INTRODUCTION 
The Quality Assurance Requirements and Description (QARD) is the principal Quality 
Assurance (QA) document for the Yucca Mountain Project. It establishes the minimum 
requirements for the QA program designed to meet the requirements of 10 CFR 60, Subpart G. 
The QARD contains regulatory requirements and program commitments necessary for the 
development of an effective QA program. Implementing documents must be based on, and be 
consistent with the QARD. 
Section 2.0, Quality Assurance Program, defines criteria for determining work subject to the 
QARD. 
The QARD is organized into sections, supplements, appendices, and a glossary. The sections 
contain requirements that are common to all Program activities. The supplements contain 
requirements for specialized activities. The appendices contain requirements that are specific to 
high-level waste form production, storage and transportation, and Monitored Geologic 
Repository. The glossary establishes a common vocabulary for the QA program. 
The QARD provides for both the achievement and verification of quality. The line organization 
has total responsibility for meeting the quality requirements, and individuals are responsible for 
the quality of their work. Therefore the line organization is responsible for the implementation 
of the QA program. The line organization and the QA organization share responsibility for the 
verification of quality. The Deputy Director, Office of Repository Development retains 
responsibility for the total QA program; ensures its development, implementation, and 
verification; and retains ultimate review and approval authority on matters pertaining to the 
implementation of the Yucca Mountain Project QA program. 
The line organizations develop implementing documents that translate applicable QARD 
requirements into work processes. In addition, each Affected Organization must develop a 
matrix that identifies where QARD requirements are contained in their implementing documents. 
QARD requirements are derived from the regulatory and industry documents listed in Figure 
Intro-1. These source documents fall into one of three categories: regulatory documents, 
commitment documents, or guidance documents. 
A. Regulatory documents define the requirements necessary for obtaining licenses 
issued by the Nuclear Regulatory Commission. Regulatory documents are 
reviewed upon revision, and changes are appropriately incorporated into the 
QARD. 
B. Commitment documents are imposed by management because they are necessary 
for the development and implementation of an effective QA program. Commitment 
documents are reviewed upon revision, and changes are incorporated into the 
QARD on a case-by-case basis. 

C. Guidance documents provide additional information useful in developing a QA 
program. Guidance documents are reviewed upon revision, and changes are 
incorporated into the QARD on a case-by-case basis. 

SOURCE DOCUMENTS 
Regulatory Documents 
10 CFR 50, Appendix B (Current) - 
10 CFR 60, Subpart G (Current) -
10 CFR 71, Subpart H (Current) -
10 CFR 72, Subpart G (Current) -
Commitment Documents 
NQA-1 (1989) -
- Basic Requirements: 
-Supplements: 
-Appendices: 
NRC Review Plan (Revision 2) -
NUREG-1297 (2/88) Staff Position-
NUREG-1298 (2/88) Staff Position-
Guidance Documents 
NQA-2 (1989) -
NQA-3 (1989) - 
FIGURE INTRO1 
Quality Assurance Criteria for Nuclear Power Plants 
and Fuel Reprocessing Plants 
Quality Assurance 
Quality Assurance 
Quality Assurance 
Quality Assurance Program Requirements for Nuclear 
Facilities 
1 through 18 
1S-1, 2S-1, 2S-2, 2S-3, 2S-4, 3S-1, 4S-1, 6S-1, 7S-1, 
8S-1, 9S-1, 10S-1, 11S-1, 12S-1, 13S-1, 15S-1, 17S-1, 
and 18S-1 
2A-1 and 2A-3 
U. S. Nuclear Regulatory Commission Review Plan for 
High-Level Waste Repository Quality Assurance 
Program Descriptions 
Peer Review for High-Level Nuclear Waste 
Repositories 
Qualification of Existing Data for High-Level Nuclear 
Waste Repositories 
Quality Assurance Requirements for Nuclear Facility 
Applications 
Quality Assurance Program Requirements for the 
Collection of Scientific and Technical Information for 
Site Characterization of High-Level Nuclear Waste 
Repositories 

FIGURE INTRO1 (Continued) 
NUREG-0856 (1983) - Final Technical Position on Documentation of 
Computer Codes for High-Level Waste Management 
NUREG-1318 (1988) Staff Position - Technical Position on Items and Activities in the High-
Level Waste Geologic Repository Program Subject to 
Quality Assurance Requirements 
NUREG-1563 (1996) - Branch Technical Position on the Use of Expert 
Elicitation in the High-Level Radioactive Waste 
Program 
NUREG-1636 (1999) - Regulatory Perspectives on Model Validation in 
High-Level Radioactive Waste Management Programs: 
A Joint NRC/SKI White Paper 
Regulatory Guide 1.28 (Revision 3) - Quality Assurance Program Requirements (Design And 
Construction) 
Regulatory Guide 7.10 (Revision 1) - Establishing Quality Assurance Programs for 
Packaging Used in the Transportation of Radioactive 
Material 

1.0 ORGANIZATION 
1.1 GENERAL 
This section establishes requirements for creating and maintaining an organizational 
structure to implement the Quality Assurance (QA) program for the Yucca Mountain 
Project (YMP). This section also provides a description of the YMP organization and 
other Affected Organizations. 
1.2 REQUIREMENTS 
Each Affected Organization shall prepare one or more controlled documents, accepted 
by the Office of Quality Assurance (OQA), that describes internal and external 
organizational interfaces, organizational structures, requirements, and responsibilities 
for its scope of work. 
1.2.1 Line Management 
Each Affected Organization shall identify the responsibilities and authorities of those 
organizations and management positions responsible for achieving and maintaining 
quality. 
1.2.2 Quality Assurance Management 
The Director, OQA, is the management position responsible for performing the QA 
function for the YMP. Authority to execute this responsibility may be delegated to the 
Affected Organization. This position shall be occupied by an individual with 
appropriate knowledge and experience in management and QA. The position shall: 
A. Be at the same or higher organization level as the highest line manager directly 
responsible for performing work subject to the Quality Assurance Requirements 
and Description (QARD). 
B. Be sufficiently independent from cost and schedule considerations. 
C. Have the organizational freedom to effectively communicate with other senior 
management positions. 
D. Be responsible for the approval and the documented interpretations of the QA 
program requirements. 
E. Have no other assigned responsibilities unrelated to the QA program that would 
prevent full attention to QA matters. 

F. Be responsible for identifying quality problems, initiating, recommending, or 
providing solutions to quality problems, and verifying solutions to quality 
problems. 
G. Be responsible for verifying the proper establishment and execution of the QA 
program. 
H. Have the authority to stop work when significant conditions adverse to quality 
warrant such action. 
1.2.3 Responsibility for Quality 
Quality shall be achieved and maintained by those who have been assigned 
responsibility for performing work. Quality achievement shall be verified by persons 
or organizations not directly responsible for performing the work. 
1.2.4 Delegation of Work 
Positions or organizations responsible for establishing and executing the QA program 
may delegate work to other organizations. The positions or organizations making the 
delegation shall retain overall responsibility for the delegated work. 
1.2.5 Resolution of Quality Disputes 
Differences of opinion involving 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 Deputy Director, 
Office of Repository Development (ORD), has ultimate resolution authority. 
1.3 DESCRIPTION 
1.3.1 General Description of the YMP 
A. YMP is comprised of the Office of the Deputy Director, ORD; the OQA; the Office 
of License Application and Strategy; the Office of Facility Operations; the Office of 
Business Support; the Office of Project Management and Engineering; and the 
Office of Performance Management and Improvement. The YMP organization, 
including those organizations reporting to the Office of Strategy and Program 
Development (OSPD) which support the YMP, are illustrated in Figure 1-1. 
B. Any substantial YMP reorganization of descriptions or functions of the offices 
described herein, will require a revision to this document. 

1.3.2 Specific YMP Offices 
A. Office of Repository Development 
1. The Deputy Director, ORD is responsible for licensing, design, procurement, 
construction, and pre-operational testing for the YMP. The Deputy Director, 
ORD is also responsible for directing the day-to-day YMP activities and has 
authority to stop unsatisfactory work performed by Affected Organizations and 
suppliers performing quality-affecting work on the YMP. Specific duties and 
responsibilities of the Deputy Director, ORD include: 
 Chief Nuclear Officer and signature authority for the DOE YMP License 
Application 
 Certification Official for the Licensing Support Network (LSN) 
 Direction and administration of ORD staff 
 Development, organization, and maintenance of control and oversight of 
the technical and quality functions of Affected Organizations in their 
support of the Project 
 Development of overall plans and schedules for licensing, design, 
procurement, construction, and testing activities 
 Development and implementation of technical and administrative controls 
to ensure quality objectives are met 
 Direction, coordination, and review of YMP Management and Operating 
Contractor (M&O) activities including design, procurement, license 
application preparation, and on-site construction testing activities 
 Review and acceptance of contract required quality-related deliverables 
submitted by the Affected Organizations and suppliers. 
2. The following functional organizations report to the Deputy Director, ORD: 
a. The Office of Quality Assurance 
The OQA is responsible for the QA functions for the YMP program. The 
QA functions are: 
 Ensuring that a QA program that meets regulatory and management 
requirements is established, maintained, and effectively executed. 

 Verifying that activities subject to the QARD have been correctly 
performed by reviews, surveillance, and audits (compliance and 
performance based), or other means of verification, as appropriate. 
The OQA is responsible for providing guidance and direction to 
organizations responsible for performing activities subject to the QARD on 
QA matters relating to YMP activities; performing overview of YMP 
Affected Organizations activities subject to the QARD, including 
verification and evaluation activities, using appropriate verification 
methods; ensuring lines of communication with other YMP Affected 
Organizations QA organizations are established and maintained; and 
reporting the overview results to senior management. 
b. Office of License Application and Strategy 
The Director, Office of License Application and Strategy is responsible for: 
 Developing the License Application 
 Regulatory strategy regarding U.S. Nuclear Regulatory Commission 
(NRC) licensing 
 NRC interaction 
 Post-closure performance assessment 
 Performance confirmation. 
c. Office of Facility Operations 
The Director, Office of Facility Operations is responsible for: 
 Managing site operations 
 Managing site support infrastructure 
 Ensuring that site construction and operations activities comply with 
applicable federal, state, local, and Indian tribe statutes 
 Managing the construction of facilities and structures associated with 
the Project, including underground construction of the Exploratory 
Studies Facility, surface-based testing facilities, and general support 
facilities and drilling operations 
 Managing and integrating all aspects of field operations including 
engineering, design, construction, and site testing activities 

 Ensuring YMP compliance with radiological protection standards and 
regulations 
 Managing the YMP Safeguards and Physical Security Program. 
d. Office of Business Support 
The Director, Office of Business Support is responsible for: 
 Ensuring execution of procurement documents 
 Developing the ORD federal employee training program 
 Overseeing contractor training programs 
 Verifying education and experience of applicable ORD employees 
 Overseeing contractor records management system. 
e. Office of Project Management and Engineering 
The Director, Office of Project Management and Engineering is 
responsible for: 
 Establishing requirements to ensure that the design meets all repository 
nuclear safety and performance requirements 
 Monitoring contractor design activities including the development of 
designs for individual features as well as adequacy of design products 
 Providing overall direction and approving the basis for placement of 
items on the Q-List (See subsection 2.2.3) 
 Pre-closure safety 
 Managing the YMP technical baseline. 
f. Office of Performance Management and Improvement 
The Office of Performance Management and Improvement is responsible 
for: 
 Coordinating the development of YMP procedures 
 Overseeing contractor document development and control system 
 Development and oversight of the YMP document hierarchy and the 
document management system 
 Identification, dissemination, and maintenance of YMP programmatic 
requirements 

 Management and oversight of YMP Corrective Action Program 
activities. 
B. Office of Strategy and Program Development 
The Office of Strategy and Program Development works with ORD in providing 
support to the YMP in the following areas: 
1. Office of Systems Analysis and Strategy Development 
The Office of System Analysis and Strategic Development (OSASD) is 
responsible for establishing waste acceptance requirements for repository and 
transportation projects; coordinating and maintaining Program interface with 
Office of Environmental Management (EM), Naval Nuclear Propulsion 
Program (NNPP), National Nuclear Security Administration, and other DOE 
offices on waste management disposal activities; developing waste acceptance 
criteria for DOE spent nuclear fuel and high-level radioactive waste; reviewing 
applicable nuclear regulatory requirements for impact and incorporating into 
Program plans and activities; establishing, implementing, and overseeing 
Safeguards policy; managing the OCRWM Security Program; and managing 
the standard contracts for disposal of spent nuclear fuel and/or high-level 
radioactive waste with owners and generators. 
2. Office of National Transportation 
The Office of National Transportation is responsible for defining requirements 
for the National Transportation Program; requests for proposal development, 
evaluations, award, cost and schedule, and work plans; monitoring contractor 
performance of activities supporting the National Transportation Program; and 
coordinating issues with the NRC, DOE/EM, U.S. Air Force, U.S. Department 
of Transportation, and NNPP, as appropriate, related to transportation 
alternatives and options. 
3. Office of Science and Technology and International 
The Office of Science and Technology and International is responsible for 
identifying, evaluating, and supporting scientific investigations and analyses of 
current and developing technologies. 
4. Office of Program Management 
The Office of Program Management is responsible for managing the Program 
Change Control process and implementing the Program Change Control Board; 
establishing procedures and training materials and coordinating the 
implementation of a configuration management system for the cost and 
schedule baseline and OCRWM Change Control Boards; establishing policy 

for training of DOE and contractor personnel on the OCRWM program 
(including QA training); overseeing the verification of qualifications of 
OCRWM personnel to ensure compliance with program QA requirements; 
managing the HQ training program; preparing the OCRWM Training Plan; 
developing an OCRWM orientation program for HQ employees; developing 
and managing the OCRWM Information Technology (IT) Program; monitoring 
contractor development and implementation of information management 
activities; and issuing policy and procedural guidance on IT Strategic Planning, 
Network and Telecommunications, and Information Architecture Baseline 
Configuration Management. 
1.3.3 YMP Affected Organizations and Direct Support Organizations 
A. YMP Affected Organizations 
1. YMP Affected Organizations include: specific programs within the DOE that 
have material planned for disposition at a monitored geologic repository, U.S. 
Geological Survey (USGS), YMP Management and Operating Contractor 
(M&O), and National Laboratories performing work for YMP (i.e., Los 
Alamos National Laboratory, Lawrence Berkeley National Laboratory, 
Lawrence Livermore National Laboratory, and Sandia National Laboratories). 
2. The QARD requirements for each YMP Affected Organization are identified in 
the appropriate procurement documents. When a Memorandum of 
Understanding, Memorandum of Agreement, Program Guidance 
Memorandum, or other document serves as a procurement document, it shall 
include the scope of work and appropriate technical and QA requirements. 
3. YMP Affected Organizations perform work subject to the QARD in 
accordance with implementing documents developed and maintained by YMP 
Affected Organizations. For certain tasks and when agreed to by involved 
organizations, an implementing document may apply to more than one YMP 
Affected Organization. 
4. YMP Affected Organizations, with the exception of the USGS and National 
Laboratories, evaluate and verify implementation of their activities through 
reviews; surveillance; audits (compliance and performance based) and 
inspection of systems, structures and components; or other means of 
verification, as appropriate. The M&O QA organization performs the 
evaluation and verification of the M&O, M&O subcontractors and suppliers, 
USGS, and National Laboratories activities. 

5. The YMP Affected Organizations position responsible for evaluation and 
verification activities shall be occupied by an individual with appropriate 
knowledge and experience in management and QA. The position shall: 
a. Be at the same or higher organization level as the highest line manager 
directly responsible for performing work subject to the QARD. 
b. Be sufficiently independent from cost and schedule considerations. 
c. Have the organizational freedom to effectively communicate with other 
senior management positions. 
d. Have no other assigned responsibilities that would prevent full attention to 
QA matters. 
e. Be responsible for identifying quality problems; initiating, recommending, 
or providing solutions to quality problems; and verifying solutions to 
quality problems. 
f. Have the authority to stop work when significant conditions adverse to 
quality warrant such action. 
g. Be responsible for providing guidance and direction to organizations 
responsible for performing activities subject to the QARD on QA matters 
relating to the YMP Affected Organizations activities. 
6. YMP Affected Organizations ensure lines of communication are established 
and maintained between their QA organizations and the OQA. 
B. YMP Direct Support Organizations 
YMP Direct Support Organizations perform work subject to the QARD in 
accordance with the appropriate YMP Affected Organizations implementing 
documents. YMP Direct Support Organizations are not required to develop and 
maintain implementing documents. 

YUCCA MOUNTAIN PROJECT 
FIGURE 1-1 

2.0 QUALITY ASSURANCE PROGRAM 
2.1 GENERAL 
This section establishes the applicability of the Quality Assurance Requirements and 
Description (QARD) document, and the requirements for planning, implementing, and 
maintaining the Quality Assurance (QA) program. This section also establishes 
requirements for special topics related to the QA program. The QA program 
establishes requirements to ensure that work meeting the criteria described in 
Subsection 2.2.2, QA Program Applicability and Related Activities; Subsection 2.2.3, 
Classifying Structures, Systems, and Components; and Subsection 2.2.4, Applying QA 
Controls, 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 QA Program Documents 
A. Affected Organizations shall issue a policy statement signed by senior line 
management directing mandatory compliance with this QA program. 
B. Affected Organizations shall establish implementing documents applicable to their 
scope of work that translate Quality Assurance Requirements and Description 
(QARD) requirements into work processes. The following requirements apply to 
implementing documents. 
1. Each Affected Organization shall establish a structured system of 
implementing documents that provides for top down implementation of the 
QARD or, if stipulated in procurement documents, shall work to the 
implementing documents of another Affected Organization. 
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 external interfaces between 
Affected Organizations and internal interfaces within an organization. 
4. Each Affected Organization shall review revisions to the QARD and 
incorporate changes into their implementing documents, as appropriate. 
C. Each Affected Organization shall complete a QARD requirements matrix for the 
portion of the QARD which they are implementing. 

1. The matrix shall identify: 
a. Where the QARD requirements are directly addressed. 
b. Where QARD requirements are not applicable based on scope of work. 
c. Where exceptions to QARD requirements have been taken including 
justification. 
2. Initial QARD requirements matrices shall be reviewed by the Office of Quality 
Assurance (OQA) in accordance with QARD Subsection 2.2.10, Document 
Review. 
3. As changes are made to implementing documents each Affected Organization 
shall ensure that respective QARD requirements matrices are revised if 
necessary. 
4. Changes to QARD requirements matrices shall be reviewed by the QA 
organization in accordance with Subsection 2.2.10. Changes delineated in 
Paragraph 2.2.1C.1b and 2.2.1C.1c shall be reviewed by the OQA in 
accordance with Subsection 2.2.10. 
2.2.2 QA Program Applicability and Related Activities 
The QA program shall be applied to: 
A. All structures, systems, and components (SSCs) important to safety or waste 
isolation 
B. Design and characterization of barriers important to waste isolation, and 
C. Related activities: 
1. Performance of the preclosure safety analysis (PCSA), total system 
performance assessment (TSPA), and their inputs. 
2. Characterization related activities (i.e., acquisition, control, and analysis of 
samples and data), tests and experiments, and scientific studies that provide 
data to support PCSA, performance confirmation and total system performance 
assessment. 
3. Activities that are important to waste isolation and important to the safety 
functions of those SSCs (i.e., design, purchasing, fabricating, handling, 
packaging, shipping, storing, cleaning, erecting, installing, inspecting, testing, 
maintaining, repairing, and modifying SSCs). 

4. Activities related to U.S. Department of Energy (DOE) high-level waste form 
from development through qualification, production, and acceptance. 
5. Activities related to the characterization of DOE spent nuclear fuel, and its 
conditioning, treatment, and/or canisterization through acceptance. 
2.2.3 Classifying Structures, Systems, and Components 
The SSCs of the repository shall be classified based upon the importance to safety 
and/or importance to waste isolation. The classification of the SSCs shall be 
documented on a Q List. 
2.2.4 Applying QA Controls 
QA controls (grading) shall be applied to the degree commensurate with the: 
A. Function or end use of the item. 
B. Consequence of failure (risk) of the item. 
C. Importance of the data being collected or analyzed. 
D. Complexity of design or fabrication of the item or design or implementation of the 
activity. 
E. Reliability of the process. 
F. Reproducibility of the results. 
G. Uniqueness of the item or degree of standardization. 
H. History of the item or service quality. 
I. Necessity for special controls or processes. 
J. Degree to which functional compliance can be demonstrated through inspection or 
test. 
2.2.5 Planning Work 
Planning shall be documented to ensure work is accomplished under suitably controlled 
conditions. Planning elements shall include, as appropriate: 
A. Definition of the work scope, objectives, and a listing of the primary tasks involved. 

B. Identification of scientific approach or technical methods used to collect, analyze, 
or study results of applicable work. 
C. Identification of applicable standards and criteria. 
D. Identification and selective application, or development, of appropriate 
implementing documents. 
E. Identification of field and laboratory testing equipment, or other equipment. 
F. Identification of, or provisions for the identification of, required records and the 
recording of objective evidence of the results of the work performed. 
G. Identification of QA program verifications of the work performed. 
H. Identification of prerequisites, special controls, environmental conditions, 
processes, or skills. 
I. Identification of computer software. 
2.2.6 Surveillances 
Surveillances shall be conducted to evaluate the quality of selected work subject to the 
QARD. Surveillances shall be: 
A. Conducted to verify the quality of work in progress; to identify conditions adverse 
to quality; to ensure that prompt corrective action is taken by management 
responsible for performing the work; and to verify the timely implementation, 
adequacy, and effectiveness of corrective action. 
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. 
2.2.7 Management Assessments 
The Office of Repository Development shall perform or direct the performance of 
management assessments of Affected Organizations by personnel outside the QA 
organization. Management Assessment shall: 
A. Be planned and documented, and performed annually. 
B. Evaluate the: 
1. Adequacy of resources and personnel provided to achieve and assure quality. 

2. Adequacy of the QA program. 
3. Effectiveness of the QA program. 
C. Be documented and results shall be distributed to Affected Organization 
management. 
2.2.8 Readiness Reviews 
The need for readiness reviews shall be identified by Affected Organization 
management for major scheduled or planned work to ensure 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. 
C. Detailed implementing documents and management controls are available and 
approved. 
2.2.9 Peer Reviews 
A. Peer reviews shall be conducted when the adequacy of information or the suitability 
of implementing documents and methods essential to meet specified objectives 
cannot be established through testing, alternate calculations, or reference to 
previously established standards and practices. 
The following conditions are situations for which a peer review shall be considered: 
1. Critical interpretations or decisions will be made in the face of significant 
uncertainty, including the planning for data collection, research, or exploratory 
testing. 
2. Decisions or interpretations having significant impact on performance 
assessment results will be made. 
3. Novel or beyond the state-of-the-art testing, plans and procedures, or analyses 
will be utilized. 
4. Detailed technical criteria or standard industry procedures are not available. 
5. Results of tests are not reproducible or repeatable. 
6. Data or interpretations are ambiguous. 
7. Data adequacy is questionable (e.g., the data may not have been collected in 
conformance with an established QA program). 

B. Management shall determine the need for and, as appropriate, shall initiate peer 
reviews when the adequacy of a critical body of information can be established by 
alternate means, but there is significant disagreement regarding the applicability or 
appropriateness of the alternate means. 
C. In conducting a peer review, management shall ensure that the: 
1. Number of the peer reviewers is commensurate with the complexity of work to 
be reviewed, its importance to Program objectives, the number of technical 
disciplines involved, the degree to which uncertainties in the data or technical 
approach exist, and the extent to which differing viewpoints are strongly held 
within the applicable technical and scientific community concerning issues 
under review. 
2. Collective technical expertise and qualifications of the peer reviewers span the 
technical issues and areas involved in the work to be reviewed, including 
differing bodies of scientific thought. 
3. Technical areas central to the work to be reviewed receive appropriate 
proportional representation among the peer reviewers. 
4. Potential for technical or organizational partiality is minimized. 
5. Peer review group chairperson is identified. 
D. Peer reviews shall be performed by individuals that have: 
1. Technical qualifications in the review area at least equivalent to that needed for 
the work under review. 
2. Technical credentials that are recognized and verifiable. 
3. Independence from the work under review. Independence means that the 
individual was not involved as a participant, supervisor, technical reviewer or 
advisor in the work under review and is, to the extent practical, free from any 
funding considerations. 
NOTE: In those cases where total independence cannot be met, the rationale 
as to why someone of equivalent technical qualification and greater 
independence was not selected shall be documented in the peer 
review report. 
E. Initiation of the peer review shall require the development of a planning document 
that: 
1. Specifies the work to be reviewed. 

2. Identifies the size and spectrum of the peer review group. 
3. Describes the expected method and reporting schedule. 
4. Establishes review criteria that shall include, as appropriate: 
a. Validity of the assumptions. 
b. Alternate interpretations. 
c. Adequacy of requirements and criteria. 
d. Appropriateness and limitations of the methods and implementing 
documents used to complete the work under review. 
e. Adequacy of application. 
f. Accuracy of calculations. 
g. Validity of conclusions. 
h. Uncertainty of results and impact if wrong. 
F. The peer review chairperson shall provide a report that: 
1. Is signed by each peer reviewer or contains information detailing which peer 
reviewers have chosen not to sign and why. 
2. States the work or issue that was reviewed and the conclusions of the review. 
3. Includes individual statements by the peer reviewers reflecting dissenting 
views or additional comments, as appropriate. 
4. Includes a listing of the peer reviewers and a statement that the qualifications 
and experience of each reviewer have been evaluated and are acceptable. 
2.2.10 Document Review 
Implementing documents and documents that specify technical or quality requirements 
shall be reviewed to the following requirements and for 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. Pertinent background information or data shall be made available to the reviewers 
by the organization requesting the review if the information is not readily available 
to the reviewer. 
C. The review shall be performed by individuals other than the preparer. 
D. Reviewers shall be technically competent for the subject area of the document being 
reviewed. 
E. The scope of the review shall consider all aspects of the document. 
1. Each organization or technical discipline affected by the document shall review 
the document according to the established review criteria. Changes to the 
document shall be reviewed by those organizations or technical disciplines 
affected by the change. 
2. The QA organization shall review implementing documents and changes 
thereto that translate the QARD into work processes as described in 
Subsection 2.2.1, QA Program Documents. The QA organization also shall 
review changes to other documents if they were required to review the 
previous version, unless the QA organization has concurred that its review is 
no longer required. 
F. Mandatory comments resulting from the review shall be documented and resolved 
before approving the document. 
2.2.11 QA Program Information Management 
Affected Organization management shall on a continuing basis be apprised of the 
status, adequacy and compliance aspects of the QA Program. Appropriate management 
shall receive, as a minimum, audit reports, surveillance reports, trend reports and 
management assessment reports. 
2.2.12 Personnel Qualification 
A. Each Affected Organization shall indoctrinate and train personnel as follows: 
1. Determine required indoctrination and training. 
2. 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. 
3. Evaluate and assess the need for additional indoctrination and training as 
assignments, positions, or implementing documents change. 

4. Ensure indoctrination and training are completed prior to performing the work. 
5. 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. Applicable implementing documents. 
c. Job responsibilities and authority. 
B. For personnel who perform or manage design, scientific investigation (including 
performance assessment and performance confirmation), software development 
activities and for personnel who verify or manage the verification of design, 
scientific investigation (including performance assessment and performance 
confirmation), software development activities, or items, Affected Organizations 
shall ensure that: 
1. Descriptions are established for the positions those personnel occupy. 
2. Minimum education and experience requirements are established for each 
position commensurate with the scope, complexity, and nature of the work. 
3. Personnel have experience and education commensurate with the minimum 
requirements established. 
4. Minimum education and experience are verified or, when minimum education 
and experience cannot be verified, documented justification is provided for the 
personnel assignment. 
2.2.13 Qualification of Personnel Who Perform Inspection, Nondestructive Examination, 
Testing, and Auditing 
Personnel who perform inspection, nondestructive examination, testing, and auditing 
shall be qualified in accordance with the requirements of the applicable QARD section 
covering the activity and QARD Subsection 2.2.12, Personnel Qualification. 

3.0 DESIGN CONTROL 
3.1 GENERAL 
This section provides requirements to ensure that designs are defined, controlled, and 
verified. 
3.2 REQUIREMENTS 
3.2.1 Design Input Control 
Applicable design inputs (such as design bases, conceptual design reports, performance 
requirements, 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. 
C. Changes from approved design inputs and reasons for the changes shall be 
identified, approved, documented, and controlled. 
D. 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 the design process to be carried out in a correct 
manner. 
B. Design documents shall be adequate to support design, fabrication, construction, 
and operation. 
C. Appropriate standards shall be identified and documented, and their selection 
reviewed and approved. 
D. Changes from specified standards, including the reasons for the change, shall be 
identified, approved, documented, and controlled. 

E. Design methods, materials, parts, equipment, and processes that are essential to the 
function of an item shall be selected and reviewed for suitability of application. 
F. Applicable information derived from experience, as set forth in reports or other 
documentation, shall be made available to cognizant design personnel. 
G. Design 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 understand the documents and verify their adequacy without recourse to 
the originator. 
H. The final design shall identify assemblies or components that are part of the item 
being designed. If a commercial grade assembly or component is modified or 
selected by special inspection or testing to meet requirements that are more 
restrictive than the supplier's published product description, then the assembly or 
component shall be represented as different from the commercial grade item in a 
manner traceable to a documented description of the difference. 
I. Drawings, specifications, and other design output documents shall contain 
appropriate inspection and testing acceptance criteria. 
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. Calculations shall be identifiable by subject (including structure, system, or 
component to which the calculation applies), originator, reviewer, and date, or by 
other designators such that the calculations are traceable. 
D. Computer software used to perform design analyses shall be developed or qualified, 
and used according to the requirements of Supplement I, Software. 
E. Documentation of design analyses shall include: 
1. Definition of the objective of the analyses. 
2. Definition of design inputs and their sources. 
3. Results of literature searches or other applicable background data. 
4. Identification of assumptions. 

5. Identification of any computer calculation, including computer type, computer 
program (e.g., name), revision identification, inputs, outputs, and the bases (or 
reference thereto) supporting application of the computer program to the 
specific physical problem. 
6. Identification of the originator, reviewer, and approver. 
3.2.4 Design Verification 
In addition to reviewing completed design analyses and design output in accordance 
with QARD Subsection 2.2.10, Document Review, the following design control 
requirements shall be applied: 
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. 
2. Alternate calculations. 
3. Qualification testing. 
B. The particular design verification method shall be identified and its use justified. 
C. The results of design verification shall be documented, including the identification 
of the verifier. 
D. Design verification shall be performed by competent individuals or groups other 
than those who performed the original design but may be from the same 
organization. If necessary, this verification may be performed by the originator's 
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; or 
2. The supervisor is the only individual in the organization competent to perform 
the verification. 
3. The verification is not hastily and superficially done. 
4. The determination to use the supervisor is documented and approved, in 
advance, with concurrence of the QA organization. 
E. Design verification shall be performed at appropriate times during the design 
process. 

1. Verification shall be performed before release for procurement, manufacture, 
or construction or release to another organization for use in other design work. 
In some cases (such as when insufficient data exists) it may be necessary to 
release unverified designs to support schedule requirements. Unverified 
portions of the design shall be clearly identified and controlled 
2. In all cases, design verification shall be completed before relying on the item to 
perform its function. 
F. The extent of the design verification required shall be a function of the importance 
to safety or waste isolation, complexity of design, degree of standardization, state of 
the art, and similarity with previously proven designs. 
G. Where the design has been subjected to a verification process in accordance with 
this Quality Assurance Requirements and Description, the verification process need 
not be duplicated for identical designs. 
H. Use of previously proven designs shall be controlled according to 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. 
I. Changes in previously verified designs shall require reverification. Such 
verification shall include the evaluation of the effects of those changes on the 
overall previously verified design and on any design analysis upon which the design 
is based. 
3.2.5 Design Reviews 
Design reviews shall be controlled and performed to ensure: 
A. The design inputs were correctly selected and incorporated. 
B. Assumptions necessary to perform the design were adequately described, 
reasonable and where applicable, identified as requiring confirmation as the design 
proceeds. 
C. Appropriate design methods, and computer programs when applicable, were used. 

D. The design outputs are reasonable compared to design inputs. 
E. The necessary design input for interfacing organizations were specified in the 
design documents. 
3.2.6 Alternate Calculations 
The appropriateness of assumptions, input data, and the computer program or other 
calculation method used shall be reviewed, and the results shall be checked through the 
use of alternate calculation methods to verify the correctness of the original calculations 
or analyses. 
3.2.7 Qualification Testing 
A. If design adequacy is to be verified by qualification tests, the tests shall be in 
accordance with Section 11.0, Test Control. 
B. The test configuration shall be defined and documented. 
C. Testing shall demonstrate the adequacy of performance under conditions that 
simulate the most adverse design conditions. Operating modes and environmental 
conditions in which the item must perform satisfactorily shall be considered in 
determining the most adverse conditions. 
D. If the tests verify only specific design features, then the other features of the design 
shall be verified by other means. 
E. Test results shall be documented and evaluated to ensure that test requirements have 
been met. 
F. If qualification testing indicates that a modification to an item is necessary to obtain 
acceptable performance, then the modification shall be documented and the item 
modified and retested or otherwise verified to ensure satisfactory performance. 
G. When tests are being performed on models or mockups, scaling laws shall be 
established and reviewed and approved. 
H. The results of model test work shall be subject to error analysis, where applicable, 
before using the results in final design work. 

3.2.8 Design Change Control 
Design changes shall be controlled according to 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. Design control measures for changes shall include provisions to assess the effect of 
the changes on the overall previously verified design and ensure that the design 
analyses for the item are still valid. 
C. 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, then a new responsible organization 
shall be designated; and 
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. 
D. 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. These design deficiencies shall be 
documented in accordance with Section 16.0, Corrective Action. Additionally, if 
the incorrect design causes constructed or partially constructed systems, structures, 
or components to be nonconforming, the affected items shall be controlled in 
accordance with Section 15.0, Nonconformances. 
E. Field changes shall be incorporated into affected design documents when such 
incorporation is appropriate, and when a field change is approved other than by 
revision to the affected design documents. 
F. Design changes that impact related implementing documents or training programs 
shall be communicated to organizations affected by the change. 
3.2.9 Design Interface Control 
A. Design interfaces shall be identified and controlled. 
B. Design efforts shall be coordinated among participating organizations and groups. 
C. Interface controls shall include the assignment of responsibility and the 
establishment of implementing documents among participating design 

organizations and groups for the review, approval, release, distribution, and revision 
of documents involving design interfaces. 
D. Design information transmitted across interfaces shall be documented and 
controlled. 
E. The status of the design information or document provided shall be identified in 
transmittals. Designs or portions of designs that require further development, 
analysis, review, or approval shall be identified. 
F. 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. 

4.0 PROCUREMENT DOCUMENT CONTROL 
4.1 GENERAL 
This section establishes requirements to ensure that procurement documents, and any 
changes thereto, contain appropriate technical and quality assurance requirements. 
4.2 REQUIREMENTS 
4.2.1 Procurement Document Preparation 
Procurement documents issued by each Affected Organization shall include the 
following provisions, as applicable to the item or service being procured: 
A. A statement of the scope of work to be performed by the supplier. 
B. Technical requirements including: 
1. Design bases shall be identified or referenced. 
2. Specific documents (such as drawings, codes, standards, regulations, 
procedures, or instructions) 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. Quality Assurance Program Requirements including: 
1. A requirement for the supplier to have a documented Quality Assurance (QA) 
program that implements applicable Quality Assurance Requirements and 
Description, (QARD) requirements prior to the initiation of work. The extent 
of the QA program shall depend on the scope, nature, or complexity of the item 
or service being procured. 
2. A requirement for the supplier to incorporate the appropriate QARD 
requirements into any subtier supplier-issued procurement document. 
3. When deemed appropriate, the purchaser shall permit some or all supplier 
work to be performed under the purchaser's or another Affected Organization's 
QA program provided the work is adequately addressed. In these cases, 
procurement documents shall specify that the purchaser's or another Affected 
Organization's implementing documents are applicable to the supplier and that 
the purchaser shall provide these applicable documents to them. 

D. Right of access to supplier facilities and records for inspection or audit by the 
purchaser, Yucca Mountain Project, or other designee authorized by the purchaser. 
E. Provisions for establishing hold points beyond which work cannot proceed without 
purchaser authorization. 
F. Documentation required to be submitted to the purchaser for information, review, 
or acceptance: 
1. The document submittal schedule shall be identified. 
2. If the purchaser requires the supplier to maintain documentation that will 
become QA records, the retention times and disposition requirements shall be 
identified. 
G. Purchaser requirements for the supplier to report nonconformances and the 
purchaser approval of the disposition of nonconformances. 
H. Identification of any spare and replacement parts or assemblies and the appropriate 
technical and QA data required for ordering. 
4.2.2 Procurement Document Review and Approval 
A. Procurement document reviews in accordance with Subsection 2.2.10, Document 
Review, shall be performed and documented prior to issuance of the procurement 
documents to the supplier. 
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 technical and QA program requirements are 
included. 
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 document reviewers shall include representatives from the technical 
and QA organizations. 
F. Procurement documents shall be approved. 

4.2.3 Procurement Document Change 
A. Changes to the scope of work, technical requirements, QA program requirements, 
right of access, documentation requirements, nonconformances, hold points, and 
lists of spare and replacement parts delineated in procurement documents 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 precontract 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. 
This evaluation shall consider: 
1. Appropriate requirements as specified in this section. 
2. Additional or modified design criteria. 
3. Analysis of exceptions or changes requested or specified by the supplier 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. 

5.0 IMPLEMENTING DOCUMENTS 
5.1 GENERAL 
This section establishes the requirements to ensure that work is prescribed by, and 
performed in accordance with, written implementing documents. 
5.2 REQUIREMENTS 
Work shall be performed in accordance with controlled implementing 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. Implementing documents include 
documents such as procedures, instructions, and drawings, with the exception of 
drawings governed by Section 3.0, Design Control. 
5.2.2 Content of Implementing Documents 
Implementing documents shall include the following information as appropriate to the 
work to be performed: 
A. Responsibilities and organizational interfaces of the organizations affected by the 
document. 
B. Technical and regulatory requirements. 
C. A sequential description of the work to be performed including controls for altering 
the sequence of required inspections, tests, and other operations. The organization 
responsible for preparing the document shall determine the appropriate level of 
detail. 
D. Quantitative or qualitative acceptance criteria sufficient for determining that 
activities were satisfactorily accomplished. 
E. Prerequisites, limits, precautions, process parameters, and environmental 
conditions. 
F. Quality verification points and hold points. 
G. Methods for demonstrating that the work was performed as required (such as 
provisions for recording inspection and test results, checkoff lists, or signoff 
blocks). 

H. Identification of the lifetime and nonpermanent quality assurance records generated 
by the implementing document. 
I. Identification of associated items and activities. 
5.2.3 Review and Approval of Implementing Documents 
Implementing documents shall be reviewed, approved, and controlled in accordance 
with Section 6.0, Document Control. 
5.2.4 Compliance with Implementing Documents 
Individuals shall comply with implementing documents, however: 
A. When work cannot be accomplished as described in the implementing document, or 
accomplishment of such work would result in an undesirable situation, the work 
shall be stopped. 
B. Work shall not resume until the implementing document is changed (in accordance 
with Section 6.0, Document Control) to reflect the correct work practices. 

6.0 DOCUMENT CONTROL 
6.1 GENERAL 
This section establishes requirements to ensure documents, including changes thereto, 
are reviewed for adequacy, approved for release, and distributed to and used at the 
location where the work is being performed. 
6.2 REQUIREMENTS 
6.2.1 Types of Documents 
Implementing documents and documents that specify technical requirements or quality 
requirements shall be controlled in accordance with this section. 
6.2.2 Preparing Documents 
The responsibility for preparing and maintaining documents shall be assigned to the 
appropriate organization. 
6.2.3 Reviewing Documents 
Documents shall be reviewed in accordance with the requirements of 
Subsection 2.2.10, Document Review. 
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 
The distribution and use of documents, including changes and editorial corrections to 
documents, shall include the following: 
A. Documents, either in hardcopy or electronic media, used to perform work shall be 
distributed to, or made available to, and used at, the work location. 
B. Effective dates shall be established for approved implementing documents. 
C. The disposition of obsolete or superseded documents shall be controlled to ensure 
that they are not used to perform work. 
D. A method shall be established to identify the current status of each document that is 
required to be controlled in accordance with this section. 

6.2.6 Changes to Documents 
A. Changes to documents shall be reviewed in accordance with the requirements of 
Subsection 2.2.10, Document Review, prior to approval for release. 
B Changes shall be approved for release by the designated organizational position that 
is 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 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. 
6.2.7 Expedited Changes 
If an activity cannot be performed as listed in a document, and the change process 
would cause unreasonable delays, then 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 
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. 

A. The following items are considered editorial corrections: 
1. Correcting grammar or spelling. 
2. Renumbering sections or attachments which do not affect the chronological 
sequence of work. 
3. Changing the title or number of the document. 
4. Updating organizational titles. 
NOTE: A change in an organizational title accompanied by a change in 
responsibilities is not considered an editorial correction. 
B. The organizational position responsible for approving the document for release 
shall approve editorial corrections. 

7.0 CONTROL OF PURCHASED ITEMS AND SERVICES 
7.1 GENERAL 
This section establishes requirements for planning and executing procurements to 
ensure that purchased items and services meet specified requirements. This section 
does not apply to direct-support services used for staff augmentation. The supplier 
selection and bid/proposal evaluation requirements of this section do not apply to 
situations where the Yucca Mountain Project obtains the services of other Department 
of Energy offices or Federal agencies through Memoranda of Understanding, 
Memoranda of Agreement, Program Guidance Memoranda, Interagency Agreement or 
other documents containing appropriate technical and Quality Assurance (QA) 
requirements. Technical and QA requirements specified in these documents shall be 
verified to be satisfactorily incorporated into the applicable program prior to starting 
work subject to the Quality Assurance Requirements and Description (QARD). 
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. 
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. Identify and document the sequence of actions and milestones needed to effectively 
complete the procurement. 
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, Procurement Document Control. 
2. Selection of procurement sources. 
3. Proposal/bid evaluation and award. 
4. Evaluation of supplier performance. 
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 possible, and no later than at the start of those 
procurement activities which are required to be controlled. 
F. Be performed relative to the level of importance, complexity, and quantity of the 
item or service being procured and the supplier's quality performance. 
G. Include the involvement of the QA organization. 
7.2.2 Source Evaluation and Selection 
A. Supplier selection shall be based on an evaluation, performed before the contract is 
awarded, of the supplier's capability to provide items or services in accordance with 
procurement document requirements. 
B. The organizational responsibilities for source evaluation and selection shall be 
identified, including provisions for input from the QA organization. 
C. Measures for evaluating and selecting procurement sources shall include one or 
more of the following elements: 
1. Evaluation of the supplier's history for providing an identical or similar product 
which performs satisfactorily in actual use. 
2. Evaluation of supplier's current QA records supported by any documented 
qualitative and quantitative information. 
3. Evaluation of the supplier's technical and quality capability based on an 
evaluation of supplier facilities, personnel, and QA program implementation. 
D. The results of procurement source evaluation and selection shall be documented. 
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. Supplier personnel. 
4. Supplier production capability. 
5. Supplier 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. Supplier QA programs shall be evaluated either before or after contract placement, 
and any deficiencies that would affect quality shall be corrected before starting 
work subject to the QARD. 
E. Supplier QA programs shall be accepted by the purchaser before the supplier starts 
work subject to the QARD. 
7.2.4 Supplier Performance Evaluation 
A. The purchaser of items and services shall establish measures to interface with the 
supplier and to verify supplier's performance. The measures shall include: 
1. Establishing an understanding between the purchaser and supplier of 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. 
B. The extent of verifications shall be a function of the relative importance, 
complexity, and quantity of items or services being procured, and the supplier's 
quality performance. 

C. Verifications shall be conducted as early as practical and shall not relieve the 
supplier of the responsibility for the verification of quality achievement. 
Verifications shall include supplier audits used as a method of evaluating the 
supplier's performance, and evaluation of purchaser's documentation to aid in the 
determination of the effectiveness of the supplier's QA program. 
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 evaluation of 
technical, inspection, and test data compared against the acceptance criteria. 
7.2.6 Acceptance of Items or Services 
A. The supplier shall verify that furnished items or services comply with the 
purchaser's procurement document requirements before offering the items or 
services for acceptance. 
B. The supplier shall provide the purchaser objective evidence that items or services 
conform to procurement documents. The documentation shall be available at the 
purchaser's facility before the item is installed or before the service is accepted. 
C. Methods for accepting supplier furnished items or services shall include one or 
more of the following, as appropriate to the items or services being procured: 
1. Evaluating the supplier certificate of conformance. 
2. Performing one or a combination of source verification, receiving inspection, 
or post-installation test. 
3. Technical verification of the item or service. 
4. Surveillance or audit of the work. 
5. Review of objective evidence (such as certifications, stress reports, or 
personnel qualifications) for conformance to the procurement document 
requirements. 

7.2.7 Certificate of Conformance 
When a certificate of conformance is used to accept an item or 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. 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. 
D. The certificate shall be signed or otherwise authenticated by a person who is 
responsible for this QA function and whose responsibilities and position are 
described in the supplier's 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 supplier's QA program. 
F. Measures shall be identified to verify the validity of supplier certificates and the 
effectiveness of the certification process (such as 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. Source verification shall be implemented consistent with the supplier's planned 
inspections, examinations, or tests at predetermined points and performed at 
intervals consistent with the importance and complexity of the item. 
B. 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. 
C. Source verification shall be performed by personnel qualified in accordance with 
Section 2.0, Quality Assurance Program. 

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 established inspection 
implementing documents. 
C. The inspection shall verify, as applicable, 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, Inspection. 
E. Receiving inspection shall be coordinated with a review for adequacy and 
completeness of any required supplier 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, Test Control. 
7.2.11 Control of Supplier Nonconformances 
The purchaser and supplier shall establish and document the process for disposition of 
items that do not meet procurement document requirements according to the following 
requirements. 
A. The supplier shall evaluate nonconforming items according to the requirements of 
Section 15.0, Nonconformances. 
B. The supplier shall submit a report of nonconformance to the purchaser including 
supplier recommended disposition (e.g., 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 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. 

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 supplier's recommendation. 
D. The purchaser shall verify implementation of the disposition. 
7.2.12 Commercial Grade Items 
Where design specifies the use of commercial grade items, the following requirements 
are an acceptable alternative to other requirements of this section. 
A. The commercial grade item shall be identified in an approved design output 
document. An alternate commercial grade item may be applied, provided the 
responsible design organization provides verification that the alternate commercial 
grade item will perform the intended function and will meet design requirements 
applicable to both the replaced item and the application. 
B. Supplier evaluation and selection, when determined necessary by the purchaser 
based on the complexity and importance to safety, shall be in accordance with the 
requirements of the Subsection 7.2.2, Source Evaluation and Selection. 
C. Commercial grade items shall be identified in the procurement document by the 
manufacturer's published product description. 
D. After receipt of a commercial grade item, the purchaser shall ensure that: 
1. Damage was not sustained during shipment. 
2. The item received was the item ordered. 
3. Inspection or testing is accomplished, to the extent determined by the 
purchaser, to ensure conformance with the manufacturer's published 
requirements. 
4. Documentation, as applicable to the item, was received and is acceptable. 

8.0 IDENTIFICATION AND CONTROL OF ITEMS 
8.1 GENERAL 
This section establishes requirements to ensure that only correct and accepted items are 
used or installed. 
8.2 REQUIREMENTS 
8.2.1 Identification 
A. Identification shall be maintained on the items or in a manner which ensures that 
identification is established and maintained. 
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. 
8.2.2 Physical Markings 
A. Item identification methods shall include use of physical markings. If physical 
markings are either impractical or insufficient, other appropriate means shall be 
employed (such as 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 or coatings, or after 
installation unless other means of identification are substituted. 
8.2.3 Traceability 
A. Item identification methods shall ensure that traceability is established and 
maintained in a manner that allows an item to be traced to applicable design or 
other specifying documents. 
B. Item traceability documentation shall ensure that the item can be traced at all times 
from its source through installation or end use. 

8.2.4 Conditional Requirements 
The controls for items shall address the following requirements, as applicable: 
A. If codes, or standards include specific identification or traceability requirements 
(such as identification or traceability of the item to applicable specification or grade 
of material; heat, batch, lot, part, or serial number; or specified inspection, test, or 
other records), then 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 have a limited operating or shelf life specified, then methods shall be 
established that preclude using the item beyond the shelf or operating life. 
D. If item storage is required, then methods shall be established for the control of item 
identification that are 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. 

9.0 CONTROL OF SPECIAL PROCESSES 
9.1 GENERAL 
This section establishes the requirements for the control of special processes (such as 
welding, weld overlay, heat treating, chemical cleaning, and nondestructive 
examinations). 
9.2 REQUIREMENTS 
9.2.1 Special Processes 
A. Special processes that control or verify quality shall be controlled according to the 
requirements of this section whether or not they are covered by existing codes and 
standards, or whether or not the quality requirements specified for an item exceed 
those of existing codes or standards. 
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; or 
2. The results are highly dependent on the skill of the operator; and 
3. Quality of the results cannot be readily determined by inspection or test of the 
item. 
C. Based on this criteria, a list of the special processes that each Affected Organization 
will perform, or be responsible for performing, shall be established and maintained. 
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. Qualification requirements for personnel, implementing documents, and equipment. 
B. 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 or product, and individual 
performing the special process. 
C. Requirements of applicable codes and standards, including acceptance criteria for 
the special process. 

9.2.3 Qualification of Nondestructive Examination Personnel 
A. Nondestructive examination shall include radiography, magnetic particle, 
ultrasonic, liquid penetrant, eddy current, neutron radiography, and leak testing. 
B. Personnel that perform nondestructive examinations shall be qualified 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 SNT-TC-1A, June 1980 edition, Level III 
Nondestructive examination personnel may be recertified on a five year interval. 
C. The Affected Organization shall establish implementing documents for the control 
and administration for the training, examination, and certification of nondestructive 
examination personnel. 

10.0 INSPECTION 
10.1 GENERAL 
This section establishes requirements for planning and executing inspections. 
10.2 REQUIREMENTS 
10.2.1 Inspection Planning 
Inspection planning shall be performed, documented and include: 
A. Identification of each work operation where inspection is necessary to ensure 
quality and implementing documents that will be used to perform the inspections. 
B. Identification of the characteristics to be inspected and the identification of when, 
during the work process, inspections are to be performed. 
C. Identification of inspection or process monitoring methods to be employed. 
D. The final inspection shall be planned to arrive at a conclusion regarding 
conformance of the item to specified requirements. 
E. Identification of the functional qualification level (category or class) of personnel 
performing inspections. 
F. Identification of acceptance criteria. 
G. Identification of sampling requirements. 
H. Methods to record inspection results. 
I. Selection and identification of the measuring and test equipment to be used to 
perform the inspection to ensure that the equipment is calibrated and is of the 
proper type, range, accuracy, and tolerance to accomplish the intended function. 
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. 
B. Data recorders, equipment operators, or other inspection team members who are 
supervised by a qualified inspector shall not be required to be a qualified inspector. 
C. The inspections shall be performed by personnel other than those who performed or 
directly supervised the item being inspected and are independent of the organization 

directly responsible for that item. These personnel shall not report directly to the 
immediate supervisor responsible for the item being examined. 
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. 
10.2.5 In-Process Inspections and Monitoring 
A. Items in-process 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. 
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. 
B. Documentation 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 an item 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 of the inspector, or the inspector's unique identifier, 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 Qualifications of Inspection and Test Personnel 
A. Qualifications 
Personnel performing inspections as described in this section and personnel 
performing tests as described in Section 11.0 shall be qualified according to the 
indoctrination and training, education and experience, and physical requirements of 
this Section. These personnel shall have experience or training commensurate with 
the scope, complexity, or special nature of the inspections or tests. 

B. Determination of Initial Capabilities 
The capabilities of a candidate for certification shall be initially determined by an 
evaluation of the candidate's education, experience, and training; and either 
examination results or capability demonstration. The evaluation shall be performed 
to the requirements of the applicable functional level, and education and experience 
requirements of this Section. 
C. Indoctrination and Training of Inspection and Test Personnel 
1. Inspection and test personnel shall be indoctrinated to the technical objectives 
and requirements of the applicable codes and standards and the quality 
assurance program requirements that are to be employed in executing their 
responsibilities. 
2. The need for formal training shall be determined, and training shall be 
conducted as required to qualify personnel for performing inspections and 
tests. 
3. On-the-job training, with emphasis on hands-on experience gained through 
actual performance of inspections and test, shall be included in the training 
program. 
a. On-the-job training for personnel qualification shall be performed under the 
direct observation and supervision of a qualified person. 
b. The documented verification of conformance shall be performed by the 
qualified person and not by the person being administered on-the-job 
training. 
D. Functional Qualification Levels of Inspection and Test Personnel 
Three levels of functional qualification shall be used depending on the complexity 
of the functions involved. The criteria for each level are not limiting with regard to 
organizational position or professional status but, rather, are limiting with regard to 
functional work. 
1. Level I Personnel Capabilities 
Level I personnel shall be capable of performing and documenting the results 
of designated inspections or tests. 

2. Level II Personnel Capabilities 
Level II personnel shall have Level I capabilities for the corresponding 
category or class. Additionally, Level II personnel shall have demonstrated 
capabilities in: 
a. Inspection or test planning. 
b. Advanced preparation, including the preparation and setup of related 
equipment, as appropriate. 
c. Supervising or monitoring the inspections or tests. 
d. Supervising and certifying lower-level personnel. 
e. Evaluating the validity and acceptability of results. 
3. Level III Personnel Capabilities 
Level III personnel shall have Level II capabilities for the corresponding 
category or class. In addition, Level III personnel shall also be capable of 
evaluating the adequacy of specific programs used to train, qualify, and certify 
the personnel. 
E. Education and Experience Requirements for Inspection and Test Personnel 
The requirements for education and experience shall be considered with recognition 
that other factors commensurate with the scope, complexity, or special nature of the 
inspections or tests affect the assurance that a person can competently perform a 
particular task. Other factors that demonstrate capability in a given job and the 
basis for their equivalency shall be documented. 
1. Level I Inspection Personnel shall meet the following education and experience 
requirements: 
a. Two years of related experience in equivalent inspections or tests; or 
b. High school graduation and six months of related experience in equivalent 
inspections or tests; or 
c. Completion of college level work leading to an associate degree in a related 
discipline plus three months of related experience in equivalent inspections 
or tests. 

2. Level II Inspection personnel shall meet the following education and 
experience requirements: 
a. One year of satisfactory performance as a Level I in the corresponding 
category or class; or 
b. High school graduation plus three years of related experience in equivalent 
inspections or tests; or 
c. Completion of college level work leading to an associate degree in a related 
discipline plus one year of related experience in equivalent inspections or 
tests; or 
d. Graduation from a four-year college plus six months of related experience 
in equivalent inspections or tests. 
3. Level III Inspection personnel shall meet the following education and 
experience requirements: 
a. Six years of satisfactory performance as a Level II in the corresponding 
category or class; or 
b. High school graduation plus ten years of related experience in equivalent 
inspections or tests; or high school graduation plus eight years of 
experience in equivalent inspections or tests with at least two years as a 
Level II and with at least two years associated with nuclear facilities; or, if 
not, at least sufficient training to be acquainted with the relevant quality 
assurance program aspects of a nuclear-related facility; or 
c. Completion of college-level work leading to an associate degree and seven 
years of related experience in equivalent inspections or tests with at least 
two years of this experience associated with nuclear facilities -- or, if not, at 
least sufficient training to be acquainted with the relevant quality assurance 
program aspects of a nuclear-related facility; or 
d. Graduation from a four-year college plus five years of related experience in 
equivalent inspections or tests with at least two years of this experience 
associated with nuclear facilities -- or, if not, at least sufficient training to 
be acquainted with the relevant quality assurance program aspects of a 
nuclear-related facility. 
F. Physical Requirements for Inspection and Test Personnel 
The responsible organization shall identify any special physical characteristics 
needed for performance in each functional level (categories or class) including 

identifying the need for initial and subsequent visual acuity and other physical 
examinations. 
G. Certifying the Qualifications of Inspection and Test Personnel 
The qualifications of inspection and test personnel shall be certified in writing by 
the responsible organization. The certification shall document the: 
1. Name of the certifying organization. 
2. Identification of the person being certified. 
3. Qualified inspection and test categories or class the individual is certified to 
perform. 
4. Basis for certification (such as education, experience, indoctrination, training, 
examination results, and results of capability demonstration). 
5. Results of periodic evaluations. 
6. Results of visual acuity and physical examination when required. 
7. Date of certification and date of certification expiration. 
8. Signature of the organization's designated representative responsible for 
certification. 
H. Periodic Evaluation of Qualification for Inspection and Test Personnel 
1. The job performance of inspection and test personnel shall be reevaluated at 
periodic intervals not to exceed three years to ensure qualifications have been 
maintained. 
a. Reevaluation shall be by evidence of continued satisfactory performance or 
redetermination of required capability in accordance with the qualification 
requirements specified for the job as described in this section. 
b. If during this evaluation or at any other time the responsible organization 
determines that the capabilities of an individual are not in accordance with 
the qualification requirements specified for the job, that person shall be 
removed from the inspection or test until the required capability has been 
demonstrated. 
2. Any person who has not performed inspections or tests in their qualified area 
for a period of one year shall be reevaluated by a redetermination of required 
capability in accordance with this section. 

I. Maintaining Qualification Documentation for Inspection and Test Personnel 
1. Documentation of personnel qualification shall be established, kept current, 
and maintained by the responsible organization. This documentation shall 
contain the information required for the initial qualification and the 
maintenance of qualification. 
2. Documentation for each person shall be maintained and updated according to 
the following requirements: 
a. Removal of a person from performing in an area of certification when the 
responsible organization determines that the capabilities of the individual 
are not in accordance with the qualification requirements specified for the 
job as described in this section. This shall be documented at the time of 
removal. 
b. Reinstatement of certifications for the qualified area when the required 
capability has been demonstrated as described in this section. This shall be 
documented at the time of reinstatement. 
c. Continued performance in each certified area or redetermination of 
required capability as described in this section for each certified area shall 
be updated annually. 
d. Reevaluation of job performance by evidence of continued satisfactory 
performance or redetermination of capability as described in this section. 
This shall be updated every three years. 

11.0 TEST CONTROL 
11.1 GENERAL 
This section establishes requirements for planning and executing tests that are used to 
verify conformance of an item to specified requirements, or to demonstrate satisfactory 
performance for service. Examples of such tests include prototype qualification tests, 
production tests, proof tests prior to installation, construction tests, and pre-operational 
tests. 
Testing of computer software is performed in accordance with Supplement I. 
Activities required to collect data (such as for siting or design input) are performed in 
accordance with Supplement III. 
11.2 REQUIREMENTS 
11.2.1 Test Planning 
Test planning shall include: 
A. Identification of the implementing documents to be developed to control and 
perform tests. 
B. Identification of item to be tested and the test requirements and acceptance limits, 
including required levels of precision and accuracy. 
C. Identification of test methods to be employed and instructions for performing the 
test. 
D. Test prerequisites that address calibrated instrumentation, appropriate and adequate 
test equipment and instrumentation, trained personnel, condition of test equipment 
and the item to be tested, suitably controlled environmental conditions, and 
provisions for data acquisition. 
E. Mandatory hold points. 
F. Methods to record data and results. 
G. Provisions for ensuring that prerequisites for the given test have been met. 
H. Selection and identification of the measuring and test equipment to be used to 
perform the test to ensure that the equipment is of the proper type, range, accuracy, 
and tolerance to accomplish the intended function. 
I. Identification of the functional qualification level of personnel performing tests. 

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. Include or reference 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. 
E. Potential sources of uncertainty and error. Test parameters affected by potential 
sources of uncertainty and error shall be identified and controlled. 
11.2.3 Use of Other Testing Documents 
A. Other testing documents (such as American Society for Testing and Materials 
(ASTM) specifications, supplier manuals, or other related documents containing 
acceptance criteria) may be used instead of preparing special test implementing 
documents. If used, then they shall incorporate the information directly into the 
approved test implementing document, or shall be incorporated by reference in the 
approved test implementing document. 
B. Implementing documents shall include adequate supplemental instructions as 
required to ensure the required quality of the testing work. 
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: 
A. Item or work product tested. 
B. Date of test. 
C. Name of the tester and data recorders. 
D. Type of observation and method of testing. 
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 the test results. 
I. Identification of the measuring and test equipment used during the test including the 
identification number and the most recent calibrated date. 
11.2.6 Qualification of Test Personnel 
Personnel who perform testing shall be qualified according to the requirements of 
Section 10.0. 

12.0 CONTROL OF MEASURING AND TEST EQUIPMENT 
12.1 GENERAL 
This section establishes requirements to ensure measuring and test equipment is 
properly controlled, calibrated, and maintained. 
12.2 REQUIREMENTS 
12.2.1 Calibration 
A. Measuring and test equipment 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 standards having 
traceability to nationally recognized standards. Software developed or modified by 
the user shall be controlled in accordance with Supplement I, Software. 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 the 
measuring and test equipment being calibrated. 
1. If calibration standards with a greater accuracy than required of the measuring 
and test equipment 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. The method and interval of calibration for each device shall be defined, based on 
the type of equipment, stability characteristics, required accuracy, intended use, and 
other conditions affecting measurement control. For measuring and test equipment 
used in one-time-only applications, the calibration shall be done both before and 
after use. 
D. A calibration or calibration check shall be performed when the accuracy of 
calibrated measuring and test equipment is suspect. 
E. Calibrated measuring and test equipment shall be labeled, tagged, or otherwise 
suitably marked or documented to indicate due date or interval of the next 
calibration. 
F. Calibrated measuring and test equipment shall be uniquely identified to provide 
traceability to its calibration data. 

G. Updates to software contained in measuring and test equipment that effect 
calibration, require recalibration of the equipment prior to use. 
12.2.2 Documenting the Use of Measuring and Test Equipment 
The use of measuring and test equipment shall be documented. 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. Measuring and test equipment shall be considered to be out-of-calibration and 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. 
B. Out-of-Calibration measuring and test equipment shall be controlled. The controls 
shall include the following requirements: 
1. Out-of-Calibration measuring and test equipment shall be tagged, segregated, 
or otherwise controlled to prevent use until they have been recalibrated. 
2. When measuring and test equipment is found 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. 
b. The evaluation shall be documented. 
C. If any measuring and test equipment 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 measuring and test equipment 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. 

12.2.5 Handling and Storage 
Measuring and test equipment shall be properly handled and stored to maintain 
accuracy. 
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 
Measuring and test equipment 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. 
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 measuring and test equipment including evaluation results, as 
appropriate. 
H. Identification of the implementing document (including revision level) used in 
performing the calibration. 

13.0 HANDLING, STORAGE AND SHIPPING 
13.1 GENERAL 
This section establishes requirements for the handling, storage, cleaning, packaging, 
shipping, and preservation of items 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 (such as containers, shock 
absorbers, and accelerometers) and special protective environments (such as 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. 

14.0 INSPECTION, TEST AND OPERATING STATUS 
14.1 GENERAL 
This section establishes requirements to identify the inspection, test, and operating 
status of items. 
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 by-passing 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 (such as tags, markings, labels, and stamps), or other means (such as 
travelers, inspection, or test records). 
D. The authority for applying and removing status indicators shall be specified. 
E. Status indicators shall be used to provide an indication of the test or operating status 
of items or facilities to prevent inadvertent changes in operating status. 

15.0 NONCONFORMANCES 
15.1 GENERAL 
This section establishes requirements for the control of items that do not conform to 
requirements in order to prevent inadvertent installation or use of the item. 
15.2 REQUIREMENTS 
15.2.1 Documenting and Evaluating Nonconforming Items 
A. Nonconformance documentation shall clearly identify and describe the 
characteristics that do not conform to specified criteria. 
B. 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, 
Corrective Action. In addition, organizations affected by the nonconformance shall 
be notified. 
C. Recommended dispositions shall be evaluated and approved. 
D. Personnel performing evaluations of recommended dispositions shall have 
demonstrated competence in the specific area they are evaluating, an adequate 
understanding of the requirements, and access to pertinent background information. 
E. The responsibility and authority for reviewing, evaluating, approving the 
disposition, and closing nonconformances shall be specified. 
F. Further processing, delivery, installation, or use of a nonconforming item shall be 
controlled pending the evaluation and approval of the disposition. 
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, then other 
precautions shall be employed to preclude inadvertent use. 
15.2.4 Disposition of Nonconforming Items 
A. The disposition of "use-as-is," "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" 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 Quality Assurance 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 (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. 
15.2.5 Quality Trending 
Nonconformance documentation shall be periodically analyzed to identify quality 
trends in accordance with Section 16.0, Corrective Action. 

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 the Quality Assurance 
Requirements and Description (QARD), or an implementing document requirement is 
not met. 
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 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. 
C. Significant conditions adverse to quality shall be evaluated for a stop work 
condition by the QA organization to determine if 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. 
Responsible management shall also 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 and help identify root causes. 
C. Trend evaluation shall be performed in a manner and at a frequency that provides 
for prompt identification of adverse quality trends. 
D. Trend evaluations shall be distributed to Affected Organization management. 
E. Identified adverse trends shall be reported to the management of the organization 
responsible for corrective action. 

17.0 QUALITY ASSURANCE RECORDS 
17.1 GENERAL 
This section establishes requirements to ensure that Quality Assurance (QA) records 
are specified, prepared and maintained. 
17.2 REQUIREMENTS 
17.2.1 Classifying Quality Assurance Records 
QA records shall be classified as lifetime or nonpermanent. 
A. Documents that meet the following requirements shall be classified as lifetime QA 
records: 
1. Documents that provide evidence of the quality of items on a Q-List. 
2. Documents that provide evidence of the quality of activities related to items on 
a Q-List. 
3. Documents that provide evidence of the quality of site characterization data 
and samples. 
4. Documents that provide evidence of those activities that provide data used to 
assess the potential dispersion of radioactive materials from the licensed 
facility. 
5. Documents that provide evidence of the quality of the production process for 
the high-level waste form and acceptance of the high-level waste form itself. 
6. Documents that provide evidence of the quality of those activities associated 
with the characterization of DOE spent fuel, and conditioning through 
acceptance of DOE spent fuel. 
7. Personnel training and qualification documents for individuals executing QA 
program requirements. 
8. Documents which are implementing documents as described in Section 5.0, 
Implementing Documents. 
B. Documents that do not meet the requirements for lifetime QA records, but provide 
objective evidence that the QA program has been properly executed shall be 
classified as nonpermanent QA records. 

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. Records shall be considered QA records when stamped, initialed, or signed and 
dated as complete. If the nature of the record (such as magnetic or optical media) 
precludes stamping, initialing or signing, then other means of identifying the record 
as complete by authorized personnel are permitted. 
E. QA records may be originals or copies. 
17.2.3 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. 
B. A method for verifying that the QA records are those designated. 
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 classification of the QA record. 

G. QA records shall be submitted to storage after processing has been completed. 
17.2.4 Correcting Information in Quality Assurance Records 
A. Corrections to QA records including documents which 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 an 
organization that was originally responsible for approving a particular document is 
no longer responsible, the new responsible organization shall be identified. 
17.2.5 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. 
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. 
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 (such as radiographs, photographs, negatives, microform, and 
magnetic media) to preclude damage from moisture, temperature, excessive 
light, electromagnetic fields, or stacking, consistent with the type of QA record 
being stored. 

4. The storage area shall be protected from unauthorized entry, larceny, and 
vandalism. 
17.2.6 Retrieval of Quality Assurance Records 
A. The records management system shall provide for retrieval of QA records with 
planned retrieval times based on record type. 
B. Access to storage facilities shall be controlled. A list shall be maintained 
designating personnel who are permitted access to the QA records. 
17.2.7 Retention of Quality Assurance Records 
A. Yucca Mountain Project (YMP) or its designee shall retain and preserve lifetime 
QA records for the operating life of the item or facility. 
B. Nonpermanent QA records shall be retained for a minimum of three years or as 
specified by procurement documents, whichever is longer. Nonpermanent QA 
records shall not be disposed of until the following conditions are met: 
1. Regulatory requirements are satisfied. 
2. Operational status permits. 
3. Purchaser's requirements are satisfied. 
17.2.8 Turnover of Quality Assurance Records 
A. Affected Organizations shall submit, to the YMP or the purchaser, those QA 
records being temporarily stored by them 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 YMP records management organization shall inventory the submittal, 
acknowledge receipt, and process the QA records. 
C. The responsible YMP line organizations shall identify those QA records in 
temporary storage to be submitted for long-term storage to the records management 
system. 
17.2.9 Long Term Single Storage Facility 
A. YMPs single storage facility for the storage of lifetime 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. Doors, structure and frames, and hardware shall be designed to comply with 
the requirements of a minimum 2-hour fire rating. 
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. Only those penetrations that are used exclusively for fire protection, 
communication, lighting, or temperature and humidity control are allowed. All 
penetrations shall be sealed or dampered to comply with the minimum 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 these criteria. 
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. 
17.2.10 Dual Storage Facilities 
A. The YMPs dual storage facilities for the storage of lifetime 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 are not required to meet the design and construction 
requirements specific for a long term single storage facility. 
17.2.11 Temporary Storage Facility 
The YMP and Affected Organizations shall provide for temporary storage of QA 
records during processing, review, or use until turnover to the YMP 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. 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 maximum time limit for keeping QA records in temporary storage shall be 
specified by the YMP or the purchaser consistent with the nature or scope of work. 
17.2.12 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. 

18.0 AUDITS 
18.1 GENERAL 
This section establishes requirements for performing internal and external Quality 
Assurance (QA) audits to verify compliance with, and to determine the effectiveness of, 
the QA program. 
18.2 REQUIREMENTS 
18.2.1 Scheduling Internal Audits 
A. Internal audits shall be scheduled in a manner to provide coverage, consistency, and 
coordination with ongoing work. 
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 
or effectiveness. 
E. Internal audits of work to verify QA program compliance shall be performed 
annually or at least once during the life of the work, whichever is shorter. 
F. Internal audits to determine QA program effectiveness (performance based audits) 
shall be performed on selected work. 
18.2.2 Scheduling External Audits 
A. The need for, and frequency of, external audits shall be determined after a supplier 
has been selected to perform work for the Yucca Mountain Project. The 
determination shall be based on the complexity and nature of the items or services 
being procured. 
B. External audits shall not be required for procured items that are relatively simple 
and standard in design, manufacturing, and testing, or 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. 
C. External audits for compliance shall be performed triennially as a minimum with 
the initial audit to occur as early in the life of the activity as practical. 

D. 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, and 
2. The pre-award survey satisfies the same audit elements and criteria as those 
used in the performance of a triennial audit. 
E. External audits to determine QA program effectiveness (performance based audits) 
shall be performed on selected work. 
F. 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 documentation furnished by the supplier (such as certificates of 
conformance, nonconformance notices, and corrective actions). 
2. Results of previous source verifications, audits, management assessments, and 
receiving inspections including audits from other sources. 
3. Operating experience of identical or similar work furnished by the same 
supplier. 
4. A review of procurement documents to determine what additional work the 
supplier has received since the initial contract. 
. G. The need to schedule additional external audits shall also be evaluated when a 
major change in the contract scope, work methodology, or organization occurs. 
18.2.3 Audit Schedule 
The audit schedule shall be developed annually and revised periodically to ensure that 
coverage is maintained current. 
18.2.4 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, type of audit personnel needed, 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 audit shall be based on evaluation of implementing documents, 
activities, and items to be audited, the results of previous audits and the impact of 
significant changes in personnel, organization, or the QA program. 
18.2.5 Audit Team Independence 
The auditing organization shall select and assign auditors who are independent of any 
direct responsibility for performing the work being audited. Audit personnel shall have 
sufficient authority and organizational freedom to make the audit process meaningful 
and effective. 
18.2.6 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 organizations. 
B. A lead auditor shall be appointed to supervise the team, organize and direct the 
audit, coordinate the preparation and issuance of the audit report, and evaluate 
responses. 
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 
qualified in accordance with the requirements of this section. 
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. 
18.2.7 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 of Section 16.0, Corrective Action. 
G. Nonconforming items identified during an audit shall be controlled by the audited 
organization in accordance with Section 15.0, Nonconformances. 
18.2.8 Reporting Audit Results 
The audit report shall be prepared and signed by the audit team leader, and issued to 
management of the audited organization and Affected Organizations. 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. A summary of the documents reviewed, persons interviewed, and the specific 
results of the reviews and interviews, that is, a summary of the checklist contents. 
E. Statement on the effectiveness of the QA program elements which were audited. 
F. 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, Corrective Action. 
18.2.9 Responding to Audits 
A. Management of the internal audited organization shall investigate conditions 
adverse to quality and determine and schedule corrective action, including measures 
to prevent recurrence. 
B. Management of the external audited organization shall investigate conditions 
adverse to quality; determine and schedule corrective action, including measures to 
prevent recurrence; and notify the auditing organization in writing of the actions 
taken or planned. 

18.2.10 Evaluating Audit Responses 
The adequacy of corrective actions for conditions adverse to quality shall be evaluated 
by the auditing organization. 
18.2.11 Follow-up Action 
Follow-up action shall be taken by the auditing organization to verify that corrective 
action is accomplished. 
18.2.12 Technical Specialist Qualifications 
Technical specialists selected for auditing assignments shall be indoctrinated and 
trained in accordance with Section 2.0, Quality Assurance Program, and shall have the 
level of experience or training commensurate with the scope, complexity, or special 
nature of the work being audited. 
18.2.13 Auditor Qualifications 
Auditors shall have appropriate training or orientation to develop their competence for 
performing audits. Competence of personnel performing various audit functions shall 
be developed by one or a combination of the following methods: 
A. QA program orientation to provide a working knowledge and understanding of the 
Quality Assurance Requirements and Description (QARD), and the implementing 
documents used to perform audits and report audit results. 
B. Training programs to provide general and specialized training in audit performance. 
1. General training shall include the fundamentals, objectives, and techniques of 
performing audits. 
2. Specialized training shall include methods of examining, questioning, 
evaluating, and documenting specific audit items and methods of closing out 
conditions adverse to quality addressed by corrective action documents. 
C. On-the-job training, guidance, and counseling under the direct supervision of a lead 
auditor. Such training shall include planning, performing, reporting, and follow-up 
action involved in conducting audits. 
18.2.14 Lead Auditor Qualifications 
A. A lead auditor shall be capable of organizing and directing audits, and reporting 
audit findings. 

B. A lead auditor shall be certified as meeting the requirements for education and 
experience, communication skills, training, audit participation, and passing the 
examination as provided in this section. 
18.2.15 Lead Auditor Education and Experience 
The prospective lead auditor shall have verifiable evidence that a minimum of ten 
credits have been accumulated under the following scoring system: 
A. Education (four credits maximum) 
1. An associate degree from an accredited institution: score one credit. If the 
degree is in engineering, physical sciences, mathematics, or QA: score two 
credits; or 
2. A bachelor's degree from an accredited institution: score two credits or, if the 
degree is in engineering, physical sciences, mathematics, or QA: score three 
credits. In addition, score one credit for a master's degree in engineering, 
physical sciences, business management, or QA from an accredited institution. 
B. Experience (nine credits maximum) 
Technical experience in such areas as scientific investigation, site characterization, 
production, transportation, engineering, manufacturing, construction, operation, 
maintenance, or experience applicable to the auditing organization's area of 
responsibility: score one credit for each full year with a maximum of five credits 
for this aspect of experience. 
1. If two years of this experience have been in the nuclear-related field: score one 
additional credit; or 
2. If two years of this experience have been in QA: score two additional credits; 
or 
3. If two years of this experience have been in auditing: score three additional 
credits; or 
4. If two years of this experience have been in nuclear-related QA: score three 
additional credits; or 
5. If two years of this experience have been in nuclear-related QA auditing: score 
four additional credits. 

C. Professional Competence (two credits maximum) 
For certification of competency in engineering science or QA specialties issued and 
approved by a state agency or national professional or technical society: score two 
credits. 
D. Rights of Management (two credits maximum) 
When determined appropriate, the auditing organization may grant up to two credits 
for other performance factors applicable to auditing that are not explicitly called out 
in this section (such as leadership, sound judgment, maturity, analytical ability, 
tenacity, past performance, and completed QA training courses). 
18.2.16 Lead Auditor Communication Skills 
The prospective lead auditor shall have the capability to communicate effectively, both 
in writing and orally. These skills shall be attested to in writing by the candidate's 
supervisor. 
18.2.17 Lead Auditor Training 
A. Prospective lead auditors shall be trained to the extent necessary to ensure their 
competence in auditing skills as established by the organization responsible for 
performing audits. 
B. Training in the following areas shall be given based upon management evaluation 
of the particular needs of each prospective lead auditor. 
1. Knowledge and understanding of the QARD and other program-related 
procedures, codes, standards, regulations, and regulatory guides. 
2. General structure of QA programs as a whole and the specific elements of the 
QARD. 
3. Auditing techniques of examining, questioning, evaluating, and reporting. 
Methods of identifying, following up on, and closing corrective action items. 
4. Audit planning in functional areas (such as scientific investigation, design, 
purchasing, construction, fabrication, handling, shipping, storage, cleaning, 
inspection, testing, statistics, nondestructive examination, maintenance, repair, 
operation, modification, and safety) of nuclear facilities. 
5. On-the-job training to include applicable elements of the audit program. 

18.2.18 Lead Auditor Audit Participation 
The prospective lead auditor shall have participated in a minimum of five QA audits 
within a period of time not to exceed three years prior to the date of certification. One 
audit shall be a nuclear-related QA audit within the year prior to certification. 
18.2.19 Lead Auditor Examination 
A. The prospective lead auditor shall pass an examination that evaluates the 
comprehension of and ability to apply the audit knowledge described in this section. 
The test shall be oral, written, practical, or any combination. 
B. The development and administration of the examination for a lead auditor is the 
responsibility of the auditing organization. The auditing organization shall: 
1. Maintain the integrity of the examination through confidentiality of files and, 
where applicable, proctoring of examinations. 
2. Develop and maintain objective evidence regarding the type and content of the 
examination. 
18.2.20 Certification of Lead Auditor Qualifications 
Each lead auditor shall be certified by the auditing organization as being qualified to 
lead audits. This certification shall document the: 
A. Name of the auditing organization. 
B. Name of the lead auditor. 
C. Date of certification or recertification. 
D. Basis of certification (such as education, experience, communication skills, and 
training). 
E. Signature of the designated representative of the auditing organization responsible 
for certification. 
18.2.21 Maintaining Lead Auditor Proficiency 
A. Lead auditors shall maintain their proficiency through one or combination of the 
following: 
1. Regular and active participation in the audit process. 

2. Review and study of codes, standards, implementing documents, instructions, 
and other documents related to the QA program and program auditing. 
3. Participation in QA training programs. 
B. Management of the auditing organization shall evaluate the proficiency of lead 
auditors annually. Based on the evaluation, management may choose to extend the 
qualification, require retraining, or require requalification. Management evaluations 
shall be documented. 
C. Lead auditors who fail to maintain their proficiency for a period of two years or more 
shall require requalification. Requalification shall include retraining and reexamination 
in accordance with this section, and participation as an auditor in at least 
one nuclear QA audit. 

SUPPLEMENT I SOFTWARE 
I.1 GENERAL 
This supplement establishes requirements for the acquisition, development, 
modification, control, and use of software. Acquired software that is integral to the 
operations, maintenance, or calibration of measuring and test equipment, and has not 
been developed or modified by the Affected Organization, is controlled by Section 
12.0, Control of Measuring and Test Equipment, and is exempt from the requirements 
of this supplement. Requirements for electronic management of data are addressed in 
Supplement V, Control of the Electronic Management of Data. 
The following types of software are not required to be qualified using this supplement: 
operating systems; system utilities; compilers and their associated libraries; word 
processors; spreadsheets; database managers; e-mail; and other types of automated 
office support systems. Any applications, other than software routines and macros, 
developed using these types of commercially available software shall meet the 
requirements of this supplement. Software routines and macros shall meet the 
requirements of Paragraph I.2.1.C. 
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 will depend 
on the nature and complexity of the software. Software life cycle activities 
may be performed in an iterative or sequential manner. 
2. Acquired software or software previously developed not using this supplement 
must either be: a) acquired through a procurement activity in accordance with 
Section I.2.6 with appropriate quality controls, or b) be controlled and qualified 
in accordance with Section I.2.7 of this supplement. In either case, software 
planning in accordance with 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 each software, for software changes, or for those system 
configurations that are determined to impact 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. Verification reviews shall identify the reviewer(s) and their specific 
responsibilities during the review. 
3. 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. 
C. Software routines or macros that are documented in each product in which they are 
used and independently verified by visual inspection or hand calculation without 
recourse to the originator shall have limited requirements applied as follows: 
1. Identification, including version of the software routine or macro. 
2. Documentation that includes inputs, computer program generated correct 
results for a specified range of input parameters, computer program generated 
evidence of the programmed algorithms or equations (e.g., computer programs 
listings and spreadsheet cell contents), and verification results. 
3. Identification, including version of the commercially available software used to 
develop the routine and macro. 
I.2.2 Software Planning 
A. A plan addressing software quality assurance (QA) shall be in existence for each 
new software project at the start of the software life cycle. 
B. The plan(s) may be prepared individually for each software project, or may exist as 
a generic document to be applied to software prepared within or procured by an 
organization, or may be incorporated into the overall QA program. 
C. The plan for software 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. 
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 be 
verified and validated. 
3. Software requirements shall be traceable throughout the remaining stages of 
the software life cycle. 
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 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. Alternative 
methods to evaluate technical adequacy may be used, such as: 
1) Analysis without computer assistance (hand calculations). 
2) Other validated computer programs. 
3) Experiments and tests. 
4) Standard problems with known solutions. 
5) Comparisons to confirmed published data correlations. 
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 the 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. 
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. Software validation activities shall be 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. 
2. Testing, to an approved plan or process, shall be the primary method of 
software validation to ensure adherence to the requirements, and to ensure that 
the software produces correct results for the test cases. 
3. 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). 
4. 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. 
5. Software validation of modifications to released software shall be subjected to 
regression testing to detect errors introduced during the modification of the 
software, to verify that the modifications have not caused unintended adverse 
affects, or 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 I.2.3.D, the 
software shall be baselined and placed under Configuration Management 
controls in accordance with section I.2.4. 
2. 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). 
3. Software modifications shall be approved, documented, verified and validated, 
and controlled. 
4. 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 those 
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 
use of the software shall be prevented. 

I.2.4 Software Configuration Management 
A software configuration management 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. Software shall not be used in activities identified under Section 
2.2.2 or 2.2.3 of this document unless it is obtained, and limited to received copies, 
from software configuration management. 
A. 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 software configuration management. 
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. 
B. Configuration change control shall include: 
1. A release and control process for baseline elements. 
2. Changes to baseline elements 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. 
C. 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 Defect Reporting and Resolution 
A. A software defect reporting and resolution system shall be implemented for 
software errors and failures to assure that problems are promptly reported to 
Affected Organizations and to assure formal processing of problem resolutions. 
B. The defect reporting and resolution system shall be integrated with the software 
configuration management system. 
C. Software defect reporting and resolution systems shall include the following 
controls: 
1. Problems are identified, evaluated, documented, and, if required, corrected. 
2. Problems are assessed for impact on past and present applications of the 
software by the responsible organization. 
3. Corrections and changes shall be controlled in accordance with applicable 
configuration change control requirements. 
4. Notification along with preventive actions and corrective actions are provided 
to the user organizations. 
D. If a defect is identified in software that adversely impacts previous applications, 
then the condition adverse to quality shall be documented and controlled in 
accordance with Section 16.0, Corrective Action. 
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 as specified in procurement documents. 
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 from the supplier, the purchaser assumes 
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 I.2.5. 
B. For procured software services, the organization providing the services shall have 
plan(s) for software QA, in accordance with I.2.2.A, that meets the requirements of 
I.2.6.A, and the user organization shall determine the adequacy of this plan. 
I.2.7 Software Previously Developed Not Using This Supplement 
This section shall apply only to unqualified software in which the history of the 
software is not known, but the software is required to be used in quality affecting 
activities. 
A. Software that was previously developed not using this supplement shall be placed 
under configuration controls prior to use. 
B. The user organization shall perform, document, and provide for an independent 
review and evaluation to: 
1. Determine its adequacy to support software operation and maintenance. 
2. Identify the activities to be performed and documents required in order for the 
software to be placed under configuration management. As a minimum, these 
activities shall include: 
a. User application requirements. 
b. Test plans and test cases required to validate the software for acceptability. 
c. User documentation required in accordance with I.2.3.C.3. 
C. Upon independent review and approval of the above activities, the software shall be 
placed under configuration control in accordance with I.2.4. 
I.2.8 Control of the Use of Software 
A. Affected Organizations shall 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 a software item falls outside the range of validation as 
baselined, changes shall be made to the appropriate baseline elements prior to 
continuing use. 

D. Documentation for the receipt of software obtained from Software Configuration 
Management in accordance with Section I.2.4 shall be provided and maintained for 
all software in operation or use. 

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. These 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. 
II.2.3 Identification 
A. Identification shall be maintained on the samples or in a manner which ensures that 
identification is established and maintained. 
B. Samples shall be identified from their initial collection through final use. 
C. Sample identification is documented and checked before released for use. 
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 (such as physical separation, labels or tags attached to containers, 
or procedural control). 

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 (such as the Site Characterization Plan, test plans, study plans, or job 
packages) contain specific identification or traceability requirements (such as 
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 are 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. 

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 (such as containers) and 
special protective environments (such as 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 
(such as Job Packages, Travelers, or Work Requests) shall be documented, 
evaluated, identified, and segregated in accordance with Section 15.0, 
Nonconformances. 
B. The disposition for nonconforming samples shall be identified and documented and 
shall be limited to use-as-is, limited use, or discard. 

Office of Civilian Radioactive Waste Management 
Quality Assurance Requirements and Description, DOE/RW-0333P 
Title: Quality Assurance Program Clarification Effective Date: 
Section: Supplement III, Scientific Investigation Page: 1 of 1 
REFER TO QUALITY ASSURANCE PROGRAM CLARIFICATION 
LOCATED BEHIND QARD GLOSSARY 
No. 99-001 Quality Assurance Program ClarificationClarification of QARD 
Supplement III, Section III.2.4.3 

SUPPLEMENT III SCIENTIFIC INVESTIGATION 
III.1 GENERAL 
This supplement establishes requirements for scientific investigations, including data 
identification, data reduction, and model development and use. Requirements for 
electronic management of data are addressed in Supplement V, Control of the 
Electronic Management of Data. Development of software including database 
applications or software that performs functions of analysis or calculation shall be 
controlled in accordance with Supplement I, Software. 
III.2 REQUIREMENTS 
III.2.1 Planning Scientific Investigations 
A. Scientific investigations shall be planned in accordance with Section 2.0, Quality 
Assurance Program. 
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. Scientific investigations shall be performed using scientific notebooks, 
implementing documents, or a combination of both. 
B. 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 programs to be used. 
3. Identification of any samples or measuring and test equipment 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. 
C. 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 directly relied upon to address safety and waste isolation issues shall be 
qualified data or established fact, except as allowed in Subsection III.2.4B.2. 
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 and design activities, 
provided traceability to its status as unqualified data is maintained. 
Unqualified data directly relied upon to address safety and waste isolation 
issues shall be qualified in accordance with III.2.4.C at appropriate times 
during the scientific investigations and design process and before: 
a. Yucca Mountain Project acceptance of DOE-EM managed high-level waste 
or spent nuclear fuel; 
b. Submittal of the License Application; 
c. Relying on the item for which the data were used as design input, to 
perform its function; or 
d. Data are relied upon to resolve safety or waste isolation issues. 
C. Unqualified data directly relied upon to address safety and waste isolation issues 
shall be qualified by one or a combination of the methods that follow: 
1. Determination that the controls under which the data were generated are 
similar in scope, requirements, 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, Quality Assurance Program. 
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; or 
c. Confirmation that the data have been used in similar applications. 
Methods 1, 2, and 3 above shall include a review to determine the technical correctness 
of the data in accordance with established review criteria. The qualification process 
shall be planned and documented. Documentation shall include the acceptance criteria 
used to determine if the data are qualified, and rationale for discontinuing any 
qualification methods abandoned after the initiation of the qualification process. 
III.2.5 Technical Report Review 
Technical reports shall be reviewed in accordance with the requirements of 
Subsection 2.2.10, Document Review. 
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 (for example, using new confirmation test data 
gathered in the field or laboratory), describe these activities in the work-planning 
document. 
B. Documentation of models shall be in accordance with QARD Section 17.0, Quality 
Assurance Records; shall be transparent; and shall 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. Include rationale for not selecting alternatives. 
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. 
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 (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 the QARD, Supplement I, Software. 
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. Criteria for model validation shall be established to reduce, to the extent practical, 
the uncertainties inherent in the model and to demonstrate that the phenomenon, 
process, or system being represented by the model is sufficiently well understood to 
support the models intended use. 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 shall be consistent with parameter uncertainties and justified in 
the model documentation. 

3.. Define the importance of the model for assessing repository system 
performance. 
4. Describe the relative level of confidence for the model. 
5. Define the supporting information needed to substantiate validation. 
F. A model progression exists (usually from conceptual model to mathematical model 
to process model to abstraction model to system model). A conceptual model is 
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 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 (QARD Paragraph 2.2.9) or independent technical review (QARD 
Paragraph 2.2.10). 
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. 
5. Calibration with experimental data sets, including the review of model 
calibration parameters for reasonableness and consistency in explanation of all 
relevant data. 

SUPPLEMENT IV FIELD SURVEYING 
IV.1 GENERAL 
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. 
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. 

SUPPLEMENT V CONTROL OF THE ELECTRONIC MANAGEMENT OF DATA 
V.1 GENERAL 
This supplement applies to the processes and controls for the management of data that 
either exist or are used in an electronic format. This includes electronic formatted data 
used in design input, developed as design output, or developed as an output of scientific 
investigation or performance assessment modeling and analysis. 
Development of software including database applications or software that performs 
functions of analysis or calculation shall be controlled in accordance with Supplement 
I, Software. The acquisition, development and use of data are controlled by the 
requirements of Section 3.0, Design Control, or Supplement III, Scientific 
Investigation. 
V.2 REQUIREMENTS 
V.2.1 Control of the Electronic Management of Data 
The Affected Organization shall establish process controls to ensure: 
A. Data are suitably protected from damage and destruction during their prescribed 
lifetime and are readily retrievable. 
B. A description is prepared of how data 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 data input and any subsequent changes to the 
data are maintained. 
E. The security and integrity of the data are maintained. 
F. Data transfers are error free, or within a defined permissible error rate, to ensure no 
information is lost in transfer and that the input is recoverable from the output. 
Examples of data transfer include copying raw data from a notebook to a 
computerized data form, copying from computer tape to disk, etc. 

APPENDIX A HIGH-LEVEL WASTE FORM PRODUCTION 
A.1 GENERAL 
A. This appendix contains amplifications of requirements and descriptions unique to 
waste form development through qualification, production, and acceptance. 
Amplifications provided relate to specific sections or supplements. In those cases 
when a section or supplement requires no amplification, reference to the section or 
supplement is omitted. 
B. The Department of Energy's Office of Environmental Management has overall 
responsibility for developing, qualifying, and producing an acceptable high-level 
waste form. 
A.2 REQUIREMENTS 
A.2.1 Amplification of QARD Section 2.0, Quality Assurance Program 
A. Line management shall plan, schedule, and conduct readiness reviews at significant 
transitional events both leading up to and during waste form production. 
B. Line management shall establish measures for controlling technical modifications 
to the waste form production process. Technical modifications subject to control 
shall include: 
1. Waste form and canistered waste form. 
2. Process control plans and other implementing documents. 
3. Waste Acceptance Product Specifications, Waste Form Compliance Plans, and 
Waste Form Qualification Reports. 
A.2.2 Amplification of QARD Supplement III, Scientific Investigation 
Implementing documents shall contain requirements for evaluating development and 
qualification results including final results within Waste Form Qualification Reports. 

APPENDIX B STORAGE AND TRANSPORTATION 
B.1 GENERAL 
A. This appendix contains amplifications of requirements and descriptions unique to 
the work conducted for the storage of spent fuel and the transportation of spent fuel 
and high-level radioactive waste. Exceptions to the Quality Assurance 
Requirements and Description (QARD) requirements are given for organizations 
that design or fabricate transportation casks, multi-purpose canisters (MPCs), or 
ancillary equipment under the licensing provisions of 10 Code of Federal 
Regulations (CFR) 71, or design or fabricate storage casks, MPCs, or ancillary 
equipment under the licensing provisions of 10 CFR 72. 
B. Activities associated with storage casks, transportation casks, MPCs, and ancillary 
equipment that are required to ensure future compliance with 10 CFR 60 are not 
covered by this appendix. For example, whereas work on translating Monitored 
Geologic Repository design criteria into MPC design criteria would be subject to 
the applicable sections of this QARD, implementing approved MPC design criteria 
would only be subject to the requirements of this appendix. 
B.2 REQUIREMENTS 
B.2.1 General 
Organizations that design or fabricate storage casks, transportation casks, MPCs, or 
ancillary equipment shall develop Quality Assurance (QA) programs that are accepted 
by the Nuclear Regulatory Commission and docketed in their license, and accepted by 
the procuring organization. The QA programs shall meet the following requirements. 
B.2.2 Storage Casks, Transportation Casks, MPCs, and Ancillary Equipment 
A. The NRC licensee/certificate holders QA program shall meet the requirements of 
10 CFR 71, Subpart H or 10 CFR 72, Subpart G, as applicable. 
B. With the exception of the requirements specified in this Appendix, the QARD does 
not apply to NRC licensee/certificate holders that design or fabricate storage casks, 
transportation casks, MPCs, or ancillary equipment in accordance with 10 CFR 71, 
Subpart H, or 10 CFR 72, Subpart G, QA programs. This appendix does not 
exempt OCRWM from implementing the QARD relative to activities it performs as 
a prospective licensee. 

APPENDIX C MONITORED GEOLOGIC REPOSITORY 
C.1 GENERAL 
This appendix contains modifications of requirements and descriptions unique to work 
conducted for the Monitored Geologic Repository. Modifications provided relate to 
specific sections or supplements. In those cases when a section or supplement requires 
no modification, reference to the section or supplement is omitted. 
C.2 REQUIREMENTS 
C.2.1 Modification of QARD Section 2.0, Quality Assurance Program 
A. The use of expert elicitation may be considered when one or more of the following 
conditions exist: 
1. Empirical data are not reasonably obtainable, or the analyses are not practical 
to perform; 
2. Uncertainties are large and significant to a demonstration of regulatory 
compliance; 
3. More than one conceptual model is permitted by the available data; or 
4. Technical interpretations are required to properly assess the knowledge and 
uncertainty in data, processes, and models. 
B. In conducting an expert elicitation, a systematic process for its conduct shall be 
implemented, including appropriate issue-focused workshops, so that the results of 
the elicitation accurately reflect data, process, and model uncertainty. 
The systematic elicitation process shall consist of the following steps: 
1. The objectives are explicitly defined to reflect a clear understanding of how the 
judgments will be used. 
2. Potential conflicts of interest and criteria used to select subject-matter experts 
are documented. 
3. The generalist and normative experts work with the subject-matter experts or 
expert teams to decompose the objectives of the assessment into focused 
subissues. 
4. Background information, including qualified and unqualified data, is 
assembled and provided to the subject-matter experts without bias before the 
elicitation. 

5. Pre-elicitation training is provided to the subject-matter experts. 
6. The elicitation interviews are structured in a consistent manner, considering the 
specific issues for which assessments are required. 
7. Post-elicitation feedback is provided before the subject-matter experts 
complete the final documentation of their assessments. 
8. The process of aggregating expert assessments is clearly described, including 
the individual expert's uncertainties and the aggregate uncertainty of multiple 
experts. 
9. Documentation of the elicitation process is assembled. 
C. New data shall be reviewed to determine relevance with respect to the experts 
assessments, including the need for reassessment. 
D. Software that has not been qualified in accordance with Supplement I and 
unqualified data may be used in the expert elicitation process. The results of the 
expert elicitation are considered qualified; however, the expert elicitation process is 
not considered a method for the qualification of software or unqualified data used 
as input. 
C.2.2 Modification of QARD Section 4.0, Procurement Document Control 
As an alternative to requiring a documented QA program (see Subsection 4.2.1C) for 
suppliers of analytical services (measurement of properties or other characterization of 
samples) supporting scientific investigations, these procurements may be controlled in 
accordance with Appendix C.2.3 
C.2.3 Modification of QARD Section 7.0, Control of Purchased Items and Services 
Where analytical services in support of scientific investigation are obtained, the 
following requirements are an acceptable alternative to the requirements of Section 7.0. 
The purchaser shall: 
A. Prior to issuing the procurement document, develop a documented quality control 
sample plan that describes: 
1. The number of quality control samples and approach to be used for submitting 
these (blind, duplicate, spike, etc.). 
2. The preparation and analysis of quality control samples, or 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. 
3. Acceptance criteria. 
4. How the number of quality control samples, the approach, and acceptance 
criteria provide confidence in the accuracy/precision of the data. 
B. Ensure that quality control analytical results are received and evaluated against 
acceptance criteria, prior to use of data. 
C. Ensure that data, quality control analytical results, the quality control sample plan, 
and evaluation documentation are submitted as QA records. 
C.2.4 Modification of QARD Section 9.0, Control of Special Processes 
Special processes associated with work products specified in work controlling 
documents (such as job packages or work requests) shall comply with the requirements 
specified in Section 9.0, Control of Special Processes. 
C.2.5 Modification of QARD Section 10.0, Inspections 
If required by work controlling documents (such as job packages or work requests) 
work products shall be subject to inspection in accordance with Section 10.0 of the 
QARD. 

GLOSSARY 
Acceptance (document)The documented determination by the receiving organization that work 
is suitable for the intended purpose. 
Affected OrganizationAn organization performing Program work subject to QARD 
requirements whose organizational relationships are defined in YMP Program documents. 
Alternate CalculationsCalculations that are made with alternate methods to verify correctness 
of the original calculation. 
Application (Software)1) Software designed to fulfill the specific needs of a user. 2) Software 
that are written where the user prescribes one or more instructions to generate data, manipulate 
data, or perform calculations. 
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 quality assurance program verification performed to 
determine by investigation of objective evidence the adequacy of and compliance with 
established implementing documents and the effectiveness of implementation. 
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. 
Certificate of ConformanceA document signed or otherwise authenticated by an authorized 
individual certifying the degree to which items or services meet specified requirements. 
CertificationThe act of determining, verifying, and attesting in writing to the achievement or 
compliance with specified requirements. 
CharacteristicA property or attribute of an item, process or service that is distinct, describable, 
and measurable. 
Code ListingAn ordered display or printout of program statements. 
Commercial Grade ItemAn item that is (i) not subject to design or specification criteria unique 
to the Program or nuclear facilities, (ii) used in applications other than the nuclear industry, and 
(iii) ordered from the manufacturer or supplier on the basis of specifications set forth in the 
manufacturer's published product description. 
Computer ProgramA sequence of instructions suitable for processing by a computer. 

Conceptual ModelA set of hypotheses consisting of assumptions, simplifications, and 
idealizations that describe the essential aspects of a system, process, or phenomenon. 
Condition Adverse to QualityAn all inclusive term used in reference to any of the following: 
failures, deficiencies, defective items, and nonconformances. 
Confirmatory TestingTesting conducted under a 10 CFR Part 60, Subpart G QA program that 
investigates the properties of interest (e.g., physical, chemical, geologic, or mechanical) of an 
unqualified database. 
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. 
Corroborating DataData that are used to support or substantiate other data. 
Data (collected)Factual information obtained from investigation activities such as sample 
collection, physical measurements, testing, and analyses, both in the field and the laboratory. 
DatabaseA collection of previously distinct data (not created by the database) which 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. 
Design BasesInformation that identifies the specific functions to be performed by items and the 
specific values or ranges of values chosen for controlling parameters as reference bounds for 
design. 
Design ChangeAny revision or alteration of the technical requirements defined by approved 
and issued design output documents and approved and issued changes thereto. 
Design InputThose criteria, parameters, bases, or other design requirements upon which design 
output documents are based. 
Design OutputDrawings, specifications, and other documents resulting from the translation of 
design input requirements of items. 
Design ProcessTechnical and management process that commences with identification of 
design input and ends with the issuance of design output documents. 

Design ReviewA documented evaluation of design output during the design process to 
determine design adequacy and conformance to specified acceptance criteria. 
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. 
Established FactInformation accepted by the scientific and engineering community as 
established fact (e.g., engineering handbooks, density tables, gravitational laws, etc.). 
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. 
Expert ElicitationA formal, structured and documented process for obtaining the judgements of 
multiple experts. 
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. 
GeneralistAn individual with technical background in one or more disciplines needed to 
address the problem of interest and who has a general understanding of the technical aspects of 
the problem. 
Implementation (Software)The process of translating the software design into a computer 
program. 
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 
10CFR63.111(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 10CFR63.111(b)(2) to any individual 
located on or beyond any point on the boundary of the site. 
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 10CFR63.113(b) and (c). 
IndoctrinationMethod of training designed to familiarize personnel in fundamental criteria, 
program elements, responsibilities, and authority applicable to assigned tasks. 

InspectionA quality assurance program verification that is used to verify whether an item 
conforms to specified technical criteria. 
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. 
Lead AuditorAn individual who is certified to organize, perform, and direct an audit; report 
audit results; and evaluate related corrective actions. 
MacroSingle computer instructions invoked by a symbol, name, or key that represents 
commands, actions, or keystrokes. 
Management AssessmentA quality assurance program verification that is conducted by 
management above or outside the Quality Assurance organization and that evaluates the scope, 
status, adequacy, programmatic compliance, and implementation effectiveness of the quality 
assurance program. 
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. 
ModelA representation of a process, system, or phenomenon, along with any hypotheses 
required to describe the process or system or explain the phenomenon, often mathematically. 
Model, AbstractionA product of the abstraction process that meets the definition of a 
mathematical model. 
Model, ConceptualA set of hypotheses consisting of assumptions, simplifications, and 
idealizations that describes the essential aspects of a system, process, or phenomenon. 
Model, MathematicalA mathematical representation of a conceptual model (system, process, or 
phenomenon) that is based on established scientific and engineering principles and from which 
the approximate behavior of a system, process, or phenomenon can be calculated within 
determinable limits of uncertainty. 
Model, ProcessA mathematical model that represents an event, phenomenon, process, 
component, etc., or series of events, phenomena, processes, or components, etc. A process 
model may undergo an abstraction for incorporation into a system model. 
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 represents with sufficient accuracy the phenomenon, 
process, or system in question. 

NonconformanceA deficiency in characteristic or record that renders the quality of an item or 
sample unacceptable or indeterminate. 
Normative ExpertAn individual with a theoretical and conceptual knowledge of probability and 
practical experience in the elicitation of judgements from individuals. 
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. 
Organizational InterfaceThe relationship between organizations when one organization 
prescribes an activity or requirement to, or shares an activity or requirement with, another 
organization. 
PeerA person having technical expertise in the subject matter to be reviewed to a degree at least 
equivalent to that needed for the original work. 
Peer ReviewA documented, in-depth critique of work by a group of peers independent from the 
work being reviewed. 
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. 
Performance ConfirmationThe program of tests, experiments, and analyses that is conducted 
to evaluate the accuracy and adequacy of the information used to demonstrate compliance with 
the performance objectives in subpart E of 10 CFR 63. 
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. 
ProcessA series of actions that achieves an end result or accomplishes work. 

Procurement DocumentPurchase orders, contracts, specifications, or other document used to 
define technical and quality assurance requirements for the procurement of items or services. 
Qualification (Personnel)The capabilities gained through education, training, or experience 
that qualify an individual to perform a required function. 
Qualification of DataA formal process that is intended to provide a desired level of confidence 
that data is suitable for its intended use. 
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 Quality Assurance program that meets the 
requirements of 10 CFR Part 60, Subpart G (i.e., qualified from origin), or unqualified data that 
have undergone the qualification process. 
Quality AssuranceAll those planned and systematic actions necessary to provide adequate 
confidence that an item will perform satisfactorily in service. 
Quality Assurance (QA) OrganizationThe OQA organization for activities performed by YMP 
and reviews of YMP-owned documents; the M&O QA organization for activities performed by 
the M&O and reviews of M&O-owned documents; and the OQA organization and the M&O QA 
organization for documents implemented by both YMP and the M&O. 
Quality Assurance RecordA completed document (or other medium) that furnishes evidence 
that items or work comply with requirements. 
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. 
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 an item 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. 
ReworkThe process by which an item is restored to original specifications by completion or 
correction. 

Right of AccessThe procurement requirement that permits the purchaser or designated 
representative to enter the premises of a supplier for verification purposes. 
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 InvestigationAny observation, identification, description, experimental study, or 
analysis and explanation of natural phenomena. 
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. 
Significant Condition Adverse to QualityA condition adverse to quality which, if uncorrected, 
could have a serious effect on safety, or the ability to isolate waste. 
Site CharacterizationThe program of exploration and research both in the laboratory and the 
field that is undertaken to establish the geologic conditions and the ranges of parameters of a 
particular site that are relevant to the implementing documents. 
SoftwareComputer programs, procedures, rules, and associated documentation pertaining to the 
operation of a computer system. 
Software BaselineA specification or product that has been formally reviewed and agreed upon, 
that thereafter is the basis for further development, and that can be changed only through formal 
change procedures. 
Software Control PointMilestones in the software life cycle when controls are applied to the 
software in which they are baselined prior to proceeding with the software project. 
Software ItemSource code, object code, job control code, control data, or a collection of these 
items that function as a single unit. 
Software Life CycleA series of activities that begins when the software product is conceived 
and ends when the software product is no longer available for routine use. 
Software RoutineA collection of computer macros or script files, a spreadsheet application, or 
other stand-alone software application (either acquired or developed) that generally operates 

within another program, such as a spreadsheet, and must be independently verified by visual 
inspection and/or hand calculation. 
Software ValidationThe test and evaluation of completed software to ensure compliance with 
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. 
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. 
Stop Work OrderA formal directive issued by management that work must be stopped until 
resolution of the related significant condition adverse to quality. 
Subject-Matter ExpertAn individual recognized by his or her peers as an authority on a specific 
topic. 
SupplierAny individual or organization who 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, or subcontractor. 
SurveillanceThe act of observing real-time activities and/or reviewing documentation to verify 
conformance with specified requirements and to evaluate their adequacy and effectiveness. 
Technical AssessmentUsed for data qualification purposes, a technical assessment is 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 specific set of test data and associated procedures developed for a particular 
objective, such as to exercise a particular program path or to verify compliance with a specific 
requirement. 
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. 
TraceabilityThe ability to trace the history, application, or location of an item, data, or sample 
using recorded documentation. 

TrainingSystematic 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. 
TransparentA document is transparent if it is 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 DataData not collected under an approved Quality Assurance program that meets 
the requirements of 10 CFR Part 60, Subpart G. 
Use-As-IsA disposition permitted for a nonconforming item when it can be established that the 
item is satisfactory for its intended use. 
VerificationThe act of reviewing, inspecting, testing, checking, auditing, or otherwise 
determining and documenting whether items, processes, services, or documents conform to 
specified requirements. 
WorkActivities that are subject to the Quality Assurance Requirements and Description. 

Office of Civilian Radioactive Waste Management 
Quality Assurance Requirements and Description, DOE/RW-0333P 
Title: Quality Assurance Program Clarification Table of Contents Page: 1 of 1 
Effective Date: 
TABLE OF CONTENTS 
Number Subject 
99-001 Quality Assurance Program ClarificationClarification of QARD 
Supplement III, Section III.2.4.3 

OFFICE OF CIVILIAN RADIOACTIVE WASTE MANAGEMENT 
OFFICE OF QUALITY ASSURANCE 
QUALITY ASSURANCE PROGRAM CLARIFICATION NUMBER 99-001 
DESCRIPTION OF CONDITION 
The DOE National Spent nuclear Fuel Program (NSNFP) has interpreted Supplement III, 
Section III.2.4.B.3 of the Quality Assurance Requirements and Description (QARD) as not 
requiring any NSNFP unqualified data to be qualified for OCRWM submittal of a License 
Application (LA) to construct a repository. 
CLARIFICATION 
The QARD Supplement III, Section III.2.4.B.3 states: 
"Unqualified data directly relied upon to address safety and waste isolation issues shall be 
qualified in accordance with III.2.4(C) at appropriate times during the scientific investigations 
and design process and before: 
a. OCRWM acceptance of DOE-owned high-level waste or spent nuclear fuel; 
b. Submittal of the License Application; 
c. Relying on the item for which the data were used as design input, to perform its 
function; or 
d. Data are relied upon to resolve safety or waste isolation issues." 
The timing of data qualification is dependent on the intended use of the data. For example: 
1. With respect to Items b and d above, DOE High-Level Waste or Spent Nuclear Fuel 
unqualified data used to support our safety case for a license to construct a repository 
must be qualified prior to submittal of the LA; whereas unqualified data that requires 
the results of confirmatory testing (beyond LA) may be identified as unqualified going 
into LA, with a commitment to the Nuclear Regulatory Commission to qualify the 
data at the appropriate time. 
2. With respect to Items a and c above, these time frames were meant for unqualified 
data relating to our license to operate a repository, not our license to construct a 
repository. 

This Quality Assurance program clarification will remain in effect until a future revision of 
QARD Supplement III, SectionIII.2.4.B.3 is issued. 
Robert W. Clark, 
R.W. Clark (signature on file)10/25/99 
Acting Director Date 
Office of Quality Assurance