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REQUIREMENTS AND POLICIES MANUAL

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Quality Assurance Policy

Title:

Quality Assurance Policy

Publication date:

8/1/2011

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:

8/1/2011

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. Qualifying suppliers
  2. Inspecting and testing, including identification of Suspect/Counterfeit Items (S/CIs) and
  3. Engineering design for hardware, software, systems, and facilities

S/CIs identified through inspection, testing, or other assessment activities must be reported to 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

Document Number

Title

PUB-5519 (1)

Issues Management Program Manual

PUB-5519 (2)

Causal Analysis Program Manual

PUB-5519 (3)

Data Monitoring and Analysis Program Manual

PUB-5519 (4)

Lessons Learned and Best Practices Program Manual

10.06.001.001

Document Management Process

10.06.001.000

Document Management Policy

10.03.001.000

Archives and Records Management Policy

04.02.002.000

Issues Management Policy

04.02.003.000

Organizational Self-Assessment Policy

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

DOCUMENT INFORMATION

Title:

Quality Assurance Policy

Document number

04.03.001.000

Revision number

1

Publication date:

8/1/2011

Effective date:

8/1/2011

Next review date:

8/1/2014

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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