Quality Assurance Policy

Title:	Quality Assurance Policy
Publication date:	11/3/2023
Effective date:	11/3/2023

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
[email protected]

Title:	Quality Assurance Policy
Publication date:	11/3/2023
Effective date:	11/3/2023

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:

Management engagement and support of the QA Program including resources (i.e., monetary, human capital, equipment, material, etc.).
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.
Design for infrastructure, hardware, software, systems, programs, processes, and tasks.
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.
Training and qualification of staff and subcontractors, as appropriate, to ensure staff have the appropriate knowledge, skill set, competency, and proficiency to perform work.
Identification, mitigation, and management of risks through resolution.
Identification, correction, and management issues and associated corrective actions through resolution.
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.
Validation that subcontractors and suppliers are meeting requirements and performing as intended.
Inspection and testing items and services to ensure they meet Lab requirements and perform/work as intended.
Identification and disposition of nonconforming items, including Suspect/Counterfeit Items (S/CIs).
Performance of assessments (i.e., self-assessment, management review, independent assessment).
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 Leadership	Sets the strategic direction, deploys resources, develops management systems, and implements process controls to address and mitigate risk. Responsible for stewardship, mission.
Office of Institutional Assurance and Integrity	Provides support, expertise and oversight of the Lab’s QAP. Responsible for day-to-day operations and authority to ensure that compliance in support of scientific excellence, best practices, and continuous improvement are achieved at LBNL. Additionally, OIAI is responsible for establishing. Maintains the Quality Management System including implementation and oversight of the Quality Assurance Program. Provides technical guidance to the Lab community on the QAP. Ensures the QAP is in conformance with contract requirements.
Line Management	Conducts daily work, processes and activities of the Laboratory using management systems and process controls to achieve the objectives set by Laboratory leadership. Evaluates performance, identifies risks and issues and mitigates/corrects them through resolution. Successfully accomplishes activities subject to this QAPD. Management provides the necessary planning, organization, direction, control, resources and support to achieve their defined objectives. Establishes and implements policies, plans and procedures that control the quality of work, consistent with the provisions of the QAPD.
Berkeley Lab Employees	Adhere to the QA policies, QAPD, and implementing documents. Ensure the quality of their work and promptly reports all risks and issues to the responsible management for evaluation and action.

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

Document Number	Title
10.06.001.000	Document Management Policy
10.03.001.000	Records Management Policy
04.02.002.000	Issues Management Policy
PUB-5519	Issues Management Program Manual
04.03.009.002	Institutional Assessment Process Description
10.06.001.001	Managing Institutional Documents
04.03.008.004	Identifying, Dispositioning and Reporting Suspect/Counterfeit Items (S/CIs)

I. Contact Information