(text) DOC.20070717.0006

OCRWM 
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DOE/RW-0333P, Revision 19 Page: 2 of 149 


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REVISION HISTORY 

EFFECTIVE 
REVISION REVISION DESCRIPTION DATE 

19  Revised the Office of Radioactive Waste Management 07-20-2007 
Quality Assurance Policy  Editorial changes. Deleted last 

(2) sentences as they are redundant with Subsections 
5.2.B and 16.2.4C 
 Updated Revision History to reflect QARD Rev. 19 
changes 
 Updated Table of Contents to reflect new QARD 
Appendix C, Storage and Transportation 
 Incorporated new Appendix C to clarify requirements 
unique to the work conducted for the storage of spent 
nuclear fuel and the transportation of spent nuclear fuel 
and high-level radioactive waste. 

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TABLE OF CONTENTS 
Section Title 

Title Page 

Policy OFFICE OF CIVILIAN RADIOACTIVE WASTE 
MANAGEMENT QUALITY ASSURANCE POLICY 

RevHist REVISION HISTORY 

TOC TABLE OF CONTENTS 

Intro INTRODUCTION 

1.0 ORGANIZATION 
1.1 GENERAL 
1.2 REQUIREMENTS 
1.2.1 Responsibility for Quality 
1.2.2 Resolution of Quality Disputes 
1.3 DESCRIPTION 
1.3.1 Specific OCRWM Offices 
1.3.2 Delegation of Authority 
1.3.3 Principal Contractors 
1.3.4 Waste Custodians (Spent Nuclear Fuel and High-Level Waste Form Producers) 
Figure 1 OCRWM Organization 
Figure 2 OCRWM External Interfaces 
2.0 QUALITY ASSURANCE PROGRAM 
2.1 GENERAL 
2.2 REQUIREMENTS 
2.2.1 Quality Assurance Program Documents 
2.2.2 Quality Assurance Program Applicability and Related Activities 
2.2.3 Classifying Structures, Systems, and Components 
2.2.4 Planning Work 
2.2.5 Surveillances 
2.2.6 Management Assessments 
2.2.7 Readiness Reviews 
2.2.8 Peer Reviews 
2.2.9 Expert Elicitation 
2.2.10 Quality Assurance Program Management Review 
2.2.11 Personnel Indoctrination, Training, Qualification, and Certification 

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TABLE OF CONTENTS (Continued) 

Section Title 

3.0 DESIGN CONTROL 
3.1 GENERAL 
3.2 REQUIREMENTS 
3.2.1 Design Input Control 
3.2.2 Design Process 
3.2.3 Design Analyses 
3.2.4 Design Verification 
3.2.5 Design Verification Methods 
3.2.6 Design Change Control 
3.2.7 Design Interface Control 
3.2.8 Sampling Plans 
4.0 PROCUREMENT DOCUMENT CONTROL 
4.1 GENERAL 
4.2 REQUIREMENTS 
4.2.1 Procurement Document Preparation 
4.2.2 Procurement Document Review and Approval 
4.2.3 Procurement Document Change 
4.2.4 Procurement Document Control 
5.0 PROCEDURES, INSTRUCTIONS, AND DRAWINGS 
5.1 GENERAL 
5.2 REQUIREMENTS 
5.2.1 Types of Implementing Documents 
5.2.2 Content of Implementing Documents 
5.2.3 Review, Approval, and Control of Implementing Documents 
6.0 DOCUMENT CONTROL 
6.1 GENERAL 
6.2 REQUIREMENTS 
6.2.1 Types of Documents 
6.2.2 Preparing Documents 
6.2.3 Reviewing Documents 
6.2.4 Approving Documents 
6.2.5 Distribution and Use of Documents 
6.2.6 Changes to Documents 
6.2.7 Expedited Changes 
6.2.8 Editorial Corrections 

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TABLE OF CONTENTS (Continued) 

Section Title 

7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND 
SERVICES 
7.1 GENERAL 
7.2 REQUIREMENTS 
7.2.1 Procurement Planning 
7.2.2 Source Evaluation and Selection 
7.2.3 Proposal/Bid Evaluation 
7.2.4 Supplier Performance Evaluation 
7.2.5 Control of Supplier Generated Documents 
7.2.6 Acceptance of Items or Services 
7.2.7 Certificate of Conformance 
7.2.8 Source Verification 
7.2.9 Receiving Inspection 
7.2.10 Post-Installation Testing 
7.2.11 Control of OCRWM Contractors/Suppliers Nonconformances 
7.2.12 Commercial Grade Procurement 
7.2.13 American Society of Mechanical Engineers Section III Code Items 
8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND 
COMPONENTS 
8.1 GENERAL 
8.2 REQUIREMENTS 
8.2.1 Identification 
8.2.2 Physical Markings 
8.2.3 Conditional Requirements 
9.0 CONTROL OF SPECIAL PROCESSES 
9.1 GENERAL 
9.2 REQUIREMENTS 
9.2.1 Special Processes 
9.2.2 Personnel, Implementing Documents, and Equipment Qualifications 
9.2.3 Qualification and Certification of Nondestructive Examination Personnel 
10.0 INSPECTION 
10.1 GENERAL 
10.2 REQUIREMENTS 
10.2.1 Inspection Planning 
10.2.2 Selecting Inspection Personnel to Perform Inspections 
10.2.3 Inspection Hold Points 

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TABLE OF CONTENTS (Continued) 

Section Title 

10.2.4 Statistical Sampling 
10.2.5 In-Process Inspections and Monitoring 
10.2.6 Final Inspection 
10.2.7 Accepting Items 
10.2.8 Inspection Documentation 
10.2.9 Qualification and Certification of Inspection Personnel 
11.0 TEST CONTROL 
11.1 GENERAL 
11.2 REQUIREMENTS 
11.2.1 Test Planning 
11.2.2 Performing Tests 
11.2.3 Use of Other Testing Documents 
11.2.4 Test Results 
11.2.5 Test Documentation 
11.2.6 Qualification and Certification of Test Personnel 
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 
12.1 GENERAL 
12.2 REQUIREMENTS 
12.2.1 Calibration 
12.2.2 Documenting the Use of Measuring and Test Equipment 
12.2.3 Out-of-Calibration Measuring and Test Equipment 
12.2.4 Lost Measuring and Test Equipment 
12.2.5 Handling, Storage, and Use 
12.2.6 Commercial Devices 
12.2.7 Measuring and Test Equipment Documentation 
13.0 HANDLING, STORAGE, AND SHIPPING 
13.1 GENERAL 
13.2 REQUIREMENTS 
13.2.1 Controls 
13.2.2 Special Equipment, Tools, and Environments 
13.2.3 Marking and Labeling 
14.0 INSPECTION, TEST AND OPERATING STATUS 
14.1 GENERAL 
14.2 REQUIREMENTS 
14.2.1 Identifying Items 
14.2.2 Indicating Status 

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TABLE OF CONTENTS (Continued) 

Section Title 

15.0 NONCONFORING MATERIAL, PARTS, OR COMPONENTS 
15.1 GENERAL 
15.2 REQUIREMENTS 
15.2.1 Documenting, Reporting, and Evaluating Nonconforming Items 
15.2.2 Identifying Nonconforming Items 
15.2.3 Segregating Nonconforming Items 
15.2.4 Disposition of Nonconforming Items 
16.0 CORRECTIVE ACTION 
16.1 GENERAL 
16.2 REQUIREMENTS 
16.2.1 Identifying Conditions Adverse to Quality 
16.2.2 Classification of Conditions Adverse to Quality 
16.2.3 Conditions Adverse to Quality 
16.2.4 Significant Conditions Adverse to Quality 
16.2.5 Follow-up 
16.2.6 Quality Trending 
17.0 QUALITY ASSURANCE RECORDS 
17.1 GENERAL 
17.2 REQUIREMENTS 
17.2.1 Quality Assurance Records 
17.2.2 Creating Valid Quality Assurance Records 
17.2.3 Submission of Quality Assurance Records 
17.2.4 Receiving and Indexing Quality Assurance Records 
17.2.5 Correcting Information in Quality Assurance Records 
17.2.6 Storing and Preserving Quality Assurance Records 
17.2.7 Retrieval of Quality Assurance Records 
17.2.8 Retention of Quality Assurance Records 
17.2.9 Turnover of Quality Assurance Records 
17.2.10 Long-Term Single Storage Facility 
17.2.11 Dual Storage Facilities 
17.2.12 Temporary Storage Facility 
17.2.13 Replacement of Quality Assurance Records 
18.0 AUDITS 
18.1 GENERAL 
18.2 REQUIREMENTS 
18.2.1 Audit Scheduling 
18.2.2 Scheduling Internal Audits 
18.2.3 Scheduling External Audits 
18.2.4 Audit Schedule 

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TABLE OF CONTENTS (Continued) 

Section Title 

18.2.5 Audit Planning 
18.2.6 Audit Team Independence 
18.2.7 Audit Team Selection 
18.2.8 Performing Audits 
18.2.9 Reporting Audit Results 
18.2.10 Responding to Audits 
18.2.11 Evaluating Audit Responses 
18.2.12 Follow-up Action 
18.2.13 Audit Team Qualification and Certification 
SUPPLEMENT I, SOFTWARE 

I.1 GENERAL 
I.2 REQUIREMENTS 
I.2.1 General Software Requirements 
I.2.2 Software Planning 
I.2.3 Software Life Cycle Requirements 
I.2.4 Software Configuration Management 
I.2.5 Problem Reporting and Resolution 
I.2.6 Software Procurement 
I.2.7 Otherwise Acquired Software 
I.2.8 Control of the Use of Software 
SUPPLEMENT II, SAMPLE CONTROL 

II.1 GENERAL 
II.2 REQUIREMENTS 
II.2.1 General Requirements 
II.2.2 Traceability 
II.2.3 Identification 
II.2.4 Conditional Requirements 
II.2.5 Archiving Samples 
II.2.6 Handling, Storage, and Shipping 
II.2.7 Disposition of Nonconforming Samples 
SUPPLEMENT III, SCIENTIFIC INVESTIGATION 

III.1 GENERAL 
III.2 REQUIREMENTS 
III.2.1 Planning Scientific Investigations 
III.2.2 Performing Scientific Investigations 
III.2.3 Data Identification 
III.2.4 Data Review, Adequacy, and Usage 
III.2.5 Technical Report Review 
III.2.6 Model Development and Use 

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TABLE OF CONTENTS (Continued) 

Section Title 

SUPPLEMENT IV, FIELD SURVEYING 

IV.1 GENERAL 
IV.2 REQUIREMENTS 
IV.2.1 Field Survey System 
IV.2.2 Field Survey Documentation 
SUPPLEMENT V, CONTROL OF THE ELECTRONIC MANAGEMENT OF 
INFORMATION 

V.1 GENERAL 
V.2 REQUIREMENTS 
V.2.1 Control of the Electronic Management of Information 
APPENDIX A, WASTE CUSTODIAN INTERFACE 

A.1 GENERAL 
A.1.1 Commercial Nuclear Utilities 
A.1.2 Federal Waste Custodians 
A.2 SPECIFIC DISCUSSION OF OCRWM INTERFACE WITH FEDERAL WASTE 
CUSTODIANS 
A.2.1 Interface with the Office of Environmental Management 
A.2.2 Interface with the Naval Nuclear Propulsion Program 
APPENDIX B, *****INTENTIONALLY BLANK***** 

APPENDIX C, STORAGE AND TRANSPORTATION 

C.1 GENERAL 
C.2 REQUIREMENTS 
TABLE 1 - REGULATORY/COMMITMENT DOCUMENT POSITIONS 
GLOSSARY 


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INTRODUCTION 

The Office of Civilian Radioactive Waste Management (OCRWM) Quality Assurance (QA) 
program consists of the Quality Assurance Requirements and Description (QARD), 
DOE/RW-0333P and those documents that implement the QARD, (i.e., procedures, 
instructions, and drawings [implementing documents]). 

The QARD establishes requirements for the OCRWM QA program that meets the 
requirements of 10 CFR 63.142, Quality Assurance Criteria, that are to be implemented for 
activities up to the time of receipt of high-level radioactive waste and spent nuclear fuel for 
disposal in the geologic repository at Yucca Mountain. The QARD will be revised as 
necessary at the appropriate time to include facility operation, permanent closure, and 
decontamination and dismantling of surface facilities. 

The QARD is applicable to structures, systems, components, and related activities described 
in Section 2.0. 

The QARD requirements are derived from regulatory and industry documents. The OCRWM 
commits to the staff positions and provisions as delineated in Table 1, 
Regulatory/Commitment Document Positions. 

The QARD is organized into sections, supplements, an appendix, table, and glossary. The 
sections are consistent with the criteria of 10 CFR 63.142 and contain requirements that are 
common to all OCRWM activities. The supplements provide specific criteria relative to 
certain unique activities. The appendix specifies how the OCRWM will ensure that waste 
custodians high-level waste and spent nuclear fuel will be acceptable for emplacement in the 
geologic repository. The table provides the commitments to certain specific regulatory and 
industry documents. The glossary establishes a common vocabulary for the OCRWM QA 
program. 

Suppliers, and principal contractors that are contracted directly to the OCRWM, are identified 
as OCRWM contractors. 

The requirements of the QARD that are applicable to suppliers are also applicable to 
OCRWM contractors unless otherwise noted. 

QA program description documents developed by suppliers incorporate the requirements of 
the purchasers QA program description document, as applicable to their scope of work. 
These documents are accepted by the purchaser prior to the start of work. 

OCRWM contractors may work to OCRWM or a principal contractors implementing 
documents when stipulated in procurement documents, in accordance with Section 4.0. 

Suppliers to a principal contractor may work to OCRWM or the principal contractors 
implementing documents, if permitted by the principal contractors QA program description 
document and if stipulated in procurement documents. 


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1.0 ORGANIZATION 
1.1 GENERAL 
A. The Office of Civilian Radioactive Waste Management (OCRWM) 

organizational structure encompasses those positions responsible for 
establishing, managing, verifying, and interpreting the OCRWM Quality 
Assurance program. The Quality Assurance Requirements and Description 
(QARD) establishes the relationships of organizations within the OCRWM, 
including principal contractors and waste custodians with overall responsibilities 
for performing activities related to structures, systems, and components (SSCs) 
important to safety or waste isolation, and to the design and characterization of 
barriers important to waste isolation. 

B. The QARD identifies the requirements and delineates the major authorities and 
responsibilities of organizations supporting the OCRWM. 
1.2 REQUIREMENTS 
The OCRWM and principal contractors shall prepare one or more controlled 
documents that describe their responsibilities and authorities, including the 
management positions responsible for achieving and maintaining quality, internal 
and external organizational interfaces, organizational structures, and responsibilities 
for their scope of work. These documents shall be revised upon any reorganization 
that impacts responsibilities associated with the implementation of QARD-related 
activities. 

1.2.1 Responsibility for Quality 
Quality shall be achieved and maintained by those who have been assigned 
responsibility for performing work. The achievement of quality shall be verified by 
persons or organizations not directly responsible for performing the work. 

1.2.2 Resolution of Quality Disputes 
Differences of opinion between the QA organization and other personnel involving 
the OCRWM QA program requirements shall be brought to the attention of the 
appropriate management and, if not resolved, shall be elevated progressively to 
successively higher levels of management. The Director, OCRWM, has ultimate 
resolution authority. 

1.3 DESCRIPTION 
A. Organization charts that clearly identify all OCRWM and principal contractor 
on-site and off-site organizational elements that function under the cognizance of 
the OCRWM QA program shall be maintained and controlled under the 

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OCRWM QA program (e.g., design, engineering, procurement, shipping, 
receiving, storage, manufacturing, construction, inspection, auditing, testing, 
instrumentation and control, maintenance, modification, etc.). These charts also 
identify lines of responsibility. Figure 1, OCRWM Organization, identifies the 
OCRWM organizational units responsible for the implementation of activities 
governed by the QARD. Figure 2, OCRWM External Interface, identifies the 
OCRWM interface with the principal contractors and waste custodians. 

B. The OCRWM is comprised of the Office of the Director and Principal Deputy 
Director, Office of Quality Assurance, Office of the Chief Scientist, Office of the 
Chief Engineer, Regulatory Authority Office, Infrastructure Management Office, 
Yucca Mountain Site Operations Office, Waste Management Office, Office of 
Logistic Management, Disposal Operations Office, Office of Project Controls, 
Office of Procurement, Office of Government Services, and Office of External 
Affairs. 
C. Any substantial OCRWM reorganization of descriptions or functions of the 
offices described herein will require a revision to this document. 
1.3.1 Specific OCRWM Offices 
A. Office of the Director/Principal Deputy Director. 
The Office of the Director/Principal Deputy Director is responsible for carrying 
out the functions of the Secretary of Energy under the Nuclear Waste Policy Act 
and for providing overall management of the OCRWM Program. 

The Director/Principal Deputy Director report to the Secretary of Energy through 
the Under and Deputy Secretaries; retains ultimate responsibility for the overall 
OCRWM Program; and are responsible for providing leadership in developing 
and implementing strategies to accomplish the OCRWM Program's mission in a 
manner that assures public and worker health and safety, protects the 
environment, merits public confidence, and is economically viable. In addition, 
the Director/Principal Deputy Director are responsible for licensing and approval 
to construct and operate a geologic repository for the safe disposal of high-level 
radioactive waste and spent nuclear fuel and for providing for the safe 
transportation of high-level radioactive waste and spent nuclear fuel to the 
geologic repository. Staff within the immediate Office of the Director provides 
advice to the Director and Principal Deputy Director and support development of 
the OCRWM Program policies. Several programmatic and technical authorities 
of the Director, OCRWM, are delegated to line management as reflected in this 
document. 

Responsibilities and authorities that are retained by the Office of the 
Director/Principal Deputy Director and are not delegated are as follows: 


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1. Ultimate responsibility for the effective implementation of the OCRWM QA 
program and for revision and approval authority of the QARD. 
2. Ultimate resolution authority for the resolution of quality disputes. 
3. Long-term planning and facility-wide safety. 
4. Mission assignments and broad OCRWM Program policy, guidance, and 
direction to the OCRWM management team through, among other things, the 
OCRWM Strategic Plan and Program Plan, Civilian Radioactive Waste 
Management System Major System Management Policy, and the Integrated 
Safety Management Plan. 
5. Establishment of the OCRWM organizational structure, including the 
organizational roles, responsibilities, authority, and accountability for key 
OCRWM Program functions. 
6. Ensuring that a sufficient number of trained personnel are available to 
implement applicable portions of the OCRWM QA program before the 
initiation of activities within the scope of the OCRWM QA program. 
7. Integration of program activities and monitoring of key performance 
indicators. 
8. Continuing involvement in OCRWM QA program activities by directing the 
performance of periodic management assessments of the OCRWM QA 
program and principal contractors QA programs to determine the adequacy 
and effectiveness of these QA programs. 
B. Office of Quality Assurance 
1. Is responsible for the QA functions for the OCRWM QA program. 
2. Is sufficiently independent from cost and schedule when opposed to safety 
considerations. 
3. Has access to work areas and the organizational freedom to effectively 
communicate with other senior managers. 
4. Has the authority to fulfill the responsibilities of the position. 
5. Has no other assigned responsibilities unrelated to the OCRWM QA program 
that would prevent full attention to QA matters. 
6. Provides guidance and direction, relative to QA matters, to identify quality 
problems; initiate, recommend, or provide solutions; and to verify 
implementation of corrective action. 

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7. Has the authority to stop work when significant conditions adverse to 
quality warrant such action. 
8. Is qualified in accordance with Subsection 2.2.11. 
9. Maintains liaison with OCRWM contractors and waste custodian QA 
organizations to remain current on the status of activities related to 
their QA programs. 
10. Specific duties and responsibilities include the following: 
a. Assuring implementation of the OCRWM Quality Assurance Policy 
b. Assuring that the OCRWM QA program complies with regulatory 
and management requirements, is established consistent with the 
schedule for accomplishing the activities, is maintained, and is 
effectively executed 
c. Developing, approving, and maintaining the QARD 
d. Interpreting QA requirements established in the QARD 
e. Documenting concurrence and/or approval (as specified in applicable 
procedures or procurement documents) of quality-related documents 
used by OCRWM contractors to ensure conformance with the 
requirements of the QARD 
f. Verifying the adequacy and implementation (i.e., compliance and 
effectiveness) of the OCRWM QA program and reporting the 
results to OCRWM senior management 
g. Verifying the adequacy and implementation of OCRWM 
contractors QA program description documents and implementing 
documents with the requirements of the QARD. Verification may 
include review of selected implementing documents as well as the 
use of audits, surveillance, and inspections, as appropriate 
h. Identifying quality problems; initiating, recommending, or 
providing solutions to quality problems; and verifying solutions to 
quality problems 
i. Ensuring that there is adequate quality assurance coverage relative to 
procedural and inspection controls, acceptance criteria, and quality 
assurance staffing and qualifications of personnel to carry out quality 
assurance assignments. 

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11. The quality assurance activities include quality engineering, quality 
verification, and OCRWM QA program and policy development. 
12. OQA staff shall be involved in day-to-day OCRWM activities such as 
work schedule and status meetings. 
13. Responsibilities are carried out through a trained staff of qualified 
personnel. The qualifications of the OQA staff, including direct 
support contractors, shall be in accordance with Subsection 2.2.11. 
C. Office of the Chief Scientist 
1. Coordinates all scientific research for the OCRWM Program. 
2. Ensures the OCRWM Program has the best data and information 
possible in the performance of scientific research. 
3. Manages interfaces with other Department of Energy supporting 
organizations including the national laboratories. 
4. Serves as approving authority for all scientific information associated with 
the OCRWM Program. 
5. Provides direction, review, and approval of contractor strategy and plan 
for the conduct of performance assessments. 
6. Ensures technical and regulatory adequacy of post-closure safety 
assessment and performance confirmation results. 
7. Develops guidance/requirements for the technical activities associated with 
identifying, evaluating, and distributing information from scientific 
investigations and repository performance assessment activities. 
8. Identifies, evaluates, and supports scientific investigations and analyses 
of current and developing technologies. 
D. Office of the Chief Engineer 
1. Serves as Project Director for the repository. 
2. Resolves all design-related project technical issues. 
3. Applies scientific requirements in the development of an approach that can 
be constructed and operated. 
4. Designs all systems and components, including aging and disposal 
canisters and their associated aging casks/overpacks. 

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5. Serves as the design authority; coordinates policy issues associated with 
design and nuclear safety. 
6. Supports OCRWM management on design bases information for 
repository performance assessment. 
7. Represents OCRWM in constituent interactions on repository design 
issues. 
8. Establishes requirements and monitors the development of repository 
design. 
9. Develops and maintains project-level requirements. 
10. Establishes design-related mechanisms for DOE control and approval of 
repository design and operational baseline changes including designation 
of appropriate DOE approval levels. 
11. Leads periodic DOE management reviews of design activities to ensure 
that workable repository design solutions are developed according to 
established schedules. 
12. Monitors contractor design activities including the development of 
designs for individual features, as well as comprehensive design 
products. 
13. Identifies and communicates to management potential design-related 
changes and issues that have policy and system implications. 
14. Ensures technical and regulatory adequacy of design and pre-closure 
safety analysis results. 
15. Monitors design product development for requirement compliance and 
reviews engineering product deliverables. 
16. Ensures appropriateness of engineering solutions. 
17. Performs and monitors project-level system engineering activities. 
18. Provides oversight of technical data management. 
19. Develops pre-closure safety and hazards analysis. 
E. Regulatory Authority Office 
1. Serves as Chief Nuclear Officer. 

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2. Provides overall direction and approves the basis for placement of items on 
the Q-list, including the actual placement of items on the Q-List and 
Management Control List for design and construction of surface and 
subsurface facilities. 
3. Integrates design, scientific, safety analysis, and performance assessment 
inputs into coherent systematic descriptions to demonstrate compliance with 
regulatory requirements. 
4. Monitors performance assessment activities, including the development of 
models that represent processes and events that could impact the ability of 
the repository to contain and isolate radioactive waste. 
5. Initiates and maintains Memoranda of Understanding and Memoranda of 
Agreement. 
F. Infrastructure Management Office 
1. Constructs all aspects of the project. 
2. Develops and implements a construction project acceptance and 
turnover program. 
3. Ensures the adequacy and correctness of engineering design documentation 
(e.g., as built/as-constructed design drawings). 
4. Verifies infrastructure system, structure and component turnover 
documentation. 
5. Supports design and construction interface to ensure project 
constructability. 
6. Participates in design reviews providing project construction input. 
7. Serves as the infrastructure construction authority. 
8. Manages and integrates all aspects of field operations including engineering, 
design, construction, and site testing activities. 
9. Maintains site construction and operations to ensure compliance with 
applicable standards and reporting requirements. 
10. Maintains a construction project authorization and control process to ensure 
that applicable Nuclear Regulatory Commission (NRC) authorizations and 
approvals are secured prior to initiation of field construction activities. 

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G. Yucca Mountain Site Operations Office 
1. Manages all facilities and operations at the Yucca Mountain site. 
2. Establishes, controls, and verifies site operations and maintenance 
requirements. 
3. Establishes and oversees the safety basis for operations. 
4. Establishes performance specifications, maintains and controls system, 
structure and component configuration for Yucca Mountain site facilities 
including the tunnel (as built/as-constructed design). 
5. Ensures that the Yucca Mountain site facilities comply with applicable 
Federal, State, and local requirements. 
6. Ensures compliance with radiological protection standards and regulations. 
7. Monitors and oversees facility NRC governed occurrence and incident 
reporting. 
8. Manages and oversees activities for lessons learned, benchmarking, trending 
and other feedback, and ensures results are incorporated as appropriate for 
continuous improvement. 
9. Manages performance assessment to include the coordination and 
integration of external assessments and audits and OCRWM responses. 
10. Performs line management and oversight activities for the development and 
implementation of objectives, policies, procedures, and plans for the 
Corrective Action Program (CAP), and administrator to the CAP. 
11. Serves as Co-Chair for the Management Review Committee for the CAP. 
12. Ensures consistent implementation and oversight of the cause analyses, 
corrective action plans, implementation of corrective actions, and feedback 
through trend reports. 
13. Manages and oversees the document hierarchy process and activities for 
policy, procedure, plan requirement, and charter development revision, 
cancellation, and control. 
H. Waste Management Office 
1. Manages the standard contracts for disposal of spent nuclear fuel and/or 
high-level radioactive waste with waste custodians. 

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2. Designs and integrates waste packaging including transportation and storage 
containers. 
3. Establishes requirements for waste (waste acceptance criteria) that will be 
shipped to Yucca Mountain. 
4. Serves as the authority on transportation packages, waste packages, and 
waste acceptance criteria. 
5. Establishes waste acceptance policy and requirements for repository and 
transportation projects. 
6. Coordinates and maintains OCRWM Program interface with DOE Office of 
Environmental Management (EM); Office of Nuclear Energy (NE); 
National Nuclear Security Administration; and Naval Nuclear Propulsion 
Program (NNPP) on waste management and disposal issues pertinent to the 
OCRWM Program. 
7. Ensures EM and NE waste acceptance quality assurance requirements are 
implemented. 
8. Coordinates and evaluates the incorporation of EM programs into OCRWM 
(e.g., National Spent Nuclear Fuel Program and National Transportation 
Program). 
9. Develops strategy, policy, requirements, and guidance for the quantities and 
associated sequence by which OCRWM will accept DOE owned and 
additional forms of radioactive waste beyond domestic commercial spent 
nuclear fuel and DOE high-level waste glass. 
10. Develops waste acceptance criteria for DOE spent nuclear fuel and high-
level waste. 
11. Ensures transportation package regulatory compliance with internal and 
external regulatory requirements. 
12. Initiates and manages performance of technical studies and alternative 
evaluations. 
13. Ensures that changes to existing programmatic policies, plans, and 
procedure related requirements, are identified, evaluated, and controlled, 
and applicable requirements are incorporated into OCRWM Program 
implementing documents. 
14. Develops and maintains the OCRWM Program-level technical management 
requirements. 

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15. Develops and maintains level 1 technical baseline and provides systems 
engineering support at the OCRWM Program level. 
16. Conducts the necessary systems analyses to confirm that system-level 
changes are acceptable from an overall systems viewpoint and provide this 
to the appropriate change control boards. 
17. Manages and oversees activities for configuration management of 
appropriate source documents (e.g., charters, plans, etc.). 
18. Monitors system interfaces and integrates where necessary. 
19. Coordinates OCRWM interfaces with NNPP and the National Spent 
Nuclear Fuel Program. 
I. Office of Logistics Management 
1. Provides technical requirements for procurement of casks. Coordinates with 
procurement on technical interchange with vendors prior to issuing Request 
for Proposals (RFP). 
2. Establishes and implements interface control and manages transportation 
interfaces with external programs. 
J. Disposal Operations Office 
Activities performed by this office are outside the scope of QARD Rev. 18. The 
QARD establishes the minimum requirements for the OCRWM QA program 
designed to meet the requirements of 10 CFR 63.142 that are implemented for 
activities up to the time of receipt of high-level radioactive waste and spent 
nuclear fuel for disposal in the geologic repository at Yucca Mountain. The 
QARD will be revised as necessary at the appropriate time to include facility 
operation, permanent closure, and decontamination and dismantling of surface 
facilities. 

K. Office of Project Controls 
Responsible for managing the configuration control management system. 

L. Office of Procurement 
1. Provides centralized business management and administration of the 
OCRWM Management & Operating (M&O) contract, program-wide 
support service contracts, grants, cooperative agreements, and interagency 
agreements. 

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2. Manages OCRWM advanced acquisition planning and provides guidance on 
acquisition regulatory requirements, including maintenance of contractual 
documents required for major system acquisitions. 
3. Prepares procedures governing OCRWM quality affecting acquisition 
instruments. 
4. Assists OCRWM staff in the establishment of acquisition strategies, 
procurement requirements, and acquisition plans for OCRWM 
requirements. 
5. Manages acquisition planning, RFP development, RFP evaluation, and 
award for OCRWM acquisition instruments. 
M. Office of Government Services 
1. Develops manpower requirements/allocations. 
2. Verifies education and experience of applicable OCRWM personnel. 
3. Manages the OCRWM training program. 
4. Establishes policy for training of DOE and contractor personnel on 
OCRWM Program (to include quality assurance training). 
5. Develops, issues, and oversees implementation of information technology 
policies and procedures. 
6. Ensures implementation of the software management functions for mission-
specific applications, including implementation of the Capability Maturity 
Model. 
7. Ensures that the software management program complies with the 
requirements of Supplement I and Supplement V. 
8. Ensures the development and implementation of effective records policies 
consistent with Section 17.0. 
N. Office of External Affairs 
This office does not perform any activities that are within the scope of the 
QARD. 

O. Line Management Functions (All Office Directors) 
1. Manage functions and resources and provide leadership. 

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2. Monitor contractor performance against approved plans and direct 
corrective actions when necessary. 
3. Coordinate and integrate activities with appropriate OCRWM organizations. 
4. Ensure that staff position descriptions are up-to-date. 
1.3.2 Delegation of Authority 
The Director, OCRWM, retains ultimate responsibility for the adequacy and 
effectiveness of the OCRWM QA program. The QA requirements applicable to 
OCRWM contractors shall be established and delineated in appropriate procurement 
documents. The QA interface between the OCRWM and waste custodians shall be 
established and delineated in appropriate agreement documents. The OCRWM has 
delegated to OCRWM contractors the work of establishing and executing an 
effective QA program to be applied to the geologic repository as specified in 
Subsection 2.2.2, as applicable to their scope of work. 

1.3.3 Principal Contractors 
The M&O contractor and the Lead Laboratory for Repository Systems (Lead 
Laboratory) are principal contractors. The transfer of responsibilities from the M&O 
to the Lead Laboratory shall be accomplished in accordance with an approved 
Transition Plan as identified in the M&O contract and Lead Laboratory agreement in 
accordance with Section 4.0. 

A. Management and Operating Contractor 
The M&O is responsible for the design, construction, and eventual operation of 
the Yucca Mountain Site (YMP) site. The senior manager of the M&O 
organization is the General Manager. The General Manager is responsible for 
setting and implementing policies, expectations, and priorities to ensure that the 
functions being performed by the M&O are in accordance with the M&O QA 
program. Supporting the General Manager is an organization that is responsible 
for performing the design and construction of the geologic repository, including 
providing related support. Specific M&O responsibilities are identified in the 
contract between the OCRWM and the M&O. 

B. Lead Laboratory 
The Lead Laboratory reports to the Office of the Chief Scientist and is 
responsible for the scientific and technical work necessary to support the 
preparation and maintenance of the postclosure portions of the License 
Application for the geologic repository, including the performance confirmation 
program. The senior manager of the Lead Laboratory organization is the Senior 
Manager. The Senior Manager is responsible for setting and implementing 
policies, expectations, and priorities to ensure that the functions being performed 


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by the Lead Laboratory are in accordance with the Lead Laboratory QA 
program. Supporting the Senior Manager is an organization that is responsible 
for performing the necessary scientific and technical work. The Lead 
Laboratory is supported by other organizations (e.g., other national laboratories 
subcontractors, Federal Agencies, and universities). Specific Lead Laboratory 
responsibilities are identified in the agreement between the OCRWM and the 
Lead Laboratory. 

C. Principal Contractors QA Function 
1. The M&O QA Manager reports directly to the M&O General Manager. 
The Lead Laboratory QA Manager reports directly to the Lead Laboratory 
Senior Manager. 
2. Duties, responsibilities, and qualifications of the principal contractor QA 
Manager as they pertain to the principal contractor, are the same as those of 
the Director, OQA, as delineated in Subsection 1.3.1B, with the following 
specific differences: 
a. Ensuring that the principal contractors QA program is implemented 
consistent with the schedule for accomplishing the activities. 
b. Developing and maintaining the principal contractors QA program 
document that implements the QARD. 
c. Reviewing and documenting concurrence (as specified in applicable 
procedures or procurement documents) of quality-related procedures. 
d. Verifying the adequacy and implementation (i.e., compliance and 
effectiveness) of the principal contractors QA program and reporting 
the results to OCRWM and principal contractors senior management. 
Verification methods include document reviews, audits, surveillances, 
and inspections, as appropriate. 
e. Performing the quality control related activities (e.g., inspection and 
nondestructive examination). (M&O only) 
1.3.4 Waste Custodians (Spent Nuclear Fuel and High-Level Waste Form Producers) 
OCRWM works to agreements that describe the interface with waste custodians 
(e.g., EM sites and the NNPP). These agreements shall identify scope, specify 
appropriate quality and technical requirements, and describe responsibilities and 
interfaces that apply to these entities. The measures taken to ensure that information 
supplied by waste custodians is suitable for use in supporting the license, and that 
waste forms are suitable for acceptance, are described in Appendix A, Waste 
Custodian Interface. 


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FIGURE 1 

OCRWM ORGANIZATION 

Office of the 
Chief Scientist 
Office of the 
Chief Engineer 
Regulatory 
Authority 
Office 
Infrastructure 
Management 
Office 
Yucca Mountain 
Site Operations 
Office 
Waste 
Management 
Office 
Office of 
Logistics 
Management 
Disposal 
Operations 
Office 
Office of 
Project 
Controls 
Office of 
Procurement 
Office of 
Government 
Services 
Office of 
External 
Affairs 
Office of the Director 
Principal Deputy Director Office of 
Quality Assurance 

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FIGURE 2
OCRWM EXTERNAL INTERFACES

Office of the Director 
Principal Deputy Director 
OCRWM 
Offices 
(See Figure 1) 
Principal Contractor 
OCRWM M&O Waste Custodians 
Principal Contractor 
Lead Laboratory 

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2.0 QUALITY ASSURANCE PROGRAM 
2.1 GENERAL 
This section establishes the applicability of the QARD and the requirements for 
planning, implementing, and maintaining the OCRWM QA program. This section 
also establishes requirements for special topics related to the OCRWM QA program. 
The OCRWM QA program provides controls for activities affecting the quality of 
the SSCs within the scope of the OCRWM Program to an extent consistent with 
their importance to safety. The OCRWM QA program establishes requirements to 
ensure that work meeting the criteria described in Subsections 2.2.2 and 2.2.3 is 
performed under suitably controlled conditions, including the use of appropriate 
equipment, suitable environmental conditions for accomplishing the activity, and 
assurance that prerequisites for a given activity have been satisfied. 

2.2 REQUIREMENTS 
2.2.1 Quality Assurance Program Documents 
A. The Director, OCRWM, shall issue a policy statement directing mandatory 
compliance with the QARD. The QA program description document of 
principal contractors shall have a similar requirement. 
B. The OCRWM shall establish implementing documents to perform work that 
translates the QARD requirements into work processes. These implementing 
documents shall be controlled. The QA program description document of 
OCRWM contractors shall have a similar requirement. The following 
requirements apply to implementing documents: 
1. A structured system of implementing documents shall provide for top-down 
implementation of upper-tier requirement documents and changes thereto. 
2. The system shall accommodate the size and location(s) of the organization, 
the organizational structure, and the nature of the work such that 
management processes will be carried out efficiently and effectively. 
3. The system shall provide positive control over internal and external 
organizational interfaces. 
C. The OCRWM and principal contractors shall maintain a matrix or other similar 
cross-reference, consistent with their scope of work, which provides the 
relationship between the criteria of 10 CFR 63.142 to implementing documents. 

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2.2.2 Quality Assurance Program Applicability and Related Activities 
The OCRWM QA program shall be applied to: 

A. All SSCs important to safety or waste isolation 
B. Design and characterization of barriers important to waste isolation 
C. Related activities that are important to waste isolation and are important to safety 
functions of those SSCs include site characterization; acquisition, control, and 
analysis of samples and data; tests and experiments; scientific studies; 
performance of the preclosure safety analysis, total system performance 
assessment, and qualification of their inputs; facility and equipment design and 
construction (i.e., designing, purchasing, fabricating, handling, packaging, 
shipping, receiving, storing, cleaning, erecting, installing, inspecting, testing, 
maintaining, repairing, and modifying); and performance confirmation. 
2.2.3 Classifying Structures, Systems, and Components 
The SSCs important to safety or waste isolation, barriers important to waste 
isolation, and consumables important to safety or waste isolation shall be classified 
based upon the importance to safety and/or importance to waste isolation. The 
classification of the SSCs important to safety or waste isolation, barriers important 
to waste isolation, and consumables important to safety or waste isolation shall be 
documented on a Q-List. 

2.2.4 Planning Work 
Planning establishes the systematic, sequential progression of actions to meet the 
defined requirements. 

A. Planning activities shall be performed and documented prior to the start of work. 
B. Planning shall ensure that work is accomplished under suitably controlled 
conditions, which includes the use of appropriate equipment, suitable 
environmental conditions for accomplishing the activity, and assurance that 
prerequisites for the given activity have been satisfied. 
C. Planning shall provide for any special controls, processes, test equipment, tools, 
and skills needed to attain the required quality/verification of quality and the 
need for verification of quality by inspection and test. 

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2.2.5 Surveillances 
Surveillances shall be: 

A. Scheduled in a manner to provide coverage, consistency, and coordination of 
ongoing work, at a frequency commensurate with the status and importance of 
work 
B. Performed by personnel who are knowledgeable about, and not directly 
responsible for, the work under surveillance 
C. Documented in a report to appropriate management. 
2.2.6 Management Assessments 
The Director, OCRWM, shall perform or direct the performance of management 
assessments of the OCRWM organizations supporting the OCRWM Program and 
principal contractors. Management assessments shall: 

A. Be performed by personnel outside the QA organization. 
B. Be planned and documented, and performed annually. 
C. Evaluate: 
1. The adequacy of resources and personnel provided to achieve and ensure 
quality 
2. The scope, status, and adequacy of the OCRWM QA program 
3. The effectiveness of the OCRWM QA program 
4. The programmatic compliance to the OCRWM QA program. 
D. Identify and track corrective action. 
2.2.7 Readiness Reviews 
The need for readiness reviews shall be identified by the OCRWM or OCRWM 
contractors management for major scheduled or planned work to ensure OCRWM 
Program objectives are met. Where needed, readiness reviews shall be conducted 
for the planned scope of work to ensure that objective evidence exists demonstrating 
that: 

A. Work prerequisites have been satisfied. 
B. Personnel have been suitably trained and qualified. 

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C. Appropriate implementing documents and management controls are available 
and approved. 
2.2.8 Peer Reviews 
Peer reviews shall be conducted in accordance with the requirements and 
recommendations of NUREG-1297, February 1988, as delineated in Table 1, 
Item D. 

2.2.9 Expert Elicitation 
Expert elicitation shall be conducted in accordance with requirements and 
recommendations of NUREG-1563, November 1996, as delineated in Table 1, 
Item F. 

2.2.10 Quality Assurance Program Management Review 
Management shall regularly review the scope, status, adequacy, and compliance 
aspects of the QA program they are executing and its compliance with 10 CFR 63, 
Subpart G, to assure its effective implementation. These reviews shall include 
frequent review of QA program status through reports, meetings, audits, 
surveillance, and observations. Appropriate management shall receive, as a 
minimum, audit reports, surveillance reports, trend reports, and management 
assessment reports. 

2.2.11 Personnel Indoctrination, Training, Qualification, and Certification 
Personnel indoctrination, training, and qualification processes shall be implemented 
in a manner that ensures the appropriate indoctrination, training, and qualification 
have been provided prior to performing activities that are important to safety or 
important to waste isolation. Personnel performing these activities are indoctrinated, 
trained, qualified, and certified as follows: 

A. Personnel shall be indoctrinated and trained as follows: 
1. Determine required indoctrination and training. 
2. Document formal training including the objective, content of the training, 
attendees, and date of attendance. 
3. Ensure personnel are indoctrinated and trained, as needed, to achieve initial 
proficiency; maintain proficiency; and to adapt to changes in technology, 
methods, or job responsibilities. 
4. Personnel that require certification are given proficiency tests. Acceptance 
criteria are developed to determine whether individuals are properly trained 
and qualified. 

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5. Evaluate and assess the need for additional indoctrination and training as 
assignments, positions, or implementing documents change. 
6. Ensure indoctrination and training are completed prior to performing the 
work. 
7. Ensure that personnel are indoctrinated in the following topics as they relate 
to a particular function: 
a. General criteria, including the QARD, applicable codes, regulations, and 
standards 
b. QA practices, concepts, and requirements 
c. Applicable implementing documents 
d. Job responsibilities and authority. 
B. Personnel performing inspections or tests shall be trained, qualified, and certified 
in accordance with the following requirements: 
1. Regulatory Guide 1.28, Revision 3, Position C.1 
2. ANSI/ASME NQA-1-1983 Edition 
a. Basic Requirement 2, Quality Assurance Program 
b. Supplementary Requirement 2S-1, Supplementary Requirements for the 
Qualification of Inspection and Test Personnel 
c. Appendix 2A-1, Nonmandatory Guidance on the Qualification of 
Inspection and Test Personnel. 
C. Personnel performing as auditors and technical specialists shall be trained and 
qualified, and lead auditors shall be trained, qualified, and certified in 
accordance with the requirements of ANSI/ASME NQA-1-1983 with 
ANSI/ASME NQA-1A-1983 addenda, as follows: 
1. Supplementary Requirement 2S-3, Supplementary Requirements for the 
Quality Assurance Program Audit Personnel 
2. Appendix 2A-3, Nonmandatory Guidance on the Education and Experience 
of Lead Auditors. 
D. Personnel who perform nondestructive examinations shall be trained, qualified, 
and certified in accordance with the American Society for Nondestructive 
Testing, Recommended Practice No. SNT-TC-1A, June 1980 Edition. In lieu of 
the three-year recertification interval specified in the Recommended Practice No. 

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SNT-TC-1A, June 1980 Edition, Level III nondestructive examination personnel 
may be recertified on a five-year interval. 

E. When required by codes, standards, and specifications, personnel who perform 
inspections shall be certified in accordance with the pertinent codes, standards, 
and specifications, (i.e., American Welding Society [Certified Welding 
Inspector], National Electric Code [Certified Electrical Inspector], American 
Concrete Institute [Concrete Construction Inspector, Concrete Transportation 
Inspector], etc.). Validity of these certifications shall be verified prior to 
performing inspections. 
F. Qualifications for the Director, OQA, M&O QA Manager, and Lead Laboratory 
QA Manager include: 
1. Management experience through assignments to responsible positions 
2. In-depth knowledge of QA regulations, policies, practices, and standards 
3. Appropriate experience working in QA or related activity in nuclear-related 
design, construction, or operation or a similar technically based industry 
4. Meeting or exceeding the qualification requirements for the Quality 
Assurance position specified in ANSI/ANS-3.1-1993, Paragraph 4.3.7, as 
modified by Regulatory Guide 1.8, Revision 3 (5/2000), Regulatory 
Position C.2.1.1. 

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3.0 DESIGN CONTROL 
3.1 GENERAL 
A. This section provides requirements to ensure that designs are defined, controlled, 
and verified. The scope of the design control program includes design activities 
associated with the preparation and review of design documents, including the 
correct translation of applicable regulatory requirements, design bases, and site 
characteristics into design, procurement, and procedural documents (such as 
drawings, calculations, specifications, plans, and procedures). Included in the 
scope are activities such as field design engineering; physics (including 
criticality physics); seismic, stress, thermal, hydraulic, and preclosure and 
postclosure analyses; radiation shielding; compatibility of materials; delineation 
of acceptance criteria for inspections and tests; Safety Analysis Report event 
sequence analyses and associated computer software; features to facilitate 
decontamination; suitability; and accessibility for in-service inspection, 
maintenance, repair, and quality standards. 
B. Design control measures shall be established and are applied to (i) the design of 
items that are important to safety; (ii) engineered and natural barriers that are 
important to waste isolation; (iii) the description of the geologic setting and the 
plans for data collection and analysis activities that will generate information 
pertinent to the repository design and that will be relied on in site 
characterization, licensing, and performance confirmation; (iv) computer 
software used in such activities; and (v) development of as-built drawings and 
related documentation in a timely manner. These design measures shall apply to 
the design inputs, outputs, and performance confirmation activities. 
C. Computer software used in all design activities shall be developed or procured, 
qualified, and used in accordance with Supplement I, Software. 
3.2 REQUIREMENTS 
3.2.1 Design Input Control 
Applicable design inputs such as design bases, conceptual design reports, 
performance requirements (including those resulting from postclosure analyses), 
regulatory requirements, codes, and standards shall be controlled by those 
responsible for the design according to the following requirements: 

A. Design inputs shall be identified and documented, and their selection reviewed 
and approved, by those responsible for the design. 
B. Design inputs shall be specified and approved on a timely basis and to the level 
of detail necessary to permit the design work to be carried out in a correct 
manner that provides a consistent basis for making design decisions, 
accomplishing design verification, and evaluating design changes. 

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C. Data from scientific investigation activities used as design input shall be 
qualified in accordance with Supplement III, Scientific Investigation, prior to use 
in the design product. 
D. Changes from approved design inputs and reasons for the changes shall be 
identified, approved, documented, and controlled. 
E. Design inputs based on assumptions that require confirmation shall be identified 
and controlled as the design proceeds. 
3.2.2 Design Process 
The design process shall be controlled according to the following requirements: 

A. Design work shall be prescribed and documented on a timely basis and to the 
level of detail necessary to permit (i) the design process to be carried out in a 
correct manner and (ii) verification that the design meets requirements. 
B. Design documents shall be adequate to support design, fabrication, construction, 
and operation. The documentation shall include not only the final design 
documents, such as drawings, specifications, and their revisions, but also 
documentation that identifies the important steps, including sources of design 
inputs supporting the final design. 
C. Appropriate technical and QA standards shall be identified and documented, and 
their selection reviewed and approved. 
D. Changes or deviations from specified quality assurance and technical standards, 
including the reasons for the change or deviation, shall be identified, evaluated, 
approved, documented, and controlled. 
E. Measures shall be established for the selection and review for suitability of 
application of materials, parts, equipment, and processes that are important to 
waste isolation or important to safety functions of SSCs. 
F. Applicable information derived from experience, as set forth in reports or other 
documentation, shall be made available to cognizant design personnel. 
G. The final design (approved design documents and approved changes thereto) 
shall: 
1. Be relatable to the design input by documentation in sufficient detail to 
permit design verification 
2. Identify assemblies and/or components that are part of the item being 
designed. 

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H. For commercial grade items, the critical characteristics to be verified and the 
acceptance criteria for those characteristics shall be documented. If a 
commercial grade assembly or component, prior to installation, is modified or 
selected by special inspection and/or testing to meet requirements that are more 
restrictive than the suppliers published product description, then the item shall 
be represented as different from the commercial grade item in a manner 
traceable to a documented description of the difference. 
I. The dimensional accuracy and completeness of design drawings and 
specifications shall be checked and documented. 
J. Design drawings, specifications, and other design output documents shall 
contain appropriate inspection and testing acceptance criteria. 
K. Design documents shall be reviewed by individuals or groups within the QA 
organization that do not have direct responsibility for performing the work being 
verified, or by individuals or groups other than the one who generated the 
document and trained and qualified in QA practices and concepts. Reviews shall 
be performed to assure that the documents are prepared, reviewed, and approved 
in accordance with implementing procedures and contain the necessary QA 
requirements, such as inspection and test requirements, acceptance requirements, 
and the extent to which inspection and test results are required to be 
documented. Training and qualification of non-QA organization individuals 
shall be in accordance with Subsection 2.2.11. 
L. The distribution and use of design documents shall be controlled in accordance 
with Section 6.0. 
3.2.3 Design Analyses 
A. Design analyses shall be planned, controlled, and documented. 
B. Design analysis documents shall be legible and in a form suitable for 
reproduction, filing, and retrieval. 
C. Design analysis documents shall be sufficiently detailed as to purpose, method, 
assumptions, design input, references, and units such that a person technically 
qualified in the subject can review and understand the analyses and verify their 
adequacy without recourse to the originator. 
D. Calculations shall be identifiable by subject (including SSC to which the 
calculation applies), originator, reviewer, and date, or by other designators such 
that the calculations are traceable and retrievable. 
E. Documentation of design analyses shall include: 
1. Definition of the objective of the analyses 

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2. Definition of design inputs and their sources 
3. Results of literature searches or other applicable background data 
4. Identification of assumptions and indication of those that must be verified as 
the design proceeds 
5. Identification of any computer calculation, including computer type, 
computer program (e.g., name), revision identification, inputs, outputs, 
evidence of or reference to computer program verification, and the bases (or 
reference thereto) that support application of the computer program to the 
specific physical problem. 
6. Computer programs may be utilized for design analysis without individual 
verification of the program for each application, provided: 
a. The computer program has been verified to show that it produces correct 
solutions for the encoded mathematical model within defined limits for 
each parameter employed. 
b. The encoded mathematical model has been shown to produce a valid 
solution to the physical problem associated with the particular 
application. 
7. Where changes to previously verified computer programs are made, 
verification shall be required for the change, including evaluation of the 
effects of these changes to Paragraph 3.2.3E.6.a and 3.2.3E.6.b. 
8. Identification of the originator, reviewer, and approver. 
3.2.4 Design Verification 
A. Design verification shall be performed to determine the adequacy of design by 
using one or a combination of the following methods: 
1. Design review (see Paragraph 3.2.5A) 
2. Alternate or simplified calculations (see Paragraph 3.2.5B) 
3. Qualification testing (see Paragraph 3.2.5C). 
B. The extent of design verification required is a function of the importance to 
safety or waste isolation of the item under consideration, the complexity of the 
design, the degree of standardization, the state of the art, and the similarity with 
previously proven designs. 
C. Guidelines or criteria shall be established and described for determining the 
method of design verification. The particular design verification method used 
shall be identified and documented. 

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D. Procedural controls shall provide criteria for determining when design 
documents that reflect the commitments of the Safety Analysis Report receive 
formal design verification by interdisciplinary or multi-organizational teams or 
by a single individual (a signature and date are acceptable documentation). 
Design documents subject to procedural controls include, but are not limited to, 
specifications, calculations, associated computer software supporting a safety or 
waste isolation function, system descriptions, parts of the Safety Analysis Report 
when used as a design document, and drawings, including flow diagrams, piping 
and instrument diagrams, control logic diagrams, electrical single line diagrams, 
structural systems for major facilities, site arrangements, and equipment 
locations. Specialized reviews should be used when uniqueness or special 
design considerations warrant. 
E. The results of design verification shall be documented, including the 
identification of the verifier. 
F. Responsibilities of the verifier, areas and features to be verified, pertinent 
considerations to be verified, and the extent of documentation shall be identified 
in procedures. 
G. Design verification shall be performed by competent individuals or groups other 
than those who performed the original design but who may be from the same 
organization. In exceptional circumstances, this verification may be performed 
by the originators immediate supervisor, provided: 
1. The supervisor did not specify a singular design approach or rule out certain 
design considerations and did not establish the design inputs used in the 
design. 
2. The supervisor is the only individual in the organization competent to 
perform the verification. 
3. The verification is not a cursory review. 
4. The determination to use the supervisor is documented and approved in 
advance by the supervisors management. 
5. QA audits are conducted to evaluate the frequency and effectiveness of the 
use of supervisors as design verifiers. 
H. Design verification shall be performed at appropriate times and in a timely 
manner during the design process. 
1. Design verification shall be performed before release for procurement, 
manufacture, or construction or the release to another organization for use in 
other design work. In cases where this timing cannot be satisfied, the 
design verification may be deferred, providing that a justification for this 

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action is documented and the unverified portion of the design output 
document and all design output documents based on the unverified portion 
are appropriately identified and controlled. 

2. Construction site activities associated with a design or design change shall 
not proceed without verification past the point where installation would 
become irreversible (i.e., require extensive demolition and rework). 
3. In all cases, design verification shall be completed before waste package 
placement in the repository or before relying on the SSC to perform its 
safety function. 
I. Where the design has been subjected to a previous verification process in 
accordance with the QARD, the verification process need not be duplicated for 
identical designs. 
J. Use of previously proven designs shall be controlled in accordance with the 
following requirements: 
1. The applicability of standardized or previously proven designs shall be 
verified with respect to meeting pertinent design inputs for each application. 
2. Known problems affecting standard or previously proven designs and their 
effects on other features shall be considered. 
3. The original design and associated verification measures shall be adequately 
documented and referenced in the files of subsequent application of the 
design. 
K. Changes in previously verified designs shall require reverification. Such 
verification shall include the evaluation of the effects of the changes on the 
overall previously verified design and on any design analyses upon which the 
design is based. Design changes shall be controlled in accordance with 
Subsection 3.2.6. 
3.2.5 Design Verification Methods 
A. Design Review 
Design reviews shall be controlled and performed to ensure: 

1. The design inputs were correctly selected and incorporated. 
2. The assumptions necessary to perform the design were adequately 
described, reasonable, and where applicable, identified as requiring 
confirmation as the design proceeds. 

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3. Appropriate design methods, and computer programs where applicable, 
were used. 
4. Design inputs were correctly incorporated into the design. 
5. The design outputs are reasonable compared to design inputs. 
6. The necessary design input and verification requirements for interfacing 
organizations were specified in the design documents or in supporting 
implementing documents. 
B. Alternate or Simplified Calculations 
These are calculations or analyses that are made with alternate methods to verify 
correctness of the original calculation or analyses. The appropriateness of 
assumptions, input data used, and the computer program or other calculation 
method used shall be reviewed. 

C. Qualification Testing 
1. Where design adequacy is to be verified by qualification tests, the tests shall 
be identified. 
2. Prototype, component, or feature testing shall be performed as early as 
possible before the installation would become irreversible. 
3. The test configuration shall be defined and documented. 
4. Testing shall demonstrate the adequacy of system, structure, or component 
performance under conditions that simulate the full range, including the 
most adverse anticipated design conditions as determined by analysis. 
Operating modes and environmental conditions in which the item must 
perform satisfactorily shall be considered in determining the most adverse 
conditions. 
5. If the tests verify only specific design features, the other features of the 
design shall be verified by other means. 
6. Test results shall be documented and evaluated by the responsible design 
organization to ensure that test requirements have been met. 
7. If qualification testing indicates that a modification to an item is necessary 
to obtain acceptable performance, the modification shall be documented and 
the item modified and retested or otherwise verified to ensure satisfactory 
performance. 
8. When tests are being performed on models or mockups, scaling laws shall 
be established, verified, and approved. 

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9. The results of model test work shall be subject to error analysis, where 
applicable, before using the results in the final design. 
3.2.6 Design Change Control 
Design changes, including field changes, shall be controlled in accordance with the 
following requirements: 

A. Changes to final designs, field changes, and nonconforming items dispositioned 
use-as-is or repair shall be justified and shall be subject to design control 
measures commensurate with those applied to the original design. 
B. Changes shall be approved by the same affected groups or organizations that 
approved the original design documents. 
1. If an organization that originally was responsible for approving a particular 
design document is no longer responsible, a new responsible organization 
shall be designated by the OCRWM. 
2. The designated approving organization shall have demonstrated competence 
in the specific design area of interest and have an adequate understanding of 
the requirements and intent of the original design. 
C. The design process and design verification methods and implementing 
documents shall be reviewed and modified, as necessary, when a significant 
design change is necessary because of an incorrect design. 
D. Errors and deficiencies in approved design documents, including design methods 
(i.e., computer software supporting a safety or waste isolation function), that 
could adversely affect SSCs important to safety or waste isolation shall be 
documented and action taken to ensure all errors and deficiencies are corrected. 
E. Deviations from specified quality standards shall be identified and formally 
documented. Procedures shall be established to ensure control of these 
deviations. 
F. Measures shall be provided to ensure personnel are notified of design 
changes/modifications that may affect the performance of their duties. 
G. Prior to the issuance of a design change initiated after the construction 
authorization, the design changes shall be evaluated pursuant to applicable 
regulatory requirements. 
3.2.7 Design Interface Control 
A. Design interfaces shall be identified and controlled. 

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B. Design efforts shall be coordinated among participating design organizations and 
across technical disciplines. Interface controls shall include the assignment of 
responsibility and the establishment of implementing documents among 
participating design organizations and technical disciplines for the review, 
approval, release, distribution, and revision of documents involving design 
interfaces to ensure that SSCs are compatible geometrically, functionally, and 
with processes and environment. 
C. Design information transmitted across interfaces shall be documented and 
controlled. 
D. The status of the design information or document provided shall be identified in 
transmittals. 
E. When it is necessary to initially transmit design information orally or by other 
informal means, the design information shall be promptly confirmed with formal 
documentation initiated in accordance with the initiating organizations 
approved implementing document. 
3.2.8 Sampling Plans 
The basis, including any supporting analyses for the use of sampling plans for items, 
barriers, and related activities, shall be documented. The following apply to the use 
of sampling plans: 

A. Sampling plans shall use a criterion that provides 95 percent confidence that 
there are only 5 percent defective items in a lot (95/5). 
B. Lots sampled shall be essentially homogeneous. 
C. Sample plans shall be based on recognized standard practices. 

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4.0 PROCUREMENT DOCUMENT CONTROL 
4.1 GENERAL 
A. This section establishes requirements to ensure that procurement documents, and 
any changes thereto, contain appropriate technical and QA requirements. 
B. When an Interagency Agreement or other document serves as a procurement 
document between the OCRWM and other federal agencies, the requirements of 
this section shall apply. 
C. The requirements of this section that are applicable to suppliers are also applicable 
to OCRWM contractors unless otherwise noted. 
4.2 REQUIREMENTS 
4.2.1 Procurement Document Preparation 
Procurement documents shall include the following provisions to assure quality, as 
applicable to the item (including spare parts and replacements) or service being 
procured: 

A. A statement of the scope of work to be performed. 
B. Technical requirements, including: 
1. Design bases shall be identified or referenced. 
2. Specific documents (i.e., drawings, specifications, codes, standards, 
regulations, procedures, or instructions), including revisions thereto, that 
describe the technical requirements of the items or services to be furnished 
shall be specified. The revision level or change status of these documents shall 
also be identified. 
3. Tests, inspections, and acceptance requirements that the purchaser will use to 
monitor and evaluate the performance of the supplier shall be specified. 
C. QA program requirements, including: 
1. A requirement for the supplier to provide, upon request, a documented QA 
program that implements applicable QA requirements prior to the initiation of 
work. A principal contractors QA program description document shall 
comply with the QARD. A suppliers QA program description documents 
shall comply with the purchasers QA program description document. The 
extent of the QA program shall depend on the scope, nature, type and use, or 
complexity of the item or service being procured. 

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2. A requirement for supplier to incorporate the appropriate QA requirements 
into any supplier procurement document issued to a subtier supplier. 
3. When deemed appropriate, a requirement for the purchaser to permit some 
or all supplier work to be performed under the OCRWM QA program or the 
purchasers QA program. In these cases, procurement documents shall 
specify that the OCRWMs or the purchasers implementing documents are 
applicable to the supplier and that the purchaser shall provide these 
applicable documents to the supplier. 
4. As an alternative to requiring a documented QA program for suppliers of 
analytical services (measurement of properties or other characterization of 
samples) supporting scientific investigations, these procurements may be 
controlled in accordance with Subsection 7.2.12B. 
5. When required data cannot be obtained from an external source through a 
procurement process that involves the imposition of applicable QA program 
requirements, the data may be obtained through a non-Q procurement action 
in accordance with Subsection 7.2.12C. 
D. Provisions for right of access to suppliers facilities shall be granted at each tier 
of procurement for the purpose of inspection, verification, audit, or surveillance 
by the purchaser or other designee authorized by the purchaser. Procurement 
documents issued by OCRWM contractors shall also include a provision to 
provide right of access to the OQA for the purpose of inspection, verification, 
audit, or surveillance by the OQA. 
E. Provisions for establishing hold points beyond which work cannot proceed 
without purchaser authorization. 
F. Identification of the schedule for submittal of documents to the purchaser for 
information, review, acceptance, and retention. 
G. Purchaser requirements for the supplier to report nonconformances dispositioned 
use-as-is or repair to the purchaser for approval of the disposition. 
H. Identification of any spare and replacement parts or assemblies and the 
appropriate technical and QA information required for ordering. Spare parts 
shall be subject to QA program controls, codes and standards, and technical 
requirements equal to or greater than the original requirements, or as required to 
preclude repetition of defects. 
I. Instructions relative to the performance of special processes. 
J. A requirement for suppliers to establish controls to mitigate the procurement and 
installation of counterfeit or fraudulent items. 

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K. Provisions for identifying that the procurement is subject to the provisions of 
10 CFR 21. 
4.2.2 Procurement Document Review and Approval 
A. Procurement document reviews shall be performed and documented prior to 
issuance of the procurement documents. 
B. A review of the procurement documents and any changes thereto shall be made 
to verify that documents include appropriate provisions to ensure that items or 
services will meet the governing requirements. 
C. Reviews shall ensure that all applicable requirements delineated in 
Subsection 4.2.1 are correctly stated, inspectable, and controllable; there are 
adequate acceptance and rejection criteria; and the procurement document has 
been prepared, reviewed, and approved in accordance with the requirements of 
this section. 
D. Reviews shall be performed by personnel who have access to pertinent 
information and who have an adequate understanding of the requirements and 
scope of the procurement. 
E. Procurement documents shall be reviewed by individuals or groups within the 
QA organization that do not have direct responsibility for performing the work 
being verified, or by individuals or groups other than the one who generated the 
document that are trained and qualified in QA practices and concepts and concur 
with these documents with respect to the QA-related aspects. The training and 
qualification of non-QA organization individuals shall be in accordance with 
Subsection 2.2.11. 
F. Procurement documents shall be approved. 
4.2.3 Procurement Document Change 
A. Changes shall be subject to the same degree of control as used in the preparation 
of the original documents. 
B. Changes made as a result of proposal/bid evaluations or pre-contract 
negotiations shall be incorporated into the procurement documents. The 
evaluation of these changes and the resulting impact shall be completed before 
the contract is awarded. The evaluation shall consider: 
1. Appropriate requirements as specified in this section 
2. Additional or modified design criteria 

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3. Analysis of exceptions or changes requested or specified by suppliers and a 
determination of the impact such changes have on the intent of the 
procurement documents or quality of the item or service to be furnished. 
4.2.4 Procurement Document Control 
The distribution and use of procurement documents and changes thereto shall be 
controlled in accordance with Section 6.0. 


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5.0 PROCEDURES, INSTRUCTIONS, AND DRAWINGS 
5.1 GENERAL 
This section establishes the requirements to ensure that work is prescribed by, and 
performed in accordance with, approved procedures, instructions, and drawings, 
(i.e., implementing documents). 

5.2 REQUIREMENTS 
A. Work shall be prescribed by controlled implementing documents of a type 
appropriate to the circumstance and shall be accomplished in accordance with 
these implementing documents. 
B. Work shall be suspended if it cannot be accomplished as described in controlled 
implementing documents. 
C. OCRWM contractors may work to OCRWMs or a principal contractors 
implementing documents when stipulated in procurement documents, in 
accordance with Section 4.0. 
D. Suppliers to a principal contractor may work to OCRWMs or the principal 
contractors implementing documents, if permitted by the principal contractors 
QA program description document and if stipulated in procurement documents. 
5.2.1 Types of Implementing Documents 
The type of document to be used to perform work shall be appropriate to the nature 
and circumstances of the work being performed. Design drawings, including 
as-built drawings, are developed and controlled in accordance with the requirements 
of Section 3.0. 

5.2.2 Content of Implementing Documents 
A Implementing documents shall be consistent with requirements delineated in the 
QA program description document applicable to the implementing organization 
and shall include the following information, as appropriate to the work to be 
performed: 

1. Responsibilities and organizational interfaces of the organizations affected 
by the document 
2. A sequential description of the work to be performed, if necessary to 
satisfactorily complete the work, including controls for altering the 
sequence 

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3. Quantitative and/or qualitative acceptance criteria for determining that 
prescribed activities have been satisfactorily accomplished and that 
prescribed results have been satisfactorily attained 
4. Methods for documenting that the work was performed as specified 
5. Identification of the QA records generated by the implementing document. 
B. The organization responsible for the implementing document shall determine the 
appropriate level of detail. 
5.2.3 Review, Approval, and Control of Implementing Documents 
Implementing documents shall be reviewed, approved, and controlled in accordance 
with Section 6.0. 


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6.0 DOCUMENT CONTROL 
6.1 GENERAL 
This section establishes requirements to ensure documents that specify technical or 
quality requirements or prescribe activities affecting quality, including changes 
thereto, are reviewed for adequacy, approved for release, distributed for use at the 
location where the work is being performed, and used at the work location. 

6.2 REQUIREMENTS 
6.2.1 Types of Documents 
A. Implementing documents and documents that specify technical requirements or 
quality requirements or prescribe activities affecting quality shall be controlled 
in accordance with this section. 
B. Controlled documents shall include, but not be limited to design documents 
(including as-builts), procurement documents, procedures, instructions, QA 
program description and requirements documents, and Safety Analysis Reports, 
including changes thereto. 
6.2.2 Preparing Documents 
The responsibility for preparing documents shall be assigned to the appropriate 
organization. 

6.2.3 Reviewing Documents 
Implementing documents and documents that specify technical or quality assurance 
requirements or prescribe activities that are governed by the QARD, including 
changes thereto, shall be reviewed prior to the start of work with respect to the 
following requirements and to any additional requirements specified by the 
applicable section of the QARD. 

A. Review criteria shall be established before performing the review. The criteria 
shall consider applicability, correctness, technical adequacy, completeness, 
accuracy, and compliance with established requirements. 
B. The review shall be performed by individuals other than the preparer. 
C. Reviewers shall be technically competent for the subject area of the document 
being reviewed. 
D. Reviewers shall have access to pertinent background data or information upon 
which to base their acceptance. 
E. Reviewers shall document acceptance. 

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F. Reviewers include: 
1. Organizations or technical disciplines affected by the document as 
determined by the manager responsible for the implementing document. 
2. Individuals or groups within the QA organization that do not have direct 
responsibility for performing the work being verified, or individuals or 
groups other than the one who generated the document that are trained and 
qualified in QA practices and concepts and concur with these documents 
with respect to the QA-related aspects. The training and qualification of 
non-QA organization individuals shall be in accordance with Subsection 
2.2.11. 
3. The OCRWM, for principal contractors procedure(s) that directs the 
development and maintenance of their quality-affecting procedures. 
Review shall be performed and acceptance documented prior to initiation of 
the activity governed by the procedure. 
G. Comments resulting from the review shall be documented and resolved to the 
satisfaction of the organization responsible for the document before approving 
the document. 
6.2.4 Approving Documents 
The organizational position responsible for approving the document for release shall 
be identified. 

6.2.5 Distribution and Use of Documents 
A. A system shall be established to identify the current status of each document that 
is required to be controlled in accordance with this section. This system shall be 
made accessible to document users. 
B. The disposition of obsolete or superseded documents shall be controlled to 
ensure that they are not used to perform work. 
C. Effective dates shall be established for approved implementing documents. 
D. The latest version (revision or change) of documents either in hardcopy or 
electronic media shall be available for use prior to the start of work at the 
location where the activity is performed. Documents shall be adhered to in the 
performance of work. 
6.2.6 Changes to Documents 
A. Changes to documents shall be reviewed in accordance with the requirements of 
Subsection 6.2.3, prior to approval for release. 

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B. Changes shall be approved for release in a timely manner by the designated 
organizational position responsible for the document. 
C. Implementing documents shall define the method used to incorporate changes. 
If the defined method is other than reissue of the entire revised controlled 
document, the implementing document shall define the maximum number of 
changes permitted prior to requiring reissue of the entire controlled document. 
D. Implementing documents shall require that a history of changes to QA program 
documents, including the reasons for the changes, be documented and 
maintained. This document history shall be reviewed each time additional 
changes to the document are proposed. 
E. Changes to documents, other than editorial corrections as delineated in 
Subsection 6.2.8, shall be reviewed and approved by the same organizations that 
performed the original review and approval unless OCRWM designates another 
responsible organization. The reviewing organization shall have access to 
pertinent background data or information upon which to base their approval. 
6.2.7 Expedited Changes 
If an activity cannot be performed as prescribed in a document and the change 
process would cause unreasonable delays, an expedited change may be made at the 
work location by responsible management. 

A. After the expedited change has been authorized, the changes shall be processed 
through the normal change process. This processing shall occur in a timely 
manner consistent with the type and nature of the document being changed. 
B. Implementing documents shall describe the process to control expedited changes 
according to the following requirements. 
1. The level of management with the authority to make expedited changes 
shall be identified. 
2. The time limits for processing expedited changes through the normal change 
process shall be specified. 
3. An evaluation of the work shall be performed, if the normal review process 
results in a change that is different from the expedited change. 
6.2.8 Editorial Corrections 
Inconsequential editorial corrections may be made to documents without being 
subject to review requirements, but such corrections shall be distributed as a revision 
or change to the document. 


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A. The following items are considered editorial corrections: 
1. Correcting grammar or spelling. 
2. Renumbering sections or attachments that do not affect the chronological 
sequence of work. 
3. Changing the title or number of the document or the title or number of 
documents referenced in the procedure. 
4. Updating organizational titles. 
B. A change in an organizational title accompanied by a change in responsibilities 
is not considered an editorial correction. 
C. The organizational position responsible for approving the document for release 
shall approve editorial corrections. 

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7.0 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, AND SERVICES 
7.1 GENERAL 
A. This section establishes requirements for planning and executing quality 
affecting procurements to ensure that purchased items and services meet 
specified requirements. This section does not apply to the procurement of direct 
support contractor services or other non-quality affecting procurements. The 
supplier selection and bid/proposal evaluation requirements of this section do not 
apply to situations where the OCRWM obtains the services of other federal 
agencies through an Interagency Agreement or other such document. When an 
Interagency Agreement or other such document serves as a procurement 
document between the OCRWM and other federal agencies, the technical and 
quality requirements, responsibilities, and interfaces specified in these 
documents shall be verified to be satisfactorily incorporated into the applicable 
federal agencys QA program description document prior to starting work 
subject to the QARD. 
B. The requirements of this section that are applicable to suppliers are also 
applicable to OCRWM contractors unless otherwise noted. 
7.2 REQUIREMENTS 
7.2.1 Procurement Planning 
Procurements shall be planned and documented to ensure a systematic approach to 
the procurement process. Procurement planning shall: 

A. Identify procurement methods and organizational responsibilities, including 
interfaces between design, procurement, and QA organizations. 
B. Identify what is to be accomplished, who is to accomplish it, how it is to be 
accomplished, and when it is to be accomplished. 
C. Prior to the initiation of each individual activity identified in Paragraph 7.2.1D, 
identify and document the sequence of actions and milestones, indicating the 
completion of these activities and the preparation of applicable procedures. 
D. Provide for the integration of the following activities: 
1. Procurement document preparation, review, and change control according to 
the requirements of Section 4.0 
2. Selection of procurement sources 
3. Proposal/bid evaluation and award 
4. Evaluation of OCRWM contractor/supplier performance 

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5. Verifications, including any hold and witness point notifications 
6. Control of nonconformances 
7. Corrective action 
8. Acceptance of the item or service 
9. Identification of QA records. 
E. Be accomplished as early as practicable, and no later than the start of those 
procurement activities that are required to be controlled, to ensure interface 
compatibility and a uniform approach to the procurement process. 
F. Be performed relative to the level of importance, complexity, and quantity of the 
item or service being procured and the suppliers quality performance. 
G. Include participation of representatives from the technical organizations and the 
QA organization. 
7.2.2 Source Evaluation and Selection 
A. Supplier selection shall be based on an evaluation, performed by or for the 
purchaser before the contract is awarded, to determine the suppliers capability 
to provide items or services in accordance with procurement document 
requirements. 
B. The organizational responsibilities of the purchaser for source evaluation and 
selection shall be identified, including provisions for input from the QA 
organization. 
C. The purchasers measures for evaluating and selecting procurement sources shall 
be documented and shall include one or more of the following elements: 
1. Evaluation of the suppliers history for providing an identical or similar 
product that performs satisfactorily in actual use. This evaluation shall 
reflect current capability. 
2. Evaluation of the suppliers current QA records, supported by documented 
qualitative and quantitative information that can be objectively evaluated. 
3. Evaluation of the suppliers technical and quality capability are determined 
by a direct evaluation of suppliers facilities and personnel, and the 
implementation of suppliers QA program. 
D. The results of procurement source evaluation and selection shall be documented. 

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7.2.3 Proposal/Bid Evaluation 
A. The proposal/bid evaluation process shall include a determination of the extent 
of conformance to the procurement document requirements. This evaluation 
shall be performed by designated, technically qualified organizations, including 
the QA organization. 
B. The evaluation shall include the following subjects consistent with the 
importance, complexity, and quantity of items or services being procured: 
1. Technical considerations 
2. QA program requirements 
3. Suppliers personnel 
4. Suppliers production capability 
5. Suppliers past performance 
6. Alternatives 
7. Exceptions. 
C. Before the contract is awarded, the purchaser shall resolve, or obtain 
commitments to resolve, unacceptable quality conditions identified during the 
proposal/bid evaluation. 
D. Any deficiencies that would affect quality shall be corrected before starting 
quality affecting work. 
E. Suppliers QA program description document shall be accepted by the purchaser 
prior to the start of work. 
7.2.4 Supplier Performance Evaluation 
A. The purchaser of items and services shall establish measures to interface with the 
supplier to verify performance. The measures shall include: 
1. Establishing an understanding between the purchaser and supplier regarding 
the requirements and specifications identified in the procurement documents 
2. Requiring the supplier to identify planning techniques and processes to be 
used in fulfilling procurement document requirements 
3. Reviewing supplier documents that are prepared or processed during work 
performed to fulfill procurement document requirements 
4. Identifying and processing necessary change information 
5. Establishing the method to be used to document information exchanges 
between purchaser and supplier 
6. Establishing the extent of source surveillance and inspection. 

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B. Annual performance evaluations shall be performed on each supplier to 
determine the need to schedule additional audits. This evaluation shall be 
documented and based on: 
1. Review of supplier furnished documents and records (i.e., certificates of 
conformance, the American Society of Mechanical Engineers [ASME] 
Certificate of Authorization, ASME Quality System Certificate, 
nonconformance notices, and corrective actions) 
2. Results of previous source verifications, audits, management assessments, 
and receiving inspections, including results of audits from other sources 
(e.g., other customers, ASME, NRC) 
3. Operating experience of identical or similar products furnished by the same 
supplier. 
C. The extent of verifications, including planning, shall be a function of the relative 
importance, complexity, and quantity of items or services being procured and the 
suppliers quality performance. 
D. Verification activities shall be accomplished by qualified personnel assigned to 
check, inspect, audit, or witness the supplier activities. 
E. Verifications shall be conducted as early as practical and shall not relieve the 
supplier of their responsibility for the verification of quality achievement. 
Verifications shall include (i) the use of audits to evaluate the suppliers 
performance and (ii) evaluation of purchasers documentation to aid in the 
determination of the effectiveness of the suppliers QA program. This 
documentation shall include, as appropriate, documentation of source 
surveillance and inspections, audits, receiving inspections, nonconformances, 
dispositions, waivers, and corrective actions. 
F. In order to determine the effectiveness of a suppliers QA program, the 
purchasers of items and services shall evaluate documentation related to that 
effectiveness, such as surveillances and inspections, audits, receiving 
inspections, nonconformances, dispositions, waivers, and corrective action as 
they relate to the scope of a procurement. 
7.2.5 Control of Supplier Generated Documents 
A. Supplier generated documents shall be controlled, processed, and accepted in 
accordance with the requirements established in the procurement documents. 
B. Measures shall be implemented to ensure that the submittal of these documents 
is accomplished in accordance with the procurement document requirements. 
These measures shall provide for the acquisition, processing, and recorded 

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evaluation of technical, inspection, and test data compared against the 
acceptance criteria. 

7.2.6 Acceptance of Items or Services 
A. Suppliers shall verify that furnished items or services comply with the 
purchasers procurement document requirements before offering the items or 
services for acceptance. 
B. Suppliers shall provide the purchaser objective evidence that items or services 
conform to procurement documents. The documentation shall be available at the 
purchasers facility before the item is installed or before the service is used. 
C. Methods for accepting supplier furnished items or services shall ensure that 
items or services comply with the purchasers procurement document 
requirements and include one or more of the following, as appropriate to the 
items or services being procured: 
1. Evaluating the suppliers certificate of conformance (items and related 
services) 
2. Performing one or a combination of source verification, receiving 
inspection, or post-installation test (items and related services) 
3. Technical verification of data produced (services only) 
4. Surveillance and/or audit of the activity (services only) 
5. Review of objective evidence (i.e., certifications, stress reports, etc.) for 
conformance to the procurement document requirements (services only). 
D. Purchaser shall accept items and services prior to installation or use. 
7.2.7 Certificate of Conformance 
When a certificate of conformance is used to accept an item or related service: 

A. The certificate shall identify the purchased item or service to the specific 
procurement document. 
B. The certificate shall identify the specific procurement document requirements 
met by the purchased item or service, such as codes, standards and other 
specifications. The procurement document requirements identified shall include 
any approved changes, waivers, or deviations applicable to the item or service. 
C. The certificate shall identify any procurement document requirements that have 
not been met, together with an explanation and the means for resolving the 
nonconformances. 

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D. The certificate shall be attested to by a person who is responsible for this QA 
function and whose responsibilities and position are described in the suppliers 
QA program. 
E. The certification process, including the implementing documents to be followed 
in filling out a certificate and the administrative implementing documents for 
review and approval of the certificates, shall be described in the suppliers QA 
program description document. 
F. Measures shall be identified to verify the validity of certificates and the 
effectiveness of the certification process (e.g., by audit of the supplier or by an 
independent inspection or test of the item). Verifications shall be conducted at 
intervals commensurate with the past quality performance of the supplier. 
7.2.8 Source Verification 
The purchaser may accept an item or service by monitoring, witnessing, or 
observing activities performed by the supplier. This method of acceptance is called 
source verification. 

A. Verification of activities is planned and performed with QA organization 
participation in accordance with written procedures to ensure conformance to 
procurement requirements. Procedures applicable to the method of procurement 
provide for: 
1. Specification of the characteristics or processes to be witnessed, inspected, 
or verified and the method of surveillance and the extent of documentation 
required. 
2. Audits, surveillance, or inspections to verify the effectiveness of the 
suppliers QA program and quality control activities and to ensure that the 
supplier complies with quality assurance and technical requirements. 
B. Source verification shall be implemented to inspect, monitor, witness, or observe 
activities consistent with the suppliers planned fabrication, inspections, 
examinations, or tests, and shipments of items at predetermined points and 
performed at intervals consistent with the importance and complexity of the 
item. 
C. Documented evidence of acceptance of source verified items or services shall be 
furnished to the receiving destination of the item, to the purchaser, and to the 
supplier. 

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7.2.9 Receiving Inspection 
When receiving inspection is used to accept an item: 

A. The inspection shall consider the results of source verifications and audits and 
the demonstrated quality performance of the supplier. 
B. The inspection shall be performed in accordance with inspection implementing 
documents. 
C. The inspection shall verify by objective evidence such features as proper 
configuration; identification; dimensional, physical, and other characteristics; 
freedom from shipping damage; and cleanliness. 
D. The inspection shall be planned and executed according to the requirements of 
Section 10.0. 
E. Receiving inspection shall be coordinated with a review for adequacy and 
completeness of any required documentation submittals. 
7.2.10 Post-Installation Testing 
A. When post-installation testing is used as a method of acceptance, the post-
installation test requirements and acceptance documentation shall be mutually 
established by the purchaser and supplier. 
B. The test shall be in accordance with the requirements of Section 11.0. 
7.2.11 Control of OCRWM Contractors/Suppliers Nonconformances 
The purchaser and supplier shall establish and document the process for disposition 
of items and services that do not meet procurement document requirements 
according to the following requirements: 

A. OCRWM contractors, other than principal contractors, shall evaluate 
nonconforming items according to the requirements of Section 15.0. Principal 
contractors shall evaluate nonconforming items according to the requirements of 
their QA program description document. 
B. Suppliers/principal contractors shall submit a report of nonconformance to the 
purchaser, including recommended disposition for use-as-is or repair, and 
technical justification. Reports of nonconformances related to procurement 
document requirements or documents approved by the purchaser shall be 
submitted to the purchaser for approval of the recommended disposition 
whenever one of the following conditions exists: 
1. Technical or material requirements are violated. 
2. A requirement in supplier documents, which have been approved by the 
purchaser, is violated. 

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3. The nonconformance cannot be corrected by continuation of the original 
manufacturing process or by rework. 
4. The item does not conform to the original requirement even though the item 
can be restored to a condition such that the capability of the item to function 
is unimpaired. 
C. The purchaser shall disposition the suppliers recommendation. 
D. The purchaser shall verify implementation of the disposition. 
E. The purchaser shall maintain records of supplier submitted nonconformances. 
7.2.12 Commercial Grade Procurement 
A. Commercial Grade Items 
Where specific quality assurance controls appropriate for nuclear applications 
cannot be imposed in a practicable manner, commercial grade items may be 
substituted for basic components, subject to the following to provide the 
necessary assurance that the dedicated item will perform its intended safety or 
waste isolation function: 

1. The items critical characteristics shall be specified in approved design and 
procurement documents. 
2. Verification of the items critical characteristics shall be achieved by 
application of a dedication process to be performed by a specified 
dedicating entity. 
3. Implementing processes shall be developed to be consistent with Electric 
Power Research Institute (EPRI) Guideline for the Utilization of 
Commercial Grade Items in Nuclear Safety Related Applications 
(NCIG-07), EPRI NP-5652 (6/88), as endorsed and modified by NRC 
Generic Letters 89-02, Actions to Improve the Detection of Counterfeit and 
Fraudulently Marketed Products (3/89) and 91-05, Licensee 
Commercial-Grade Procurement and Dedication Programs (4/91). 

B. Commercial Grade Analytical Services 
For analytical services in support of scientific investigation, the following 
requirements shall be an acceptable alternative to all other requirements of 
Section 7.0. The purchaser shall: 

1. Prior to issuing the procurement document, develop a documented quality 
control sample plan that describes: 

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a. The number of quality control samples and approach to be used for 
submitting the samples (e.g., blind, duplicate, spike, etc.). 
b. The preparation and analysis of quality control samples or the 
identification of the source of the preparation and analysis method. 
Standards used in the preparation of quality control samples shall be 
traceable to nationally recognized standards. If no nationally recognized 
standard exists, the basis for use shall be documented. 
c. Acceptance criteria. 
d. How the number of quality control samples, the approach, and the 
acceptance criteria provide confidence in the accuracy/precision of the 
data. 
2. Ensure that quality control analytical results are received and evaluated 
against acceptance criteria, prior to use of data. 
3. Ensure that data, quality control analytical results, the quality control 
sample plan, and evaluation documentation are submitted as QA records. 
C. Commercial Grade Data 
When required data cannot be obtained from any external source through a 
procurement process that involves the imposition of applicable QA program 
requirements, the data may be obtained through a non-Q procurement action, 
provided: 

1. Prior review and approval by the responsible OCRWM line organization 
director and the Director, Office of Quality Assurance, is obtained. 
2. Planning for data acquisition and use is performed in accordance with 
Supplement III, Subsection III.2.1. 
3. The data produced by the procurement is identified, controlled, and 
qualified as described in Supplement III, Subsections III.2.3 and III.2.4. 
7.2.13 American Society of Mechanical Engineers Section III Code Items 
The following requirements relative to suppliers of ASME Section III Code items 
apply only to items designed and fabricated in accordance with ASME Section III, 
Rules for Construction of Nuclear Power Plant Components, and do not apply to 
non-code items that may be supplied by ASME Section III Code suppliers. 

A. For the purchase of ASME Section III Code items, editions of ANSI/ASME 
NQA-1 identified in NRC endorsed or otherwise approved by the NRC versions 
of the Code may be used for the construction of ASME Section III Code items 

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when the referenced edition of ANSI/ASME NQA-1 is used in conjunction with 
other quality assurance, administrative, and reporting requirements contained in 
the Code. Further, applicable requirements contained in the QARD or suppliers 
QA program description document shall also be met in conjunction with the 
ASME Section III Code. 

B. When assessing whether a company has an acceptable QA program to enable it 
to become a supplier, credit may be taken for the fact that ASME has surveyed 
the ASME Code supplier and issued a Certificate of Authorization or Quality 
System Certification of the appropriate scope and for the desired location, 
without performing any additional evaluation of the suppliers QA program. 
C. Audits of ASME Code suppliers shall confirm that the suppliers are 
satisfactorily implementing: 
1. Their accredited ASME Code QA program 
2. The technical and quality provisions specified in the purchase order 
3. The applicable provisions of the QARD or principal contractors QA 
program description document 
4. Applicable requirements contained in the regulations. 

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8.0 IDENTIFICATION AND CONTROL OF MATERIAL, PARTS, AND 
COMPONENTS 
8.1 GENERAL 
A. This section establishes requirements for the identification and control of items 
(including consumables and partially fabricated assemblies) to ensure that only 
correct and accepted items are used or installed. 
B. Computer software nonconformances shall be controlled in accordance with 
Subsection I.2.5. 
8.2 REQUIREMENTS 
8.2.1 Identification 
A. Identification shall be maintained on the items or in documents traceable to the 
items. 
B. Items shall be identified from the time of initial fabrication, or receipt, up to and 
including installation or end use. 
C. Identification shall relate an item to an applicable design or other pertinent 
specifying document. 
D. Correct identification of items shall be verified and documented prior to release 
for fabrication, assembly, shipping, or installation. 
8.2.2 Physical Markings 
A. Item identification methods shall include use of physical markings to the 
maximum extent possible. If physical markings are either impractical or 
insufficient, other appropriate means shall be employed (i.e., physical separation, 
labels or tags attached to containers, or procedural control). 
B. Physical markings, when used, shall: 
1. Be applied using materials and methods that provide a clear and legible 
identification. 
2. Not detrimentally affect the function or service life of the item. 
3. Be transferred to each part of an identified item when the item is 
subdivided. 
4. Not be obliterated or hidden by surface treatments, coatings, or after 
installation unless other means of identification are substituted. 

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8.2.3 Conditional Requirements 
The controls for items shall address the following requirements, as applicable: 

A. If codes, standards, or specifications include specific identification or traceability 
requirements (i.e., identification or traceability of the item to applicable 
specification and grade of material; heat, batch, lot, part, or serial number; 
specified inspection, test, or other records), the identification and traceability 
methods shall be specified in specifications. 
B. If codes or standards do not include specific identification or traceability 
requirements, specifications shall specify identification and traceability methods 
appropriate to the item. 
C. If items, including consumables, have a limited calendar (shelf) life, operating 
life, or operating cycles, their use shall be subjected to methods established to: 
1. Uniquely identify them. 
2. Establish records identifying the calendar (shelf) life, operating life, and/or 
operating cycles remaining. 
3. Prevent the further use of such items, including consumables, which have 
reached the end of their calendar (shelf) life, operating life, or operating 
cycles. 
D. If item storage is required, methods shall be established for the control of item 
identification that is commensurate with the planned duration and conditions of 
storage. These methods shall provide for, as applicable: 
1. Maintenance or replacement of markings and identification tags damaged 
during handling or aging 
2. Protection of identification markings subject to excessive deterioration 
resulting from environmental exposure or adverse storage conditions 
3. Updating related documentation. 

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9.0 CONTROL OF SPECIAL PROCESSES 
9.1 GENERAL 
A. This section establishes the requirements to ensure that special processes, 
including welding, heat treating, chemical cleaning, and nondestructive testing 
are controlled and accomplished by qualified personnel using qualified 
procedures in accordance with applicable codes, standards, specifications, 
criteria, and other requirements. 
B. Processes performed to acquire or analyze data for scientific investigations 
(i.e., siting or design input) are performed in accordance with Supplement III. 
9.2 REQUIREMENTS 
9.2.1 Special Processes 
A. For special processes not covered by existing codes and standards or where 
quality requirements specified for an item exceed those of existing codes or 
standards, the necessary requirements for qualification of personnel, procedures, 
or equipment shall be specified or referenced in implementing documents. 
B. Processes to be controlled as special processes shall meet the following criteria: 
1. The results are highly dependent on the control of the process. 
2. The results are highly dependent on the skill of the operator. 
3. Quality of the results cannot be readily determined by inspection or test of 
the item. 
9.2.2 Personnel, Implementing Documents, and Equipment Qualifications 
Implementing documents shall be used to ensure that process parameters are 
controlled and that the specified environmental conditions are maintained. Special 
process implementing documents shall include or reference: 

A. Organizational responsibilities, including those for the QA organization, for the 
qualification of special process equipment and personnel. 
B. Provisions for recording evidence of acceptable accomplishment of special 
processes using qualified procedures, equipment, and personnel. 
C. Qualification requirements for personnel, implementing documents, and 
equipment. Certificates of qualification shall clearly delineate the specific 
processes that personnel are qualified to perform and the criteria used to qualify 
personnel in each process. 

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D. Conditions necessary for accomplishment of the special process. These 
conditions shall include proper equipment, controlled parameters of the process, 
calibration requirements, and traceability between the item and the individual 
performing the special process. 
E. Requirements of applicable codes, standards, and specifications, including 
acceptance criteria for the special process. 
F. A requirement for the QA organization to be involved in special process 
personnel, equipment, and process qualification to ensure satisfactory 
performance. This involvement includes, but is not limited to the performance 
of surveillances and audits. 
9.2.3 Qualification and Certification of Nondestructive Examination Personnel 
A. Nondestructive examination shall include radiography, magnetic particle, 
ultrasonic, liquid penetrant, eddy current, neutron radiography, acoustic 
emission, and leak testing. 
B. Personnel who perform nondestructive examinations shall be qualified and 
certified in accordance with Subsection 2.2.11. In lieu of the three-year 
recertification interval specified in Recommended Practice No. SNT-TC-1A, June 
1980 Edition, Level III nondestructive examination personnel may be recertified 
on a five-year interval. 
C. Suppliers, other than principal contractors, may qualify their nondestructive 
examination personnel to other editions of the Recommended Practice No. 
SNT-TC-1A, provided other editions are reconciled to the 1980 edition of the 
Recommended Practice No. SNT-TC-1A and found acceptable to the OQA. 
D. Implementing documents shall be established for the control and administration 
of nondestructive examination personnel training, examination, and certification. 

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10.0 INSPECTION 
10.1 GENERAL 
This section establishes requirements for developing an effective inspection program 
that verifies conformance of items and activities to specified requirements through 
planning and executing inspections. 

10.2 REQUIREMENTS 
10.2.1 Inspection Planning 
A. Inspection planning shall be performed and documented. Inspection plans may 
be separate documents governed by procedural controls, or an integral part of 
approved implementing documents. 
B. Representatives of the interested technical organizations and the QA 
organization shall participate in planning activities. 
C. Related codes, standards, specifications, and design documents shall be used to 
develop inspection plans. 
D. The elements of inspection plans identify: 
1. Characteristics to be inspected 
2. Description of inspection or process monitoring that will be used 
3. Identification of the organization responsible for performing the inspection 
4. Acceptance criteria 
5. Measuring and test equipment to be used to perform the inspection to ensure 
the equipment is of the proper type, range, accuracy, and tolerance to 
accomplish the intended function 
6. If applicable, identification of a sampling plan in accordance with 
Subsection 10.2.4 
7. Methods to record inspection results. 
10.2.2 Selecting Inspection Personnel to Perform Inspections 
A. The individual who performs an inspection to verify conformance of an item to 
specified acceptance criteria shall be qualified to the requirements of this 
section. 

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B. Data recorders, equipment operators, or other inspection or test team members 
who are supervised by a qualified inspector shall not be required to be a 
qualified inspector. 
C. Inspections shall be performed by individuals other than those who performed 
the activity being inspected, and those individuals shall not report directly to the 
supervisor immediately responsible for performance of the work. 
10.2.3 Inspection Hold Points 
A. When mandatory hold points are used to control work that shall not proceed 
without the specific consent of the organization placing the hold point, then the 
specific hold points shall be indicated in implementing documents. 
B. Consent to waive specified hold points shall be documented before continuing 
work beyond the designated hold point. 
10.2.4 Statistical Sampling 
When statistical sampling is used to verify the acceptability of a group of items, the 
statistical sampling method shall be based on recognized standard practices and shall 
comply with the sampling plan requirements delineated in Section 3.0. 

10.2.5 In-Process Inspections and Monitoring 
A. Items in-process or under construction shall be inspected when necessary to 
verify quality. If inspection of processed items is impossible or 
disadvantageous, indirect control by monitoring of processing methods, 
equipment, and personnel shall be provided. 
B. Inspection and process monitoring both shall be conducted when control is 
inadequate with only one method. 
C. A combination of inspection and process monitoring methods, when used, shall 
be performed in a systematic manner to ensure that the specified requirements 
for control of the process and the quality of the item are met throughout the 
duration of the process. 
D. Controls shall be established and documented for the coordination and 
sequencing of the work at established inspection points during successive stages 
of the process or construction. 
10.2.6 Final Inspection 
A. Finished items shall be inspected for completeness, markings, calibration, 
adjustments, protection from damage, or other characteristics, as required to 
verify the quality and conformance of the item to specified requirements. 

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B. Quality records not previously examined shall be examined for adequacy and 
completeness. 
C. Final inspections shall include a review of the results and resolution of 
nonconformances identified by earlier inspections. 
D. Modifications, repairs, or replacements of items performed subsequent to final 
inspection shall require reinspection or retest, as appropriate, to verify 
acceptability. 
10.2.7 Accepting Items 
A. The acceptance of inspection results shall be documented and approved by 
qualified and authorized personnel. 
B. The inspection status of an item shall be identified according to Section 14.0. 
10.2.8 Inspection Documentation 
Inspection documentation shall identify: 

A. The item inspected 
B. The date of inspection 
C. The name or unique identifier of the inspector who documented, evaluated, and 
determined acceptability 
D. The name of the data recorder, as applicable 
E. The type of observation or method of inspection 
F. The inspection criteria, sampling plan, or reference documents (including 
revision levels) used to determine acceptance 
G. Results indicating acceptability of characteristics inspected 
H. Measuring and test equipment used during the inspection, including the 
identification number and the most recent calibration date 
I. Reference to information on actions taken in connection with nonconformances, 
as applicable. 
10.2.9 Qualification and Certification of Inspection Personnel 
Personnel who perform inspections shall be qualified and certified in accordance 
with Subsection 2.2.11. 


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11.0 TEST CONTROL 
11.1 GENERAL 
A. This section establishes requirements for planning and executing tests required to 
demonstrate that items will perform satisfactorily in service. 
1. Tests shall be performed in accordance with implementing documents that 
incorporate requirements and acceptance criteria contained in applicable 
design documents. 
2. Examples of such tests include: prototype, component, or feature 
qualification tests; production tests; proof tests prior to installation; 
construction tests; and preoperational tests (i.e., the test program before the 
start of preclosure operations). 
B. Testing of computer software supporting a safety or waste isolation function 
shall be performed in accordance with Supplement I. 
C. Tests supporting the acquisition of data from samples, and scientific 
investigation shall be performed in accordance with Supplement III. 
11.2 REQUIREMENTS 
11.2.1 Test Planning 
Test planning shall require that test implementing documents provide for the 
following: 

A. Identification of the implementing documents to be developed to control and 
perform tests and provide criteria for (i) determining the accuracy requirements 
of test equipment and (ii) determining when tests are required and defining how 
and when testing activities are performed 
B. Provisions for performing prototype, component, or feature qualification testing, 
including design verification testing, as early as possible before the installation 
would become irreversible 
C. Identification of the item to be tested and the test requirements and acceptance 
limits contained in applicable design and procurement documents 
D. Identification of test methods to be employed and instructions for performing the 
test 
E. Test prerequisites that address the following: calibrated instrumentation; 
appropriate and adequate test equipment and instrumentation, including accuracy 
requirements, trained personnel, condition of test equipment, and the 

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completeness of the item to be tested; suitably controlled environmental 
conditions; and provisions for data acquisition and storage 

F. Mandatory inspection hold points for witnessing by the organization placing the 
hold point 
G. Methods to record data and results 
H. Provisions for ensuring that test prerequisites have been met 
I. Selection and identification of the measuring and test equipment to be used to 
perform the test to ensure that the measuring and test equipment is of the proper 
type, range, accuracy, and tolerance to accomplish the intended function. 
11.2.2 Performing Tests 
Tests shall be performed in accordance with implementing documents that address 
the following requirements, as applicable: 

A. Provisions for determining when a test is required, describing how tests are 
performed, and ensuring that testing is conducted by trained and appropriately 
qualified personnel 
B. Inclusion of or reference to test objectives and provisions for ensuring that 
prerequisites for the given test have been met, adequate calibrated 
instrumentation is available and used, necessary monitoring is performed, and 
suitable environmental conditions are maintained 
C. Test requirements and acceptance criteria provided or approved by the 
organization responsible for the design of the item to be tested, unless otherwise 
designated 
D. Test requirements and acceptance criteria based upon specified requirements 
contained in applicable design or other pertinent technical documents. 
11.2.3 Use of Other Testing Documents 
A. Other testing documents (i.e., American Society for Testing and Materials 
specifications, supplier manuals, equipment maintenance instructions, controlled 
drawings, or other related documents containing acceptance criteria) may be 
used instead of preparing special test implementing documents. If used, these 
documents shall incorporate the information directly into the approved test 
document governing the test. 
B. Other testing documents shall include adequate supplemental instructions, as 
required, to ensure the required quality of the testing work. 

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11.2.4 Test Results 
A. Test results shall be documented, and their conformance with acceptance criteria 
shall be evaluated, by a qualified individual within the responsible organization 
to ensure that test requirements have been satisfied. 
B. The test status of an item shall be identified in accordance with Section 14.0. 
11.2.5 Test Documentation 
Test documentation shall identify the following: 

A. Item or work product tested 
B. Date of test 
C. Name of the tester and data recorders 
D. Type of observation 
E. Identification of test criteria or reference documents used to determine 
acceptance 
F. Results and acceptability of the test 
G. Actions taken in connection with any nonconformances noted 
H. Name of the person evaluating and accepting the test results 
I. Identification of the measuring and test equipment used during the test, including 
the identification number and the next calibration due date. 
11.2.6 Qualification and Certification of Test Personnel 
Personnel who direct tests shall be qualified and certified according to the 
requirements of Subsection 2.2.11. 


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12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 
12.1 GENERAL 
This section prescribes requirements applicable to the establishment of measures 
that ensure tools, gages, instruments, and other measuring and testing devices used 
in activities affecting quality are properly controlled, calibrated, and adjusted at 
specified periods to maintain accuracy within necessary limits. 

12.2 REQUIREMENTS 
12.2.1 Calibration 
A. Measuring and test equipment (M&TE), including equipment that contains 
software or programmable hardware, shall be calibrated, adjusted, and 
maintained as a unit at prescribed intervals, or prior to use, against reference 
calibration or transfer standards having traceability to nationally recognized 
standards. Software developed or modified by the user shall be controlled in 
accordance with Supplement I. If no nationally recognized standards or physical 
constants exist, the basis for calibration shall be documented. 
B. Calibration standards shall have a greater accuracy than the required accuracy 
of standards being calibrated. 
1. If calibration standards with a greater accuracy than required of the standard 
being calibrated do not exist or are unavailable, calibration standards with 
accuracy equal to the required calibration accuracy may be used if they can 
be shown to be adequate for the requirements. 
2. The basis for the calibration acceptance shall be documented and authorized 
by responsible management. The level of management authorized to 
perform this function shall be identified. 
C. Calibration standards used for the calibration of M&TE shall have an accuracy 
of at least four times the required accuracy of the equipment being calibrated or, 
when this is not possible, shall have an accuracy that ensures that the equipment 
being calibrated will be within required tolerance. The basis of acceptance shall 
be approved by responsible management. The level of management authorized 
to perform this function shall be identified. 
D. The method and interval of calibration for each device shall be defined based on 
the type of equipment, stability characteristics, required accuracy, precision, 
intended use, degree of use, and other conditions affecting measurement control. 
For M&TE used in one-time-only applications, the calibration shall be done both 
before and after use. 

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E. A calibration or calibration check shall be performed: 
1. When the accuracy of calibrated in-service M&TE is suspect 
2. When calibrated M&TE is removed from service (i.e., retired or surplus). 
F. Calibrated M&TE shall be labeled, tagged, or otherwise suitably marked or 
documented to indicate due date of the next calibration. 
G. Calibrated M&TE shall be uniquely identified to provide traceability to its 
calibration data. 
H. Updates to software contained in M&TE that affect calibration shall require 
recalibration of the equipment prior to use. 
12.2.2 Documenting the Use of Measuring and Test Equipment 
A. The use of M&TE shall be documented. 
B. Selection of M&TE shall be controlled to ensure that such items are of proper 
type, range, accuracy, and tolerance to accomplish the functions of determining 
conformance to specified requirements. 
C. As appropriate to equipment use and its calibration schedule, the documentation 
shall identify the processes monitored, data collected, or items inspected or 
tested since the last calibration. 
12.2.3 Out-of-Calibration Measuring and Test Equipment 
A. M&TE shall be considered to be out-of-calibration and shall not be used until 
calibrated if any of the following conditions exist: 
1. The calibration due date or interval has passed without recalibration. 
2. The device produces results known to be in error. 
3. The calibration status cannot be determined. 
B. Out-of-calibration M&TE shall be controlled. The controls shall include the 
following requirements: 
1. Out-of-calibration M&TE shall be tagged, segregated, or otherwise 
controlled to prevent use until it has been recalibrated. 
2. When M&TE is found to be out-of-calibration during recalibration, the 
validity of results obtained using that equipment since its last valid 
calibration shall be evaluated. 
a. The evaluation shall include the determination of acceptability for 
previously collected data, processes monitored, or items previously 
inspected or tested. 

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b. The evaluation shall be documented. 
c. If evaluation determines that processes monitored or items inspected or 
tested are suspect, it shall be documented in accordance with 
Section 15.0. Inspections or tests shall be repeated for items determined 
to be suspect. 
C. If M&TE is consistently found to be out-of-calibration during the recalibration 
process, it shall be repaired or replaced. 
12.2.4 Lost Measuring and Test Equipment 
When M&TE is lost, the validity of results obtained using that equipment since its 
last valid calibration shall be evaluated. 

A. The evaluation shall include the determination of acceptability for previously 
collected data, processes monitored, or items previously inspected or tested. 
B. The evaluation shall be documented. 
C. If evaluation determines that processes monitored or items inspected or tested 
are suspect, it shall be documented in accordance with Section 15.0. 
12.2.5 Handling, Storage, and Use 
A. M&TE shall be properly handled and stored to maintain accuracy. 
B. Selection of M&TE shall be controlled to ensure that such items are the proper 
type for the intended use. 
12.2.6 Commercial Devices 
Calibration and control shall not be required for rulers, tape measures, levels, and 
other normal commercial equipment that provides adequate accuracy. 

12.2.7 Measuring and Test Equipment Documentation 
M&TE calibration documentation shall include the following information: 

A. Identification of the measuring or test equipment calibrated 
B. Traceability to the calibration standard used for calibration 
C. Calibration data 
D. Identification of the individual performing the calibration 

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E. Identification of the date of calibration and the recalibration due date or interval, 
as appropriate 
F. Results of the calibration and statement of acceptability 
G. Reference to any actions taken in connection with out-of-calibration or 
nonconforming M&TE, including evaluation results and repeated inspections or 
tests, as appropriate 
H. Identification of the implementing document (including revision level) used in 
performing the calibration. 

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13.0 HANDLING, STORAGE, AND SHIPPING 
13.1 GENERAL 
This section establishes requirements for the handling, storage, cleaning, packaging, 
shipping, and preservation of items and consumables, in accordance with design and 
procurement requirements, to prevent damage or loss and to minimize deterioration. 

13.2 REQUIREMENTS 
13.2.1 Controls 
A. Handling, storage, cleaning, packaging, shipping, and preservation of items shall 
be conducted in accordance with established work and inspection implementing 
documents, shipping instructions, or other specified documents. 
B. If required for critical, sensitive, perishable, or high-value articles, specific 
implementing documents for handling, storage, cleaning, packaging, shipping, 
and preservation shall be prepared and used. 
13.2.2 Special Equipment, Tools, and Environments 
A. If required for particular items, special equipment (e.g., containers, shock 
absorbers, and accelerometers) and special protective environments (i.e., inert 
gas and specific moisture and temperature levels) shall be specified and 
provided. 
B. If special equipment and environments are used, provisions shall be made for 
their verification. 
C. Special handling tools and equipment shall be used and controlled, as necessary, 
to ensure safe and adequate handling. 
D. Special handling tools and equipment shall be inspected and tested at specified 
time intervals and in accordance with implementing documents to verify that the 
tools and equipment are adequately maintained. 
E. Operators of special handling and lifting equipment shall be experienced or 
trained to use the equipment. 
13.2.3 Marking and Labeling 
A. Measures shall be established for marking and labeling for the packaging, 
shipping, handling, and storage of items as necessary to adequately identify, 
maintain, and preserve the item. 
B. Markings and labels shall indicate the presence of special environments or the 
need for special controls, if necessary. 

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14.0 INSPECTION, TEST, AND OPERATING STATUS 
14.1 GENERAL 
This section establishes requirements to identify the inspection, test, and operating 
status of items throughout fabrication, construction, installation, and testing. 

14.2 REQUIREMENTS 
14.2.1 Identifying Items 
A. Items that have satisfactorily passed required inspections and tests shall be 
identified. 
B. The identification methods shall preclude the inadvertent installation, use, or 
operation of items that have not passed required inspections and tests. 
14.2.2 Indicating Status 
A. The status of required inspection and tests of items shall be indicated when 
necessary to preclude inadvertent bypassing of such inspections and tests. 
B. The status of inspections and tests shall be identified either on the items or in 
documents traceable to the items. 
C. Status shall be maintained through the use of legible and easily recognizable 
status indicators (i.e., tags, markings, labels, and stamps) or other means 
(i.e., travelers, inspection, or test records). 
D. The authority for applying and removing status indicators shall be specified. 
E. To prevent the inadvertent use or operation of an item that is out of service 
(e.g., a nonconforming, inoperative, or malfunctioning item), status indicators, 
such as tags or markings, shall be placed at all locations where operation of the 
item can be initiated, such as control panels, switches, breakers, valves, or 
systems. 

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15.0 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS 
15.1 GENERAL 
A. This section establishes requirements for the control of items (including samples, 
boreholes, services, etc.) that do not conform to requirements in order to prevent 
inadvertent installation or use of the item. 
B. Computer software nonconformances shall be controlled in accordance with 
Subsection I.2.5. 
15.2 REQUIREMENTS 
15.2.1 Documenting, Reporting, and Evaluating Nonconforming Items 
A. Nonconformances shall be documented and reported to the appropriate levels of 
management responsible for the conditions. In addition, organizations affected 
by the nonconformance shall be notified. 
B. Nonconformances shall be tracked and trended in accordance with the 
requirements of Section 16.0. 
C. Nonconformance documentation shall clearly identify and describe the 
characteristics that do not conform to specified criteria. 
D. Nonconformance documentation shall be reviewed, and recommended 
dispositions of nonconforming items shall be proposed. The review shall 
include determining the need for corrective action according to the requirements 
of Section 16.0. 
E. Recommended dispositions shall be evaluated and approved by individuals who 
are independent of the work that produced the disposition. 
F. Personnel performing evaluations to determine a disposition as well as those 
evaluating a recommended disposition shall have demonstrated competence in 
the specific area being evaluated, have an adequate understanding of the 
requirements, and access to pertinent background information. 
G. The responsibility and authority for reviewing, evaluating, and approving the 
disposition, and closing nonconformances shall be specified. 
H. Further processing, delivery, installation, or use of a nonconforming item shall 
be controlled pending the evaluation and approval of the disposition. 
I. Nonconformances shall be corrected or dispositioned before initiation of the 
preoperational test program on the item. 

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15.2.2 Identifying Nonconforming Items 
A. Nonconforming items shall be identified by marking, tagging, or other methods 
that do not adversely affect their end use. The identification shall be legible and 
easily recognizable. 
B. If the identification of a nonconforming item is not practical, then the container, 
package, or segregated storage area, as appropriate, shall be identified. 
15.2.3 Segregating Nonconforming Items 
A. Nonconforming items shall be segregated, when practical, by placing them in a 
clearly identified and designated hold area until properly dispositioned. 
B. If segregation is impractical or impossible due to physical conditions, other 
precautions shall be employed to preclude inadvertent use. 
15.2.4 Disposition of Nonconforming Items 
A. The disposition of use-as-is, limited use (this disposition is limited to 
Supplement II nonconforming samples), reject, repair, or rework for 
nonconforming items shall be identified and documented. 
B. The technical justification for the acceptability of a nonconforming item that has 
been dispositioned repair, limited use, or use-as-is shall be documented. 
C. Items that do not meet original design requirements that are dispositioned 
use-as-is or repair shall be subject to design control measures commensurate 
with those applied to the original design. 
1. If changes to the specifying document are required to reflect the as-built 
condition, then the disposition shall require action to change the specifying 
document to reflect the accepted nonconformance. 
2. Any document or QA record change required by the disposition of the 
nonconformance shall be identified in the nonconformance documentation, 
and when each document or record is changed, the justification for the 
change shall identify the nonconformance documentation. 
D. The disposition of an item to be reworked or repaired shall contain a requirement 
to reexamine (i.e., inspect, test, or nondestructive examination) the item to verify 
acceptability. Repaired or reworked items shall be reexamined using the original 
process and acceptance criteria unless the nonconforming item disposition has 
established alternate acceptance criteria. 

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E. Replacement items shall be inspected and tested in accordance with the original 
inspection and test requirements or acceptable alternatives. 

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16.0 CORRECTIVE ACTION 
16.1 GENERAL 
This section establishes requirements to ensure conditions adverse to quality are 
promptly identified and corrected as soon as practical. 

16.2 REQUIREMENTS 
16.2.1 Identifying Conditions Adverse to Quality 
A condition adverse to quality shall be identified when a failure, malfunction, 
deficiency, defective item, or nonconformance is identified. 

16.2.2 Classification of Conditions Adverse to Quality 
A. Conditions adverse to quality shall be classified in regard to their significance, 
and corrective actions shall be taken accordingly. 
B. Categories of classification shall be established to distinguish between: 
1. Conditions adverse to quality 
2. Significant conditions adverse to quality. 
16.2.3 Conditions Adverse to Quality 
A. Conditions adverse to quality shall be documented, tracked, and reported to the 
appropriate levels of management responsible for the conditions. 
B. Responsible management shall determine the extent of the adverse condition and 
complete remedial action as soon as practical. 
16.2.4 Significant Conditions Adverse to Quality 
A. Criteria for determining a significant condition adverse to quality shall be 
established. 
B. Significant conditions adverse to quality shall be documented and reported to 
management responsible for the condition and their upper management. 

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C. Significant conditions adverse to quality shall be evaluated for a stop work 
condition by the QA organization to determine whether stopping work is 
warranted. 
1. QA management shall issue stop work orders to responsible management 
after a stop work condition has been identified. 
2. QA management shall take appropriate action to lift and close (in part or 
total) the stop work issued by the QA organization based on the resolution 
of the related significant condition adverse to quality. 
D. Responsible management shall perform investigative action to determine the 
extent and impact of the condition, and document the results. 
E. Responsible management shall determine, document, and complete remedial 
action. 
F. Responsible management shall determine the root cause of the problem and take 
corrective action to prevent recurrence as soon as practical. 
16.2.5 Follow-up 
Processes shall be established to verify the implementation of corrective actions 
prior to closeout of the documentation associated with conditions adverse to quality. 

16.2.6 Quality Trending 
A. Criteria shall be established for determining adverse quality trends. 
B. Reports of nonconformances and conditions adverse to quality shall be evaluated 
to identify adverse quality trends. 
C. Trend evaluation shall be performed in a manner and at a frequency that 
provides for prompt identification of adverse quality trends and assist in 
identifying root cause. 
D. Trend evaluations shall be promptly distributed to OCRWM and OCRWM 
contractor management for review and appropriate corrective action. 

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17.0 QUALITY ASSURANCE RECORDS 
17.1 GENERAL 
A. This section establishes requirements to ensure that QA records that furnish 
documentary evidence of quality are specified, prepared, and maintained. The 
records system shall be established at the earliest practicable time consistent with 
the schedule for accomplishing activities affecting quality. 
B. The requirements of this section that are applicable to suppliers are also 
applicable to OCRWM contractors unless otherwise noted. 
17.2 REQUIREMENTS 
17.2.1 Quality Assurance Records 
A. Specific QA record types include, but are not limited to: 
1. Scientific, engineering, and operational data and logs; laboratory and field 
notebooks and logbooks; and data reduction documents 
2. Results of reviews, inspections, tests, audits, and material analysis 
3. Monitoring of work performance 
4. Maintenance and modification procedures and related inspection results 
5. Reportable occurrences 
6. QA program changes that reduce commitments 
7. Computer software supporting a safety or waste isolation function 
8. Qualification of personnel, procedures, and equipment 
9. Documentation such as design records, drawings, specifications, 
procurement documents, calibration procedures and reports, design review 
reports, peer review reports, nonconformance reports, corrective action 
reports, and as-built drawings 
10. Other records required by preclosure and postclosure operating conditions 
11. Construction records required by 10 CFR 63.72. 

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B. Additional guidance relative to the types of documents considered to be QA 
records is provided in ANSI/ASME NQA-1-1983, Appendix 17A-1, and NRC 
Regulatory Guide 1.28, Revision 3. 
17.2.2 Creating Valid Quality Assurance Records 
A. Implementing documents shall: 
1. Identify those documents that will become QA records. 
2. Identify the organization responsible for submitting the QA records to the 
records management system. 
B. Individuals creating QA records shall ensure that the QA records are legible, 
accurate, complete, appropriate to the work accomplished, and identifiable to the 
item(s) or activity(s) to which they apply. 
C. Individuals handling QA records shall protect them from damage or loss until 
the records are submitted to the records management system. 
D. Documents shall be considered valid records when stamped, initialed, or signed 
and dated by authorized personnel or otherwise authenticated as complete. This 
authentication may take the form of a statement by the reporting individual or 
organization. If the nature of the record (i.e., magnetic or optical media) 
precludes stamping, initialing, or signing, then other means of identifying the 
record as complete by authorized personnel are permitted. 
E. Handwritten signatures shall not be required if the document is clearly identified 
as a statement of the reporting individual or organization. 
F. QA records may be originals or copies. 
17.2.3 Submission of Quality Assurance Records 
QA records shall be submitted to the records management system for receipt, 
processing, and storage. 

17.2.4 Receiving and Indexing Quality Assurance Records 
A receipt control system shall be established for QA records according to the 
following requirements: 

A. An individual or organization shall be assigned the responsibility for receiving 
QA records. The designee shall be responsible for organizing and implementing 
a system of receipt control of records for permanent and temporary storage. 

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B. A method shall be established for verifying that the QA records received are in 
agreement with the transmittal document. 
C. QA records shall be protected from damage, deterioration, or loss when 
received. 
D. Legibility and completeness of QA records shall be verified. 
E. The receipt control system shall permit a current and accurate assessment of the 
status of QA records during processing. 
F. QA records shall be indexed to ensure retrievability. The indexing system shall 
include: 
1. The location of the QA records within the records management system 
2. Identification of the item or related activity to which the QA records pertain 
3. The record retention times. 
17.2.5 Correcting Information in Quality Assurance Records 
A. Corrections to QA records, including documents that will become QA records, 
shall include the initials or signature of the person authorized to make the 
correction and the date the correction was made. 
B. Corrections to QA records shall be approved by the originating organization. If 
the organization responsible for generating the record is no longer available, a 
new responsible organization shall be identified. 
17.2.6 Storing and Preserving Quality Assurance Records 
A. QA records shall be stored and preserved in predetermined storage facilities in 
accordance with an approved implementing document that provides: 
1. A description of the storage facility 
2. A description of the filing system to be used 
3. A method for verifying that the QA records received are in agreement with 
the transmittal document and that the records are legible 
4. A description of controls governing QA record access, retrieval, and 
removal 
5. A method for filing supplemental information 
6. A method for disposition of superseded QA records. 

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B. Storage methods shall be developed to preclude deterioration of QA records in 
accordance with the following: 
1. The storage area shall minimize the risk of damage or destruction by natural 
disasters, extremes in environmental conditions, and infestations of pests or 
molds. 
2. Approved filing methods shall require QA records to be firmly attached in 
binders or placed in folders or envelopes, for storage in steel file cabinets or 
on shelving in containers appropriate for the QA record medium being 
stored. 
3. The storage arrangement shall provide adequate protection of special 
processed QA records (i.e., radiographs, photographs, negatives, microform, 
and electronic and magnetic media) to preclude damage from moisture, 
temperature, excessive light, electromagnetic fields, or stacking, consistent 
with the type of QA record being stored. The guidance provided in NRC 
Regulatory Issue Summary 2000-18, Guidance on Managing Quality 
Assurance Records in Electronic Media, shall be complied with in the 
development of procedures governing the management of electronic media 
records. 
4. The storage area shall be protected from unauthorized entry, larceny, and 
vandalism. 
17.2.7 Retrieval of Quality Assurance Records 
A. The records management system shall provide for retrieval of QA records. 
B. Access to storage facilities shall be controlled. A list shall be maintained 
designating personnel who are permitted access to the QA records. 
17.2.8 Retention of Quality Assurance Records 
A. Retention of OCRWM QA records shall be in accordance with the retention and 
disposition instructions contained in a records retention schedule. 
B. The retention periods delineated in the records retention schedule shall meet or 
exceed the retention requirements delineated in ANSI/ASME NQA-1-1983 and 
NRC Regulatory Guide 1.28, Revision 3. At a minimum, QA records shall be 
maintained until the end of the operating period. 
C. Records retained by suppliers shall be retained in accordance with procurement 
document requirements. Records shall be made available to the OCRWM or its 
designee upon request. 

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17.2.9 Turnover of Quality Assurance Records 
A. Suppliers shall submit, to the OCRWM, those QA records being temporarily 
stored by supplier that are subject to records turnover requirements. The timing 
of the submittal shall be as records packages become complete or, as items are 
released for shipment, or as prescribed by the purchaser. 
B. The records management organization shall inventory the submittal, 
acknowledge receipt, and process the QA records. 
C. The responsible line organizations shall identify those QA records in temporary 
storage to be submitted for long-term storage to the records management system 
in accordance with Subsection 17.2.10, or Subsection 17.2.11. 
17.2.10 Long-Term Single Storage Facility 
A. Single storage facilities for the storage of QA records shall meet the following 
design and construction requirements: 
1. Reinforced concrete, concrete block, masonry, or equal construction. 
2. Floor and roof with drainage control. If a floor drain is provided, a check 
valve or equal shall be included. 
3. Minimum 2-hour fire-rated structure, doors, and frames. 
4. Sealant applied over walls as a moisture or condensation barrier. 
5. Surface sealant on floor providing a hard wear surface to minimize concrete 
dusting. 
6. Foundation sealant and provisions for drainage. 
7. Forced air circulation with filter system. 
8. Fire protection system. 
9. Penetrations limited to fire protection, communication, lighting, and 
temperature and humidity controls. Seal or damper penetrations to meet 
2-hour fire protection rating. 
B. If the facility is located within a building or structure, the environment and 
construction of that building can provide a portion or all of the criteria in 
Paragraph 17.2.10A. 

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C. Construction details shall be reviewed for the adequacy of record protection by a 
person competent in the technical field of fire protection and fire extinguishing. 
17.2.11 Dual Storage Facilities 
A. Dual storage facilities for the storage of QA records shall provide facilities for 
copies of each record at locations sufficiently remote from each other to 
eliminate the chance of exposure to a simultaneous hazard. 
B. Dual storage facilities shall not be required to meet the design and construction 
requirements specific for a long-term single storage facility. 
17.2.12 Temporary Storage Facility 
Temporary storage shall provide for the storage of QA records during processing, 
review, or use until turnover to the OCRWM for disposition according to the 
following requirements: 

A. QA records shall be temporarily stored in a container or facility with a fire rating 
of 1-hour, or dual storage shall be provided. 
B. Single storage containers or facilities shall bear an Underwriters Laboratories 
label (or equivalent) certifying 1-hour fire protection or be certified by a person 
competent in the technical field of fire protection. 
C. Procedures shall specify the maximum allowable time for the temporary storage 
of QA records. 
17.2.13 Replacement of Quality Assurance Records 
Organizations originating QA records shall develop implementing documents that 
identify means for replacement, restoration, or substitution of lost or damaged QA 
records. 


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18.0 AUDITS 
18.1 GENERAL 
A. This section establishes requirements for performing a comprehensive system of 
planned and periodic internal and external QA audits to verify compliance with 
all aspects of the OCRWM QA program, and to determine the effectiveness of 
the OCRWM QA program. 
B. The requirements of this section that are applicable to suppliers are also 
applicable to OCRWM contractors unless otherwise noted. 
18.2 REQUIREMENTS 
18.2.1 Audit Scheduling 
Audits shall be performed in all areas where the requirements of the QARD or 
suppliers QA program description document are applicable. The following areas 
shall also be considered when scheduling audits: 

A. The determination of site features that effect site safety (e.g., site 
characterization, performance confirmation, core sampling, site and foundation 
preparation, and methodology) 
B. The preparation, review, approval, and control of early procurements 
C. Indoctrination and training programs 
D. Interface control between the OCRWM and suppliers 
E. Corrective action, calibration, and nonconformance control systems 
F. Safety Analysis Report commitments 
G. Development and control of computer software supporting a safety or waste 
isolation function 
H. The purchase of ASME Code items 
I. Audits of ASME Code suppliers. 
18.2.2 Scheduling Internal Audits 
A. Internal audits shall be scheduled in a manner to provide coverage, consistency, 
and coordination with ongoing work. 

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B. Internal audits shall be scheduled at a frequency commensurate with the status 
and importance of the work. 
C. Internal audits shall be scheduled to begin as early in the life of the work as 
practical and shall be scheduled to continue at intervals consistent with the 
schedule for accomplishing the work. 
D. Regularly scheduled internal audits shall be supplemented by additional audits of 
specific subjects, when necessary, to provide an adequate assessment of 
compliance and effectiveness. 
E. Internal audits of applicable QARD elements to verify OCRWM QA program 
compliance and effectiveness shall be performed at intervals not to exceed 12 
months or at least once during the life of the work, whichever is shorter. 
F. Performance-based internal audits shall be performed on selected work to 
determine OCRWM QA program effectiveness. 
18.2.3 Scheduling External Audits 
A. External audits (audits of suppliers) shall be scheduled in a manner to provide 
coverage, consistency, and coordination with ongoing work. 
B. External audits shall be scheduled: 
1. To begin as early in the life of the work as practical. 
2. To continue at intervals consistent with the schedule for accomplishing the 
work. 
3. At a frequency commensurate with the status and importance of the work. 
C. External supplier audits for compliance and effectiveness shall be performed 
triennially or at least once during the life of the work, whichever is shorter. 
Audits of principal contractors, for compliance and effectiveness, shall be 
performed at intervals not to exceed 12 months or at least once during the life of 
the work, whichever is shorter. Regularly scheduled external audits shall be 
supplemented by additional audits of specific subjects when necessary to provide 
an adequate assessment of compliance or effectiveness (performance based). 
1. The audit period (triennial or annual) shall begin when the audit is 
performed. 
2. The initial audit shall be performed when the supplier has completed 
sufficient work to demonstrate that its organization is implementing a QA 

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program that has the required scope for purchases placed during the audit 
period (triennial or annual). 

3. An audit of the modified requirements shall be performed when a major 
change in the contract scope, work methodology, or organization occurs. 
This audit shall start a new audit period (triennial or annual). 
D. Performance-based external audits shall be performed on selected work to 
determine QA program effectiveness. 
E. External audits may not be required for procured items that are relatively simple 
and standard in design, manufacturing, and testing, and adaptable to standard or 
automated inspections or tests of the end item to verify quality characteristics 
after delivery. Rationale for not performing audits for these items shall be 
documented. 
F. Pre-award surveys, if applicable, may serve as the first triennial audit, provided: 
1. The supplier is implementing the same QA program for other contracts that 
is proposed for the purchasers contract. 
2. The pre-award survey satisfies the same audit elements and criteria as those 
used in the performance of a triennial audit. 
G. OCRWM purchasers include the OCRWM and OCRWM contractors. If more 
than one OCRWM purchaser buys from a single supplier, the OCRWM 
purchaser may either perform or arrange for an audit of the supplier on behalf of 
itself and other OCRWM purchasers to reduce the number of external audits of 
the supplier. 
1. The scope of this audit shall satisfy the needs of all OCRWM purchasers 
having a need to use the supplier. 
2. The audit report shall be distributed to all OCRWM purchasers for whom 
the audit was conducted. 
3. Each OCRWM purchaser relying on the results of the audit shall be 
responsible for the adequacy of the audit. 
18.2.4 Audit Schedule 
The audit schedule(s) shall be developed annually and revised periodically to ensure 
that coverage is maintained current. 


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18.2.5 Audit Planning 
A. The auditing organization shall develop and document an audit plan for each 
scheduled audit. This plan shall identify the audit scope, requirements for 
performing the audit, audit personnel, work to be audited, organizations to be 
notified, applicable documents, audit schedule, and implementing documents or 
checklists to be used. Audits shall include technical evaluations of the 
applicable procedures, instructions, activities, and items. 
B. The scope of each internal audit shall be based on evaluation of implementing 
documents, activities, and items to be audited; results of previous audits; nature 
and frequency of previously identified deficiencies; and impact of significant 
changes in personnel, organization, or the QA program. 
18.2.6 Audit Team Independence 
The auditing organization shall select and assign auditors who are independent of 
any direct responsibility for performance of the activity being audited. Audit 
personnel shall have sufficient authority and organizational freedom to make the 
audit process meaningful and effective. 

18.2.7 Audit Team Selection 
A. An audit team shall be identified before beginning each audit. The audit team 
shall include representatives from the QA organization, and when appropriate, 
applicable technical specialists. 
B. A lead auditor shall be appointed to supervise the team, organize and direct the 
audit, and coordinate the preparation and issuance of the audit report. 
C. Lead auditors and auditors shall be qualified in accordance with the requirements 
of this section. 
D. Technical specialists may be used by the auditing organization to assist in 
assessing the adequacy of technical processes. Technical specialists, when used, 
shall be indoctrinated and trained in accordance with Subsection 18.2.13. 
. E. In the case of internal audits, personnel having direct responsibility for 
performing the work being audited shall not be involved in the selection of the 
audit team. 

F. The lead auditor shall, before starting the audit, ensure that the assigned 
personnel collectively have experience or training commensurate with the scope, 
complexity, or special nature of the work to be audited. 

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18.2.8 Performing Audits 
A. The audit team leader shall ensure that the audit team is prepared before starting 
the audit. 
B. Audits shall be performed in accordance with written procedures or checklists. 
C. Elements that have been selected for audit shall be evaluated against specified 
requirements. 
D. Objective evidence shall be examined to the depth necessary to determine if 
these elements are being implemented effectively. 
E. Audit results shall be documented by auditing personnel and reported to and 
reviewed by management having responsibility for the area audited. Conditions 
requiring prompt corrective action shall be reported immediately to management 
of the audited organization. 
F. Identified conditions adverse to quality shall be documented and corrected in 
accordance with Section 16.0. 
18.2.9 Reporting Audit Results 
The audit report shall be prepared and signed by the audit team leader, and issued to 
management of the audited organization. The audit report shall include the 
following information: 

A. A description of the audit scope 
B. Identification of the auditors 
C. Identification of persons contacted during the audit 
D. Summary of the audit results including a statement on the effectiveness of the 
QA program elements that were audited 
E. A description of each reported condition adverse to quality in sufficient detail to 
enable corrective action to be taken by the audited organization according to the 
requirements of Section 16.0. 
18.2.10 Responding to Audits 
A. Management of the internal audited organization, including principal 
contractors, shall investigate conditions adverse to quality and determine and 
schedule corrective action in accordance with Section 16.0. 

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B. Management of the external audited organization (other than principal 
contractors) shall investigate conditions adverse to quality, determine and 
schedule corrective action in accordance with Section 16.0, and notify the 
auditing organization in writing of the actions taken or planned. 
18.2.11 Evaluating Audit Responses 
The adequacy of corrective actions for conditions adverse to quality shall be 
evaluated by the auditing organization. 

18.2.12 Follow-up Action 
Follow-up action shall be taken by the auditing organization to verify that corrective 
action is accomplished as scheduled. 

18.2.13 Audit Team Qualification and Certification 
Personnel performing audits, including auditors, technical specialists, and lead 
auditors shall be qualified and certified in accordance with Subsection 2.2.11. 


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SUPPLEMENT I SOFTWARE 

GENERAL 

A. This supplement establishes requirements for the acquisition, development, 
modification, control, and use of software. 
B. Requirements of this supplement shall be implemented through policies, 
procedures, plans, specifications, work practices, etc., that provide the 
framework for software engineering activities. Software engineering elements 
must define the baseline documents that are to be maintained as records. The 
scope of software engineering activities includes the following elements, as 
appropriate: 
1. Software acquisition method(s) for controlling the acquisition process for 
software and software services 
2. Software engineering method(s) used to manage the software life cycle 
activities 
3. Application of standards, conventions, and other work practices that support 
the software life cycle 
4. Controls for support software used to develop, operate, and maintain 
computer programs. 
C. Embedded software that is integral to the operations, maintenance, or calibration 
of M&TE that is verified or validated in conjunction with hardware as a unit and 
has not been developed or modified by the user organization is controlled by 
Section 12.0, and is exempt from the requirements of this supplement. 
D. The following types of commercial off-the-shelf (COTS) software are not 
required to be qualified using this supplement: word processors, spreadsheets, 
database managers, e-mail, and other types of automated office support systems. 
Applications developed using these types of COTS software shall meet the 
requirements of this supplement. 
E. COTS support software, such as software tools or system software, shall, at a 
minimum, be evaluated, reviewed, tested, accepted for use, and placed under 
configuration control as part of the supported software development. Changes to 
the software tool and system software shall be evaluated for impact on the 
software product to determine the level of reviews and retesting that will be 
required. 
F. The requirements of this supplement that are applicable to suppliers are also 
applicable to OCRWM contractors unless otherwise noted. 

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I.2 REQUIREMENTS 
I.2.1 General Software Requirements 
A. Software acquisition, development, modification, and maintenance shall proceed 
in a planned, traceable, and orderly manner utilizing a defined software life cycle 
methodology. 
1. A defined software life cycle methodology shall address the following 
phases: requirements, design, implementation, testing, installation and 
checkout, operations and maintenance, and retirement. The number of 
phases and relative emphasis placed on each phase of the software life cycle 
depend on the nature and complexity of the software. The number of life 
cycle phases may be combined for documentation purposes; however, the 
combining of phases does not eliminate the requirement for addressing each 
life cycle element of the life cycle phase. Software life cycle activities may 
be performed in an iterative or sequential manner. 
2. Acquired software or software previously developed not using this 
supplement shall be either: 
a. Acquired through a procurement activity in accordance with 
Subsection I.2.6, with appropriate quality controls, or 
b. Be controlled and qualified in accordance with Subsection I.2.7. 
In either case, software planning in accordance with Subsection I.2.2, and a 
defined software life cycle methodology, excluding a design document and 
code development, shall be applied. 

3. Software life cycles shall contain control points that, when reached, shall 
ensure specified software is documented, reviewed, and baselined. 
B. Software verification and validation activities shall be planned, documented, and 
performed for software, software changes, or system configurations that are 
determined to impact the software. The validation test plans, test cases, and test 
results shall be documented, reviewed, and approved prior to use of the software. 
1. Software verification shall be performed at the end of the requirements, 
design, implementation, and testing life cycle phases to ensure that the 
products of a given life cycle phase are traceable and fulfill the requirements 
of the previous phase and/or previous phases. 
2. Software verification shall evaluate the technical adequacy of the design 
approach and ensure internal completeness, consistency, clarity, and 

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correctness of the software and shall verify that software is traceable to the 
software design requirements. 

a. Tests and test results from reviews and verifications shall be included in 
the acceptance test documentation. 
b. Tests conducted as reviews or verifications do not substitute for 
performing comprehensive, end-of-development acceptance tests. 
3. Software verification shall include review of the test results. 
4. Software verification shall be completed prior to approval of the computer 
program for use. 
5. Verification reviews shall identify the reviewer(s) and each reviewers 
specific responsibilities during the review. 
6. Documentation of all review comments and their disposition shall be 
retained as part of the records package. 
7. Software verification and validation activities shall be performed by 
individuals not associated with the development of the software. In those 
instances where this level of independence may not be achieved, an 
individual associated with the development of the software may perform 
these activities with a higher level of management approval and documented 
justification. 
I.2.2 Software Planning 
A. A plan addressing software quality assurance shall be in existence for each new 
software project at the start of the software life cycle. 
B. The plan for software quality assurance shall identify: 
1. A description of the overall nature and purpose of the software 
2. The software products to which it applies 
3. The organizations responsible for performing the work and achieving 
software quality and their tasks and responsibilities 
4. Required documentation 
5. Standards, conventions, techniques, or methodologies that shall guide the 
software activity 

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6. Required software reviews 
7. Methods for error reporting and corrective action. 
I.2.3 Software Life Cycle Requirements 
A. Requirement Phase 
1. Software requirements that address functionality, performance, design 
constraints, attributes, and external interfaces shall be specified, 
documented, and reviewed. 
a. FunctionalityThe functions the software is to perform. 
b. PerformanceThe time-related issues of software operation such as 
speed, recovery time, response time, etc. 
c. Design constraints imposed on implementation phase activitiesAny 
elements that will restrict design options. 
d. AttributesNon-time-related issues of software operation such as 
portability, acceptance criteria, access control, maintainability, etc. 
e. External interfacesInteractions with people, hardware, and other 
software. 
2. A software requirement shall only be specified if its achievement can and 
will be verified and validated. 
3. Software requirements shall be traceable throughout the remaining stages of 
the software life cycle (i.e., design, installation and validation test cases, and 
user manual). Traceability shall be documented. 
4. Software requirements shall provide enough detail to either design the 
software or make an acquisition decision. 
B. Design Phase 
1. The software design shall be developed, documented, and reviewed based 
on the requirements depicted in the requirements document. 
2. The software design shall consider the computer software operating 
environment. 
3. Measures to mitigate the consequences of potential problems shall be an 
integral part of the design. These potential problems include external and 

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internal abnormal conditions and events that can affect the computer 
program. 

4. The design documentation shall specify: 
a. A description of the major components of the software design as they 
relate to the software requirements. 
b. A technical description of the software with respect to the theoretical 
basis, mathematical model, control flow, data flow, control logic, and 
data structure. 
c. A description of the allowable or defined ranges for inputs and outputs. 
d. The design, described in a manner that can be translated into code. 
e. The generation of design-based test cases. 
f. The generation of test plans/cases, based on the requirements and 
design, shall provide for acceptance criteria and verification of results. 
g. For those computer programs used in design activities, the test plans 
shall provide for ensuring that the software produces correct results. For 
those computer programs used for operational control, computer test 
plans shall provide for demonstrating required performance over the 
range of operation of the controlled function or process. 
C. Implementation Phase 
1. The design shall be translated into source code and resulting executables 
necessary to perform the functions required. 
2. The source code and resulting executables shall adhere to specified coding 
standards, conventions, and design specifications. 
3. User information shall be developed, documented, and reviewed in 
accordance with the design to delineate how to use the software, including 
the following, as applicable: 
a. Instructions that contain an introduction (e.g., purpose, scope, etc.), 
description of the users interaction with the software, and a description 
of any required training necessary to use the software 
b. Input and output specifications 
c. Data files, input and output data, defaults, and file formats 

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d. A description of the allowable and tolerable ranges for inputs and 
outputs 
e. Anticipated errors and how the user can respond 
f. The hardware and software environments 
g. Available sample problems 
h. Installation procedures. 
D. Testing Phase 
1. Configuration items shall be under configuration change control prior to 
acceptance testing. 
2. Software validation activities shall be planned, performed, documented, and 
verified at the end of the implementation phase to ensure that the software 
installs properly and satisfies the requirements for its intended use. 
3. Testing, to an approved plan or process and on a different computer with an 
identical operating environment as that on which it was developed, shall be 
the primary method of software validation to ensure adherence to the 
requirements and to ensure the software produces correct results for the test 
cases. 
4. Testing shall demonstrate, as appropriate, that the computer program: 
a. Properly handles abnormal conditions and events as well as failures. 
b. Does not perform adverse unintended functions. Observations of 
unexpected or unintended results shall be documented and dispositioned 
prior to test result approval. 
c. Does not unexpectedly degrade the system either by itself or in 
combination with other functions or configuration items. 
5. To evaluate technical adequacy, the software test case results may be 
compared to results from alternative methods, such as: 
a. Analysis without computer assistance (hand calculations) 
b. Other validated computer programs 
c. Experiments and tests 
d. Standard problems with known solutions 
e. Comparisons to confirmed published data correlations. 

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6. Software validation documentation shall describe the task and criteria for 
accomplishing the validation of the software at the end of the development 
cycle. The documentation shall: 
. 

a. Specify the hardware and software configurations. 
b. Be organized in a manner that allows traceability to both software 
requirements and design. 
c. Contain the results of the execution of the validation activity. 
d. Include the results of reviews and tests along with a summary of the 
status of the software (e.g., indication of incomplete design performance 
and application requirements). 
7. Failure to successfully execute the test cases shall be documented and 
reviewed to determine if modifications to the requirements, design, 
implementation, or test plans and cases are required. 
8. Software validation of modifications to released software shall be subjected 
to selective testing (e.g., regression) to detect unintended adverse effects 
introduced during the modification of the software, to verify that the 
modifications have not caused unintended adverse affects, and to verify that 
a modified software still meets specified requirements. 
E. Operations and Maintenance Phase 
1. Upon acceptable validation of the software, in accordance with 
Paragraph I.2.3.D, Testing Phase, the software shall be baselined and placed 
under Configuration Management controls in accordance with Subsection 
I.2.4. 
2. After the software is approved for use and installed in the operating 
environment, the use of the software shall be controlled, in accordance with 
Subsection I.2.8, within approved procedures and instructions. 
3. Further operations and maintenance activities shall consist of maintenance 
of the software: 
a. To remove latent errors (corrective maintenance) 
b. To respond to new or revised requirements (perfective maintenance) 
c. To adapt the software to changes in the operating environment (adaptive 
maintenance). 

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4. Software modifications shall be approved, documented, verified and 
validated, and controlled. 
5. In-use tests shall be developed, performed, documented, and verified to 
provide confirmation of acceptable performance of software that is 
performing continuous data acquisition or process control functions. 
Periodic manual or automatic self-check in-use tests shall be defined and 
performed for that software where computer program errors, data errors, 
computer hardware failures, or instrument drift can affect the required 
performance. 
F. Installation and Checkout Phase 
1. Software installation and checkout activities shall be performed and 
documented when the software is installed on a computer or when there are 
changes in the operating system to ensure that the software installs properly 
and satisfies the requirements for its intended use. 
2. The software validation activities for the installation and checkout shall 
consist of: 
a. The execution of tests for installation 
b. The documentation that the software was successfully installed and 
ready for operational use. 
G. Retirement Phase 
During the retirement phase, the support for a software product is terminated and 
continued routine use of the software shall be prevented. 

I.2.4 Software Configuration Management 
A. A software configuration management (SCM) system shall be established to 
include configuration identification, configuration change control, and status 
accounting. Software shall be placed under configuration management control 
as each baseline element is approved. 
B. Software shall not be used in activities identified under Subsection 2.2.2 unless it 
has been qualified and baselined. Software used in activities affecting quality is 
limited to copies obtained from SCM. 
C. Support software (i.e., systems software and software tools) is not qualified nor 
is it baselined. However, such software shall be placed under configuration 
management control (including change control) by SCM (see Subsection I.1.D). 

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D. Configuration items to be controlled shall include the following, at a minimum 
and as appropriate: 
1. Documentation (i.e., plans, requirements, designs, user manuals, test 
reports, user information, etc.) 
2. Computer program(s) (i.e., source, object, backup files, media, etc.) 
3. Support software. 
E. Configuration identification shall include: 
1. A definition of the baseline elements of each software baseline. 
2. A unique identification of each software item, including version or revision, 
to be placed under SCM. 
3. Assignment of unique identifiers that relate baseline documents to their 
associated software items. Cross-references between baseline documents 
and associated software shall be maintained. 
F. Configuration change control shall include: 
1. A release and control process for baseline elements. 
2. Changes to baseline elements. These changes shall be formally controlled 
and documented. This documentation shall contain a description of the 
change, the rationale for the change, and the identification of affected 
baseline elements. 
3. A formal evaluation of the baseline element or change to the baseline 
element and approval by the organization responsible for approving the 
baseline element. 
4. The transmission of information concerning approved changes to all 
organizations affected by the changes. 
5. Software verifications performed for the changes, as necessary, to ensure 
the changes are appropriately reflected in software documentation and to 
ensure that document traceability is maintained. 
6. Software validation performed as necessary for the change. 

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 G. Configuration status accounting shall include: 
1. A listing of the approved baseline elements and unique identifiers 
2. The status of proposed, in-process, or approved changes to the baseline 
elements 
3. A history of changes to the software items, including descriptions of the 
changes made between versions of software items. 
I.2.5 Problem Reporting and Resolution 
A. A software problem reporting and resolution system shall be implemented for 
software errors and failures to ensure problems are promptly reported to 
impacted organizations and to ensure formal processing of problem resolutions. 
B. The problem reporting and resolution system shall be integrated with the SCM 
system. 
C. Software problem reporting and resolution systems shall provide methods to 
ensure that: 
1. Problems are identified, evaluated, documented, and, if required, corrected. 
2. Description of the evaluation process for determining if the problem is an 
error or other type of problem (e.g., user mistake) and define the 
responsibilities for disposition of the problem reports, including notification 
to the originator of the results of the evaluation is provided. 
3. Problems are assessed for impact, which includes: 
a. How the error relates to appropriate software engineering elements 
b. Impact on past and present use of the software by an organization 
c. How the corrective action impacts previous development activities. 
4. Corrections and changes shall be controlled in accordance with applicable 
configuration change control requirements. 
5. Notification of the error, its impacts, and how to avoid the error, pending 
implementation of corrective actions, is provided to the user organizations. 
D. If a problem that constitutes a condition adverse to quality is identified in 
software, the condition adverse to quality shall be documented and controlled in 
accordance with Section 16.0. 

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I.2.6 Software Procurement 
A. Individuals or organizations developing and supplying software under contract 
shall be required to have policies and procedures that meet the applicable 
requirements of this supplement. Software shall be procured as specified in 
Sections 4.0 and 7.0. 
1. Documentation as required by this supplement shall be delivered or made 
available by the supplier to the purchaser. 
2. Upon receipt of the software, the purchaser shall assume responsibility of 
the applicable requirements as specified in this supplement. 
3. Software errors and failures shall be reported between the supplier and 
purchaser in accordance with Subsection I.2.5. 
B. For procured software services, the organization providing the services shall 
have plan(s) for software quality assurance, in accordance with 
Paragraph I.2.2.A, that meets the requirements of Subsection I.2.7. The user 
organization shall determine the adequacy of this plan. 
I.2.7 Otherwise Acquired Software 
Software that has not been previously approved under a program consistent with this 
supplement for use in its intended application (e.g., freeware, shareware, procured 
COTS, or otherwise acquired software), other than software described in 
Paragraphs I.1C and I.1D, shall be qualified in accordance with the requirements of 
this supplement. The software shall be identified and controlled in accordance with 
Subsection I.2.4 prior to qualification. 

I.2.8 Control of the Use of Software 
A. User organizations control and document the use of released software items such 
that comparable results can be obtained, with any differences explained, through 
independent replication of the process. 
B. Use of software shall be independently reviewed and approved to ensure that the 
software selected is suitable to the problem being solved. 
C. If the intended use of the software item will require the use of inputs outside the 
ranges verified during validation testing, the appropriate baseline elements shall 
be reverified and revalidated for the expected range of inputs prior to continuing 
use. 

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D. Documentation for the receipt of software obtained from SCM in accordance 
with Subsection I.2.4 shall be provided and maintained for software in operation 
or use. 
E. Controls shall be established to permit authorized access and prevent 
unauthorized access to computer systems. 

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SUPPLEMENT II SAMPLE CONTROL 

II.1 GENERAL 
This supplement establishes requirements for the control of physical samples. 

II.2 REQUIREMENTS 
II.2.1 General Requirements 
A. Samples shall be controlled and identified in a manner consistent with their 
intended use. 
B. Controls shall identify responsibilities, including interfaces between 
organizations, for documenting and tracking sample possession from sample 
collection and identification through handling, preservation, shipment, transfer, 
analysis, storage, and final use. 
C. Controls shall include specifics on orientation relative to the location that was 
sampled, as appropriate. 
II.2.2 Traceability 
A. Sample identification methods shall ensure that traceability is established and 
maintained from the samples to applicable implementing documents or other 
specifying documents. 
B. Sample traceability shall ensure that the sample can be traced at all times from 
its collection through final use and any post-test retention that may be 
appropriate. 
II.2.3 Identification 
A. Identification shall be maintained on the samples or in a manner that ensures that 
identification is established and maintained. 
B. Samples shall be identified from their initial collection through final use. 
C. Sample identification shall be documented and checked before the sample is 
released for use or analysis. 
D. Sample identification methods shall include use of physical markings. 
E. If physical markings are either impractical or insufficient, other appropriate 
means shall be employed (i.e., physical separation, labels or tags attached to 
containers, or other procedural control). 

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F. Physical markings, when used, shall: 
1. Be applied using materials and methods that provide a clear and legible 
identification. 
2. Not detrimentally affect the sample content or form. 
3. Be transferred to each identified sample part when the sample is subdivided. 
4. Not be obliterated or hidden by surface treatments or sample preparations 
unless other means of identification are substituted. 
II.2.4 Conditional Requirements 
The controls for samples shall address the following requirements, as applicable: 

A. If documents contain specific identification or traceability requirements (i.e., 
identification or traceability of the sample to applicable study plan, site 
characterization activity, or other records), those specified controls shall be 
implemented. 
B. If samples have limited use or storage life, then methods shall be established that 
preclude using the sample beyond its intended use or storage life. 
C. If sample storage is required, then methods shall be established for the control of 
sample identification that is commensurate with the planned duration and 
conditions of storage. These methods shall provide for, as applicable: 
1. Maintenance or replacement of markings and identification tags damaged 
during handling or aging 
2. Protection of identification markings subject to excessive deterioration 
resulting from environmental exposure 
3. Updating related documentation. 
II.2.5 Archiving Samples 
Implementing documents shall specify the representative samples to be archived if 
the need to archive samples is identified. 

II.2.6 Handling, Storage, and Shipping 
A. Handling, storage, cleaning, packaging, shipping, and preservation of samples 
shall be conducted in accordance with established implementing documents or 
other specified documents. 

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B. If required for critical, sensitive, perishable, or high-value samples, specific 
measures for handling, storage, cleaning, packaging, shipping, and preservation 
shall be identified and used. 
C. Measures shall be established for the marking and labeling for packaging, 
shipping, handling, and storage of samples, as necessary, to adequately identify, 
maintain, and preserve the sample. 
D. Markings and labels shall indicate the presence of special environments or the 
need for special controls, if necessary. 
E. If required for particular samples, special equipment (i.e., containers) and special 
protective environments (i.e., inert gas and moisture and temperature limits) 
shall be specified and provided. 
F. Special handling tools and equipment shall be used and controlled as necessary 
to ensure safe and adequate handling. 
1. Special handling tools and equipment shall be inspected and tested in 
accordance with implementing documents and at specified time intervals to 
verify that the tools and equipment are adequately maintained. 
2. Operators of special handling and lifting equipment shall be experienced or 
trained to use the equipment. 
II.2.7 Disposition of Nonconforming Samples 
A. Samples that do not meet requirements specified in work-controlling documents 
shall be documented, evaluated, identified, and segregated in accordance with 
Section 15.0. 
B. The disposition for nonconforming samples shall be identified and documented 
and shall be limited to use-as-is, limited use, or reject. 

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SUPPLEMENT III SCIENTIFIC INVESTIGATION 

III.1 GENERAL 
A. This supplement establishes requirements for scientific investigations, including 
data identification, data reduction, and model development and use. 
B. Other applicable sections and supplements of the QARD also apply to scientific 
investigations. 
III.2 REQUIREMENTS 
III.2.1 Planning Scientific Investigations 
A. Scientific investigations shall be planned in accordance with Section 2.0. 
B. Planning shall be coordinated with organizations providing input to or using the 
results of the investigation. 
C. Planning shall address provisions for determining the accuracy, precision, and 
representativeness of results. 
III.2.2 Performing Scientific Investigations 
A. All documentation resulting from scientific investigation shall be transparent, 
identify principal lines of investigation considered, and be legible and in a form 
suitable for reproduction, filing, and retrieval. 
B. Scientific investigations shall be performed using scientific notebooks, 
implementing documents, or a combination of both. 
C. Scientific notebooks shall contain the following: 
1. Statement of objective and description of work to be performed, or 
reference to an approved planning document or implementing document 
that addresses those topics 
2. Identification of method(s) and computer software used 
3. Identification of any samples or M&TE used 
4. Description of the work as it was performed and results obtained, names of 
individuals performing the work, and dated initials or signature, as 
appropriate, of individuals making the entries 
5. Description of changes made to methods used, as appropriate. 

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D. Scientific notebooks shall be reviewed by an independent qualified individual to 
verify there is sufficient detail to: 
1. Retrace the investigations and confirm the results, or 
2. Repeat the investigation and achieve comparable results, without recourse to 
the original investigator. 
III.2.3 Data Identification 
A. Data shall be identified in a manner that facilitates traceability to associated 
documentation. 
B. Data shall be identified in a manner that facilitates traceability to its qualification 
status. 
C. Identification and traceability shall be maintained throughout the lifetime of the 
data. 
III.2.4 Data Review, Adequacy, and Usage 
A. Data reduction shall be described to permit independent reproducibility by 
another qualified individual. 
B. Data from scientific investigation activities that are used as direct input to site 
characterization, and scientific analysis or performance modeling that address 
safety and waste isolation issues shall be qualified from origin, except as allowed 
in Paragraph III.2.4B.2. External source data that are not identified as 
established fact and are used as direct input to scientific analysis or performance 
modeling must be qualified for its intended use. 
1. Data shall be reviewed by individuals other than those who collected or 
reduced the data to ensure technical correctness. 
2. Unqualified data may be used in scientific investigation provided 
traceability to its status as unqualified data is maintained. Unqualified data 
that are used as direct input to scientific analysis or performance modeling 
that address safety and waste isolation issues shall be qualified in 
accordance with Paragraph III.2.4C at appropriate times during the 
scientific investigations and before: 
a. Relying on the data to support the License Application (e.g., prior to 
submittal of the application to the NRC), 
b. Relying on the item for which the data were used as design input to 
perform its function, or 

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c. Relying on the data to resolve safety or waste isolation issues. 
C. Unqualified data developed from scientific investigation activities that are used 
as direct input to site characterization, scientific analysis or performance 
modeling that address safety and waste isolation issues shall be qualified. 
External source data that are not identified as established fact and are used as 
direct input to scientific analyses or performance modeling shall be qualified. 
One or a combination of the following methods shall be used in performing 
qualification activities: 
1. Determination that the controls under which the data were generated are 
similar in scope and implementation to the QARD 
2. Evaluation of corroborating data  Rationale for selecting one set of data to 
corroborate another set of data shall be clearly explained and justified 
3. Confirmatory testing 
4. Peer review in accordance with Section 2.0 
5. Technical assessment to independently evaluate data, which includes one or 
a combination of the following: 
a. Determination that the employed methodology is acceptable 
b. Determination that confidence in the data acquisition or developmental 
results is warranted 
c. Confirmation that the data have been used in similar applications. 
D. The methods in Paragraphs III.2.4C.1, III.2.4C.2, and III.2.4C.3 shall include a 
review to determine the technical correctness of the data in accordance with 
established review criteria. 
E. The qualification process shall be planned and documented. Documentation 
shall include: 
1. The factors used in arriving at the choice of the qualification method(s) 
2. The acceptance criteria used to determine if the data are qualified 
3. The rationale for discontinuing any qualification methods abandoned after 
the initiation of the qualification process 
4. The decision as to the qualification of the data. 

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F. When acquired non-Q data is subsequently identified as necessary to support an 
activity in which the QARD applies, that data may be used in the Q application 
provided: 
1. Prior review and approval by the responsible OCRWM line organization 
director and the Director, Office of Quality Assurance, is obtained. 
2. Planning for data use is performed in accordance with Subsection III.2.1. 
3. The data to be used is identified, controlled, and qualified as described in 
Subsections III.2.3 and III.2.4. 
III.2.5 Technical Report Review 
Technical reports shall be reviewed in accordance with the requirements of 
Subsection 6.2.3. 

III.2.6 Model Development and Use 
A. Model development and approaches to validation shall be planned, controlled, 
and documented. Planning for model validation shall identify the validation 
methods and the validation criteria used. If model validation activities will be 
completed after documentation of the model (e.g., using new confirmation test 
data gathered in the field or laboratory), these activities shall be described in the 
work-planning document. 
B. Documentation of models shall be in accordance with Section 17.0, be 
transparent, and include: 
1. Definition of the objective (intended use) of the model. 
2. Description of conceptual model and scientific basis, as well as alternatives 
for the selected conceptual model. Rationale for not selecting alternatives 
shall also be included. 
3. Results of literature searches and other applicable background information. 
4. Identification of inputs and their sources. 
5. Identification of, and rationale for, assumptions that are made to develop or 
apply the model, including model idealizations, as well as those 
assumptions that support the input to the model and impact model results. 
6. Discussion of mathematical and numerical methods that are used in the 
model, including governing equations, formulas, and algorithms, and their 
scientific and mathematical bases. 

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7. Identification of any associated software used, computer calculations 
performed, and basis to permit traceability of inputs and outputs. 
8. Discussion of initial and/or boundary conditions. 
9. Discussion of model limitations (e.g., data available for model development, 
valid ranges of model application, spatial and temporal scaling). 
10. Discussion of model uncertainties (i.e., conceptual model, mathematical 
model, process model, abstraction model, system model, parameters) and 
how they affect the model. 
11. Identification of the originator, reviewer, and approver. 
C. Computer software used to develop or execute the model shall be qualified in 
accordance with the requirements of Supplement I. 
1. Unqualified software may be used to produce preliminary output that may 
be used in preliminary technical products, subject to the following controls: 
a. Unqualified software used to produce preliminary output shall be 
identified to SCM for the purpose of tracking the preliminary 
application of in-process software that is anticipated to be controlled per 
SCM procedures once it is qualified. 
b. Use of all outputs from unqualified software shall be documented and 
tracked in accordance with the procedure for management of technical 
product inputs. 
c. Outputs from unqualified software shall be appropriately identified as 
To Be Verified (TBV) or TBV-Temp in accordance with the procedure 
for management of technical product inputs. 
d. When unqualified software has been qualified and baselined, all 
preliminary data runs shall be rerun using the qualified software for 
comparison with the preliminary outputs. 
i. If outputs are identical, then update the preliminary output with the 
final output in accordance with the governing technical product 
procedure. 
ii. If outputs are not identical, then supersede the preliminary output 
with the output from the qualified software in accordance with the 
governing technical product procedure. 

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iii. The results of the comparisons and subsequent actions shall be 
documented within the technical product. 
e. Responsible managers, leads, checkers, and quality engineering 
representatives for technical products shall ensure that all software used 
within the technical product has been qualified and baselined prior to 
final approval of the technical product in accordance with the governing 
technical product procedure. 
2. Use of unqualified software under these provisions is strictly limited to use 
within preliminary technical products in direct support of OCRWM 
activities related to obtaining a license to construct a repository, including 
rework in support of the License Application. No other use of these 
provisions shall be permitted for any other purpose. 
D. The intended use of the model and the importance of the model for assessing 
repository system performance shall determine the appropriate level of 
confidence for a model (i.e., models of system components most relied upon 
shall be validated with the highest levels of confidence to the extent practical). 
E. Model validation criteria shall address the following: 
1. Criteria used to establish the adequacy of the scientific basis for the model 
shall be consistent with the model application and justified in the model 
documentation. 
2. Criteria used to demonstrate that the model is sufficiently accurate for its 
intended use. Model documentation shall provide an accounting for 
uncertainties and variabilities in parameter values and provide the technical 
basis for parameter ranges, probability distributions, or bounding values 
used in process, abstraction, and system models used in (or supporting) the 
post-closure performance assessment. 
3. The importance of the model for assessing repository system performance 
shall be defined. 
4. The relative level of confidence for the model shall be described. 
5. The supporting information needed to substantiate validation shall be 
defined. 
F. The usual progression of a model is from conceptual model to mathematical 
model to process model to abstraction model to system model. A conceptual 
model shall be validated when its implementation as a mathematical, process, 
abstraction, or system-level model is validated. Technical review through 
publication in a refereed professional journal or review by an external agency 

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may be used to corroborate model validation when used in conjunction with one 
or more of the following: 

1. Corroboration of model results with data acquired from field experiments, 
analogue studies, laboratory experiments, or subsequent relevant 
observations (e.g., refereed journals or literature). Data used to develop and 
calibrate a model shall not be used to validate a model. 
2. Peer review (Subsection 2.2.8) or independent technical review (Subsection 
6.2.3). 
3. Performance confirmation studies using validation test model predictions 
prior to comparison with field or laboratory data. 
4. Comparison of model results with other model results obtained from the 
implementation of an alternative model. 

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SUPPLEMENT IV FIELD SURVEYING 

IV.1 GENERAL 
A. This supplement establishes requirements for field surveying. Examples of work 
that have the potential to require field surveying services for location 
determination include site characterization, explorations, and installations. 
B. Other applicable sections of the QARD also apply to field surveying activities. 
IV.2 REQUIREMENTS 
IV.2.1 Field Survey System 
A. A permanent system of horizontal and vertical controls shall be established and 
maintained. 
B. This system shall be used in accordance with implementing documents to obtain 
the accurate location and relocation of designated features, including locations of 
sample or data collection. 
IV.2.2 Field Survey Documentation 
Pertinent survey documents shall be identified, maintained, and verified for 
completeness as the work progresses. 


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SUPPLEMENT V CONTROL OF THE ELECTRONIC MANAGEMENT OF 
INFORMATION 

V.1 GENERAL 
This supplement applies to the processes and controls for the management of 
information that either exists or is used in an electronic format. This includes 
electronically formatted information used in design input, developed as design 
output, or developed as an output of scientific investigation or performance 
assessment modeling and analysis. 

Development, acquisition, and modification of software, including database 
applications or software that performs functions of analysis or calculation, shall be 
controlled in accordance with Supplement I. The acquisition, development, and use 
of information shall be controlled by the requirements of Section 3.0 or 
Supplement III. 

V.2 REQUIREMENTS 
V.2.1 Control of the Electronic Management of Information 
Controls shall be established to ensure that: 

A. Information is suitably protected from damage and destruction during its 
prescribed lifetime and is readily retrievable. 
B. A description is prepared of how information will be stored with respect to 
media, conditions, location, retention time, security, and access. 
C. Storage and transfer media are properly identified as to source, physical and 
logical format, and relevant date (i.e., date written). 
D. The completeness and accuracy of the information input and any subsequent 
changes to the information are maintained. 
E. The security and integrity of the information is maintained. 
F. Transfers of information are error free or (where applicable) within a defined 
permissible error rate, to ensure that no information is lost in transfer and the 
input is recoverable from the output. Examples of information transfers include 
copying raw information from a notebook to a computerized form, copying from 
computer tape to disk, writing to a compact disk, etc. 

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APPENDIX A WASTE CUSTODIAN INTERFACE 

A.1 GENERAL 
The term waste custodian refers to an organizational entity that is in possession of 
high-level radioactive waste (HLW) or spent nuclear fuel (SNF) planned for 
disposition at the geologic repository. This includes commercial nuclear utilities, 

U.S. Department of Energy (DOE) Office of Environmental Management (EM) 
sites, and the Naval Nuclear Propulsion Program (NNPP). 
A.1.1 Commercial Nuclear Utilities 
A. Because the characteristics of commercial SNF are well known and readily 
available, the OCRWM does not rely on specific information submittals from 
commercial nuclear utilities to perform activities subject to the QARD. In 
addition, commercial nuclear utilities are already required to work to U.S. 
Nuclear Regulatory Commission (NRC) approved 10 CFR 50, Appendix B, 
Quality Assurance (QA) programs. 
B. In the future, the OCRWM intends to rely on information provided by 
commercial nuclear utilities to support waste acceptance activities. The 
OCRWM anticipates that commercial nuclear utilities will be able to support 
waste acceptance activities with information gathered under their NRC-approved 
10 CFR 50, Appendix B, QA programs. If necessary, the interface between 
commercial nuclear utilities and the OCRWM will be addressed in greater detail 
when the QARD is revised to address waste acceptance activities (i.e., prior to 
issuance of license to receive and possess HLW and SNF). 
A.1.2. Federal Waste Custodians 
A. The OCRWM interfaces directly with federal waste custodians and their 
principal contractors to obtain information and/or data to support activities 
subject to the QARD (e.g., scientific document development, design, etc.). The 
OCRWM has developed the requirements described in this appendix to ensure 
that appropriate QA controls are implemented by federal waste custodians and 
their principal contractors. 
B. Federal waste custodians and their principal contractors perform activities to 
ensure and document that their HLW and SNF will meet OCRWM waste 
acceptance criteria. In some cases federal waste custodians and/or their principal 
contractors also design and fabricate items that will be considered important to 
safety or waste isolation. Although these activities do not affect DOEs ability 
to comply with 10 CFR 63 at this time, they will in the future (i.e., during and 
after waste acceptance). Federal waste custodians and/or their principal 
contractors work to QA programs that meet the applicable requirements of either 
an NRC-approved 10 CFR 50, Appendix B, QA program, or a 10 CFR 63.142 
QA program. The applicable requirements of these QA programs are flowed 

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down to their principal contractors by the federal waste custodians. The controls 
identified in this appendix also apply to work performed to support future HLW 
and SNF acceptance. 

C. Interfaces between the OCRWM and federal waste custodians are defined in 
formal agreement documents (i.e., Memoranda of Agreement or Understanding). 
Agreement documents also identify requirements that the federal waste 
custodians will need to meet for OCRWM to use their work products (e.g., 
License Application input and designed or fabricated items that will be 
considered important to safety or waste isolation) and accept their HLW or SNF 
for disposal. The OCRWM will verify the implementation of these requirements 
through audits, surveillance, reviews, or observations prior to accepting their 
work products or accepting HLW or SNF. 
D. Federal waste custodians normally contract some or all of the work addressed in 
this appendix to their principal contractors. Agreement documents will be 
executed between the OCRWM and senior management of the office that 
encompasses the federal waste custodians. Federal waste custodians are 
responsible for passing the appropriate provisions of the agreement document 
down to their principal contractors. 
E. Agreement documents are not procurement documents; however, for the purpose 
of providing the appropriate level of control over OCRWM and federal waste 
custodian interface, the applicable requirements of 10 CFR 63.142 will be 
applied to the development, control, and revision of agreement documents. 
A2. SPECIFIC DISCUSSION OF OCRWM INTERFACE WITH FEDERAL 
WASTE CUSTODIANS 

A.2.1 Interface with the Office of Environmental Management 
A. The OCRWMs agreement with EM identifies the technical and quality 
requirements that apply to work associated with HLW and SNF and identifies 
the requirements of 10 CFR 63.142 that are applicable to EM federal waste 
custodians principal contractors. 
B. The agreement also describes the oversight of EM federal waste custodians and 
their principal contractors performing work covered in the agreement. EM and 
the OCRWM jointly perform audits of EM federal waste custodians and their 
principal contractors. Audit teams include at least one OCRWM OQA team 
member. Audits are performed in accordance with approved OCRWM 
implementing documents. 
C. The EM National Spent Nuclear Fuel Program provides the OCRWM with 
information related to DOE SNF, so it is treated as a waste custodian even 
though it does not actually possess SNF or HLW. 

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A.2.2 Interface with the Naval Nuclear Propulsion Program 
A. The NNPP is a joint U.S. Department of the Navy/DOE organization and, as 
promulgated under Executive Order 12344 (42 U.S.C. Section 7158 and 
50 U.S.C. Section 2406), is responsible for all matters pertaining to naval 
nuclear propulsion. Within DOE, the NNPP is known as the Office of Naval 
Reactors and is considered a federal waste custodian. The NNPPs QA program 
has been a key contributor to the success of the NNPP throughout its over 50year history. The QA program validates that the fundamental quality necessary 
for a successful naval nuclear program is built into all components and 
processes. 
B. The NNPP QA program applies to all aspects of design, operation, construction, 
and maintenance of naval nuclear propulsion plants, including work to support 
emplacement of naval SNF in the geologic repository. NNPP QA requirements 
embody the 18 quality criteria of 10 CFR 63.142. An agreement document 
defines the interface between the NNPP and OCRWM for the purpose of 
OCRWM acceptance of naval SNF for disposal. This agreement specifies that 
the NNPP QA program shall be defined and administered solely by the NNPP in 
accordance with its statutory obligations and that the NNPP is responsible for 
conducting all oversight of NNPP activities related to acceptance of naval SNF. 
Under the agreement, OCRWM is responsible for reviewing NNPP QA practices 
regarding naval SNF and for determination of the sufficiency of these practices 
for disposal at the repository. The agreement provides for OCRWM 
observations of NNPP QA practices and periodic discussion and updates 
regarding these practices so that the OCRWM can fulfill its responsibilities 
under the agreement. 
C. Interactions between the OCRWM and NNPP regarding the NNPP QA program 
started in the mid-1990s and led to a comprehensive OQA review and 
acceptance of the NNPP QA program as it applies to disposal of naval SNF in 
the geologic repository. 
D. The OCRWM monitors the NNPP QA program to ensure it remains acceptable 
to the OCRWM. Monitoring activities include periodic observations of NNPP 
QA program oversight of various NNPP QA program elements and contractor 
QA program activities, as well as annual reviews of NNPP QA audits, 
surveillance, inspection reports, implementing document revisions, compliance 
matrices, and organizational changes. 

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APPENDIX B 

*****INTENTIONALLY BLANK***** 


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APPENDIX C STORAGE AND TRANSPORTATION 

C.1 GENERAL 
This appendix contains amplifications of requirements unique to the work conducted 
for the storage of spent nuclear fuel and the transportation of spent nuclear fuel and 
high-level radioactive waste. The NRC approved Quality Assurance Programs 
implemented under 10 CFR 50, 71, and 72 include provisions that are generally 
equivalent to 10 CFR 63.142. Those programs provide controls comparable to those in 
the Quality Assurance Requirements and Description (QARD). 

The QARD does not apply to non-OCRWM NRC licensees/certificate holders that 
design, fabricate acquire or use storage casks, transportation casks, canisters, or 
ancillary equipment in accordance with an NRC approved QA program that meets the 
provisions of 10 CFR 50, Appendix B; 10 CFR 71, Subpart H; or 10 CFR 72, Subpart 

G. 
C.2 REQUIREMENTS 
The activities executed and products produced under the above mentioned NRC 
approved QA programs have quality assurance provisions applied to them that are 
equivalent to the provisions of the QARD. Those activities and products used to satisfy 
the applicable licenses or certifications are acceptable for OCRWM to use as a basis for 
demonstrating compliance with 10 CFR 63. For example: 

1. Transportation/Storage System vendor design and safety analysis calculations 
performed under a 10 CFR 71 or 72 approved QA Program are acceptable for use, 
by OCRWM, in demonstrating compliance with 10 CFR 63. 
2. Where vendor work is procured by OCRWM, and such work is used to demonstrate 
compliance with 10 CFR 63, OCRWM oversight of such vendor work will be 
performed in accordance with the QARD. 
3. Development of cask/canister loading operation requirements to meet 10 CFR 63 
safety analysis design bases for disposal at the Monitored Geological Repository, 
and the imposition of those requirements by OCRWM on vendors/utilities will be in 
accordance with the provisions of the QARD. 
4. Handling, loading, verification, and maintenance of casks/canisters to be 
accomplished by utilities, vendors, or others will be subject to the provisions of their 
NRC approved 10 CFR 50 Appendix B, 10 CFR 71 Subpart H, or 10 CFR 72 
Subpart G quality assurance programs, or the QARD if the former programs are not 
available. 
The requirements of this Appendix do not relieve OCRWM of the need to implement 
the requirements of the QARD. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
A 
Regulatory Guide 1.28, Revision 3, 
(8/1985), Quality Assurance 
Program Requirements (Design 
and Construction), which 
endorses ANSI/ASME 
NQA-1-1983 and ANSI/ASME 
NQA-1a-1983 Addenda (NQA-1) 
ANSI/ASME 
NQA-1-1983 with 
ANSI/ASME 
NQA-1a-1983 
Addenda, as 
supplemented or 
modified by the 
regulatory positions 
cited in section C of 
Regulatory Guide 1.28 
The OCRWM commits to the 
requirements and recommendations of the 
Regulatory Positions of this Regulatory 
Guide and the basic, supplementary 
requirements, and Appendix 2A-1 and 
Appendix 2A-3 of the endorsed standard 
as supplemented or modified by the 
Regulatory Positions, with the following 
exceptions: 
1. In lieu of implementing the 
requirements and recommendations of 
Regulatory Guide position C.2, Quality 
Assurance Records, the OCRWM will 
retain QA records in accordance with the 
retention and disposition instructions 
contained in a records retention schedule 
maintained by the OCRWM. The 
retention periods delineated in this 
records retention schedule shall meet or 
exceed the retention requirements 
delineated in Regulatory Guide 1.28, 
Revision 3, Table 1. 
2. General comment: ANSI/ASME 
NQA-1 refers to terms such as refueling, 
operations, inservice inspection, 
decommissioning, etc. These are 
examples of activities that will occur 
during the period of time that DOE has 
received a license to receive and possess 
Spent Nuclear Fuel and High Level 
Waste. At the appropriate time the 
QARD will be revised to address these 
activities. 
3. In lieu of ANSI/ASME NQA-1, 
Supplement S-1, Terms and Definitions, 
the QARD will maintain a glossary of 
terms and definitions independent of this 
standard. The terms and definitions in the 
QARD glossary are consistent with 
Supplement S-1. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
4. ANSI/ASME NQA-1, Supplement 
2S-2, requires implementing American 
Society of Nondestructive Testing 
Recommended Practice No. SNT TC-1A 
(6/1975) and applicable supplements to 
Nondestructive Examination (NDE) 
personnel. In lieu of this requirement the 
ORD will implement the requirements of 
SNT-TC-1A (6/1980) edition with one 
additional exception. In lieu of the three 
(3) year re-certification interval specified 
in SNT-TC-1A (6/1980) edition, Level III 
NDE personnel may be re-certified on a 
five year interval. The qualification and 
certification will include a performance 
demonstration as part of the practical 
examination. 
5. ANSI/ASME NQA-1, Supplement 
2S-3, Supplementary Requirements for 
the Qualification of Quality Assurance 
Program Audit Personnel, requires that, 
Personnel selected for quality assurance 
auditing assignments shall have 
experience or training commensurate with 
the scope, complexity, or special nature 
of the activities to be audited. 
In lieu of this requirement the QARD will 
require as an alternative the following: 
The lead auditor shall, before starting the 
audit, ensure that the assigned personnel 
collectively have experience or training 
commensurate with the scope, 
complexity, or special nature of the work 
to be audited. 
6. INTENTIONALLY BLANK 
7. ANSI/ASME NQA-1-1983, 
Supplement 7S-1, Supplementary 
Requirements for Control of Purchased 
Items and Services, provides amplified 
requirements for the control of purchased 
items and services. 
As an alternative to the imposition of all 
otherwise applicable requirements for the 
procurement of analytical services in 
support of scientific investigations, the 
OCRWM will implement the purchaser 
related requirements described in QARD, 
Subsection 7.2.12B. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
8. ANSI/ASME NQA-1, Supplement 
6S-1, Supplementary Requirements for 
Document Control, Section 3.1, Major 
Changes, requires that changes to 
documents, other than those defined as 
minor in 3.2 below, are considered as 
major changes and shall be reviewed and 
approved by the same organizations that 
performed the original review and 
approval unless other organizations are 
specifically designated. 
The OCRWM will implement the 
following alternative: 
The OCRWM will limit the scope of the 
Minor Changes category to the 
inconsequential editorial corrections 
described in QARD, Subsection 6.2.8. 
Controlled document changes outside this 
scope will be treated as Major Changes 
and reviewed and approved as described 
in QARD, Subsection 6.2.6. 
9. ANSI/ASME NQA-1, Supplement 
7S-1, Supplementary Requirements for 
Control of Purchased Items and Services, 
Section 10, Commercial Grade Items. 
NUREG-1804, Acceptance Criteria 7 
takes exception to the provisions of 
ANSI/ASME NQA-1 regarding 
commercial grade item dedication. 
Consistent with the NRC position stated 
in NUREG-1804, the OCRWM will not 
conduct a commercial grade program in 
accordance with the provisions in 
ANSI/ASME NQA-1. 
The OCRWM commercial grade item 
dedication program is based on the 
guidance of NUREG-1804, acceptance 
criteria AC-7(8) and the applicable 
requirements of 10 CFR 21. 
10. ANSI/ASME NQA-1, Supplement 
17S-1, Supplementary Requirements for 
Quality Assurance Records, Sections 2.7 
and 2.8, Classification, addresses criteria 
and requirements for the classification 
(lifetime and nonpermanent) and 
retention of Quality Assurance records, 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
respectively. 
Regulatory Guide 1.28, Regulatory 
Position C.2, Quality Assurance Records 
in conjunction with Table 1, Retention 
Times for Lifetime and Nonpermanent 
Records, and NQA-1-1983, Supplement 
17S-1, Supplementary Requirements for 
Quality Assurance Records, Sections 2.7, 
Classification, and 2.8, Retention of 
Records, prescribe requirements for the 
development of a number of classes of 
QA records and rules and guidance for 
specifying the minimum retention time to 
be applied to each class of record. The 
objective of these directions is to ensure 
the availability and retrievability of each 
class of QA records during the specified 
retention period and to provide relief 
from the necessity to retain the specified 
records beyond the required retention 
period. 
As an alternative to the above, all QA 
records will be treated as one class of 
record without further classification such 
as Lifetime, Nonpermanent, 
Programmatic Nonpermanent, or Product 
Nonpermanent. Retention of all QA 
records is specified in the comprehensive 
schedule required by 36 CFR, 
Chapter XII, Subchapter B, Records 
Management, Part 1220, Federal Records, 
General. That schedule is titled 
OCRWM Program Records Retention 
Schedule (OPRRS), which will be 
superseded by the YMP Records 
Retention Schedule in the near future. 
This schedule now requires and will 
continue to require in the future that all 
QA records be retained until the end of 
the operating period. At that time, the 
records will be reappraised for utility 
during the postclosure period. If retention 
during the postclosure period is indicated, 
disposition instructions will be revised at 
that time. If retention during the 
postclosure period is not required, the 
records will be destroyed. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
11. ANSI/ASME NQA-1, Supplement 
17S-1, Supplementary Requirements for 
Quality Assurance Records, addresses the 
requirements and recommendations for 
the storage of records that are determined 
to be QA records. This supplement does 
not include a provision for the temporary 
storage of QA records. The QARD 
includes the following provision for 
temporary storage of QA records: 
a. QA records shall be temporarily stored 
in a container or facility with a fire rating 
of one hour, or dual storage shall be 
provided. 
b. For single storage, containers or 
facilities shall bear an Underwriters 
Laboratories label (or equivalent) 
certifying 1-hour fire protection or be 
certified by a person competent in the 
technical field of fire protection. 
c. The period of time allowed for records 
to be in temporary storage will be 
specified in appropriate procedures. 
12. ANSI/ASME NQA-1, Supplement 
17S-1, Supplementary Requirements for 
Quality Assurance Records, 
Section 4.4.2, Alternate Single Facility, 
since OCRWM will not be using the 
alternate facility, the QARD is silent on 
this aspect of ANSI/ASME NQA-1. 
13. ANSI/ASME NQA-1, Supplement 
17S-1, Supplementary Requirements for 
Quality Assurance Records, Section 5, 
Retrieval, the OCRWM records retrieval 
system is not configured in such a manner 
as to provide retrieval times based on the 
type of record. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
14. ANSI/ASME NQA-1, Supplement 
17S-1, Supplementary Requirements for 
Quality Assurance Records, Section 6, 
3rd paragraph, specifies certain 
conditions and events prior to which 
suppliers nonpermanent records shall not 
be disposed of. 
As an alternative to directing the disposal 
of any QA records by a supplier, the 
supplier shall be required to submit all 
QA records generated in the course of a 
procurement action to the OCRWM. 
These QA records shall thereafter be 
retained in accordance with the direction 
of the OPRRS. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
15. ANSI/ASME NQA-1, Supplement 
18S-1, Supplementary Requirements for 
Audits, Section 3.3, 2nd sentence requires 
audit response evaluation to be a function 
of the individual appointed to lead the 
(audit) team. 
As an alternative, conditions identified 
during performance of an audit, which 
require the attention of the audited 
organization, are processed in accordance 
with the requirements of QARD 
Section 16.0. Thereafter, all actions 
related to those corrective actions, e.g., 
responses, evaluation of responses, 
corrective action planning, performance, 
and verification, are managed through the 
implementation of QARD Section 16.0. 
16. ANSI/ASME NQA-1, Supplement 
18S-1, Supplementary Requirements for 
Audits, Section 6, Response, requires that 
the Management of the audited 
organization notify in writing of the 
action taken or planned. 
In the case of internal audits, it is 
OCRWMs position that such a response 
is not necessary. 
The results of internal audits are placed 
into the electronic Corrective Action 
system. The results of the investigation, 
including determination of cause, as 
appropriate, reviews, approvals, 
corrective actions, and schedules are 
available to the auditing organization. 
Therefore, there is not a necessity for a 
written response. 
17. ANSI/ASME NQA-1, Supplement 
18S-1, Supplementary Requirements for 
Audits, Section 6, requires measures to 
prevent recurrence to be identified for 
adverse audit findings. In lieu of this 
requirement, OCRWM will process 
adverse audit findings in accordance with 
QARD Section 16.0. QARD Section 16.0 
requires responsible management to take 
corrective action to prevent recurrence for 
significant conditions adverse to quality. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
B Regulatory Guide 1.8, Revision 3 
(5/2000), Qualification and 
Training of Personnel for Nuclear 
Power Plants 
This regulatory guide 
endorses 
ANSI/ANS-3.1-1993, 
Selection, 
Qualification, and 
Training of Personnel 
for Nuclear Power 
Plants, with certain 
additions and 
exceptions that are 
listed in the Regulatory 
Position of this guide. 
The OCRWM commits to the 
requirements and recommendations for 
the selection, qualification, and training 
of personnel, subject to the additions, 
exceptions, and clarifications provided in 
Section C, Regulatory Position, of the 
Regulatory Guide, with the following 
exceptions: 
For the purpose of the Construction 
Authorization, the commitment is limited 
to the following Regulatory Position; 
C.2.1.1. 
These include Paragraph 4.3.7 of the 
endorsed standard. 
In addition, for the purpose of the 
Construction Authorization, 
NUREG-1804, Section 2.5.1, Acceptance 
Criteria 1, item 7, requests that the 
qualification requirements for the QA 
Manager be equivalent to those provided 
in the ANSI/ANS Standard as endorsed 
by the Regulatory Guide. 
C NRC Information Notice 86-21, 
Recognition of American Society 
of Mechanical Engineers 
Accreditation Program for N 
Stamp Holders, (3/31/1986), 
including Supplement 1 
(12/04/1986), and Supplement 2 
(4/16/1991) 
The ORD will recognize ASME 
accreditation of suppliers as stated in the 
NRC Information Notice. 
D NUREG-1297, Peer Review for 
High-Level Nuclear Waste 
Repositories (1988) 
The OCRWM commits to the 
requirements and recommendations of 
Section III, Definitions, and Section IV, 
Staff Position, of this NUREG-1297. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
E NUREG-1298, Qualification of 
Existing Data for High-Level 
Nuclear Waste Repositories 
(1988) 
The OCRWM commits to the 
requirements and recommendations of 
Section IV, Staff Positions of 
NUREG-1298, with the following 
alternatives: 
NOTE: If the requirements of 
NUREG-1298 are in conflict with the 
requirements of 10 CFR 63, the 
requirements of 10 CFR 63 shall take 
precedence. 
E.1 In addition to the four methods listed 
in Staff Position 2, OCRWM uses a fifth 
method, Technical Assessment, which 
includes one or a combination of the 
following: 
 Determination that the employed 
methodology is acceptable; 
 Determination that confidence in the 
data acquisition or developmental results 
is warranted; or 
 Confirmation that the data have been 
used in similar applications. 
Additionally, the QA program that is 
discussed in Staff Position IV.1 is 
understood to mean 10 CFR 60, 
Subpart G, or 10 CFR 63.142, depending 
at the point in time when the data was 
required to be qualified. 
E.2 In those instances after 
implementation of the 10 CFR 60/63 QA 
program, when the development of 
required data by any external source 
cannot be obtained through the imposition 
of otherwise applicable requirements of 
the QARD Section 7.0, the OCRWM will 
permit such development as a routine 
commercial procurement activity upon 
prior approval by the responsible 
OCRWM line organization director and 
the Director, Office of Quality Assurance. 
Data developed in this manner shall be 
subjected to the data qualification process 
applicable to qualification of unqualified 
data. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
E.3 In those instances after the 
implementation of the 10 CFR 60/63 QA 
Program, when required data is shown to 
already exist in the form of the product of 
a non-Q acquisition, the OCRWM will 
permit use of that data in an activity to 
which the QA program applies upon prior 
approval by the responsible OCRWM line 
organization director and the Director, 
Office of Quality Assurance. Such data 
shall be subjected to the data qualification 
process applicable to the qualification of 
unqualified data. 
F NUREG-1563, Branch Technical 
Position on the Use of Expert 
Elicitation in the High-Level 
Radioactive Waste Program 
(1996) 
The OCRWM commits to the 
requirements and recommendations of 
Section 3, Branch Technical Position, and 
Appendix A, Glossary, of this NUREG 
with the following exception: 
Step 7 of NUREG-1563 recommends 
documenting the rationale for any 
revisions to elicited evaluations after the 
experts receive feedback on their initial 
evaluations. OCRWM does not require 
documentation of the rationale for 
revisions to an experts initial assessment 
in the expert elicitation report. 
G NUREG-1636, Regulatory 
Perspectives on Model Validation 
in High-Level Radiation Waste 
Management Programs: A Joint 
NRC/SKI White Paper (1999) 
The OCRWM commits to the 
requirements and recommendations in 
Section 3, Model Validation Approach 
from a Regulatory Perspective of 
NUREG-1636, to the extent presented in 
QARD Supplement III, Scientific 
Investigation, Section III.2.6. 
H ASME NQA-1 (2000), 
Subpart 2.7, Quality 
Assurance 
Requirements for 
Computer Software for 
Nuclear Facility 
Applications. 
The OCRWM commits to the 
requirements of ASME NQA-1 (2000) 
Subpart 2.7 with the following exception: 
All references to other requirements of 
Part I in ASME NQA-1 (2000), 
Subpart 2.7, are understood to be 
referring to the appropriate criteria of 
ANSI/ASME NQA-1-1983 with 
ANSI/ASME NQA-1a-1983 addenda, as 
supplemented or modified by regulatory 
positions cited in Section C of Regulatory 
Guide 1.28. 


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Table 1. Regulatory/Commitment Document Positions 

Item U.S. NRC Document National/Industry 
Standard OCRWM Position 
I Regulatory issue Summary 
2000-18, Guidance on Managing 
Quality Assurance Records in 
Electronic Media 
The OCRWM will be using an electronic 
records system for Quality Assurance 
records. As such, OCRWM commits to 
the use of the NRC guidance contained 
within the RIS. 
J Electric Power Research Institute 
(EPRI) Guideline for the 
Utilization of Commercial Grade 
Items in Nuclear Safety Related 
Applications (NCIG-07), EPRI 
NP-5652 (6/88), as endorsed and 
modified by U.S. Nuclear 
Regulatory Commission Generic 
Letters 89-02, Actions to Improve 
the Detection of Counterfeit and 
Fraudulently Marketed Products 
(3/89) and 91-05, Licensee 
Commercial-Grade Procurement 
and Dedication Programs (4/91) 
Electric Power 
Research Institute 
(EPRI) Guideline for 
the Utilization of 
Commercial Grade 
Items in Nuclear Safety 
Related Applications 
(NCIG-07), EPRI 
NP-5652 (6/88), as 
endorsed and modified 
by U.S. Nuclear 
Regulatory 
Commission Generic 
Letters 89-02, Actions 
to Improve the 
Detection of 
Counterfeit and 
Fraudulently Marketed 
Products (3/89) and 
91-05, Licensee 
Commercial-Grade 
Procurement and 
Dedication Programs 
(4/91). 
If OCRWM, OCRWM contractors, or 
suppliers implement a commercial grade 
item dedication process as defined in 
10 CFR 21.3, the implementing processes 
shall be developed with the guidance 
contained in Electric Power Research 
Institute (EPRI) Guideline for the 
Utilization of Commercial Grade Items in 
Nuclear Safety Related Applications 
(NCIG-07), EPRI NP-5652 (6/88), as 
endorsed and modified by U.S. Nuclear 
Regulatory Commission Generic Letters 
89-02, Actions to Improve the Detection 
of Counterfeit and Fraudulently Marketed 
Products (3/89) and 91-05, Licensee 
Commercial-Grade Procurement and 
Dedication Programs (4/91). 
K American Society for 
Nondestructive Testing 
(ASNT) Recommended 
Practice No. 
SNT-TC-1A, June 1980 
Edition 
The OCRWM commits to the 
requirements of SNT-TC-1A (6/1980) 
edition with one additional exception. In 
lieu of the three (3) year re-certification 
interval specified in SNT-TC-1A 
(6/1980) edition, Level III NDE 
personnel may be re-certified on a five 
year interval. The qualification and 
certification will include a performance 
demonstration as part of the practical 
examination. 


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GLOSSARY 

Acceptance (Document)The documented determination by the receiving organization that 
work is suitable for the intended purpose. 

Acceptance Testing (Software)The process of exercising or evaluating a system or system 
component by manual or automated means to ensure that it satisfies the specified 
requirements and to identify differences between expected and actual results in the operating 
environment. (NQA-1-2000, Subpart 2.7, Section 102) 

Application (Software)Includes software designed to fulfill the specific needs of a user and 
software that are written where the user prescribes one or more instructions to generate data, 
manipulate data, or perform calculations. (IEEE Std. 610.12-1990) 

ApprovalThe documented determination by a responsible organization that work is suitable 
for the intended purpose and shall be used as required. 

AuditA planned and documented activity performed to determine by investigation, 
examination, or evaluation of objective evidence the adequacy of and compliance with 
established procedures, instructions, drawings, and other applicable documents and the 
effectiveness of implementation. An audit should not be confused with surveillance or 
inspection activities performed for the sole purpose of process control or product acceptance. 
(NQA-1-1983, Supplement S-1) 

Audit Team LeaderA lead auditor who is assigned to direct the efforts of an audit team. 

AuditorAn individual who is qualified to perform assigned portions of an audit. 

Baseline Element (Software)An individual software component (e.g., requirements 
document, design document, source code, etc.) that is under configuration management 
control. 

Basic ComponentWhen applied to facilities or activities licensed pursuant to 10 CFR 63, a 
structure, system, or component or part thereof that affects their safety or waste isolation 
function, that is directly procured by the licensee of a facility or activity subject to the 
regulations in 10 CFR 21 and in which a defect or failure to comply with any applicable 
regulation in Title 10, Chapter I, order, or license issued by the U.S. Nuclear Regulatory 
Commission could create a substantial safety hazard. The term includes activities important to 
safety or important to waste isolation such as design, analysis, inspection, testing, fabrication, 
replacement of parts, or consulting services that are associated with the component hardware 
whether these services are performed by the component supplier or others. (10 CFR 21.3) 

Certificate of ConformanceA document signed by an authorized individual certifying the 
degree to which items or services meet specified requirements. (NQA-1-1983, 
Supplement S-1) 


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CertificationThe act of determining, verifying, and attesting in writing to the qualifications 
of personnel, processes, procedures, or items in accordance with specified requirements. 
(NQA-1-1983, Supplement S-1) 

CharacteristicA property or attribute of an item, process, or service that is distinct, 
describable, and measurable. (NQA-1-1983, Supplement S-1) 

Code Data Report (ASME Section III)A report required by the ASME Boiler and Pressure 
Vessel Code, such as Form N-1, Certificate Holders Data Report For Nuclear Vessels, or 
Form N-3, Owners Data Report for Nuclear Power Plant Components. 

Commercial Grade ItemAn item that is not subject to design or specification requirements 
that are unique to nuclear facilities or activities, is used in applications other than nuclear 
facilities or activities, and is to be ordered from the manufacturer/supplier on the basis of 
specifications set forth in the manufacturers published product description (e.g., catalog). 
(10 CFR 21.3) 

Commercial Grade SurveyActivities conducted by the purchaser or its agent to verify that a 
principal contractor/supplier of commercial grade items controls through quality activities, the 
critical characteristics of specifically designated commercial grade items, as a method to 
accept those items for important to safety or important to waste isolation use. (EPRI 
NP-5652, 6/88-Modified) 

Commercial Off-The-Shelf SoftwareSoftware items that can be purchased, ready-made, 
from a principal contractors/suppliers/retailers store shelf or manufacturers virtual store 
shelf (e.g., through a catalog or from a price list) on the basis of specifications set forth in the 
manufacturers published product description (e.g., a catalog or other published specification). 

Computer ProgramA combination of computer instructions and data definitions that enable 
computer hardware to perform computational or control functions. Computer programs 
covered by this document are those used in quality affecting activities. (NQA-1-2000, Part I, 
Section 400, Modified) 

Conceptual ModelA set of qualitative assumptions used to describe a system or subsystem 
for a given purpose. Assumptions for the model are compatible with one another and fit the 
existing data within the context of the given purpose of the model. (NUREG-1804, Section 3, 
Glossary) 

Condition Adverse to QualityAn all-inclusive term used in reference to any of the following: 
failures, malfunctions, deficiencies, defective items, and nonconformances. (NQA-1-1983, 
Supplement S-1) 

Configuration Item (Software)A collection of hardware or software elements treated as a 
unit for the purpose of configuration control. (NQA-1-2000, Subpart 2.7, Section 102) 


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Configuration Management (Software)The process of identifying and defining 
configuration items in a system (i.e., software and hardware), controlling the release and 
change of these items throughout the systems life cycle, and recording and reporting the 
status of configuration items and change requests. (NQA-1-2000, Subpart 2.7, Section 102) 

Confirmatory TestingTesting conducted under a 10 CFR 60, Subpart G, or 10 CFR 63, 
Subpart G, QA program that investigates the properties of interest (e.g., physical, chemical, 
geologic, or mechanical) of an unqualified database. 

ConsumablesItems that in the process of being used are consumed (e.g., weld rods). 

Control Point (Software)A point in the software life cycle at which specified agreements or 
controls (typically a test or review) are applied to the software configuration items being 
developed (e.g., an approved baseline or release of a specified document or computer 
program). (NQA-1-2000, Subpart 2.7, Section 102) 

Controlled DocumentA document that is prepared, reviewed, and approved in accordance 
with established implementing documents; subject to controlled distribution; and subject to a 
defined change process. 

Corrective ActionMeasures taken to rectify conditions adverse to quality and, where 
necessary, to preclude repetition. (NQA-1-1983, Supplement S-1) 

Corroborating DataUnqualified or qualified data used to support or substantiate other 
unqualified data. (NUREG-1298 [2/88]-Modified) 

Critical CharacteristicsThe important design, material, and performance characteristics of a 
commercial grade item that, once verified, will provide reasonable assurance that the item will 
perform its intended safety function, or reasonable expectation that the item will perform its 
intended waste isolation function. (NUREG-1804, AC-7[8][b]) 

DataInformation measured or derived from scientific investigation activities both in the field 
and the laboratory. Parameters that have been derived from raw data are sometimes 
themselves considered to be data. 

DatabaseA collection of previously distinct data (not created by the database) that have been 
logically organized to facilitate data access. 

Data ReductionProcesses that change the form of expression, quantity of data or values, or 
the number of data items. 

Dedicating EntityThe organization that performs the dedication process. Dedication may be 
performed by the manufacturer of the item, a third-party dedicating entity, or the U.S. 
Department of Energy itself. The dedicating entity pursuant to 10 CFR 21.21(c) is 
responsible for identifying and evaluating deviations, reporting defects and failures to comply 


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for the dedicated item, and maintaining auditable records of the dedication process. 
(10 CFR 21.3) 

DedicationAn acceptance process undertaken to provide (i) reasonable assurance that a 
commercial grade item to be used as a basic component will perform its intended safety 
function or (ii) reasonable expectation that the item will perform its intended waste isolation 
function and, in this respect, is deemed equivalent to an item designed and manufactured 
under a 10 CFR 63, Subpart G, quality assurance program. This assurance is achieved by 
identifying the critical characteristics of the item and verifying their acceptability by 
inspections, tests, or analyses performed by a purchaser or third-party dedicating entity after 
delivery, supplemented as necessary by one or more of the following: 

(1) Commercial grade surveys 
(2) Product inspections or witnessing at hold points at the manufacturers facilities, and 
(3) Analyses of historical records for acceptable performance. 
In all cases, the dedication process shall be conducted in accordance with the applicable 
requirements of 10 CFR 63, Subpart G. Final dedication of an item occurs after receipt 
inspection and final acceptance by the U.S. Department of Energy or its contractor, when the 
item is designated for use as a basic component. (10 CFR 21.3) 

Defect 

(1) A deviation in a basic component delivered to a purchaser for use in a facility or 
activity subject to the regulation in 10 CFR 21 if, on the basis of an evaluation, the 
deviation could create a substantial safety hazard; or 
(2) The installation, use, or operation of a basic component containing a defect; or 
(3) A deviation in a portion of a facility subject to the Construction Authorization or 
licensing requirements of 10 CFR 63, provided the deviation could, on the basis of an 
evaluation, create a substantial safety hazard and the portion of the facility containing 
the deviation has been offered to the purchaser for acceptance; or 
(4) A condition or circumstance involving a basic component that could contribute to the 
exceeding of a safety limit, as defined in the technical specifications of a license for 
operation issued pursuant to part 63 of this chapter. (10 CFR 21.3) 
DesignThe term design includes specifications; drawings; design criteria; design bases; 
structures, systems, and components performance requirements for preclosure; and natural 
and engineered barriers of the repository system. It also includes inputs and outputs at each 
stage of design development (e.g., from conceptual design to final design). Design 
information and design activities also refer to data collection and analyses and computer 
software that are used in supporting design development and verification. Design information 
and activities include general plans and detailed procedures for data collection and analyses 
and related information such as test and analyses results. Data analyses include the initial 


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step, data reduction, as well as broad system analyses (i.e., performance assessments) that 
integrate other data and analyses for individual parameters. (NUREG 1804, AC-3 [2]) 

Design BasesInformation that identifies the specific functions to be performed by a 
structure, system, or component of a facility and the specific values or ranges of values 
chosen for controlling parameters as reference bounds for design. These values may be 
constraints derived from generally accepted state-of-the-art practices for achieving 
functional goals or requirements derived from analysis (based on calculation or experiments) 
of the effects of a postulated event under which the structure, system, or component must 
meet its functional goals. 

The values for controlling parameters for external events include: 

(1) Estimates of severe natural events to be used for deriving design bases that will be 
based on consideration of historical data on the associated parameters, physical data, 
or analysis of upper limits of the physical processes involved, and 
(2) Estimates of severe external human-induced events to be used for deriving design 
bases that will be based on analysis of human activity in the region, taking into 
account the site characteristics and the risks associated with the event. (10 CFR 63.2) 
Design ChangeAny revision or alteration of the technical requirements defined by approved 
and issued design output documents and approved and issued changes thereto. (NQA-1-1983, 
Supplement S-1) 

Design DocumentsInclude, but are not limited to, specifications, calculations, associated 
computer software, system descriptions, and drawings, including flow diagrams, piping and 
instrument diagrams, control logic diagrams, electrical single line diagrams, structural 
systems for major facilities, site arrangements, and equipment locations. (NUREG-1804, 
AC-3[13][c]) 

Design InputThose criteria, parameters, bases, or other design requirements upon which 
detailed final design is based. (NQA-1-1983, Supplement S-1) 

Design OutputDocuments, such as drawings, specifications, and other documents defining 
technical requirements of structures, systems, and components. (NQA-1-1983, Supplement 
S-1) 

Design ProcessTechnical and management processes that commence with identification of 
design input and that lead to and include the issuance of design output documents. 
(NQA-1-1983, Supplement S-1) 

Design ReviewA critical review to provide assurance that the final design is correct and 
satisfactory. (NQA-1-1983, Supplement 3S-1, Paragraph 4.2.1) 

DeviationA departure from specified requirements. (NQA-1-1983, Supplement S-1) 


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Document ControlThe process for controlling documents that provides for adequacy review, 
approval for release by authorized personnel, and distribution for use at the prescribed work 
locations. (10 CFR 63.142[g]) 

Effective DateThe date after approval that the document is required to be fully implemented. 

Embedded SoftwareSoftware that is a part of a larger system and performs some of the 
functions of that system, such as keypad controls or function and control capabilities. (IEEE 
Std. 610.12-1990, Modified) 

Error (Software)A condition deviating from an established baseline, including deviations 
from the current approved computer program and its baseline requirements. (NQA-1-2000, 
Subpart 2.7, Section 102) 

Established FactInformation accepted by the scientific and engineering community as 
established fact (e.g., engineering handbooks, density tables, gravitational laws, etc.). 

Event SequenceA series of actions and/or occurrences within the natural and engineered 
components of a geologic repository operations area that could potentially lead to exposure of 
individuals to radiation. An event sequence includes one or more initiating events and 
associated combinations of repository system component failures, including those produced 
by an action or inaction of operating personnel. Those event sequences that are expected to 
occur one or more times before permanent closure of the geologic repository operations area 
are referred to as Category 1 event sequences. Other event sequences that have at least 1 
chance in 10,000 of occurring before permanent closure are referred to as Category 2 event 
sequences. (10 CFR 63.2) 

Expedited ChangeAn abbreviated method of revising a document at the work location 
where the document is used, when the normal change process would cause unnecessary 
delays. The management responsible for the work makes the expedited change. 

Field SurveyingThe process of determining the boundaries, area, elevation, and location of 
land, structures, reference points, or other designated features either on, above, or below the 
earth surface relative to a permanent system of horizontal and vertical controls. 

Hold PointA step in a document that requires witnessing or inspection by the requesting 
individual or organization and beyond which work shall not proceed without the written 
consent of the requesting individual or organization. (NQA-1-1983, Supplement 10S-1, 
Paragraph 3) 

Implementation (Software)The process of translating the software design into a computer 
program. (IEEE Std. 610.12-1990) 


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Important to SafetyWith reference to structures, systems, and components, means those 
engineered features of the geologic repository operations area whose function is: 

(1) To provide reasonable assurance that high-level waste can be received, handled, 
packaged, stored, emplaced, and retrieved without exceeding the requirements of 
10 CFR 63.111(b)(1) for Category 1 event sequences; or 
(2) To prevent or mitigate Category 2 event sequences that could result in radiological 
exposures exceeding the values specified at 10 CFR 63.111(b)(2) to any individual 
located on or beyond any point on the boundary of the site. (10 CFR 63.2) 
Important to Waste IsolationWith reference to design of the engineered barrier system and 
characterization of natural barriers, means those engineered and natural barriers whose 
function is to provide reasonable expectation that high-level waste can be disposed of without 
exceeding the requirements of 10 CFR 63.113(b) and (c). (10 CFR 63.2) 

IndoctrinationA method of training designed to familiarize personnel in fundamental 
criteria, program elements, responsibilities, and authority applicable to assigned tasks. 
(NQA-1-1989, Supplement 2S-4, Paragraph 3) 

InformationA representation of data, facts, concepts, or instructions in a manner suitable for 
communication, interpretation, or processing by individuals or by automatic means. 

InspectionExamination or measurement to verify whether an item or activity conforms to 
specified requirements. (NQA-1-1983, Section II, Basic Requirement 10) 

ItemAn all-inclusive term used in place of any of the following: appurtenance, assembly, 
component, equipment, material, module, part, structure, subassembly, subsystem, system, or 
unit. (NQA-1-1983, Supplement S-1) 

Lead AuditorAn individual who is certified to organize, perform, and direct an audit; report 
audit results; and evaluate related corrective actions. 

Limited UseA disposition permitted for a nonconforming sample when it can be established 
that a sample has potential value to the project even though the sample has been determined to 
be nonconforming in respect to its original obtained condition. For example, samples 
contaminated by water may still hold value for rock mechanic studies, but hold no value for 
water infiltration investigations. Conditions for Limited Use will be established and set forth 
in the disposition of the nonconforming sample. 

Management AssessmentAn OCRWM QA program verification that is conducted by 
management above or outside the OCRWM QA organization and that evaluates the scope, 
status, adequacy, programmatic compliance, and implementation effectiveness of the 
OCRWM QA program. 


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Measuring and Test EquipmentDevices or systems used to calibrate, measure, gage, test, or 
inspect in order to control or acquire data to verify conformance to specified requirements. 
(NQA-1-1983, Supplement S-1) 

ModelA depiction of a system, phenomenon, or process including any hypotheses required 
to describe the system or explain the phenomenon or process. (NUREG-1804, Section 3, 
Glossary) 

Model, AbstractedA model that reproduces, or bounds, the essential elements of a more 
detailed process model and captures uncertainty and variability in what is often, but not 
always, a simplified or idealized form. (NUREG-1804, Section 3, Glossary) 

Model, ConceptualA set of qualitative assumptions used to describe a system or subsystem 
for a given purpose. Assumptions for the model are compatible with one another and fit the 
existing data within the context of the given purpose of the model. (NUREG-1804, Section 3, 
Glossary) 

Model, MathematicalA mathematical description of a conceptual model. (NUREG-1804, 
Section 3, Glossary) 

Model, ProcessA depiction or representation of a process, along with any hypotheses 
required to describe or to explain the process. (NUREG-1804, Section 3, Glossary) 

Model, SystemA collection of interrelated mathematical models that represents the overall 
geologic repository or overall component subsystem of the geologic repository. 

Model ValidationA process used to establish confidence that a mathematical model and its 
underlying conceptual model adequately represent with sufficient accuracy the phenomenon, 
process, or system in question. 

NonconformanceA deficiency in characteristic, documentation, or procedure that renders 
the quality of an item, sample, or activity unacceptable or indeterminate. (NQA-1-1983, 
Supplement S-1) 

Objective EvidenceAny documented statement of fact, other information, or record, either 
quantitative or qualitative, pertaining to the quality of an item or activity, based on 
observations, measurements, or test which can be verified. (NQA-1-1983, Supplement S-1) 

Organizational InterfaceThe relationship between organizations in which one organization 
prescribes an activity or requirement to, or shares an activity or requirement with, another 
organization. 


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Performance Assessment (Total System Performance Assessment)An analysis that: 

(1) Identifies the features, events, processes (except human intrusion), and sequences of 
events and processes (except human intrusion) that might affect the Yucca Mountain 
disposal system and their probabilities of occurring during 10,000 years after disposal; 
(2) Examines the effects of those features, events, processes, and sequences of events and 
processes upon the performance of the Yucca Mountain disposal system; and 
(3) Estimates of the dose incurred by the reasonably maximally exposed individual, 
including the associated uncertainties, as a result of releases caused by all significant 
features, events, processes, and sequences of events and processes, weighted by their 
probability of occurrence. (10 CFR 63.2) 
Performance ConfirmationThe program of tests, experiments, and analyses that is 
conducted to evaluate the adequacy of the information used to demonstrate compliance with 
the performance objectives in 10 CFR 63, Subpart E. (10 CFR 63.2) 

Personnel QualificationSee Qualification (Personnel). 

Preclosure Safety AnalysisA systematic examination of the site; the design; and the 
potential hazards, initiating events, and event sequences and their consequences 
(e.g., radiological exposure to workers and the public). The analysis identifies structures, 
systems, and components important to safety. (10 CFR 63.2) 

Principal ContractorsOrganizations that provide items or services in accordance with an 
appropriate contractual document and that perform the functions of Management and 
Operating contractor, Management and Integration contractor, Construction contractor or 
Lead Laboratory. 

ProcessA series of actions that achieves an end result or accomplishes work. 

Procurement DocumentPurchase requisitions, purchase orders, drawings, contracts, 
specifications, or instructions used to define requirements for purchase. (NQA-1-1983, 
Supplement S-1) 

PurchaserThe organization responsible for establishment of procurement requirements and 
for issuance, administration, or both, of procurement documents. (NQA-1-1983, Supplement 
S-1) 

Qualification (Personnel)The characteristics or abilities gained through education, training, 
or experience, as measured against established requirements, such as standards or tests, that 
qualify an individual to perform a required function. (NQA-1-1983, Supplement S-1) 

Qualification of DataA formal process that is intended to provide a desired level of 
confidence that data are suitable for their intended use. 


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Qualification TestingA test that is intended to provide a desired level of confidence that an 
item meets specified criteria. 

Qualified DataData collected under an approved QA program that meets the requirements of 
10 CFR 63.142 (or previously implemented 10 CFR 60 QA program) (i.e., qualified from 
origin) or unqualified data that have undergone the qualification process. (NUREG-1298, 
2/88) 

Quality Assurance (QA)All those planned and systematic actions necessary to provide 
adequate confidence that the geologic repository and its structures, systems, and components 
important to safety, the design and characterization of engineered and natural barriers 
important to waste isolation, and activities related thereto will perform satisfactorily in 
service. Quality assurance includes quality control, which comprises those quality assurance 
actions related to the physical characteristics of a material, structure, system, or component 
that provide a means to control the quality of the material, structure, system, or component to 
predetermined requirements. (10 CFR 63.141) 

Quality Assurance (QA) OrganizationThe Office of Quality Assurance organization for 
activities performed by the OCRWM and reviews of OCRWM owned documents, the 
Management and Operating contractor (M&O) QA organization for activities performed by 
the M&O and reviews of M&O owned documents; the Lead Laboratory QA organization for 
activities performed by the Lead Laboratory and reviews of Lead Laboratory owned 
documents; and the Office of Quality Assurance organization, the M&O QA organization, 
and the Lead Laboratory QA organization for the review of documents implemented by the 
OCRWM, the M&O, and/or the Lead Laboratory jointly. 

Quality Assurance (QA) RecordA completed document (or other medium) that furnishes 
evidence of the quality of items and/or activities affecting quality. (NQA-1-1983, 
Supplement S-1) 

Readiness ReviewA systematic assessment of the preparedness of an organization to start or 
continue a process or project phase. 

Regression TestingSelective retesting of a system or component to verify that modifications 
have not caused unintended effects and that the system or component still complies with its 
specified requirements. (IEEE Std. 610.12-1990) 

Release (Software)The formal notification and distribution of approved software. 

Remedial ActionThe actions taken to correct specifically identified conditions adverse to 
quality. 

RepairThe process of restoring a nonconforming characteristic to a condition such that the 
capability of an item to function reliably and safely is unimpaired even though that item still 
does not conform to the original requirement. (NQA-1-1983, Supplement S-1) 


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ReworkThe process by which an item is made to conform to original requirements by 
completion or correction. (NQA-1-1983, Supplement S-1) 

Right of AccessThe right of a purchaser or designated representative to enter the premises of 
a principal contractor/supplier for the purposes of inspection, surveillance, or quality 
assurance audit. (NQA-1-1983, Supplement S-1) 

Root CauseThe identified cause of a condition adverse to quality that, if corrected, will 
preclude recurrence or greatly reduce the probability of recurrence of the same or a similar 
condition adverse to quality. 

Sample (Physical)A physical part of a whole whose properties are studied to gain 
information about the whole. 

Scientific InvestigationAn analysis consisting of an explanation, observation, identification, 
description, or experimental study either of natural phenomena or of engineered materials that 
describe the postclosure repository system or its performance. 

Scientific NotebookA record of the methodology and results of scientific investigations that 
is used when the work involves a high degree of professional judgment or trial and error 
methods or both. 

ServiceThe performance of activities such as design, fabrication, inspection, nondestructive 
examination, repair, or installation. (NQA-1-1983, Supplement S-1) 

Significant Condition Adverse to QualityA condition adverse to quality that, if uncorrected, 
could have a serious effect on safety, operability, or the ability to isolate waste. Significant 
conditions adverse to quality include, but are not limited to (1) loss, or potential loss, of a 
safety or waste-isolation function to the extent that there is a reduction in the degree of 
protection provided to the public health and safety; (2) loss, or potential loss, of a safety or 
waste-isolation function to the extent that there is a reduction in the degree of protection 
provided for worker safety; (3) common-cause failures; and (4) any adverse quality trends. 
Additionally, repetitive conditions that are less significant but when taken collectively 

(1) indicate programmatic failure to properly implement the QA program, (2) may be 
precursors for a significant technical deficiency or problem or, (3) may reduce the margin of 
safety are considered to be significant conditions adverse to quality. (NQA-1-1983, 
Supplement S-1, Modified) 

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Site CharacterizationThe program of exploration and research, both in the laboratory and in 
the field, undertaken to establish the geologic conditions and the ranges of those parameters of 
the Yucca Mountain site, and the surrounding region to the extent necessary, relevant to the 
procedures under 10 CFR 63. Site characterization includes borings, surface excavations, 
excavation of the exploratory shafts and/or ramps, limited subsurface lateral excavations and 
borings, and in situ testing at a depth needed to determine the suitability of the site for a 
geologic repository. (10 CFR 63.2) 

SoftwareComputer programs and associated documentation, and data pertaining to the 
operation of a computer system. (NQA-1-2000, Part I, Section 400) 

Software BaselineA specification or product that (i) has been formally reviewed and agreed 
upon, (ii) thereafter is the basis for further development, and (iii) can be changed only 
through formal change procedures. 

Software Design VerificationThe process of determining if the product of the software 
design activity fulfills the software design requirements. (NQA-1-2000, Subpart 2.7, 
Section 102) 

Software Development CycleThe activities that begin with the decision to develop a 
software product and end when the software is delivered. The software development cycle 
typically includes the following activities: (1) software design requirements, (2) software 
design, (3) implementation, (4) test, and sometimes (5) installation. (NQA-1-2000, 
Subpart 2.7, Section 102) 

Software Engineering(a) The application of a systematic, disciplined, quantifiable approach 
to the development, operation, and maintenance of software, that is, the application of 
engineering to software; and (b) the study of the approaches as in (a). (NQA-1-2000, 
Subpart 2.7, Section 102) 

Software ItemSource code, object code, job control code, control data, or a collection of 
these items that function as a single unit. (IEEE Std. 610.12-1990) 

Software Life CycleThe activities that comprise the evolution of software from conception 
to retirement. The software life cycle typically includes the software development cycle 
phases and the activities associated with operation, maintenance, and retirement. 
(NQA-1-2000, Subpart 2.7, Section 102) 

Software Life Cycle ElementA fundamental, constituent part of a life cycle phase. For 
example, the requirements phase consists of the individual requirements, the design phase 
consists of the individual design elements and the individual test cases, the implementation 
phase consists of source code and user instructions, and the testing phase consists of 
documented test results. 


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Software Operating EnvironmentA collection of software, firmware, and hardware 
elements that provide for the execution of computer programs. (NQA-1-2000, Subpart 2.7, 
Section 102) 

Software ToolA computer program used in the development, testing, analysis, or 
maintenance of a program or its documentation. Examples include comparators, 
cross-reference generators, compilers, Computer Aided Software Engineering (CASE) tools, 
configuration and code management software, decompilers, disassemblers, editors, 
flowcharts, monitor test case generators, and timing analyzers. (NQA-1-2000, Subpart 2.7, 
Section 102) 

Software ValidationThe testing and evaluation of completed software to ensure compliance 
with specified software requirements. 

Software VerificationThe process of determining whether or not the product(s) of a given 
phase of the software development cycle fulfills the requirements imposed by the previous 
phase. (IEEE Std. 610.12-1990, Modified) 

Special ProcessA process, the results of which are highly dependent on the control of the 
process or the skill of the operators, or both, and in which the specified quality cannot be 
readily determined by inspection or test of the product. (NQA-1-1983, Supplement S-1) 

Stop Work OrderA formal directive issued by management that work must be stopped until 
resolution of the related significant condition adverse to quality. 

Substantial Safety HazardA loss of safety function to the extent that there is a major 
reduction in the degree of protection provided to public health or safety for any facility or 
activity licensed pursuant to 10 CFR 63. (10 CFR 21.3) 

SupplierAny individual or organization (except principal contractors) that furnishes items or 
services in accordance with a procurement document. An all-inclusive term used in place of 
any of the following: vendor, seller, contractor, subcontractor, fabricator, consultant, and 
their subtier levels. 

Support SoftwareSoftware that aids in the development and maintenance of other software 
(e.g., compilers, loaders, and other utilities), including software tools and system software. 
(IEEE Std. 610.12-1990) 

SurveillanceThe act of monitoring or observing to verify whether an item or activity 
conforms to specified requirements. (NQA-1-1983, Supplement S-1) 

System SoftwareSoftware designed to enable the operation and maintenance of a computer 
system and its associated computer programs (e.g., operating systems, assemblers, and 
utilities). (NQA-1-2000, Subpart 2.7, Section 102) 


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Technical AssessmentWhen used for data qualification, an evaluation of the technical merit 
of unqualified data against established criteria. 

Technical ReportAs it pertains to scientific investigation, a document that presents scientific 
information such as data, analyses, interpretations, or conclusions. 

Technical SpecialistAn individual who is assigned to an audit team when the scope, 
complexity, or special nature of the work to be audited warrants assistance from a technical 
standpoint. 

Test CaseA set of test inputs, execution conditions, and expected results developed for a 
particular objective, such as to exercise a particular program path or to verify compliance with 
a specific requirement. (NQA-1-2000, Subpart 2.7, Section 102) 

Test Plan (procedure)A document that describes the approach to be followed for testing a 
system or component. Typical contents identify items to be tested, tasks to be performed, and 
responsibilities for the testing activities. (NQA-1-2000, Subpart 2.7, Section 102) 

TestingAn element of verification for the determination of the capability of an item to meet 
specified requirements by subjecting the item to a set of physical, chemical, environmental, or 
operating conditions. (NQA-1-1983, Supplement S-1) 

Testing (Software)The process of operating a system (i.e., software and hardware) or system 
component under specified conditions, observing and recording the results, and making an 
evaluation of some aspect of the system (i.e., software and hardware) or system component in 
order to verify that it satisfies specified requirements and to identify errors. (NQA-1-2000, 
Subpart 2.7, Section 102) 

TraceabilityThe ability to trace the history, application, or location of an item and like items 
or activities by means of recorded identification. (NQA-1-1983, Supplement S-1) 

TrainingA systematic process provided to personnel so that they achieve proficiency, 
maintain proficiency, and adapt to changes in technology, methods, processes, or 
responsibilities as necessary to perform assigned tasks. (NQA-1-1989, Supplement 2S-4, 
Paragraph 4) 

TransparentA document sufficiently detailed as to purpose, method, assumptions, inputs, 
conclusions, references, and units such that a person technically qualified in the subject can 
understand the document and ensure its adequacy without recourse to the originator. 

Unqualified Data (Existing Data) 

A. Unqualified data includes: 
(i) Data developed prior to the implementation of a 10 CFR 60, Subpart G, or 10 CFR 63, 
Subpart G, Quality Assurance program, or 

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(ii) Data developed outside the Yucca Mountain Project, such as by oil companies, 
national laboratories, or universities, or 
(iii)Data published in technical or scientific publications. (NUREG-1298, 2/88). 

B. Unqualified data does not include established fact. 
Use-As-IsA disposition permitted for a nonconforming item when it can be established that 
the item is satisfactory for its intended use. (NQA-1-1983, Supplement S-1) 

VerificationThe act of reviewing, inspecting, testing, checking, auditing, or otherwise 
determining and documenting whether items, processes, services, or documents conform to 
specified requirements. (NQA-1-1983, Supplement S-1) 

Witness PointA step in a document that requires notification to the specifying individual or 
organization that the activity is scheduled to take place. Work may proceed after notification. 

WorkActivities that are subject to the Quality Assurance Requirements and Description.