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that the nuclear facility can be oper- rial exposure to the public, as deterated safely through the consideration mined from safety analyses. of factors such as

Safety evaluation report means the re(1) The nuclear safety design criteria

port prepared by DOE to document to be satisfied;

(1) The sufficiency of the documented (2) A safety analysis that derives as

safety analysis for a hazard category 1, pects of design that are necessary to

2, or 3 DOE nuclear facility; satisfy the nuclear safety design cri

(2) The extent to which a contractor teria; and (3) An initial listing of the safety

has satisfied the requirements of Submanagement programs that must be

part B of this part; and developed to address operational safety

(3) The basis for approval by DOE of considerations.

the safety basis for the facility, includProcess means a series of actions that ing any conditions for approval. achieves an end or result.

Safety limits means the limits on Quality means the condition achieved process variables associated with those when an item, service, or process meets safety class physical barriers, genor exceeds the user's requirements and

erally passive, that are necessary for expectations.

the intended facility function and that Quality assurance means all those ac

are required to guard against the untions that provide confidence that

controlled release of radioactive matequality is achieved.

rials. Quality Assurance Program (QAP)

Safety management program means a means the overall program or management system established to assign re

program designed to ensure a facility is sponsibilities and authorities, define

operated in a manner that adequately policies and requirements, and provide

protects workers, the public, and the for the performance and assessment of environment by covering a topic such work.

as: quality assurance; maintenance of Reactor means any apparatus that is safety systems; personnel training; designed or used to sustain nuclear conduct of operations; inadvertent chain reactions in a controlled manner criticality protection; emergency presuch as research, test, and power reac paredness; fire protection; waste mantors, and critical and pulsed assemblies agement; or radiological protection of and any assembly that is designed to workers, the public, and the environperform subcritical experiments that

ment. could potentially reach criticality;

Safety management system means an and, unless modified by words such as

integrated safety management system containment, vessel, or core, refers to

established consistent with 48 CFR the entire facility, including the hous

970.5223-1. ing, equipment and associated areas devoted to the operation and mainte

Safety significant structures, systems, nance of one or more reactor cores.

and components means the structures, Record means a completed document

systems, and components which are or other media that provides objective

not designated as safety class strucevidence of an item, service, or process.

tures, systems, and components, but Safety basis means the documented whose preventive or mitigative funcsafety analysis and hazard controls tion is a major contributor to defer that provide reasonable assurance that in depth and/or worker safety as detera DOE nuclear facility can be operated mined from safety analyses. safely in a manner that adequately Safety structures, systems, and compoprotects workers, the public, and the

nents means both safety class strucenvironment.

tures, systems, and components and Safety class structures, systems, and

safety significant structures, systems, components means the structures, sys

and components. tems, or components, including por

Service means the performance of tions of process systems, whose preven

work, such as design, manufacturing, tive or mitigative function is necessary

construction, fabrication, assembly, to limit radioactive hazardous mate

decontamination, environmental res- Use and application provisions means toration, waste management, labora- the basic instructions for applying tory sample analyses, inspection, non- technical safety requirements. destructive examination/testing, envi (b) Terms defined in the Act or in 10 ronmental qualification, equipment CFR Part 820 and not defined in this qualification, repair, installation, or section of the rule are to be used conthe like.

sistent with the meanings given in the Surveillance requirements means re- Act or in 10 CFR Part 820. quirements relating to test, calibration, or inspection to ensure that the $830.4 General requirements. necessary operability and quality of (a) No person may take or cause to be safety structures, systems, and compo

taken any action inconsistent with the nents and their support systems re

requirements of this part. quired for safe operations are main

(b) A contractor responsible for a nutained, that facility operation is within

clear facility must ensure implementasafety limits, and that limiting control

tion of, and compliance with, the resettings and limiting conditions for op

quirements of this part. eration are met.

(c) The requirements of this part Technical safety requirements (TSRs)

must be implemented in a manner that means the limits, controls, and related

provides reasonable assurance of adeactions that establish the specific pa

quate protection of workers, the pubrameters and requisite actions for the

lic, and the environment from adverse safe operation of a nuclear facility and

consequences, taking into account the include, as appropriate for the work

work to be performed and the associand the hazards identified in the docu

ated hazards. mented safety analysis for the facility:

(d) If there is no contractor for a Safety limits, operating limits, surveil

DOE nuclear facility, DOE must ensure lance requirements, administrative and

implementation of, and compliance management controls, use and applica

with, the requirements of this part. tion provisions, and design features, as well as a bases appendix.

8830.5 Enforcement. Unreviewed Safety Question (USD) means a situation where

The requirements in this part are (1) The probability of the occurrence

DOE Nuclear Safety Requirements and or the consequences of an accident or

are subject to enforcement by all apthe malfunction of equipment impor

propriate means, including the impositant to safety previously evaluated in

tion of civil and criminal penalties in the documented safety analysis could

accordance with the provisions of 10 be increased;

CFR Part 820. (2) The possibility of an accident or

8830.6 Recordkeeping. malfunction of a different type than any evaluated previously in the docu

A contractor must maintain commented safety analysis could be cre plete and accurate records as necessary ated;

to substantiate compliance with the re(3) A margin of safety could be re- quirements of this part. duced; or (4) The documented safety analysis

$ 830.7 Graded approach. may not be bounding or may be other Where appropriate, a contractor wise inadequate.

must use a graded approach to impleUnreviewed Safety Question process ment the requirements of this part, means the mechanism for keeping a document the basis of the graded apsafety basis current by reviewing po- proach used, and submit that docutential unreviewed safety questions, re mentation to DOE. The graded apporting unreviewed safety questions to proach may not be used in impleDOE, and obtaining approval from DOE menting the unreviewed safety quesprior to taking any action that in- tion (USQ) process or in implementing volves an unreviewed safety question technical safety requirements.

Subpart A-Quality Assurance

Requirements

8830.120 Scope.

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.

8 830.121 Quality 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 8830.122.

(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 8 830.122 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.

(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 qualityrelated information to identify items, services, and processes needing improvement.

(d) Criterion 4Management/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.

$ 830.122 Quality assurance criteria.

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

Subpart B-Satety Basis

Requirements $830.200 Scope.

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

$830.201 Performance of work.

A contractor must perform work in accordance with the 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.

(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.

(3) Establish and implement processes to ensure that approved suppliers continue to provide acceptable items and services.

(h) Criterion & 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 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 inde pendent assessments are technically qualified and knowledgeable in the areas to be assessed.

$ 830.202 Safety 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 submit to DOE either the updated documented safety analysis for approval or a letter stating that there have been no changes in the documented safety analysis since the prior submission; and

(3) Incorporate in the safety basis a summary of the USQ determinations any changes, conditions, or hazard con- performed since the prior submission. trols directed by DOE.

(g) If a contractor responsible for a

hazard category 1, 2, or 3 DOE nuclear 8830.203 Unreviewed safety question facility discovers or is made aware of a process.

potential inadequacy of the docu(a) The contractor responsible for a mented safety analysis, it must: hazard category 1, 2, or 3 DOE nuclear (1) Take action, as appropriate, to facility must establish, implement, and place or maintain the facility in a safe take actions consistent with a USQ condition until an evaluation of the process that meets the requirements of safety of the situation is completed; this section.

(2) Notify DOE of the situation; (b) The contractor responsible for a (3) Perform a USQ determination and hazard category 1, 2, or 3 DOE existing notify DOE promptly of the results; nuclear facility must submit for DOE and (4) Submit the evaluation of the approval a procedure for its USQ proc safety of the situation to DOE prior to ess by April 10, 2001. Pending DOE ap removing any operational restrictions proval of the USQ procedure, the con- initiated to meet paragraph (g)(1) of tractor must continue to use its exist this section. ing USQ procedure. If the existing procedure already meets the requirements

$ 830.204 Documented safety analysis. of this section, the contractor must no- (a) The contractor responsible for a tify DOE by April 10, 2001 and request hazard category 1, 2, or 3 DOE nuclear that DOE issue an approval of the ex facility must obtain approval from isting procedure.

DOE for the methodology used to pre(c) The contractor responsible for a pare the documented safety analysis hazard category 1, 2, or 3 DOE new nu for the facility unless the contractor clear facility must submit for DOE ap- uses a methodology set forth in Table 2 proval a procedure for its USQ process of Appendix A to this part on a schedule that allows DOE ap- (b) The documented safety analysis proval in a safety evaluation report for a hazard category 1, 2, or 3 DOE nuissued pursuant to section 207(d) of this clear facility must, as appropriate for Part.

the complexities and hazards associ(d) The contractor responsible for a ated with the facility: hazard category 1, 2, or 3 DOE nuclear (1) Describe the facility (including facility must implement the DOE-ap- the design of safety structures, sysproved USQ procedure in situations tems and components) and the work to where there is a:

be performed; (1) Temporary or permanent change (2) Provide a systematic identificain the facility as described in the exist tion of both natural and man-made ing documented safety analysis;

hazards associated with the facility; (2) Temporary or permanent change (3) Evaluate normal, abnormal, and in the procedures as described in the accident conditions, including considexisting documented safety analysis; eration of natural and man-made exter

(3) Test or experiment not described nal events, identification of energy in the existing documented safety anal sources or processes that might conysis; or (4) Potential inadequacy of the tribute to the generation or uncondocumented safety analysis because trolled release of radioactive and other the analysis potentially may not be hazardous materials, and consideration bounding or may be otherwise inad of the need for analysis of accidents equate.

which may be beyond the design basis (e) A contractor responsible for a of the facility; hazard category 1, 2, or 3 DOE nuclear (4) Derive the hazard controls necfacility must obtain DOE approval essary to ensure adequate protection of prior to taking any action determined workers, the public, and the environto involve a USQ.

ment, demonstrate the adequacy of (f) The contractor responsible for a these controls to eliminate, limit, or hazard category 1, 2, or 3 DOE nuclear mitigate identified hazards, and define facility must annually submit to DOE the process for maintaining the hazard

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