AL-1024-3173F.pdf

ALS-U QA PLAN

RELEASE DATE : 2025-11-12

AUTHOR: JIANI NIU

DOCUMENT NUMBER: AL-1024-3173 REVISION: F

DOCUMENT STATUS: INFORMATIVE

DOCUMENT TYPE: NOTE

CATEGORY CODE: AL7001

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TABLE OF CONTENTS

1 Approvals 4 2 Abbreviations and Acronyms 4 3 Introduction 5 4 Quality Assurance Program 6

4.1 Organization 7

4.1.1 Roles and Responsibilities 7

4.1.2 Functional Authority, Lines of Authority & Interfaces 9

4.1.3 Graded Approach 9

4.1.4 Control of Software 11

4.2 Personnel Training and Qualification 12

4.3 Quality Improvement 12

4.3.1 Control of Items or Activities that do not meet the established requirements 13

4.3.1.1 Deviation Request 13

4.3.1.2 Non-conformance report 14

4.3.1.3 Corrective Action 15

4.3.1.4 Change Control 15

4.3.1.5 Approval Selection Guidelines 16

4.3.1.6 Issue Track Log 16

4.3.1.7 Task Force Teams 16

4.4 Documents and Records Management 16

4.4.1 Documents Management 17

4.4.2 Records Management 18

4.5 Work Processes Management 19

4.5.1 Work Planning 20

4.5.2 Stop Work Authority 20

4.5.3 Item Control and Protection 21

4.5.4 Calibration 21

4.6 Design Process 21

4.6.1 Design Inputs 22

4.6.2 Design Interfaces 23

4.6.3 Design Outputs 24

4.6.4 Design Verification 25

4.6.5 Reviews 25

Advanced Light Source

Lawrence Berkeley National Laboratory

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Printed hard copies of this document are for reference only.

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4.7 Procurement 26

4.7.1 Supplier Selection, Evaluation and Management 26

4.7.2 In-house Manufacturing 28

4.8 Inspection and Acceptance Testing 29

4.8.1 Establishment of Acceptance Criteria 30

4.8.2 Development of Inspection Plans 30

4.8.3 Suspect/Counterfeit Item prevention 30

4.9 31

4.10 32

4.11 Project Management Assessments 32

4.11.1 Self-Assessment 32

4.11.2 Project Reviews 33

4.11.3 Project Management Assessments 33

4.12 Independent Assessment 34

3. Reference documents 34

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REVISION HISTORY

Rev. CM Number Description of Change

A Baseline

B Rebaseline

1 APPROVALS

The following individual(s) shall review this document:

Reviewer Project Role

The following individual(s) reviewed this document:

Reviewed by: FMATICHARD,MLEITNER,DCOCCO,MERDMANN,KHANZEL

The following individual(s) shall approve this document:

Approver Project Role

The following individual(s) approved this document:

Approved by: EPEOPLES

{CAT_CODE}

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2 ABBREVIATIONS AND ACRONYMS

ALS Advanced Light Source

ALS-U

BES

Advanced Light Source Upgrade Project

Basic Energy Sciences

CAR Corrective Action Report

CCB Change Control Board

CDR Conceptual Design Review

DEV Deviation Request

DOE Department of Energy

CN Change Note

EH&S Environmental Health and Safety

EPG LBNL Engineering Process Guide

IMS Integrated Master Schedule

ISM Integrated Safety Management

LBNL Lawrence Berkeley National Laboratory

MBA Multibend Achromat

NCR

OCA

Nonconformance Report

Office of Contractor Assurance

PDR Preliminary Design Review

PEP Project Execution Plan

PMP Project Management Plan

PRR

QA

QAP

QC

S/CI

TPRD

Production Readiness Review

Quality Assurance

Quality Assurance Program or Quality Assurance Plan

Quality Control

Suspect and counterfeit item

Technical Procurement Requirements Documents

WBS

wtPart

Work Breakdown Schedule

Windchill Technology Part

3 INTRODUCTION

ALS-U is an upgrade project to the LBNL Advanced Light Source (ALS). The ALS is a

1.9 GeV storage ring operating at 500 mA of beam current. It is optimized to produce intense beams of soft x-rays, which offer spectroscopic contrast, nanometer-scale resolution, and broad temporal sensitivity. The ALS facility includes an accelerator complex and photon delivery system that is capable of providing the foundations for an upgrade that will achieve world-leading soft x-ray coherent flux. The existing ALS provides a ready-made foundation, including conventional facilities, a roughly $0.5B scientific infrastructure investment and a vibrant user community of over 2,300 users

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AL-1024-3173 REV.F Doc.Status:INFORMATIVE Page 6 of 31 per year already attuned to the potential scientific opportunities an upgrade offers. The facility also includes extensive beamlines (up to 40 simultaneously operating beamlines) and instrumentation, an experimental hall, computing resources, ancillary laboratories, offices, and related infrastructure that will be heavily utilized in an upgrade scenario.

The ALS will be upgraded with a multibend achromat (MBA) lattice design that will provide a soft x-ray source that is orders of magnitudes brighter — an up to 100-1000 times increase in brightness and will provide a significantly higher fraction of coherent light in the soft x-ray region than is currently available at ALS.

The scope of the upgrade includes:

● A new 2 GeV high-brightness MBA storage ring, in the existing tunnel, that reduces emittance by a factor of about 30 relative to today’s ALS storage ring;

● An accumulator ring that enables on-axis swap-out and recovery and exchange of bunch trains

● New beamlines designed to exploit the high coherent-flux source;

● Relocation and adjustment of existing beamlines where required.

4 QUALITY ASSURANCE PROGRAM

ALS-U is managed by Lawrence Berkeley National Laboratory (LBNL) as described in the ALS-U Project Execution Plan (PEP) (AL-1017-1282) [1].

The ALS-U Quality Assurance Program adheres to DOE O414.1D Quality Assurance [2] and fulfills the quality assurance criteria and requirements outlined in the order. The

ALS-U Quality Assurance Program follows DOE G 413.3-2 Quality Assurance Guide for

Project Management [3], and DOE G 414.1-2B Quality Assurance Program Guide [4], to develop concrete QA processes and to guide the project’s QA/QC activities.

Embedded within the LBNL Quality Management System, the ALS-U QA program maintains consistency with the LBNL Quality Assurance Plan PUB 3111 [5]. The ALS-U

QA program places equal emphasis on Quality Control and Quality Assurance, ensuring the integration of quality into work processes. ALS-U follows the international consensus standard ANSI/ISO/ASQ 9000-2015 for quality management.

The Quality Assurance Program is described in this ALS-U Quality Assurance Plan, and the implementation of the program follows the processes detailed in the Engineering

Process Guide [6]. This QA Plan was initially approved by the ALS-U Project Director, the Project Manager, concurred by the Project Safety Coordinator, and concurred and

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AL-1024-3173 REV.F Doc.Status:INFORMATIVE Page 7 of 31 executed by the Project QA Manager. This QAP is reviewed at least annually by the

ALS-U Project Management team, and revised, as necessary, with the approval of the

ALS-U Project Manager, Technical Director, Chief Engineer, and Procurement

Manager.

4.1 Organization

The ALS-U organization is described in the ALS-U Project Execution Plan.

4.1.1Roles and Responsibilities

The roles and responsibilities of the project management team are detailed in the ALS-U

PEP and ALS-U Project Management Plan (PMP) (AL-1131-2071) [7]. QA/QC-related responsibilities of the project management team are:

Project Director ● Responsible for project level QA/QC oversight.

Project Manager ● Responsible for integration of the QA program with EH&S, procurement, and other project-wide functions.

Technical Director ● Responsible for ensuring adequate QA/QC practices within each technical area.

Chief Engineer

● Responsible for enforcing and verifying project level Quality

Control.

● Direct and coordinate the ALS-U systems engineering and technical integration teams.

● Coordinate all quality assurance activities with the quality assurance team.

● Initiate, as necessary, internal or external QA/QC audits.

Project QA Manager

● Represent the project on all matters of Quality Assurance and

Quality Control.

● Create and maintain the Quality Assurance Plan.

● In consultation with the Project Director, Project Manager, Technical Director and Chief Engineer, establish quality-related goals, milestones, directions, practices and policies, planning and reporting templates, and implement quality-related activities.

● Develop, review and approve, as necessary, acceptance criteria documentations, vendor surveillance procedures and reports, All officially released LBNL documents are watermarked and contain LBNL Document Control

AL-1024-3173 REV.F Doc.Status:INFORMATIVE Page 8 of 31 non-conformance reports, “traveler” documentations, test plans, vendor control programs, work procedures.

● Provide or coordinate project-specific QA training for project members.

● Perform QA reviews as requested by ALS-U Chief Engineer, Project Office and/or Technical Managers.

● Participate as a member of the ALS-U Change Control Board.

● Assists the Technical Project Managers, System Leads and CAMs in the implementation of ALS-U quality assurance program.

● Responsible for project level QA oversight as delegated by the

Project Manager and Chief Engineer.

● Responsible for reviewing technical design/performance parameters, technical/QA documentation to ensure compliance to the QAP.

● Assess the status of the QA/QC program and report it to the

Project Director, Project Manager, Technical Director and Chief

Engineer.

Technical Project

Manager/System Lead

● Provide oversight of the ALS-U quality assurance program within their respective system area.

● Responsible for ensuring adequate QC within their relevant ALS-U project subsystem is implemented as delegated by the Project

Director, Project Manager, Technical director and Chief Engineer.

● Responsible for ensuring that all appropriate corrective actions are adequate and implemented in a timely manner.

CAM/Responsible

Engineer

● Responsible for the day-to-day coordination and progress of the task to which they are assigned.

● Responsible for developing engineering specification documents.

● Responsible for assigning, supervising, and managing the Quality

Assurance Engineers/Manufacturing Engineers within their system areas to develop the required QA documents and packages.

Quality Assurance

Engineer/Manufacturing

Engineer

● Develop, maintain, and control the required QA documents and packages.

● File QA documents in the project document repository.

● Request and review technical documentation and quality assurance documents submitted by vendors.

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● Record the non-conformance incidence and deviation request.

Drive the non-conformance process. Tag and dispose the impacted materials.

Procurement Agents ● Hold sole authority to make procurement commitments on behalf of the laboratory.

● Ensure that LBNL procurements adhere to LBNL, UC, DOE, state, and federal mandates, rules, and regulations.

● Responsible for administering all contractual aspects of procurements.

● May assist in contract negotiations, identifying sources, and compliance.

ALS-U project contributor

● Follow applicable QA/QC procedures and processes.

● Perform activities within acceptable quality assurance standards, and maintains current records whenever required

● Inform the System Managers about activities that do not follow the applicable QA/QC procedures and processes.

Safety Coordinator ● Supports the ALS-U project QA program and provides EH&S oversight.

4.1.2Functional Authority, Lines of Authority & Interfaces

Responsibility for quality starts with the Project Director, Project Manager, Technical director and Chief Engineer and is delegated throughout the organization.

Implementation of QA/QC is the daily responsibility of all personnel. It is part of their duties to ensure that the activities for which each person is responsible are compliant with this QAP and all applicable requirements.

The ALS-U project comprises three primary technical systems. At this level, Technical

Project Managers assume responsibility for all facets, encompassing QA/QC, related to these systems. The ALS-U QA Manager is appointed to develop and execute ALS-U specific aspects of the QA program within the institutional framework of PUB 3111.

4.1.3Graded Approach

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ALS-U shall implement a graded approach, which gives flexibility in the degree of rigor involved when implementing requirements. This allows the requirements to be applied appropriately to items and activities.

The graded approach is a process for determining that the appropriate level of analysis, control, documentation and necessary actions are commensurate with the potential of an item or activity to:

● create an environmental, safety, health or radiological hazard,

● incur significant monetary cost or schedule delay to the project, and/or

● result in an unfavorable impact to the programmatic mission of the project.

The impact matrix is used as a guide for the ALS-U project graded approach implementation. Additional information on specific implementations of the graded approach is contained in subsequent sections of the QAP. Any interpretation needed for quality requirements or graded approach application of the quality program requirements implementation shall be provided by the QA Manager.

Table 5.1: Impact matrix for programmatic, ESH, cost and schedule categories

Impact

Category

Very High

Impact

High Impact Moderate

Impact

Low Impact

Mission Need There are no expected

Mission Need requirements beyond the expectation of

High Impact level

Potential for significant adverse impact to completion of

ALS-U project or achieving key performance goals

Potential for moderately adverse impact to the ALS-U project by affecting one or more major systems or components

Potential for minimal impact to an ALS-U project task, single subsystem, or component

Environment, Safety and

Health

Adverse EH&S impacts beyond the boundaries of the lab.

Significant hazard to health and safety of facility workers, public or environment, including exposure above

Hazard to the safety and health of workers, public and environment including exposures near regulatory

Minor hazardous material released within building.

Minor or negligible

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Significant impact to the safety of ALS-U personnel or is a DOE

Reportable

Incident limits, minor environmental release outside of building but on site, or major release within building.

DOE

non-reportable incident impact to the safety of ALS-U personnel

Project Cost

Exposure

Potential financial loss greater than

$3,000,000

Potential financial loss of between

$500,000 and

$3,000,000

Potential financial Loss of between

$100,000 and

$500,000

Potential financial loss of

$100,000 or less

Project

Schedule

Exposure

Potential schedule impact of more than 6 months

Potential schedule impact of more than 3 months but less than 6 months

Potential schedule impact of more than 1 month but less than 3 months

Potential schedule impact of less than 1 month

4.1.4Control of Software

The use of software consists of commercial off-the-shelf products, community shared products, and in-house developed products. The results of software related activities, including development, review, procurement, validation, testing, and configuration control shall be recorded.

Software products whose failure could adversely affect the environment, safety and/or health of the public, or LBNL personnel in a substantive way are considered to be safety software and must be appropriately controlled and tested.

Safety software includes:

1. Safety system software, safety and hazard analysis software and design software,

2. Safety management and administrative control software.

3. Software that performs a safety function as part of a system, structure or component

(SSC); and

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4. Software that is cited in either a DOE-approved safety analysis document (SAD) or a

Lab Directorate-approved hazard analysis document (HAD).

Below are four core requirements for safety software:

1. The process owner must consider the system as a whole in considering the risks, taking into account software and non-software components.

2. The Software must be documented to a level where users, developers, and those providing oversight can understand its functions.

3. Tests must be created and executed which clearly show that the software is performing as intended across a range of operating conditions. These tests must be repeated at any time that the environment or the software changes in a way that could create differences in behavior.

4. Changes to the software must be approved, documented, tested, and archived to provide for rigorous, continuous oversight.

4.2 Personnel Training and Qualification

The Project Director, Project Manager, Technical Director and Chief Engineer require that all project personnel be trained and have the appropriate experience to ensure that they are capable of performing their assigned work in a safe and efficient manner.

ALS-U Technical Project Manager, along with the appropriate project institutional leads, are responsible for ensuring that their staff members are adequately trained and qualified to perform their assigned work. Personnel qualifications are based on factors such as:

● Previous experience, education, and training;

● Performance demonstrations or tests to verify previously acquired skills;

● Completion of training or qualification programs

● On-the-job training

ALS-U work shall be managed within the framework of LBNL’s EH&S framework. The

ALS-U Integrated Safety Management Plan (AL-1006-7072)[8] describes project-specific implementation of those portions of the institutional plan that has been tailored for the project.

4.3 Quality Improvement

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It is Project Management's intent that all ALS-U Project personnel be continually alerted to the project's QA Program objectives of preventing conditions and situations that may compromise the successful accomplishment of the technical, scientific, EH&S, and QA goals and obligations of the project. The project aims for a continually improving level of quality in meeting these goals and obligations with the participation of everyone in the early identification, documentation, and remedy of problems that might result in excess costs or schedule delays, among other consequences.

Processes to detect and reduce quality problems have been established, including:

● Equipment inspections and verifications

● Software code inspections, verifications, and validations

● Documentation and data management

● Design reviews

● Baseline change reviews

● Work planning

● Self and external assessment

The project management established a Lessons Learned and Best Practices Program to ensure ongoing improvement of safety, quality and reliability, prevent the recurrence of significant adverse events/trends, and determine implementation strategies that will help project successfully meet the missions and goals set forth by the DOE. The lessons learned/Best practice Database [9] is an online tool maintained by the LBNL institution.

ALS-U project utilizes this tool to develop and disseminated the Lessons Learned and

Best Practices reports to applicable personnel.

Item characteristics, process implementation, and other quality-related information shall be reviewed, and analyzed to identify items, services and processes that need improvement.

Project management encourages a "no fault" attitude regarding the identification of problems that compromise either facility safety, quality, or reliability. All project personnel and subcontractors are encouraged to identify problems or potential quality improvements and may do so without fear of reprisal or recrimination.

4.3.1Control of Items or Activities that do not meet the established requirements

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4.3.1.1 DEVIATION REQUEST

It is a proactive request for formal approval to accept a known or anticipated departure from a specification before fabrication. The ALS-U Project shall ensure that deviation request processes are integrated and documented for situations in which a product or procedure deviates from the specification. The deviation request shall be initiated by the vendor or relevant ALS-U personnel. Based on the impact level, the CAM shall determine the approvals for the disposition actions of the deviated items (granted or not granted). CAM with the assistance of QA Manager will decide the follow up actions which can be None, Corrective Action or Engineering Change Report. The workflow is defined in the LBNL Engineering Process Guide-Deviation Request Process [10]

4.3.1.2 NON-CONFORMANCE REPORT

It is a reactive report used to document an unexpected deviation from a specification that is typically discovered during inspection, testing, or installation. The ALS-U Project shall ensure that products and procedures which do not conform to product and procedures requirements are identified and controlled to prevent their unintended use or delivery. The CAM, System Lead, Technical Project Manager, QA Manager, Chief

Engineer, Technical Director, Project Manager and Project Director may place a hold on work-in-progress while causes and compensatory measures are being evaluated.

Non-conformances can be determined by the supplier or by the LBNL staff. In either case the workflow as defined in the LBNL Engineering Process Guide-Nonconformance

Reporting [11] shall be applied.

A nonconformance report (NCR) must be completed by the responsible engineer , with review and acknowledged by the stakeholders. A graded approach is applied to determine the impact level and required signoff of the NCR. Non-conformances for

“High Impact” as defined in table 5.1 require additional signoff by Technical Project

Manager and the “Very High Impact” report shall be signed off by Chief Engineer, who shall escalate to Technical Director, Project Manager and Project Director as needed.

The NCR are put forward to the approvers appointed by the CAM for review. The disposition methods of the non-conforming material shall be one of the following:

1. Use as-is: The item does not fully meet specification, but can still be accepted and used without repair or rework, because the discrepancy does not affect the item’s safety, performance, reliability, or function for its intended use.

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2. Rework: If non-conforming parts are kept and re-processed to make them usable, then the parts are to be reinspected after the re-processed work.

3. Scrap/Reject: If non-conforming parts are scrapped or rejected, they are to be tagged and/or marked accordingly, and then segregated and disposed to eliminate any possibility of use in the project.

CAM with the assistance of QA Manager will decide the follow up actions which can be

None, Corrective Action or Change Report. Any holds placed on work-in-progress are lifted once the review, recommendations, and approvals indicate that the issue is under control.

Nonconforming materials are tagged with their corresponding Nonconformance Report or Deviation Request in Windchill. The status of these reports is tracked in the Project

QA Dashboard and regularly reported to the project management team.

4.3.1.3 CORRECTIVE ACTION

Action shall be taken, as appropriate, to rectify and prevent recurrence of significant conditions adverse to quality or environment, safety, and health. The decision to initiate any corrective action and Corrective Action Report (CAR) will also be based upon an evaluation of the seriousness, and the adverse cost and schedule impact of the problem relative to the cost and difficulty of its correction.

The primary responsibility for eliminating or minimizing defective elements and nonconforming articles and for correcting conditions which would initiate these problems rests with the individual group responsible for performing the tasks or producing the articles. The CAM is responsible for overseeing that all appropriate corrective actions are adequate and executed in a timely manner. In case that the CAM believes that a correction is inadequate or not in a timely manner, the issue shall be documented and escalated to the Project Director, Project Manager and Chief Engineer for resolution.

4.3.1.4 CHANGE CONTROL ON TECHNICAL DOCUMENTS

The ALS-U project follows a Change control process for technical documents that includes Change Request (CR) and Change Notice (CN) to document the proposal and authorization of a design change after the initial design is completed.

As part of the graded approach, the CAM shall evaluate the impact of an engineering change and determine the appropriate level of approvers. The guidance of the change

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(AL-1803-2442). The approval selection guideline follows a graded approach and is also included in the document. .

4.3.1.5 APPROVAL SELECTION GUIDELINES

Using a graded approach, the ALS-U has developed the approval selection guidance [12] for documents based on the impact level.

CAM shall reference the impact criteria listed in the Impact Level Evaluation Table

(AL-1220-9276) [13] to evaluate the impact of the activity and select the approvers for the deviation, non-conformance, or changes.

4.3.1.6 ISSUE TRACK LOG

Issue track logs is an optional tool that can be utilized to track the issues during the day to day work process. The Responsible Engineer, QA representative, CAM, System Lead and QA Manager will monitor the issue trends, identify the hotspots of the issues and provide insights for technical engineers in prioritizing the development of corrective actions.

4.3.1.7 TASK FORCE TEAMS

Task force teams may be appointed by the Project Director, the Project Manager, Technical Director, Chief Engineer and/or the QA Manager to work on resolving significant problems or on improving operations. A task force team may be composed of persons from several groups. These teams may work on generic problems such as difficulties with the timeliness of procurements, or the lack of coordination of design activities.

4.4 Documents and Records Management

The ALS-U project staff will prepare, review, approve, revise documents to establish authorities, prescribe processes, identify requirements, specify designs, and describe final products.

4.4.1Documents Management

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As part of the graded approach, 3 main categories of documentation have been established for the ALS-U project. The category description and change control requirements are listed below:

1. Project Control Documents: These are top level project items used to assess, manage, and control technical scope, requirements, schedule and cost. For example,

● ALS-U Project Execution Plan

● ALS-U Quality Assurance Plan

● ALS-U Systems Engineering Management Plan

● ALS-U Project Review Cycle

● ALS-U Risk Management Plan

● ALS-U Procurement Plan

● ALS-U Integrated Safety Management Plan

● ALS-U Global Requirements Document

● ALS-U Functional Requirements Documents

● WBS Dictionary

● Integrated Master Schedule

● ALS-U Accelerator Physics Design

● ALS-U Beamline Optical Design

● Critical Decision Record Documents

● Acquisition Strategy

● Hazard Analysis Report

● Risk Registry

● Major Conceptual or Technical Design Reports

● Approved Baseline Change Proposals

2. System Control Documents: Documentation that communicates information needed to produce the project outcome or information on processes used repetitively during the course of the project. This category includes most documents needed to produce project deliverables. The technical teams will use

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AL-1024-3173 REV.F Doc.Status:INFORMATIVE Page 18 of 31 the graded approach described in this plan to determine which work in their scope requires the preparation of system control documents. For example:

● Mechanical CAD models and Drawings

● Electrical CAD models and Drawings

● Facility Design CAD models and Drawings

● Engineering Specifications, Interface Controls

● Acceptance Criteria Lists

● Test and Inspection Procedures, Work Instructions

● Change Control Documents (DEV, NCR, CAR, ECN)

● Technical Design Reports

● Engineering Notes

● Official Vendor Communication

3. Informal Documents: Documentation that communicates information or procedures for activities with low significance, consequences or prototyping activities (as determined by the Technical Project Manager) may have less formal procedures or instructions. Notes, desk manuals, emails, notebooks, and sketches are acceptable methods for this level of written communication. Documents shall be kept in the project repository.

The Project Control Documents and System Control Documents are controlled documents. They shall be archived in the LBNL Product Lifecycle Manager (PLM)

WindchillTM and Document Control Center (DCC) database. All controlled documents are uniquely identified, along with the revision, the approvals, and the dates. All documents provided to external parties shall be retrieved from the DCC as a PDF file with the appropriate watermark, including all engineering drawings.

4.4.2Records Management

Records are prepared and maintained to provide evidence that activities have been performed or results have been achieved. Guidelines are followed for storing and maintaining records for the project in accordance with the LBNL PUB3111 Quality

Management Plan. Windchill Technology (WT) part is used to organize the records on a per item basis. CAMs with the support from lead engineers, manufacturing engineers and QA engineers are responsible for identifying the records to be preserved.

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4.5 Work Processes Management

ALS-U personnel are responsible for the quality of their work, and CAMs and System

Leads are required to identify the resources and support systems to enable staff to do their work. All work shall be performed using methods that promote successful completion of tasks, conformance to project requirements, and compliance with

Environment, Health & Safety (EH&S) rules. Work processes consist of a series of actions planned and carried out by qualified personnel using approved procedures, instructions, and equipment under administrative, technical, and environmental controls to achieve a result. The Project Safety Officer is responsible for the project

ES&H activities. This is done by understanding and minimizing the impact of hazards, overseeing an effective safety-training program, and reviewing designs and work-planning efforts to ensure safety and minimize impact on the environment.

Project organization is described in the ALS-U PEP and PMP.

Work Processes shall be managed according to the following criteria:

● Resources – Managers throughout the ALS-U project will ensure that resources and support systems are sufficient to enable their staff to do their work using methods that promote successful completion of tasks, conformance to the project requirements, and compliance with ESH rules.

● Graded Approach – The ALS-U management will use the graded approach as described in this plan to determine the appropriate work controls based on the type of work being done.

● EH&S – ALS-U project management will ensure that management of EH&S functions and activities is an integral and visible part of the work planning and execution processes, including use of ALS-U Integrated Safety Management guiding principles and worker participation in work planning.

● Training – ALS-U project management will ensure that employees, collaborators, 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.

4.5.1Work Planning

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● Acceptance Planning – Systems or components that are determined to have high

EH&S or programmatic impact shall have plans for acceptance based on the creation and completion of verification and test records.

● 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.

4.5.2Stop Work Authority

Any individual involved in the project that becomes aware of an activity or workmanship that they believe to be of inadequate quality should bring the condition(s) to the attention of the assigned Quality Assurance Engineer, the Lead Engineer, CAM, System

Lead and Quality Assurance Manager. Depending on the severity and impact of the issue

(graded approach) the project management team may need to be alerted. It is the responsibility of the institution and project management to investigate the condition(s) believed to be inadequate, to communicate the problem to the Project Director, Project

Manager, Technical Project Manager and Chief Engineer, and to ensure appropriate corrective actions are taken based on the condition(s). Project Director, Project

Manager, Technical Project Manager, Chief Engineer, QA Manager have the authority to stop work of inadequate quality if deemed appropriate. CAMs and System Leads have the authority within their system to stop work of inadequate quality if deemed appropriate.

All Berkeley Lab employees, affiliates, and contractors are responsible for stopping work activities considered to be an imminent danger.

4.5.3Item Control and Protection

Items, potentially including consumables, shall be identified and managed to ensure their proper use and prevent the use of incorrect, unaccepted, or unidentified items.

Following receiving inspection and acceptance, the procured items are placed in an appropriate storage area. Items with special storage requirements shall be identified before storage and appropriate measures shall be taken to avoid deterioration during storage. The quantity, location and status of the procured item are logged in the EZ

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Office inventory system. The vendor datasheet, inspection reports and other QA data files are stored in the ALS-U Windchill repository. QR code technology is implemented to facilitate the retrieval of information. Graded approach is applied to determine the level of information details that ALS-U database is tracking for items.

4.5.4Calibration

The necessity for calibration and control is dependent upon the application and criticality of the equipment. As part of the graded approach, each CAM and System Lead shall analyze their work process measuring and test equipment to determine the appropriate calibration requirements and develop an effective program for the necessary calibration activities.

In cases where applicable and relevant industry standards exist, these standards are applied and the test equipment is used and maintained in accordance with such standards. This QA Plan recommends ISO/IEC 17025, Testing and Calibration

Laboratories as a common standard. American National Standards Institute

(ANSI)/NCSL Z540-1-1994, Calibration - Calibration Laboratories and Measuring and

Test Equipment - General Requirements, and/or ANSI/NCSL 540.3-2006, Requirements for the Calibration, are acceptable alternatives to ISO/IEC 17025

In cases where the acceptance criteria are based on the particular requirements of the

ALS-U experiments, industry standards may not exist, and test procedures and equipment must be designed and fabricated specifically for these items.

4.6 Design Process

The ALS-U design shall be defined, controlled and verified. The design for the ALS-U project is defined by key performance parameters that flow down to the Accelerator

Physics managed Functional Requirements. The Functional Requirements further derive into sub-system requirements and engineering specifications. Ultimately, the functional requirements, the sub-system requirements, and the engineering specifications are verified through review of design, analysis, demonstration, inspection or test.

A detailed description of the design processes is documented in System Engineering

Management Plan (Al-1046-1854) [14] The design output documents are reviewed and approved as documented in the design reviews and change control process described in ALS-U Configuration Management

Plan.

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A configuration control process is in place to systematically manage and maintain the integrity of the ALS-U project. It ensures the configuration of the WBS, design, and associated documentation is properly approved, documented and traceable to maintain consistency and compliance with the project baseline. Details of the ALS-U configuration control process are described in the ALS-U Configuration Management

Plan (AL-1115-6080) [15]

4.7 Procurement

Procurement controls that are described in ALS-U Procurement Plan (AL-1024-3198)

[18] are implemented to ensure that purchased items and services meet project needs and comply with applicable quality requirements.

Published categories and cycle times can be found on the LBNL Procurement and

Property website

(https://procurement.lbl.gov/welcome-to-procurement-property/make-a-purchase/kn ow-before-you-buy-2/).

ALS-U has several items considered for Long Lead Procurement (LLP). [19]is released to ensure the successful acquisition of the LLP items.

4.7.1Supplier Selection, Evaluation and Management

The procurement department has the sole authority to commit the laboratory contractually. The supplier management and procurement planning are detailed in the

Engineering Process Guide [19] Potential suppliers of major procurements, prior to award, shall be evaluated to ensure they have the capability to provide the items or services in conformance with the technical and quality requirements of the procurement. The determination of which suppliers shall be evaluated by the ALS-U project technical personnel, in conjunction with the appropriate institutional procurement personnel.

A supplier’s evaluation may be based upon the results of one, or a combination of, the following:

● ALS-U Supplier quality evaluation survey (AL-1208-0209) [20]

● Supplier onsite visit with review of supplier’s quality program referencing Vendor

QA program evaluation checklist (AL-1474-3076) [21]

● Review of supplier references for similar projects

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● ALS-U technical team previous experience with supplier

Ongoing evaluation and management of supplier performance shall be performed. This shall help ensure technically acceptable components are delivered and the supplier continues to meet all quality, technical, delivery, and other performance requirements.

Unacceptable items or services for all procurements shall be documented and corrective actions shall be implemented (see section 4.3.1) in accordance with purchase order conditions should a supplier not perform as required.

The program shall ensure adequate oversight of contractor’s QA program. In-depth supervision shall be provided to the primary contractors or key subcontractors.

Methods of supplier management that may be employed are listed below. The relevant

CAM and System Lead with the assistance of technical lead shall determine which methods are appropriate for an individual procurement.

● Periodic Phone Conferences

● Periodic Supplier Reporting - Status, Schedule, Photos

● On-Site Visit

● Supplier Manufacturing Plan & Evaluation

● Raw Material Certifications, Inspections, Testing

● First Article Sampling & Inspection

● Production Sampling & Inspection

● On-Site Verifications

● Supplier In-Process Inspection & Testing

● Supplier Post Fabrication Inspection & Testing

● Supplier Packaging/Shipping Plan & Evaluation

The ALS-U personnel requesting procurement of items and services is responsible for providing a statement of work that adequately describes the item or service being procured such that the supplier can understand the requirements and the condition for acceptance. A documentation (such as certifications) requirement that is commensurate with the impact of the product shall be determined via graded approach.

The ALS-U Project Review Cycle specifies a list of technical documentation deliverables for Procurement Readiness Review (PRR). CAMs and System Leads shall evaluate the

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For all procurements, counterfeit and/or suspect parts are prohibited. Inspections shall be used to detect violations. When counterfeit/suspect parts are found, they shall be identified, segregated, and disposed of in accordance with DOE G 414.1-3, Suspect/Counterfeit Items Guide for Use with 10 CFR 830 Subpart A [23]and DOE O

414.1D, Quality Assurance. Refer to section 4.8.3 for details.

4.7.2In-house Manufacturing

Selected subsystems within the ALS-U project are fabricating and/or assembling components in-house. Quality controls shall be established to ensure these activities and components meet project needs and comply with applicable project requirements.

For ALS-U, three levels of manufacturing have been established as part of the graded approach for the ALS-U quality program. The levels and criteria are listed below:

● Production Manufacturing: Fabrication of more than several (~20) substantially similar items shall typically be considered production manufacturing. The ALS-U

Chief Engineer helps System Lead determine which items are considered production fabrications for ALS-U.

● Non-Production Manufacturing: Fabrication of fewer than approximately 20 substantially similar items. The finished product shall be deliverable as part of the ALS-U project.

● Prototype or R&D Fabrication: These components and activities are for research and prototyping efforts only. The finished product of these fabrications will not be part of the deliverable ALS-U project.

The following factors should be considered as part of the manufacturing planning process:

● Technical performance requirements

● Manufacturing drawing package

● Compliance to appropriate industry standards

● Laws and regulations

● EH&S requirements

● Assembly procedures

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● Verifications (Inspections) & Acceptance Criteria

● Testing requirements

● Handling and cleanliness requirements

● Shipping and packaging requirements

● Storage requirements

● Commissioning requirements

As mentioned above, ALS-U has established 3 manufacturing levels to ensure an appropriate level of quality is applied. The list below details the decision authority for each manufacturing level.

● Production Manufacturing - For production manufacturing, the CAMs, System

Lead, and QA manager shall evaluate the adequacy of the manufacturing documentation package. A manufacturing readiness review may be convened at the request of the Chief Engineer and/or Technical Project Manager and/or

Project Manager and/or Project Director to review manufacturing readiness.

● Non-Production Manufacturing - For non-production manufacturing, the System

Lead shall determine the required manufacturing documents and associated quality requirements with assistance of the QA manager and/or QA engineer.

● Prototype or R&D Fabrication - For prototype or R&D fabrication, the System

Lead shall determine the required manufacturing documents and quality requirements, if any with assistance of the QA manager and/or QA engineer.

4.8 Inspection and Acceptance Testing

The implementation of testing procedures and establishment of acceptance criteria are important elements of the ALS-U QAP that apply to both outsourced procurements and fabrication activities performed by the project personnel.

CAM, System Lead, Technical Project Manager with assistance of the QA manager and/or QA engineer shall ensure that any in-house work along with procured components requiring formal inspection and acceptance testing is identified and communicated to relevant stakeholders to ensure the inspection and acceptance plan is consistently followed.Products are handed over to the next state when the acceptance testing from the previous state is complete. The product state is tracked by windchill serial wtPart. The change of states follows the windchill serial wtPart lifecycle. The

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AL-1548-3088 [24]

Special attention should be paid to ensure all essential safety items or systems that require formal inspection and testing are identified.

4.8.1Establishment of Acceptance Criteria

System Lead and CAM along with the appropriate technical personnel is responsible for developing acceptance criteria. These criteria shall be sufficient to ensure that components/assemblies meet relevant technical and scientific project requirements.

4.8.2Development of Test and Inspection Procedure

Test and Inspection Procedure shall be developed to describe the verification activities for the corresponding acceptance criteria as deemed necessary. Each CAM is responsible for developing and executing Test and Inspection procedures within their system. The test techniques to be used shall be defined and the step-by-step instruction shall be documented in the procedure by the subsystem with the assistance of the relevant

SMEs. Per the graded approach, Lead Engineer, QA, CAM, System Lead, Technical project Manager and Chief Engineer shall be selected to review the documents to ensure the detail in documenting these procedures is commensurate with the complexity and the scope of the testing. System Engineer shall be included in the review process if the procedure involves verification of project requirements or specification. Designated tests shall be performed using equipment that is calibrated and maintained.

4.8.3Suspect/Counterfeit Item prevention

Inspection for suspect/counterfeit items shall be included in the receiving inspection.

Items that are suspected to be S/CI shall be reported to the ALS-U project management team. The ALS-U project management team shall then notify the Office of Contractor

Assurance (OCA) to make a final determination regarding whether the item is counterfeit. Upon confirmation by the OCA that an item is an S/CI, the S/CI is reported in:

1. the Occurrence Reporting and Processing System (ORPS) database, in accordance with DOE 0 232.1, Occurrence Reporting; and

2. the Corrective Action Tracking System (CATS) database in accordance with

LBNL/PUB-5519 (I), Issues Management Program.

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S/CIs are reported to the DOE Inspector General in accordance with DOE 0 221. IA, Reporting Fraud, Waste, and Abuse to the Inspector General [25] via the ORPS database.

An item that does not conform to established requirements is not normally considered an S/CI if the nonconformity results from one or more of the following conditions, which are controlled by site procedures as nonconforming items:

• Defects resulting from inadequate design or production quality control.

• Damage during shipping, handling, or storage.

• Improper installation.

• Deterioration during service.

• Degradation during removal.

• Failure resulting from aging or misapplication; or

• Other controllable causes.

4.9 Hand-off process

To ensure that each technical system has fully completed its defined scope of work, a formal hand-off process shall be conducted prior to transferring responsibility to the downstream system.

During the hand-off, the…