10 CFR Part 830 · GlobalLawDB

Contents

Subpart A · Subpart A—Quality Assurance Requirements

830.120Scope.#

This subpart establishes quality assurance requirements for contractors conducting activities, including providing items or services that affect, or may affect, nuclear safety of DOE nuclear facilities.

830.121Quality Assurance Program (QAP).#

(a)Contractors conducting activities, including providing items or services, that affect, or may affect, the nuclear safety of DOE nuclear facilities must conduct work in accordance with the Quality Assurance criteria in § 830.122.

(b)The contractor responsible for a DOE nuclear facility must:

(1)Submit a QAP to DOE for approval and regard the QAP as approved 90 days after submittal, unless it is approved or rejected by DOE at an earlier date.

(2)Modify the QAP as directed by DOE.

(3)Annually submit any changes to the DOE-approved QAP to DOE for approval. Justify in the submittal why the changes continue to satisfy the quality assurance requirements.

(4)Conduct work in accordance with the QAP.

(c)The QAP must:

(1)Describe how the quality assurance criteria of § 830.122 are satisfied.

(2)Integrate the quality assurance criteria with the Safety Management System, or describe how the quality assurance criteria apply to the Safety Management System.

(3)Use voluntary consensus standards in its development and implementation, where practicable and consistent with contractual and regulatory requirements, and identify the standards used.

(4)Describe how the contractor responsible for the nuclear facility ensures that subcontractors and suppliers satisfy the criteria of § 830.122.

830.122Quality assurance criteria.#

The QAP must address the following management, performance, and assessment criteria:

(a)Criterion 1—Management/Program. (1) Establish an organizational structure, functional responsibilities, levels of authority, and interfaces for those managing, performing, and assessing the work.

(2)Establish management processes, including planning, scheduling, and providing resources for the work.

(b)Criterion 2—Management/Personnel Training and Qualification. (1) Train and qualify personnel to be capable of performing their assigned work.

(2)Provide continuing training to personnel to maintain their job proficiency.

(c)Criterion 3—Management/Quality Improvement. (1) Establish and implement processes to detect and prevent quality problems.

(2)Identify, control, and correct items, services, and processes that do not meet established requirements.

(3)Identify the causes of problems and work to prevent recurrence as a part of correcting the problem.

(4)Review item characteristics, process implementation, and other quality-related information to identify items, services, and processes needing improvement.

(d)Criterion 4—Management/Documents and Records. (1) Prepare, review, approve, issue, use, and revise documents to prescribe processes, specify requirements, or establish design.

(2)Specify, prepare, review, approve, and maintain records.

(e)Criterion 5—Performance/Work Processes. (1) Perform work consistent with technical standards, administrative controls, and other hazard controls adopted to meet regulatory or contract requirements, using approved instructions, procedures, or other appropriate means.

(2)Identify and control items to ensure their proper use.

(3)Maintain items to prevent their damage, loss, or deterioration.

(4)Calibrate and maintain equipment used for process monitoring or data collection.

(f)Criterion 6—Performance/Design. (1) Design items and processes using sound engineering/scientific principles and appropriate standards.

(2)Incorporate applicable requirements and design bases in design work and design changes.

(3)Identify and control design interfaces.

(4)Verify or validate the adequacy of design products using individuals or groups other than those who performed the work.

(5)Verify or validate work before approval and implementation of the design.

(g)Criterion 7—Performance/Procurement. (1) Procure items and services that meet established requirements and perform as specified.

(2)Evaluate and select prospective suppliers on the basis of specified criteria. Establish and implement processes to ensure that approved suppliers continue to provide acceptable items and services.

(h)Criterion 8—Performance/Inspection and Acceptance Testing. (1) Inspect and test specified items, services, and processes using established acceptance and performance criteria.

(2)Calibrate and maintain equipment used for inspections and tests.

(i)Criterion 9—Assessment/Management Assessment. Ensure managers assess their management processes and identify and correct problems that hinder the organization from achieving its objectives.

(j)Criterion 10—Assessment/Independent Assessment. (1) Plan and conduct independent assessments to measure item and service quality, to measure the adequacy of work performance, and to promote improvement.

(2)Establish sufficient authority, and freedom from line management, for the group performing independent assessments.

(3)Ensure persons who perform independent assessments are technically qualified and knowledgeable in the areas to be assessed.

Subpart B · Subpart B—Safety Basis Requirements

830.200Scope.#

This Subpart establishes safety basis requirements for Hazard Category 1, 2, and 3 DOE nuclear facilities.

830.201Performance of work.#

A contractor must perform work in accordance with the DOE-approved safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility and, in particular, with the hazard controls that ensure adequate protection of workers, the public, and the environment.

830.202Safety basis.#

(a)The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must establish and maintain the safety basis for the facility.

(b)In establishing the safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the facility must:

(1)Define the scope of the work to be performed;

(2)Identify and analyze the hazards associated with the work;

(3)Categorize the facility consistent with DOE-STD-1027-92 (“Hazard Categorization and Accident Analysis Techniques for compliance with DOE Order 5480.23, Nuclear Safety Analysis Reports,” Change Notice 1, September 1997);

(4)Prepare a documented safety analysis for the facility; and

(5)Establish the hazard controls upon which the contractor will rely to ensure adequate protection of workers, the public, and the environment.

(c)In maintaining the safety basis for a Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the facility must:

(1)Update the safety basis to keep it current and to reflect changes in the facility, the work and the hazards as they are analyzed in the documented safety analysis;

(2)Annually provide DOE the current documented safety analysis or a letter stating that there have been no changes in the documented safety analysis since the prior submittal; and

(3)Incorporate in the safety basis any changes, conditions, or hazard controls directed by DOE.

830.203Unreviewed safety question process.#

(a)The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must establish, implement, and take actions consistent with a DOE-approved USQ procedure that meets the requirements of this section.

(b)The contractor responsible for a new Hazard Category 1, 2, or 3 DOE nuclear facility must submit for DOE approval a procedure for its USQ process on a schedule that allows DOE approval in a safety evaluation report issued pursuant to § 830. 207(a) of this part.

(c)The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must implement the DOE-approved USQ procedure in situations where there is a:

(1)Temporary or permanent change in the facility as described in the existing documented safety analysis;

(2)Temporary or permanent change in the procedures as described in the existing documented safety analysis;

(3)Test or experiment not described in the existing documented safety analysis; or

(4)Potential inadequacy of the documented safety analysis because the analysis potentially may not be bounding or may be otherwise inadequate.

(d)A contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must obtain DOE approval prior to taking any action determined to involve a USQ.

(e)The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must annually provide to DOE a summary of the USQ determinations performed since the prior submittal.

(f)If a contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility discovers or is made aware of a potential inadequacy of the documented safety analysis, it must:

(1)Take action, as appropriate, to place or maintain the facility in a safe condition until an evaluation of the safety of the situation is completed;

(2)Notify DOE of the situation;

(3)Perform a USQ determination and notify DOE promptly of the results; and

(4)Submit the evaluation of the safety of the situation to DOE prior to removing any operational restrictions initiated to meet paragraph (f)(1) of this section.

830.204Documented safety analysis.#

(a)The contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must obtain approval from DOE for the methodology used to prepare the documented safety analysis for the facility unless the contractor uses a methodology set forth in Table 1 of Appendix A to this part.

(b)The documented safety analysis for a Hazard Category 1, 2, or 3 DOE nuclear facility must, as appropriate for the complexities and hazards associated with the facility:

(1)Describe the facility (including the design of safety structures, systems and components) and the work to be performed;

(2)Provide a systematic identification of both natural and man-made hazards associated with the facility;

(3)Evaluate normal, abnormal, and accident conditions, including consideration of natural and man-made external events, identification of energy sources or processes that might contribute to the generation or uncontrolled release of radioactive and other hazardous materials, and consideration of the need for analysis of accidents which may be beyond the design basis of the facility;

(4)Derive the hazard controls necessary to ensure adequate protection of workers, the public, and the environment, demonstrate the adequacy of these controls to eliminate, limit, or mitigate identified hazards, and define the process for maintaining the hazard controls current at all times and controlling their use;

(5)Define the characteristics of the safety management programs necessary to ensure the safe operation of the facility, including (where applicable) quality assurance, procedures, maintenance, personnel training, conduct of operations, emergency preparedness, fire protection, waste management, and radiation protection; and

(6)With respect to a nonreactor nuclear facility with fissionable material in a form and amount sufficient to pose a potential for criticality, define a criticality safety program that:

(i)Ensures that operations with fissionable material remain subcritical under all normal and credible abnormal conditions;

(ii)Identifies applicable nuclear criticality safety standards; and

(iii)Describes how the program meets applicable nuclear criticality safety standards.

830.205Technical safety requirements.#

(a)A contractor responsible for a Hazard Category 1, 2, or 3 DOE nuclear facility must:

(1)Develop technical safety requirements that are derived from the documented safety analysis;

(2)Prior to use, obtain DOE approval of technical safety requirements and any change to technical safety requirements; and

(3)Notify DOE of any violation of a technical safety requirement.

(b)A contractor may take emergency actions that depart from an approved technical safety requirement when no actions consistent with the technical safety requirement are immediately apparent, and when these actions are needed to protect workers, the public or the environment from imminent and significant harm. Such actions must be approved by a certified operator for a reactor or by a person in authority as designated in the technical safety requirements for nonreactor nuclear facilities. The contractor must report the emergency actions to DOE as soon as practicable.

(c)A contractor for an environmental restoration activity may follow the provisions of 29 CFR 1910.120 or 29 CFR 1926.65 to develop the appropriate hazard controls (rather than the provisions for technical safety requirements in paragraph (a) of this section), provided the activity involves either:

(1)Work not done within a permanent structure, or

(2)The decommissioning of a facility with only low-level residual fixed radioactivity.

830.206Preliminary documented safety analysis.#

Prior to construction of a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the design and construction of the new facility or major modification must:

(a)Prepare a preliminary documented safety analysis for the facility, and

(b)Obtain DOE approval of:

(1)The nuclear safety design criteria to be used in preparing the preliminary documented safety analysis unless the contractor uses the design criteria in DOE Order 420.1, Facility Safety, or successor document; and

(2)The preliminary documented safety analysis before the contractor can procure materials or components or begin construction; provided that DOE may authorize the contractor to perform limited procurement and construction activities without approval of a preliminary documented safety analysis if DOE determines that the activities are not detrimental to public health and safety and are in the best interests of DOE.

830.207DOE approval of safety basis.#

(a)With respect to a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility, a contractor may not begin operation of the facility or modification prior to the issuance of a safety evaluation report in which DOE approves the safety basis for the facility or modification.

(b)Pending issuance of a safety evaluation report in which DOE approves an updated or amended safety basis for an existing Hazard Category 1, 2, or 3 DOE nuclear facility, the contractor responsible for the facility must continue to perform work in accordance with the DOE-approved safety basis for the facility and maintain the existing safety basis consistent with the requirements of this Subpart.

830.1Scope.#

This part governs the conduct of DOE contractors, DOE personnel, and other persons conducting activities (including providing items and services) that affect, or may affect, the safety of DOE nuclear facilities.

830.2Exclusions.#

This part does not apply to:

(a)Activities that are regulated through a license by the Nuclear Regulatory Commission (NRC) or a State under an Agreement with the NRC, including activities certified by the NRC under section 1701 of the Atomic Energy Act (Act);

(b)Activities conducted under the authority of the Director, Naval Nuclear Propulsion, pursuant to Executive Order 12344, as set forth in Public Law 106- 65;

(c)Transportation activities which are regulated by the Department of Transportation;

(d)Activities conducted under the Nuclear Waste Policy Act of 1982, as amended, and any facility identified under section 202(5) of the Energy Reorganization Act of 1974, as amended; and

(e)Activities related to the launch approval and actual launch of nuclear energy systems into space.

830.3Definitions.#

(a)The following definitions apply to this part: Administrative controls means the provisions relating to organization and management, procedures, recordkeeping, assessment, and reporting necessary to ensure safe operation of a facility. Bases appendix means an appendix that describes the basis of the limits and other requirements in technical safety requirements. Critical assembly means special nuclear devices designed and used to sustain nuclear reactions, which may be subject to frequent core and lattice configuration change and which frequently may be used as mockups of reactor configurations. Criticality means the condition in which a nuclear fission chain reaction becomes self-sustaining. Design features means the design features of a nuclear facility specified in the technical safety requirements that, if altered or modified, would have a significant effect on safe operation. Document means recorded information that describes, specifies, reports, certifies, requires, or provides data or results. Documented safety analysis means a documented analysis of the extent to which a nuclear facility can be operated safely with respect to workers, the public, and the environment, including a description of the conditions, safe boundaries, and hazard controls that provide the basis for ensuring safety. Environmental restoration activities means the process(es) by which contaminated sites and facilities are identified and characterized and by which contamination is contained, treated, or removed and disposed. Fissionable materials means a nuclide capable of sustaining a neutron-induced chain reaction (e.g., uranium-233, uranium-235, plutonium-238, plutonium-239, plutonium-241, neptunium-237, americium-241, and curium-244). Graded approach means the process of ensuring that the level of analysis, documentation, and actions used to comply with a requirement in this part are commensurate with:

(1)The probability of the occurrence or the consequences of an accident or the malfunction of equipment important to safety previously evaluated in the documented safety analysis could be increased;

(2)The possibility of an accident or malfunction of a different type than any evaluated previously in the documented safety analysis could be created; or

(3)The documented safety analysis may not be bounding or may be otherwise inadequate. Unreviewed Safety Question process means the mechanism for keeping a safety basis current by reviewing potential unreviewed safety questions, reporting unreviewed safety questions to DOE, and obtaining approval from DOE prior to taking any action that involves an unreviewed safety question. Use and application provisions means the basic instructions for applying technical safety requirements.

(4)Technical safety requirements; and

(5)Other controls necessary to provide adequate protection from hazards. Item is an all-inclusive term used in place of any of the following: Appurtenance, assembly, component, equipment, material, module, part, product, structure, subassembly, subsystem, system, unit, or support systems. Limiting conditions for operation means the limits that represent the lowest functional capability or performance level of safety structures, systems, and components required for safe operations. Limiting control settings means the settings on safety systems that control process variables to prevent exceeding a safety limit. Low-level residual fixed radioactivity means the remaining radioactivity following reasonable efforts to remove radioactive systems, components, and stored materials. The remaining radioactivity is composed of surface contamination that is fixed following chemical cleaning or some similar process; a component of surface contamination that can be picked up by smears; or activated materials within structures. The radioactivity can be characterized as low-level if the smearable radioactivity is less than the values defined for removable contamination by 10 CFR part 835, Appendix D, Surface Contamination Values, and the hazard analysis results show that no credible accident scenario or work practices would release the remaining fixed radioactivity or activation components at levels that would prudently require the use of active safety systems, structures, or components to prevent or mitigate a release of radioactive materials. Major modification means a modification to a DOE nuclear facility that substantially changes the existing safety basis for the facility. New Hazard Category 1, 2, and 3 DOE nuclear facility means a Hazard Category 1, 2, or 3 DOE nuclear facility that is in design or under construction that does not yet have a DOE approved safety basis. Nonreactor nuclear facility means those facilities, activities or operations that involve, or will involve, radioactive and/or fissionable materials in such form and quantity that a nuclear or a nuclear explosive hazard potentially exists to workers, the public, or the environment, but does not include accelerators and their operations and does not include activities involving only incidental use and generation of radioactive materials or radiation such as check and calibration sources, use of radioactive sources in research and experimental and analytical laboratory activities, electron microscopes, and X-ray machines. Nuclear facility means a reactor or a nonreactor nuclear facility where an activity is conducted for or on behalf of DOE and includes any related area, structure, facility, or activity to the extent necessary to ensure proper implementation of the requirements established by this Part. Operating limits means those limits required to ensure the safe operation of a nuclear facility, including limiting control settings and limiting conditions for operation. Preliminary documented safety analysis means documentation prepared in connection with the design and construction of a new Hazard Category 1, 2, or 3 DOE nuclear facility or a major modification to an existing Hazard Category 1, 2, or 3 DOE nuclear facility that provides a reasonable basis for the preliminary conclusion that the nuclear facility can be operated safely through the consideration of factors such as:

(6)The relative importance of radiological and nonradiological hazards; and

(7)Any other relevant factor. Hazard means a source of danger (i.e., material, energy source, or operation) with the potential to cause illness, injury, or death to a person or damage to a facility or to the environment (without regard to the likelihood or credibility of accident scenarios or consequence mitigation). Hazard Category 1, 2, and 3 DOE nuclear facilities means nuclear facilities that meet the criteria for their respective hazard category consistent with the provisions of DOE-STD-1027-92, Change Notice 1. Hazard Category 1, 2, and 3 DOE nuclear facilities are required to have safety bases established in accordance with Subpart B of this part. Hazard categories are based on their radioactive material inventories and the potential consequences to the public, workers, and the environment. Hazard Category 1 represents the highest potential consequence and Hazard Category 3 represents the lowest potential consequence of the facilities required to establish safety bases. Hazard controls means measures to eliminate, limit, or mitigate hazards to workers, the public, or the environment, including:

(b)Terms defined in the Act or in 10 CFR part 820 and not defined in this section of the rule are to be used consistent with the meanings given in the Act or in 10 CFR part 820.

830.4General requirements.#

(a)No person may take or cause to be taken any action inconsistent with the requirements of this part.

(b)A contractor responsible for a nuclear facility must ensure implementation of, and compliance with, the requirements of this part.

(c)The requirements of this part must be implemented in a manner that provides reasonable assurance of adequate protection of workers, the public, and the environment from adverse consequences, taking into account the work to be performed and the associated hazards.

(d)If there is no contractor for a DOE nuclear facility, DOE must ensure implementation of, and compliance with, the requirements of this part.

830.5Enforcement.#

The requirements in this part are DOE Nuclear Safety Requirements and are subject to enforcement by all appropriate means, including the imposition of civil and criminal penalties in accordance with the provisions of 10 CFR part 820.

830.6Recordkeeping.#

A contractor must maintain complete and accurate records as necessary to substantiate compliance with the requirements of this part.

830.7Graded approach.#

Where appropriate, a contractor must use a graded approach to implement the requirements of this part, document the basis of the graded approach used, and submit that documentation to DOE. The graded approach may not be used in implementing the unreviewed safety question (USQ) process or in implementing technical safety requirements.

United States Government work; public domain under 17 U.S.C. § 105.

Subpart A · Subpart A&#x2014;Quality Assurance Requirements