PUB 3111 QAPD.pdf

QUALITY ASSURANCE PROGRAM

DESCRIPTION (QAPD)

LBNL/PUB-3111, Rev. 13

EFFECTIVE DATE: September 9, 2026

Ernest Orlando Lawrence Berkeley National Laboratory

This work is supported by the U.S. Department of Energy under Contract No. DE-AC02-05CH11231.

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LBNL/PUB-3111, Quality Assurance Program Description, Revision 13

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1.0 OVERVIEW 6 2.0 PROGRAM AND ORGANIZATION 7 2.1 ORGANIZATION 8 2.2 GRADED APPROACH 9

3.0 TRAINING AND QUALIFICATION 9 4.0 QUALITY IMPROVEMENT 10 4.1 ISSUES MANAGEMENT 11 4.2

LESSONS LEARNED & BEST PRACTICES 11 4.3 PERFORMANCE MEASUREMENT, MONITORING AND

ANALYSIS 11 4.4 MANAGEMENT REPORTING 11 5.0 DOCUMENT AND RECORDS MANAGEMENT AND

CONTROL 12 5.1 DOCUMENT CONTROL 12 5.2 RECORDS MANAGEMENT 12 6.0 WORK PROCESSES

12 6.1 CONSENSUS STANDARDS 13 6.2 ITEM IDENTIFICATION AND CONTROL 13 6.3 MEASUREMENT

AND TEST EQUIPMENT (M&TE) 13 6.4 CALIBRATION 14 7.0 DESIGN 14 8.0 PROCUREMENT 15 8.1

ACCEPTANCE OF PROCURED ITEMS OR SERVICES 16 8.2 CONTROL OF SUPPLIER NONCONFORMANCES

16 8.3 COMMERCIAL GRADE ITEMS 17

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9.0 INSPECTION & TESTING 17 9.1 INSPECTION 17 9.2 TESTING 17

9.3 NONCONFORMING AND SUSPECT/COUNTERFEIT ITEMS 18 10.0 ASSESSMENT 19 11.0 SAFETY

SOFTWARE QUALITY ASSURANCE 20 ATTACHMENT A – DEFINITIONS 21 ATTACHMENT B - RISK

DETERMINATION: GRADED APPROACH TO THE APPLICATION OF CONTROLS25

ATTACHMENT C - QUALITY CLAUSES 27

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Record of Revision Rev. No. Date Description

3 DRAFT

(11/11/92)

Rewrite of the LBL Institutional Quality Assurance Program Plan, Rev. 2, dated December 21, 1988, to incorporate requirements of DOE Order 5700.6C.

3 2/3/93 Comments incorporated. Issued to Laboratory for use.

4 6/15/94 Updated in the following areas:

-suspect/counterfeit parts program -maintenance management -DOE Order 5480.25, Accelerator Safety -total quality management -general editorial

5 1/15/96 Rewrite of OAP, Rev. 4

6 1/15/98 Revise to integrate with ISMS

7 4/18/00 Updated in the following areas:

- 10 CFR 830.120 and 414.1, Quality Assurance

- conduct of operations

- maintenance management

8 12/06 Rewrite of the LBNL Operating and Quality Management Plan, dated April 18, 2000, to incorporate requirements of DOE Order 414.1C and ISO 9001-2000. Also updated to reflect current LBNL organizations and operations.

Appendix D demonstrates how QAPD addresses DOE O 414.1C requirements.

9 06/08 Clarified section 2.7, Document Control policy.

10 10/08 Clarified and expanded upon section 2.6.5, Software Quality Assurance

11 12/31/13 Changed the title of this document from “Operating and Quality Management Plan” to “Quality Assurance Program Description” (QAPD); rewrote to describe how the Lab implements QA requirements; moved policy to the RPM and removed procedural steps; aligned QAPD with the Contractor Assurance and Integrated Safety Management systems; better aligned QAPD elements with DOE O 414.1D and ANSI/ISO/ASQ Q9001-2008;

added definitions and quality clauses; and revised the Graded Approach Risk Methodology.

12 9/30/20 Updated to align with other institutional assurance documents, address improvements with supplier evaluation and selection for Capital Projects.

13 9/8/26 Minor Change: Updated reference from DOE O 414.1D to .1F in support of Directive Modernization Phase 1 implementation, Institutional Contractor Assurance Office (ICAO) and other document references to reflect current and correct information

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1.0 Overview

The Lawrence Berkeley National Laboratory (LBNL; hereinafter called the Lab or LBNL) Quality Management System (QMS) complements, and is integrated with, the Integrated Safety Management System (ISMS) and the Contractor Assurance System (CAS). The QMS is a system of policies, programs, processes and tools designed to provide assurance that the Laboratory’s mission objectives are achieved; its workers, the public, and the environment are protected; its operational, facility and business systems are effectively managed; and the requirements of the UC / DOE contract are met. The QMS incorporates, where applicable, the Quality Assurance (QA) principles from ANSI/ISO/ASQ 9001:2008, Quality Management Systems – Requirements.

The Quality Assurance Program (QAP), which is an output of the QMS, provides the framework, such as management systems, processes and tools to ensure that reliability, repeatability and sustainability are achieved in work planning, implementation and execution across all Lab functions, in conjunction with the ISMS and CAS objectives, and to ensure work in all functions are continuously improved upon.

The QAP is provides the framework to line management and staff in:

a) Identifying and documenting key processes for all Lab functions;

b) Ensuring the availability of resources and information necessary to support the operation and monitoring of these processes;

c) Planning, documenting and controlling work;

d) Executing work in accordance with controls;

e) Monitoring, measuring and analyzing performance of these processes;

f) Identifying risks and issues, and mitigating/correcting them;

g) Identifying and sharing lessons learned and best practices, and incorporating them into existing management system, programs and processes; and

h) Minimizing or eliminating rework such as poor planning, scoping of work, excessive change orders, inadequate controls, noncompliances, nonconforming material or services, adverse events and incidents, injuries, stop/pause work issuance, etc.

In addition to the QA Policy, documented in the Requirements and Policies Manual (RPM), the LBNL Quality Assurance Program Description (QAPD) describes how the Lab manages and implements quality at the Lab.

The QMS and QAP are applicable to all Lab management, staff, guests, and visitors who work at or for the Lab, and it is expected that the appropriate business, technical, quality, and safety requirements are flowed down to, and implemented by, subtier subcontractors and suppliers.

The level of rigor in applying the QAPD principles, requirements, and practices is based on a graded approach, which is detailed in Attachment B, Graded Approach Risk Determination. Attachment B contains a methodology that should be used to determine the applicable level of control and rigor with which the control and rigor is applied to a system, program, project, and/or work activity, including but not limited to, requirements management, risk management, planning, design (i.e., system, work process, hardware, software), work process development, procurement, development, fabrication, construction, material handling and control, calibration of measurement and test (M&TE) equipment, inspection, testing, maintenance, assessment, performance monitoring, analysis and metrics, issues management, and lessons learned and best practices.

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Line management may require additional program-, project-, activity- or facility-specific policies, plans, program manuals or descriptions, procedures and/or work instructions to ensure that Institutional expectations and requirements are adhered to. Where applicable, national or international consensus standards should be incorporated into implementing documents to ensure that up-to-date and current work practices are incorporated into management systems, processes, projects and activities.

Source Documents

● 10 CFR 830, Nuclear Safety Requirements, Subpart A, Quality Assurance Requirements

● Contract 31, Clause H30 , Contractor Assurance System

● DOE O 414.1F, Quality Assurance

● DOE O 413.3B, Program and Project Management for the Acquisition of Capital Assets

● ANSI/ISO/ASQ 9001:2008, Quality Management Systems – Requirements

Referenced Documents

● DOE O 413.3B, Program and Project Management for the Acquisition of Capital Assets

● DOE O 221.1A, Reporting Fraud, Waste, and Abuse to the Inspector General ● DOE O

232.1, Occurrence Reporting

● Requirements and Policies Manual (RPM)

● Policy 04.03.0001.000, Quality Assurance

● LBNL/PUB-3140, Integrated Environment, Safety & Health Management Plan

● LBNL/PUB-5519, Issues Management Program Manual

● Engineering Process Guide

● PIMD-PROC-001, LBNL Projects & Infrastructure Modernization Division Procedures Manual

● Process 04.02.002.001, Institutional Assessment Process Description

● Procedure 10.01.003.03, Safety Software Quality Assurance Requirements

● Procedure 10.06.001.101, Developing, Reviewing and Approving Non-Policy Institutional Documents

● Procedure 10.06.001.102, Developing, Reviewing and Approving Institutional Policies ● Procedure

04.03.001.002, Safety System Software Quality Assurance

● Procedure 04.03.007.001, Institutional QA Specification for Construction, Decommissioning, Demolition and Fabrication Projects.

● Procedure 04.03.007.006, Subcontractor QA Requirements for Design-Build Projects ●

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2.0 Program and Organization

2.1 Organization

The Laboratory is organized hierarchically by divisions, departments, groups, and offices. A description of the organization is maintained for each of these levels. This information is the basis for identifying the functional responsibilities, levels of authority, and interfaces both within and among organizations. Organizational information is communicated to all affected Laboratory personnel, guests, subcontractors and suppliers. The description of the organization includes the following information:

● The organization name;

● The core function(s) or mission of the organization; and

● The roles, responsibilities, authorities and accountabilities (R2A2s) of managers and staff.

The Lab’s organization chart is found at the LBNL internet website https://www.lbl.gov/laboratory-organization-chart/. Each division is responsible for maintaining the currency of its organization chart in both printed and electronic versions.

2.1.1 Senior Management

The Berkeley Laboratory Director is an officer of the University of California (UC) with overall responsibility for the strategic direction and day-to-day management of the Lab.

The Director’s leadership team sets the strategic direction, deploys resources, develops management systems, and implements process controls to address and mitigate risk. The Laboratory Director’s leadership team has the responsibility for stewardship, mission accomplishment, management systems’ development and execution, and operational excellence.

2.1.2 Institutional Contractor Assurance Office (ICAO)

Reporting to the Laboratory Director, and indirectly to the UC Vice President of National Laboratories (VPNL) and Deputy Director for Operations, the Institutional Contractor Assurance Office (ICAO) is an internal independent assurance organization that provides oversight of Berkeley Lab’s CAS. ICAO provides support, expertise and oversight of the Lab’s QAP. This oversight ensures that Berkeley Lab achieves compliance, effective and efficient operational support for science, best management practices, and continuous improvement. ICAO provides assistance and expertise in UC/DOE Prime Contract administration and manages Requirements Management, Risk Management, Quality Assurance, Price Anderson Amendment Act (PAAA) Enforcement, Assessment, Issues Management and Employee Concerns Programs.

ICAO is authorized to have unrestricted access to personnel, records, and other information sources necessary to carry out its duties. ICAO staff possess the requisite experience, training, and skills to manage the QAP, as documented in staff position descriptions.

The ICAO Manager is the senior LBNL leader who has the responsibility and authority to develop, implement, assess, improve and oversee the QMS.

The ICAO QAP Manager maintains, implements and provides oversight of the QAP;

provides technical guidance to the Lab community on the QAP; and ensures that the

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QAPD is in conformance with the requirements of 10 CFR 830, DOE O 414.1F and the applicable elements of ANSI/ISO/ASQ9001-2015 which form the basis of the LBNL QA Program.

The ICAO has the day-to-day operational responsibility and authority to ensure that compliance in support of scientific excellence, best practices, and continuous improvement are achieved at LBNL. Additionally, ICAO is responsible for establishing and maintaining the system, processes and tools for managing the Lab’s contractually-based requirements, which includes:

1. Providing a structure for oversight and assurance activities; and

2. Designing, developing, implementing, maintaining and overseeing the Institutional quality assurance program which includes:

a. Graded Approach: A risk-based approach that drives the appropriate level of control and rigor for all systems, programs, projects, activities, items and services at the lab.

b. Work Processes: Identification of key processes; and design, documentation and implementation of engineered and administrative controls to ensure that work performed is repeatable, reliable and sustainable.

c. Continuous improvement: Assessment (i.e., audits, reviews, peer reviews, management review, surveillances, inspection, etc.) of work performance and controls; measures and metrics to monitor performance and controls;

management of issues and nonconforming items and equipment; stakeholder reporting; and an Operating Experience Program for communication of lessons learned and best practices within the Laboratory and the DOE complex.

2.1.3 Line Management

Line management and staff conduct the daily work, processes and activities of the Laboratory using management systems and process controls to achieve the objectives set by the Laboratory leadership. Line managers and staff regularly evaluate performance and assess risks with tools developed by Laboratory leadership, ICAO and line management and organizations. Line management has overall responsibility for successfully accomplishing activities subject to this QAPD. Management provides the necessary planning, organization, direction, control, resources and support to achieve their defined objectives. Additionally, management is responsible and accountable for establishing and implementing policies, plans and procedures that control the quality of work, consistent with the provisions of this QAPD.

2.1.4 Employees

Employees are responsible for adhering to the QA policies, QAPD, and implementing documents as well as the quality of their work and promptly reporting all risks and issues to the responsible management for evaluation and action.

2.2 Graded Approach

LBNL uses a graded approach to determine the level of controls and the rigor with which controls are applied to management systems, programs, projects, activities, systems, structures, LBNL/PUB-3111, Quality Assurance Program Description, Revision 13 Effective Date: 9/10/26 Page 10 of 37 components, items, and services to ensure that work is managed commensurate with the risks involved.

The extent of controls applied vary based on the degree of confidence needed to achieve the desired quality of the system, program, project, activity, item or service, and is balanced with the flexibility to design and implement controls using a tailored approach. Organizations develop and implement a method to determine the effectiveness of their controls and rigor of application.

Attachment B is used by the line organizations to determine the actual and potential risk of an item, service or activity, which drives the level of controls and the rigor with which quality requirements are applied.

3.0 Training and Qualification

LBNL ensures that personnel selected to perform work have the education, skills, experience and training commensurate with the work to be performed.

To ensure consistent hiring practices, the Human Resources (HR) Department provides the institutional policies and procedures for personnel qualification, selection, and training. Additionally line management ensures that personnel receive indoctrination, training and qualification, including hands-on and on-the-job training (OJT), as needed, to achieve and maintain proficiency and competency; and adapt to changes in technology, methods, job responsibilities and implementing procedures necessary to perform work. The Lab’s training and qualification program includes:

● Position requirements, which are established at the time of recruitment and selection. Each job position is analyzed to determine the task responsibilities of the position. The position requirements define the minimum education, experience, and skills necessary to fill the position. Requirements for certification and licenses are also identified at this time, and candidates’ qualifications are verified during the hiring process.

● Training needs for each position, which are determined and documented based on the scope, risk and complexity of the job as well as regulatory, Institutional and organizational requirements. ● Job orientation, required reading, and OJT, which is completed as early as possible after the job assignment. Some training is required prior to the actual performance of work. OJT is administratively controlled to ensure that such training is not allowed to adversely affect work quality. ● Guest/visitor or affiliate training or orientation, which may be required based on the scope, length of time, risk and complexity of the job assignment. Training for affiliates, guests and visitors is documented.

● Periodic/refresher training, which is provided to ensure continued job proficiency and to improve overall performance and safety.

● Performance evaluations, which are conducted at least annually for every position to ensure that job proficiency and competency is being maintained and improved. This process is described in the performance management guidance issued annually by Human Resources.

● Professional development plans, which are developed to encourage staff to improve their knowledge, abilities, and skills. This process is described in the performance management guidance issued annually by Human Resources.

4.0 Quality Improvement

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The Lab implements assurance activities to identify and monitor risks and issues, the effectiveness of management systems and process controls, and work execution and performance. These activities promote improvement through mitigation, corrective action development and implementation, and communication and application of operating experiences within the Lab and across the DOE complex.

The output of these activities provides Lab leadership with regular data and information on performance trends, issues, and significant or emerging risks.

Continuous improvement is an ongoing process that uses feedback to manage risks; improve processes, products, and services; and prevent or minimize quality-related problems (i.e. deficiency or nonconformance of a management system, program, project, activity, item and services with internal or external requirements). Improvement involves:

• Engaging management in prioritizing risk management and improvement opportunities; • Learning from operating experiences and the experiences of others, and developing and disseminating the associated lessons learned and best practices within specific Laboratory organizations, Lab-wide, and/or to the DOE complex; and

• Incorporating those lessons and best practices into management systems, programs, projects and other activities.

Managers at all levels have the responsibility to correct deficiencies and improve, whenever possible, the management, systems, processes, projects, activities, products and services under their supervision.

4.1 Issues Management

Through the Issues Management Program, the Lab promptly identifies and manages issues to:

● Determine risk and significance,

● Identify and analyze causes, and

● Develop and effectively implement corrective actions to ensure successful resolution and prevent the same or similar problems from occurring.

Issues are addressed on a risk-based graded approach. Depending on significance, issues may merit corrective action plan development, causal analysis, extent-of-condition review, and verification and validation of corrective actions. Issues are managed and tracked through resolution in accordance with LBNL/PUB-5519.

4.2 Lessons Learned & Best Practices

The LBNL Operating Experience Program is designed to ensure ongoing performance improvement, prevent the recurrence of significant adverse events/trends, and communicate implementation strategies that will help LBNL successfully meet the missions and goals set forth by DOE. LBNL reviews lessons learned and best practices from external sources (e.g., DOE corporate Lessons Learned, industry notifications, etc.) for applicability to the Lab. LBNL/PUB 5519 outlines the requirements for sharing internal and external operational experiences within specific Laboratory organizations, Laboratory-wide, or with other facilities across the DOE complex.

4.3 Performance Measurement, Monitoring and Analysis

Performance Measurement is used by Lab management to:

● Demonstrate and validate that work is executed and/or systems, structures and components are operating as intended in accordance with goals and objectives;

● Identify adverse trends, risks and issues, and appropriately characterize and mitigate/correct them; and LBNL/PUB-3111, Quality Assurance Program Description, Revision 13

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● Make data-driven decisions that result in performance improvement.

Performance measurement mechanisms used include, but are not limited to, the Institutional Management Assurance Plan and division-level key performance indicators, metrics, QuadCharts, risk registries.

4.4 Management Reporting

The Lab uses several formal reporting mechanisms to communicate performance and associated trends, risks and issues to DOE, UC and Lab management. Lab Management uses this information and, as appropriate, feedback from DOE and UC, to prioritize strategic objectives, risk mitigation and corrective action. Reporting mechanisms includes, but is not limited to: Performance Evaluation and Measurement Plan (PEMP), FMFIA declaration, Occurrence and Reporting Processing System (ORPS) database, Noncompliance Tracking System (NTS) database, Corrective Action Tracking System (CATS) database, risk registries, quad charts, metrics, and performance analysis reports.

At the Institutional level, the Lab has developed and implemented a Management Assurance process to improve assurance at various levels within the Laboratory as well as increase line management accountability at all levels in the Laboratory. The process includes a high level Institutional risk register with line management accountability and assignments, quad charts and metrics, and evaluation of performance trends to ensure that risks are addressed and mitigated to improve operational performance. The Chief Operating Officer (COO) receives quarterly performance updates from line management and holds periodic performance discussions with the Associate Laboratory Directors, Operations Division Directors and the A&I Manager to discuss significant risks and overall performance.

5.0 Document and Records Management and Control

5.1 Document Control

Document control ensures that documents are prepared, reviewed, approved, issued, used, revised and retired to prescribe processes, specify requirements, establish design, or provide results of scientific or technical research and associated activities. Document control also ensures that the most current version of a document is available for those who perform work. Responsible divisions are responsible for ensuring that documents are controlled to ensure the correct documents are being used.

LBNL organizations identify, document and describe the key processes used to meet the organization’s scientific or operational objectives.

Core functions have descriptions, procedures, instructions, training material and/or drawings to direct and inform personnel how to perform the functions in an efficient and safe manner.

Modification of approved procedures for core functions and other significant work processes requires use of a formal change control process if the changes impact the quality and/or safety of the activity. Change control must include approval signatures, effective date, and revision number for the changed procedure.

Notes, desk manuals, memos, operator aids, logbooks, notebooks, postings, and drawings are acceptable methods of written communication.

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Oral instruction, when it is the only communication method used, is not considered sufficient for directing and/or communicating with personnel on core functions or other significant work processes.

Document control requirements are outlined in Procedure 10.06.001.101, Developing, Reviewing and Approving Non-Policy Institutional Documents and Procedure 10.06.001.102, Developing, Reviewing and Approving Institutional Policies. ANSI/ISO/ASQ Q9001:2015, Quality Management Systems – Requirements, is the international consensus standard that LBNL uses for quality management.

5.2 Records Management

The Lab implements a records management process to ensure that records of policies, procedures, activities, and decisions are generated, maintained, and readily retrievable. Information and data that document the organization’s research, operational, or administrative activities are retained as evidence of completed work and adherence to standards and procedures. A records or file inventory is established and maintained by the organizations. Records are transmitted to the Lab’s Archives and Records Office in accordance with retention and disposition requirements.

6.0 Work Processes

Work is performed in accordance with established technical standards and administrative controls, including procedures, drawings, specifications, and work instructions. Items are controlled to ensure their proper use and are maintained to prevent their damage, loss or deterioration; and equipment used for measurement, test, monitoring or data collection is calibrated and maintained on regular periodicities.

Personnel performing work are responsible for the quality of their work and line management is responsible for ensuring that the desired quality is achieved and improvement opportunities are identified.

6.1 Consensus Standards

The use of consensus standards where practicable and consistent with contractual or regulatory requirements is the preferred method on which to base a controlled work process or program.

Consensus standards, for the purpose of the QAPD, include national and international standards, DOE technical standards, and standards and codes from nationally recognized professional societies. These standards, as applicable, may supplement or replace written procedures, instructions, and drawings.

6.2 Item Identification and Control

Lab systems, structures, components (SSCs), items and equipment are controlled to ensure their proper use and are maintained, stored and handled to prevent their damage, or deterioration.

Mechanisms used to identify and control items include, but are not limited to:

● Institutional identification and assignment of a property number (e.g., DOE property inventory, Facilities Division (FAC) MAXIMO system/equipment inventory, hazardous waste inventory, radiological material and equipment inventory, chemical management inventory, etc.), which is maintained in an Institutional database with an identification tag and/or barcode affixed to an item;

● Division or organizational identification and assignment of a system, structure and/or component (SSC), item or equipment number (e.g., capital assets inventory, chain of custody or research sample inventory, equipment registries, etc.), which is maintained in a local

LBNL/PUB-3111, Quality Assurance Program Description, Revision 13 Effective Date: 9/10/26 Page 14 of 37 database that may include an identification and/or barcode affixed to the SSC, item or equipment;

● Periodic verification and maintenance to ensure SSCs, items, and equipment are operational, climate controlled (e.g., clean rooms, laboratories, warehouses), and/or in a secured storage location (e.g., key card or code access by authorized personnel only), as appropriate.

6.3 Measurement and Test Equipment (M&TE)

M&TE includes inspection and test equipment, measuring and data collection equipment, equipment (either hand-held or installed) used for data indication, and other equipment used for data indication, collection, or evaluation. Calibration and control measures may not be required for rulers, tape measures, levels, and other such devices, if normal commercial equipment provides adequate accuracy.

Line organizations that use M&TE are responsible for establishing and documenting a system to control the use and calibration of M&TE. This system includes a process to recall for calibration or removal from service M&TE that:

● has exceeded its calibration interval;

● has broken calibration seals;

● has been modified, repaired, or has had components replaced; or

● is suspected to be malfunctioning because of mishandling, misuse, or unusual results.

Additionally, an assurance mechanism is included in the process to evaluate the adequacy of the calibration system.

When M&TE is found to be out-of-calibration, an evaluation of the validity of previous inspection and test results, and the acceptability of related items, data collected, and processes are monitored.

M&TE schedules, calibration records and other records are maintained by the organizations that own the M&TE. Records of calibration include:

● a description or identification of the item,

● calibration interval,

● date calibrated,

● identification of the calibration source,

● calibration results (data and status),

● calibration action taken (e.g., adjusted, repaired, new value assigned), and

● evaluation and corrective action taken in response to out-of-calibration conditions.

M&TE is labeled to indicate the calibration status, the date calibrated, the calibration due date or usage equivalent, and the identification of any limitations. When it is impractical to apply a label directly to an item, the label may be affixed to the instrument container or some other suitable means may be used to reflect calibration status.

M&TE is handled, stored and transported in a manner that does not adversely affect the accuracy of the equipment. Due consideration is given to temperature, humidity, lighting, vibration, dust control, cleanliness, electromagnetic interference, and any other factors affecting the results of measurements.

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6.4 Calibration

M&TE requiring calibration is calibrated at periodic intervals established and maintained to ensure acceptable reliability. Reliability is described as the probability that M&TE will remain in tolerance throughout the interval.

Intervals are established for M&TE requiring calibration unless the equipment is regularly monitored through the use of check standards in a documented measurement assurance process.

Check standards closely represent the item parameters normally tested in the process, and the check standard is verified periodically. Where intervals are used to ensure reliability, the interval setting system is systematically applied and states reliability goals and a method of verifying that the goals are being attained. Intervals may be based on usage or time since last calibration.

Exemptions from periodic calibration may be approved. The recall system may provide for the temporary extension of the calibration due date for limited periods of time under specified conditions that do not unreasonably impair the satisfaction of task objectives.

If M&TE is found to be significantly out-of-tolerance during the calibration process, the cognizant organization notifies the appropriate personnel of the out-of-tolerance condition, and provides them with the associated measurement data so appropriate action can be taken.

7.0 Design

LBNL uses sound engineering and scientific principles as well as appropriate standards to develop and design management systems, processes, and items, including software. The design process includes: 1.

conceptualization;

2. identification of business, technical, quality and safety requirements;

3. feasibility assessment;

4. detailed design and analysis;

5. verification and validation of the design; and

6. production or operation.

Line organizations implement configuration management procedures, techniques, and tools to manage, evaluate proposed changes, track the status of changes, and to maintain an inventory of system and support documents as the system changes. Configuration management, applied throughout the lifecycle, establishes and maintains the consistency of an item’s performance, functional and/or physical attributes with its requirements, and design and operational information throughout its life. A configuration management process allows management to track requirements throughout the lifecycle through acceptance, operations and maintenance. As changes are inevitably made to the requirements and design, they are approved and documented, creating an accurate record of the system baseline and status.

Additional requirements for design of fabricated items and buildings may be found in the Engineering Process Guide and LBNL/PUB-3193, Design and Construction Management Procedures Manual.

8.0 Procurement

LBNL ensures that procured items and services meet established technical, quality and business requirements, and that they perform as intended. Prospective suppliers are evaluated and selected based on their capability to provide items or services in accordance with technical, quality and business LBNL/PUB-3111, Quality Assurance Program Description, Revision 13

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Procurement of items known to have been suspect or counterfeit in the past (e.g., high-strength fasteners, electrical equipment, hoisting and rigging equipment, M&TE and other suspect/counterfeit items (S/CIs)), that serve a safety function or are intended for use in safety systems or critical applications are reviewed and approved by ICAO. These types of items are purchased directly through the Procurement Department and specific supplier submittals, such as Certificates of Conformance (CoCs), Certified Material Test Report (CMTRs), Certificates of Calibration or Analysis, are included in purchase orders (POs) and provided to the end user to ensure the end user received what was requested.

For capital projects governed by DOE O 413.3B, Program and Project Management for the Acquisition of Capital Assets, QA criteria is included in solicitation procurement documentation that is provided to Offerors, and QA requirements are included in procurement subcontracts.

QA Program documentation (e.g. QA Manuals, 3rd party accreditations, QA Project Plans (QAPjPs), procedures, resumes of key personnel, past project history, training and qualification certifications, the number of default notifications and litigation, etc.) is submitted by potential offerors for review by ICAO as part of the bid process and again prior to the selected subcontractor receiving a Notice to Proceed (NTP) or prior to fabrication or field work from the Procurement Department. ICAO participates in procurement solicitation and subcontract activities to assure that first tier or key subcontractors and suppliers have the quality capability to meet project requirements and perform as intended during Critical Design (CD) phases of a project, prior to issuance of a subcontract and/or prior to issuing a Notice-to-Proceed to a subcontractor. Some of these activities include:

● Participating in the subcontractor bid process to determine an Offeror’s quality capability to meet the Lab’s requirements and performance expectations, and to identify risks to successful completion of a project. Participation includes o Reviewing Offerors’ QA Program documentation, o Attending Supplier Selection Committee meetings, o Attending Pre-bid Conferences, and o Providing an Institutional QA Overview to Offerors during Pre-bid Conferences; ● Participating in a subcontractor’s orientation or pre-construction meetings;

● Providing QA Overview/Orientation, as needed, to subcontractors prior to commencement of project work;

● Reviewing Lab QAPjPs and providing feedback to project management teams; ● Reviewing subcontractor QAPjPs and implementing procedures, and providing feedback to Lab and subcontractor project management teams; and

● Providing technical QA expertise to Lab and subcontractor project management teams. The Procurement Department’s suite of Standard Practices that outlines specific requirements for procuring items and services is located on their website. Procedures 04.03.007.001, Subcontractor QA Requirements for Construction, Decommissioning, Demolition and Fabrication Projects and 04.03.007.006, Subcontractor QA Requirements for Design-Build Projects outline the QA requirements that are included in capital projects subcontracts.

8.1 Acceptance of Procured Items or Services

To ensure that items and services meet specified technical and quality requirements prior to use, the purchaser or designee accepts them through verification methods. Verification includes inspection and testing of components, structures or systems to acceptance criteria. Verification methods include:

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● Source Inspection

● Receiving Inspection

● Systems Acceptance Testing

● Commissioning

● Post Installation Testing

● Supplier Certificate of Conformance/Compliance

● Supplier Inspection and Test Results

8.2 Control of Supplier Nonconformances

The purchaser and supplier establish a process for dispositioning items and services that do not meet procurement document requirements. Nonconforming items (NCIs) are uniquely identified, tagged and/or segregated to prevent inadvertent use. Examples of conditions requiring a report of nonconformance include:

● failure to meet technical or material requirements,

● failure to meet a requirement in supplier documents that have been approved by the purchaser,

● a nonconformance that cannot be corrected by continuation of the original manufacturing process or by rework, and

● an item that does not conform to the original requirement even though it can be restored to a condition such that its capability to function is unimpaired.

NCIs that are dispositioned as “used-as-is” or “rework” are evaluated by a Technical Authority such as a Professional Engineer (PE), Authority Having Jurisdiction (AHJ), Building Code Official (BCO) or other technically competent authority to ensure that the item is similar in form, fit and/or function as the original requirements or specifications; will not cause catastrophic failure; will meet operational and functional requirements; and will not result in regulatory noncompliance. The results of such evaluations are documented in a technical justification and maintained as part of the nonconformance report (NCR) and project file.

When nonconforming items are identified, the purchaser works with the supplier to determine the disposition (e.g. “use as is”, “repair”, “scrap”, “replace”).

8.3 Commercial Grade Items

Commercial grade items are identified in an approved design output document, such as a drawing, specification, or other document translated from a design input document. An alternative commercial grade item may be applied as long as the responsible design organization provides verification that the alternative commercial grade item performs the intended function and meets design requirements that are applicable to both the replaced item and its application.

Commercial grade items may be specified in the procurement document by the manufacturer's published product description. After receipt of a commercial grade item, the purchaser may perform inspections to ensure that:

● damage was not sustained during shipment;

● the item received was the item ordered;

● inspection or testing is accomplished, to the extent determined by the purchaser, to ensure conformance with the manufacturer's published requirements; and

● documentation, as applicable to the item, was received and is acceptable.

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9.0 Inspection & Testing

9.1 Inspection

Inspection is performed during the manufacturing, construction, or receipt process of items or equipment. The extent of inspection is a function of the relative importance, complexity, and quantity of items or services. Inspections are performed by technically competent personnel and are documented.

In some instances, hold points are used to control work that should not proceed without the specific consent of the organization placing the hold point. The specific hold points are indicated in appropriate documents (e.g., inspection plans, manufacturing travelers). Only the organization responsible for the hold point may waive the hold point.

There are various types of inspections that are used to determine whether the system, structure, component or service performs as intended. Such as:

1. source inspection,

2. first article inspection,

3. special process inspections,

4. in-process inspections and monitoring,

5. weld inspections,

6. final inspections, and

7. in-service inspections.

Documented inspection results are retained in accordance with Section 5.0, Document and Records Management. Nonconforming items, including S/CIs, are identified and dispositioned in accordance with Section 9.3, Nonconforming Items, Including Suspect/Counterfeit Items.

9.2 Testing

LBNL performs testing to determine the capability, reliability and sustainability of an item against specified requirements by subjecting the item to a set of physical, chemical, environmental, or operating conditions. Examples of such tests include prototype qualification tests, production tests, proof tests prior to installation, construction tests, and pre-operational tests.

Test results are documented and their conformance with acceptance criteria is evaluated by a qualified individual within the responsible organization to ensure that all test requirements have been satisfied. Documented testing results are retained in accordance with Section 5.0, Document and Records Management. During testing activities, if nonconforming items, including S/CIs, are identified they are dispositioned in accordance with Section 9.3, Nonconforming Items, Including Suspect/Counterfeit Items.

9.3 Nonconforming Items, including Suspect/Counterfeit Items

Organizations that perform inspection, testing and maintenance activities have established processes for dispositioning items and services that do not meet design requirements. NCIs, including S/CIs, are uniquely identified and/or segregated to prevent inadvertent use, and are dispositioned accordingly.

Examples of conditions that result in nonconformance include:

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● failure to meet technical or material requirements,

● failure to meet a requirement in design documents,

● inability to correct a nonconformance by continuation of the original manufacturing process or by rework, and

● inability of an item to conform to the original requirement even though it can be restored to a condition such that its capability to function is unimpaired.

When NCIs are identified, the responsible engineer is notified to determine the disposition, which is either “use as is”, “rework”, “scrap”, or “replace”. For “use as is” or "rework" dispositions, the responsible engineer reviews and approves the technical engineering justification for the disposition.

When NCIs are thought to be suspect or counterfeit, the Institutional QA Program Manager, who is the Subject Matter Expert (SME) for S/CIs, is notified by the organization that owns the S/CI to make the final determination regarding whether the item is suspect or counterfeit. Upon confirmation by the Institutional QA Program Manager that an item is an S/CI, the organization that owns it:

1. ensures that it is reported in the Institutional NCR database, and

2. retains the counterfeit item until the Institutional QAP Manager notifies the DOE Inspector

General (IG) and DOE Contracting Officer (CO) of counterfeit items so they can determine how to manage the issue.The institutional QA Program Manager ensures that S/CIs are reported to the DOE IG in accordance with DOE O 221.1A, Reporting Fraud, Waste, and Abuse; and Government Industry Data Exchange Program (GIDEP).

S/CIs, are managed in accordance with Procedure 04.03.008.004, Identifying, Reporting & Dispositioning Suspect Counterfeit Items.

10.0 Assessment

The Institutional Assessment Process is a key mechanism by which LBNL exercises its stewardship and contractual responsibilities by assuring that we have effective, efficient and safe processes in place to support our scientific mission. This includes:

1. monitoring the performance and effectiveness of controls (i.e. administrative, engineering, etc.);

2. identifying Institutional risks and issues; and

3. sharing lessons learned and best practices that promote continuous improvement in programs, projects and work processes.

The Institutional Assessment Process is performed using a risk-based approach and leverages efforts by the tri-parties (i.e. DOE BASO, UCNL, LBNL) to minimize duplication and burden on the organizations who will be assessed, to the extent feasible. Every fiscal year, the ICAO, in conjunction with BASO and UC, launches and oversees the Institutional Assessment Process. All LBNL Divisions, business areas, programs and/or projects are responsible for performing assessments of their operations to assure that they are designed, implemented and performing as intended and to assure that identified risks and issues are addressed, and best practices are applied to promote continuous improvement. Correspondingly, senior managers, line managers, program or project managers, and staff are responsible for conducting assessments as determined by contract requirements and/or Institutional policy and performance needs.

There are many types of Assessment performed at the Laboratory. These assessments are either performed by the LBNL or by external parties, such as UC, DOE (i.e. Headquarter areas, BASO, Office of Inspector LBNL/PUB-3111, Quality Assurance Program Description, Revision 13

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General, etc.), the City of Berkeley, the National Institute for Health (NIH), the Food and Drug Administration (FDA), etc. The types of assessments performed by the lab includes, but is not limited to, the following:

● Audits

● Corrective Action Implementation Effectiveness Reviews

● Directors Reviews

● Division Self-Assessments

● Field Inspections/Walk-arounds

● Integrated Project Reviews

● Management Reviews

● Peer Reviews

● Prime Contract Implementation Plan Validations

● Program Reviews

● Quality Assurance Reviews

● Regulatory Inspections/Site Visits

Annually, LBNL develops and maintains an Integrated Assessment Schedule (IAS) that captures all planned assessments of programs, processes, projects and other activities. The IAS is documented on a web-based platform and is the LBNL’s official assessments tracking tool, and it demonstrates to DOE, UC and Laboratory management that rigorous, risk-based, credible assessments, and feedback and improvement activities are performed to assure that LBNL has effective, efficient and safe processes.

Assessment results (i.e., issues, risks, observations, best practices, opportunities for improvements (OFIs), etc.) are analyzed by ICAO, and division and line management to identify adverse trends, risks and issues.

Assessments are performed in accordance with document 04.02.002.001, Institutional Assessment Process Description.

11.0 Safety Software Quality Assurance

The LBNL approach to Safety Software Quality Assurance (SSQA) is based on the principle that software that has a significant impact on human safety, such as serves a personnel protection or design function and/or whose output is relied upon to make decisions, must be appropriately designed, controlled and tested.

The SSQA approach sets four core requirements:

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.

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

LBN…