ML20237B922

Quality Assurance Guidance for LOW-LEVEL Radioactive Waste Disposal Facility.Draft for Comment

ML20237B922
Person / Time
Issue date:	11/30/1987
From:	Pittiglio C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS)
To:
References
NUREG-1293, NUREG-1293-DRFT, NUREG-1293-DRFT-FC, NUDOCS 8712170240
Download: ML20237B922 (13)

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Quality Assurance Guidance 1

. for Low-Level Radioactive i Waste: Disposal Facility q F

$ Draft for Comment:

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. Commission l Office of Nuclear Material Safety and Safeguards C. L. Pittiglio, Jr.

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NOTICE Availability of Reference Materials Cited in NRC Publications Must documents cited in NRC publications will be available from one of the following sources: <

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1. ' The NRC Public Document Room,1717 H Street, N.W.

. Washington, DC 20555

2. The Superintendent of Documents. U.S.' Government Printing Office, Post Office Box 37082, Washington, DC 20013-7082

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3. The National Technical Information Service, Springfield, VA 22161 i

. Although the listing that follows represents the majority of documents cited in NRC publications, it is not intended to be exhaustive. j Referenced documents available for inspection and copying for a fee from the NRC Public Docu- '(

ment Room include NRC correspondence and internal NRC memoranda; NRC Office of Inspection and Enforcement bulletins, circulars, information notices, inspection and investigation notices;  ;

Licensee Event Reports; vendor reports and correspondence; Commission papers; and applicant and licensee documents and correspondence.

The following documents in the NUREG series are available for purchase from the GPO Sales Program: formal 9RC staff and contractor reports, NRC-sponsored conference proceedings, and NRC bookiats and brochures. Also available are Regulatory Guides, NRC regulations in the Code of Federal Regulations, and Nuclear Regulatory Commission issuances.

Documents available frorn the National Technical Information Service include NUREG series reports and technical reports prepared by other federal agencies and reports prepared by the Atomic Energy Commission, forerunner agency to the Nuclear Regulatory Commission.

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Copies of industry codes and standards used in a substantive manner in the NRC regulatory process are maintained at the NRC Library,7920 Norfolk Avenue, Bethesda, Maryland, and are available there for reference use by the public. Codes and standards are usue,lly copyrighted and may be purchased from the originating organization or, if they are American National Standard *, from the American National Standards institute,1430 Broadway, New York, NY 10018.

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Quality Assurance Guidance '

) for Low-Level Radioactive

) Waste Disposal Facility I

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} Draft for Comment Manuscript Completed: November 1987 Date Published: November 1987 f C. L. Pittiglio, Jr.

2 Division of Low-Level Waste Management and Decommissioning Office of Nuclear Materia! Safety and Safeguards U.S. Nuclear Regulatory Commission I Washington, DC 20555 f .". %,,

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l ABSTRACT l

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This docement provides guidance to an applicant on development of a lw-level waste (LLW) disposal facility in meeting the quality control (QC) require,r.?nts of 10 CFR 61.12. The QC requirements are the basis for developing of a quality assurance (QA) prograin and for the guidance p;evided herein. The criteria developed for this document are similar to the criteria developed for 10 CFR Part 50 Appendix B. Although Appendix B of 10 CFR Pcrt 50 is not a regulatory requirement for an LLW disposal facility, the critaria that were developed for 10 CFR Part 50 are besic to any QA program. The document specifically establishes j QA guidance for tiie design, construction, and operation of those structures, systems, corrponents, as well as, for site characterization activities nece:sary to meet the perfor. nance objectives .of 10 CFR Part 61 and to limit exposure to or release of radioacti.'ity.

l l This document is issued as a draft and comments are requested. After the

! comments are revicwed and analyzed, the decument will be revised. This draft was reviewed by the NRC staff, an NRC consultant, and personnel from the Idaho National Engineering Laboratory.

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TABLE OF CONTENTS P_ajte 7 ABSTRACT .............. .......................................... iii l

! I. INTRODUCTION ................................................ 1-1

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II. QUALITY LEVELS ................................... .......... II-1

1. Application of Quality Assurance To Ensure Performance l Objectives Are Met ............ ........................ 11-1

2. Quality Classification Definitions ..................... 11-1

3. Quality Level Identification ........................... 11-2

4. Quality Assurance Program Application Based on Assigned Quality Level ...... ................................... II-2 l

III-1 III. QUALITY ASSURANCE CRITERIA ... ..............................

1. Organization ..... ..................... .......... .... III-1

2. Quality Assurance Program .............................. 111-1

3. Design Cortrols ..................................... .. III-2

4. Procurement Document Control ............. ............. III-3

5. Instructions, Procedures, and Drawings ........... ..... III-4

6. Document Control .......... ............................ III-5

7. Control of Purchased Material, Equipment, and Services . III-5

) 8. Identification and Control of Material, Parts, l

and Components ... ........ .......... ................. III-6

9. Control of Processes ................................... III-6

10. Inspection ............ ............................... III-6

11. Test Control ... . ................................... . III-7

12. Control of Measuring and Test Equipment ................ III-7

13. Handling, Storage, and Shippino ..................... .. III-8

14. Inspection, Test, and Operating Status ................ III-8

15. Nonconforming Materials, Parts, or Components .......... III-9

16. Corrective Actions ..................................... III-9

17. Quality Assurance Records . ....... .................... III-9

18. Audits, Surveillance, and Managerial Controls ......... III-9 l

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NUREG-1293 v

I. INTRODUCTION I The NRC staff prepared this quality assurance (QA) guidance document for appli-cation in the development of low-level waste (LLW) disposal facilities. This document provides' guidance to an applicant in meeting the quality control (QC)

! requirements of 10 CFR 61.12. The QC regulations (10 CFR 61.12(j)) require ,

! that a license application for an LLW facility include a description of the QC

i program to be applied to determining the characteristics of a natural disposal *

! site. The regulation also requires a QC program during design, construction, l operation, and closure of the land disposal facility and the receipt, handling, ,

I and emplacement of waste. Audits, and managerial controls must be included. .

The requirements stated in 10 CFR 61.12(j) provide the bases for developing  ; '

a QA program and the guidance provided herein. <

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The criteria developed for this document are similar to the criteria developed for Appendix B of 10 CFR Part 50. Although Appendix B of 10 CFR Part 50 is not a regulatory requirement for on LLW disposal facility, the criteria that were i developed for 10 CFR Part 50 are basic to any QA program. Some of the criteria addressed here are identical to criteria addressed in 10 CFR Part 50; some of the criteria addressed here have been modified to address an LLW disposal -3 facility, s

This document establishes QA guidance for any activity, structure, system, or

component that is required to meet the performance objectives of 10 CFR Part 61 and to limit exposure to or releases of radioactivity. This document specifically establishes QA guidance for the design, construction, and operation of those

• structures, systems, and components as well as site characterization activities.

The pertinent guidance contained in this document applies to all activities affecting the performance of the above mentioned requirements. These include designing, purchasing, f abricating, erecting, installing, and cleaning activ-ities; inspecting, testing, operating, receiving, handling, and emplacing waste; ,

as well as closure and active maintenance.

QA is defined in regulations, codes, and standards as comprising all those ,

planned and systematic actions necessary to prove that a structure, system, or component will perform satisfactorily in service. When the product is a report s of a significant study or investigation, Qi also comprises those planned and systematic actions necessary to provide adeanate confidence in the validity and ,

integrity of the reported data, methods and procedures and in the protection, '

retrievability, and possible replicability of the data. QA includes a multi-disciplinary system of management centrols backed by quality verification and

) overview activities that demonstrate completeness and appropriateness of '

achieved quality.

Chapter 9 of NUREG-1199, Standard Format and Content of a License Application for Low-Leve: Radioactive Waste Disporal Facility," and Chapter 9 of NUREG-1200, l " Standard Review Plans for Review of a License Application for a Low-level .

l Radioactive W ste Disposal Facility," will be revised to reflect the applica-tion of the QA guidance provided herein.

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y II. QUALITY LEVELS l-

1. Application of Quality Assurance To Ensure Performance Objectives Are Met i

Management systems must be designed and documented in the form of policies, procedures, and instructions to ensure meeting the performance objectives of 10 CFR Part 61 and to limit exposure to or releases of radioactivity. The L integrated plans, procedures, and instructions necessary to meet these require'-

l ments make up the QA program. The degree of control to be exercised by manage-l ment will be determined by the importance of the data being gathered and/or

! the product produced in relation to meeting the performance objectives of p 10 CFR Part 61 or required to limit the exposure to or releases of radioactivity.

One method to assist in early planning of the degree of management controls to be exercised is to analyze wt.% activities to determine the importance of the l' activities in relation to attaining and demonstrating attainment of performance objectives. By careful, up-front analysis of the work activities to be per-p formed, work controls vill be appropriately planned and applied, to obtain an appropriate level of QA.

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2. Quality Classification Definitions To assist in identifying and reporting work activities that must have more rigid management controls from those mrk activities that need more flexible or limited controls, a system to categorize work activities is recommended. Within the industry, there are several categorization systems in use. The categorization system described bclow provides for two levels, although the applicant may propose a single or multi-level system. The important factor is the identifica-tion and control of any activities that are required to meet the performance objectives of'10 CFR Part 61 or required to limit exposure to or releases of radioactivity, 2.1 Classification The relative extent of the application of the QA program to ensure the intended

! performance of a designated system, structure, component, or activity is identi-fied by the consequence of the failure of the designated system, structure, component or activity. Quality levels denoted A and B are assigned by the applicant using the following considerations. Items or activities identified as level A require' the more rigia management controls; level B items or activ-ities require more flexible management' controls because the work activities assigned to that level have little or no impact upon meeting the performance 3

objectives, but are required to limit exposure to or releases of radioactivity.

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2. 2 Quality Level A Systems, structures, components, or activities v. hose f ailure would result in, or have the potential to result in not meeting the performance objectives of  !

10 CFR Part 61 are designated as quality level A. d Quality level A' requires the applicant to implement the applicable 18 criteria f defined in this document. It is the responsibility of the applicant to deter- (

mine the scope of the planned and systematic actions to be applied for each j criterion.  ;

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2. 3 Quality Level B Items or activities not considered level A and whose failure, although not <

resulting in failure to meet the performance objectives, could result in some l limited exposure to or. releases of radioactivity are designated as cuality level B. The applicant will still be expected to apply good QA practices to work activities identified as level B. The applicant is responsible for defer-mining the scope of the planned and systematic actions to be applied for each of the criterion.

3. Quality Level Identification i The applicant is responsible for listing the activities, structures, systems, or components, and their proposed assigned quality level (A or B) during prelim nary design activities. The 1ist should be distributed Ly C e applicant to all participating organizations so that these participating organizations have a clear understanding of the impact of the quality level on the design and on other quality-related activities. Activities, structures, systems, and components designated as level A or B will be reviewed by NRC to determine that they are properly listed.

4. Quality Assurance Program Application Based on Assigned Quality Level 4.1 Quality Level A Activities, structures, systems, ur components, ioentified in the list as level A should be covered by a QA program that will ensure that performance objectives of 10 CFR Part 61 are met a.1d can be de,Tonstrated. The QA program should be approved by the applicant and be in place before work starts.

4.2 Quality Level B Activities, structures, systems, or components, identified as level B can be <

expected to be controlled consistent with their importance to the overall project. The NRC will also review work performed in the level B category as well as those identified in level A. The QA program should be approved by the applicant and be in place before work starts.

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! III. QUALITY ASSURANCE CRITERIA f I

In order to provide guidance on the development of a QA plan for an LLW disposal facility, the foll0 wing 18 criteria are identified. j

1. Organization The applicant should be responsible for establishing and executing the QA progrem.

The applicant may delegate to others, such as contractors, agents, or consultants, l

, the work of establishing anu executing the QA program or any part thereof, but  !

l the applicant retains ultimate responsibility for that pregram. The authority j end duties of persors and organizations performing activities affecting the j i

performance of those activities, structures, systems, or components to be covered i by the QA program should be clearly established and delineated in writing.

l' These activities include both the performing functions of attaining quality objectives and the assurance functions that verify the attainment of quality.

The QA functions are those of (a) assuring that an appropriate QA program is j established and effectively executed and (b) verifying, such as by surveillance, i auditing, and inspection, that activities affecting the performance have been

!- correctly performed. The persons and organizations performing QA functions l should have sufficient authority and organizational freedom to identify problems with quality, to initiate, recommend, or provide solutions; and to verify imple-mentation of solutions. Such persons and organizations performing QA functions should report to management at such a level that this required authority and organizational freedom, including sufficient independence from cost and schedule when opposed to safety considerations, are provided. Because of the many variables involved, such as the number of personnel, the type of activity being performed, and the location or locations at which activities are performed, the organizational structure for executing the QA program may take various forms, provided that the persons and organizations assigned the QA functions have the required authority and organizational freedom, Irrespective of the organiza-tional structure, the individual (s) assigned the responsibility for ensuring effective execution of any portion of the QA prograrn at any location at which activities subject to this guitiance documer,t are being performed should have direct access to whatever levels of canagement may be necessary to perform this function.

2. ,uality Q Assurance Program

, The applicant should establish, at the earliest practicable time consistent

) with the schedule, a QA program that complies with the recommendations of this document. The QA program should be documented by written policies, procedures, or instructions and should be carried out throughout the life of the facility, {

) in accordance with those policies, procedures, and instructions. The applicant should identify the activities, structures, systems, and components to be covered by the QA program and the major organizations participating in the program, together with the designated functions of the organizations. The QA program should provide control over activities affecting the quality of the identified activities, structures, systems, and components to an extent consistent with their required performance. Activities affecting quality should be oerformed  ;

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i under suitably controlled conditions. Controlled conditions include the use of appropriate equipment; suitable environinental conditions for performing the activity, such as adequate cleanliness; and assurance that all prerequisites for the given activity have been satisfied. The program should take into account the need for special controls, processes, test equipment, tools, and skills to tttain the required quality of the designated activity, structures, systems, or components, and the need for verification of quality by inspection and testing. The program should provide for indoctrinating and training personnel performing activities affccting quality to ensure that suitable proficiency is achieved and maintained. The applicant should regularly review the status and adequacy of the QA program. Management personnel from other organizations participating in the QA program shouid regularly review the status and adequacy of their particular QA section.

3. Design Controls As defined in the Atomic Energy Act of 1954, the term " design" means:

(a) specifications, plans, drawings, blueprints and other items c'. like nature; (b) the information contained therein; and (c) the research and development data pertinent to the information contained therein. The term "research and development" means: (a) theoretical analysis, exploration,-or experimentation or (b) the extension of investigative findings and theories of scientific or technical nature into practical application for experimental and demonstration purposes, including experimental production and testing of models, devices, equipment, materials, and processes.

The design of an LLW facility includes: characterizing the geologic setting; predicting the long-term stability of the site; predicting the environmental interactions between the site and its surroundings; planning and specifying processes for handling LLW; and specifying requirements for constructing facil-ities for handling LLW. The design process includes developing computer codes used in modeling the characteristics of the geologic setting or in predicting environmental impacts, such as groundwater travel and seismic activity. The degree of design control that management must. exercise over a given element of the design depends to a great degt ee on how important that element is in meeting the performance objectives of the LLW facility. The ability to demonstrate the soundness of the design is a key consideration la establishing management controls.

A design control program should be documenteM and implemented before design work starts. Measures should be established to ensure that applicable regulatory rec >airements, es defined in 10 CFR Part 61 regulations, are correctly translated into specifications, plans, drawings, procedures, and instructions. These measures should include provisions to ensure that appropriate quality standards are specified and included in the design documents, and that derivations from such standards are controlled. Measures should also be established for selecting and reviewing for suitability, application of materials, parts, equipment, and '

processes that are essential to the functions of the structures, systems, and components. The program should (a) describe the measures that ensure verifica-tion or checking of design adequacy, such as design review, use of alternative -

calculational methods, or performance of a qualification testing program under the most adverse design conditions; (b) identify the positions or organize-tions responsible for aesign verification or checking; and (c) describe the measures taken to ensure that the verification or checking process is perfermed a NUREG-1293 III-2 .

by individucis or groups other than those responsible for the original design, but who may be from the same organization.

The design program should describe the measures of identifying and contrciling design interrelationships, both internal and external, and for providing co-ordination between participating design organizations. <

Neither the eriginal designer (nor normally his immediate supervisor) should be resp.nsible for design verification. Design " verification" consists of confirming that the design of tha structure, system, or component is suitable for its inten(ed purpose. Design " checking," which must also be performed, includes such things as confirming the numerical accuracy of computations and the accuracy cf data input to computer codes. Confirming that the correct computer code has been used is part of design verification. Design verifica-tion requires that the responsible individual or group possesses a level of skill at least equal to that of the original designer; design checking, however, can be performed by less skilled persons. Design should not be verified by persons who checked the design.

Design changes, including field changes, should be subject to design control measures commensurate with those applied to the original design and should be approved by the organization that performed the original design, unless the applicant designates another responsible organization.

Errors and deficiencies in the design, including the design process, that could

adversely affect the performance of any structures, systems, components, or activities covered by the QA program are documented; and corrective action, including root cause evaluation of significant errors and deficiencies, is taken to prevent repetition.

4. Procurement Document Control Measures shall be estab Hshed to ensure that applicable regulatory requirements, design bases and other requirements needed to ensure adequate quality are suitably included or referenced in the document for procurement of material, equipment, and services whether purchased by the applicant or by its contractors or subcontrar. tors. To the extent necessary, procurement documents should require

! contractors or subcontractors to provide a QA program consistent with this guidance.

l Procedures shoula be established that clearly describe the sequence of actions to he performed in the preparation, review, approval, and control of procure-ment documents. Procurement documents are the medium of exchange of information between the applicant and its contractors or between the prime contractors and

( subcontractors. It is paramount to the success of the design, construction, i and operation of an LLW facility that these documents be planned, released, and i distributed with utmost care. For the more important instructions conveyed by procurement documents, it is prudent to also conduct meetings to review the contents and ensare that the resulting actions will take place as planned.

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i Particular care should be exercised in communicatirig the required management ,

controls to contractors and subcontractors supplying services related to site '

characterization, to ensure that results can be reliably demonstrated. Proce-dures that are to be followed and records that are to be generated and retained i

must be clearly identified in the procurement documents. It is the responsibil- l ity of the applicant to ensure that contractors and subcontractors have the l needed information and fully comprehend the information and the significance i of its use. j Qualified personnel should review and concur on the adequacy of quality require-  ;

ments stated in procurement documents. This review should determine that ]

quality requireu nts are correctly stated, inspectable, and controllable; there i are aJequate acceptance and rejection criteria; and the procurement document has been p.mpared, reviewed, and approved in x cordance with QA program requirements.

The review and approval of procurement documents should be documented before such documents are released, and the documentation should be available for verification. 1 i

Procurement documents should identify the documentation (e.g., drawings, speci-fications, procedures, inspection and fabrication plans, inspection and test i records, personnel and procedure qualifications, and chemical and physicel test I results of material) to be prepared, meir.tained, and submitted to the purchaser for review and approval.

Procurement documents should identify those records to be retainea, controlled,  ;

and maintained by the supplier and those to be delivered to the purchaser before the hardware is used or installed.

Procurement documents should contain the procuring agency's right of access to j the supplier's facilities and records for source inspection and audit.

Changes and revisions to procurement documents should receive the same or equivalent review and approval as the original documents.

5. Instructions, Procedures, and Drawings The applicant is responsible for ensuring that activities affecting quality are  ;

prescribed and performed in accordance with documented instructions, procedures, j or drawings. Procedures should be established that clearly delineate the  !

sequence of actions to be performed in the preparation, review, approval, and control of instructions, procedures, and drawings. Instruction, procedures, ,

or drawings should include appropriate quantitative acceptance criteria for j determining that important activities have been satisfactorily accomplished. j Two primary reasons exist for maintaining planned and approved instructions, i procedures, and drawings for the performance of the designated activities, j structures, systems and components. The first occurs when there is a need to  !

perform an activity in a specific way and sequence. The formal instruction, l procedure, or drawing provides not only the specific way and aequence but provides criteria to permit an independent verification that the activity was j performed correctly. The second occurs when there is a need to document the  !'

tools, methods, and in process results for the benefit of others who will later review the decision process and evaluate the conclusions reached. The conduct l

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l of field and laboratory geotechnical tests requires preplanned procedures to be

! followed by a scientist, but as the testing progtesses, the procedures will be l changed to reflect new and different practices dictated by in process informa- i tion. At the conclusion, the procedure followed by the scientist and the '

L information gathered will be fully documented for review by peers at a later date.  !

l A key question for the applicant to consider in determining whether instructions., I procedures, and drawings are needed is, "What information will be needed to  ;

demonstrate that the LLW facility was designed, constructed, and operated in a

, way that ensures the performance objectives of 10 CFR Part 61 are met and to l limit exposures to or releases of radioactivity.

6. Document Control l Documents that contain design, construction, operation, closure, and active maintenance requirements should be contyolled in their approval, issuance, and distribution to ensure that directions are understood and reach those people f responsible for achieving the project's objectives.

tiefore such documents and changes theretc are released, they should be procedurally contre 11ed to ensure the contents of the documents are adequate and the quality requirements are appropriately stated.

Procedures should be established for identifying those individuals or groups responsible for reviewing, approving, and issuing documents and revisions to those documents.

Changes to documents shoald be reviewed and approved by the same organization tnat reviewed the documents originally and approved them, or by other qualified responsible organizations delegated by the applicant.

l Approved changes should be ircluded in instructions, procedures, drawings, and other documents before the chanpe is implemented.

Obsolete or superseaed documents should be controlled to prevent inadvertent i use.

Before the work commencer, documents should be available at the work site at which the activity will be performed.

l A master list or its equivalent should be established to identify the current revision number of instructions, procedures, specifications, drawings, and pro-curement documents. The 1ist should be revised and distributed to predetermined, responsible personnel to prevent Lse of superseded (outdated) documents.

7. Co_n. trol of Purchased Material, Equipment, and Services Measures should be established to ensure that material, equipment, and services, purchased directly or through contractors and subcontractors, conf 0rm to the procurement documents. As appropriate, these measures should provide, for source etaluation and selection, objective evidence of quality furnished by the contrx tor or subcontractor, inspection at the contractor or subcontractor source, and examination of products upon delivery. Documentary evidence that l l

NUREG-1293 III-5 l

material and equipment conform to the procurement requirements should be avail-able at the LLW disposal facility before such material and equipment are .

installed or used. This documentary evidence should be retained by the applicant '

and should be detailed enough to identify the specific requirements imposed on the purchased material and equipment. At intervals consistent with the importonce, complexity, and quantity of the product or services, the applicant or its designee should assess how effectively contractors and subcontractors control quality.

k It can be difficult to implement the requirements of this criterion if a component j or service is contracted and subcontracted through a series of subcontractors '

or if it is broken down into elements and subcontracted. It is important that the applicant recognize that the applicant retains the responsibility for the end results. The applicant should review t.Te contracting and subcontracting to ensure that cor.trols exercised guarantee that the planned products and services are acceptable. f

8. Identification and Control of Material, Parts, and Components The purpose of this criterion is to provide for formal contrcl over and identification of items such as core, laboratory test samples, raw materials to be used in construction, fabricated parts and assemblies, and material or compo-nents found to be defective. All material collected for observation, or tests I that contribute to the oesign oases, all material that contributes to the constructed LLW facility, and all material related to the operation of the LLW facility should be identified and controlled.

Measures should be established for identifying and controlling materials, parts, and components. These measures should ensure that, where appropriate, the item is identified by heat nun,ber, part number, serial number, or other suitable means, either on the item or on records traceable to the item, ac required throughout fabrication, erection, installation, and use of the item. These identification and control measures should be designed to prevent the use of incorrect or defective material, parts, and components.

9. Control of Processes Processes affecting the quality of items or services should be controlled by instructions, procedures, drawings, checklists or other appropriate means.

Processes that control or verify quality should be performed by qualified )

personnel using documented procedures. It is ioportant that operator training ]

be specified and documented for such processes, and that the process and its controls be detailed in procedures.

Qualification records of procedures, equipment, and personnel associated with special processes should be established, filed, and kept current.

10. Inspection

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The primary purpose of inspection activities is to accept or reject completed work. Inspection can be performed as a verification activity to ensure that work, including prior inspections, has been properly performed.

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NUREG-1293 III-6 i i

A program for inspecting activities affecting quality should be established and axecuted by or for the organization performing the activity to verify conform-ance with the documented instructions, procedures, and drawings for conducting the activity. Such inspection should be performed by individuals other than those who executed the activity being inspected. Examinations, measurements, and tests of material or products processed should be performed for each work operation as appropriate. If inspection of processed material or products is impossible or provides a hindrance, processing methods, equipment, and personnel should be monitored, and thus controlled indirectly. Both inspection and pro-cess monitoring should be provided when control is inadequate without both. If mandatory inspection hold points (which require witnessing or inspecting by the applicant's designated representative and beyond which work should not proceed without the consent of its designated representative) are required, the specific hold points should be indicated in appropriate documents.

11. Test Control A test may be conducted to determine if an item or service is acceptable, or it may be conducted to acquire additional information. Test is defined as: an operation employed to resolve an uncertainty; a procedure to ascertain effective-I ness, value, proper function, quality, or other characteristics; a procedure to understand a system, subsystem, component, or structure; or a procedure of submitting a statement to such conditions as will lead to its proof or refuta-tion or to its acceptance or rejection. The description of the test should indicate the purpose of the test.

A test program should be established to ensure that all testing required to demonstrate that structures, systems, and components will perform satisfactorily in service is identified and performed in accordance with written test procedures that incorporate the requirements and acceptable limits contained in applicable design documerits. The test program should include, as appro riate, proof tests prior to installation and preoperational tests performed dur .ng the operation of the LLW disposal facility structures, systems, and components.

Tests should be planned and conducted according to documented procedures, and results should be documented and retained as QA records. Test procedures should include provisions for ensuring that all prerequisites have been met, that adequate test instrumentation is available and used, and that the test is f performed under suitable environmental conditions. Test results should be evaluated to ensure that test requirements have been satisfied.

12. Control of Measuring and Test Equipment All measurements that affect the quality of the design, construction, or opera-tion of an LLW facility should be taken only with instruments, tools, gauges, or other measuring devices that are accurate, controlled, calibrated, and adjusted at predetermined intervals to maintain accuracy within necessary limits.

Provisions contained in procedures describe the calibration technique and fre-quency, maintenance, and control of the measuring and test equipment that is used in the measurements, as well as inspection and monitoring of any activities, structures, systems, and components important to meeting the applicable requirements.

NUREG-1293 III-7

Measuring and test equipment is labeled, tagged, or otherwise documented to.

indicate when the next calibration is due and to provide traceability to cali-bration test data.

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Measuring and test equipment is calibrated at specific intervals based on required accuracy and equipment history of drifting, precision, purpose, and l- other characteristics that could affect accuracy.

When a piece of measuring and test equipment is found to be out of calibration, L evaluations are made to determine the validity and acceptability of measure-ments performed since the last calibration. Inspections or tests are repeated on suspect items.

Reference and transfer standards should be traceable to nationally recognized standards or, should national standards not exist, provisions sh~'id be estab-lished to document the basis for calibration.

13. Handling, Storage, and Shipping The purpose of this-criterion is to control handling, storage, cleaning, pack-i aging, preservation,.and shipping of items af fecting the quality of the design, j l construction, operation, closure, and active maintenance of an LLW facility.

It is of particular importance that attention be given to application of this criterion to the control of samples to prevent damage, loss, deterioration, and misidentification. When necessary for particular products, a special protective environment (such as an inert gas atmosphere), moisture content levels, and temperature levels should be specified and provided.

l l Procedures should be prepared that provide for the cleaning, handling, packaging, .

preservation, storage, and shipping of samples, materials, components, and l assemblies, in accordance with design and specification requirements to prevent  ;

damage, loss, or deterioration by environmental conditions. Qualified indi-5 viduals should provide special handling, preservation, storage, cleaning, pack-aging, and shipping, in accordance with preplanned work instructions.

14. Inspection, Test, and'0perating Status The inspection and test status of samples, structures, systems, and components must be identified. Such identification will prevent inadvertent use of a j l sample, structure, system, or component yet to be inspected or tested or that has been found unacceptable for use.

Measures should be established to indicate, by the use of markings such as stamps, tags', labels, routing cards, or other suitable means, the status of inspections and tests performed on individual items of the LLW disposal facility. These measures should provide for identifying items that have satisfactorily passed required inspections and tests, where necessary to preclude inadvertent bypas-sing of such inspections and tests.

Measures should also be established for indicating the operating status of structures, systems, and corponents of the LLW disposal facility to prevent inadvertent operation. Such measures should be subject to the same controls as the original review and approval.

NUREG-1293 III-8

15. Nonconforming Materials, Parts, or Components Measures should be established to control materials, parts, or components that do not conform to requirements in order to prevent their inadvertent use or installation. These measures should include, as appropriate, procedures for identification and documentation, including followup verification for the proper implementation of corrective actions by the QA organization in a timely manner, as well as segregation, disposition, and notification to affected organizations. Nonconforming items should be reviewed and either accepted, rejected, repaired, or reworked in accordance with documented procedures, including providing acceptable alternatives.

16. Corrective Actions Corrective measures should be established to ensure that conditions adverse to quality, such as failures, malfunctions, deficiencies, deviations, defective material and equipment, and nonconformances are promptly identified and cor-rected by those individuals or groups that have been authorized to perform this function. In the case of significant conditions adverse to quality, the measures should ensure that the cause of the condition is determined and that corrective action is taken to prevent the condition adverse to quality from occurring again. Actions taken should be documented and reported to appropriate levels of management in a timely manner.

17. Quality Assurance Records QA records furnish evidence that activities affecting quality have been properly performed. The records should include at least the following: operating logs and the results of reviews, inspections, tests, audits, monitoring of work performance, and material analyses. The records should also include closely related data such as qualifications of personnel, proceaures, and equipment.

Also, the records should include, for example, the evaluations of the various radiation exposure pathways and the analyzed doses from the pathways included in the license application. Inspection and test records should, at a minimum, identify the inspector or data recorder, the type of observation, the results, the acceptability, and the action taken in connection with any deficiencies noted. Records should be identifiable and retrievable. Consistent with j applicable regulatory requirements, the applicant should establish requirements concerning record retention, such as duration, location, and assigned responsibility.

18. Audits, Surveillance, and Managerial Controls A comprehensive system of planned and periodic surveillance and audits should be carried out to verify compliance with all aspects of the QA program and to determine the effectiveness of that program. The audits should be performed in accordance with the written procedures or checklists by appropriately trained personnel who do not have direct responsibilities in the area audited. Audit results should be documented and reviewed by management personnel who have responsibility in the area audited. Controls should include documentation, review, and record maintenance of the audit program; frequency of audits; and followup action, including correction and reauditing of deficient areas.

NUREG-1293 III-9

.I The purpose of this criterion is to measure and feed back the status of the i design, construction, and. operation activities as they relate to meeting 10 CFR Part 61 requirements. Real-time awareness of anomalies permits immediate analysis and correction of identified problems and of.the cause of the problems. ,

By using well planned verification techniques, one is better able to demonstrate '

l that design, construction, and operation activities conform to the requirements of 10 CFR Part 61.

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NUREG-1293 111-10

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2 Tiitt AND SV5 fit *,1 'J LE Avt SL ann Quality Assu ce Guidance for Low-Level Radioactive I Waste Disposal acility--Draf t for Comment

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7 PtRFoRMING ORGANIJ AP SON NAME AND MA NCs ADDatss ,,.orsese lgo corse, November s PM0 JECT,T Aba;wosen UN fl / 1987 Mot a Division of Low-Level Wa e Management and Decommissioning j Office of Nuclear Materia Safety and Safeguards . m oa t.s Au hu ,

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This document provides guidance to an A .ic on development of a low-level waste (LLW) disposal facility in meeti t quality control (QC) requirements of 10 CFR 61.12. The QC requirements a ..he basis for developing of a quality assurance (QA) program and for the guid< e provided herein. The criteria developed for this document are simil - . the criteria developed for 10 CFR Part 50 Appendix 8. Although Append' B 10 CFR Part 50 is not a regulatory requirement for an LLW disposal fa . ity, le criteria that were developed for 10 CFR Part 50 are basic to any Q program. The document specifically establishes QA guidance for the design, con uction, an operation of those structures, systems, components, as well a , for site cha acterization activities necessary to meet the performance obje ves of 10 CFR P t 61 and to limit exposure to or release of radioactivity This document is issued a draft and comments a e requested. After the

, comments are reviewed a analyzed, the document 11 be revised. This draft was reviewed by the N staff, an NRC consultant, a d personnel from the Idaho National Engineerin, aboratory.

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