Rev. 11/07; links updated 09/08

1. Policy
2. Responsibilities
3. Implementing Elements and Guidelines
   1. Organization
   2. Process Management
   3. Performance Assessments and Improvements

A. POLICY

It is the policy of Lawrence Berkeley National Laboratory to conduct activities that contribute to its scientific and operational objectives in accordance with sound quality assurance and conduct of operations principles. These principles, as described in the Laboratory's Operating and Quality Management Plan (OQMP) (PUB-3111), are the basis for the Laboratory's standards for organization, process management, and performance assessments.

Application of OQMP principles is based on a graded approach, with consideration given to the unit's mission; its programmatic or operational significance; and its commitment to environment, safety, and health consequences for personnel and the general public.

B. RESPONSIBILITIES

The Laboratory Director is responsible for providing the institutional authority for the OQMP. The Director ensures the full cooperation of divisions in implementing the requirements of the plan.

The Associate Laboratory Director for Operations (ALDO) is responsible for (1) communicating the OQMP to all Laboratory divisions and other appropriate organizations and (2) ensuring its full implementation.

The Office of Institutional Assurance is responsible for (1) developing and maintaining the OQMP and (2) assessing implementation of the plan by divisions and other appropriate organizations.

Division directors and department heads are responsible for ensuring that OQMP requirements are communicated and implemented in their responsible areas.

Berkeley Lab employees are individually responsible for compliance with these requirements and for the quality of their work.

C. IMPLEMENTING ELEMENTS AND GUIDELINES

1. Organization

1. Organizational Elements

An appropriate management structure, a proficient staff, and a systematic approach in planning work functions are key elements in sustaining a satisfactory level of quality performance. Berkeley Lab organizations must:

• Describe in writing their organizational structure.
• Plan their work functions and activities.
• Hire and retain staff proficient to perform their work.

2. Process Management

A process is defined as a combination of people, materials, equipment, and actions interacting to produce a product or service. The process is managed by the application of system controls to assure the quality of the product or service.

Berkeley Lab organizations must manage their work processes by:

• Communicating to affected staff the goals, objectives, and procedures of the work processes.
• Identifying and mitigating the hazards and risks of the work processes.
• Instituting process controls to enhance performance and quality.
• Establishing document and records control measures to ensure the availability and use of accurate information.

1. Operating Documents

Organizing the responsibilities, procedures, and controls for the organization's functions requires the development and maintenance of documents that establish the organization's method of operation. The operating documents must be able to direct and inform affected personnel on how to perform their functions in an efficient and safe manner. All hazards related to the functions and the corresponding mitigation measures must also be identified and communicated to the affected personnel. Operating documents include, but are not limited to, manuals, notebooks, standard operating procedures, desk references, instructions, and drawings.

2. Process Control

Process control is intended to reduce the variation in work process, thereby improving performance and quality. Line managers responsible for programs and operations must review their core functions to ensure that appropriate controls are in place. The controls include, but are not limited to, the following:

• Proper management review and approval of processes
• Use of safety standards and requirements necessary and sufficient to mitigate the hazards of the work processes
• Assurance that only qualified and trained personnel are assigned to perform the work
• Assurance that only the appropriate equipment and material are being used and maintained
• Assurance that only up-to-date written procedures to direct the work are being used
• Acceptance criteria for final review of the end product or service
3. Document and Records Management

Document control and records management are intended to ensure the availability of accurate information for Berkeley Lab work processes and other activities. Documents and records are managed to provide for retention, preservation, assurances of currency, and retrievability:

• Document control provisions ensure that only approved and up-to-date information pertaining to policy, prescribing work, specifying requirements, or establishing design criteria are available to users when needed. The ALDO and division directors are responsible for identifying which Laboratory documents require this formal and rigorous control. Controlled documents are made available to users by either print or electronic means.
  


• Effective records management ensures that records of completed activities are generated, maintained, and readily retrievable. Information and data that authenticate the organization's research, operational, or administrative activities are retained as evidence of completed work and adherence to standards and procedures. Berkeley Lab organizations must follow the policies and requirements of records management described in RPM §1.17 (Archives and Records Management).

3. Performance Assessments and Improvements

Berkeley Lab organizations must routinely (at least annually) evaluate their work performance to identify, correct, and prevent problems that may hinder the organization in achieving its scientific and operational objectives. Some of these assessments are required under the terms of the DOE/LBNL Contract between the University and DOE. Assessments can also affirm that objectives and goals are being met  in accordance with LBNL/PUB-5520, UC Assurance Plan for LBNL.

1. Management Assessments

Line managers and division administrators must periodically evaluate the performance of their work activities and take an active role in improving performance and seeking excellence. These assessments can be readiness reviews, design reviews, quality control inspections, program reviews, and any other evaluations to ensure that performance is at a satisfactory level.

2. Independent Assessments

Independent assessments are internal reviews performed routinely by the Environment, Health & Safety Division (EH&S); Internal Audit Services; the Office of Institutional Assurance (OIA); and the Safety Review Committee. These reviews are performed by technically and programmatically knowledgeable personnel within the Laboratory who do not have direct responsibility in the areas they assess. Each assessment organization has established protocols for conducting the reviews.

3. Peer Reviews

Peer reviews, which are a form of independent assessment, are evaluations of scientific and operational programs and projects conducted by peers in that particular field. Reviewers cannot have direct responsibility in the areas being reviewed.

4. ES&H Self-Assessment Program

This program directs divisions and other Berkeley Lab organizations to self-evaluate their operations to ensure that environment, safety, and health and quality assurance concerns are routinely addressed to promote continuous improvement and excellence in these topical areas. The self-assessment program provides a structured process to perform routine inspections; identify issues; develop and track corrective actions; conduct root cause analysis, and data monitoring and analysis; and institute lessons learned. The program elements and requirements are described in the LBNL ES&H Self-Assessment Program (PUB-5344) and the LBNL Self-Assessment Manual (PUB-3105).

5. Corrective Actions

Corrective actions are developed for issues (findings, concerns, and deficiencies) identified in an assessment, and are managed and tracked through resolution. Corrective actions that cannot be completed immediately must be tracked through the LBNL Corrective Action Tracking System (CATS). The program elements and requirements are described in the LBNL Issues Management Program (PUB-5519 (1)).

Line management, with assistance from EH&S and OIA, also perform root cause analyses and develop lessons learned to prevent problems from recurring. Such activity is commensurate with the risk, significance, and consequence of the problem.

 

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