Role

Responsibility

Laboratory Director

• Provides the institutional authority for the Operating and Quality Management Plan (OQMP)
• Ensures the full cooperation of divisions in implementing the requirements of the plan

Associate Laboratory Director for Operations (ALDO)

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

Office of Institutional Assurance (OIA)

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

Division directors and department heads

• Ensure that OQMP 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

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)

ALDO

Associate Laboratory Director for Operations

OQMP

Operating and Quality Management Plan (PUB-3111)

ORPS

Occurrence Reporting and Processing System

QA

Quality Assurance

RPM

Requirements and Policies Manual (PUB-201)

S/CI

Suspect/Counterfeit Item

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

The Implementing Documents listed below have not been released as of August 2011. To request a copy, contact the Requirements Management Program Manager at requirementsmgmt@lbl.gov.

10.06.001.000

Document Management Policy

10.03.000.000

Archives and Records Management Policy

04.03.001.xxx

Graded Approach to Application of QA Requirements

04.03.001.xxx

Supplier Qualification

04.03.001.xxx

Inspection & Testing Process

Date

Revision

By whom

Revision Description

Section(s) affected

Change Type

8/1/2011

0

M. Gravois

Re-write for Wiki conversion

All

Minor