Quality Assurance Program for United States Contributions to ITER Program_803fa837 - 3.0.pdf

803fa837 Quality Assurance Program

Quality Assurance Program for

United States Contributions to ITER

April 2023

[803fa837 - 3.0]

QUALITY ASSURANCE PROGRAM

FOR

UNITED STATES CONTRIBUTIONS TO ITER

(US ITER)

Frank Casella Glen Cowart

Date Published: April 2023

Prepared by

OAK RIDGE NATIONAL LABORATORY

Oak Ridge, Tennessee 37831-6283 managed by

UT-BATTELLE, LLC

for the

US DEPARTMENT OF ENERGY

under contract DE-AC05-00OR22725

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Federal Prolect Director US DOE, ORNL Srte 0ffice

Quality Assumnce Pr ogram

QUALTTY ASSURANCE PROGRA1W

FOR

UNITED STATES CONTRIBUTIONS TO ITER

(us rTER)

$,3, Ltzs

RECORD O}-REVISIONS

April2023 and ES&H andNuclear Safe$

US ITER Pro;ecl .Drector, ORNL

Revision Description of Changes

Rev 0

Rev I

Rev 2

November 2*47

May 2008

July 2008

Inrtnl tssue lncorporate commsnts provided by IO dunng ap,proval proces$.

Organrzatron chart change,pageZ of 22

[803fa837 - 3 OI

Rev 3 March 2011 Changed the name of the document to Quality Assurance Program.

Removed QA grading tables (1 and 2) from Section 4 and added a reference to USDA procedure US ITER 16202-PR0005.

Added multiple references (ITER IO and US ITER) to Section 6.

Replaced the use of acceptance criteria listings with quality plans and manufacturing inspection plans to reflect provisions in the PA’s.

Numerous text edits throughout the document.

Rev 4 July 2011 Added a commitment to continual improvement to the quality policy, and a statement that it is the framework for quality objectives.

Under Criterion 5, Work Processes, added a statement that PA or TA requirements are reviewed to verify that US ITER can satisfy them.

Added management review to the management assessments section. Other minor edits and additional references.

Rev 5 December

Rewritten using a new outline and a careful selection of relevant requirements from the applicable laws, regulations, and standards.

Rev 6

Rev 7

Rev 8

January 2013

August 2018

March 2023

Corrected some references and made minor edits to clarify or extend intent following IO review comments (marginal bars indicate changed paragraphs).

Revised to describe better clarity throughout with regard to the IO’s QAP and USDA interaction activities. Revision included clean- up of minor typos, identification of new references and correction of title and or iDOCs numbers throughout.

Revised to bring current with new organization and

Page v

CONTENTS

LIST OF FIGURES .............................................................................................................................. vii US ITER QUALITY POLICY ............................................................................................................ viii

PART I OVERVIEW

THE ITER PROJECT

THE US ITER PROJECT

PURPOSE OF THE QA PROGRAM

QAP SCOPE

PART II PROJECT MANAGEMENT REQUIREMENTS

1 PROJECT MANAGEMENT AND ORGANIZATION

1.1 ORGANIZATION—LEVELS OF AUTHORITY

1.1.1 The US Domestic Agency

1.1.2 Federal Project Director

1.1.3 US ITER Project Management

1.1.4 US ITER Project Director

1.1.5 Management Representative for Quality

1.2 MANAGEMENT COMMITMENT TO SAFETY AND QUALITY

1.2.1 Commitment to Safety

1.2.2 Commitment to Quality

1.3 PROVISION OF RESOURCES

1.3.1 Infrastructure

1.3.2 Work Environment

1.4 PERSONAL RESPONSIBILITY

1.4.1 Stop-Work Responsibility

1.5 TRAINING AND QUALIFICATION

1.5.1 General Competence, Training, and Awareness

1.5.2 Protection-Important Activities

1.5.3 Special Processes

1.5.4 Inspection and Test Personnel

1.5.5 Lead Auditors

1.5.6 Auditors

1.5.7 Training Records

PART III QUALITY MANAGEMENT SYSTEM REQUIREMENTS

2 QUALITY MANAGEMENT SYSTEM

2.1 QUALITY MANAGEMENT SYSTEM PLANNING

2.2 USE OF QUALITY POLICY

2.3 USE OF QUALITY OBJECTIVES

2.4 PROCESS APPROACH

2.4.1 Customer-Related Processes

2.4.2 Quality Management System Documentation

2.5 DOCUMENT CONTROL

2.5.1 Document Changes

2.5.2 Document Control Procedure

2.5.3 External Documents

2.6 SATISFACTION OF INTERESTED PARTIES

2.6.1 Customer Focus (ITER Project Performance)

2.6.2 Surveillance of External Interveners

Page vi

2.7 IMPLEMENTING THE QUALITY PROGRAM

2.7.1 Graded Approach

2.7.2 Communication

3 DESIGN

3.1 DESIGN AND DEVELOPMENT PLANNING

3.2 DESIGN PROCESS

3.3 DESIGN INPUT

3.4 DESIGN AND DEVELOPMENT REVIEW

3.5 DESIGN ANALYSIS

3.6 DESIGN AND DEVELOPMENT OUTPUTS

3.7 CRITICAL CHARACTERISTICS FOR ACCEPTANCE

3.8 CRITICAL CHARACTERISTICS FOR COMMERCIAL-GRADE ITEM DEDICATION

3.9 DESIGN VERIFICATION

3.10 DESIGN AND DEVELOPMENT VALIDATION

3.11 DESIGN CHANGE CONTROL

3.12 CONFIGURATION MANAGEMENT

3.13 CONTROL OF CAD MODELS

3.14 SAFETY SOFTWARE DEVELOPMENT

3.15 DESIGN DOCUMENTS AND RECORDS

4 PROCUREMENT

4.1 PURCHASING PROCESS

4.2 PROCUREMENT DOCUMENTS

4.2.1 Content of Procurement Documents

4.3 SUBCONTRACTOR EVALUATION AND SELECTION

4.4 ACCEPTANCE OF ITEMS OR SERVICES

4.4.1 Methods of Accepting Commercial-Grade Items for Nuclear Safety-Related or Protection-Important Application

4.4.2 Deviation Requests

4.5 VERIFICATION OF PURCHASED PRODUCT

4.6 CONTROL OF SUBCONTRACTOR NONCONFORMANCES

5 RESEARCH AND DEVELOPMENT

5.1 R&D QUALITY CONTROLS

5.2 R&D CALCULATIONS

6 PRODUCTION PROCESSES

6.1 PLANNING OF PRODUCTION PROCESSES

6.1.1 Instructions, Procedures, and Drawings

6.2 PROCESS CONTROL

6.2.1 Special Processes for Production and Service Provision

6.2.2 Monitoring and Measurement of Processes

6.2.3 Process Records

6.2.4 Monitoring and Measurement of Product

6.3 CONTROL OF MONITORING AND MEASURING EQUIPMENT

6.4 CONTROL OF PRODUCTS

6.4.1 Identification and Control of Materials, Parts, and Components

6.4.2 Preservation of Product

6.4.3 Property of Others

6.4.4 Handling, Storage, and Shipping

6.4.5 Marking and Labeling

7 TESTING

7.1 TEST CONTROL

7.1.1 Test Requirements

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7.1.2 Test Procedures

7.1.3 Test Results

7.1.4 Test Records

7.2 CONTROL OF MEASURING AND TEST EQUIPMENT (M&TE)

7.2.1 Selection

7.2.2 Calibration and Control

7.2.3 Calibration Records

8 RECORDS

8.1 GENERATION OF RECORDS

8.2 RECORDS AUTHENTICATION

8.3 RECORD RETENTION, CLASSIFICATION

8.4 RECORD MAINTENANCE AND STORAGE

9 CONTINUOUS IMPROVEMENT SYSTEM

9.1 PREVENTION

9.2 DETECTION

9.2.1 Trending

9.2.2 Assessment

9.3 ACTION

9.3.1 Control of Nonconforming Items

9.3.2 Corrective Action

REFERENCES

DEFINITIONS, ACRONYMS, AND INITIALISMS

ACRONYMS AND INITIALISMS

List of Figures

Figure 1. US Domestic Agency Figure 2. US ITER Project Management Figure 3. US ITER QA Organization and Reporting Figure 4. Key Process

Page viii

US ITER QUALITY POLICY

It is the policy of the US ITER project (US ITER) to design, procure, fabricate, and deliver items, and to provide services, that meet or exceed all contractual and regulatory requirements while providing for the health and safety of the work force, the public, and the environment.

The fundamental processes and expected practices needed to fulfill this policy are expressed by the US ITER project Quality Assurance Program (QAP). The QAP is designed to meet the quality performance objectives and expectations of the US Department of Energy, the host country nuclear safety rules [1], and the ITER Organization (IO) [2].

The QAP is applied with a graded approach that provides the mechanism to effectively evaluate requirements and better allocate resources based on the risk significance of the item or activity to optimize quality. The intent of grading is to improve performance and safety in all programmatic and operational applications.

US ITER cooperates with the IO by reporting conditions adverse to quality and by providing copies of reports and correspondence applicable to US ITER work being performed for the IO.

Stop work authority is extended to each employee in the event that a situation exists deemed to be a potentially significant threat to the safety of the environment, the general public, or workers or if the final product quality is significantly in doubt.

Implementation of the QAP is monitored for performance in meeting these quality objectives and continuously improved to exceed those expectations. This policy serves as a framework for establishing and reviewing those objectives.

US ITER project personnel are individually accountable for fulfilling this policy by implementing the QAP. They are each required to know the QAP and the related procedures, and to implement these in their work processes [2].

PART I OVERVIEW

THE ITER PROJECT

The ITER project will demonstrate the scientific and technological feasibility of fusion energy for peaceful purposes by constructing, licensing, and operating the ITER machine as a nuclear facility in accordance with French regulations. To do this, the ITER facility will demonstrate moderate power multiplication, demonstrate essential fusion energy technologies such as “burning plasma” in a system integrating the appropriate physics and technology, and test key elements required to use fusion as a practical energy source.

ITER will be the first fusion device to produce thermal energy at the level of an electricity-producing power station. It will provide the next major step in the advancement of fusion science and technology and is the key element in the global strategy to prepare for future demonstration of electricity-generating power plants in a single experimental step.

The ITER project is managed by the ITER Organization (IO), which is responsible for integrated management, systems engineering, licensing, nuclear safety, industrial safety, public safety, and component assembly, installation, testing, and commissioning [2].

THE US ITER PROJECT

The Agreement on the Establishment of the ITER International Fusion Energy Organization for the Joint Implementation of the ITER project (the ITER Agreement), signed on November 21, 2006, provides the legal framework for construction, operation, deactivation, and decommissioning of the ITER site. The Agreement identifies the hardware procurement allocations among the seven members, which in turn, helps define the scope of the US contributions to the ITER project, referred to hereafter as US ITER. The US ITER project will provide design, fabrication, and delivery of designated in-kind hardware that meet the IO’s design and performance specifications.

The governing regulations, codes, and standards for the design of ITER components are determined by the host country, France. For this reason, and in keeping with Article 14 of the ITER Agreement, the US ITER Quality Assurance Program (QAP) is aligned both to US quality assurance (QA) consensus standards, international and French nuclear quality assurance standards. The French standards are set forth in the Order of 7 February 2012 establishing the general rules for basic nuclear installations [1].

The US Department of Energy (DOE) serves as the US Domestic Agency for the ITER project, as shown in Figure 1. US ITER is a team led by Oak Ridge National Laboratory (ORNL) with two partner labs, Princeton Plasma Physics Laboratory (PPPL) and Savannah River National Laboratory (SRNL).

Figure 1. US Domestic Agency

PURPOSE OF THE QA PROGRAM

A DOE project such as US ITER is required to have a DOE-approved QA program. The QAP for US ITER defines the QA requirements for the project, including Protection Important Activities (PIAs). It provides statements as to how the QA requirements of the IO and DOE are to be met. This program was developed based on specified QA criteria and satisfies these criteria using a graded approach. The criteria for the US ITER QAP are in compliance with the French Order of February 7, 2012; DOE orders; Federal Code of Regulations Title 10, Parts 830 (subpart A), 851 and 708; ASME NQA-1, ISO 9001 and 14001, IAEA Safety Series No.

GSR Part 2, and the IO QAP [1, 3- 18]. The French order [1] establishes general rules relating to the design, construction, operation, final shutdown, dismantling, surveillance, and maintenance of nuclear facilities during their full life cycle.

This QAP is implemented by lower-tier quality plans, procedures, instructions, and guides that have been or will be developed to accommodate specific quality requirements. If there is a conflict between such implementing documents and this program document, this QAP governs until the conflict is resolved.

QAP SCOPE

This QAP provides requirements applicable to all US ITER project participants and encompasses activities performed by or for the US ITER project, ranging from research and development (R&D) to system acceptance. Furthermore, it is expected that contractors to US ITER will have implemented quality assurance programs aligned with this QAP. This QAP has been written in compliance with the DOE approved ORNL laboratory quality assurance program. The partner labs, PPPL and SRNL, each will work within their own QA or management program and procedure system, which must also meet or be extended by their ITER-related QA plans and procedures to comply with the requirements in this program.

This QAP covers all deliverable-to-ITER items and all US ITER activities important to the safety, reliability, and performance of the ITER facility. It encompasses all the activities that are necessary for verifying that the required quality is achieved, and that objective evidence is produced to that effect [18]. This includes, in particular, items whose failure would result in a significant:

• safety problem to the public and/or workers,

• loss of time and investment,

• unscheduled shutdown of the machine,

• reduction in the quality of data that could be acquired during operation,

• or impact on the environment.

Items delivered to a second party for incorporation into assemblies or systems that are then incorporated into ITER are included in the scope of this QA program. This QA program applies to all US ITER personnel, including those responsible for planning, scheduling, and indirect functions as well as those directly involved in the creation and verification of items and information for ITER.

This QAP, together with discipline and project-specific procedures (e.g., documents that give specific work direction or work instructions), form the basis for an integrated management control system for conducting activities in a manner that produces a high-quality product, while protecting the worker, the environment, and the general public. The significant features of this QAP are:

• quality verification, monitoring activities against predetermined acceptance criteria, and overview of activities that demonstrate the completeness, appropriateness and recording of achieved quality;

• assurance that an activity is performed to specified requirements with appropriate documentation;

• assurance that the activity is performed by personnel qualified for the task;

• assurance that an item will perform its design function, or that the design output (e.g., safety basis document, calculation note, etc.) is developed and checked by qualified personnel;

• that a Quality Plan (QP) is prepared and approved as required by the Procurement Arrangement (PA) or

Task Agreement (TA) [19]; and

• that an Inspection Plan (IP) will be prepared and approved when required by the applicable PA or TA [20].

The achievement of quality is accomplished by assuring that each individual performing PIAs and management at all levels is responsible and personally accountable for achieving quality. This accountability addresses the commitments made in the US ITER Quality Policy.

Exclusions: In relation to the standards and governing requirements [1, 2, 9, 14, 15, 16, 18], the US ITER project does not include installation, operation, or field service at the ITER site, so QA requirements in those areas have no foreseen opportunity for implementation. If local applications arise because test stands or production lines are created as part of the project, then a specific program will cover those activities.

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PART II PROJECT MANAGEMENT REQUIREMENTS

1 PROJECT MANAGEMENT AND ORGANIZATION

1.1 ORGANIZATION—LEVELS OF AUTHORITY

1.1.1 The US Domestic Agency

The US Department of Energy (DOE) Office of Science (SC) and the DOE ORNL Site Office (DOE-OSO) function as the Domestic Agency (DA) for the US ITER project. The US ITER Project Office (USIPO), led by its Project Director, is assigned responsibility and authority for managing the day-to-day activities related to planning, managing, and delivering the full scope of the US ITER project [27].

1.1.2 Federal Project Director

The Federal Project Director (FPD) represents DOE and oversees the US ITER project, while the management and operating contractor for Oak Ridge National Laboratory (ORNL), currently UT-Battelle, LLC, is responsible for project coordination and execution. The FPD is responsible for a Quality Assurance Program (QAP) for the project, in which all applicable QA requirements must be addressed. By his approval signature, the FPD endorses this QAP as governing the quality performance of the project.

1.1.3 US ITER Project Management

The organizational structure, functional responsibilities, levels of authority, and lines of communications (including PIAs) are documented in this section and Figures 2–3.

US ITER project management develops the policies of the US ITER project that are appropriate to the activities and facilities of the project;

• ensures that it is clear when, how, and by whom decisions are to be made within the quality management system;

• ensures that authority is properly delegated during times of absence from the project;

• establishes goals, strategies, plans, and objectives that are consistent with the policies of US ITER, in an integrated manner so that their collective impact on safety is understood and managed;

• establishes an organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing the work;

• hires or contracts personnel with education, skills, and experience commensurate with the job responsibilities to perform the required work;

• ensures project personnel are sufficiently trained on technical, administrative, and procedural elements of project work;

• delineates authorities and duties in writing; and

• ensures the availability of resources and information necessary to support the operation and monitoring of the processes needed for the quality management system and their application throughout US ITER.

Figure 2 shows the Project Director and the reporting managers, who are collectively referred to as “project management” in later sections of this document.

Figure 2. US ITER Project Management

NOTE: US ITER project staff members are listed within organization charts found at www.usiter.org

1.1.4 US ITER Project Director

ORNL’s US ITER Project Director is assigned line management responsibility and authority for carrying out the US ITER project in a manner consistent with the Project Execution Plan (PEP) [27]. This responsibility includes leadership of the project staff within the partner laboratories (ORNL, PPPL, and SRNL), along with authority and accountability for all project activities.

Within the ORNL organization, the US ITER Project Director reports directly to the ORNL Laboratory Director. The Project Director is responsible for the overall successful execution of the US ITER project, including responsibility to ensure that US ITER project goals for environment, safety, and health (ES&H) and QA are achieved [27]. The US ITER Project Director is responsible for the quality management system and ensures that it is established, implemented, assessed, and continually improved.

http://www.usiter.org/

1.1.5 Management Representative for Quality

The US ITER Project Director has assigned the Manager QA, ES&H, and Nuclear Safety, a member of the US ITER management team, the responsibility and authority to develop, organize, and maintain quality programs and procedures for US ITER that will provide for compliance with the US ITER Quality Policy. Further, the QA Manager, along with Quality Assurance (QA) staff, is given the organizational freedom and access to all work areas to identify quality problems, initiate actions that result in solutions, and verify implementation of those solutions. The QA Manager has the responsibility and full authority to initiate stop work when there are quantitative indications that the quality of the designed or manufactured product places the company or project at significant risk. Additional responsibilities include:

a. Serving as primary interface between DOE-OSO/FPD and US ITER on QA matters;

b. Ensuring the promotion of awareness of customer quality requirements throughout the project organization;

c. Coordinating the development and implementation of the quality management system, and its assessment and continual improvement;

d. Reporting on the performance of the quality management system, including its influence on safety and safety culture, and any need for improvement;

e. Resolving any potential conflicts between requirements and within the processes of the quality management system; and

f. Implementing improvement projects as described in Section 9 of this QAP.

The US ITER project QA organization includes matrixed QA personnel embedded within each WBS group to better understand the unique requirements of that organizational element and to provide a level of independent QA oversight and expertise. Figure 3 shows the US ITER Project QA organization.

Figure 3. US ITER QA Organization and Reporting

1.2 MANAGEMENT COMMITMENT TO SAFETY AND QUALITY

1.2.1 Commitment to Safety

Safety will always be paramount within the US ITER quality management system, overriding all other demands.

The quality management system promotes and supports a safety culture by:

• ensuring a common understanding of the key aspects of safety culture within US ITER;

• providing the means by which US ITER supports individuals and teams in carrying out their tasks safely and successfully, taking into account the interaction between individuals, technology, and US ITER;

• participating in the design effort to ensure that safety is integrated into the design solution and that hazard identification is included in the design solution, as appropriate;

• reinforcing a learning and questioning attitude at all levels of US ITER; and

• providing the means by which US ITER continually seeks to develop and improve its safety.

1.2.2 Commitment to Quality

US ITER project management develops individual values, institutional values, and behavioral expectations for the US ITER organization to support the implementation of the quality management system and they act as role models in the promulgation of these values and expectations.

Managers at all levels are required to demonstrate their commitment to the establishment, implementation, assessment, and continual improvement of the quality management system and to allocate adequate resources to carry out these activities [2, 14].

US ITER management provides evidence of its commitment to the development and implementation of the quality management system and continually improving its effectiveness by

a. communicating to the entire US ITER organization the importance of meeting customer requirements, especially as agreed in Procurement Arrangements (PAs) and Task Agreements (TAs), as well as statutory and regulatory requirements;

b. establishing the quality policy;

c. ensuring that quality objectives are established;

d. implementing internal programs and procedures that flow the tenets of the QAP into working level documents;

e. supporting the review and approval of document deliverables to the IO;

f. conducting management assessments and trend analyses; and

g. ensuring the availability of resources. The US ITER organization will identify and manage the resources needed to implement and maintain the quality management system and continually improve its effectiveness [16].

1.3 PROVISION OF RESOURCES

Graded Approach The application of quality management system requirements is graded so as to deploy appropriate resources, on the basis of the consideration of:

• the significance and complexity of each product or activity;

• the hazards and the magnitude of the potential impact (risks) associated with the safety, health, environmental, security, quality, and economic elements of each product or activity; and

• the possible consequences if a product fails or an activity is carried out incorrectly [14].

The information and knowledge of US ITER will be managed as a resource.

Project management determines the number of resources necessary and provides the resources to carry out the activities of US ITER and to establish, implement, assess, and continually improve the quality management system. Resources in this context include individuals, infrastructure, the working environment, information and knowledge, and subcontractors, as well as material and financial resources.

US ITER retains overall responsibility for the quality management system when an external organization is involved in the work of developing documents or processes that support the quality management system.

1.3.1 Infrastructure

US ITER determines, provides, and maintains the infrastructure needed to achieve conformity to product requirements. Infrastructure includes, as applicable,

a. buildings, workspace, and associated utilities;

b. process equipment (both hardware and software); and

c. supporting services (such as transport, communication, or information systems).

1.3.2 Work Environment

US ITER determines and manages the safe work environment needed to achieve conformity to product requirements.

1.4 PERSONAL RESPONSIBILITY

Each person performing work is responsible for their own safety and the safety of the people around them and for the quality of the work they perform, meeting the project requirements, and consistently striving for improvement.

Management at all levels fosters the involvement of all individuals in the implementation and continual improvement of the quality management system.

Every activity necessary to the achievement of safety, quality, and project performance is assigned to someone who is aware they are accountable for that activity. There are no orphan areas.

US ITER organizational structure and responsibility assignments are such that quality is achieved and maintained by those accountable for performing work. Accountable persons have a sense of ownership for their work. As they perform work, they are expected to preemptively seek out potential problems and solve them. Such activity may be part of self-assessment and preventive action (see Section 9) [2].

1.4.1 Stop-Work Responsibility

Everyone in US ITER has the right and responsibility to notify their management if they become aware of unsatisfactory work or practices and, if necessary, to recommend to their management to stop or improve unsatisfactory or unsafe work, and to control further processing, delivery, or installation of nonconforming materials.

Furthermore, stop-work authority is extended to each employee if a situation exists that they judge to be a potentially significant threat to the safety of the environment, the general public, or workers or if the final product quality is significantly in doubt. This authority must be exercised in a justifiable and responsible manner in accordance with procedures established in the US ITER worker safety and health program [33].

1.5 TRAINING AND QUALIFICATION

Personnel are trained and qualified commensurate with responsibility. Management verifies the training qualification and proficiencies of personnel prior to assigning activity.

1.5.1 General Competence, Training, and Awareness

US ITER management [9, 14, 15, 16]:

a. determines the necessary competence for personnel performing work affecting conformity to product requirements;

b. where applicable, provides training or takes other actions to achieve the necessary competence;

c. evaluates the effectiveness of the actions taken;

d. ensures that suitable proficiency is maintained;

e. ensures that its personnel are aware of the relevance and importance of their activities and how they contribute to the achievement of the quality objectives;

f. understands the consequences for safety of their activities; and

g. maintains appropriate records of education, training, skills, and experience.

Training program The training program for project personnel focuses on the information and understanding necessary to perform their assigned project functions. Training ensures that project personnel possess [9, 18, 32].

a. knowledge of applicable procedures to be used to conduct assigned tasks;

b. working knowledge of design, construction, operation, and maintenance activities pertinent to project personnel assigned tasks;

c. knowledge of suspect/counterfeit item (S/CI) processes and controls, including prevention, detection, and disposition of S/CIs;

d. a working knowledge of project requirements;

e. current information through continuing training;

f. understanding of project terminology and organizational arrangements;

g. understanding of the safety conditions of the work tasks, ranging from office environments to experimental test stands; and

h. understanding of the consequences of project delays, increased cost, and inadequate quality attainment.

Self-improvement Project personnel are encouraged to

a. continue to maintain technical proficiency through attendance at organizational staff meetings, attendance at professional seminars, and reading literature pertaining to task functions;

b. review management control systems for process improvement considerations; and

c. understand the value of self-assessments and the importance of continuous improvement.

Requirements for qualification The responsible manager or team leader designates those activities that require qualification of personnel and the minimum requirements for such personnel [15, 32].

1.5.2 Protection-Important Activities

When Protection-Important Activities are identified using the grading process [36], those protection-important activities, their technical monitoring, and the checking and assessment actions are required to be carried out by individuals with the appropriate skills and qualifications. As such, US ITER project management makes the necessary provisions for training in order to maintain these skills and qualifications for the staff and, whenever necessary, to develop them, and ensures that subcontractors make analogous provisions for their own staff who carry out protection-important activities [1, 2].

1.5.3 Special Processes

A special process is a process whose results are highly dependent on the control of the process or the skill of the operators, or both, and for which the specified quality cannot be readily determined by inspection or test of the product afterward. If we are relying on the process to provide acceptable and repeatable results, that process must be continually demonstrated to be under statistical control.

Also, a special process might be employed even when the final product could actually be measured but is instead handled through an approved sampling program.

Personnel who perform special processes such as welding, heat-treating, and nondestructive examination (NDE) are suitably qualified to do so. The standard of qualification of these personnel will be in accordance with specifications supplied by the design authority (the ITER design authority is the IO unless delegated through the PA, TA, or other formal documents). The performing organizations will establish and maintain special process procedures and documentation of personnel qualifications.

1.5.4 Inspection and Test Personnel

The initial capabilities of a candidate to conduct inspection and testing will be determined by an evaluation of the candidate’s education, experience, training, and either test results or capability demonstration.

1.5.5 Lead Auditors

Lead auditors will be qualified in accordance with the appropriate standard for the audit subject.

1.5.6 Auditors

Auditors will have appropriate training or orientation to develop their competence for performing audits.

1.5.7 Training Records

The QA Manager will ensure that records for indoctrination and training of Auditor and Lead Auditor qualification and requalification are maintained, as well as NDE and other inspection and test personnel qualification and requalification records.

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PART III QUALITY MANAGEMENT SYSTEM REQUIREMENTS

2 QUALITY MANAGEMENT SYSTEM

2.1 QUALITY MANAGEMENT SYSTEM PLANNING

US ITER management will ensure that:

• the planning of the quality management system (this QAP and its implementing procedures and tools) is carried out in order to meet requirements, as well as the quality objectives, and

• the integrity of the quality management system is maintained when changes to the quality management system are planned and implemented.

As a project of the US DOE, US ITER is required to use appropriate national or international consensus standards consistent with contractual and regulatory requirements, and Secretarial Officer direction. It must clearly identify which standards, or parts of the standards, are used. When standards do not fully address the requirements delineated in DOE O 414.1D, Attachment 1, Contractor Requirements Document [9], they are addressed in this QAP.

In order to fulfill this DOE requirement, and other requirements flowed down from the IO, this QAP integrates requirements from Refs. [1, 9, 14, 15, 16, 18] resulting from a systematic comparison and selection process.

The US ITER Project Execution Plan (PEP) establishes the overall framework for the project to be managed and executed in accordance with the quality management systems discussed and included therein. The management processes and tailoring strategy set forth in the PEP also recognize the unique aspects of the project, which is aimed at procuring and delivering in-kind hardware to the IO for its use in constructing the ITER facility [27].

The PEP and the QAP are the primary reference documents for use by all elements of the US ITER project team. All aspects of project execution flow down from the PEP [27] and QAP [this document].

US ITER organizational structure and responsibility assignments are such that quality achievement is verified by those not directly responsible for performing the work. Verification activities occur in connection with many processes including, for example, design, software design, configuration management, procurement, installation, test, inspections, assessments, corrective actions, and personnel qualifications.

Where more than one organization is involved in the execution of activities, the responsibilities, interfaces, and authority of each organization will be clearly defined and documented.

US ITER has established management processes, including planning, scheduling, and providing resources for the work.

US ITER has established, documented, implemented, and will maintain a quality assurance program and continually improve its effectiveness in accordance with the requirements of Refs. [1, 9, 14, 15, 16, 18] on which it is based. The program provides control over PIAs to an extent consistent with their importance.

Responsibilities for the establishment and implementation of the quality assurance program are defined.

The US ITER quality assurance program is comprehensive and embraces the functions of quality assurance, quality control, and quality engineering [8].

Suspect/counterfeit items (S/CI) oversight and prevention processes commensurate with the facility/activity hazards and mission impact are a part of the US ITER quality program and are implemented in procurement documents.

The US ITER quality management system supports the IO in its role as operator, in which the operator (IO) has defined and implemented an integrated management system that ensures that the requirements of Refs. [1, 2] are systematically taken into account. By incorporating requirements from Ref. [9], the US ITER QAP has committed to its part in fulfilling Refs. [1, 2] obligations.

The US ITER quality management system is established, implemented, assessed, and continually improved [14]. It is aligned with the goals of US ITER and will contribute to their achievement.

The main aim of the quality management system is to achieve and enhance safety by

• bringing together in a coherent manner all the requirements for managing US ITER.

• describing the planned and systematic actions necessary to provide adequate confidence that all these requirements are satisfied; and

• ensuring that health, environmental, security, quality, and economic requirements are not considered separately from safety requirements, to help preclude their possible negative impact on safety.

The management system identifies and integrates with these requirements contained within Ref. [14], to the extent they apply to the US ITER project:

• the statutory and regulatory requirements of the Member State (France);

• any requirement formally agreed with interested parties (also known as “stakeholders”); and

• requirements from other relevant codes and standards adopted for use by US ITER.

US ITER is able to demonstrate the effective fulfillment of its quality management system requirements (see Section 9).

2.2 USE OF QUALITY POLICY

Guided by the QA Manager, US ITER management ensures that the quality policy [16]

a. is appropriate to the purpose of the project,

b. includes a commitment to comply with requirements and continually improve the effectiveness of the quality management system,

c. provides a framework for establishing and reviewing quality objectives,

d. is communicated and understood within the project organization, and

e. is reviewed for continuing suitability.

2.3 USE OF QUALITY OBJECTIVES

US ITER management ensures that quality objectives for implementing the goals, strategies, and plans, including those needed to meet requirements, for its products are established through appropriate processes at relevant functions and levels within US ITER. The Quality objectives are established in accordance with the graded approach described in section 2.7.1 of this QAP and are required to be measurable and consistent with the quality policy.

US ITER project management, guided by the QA Manager, will ensure that the execution of the project is regularly reviewed against these objectives and that actions are taken to address deviations where necessary.

The US ITER quality objectives support the IO quality objectives [18]:

• “the attainment of the level of quality necessary to accomplish the project objectives commensurate with the project's responsibility for protection of the public health and safety, protection of the environment, and reliable facility operation”; and

• “that structures, systems, and components designed, procured, fabricated, installed, constructed, and tested for the project conform to established and documented requirements.”

US ITER objectives include support for the IO in meeting its protection-important obligations as the ITER Operator [1] by

• incorporating the IO-identified protection-important activities, with the related defined requirements, within the scope and bounds of this QAP;

• assuring those protection-important activities meet their defined requirements through application of approved procedures; and

• applying activity-adapted preventive and corrective actions to manage identified deviations/discrepancies.

2.4 PROCESS APPROACH

US ITER determines the processes needed for the quality management system and their application throughout the project and determines the sequence and interaction of these processes. The majority of the project activity is focused on design and acquisition of equipment made by industry and supplied to ITER.

US ITER will determine criteria and methods needed to ensure that both the operation and control of these processes are effective. The production of items for ITER can be thought of as the key process that best illustrates the project’s process approach, as shown in Figure 4.

US ITER will implement actions necessary to achieve planned results and continual improvement of these processes.

Where it or a subcontractor chooses to outsource any process that affects product conformity to requirements, US ITER will ensure control over such processes.

The type and extent of control to be applied to these outsourced processes is defined within the quality management system.

Figure 4. Key Process

2.4.1 Customer-Related Processes

2.4.1.1 Customer communication

US ITER will determine and implement effective arrangements for communicating with IO and DOE as customers in relation to

a. product information.

b. inquiries, contracts (typically PAs and TAs), or order handling, including amendments; and

c. customer feedback, including customer complaints.

2.4.1.2 Determination of requirements related to the product

US ITER determines

a. requirements specified by the customer, including the requirements for delivery and post-delivery activities.

b. requirements not stated by the customer but necessary for specified or intended use, where known.

c. statutory and regulatory requirements applicable to the product, including especially those identified in the PAs and TAs and other applicable IO documents; and

d. any additional requirements considered necessary by US ITER.

2.4.1.3 Review of requirements related to the product

US ITER reviews the requirements related to the product. This review is conducted prior to US ITER's commitment to supply a product to the customer (e.g., creation of TAs or PAs, submission of tenders, acceptance of contracts or orders, acceptance of changes to contracts or orders) and will ensure that

a. product requirements are defined,

b. contract or order requirements differing from those previously expressed are resolved, and

c. US ITER has the ability to meet the defined requirements.

Records of the results of the review and actions arising from the review are maintained.

Where the IO customer provides no previously documented statement of requirements, the customer requirements are confirmed by US ITER as part of acceptance of the delegated work.

Where product requirements are changed, US ITER will ensure that relevant documents are amended and that relevant personnel are made aware of the changed requirements.

2.4.2 Quality Management System Documentation

US ITER has identified and assigned an individual (the QA Manager) to have responsibility, authority, and accountability to ensure the development, implementation, assessment, maintenance, and improvement of the QAP.

Under his/her leadership, US ITER has implemented an organization and resources that are appropriate for defining its integrated quality management system; for implementing, maintaining, and assessing it; and for improving its effectiveness.

The documentation of the quality management system reflects the characteristics of US ITER and its activities, as well as the complexities of processes and their interactions.

The documentation of the quality management system includes the following:

• the documented statement of a quality policy and quality objectives.

• a description of the quality management system (this QAP).

• this QAP and the set of quality procedures [29-50, (except 46)], which together can be thought of as a quality manual.

• a description of the structure of US ITER—included in this QAP.

• a description of the functional responsibilities, accountabilities, levels of authority and interactions of those managing, performing, and assessing work— [27, 39] and included in this

QAP.

• documented procedures and records required by Ref. [16], and a description of the processes and supporting information that explain how work is to be prepared, reviewed, carried out, recorded, assessed, and improved; and

• documents, including records, determined by US ITER to be necessary to ensure the effective planning, operation, and control of its processes (procedures and procurement documents typically establish the requirements for records).

US ITER periodically carries out a review of its integrated quality management system to assess its performance, to identify any possible improvements, and to program the implementation of improvements retained. Section 9 describes the assessment program in more detail.

2.5 DOCUMENT CONTROL

US ITER prepares, reviews, approves, issues, uses, and revises documents to prescribe processes, specify requirements, or establish design.

The preparation, issue, and change of documents that specify quality requirements or prescribe PIAs such as instructions, procedures, and drawings will be controlled to ensure that correct documents are being employed.

Documents will be controlled. All individuals involved in preparing, revising, reviewing, or approving documents will be specifically assigned this work, will be competent to carry it out, and will be given access to appropriate information on which to base their input or decisions. It will be ensured that document users are aware of and use appropriate and correct documents.

2.5.1 Document Changes

Changes to documents, other than those defined as minor changes, are considered major changes, and will be reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated.

Minor changes, such as inconsequential editorial corrections, are those that do not require the same review and approval as the original documents. To avoid a possible omission of a required review, the type of minor changes that do not require such a review and approval and the persons who can authorize such a decision are clearly delineated [15, 37]. The following controls will be applied to documents and changes thereto [15, 37]:

a. the identification of controlled documents.

b. the specified distribution of controlled documents for use at the appropriate location.

c. the identification of individuals responsible for the preparation, review, approval, and distribution of controlled documents.

d. the review of controlled documents for adequacy, completeness, and approval prior to distribution.

e. a method to ensure the correct documents are being used.

2.5.2 Document Control Procedure

A documented procedure has been established to define the controls needed [15, 37] to

• approve documents for adequacy prior to issue,

• review and update as necessary and reapprove documents,

• ensure that changes and the current revision status of documents are identified,

• ensure that relevant versions of applicable documents are available at points of use,

• ensure that documents remain legible and readily identifiable,

• ensure that documents of external origin determined by US ITER to be necessary for the planning and operation of the quality management system are identified and their distribution controlled, and

• prevent the unintended use of obsolete documents and to apply suitable identification to them if they are retained for any purpose.

2.5.3 External Documents

Procurements may involve regulations of other countries with additional independent inspections, conformity assessments, or other product compliance requirements such as found, for example, in the Pressure Equipment Directive (PED) [46] that is obligatory throughout the European Union or the French Order on Nuclear Pressure Equipment (ESPN) [51] requirements for nuclear pressure equipment. Where these requirements exist, they will be considered in addition to (or replacing in such cases where they exceed) the US ITER QA Program requirements contained in this QAP.

Such external documents will be identified and reviewed, and their usage controlled [18, 37].

2.6 SATISFACTION OF INTERESTED PARTIES

The expectations of interested parties are considered by US ITER management in the activities and interactions in the processes of the quality management system, with the aim of enhancing the satisfaction of interested parties while at the same time ensuring that safety is not compromised [3, 4, 5].

2.6.1 Customer Focus (ITER Project Performance)

US ITER management ensures that IO and DOE requirements are determined and are met with the aim of enhancing project performance [16].

Applicable quality requirements are passed on to subcontractors, but the responsibility for meeting the necessary quality requirements remains with US ITER [18].

The following are put into place to ensure the quality of the final products (typically in executing the requirements of PAs and TAs) [18]:

• US ITER will continue to have a well-defined management and quality program that is reviewed and accepted by the IO.

• US ITER will take due consideration of the IO technical opinion with regard to

– technical scope of contract,

– subcontractor selection,

– release of delivery, and

– release of stop work order.

• US ITER will allow and facilitate IO or ASN presence on the premises of any subcontractor, if requested.

The scope of this QAP includes all deliverable-to-ITER items and all US ITER activities important to the safety, reliability, and performance of the ITER facility, and it encompasses all the activities that are necessary for verifying that the required quality is achieved and that objective evidence is produced to that effect [18]. Items delivered to other parties for later incorporation into ITER are included.

This includes particular items whose failure would result in a significant:

• safety problem to the public and/or workers,

• loss of time and investment,

• unscheduled shutdown of the machine,

• reduction of the quality of data that could be acquired during operation, or

• impact on the environment.

2.6.2 Surveillance of External Interveners

Through execution of this QAP, US ITER (as an external intervener) cooperates with the IO in this obligation to the French Government: The IO informs all external interveners of the provisions required for implementing Ref. [1].

• The IO as operator surveys external interveners to ensure that they apply IO policy mentioned under Ref. [1] Article 2.3.1, for giving priority to preventing accidents and limiting their consequences pursuant to nuclear safety.

• The operations they carry out, or the goods or services that they provide, comply with the defined requirements.

• This surveillance is proportional to the level of importance for the activities carried out. It is documented. It is undertaken by individuals with the appropriate skills and qualifications.

2.7 IMPLEMENTING THE…