ML19312D303

QA Program for Facility

ML19312D303
Person / Time
Site:	07000824, 07100230
Issue date:	01/31/1980
From:	BABCOCK & WILCOX CO.
To:
Shared Package
ML19312D298	List: ML19312D297 ML19312D303
References
15509, NUDOCS 8003240176
Download: ML19312D303 (31)

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REVISIONS ',

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. ~ 12 /78 -:

' Original: Issue-g-

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~ Revision 1 - Revised to' include-NRC's coassenta of 11/1/79.-.

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INTRODUCTION This. manual. describes the' Quality' Assurance (QA) Program for. shipping

-' packages which transport certain quantities of radioactive material that is currently.in force at the Lynchburg-Research. Center. (LRC) of the-J Babcock & Wilcox' Company-(B&W).. The QA Program imposes standards of

- quality through.the development of. policies, procedures and instructions, and the. implementation of effective plans and disciplines.

i This manual meets the requirements of 10 CFR Part 71,. Appendix-E,

" Quality Assurance Criteria for Shipping Packages for Radioactive Material".

h It should be' noted that for any specific package, not.all of the sections of this manual will necessarily be imposed.

The Q.A. Program, however, requires.the development of a formal Q.A. Plan which shall specify the a

applicable. sections of this manual.

The LRC Q.A. Administrator has the responsibility and authority for the: administration and assurance of conformance with the requirements of the' program. described in'this manual.

He has-the authority and duty to l

l require corrective action on activities relating'to'any shipping packages q

- which-do'not conform to the objectives and policies outlined in this manual.

Compliance with the intent of these objectives is.also required of suppliers 4

to. LRC through requirements-transmitted in procurement documents.

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- TABLE OF CONTENTS 3

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'i Revisions' ii-Introduction 111 Table of Contents

' Organization

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1.0-Quality Assurance Program 2.0 Design Control 3.0 4.0 Procurement Document Control

'5.0 Instructions, Procedures, and Drawings i

6.0 Document Control

7. 0 Control of Purchased Material, Parts, and Components 8.0 Identification and Control of Materials, ~ Parts,'and Components h-

9. 0 Control of Special Processes 10.0

~ Inspection 11.0 Test Control

' 12.0 --

-Control of Measuring and Test Equipment 13.0- '-

Handling, Storage, and' Shipping 14.0 Inspection Test and Operating Status 15.0 Nonconforming Material, Parts, or Components

.16.0 Corrective Action 17.0 Quality Assurance Records.

18.0

' Audits 3(I' e

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' Date' January'1980 ORGAiiATI0tl-Implementation and maintenance of the QA program for manufacture,' use, cand~ repair'of radioactive material shipping containers shall be the responsibility of LRC management.

Containers for. shipment of NRC licensed imaterial may.be designed and constructed by an LRC approved contractor or designed : constructed, ' purchased,' repaired or used by the LRC.

However, responsibility for quality assurance will reside with LRC management..

J The Lynchburg Research Center is organized as shown by the organization

. chart illustrate'd in Figure 1.

Written administrative procedures delineate (the functions.and responsibilities of the organizations within LRC.

LO All personnel' performing shipping container QA functions are deemed

. to be qualified in this area since ~ current programs for the application of 10 CFR 50, ' Appendix B are in effect. All verifications of conformance to

',. established requirements are accomplished by individuals or groups who do not have ~ direct responsibility for performi.ng the work being verified.

Trained,~ qualified personnel within" B&W shall be assigned to determine that functions delegated to suppliers are bei.ng properly accomplished.

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.Date January.1980

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DIRECTOR.

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MANAGER MANAGER

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ACCOUNTING &

ADMIN. SERVICES FACILITIES I

i QA SNM HEALTil ACCOUNTABILITY ADMINISTRATOR SPECIALIST PHYSICS O

FI6URE 1.

The principal responsibilities and authorities of. the LRC Quality Assurance Program for Shipping Packages are vested in the following positions at the LRC.

QA Administrator The direct responsibility for implementing the QA program lies with the QA Administrator.

He reports to the Director through Manager, Accounting and Administrative Services and is totally independent of all other sections thus assuring independence in carrying out the functions of inspecting, auditing, or otherwise verifying conformance to 10 CFR 71, Appendix E

criteria, lie is responsible for the implementation of facets of the

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-QA~ Program including review and approval of all vendor quality assurance v.

programs.

He has the authority to withhold from further processing or use P

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w w purpose, scope _, and mandatory implementation of the quality related manuals, instructions, and procedures..

b. : Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.-

c.

The. scope, the objective, and the method of implementing the

' indoctrination and training program are documented.

' d.1 ; Proficiency of personnel performing ' quality-affecting activities is mantained by retraining, reexamining, ahd/or recertifying.

' Safety-related structures, systems,'and components co_ntrolled by

. the QA' program at a minimum will include structural requirements to maintain container.~ integrity,- radiation shielding, and neutron absorbents. -

- Controls.-shall be maintained overzvendor or consulting organizations

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-Q t'o' assure.that Appendix E is implemented.

Management reviews of the QA program are conducted periodically

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ito asses--its_ scope, implementation, and effectiveness.

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-Section No.

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- Date January 1980 o

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"-. DESIGN. CONTROL'

- Design ~ activities atitbe Lynchburg Ilesearch. Center arecconducted in

'accordance:with writter. administrative procedures which. assure ~ that appli-cable quality standards:and necessary design' features are correctly translated linto specifications,1 drawings;. written procedures, and instructions; and that '

any ' deviations or changes from these quality standards are' controlled. Design Lreviews'are made by individuals or' groups other than those. involved in the

original design and are specifically directed to those items critical to the quality-.of the component or system being designed.

Suitable design controls are_ applied to such. activities as siesmic, stress, thermal, hydraulic,

. radiation, and a'ccident analysis, compatibility of materials; and accessibility

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for in-service ins'pection, maintenance and' repair. Designs are also reviewed

to-assure that.(1) design ~ characteristics can be controlled, inspected, and 1

~ tested, and (2) inspection and test' criteria are identified. Materials, parts,'and equipment which are standard, commercial, or which have been previously approved for a different application are reviewed for ::uitability I :priorKto selection. Measures are established for the selection of suitable materials, parts, equipment, and' processes for safety-related structures, 4 -

-systems,.and components which include.the use of valid industry standards

.and specifications.

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. Proper selection.and accomplishment of design ~ verification or checking

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.processer.such as by design feviews, alternate calculation.s or qualification

. testing are performed.

When 'a -test program is used to verify the adequacy of a design, a qualification test.of a prototype unit under adverse design

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' conditions shall be used.

' Design interface controls include the review, approval _,-release, o

distribution and-revision of documents'with participating design organizations..

Any design and specification changes.are subject to the same design controls' and approvals' that were applicable.to the original design. Any errors or-

deficiencies 51n the design, including the design process, that could adversely-

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affect safety-related structures, systems, and components are documented and

.e handled (in'accordance with -Section 16.0 of this manual..

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Section No.

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Date

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c-4 PROCUREMENT. DOCUMENT CONTROL-Quality Assurance-will review and approve purchasing' documents prior

-to release to verify inclusion of basic -technical, requirements, provisions

'for access. to the ' suppliers facility for. source inspection 'or audit, _

documentation submittal / retention requirements, quality assurance program requirements, provisions for. extending applicable requirements to lcwer s

tier s'uppliers,- requirements.for, material; certifications or certificates of conformance,.and any other applicable Appendix E requirements..

Quality Assurance will verify whether the proposed supplier has been evaluated and approved per'the provi'sions of Se'ction 7.0 of this

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[I) manual and will' notify Purchasing if an approved supplier _ must be used

-for-the purchase.

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- Procurement _docunents for ' spare or replacement -parts of safety '

- related structures, systems, and. components are subject to controls at least~ equivalent.to those used.for.the~ original equipment.

Changes'to purchase requisitions or purchase orders shall receive the'same level ~of approvals as the original docunient.

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' Section No.

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INSTRUCTIONS, PROCEDURES,'AND DRAWINGS Activities attthe$Lynchburg Research Center.are directed by documented.

instructions,Tprocedures, and drawings. appropriate to the' circumstances to

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twhich they4are applied. -Detailed fabrication drawings are prepared by Design -

- Services, or other appropriate organizations, checked by Design Services for Lsafety,l functional and structural adequacies, and dimensio,nal accuracy for critical components. LThe drawings are then~ reviewed by the responsible section to verify that design requirements are met. Revision level and 1

. approval control is applied to the_ drawings prior to re' lease to the shop for n

- ; fabrication.

Any changes to.the drawings are subject to the same level of approval prior to being implemented.

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O When Design Services and Quality Assurance determine that fa'brication, assembly, or process control is required, the drawings will contain a note p

stating that route sheets are required. The route sheets will reference the ' drawing and revision number to:be used, will indicate the sequence of

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operations to be followed, provide a place for recording data such as critical dimensions, reference lany technical procedures (including revisioa) to be used-in performing the~ operation, identify acceptance criteria if not

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on the. drawing or in the technical procedure, and provide for the initiels of the person completing the operations.

If an independent inspection function.is to be employed, the route sheet will also provide for initials of'the inspector accept;ing the operation.

. Inspection = Checklists are used for verification and recording of

-physical: characteristics which are considered critical to the component.

Checklists are_used in place of route sheets when the inspection can be performed after the part has-been completed per the drawing and when no

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ia-P.rocess control of fabrication of the part is required.

Administrative ~. Procedures are.used to implement-policies and to

~ They describe interface-direct the activitiesfof one.or_ more organizations.

crequirements and provide the detailed work directions-for recurring functions..

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-Technical Procedures'arelused to direct specific technical activities such as the performance 'of experiments oktests, calibration of equipment,-

error: analysis, or special process control'; i.e.,' welding, nondestructive p

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examination', _.etc. - When~ used as test; performance procedures : the technical (prQcedures will include provisions for assuring that all test prerequisites ihave'_beenmet(referenceSection'li.0)thatthereareprovisionsforrecording data either. on test data. sheets-or in test logs, and that all requirements.

. for' customer witnessing o'f the test 'are met. When material control:is required

-during the performance of a test or experiment, the test procedures will also

= direct ~ the handling and identification of the controlled material.

The QA-organization shall review and concur with technical procedures, N

inspection plans, drawi.ngs and specifications, and all changes thereto.

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Section No.

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January 1980

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DOCUMENT CONTROL The documents, affecting quality and to be controlled by the provisions

- of.this section are the following:

Administrative Procedures Drawings Inspection Checklists' Quality Assurance Manual Quality Assurance Plans Route Sheets Technical Procedures Administrative Procedures are prepared and revised by personnel U

reporting 'directly to either the Vice President of R&D or the Director of LRC. The resolution of differing requirements will be the responsibility of the Vice President or the Director.

The editing,-arranging, and issuance of procedures to authorized personnel will be the responsibility of the Administrative Procedure Manual' Coordinator of the R&D Division.

The Manual Coordinator will also be responsible. for obtaining approval signatures from the Vice President, Director, and the Managers on the master file copy and for retention of. all histor,ical -file copies of the manual.

Drawings ~are prepared by appropriate organizations and controlled by Design Services.

Revision level and approvals are reflected on the

- drawings.and on status cards maintained by the-engineering group.

Original releases and revisions must be approved by the design engineer and the responsible section personnel.

Design Services maintains a distribution _ list and assures that only the latest approved revision n\\

. applicable to 'a job is used. Drawing masters are retained as required

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by contract requirements or'R&D retention policy.

' Inspection Checklists are prepared and revised by Design Services or responsible section and: approved by the individual specifically in b

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6.0 Section No.

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-Date January 1980

. charge'.of the. container. ~ The che'cklists are issued to the person performing the verification. When completed,'the dhecklists are returned to the responsible section for inclusion in the' project: file.

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The' Quality Assurance Manual is. prepared by LRC Quality Assurance and approved by the LRC Quality Assurance' Administrator.

The LRC Q A. Admin-istrator maintains the distribution lists and issues copies of the manual on a controlled and noncontrolled-basis.

Controlled manuals have an issue number' assigned to each recipient and are kept up-to-date. Noncontrolled copies are. issued on a one time basis for informati only; however, a record of recipients of noncontrol copies will be ms

-ined.

Revisions of the manual are subject to-the same control as the s jinal release.

The revision page shall.be signed by the LRC Q.A. Administrator to indicate all necessary approvals,have been received.

Q Q.A. Plans are prepared jointly by those personnel responsible for the use.of the container and Quality Assurance. The responsible !;ection-maintains revision status and distribution lists.

Revisions are subject to~the same control as the originals.

Route Sheets are prepared-by Design Services when fabrication, assembly, or process. control is required.

Route sheets will be reviewed by Q.A. for requirements prior to release to the project construction supervisor.

Revisionsito route sheets will' receive the same control ~as the originals.

. Design Services will maintain revision status and distribution control.

Technical Procedures.

Initiation.and approval of a technical procedure is the responsibility of the using organization. The originator will be responsible 'for. the technical content, revisions, obtaining approvals and identifying distribution. -Quality Assurance will provide the originator with a-unique identification number and once the procedure has been approved, g.

U will' obtain final release, reproduction and distribution of copies.

, - Revisions r'equire.the same. level of approvals as the original.

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Section No;.

7.'O yy Q

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Date" January 1980 8

.CQNT80LL0fPURCllASEDMATERIA,L, EQUIPMENT,ANDSERVICES.

i Pre " award. audits and surveillance of suppliers dur'ng fabrication, linspection, testing,' and shipment of materials, equipmant 'and components

-is planne'd and performed in accordance with written procedures to assure -

conformance to quality and purchase order requirements:. These procedures

. provide.for instructions. that specify. the characteristics or processes to be witnessed, inspected,- or. verified, and acceptw'; the method of-surveillance.and the' extent of documentation required; and those responsible

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for, implementing these instructions.

Suppliers' certificates of conformance are periodica_11y evaluated-by audits, independent inspections, or tests to assure they are valid.

77.i SOURCE EVALUATION AND SELECTION

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If evaluation-and selection of suppliers is required by the Quality Assurance Plan, one of the following criteria will. be used:

a.

The supplier will have a previous and continuous record of.

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.supp1ying acceptable i_tems, processes, or services to the requirements of R&DD procurement documents.

For purposes of-meeting this criterion, R&D may elect to use supplier quality history data obtained from other B&W divisions provided that data :is for similar items, process.es, or

. 7 services: purchased.

b.. An audit o' f the. supplier's quality assurance system will indicate acceptab'ility of that supplier.

For commercial or "off the' shelf" items, 'a receiving inspection

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will be performed to determine compliance with procurement document reuqirements.

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S:ction'No.

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7.2 -APPROVED SUPPLIER LIST Once a supplier has been evaluated ard approved, Quality Assurance will add the supplier's name to an approved supplier list. The list will be distributed to laborato'ry section managers and Purchasing. Purchase orders for items requiring quality assurance per this section may be placed only with suppliers shown on. the approved supplier. list.

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t 7.3 SUPPLIER QUALITY HISTORY

. A supplier quality history file will be maintained by Quality Assurance, when required, to provide an indication of undesirable ' trends developing in the quality of a supplier's items, processes, or services. The file will

' include applicable receivir)g inspection. reports, supplier audit reports, and -

source inspection reports. The history' file will be used as a basis for Q

determining if a supplier's approval status should be revised.

7.4' SUPPLIER AUDITS If an audit of a-supplier's quality system by R&DD is required, the audit will be coordinated with Quality Assurance, Purchasing, and the cogniza'nt project leader. The. audit will be performed in accordance with Section 18.0 of this manual. [ Supplier audits for DOT specification containers will not be performed.

7.5 SOURCE INSPECTION When it is determined that source inspection is required, an inspection plan will be developed by the project leader and Quality Assurance and will t:

u sign. ate. specific witness and hold points.

Copies of the source inspection reports will be maintained on file by the project leader and Quality Assurance.

Surveillance shall be performed on those items where verification of procurement requirements c.innot be determined upon receipt.

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7.6 -RECEIVING' INSPECTION Receiving inspection of the supplier furnished material, equipment,

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and' services ~ i.s performed 'to-assure:

a.; The material, component, or equipment is' properly identified and corresponds with the identification or receiving documents.

b.'. Materials, components, equipment, and acceptance records are

.- inspected and judged acceptable in accordance with pre-determined inspection instructions, prior to installation c

or use.~.

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Inspection records or certificates of conformance attesting to the acceptance of material components, and equipment are

y available prior to installation or use.

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.d.

-Items accepted and released are identified as to their m

inspection status prior to forwarding them to a controlled storage' area or releasing them for installation or further work.

Requirements for receiving" ins'pection for an'. item will be noted on the purchase order. A copy of, the purchase order will be forwarded to the receiving group. :Upon arrival of the materiaf, it will be segregated and not released for use.until accepted by the inspection.

If-specific procedures arel required to perform the inspection, Gey will be provided

to the inspe'ctor prior to ' commencement of the rLceipt. inspection. A notation'that-special instructions are requi,edlwill be made on the ipurchase order.

7.7 SUPPLIER' PROCEDURES.

~ Requirements for. suppliers to submit specific procedures for R&DD '

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review / approval' will be -included (when applicable) on the purchase order.

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V When the procedures are received, they will be routed;to the projectlader'

for review / approval.

Supplier QA procedures will be reviewed byihe project.

' Supplier QA manuals will be routed to R&DD QA for review,- approval.and-retention.

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- 7.8'. RECORDS

Any supplier shall furnish the following records _as a minimum:

fa.. Documentation that: identifies the purchased material or equipment and the specific requirements (e.g., codes,

-standards, and. specifications) met by the items.

b.

Documentation that -identifies any procurement requirements i

which have-not been met 'together with. a description of-

- those nonconformances-dispositioned " accept as is",or

" repair".

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' in the QA Program and shall be undertaken by a responsible QA individual.

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' iSection'No;

'8.0' O

-Date.

January 1980

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IDENTIFICATION AND~ CONTROL OF MATERIALS ' PARTS & COMPONENTS

- 1 Material will be controlled using;a system of tags, route sheets, and, technical ' procedures to. assure accurate recording or traceability of material or:part-and identification : including part number, lot number, serial number,

.or heat. number.

Identification must be verified and documented.

Identifi-cationL requirements are determined during generation of specifications and design drawings.

Written administrative-procedures.will direct-the use of a tagging system to be applied to all controlled materials.

When route sheets or technical

.pyocedures are used, material identification will be transferred to route sheets,' test data sheets, or test 1.ogs to maintain accountability and

control during. fabrication and assembly or during the performance of a test or' experiment.

Upon completion of the activity, the parts or material will be reidentified to show their resultant condition.

The location and the

-method of identification shall in no way affect the fit, function, or quality of the item being identified.

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_ l S ction110.

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CONTRQl, Of SPECIA PROCESSES

, Special proc'essing techniques. that are :u ~ed 'to support fabrication or performance of an experiment or test will be documented in technical-procedures with the requisite approvals.

Qualification 'of.the equipment to'be used will'either be in accordance with the direction provided by the

technical' procedure:or by. standard ' alibration procedures used as a part c

- of the ' normal.' measurement control program defined in-Section 12,0 of this-

• manual.. If personnel qualifications are required, such as for welding, appropriate-qualification records will be maintained reflecting examination results, training records, and' maintenance of proficiency. ' In most areas, however, the performance _ of a special process (for example,_ NDE) will be by laboratory personnel directly engaged in the research aspects of that-

. process who are, by nature of their work, qualified well above standards imposed on production facilities. These qualifications are on file in the Personnel Department. When required in direct support of an experiment-or test; appropriate process control records will be maintained.

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S ction No; 10.0 i,_ ).

. Date'

' January 1980 t

INSPECTION LInspectionsLare performed on~ those activit'ics affecting quality to assure.conformance.with ' documented instructions,- procedures, and -drawings.

cThe need Lfor: inspection.is identified on the receiving copy of the purchase order, route sheets,. technical procedures, and inspection checklists.

i Mandatory. inspection hold points for witness by an' inspector shall also be identified on these documents.

Critical dimensions are identified on the drawings. Any modifications, repairs, or replacements shall be. inspected

'in accordance with the original-design and inspection requirements or acceptable' alternatives.

In the case that direct inspection is not possible, Lindirect control will be achieved by monitoring processing methods, equipment, personnel, etc.

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Inspection will be' performed by a person (s) familiar with the operation being inspected.. Inspectors shall be' qualified in accordance with appli-cable codes, standards, and training programs; and their qualifications

and certifications shall be kep't' current.

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Secti.on No.

11.0' V

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Date January 1980 TEST CONTR'01..

Test ~controlLis handled through-technica1' procedures (Reference Section5.0).. Responsibility for preparation of the test program and test performance procedure is assigned to the project leader.

He will obtain the necessary approval and the revision and distribution control

- will be as described in.Section 6.0 of this manual.

Each' test procedure will include provisions-for ensuring that test prerequisites have been

-met.

Prerequisites will include items such as calibrated instrumentation',

. appropriate equipment, trained personnel, condition of test equipment and the item to be tested, suitable environmental conditions anc. provisions for data acquisition.

WHtten test procedures shall incorporate the;

-following:

a.- The requirements and acceptance limits contained in applicable designs and procuremer)t documents.

t b.

Instructions for performi.ng the test.

c.

Mandatory inspection hold points for. witness by owner,

. co'ntractior, or inspector.

d.

Acceptance and_ rejection criteria.

Test data and results will be documented using test logs, data sheets, or a. computer data acquisition system. - These data will be amlyzed by the-project engineer and reviewed by his supervisor to ensure that test objectives have been met.

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,1-f'y Sectton No, 12.0

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Date January 1980 CONTROL OF MEASURING AND :TESTEQUIPMENT A documented system is established and maintained to assure that those tools, gauges, instruments, inspection and measuring and test equipment that are used in activities affecting quality are of the proper range, type and accuracy to verify conformance to established requirements.

.This system, as a minimum, meets the requirements of Specification HIL-C-45662A, " Calibration System Requirements".

The system shall include calibration and certification records, calibration procedures and a recall system to assure that equipment is calibrated in' accordance with established intervals. The accuracy of C.

calibrated' equipment is assured by:

a.

Traceability to standards maintained by the National Bureau of Standards; b.

Comparison to natural physical phenomenon; or c.

The. ratio type of self calibration techniques.

All items within this system shall be given a unique serial number

.for traceability to calibration test data.

All calibra'tions are recorded on a service log form which reflects the serial number of the item and the procedure to which it is calibrated.

A label is applied to the item to indicate the calibration status, including calibration due.date.- The completc status of all items under the calibration system is maintained.

When inspection, measuring and test equipment is found to be out of calibration,Lan-evaluation is made and. documented uf tk n1Mity of fy);

previous 1nspection or test results and of the acceptablitt; of items-

'previously' inspected or. tested.. If any inspection, measuring or test-

- equipment -is consistently found to be out of. calibration', it is repaired

or replaced._

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'Section(o.

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'12.0 M-

'Date:

- -January 1980 s

A111calibratirig standards have an uncertainty (error) requirement of no'more..than one'-fourth' of.the tolerance of the cquipment being calibrate'd.

7A greater uncertainty may be acceptable when limited by " state-of-the' art".

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Section No.

13.0

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Date January 1980 e

llANDLING, STORAGE,1 AND SHIPPING Any special handling, storage, shipping, packaging, preservation, or cleaning instructions required for containers is identified by the project leader. The project leader either issues a technical procedure detailing these regirements or coordinates with the Design Services Group to have the reqirements defined hy drawings.

The technical procedures include provisions for recording inspection of the work when such inspection is required.

If drawings are used, the drawing requires route sheets or inspection checklists to document accomplishment and the inspection (if necessary) of the activity.

Special handling and loading procedures for NRC and DOT approved

(_)

. containers are documented in the specification or license certificate.

Completion of these requirenents are assured by the project leader and documented.

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Sectign ib,

-14.0 Date January 1980' INSPECTI0fi, TEST, At:0'0 PEP TING STATUS

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When required by contracts or work orders involving material controls, a system of marking, tags, route sheets, inspection check lists, tes't data sheets, test logs, or inspection records is used to identify the inspection t

and test status. This system assures that nonconforming items are clearly

- marked and that only items that have passed the required inspections or tests are used.- This system includes written procedures for control of the above status indicato'rs.

Bypassing of reqired inspections, tests, and other critical operations is procedurally controlled under the cognizance of the Q.A.. organization.

When required, this ~ system also includes a means for indicating operating status of test systems such as by tagging valves and switches to prevent inadvertent operation.

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-Section No.

15.0 Date

January 1980~

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- NONCONFORMING. MATERIALS, PARTS OR COMPONENTS T

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- Nonconforming items shall be tagged with a red _" discrepancy" tag, segregated whenever possible, and the nonconformance documented on a CorrectiveAction' Report (CAR).. The. CAR identifies the nonconforming f

item; describes the non'conformance, the disposition of the nonconformance, and the inspection requirements; and includes signature approval of the disposition.

The project leader shall review all nonconformances to determine any adverse' affect to the' test results. -The project leader shall approve all actions"taken to correc't the nonco'nformance or to "use-as-is".' ' Quality

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Assurance shall approve all Corrective Action Reports and, when the non-conformance is satisfactorily _ resolved,-shall remove the " discrepancy" tag from the item.

In all instances where a " repair" or "use-as'is" decision is contem-plated,; the project-leader shall_ determine whether such a decision will cause a deviation to customer requirements or commitments made in the

proposal;or-project technical plan.

If a ' deviation will ' exist, the project leader shall.obtain approval from the customer before approving the " repair" or "use-as is"' decision. -Acceptability of~" rework" or " repair" of materials, parts, components,. systems, and structures is verified by reinspecting and

-retesting the item as originally inspected and tested or by a method which is at '.least equal to the original inspection and testing method.

Inspection, testing, rework. and repair procedures are documented.-

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Section No.

16.0 Date January 1980 k

.h CORRECTIVE ACTION.

.There are three basic -aspects to the corrective-action system. The-first is the corrective action obtained for a specific hardware noncon-formance (See Section 15.0). ' Quality Assurance will verify the-appropriate corrective action hasi been taken before final acceptance of the Corrective

' Action Report.

The second aspect'is corrective action obtained during formal audits.

- Quality Assurance $erforms~ periodic audits as described in Section 18.0 of this manual.

Whenever quality system deficiencies are detected, they will be identified in the audit report. The response to audit findings is O_

evaluated by Quality Assurance for adequacy. After the time for implementation of the corrective action has elapsed, Quality Assurance will verify that the action was taken and is effective.

4 The third' aspect of corrective action is where a quality system deficiency is detected other than by a specific nonconformance or by an audit finding.

If an incident has occurred or a condition exists which could jeopardize the attainment of Quality Assurance objectives, Quality Assurance will initiate a Corrective Action Report describing the deficiency and will forward the report to the cognizant project leader, group supervisor or section manager.

Note: Deficiencies involving multiple projects, tests, programs or sections shall be reported to the appropriate section manager (s) for corrective action.

The recipient will (1) conduct an investigation for the cause of the incident

- or condition, (2) document-the results of the investigation and the corrective

" action taken on the report, and (3) forward the report to Quality Assurance.

Quality Assurance will follow-up within a reasonable time to assure that the corrective action has been implemented and is effective.

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Section No.

' 17.0

~ Date~ January 1980' QUALITY ASSURANCE RECORDS' R&DD will establish a system for preparation, collection and retention of records-sufficient t.ol provide documentary e'vidence of activities affecting quality and (where applicable) of the acceptability of materials, parts, or

.assemblics having an effect on the validity sf the test or experiment. These

. records will be consistent with applicable codes, standards, specifications, and contracts and will be adequate for use in managing the program. The records will be identifiable and retrievable.

' The record system will encompass.those records required by each section of the manual but specific records will be generated only if the applicable section of this manual is 1nyoked by the quality Assurance. Plan on the project f}

.in question.

Q.A. records may include, as applicable, results of reviews, inspections, tests, audits, and material analyses; monitoring of work performance, qualification of personnel, procedures, and equipment; and other documentation such as drawi.ngs, specifications, procurement documents,

. calibration pro'cedures and reports; nonconformance reports, and corrective action reportr,.-

Inspection and test record' will, as a minimum,-identify the inspector s

or person recordi.ng data, the type and date of observation, the results,

.the acceptability and the. action-taken in connection with any deficiencies

.noted.

The retention of records will oe in accordance with B&W policy and as

. required by contract. work order or applicable codes, standards or specifi, cations..B&W policy provides for record retention in an already established storage facility' that is located and secured to prevent-destruction of the records by-fire, flooding, theft, and deterioration

.h by enytronmentalconditions such as temperature or humidity.

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. Section No.

17.0 t

Date '-

January 1980

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If-any quali.ty system deficiency is considered to be significant, Quality Assurance will imediately notify the cognizant project leader, group supervisor, section manager, and lab manager and will require a work stoppage in the affected area of operation until. the condition has been corrected. - A report of. this action will be made to the Director-within forty-eight hours.

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Section tio.

'18.0' Date' January'1980 AUDITS Quality Assurance will implement a system of ~ audits to verify com-pliance with all aspects of the Quality Assurance Program and to include an objective evaluation ~ of quality. related practices, procedures, and instructions and the effectiveness of implementation.

Audits will, more specifically, consist of-an objective evaluation of work areas, activities, processes, and items and the review of comments and records..The audits will be performed in accordance with written procedures or checklists by appropriately. trained personnel having no direct responsibilities in the areas being audited.

The audit. team may. employ personnel from various j

secti.ons within R&DD to provide additional technical expertise and ensure a comprehensive assessment of the activity.

Internal audits'wil.1 be performed on individual projects to verify compliance with the Quality Assurance Plan.

Audits will also be performed on selected systems which apply to more than one project.

Project audits will be performed at least once' during the project or at least once annually, whichever is the shorter interval.

" Generic" systems, applicable to more than one. project, will be audited at least annually.

Supplier. audits will be performed when regt ired by the provisions of Section 7.0 of this manual.

R&DD procurements do r.ot require long supplier

. production ' runs; therefore, the R&DD policy will be to perform a pre-award -

evaluation and then monitor the supplier's quality system using selected source inspections and receiving inspection data.

Supplier audits must bs

' performed at' intervals consistent with the importance, complexity, and

,quanity of the item..

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Audit findi.ngs will 12 documented in a formal audit report and I

l transmitted to the project leader and group superyisor '(for project ' audits),

the cognizant sdction manager (for, generic system audi.ts), or to the supplier. -If deficiencies have been found, the recipient of the audit

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f'y Section Ng, 18J0'

.v Date January 1980

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report will be required to take the necessary corrective action and to report the action taken (or scheduled) to QA within two weeks.

Quality

'Assu'rance will. follow up' to verify that the comitted corrective action

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has been tanen and is effective.

Supplementing the formal audits will be a program of informal surveillancesconducted by Quality. Assurance during the course of a project. The Quality-Assurance-Administrator wiil monitor the activities on a-day-to-day basis to assure'the project is being conducted in accordance with the QA Plan. Any deficiencies requiring formal corrective action will be documented on a Corrective' Action Report and resolved in accordance with Section 16.0 of this. manual.

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