MPEX-12-PLAN-001- Quality Assurance Plan for MPEX.pdf

Controlled Copy MPEX-12-PLAN-001, Rev. 1 Effective Date: 07/31/2023 MPEX Quality Assurance Program Plan 1 of 78

Material Plasma Exposure eXperiment Oak Ridge National Laboratory

Material Plasma Exposure eXperiment

QUALITY ASSURANCE PROGRAM PLAN

MPEX-12-PLAN-001

REV. 1

AUTHOR:

LaTravia Harmon FFESD Quality Assurance Manager

Date

CONCURRENCE:

Valentino Jefferson Quality Assurance Subject Matter Expert Performance Analysis and Quality Division

Date

Aftab Hussain MPEX Lead Engineer

Date

APPROVAL:

Robyn Rose MPEX Project Manager

Date

Phil Ferguson MPEX Project Director

Date

The official record of this document is the electronic file located in the Enterprise Document and Record Management (EDRM) System.

A controlled copy is provided on the network.

It is the user’s responsibility to verify that work is being performed using the latest revision.

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Material Plasma Exposure eXperiment Oak Ridge National Laboratory

REVISION HISTORY

REVISION DESCRIPTION OF CHANGE

REVISION TYPE

Major Minor

0 Initial Issue. Redefined Quality Assurance Program/Supersedes MPEX Quality Assurance Plan version 0

1 Added Operations lead role, updated references to systems (ORNL Buy and Enterprise Document and Record Management), expanded definitions, Updated Software Quality Assurance, Work Control Planning align with project phases.

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CONTENTS

REVISION HISTORY

1. STATEMENT OF QUALITY POLICIES AND OBJECTIVES

2. INTRODUCTION

2.1 Policy

3. BACKGROUND

4. PURPOSE AND SCOPE

5. APPLICABILITY

6. QUALITY ASSURANCE MANAGEMENT SYSTEM

6.1 QAP Requirements

6.2 Risk Management

6.3 Graded Approach

6.4 MPEX Graded Approach to Quality

6.5 Graded Approach in Commercial Codes and Standards

7. QUALITY ASSURANCE CRITERIA DESCRIPTION IMPLEMENTING ELEMENTS

7.1 Organization

7.2 MPEX Management Structure

7.3 Roles and Responsibilities

8. QUALITY ASSURANCE PROGRAM

8.2 Indoctrination, Training, Qualification, and Certification

8.3 Design Control

8.4 Procurement Document Control

8.5 Instructions, Procedures, and Drawings Requirements

8.6 Document Control

8.7 Control of Purchased Items and Services

8.8 Identification and Control of Items

8.9 Control of Special Processes

8.10 Inspections

8.11 Test Control

8.12 Control of Measuring and Test Equipment

8.13 Handling, Storage, and Shipping

8.14 Inspections, Tests, and Operating Status

8.15 Control of Nonconforming Items

8.16 Corrective Action

8.17 Quality Assurance Records

8.18 Storage of Records

8.19 Audits, Assessments, and Surveillances

8.20 Software Quality Assurance

8.21 Suspect/Counterfeit Items

9. ACRONYMS AND DEFINITIONS

10. DEFINITIONS

11. REFERENCES

11.1 ORNL SBMS Documents

11.2 ORNL Facilities and Operations Procedures

11.3 ORNL PAQ Procedures

11.4 ORNL Systems

11.5 Interfacing References

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12. Attachments

ATTACHMENT A GOVERNANCE AND IMPLEMENTING DOCUMENTS

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1. STATEMENT OF QUALITY POLICIES AND OBJECTIVES

The Oak Ridge National Laboratory (ORNL) Quality Assurance Program (QAP) supports excellence in in the lab’s science and technology missions by developing a quality culture that contributes to scientific and operational excellence, research integrity, and continued improvement of processes to deliver quality products and services to both our internal and external customers.1 In keeping with this objective, the Material Plasma Exposure eXperiment (MPEX) is committed to meeting and exceeding the requirements and expectations of internal and external customers by successfully designing, fabricating, and commissioning the performance of MPEX to produce valid and verifiable results that advance capability and preserve subject matter expert (SME) knowledge of linear plasma device technology.

The quality objective of MPEX is to establish and maintain a culture of excellence in scientific integrity, research, development, operations, and support processes. These objectives are accomplished by

• Planning, developing, communicating, and deploying credible and compliant program documentation and project procedures;

• Implementing safe, compliant, efficient, and reliable processes with timely deliverables;

• Providing appropriately trained and highly proficient staff;

• Conducting effective in-process peer reviews and independent quality assessments;

• Evaluating, reporting, and resolving quality issues; and

• Incorporating lessons learned.

2. INTRODUCTION

The US Department of Energy (DOE) Office of Fusion Energy Sciences (FES) has determined that the availability of future fusion devices, such as a fusion nuclear science facility or a demonstration fusion power station, greatly depends on the development of plasma-facing divertor components with long operating lifetimes. In response to this need, the ORNL has been selected to lead the MPEX project. The project is planned to design, fabricate, install, and commission a superconducting magnet, steady-state linear plasma device (LPD) to study the plasma material interactions of fusion reactors.

MPEX uses a new high-intensity plasma source concept based on radio frequency technology. This source concept will allow the experiment to cover the entire spectrum of expected plasma conditions in the divertor of a future fusion reactor. The project will enable the study of erosion and redeposition for relevant geometries with relevant target-facing electric and magnetic fields, allow for the exposure of a priori neutron-irradiated samples, and include diagnostics stations for more detailed material surface analysis.

The MPEX project is being developed in a staged approach with successively increased capabilities. As such, identified systems, components, and processes are also included to reduce project risk, including research on efficient plasma heating and plasma transport to the target. In addition, equipment checkout

1 Quality Assurance Program, ORNL Standards Based Management System (SBMS), January 20, 2023.

MPEX Quality Assurance Program Plan 6 of 78 and commissioning are required to confirm hardware performance and will be executed as part of the project scope.

2.1 Policy

Safety, health, and quality are the core values driving performance on the MPEX project. It is the MPEX project policy to provide consistent quality and fully compliant activities and services in a safe, secure, reliable, and cost-effective manner. The MPEX project is committed to meeting and exceeding internal and external customers’ requirements and expectations by focusing on preventing rework and nonconformances, reducing variability, building quality into processes, and establishing an effective safety and quality culture.

The MPEX project is also committed to continuously improving the quality of products, facilities, and services by constantly evaluating and improving efficiency and effectiveness. Personal ownership of safety and quality is imperative for all members of the MPEX project team.

This quality assurance program plan (QAPP) identifies the essential requirements and process controls for activities affecting quality, including monitoring to ensure procedural compliance and performance effectiveness across the overall spectrum of project activities.

3. BACKGROUND

To compete with electricity, fusion energy must be made more cost-effective, which requires the design of fusion reactors with high availability. The major driver of high availability of fusion reactor is a long-lifetime power exhaust system, which must be replaced periodically. This exhaust system, the divertor, will be exposed to unprecedented heat and particle fluxes for long periods. These particles (ions, electrons, and neutrons) from the hot plasma will interact with the materials in the divertor and cause damage and erosion. Understanding these plasma-material interfaces (PMIs) by accelerated exposure of materials under relevant fusion reactor conditions of high fluxes, long duration, and at high temperatures is needed to develop plasma-facing components that can survive the conditions of fusion reactors for several years.

This is why over the past decade, PMI and materials sciences have been repeatedly identified as high‑priority issues by a variety of FES strategic planning and community-led activities.

In its 2007 Greenwald Report2, the Fusion Energy Science Advisory Committee classified plasma-facing components and materials issues as the only Tier 1 (highest priority) item. In 2009, the community-based Research Need Workshop report identified “Taming the Plasma Material Interface” as one of the five major research themes. The report also identified the potential need for a series of new facilities, including dedicated test facilities to evaluate the performance of plasma-facing materials in the presence of intense plasma fluxes for long periods and at elevated temperatures.

In 2015, in response to strategic planning activities in 2012 and 2014 and a directive from Congress, FES commissioned several community-led Research Needs Workshops focused on previously identified high‑priority research items, one of which was PMIs. The associated report from this community workshop identified four high-impact, cross-cutting research activities for addressing PMI issues, one of which was the development of a world-leading capability in the form of an LPD, specifically “a new high fluence, linear divertor simulator with flexible target stations.”

2 Greenwald Panel Fusion Energy Sciences Advisory Committee Report, October 2007, https://science.osti.gov/- /media/fes/fesac/pdf/2007/Fesac_planning_report.pdf https://science.osti.gov/-/media/fes/fesac/pdf/2007/Fesac_planning_report.pdf https://science.osti.gov/-/media/fes/fesac/pdf/2007/Fesac_planning_report.pdf

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Considering these developments, the report The Office of Fusion Energy Sciences: A Ten-Year Perspective3 (submitted to Congress in 2015) highlighted fusion materials science as one of five areas of critical importance. Furthermore, this report highlighted the expansion of materials research capabilities to enable exploration of previously inaccessible regimes as a high-priority objective for the next decade.

The report states that “the overall motivation is to gain entry into a new class of fusion materials science wherein the combined effects of fusion-relevant heat, particle, and neutron fluxes can be studied for the first time anywhere.” Consistent with the previously mentioned studies, this report also highlighted the important role that a dedicated LPD could play in advancing the understanding of PMI, materials, and component development.

The scientific demonstration of magnetic fusion energy as an environmentally sustainable and economically competitive energy source will require mastering of these material science issues, particularly those associated with the PMI. As such, FES places a high priority on gaining an improved understanding of the science of PMIs and materials degradation, particularly as it pertains to the development of high-performance materials for next-step devices and future fusion reactors.

4. PURPOSE AND SCOPE

This MPEX QAPP describes the applicable quality assurance requirements and identifies the policies and processes for designing, fabricating, and performing initial operations necessary to commission an integrated LPD capable of testing materials exposed to plasmas. It describes a systematic approach to achieving and maintaining process and product quality by ensuring that the stated and implied needs of interested parties are met. This QAPP applies to the scope of work associated with (1) completing a preliminary and final design, (2) procuring and fabricating all technical components, (3) modifying the facility to house the LPD, (4) installing the LPD, and (5) commissioning and operating the device.

The ORNL QAP supports excellence in science and technology missions through the development of a quality culture that contributes to scientific and operational excellence, research integrity, and continual improvement by defining the processes to deliver quality products and services to both internal and external customers. This QAPP describes the MPEX project’s approach to integrating quality principles and methodologies identified under the ORNL QAP and DOE O 413.3B into project processes and products.

5. APPLICABILITY

This QAPP applies to MPEX efforts that develop, engineer, fabricate, and commission the project infrastructure necessary for fabricating components. MPEX designs will be deployed with a continued focus on improving efficiencies within design advancement initiatives.

MPEX efforts are organized into a work breakdown system (WBS) composed of elements assigned to control account managers (CAMs). The following list describes each WBS element:

• Project Management and Support comprises the project director, project manager, chief scientist, project controls, and quality assurance efforts necessary to perform oversight, risk management activities, and all required support to the management team in managing the project. In addition to

3 The Office of Fusion Energy Sciences: A Ten-Year Perspective (2015–2025). https://science.osti.gov/- /media/fes/pdf/program-documents/FES_A_Ten-Year_Perspective_2015-2025.pdf https://science.osti.gov/-/media/fes/pdf/program-documents/FES_A_Ten-Year_Perspective_2015-2025.pdf https://science.osti.gov/-/media/fes/pdf/program-documents/FES_A_Ten-Year_Perspective_2015-2025.pdf

MPEX Quality Assurance Program Plan 8 of 78 performing overall management of the project, this team coordinates with and provides accountability to the sponsor and ORNL line management.

• Preliminary Design Management and Integration coordinates all preliminary design activities, including overall systems design, integration, and engineering configuration management for all components.

• Magnet System Design supports development of the magnet system reference design as well as development of vendor specifications and selection criteria in preparation for magnetic system design, fabrication, and solicitation.

• Plasma Source and Heating provides MPEX plasma heating systems, including the helicon source, electron heating system (gyrotrons), and ion cyclotron heating system. This includes efforts associated with design drawings; calculations; modeling; and developing vendor specifications and selection criteria for the gyrotron, high-voltage power supply, and diamond window procurements.

• Vacuum System Design is responsible for the MPEX vacuum system, including the vacuum boundary and chambers, pumping and gas distribution systems, MPEX support structure, and target extraction and transport systems (e.g., track, cart components, auto couplers). This WBS element includes efforts associated with design drawings, calculations, and modeling as well as test articles for the periscope and key components of the target exchange chamber.

• In-Vessel Components focuses on MPEX in-vessel cooling components, including limiters, skimmers, microwave protection units, the plasma dump assembly, and the target assembly. This also includes drawings, calculations, modeling, specifications, and acceptance criteria.

• Instrumentation & Control and Data Acquisition System Design focuses on system requirements elaboration, operations narrative development, piping and instrumentation diagram development, hardware selection, custom electronic design, and layout of instrumentation & control architecture.

This also includes defining data storage and local and remote user interaction concepts.

• Diagnostics is responsible for design of the MPEX hardware systems necessary to produce device-performance data outputs, including design of transferred diagnostic equipment from Proto-MPEX and new diagnostic systems (e.g., spectroscopy, interferometers, bolometers, infrared cameras).

• Procurement and Fabrication includes the efforts of the Design Authority and integration lead to oversee and coordinate procurement activities.

• Final Design includes the coordination of all final design activities, including overall systems design, integration, and engineering configuration management across all components.

• Infrastructure provides the design of required facility enhancements (e.g., structural modifications, radiological containment and safety systems, electrical system upgrades, and cooling circuit design);

leads the design effort associated with facility reconfiguration (e.g., updating drawings to depict current facility and system configurations, demolition drawings, utility isolation lists, and contractor solicitation packages); and develops architecture/engineer design requirements in preparation for CD- 3A solicitation.

• Pre-Operations and Commissioning includes startup and testing of the integrated MPEX device, commissioning with plasma, procedure development and training, operational readiness review, and turnover to operations.

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6. QUALITY ASSURANCE MANAGEMENT SYSTEM

6.1 QAP Requirements

As a DOE national laboratory, ORNL has prime contract–imposed mandates and expectations for the laboratory’s overall QAP. These are contained in DOE Order 414.1D, Quality Assurance, and in 10 Code of Federal Regulation (CFR) 830, Subpart A, “Quality Assurance Requirements,” which apply to nuclear facilities, radiological areas, and programs and activities that have the potential to affect nuclear or radiological safety. The ORNL Standards-Based Management System (SBMS) translates these and other external requirements into laboratory-wide policies and procedures, as summarized in the laboratory quality assurance program description (QAPD). The QAPD is the highest-tier quality assurance (QA) document for the laboratory. The QAPD addresses sponsor requirements through either the imposition of a QAPP based on ANSI/ISO/ASQ(E) Q9001:2015, ORNL’s baseline QA standard, or an alternate standard when it is advantageous or required to do so.

MPEX efforts conducted under the auspices of this plan invoke NQA-1-2008, Quality Assurance Requirements for Nuclear Facility Applications, including the NQA-1a-2009 Addendum (NQA‑1‑2008/9a). This standard including the 2009 addendum is hereafter referred to as simply

NQA‑1‑2008.

This QAPP is also 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 QAPP governs until the conflict is resolved.

The overall QAP is designed to evolve over time as processes are more fully understood and technical direction is determined.

6.2 Risk Management

Risk management, as described in MPEX-11-PLAN-005, Risk Management Plan for the Material Plasma Exposure Experiment (MPEX) Project at ORNL, is the process used to understand and influence conditions and control event uncertainties associated with project execution. A quantitative risk analysis process is used for the MPEX project to provide a systematic approach to identify potential risks, forecast impacts, and capture the best‑suited mitigation recommendations so that overall project uncertainties associated with cost, schedule, and performance are reduced to an acceptable level. Risk management is factored into project decisions at all levels throughout the life of the project.

6.3 Graded Approach

The use of a graded approach is permissible under Section 4.1.3 of DOE G 414.1-2B, Quality Assurance Program Guide, which specifically references ASME NQA-1, Subpart 4.2 as guidance on implementing a graded approach. The purpose of the graded approach is to govern the selection of appropriate controls and verifications to be applied to all project items, activities, and processes based on risk. It defines the process by which the extent of documentation and degree of rigor for process controls are applied commensurate with potential risk factors, importance to safety, technological impact, and stage in project life cycle.

The graded approach used in the MPEX project is based on four quality levels. It provides the process and rationale for establishing the appropriate level of quality rigor and oversight for each item, activity, or

MPEX Quality Assurance Program Plan 10 of 78 process. Activities with higher risks or greater consequences must implement a higher level of quality rigor and oversight.

Activities with lower risks or lesser consequences may require minimal quality controls and verifications.

In no case may quality be graded to “zero.” All project activities, even those of the lowest risk, must be compliant with the applicable quality assurance requirements, defined in this QAPP.

Depending on the approach, compliance with requirements may be achieved via a supplier’s (Supplier’s) QA program or via compliance with industry standards and codes or other specific quality requirements identified in engineering, procurement, construction, or startup testing documents.

6.4 MPEX Graded Approach to Quality

In addition to the approaches described in the previous section, MPEX implements a project-specific approach aligned with the ORNL graded approach to the quality process. Continued, adequate alignment with the ORNL graded approach will ensure that permanent ORNL facilities that are part of MPEX are assigned quality levels consistent with ORNL requirements and will be acceptable to end users. The following four MPEX quality levels define the extent to which quality requirements and verifications are applied:

Quality Level 1 ⎯ Applies to items, services, or projects (specific to work processes) whose functionality directly affects activities that are critical to the safe and reliable operation of components, systems, or structures. They include items, services, or activities whose failure could have severe consequences to public or personnel safety, the environment, compliance with the law, contract agreement or regulation, or ORNL’s mission or public perception. Appropriate controls for items, services, or activities identified as quality level 1 provide reasonable assurance that the assigned function will perform reliably.

Quality Level 2 ⎯ Applies to items, services, or activities that are important to the safe and reliable operation of components, systems, or structures. They include items, services, or activities whose failure or malfunction could result in unfavorable conditions and are important to the mission but are of low to medium risk where quality controls are needed to verify risk attributes. This level includes some software with risks that warrant increased rigor and application of quality requirements above the standard (commercial controls) to ensure that the basic design characteristics are met and identified risks are reduced.

Quality Level 3 – Applies to items, services, or activities that have minor impacts on the safe and reliable operation of components, systems, or structures. They require some engineering or management controls to ensure the item or service will fulfill its intended function and maintain compliance with applicable programmatic documents and procedures. These include items, services, or activities whose failure would be unlikely to affect public or workers’ health and safety adversely.

Quality Level 4 – Applies to items, services, or activities that have the lowest project risks and require minimal rigor. This level imposes the least amount of rigor and controls, allowing more flexibility for science and technology discovery. However, a minimal level of documentation is required to identify basic objectives, approach, assumptions and to anticipate results and conclusions.

In no case may quality be graded as quality level 0. All project activities, even those of the lowest risk, must be compliant with the applicable quality assurance requirements defined in this QAPP.

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In addition to the approaches described, commercial controls described in Section 6.5 may be applicable for the level of controls for those items, activities, or processes evaluated as low risk requires no additional quality controls beyond the supplier’s published or stated attributes of the item, services, activity, or process, general receipt inspections and/or acceptance processes ensure item, quantity, and basic design characteristics (documentation, physical condition count, form, fit, function, and materials).

A subset of this level is used when additional or enhanced quality controls are required over and above the standard commercial practices to reduce identified risks. The potential drivers for enhanced or minor quality controls flow from DOE O 414.1D, Quality Assurance, and include industry safety, environmental, radiological, and non-radiological hazards.

The MPEX project aims to balance the application of QA requirements and process controls that are necessary, appropriate, and sufficient to achieve mission objectives. Project procedures and task-specific procedures and instructions provide additional details that implement the graded approach. A crosswalk of NQA-1 requirements applicable to MPEX and the associated governing and implementing documents is provided in Attachment A, Governance, and Implementing Documents.

6.5 Graded Approach in Commercial Codes and Standards

A graded approach is also embedded in the standard commercial processes for engineering, procurement, construction, and startup. Industry standards and codes apply grading based on the risks to personnel, the public, and the environment. For example, the international building code considers the type of occupancy in a building, seismic risks, and other factors. Increased risks in these areas may necessitate enhancements and increased rigor in design, fabrication, and construction. The degree of oversight and quality verifications of these activities as part of standard commercial practices is also increased as the risk increases. It is important from a project effectiveness perspective not to disregard the quality controls inherent in industry codes and standards. The standard practices to grading that exist in industry codes and standards are considered part of the MPEX approach to grading as required by DOE O 414.1D.

7. QUALITY ASSURANCE CRITERIA DESCRIPTION IMPLEMENTING ELEMENTS

The following sections contain the specific QA criteria described in the NQA-1 QAP requirements. These criteria also address the quality requirements associated with DOE O 414.1D, Quality Assurance, and 10 CFR 830 Subpart A, “Quality Assurance Requirements.”

7.1 Organization

The MPEX project reports to the Fusion and Fission Energy and Science Directorate (FFESD) at ORNL.

Project support is provided by personnel matrixed from the Fusion Energy Division, the project management office, and ORNL quality and safety organizations. The project management structure is shown in Figure 1 (green boxes).

The DOE FES is the sponsor of the project (Figure 1, yellow boxes). The project is managed by an Integrated Project Team that meets biweekly (Figure 1, blue box).

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Figure 1. MPEX project management structure.

7.2 MPEX Management Structure

MPEX project management is responsible for defining the project technical work scope, plans, deliverables, reports, schedules, and quality objectives and for effectively communicating, tracking, and reviewing these items throughout the organization. Project management is also responsible for ensuring that adequate personnel and resources are provided to organizations performing quality-related activities.

The MPEX Preliminary Project Execution Plan establishes the project-specific organizational structure, roles, and responsibilities necessary for effective management. Organizational structures, interfaces, roles, and responsibilities specific to QA are defined in this QAPP.

MPEX management is continually in contact with project sponsors, vendors, technical integration staff, and operations staff and receives regular feedback regarding project performance and product quality.

Although project management may delegate aspects of management or execution of this plan to contractors, agents, or consultants, the overall responsibility for quality is retained by project management. Quality is achieved and maintained by those who have been assigned responsibility for performing work; the achievement of quality is verified by individuals not directly responsible for performing the work when verification is necessary.

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Any individual(s) assigned any responsibility for ensuring effective execution of any portion of this plan at any location where activities subject to QA are being performed shall have direct access to and support from the levels of management necessary to perform their assigned function. The persons and organizations responsible for executing the project shall have sufficient authority and organizational freedom to identify quality problems; initiate, recommend, or provide solutions; and verify the implementation of solutions.

The MPEX project director is matrixed to the FFESD associate laboratory director for this project and reports directly to the director.

The MPEX project manager (PM) is responsible for the execution of the MPEX project scope of work.

The MPEX PM has overall responsibility and accountability for establishing the QAP and has overall responsibility for the effective implementation of the QAP. CAMs are responsible for determining the procedures necessary to ensure assigned work is performed safely and for ensuring that individuals assigned the work are qualified and trained to those procedures. The MPEX PM is responsible for determining the procedures necessary for adequate performance of work activities.

The individual(s) or group(s) responsible for establishing and executing this QAP may delegate any or all of the work to others but shall retain responsibility and accountability implementing applicable requirements.

The MPEX project director, MPEX PM, and the quality manager shall approve this QAPP.

The PM will designate staff who will work on the project and will ensure that they are trained to the standards of this QAPP. All project staff are responsible and accountable for being knowledgeable of procedures; performing work in a compliant manner; identifying unsatisfactory procedures, processes, or products; and actively supporting continuous quality improvement. Staff have the authority to stop work, are responsible to report conditions adverse to quality (CAQs) (i.e., issues) to management, and resume work only upon approved resolution of the issue.

7.3 Roles and Responsibilities

This section describes the key program roles and responsibilities necessary for developing, implementing, and maintaining an effective QAP.

The organizational roles and responsibilities of the PM, CAMs, and other key program personnel are defined in this QAPP.

The project organization chart is maintained separately, and the latest version is available upon request.

7.3.1 Project Director

The project director is responsible for the following:

• Establishing and approving this QAP and ensuring compliance with its requirements

• Communicating the project’s quality policy and objectives to project staff and stakeholders

• Overseeing and managing project work to ensure the overall quality of deliverables

• Ensuring that necessary personnel and resources are supplied to enable quality work

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• Fostering a culture of continuous quality improvement and problem prevention

• Reporting quality-related issues as they occur and ensuring that corrective actions are taken

7.3.2 Project Lead Engineer

The MPEX project lead engineer provides all necessary support to the MPEX project director to effectively manage the project, including the following:

• Overseeing technical design and leading a project team in the design of the MPEX device

• Overseeing contracting and manufacturing of all hardware components for MPEX

• Ensuring that all quality standards are being administered in the manufacturing process for all hardware components

• Working with project CAMs to track project status and to identify problems that may affect the project

7.3.3 Project Manager

The MPEX PM assists the project director and project lead engineer in establishing the appropriate project planning, execution, and controls procedures to ensure that the project is executed within approved cost, schedule, and technical scope.

The PM has overall accountability for effective implementation of the QAP and has the following responsibilities:

• Managing the project within scope, schedule, and budget or available funding

• Reviewing and approving the QAPP and associated processes

• Ensuring that adequate levels of trained and proficient staffing are identified

• Providing direction to ensure that work is carried out on a timely schedule and within budget

• Ensuring that products and services are acquired in accordance with ORNL procurement requirements

• Serving as the official interface with the sponsor on all project commitments and project management issues

• Ensuring management assessments are performed to determine the effectiveness of QAP implementation

• Ensuring that the adequacy and effectiveness of the QAPP’s implementation is assessed periodically

• Developing the project execution plan, the WBS, and other project documentation

• Working with project CAMs to track project status and to identify problems that may affect the project

• Maintaining the risk register and conducts monthly risk reviews

• Working with the federal project director and project director to coordinate all independent project reviews

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7.3.4 Control Account Managers

Funding is distributed to projects that is supported by various work groups to perform related activities that contribute to the completion of program/project milestones. Program/project milestones are described in project management plans. CAMs are the leads assigned responsibility for WBSs, milestones, and the quality of the activities conducted to complete the milestones. They oversee the staff who conduct the technical activities necessary to fulfill the WBS milestones. The CAMs work with the project managers, who typically delegate responsibilities for executing project-associated activities.

CAMs are the focal point for quality within each WBS and are the SMEs and project contacts for line management and the quality representative (QR). In response to sponsor’s expectations and requirements, each CAM develops the overall structure for the segment of work under their purview through planning documents such as project plans, test plans, procedures, and any other work-controlling documentation considered necessary. The CAM is responsible for satisfactorily meeting the applicable work scope specifications, processing plans, and test requirements and related quality requirements defined or referenced in the QAP. The CAM is also responsible for obtaining desired project results.

CAMs have overall responsibility for project execution and technical direction. CAMs are responsible for meeting requirements, achieving quality of the work, and implementing this QAPP in their areas of control. CAMs are responsible for the following:

• Developing appropriate procedures for assigned work

• Ensuring that the project incorporates and implements the applicable requirements and controls into project documents, processes, systems, and activities

• Ensuring appropriate and effective implementation of the QAPP, including continuous improvement of processes and systems

• Ensuring that the scope of work under their authority meets the sponsor, ORNL, and project requirements and objectives relative to quality

• Monitoring progress on corrective actions when required to resolve problems and conflicts that affect project implementation

• Managing document control and records

• Securing adequate staffing for execution of authorized work

• Providing input to the project baseline plan and necessary changes

• Executing work in accordance with the baseline and subsequent changes

7.3.5 Procurement Officer

The MPEX procurement officer is the project’s point of contact for all procurement activities, including the following:

• Creating, reviewing, approving, and issuing requests for information and requests for proposal

• Reviewing and performing technical evaluations of vendor proposals

• Selecting and approving vendors

• Negotiating and awarding contracts

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• Monitoring contract execution and making modifications as necessary

• Facilitating payments to the vendor

7.3.6 Quality Representative

The QR is a member of the ORNL Performance Analysis and Quality (PAQ) organization who supports the PM in ensuring that an appropriate QAPP is established and implemented. The QR is the primary point of contact for MPEX interfaces with the ORNL QAPD and assists the project staff with the following:

• Developing and maintaining the QAP

• Interpreting QAP requirements

• Performing independent quality assessments of work in progress, including document reviews against specifications

• Assessing the implementation of quality programs

• Coordinating internal and external assessments and responses to these assessments

• Ensuring that the QAP is executed as described in the QAPP

• Preparing and maintaining the QAPP and supporting QA procedures

• Participating in the resolution of CAQs, as appropriate

• Identifying quality-related problems and their impacts

• Initiating, recommending, or providing solutions to quality-related problems through designated channels

• Suspending or stopping work—including work performed by suppliers who provide materials and services to the project as coordinated through the ORNL procurement process—after consultation with project or line management when a CAQ cannot be satisfactorily resolved and verifying that adequate corrective actions are in place before permitting work to resume

7.3.7 Suspect/Counterfeit Items Representative

The project suspect/counterfeit items (S/CIs) representative is responsible for the following:

• Serving as the project point of contact for the S/CI program and interfacing with the ORNL S/CI program coordinator

• Ensuring documentation and closure of S/CIs as described in applicable procedures

• Ensuring the ORNL Occurrence Reporting Program manager and DOE Oak Ridge Site Office, Office of Inspector General are notified, as necessary

• Generating lessons learned for use in improving all S/CI activities

• Disseminating S/CI information to project personnel

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7.3.8 Records Management Officer

The project records management officer (RMO) assists and advises the project in identifying, scheduling, and maintaining records in compliance with ORNL records management requirements and is responsible for the following:

• Serving as the organizational contact for electronic recordkeeping to capture, declare, and disposition electronic records

• Serving as a liaison between ORNL Records Management Services and organizational records contacts and owners

• Performing and/or participating in reviews, assessments, and internal and external audits as required

• Coordinating the transfer of project records to ORNL Records Management Services at project closeout

7.3.9 Document Management Coordinator

The document control coordinator is responsible for the following functions:

• Acting as the point of contact for the project document management system

• Ensuring that project documents are properly reviewed, approved, and entered into project records

• Assisting the RMO with scheduling and indexing project records

7.3.10 Lessons Learned Coordinator

The lessons learned coordinator is responsible for the following functions:

• Identifying, analyzing, and documenting project lessons learned

• Maintaining a register of lessons learned

• Interfacing with the QR to escalate lessons learned to site or DOE complex scope as appropriate

• Maintaining the formal lessons learned report to be provided at CD-2/3 and CD-4 and at intermediate independent project reviews as required

• Identifying relevant lessons learned from other DOE projects and communicating them to project management for appropriate action

7.3.11 Technical Project Officer

The technical project officer is responsible for the following functions:

• Controlling all technical interfaces with and providing technical direction to the subcontractor

• Providing the subcontractor with pre-job briefing when on-site work involves hazards and authorizing work to proceed

• Monitoring subcontractor’s work and providing oversight to make sure work is done in conformance with subcontract requirements

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• Maintaining records documenting compliance with the subcontract, including documentation of technical direction provided as applicable

• Retaining appropriate files, including deliverables and submittals during subcontract performance and after subcontract completion and closeout

• Reporting any problems to the procurement officer, including threats to costs or schedule; changes needed to the subcontract; nonconforming products or services, including those previously accepted;

unsatisfactory completion of delivery or performance; and other performance issues that need to be addressed with the subcontractor

• Participating in corrective actions for performance issues

7.3.12 Project Technical Staff

Technical staff members are responsible for ensuring quality and for continuous improvement at the working level. Quality is achieved and maintained by those who have been assigned responsibility for performing the work. The staff members performing activities in support of technical tasks are personnel with the recognized expertise necessary to complete program activities successfully within their assigned teams. All staff members are authorized to do the following:

• Prevent the occurrence of any potential nonconforming conditions

• Identify opportunities for actions and continuous improvement initiatives

• Verify the effectiveness of preventive or corrective actions and initiatives

Staff members also have the responsibility and authority to stop work that is considered to be a serious threat to their safety or health, the health and safety of other personnel, or the environment. They are authorized to stop work if they identify a potential impact to the quality of the work, the goals of the sponsor, or the reputation of the project. Management expectations and the process associated with stop‑work actions are contained in ORNL SBMS subject area, “Stop Work,” under the Worker Safety and Health management system. In addition, each staff member is responsible for ensuring that equipment operates correctly and is calibrated to the accuracy necessary to support their planned work and for verifying that work-controlling documents are of the latest revision prior to starting work.

7.3.13 Operations Lead

The operations lead is responsible for operations, maintenance, safe operations, implementation activities, and requirements oversight, as well as the following functions:

• Implementing safety authorization documents with the approval of sponsors and project management

• Establishing conduct of operations programs and operations procedures

• Managing the operations to safely and compliantly oversee plasma material science research within the facility

• Supporting MPEX project management by reviewing technical and programmatic documentation.

• Working with CAMs, the MPEX Lead Chief Engineer, and MPEX project management to establish robust designs that support machine availability to perform the MPEX mission of plasma material science

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• Ensuring safety envelope program requirements are being implemented

• Supporting the execution of Integrated Safety Management System guiding principles, work control in accordance with SBMS core functions, and MPEX safety culture

• Working with Division Safety to develop an MPEX-specific safety program that focuses on safety hazards relevant for MPEX and MPEX operations

8. QUALITY ASSURANCE PROGRAM

This section defines the processes and actions that meet the requirements of ASME NQA-1-2008, Requirement 2, Quality Assurance Program. MPEX project activities shall be planned, implemented, executed, and maintained in accordance with this QAPP. This MPEX QAPP ensures

• The identification and control of activities affecting quality to an extent consistent with their importance;

• Indoctrination, training, and qualification as necessary of personnel performing or managing activities affecting quality; and

• Regular management assessment of the adequacy and effective implementation of the quality assurance program.

The QAPP provides for the planning and accomplishment of activities under suitably controlled conditions by judiciously applying the requirements of NQA-1-2008 based on the NQA-1-2008 standard’s Part IV, Subpart 4.2 guidance. Controlled conditions include the use of appropriate equipment, suitable environmental conditions for accomplishing the activity, and assurance that prerequisites for the given activity have been satisfied. The QAP provides for special controls processes, test equipment, tools, and skills to achieve and verify the achievement of the required quality of activities and items.

Processes shall be established and implemented to detect and correct quality problems.

The QAPP is implemented by project management. The controls required by this QAPP are administrated on a graded basis with the importance of activities, consequence of failure, and the nature of the final deliverables as the grading criteria. The purpose of this approach is to control the work activities to the degree necessary to ensure that applicable requirements are met regarding the items and activities that affect each work scope and its success.

Project management has endorsed a set of expectations for ensuring that data and other deliverables are of a pedigree that will withstand any future use. This QAPP is intended to provide personnel the information necessary to meet sponsor expectations and requirements, which are based on NQA-1-2008.

The QAPP has been designed to ensure that appropriate planning is established and implemented commensurate with project responsibilities for the

• Health and safety of workers and the public;

• Environmental protection;

• Reliability and continuity of operations;

• Successful accomplishment of the program’s mission and objectives; and

• Generation of valid results and completion of program deliverables.

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This document is prepared and shall be reviewed, approved, issued, implemented, and maintained for ORNL staff responsible for performing quality-related activities governed by requirements imposed by the MPEX sponsor. Before project activities are closed out, opened, or not completed, quality-related action items shall be resolved, records shall be completed and transmitted and/or disposed of as required, and leftover or archival test materials shall be shipped or disposed of in accordance with applicable regulations and agreements between ORNL and DOE or any entities designated by DOE.

8.1.1 Work Planning, Control, and Documentation Considerations

The management controls described in this QAP—in conjunction with the ORNL Integrated Safety Management System, as defined in MPEX Safety Envelope—provide systems and processes that enable MPEX participants to deliver products that meet or exceed the expectations of project sponsors. MPEX construction work control will be applied per SBMS requirements or similar construction oversight organization, and operational and post construction work planning activities are expected to be controlled according to the Work Controls procedure . Quality controls shall be applied to the degree commensurate with the

• Planned or possible future function or end use of the deliverable,

• Consequence of failure (i.e., risk) associated with the deliverable,

• Importance of the data or information being collected or analyzed,

• Complexity of the equipment or software required to achieve the sponsor goals,

• Uniqueness of the deliverable or degree of standardization, and

• Degree to which functional compliance can be demonstrated through inspection or testing.

Activities that could affect the quality of the deliverables for which ORNL is responsible are defined as quality-related activities. The MPEX QAP shall control quality-related activities to an extent consistent with their importance to the results associated with the project deliverables. For planned future activities, the applicable MPEX Management Leadership Team, with guidance from the QR, shall determine the level of formality needed in the work-controlling documents before beginning the associated activity.

Implementing documents applicable to the project work scope shall translate the QAP requirements into work processes. The MPEX director and PM direct the activities and resources required to develop and implement this QAP and to ensure the following during work planning activities:

• The work scope and objectives are defined, and a list of the primary tasks involved is created.

• QA requirements are appropriately applied.

• Necessary activities and methods for accomplishing them are defined.

• The appropriate implementing documents are identified or developed.

• Testing equipment, software, or other equipment is identified.

• Prerequisites, special controls, environmental conditions, processes, or skills are identified.

• Applicable technical and management controls, required records, and verification activities are identified.

• Responsibilities are assigned.

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• Training and qualification are complete.

• Project closeout activities

The technical activities undertaken to produce project deliverables are identified and documented in…