J-8 - Section 014100 Cryo Quality Requirements_2-16-2024.pdf

QUALITY REQUIREMENTS CRYO Feb 2024– 014100-1

INTERNAL CRYOGENICS

SECTION 014100 QUALITY REQUIREMENTS

SECTION 014100 – QUALITY REQUIREMENTS CRYO

LBNF INTERNAL CRYOGENICS

PART 1 GENERAL

1.1 PURPOSE

The Subcontractor is responsible for all activities necessary to manage, control, and document work so as to ensure compliance with the Subcontract documents. The Subcontractor’s responsibility includes ensuring adequate Quality Assurance/Control services are provided for work accomplished on- and off-site by its organization, suppliers, sub-tier subcontractors, technical laboratories, and consultants.

B. The work activities include safety, submittal management, testing, and inspection, and all other functions relating to the requirement for quality manufacturing. The Subcontractor shall implement a Quality Assurance program and designate a quality responsible person(s) to achieve these goals.

C. The Subcontractor will be required to submit its Company Quality Assurance Program with its proposal. Revisions issued during the period of performance shall be provided to FRA within 10 business days of issue. The Subcontractor’s quality program shall meet an applicable internationally recognized standard such as ISO 9001, ASME, etc. The Subcontractor’s welding program shall meet applicable nationally recognized standards such as ASME, AWS, etc. utilizing qualified welders, Weld Procedure Specifications and Weld Qualification Records.

1.2 REFERENCES

The publications listed below form a part of this Subcontract to the extent referenced.

010010 Subcontract General Requirements

Internal Cryogenics Statement of Work and Performance Specification

1.3 THE QUALITY ASSURANCE PROGRAM

The Subcontractor’s QA Program shall include, as a minimum, the following information to cover all the work scope, including work by sub-tier subcontractors, fabricators, suppliers, and purchasing agents:

a QA/QC Organization: The name, qualifications, duties, responsibilities, and authorities of each person assigned a Quality function, including the identity of the Project Quality Assurance Manager, In-Process Inspection and Testing, completion inspections, and the QC certifications and documentation necessary to verify that all subcontracted work complies with the requirements of the Subcontract, including materials, equipment, workmanship, and manufacturing.

Subcontractor shall maintain an adequate inspection system and perform such inspections as will ensure that the work called for by the contract conforms to contract requirements. The

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Subcontractor shall maintain complete inspection records and make them available to the LBNF Project for review.

1.4 REQUIREMENTS

Quality Assurance Plan:

The Subcontractor is required to submit to the LBNF Procurement Representative a tailored Quality Assurance (QA) Plan document that meets the specific project quality control requirements. This plan shall detail the procedures, instructions, and reports the Subcontractor will use during the project. The QA Plan shall contain the following elements, as applicable:

Table of Contents

QA Organization Chart

Personnel Training and Qualifications

Duties and Responsibilities

Procurement Quality Assurance

Design Process

Work Process

Submittal Procedures

Inspection and Acceptance Testing

Control of Nonconforming Material and Equipment

Quality Improvement

Documents and Records

Independent Assessment

Completion Inspection Procedures

Suspect and Counterfeit Items

The LBNF Project must approve the QA Plan before the Subcontractor starts work. The plan outlines and describes the process that the Subcontractor will use and the roles personnel will take on to satisfy the requirements of the QA Program.

In general, work will not be allowed prior to the approval of the QA Plan. Any exceptions must be authorized in writing by the LBNF QA Manager.

Recognizing that it is not always practical to delay the start of work until a complete QA Plan is submitted and approved, exceptions may be made for mobilization work. The only other possible exception is work approved under an “Approved As Noted” submittal of the QA Plan, which may be appropriate under any of the following two (2) circumstances.

First 90 Days: In the case that the QA Plan is a preliminary submittal

QUALITY REQUIREMENTS CRYO Feb 2024– 014100-3 to cover the first ninety (90) days of work, the LBNF QA Manager may approve this QA Plan as “Approved as Noted” to allow the Subcontractor to start these and only these initial activities. Upon completion of the authorized work, unless an acceptable follow-up QA plan has been submitted and approved, the Cryogenics Infrastructure Project Manager must stop the work.

Minor Changes: It is permissible to approve the QA Plan with minor changes or additions. The Cryogenics Infrastructure Project Manager may use an “Approved as Noted” approval to grant permission to start work if the Subcontractor agrees in writing to correct the plan by a specified date. The Cryogenics Infrastructure Project Manager must not allow the Subcontractor to continue work beyond the specified date if a corrected plan has not been approved.

4. If Subcontractor elects to make any changes to its QA Plan, including any personnel changes, the Subcontractor shall submit the revised QA Plan to LBNF for approval. The LBNF Project reserves the right to make changes to the QA Plan, including interviewing QA/QC Personnel to verify submitted qualifications and if necessary, to have personnel replaced.

Quality Assurance Organization

The personnel involved in Quality Assurance range from the laborers and mechanics performing the work, through the on-site supervision and up to the management of the Subcontractor’s firms. Examples of roles with specific Quality Assurance responsibilities would be:

Quality Assurance (QA) Manager

Submittal Reviewer(s)

QC Specialist(s)

Manufacturer or Factory Representative

Collectively, these individuals are responsible for carrying out the requirements of the QA System. As needed, some or all the positions and their qualifications, duties and responsibilities will be included in the Subcontract requirements. The positions needed would depend on the work scope.

The QA Manager implements and manages the QA System and is directly responsible to Subcontractor’s project management.

Responsibilities of the QA Manager include:

Interface with LBNF/DUNE Quality Assurance Manager on all quality matters;

Manage, coordinate, and document work by designated Testing Laboratory personnel and any other inspection and testing personnel required by the Subcontract;

Coordinate changes or substitution requests made by the Subcontractor to the LBNF Project Manager;

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Inspect all work for compliance and maintain a Rework Items List on all nonconforming work;

Coordinate all testing required in such a way as to maintain the schedule;

Maintain all quality related records;

Provide required QC certifications and documentation;

Ensure that As-Built Drawings and As-Built Record of Materials are kept current and onsite;

Participate in non-conformance resolution and final inspections.

The QA Manager has specific responsibilities regarding submittals (this includes submittals from Subcontractor, the sub-subcontractors, vendors, etc.):

Coordinate all submittal actions in a timely manner so as to avoid project delays;

Maintain necessary submittal records in an organized fashion;

Review and certify all submittals for compliance;

Approve all submittals except those designated to be approved by the LBNF Project;

Check all material and equipment prior to delivery to the project for compliance with the Subcontract.

Manufacturing quality equipment requires proper planning of the work to prevent deficiencies with costly rework and replacement. The QA Manager should focus on the planning of the work to minimize or prevent rework. The QA Manager is required to obtain assistance from the QC staff or an outside consultant for any discipline(s) where he or she lacks proficiency. The QA Manager must have the authority to correct any deficiency even though it might result in stopping work on a segment of the project.

The QA Manager is always responsible for observing the work and monitoring safe work practices during the normal course of his or her jobsite duties, but as a rule is not assigned as the safety competent person.

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A Subcontractor may be required to designate a QC specialist at the work site for each of the specific areas of responsibility that include particularly complex or demanding work. These specialists shall assist and report to the QA Manager. QC specialists may perform production-related duties as long as they are allowed sufficient time to perform their assigned QC duties; or they may be assigned only quality control duties. QC specialists are required to:

Attend QC meetings;

Prepare specific sections of the Subcontractor’s QC reports specifically covering the work in their area of responsibility performed by the sub-subcontractor/vendors.

3 Depending on the technical specifications, a contract may require the presence of technical representative(s) from a manufacturer or factory to be on-site during certain periods of the work to ensure compliance with installation recommendations, etc. The representative(s) shall be considered an extension of the QA Program during their presence on-site.

Required Meetings

The Project Kickoff Meeting is an important meeting required on all major subcontracts for discussion of the administrative procedures for the Subcontract. During the Kickoff Meeting, which takes place before starting work, ground rules are established and understandings reached that will establish positive relationships at the start of the Subcontract.

This will be done before the start of Phase 2 engineering, and manufacturing.

This is also an opportunity to emphasize the importance of the QA organization to the Subcontractor. Discussion of the QA System requirements and their due dates should be included. An extensive discussion of the Quality Program, however, is best reserved for the QA Plan meeting. Where practical, the Project Kickoff Meeting and QA Plan Meeting (if required) may be scheduled for the same day, provided the two agendas are properly separated.

The first meeting specifically relating to Quality Program is the QA Plan Meeting. This meeting is an excellent communication forum to ensure the QA Plan and Program are quickly and efficiently instituted. The purpose for meeting is to develop a mutual understanding of the QA Plan requirements. All QA/QC requirements from the contract and the specifications should be discussed.

3. QA Meetings shall be held on a regular basis, e.g., weekly. The QA Manager develops the agenda, conducts the meeting, and prepares the minutes. All problems or questions should be directed to him or her.

These meetings should be used to reinforce the philosophy of the Quality Program. Submittal status should be the lead off agenda item of each QA Meeting.

Sub-Subcontractor QA/QC personnel should attend the meetings to discuss approaches to upcoming phases of work and correction of any deficiencies. Agendas for these meetings include items such as:

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Status of submittals;

Review of test reports for deficiencies and results;

Review of Schedules to see which tests or inspections are scheduled for upcoming work; and

Review of outstanding problems from previous meeting.

The QA Manager shall be required to address how the Subcontractor intend to correct any problems. As part of the project documentation, the QA Manager must keep minutes of the meeting and distribute them to attendees. These minutes become part of the official contract file.

D. Design Process

Design shall be verified and validated to an extent commensurate with its importance to safety, complexity of design, degree of standardization, state of the art, and similarity to proven design approaches. Acceptable verification methods include but are not limited to any one or combination of (1) design reviews, (2) alternative calculations, and (3) prototype, qualification testing and/or comparison of the new design with a similar proven design if available. Verification work shall be completed before approval and implementation of the design.

Wherever the design method involves the use of computer software to make engineering calculations or static dynamic models of the structure, system, or component's functionality, the software must have been demonstrated to produce valid results. The demonstration needs to be documented in a formal Report of Validation that is maintained in records that are accessible for inspection. However, exemptions may be made for commercially available software that is widely used and for codes with an extensive history of refinement and use by multiple institutions. Exemptions affecting systems or components shall be identified to the LBNF/DUNE Systems Engineering team.

Critical software and firmware computer codes shall also be subjected to reviews for verification and validation. Some items to be considered during computer code review are as follows:

Adequacy of code testing scheme Code release control and configuration management Output data verification against code configuration Verification that code meets applicable standards Verification of code compatibility to other systems that use the data Verification that code meets applicable hardware requirements Adequacy of code maintenance plans Adequacy of code and data backup systems

E. Testing

Tests shall be identified as individual activities in the specifications during the design.

The LBNF Cryogenic Team shall identify critical tests (e.g. x-rays, pressure test, cold test) that must be included as schedule activities. Subcontractor are required to perform

QUALITY REQUIREMENTS CRYO Feb-2024 – 014100-7 any sampling and testing required under the Subcontract.

When reporting on test results, the Subcontractor must cite applicable Subcontract requirements, tests and the analytical procedures used. Actual results must be provided and include a statement that the item tested or analyzed conforms or fails to conform to specified requirement(s). Subcontractor must notify the LBNF Project immediately if the item fails to conform. An authorized Subcontractor representative shall certify test results by signing the test report. Subcontractor must furnish the reports, certifications, and other documentation to the QA Manager. A summary report of field tests is required at the end of each month.

The QA Manager is required to furnish the signed reports, certifications, and a summary report of field tests at the end of each month to the LBNF Project and attach a copy of the summary report to the last Daily Report of each month.

F. Quality Control Completion Inspections

1. The LBNF Project will perform interim inspections as part of its source surveillance efforts. As applicable, a list of non-conformances may be developed as a result of this inspection. Each deficiency noted as non-conformances shall reference the applicable specification paragraph, Drawing No., etc., from which the deficiency stems. Any items noted on the inspection shall be corrected in timely manner and shall be accomplished within the time slated for completion of the entire work, or any increment thereof if the project is divided into increments by separate completion dates. The QA Manager shall ensure that all items on this list are corrected prior to notifying the LBNF Project that a "Final" inspection can be scheduled.

2. A Final inspection will be formally scheduled. The QA Manager, the QC Specialists, the Superintendent or other primary Subcontractor management personnel, and LBNF Project representatives, and possible other LBNF Project personnel, will attend this inspection.

At least 5 days prior to the final inspection, notice shall be given to LBNF Procurement stating that all items previously identified to the Subcontractor as being unacceptable, along with all the remaining work performed under the contract, will be complete and acceptable by the date of the final acceptance inspection.

3. Details of testing and inspection can be found in the Scope of Work and Performance Specification and 010010 General Requirements.

G. Subcontractor Documentation

The Subcontractor’s reports in conjunction with the LBNF Project’s reports provide the written record of job progress, control inspections, and tests. It is therefore critical that the Subcontractor’s reports be correct and timely. These reports constitute the official record of work performance and compliance with drawings and specifications. The QA Representative must obtain and review the Subcontractor’s reports daily for accuracy and completeness. Any area(s) of disagreement must be resolved at the field level that day if possible. The LBNF Cryogenics Infrastructure Project Manager should review these reports and ensure the QA/QC process is working.

The documentation that is generated by the QA System must be maintained in the document management system.

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1. Subcontractors are required to develop and provide daily Subcontractor Production and Quality Control Reports to the LBNF Project. These reports are the daily record of operations on the job site. This series of reports is intended to fully document the work, any test results, dimensional checks, equipment, and material checks. Depending on the complexity of the work being performed and the duties of the QA Manager, the Subcontractor may combine these reports into one daily report. The QC portion of the report will include the reports from each sub-subcontractor working on the site. Entries on the report(s) must be tied to the schedule activities.

These reports are to be delivered to the Quality Assurance Representative no later than 10:00 a.m. local time the following workday. It is important that the reports be current, factual and complete as they provide a complete record of the contract.

The LBNF QA Representative and the LBNF Cryogenics Infrastructure Project Manager shall obtain and review the Subcontractor’s reports for accuracy and completeness, and to ensure the QA/QC process is working.

The submittal status log shows the status of all shop drawings, certifications, and other submittals. For each submittal, the log shall show the contract and/or specification paragraphs requiring the submittal, a description of the submittal, whether it is Subcontractor-approved or LBNF-approved, and actual submission and approval dates on all actions. This allows the QA Manager to track the status as well as pending or planned actions required by the Subcontractor or the LBNF Project.

Subcontractor are required to prepare and maintain a Testing Plan and Log to document the specification requirements, test plan, test location, tester, and frequency of all required tests. With this information, the QA Manager and the QA Representative can monitor the plans and status of all required testing.

The QA Manager shall establish a list of items requiring rework, and an agenda item for the QC meetings to review the progress of corrective actions on these items. The list shall indicate the date identified, describe each deficiency, contract requirement, action taken, and resolution, and indicate the date corrected. Deficiencies corrected on the same day they are discovered are exempt from the rework list. The QA Manager should not allow the adding to, building upon or enclosing of, nonconforming work.

H. Non-Compliance

The QA organization shall identify, document, and correct the non-compliance. The Subcontractor shall maintain a procedure for controlling, tracking, and reporting deficiencies, nonconforming items from identification through acceptable corrective action. The procedure shall establish measures to identify, segregate (when possible), and remove from work operation the nonconforming items to prevent inadvertent use/incorporation into the subcontract, identify root cause and provide documented verification that the identified deficiencies have been corrected and approved by LBNF Cryogenics Infrastructure Project Manager if required (for dispositions of Use As Is or Repair). . A technical justification is required for the Use AS Is and Repair dispositions.

These dispositions mean the item can be used even though not in compliance with the specification, but its form fit, or function has not been affected

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I. Control of Suspect and Counterfeit Items (S/CIs)

The QAP must:

a. Include a S/CI oversight and prevention process commensurate with the facility/activity hazards and mission impact.

b. Identify the position responsible for S/CI activities and for serving as a point of contact with the Office of Health, Safety, and Security.

c. Provide for training and informing managers, supervisors, and workers on S/CI processes and controls (including prevention, detection, and disposition of S/CIs).

d. Prevent introduction of S/CIs into DOE work by—

(1) engineering involvement:

(a) in the development of procurement specifications;

(b) during inspection and testing; and

(c) when maintaining, replacing, or modifying equipment;

(2) identifying and placing technical and QA requirements in procurement specifications;

(3) accepting only those items that comply with procurement specifications, consensus standards, and commonly accepted industry practices; and

(4) inspecting inventory and storage areas to identify, control, and disposition for S/CIs.

e. Include processes for inspection, identification, evaluation, and disposition of S/CIs that have been installed in safety applications1 and other applications that create potential hazards. Also address the use of supporting engineering evaluations for acceptance of installed S/CI as well as marking to prevent future reuse.

f. Conduct engineering evaluations to be used in the disposition of identified S/CIs installed in safety applications/systems or in applications that create potential hazards. Evaluations must consider potential risks to the environment, the public and workers along with a cost/benefit impact, and a schedule for replacement (if required).

g. Perform the evaluation to determine whether S/CIs installed in non-safety applications pose potential safety hazards or may remain in place. Disposition S/CIs identified during routine maintenance and/or inspections to prevent future use in these applications.

END OF SECTION