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REQUIREMENTS AND POLICIES MANUAL

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Quality Assurance Policy

    Title:

    Quality Assurance Policy

    Publication date:

    8/15/2014

    Effective date:

    8/1/2011

    BRIEF

    Policy Summary

    Berkeley Lab must establish and maintain a quality assurance system in accordance with good business practices and contract requirements.

    Who Should Read This Policy

    • Senior-level management, including the Laboratory Director, the Assistant Laboratory Director for Operations (ALDO), the Office of Institutional Assurance (OIA), division directors, and department heads
    • Berkeley Lab employees who develop internal procedures or processes; maintain and disposition records; procure goods and services; perform equipment or software design activities; fabricate items, equipment, or systems; perform construction activities; inspect, test, and/ or maintain items and equipment; perform assessments; and/ or manage issues and associated corrective actions

    To Read the Full Policy, Go To:

    The POLICY tab on this wiki page.

    Contact Information

    Assurance and Quality Program Manager
    Office of Contractor Assurance
    MCGravois@lbl.gov

    Title:

    Quality Assurance Policy

    Publication date:

    8/15/2014

    Effective date:

    8/1/2011

    POLICY

    A. Purpose

    This policy is designed to establish, implement, and maintain Lawrence Berkeley National Laboratory's quality assurance system in a manner that ensures compliance with U.S. Department of Energy (DOE) requirements and customer agreements, and continued scientific research and programmatic success.

    B. Persons Affected

    Berkeley Lab employees who develop internal procedures or processes; maintain and disposition records; procure goods and services; perform equipment or software design activities; fabricate items, equipment, or systems; oversee construction or perform construction activities; inspect, test, and/or maintain items and equipment; perform internal or external assessments; and/or manage issues and associated corrective actions through resolution.

    C. Exceptions

    Not applicable.

    D. Policy Statement

    Berkeley Lab must establish and maintain a system for performing all activities in a reliable, safe, and quality manner in accordance with good industry business practices and requirements set forth in DOE Contract No. DE-AC02-05CH11231 and any Berkeley Lab-generated requirements and policies. For specific details, refer to the Quality Assurance Program Description (PUB-3111). The system for implementing quality requirements must include at least controls for:

    1. Developing procedures and other implementing documents for work processes that must be repeatable and sustainable
    2. Training and qualifying people who perform quality-affecting functions, including those who perform inspections, testing, and audits
    3. Qualifying suppliers
    4. Inspecting and testing items, equipment, systems, structures, and components
    5. Identifying and dispositioning nonconforming items, including Suspect/Counterfeit Items (S/CIs)
    6. Engineering design for hardware, software, systems, and facilities
    7. Managing issues and associated corrective actions through resolution
    8. Performing management assessments and
    9. Performing audits

    S/CIs identified through inspection, testing, or other assessment activities must be reported to the Office of Contractor Assurance and the Occurrence Reporting and Processing System (ORPS) Coordinator, and documented in the ORPS database.

    E. Roles and Responsibilities

    Role

    Responsibility

    Laboratory Director

    • Provides the institutional authority for the Quality Assurance Program Description (QAPD)
    • Ensures the full cooperation of divisions in implementing the requirements of the plan

    Associate Laboratory Director for Operations (ALDO)

    • Communicates the QAPD to all Laboratory divisions and other appropriate organizations
    • Ensures its full implementation

    Office of Institutional Assurance (OIA)

    • Develops and maintains the QAPD
    • Assesses implementation of the plan by divisions and other appropriate organizations

    Division directors and department heads

    • Ensure that QAPD requirements are communicated and implemented in their responsible areas
    • Assess implementation of the plan by divisions and other appropriate organizations

    Berkeley Lab employees

    Are individually responsible for:

    • Compliance with these requirements and
    • The quality of their work

    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

    ALDO

    Associate Laboratory Director for Operations

    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 quality assurance 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

    Questions on this policy should be directed to:
    Assurance and Quality Program Manager
    Office of Contractor Assurance
    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

    DOCUMENT INFORMATION

    Title:

    Quality Assurance Policy

    Document number

    04.03.001.000

    Revision number

    1.1

    Publication date:

    8/15/2014

    Effective date:

    8/1/2011

    Next review date:

    8/15/2017

    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

    PUB-5519 (1)

    Issues Management Program Manual

    System

    PUB-5519 (2)

    Causal Analysis Program Manual

    System

    PUB-5519 (3)

    Data Monitoring and Analysis Program Manual

    System

    PUB-5519 (4)

    Lessons Learned and Best Practices Program Manual

    System

    10.06.001.001

    Document Management Process

    Process

    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

    04.02.003.000

    Organizational Self-Assessment Policy

    Policy

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