EIC-QAG-PLN-002 Quality Assurance Plan for EIC.pdf

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

Plan: Quality Assurance Plan for the Electron-Ion Collider Revision: 05

Electron-Ion Collider Plan

Quality Assurance Plan for the Electron-Ion Collider

December 17, 2024 Prepared by:

____________________________________________________ Date: __________________ Christopher Porretto, Quality Assurance Manager

Reviewed by:

Glenn Falluca, QMO Manager

Luisella Lari, EIC Project Manager

Sergei Nagaitsev, EIC Technical Director

Jacob Harris, Quality Assurance Manager for TJNAF Partnership

Jim Fast, EIC Associate Project Manager for TJNAF Partnership

Docusign Envelope ID: DFDBD754-1637-4D18-A222-D1C8ED214F6D

12/17/2024

12/19/2024

12/17/2024

12/17/2024

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

Approved by:

Jim Yeck, EIC Project Director

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

REVISION HISTORY

Revision # Effective Date Summary of Change

00 February 2020 Initial Draft

01 November 2020 Added collaboration with TJNAF as major partner.

02 August 2023

Added references to In-kind Contributions and PPD docs; added references to requirements management plan and requirement documents;

added reference to configuration control assessments; added Appendix A; minor updates, e.g., delete references to DOE LL Listserver.

03 October 2023 Revised Appendix A to delete references to obsolete draft PPD description.

04 September 2024 Added Appendix B Partner QA Plan template.

05 December 2024 Deleted Appendix B Partner QA Plan template;

added missing document numbers to referenced documents.

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

List of Acronyms

AE Architect-Engineer BNL Brookhaven National Laboratory BTMS Brookhaven Training Management System CCI Count, Condition, & Identity CD Critical Decision CDR Conceptual Design Report CM Construction Manager DOE Department of Energy EIC Electron-Ion Collider ES&H Environment, Safety, & Health HQ DOE Headquarters IOPS Integrated Operational and Performance System ISMS Integrated Safety Management System ITR Inspection Test Record JTA Job Training Assessment M&TE Measurement and Test Equipment NAS National Academy of Sciences OPA DOE Office of Project Assessment PPEP Preliminary Project Execution Plan QA Quality Assurance QC Quality Control QMO Quality Management Office R&D Research & Development RIDS Records Inventory and Disposition Schedule SBMS Standards Based Management System SLA Service Level Agreement SOW Statement of Work SSC Structures, Systems and Components TJNAF Thomas Jefferson National Accelerator Facility U.S. United States WBS Work Breakdown Structure

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

TABLE OF CONTENTS

1. Introduction

1.1 Purpose

1.2 Scope

2. Definitions

3. Graded Approach

4. Quality Assurance Program

4.1 Organization and Functional Responsibilities

4.2 Responsibility for Managing

4.3 Levels of Authority and Interface

5. Personnel Training and Qualification

6. Quality Improvement

7. Lessons Learned

8. Documents and Records

9. Work Processes

10. Design

10.1 Design Verification and Validation

10.2 Configuration Control

11. Procurement

11.1 In-kind Contributions

12. Inspection and Acceptance Testing

13. Management Assessments

14. Independent Assessments

15. Software Quality Assurance

16. References for Use with This Plan

16.1 DOE

16.2 Code of Federal Regulations, Part 10 (10 CFR)

16.3 Other Documents

Appendix A - Strategy Regarding In-kind Contributions and Non-US Pressure System Codes

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

Quality Assurance Plan for the Electron-Ion Collider

1. INTRODUCTION

1.1 Purpose

The Electron-Ion Collider (EIC) is a U.S. Department of Energy (DOE) Major System project that is being carried out to design and build a world-class user facility for scientific research. The project is controlled by management systems described in the EIC Preliminary Project Execution Plan [23]. The primary objective of the EIC Quality Assurance Program, as mandated by the Preliminary Project Execution Plan (PPEP), is to implement quality assurance (QA) criteria in a way that achieves adequate protection of the workers, the public, and the environment, taking into account the work to be performed and the associated hazards. The objectives include:

• designing in quality and reliability;

• assuring that all personnel involved in the project, including personnel at partner institutions, uphold this QA plan;

• promoting early detection of problems to minimize failure costs and impact on schedule;

• developing appropriate documentation to support construction and operational requirements;

• assuring that personnel have the necessary training as needed before performing critical activities, especially those activities that have programmatic, environment, safety, security, or health consequences; and

• defining the general requirements for design and readiness reviews, including environment, safety, security, and health issues related to EIC and contractor hardware, software, and processes.

This document is the QA plan for the EIC project. Its purpose is to give the QA requirements for EIC and describe how the requirements will be met. It discusses how the QA criteria will be satisfied, using a graded approach. This QA plan follows DOE Order 414.1D, Quality Assurance [1], and integrates quality requirements outlined in the Brookhaven National Laboratory (BNL) Standards-Based Management System (SBMS). The BNL SBMS contains the BNL Quality Management Management System Description, Quality Assurance Program Description [7], and various QA-related subject areas. This plan is implemented by quality plans, procedures, and guides that are developed to accommodate specific quality requirements.

The EIC QA Plan is to be considered a living document and expected to be updated throughout the lifecycle of the Project.

The BNL Quality Assurance Program uses an integrated management systems approach. It describes how the various BNL management system processes and functions provide a sound approach that conforms to the 10 criteria defined in DOE Order 414.1D, Quality Assurance [1].

Although BNL has been identified as the contractor to manage and execute the acquisition of the EIC, BNL will collaborate with other partners through formal signed agreements to perform significant portions of the EIC scope of work. Thomas Jefferson National Accelerator Facility (TJNAF) will serve

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years as a major partner, with both BNL and TJNAF committed to the successful development and execution of the EIC Project and the scientific goals of the EIC through full intellectual partnership between their respective teams and other collaborators. TJNAF staff will participate as members of the Integrated Project Team (IPT) and the Executive Management Team, as well as assisting in the design, fabrication, assembly, installation, testing, and commissioning of the EIC Project. Work performed by TJNAF staff at TJNAF will follow the TJNAF corporate QA Program and this Plan.

The TJNAF Quality Assurance Program is described in the TJNAF Contractor Assurance System Program Description [22], and various QA-related implementing procedures. Its purpose is to provide a high-level description of the structure of Jefferson Lab’s Quality Assurance Program, and how it meets the ten (10) criteria, including suspect/counterfeit item requirements, contained in Department of Energy (DOE) Order 414.1D, Quality Assurance [1].

The QA strategy of the Project is to leverage the QA systems, tools, and personnel knowledge and experience at each partner institution. To this end, the Project requires a formal (i.e., documented) QA system and plan be in place and used at each partner institution, which covers the scope of their work.

In addition, certain project-specific procedures will be instituted, as well as integration of various QA topics between the institutions.

1.2 Scope

This plan provides requirements applicable to all project participants (i.e., BNL, TJNAF and all collaborating institutions), encompassing all activities performed by or for the EIC Project from research and development (R&D) through facility acceptance. Each collaboration participant shall work within its own QA and procedure system, which must be consistent with the requirements in this plan and the associated implementing procedures. Specific requirements for partner laboratories will be established and documented in memoranda of agreement.

The quality requirements identified in this EIC QA Plan provide the framework for a results-oriented project management system that focuses on performing work safely, and meeting project requirements and DOE expectations while allowing the EIC Project and Partners to operate efficiently.

A QA Plan will be requested from international partners that provide in-kind contributions. The respective QA Plans will be reviewed for adequacy by the EIC Project, and concurred by the EIC QA Manager. A risk-based, graded approach will be applied to the review for adequacy with the level of rigor expected in a robust quality plan.

2. DEFINITIONS

As used in this plan:

Independent Assessment – An assessment conducted by individuals within the organization but independent from the work or process being evaluated, or by individuals from an external organization.

Inspection Test Record – A document listing the criteria that will be checked to deem an item or service acceptable.

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Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

Management Assessment – A periodic, introspective self-analysis conducted by management to evaluate management systems, processes, and programs and ensure the project team’s work is properly focused on achieving desired results.

Quality – The condition achieved when an item, service, or process meets or exceeds the user’s requirements and expectations.

Quality Assurance – All actions and controls necessary to provide confidence that quality is achieved.

Safety – Environment, safety, and health (ES&H), including pollution prevention and waste minimization.

3. GRADED APPROACH

A key element of the QA Program is the concept of a graded approach; that is, selecting and applying an appropriate level of analysis, controls, and documentation commensurate with the potential to have an ES&H, radiological, or programmatic impact. This methodology is described in the BNL SBMS Graded Approach for Requirements Subject Area [8] and was developed to facilitate the application of the graded approach. The graded approach does not allow the EIC Project’s internal or external requirements to be ignored or waived, but does allow the degree of controls, verification, and documentation to vary in meeting requirements based on the risk level.

In general, each partner/collaborating institution is responsible for instituting the “graded approach” in a manner which is already being done at that institution (i.e., leverage the systems already being used).

4. QUALITY ASSURANCE PROGRAM

4.1 Organization and Functional Responsibilities

The EIC Project is carried out by BNL and TJNAF as described in the EIC Preliminary Project Execution Plan [23] and managed by EIC Project Management. The project is structured according to the Work Breakdown Structure (WBS). The Project Director maintains an organization chart, which includes a matrixed QA Manager from BNL’s Quality Management Office. This allows for a tiered structure for the flow-down of institutional QA requirements, as well as the development of project-specific requirements. This allows a level of QA independence to ensure that the project meets all BNL institutional and EIC project-specific quality-related requirements. This matrixed service is maintained with an annual Service Level Agreement (SLA) that allows for other quality engineering support from the BNL Quality Management Office when necessary.

TJNAF will have an EIC QA Manager for the TJNAF Partnership, who shall have QA responsibilities for the EIC Project at TJNAF. The EIC QA Manager for the TJNAF Partnership shall ensure that EIC

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Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

Project-specific QA activities are implemented in accordance with the TJNAF Quality Assurance Program Description [22] TJNAF QA processes, and this EIC QA Plan.

International Participants that provide in-kind contributions shall be required to assign a designated QA Representative, who shall have QA responsibilities for the EIC Project at their home institution. The Participant EIC QA Representative shall ensure that EIC Project-specific QA activities are implemented in accordance with the Participant institution's QA Program and the requirements agreed to in the Project Planning Documents (PPD), which describe the mutual understandings between the Participant and BNL, regarding the scope of work, deliverables, and conditions of acceptance of the planned in-kind contribution to the EIC Project.

A contracted AE firm is responsible for the design of the conventional facilities. A contracted CM agent firm is responsible for supplying design phase/pre-construction services and construction management during the construction phase of the project.

4.2 Responsibility for Managing

The EIC Project Director manages the project and is responsible for achieving performance goals.

The EIC QA Manager is responsible for ensuring that a quality system is established, implemented, and maintained in accordance with BNL’s institutional QA requirements, as well as EIC Project-specific QA requirements. The QA Manager reports to the BNL Quality Management Office Manager and the EIC Project Manager and provides oversight and support to the project participants to ensure a consistent quality program.

Similarly, the EIC QA Manager for the TJNAF Partnership is responsible for ensuring that a quality system is established, implemented, and maintained in accordance with TJNAF’s institutional QA requirements, as well as EIC Project-specific QA requirements. The EIC QA Manager for the TJNAF Partnership supports the TJNAF project organization led by the EIC Associate Project Manager for the TJNAF Partnership. In addition, the EIC QA Manager for the TJNAF Partnership is responsible for providing QA oversight of the EIC Project at TJNAF and shall provide reporting of performance monitoring to the EIC QA Manager, as requested.

The EIC Project organization is composed of 12 Level 2 WBS elements, each with a Level 2 WBS Manager. See the EIC WBS, shown to the Second Level, in the Preliminary Project Execution Plan for the Electron-Ion Collider (EIC) [23].

The EIC Level 2 Managers (L2Ms) are responsible for implementing the requirements established in this QA Plan within their project system and subsystems. The L2Ms have the responsibility to ensure the EIC Partners, vendors/subcontractors, and collaborating institutions relating to their subsystems adhere to the requirements established in this QA Plan via their own documented and accepted quality planning documents which will subsequently be reviewed prior to the start of work. L2Ms can delegate responsibility for the QA Plan implementation to their Level 3 Managers (L3Ms). L2 and L3 Managers are responsible for immediately communicating issues or adverse conditions that may negatively impact safety, quality, technical performance, cost, or schedule. L3Ms are responsible for developing Quality Control (QC) Plans for their areas of responsibility and promote collaboration with the Partners.

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Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

4.3 Levels of Authority and Interface

The EIC Preliminary Project Execution Plan [23] and this EIC Quality Assurance Plan define the responsibility, authority, and interrelation of personnel who manage, perform, and verify work that affects quality.

Roles and responsibilities addressed in this plan include the following:

• Responsibility for performing work – All employees, collaborators, contractors, and subcontractors are responsible for the quality of the work that they perform and/or supervise and for ensuring that all work is planned and performed in accordance with the institutional requirements outlined in the BNL SBMS Work Planning and Control for Experiments and Operations Subject Area [9]. Each has the authority to report adverse conditions that affect the quality of the project deliverables to their respective line managers.

• Responsibility for acceptance – The WBS manager (L2, L3, L4) responsible for EIC components or systems is required to determine their acceptance criteria.

• Responsibility for assessing work – Management at each level is responsible for evaluation of quality through management assessments. Independent assessments may be requested by EIC Project Management.

• QA Program – The EIC QA Manager is responsible for development, implementation, assessment, and improvement of the QA Program.

• Periodic reporting – The EIC QA Manager is responsible for periodically reporting on the performance of the quality system to the EIC Project Director and the BNL Quality Management Office Manager for review and as a basis for improvement of the quality system.

• Readiness assessments – The EIC Project Director or higher authority may call for readiness assessments as the project nears completion.

• Resource considerations – Managers are responsible for providing the resources needed to conduct the project successfully. Project control systems are used to aid in the dispersal of funding to the proper point at the time needed.

5. PERSONNEL TRAINING AND QUALIFICATION

EIC managers are responsible for ensuring that their staff members are adequately trained and qualified to perform their assigned work effectively and safely, in accordance with the institutional requirements outlined in the BNL SBMS Training and Qualification Subject Area [10].

Before personnel are allowed to work independently, management is responsible to ensure personnel have the necessary experience, knowledge, skills, and abilities. Personnel qualifications are based on factors such as:

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Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

• previous experience, education, and training;

• performance demonstrations or tests to verify previously acquired skills;

• completion of training or qualification programs; and/or

• on-the-job training.

The BNL SBMS Training and Qualification Subject Area [10] describes the training process for employees, guests, and contractors. EIC personnel will each have a Job Training Assessment (JTA) that identifies the required training for their position. The Brookhaven Training Management System (BTMS) will be used to track the JTA status of each EIC worker.

All project participants are responsible for ensuring that their training and qualification requirements are fulfilled, including continuing training to maintain proficiency and qualifications, as applicable.

6. QUALITY IMPROVEMENT

Processes to detect and prevent quality problems will be established and implemented, including:

• design reviews;

• software verifications and validations;

• work planning;

• equipment inspections and tests; and

• assessments.

Item characteristics, process implementation, and other quality-related information will be reviewed and the data analyzed to identify items, services, and processes needing improvement.

Problems identified by assessment, analysis, test, inspection, and other means will be controlled and corrected using the graded approach described in this plan. Where appropriate, the cause(s) of the problem will be identified and corrected to prevent recurrence. The Integrated Operational Performance System (IOPS) and the construction project management software system (Primavera Contract Manager) will be the primary tools used to track conformity of EIC items.

Occurrence reporting will be executed as required by DOE for certain defined events or conditions, as described in the BNL SBMS Event/Issues Management Subject Area [11].

All project personnel and subcontractors are encouraged to identify problems or potential quality improvements and may do so without fear of reprisal or recrimination.

Items, services, and processes that do not conform to specified requirements shall be identified and controlled to prevent their unintended use. Inspection Test Records (ITRs), the Nonconformance Module in IOPS, or similar tools will be used to implement this requirement. The QA Manager will periodically report these nonconformances to EIC management.

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Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

7. LESSONS LEARNED

To promote continuous improvement, the EIC Project shall implement and maintain a Lessons Learned program. The program provides a systematic approach to identify and analyze relevant information for both good work practices and adverse work practices that can influence successful project execution.

Where appropriate, improvement actions are taken to either promote repeat application of a positive lesson learned, or prevent recurrence of a negative lesson learned.

The EIC program is integrated with the BNL institutional Lessons Learned Program, which is described in the BNL SBMS Lessons Learned Subject Area [12]. Lessons learned from the EIC Project are screened for applicability to other BNL and DOE organizations. Those that are relevant are published and disseminated to BNL staff via the BNL Lessons Learned database, and when applicable, to the DOE complex via the DOE OPEXShare database.

In addition, EIC periodically checks external lessons learned sources for lessons learned that are applicable to the EIC project. Sources of lessons learned include the BNL Lessons Learned Database, the DOE OPEXShare database, the DOE OPA website, and feedback from EIC staff members who participate in peer reviews of other DOE projects. The EIC has established a lessons learned site where these external lessons learned are posted and project team members are encouraged to view the lessons learned on the site.

The EIC Organizational Lessons Learned Coordinator is responsible to ensure that a program is established, implemented, and maintained. Publication and dissemination of EIC lessons learned are coordinated through the BNL Institutional Lessons Learned Coordinator.

Lessons learned shall be gathered throughout the project life cycle, starting before Critical Decision 0 (CD-0) and continuing through CD-4 and project closeout. After CD-2 approval, and continuing beyond CD-3 approval, EIC shall elicit lessons learned and submit to the DOE OPEXShare database on an annual basis, as part of project reviews. In addition, lessons learned shall be elicited and submitted within 90 days after CD-3 approval, for lessons learned not previously recognized regarding up-front project planning and design; and within 90 days after CD-4 approval, for lessons learned not previously recognized regarding project execution and facility start-up.

8. DOCUMENTS AND RECORDS

Documents shall be prepared, reviewed, approved, issued, used, and revised to prescribe processes, specify requirements, or establish a design that is adequate to procure, fabricate, review, install, locate, repair, and maintain systems that comprise the EIC. The EIC Project manages all specifications, technical notes, database records, drawings, test and/or calibration records, and other controlled documents under a central document control system. EIC managers will use the graded approach described in this plan to determine work in their scope that requires the preparation of controlled documents. The system to control document preparation, approval, issuance to users, and revision is described in the EIC Process Description: Management of EIC Documents and Records (EIC-ISG-PDN-001) [28], which implements the institutional requirements outlined in the BNL SBMS Document Control Subject Area [13].

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

Required records shall be specified, prepared, reviewed, approved, authenticated, and maintained.

Guidelines will be established to aid in the selection of information and processes for storing and maintaining records for the project in accordance with the institutional requirements outlined in the BNL SBMS Records Management Subject Area [14]. Project Management, and Level 2, 3 and 4 WBS Managers are responsible for identifying the information to be preserved in accordance with the EIC Records Inventory and Disposition Schedule (RIDS), as documented in the EIC Process Description:

Management of EIC Documents and Records (EIC-ISG-PDN-001) [28]. In addition to the technical, cost, and schedule baseline and all changes to it, the RIDS will identify types of records that must be preserved as evidence or proof that a decision was made or an action taken and the justification for the decision or action. In addition to the EIC QA Manager and QA Representatives, the EIC Document and Records Administrator is also available for guidance on these decisions.

9. WORK PROCESSES

All work performed at BNL shall be planned and performed in accordance with the institutional requirements outlined in the BNL SBMS Work Planning and Control for Experiments and Operations Subject Area [9].

EIC workers are responsible for the quality of their work, which shall be performed in accordance with established procedures and work instructions. EIC managers are responsible for ensuring that those under their supervision have the training, skills, equipment, work process documents, and resources needed to accomplish their work.

Work processes will be managed according to the following criteria:

• Resources – Managers throughout the EIC Project are expected to provide the resources and support systems needed to enable their staff to do their work using methods that promote successful completion of tasks, conformance to EIC requirements, and compliance with ES&H rules.

• Graded Approach – EIC management (Level 1, 2, 3 and 4 WBS Managers) will use the graded approach described in this plan to determine the appropriate work controls based on the type of work being done. EIC QA Representatives may assist in these determinations.

• Safety – EIC management will ensure that management of ES&H functions and activities is an integral and visible part of the work planning and execution processes, including use of Integrated Safety Management System (ISMS) guiding principles and worker participation in work planning.

• Training – EIC management will ensure that employees and subcontractors are properly trained in and knowledgeable of the procedures, instructions, drawings, specifications, and other related administrative and technical documents that control their work. Where processes require specially qualified personnel, the performing personnel shall be appropriately trained and certified to the qualified process/procedure before performing those processes.

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• Work Planning – Work on the EIC Project shall be performed to established technical standards and administrative controls using documented and approved procedures, work instructions, or other appropriate means. The scope and detail of the documentation used shall be commensurate with the complexity and importance of the work, and the hazards and risks or consequences of quality problems in the product or process.

• Acceptance Planning – Critical systems or components should have plans for acceptance based on the creation and completion of acceptance test plans, ITRs, or travelers.

• Conduct of Work – Work shall be performed safely, in a manner that ensures adequate protection for employees, the public, and the environment, and management shall be accountable for the safe performance of work. Employees and management shall exercise a degree of care commensurate with the work and the associated hazards.

• Item Control and Protection – Items, including consumables, shall be identified and controlled to ensure their proper use and prevent the use of incorrect, unaccepted, or unidentified items.

The project will define a system of controls to ensure that items are handled, stored, shipped, cleaned, and preserved to prevent them from deteriorating, being damaged, or becoming lost.

These controls will be established according to instructions, specifications, drawings, and technical manuals for items that are sensitive, have a high cost, or have been identified as having a significant impact on the environment or schedule.

• Calibration – Equipment used for process monitoring or data collection shall be calibrated and maintained. Calibration will be controlled by a system or systems making appropriate use of qualified calibration service providers, equipment calibration-status tracking database(s), and approved methods for adding equipment items to the controlled system. The QA Manager will oversee and support the calibration system.

When work is performed by a Partner, these requirements are addressed by requiring Partners to perform work under the EIC QA Plan, or to provide a QA Plan or other work control documents to address these requirements. Programmatic requirements imposed on the Partner are defined by agreement. The Partner QA Plan will be reviewed for adequacy by the EIC Project , and concurred by the EIC QA Manager.

10. DESIGN

To facilitate an integrated, high-quality design for the EIC, the key design specifications and requirements for the EIC systems and components are well defined and formally approved and maintained as controlled documents within a centrally available documentation database. These documents, initially predicated upon the Mission Need of the EIC, are defined in the Requirements Management Plan (EIC-SEG-PLN-016) [24] and the Requirements Management for Detector Systems (EIC-SEG-PLN-017) [25] as follows:

• Reference Documents – These include the EIC Global Requirements Document (Electron- Ion Collider Global Requirements, EIC-ORG-PLN-010) [26], the EIC Global Parameters List

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Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

(Master Parameter Tables for the EIC, EIC-SEG-RSI-005) [29], and the EIC WBS Dictionary.

These provide high-level summaries of selected information that is of general interest to project team members. They are updated as needed based on changes within the project scope or requirements, responding to drivers external to the project.

• Requirements, Specification, and Interface Documents – These documents provide a comprehensive description of the technical attributes and design basis for major EIC systems or facilities. They are the key design basis documents that provide the framework for how each system design will be developed. They include functional descriptions of major systems and facilities broken down by WBS element, and outline the design criteria. They also include a technical description of the design requirements for the associated building or component. They further establish the very detailed design basis criteria associated with the subsystems, components, and elements of the facility, providing expanded design criteria and requirements details at the lowest project technical baseline levels. Interface requirements regarding other project systems are also provided to ensure that the framework for design integration is developed, scrutinized, and reviewed at the lowest levels of design activity. These include both system-level technical interface requirements as well as design authority definitions that must be managed between the various EIC project participants.

The requirements for any system in the EIC flow down from the system top level General Requirements, to the Functional Requirements and finally to the Performance Requirements. These requirements are captured in a suite of related documents.

The Conceptual Design Report (CDR) set forth a conceptual design for the EIC which could meet NAS requirements. It was used to develop the high-level requirements contained in the Global Requirements Document (Electron-Ion Collider Global Requirements, EIC-ORG-PLN-010) [26]. The Global Requirements Document defines the highest-level requirements for the EIC. These requirements flow-down to the General Requirement Document, then to the lower-level Functional Requirement Document, Interface Requirement Document, Performance Requirement Document, and Interface Control Document.

General Requirement Documents, Functional Requirement Documents, and Interface Requirement Documents will be developed for each of the major systems described in the WBS at Level 2.

Performance Requirement Documents and Interface Control Documents are developed for all the systems/subsystems.

Design work will be carried out according to the following criteria:

• Principles and Standards – Items and processes shall be designed using sound engineering/scientific principles and appropriate codes and standards. Applicable requirements and design bases shall be used in the design.

• Graded Approach – The EIC Project will use a system of formal controls for creating, documenting, and verifying designs. The formality of design control activities will be determined based on the scale, cost, complexity, and hazards associated with the item using the graded approach given in this plan.

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• Changes – Design changes, including project change orders, field changes, and nonconforming items designated "use-as-is" or "repair," shall be controlled by measures commensurate with those applied to the original design. Temporary modifications will have a level of control similar to the design of permanent modifications.

• Configuration Management – Systems will be implemented to control designs and to inform facility operators of the current configuration of equipment in the facility. Configuration management and control is discussed in the EIC Configuration Management Plan, (EIC-ORG- PLN-025) [30] and configuration management procedures.

• Verification and Validation – Verification and validation of design is established through many layers of review from inception to startup, such as the following:

o Requirements are reviewed during the project planning phase.

o Design documents are internally reviewed during creation by the design organization.

o Designs are further reviewed by formal multidisciplinary design review teams where warranted.

o The fabricated design is inspected and tested during fabrication and assembly.

o Commissioning tests will prove the adequacy of equipment and systems.

o A formal readiness assessment or readiness review is conducted before startup of complex systems or facilities.

• Software – Design and development of computer software shall be accomplished in accordance with this plan, using a graded approach and quality representative support to determine appropriate controls based on the complexity, cost, and hazard associated with the intended use of the software.

10.1 Design Verification and Validation

Using a graded approach, designs will be verified to an extent commensurate with their importance to safety (refer to BNL SBMS Graded Approach for Requirements Subject Area [8]), complexity of design, degree of standardization, state of the art, and similarity to proven design approaches. Acceptable verification methods include but are not limited to any one or combination of the following: (1) design reviews, (2) alternate calculations, and (3) prototype or qualification testing and comparison of the new design with a similar proven design, if available. Verification work will be completed before approval and implementation of the design.

Design reviews are performed as defined in the EIC Technical Review Plan, (EIC-SEG-PDN-009) [27] and should verify/validate the following at the appropriate time:

• technical adequacy of the design;

• specifications;

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

• adherence to requirements;

• interface compatibility;

• work instructions;

• review of test results and other applicable technical reports;

• design calculations and drawings;

• reliability and useful life considerations; and

• calibration program for measurement and test data.

Where the design method involves the use of computer software to make design calculations or dynamic models of the structure, system, or component's functionality, that software must have been demonstrated to produce validated results.

Critical computer codes, especially those codes that are involved in controlling the operation of the EIC controls network, shall also be subjected to review. Some items to be considered during computer code review are provided below:

• technical adequacy of the design;

• documentation;

• code validation testing scheme;

• consistency of structure of code to any applicable standards;

• compatibility of code with other systems that may use data;

• consideration of hardware requirements to support system;

• maintenance of code; and

• backup systems.

Design validation shall be performed to ensure that the design product conforms to defined project needs and/or requirements. Design validation follows successful design verification. Designs shall be validated, preferably before procurement, manufacture, or construction, but no later than acceptance and use of the item, in order to ensure the design:

• meets the design-input requirements;

• contains or makes reference to acceptance criteria; and

• identifies those design characteristics that are crucial to the safe and proper functioning of the equipment or system.

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

Each independent inspection, test, or review will feed the evaluation process, which is a comparison of results with acceptance criteria to determine acceptance or rejection, or the need for corrective action.

In some cases, the outcome may be to seek adjustments to requirements.

Design-output documents will be reviewed and approved before release.

10.2 Configuration Control

Configuration control is accomplished throughout the project lifecycle through use of fundamental engineering documentation principles such as design requirements change control, drawing and specification change control, and revision control.

Application of a sound configuration control process protects the integrity of EIC’s Structures, Systems, and Components (SSCs), as well as design information and documentation. The EIC configuration control process is applied during the design phase of SSCs and maintained throughout their lifecycle.

The BNL SBMS Engineering Design Subject Area [15] describes how to establish configuration control for equipment used for scientific purposes and facility construction. It provides for the verification and validation of design adequacy by Technical Authorities (i.e., competent individuals, approved by management, other than those who performed the work) before the approval and implementation of the design. It uses a process that fosters the use of sound engineering/scientific principles, risk management, and standards for design work.

The EIC Configuration Management Plan, (EIC-ORG-PLN-025) [30] describes the process by which changes to the configuration of SCCs are documented to assure that a reliable and consistent system reflects the current configuration of the parts, assemblies, and/or complete articles that comprise the SCCs.

Revised drawings and specifications are to be created, maintained, and controlled as described in the EIC Preparing and Revising Drawings and Specifications procedure.

Assessments of the configuration control program shall be performed as part of the Independent Assessment program element described in section 14 of this QA Plan. Assessments to be considered shall include the process for change control, including the documentation, approval, and implementation of changes, to ensure that it is effectively implemented. Physical configuration assessments will also be considered, which may include physical walkdowns of SSCs to determine the degree of agreement between the physical configuration and the configuration depicted in technical documentation (i.e., “as-built” vs. “as- designed”).

11. PROCUREMENT

Procurement controls will be implemented to ensure that purchased items and services meet project needs and comply with applicable quality requirements.

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EIC personnel requesting procurement of items and services are responsible for providing technical, quality, ES&H, and other requirements that adequately describe the item or service being procured so that the supplier can understand what is desired and what will be accepted. Development of these requirements in specifications and/or statements of work (SOW) may be achieved through the involvement of QA Representatives and through established review and approval systems. The following factors should be considered:

• technical performance requirements;

• compliance to appropriate industry standards;

• laws and regulations;

• acceptance criteria, including requirements for receiving inspection and/or source inspection;

• vendor qualifications and certifications;

• vendor end-item documentation requirements; and

• acceptance sampling.

The BNL SBMS Purchase Requisition Review for Quality-related Requirements Subject Area [16] provides a methodology for selecting and applying quality-related requirements to be imposed upon a supplier. Quality requirements that become part of the procurement/contract document are selected based upon the graded approach. The graded approach is used to ensure that only those requirements necessary are selected, i.e., requirements that may incur a cost are selected based on the mitigation of programmatic and/or ES&H concerns.

EIC Managers will use established BNL processes to ensure that procured items and services meet the established requirements, perform as specified, and meet the expectations of the end user. The need for inspection and acceptance testing is determined during project or activity planning, based on the graded approach. In addition, the processes will ensure that suppliers are evaluated and selected based on specified criteria. The stringency of the procurement requirements is commensurate with the ES&H and QA risk of the purchased items or services to the project or activity. For critical items, these requirements may include but are not limited to establishing supplier milestones, surveillance inspections of vendor progress during the manufacturing phase, production of prototypes, and delivery of pre-production units for inspection and testing.

Incoming items will be verified against previously established acceptance criteria. Unacceptable items or services are documented. Records of supplier performance (ITRs and contract-required submittals) are kept for future procurement consideration.

Counterfeit and/or suspect parts are prohibited. Inspections will be used to detect violations. When counterfeit/suspect parts are found, they will be identified, segregated, and disposed of in accordance with the institutional requirements outlined in the BNL SBMS Suspect/Counterfeit Items Subject Area [17].

There is an expectation for Partners to have a process for monitoring and handling suspect/counterfeit items to prevent quality, safety, or performance issues in work performed under the EIC scope.

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Electron-Ion Collider, Brookhaven National Laboratory

Doc No. EIC-QAG-PLN-002 Author: C. Porretto Effective Date: December 17, 2024 Review Frequency: 5 years

11.1 In-kind Contributions

QA requirements for…