DRAFT_B2_03.05_CUIR's_Quality_Requirements_for_Subcontractors.pdf

CUIR’s Quality Assurance Requirements for Subcontractors & Suppliers

Critical Utilities Infrastructure Revitalization (CUIR)

Project # 20-SC-79 at

SLAC National Accelerator Laboratory

CUIR-QA-0175

DRAFT

CUIR Quality Assurance Procedure Document

Document Title: CUIR’s Quality Clause Descriptions for Subcontractors & Suppliers

Document Number: CUIR-QA-0175 Page 2 of 21

The only official copy of this file is located in the CUIR Controlled Document Site.

Before using a printed/electronic copy, verify that it is the most current version.

Document Approval:

Originator: Alayna Albert – Quality Assurance Manager

• General QA Provisions • Compliance with DOE O 414.1E

Approver: Larry Ge – Deputy Director of Quality Assurance

• Final QA Authorization

Approver: Tracy Ng – CUIR Project Manager

• Final Authorization

Informed on July 7, 2025

Janet Kan – CUIR Project Director

Revision History

Revision Date Released Description of Change

R0 August 27, 2025 Original Release.

Document Number: CUIR-QA-0175 Page 3 of 21

Table of Contents

1 Purpose

2 Scope

3 Responsibilities

3.1 Project Manager

3.2 Design Manager

3.3 Quality Assurance Manager

4 Program

5 Definitions

6 References

Appendix A: Quality Program Requirements

Appendix B: Quality Program Requirements & Deliverables Checklist

Appendix C: Quality Program Requirements & Deliverables

Document Number: CUIR-QA-0175 Page 4 of 21

1 Purpose

The Critical Utilities Infrastructure Revitalization (CUIR) project at SLAC National Accelerator Laboratory (SLAC) incorporates a graded approach to procurement actions at a level of rigor commensurate with the risk associated with the intended use or application of the procured item. To meet project quality requirements, the subcontractor shall adhere to the quality requirements outlined in the statement of work (SOW).

2 Scope

This document provides descriptions of each of the quality clauses included on the subcontractor SOW.

3 Responsibilities

3.1 Project Manager

The Project Manager (PM) or designee shall be responsible for ensuring a copy of CUIR-QA-0175 Appendix C is provided to the supplier/subcontractor. The PM will ensure that all relevant project requirements are appropriately selected.

3.2 Design Manager

The Design Manager (DM) will ensure that all technical design and construction requirements are appropriately selected.

3.3 Quality Assurance Manager

The CUIR Quality Assurance Manager (QAM) shall be responsible for:

The management of the Quality Requirements outlined in this document.

Ensuring quality requirements are flowed down to subcontractors IAW DOE O 414.1E “Quality Assurance”, SLAC Quality Assurance Program (CACM-2018-049), and CUIR Quality Assurance Plan (CUIR-QA-0011).

4 Program

CUIR-QA-0175 Appendix A outlines a template for the QA Requirements that may be integrated into the main body of all Statements of Work (SOW) for suppliers and subcontractors. Additional Quality requirements must be included in the SOW.

CUIR-QA-0175 Appendix B functions as a checklist to delineate the specific Quality Requirements and

Deliverables applicable to suppliers and subcontractors. This checklist may be integrated into the SOW, and the relevant requirements will be selected as part of the documentation process for each supplier or subcontractor.

CUIR-QA-0175 Appendix A will undergo review and approval in accordance with CUIR’s Document

Review and Approval Matrix Guideline (CUIR-QA-0052) as part of the SOW for suppliers and subcontractors. CUIR-QA-0175 Appendix B will require review and approval by the DM, PM, and QAM, but approval may be integrated as part of the SOW review and approval process.

Finally, CUIR-QA-0175 Appendix C provides detailed descriptions of each Quality Program Requirement and Deliverable. CUIR-QA-0175 Appendix C must be attached to the final procurement package or may be included as part of the SOW for reference by the supplier or subcontractor.

Document Number: CUIR-QA-0175 Page 5 of 21

5 Definitions

Acronym Definition

CMTR Certified Material Test Report

CoA Certificate of Analysis

CoC Certificate of Conformance

CUIR Critical Utilities Infrastructure Revitalization

ECN Engineering Change Notice

FCR Field Change Requests

M&TE Measuring & Test Equipment

MSDS Material Safety Data Sheets

NIST National Institute of Standards and Technology

PRR Production Readiness Review

QA Quality Assurance

QC Quality Control

RFI Requests for Information

SLAC SLAC National Accelerator Laboratory

S/CI Suspect/Counterfeit item

6 References

Document Number Description

CUIR-PM-0011 CUIR Quality Assurance Plan

CUIR-QA-0052 CUIR’s Document Review and Approval Matrix Guideline

CACM-2018-049 SLAC Quality Assurance Program

DOE O 414.1E Quality Assurance

ISO 9001: 2015 Quality Management System

Document Number: CUIR-QA-0175 Page 6 of 21

Appendix A: Quality Program Requirements

The subcontractor is responsible for ensuring the quality of all their activities, including work performed by sub-tier subcontractors. The subcontractor shall ensure that all efforts conform to applicable codes, regulations, subcontract requirements, and the approved design and specifications.

The selected firm shall establish and maintain a Quality Management System (QMS) that is compliant with the CUIR’s Quality Assurance Requirements for Subcontractors/Suppliers (CUIR-QA-0175) requirements; Department of Energy (DOE) Order 414.1E Chg. 2, "Quality Assurance"; and the standards of a U.S. industry-recognized Quality Management System (QMS) or program (e.g., ISO

9001).

The subcontractor shall adhere to the Subcontractor/Supplier Quality Requirements & Deliverables for purchases of items, goods, and services as specified in [CUIR-QA-0175 Appendix B or in the SOW].

For definitions, refer to CUIR-QA-0175 Appendix C.

Document Number: CUIR-QA-0175 Page 7 of 21

Appendix B: Quality Program Requirements & Deliverables Checklist

SUBCONTRACTOR/SUPPLIER shall comply with the SLAC (herein known as the CONTRACTOR) requirements in this document that have been indicated as being incorporated into this subcontract. For additional guidance of requirements, SUBCONTRACTOR/SUPPLIER may reference ISO 9001:2015.

Statement of Work Number and Title

(include Revision):

Click or tap here to enter text.

QA ID Check box, if applicable QA Title

QA-01A ☒ GENERAL QUALITY MANAGEMENT (QA/QC) PROGRAM REQUIREMENTS

FOR SUBCONTRACTOR IMPLEMENTED PROGRAM

QA-01B ☐ SUPPLEMENTARY CODES AND STANDARDS REQUIREMENTS

QA-01C ☐ SUPPLEMENTARY ISO/IEC-17025 CALIBRATION PROGRAM

QA-02 ☐ ORGANIZATION REQUIREMENTS

QA-03 ☐ PERSONNEL TRAINING AND QUALIFICATION

QA-04 ☐ DESIGN

QA-05 ☐ SUBCONTRACTOR GENERATED PROCUREMENT DOCUMENTS

QA-06 ☐ CONTROL OF QUALITY AFFECTING ACTIVITIES

QA-07 ☐ DOCUMENT CONTROL

QA-08 ☐ SUPPLIER EVALUATION AND SELECTION

QA-09 ☐ SUBCONTRACTOR ACCEPTANCE OF ITEMS/SERVICES

QA-10 ☐ PRODUCT CERTIFICATION PROGRAM

QA-11 ☐ SUBCONTRACTOR OBLIGATION TO VERIFY CONFORMANCE

QA-12 ☒ RIGHT OF ACCESS

QA-13 ☐ ITEM/SERVICE QUALITY VERIFICATION

QA-14 ☐ QUALITY SOURCE VERIFICATION

QA-15 ☐ IDENTIFICATION AND CONTROL OF ITEMS

QA-16 ☐ IDENTIFICATION AND CONTROL OF SPECIAL PROCESSES

QA-17 ☐ CONTROL OF INSPECTION AND TEST

QA-18 ☐ CONTROL OF MEASURING AND TEST EQUIPMENT

QA-19 ☐ HANDLING, STORAGE, AND SHIPPING

QA-20 ☐ ITEM STATUS CONTROL

QA-21 ☐ NONCONFORMING ITEMS

QA-22 ☐ CORRECTIVE ACTION AND CONTINUOUS IMPROVEMENT

QA-23 ☐ SUBCONTRACTOR OBLIGATION TO RESPOND TO CORRECTIVE ACTION

REQUEST

QA-24 ☐ QUALITY RECORDS

QA-25 ☐ SUBCONTRACTOR INDEPENDENT ASSESSMENT

QA-26 ☐ AUDIT PERFORMANCE

QA-27 ☐ SOFTWARE ERROR REPORTING

QA-28 ☐ SUSPECT/COUNTERFEIT ITEM PREVENTION

QD-01 ☒ PROJECT SPECIFIC QUALITY MANAGMENT (QA/QC) PLAN

QD-02 ☐ SUBCONTRACTOR PERSONNEL QUALIFICATIONS / CERTIFICATIONS

QD-03 ☐ ENGINEERING DRAWINGS, CALCULATIONS, AND ANALYSES

QD-04 ☐ AS-BUILT DRAWINGS

QD-05 ☐ ITEM/COMPONENT TRACEABILITY DOCUMENTATION

QD-06 ☐ MANUALS / INSTRUCTIONS

QD-07 ☐ SERIALIZATION AND MARKING

QD-08 ☐ SPARE AND REPLACEMENT PART IDENTIFICATION

Document Number: CUIR-QA-0175 Page 8 of 21

QA ID Check box, if applicable

QA Title

QD-09 ☐ INSPECTION AND TEST REPORTS

QD-10 ☐ HOLD POINTS

QD-11 ☐ AUDIT REPORT

QD-13 ☐ CERTIFICATE OF COMPLIANCE/CONFORMANCE

QD-14 ☐ CERTIFICATE OF CALIBRATION

QD-15 ☐ CERTIFICATE OF ANALYSIS

QD-16 ☐ CERTIFIED MATERIAL TEST REPORTS

QD-17 ☐ CERTIFICATE OF CALIBRATION FOR SUBCONTRACTOR OWNED

MEASURING AND TEST EQUIPMENT (M&TE)

QD-18 ☐ SHELF-LIFE CERTIFICATION / STORAGE REQUIREMENTS

QD-19 ☐ CERTIFICATE OF PROOF LOAD TEST

QD-20A ☐ NONCONFORMANCE REPORTS

QD-20B ☐ NONCONFORMANCE REPORTS FOR CONSTRUCTION

QD-21 ☐ SUSPECT/COUNTERFEIT ITEM REPORTS

QD-22 ☐ ISO 9001: 2015 Certification

Approval:

Approver: Design Manager

• Technical Design and Construction Requirements

Approver: Project Manager

• Project Requirements

Approver: Quality Assurance Manager

• QA Requirements

Document Number: CUIR-QA-0175 Page 9 of 21

Appendix C: Quality Program Requirements & Deliverables

QA-01A, GENERAL QUALITY MANAGEMENT (QA/QC) PROGRAM REQUIREMENTS FOR

SUBCONTRACTOR IMPLEMENTED PROGRAM

In accordance with SLAC (the CONTRACTOR’s) responsibilities under DOE Order 414.1E, Admin.

Chg. 2, Quality Assurance, the requirements established for SUBCONTRACTOR’s Quality Management Program (QMP) in this document are derived from the applicable Quality Assurance (QA) and Quality Control (QC) requirements of the DOE Order 414.1E, Admin. Chg. 2, Quality Assurance.

SUBCONTRACTOR’s QMP is required to be evaluated for the capability of providing items/services in accordance with subcontract technical and quality requirements and is required to be approved by CONTRACTOR prior to the start of work. SUBCONTRACTOR will be notified of approval of their QMP, and the approval documentation will be maintained by CONTRACTOR. SUBCONTRACTOR will perform all work under this subcontract in accordance with its approved QMP and must notify CONTRACTOR of any changes made to its QMP, whereupon CONTRACTOR will determine the need for re-evaluation/re-approval and any need to pause work pending re-evaluation/re-approval.

SUBCONTRACTOR’s QMP shall be subject to ongoing evaluation and monitoring by CONTRACTOR.

Documents supplied by SUBCONTRACTOR that contain proprietary information or describe proprietary processes must be clearly marked to prevent disclosure. Definitions of terms used in this document are found in DOE O 414.1E, Chg. 2, 6. Definitions.

QA-01B, SUPPLEMENTARY CODE & STANDARDS REQUIREMENTS

In addition to the requirements of the procurement documents, SUBCONTRACTOR must implement a QMP in accordance with the codes or standards specified in the statement of work (SOW) (e.g., boiler code, pressure safety code, International Building Code, etc.).

QA-01C, SUPPLEMENTARY ISO/IEC-17025 CALIBRATION PROGRAM

In addition to the requirements of this document, SUBCONTRACTOR must implement a QMP that meets the requirements of ISO/IEC-17025, General Requirements for the Competence of Testing and Calibration Laboratories, for the performance of calibration of measuring and test equipment (M&TE) provided to CONTRACTOR. If SUBCONTRACTOR is procuring these calibration services from a sub-tier supplier, then they must flow this requirement down to the supplier.

QA-02, ORGANIZATION REQUIREMENTS

SUBCONTRACTOR must establish an organization structure including defining functional responsibilities, levels of authority, and interfaces for personnel managing, performing, and assessing work for CONTRACTOR. The structure must be such that quality is achieved by those performing the work and verified by the person not responsible for the performance of the work. SUBCONTRACTOR must establish management processes to plan, schedule, and provide resources for work for CONTRACTOR such that quality is able to be achieved, and delivery timelines are able to be met.

SUBCONTRACTOR must establish a program to ensure that management regularly assesses their management program, and QA processes and corrects problems that hinder the organization from achieving the quality and performance requirements specified by CONTRACTOR.

QA-03, PERSONNEL TRAINING AND QUALIFICATION

SUBCONTRACTOR must establish a program to ensure that personnel performing activities affecting the quality of items or services supplied to CONTRACTOR are adequately trained and qualified to perform the work. This program must include the evaluation of activities and establish the minimum qualifications to be able to adequately perform those activities. SUBCONTRACTOR must establish a program to evaluate the need for requiring continued training for personnel performing activities affecting the quality of items or services supplied to CONTRACTOR. This program must also ensure

Document Number: CUIR-QA-0175 Page 10 of 21 that personnel satisfactorily complete training as required to be allowed to continue performing those activities.

QA-04, DESIGN

SUBCONTRACTOR must establish a process to ensure that SUBCONTRACTOR:

a) designs items and processes affecting the quality of products or services supplied to CONTRACTOR using sound engineering/scientific principles and appropriate standards.

b) designs activities are in accordance with any standards or requirements included or referenced in this subcontract.

c) incorporates applicable requirements and design basis in design work and design changes for products delivered to CONTRACTOR.

d) incorporates any requirements or design basis included or referenced in this subcontract.

SUBCONTRACTOR must establish a process to identify and control design interfaces for design activities affecting products delivered to CONTRACTOR. SUBCONTRACTOR must establish a process for the validation and/or verification of design products affecting the quality of products delivered to CONTRACTOR for adequacy against the requirements of this subcontract. The process must ensure that personnel who perform validation and/or verification activities of design products affecting the quality of products delivered to CONTRACTOR are not the same personnel who performed the design work. SUBCONTRACTOR must ensure that verification and/or validation of work has been performed, and the work is found to meet any applicable requirements prior to approval and implementation of the design.

QA-05, PROCUREMENT DOCUMENTS

SUBCONTRACTOR must establish and implement a process to identify and flow down appropriate requirements to sub-tier suppliers to ensure that technical and quality characteristics and requirements are met. SUBCONTRACTOR must accomplish this by defining the scope of work to include technical requirements that must be met, and QMP requirements necessary to provide reasonable assurance of acceptability. The procurement documents must establish and define the documentation to be delivered, and the requirements for document content. Procurement documents, and changes thereto, must be reviewed by personnel defined in SUBCONTRACTOR’s QMP.

QA-06, CONTROL OF QUALITY AFFECTING ACTIVITIES

SUBCONTRACTOR must establish processes to ensure that work for this subcontract is performed consistently with technical standards, administrative controls, and any other hazard controls adopted to meet regulatory or contract requirements. SUBCONTRACTOR must use approved work control documents such as instructions, procedures, drawings, or other appropriate means to ensure the work is satisfactorily accomplished. Such work control documents must establish or reference acceptance criteria for determining if the activities described have been satisfactorily accomplished. The level of detail and instruction must be commensurate with the proficiency of workers and the complexity of the work.

QA-07, DOCUMENT CONTROL

SUBCONTRACTOR’s QMP shall address configuration control of subcontract requirements, including CONTRACTOR approval of substitutions and configuration control of any provided CONTRACTOR procedures, specifications, or items. SUBCONTRACTOR must establish a process for identifying and controlling documents that prescribe processes, specify requirements, or establish design. This process must include methods to prepare, review, approve, issue, use, and revise these documents. The process must ensure that current controlled documents are available at the location(s) where the

Document Number: CUIR-QA-0175 Page 11 of 21 associated work is being performed. A method of ensuring that the correct documents are used must be established and implemented.

QA-08, SUPPLIER EVALUATION AND SELECTION

SUBCONTRACTOR must establish and implement a process to evaluate sub-tier suppliers, who provide items or services affecting the quality of items or services that SUBCONTRACTOR provides to CONTRACTOR, to ensure that they have adequate technical capability and QA controls in place to be able to meet the technical and quality requirements of SUBCONTRACTOR’s contract with CONTRACTOR. These processes must serve to ensure that the sub-tier supplier has the capability and programs in place to meet the requirements for the work they will perform. SUBCONTRACTOR must establish methods to ensure that their sub-tier suppliers continue to provide acceptable items and services, including re-evaluation if necessary and performance monitoring as applicable.

QA-09 SUBCONTRACTOR ACCEPTANCE OF ITEMS/SERVICES

SUBCONTRACTOR must establish and implement processes to evaluate and document the conformance and acceptability of items and/or services provided by sub-tier suppliers that SUBCONTRACTOR will provide to CONTRACTOR for this subcontract. Methods of acceptance for items and/or services must be in accordance with the SUBCONTRACTOR’s procurement requirements for each procurement.

QA-10, PRODUCT CERTIFICATION PROGRAM

SUBCONTRACTOR must establish, document, and implement a certification system for the product(s) they provide to CONTRACTOR including procedures for the certification activities and generation of the certificate, and the administrative process for review and approval of the certificate. Certificates must meet the content requirements specified for this procurement; identify the material(s) or products being certified traceable to the items delivered; identify the specific requirements of the procurement that are certified to have been met; identify any approved changes and/or deviations from the contract with CONTRACTOR; and must describe or reference any requirements that have not been met.

QA-11, SUBCONTRACTOR OBLIGATION TO VERIFY CONFORMANCE

SUBCONTRACTOR must verify that items or services offered to CONTRACTOR for acceptance comply with the procurement requirements prior to offering them for acceptance. Any modifications, repairs, or replacements of items after final inspection/test/verification by SUBCONTRACTOR must be re-inspected, re-tested, or re-verified as appropriate to verify acceptability. Should SUBCONTRACTOR identify potential negative impacts to the quality of items or services they have provided to CONTRACTOR they must: (1) consider any impacted items/services as nonconforming and meet the requirements for nonconforming items for this subcontract, and (2) notify CONTRACTOR of impacted items/services within four (4) business days to include a description of the potential impacts and any risk associated.

QA-12, RIGHT OF ACCESS

SUBCONTRACTOR must provide CONTRACTOR and/or DOE access to SUBCONTRACTOR’s facilities and records to conduct evaluations of SUBCONTRACTOR’s quality systems and verify compliance with subcontract requirements as well as access to conduct inspection and/or testing of SUBCONTRACTOR’s product to assure conformance with subcontract requirements.

SUBCONTRACTOR must contractually flow this right of access down to any sub-tier suppliers.

QA-13, ITEM/SERVICE QUALITY VERIFICATION

The item(s) and/or service(s) provided under this subcontract must be verified to be acceptable for their intended use. CONTRACTOR assumes the responsibility for verification and the final determination as

Document Number: CUIR-QA-0175 Page 12 of 21 to the acceptability of item(s)/service(s) for their intended use. SUBCONTRACTOR must ensure that the item(s)/service(s) provided under this subcontract are in accordance with subcontract requirements and should raise any concerns regarding the possible use of the item(s)/service(s) to CONTRACTOR.

Item(s) or assemblies provided to CONTRACTOR under this subcontract that are not installed by SUBCONTRACTOR must be identified either on the item(s) or on the item packaging such that each item is easily identified as a part of the subcontract. This may include permanent labeling or non-permanent labels as appropriate and/or defined in this subcontract. SUBCONTRACTOR must perform work for this subcontract in accordance with the requirements of this document and all other documents incorporated into the subcontract. SUBCONTRACTOR shall correct and provide documented evidence of correction of any deficiencies with SUBCONTRACTOR’s processes that affect the quality of products provided under this subcontract.

QA-14, QUALITY SOURCE VERIFICATION

SUBCONTRACTOR must grant access to its facilities, personnel, and records to CONTRACTOR and/or DOE for the purpose of witnessing, verifying, inspecting activities or items as described in the SOW listed mandatory hold points. Work may not proceed beyond these hold points until authorized by the CONTRACTOR. SUBCONTRACTOR must notify CONTRACTOR for a minimum of seven (7) calendar days in advance of reaching the hold point for subcontractor facility is within 50 miles of contractor facility and fifteen (15) calendar days if subcontractor facilities is more than 50 miles of contractor facility.

QA-15, IDENTIFICATION AND CONTROL OF ITEMS

SUBCONTRACTOR must establish and implement processes to establish and maintain traceability of items and components to their specific end use. Methods of identification and/or traceability must be in accordance with any codes, standards, or specifications invoked by the procurement requirements.

Item(s) or assemblies provided to CONTRACTOR under this subcontract that are not installed by SUBCONTRACTOR must be identified either on the item(s) or on the item packaging such that each item is traceable to the subcontract. This may include permanent labeling or non-permanent labels as appropriate and/or defined in this subcontract.

QA-16, IDENTIFICATION AND CONTROL OF SPECIAL PROCESSES

SUBCONTRACTOR must establish a process to identify special processes. A special process is one where the quality of the product or service is highly dependent on the skill of the worker and/or the control of the procedure and where quality of the work cannot be readily determined by inspection or test. SUBCONTRACTOR must identify any special processes which control or verify the quality of the item(s) or service(s) they will provide to CONTRACTOR and must establish methods to control those special processes to ensure quality is achieved. Methods of control must be documented, must specify the procedures, personnel, and equipment qualification requirements, and must include the necessary conditions such as the equipment, parameters, environment, and calibration requirements.

SUBCONTRACTOR must maintain records demonstrating the qualification of personnel, processes, and equipment as applicable to the processes. Persons performing Nondestructive Examination (NDE) must be qualified and certified in accordance with ANSI/ASNT CP-189, ASNT Standard for Qualification and Certification of Nondestructive Testing Personnel or other governing code or standard for the type of examination they are performing.

QA-17, CONTROL OF INSPECTION AND TEST

SUBCONTRACTOR must establish programs to ensure that products delivered to CONTRACTOR are inspected and tested according to the acceptance and performance criteria established in CONTRACTOR procurement documents. Inspection and test plan (ITP) must be submitted to CONTRACTOR for approval. Inspections and tests must be performed in accordance with any codes, Document Number: CUIR-QA-0175 Page 13 of 21 standards, or specific instructions included or referenced in CONTRACTOR procurement documents.

These results of the inspection/test must be documented to include a determination of whether acceptance and performance criteria have been met. Personnel performing inspections/tests to evaluate the acceptability of items or services must not be directly responsible for performing the work being verified and must have their qualifications to perform the inspection/test certified in writing by an appropriate authority.

QA-18, CONTROL OF MEASURING AND TEST EQUIPMENT

SUBCONTRACTOR must establish and maintain a program to ensure that tools, gauges, instruments and other measuring and test equipment (M&TE) that are used to monitor, verify, and/or control the quality of items or services supplied to CONTRACTOR are appropriately selected, controlled, calibrated and/or adjusted, and maintained to ensure adequate accuracy and validity of the data gathered.

Traceability must be established between M&TE used to verify quality and its use(s). If M&TE used to verify quality is found to be out of tolerance or otherwise indeterminate, the quality of any items verified since its last acceptable calibration must be re-evaluated. If impacts are found on the quality of products delivered to CONTRACTOR, SUBCONTRACTOR must: (1) consider any impacted items/services to be nonconforming and meet the requirements for nonconforming items for this subcontract, and (2) notify CONTRACTOR of impacted items/services within four (4) business days to include a description of the potential impacts and any risk associated.

QA-19, HANDLING, STORAGE, AND SHIPPING

SUBCONTRACTOR must establish and maintain processes and/or procedures to ensure that items are not damaged or lost, and to minimize deterioration during handling, storage, cleaning, packaging, and shipping. Items must be marked and/or labeled as necessary to adequately maintain and preserve the item, such as when special environments are present or when an item has special controls in place.

QA-20, ITEM STATUS CONTROL

SUBCONTRACTOR must establish and maintain processes to ensure that the status of items or components provided under this subcontract are identified either through marking or labelling of the items or in documents traceable to the items. These processes must ensure that required inspections and tests are performed, and that items are not inadvertently installed, used, or operated without required inspections, and tests have been performed and passed. The processes must also establish the authority to determine whether a required inspection, test, or other process has been adequately performed and is acceptable. Methods of identification must include the physical location of items, tags, labels, markings, shop travelers, stamps, inspection records, or other suitable and documented means.

QA-21, NONCONFORMING ITEMS

SUBCONTRACTOR must establish and maintain a process to identify, control, evaluate, and resolve nonconformances with items and/or services to be provided to CONTRACTOR. Nonconforming items must be controlled by SUBCONTRACTOR to prevent inadvertent installation or use. Nonconforming items must be identified by legible and non-detrimental marking or tagging either on the item or its container. When practical, items should be segregated, and when not practical other methods established, documented, and used to control the item(s).

If the SUBCONTRACTOR is the designer of the item(s), demonstrated competent personnel must provide evaluation, disposition, recommendation, and technical justifications, as applicable. Use-as-is disposition requires review and approval from CONTRACTOR. Items that have been re-worked and/or repaired must be re-examined in accordance with the original acceptance criteria. Acceptance of repaired items will be based on verification of resolution of the issue(s) that required repair; and shall be approved by CONTRACTOR.

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QA-22, CORRECTIVE ACTION AND CONTINUOUS IMPROVEMENT

SUBCONTRACTOR must establish, implement, and maintain a process to identify conditions adverse to quality, identify their cause(s), and correct them in a manner that minimizes recurrence. This process must include provisions to determine if a condition adverse to quality may impact on the quality of an item or service provided to CONTRACTOR. If a condition adverse to quality has an impact on an item or service provided to CONTRACTOR, SUBCONTRACTOR must: (1) consider any impacted items/services to be nonconforming and meet the requirements for nonconforming items for this subcontract, and (2) notify CONTRACTOR of impacted items/services within four (4) business days of the potential impacts and any risks that are associated with the impacts. The conditions adverse to quality must be documented when the conditions adverse to quality may have a significant impact on the quality of an item or service to be or previously delivered to CONTRACTOR. Corrective actions must be established and documented to resolve conditions adverse to quality and to minimize recurrence. Completion of corrective actions must be verified as defined in SUBCONTRACTOR’s QMP.

SUBCONTRACTOR must establish a process for evaluating item characteristics, process implementation, and other quality related attributes of their products, services, and programs to identify areas which require improvement, or which do not meet requirements of CONTRACTOR procurement documents. This process must ensure that areas identified as needing improvement or not meeting requirements are evaluated for the cause of deficiencies, and that actions are taken to improve performance.

QA-23, SUBCONTRACTOR OBLIGATION TO RESPOND TO SUPPLIER CORRECTIVE ACTION

REQUEST (SCAR)

When the SUBCONTRACTOR is notified by CONTRACTOR of a Supplier Corrective Action Request (SCAR), SUBCONTRACTOR must respond within fifteen (15) calendar days with proposed corrective actions and anticipated completion dates. These will be reviewed by CONTRACTOR for acceptability and tracked to completion.

QA-24, QUALITY RECORDS

SUBCONTRACTOR must establish a program to ensure that records of activities or attributes affecting the quality of item(s) or services delivered to CONTRACTOR are documented, retained, and delivered to CONTRACTOR as required by procurement documents. The program must ensure that records are legible, complete, accurate, and traceable to the items or activities they represent. Record requirements must be established in quality affecting procedures and documents and must include provisions for the minimum content and the review and authentication of the records. Once generated, records must be stored in a retrievable manner that will protect them from loss, damage, or destruction for the minimum duration from subcontract completion specified in the SOW or for at least 3 years.

QA-25, SUBCONTRACTOR INDEPENDENT ASSESSMENT

SUBCONTRACTOR must establish and maintain programs and/or procedures to plan and conduct assessments to measure the adequacy of work and quality program performance to CONTRACTOR requirements, and to promote improvement in the quality of items and/or services provided to CONTRACTOR. The program must include a process for ensuring that any assessment results are responded to, and action taken where appropriate to enhance quality and/or performance.

SUBCONTRACTOR must establish a process to ensure that organizations that perform independent assessments have sufficient authority and freedom from line management of the assessed areas, to be able to reach conclusions regarding the acceptability and effectiveness of the assessed areas.

SUBCONTRACTOR must establish a process to ensure persons who perform assessments are technically qualified and knowledgeable in the areas to be assessed.

Document Number: CUIR-QA-0175 Page 15 of 21

QA-26, AUDIT PERFORMANCE

SUBCONTRACTOR must establish, document, and maintain programs and/or procedures to perform audits using qualified and certified 3rd party personnel (e.g. ISO 9001:2015 audit). These programs and/or procedures must provide for the scheduling, preparation, planning, performance, reporting, and response to audits.

QA-27, SOFTWARE ERROR REPORTING

SUBCONTRACTOR must establish a process to ensure that any errors identified with the software provided to CONTRACTOR are communicated to CONTRACTOR within seven (7) calendar days of identification. SUBCONTRACTOR must also establish a process for CONTRACTOR to communicate any potential errors to SUBCONTRACTOR for their evaluation.

QA-28, SUSPECT/COUNTERFEIT ITEM PREVENTION

SUBCONTRACTOR must establish and implement programs and/or processes to ensure that products they provide to CONTRACTOR do not contain Suspect/Counterfeit Items (S/CI), and to identify and inform CONTRACTOR should any S/CI be identified while performing work under this subcontract.

These programs and/or processes must include evidence of a) traceability of items to the manufacturer or authorized distributors; b) as appropriate, inspections and tests to confirm that items are genuine, training of personnel in S/CI prevention processes and controls, and the identification, segregation, and preclusion from use of any S/CI identified pending instruction from CONTRACTOR.

QD-01, SUBCONTRACTOR SPECIFIC QUALITY MANAGEMENT (QA/QC) PLAN

Prior to performing quality affecting work under this subcontract, SUBCONTRACTOR must develop a subcontract-specific Quality Management Plan IAW DOE Order 414.1E, Admin. Chg. 2, Quality Assurance and submit to CONTRACTOR for review and approval. The Quality Management Plan must include all applicable Quality Assurance (QA) and Quality Control (QC) requirements. The plan and any quality affecting revisions to the plan must be reviewed and approved by CONTRACTOR prior to SUBCONTRACTOR performing work under this subcontract.

The plan must describe the specific work control documents that will be used to control the work activities to be performed and must identify which activities will be controlled by which documents.

Samples of applicable forms (e.g., non-conformance report, inspection and test report, travelers, certifications, etc.) must be submitted as part of the Quality Management Plan. All work performed under this subcontract must be performed in accordance with the CONTRACTOR approved Quality Management Plan.

QD-02, SUBCONTRACTOR PERSONNEL QUALIFICATIONS / CERTIFICATIONS

SUBCONTRACTOR must provide with or prior to delivery of products/services records showing that personnel who have or will perform the specific tasks and/or types of work specified in the SOW have the necessary qualifications and/or certifications to perform the work as determined by SUBCONTRACTOR’s Quality Management Program or as specified in this subcontract. These may include by are not limited to non-destructive examination certifications, welder certifications, inspection personnel certifications, lead auditor qualifications/certifications, etc.

QD-03, ENGINEERING DRAWINGS, CALCULATIONS, AND ANALYSES

SUBCONTRACTOR must provide with or prior to delivery, engineering drawings, calculations, and/or analyses as specified in the SOW. Any drawings must detail the design of the items/systems and be traceable to any item(s) provided. For items, this requirement may be satisfied by inclusion of drawings, calculations, and/or analyses in a technical operations/maintenance manual. Drawings, calculations, and/or analyses may be for use in design activities only and/or for fabrication/construction to occur later. Drawings, calculations, and/or analyses must be submitted as required by the subcontract.

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QD-04, AS-BUILT DRAWINGS

SUBCONTRACTOR must provide with or prior to delivery, drawing(s) detailing the as-built condition of any items, assemblies, and/or components provided to CONTRACTOR under this subcontract. As-built drawings must be generated using the approved final drawing(s) for the subcontract, including any changes made during subcontract performance by adding as-built condition information to the drawing(s). As-built drawings must be authenticated by SUBCONTRACTOR personnel who are responsible for verifying the as-built conditions. The as-built condition includes identifying as applicable:

final dimensions, material identification, weld maps including filler material used, serial numbers, and test results.

QD-05, ITEM/COMPONENT TRACEABILITY DOCUMENTATION

SUBCONTRACTOR must submit with or prior to delivery authenticated documentation demonstrating the traceability of items, components, and/or materials used in products provided for this subcontract to the lot/batch/heat or other unique identifier for the item, component, and/or material. This traceability must establish the link between the unique item, component, and/or material used, its lot/batch/heat or other identifier, and its installation/incorporation and/or use as applicable in product(s) supplied under this subcontract. Lot/batch/heat or other identifiers used must be traceable to any supporting documentation of the item, component, and/or material such as test reports.

QD-06, MANUALS / INSTRUCTIONS

SUBCONTRACTOR must submit with or prior to delivery manuals, instructions, or other documents that identify the items and/or software specified in the SOW and include as applicable safety precautions, installation/test instructions, and operating and maintenance instructions. The manual/instructions must be provided in English, written in clear, concise language readily understandable by a technician, craftsman, or programmer, and must conform to applicable industry standards for the preparation of such documents.

QD-07, SERIALIZATION AND MARKING

SUBCONTRACTOR shall serialize parts, components, subassemblies, and assemblies as required by drawings, specifications, and this subcontract. The SUBCONTRACTOR’s serial number control system shall ensure that the same serial number is not used more than once, across their entire product line.

QD-08, SPARE AND REPLACEMENT PART IDENTIFICATION

SUBCONTRACTOR must provide with or prior to delivery, a list of recommended spare or replacement parts for the items and/or assemblies specified in the SOW, and the necessary information to be able to order those parts, such as part numbers, manufacturer identification numbers, or product lines.

QD-09, INSPECTION AND TEST REPORTS

SUBCONTRACTOR must provide with or prior to delivery, inspection and/or test reports for the items and attributes thereof described. Inspection and test reports must meet the content requirements specified for the inspection and/or test program QA clause and any other applicable requirements for the procurement. These inspection and/or test reports must demonstrate compliance to the specific subcontract requirements and acceptance criteria described. SUBCONTRACTOR must include, at a minimum, the following as part of the report:

a) Identification of individuals performing and witnessing inspections and/or test, as applicable

b) Date of the inspection and/or test

c) Identification of the location of the inspection and/or test

d) Identification of item(s) to be inspected and/or tested (e.g., nomenclature, lot number, and/or serial numbers);

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e) M&TE identification and calibration next due date (e.g. serial number(s)), if applicable

f) Identification of inspection and/or test conditions (e.g. time, environmental conditions, etc.), as applicable

g) Acceptance criteria

h) Results achieved

i) Identification of all nonconforming item(s) or services, as applicable.

j) Records of training and/or certification if unique to the inspection and/or test

QD-10, HOLD POINTS

Mandatory hold points (as defined in the SOW) are associated with this subcontract beyond which work may not proceed unless written authorization is received from CONTRACTOR in accordance with subcontract requirements. SUBCONTRACTOR must notify CONTRACTOR a minimum of seven (7) days for work performed off the SLAC site and a minimum of two (2) days for work performed on the SLAC site in advance of performing the following activities so that CONTRACTOR may witness the activities.

QD-11, AUDIT REPORT

SUBCONTRACTOR must provide to CONTRACTOR copies of the following:

a) Audit plan(s);

b) Audit Report(s); and

c) any additional records as specified in the subcontract.

QD-13, CERTIFICATE OF COMPLIANCE/CONFORMNACE DOCUMENT

SUBCONTRACTOR must provide with or prior to delivery, a certificate, regardless of document title/name, signed by an authorized representative of the item(s) manufacturer stating that the item(s) provided under this subcontract and specified in the SOW, have been manufactured in accordance with the applicable industry and/or commercial codes, standards, or other requirements specified in the SOW. The certificate must be traceable to the applicable item(s) provided such as through lot, purchase order, or another similar identifier. If applicable, the certificate must identify any approved changes, waivers, or deviations, and any specific procurement requirement that were not met.

QD-14, CERTIFICATE OF CALIBRATION

SUBCONTRACTOR must provide with or prior to delivery, for each instrument/system specified in the SOW, a certificate of calibration stating the calibration instrument/system has been calibrated, the calibration results, and, if required by procurement documentation, the SUBCONTRACTOR was ISO/IEC 17025 accredited through a Signatory to the ILAC Mutual Recognition Arrangement (e.g., A2LA, NVLAP, ANAB, PJLA, DAkks, etc.). The certification must contain, at a minimum, the following:

a) title;

b) the name and address of the laboratory;

c) the location of performance of the laboratory activities, including when performed at a customer facility or at sites away from the laboratory’s permanent facilities, or in associated temporary or mobile facilities;

d) unique identification that all its components are recognized as a portion of a complete report and a clear identification of the end;

e) the name and contact information of the customer;

f) identification of the method used;

g) a description, unambiguous identification, and, when necessary, the condition of the item;

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h) the date of receipt of the test or calibration item(s), and the date of sampling, where this is critical to the validity and application of the results;

i) the date(s) of performance of the laboratory activity;

j) the date of issue of the report;

k) reference to the sampling plan and sampling method used by the laboratory or other bodies where these are relevant to the validity or application of the results;

l) a statement to the effect that the results relate only to the items tested, calibrated, or sampled;

m) the results with, where appropriate, the units of measurement;

n) additions to, deviations, or exclusions from the method;

o) identification of the person(s) authorizing the report;

p) clear identification when results are from external providers;

q) the measurement uncertainty of the measurement result presented in the same unit as that of the measurand or in a term relative to the measurand (e.g., percent); NOTE According to ISO/IEC Guide 99, a measurement result is generally expressed as a single measured quantity value including unit of measurement and a measurement uncertainty;

r) the conditions (e.g., environmental) under which the calibrations were made that have an influence on the measurement results;

s) a statement identifying how the measurements are metrologically traceable;

t) the results before and after any adjustment or repair, if available;

u) where relevant, a statement of conformity with requirements or specifications;

v) where appropriate, opinions and interpretations.

QD-15, CERTIFICATE OF ANALYSIS

SUBCONTRACTOR must provide with or prior to delivery to CONTRACTOR, a Certificate of Analysis

(C of A) and any associated Safety Data Sheets (SDS) for the material(s). The C of A must include:

a) Name of chemical/product;

b) Purchase Order # and/or Lot # traceable to purchase document and/or chemical container;

c) Name and address of facility manufacturing/supplying product;

d) Quantity of certified material;

e) Analyzed concentration/purity;

f) Analytical accuracy;

g) Date of manufacture and/or date of shelf-life expiration (only applicable for items which are identified by the manufacturer as having an expiration date).

h) Signature and date of the certifying authority

QD-16, CERTIFIED MATERIAL TEST REPORTS

SUBCONTRACTOR must provide with or prior to delivery, Certified Material Test Reports (CMTRs) for the materials specified. CMTRs must report physical and/or chemical properties of the material(s) as described in the SOW and be in accordance with any referenced national or international material standards (e.g., ASTM, ANSI) for the material type. CMTRs must be the results of test performed by the material manufacturer or by a material verification process, if such a process is allowed by the standard governing the material type and must specify the test method and the source of the acceptance criteria. Each CMTR must be authenticated by an authorized representative of the testing entity, be traceable to the materials delivered via heat, lot, or other identification, and must meet any content requirements of the applicable national or international standards invoked for the material type.

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QD-17, CERTIFICATE OF CALIBRATION FOR SUBCONTRACTOR OWNED MEASURING AND

TEST EQUIPMENT (M&TE)

SUBCONTRACTOR must provide with or prior to delivery of items or services, records demonstrating the calibration status of any M&TE used to perform the inspections or tests specified in QD-02, Inspection and Test Reports. These records must be generated either by an ISO 17025 accredited calibration laboratory, or, when generated by a non-accredited entity (including when generated by SUBCONTRACTOR), must include, at a minimum, the following:

a) title;

b) the name and address/location of the calibrating activities;

c) traceability information to the equipment calibrated such as through a unique identification number or the name and contact information of the customer;

d) identification of the calibration procedure used;

e) a description, unambiguous identification, and, when necessary, the condition of the item;

f) the date(s) of performance of the calibration activity;

g) a statement to the effect that the results relate only to the items calibrated;

h) the calibration results with the units of measurement;

i) any additions to, deviations, or exclusions from the calibration procedure;

j) the measurement uncertainty of the measurement result presented in the same unit as that of the measurand or in a term relative to the measurand (e.g., percent). In the absence of measurement uncertainty, identification of the accuracy of the reference standards as a test accuracy ratio (TAR) of the accuracy of the equipment being calibrated. Where this TAR is less than 4:1, the technical justification of the basis for standard selection;

k) the conditions (e.g., environmental) under which the calibrations were made that have an influence on the measurement results;

l) identification of standards used traceable to the calibrated equipment and to one or more nationally recognized standards (e.g., NIST);

m) the results before and after any adjustment or repair;

n) where relevant, a statement of conformity with calibration requirements or specifications (pass/fail is acceptable).

QD-18, SHELF-LIFE CERTIFICATION / STORAGE REQUIREMENTS

The items described with limited shelf life, expirations dates, or similar must be delivered with accompanying documentation or labelling which defines the lifecycle for those items and their expiration date. The documentation must also specify storage requirements for the specific item(s) provided.

QD-19, CERTIFICATE OF PROOF LOAD TEST

The items or assemblies described must be accompanied by test reports and records of performance which demonstrate successful Proof Load Testing of the items delivered in accordance with the specified standards for the item type.

QD-20A, NONCONFORMANCE REPORTS

SUBCONTRACTOR must notify CONTRACTOR’s representative, as identified for this subcontract, in writing of each nonconformance to subcontract requirements identified for items and/or services affecting items to be provided under this subcontract. Excluded from reporting are nonconformances corrected prior to offering item(s) for CONTRACTOR acceptance by continuing or repeating the original manufacturing process, or by performing a SLAC approved rework process. Nonconformances that

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SUBCONTRACTOR must document and evaluate each reportable nonconformance and submit it to CONTRACTOR within four (4) business days of discovery. Documentation and evaluation of the nonconformance must include a written description of the nonconformance (with sketches and pictures highlighting the nonconforming condition if necessary to clearly describe the condition), and an assessment of the cause and the proposed disposition/corrective action including technical justification.

CONTRACTOR must approve the disposition of the nonconformance with corresponding disposition implementation.

Completed nonconformance documentation must be supplied by SUBCONTRACTOR to CONTRACTOR with or prior to delivery or acceptance of the items by CONTRACTOR and all records of nonconformance must be maintained by the SUBCONTRACTOR in accordance with subcontract requirements. SUBCONTRACTOR must not intentionally perform work that will result in a nonconforming condition without express written approval by CONTRACTOR.

SUBCONTRACTOR must flow this requirement down to any of their sub-tier suppliers who will provide quality affecting items for this subcontract.

These reports must include, at a minimum, the following:

a) Unique NCR Number.

b) Description of the nonconformance.

c) Containment actions…