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REQUIREMENTS AND POLICIES MANUAL

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    Title:

    Quality Assurance Policy

    Publication date:

    10/2/2020

    Effective date:

    10/2/2020

    BRIEF

    Policy Summary

    Lawrence Berkeley National Laboratory (Berkeley Lab) is required by the University of California-Department of Energy (UC-DOE) Prime Contract to establish and maintain a Quality Assurance (QA) Program that assures work is performed in a reliable, repeatable, and sustainable manner and that requirements of the QA Program are flowed down to subcontractors and suppliers.

    Who Should Read This Policy

    • All levels of management, including the Laboratory Director, Deputy Director for Operations, General Counsel, Associate Laboratory Directors (ALDs), division directors, division deputies, and department heads; and
    • Berkeley Lab employees who perform work at or for Berkeley Lab.

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page.

    Contact Information

    Quality Assurance Program (QAP) Manager

    Office of Institutional Assurance and Integrity

    MCGravois@lbl.gov

    Title:

    Quality Assurance Policy

    Publication date:

    10/2/2020

    Effective date:

    10/2/2020

    POLICY

    A. Purpose

    This document describes the Lawrence Berkeley National Laboratory (LBNL, herein referred to as Berkeley Lab or Lab) policy on compliance with the UC-DOE Prime Contract.

    B. Persons Affected

    All persons who work at or visit Berkeley Lab.

    C. Exceptions

    None

    D. Policy Statement

    Berkeley Lab has established and maintains a Quality Assurance (QA) Program for performing all activities in a reliable, repeatable, safe, and sustainable manner in accordance with good industry business practices and requirements set forth in the UC-DOE Prime Contract and any Berkeley Lab-generated requirements and policies.
    The Berkeley Lab QA Program follows a structured approach that, at a minimum, includes requirements for all functional areas, such as:

    1. Management engagement and support of the QA Program including resources (i.e., monetary, human capital, equipment, material, etc.).
    2. Organizational structure (description and organization chart) including independence of the assurance function from the line, cost and schedule considerations, and identification of roles and responsibilities at all levels.
    3. Design for infrastructure, hardware, software, systems, programs, processes, and tasks.
    4. Identification of key work processes for planning, control, implementation, and execution; development and documentation of implementing documents (e.g., policies, Standard Operating Procedures [SOPs], work instructions, memoranda of agreement/understanding [MOAs/MOUs] forms, training modules, work packages, etc.); and development and implementation of engineered controls.

    5. Training and qualification of staff and subcontractors, as appropriate, to ensure staff have the appropriate knowledge, skill set, competency, and proficiency to perform work.
    6. Identification, mitigation, and management of risks through resolution.
    7. Identification, correction, and management issues and associated corrective actions through resolution.
    8. Evaluation of subcontractors and suppliers to ensure that their goods and services are able to meet the Lab's requirements and perform as intended and selecting capable suppliers.
    9. Validation that subcontractors and suppliers are meeting requirements and performing as intended.
    10. Inspection and testing items and services to ensure they meet Lab requirements and perform/work as intended.
    11. Identification and disposition of nonconforming items, including Suspect/Counterfeit Items (S/CIs).
    12. Performance of assessments (i.e., self-assessment, management review, independent assessment).
    13. Monitoring and analysis of data to identify risks and issues, adverse trends, and/or recurring issues in order to improve performance.

    S/CIs identified through inspection, testing, or other assessment activities must be reported to the Office of Institutional Assurance and Integrity and the Occurrence Reporting and Processing System (ORPS) Coordinator, and documented in the ORPS and Corrective Action Tracking System (CATS) databases.

    E. Roles and Responsibilities

    Role

    Responsibility

    Laboratory Director

    • Provides the institutional authority for the QA Program.
    • Ensures the full cooperation of divisions in implementing the requirements.

    Deputy Director for Operations

    • Ensures QA Program implementation and execution by divisions.
    • Monitors performance of QA Program implementation and execution by divisions.
    • Ensures divisions are identifying risks and issues and mitigating/correcting and managing them through resolution.

    Office of Institutional Assurance and Integrity

    • Communicates the QA Program requirements to all Laboratory divisions and other appropriate organizations.
    • Develops and maintains the QA Program.
    • Oversees the QA Program implementation and execution.
    • Assesses implementation and execution of the QA Program requirements by divisions and other appropriate organizations.
    • Monitors performance of QA Program implementation and execution by divisions.
    • Identifies risks and issues, and ensure divisions are mitigating/correcting and managing them through resolution.

    ALDs, division directors, and department heads

    • Ensure that QA Program requirements are communicated and implemented in their responsible areas.
    • Assess implementation and execution of the QA Program by divisions and other appropriate organizations.
    • Monitor and analyze performance of ALDs, divisions, departments, and other appropriate organizations.
    • Identify risks and issues, and mitigate/correct and manage them through resolution.

    Berkeley Lab employees

    Are individually responsible for:

    • Compliance with QA Program requirements.
    • The quality of their work.
    • Working within work authorizations and following policies, procedures, etc.
    • Reporting risks and issues to their supervisors/managers.

    F. Definitions/Acronyms

    Term

    Definition

    Assessment

    The act of reviewing, inspecting, testing, checking, conducting surveillances, auditing, or otherwise determining and documenting whether items, processes, or services meet specified requirements

    Configuration Management

    The process of identifying and defining the configuration items in a system, controlling the release and change of these items throughout the system life cycle, and the recording and reporting of the status of configuration items and change requests

    Document

    Written, visual, audio-, or video-recorded information stored in the form of hard copy, film, magnetic tape, electronic data, or in an online, Web-based format

    Graded Approach

    The process by which the level of analysis, documentation, verification, and other controls necessary to comply with program requirements are developed commensurate with specified factors

    Issues Management

    The process by which issues are managed and tracked through resolution to prevent recurrence

    Item

    An all-inclusive term used in place of any of the following: assembly, component, equipment, material, module, structure, software, subassembly, subsystem, system, unit, support system. or data

    Nonconformance

    A deficiency in a characteristic or record that renders the quality of an item or sample unacceptable or indeterminate

    Policy

    Statements or directives from the federal, state, or local government; the University of California; or Berkeley Lab senior management that set a course of action, define acceptable conduct, or implement governing principles. Example: Berkeley Lab Site Access

    Procedure

    A series of specific steps to be followed to accomplish work or to carry out a policy or requirement. Procedures are controls meant to mitigate risk, improve efficiency, or assure compliance. Examples: Obtaining a Berkeley Lab badge, maintaining the Laboratory's 12 kV electrical system, completing a travel expense form

    Quality

    The condition achieved when an item, service, or process meets or exceeds the user's requirements and expectations

    Quality Assurance

    All those planned and systematic actions necessary to provide adequate confidence that an item will perform satisfactorily in service

    Record

    All books, papers, maps, photographs, machine-readable materials, or other documentary materials — regardless of physical form or characteristics — made or received that are preserved or appropriate for preservation that serves as evidence of the organization, functions, policies, decisions, procedures, operations, or other activities

    Requirement

    A specific obligation to perform an action mandated by Berkeley Lab senior management or the federal, state, or local government; or to comply with the Laboratory's contract with the U.S. Department of Energy; or to comply with agreements made between the Laboratory and its corporate manager, the University of California

    Suspect / Counterfeit Items

    A component or assembly of questionable manufacture and/or origin, i.e., known to have been previously counterfeited, or having sufficient physical attributes to raise questions as to its acceptability. These include mechanical components (e.g., fasteners, bolts, studs, fittings, valves, flanges, and couplings), and electrical/ electronic components (e.g., semiconductors and circuit breakers). Parts made of inferior materials and/or that are incorrectly processed and intentionally marked or labeled to indicate that they comply with appropriate design/technical criteria.

    Validation

    The process of (a) evaluating a system or component during or at the end of the development process to determine whether it satisfies specified requirements or (b) providing evidence that the software and its associated products satisfy system requirements allocated to software at the end of each life-cycle activity; solve the right problem (e.g., correctly model physical laws, implement business rules, use the proper system assumptions); and satisfy the intended use and user needs (Reference: IEEE Standard 1012-2004)

    Verification

    The process of (a) evaluating a system or component to determine whether the products of a given development phase satisfy the conditions imposed at the start of that phase or (b) providing objective evidence that the software and its associated products conform to requirements (e.g., for correctness, completeness, consistency, accuracy) for all life-cycle activities during each life-cycle process (acquisition, supply, development, operation, and maintenance); satisfy standards, practices, and conventions during life-cycle processes; and, successfully complete each life-cycle activity and satisfy all the criteria for initiating succeeding life-cycle activities (e.g., building the software correctly) (Reference: IEEE Standard 1012-2004)

    Acronym

    Term

    QAPD

    Quality Assurance Program Description (PUB-3111)

    ORPS

    Occurrence Reporting and Processing System

    QA

    Quality Assurance

    RPM

    Requirements and Policies Manual (PUB-201)

    S/CI

    Suspect/Counterfeit Item

    G. Recordkeeping Requirements

    Records used to demonstrate objective evidence of performance of QA requirements must be maintained in accordance with records-retention requirements outlined in Berkeley Lab's Requirements and Policies Manual (RPM) and Laboratory implementing documents.

    H. Implementing Documents

    I. Contact Information

    Quality Assurance Program (QAP) Manager
    Office of Institutional Assurance and Integrity
    MCGravois@lbl.gov

    J. Revision History

    Date

    Revision

    By Whom

    Revision Description

    Section(s) Affected

    Change Type

    8/1/2011

    1

    M. Gravois

    Re-write for Wiki conversion

    All

    Minor

    8/15/2014

    1.1

    M. Gravois

    Regular review

    D

    Minor

    3/9/2017

    1.2

    M. Stoufer

    Update "Associate Laboratory Director for Operations" position title to "Deputy Director for Operations"

    All

    Editorial

    10/2/2020

    1.3

    M. Gravois

    Periodic review: revise to update and clarify QA Policy

    All

    Minor

    DOCUMENT INFORMATION

    Title:

    Quality Assurance Policy

    Document number

    04.03.001.000

    Revision number

    1.3

    Publication date:

    10/2/2020

    Effective date:

    10/2/2020

    Next review date:

    10/2/2023

    Policy Area:

    Quality Assurance

    RPM Section (home)

    Contractor Performance Management

    RPM Section (cross-reference)

    none

    Functional Division

    Office of Contractor Assurance

    Prior reference information (optional)

    RPM Section 8.01

    Source Requirements Documents

    Implementing Documents

    Document Number

    Title

    10.06.001.000

    Document Management Policy

    Policy

    10.03.001.000

    Archives and Records Management Policy

    Policy

    04.02.002.000

    Issues Management Policy

    Policy

    PUB-5519 (1)

    Issues Management Program Manual

    System

    04.02.002.001

    Integrated Assessment Process Description

    System

    10.06.001.001

    Document Management Process

    Process

    04.03.008.004

    Identifying, Dispositioning and Reporting
    Suspect/Counterfeit Items (S/CIs)

    Process