organizations – Identify records TVAN Organizations – Identify records administrator & advise Management administrator & advise Management Svs.Svs.

Each Site – Maintain records list with:Each Site – Maintain records list with:Classification, Retention, Location, and Classification, Retention, Location, and Responsible OrganizationResponsible Organization

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Records ResponsibilitiesRecords ResponsibilitiesEach Organization – Maintain list of Each Organization – Maintain list of

all records generated and ensure all records generated and ensure completeness and accuracy of completeness and accuracy of recordsrecords

Originating Organizations – Maintain Originating Organizations – Maintain accountability for storage of records accountability for storage of records and protect QA records from and protect QA records from damage, loss, misplacement, or damage, loss, misplacement, or destructiondestruction

HPT001.022Rev. 1 of 49


Computer Software Computer Software ControlControl

SPP-2.6, “Computer Software SPP-2.6, “Computer Software Control” – Describes processes Control” – Describes processes necessary to control computer necessary to control computer software applications within TVANsoftware applications within TVAN

Software Quality Assurance – Software Quality Assurance – Controls and actions which provide Controls and actions which provide assurance that computer software assurance that computer software performs as intended.performs as intended.

HPT001.022Rev. 1 of 49


Computer ControlComputer Control Responsibilities Responsibilities

Corporate Document Control Records Corporate Document Control Records Management (DCRM) – Document Management (DCRM) – Document Control for computer applications Control for computer applications softwaresoftware

Application Owner – Ensures Application Owner – Ensures application software & software application software & software documentation meets requirementsdocumentation meets requirements

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Computer ControlComputer Control Responsibilities Responsibilities

Application DeveloperApplication Developer

1. Develops/Modifying software1. Develops/Modifying software2. Preparing/Revising software 2. Preparing/Revising software

documentationdocumentation3. Prepare software design 3. Prepare software design descriptiondescription4. Perform & Document validation & 4. Perform & Document validation &

operability testingoperability testing

HPT001.022Rev. 1 of 49


SummarySummary

Nuclear Quality Assurance Plan Nuclear Quality Assurance Plan (NQAP)(NQAP)

Radiological Control & Radiological Control & Radioactive Material Shipment Radioactive Material Shipment Augmented Quality Assurance Augmented Quality Assurance Program (RC&RMS)Program (RC&RMS)

Document ControlDocument ControlRecords ManagementRecords ManagementComputer Software ControlComputer Software Control