ML20029D918

Forwards Ballot for ANS 15.8, QAP Requirements for Research Reactors

ML20029D918
Person / Time
Issue date:	04/20/1994
From:	Alexander Adams Office of Nuclear Reactor Regulation
To:	Richards W AFFILIATION NOT ASSIGNED
References
NUDOCS 9405120296
Download: ML20029D918 (20)

Text

...

April 20, 1994 Dr. Wade J. Richards Chairman, ANS 15 SM-ALC/T1-1 5335 Price Avenue McClellan AFB, California 95652-2504

SUBJECT:

BALLOTING FOR ANS 15.8, QUALITY ASSURANCE PROGRAM REQUIREMENT FOR RESEARCH REACTORS Please find enclosed our ballot for ANS 15.8, " Quality Assurance Program Requirements for Research Reactors." We have voted " Approved With Comments."

Our comments are annotated on the enclosed copy of ANS 15.8.

If you have any questions concern our ballot or comments, please contact me at 301-504-1127.

Sincerely, Original signed by:

Aloxander Adams, Jr., Senior Project Manager Non-Power Reactors and Decommissioning Project Directorate Division of Operating Reactor Support Office of Nuclear Reactor Regulation

Enclosure:

As stated DISTRIBUTION:

Docket File EHylton NRC PDRs AAdams ONDD r/f OGC (15-B-18)

BGrimes HZibulsky (4-E-4)

SWeiss ONDD:L' ONDD:P ONDD:D EP)ft'on AAdams SWeiss jf/('/94

'{/0/

f/20/94 0FFICIAL RECORD COPY l

DOCUMENT NAME:

G:\\SECY\\ ADAMS \\RICHARDS.AXA

( - J /] / - ?- b /() G 5120296 940420 ORO NRRB

'y'

,f[j). [ Gha 7

/

PDR py:[g w

u

-110034 003045

. A :a Ecute gagghus

-=

3 f"*%'*$

gs

'O 4

UNITED STATES 5

i!

NUCLEAR REGULATORY COMMISSION

%,,*****,/

WASHINGTON, D.C. 20555-0001 April 20, 1994 Dr. Wade J. Richards Chairman, ANS 15 SM-ALC/T1-1 5335 Price Avenue McClellan AFB, California 95652-2504

SUBJECT:

BALLOTING FOR ANS 15.8, QUALITY ASSURANCE PROGRAM REQUIREMENT FOR RESEARCH REACTORS Please find enclosed our ballot for ANS 15.8, " Quality Assurance Program Requirements for Research Reactors." We have voted " Approved With Comments."

Our comments are annotated on the enclosed copy of ANS 15.8.

If you have any questions concern our ballot or comments, please contact me at 301-504-1127.

Sincerely, h0

~

Alexander Adams, Jr.,

e ior Project Manager Non-Power Reactors and ecommissioning Project Directorate Division of Operating Reactor Support Office of Nuclear Reactor Regulation

Enclosure:

As stated I

b

j BALLOT FOR THE ANS 15.8, QUALITY ASSURANCE PROGRAM REQUIREMENTS FOR RESEARCH REACTORS APPROVED X

APPROVED WITH COMMENTS DISAPPROVED WITH COMMENTS COMMENTS:

See attached for comments Alexander Adams, Jr.

Mg L/[//[9[

(PRINT) NAME SIGNATURE /DATy/

DUE NLT 1 MAY 94 L

's.

ANS 15.8 QUALITY ASSURANCE PROGRAM REQUIREMENTS FOR RESEARCH REACTORS Foreword The first version of ANS-15.8, " Quality Assurance Program Requirements' for Research Reactors" was approved August 19,1976, and subsequently reaffirmed December 15,1986. It has been twenty years since the first working group started development of the standard. During this period of time, significant changes have occurred in the requirements associated with management of research reactor facilities, particularly in the degree of rigor and documentation.

This edition of the standard is a complete rewrite and provides the applicable quality assurance program requirements for all phases of a facility's life.

The membership of ANS-15.8 at the time of the completion of the standard was:

T. R. Schmidt, Chairman, Sandia National Laboratories A. Adams, Jr., U. S. Nuclear Regulatory Commission T. L. Bauer, University of Texas, Austin M. L. Gildner, Oak Ridge National Laboratory K. Hodgdon, U.S. Air Force D. E. Hughes, Pennsylvania State University B. Q. Partain, Los Alamos National Laboratory J. Razvi, General Atomics W. G. Vernetson, University of Florida In the process ofimplementing this standard with respect to the existing and varied practices in many operating facilities, it is important to recognize that:

a.

Considered use of the standard should assist in implementing regulatory requirements.

b.

The standard is intended to be a significant aid for existing and new owner or operator.

c.

The standard should be helpful for both the facility undergoing change or modification.

d.

Each provision of the standard should be used only to the extent appropriate to the individual facility, e.

The standard is not intended to require backfitting.

With regard to this particular Standard, it must be noted that research reactors have two characteristics which affect the type of quality assurance program that should be applied to them, when compared to power reactors. First, the reliability of most of the parts used in a research reactor is not relevant to the health and safety of the public since failure of the item generally shuts the system down and little else occurs. Secondly, the typical research reactor operates on a limited budget with its continued existence dependent upon maintaining a low cost reliable operation. Because of these inherent characteristics, the quality assurance program for research i

L

reactors is applied primarily to safety-related and important items, and should be graded appropriately to be economically feasible. It is the intent of this Standard to state the requirements for such a program.

- < L.~ r For those not yet exposed to odern quality assurance requirements, it is difficult to grasp the value of adequate docume ation. Although documentation is not the totality of a quality assurance program, it isyJmponanFkey to an appropriate program for research reactors. Much of the documentation required by a quality assurance program already exists for an operating research reactor, and little additional documentation may be needed when the quality assurance program is established.

Appropriate application of a standard is very important, and a careful and comprehensive reading of this Standard is highly recommended before use. Two comments are presented as aids to interpretation:

(1) It is recognized that it is not necessag to apply the same degree of control to all items in a research reactor. Where this Standard uses words such as "as appropriate" or "as necessary," these are to be interpreted as meaning variation in the degree of application.

(2) It is not intended that this Standard require modification of existing charter or licensing requirements and should not be so interpreted.

The membership of Subcommittee ANS-15 at the time ofits approval of the standard was:

W. J. Richards, Chainnan, U.S. Department of Defense A. Adams, Jr., U.S. Nuclear Regulatory Commission W. J. Brynda, Brookhaven National Laboratory A. F. DiMeglio, Rhode Island Nuclear Science Center J. P. Farrar, University of Virginia D. E. Feltz, Texas A&M University D. Harris, Renssealaer Polytechnic Institute T. F. Luera, Sandia National Laboratog R. C. Nelson, EG&G D. P. Pruett, Argonne National Laboratory West T. M. Raby, National Institute of Standards and Technology E. Roybal, U.S. Department of Energy T. R. Schmidt, Sandia National Laboratory M. H. Voth, Pennsylvania State University R. R. Walston, U.S. Department of Energy W. L. Whittemore, GA Technologies, Inc.

Consensus Committee N17, Research Reactors, Reactor Physics, Radiation Shielding, and Computational Methods, had the following membership at the time it reviewed and approved this standard:

e

l T. M.'Raby, Chairman

A. Weitzberg, Vice Chairman.

J. D. Buchanan, Individual'

. A. D. Callihan, Individual -

D. Cokinos, Brookhaven National Laboratory A. De La Paz, Department of U.S. Army D. Duffey, American Institute of Chemical Engineers H. Goldstein, American Physical Society S. Hartzell, Power Computing P. B. Hemmig, U.S. Department of Energy J. W. Lewellen (Alt.)

W - A. Holt, American Public Health Association J. E. Hyder, Health Physics Society A. Johnson (Alt.)

L. I. Kopp, Individual

. J. E. Olhoeft, Individual T. M. Raby, American Nuclear Society W. J. Richards, U.- S. Department of Defense M. M. Ter Pogossian, American College of Radiology

. J. F. Torrence, National Institute of Standards and Technology D. K. Trubey, Oak Ridge National Laboratory -

S. H. Weiss, U.S. Nuclear Regulatory Commission A. Adams, Jr. (Alt.)

A. Weitzberg,NUS Corporation W. L. Whittemore, GA Technologies, Inc.

~'

t f

r s

Contents Section Page

1. Introduction................

.................1 1.1 S cope...................

..........................I 1.2 Application......

............1

1. 3 D enniti o n s............................................................ I

2. Design, Construction, and Modifications.

.........3 2.1 Organization.....

.....3 2.2 Quality Assurance Program......

..............................3 2.3 Design Control........................

.. 3 2.3.1 Design Requirements............

.....................3 2.3.2 Design Process.....

.....3 2.3.3 Design Verification....

.............................4 2.3.4 Design Documents and Records...

..................4 2.3.5 Commercial Grade Items........

....4 2.3.6 Change Control...........

.4 2.4 Procurement Document Control...

.. 4 2.5 Procedures, Instmctions, and Drawings.........

.........5 2.6 Docum ent Control.,................................

.5 2.7 Control ofPurchased Items and Services.

.5 2.7.1 Supplier Selection........

.5 2.7.2 Work Control............

................5 2.7.3 Verification Activities....

.........5 2.7.4 Item or Service Acceptance.........

...............5 2.8 Identi6 cation and Control ofItems..

........6 2.9 Control of Special Processes....

......6 2.10 Inspections........

... 6 2.11 Test Control.........

.7 2.12 Control ofMeasuring and Test Equipment...

.7 2.13 Handling, Storage, and Shipping..

....7 2.14 Inspection, Test, and Operating Status..

.....7 2.15 Control ofNonconforming Items and Services..

.........7 2.16 Corrective Actions...................................... 8 2.17 Qu ality Records.............................

............8 2.18 Assessments............

.....8 2.19 Experimental Equipment....

....................................9

3. Facility Operations......

.. 9 3.1 Organization...

..............9 3.2 Quality Assurance Program.

................................9 3.3 Performance Monitoring....

..........9 3.4 Operator Experience...............

............................9 3.5 Operating Conditions......................

....................10 3.6 Operational Authority.......................................... 10 3.7 Control Area..........

...................................10

Contents (Cont'd)

3. 8 Ancillary Duties.................................................... 10 3.9 Emergency Communications........

..............10 3.10 Configuration Control............................................... 10 3.11 Lockouts and Tagouts...................................10 3.12 Test and Inspection..

..................I1 3.13 Operating Procedures................

..................I1 3.14 Operator Aid Postings.........

.. 11 3.15 Equipment Labeling.....

.............I1

4. Existing Facilities....

.........I1

5. Decommissioning......

.............................................I1

6. References....

.. 12

ANS 15.8 QUALITY ASSURANCE PROGRAM REQUIREMENTS FOR RESEARCII REACTORS

1. Introduction 1.1 Scope. This standard provides criteria for quality assurance in the design, construction, operation, and decommissioning of research reactors.

1.2 Application. The quality assurance program applied by the owner or operator to research reactor activities is to be consistent with the importance of these activities to safety and reliability.

Activities included in the quality assurance program shall be, as a minimum, those related to the reactor safety and protection system, engineered safety features, and the applicable radiation monitoring systems as identified in the Limiting Conditions for Operations section in the Technical Specifications for a given reactor. The program applies in a graded manner to those items and activities which could affect the quality of structures, systems, and components of research reactor facilities. Activities affecting quality include siting, designing, purchasing, fabrication, handling, shipping, receiving, storing, cleaning, erecting, installing, inspecting, testing, and operations. The program shall consider the tangible and intangible attributes of replacement costs, schedule delays and facility availability.

The development and implementation of a research reactor facility quality assurance program begins during the design and constmetion phase of the facility. It focuses o0 the development of appropriate controls that ensure the facility is properly designed and fabricatec to meet owner / operator requirements. The majority of these controls provide documentation attesting to the facility quality to support the application for an operating license or permit. These design and construction program requirements are defined in Section 2.0 of this Standard. Following facility construction and' commissioning, the focus of the quality program shifts to establishing those controls that ensure proper and reliable facility operation. All of the program provisions established during the design and construction phase remain in place, but will change in level of implementation appropriate to support facility operations. Each section of 2.0 would be implemented only as necessary. The operating phase license or permit imposes additional requirements related to the conduct of operations. These additional program requirements are defined in Section 3.0 of the Standard.

1.3 Definitions. The following definitions are listed to provide uniform interpretation of terms and phrases used in this and associated standards.

certified operator. A certified operator is an individual authorized by the chartering or licensing organization to carry out the duties and responsibilities associated with the position requiring the certification.

commissioning. The process during which constructed reactor structures, components and systems are made operational and verified to meet design requirements.

corrective action. Measures taken to rectify conditions adverse to quality and, where necessary, to prevent repetition.

s document. Any written or pictorial information describing, defining, specifying, reporting, or certifying activities requirements, procedures, or results.

experiment. Any operation, hardware, or target (excluding devices such as detectors, foils, etc.),

that is designed to investigate non-routine reactor characteristics or that is intended for irradiation within the pool, on or in a beamport or irradiation facility, and that is not rigidly secured to a core or shield structure so as to be a part of their design.

licensed operator. See certified operator.

W maintenance. Those activities necessary to maintain,d'a or restore systems to within specified design limits. Maintenance consists of repair, rework, replacement, adjustment, cleaning or other actions necessary to maintain an item in or restore an item to acceptable conditions.

management. Management means those persons within the research reactor organization whose responsibility and authority includes the quality assurance program. The levels of management are as described in the American National Standarf for Development ofTechnical Specifications for Research Reactors, ANSI /ANS-15.1-1990 [1]

% La,

modification. A change in the physical design or functional characteristic of a component or system.

non power reactor. See research reactor procedure. A document that specifies or describes how an activity is to be performed.

quality assurance. Comprises those planned and systematic actions necessary to provide adequate confidence that the structure, system or component will perform satisfactorily in service.

research reactor. A research reactor is defined as a device designed to support a self-sustaining neutron chain reaction for research, development, educational training, or experimental purposes, and that may have provisions for the production of radioisotopes.

safety related items. Those physical structures, systems and components whose intended functions are to prevent accidents that could cause undue risk to the health and safety of the public, the workers or to the programs and to control or mitigate the consequences of such accidents.

shall, should and may. The word "shall" is used to denote a requirement; the word "should" to denote a recommendation; and the word "may" to denote permission, neither a requirement nor a recommendation.

I Numbers in brackets refer to corresponding numbers in Section 6, References.

test reactor. See research reactor -

2. Design, Construction, and Modifications This section provides requirements for establishing, managing, conducting, and assessing the program of controls over the design, construction, and modification of a research reactor facility.

This standard recognizes that the described controls are integral to the management of a project or facility and do not necessitate the establishment of a separate program. This section should be implemented as applicable to the specific scope of work activities.

2.1 Organization. It is recognized that for most research reactor facilities, the owner / operator's organization is small with its personnel performing multiple functions. During the design, construction, or modification of a research reactor, most of the work may be performed by outside organizations or support contractors. The owner / operator's role is then pdmarily one of providing requirements and verifying compliance with those requirements. The organizational structure and assignment of responsibilities shall be defined and documented such that: (a) quality is achieved and maintained by those who have been assigned responsibility for performing work; and (b) quality achievement is verified by persons not directly perfonning the work. Persons responsible for ensuring that appropriate controls have been established and for verifying that activities have been correctly performed need sufficient authority, access to work areas, and freedom to: (a) identify problems; (b) initiate, recommend, or provide corrective action and (c) vedfy,, corrective action implementation.

w a-2.2 Quality Assurance Program. A documented quality assurance program shall be established in accordance with the requirements of this Standard, or portions thereof, at the earliest time consistent with the schedule for accomplishing quality effecting activities. The program shall identify the items and activities to which it applies and the extent of program application for each 1

item and activity. The program shall provide for the appropriate and necessary indoctrination and training of personnel performing activities effecting quality, to ensure that suitable proficiency is achieved and maintained.

i 2.3 Design Control. The responsible design organization shall prescribe, develop, document, and preserve the design of the structures, systems, and components of the research reactor facility.

i 2.3.1 Design Requirements-Applicable design inputs, such as design bases, performance requirements, regulatory requirements, codes, and standards shall be identified and documented.

2.3.2 Design Process-Design interfaces shall be identified and controlled and the design efforts shall be coordinated among the participating organizations. The applicability of standardized or previously proven designs, with respect to meeting pertinent design inputs, shall be verified for each application. Known problems affecting the standard or previously proven designs and their effects on other features shall be considered. Deviations from the established and documented design inputs, including the reason for the changes, shall be documented and controlled.

The final design shall: (a) be relatable to the design input by documentation in sufficient detail to permit design traceability and verification; and (b) identify assemblies and/or components that are pan of the item being designed. When a computer design program is used to develop portions of the facility design or to analyze a design for acceptability, that program shall be fully documented, validated, and controlled to ensure the correctness ofits output. When a design program must be developed, the program shall be controlled to assure that it is fully documented and validated.

Where changes to previously valid computer programs are made, documented revalidation shall be required for the change. Verification of design unique computer programs shall include appropriate benchmark testing.

2.3.3 Design Verification-Independent design reviews shall be used to verify the adequacy of design by one or more of the following: (a)the performance of design reviews, (b)the use of alternate calculations, (c)the performance of qualification tests, or (d) comparison to similar proven systems. The responsible design organization shall identify and document the panicular design verification method (s) used. Design verification shall be performed by competent individual (s) or group (s) other than those who performed the design but who may be from the same organization. In all cases the design verification shall be completed prior to relying upon the component, system, structure, component or computer program to perform its function in operations.

The need for or the use of qualification tests shall be defmed in a formal test plan that includes appropriate acceptance criteria and shall demonstrate the adequacy of performance under conditions that simulate the most adverse design conditions. Test results shall be documented and evaluated by the responsible design organiz.ation to assure that test requirements have been met.

2.3.4 Design Documents and Records-Design documentation and records, which provide evidence that the design and design verification processes were performed, shall be collected, stored, and maintained.

2.3.5 Commercial Grade Items-The use of commercial grade equipment in safety-related applications shall be reviewed to assure that it can adequately perform its intended function.

When a commercial item, prior to its installation, is modified or selected by special inspection and/or testing to requirements that are more restrictive than the supplier's published product description, the component part shall be represented as different from the commercial grade item in a manner traceable to a documented definition of the difTerence.

2.3.6 Change Control-Modifications to facility structures, systems, components, or computer codes shall be based on a defined "as-exists" design. Changes to verified designs shall be documented, justified, and subject to design control measures commensurate with those applied to the original design. These measures shall include assurance that the design analyses for the structure, system, component, or computer code are still valid. Where a significant design change is necessary because of an incorrect design, the design process and verification procedure should be reviewed and modified as necessary.

2.4 Procurement Document Control. Procurement documents shall contain sufBeient technical and quality requirements to ensure the items or services satisfy the needs of the purchaser. The procurent documents at all procurement levels shall identify the documentation required to be submitted for information, review, or approval by the purchaser. At each level of a procurement, the procurement documents shall provide for access to the supplier's plant facilities and records for inspection or audit by the purchaser, his designated representative, or other parties authorized by the purchaser. The procurement documents shallinclude purchaser's requirements for reporting and approving disposition of supplier non-conformances associated with the items or services being procured.

2.5 Procedures, Instructions, and Drawings. Activities effecting quality shall be performed in accordance with documented instructions, procedures, or drawings appropriate to the circumstances. These documents shall include or reference appropriate quantitative or qualitative acceptance criteria for determining that activities have been satisfactorily accomplished.

2.6 Document Control. The preparation, issue, and change of documents that specify quality effecting requirements or prescribe activities effecting quality shall be controlled to assure that correct documents are used. The document control system shall be documented and provide for:

(a) identification of documents to be controlled and their specified distribution; (b) identification of assignment of responsibility for preparing, reviewing, approving, and issuing documents; and (c) review of documents for adequacy, completeness, and correctness prior to approval and issuance. Major changes to controlled documents shall be reviewed and approved by the same organizations that performed the original review and approval unless other organizations are specifically designated.

2.7 Control of Purchased Items and Services. The procurement ofitems and senices shall be controlled to ensure appropriate procurement planning, source evaluation and selection, evaluation of objective evidence of quality furnished by the supplier, source inspection, audit, and examination ofitems or services for acceptance upon delivery or completion.

2.7.1 Supplier Selection-The selection of suppliers shall be based on evaluation of their capability to provide items or services in accordance with the requirements of the procurement documents.

2.7.2 Work Control-The purchaser shall establish measures to control the supplier's performance as appropriate.

2.7.3 Verification Activities-The supplier shall be responsible for the quality of his product and shall verify and provide evidence of that quality. Supplier generated documents shall be controlled, handled, and approved in accordance with established methods. Means shall be p) WM" implemented to provide for the acquisition, processing, and recorded evaluation of technical, b; /a W inspection, and test data against acceptance criteria. Based on the complexity of the product, the purchaser shall consider independently verifying the quality of a supplier's product through source surveillances or inspections, audits, or review of supplier non-conformances, dispositions, waivers, and corrective actions.

-5

2.7.4 Item or Service Acceptance. The purchaser shall establish a system to provide assurances that purchased items and services conform to procurement specifications. Purchaser methods used to accept an item or related service from a supplier shall be a supplier Certificate of Conformance, source verification, receiving inspection, or post installation test or a combination thereof. Receiving inspections shall be performed in accordance with established procedures and instructions, to verify by objective evidence such features as proper configuration, identification, freedom from shipping damage, and cleanliness.

2.8 Identification and Control ofItems. When specified by codes, standards, or specifications that include speciSc identification or traceability requirements, the process shall be capable of providing identification and traceability control. Items shall be identified from the initial receipt or fabrication of the items up to and including installation and use. Where physical identification on the item is either impractical or insufficient, physical separation, procedural control, or other appropriate means shall be employed. Identification markings shall be applied using materials and methods which provide a clear and legible identification and do not detrimentally effect the function or service life of the item. Markings shall be transferred to each part of an identified item when subdivided and shall not be obliterated or hidden by surface treatment or coatings unless substitute means are provided. Where specified, items having limited calendar or operating life shall be identified and controlled to preclude use ofitems whose shelflife or operating life has expired.

2.9 Control of Special Processes. Special processes include any process in which the results are highly dependent on the control of the process or the skill of the personnel. These are also those processes in which the specified quality can not be readily determined by inspection or non-destructive testing of the product. Special processes shall be controlled by instructions, procedures, drawings, checklists, travelers, or other appropriate means. It is the responsibility of the organization performing the special process to adhere to the approved procedures and processes. The requirements of applicable codes and standards, including acceptance criteria for the process, shall be specified or referenced in the process controlling procedures or instructions.

Records shall be maintained as appropriate for the currently qualified personnel, processes, and equipment associated with special processes.

2.10 Inspections. Inspections to verify conformance of an item or activity to requirements shall be planned, documented, and performed. The inspection program shall apply to procurement, construction, modification, maintenance, and experiment fabrication. Inspection ofitems in-process or under construction shall be performed for work activities where product quality cannot be determined by inspection of the completed product. The final inspection shall be planned to arrive at a conclusion regarding conformance of the item to specified requirements.

Completed items shall be inspected for completeness, markings, calibration, adjustments, protection from damage, or other characteristics as required to verify the quality and conformance of the item to specified requirements. Associated quality records shall be examined for adequacy and completeness. Only items that have passed the required inspections and tests shall be used, installed, or operated. Measuring and Test Equipment (M&TE) used to perform inspections shall be identified in inspection documentation for traceability ofinspection results.

l 1 l

l Inspection results shall be documented. Acceptance ofitems shall be documented and approved j

by authorized personnel. Inspection shall be performed by persons other than those who l

performed the work being inspected, but they may be from the same organization. Each person who verifies conformance ofwork activities for purposes of acceptance shall be qualified to perform the assigned inspection task. The need for formal training shall be determined, and training activities conducted as required to qualify personnel who perform inspections and test.

On-the-job training shall be included with emphasis on firsthand experience gained through actual performance ofinspections. Records ofinspection personners qualification shall be established and maintained by the employer.

2.11 Test Control. Formal testing shall be required to verify conformance of designated structures, systems, or components to specified requirements and demonstrate satisfactory performance for service or to collect data in support of design or fabrication. Testing shall include prototype qualification tests, proof tests prior to installation, and functional tests. Test results shall be documented and evaluated by a responsible authority to assure that test requirements have been satisfied. Computer programs used for operational control shall be tested in accordance with abpproved verification and validation plan and shall demonstrate required performance over the range of operation of the controlled function or process.

2.12 Control of Measuring and Test Equipment. Tools, gages, instruments, and other M&TE used for activities effecting quality shall be controlled and calibrated or adjusted at specified periods to maintain accuracy within specified limits. Out-of-calibration devices shall be tagged or segregated and not used until they have been recalibrated. Records shall be maintained of calibration data traceable to the individual piece of M&TE. Calibration and control measures are not required when normal commercial equipment provides adequate accuracy, 2.13 Handling, Storage, and Shipping. Handling, storage, and shipping ofitems shall be in accordance with work and inspection instructions, drawings, specifications, shipping instructions, or other pertinent documents or procedures for conducting the actisity.

2.14 Inspection, Test, and Operating Status. The status ofinspection and test activities shall be identified on the items or in documents traceable to the items for assuring that required inspections and tests are performed and to assure that items which have not passed the required inspections and tests are not inadvertently installed or operated.

2.15 Control of Nonconforming Items and Services. Items that do not conform to requirements shall be controlled to prevent inadvertent installation or use. Controls on nonconforming items shall provide for identification, documentation, evaluation, segregation from like conforming items when practical, and disposition ofnonconforming items. Nonconforming conditions shall be evaluated for further reporting to appropriate regulatory agencies. Non-conforming characteristics shall be reviewed and recommended dispositions of nonconforming items proposed and approved in accordance with documented procedures.

The disposition (use-as-is, reject, repair, or rework) of nonconforming items shall be identified and documented. Technicaljustification for the acceptability of a nonconforming item, dispositioned repair, or use-as is shall be documented. Nonconformances to design requirements i

1 dispositioned use-as-is or repair shall be subject to design control measures commensurate with those applied to the original design: The as-built records shall reflect the accepted deviation.

)

Repaired or reworked items shall be reexamined in accordance with applicable procedures and with the original acceptance criteria unless the nonconforming item disposition has established alternate acceptance criteria.

2.16 Corrective Actions. Conditions adverse to quality shall be identified promptly and corrected as soon as practical. The corrective actions shall be in accordance with the design requirements unless those requirements were faulty. In the case of a significant condition adverse to quality, the cause of the condition shall be investigated and corrective action taken to preclude recurrence.

2.17 Quality Records. A records system (s) shall be established at the earliest practicable time consistent with the schedule for accomplishing work activities. The records system (s) shall be defined, implemented, and enforced in accordance with written procedures, instructions, or other documentation. The records shall include as a minimum: inspection and test results, results of quality assurance reviews, quality assurance procedures, and engineering reviews and analysis in support of designs or changes and modifications.

Some records shall be maintained by or for the plant owner for the life of the particular item while it is installed in the plant or stored for future use. Such records shall be classified in accordance with the following criteria: (a) those which would be of significant value in demonstrating capability for safe operation; (b) those which would be of significant value in maintaining, reworking, repairing, replacing, or modifying an item; (c) those which would be of significant value in determining the cause or results of an accident or malfunction of a safety related item;(d) those which provide required baseline data for in service inspections; or (e) those which would be of significant value in planning for facility decommissioning.

Other records shall be retained for a shorter period as determined by the owner / operator. The records shall be stored in location (s) that prevent damage from moisture, temperature, and pestilence. Additional provisions shall be made for special processed records such as radiographs, photographs, negatives, microfilm, and magnetic media to prevent damage from excessive light, stacking, electromagnetic fields, temperature, and humidity. Records maintained by a supplier shall be accessible to the purchaser or the Owner / Operator.

2.18 Assessments. The Owner / Operator and/or his representative shall conduct periodic assessments of quality effecting activities during design, constmetion, or modification to evaluate the effectiveness of the as-implemented quality program. Assessments shall be performed in accordance with written procedures or checklists. Assessment results shall be documented and should be reviewed by management having responsibility for the area assessed. Conditions requiring prompt corrective action shall be reported immediately to the appropriate management of the assessed organization.

Management of the assessed organization or activity shallinvestigate adverse findings, schedule corrective action, including measures to prevent recurrence, and notify the appropriate assessing organization in writing of action taken or planned. The adequacy of the responses shall be evaluated by or for the assessing organization. Assessment records include assessment plans, reports, written replies, and the record of completion of corrective action. Personnel selected for assessment assignments shall have experience or training commensurate with the scope, complexity, or special nature of the activities to be assessed. The assessor shall have the capability to communicate effectively, both in writing and orally.

2.19 Experimental Equipment. The quality assurance program shall provide controls over the design, fabrication, installation, and modification of experimental equipment to the extent that these impact safety related items.

3. Facility Operations.

This section provides the elements of a quality assurance program for conduct of operations at research reactor facilities. The requirements shall be applied to any equipment or operation as appropriate and consistent with its potential safety impact or program goals. Many of the program requirements are satisfied by existing documentation, procedures and activities required by other standards and requirements of the chartering or licensing agency. Some requirements of the quality assurance program for operations may also be found in the Training Program, Emergency Plan, Security Plan, and the Technical Specifications.

3.1 Organization. Management shall provide sufficient resources in personnel and materials to conduct operations. Planning should anticipate needs as appropriate for any task. The organizational structure shall be defined as required by the Technical Specifications.

3.2 Quality Assurance Program. Management shall establish a quality assurance program by implementing a policy for the conduct of operations. The policy should assign personnel to implement the policy and identify the goals for operating the reactor. Personnel assignments and progress toward achieving goals should be documented.

3.3 Performance Monitoring. Management shall monitor facility performance relative to the goals. Management shall document periodical obseivations of operations and identify any deficiencies. Management should assess deficiencies to ensure that corrective actions are taken that will prevent recurrence. If appropriate, trend analysis should be performed to indicate where improvements or lessons learned could be implemented. Violations of operating practices should be addressed and documented as appropriate.

3.4 Operator Experience. Management shall document the methods for maintaining operator experience. Operators should be responsible for maintaining experience in operating the reactor.

This may be achieved by routine operation of the reactor and documenting the activity. A method should be provided to make Operators aware ofimportant information that is related to facility operations and individualjob assignments. Operator training is addressed in the American National Standard for the Selection and Training of Personnel for Research Reactors, ANSl/ANS-15.4-1988[2].

9

3.5 Operating Conditions. Preoperations checklists shall be used to determine or verify required preoperational conditions and readiness to operate. Operating equipment shall be periodically monitored to detect abnormal conditions or adverse trends. Operating conditions should be documented in an operations logbook or other record. The operator should notify the approrpriate level of management of any abnormal situations.

3.6 Operational Authority. Management shall establish the method for conducting operations and the responsibility for each shift Operating personnel shall conduct a comprehensive review of appropriate records and equipment before assuming responsibility for the facility. It may be transferred through documented turnover briefing and facility walk through procedures. These procedures should include checklists to record items important to facility status.

3.7 Control Area. Operators shall be alert and attentive to control console indications, alarms, and other activities within the control area. Only persons specifically authorized or certified to operate the reactor shall operate control area equipment. Trainees may operate equipment only when they are directly supervised by certified operators. Control area activities and access should be limited to ensure that the operators are attentive to control responsibilities. A procedure shall be in place for quickly placing the reactor in a safe configuration if evacuation of the control area or site is necessary.

3.8 Ancillary Duties. Operators shall not be assigned ancillary duties to be performed during operations to the extent that they could interfere with the ability to monitor facility parameters and maintain control of the reactor.

~

3.9 Emergency Communications. Operators shall be able to contact the appropriate level of management rapidly and shall have the means to notify all affected personnel promptly of operations or emergencies onsite.

3.10 Configuration Control. Equipment shall be identified that requires configuration control.

Management is responsible for establishing and maintaining proper configuration and should authorize any changes to safety related items. All configuration changes to safety related items should be documented. Before placing equipment into operation, the system shall be properly calibrated or checked as appropriate and any deficiencies in the equipment or the current j

configuration of the system documented. This should also address methods for temporary modifications. Reactor maintenance that requires a change in the system shall be documented.

3.11 Lockouts and Tagouts. Locks and tags shall be placed on equipment when, for safety or other special administrative reasons, controls must be established. If there is potential for equipment damage or personnelinjury during equipment operation, maintenance, inspection or modification activities or from inadvertent activation of equipment, a facility lockout /tagout procedure shall be implemented.

D.b A.Il k (vL.

J g

3.12 Test and Inspection.following system maintenance, design changes, inspection that, -

involves dismantlement of d6mponents or systems, equipment 4hald bc c=d=d = t=dusing a documented test plan to demonstrate that k.is capable of performing its intended function. The W w y.- I o r,, %

ge) kr up p h ' " YA results of the test should be documented and retained in facility r rds as appropriate.

3.13 Operating Procedures. Operating procedures shall provid appropriate direction to ensure that the facility is operated normally within its design basis, and ' compliance with technical specifications. Operating procedures shall be written, reviewed, controlled and monitored to ensure that the content is technically correct and the wording and format are clear and concise.

The facility policy on use of procedures should be documented and clearly understood by all operators. The extent of detail in a prccedure should depend on the complexity of the task, the experience, education, and training of the users, and the potential significance of the consequences of error. The process for making changes and revisions to procedures should be documented. A controlled copy of all operations procedures should be maintained in the control room or equivalent area.

3.14 Operator Aid Postings. Any posted information that aids operators in performing their duties should be current and correct. Management should review operator aids to determine that they are necessary and correct before approving their posting. Postings should be checked periodically for continued applicability.

3.15 Equipment Labeling. Equipment shall be labeled to help facility personnel positively identify equipment they operate and maintain. Information on labels should be consistent with information found in facility procedures, valve lineup sheets, and piping and instrument diagrams or other documents. Labels should be permanent, securely attached, readable, and have appropriate information.

'h

4. EsistingfaeilitiesIfN p 'y N

q,,h L.I,b.v M Existing facilities shall not be requireIto prepare quality assurance documentation for the(facility ebui!!- However, all available pf built records should be collected and stored in accordance with the provision of Section 2.17.gli replacements, modifications, and changes to safety-related ijt ms shall meet the applicable quality assurance requirements of this Standard. %ks M dhe replacement, modification, or changey(nponent, hall be documentedeme 1

ur,-tg u.4 f,< &, u eL-p Ml requirements of the original system or co 46 t

\\

k dicm M

5. Decommissioning b bMy The quality assurance requirements for a facility during the decommissioning phase are addressed by the appropriate sections of this standard and the American National Standard for Decommissioning of Research Reactors, ANSI /ANS-15.10-1981 [3].

l 11

6. References

[1]

Arnerican National Standard for the Development of Technical Specifications for Research Reactors, ANSUANS-15.1-1990. American Nuclear Society, La Grange Park, Blinois.

[2]

American National Standard for the Selection and Training of Personnel for Research Reactors, ANS1/ANS-15.4-1988. American Nuclear Society, La Grange Park, Blinois.

[3]

American National Standard for Decommissioning of Research Reactors, ANSUANS-15.10-1981. American Nuclear Society, La Grange Park, Illinois.

I