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C.5 QUALITY ASSURANCE

This section presents the protocols used to assure the quality of the environment, safety, and health programs at LLNL and SNL, Livermore. It provides an account of LLNL and SNL, Livermore activities and operations encompassing quality assurance and quality control, but does not provide an assessment of the environment, safety, and health programs or their effectiveness. The protocols presented are limited to:

• The standards and regulations governing the quality of the environment, safety, and health programs (section C.5.1);
• Protocols and procedures used to assure quality in environment, safety, and health (section C.5.2);
• The Tiger Team Assessment (section C.5.3); and
• Other Organizations Performing Environmental Inspections/Appraisal at LLNL and SNL, Livermore (section C.5.4).

C.5.1 Regulations and Standards Pertaining to the Quality of Environment, Safety, and Health Programs

As discussed in section C.1, the quality and maintenance of environment, safety, and health programs is addressed in the regulations and standards of several governmental agencies. Most private and governmental agencies must establish programs that comply with these requirements to assure the protection of the workers, the public, and the environment.

C.5.2 Protocols and Procedures Used to Assure Quality in Environment, Safety, and Health

C.5.2.1 LLNL

LLNL policy includes quality assurance in the ongoing efforts of the technical and administrative personnel at all levels and in all functions of the Laboratory in order to be effective. The Quality Assurance (QA) Program is consistent with DOE directives and is based upon good management and professional practices. Management dictates that all programs and line organizations use QA to assist in ascertaining that the Laboratory's programmatic objectives are achieved with appropriate considerations for environment, safety, and health. All risks to people, property, and the environment must be reduced to levels as low as reasonably achievable (LLNL, 1991e). The LLNL QA Program is intended to meet the goal of assuring quality through existing line organizations.

The Quality Assurance Office is the LLNL primary interface to DOE on QA matters and provides the point of contact for all external audits and appraisals of QA activities. The Associate Director for Plant Operations appoints the manager of the Quality Assurance Office and provides the resources for staffing and operating it. This office reviews all new and revised QA plans to assure conformity with the LLNL QA Program requirements, maintains a list of all QA plans and audits, and coordinates independent appraisals of the LLNL QA Program as directed by the Associate Director.

The manager of the Quality Assurance Office is responsible for preparing and revising the LLNL QA Manual. The office also provides each directorate with the following:

• Professional guidance and advice in QA methodologies, including the publication of QA guides.
• Assistance in developing QA plans and implementing procedures.
• A training and auditor-certification program for line-organization personnel in QA and audit procedures.
• Assistance in conducting internal audits and reviews, and in coordinating external audits and reviews.

Each QA plan focuses on a specific activity (i.e., facilities, research activities, or development of prototype and test equipment). Activity leaders are accountable to the program leader or line manager funding the activity for the following:

• Preparing QA plans and implementing procedures that assure achievement of objectives and quality goals that are consistent with the cognizant Associate Director's policy.
• Implementing and monitoring plans to ensure that required actions are carried out to assure achievement of objectives and quality goals.
• Promptly correcting deviations from plans and/or modifying the plans/procedures to improve effectiveness.

UC has established a Health, Safety, and Environment Advisory Committee to assist in managing health, safety and environmental issues related to LLNL. In addition, at this time a UC staff person is assigned to the LLNL Livermore site to serve as a liaison and help ensure timely management oversight (LLNL, 1990a).

Quality assurance and quality control are integral parts of the operations of the Environmental Protection Department, Health Services Department, and Hazards Control Department. The quality of the environment, safety, and health programs is maintained and improved by comprehensive training courses developed and presented at LLNL. All program employees must meet the training requirements by completing general training courses and other courses pertinent to their fields. Training requirements include an initial employee orientation on the LLNL facilities. One of the primary topics of the new employee orientation training is a course describing the hazards to which workers may be exposed at LLNL; this course meets the requirements of OSHA 29 C.F.R. section 1910.1200. All employees are informed of the various health and safety hazards, including radiation (non-ionizing and ionizing), chemical, biological, and physical hazards. In addition, LLNL provides on-the-job employee development training in many environment, safety, and health topics.

The training courses given at LLNL are taught by qualified professionals and are an essential part of the LLNL environment, safety, and health training program. Some of the Health and Safety training courses must be satisfactorily completed before the employee is allowed to perform certain tasks or before using designated equipment. Examples include New Employee Safety Orientation; Health Hazard Communication; Working with Blood and Blood-Borne Pathogens; Laser Safety; Radiation Safety; Radiation Survey Instruments; Glovebox Safety; Chemical Hygiene; First Aid; Electrical Safety; Forklift Safety; Crane Safety; Pressure Safety; and Cardiopulmonary Resuscitation (CPR) (LLNL, 1991f, 1991k).

In addition to the courses given by the Hazards Control Department, the Environmental Protection Department requires certain training for their employees. These courses include Transuranic Waste Certification Program; Initial SARA/OSHA Training: Hazardous Waste Operations and Emergency Response (24hr/40hr) (29 C.F.R. section 1910.120); SARA/OSHA Supervisory Training; SARA/OSHA Field Experience; Annual SARA/OSHA Refresher Training; and Sewer Monitoring Alarm Station Training (LLNL, 1991n). All generators of hazardous waste are required to take a course on Hazardous Waste Handling Practices within 6 months of employment or of beginning to generate hazardous waste; they must repeat this course annually. Other courses include HE Waste Handling and TRU Waste Handling.

Workers in the Hazards Control Department and the Environmental Protection Department are also informed and instructed on an assortment of standards and procedures which guide and define their work activities. Standards and procedures used by environment, safety, and health staff are derived from either DOE orders and notices, or from other regulatory agencies' policies and procedures. For instance, the LLNL Environmental Protection Department has been using the NQA-1 standard instituted by ANSI/ASME and referenced in DOE Order 5700.6C as a guide for the development of their QA Program. This standard characterizes the quality assurance/quality control program for a nuclear facility. As will all LLNL staff, the LLNL environment, safety, and health staff must also comply with DOE directives which detail the requirements for environment, safety, and health programs.

Planning environment, safety, and health programs has been and is still an important aspect of LLNL operations. To plan environment, safety, and health programs, several documents have been prepared:

• Health and Safety Manual;
• Environmental Protection Manual;
• Facility Safety Procedures; and
• Operational Safety Procedures.

The Health and Safety Manual describes the policies and procedures that are used by LLNL personnel to ensure that they are adequately protected from work hazards they may encounter during their work activities. The initial chapters of the Health and Safety Manual deal with general policy and methods, and the later chapters deal with specific hazards and their control. This manual was written primarily to assist management personnel in the establishment and maintenance of the minimum-risk work environment acceptable to LLNL.

The Environmental Protection Handbook has been prepared to establish the Laboratory's Environmental Policy and to offer information on applicable environmental issues. This handbook consists of a series of guidance documents prepared by the Environmental Protection Department; each document combines relevant environmental regulations and Laboratory policy on specific environmental subjects.

There are two types of safety procedures used at LLNL: Facility Safety Procedures and Operational Safety Procedures. Both types of procedures address environment, safety and health concerns associated with a facility or operation. The Facility Safety Procedures describe the policies, procedures, and requirements not covered in the Health and Safety Manual, and they establish the basic safety rules that must be followed by all personnel within a specific facility or area. Each Facility Safety Procedure is reviewed every 3 years. Operational Safety Procedures are developed for specific operations. They are more limited in scope and more specific in content than Facility Safety Procedures. Operational Safety Procedures are primarily used by experimenters and establish specific procedures and policies for various operations requiring special attention to health and safety. If the facility is under the management of a separate directorate, the facility management must concur in approval of the Operational Safety Procedure. Each Operational Safety Procedure is reviewed annually and revised when appropriate.

Facility Safety Procedures and Operational Safety Procedures have been established to prevent injury and illness to LLNL personnel and to protect the environment. The purpose of developing safety procedures is to identify all potential hazards and to determine which steps must be taken to ensure that all potential hazards are controlled. All safety procedures are reviewed by designated reviewers and management. The safety procedures must be reviewed, modified if necessary, and approved before implementation. Each safety procedure is reviewed whenever an operational change causes it to become outdated (LLNL, 1990g). Safety procedures must be developed for designated activities. Before an operation begins, the responsible individual must verify that each participant has read and understands the relevant safety procedures (LLNL, 1990g). Individuals who are responsible for experiments and activities are also responsible for ensuring that all necessary safety precautions are taken. The person who is responsible for a proposed activity is also responsible for preparing the safety procedure.

LLNL has been appraised and audited by internal and external groups to assure that LLNL has been following DOE directives and the regulations and standards of other agencies. LLNL conducts many self-assessments of the environment, safety, and health programs. DOE and LLNL have conducted audits of various environment, safety, and health issues including the Tiger Team Assessment, Nuclear Safety Audits, Industrial Safety Appraisals, Industrial Hygiene Assessments, Technical Safety Appraisals, Health Physics Audits, Fire Protection Engineering Audits, Environmental Protection Audits, and Explosive Safety Appraisals. Other Health and Safety related appraisals include Criticality Safety Audits, Discipline Program Reviews, Safety Services Division Audits, and Standards Audits (LLNL, 1991j).

C.5.2.2 SNL, Livermore

The environment, safety, and health programs at SNL, Livermore are conducted by the Center for Environment, Safety, and Health and Facilities Management. Quality assurance and quality control are an integral part of the environment, safety, and health programs. Key areas of concern regarding quality include training requirements, standards and procedures used on a daily basis, and appraisals/audits (SNL, Livermore, 1991k, 1991h).

Training requirements for SNL, Livermore environment, safety, and health staff are similar to those at LLNL. When hired, all employees are required to attend an SNL, Livermore facility orientation that presents various hazards associated with the facility and additional requirements of the site. Specialized training is provided to assure that personnel achieve and maintain suitable proficiency in the quality-affecting activities they perform. Training is provided at SNL, Livermore by the Center for Environment, Safety, and Health and Facilities Management in compliance with their own requirements. Some of the courses include First Aid/Cardiopulmonary Resuscitation, Hazardous Waste Training, Hazards Communication Training, Respiratory Protection, and Radiation Safety.

It is the responsibility of the Center for Environment, Safety, and Health and Facilities Management Manager to assure that the Department Supervisors (or other applicable personnel) have ascertained that the staff has received complete training commensurate with the scope and complexity of their assigned tasks. It is the responsibility of the Department Supervisors to make sure that documentation is available to verify staff education and experience. Also, the Department Supervisors assure that the job proficiency of personnel performing quality-affecting activities is adequately monitored and is documented at least annually according to the personnel qualification system.

Compliance with the Center for Environment, Safety, and Health and Facilities Management's requirements is independently verified by persons or organizations not directly responsible for performing the quality-affecting activities. Independent verification methods include audits, surveillances, peer reviews, technical reviews, design reviews, and technical assessments. A Management Assurance Division has been established to conduct internal audits at SNL, Livermore. This organization reports directly to the Vice Presidential Environment, Safety and Health Council.

Several internal and external agency audits, assessments, and inspections of environment, safety, and health programs have been performed at SNL, Livermore. The adequacy and effectiveness of the QA Program are determined by conducting specific internal management assessments on a periodic basis (at least annually). These assessments consider the following:

• Effectiveness of controls that achieve and assure quality.
• Adequacy of resources and personnel provided to the Quality Assurance Program.
• Appropriateness of personnel training.

Audits and appraisals of the SNL, Livermore facility by DOE include the Tiger Team Assessment, Industrial Safety Appraisals, Industrial Hygiene Assessments, Technical Safety Appraisals, Health Physics Audits, Fire Protection Engineering Audits, and Explosive Safety Appraisals.

Procedures and standards used at SNL, Livermore concerning environment, safety, and health programs have been derived from either DOE directives or from standards-setting organizations. These standards and procedures are used as Safe Operating Procedures and Operating Procedures to assure that operations and activities are performed according to established methods and techniques.

C.5.3 The Tiger Team Assessments

In 1989, James D. Watkins, Secretary of Energy, established teams to assess environment, safety, and health at all DOE facilities in order to determine if changes were needed to improve the protection of the environment, safety, and health. These assessments have been referred to as the "Tiger Team Assessments."

During the period of February to May 1990, Tiger Teams assessed both LLNL and SNL, Livermore and made recommendations regarding the environment, safety, and health programs, including the quality assurance/quality control of some of these programs. Conclusions of the Tiger Team Assessments and actions to correct some of the important Tiger Team Assessment findings for both LLNL and SNL, Livermore are presented here. The assessment showed that at both Laboratories there were deficiencies in documentation and there was no formalized QA program for environment, safety, and health activities.

C.5.3.1 LLNL

Key Tiger Team Assessment Environment, Safety, and Health Findings

The Tiger Team Assessment identified a number of key findings and concerns in the area of quality assurance/quality control of environment, safety, and health programs. These findings were in the areas of environment, safety, and health, OSHA, and management. The findings were reviewed and analyzed by the Tiger Team; 15 environment, safety, and health quality related root causes were identified (DOE, 1990e). The root causes are presented in Table C-16.

In response to the 15 root causes identified by the Tiger Team Assessment as affecting the performance of QA in the environment, safety, and health programs, LLNL has already taken action, or is doing so, to ensure that these deficiencies are corrected. These actions include (LLNL, 1990a):

• Reinforcement by the Director of the assigned responsibility and accountability of the Associate Directors for environment, safety, and health and QA activities in their programs, and inclusion of environment, safety, and health performance in annual performance reviews of line managers.
• Development of a Laboratory management plan that describe strategies and define management and staff responsibilities for environment, safety, and health.
• Establishment within each programmatic and support directorate of an assurance function responsible for developing local policy and plans for the conduct of environment, safety, and health and related QA activities and monitoring their implementation.
• Requirements that all managers and supervisors participate in appropriate training and additional specialized training be provided for all employees.
• Establishment of an accounting process for Tiger Team Action Plan activities to identify and protect the necessary resources and to measure and monitor progress.
• Expansion of Operational Safety Procedures and Facility Safety Procedures, the fundamental documents that control hazardous operations in LLNL facilities, to include environment, health, maintenance, QA, and training requirements.

In addition, key actions have been or are being taken to enhance oversight of environment, safety, and health activities, which include:

• Appointment of a Deputy Director to assist the Director in discharging environment, safety, and health oversight responsibilities for both programmatic and institutional areas.
• Creation of an Environment, Safety, and Health Council, chaired by the Deputy Director and composed of nine Associate Directors, to recommend policy and review key environment, safety, and health issues.
• Formation of an Assurance Review Office, reporting to the Deputy Director, which has two functions: to ensure that timely assessments are conducted and follow-up actions are taken, and to conduct independent appraisals.
• Creation of the Plant Operations Directorate whose prime responsibility is environment, safety, and health support and which has sufficient resources to carry out its activities.
• Holding of weekly DOE/SAN and LLNL top management meetings to address environment, safety, and health topics.
• Increased DOE/SAN onsite presence to about 100 personnel to provide enhanced oversight of LLNL activities.

Table C-16 Findings of the 1990 Tiger Team Assessment

Source: LLNL, 1990a; SNL, Livermore 1991l.

C.5.3.2 SNL, Livermore

In the Tiger Team Assessment of SNL, Livermore, several findings and concerns were identified in the area of quality assurance/quality control of environment, safety, and health programs. These findings were in the areas of environment, safety, and health, OSHA, and management. These findings were reviewed and analyzed by the Tiger Team, resulting in the identification of six root causes (see Table C-16).

Actions to Correct the Tiger Team Assessment Findings at SNL, Livermore

SNL, Livermore has been and is currently addressing the Tiger Team's assessment findings. The actions to correct the identified Tiger Team assessments root causes include (SNL, Livermore, 1991l, 1991k):

• Establishment of a new structure to assist SNL, Livermore management in fulfilling its oversight responsibility for environment, safety, and health: a Vice Presidential Environmental Safety and Health Council. The Vice Presidential Environmental Safety and Health Council is chaired by the Vice President, SNL, Livermore site manager. Council members include all five of the SNL, Livermore line organization Directors; the Manager of the Center for Environment, Safety, and Health and Facilities Management; and the five staff members who have been appointed to directly assist line Directors in environment, safety, and health management. Formal reporting of environment, safety, and health program status to the Vice President. This will be handled by the newly formed Management Assurance Division. The Management Assurance Division is responsible for performing audits of line organizations to assure that they are completely fulfilling their line responsibilities and are in compliance with all SNL, Livermore requirements.
• The Environment, Safety, and Health Department was reorganized to establish separate Environmental Protection, Health Protection, and Safety Programs Departments.
• Institution of a control and release process for tracking the compliance of SNL, Livermore via the newly established Management Assurance Division. The Management Assurance Division will be responsible for monitoring the requirements of all internal self-assessments as well as all external audits such as those conducted by various DOE organizations and state and federal regulators.
• Comprehensive review of operational procedures to determine those to be documented and controlled. This will be accomplished by requesting technicians to write down, in checklist form, the steps taken to perform a specific procedure. The procedure will be compared to relevant Safety Operating Procedures to determine whether the procedures are being performed safely and correctly.

C.5.4 Other Organizations Performing Environmental Inspections and Appraisals at LLNL and SNL, Livermore

Planned and unannounced inspections and appraisals of the Environmental Programs have also been conducted by other agencies including EPA, California Department of Health Services, Alameda County Health Department, Bay Area Air Quality Management District, San Joaquin County Health Department, San Joaquin Unified Air Pollution Control District, Regional Water Quality Control Board (San Francisco Bay and Central Valley Regional Offices), and the Livermore Water Reclamation Plant (LLNL, 1991m).

In 1990 the DOE entered into an Agreement in Principle with the State of California. The specific provisions of the agreement have not been fully developed, but, in principle, the agreement provides the funds and mechanisms for the State to conduct environmental monitoring at any DOE facility within the State, with the purpose of providing independent oversight.