QUALITY ASSURANCE/ QUALITY CONTROL AS APPLIED TO

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TP-1

HPT001.022

Rev. 1

Page 1 of 17

QUALITY ASSURANCE/

QUALITY CONTROL AS

APPLIED TO RADIOLOGICAL

CONTROL AND RECORDS

HPT001.022

TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Enabling Objectives

HPT001.022

Rev. 1

Page 2 of 49

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

TP-2 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Enabling Objectives

HPT001.022

Rev. 1

Page 3 of 49

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

TP-3 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Quality Assurance

Rev. 1

Page 4 of 49

Quality Assurance

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

TP-4 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Quality Control

HPT001.022

Rev. 1

Page 5 of 49

Quality Control

Component of Quality Assurance

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

TP-5 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

TP-6

HPT001.022

Rev. 1

Page 6 of 49

Applicable Documents

10 CFR 20

NRC Reg Guide 1.33

TVA NQAP

SPP-1.4

SPP-5.9

SPP-2.0

SPP-2.2

SPP-2.3

SPP-2.4

SPP-2.6

TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Page 7 of 49

Regulations & Guidelines

Regulation:

10 CFR 50, Appendix B

Guidelines:

NRC Regulatory Guide 1.33, “Quality

Assurance Program Requirements”

TP-7 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

NQAP

HPT001.022

Rev. 1

Page 8 of 49

TVA Nuclear Quality Assurance

Plan (NQAP)

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

TP-8 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Page 9 of 49

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.

TP-9 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Programs & Features Rev. 1

Page 10 of 49 for which NQAP Applies

Radiological Control

Emergency Preparedness

Nuclear Plant Security

Radioactive Material Shipment

Special Nuclear Material Management

Fire Protection

Radwaste Management Systems, etc.

Chemistry

TP-10 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Elements of NQAP

Rev. 1

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List of Safety-Related Items/Systems

Graded Approach to NQAP

Requirements

Assignment of Responsibilities

Preparation of Nuclear Procurement

System Documents

Training of Personnel

TP-11 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Elements of NQAP

Rev. 1

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Provisions for Special Controls,

Processes, Test Equipment, Tools &

Skills

Measures to Control Cleanliness of

Facilities, Material & Equipment

Prompt Corrective Actions

Control of Adequate Records

TP-12 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Page 13 of 49

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.

TP-13 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

RC&RMS Programs

Rev. 1

Page 14 of 49

RC&RMS Programs not Regulated by

10 CFR 50

TP-14

Dosimetry Processing (15CFR285–NVLAP)

Radioactive Materials Shipment (10CFR71)

Personnel Exposure Data (Privacy Act)

Land Use Survey Data (Privacy Act)

(For Radiological Environmental

Monitoring Program)

TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Management Controls

Page 15 of 49

Ensure that the Program Activities:

TP-15

1. Meet Regulatory Requirements &

TVA Policy

2. Are Performed as Required

3. Satisfactory Completion Verified &

Documented

4. Accomplished by Approved

Procedures & Instructions.

TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

QA Records Retention

Page 16 of 49

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

TP-16 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Contents of QA Record

History Files

Rev. 1

Page 17 of 49

Instrument Calibration Records

Radiological Surveys

RWPs

Program Bases & Documentation

Environmental & Effluent Measurements

Radioactive Material Shipment & Disposal

Source & Byproduct Material

Miscellaneous Records

TP-17 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Miscellaneous Records

HPT001.022

Rev. 1

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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

TP-18 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

QA Responsibilities

HPT001.022

Rev. 1

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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.

TP-19 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

QA Responsibilities

HPT001.022

Rev. 1

Page 20 of 49

Each Organization: Designate Individual to be Responsible to Assure QA

Requirements Fully Implemented.

Each Employee:

1. Expected to do Job Right First Time

2. Comply with Requirements of NQAP & its Implementing Documents.

TP-20 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Document Control

Rev. 1

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SPP-2.0, “Procedures and Document

Control”

SPP-2.2, “Administration of Site

Technical Procedures”

SPP-2.3, “Document Control”

TP-21 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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Procedure Use Classifications

Continuous Use

Reference Use

Information Use

Multiple Use

TP-22 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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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.

TP-23 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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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

TP-24 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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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

TP-25 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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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

TP-26 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Page 27 of 49

Information Use Procedures

Characteristics:

Performed frequently or not complex

Can easily be performed from memory

Within knowledge & skills of performers

TP-27 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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Information Use Procedures

Procedure should be reviewed periodically, such as:

1. Before performance

2. During continuing training

3. Following revisions

User responsible for results obtained when not referring to procedure

TP-28 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Page 29 of 49

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

TP-29 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Page 30 of 49

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

TP-30 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Controlled Copy

HPT001.022

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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

TP-31 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Controlled Copy

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Document Identifications

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

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

– Verified as

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

Reactivated by subsequent revision

“ADMINISTRATIVE HOLD” – Technical or other difficulties preclude use

TP-32 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Document Control

Responsibilities

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Management Services

1. Maintain Controlled Document List

2. 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

TP-33 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Document Control

Responsibilities

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Rev. 1

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Procedure Performer:

1. Ensure latest revision being used

2. Understand activity and procedural requirements

3. Adhere to procedure requirements

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

TP-34 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Records Management

Page 35 of 49

SPP-2.4, “Records Management” & NQAP

QA Records must be:

1. Identified

2. Reviewed

3. Authenticated

4. Retained

5. Retrievable

QA Records are auditable

TP-35 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Lifetime QA Records

HPT001.022

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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

TP-36 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Definitions

HPT001.022

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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

TP-37 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Definitions

HPT001.022

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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

TP-38 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Records Requirements

Page 39 of 49

Legible

Technically Accurate

Complete

Retrievable

Traceable

Secure

Pages Accountable

TP-39 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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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 significance

2. Security measures for physical protection & location of certain plant equipment vital to safety

TP-40 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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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

TP-41 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Page 42 of 49

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

TP-42 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

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Rev. 1

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Sensitive Security Information

Any commercial, financial, attorney/client, law enforcement, security, attorney work product, strategic business, privacy or other whose disclosure could:

1. Be Illegal

2. Be Prejudicial to TVA or Private Co.

3. Violate Privacy of an Individual

4. Not be available in Civil Discovery

TP-43 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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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

TP-44 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

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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

TP-45 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

HPT001.022

Rev. 1

Page 46 of 49

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.

TP-46 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Computer Control

Responsibilities

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Rev. 1

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Corporate Document Control Records

Management (DCRM) – Document Control for computer applications software

Application Owner – Ensures application software & software documentation meets requirements

TP-47 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Computer Control

Responsibilities

Application Developer

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1. Develops/Modifying software

2. Preparing/Revising software documentation

3. Prepare software design description

4. Perform & Document validation & operability testing

TP-48 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

Summary

HPT001.022

Rev. 1

Page 49 of 49

Nuclear Quality Assurance Plan

(NQAP)

Radiological Control & Radioactive

Material Shipment Augmented

Quality Assurance Program

(RC&RMS)

Document Control

Records Management

Computer Software Control

TP-49 TVAN Technical Training

Health Physics (RADCON) Initial Training Program

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