QAP-008, Document Control (10/02/1990-09/12/2003).general, the next sequential three digit number shall be assigned to new OPs, such as TOP-OOn. OPs of similar application may be assigned

CENTER FOR NUCLEAR WASTE Proc. 0AP-008

REGULATORY ANALYSES Revision 0

QUALITY ASSURANCE PROCEDURE Page 1 of 15

Title Document Control

EFFECTIVITY AND APPROVAL

Revision 0 of this procedure became effective on 10/02/90 . This procedureconsists of the pages and changes listed below.

Page No. Change Date Effective

ALL 0 10/02/90

SUPERSEDEDSupersedes Procedure No. N/A

Approvals

Written By

R 6er t B ri e n t_-

Quality Assurance

CNWRA Form QAP-1

CENTER FOR NUCLEAR WASTE Proc. QAP-008

REGULATORY ANALYSES Revision °


QAP-008 Document Control

1. PURPOSE

The purpose of this procedure is to describe the methods ofpreparing, approving, distributing and controlling Center plans,procedures, and instructions. This procedure implements therequirements of CQAM Section 6.

2. RESPONSIBILITIES

2.1 The Director of Administration is responsible for theoverall implementation of this procedure and for thefunctions of Document Control identified in thisprocedure.

2.2 Element Managers are responsible for identifyingrecipients of controlled documents.

2.3 Controlled document recipients are responsible foracknowledging receipt of documents and incorporatingrevisions and changes.

3. PROCEDURE

3.1 Document Identification

3.1.1 The Center Quality Assurance Manual (CQAM),Operations Plans and Project Plans shall beidentified by unique titles reflecting theircontent and subject matter. Revisions andchanges to these documents shall be identifiedby sequential numbers. Issuance of a revisionshall reset the change number to zero. Duringthe development of the CQAM, Operations Plansand Project Plans and their revisions andchanges, Document Control shall be notified bythe author in order to update the MasterDocument List (see paragraph 3.2.4) by listingthe document status as "in process."

CNWRA Form QAP-2




3.1.2 Operating Procedures (OPs), which includeQuality Assurance Procedures (QAPs) andTechnical Operating Procedures (TOPs), shall beidentified by unique numbers assigned byDocument Control, and sequential revision andchange numbers. The change number shall resetto zero upon revision of the document. Theauthor shall contact Document Control during thepreparation of new OPs to obtain the documentnumber, and during preparation of revisions andchanges, to update the Master Document List. Ingeneral, the next sequential three digit numbershall be assigned to new OPs, such as TOP-OOn.OPs of similar application may be assigned thesame three digit base number with a two digitsub-number, such as TOP-001-02.

3.1.3 Unfilled Scientific Notebooks shall be assigneda unique number upon issuance. A log ofScientific Notebook issuance shall be maintainedby Document Control containing its number, dateof issuance, the Research Project, and theindividual to whom the notebook was issued.

3.2 Document Format

3.2.1 As contractually specified documents, the formatand content of Operations Plans is primarilyguided by applicable contract requirements.These documents shall specify that activitiesshall be conducted in accordance with applicableportions of the CQAM. In addition, theapplicable portions of the CQAM shall beidentified to the extent possible.

3.2.2 The CQAM shall consist of an Introduction and 18sections corresponding to the 18 criteria oflOCFR50, Appendix B. In general, CQAM Sectionsinclude a Purpose, Responsibilities, descriptionof requirements, and Records.

3.2.3 The CQAM shall include a policy statement signedby the President of the Center, and an

CNWRA Form QAP-2

m




Effectivity and Approval page, CNWRA Form QAP-3(Figure 1). The Effectivity and Approval pageshall indicate the change status and date of thedocument and its individual pages. In addition,it shall contain the required approvalsignatures.

3.2.4 The body of the CQAM shall be printed on CNWRAForm QAP-4 (Figure 2), each page identifying inheadings the Section number, revision and changenumber, and page number (page 1 of n).

3.2.5 OPs shall include, as a minimum, sectionsdescribing Purpose, Responsibilities, Procedure,and Records. OPs are the principal media ofinstructions for conducting Center activitiesand shall provide sufficient details andstep-by-step descriptions of the methods to beused that may be easily understood by theintended user of the procedure.

3.2.6 OPs shall include an Effectivity and Approvalpage, CNWRA Forms TOP-1 (Figure 3) and QAP-1(Figure 4), as applicable, indicating therevision and change status of the procedure andeach page and shall contain the requiredapproval signatures.

3.2.7 The body of OPs shall be printed on CNWRA FormsTOP-2 (Figure 5) and QAP-2 (Figure 6), asapplicable, each page identifying in headingsthe Procedure number, revision and changenumber, and page number (page 1 of n).

3.3 Document Approval and Effectivity

3.3.1 Original documents, changes and revisions shallreceive approvals as specified in the CQAM andQAP-002. Documents not requiring NRC acceptanceshall become effective on the date of the latestapproval signature. Documents requiring NRCacceptance shall be classified as "ApprovedDraft" and shall not become effective until NRCcomments are resolved.

CNWRA Form QAP-2

ft




3.3.2 Documents may be changed on a page by page basisor revised in total. For changes, aneffectivity page with signatures approving thechange and the changed pages (only) shall bedistributed. Revisions shall include aneffectivity page approving the changes and theentire document.

3.3.3 TOPs may be changed in the laboratory or in thefield without the required approvals providedthat the change is authorized by the PrincipalInvestigator and that the change is documentedin the appropriate Scientific Notebook. Therequired approvals shall be obtained by thePrincipal Investigator within a reasonableperiod, and may be documented by signatures inthe Scientific Notebook. Field or laboratorychanges are not permanent and apply only to theimmediately affected activities. Permanentchanges to TOPS require the usual review andapproval process.

3.3.4 Document Control shall maintain a MasterDocument List on electronic media withcontinuous updating, and provide hardcopydistribution to Directors, Element Managers, andPrincipal Investigators bi-monthly. The MasterDocument List shall include the followinginformation:

Document TitleDocument Number, as applicableRevision and Change numbersDocument Date (preparation date)Effective DateStatus; "In Process","Approved Draft","In

Effect" or "Superseded"Master Document List Effective Date

Documents that have been revised, changed, orotherwise superseded shall be retained on theMaster Document List with their supersededstatus so indicated.

CNWRA Form QAP-2




3.4 Distribution

3.4.1 Documents shall be distributed to thoseindividuals performing activities so that theprocedures are available at the point of use.Individuals requiring documents shall beidentified on the Controlled Document Request,CNWRA Form AP-3 (Figure 7), by the ElementManager responsible for the activity controlledby the document. In addition to the affectedtechnical staff, document distribution shallinclude:

CQAM - Center President, Directors, ElementManagers, Principal Investigators, SwRI QAManager, SwRI QAC Chairman.

TOPs, Operations Plans, Project Plans -Technical Director, Director of SystemsEngineering and Integration, Director of QA,affected Element Managers.

QAPs - Center President, Directors, ElementManagers, Principal Investigators.

Controlled distribution to the NRC shall madebe as requested.

3.4.2 Additions to the Controlled Document Request,approved by the cognizant Element Manager, shallbe made as necessary as new staff are added oras assignments to different activities are made.

3.4.3 On a quarterly basis, a list of Center staff anddocument distribution shall be provided toElement Managers in order to determine thatprocedures are available to those requiringthem.

3.4.4 Controlled documents, revisions and changesshall be distributed to those listed on theControlled Document Request by the use of theControlled Document Transmittal and

CNWRA Form QAP-2




Acknowledgement Record, CNWRA Form DC-1 (Figure8). The recipient is required to review thetransmitted document, incorporate changes orrevisions, destroy or mark as obsoletesuperseded items, and acknowledge receipt withinone month of transmittal.

3.4.5 The Director of QA shall notify Element Managersof those individuals not acknowledging withinthe allotted time. The Director of QA andElement Managers shall take action as necessaryto obtain the acknowledgements.

3.4.6 Uncontrolled copies of documents may be issuedupon approval by the Element Manager.Uncontrolled copies shall be clearly identifiedas such.

3.4.7 Element Managers and Principal Investigatorsshall take actions as necessary to providecurrent and correct procedures to the point ofuse, and to prevent obsolete copies (controlledor uncontrolled) from being available.

4. RECORDS

4.1 Controlled Document Request and Controlled DocumentTransmittal and Acknowledgement Records forms shall bemaintained as QA Records in accordance with CQAMSection 17 and retained for the period of use of thedocuments plus six years thereafter.

4.2 The Master Document List monthly hardcopy printoutsshall be retained as QA Records for one year. Computerfiles should be adequately protected to prevent lossbetween the monthly printouts.

CNWRA Form QAP-2




CENTER FOR NUCLEAR WASTEREGULATORY ANALYSES

QUALITY ASSURANCE MANUAL


Revision of this procedure became effective on . This procedure consists ofthe pages and changes listed below.

Section Page No. Change Date Effective

Approvals

Director of QA Date Center President Date

CNWRA Form QAP-3

Figure 1

CNWRA Form QAP-2

ftI.


QUALITY ASSURANCE PROCEDURE

Proc. QAP-008

Revision 0

Page 9 of 15



fllAWRA CA.-. flliD-1-vn rorml Umr-4

Figure 2

CNWRA Form QAP-2

of




CENTER FOR NUCLEAR WASTE Proc.REGULATORY ANALYSES Revision .

TECHNICAL OPERATING PROCEDURE Page - of-

Title


Revision . .of this procedure became effective on . This procedureconsists of the pages and changes listed below.


Supersedes Procedure No.

Approvals

Written By rhnical Review

Quality Assurance Cognizant Director

CNWRA Form TOP-1

Figure 3

CNWRA Form QAP-2

ftCENTER FOR NUCLEAR WASTE

REGULATORY ANALYSES


Proc. QAP-008

Revision 0

Page 11 of 15

CENTER FOR NUCLEAR WASTE Proc.-

REGULATORY ANALYSES Revision .

QUALITY ASSURANCE PROCEDURE Page - of.-

Title


Revision of this procedure became effective on . This procedure I

consists of the pages and changes listed below. I



Approvals

Written By Date Technical Review Date

Quality Assurance Date Cognizant Director Date

CNWRA Form QAP-1

Figure 4

CNWRA Form QAP-2

f GoCENTER FOR NUCLEAR WASTE Proc. QAP-008



i CENTER FOR NUCLEAR WASTE Proc.REGULATORY ANALYSES Revision .

TECHNICAL OPERATING PROCEDURE Page_- of-

CNWRA Form TOP-2

Figure 5

ICNWRA Form QAP-2

deCENTER FOR NUCLEAR WASTE Proc. QAP-008



CENTER FOR NUCLEAR WASTE Proc.

REGULATORY ANALYSES Revision___

QUALITY ASSURANCE PROCEDURE Page- of

CNWRA Form QAP-2

Figure 6

CNWRA Form QAP-2

sotoCENTER FOR NUCLEAR WASTE Proc. QAP-008



CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESCONTROLLED DOCUMENT REQUEST

PAGE OF

authorizes that Center Controlled(Element Manager or DLrereor)

Document(s)

be sent to the following individual(s)Name Address

ELEMENT MANAGER (SIGNATURE) DATE DIRECTOR (SIGNATURE) DATE

CNWRA FORM AP-3

Figure 7

CNWRA Form QAP-2

*a

CENTER FOR NUCLEAR WASTE Proc. OAP-008



CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESCONTROLLED DOCUMENT TRANSMITTAL AND ACKNOWLEDGEMENT RECORD

TO: FROM:

Center Document Control OfficeCanter for Nuclear Waste Regulatory Analyses6220 Culebra Rd.P. 0. Drawer 28510San Antonio, Texas 78228-0510

Date Sent:

Attached are the following CNWRA controlled documents:

Document Revision/ TitleNumber Change Number

............. ......... ....... . ..... .............. ...................... .... .. ... . .............. ................. . .. .

............. . .. ...... .... ....... ....... ....... .. ............ .... ...... ... ...... ............ ............ ...... ........ .......... ...... ...... ..................

...........................I........ ............ ...... ......... .................. ......... .........................-.......

.................... ............... .................... .. ........ ................. .. ................................... ......... ........................... ......... ........... ..... ... ..... ....... ........... .... .. ................ .. ........ ... .. ............ .......... .. ..... ... ..........

....................... ......................... ............ ... ............. ........................................... ...............- ..........

Instructions to Recipents:

1. Review and become familiar with the subject documents. Please contact the

author for further clanfication, if necessary.

2. For revisions and changes, destroy or mark as obsolete the supersededdocuments or document pages and insert the current document or pages.

3. Sign and date the acknowledgement below attesting that the attached controlled

documents, revisions, and changes have been reviewed and understood, and

that obsolete documents and pages have been removed.

4. Upon completion, return this form to Document Control at the address

indicated above.

Acknowtedged by Date

CNWRA~wm DC-i-2

Figure 8

CNWRA Form QAP-2

0CENTER FOR NUCLEAR WASTE Proc. QAP-008

REGULATORY ANALYSES Revision 0, chg. 1

QUALITY ASSURANCE PROCEDURE Page .1 of 15

TitleDocument Control




1-23-56-78-15

1010

05/01/9210/02/9005/01/9210/02/90

SUPERSEDED, Leo 7//I 7/. &

Supersedes Procedure No.QAP-008, Rev. 0, Chg. 0

Approvals

Date Technical Revi Date

i( 4 61) )i7 J/-//?z2Rob Rrient~~~~~~~Bruce E. Mv{ritg, "' of/

Quality Assurance <at s Cognin ~r or yHate

D~~~~~~~~~///y /z /E5,1fBruce E. Mabrito s . atrick

CNWRA Form QAP-l 7


REGULATORY ANALYSES Revision .0. chg I

QUALITY ASSURANCE PROCEDURE Page 2 of JI

QAP-008 Document Control

1. PURPOSE

The purpose of this procedure is to describe the methods ofpreparing, approving, distribution and controlling Center plans,procedures, and instructions. This procedure implements therequirements of CQAM Section 6.

2. RESPONSIBILITIES

2.1 The Director of Administration is responsible for theoverall implementation of this procedure and for thefunctions of Document Control identified in thisprocedure.

2.2 Element Managers are responsible for identifyingrecipients of controlled documents.

2.3 Controlled document recipients are responsible foracknowledging receipt of documents and incorporatingrevisions and changes.

3. PROCEDURE


3.1.1 The Center Quality Assurance Manual (CQAM),Operations Plans, Project Plans, Work Plans andTest Plans shall be identified by unique titlesreflecting their content and subject matter.Revisions and changes to these documents shall beidentified by sequential numbers. Issuance of arevision shall reset the change number to zero.During the development of these documents andtheir revisions and changes, Document Controlshould be notified by the author in order toupdate the Master Document List (see paragraph3.2.4) by listing the document status as "inprocess."

CNWRA Form QAP-2

CCENTER FOR NUCLEAR WASTE Proc. QAP-008

REGULATORY ANALYSES Revision 0. chg. 1


3.4 Distribution

3.4.1 Documents shall be distributed to thoseindividuals performing activities so that theprocedures are available at the point of use.Individuals requiring documents shall beidentified on the Controlled Document Request,CNWRA Form AP-3 (Figure 7), by the ElementManager responsible for the activity controlledby the document. In addition to the affectedtechnical staff, document distribution shallinclude:

CQAM - Center President, Directors, ElementManagers, Principal Investigators, SwRI QAManager, SwRI QAC Chairman.

TOPs, Operations Plans, Work Plans, ProjectPlans, Test Plans - Technical Director, DeputyTechnical Director of Systems Engineering andIntegration, Director of QA, affected ElementManagers.

QAPs - Center President, Directors, ElementManagers, Principal Investigators.

Controlled distribution to the NRC shall be madeas requested.

3.4.2 Additions to the Controlled Document Request,approved by the cognizant Element Manager, shallbe made as necessary as new staff are added or asassignments to different activities are made.

3.4.3 Controlled documents, revisions and changes shallbe distributed to those listed on the ControlledDocument Request by the use of the ControlledDocument Transmittal and Acknowledgement Record,CNWRA Form DC-1 (Figure 8). The recipient isrequired to review the transmitted document,incorporate changes or revisions, destroy or markas obsolete superseded items, and acknowledgereceipt within one month of transmittal.

CNWRA Form QAP-2

eCENTER FOR NUCLEAR WASTE Proc. QAP-008

REGULATORY ANALYSES Revision 0, chg. 1


3.4.4 The Director of QA shall notify Element Managersof those individuals not acknowledging within theallotted time. The Director of QA and ElementManagers shall take action as necessary to obtainthe acknowledgements.

3.4.5 Uncontrolled copies of documents may be issuedupon approval by the Element Manager.Uncontrolled copies shall be clearly identifiedas such.

3.4.6 Element Managers and Principal Investigatorsshall take actions as necessary to providecurrent and correct procedures to the point ofuse, and to prevent obsolete copies (controlledor uncontrolled) from being available.

4. RECORDS

4.1 Controlled Document Request and Controlled DocumentTransmittal and Acknowledgement Records forms shall bemaintained as QA Records in accordance with CQAM Section17 and retained for the period of use of the documentsplus six years thereafter.

4.2 The Master Document List monthly hardcopy printoutsshall be retained as QA Records for one year. Computerfiles should be adequately protected to prevent lossbetween the monthly printouts.

CNWRA Form QAP-2

.



QUALIY ASSURANCE PROCEDURE Page 1 of 15

Title

QAP-008 - Document Control



Paae No. Chanae Date Effective

All 0 7/14/92

SUPERSEDED -

Supercedes Procedure No. QAP-008, Rev. 0, Chg. 1

Approvals

Written By Date Technical Review ;~Da


CNWRA Form QAP-1

0





1. PURPOSE

The purpose of this procedure is to describe the methods ofpreparing, approving, distribution and controlling Center plans,procedures, and instructions. This procedure implements therequirements of CQAM Section 6.

2. RESPONSIBILITIES

2.1 The Director of Administration is responsible for the overallimplementation of this procedure and for the functions ofDocument Control identified in this procedure.

2.2 Element Managers are responsible for identifying recipients ofcontrolled documents.

2.3 Controlled document recipients are responsible foracknowledging receipt of documents and incorporating revisionsand changes.

3. PROCEDURE


3.1.1 The Center Quality Assurance Manual (CQAM), OperationsPlans, Project Plans, Work Plans and Test Plans shallbe identified by unique titles reflecting their contentand subject matter. Revisions and changes to thesedocuments shall be identified by sequential numbers.Issuance of a revision shall reset the change number tozero. During the development of these documents andtheir revisions and changes, Document Control should benotified by the author in order to update the MasterDocument List (see paragraph 3.2.4) by listing thedocument status as "in process."

3.1.2 Operating Procedures (OPs), which include QualityAssurance Procedures (QAPs) and Technical OperatingProcedures (TOPs), shall be identified by uniquenumbers assigned by Document Control, and sequentialrevision and change numbers. The change number shallreset to zero upon revision of the document. Theauthor shall contact Document Control during the

CNWRA Form QAP-2

0

CENTER FOR NUCLEAR WASTE Proc. QAP-008REGULATORY ANALYSES Revision 1


preparation of new Ops to obtain the document number,and during preparation of revisions and changes, toupdate the Master Document List. In general, the nextsequential three digit number shall be assigned to newOPs, such as TOP-OOn. OPs of similar application maybe assigned the same three digit base number with a twodigit sub-number, such as TOP-001-02.

3.1.3 Unfilled Scientific Notebooks shall be assigned aunique number upon issuance. A log of ScientificNotebook issuance shall be maintained by DocumentControl containing its number, date of issuance, theResearch Project, and the individual to whom thenotebook was issued.

3.2 Document Format: COAM. OAPs. and TOPs

3.2.1 The CQAM shall consist of an Introduction and 18sections corresponding to the 18 criteria of 1OCFR50,Appendix B. In general, CQAM Sections include aPurpose, Responsibilities, description of requirements,and Records.

3.2.2 The CQAM shall include a policy statement signed by thePresident of the Center, and an Effectivity andApproval page, CNWRA Form QAP-3 (Figure 1). TheEffectivity and Approval page shall indicate the changestatus and date of the document and its individualpages. In addition, it shall contain the requiredapproval signatures.

3.2.3 The body of the CQAM shall be printed on CNWRA FormQAP-4 (Figure 2), each page identifying in headings theSection number, revision and change number, and pagenumber (page 1 of n).

3.2.4 OPs shall include, as a minimum, sections describingPurpose, Responsibilities, Procedure, and Records. OPsare the principal media of instructions for conductingCenter activities and shall provide sufficient detailsand step-by-step descriptions of the methods to be usedthat may be easily understood by the intended user ofthe procedure.

CNWRA Form QAP-2

0



3.2.5 OPs shall include an Effectivity and Approval page,CNWRA Forms TOP-1 (Figure 3) or QAP-l (Figure 4), asapplicable, indicating the revision and change statusof the procedure and each of its pages, and shallcontain the required approval signatures.

3.2.6 The body of OPs shall be printed on CNWRA Forms TOP-2(Figure 5) and QAP-2 (Figure 6), as applicable, eachpage identifying in headings the Procedure number,revision and change number, and page number (page 1 ofn).


3.3.1 Original documents, changes and revisions shall receiveapprovals as specified in the CQAM and QAP-002.Documents not requiring NRC acceptance shall becomeeffective on the date of the latest approval signature.Documents requiring NRC acceptance shall be classifiedas 'Approved Draft" and shall not become effectiveuntil NRC comments are resolved.

3.3.2 Documents may be changed on a page by page basis orrevised in total. For a changed document, aneffectivity page with signatures approving the changeand the changed pages (only) shall be prepared. Arevised document shall include an effectivity pageapproving the entire document.

3.3.3 TOPs may be changed in the laboratory or field withoutthe required approvals provided that the change isauthorized by the Principal Investigator and that thechange is documented in the appropriate ScientificNotebook. The approvals (required by QAP-002) shall beobtained by the Principal Investigator within areasonable period, and may be documented by signaturesin the Scientific Notebook. Field or laboratorychanges are not permanent and apply only to theimmediately affected activities. Permanent changes toTOPS require the usual (QAP-002) review and approvalprocess.

CNWRA Form QAP-2

.




4. RECORDS

4.1 Controlled Document Request and Controlled Document Transmittaland Acknowledgement Records forms shall be maintained as QARecords in accordance with CQAM Section 17 and retained for theperiod of use of the documents plus six years thereafter.

4.2 The Master Document List quarterly hardcopy printouts shall beretained as QA Records for one year.

CNWRA Form QAP-2







Revision of this procedure became effective onof the pages and changes listed below.

Section Paoe No. Chanoe

. This procedure consists

Date Effective

Approvals

Director of QA Date Center President Date

CNWRA Form QAP-3

Figure 1

CNWRA Form QAP-2

0






CNWRA Form OAP-4

Figure 2

CNWRA Form QAP-2



CENTER FOR NUCLEAR WASTE Proc.REGULATORY ANALYSES Revision

TECHNICAL OPERATING PROCEDURE Page of

Title


Revision of this procedure became effective on . This procedure consistsof the pages and changes listed below.

Paoe No. Chance Date Effective

Supercedes Procedure No.

Approvals



CNWRA Form TOP-1

Figure 3

CNWRA Form QAP-2




CENTER FOR NUCLEAR WASTE Proc.REGULATORY ANALYSES Revision

QUALITY ASSURANCE PROCEDURE Page of

Title



Paoe No. Chanoe Date Effective


Approvals



CNWRA Form OAP-1

Figure 4

CNWRA Form QAP-2





REGULATORY ANALYSES Revision

TECHNICAL OPERATING PROCEDURE Page of

CNWRA Form TOP-2

Figure 5

CNWRA Form QAP-2






Proc.

Revision

Page of

CNWRA Form QAP-2

Figure 6

CNWRA Form QAP-2

.



Proc. OAP-008

Revision 1

Page 14 of 15A.

CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESCONTROLLED DOCUMENT REQUEST

PAGE OF_

authorizes that Center Controlled(Element Manager or Director)

Document(s)

be sent to the following individual(s)

Name Address

Element Manager IS~gnature) Date Diroot (

CNWRA FORM AP-3

Figure 7

CNWRA Form OAP-2

0




CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESCONTROLLED DOCUMENT TRANSMITTAL AND ACKNOWLEDGEMENT RECORD

TO: FROM:Center Document Control OfficeCenter for Nuclear Waste Regulatory Analyses6220 Culebra Rd.P.O. Drawer 28510San Antonio. Texas 78228-0510

Date Sent:


Document j Revision/ TitleNumber i Change Number i

._ ____ I ___________________ __.

. _ _ _. _ _ _ _ _.. _ _ _ _ . ........ .-. . ... __...

Instructions to Recipients:

1. Review and become familiar with the subject documents. Please contactthe author for further clarification, if necessary.


3. Sign and date the acknowledgement below attesting that the attachedcontrolled documents, revisions, and changes have been reviewed andunderstood, and that obsolete documents and pages have been removed.

4. Upon completion, return this form to Document Control at the addressindicated above.

Acknowledged by Date

CNWRA Form DC-1-2

Figure 8

CNWRA Form QAP-2



Proc. QAP-008

Revision 1, Chg 1

Page 1 of 15



Revision 1 of this procedure became effective on 7/14/92consists of the pages and changes listed below.

Page No. rhanna

. This procedure

--- IZZ , I -n Date Effective

1-4

5-6

7-10

1 1

12-13

14

15

0

1

0

1

0

1

0

7/14/92

12/8/92

7/14/92

12/8/92

7/14/92

12/8/92

7/14/92

SUPERSEDED

Concurrence Review

Cognizant Director r

Date

CNWRA Form QAP-1

.


REGULATORY ANALYSES Revision 1, Chg 1


3.3.4 Document Control shall maintain a Master Document List,and provide hardcopy distribution to Directors, ElementManagers, and Principal Investigators quarterly. TheMaster Document List shall include the followinginformation:

Document TitleDocument Number, as applicableRevision and Change numbersDocument Date (preparation date)Effective DateStatus: "In Process", "Approved Draft", In

Effect", or "Superseded"Master Document List Effective Date

Documents that have been revised, changed, or otherwisesuperseded shall be retained on the Master DocumentList with their superseded status so indicated.

3.4 Distribution

3.4.1 Controlled documents may be distributed by means ofaccess to electronic media (i.e., read only informationon computer networks) or by distribution of hardcopies. As applicable, hard copies of documents shallbe available for general access in each building whereelectronic distribution is used.

3.4.2 Documents shall be distributed to those individualsperforming activities so that the procedures areavailable at the point of use. Individuals requiringdocuments shall be identified by Element Managers, andrecipients shall be documented on the ControlledDocument Distribution List, CNWRA Form AP-3 (Figure 7).In addition to the affected technical staff, documentdistribution shall include:

CQAM - Center President, Directors, Element Managers,Principal Investigators, SwRI QA Manager, SwRI QACChairman.

CNWRA Form QAP-2

CENTER FOR NUCLEAR WASTE Proc. QAP-008REGULATORY ANALYSES Revision 1, Chg 1


TOPs, Operations Plans, Work Plans, Project Plans, TestPlans - Technical Director, Deputy Technical Directorfor Systems Engineering and Integration, Director ofQA, affected Element Managers.

QAPs - Center President, Directors, Element Managers,Principal Investigators.

Controlled distribution to the NRC shall be made asrequested.

3.4.3 Additions to the Controlled Document Distribution Listshall be made as necessary as new staff are added or asassignments to different activities are made.

3.4.4 Controlled documents, revisions and changes shall bedistributed to those individuals on the ControlledDocument Distribution List by the use of the ControlledDocument Transmittal and Acknowledgement Record, CNWRAForm DC-1 (Figure 8). The recipient is required toreview the transmitted document. In addition, therecipient shall incorporate changes or revisions anddestroy or mark as obsolete superseded items, asapplicable. Recipients shall acknowledge receiptwithin one month of transmittal by signing andreturning the Form DC-1 to Document Control.

3.4.5 The Director of QA shall notify Element Managers ofthose individuals not acknowledging within the allottedtime. The Director of QA and Element Managers shalltake action as necessary to obtain theacknowledgements.

3.4.6 Uncontrolled copies of documents shall be clearlyidentified as such. No record of uncontrolleddistribution is necessary.

3.4.7 Element Managers and Principal Investigators shall takeactions as necessary to provide current and correctprocedures to the point of use, and to prevent obsoletecopies (controlled or uncontrolled) from beingavailable for use in quality affecting activities.

CNWRA Form QAP-2

4CENTER FOR NUCLEAR WASTE

REGULATORY ANALYSES


Proc. OAP-008

Revision 1, Chg 1

Page 11 of 15I.

CENTER FOR NUCLEAR WASTE Proc. QAP-REGULATORY ANALYSES Revision


TitleQAP-



Paae No. Chanae Date Effective


Approvals

Written By Date Concurrence Review Date


CNWRA Form QAP 1-1 (12/92)

Figure 4

CNWRA Form QAP-2

0


REGULATORY ANALYSES Revision 1, Chg 1


CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESCONTROLLED DOCUMENT DISTRIBUTION LIST

PAGE _ OF_

Document

Name Address

j__________ I __________ I~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~~

-4.

+

+

+

.4.

4-

i

CNWRA FORM AP-3-1 (12/92)Figure 7

CNWRA Form QAP-2

f I

0


REGULATORY ANALYSES Revision 2 Chg 0


TitleQAP-008 DOCUMENT CONTROL


Revision 2 of this procedure became effective on 08/22/96 . This procedure consists of the pagesand changes listed below.

Page No.

All

Change Date Effective

08/22/960

SUPERSEDED

Supersedes Procedure No. QAP-008, Rev. 1, Chg 1 dated 12/08/92

Approvals

Wri n By Date Co currence Revi w Date

_ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ _ R o t rient D 5 '

Quality Assurance Date Cogniza or Dtoe

Bruce Mabrito

CNWRA Form QAP 1 (12/92)

* 0




QAP-008 DOCUMENT CONTROL

1. PURPOSE

The purpose of this procedure is to describe the methods of preparing, approving, distributing,and controlling Center for Nuclear Waste Regulatory Analyses (CNWRA) plans, procedures, andinstructions. This procedure implements the requirements of CNWRA Quality Assurance Manual(CQAM) Section 6.

2. RESPONSIBILITIES

2.1 The Director of Quality Assurance (QA) is responsible for the overall implementation ofthis procedure.

2.2 Element Managers (EMs) are responsible for identifying recipients of controlleddocuments.

2.3 Controlled document recipients are responsible for acknowledging receipt of documentsand incorporating revisions and changes.

3. PROCEDURE


3.1.1 The CQAM, Operations Plans, Project Plans, Work Plans, and Test Plans shallbe identified by unique titles reflecting their content and subject matter. Revisionsand changes to these documents shall be identified by sequential numbers.Issuance of a revision shall reset the change number to zero.

3.1.2 Quality Assurance Procedures (QAPs) and Technical Operating Procedures(TOPs) shall be identified by unique numbers assigned by Document Control, andsequential revision and change numbers. The change number shall reset to zeroupon revision of the document. The author shall contact Document Control duringthe preparation of new QAPs/TOPs to obtain the document and revision/changenumber. In general, the next sequential three digit number shall be assigned tonew QAPs/TOPs, such as TOP-OOn. QAPs/TOPs of similar application may beassigned the same three digit base number with a two digit sub-number, such asTOP-001-02.

CNWRA Form QAP-2

0 0




3.1.3 Scientific notebooks shall be assigned a unique number upon issuance. A log ofscientific notebook issuance shall be maintained by Document Control containingits number, date of issuance, the activity, and the individual to whom thenotebook was issued.

3.2 Document Format: COAM. OAPs, and TOPs

3.2.1 The CQAM shall consist of an Introduction and 18 sections corresponding to the18 criteria of 10CFR50, Appendix B. In general, CQAM Sections include aPurpose, Responsibilities, and Description of Requirements.

3.2.2 The CQAM shall include a policy statement signed by the President of theCNWRA, and an Effectivity and Approval page, CNWRA Form QAP-3(Figure 1). The Effectivity and Approval page shall indicate the change status anddate of the document and its individual pages. In addition, it shall contain therequired approval signatures.

3.2.3 The body of the CQAM shall be printed on CNWRA Form QAP-4 (Figure 2),each page identifying in headings the Section number, revision and changenumber, and page number (page 1 of n).

3.2.4 QAPs/TOPs shall include, as a minimum, sections describing Purpose,Responsibilities, Procedure, and Records. QAPs/TOPs are the principal media ofinstructions for conducting CNWRA activities and shall provide sufficient detailsand step-by-step descriptions of the methods to be used that may be easilyunderstood by the intended user of the procedure.

3.2.5 QAPs/TOPs shall include an Effectivity and Approval page, CNWRA FormsTOP-1 (Figure 3) or QAP-1 (Figure 4), as applicable, indicating the revision andchange status of the procedure and each of its pages, and shall contain therequired approval signatures.

3.2.6 The body of QAPs/TOPs shall be printed on CNWRA Forms TOP-2 (Figure 5)and QAP-2 (Figure 6), as applicable, each page identifying in headings theProcedure number, revision and change number, and page number (page 1 of n).

...... __ - - - - -UNWRA Form UAP-2





3.3.1 Original documents, changes, and revisions shall receive approvals as specifiedin the CQAM and QAP-002.

3.3.2 Documents may be changed on a page-by-page basis or revised in total. For achanged document, an effectivity page with signatures approving the change andthe changed pages (only) shall be prepared. A revised document shall include aneffectivity page approving the entire document.

3.3.3 TOPs may be changed in the laboratory or field without the required approvalsprovided that the change is authorized by the PI and that the change isdocumented in the appropriate Scientific Notebook. The approvals (required byQAP-002) shall be obtained by the PI within a reasonable period, and may bedocumented by signatures in the Scientific Notebook. Field or laboratory changesare not permanent and apply only to the immediately affected activities.Permanent changes to TOPs require the usual (QAP-002) review and approvalprocess.

3.3.4 Document Control shall maintain an electronic Master Document List updatedwith each document change. The Master Document List shall include thefollowing information:

Document TitleDocument Number, as applicableRevision and Change NumbersDocument Date or Date of IssueMaster Document List Effective Date

3.4 Distribution

3.4.1 Controlled documents may also be distributed by means of access to electronicmedia (i.e., read-only information on computer networks) or by distribution ofhard copies. As applicable, hard copies of documents shall be available forgeneral access in each building where electronic distribution is used.

LNWKA Form UAP-2

* 0




3.4.2 Documents shall be distributed so that the procedures are available at the point ofuse. Individuals requiring documents shall be identified by EMs, and recipientsshall be documented on the Controlled Document Distribution List, CNWRAForm AP-3 (Figure 7). In addition to the affected technical staff, documentdistribution shall include:

CQAM - CNWRA President, Directors, EMs, PIs, SwRI QA Manager, SwRIQAC Chairman

TOPs, Operations Plans, Work Plans, Research Project Plans, Test Plans -CNWRA President, Directors, EMs, and affected PIs.

QAPs - CNWRA President, Directors, EMs, and affected PIs.

3.4.3 Additions to the Controlled Document Distribution Lists shall be made asnecessary as new staff are added or as assignments to different activities aremade.

3.4.4 Controlled documents, revisions, and changes shall be distributed to thoseindividuals on the Controlled Document Distribution List.

3.4.5 Distribution to CNWRA, SwRI, CNWRA Consultants or Subcontractors shall beby the use of the Controlled Document Transmittal and AcknowledgementRecord, CNWRA Form DC-1 (Figure 8). Recipients shall incorporate the changesor revisions and destroy or mark as obsolete superseded documents, as applicable,and acknowledge receipt of transmittal by signing and returning the Form DC-Ito Document Control.

3.4.6 As appropriate, information copies may be distributed to clients and others listedin the Controlled Document Distribution Lists, however, receipt acknowledgement(para. 3.4.5) is not required.

3.4.7 The Director of QA shall notify EMs of those individuals not acknowledgingreceipt. The Director of QA and EM shall take action as necessary to obtain theacknowledgements.

3.4.8 Uncontrolled copies of documents shall be clearly identified as such. No recordof uncontrolled distribution is necessary.

3.4.9 EMs and PIs shall take action as necessary to provide current and correctprocedures to the point of use and to prevent obsolete copies (controlled oruncontrolled) from being available for use in quality affecting activities.

CNWRA Form QAP-2

0



Proc. QAP-008

Revision 2 Chg 0

Page 6 of 14

4. RECORDS

4.1 Controlled Document Transmittal and Acknowledgement Record forms shall bemaintained as QA Records in accordance with CQAM Section 17 and retained for sixyears.

...... -- - - - - -LNWKA Form UAP-Z



Proc. QAP-008

Revision 2 Chg 0

Page 7 of 14l.


QUAUTY ASSURANCE MANUAL

Rev._ Chg _

Month Year

Page_ of_


Revision _ of this procedure became effective on mmidd/vv. This procedure consists of the pagesand changes listed below.

Section Page No. Chanae Date of Effective

Approvals

Director of Quality Assurance Date CNWRA President Date

CNWRA Form QAP-3SAMPLE

Figure 1

ICWvW rForm uGAP-s



Proc. QAP-008

Revision 2 Chg 0

Page 8 of 14



Section

Revision_ Change_

Page _ of

CNWRA FORM QAP-4

SAMPLE

Figure 2

UNWKA Form UAP-Z



Proc. QAP-008

Revision 2 Chg 0

Page 9 of 14

Proc.

CENTER FOR NUCLEAR WASTEREGULATORY ANALYSES Revision

Page 1 of 3TECHNICAL OPERATING PROCEDURE

Title

EFFECTIVITYRevision of this procedure became effective onThis procedure consists of the pages and changes listed below.

Page No. Change No. Date Effective

Supercedes Procedure No.

Approvals

Written by Date Technical Review Date


CNWRA Form TOP-1 (8/93) SAMPLE

Figure 3

...... -- - - - - -UNWHA Form GAP-2



Proc. QAP-008

Revision 2 Chg 0

Page 10 of 14l.

CENTER FOR NUCLEAR WASTE Proc. OAP-

REGULATORY ANALYSES Revision


TitleQAP-


Revision of this procedure became effective on This procedure consistsof the pages and changes listed below.



Approvals

Written By Date Concurrence Review Date


CNWRA Form QAP 1-1 (12192) SAMPLE

Figure 4

------ -- - --- -CNWHA Form QAP-2

0



Proc. QAP-008

Revision 2 Chg 0

Page 11 of 14

Proc.

CENTER FOR NUCLEAR WASTEREGULATORY ANALYSES Revision _ Change

Page _ ofTECHNICAL OPERATING PROCEDURE I

CNWRA Form TOP-2

SAMPLE

Figure 5

CNWRA Form QAP-2



Proc. QAP-008

Revision 2 Chg 0

Page 12 of 14


REGULATORY ANALYSES Revision _Chg _

QUALITY ASSURANCE PROCEDURE Page - of __

CNWRA Form, QAP-2SAMPLE

Figure 6

CNWKA Form QAp-Z

0



Proc. QAP-008

Revision 2 Chg 0

Page 13 of 14

CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESY& CONTROLLED DOCUMENT DISTRIBUTION LIST

PAGE OF _

Document

Name Address

i

i

i

SAMPLECNWRA FORM AP-3-1 (12/921

Figure 7

I--- - - -rCrvvMF rorm uGAr-

46CENTER FOR NUCLEAR WASTE

REGULATORY ANALYSES


Proc. QAP-008

Revision 2 Chg 0

Page 14 of 14

CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESUUNTROLLED DOCUMENT TRANSMITTAL AND ACKNOWLEDGEMENT RECORD

TO: FROM:Center Document Control OfficeCenter for Nuclear Waste Regulatory Analyses6220 Culebra Rd.P.O. Drawer 28510San Antonio, Texas 78228-0510

Date Sent:


Document Revision/ TitleNumber Change Number

.... ..-.-.-..................... ........ -..-................ ... .. . ...... ..~~~~'' '-~~- ~

.. _..... ;................... ............... ........... ;............. .............. ...... ... .......... .. ....... ...... ..... .... .... .... ... ..... ............

............. .............. ............... _....:.................... ................... ...__.... _.__........_................... .._.......................__..... .. ._ .... ........ ............. __.. .._...........

.................... _.... . ................. .. . _....... .... . _._._._.._........................._ ._._ .......... ................ __..__ ._ ........................ .... ......................................... ._

~~~~~~~~~~~. ....... _....


1. Review and become familiar with the subject documents. Please contactthe author for further clarification, if necessary.


3. Sign and date the acknowledgement below attesting that the attachedcontrolled documents, revisions, and changes have been reviewed andunderstood, and that obsolete documents and pages have been removed.

4. Upon completion, return this form to Document Control at the addressindicated above within 30 days.

Acknowledged by.;NWRA Form DC-1-2

Date

SAMPLE

Figure 8

------ -- - - - - -CNWRA Form UAP-2


REGULATORY ANALYSESRevisioni3 Chg~.0

QUALITY ASSURANCE PROCEDURE Page I of 16



Revision 3 of this procedure became effective on 11/07/2001. This procedure consists of the pagesand changes listed below.


All 0 11/07/2001

SUPERSEDED

Supersedes Procedure No. QAP-008, Rev. 2, Chg 1 dated 8122/96

Approvals

Written By _ Date Conc rrene few/ Date,

Maria Padilla rk nstrom

Quality Assurance Date Cogniz irector7'or Date

e_ _ __ _to He a _

I,CNWRA Form OAP 1 (12/92)

.


REGULATORY ANALYSES Revision 3 Chg_


QAP-008 DOCUMENT CONTROL

1. PURPOSE

The purpose of this procedure is to describe the methods of preparing, approving, distributing, andcontrolling Center for Nuclear Waste Regulatory Analyses (CNWRA) plans, manuals, procedures,and instructions. This procedure implements the requirements of CQAM Section 6.

2. RESPONSIBILITIES

2.1 The Director of Quality Assurance (QA) is responsible for the overall implementation of thisprocedure.

2.2 Element Managers (EMs) are responsible for identifying recipients of controlled documents.

2.3 CNWRA staff performing project work are responsible for assuring they are using theappropriate document revision

2.4 Controlled document recipients are responsible for acknowledging receipt and understandingdocuments and incorporating revisions and changes.

3. PROCEDURE


3.1.1 The CNWRA Quality Assurance Manual (CQAM), Operations Plans, Project Plans,Work Plans, Test Plans, and Documents of External Origin shall be identified by uniquetitles reflecting their content and subject matter. Revisions and changes to thesedocuments shall be identified by sequential numbers. Issuance of a revision shall reset thechange number to zero.

3.1.2 Quality Assurance Procedures (QAPs), Technical Operating Procedures (TOPs), andAdministrative Procedures (APs) shall be identified by unique numbers assigned byDocument Control, and sequential revision and change numbers. The change number shallreset to zero upon revision of the document. The author shall contact Document Controlduring the preparation of new QAPs/TOPs/APs to obtain the document andrevision/change number. In general, the next sequential three digit number shall beassigned to new QAPs/TOPs/APs, such as TOP-00n. QAPs/TOPs/APs of similarapplication may be assigned the same three digit base number with a sub-number orrevision date.

CNWRA Form QAP-2


REGULATORY ANALYSES Revision 3 Chg.


3.1.3 Scientific notebooks shall be assigned a unique number upon issuance. A log of scientificnotebook issuance shall be maintained by Document Control containing its number, dateof issuance, the project number, and the individual to whom the notebook was issued.

3.1.4 CNWRA proposals are generated to obtain work for CNWRA staff and to satisfy theneeds of clients. These proposals are processed through the approval system of SwRIand are assigned a unique proposal number by the Program Development Office (PDO)in accordance with PDO internal procedures.

3.2 Document Format: COAM. OAPs. and TOPs

3.2.1 The CQAM shall consist of an Introduction and sufficient sections to describe thecorresponding quality requirements of the CNWRA sponsor and clients. In general,individual CQAM Sections should include a Purpose, Responsibilities, and Description ofRequirements.

3.2.2 The CQAM shall include a policy statement signed by the President of the CNWRA, andan Effectivity and Approval page, CNWRA Form QAP-3 (Figure 1). The Effectivity andApproval page shall indicate the change status and date of the document and its individualpages. In addition, it shall contain the required approval signatures.

3.2.3 The body of the CQAM shall be printed on CNWRA Form QAP-4 (Figure 2), each pageidentifying in headings the Section number, revision and change number, and page number(page 1 of n).

3.2.4 QAPs/TOPs/APs shall include, as a minimum, sections describing the Purpose,Responsibilities, Procedure, and Records requirements. QAPs/TOPs/APs are theprincipal media of instructions for conducting CNWRA activities and shall providesufficient details and step-by-step descriptions of the methods to be used that may beeasily understood by the intended user of the procedure.

3.2.5 QAPs/TOPs/APs shall include an Effectivity and Approval page, CNWRA Forms TOP-1 (Figure 3), QAP- 1 (Figure 4), or AP- 1 (Figure 5) as applicable, indicating the revisionand change status of the procedure and each of its pages, and shall contain the requiredapproval signatures.

3.2.6 The body of QAPs/TOPs/APs shall be printed on CNWRA Forms TOP-2 (Figure 6),QAP-2 (Figure 7), or AP-2 (Figure 8) as applicable, each page identifying in headings theProcedure number, revision and change number, and page number (page 1 of n).

CNWRA Form QAP-2





3.3.1 Original documents, changes, and revisions shall receive approvals as specified in theCQAM and QAP-002.

3.3.2 Documents may be "changed" on a page-by-page basis or revised in total. For a changeddocument, an effectivity page with signatures approving the change and the changedpages (only) shall be prepared. Changes in such documents shall be identified in the rightmargin with a vertical bar. A "revised" document shall include an effectivity pageapproving the entire document, but no vertical bars will be shown.

3.3.3 TOPs may be changed in the laboratory or field without the required approvals providedthat the change is authorized by the PI and that the change is documented in theappropriate Scientific Notebook. The approvals (required by QAP-002) shall be obtainedby the PI within a 30-day period, and may be documented by signatures in the ScientificNotebook. Field or laboratory changes are not permanent unless officially incorporatedas changes, and apply only to the immediately affected activities. Permanent changes toTOPs require the usual (QAP-002) review and approval process.

3.3.4 Document Control shall maintain an electronic Master Document List updated with eachdocument change. The Master Document List shall include the following information:


3.4 Distribution

3.4.1 Controlled documents may also be distributed by means of electronic media (e.g., read-only information on computer networks) or by distribution of hard copies.

3.4.2 Documents shall be distributed so that the procedures are available at the point of use.Individuals requiring documents shall be identified by EMs, and recipients shall bedocumented on the Controlled Document Distribution List, CNWRA Form AP-3 (Figure9). In addition to the affected technical staff, document distribution shall include:

CQAM - CNWRA President, Directors, EMs, and SwRI QA Manager.

TOPs, Operations Plans, Work Plans, Research Project Plans, Test Plans-CNWRAPresident, Directors, EMs, and affected PIs.

CNWRA Form QAP-2

.


REGULATORY ANALYSES Revision 3 ChgO


QAPs-CNWRA President, Directors, EMs, and affected PIs.

APs-CNWRA President, Directors, and EMs.

3.4.3 Additions to the Controlled Document Distribution Lists shall be made as necessary asnew staff are added or as assignments to different activities are made.

3.4.4 Controlled documents, revisions, and changes shall be distributed to those individuals onthe Controlled Document Distribution List.

3.4.5 Distribution to CNWRA staff, SwRI staff, CNWRA Consultants or Subcontractors shallbe by the use of the Controlled Document Transmittal, Training and AcknowledgementRecord, CNWRA Form DC- 1-2 (Figure 10). Recipients shall incorporate the changes orrevisions and destroy or mark as obsolete superseded documents, as applicable, andacknowledge receipt of transmittal by signing and returning the Form DC-1-2 toDocument Control.

3.4.6 As appropriate, uncontrolled copies may be distributed to clients and others listed in theControlled Document Distribution Lists, however, receipt acknowledgement (para. 3.4.5)is not required.

3.4.7 The Director of QA shall notify EMs of those individuals not acknowledging receipt. TheDirector of QA and EM shall take action as necessary to obtain the acknowledgements.

3.4.8 The effectivity page of uncontrolled copies of documents shall be clearly identified assuch. A record of uncontrolled distribution may be kept.

3.4.9 EMs and PIs shall take action as necessary to provide current and correct procedures tothe point of use and to prevent obsolete copies (controlled or uncontrolled) from beingavailable for use in quality affecting activities.

3.5 Documents of External Origin

3.5.1 The CNWRA Library shall be the central location for the collection, issuance, and storagefor documents of external origin. Documents are entered into the Electronic LibraryFunction (ELF) database and the physical document is labeled accordingly.

3.5.2 The CNWRA staff members can request from the CNWRA Library a document ofexternal origin by identifying the document's title, author, identifying number, or publisheddate.

CNWRA Form QAP-2




3.5.3 The CNWRA staff member is responsible for determining if the external document in thelibrary is acceptable for use on project work. The CNWRA staff member also has theresponsibility for assuring that distribution is made of the appropriate revision of thedocument to CNWRA staff members and consultants/subcontractors for project use.

3.5.4 If the CNWRA staff memberobtains an external document that should be maintained inthe CNWRA library, the staff member shall interface with the CNWRA DocumentControl staff person. The external document shall be entered in the CNWRA librarydatabase, given a control number, and placed in the CNWRA library.

3.5.5 Classified, proprietary, company sensitive, and other information not releaseable shall becontrolled in accordance with the security level of the document. Appropriate protectionshall be provided where necessary.

3.5.6 Electronic media, databases, codes, maps, drawings, photos and other non-printed externalorigin text shall be maintained as shelved library documents and are entered into the ELFdatabase. Such documents of external origin shall be protected so the media/data are notcompromised and shall be available for review to CNWRA staff member for their use inproject work.

4. RECORDS

4.1 Controlled Document Transmittal, Training and Acknowledgement Record forms shall bemaintained as QA Records in accordance with CQAM Section 17.

CNWRA Forn QAP-2

CENTER FOR NUCLEAR WASTE Proc. OAP-008REGULATORY ANALYSES Revision 3 Chg. 0


CEN|TER FOR NUCLEAR WASTE Rev._ CbeREGULATORY ANALYSES Month Yaw

QUAUTrY ASSURANCE MbIANUAL Page of_-


Revision _ of this procedure became effective on mm/ddtvv. This procedure consists of the pagesand changes listed below.

Section Change Date of Effective

Approvals

Director of Quality Assurance CNWRA President

a CS

CNWRA Form OAP-3

Sample

Figure 1NWRA Form QAP-2


REGULATORY ANALYSES Revislon 3 ChgO


CENTER FOR NUCLEAR WASTECENTER FOR NUCLEAR WASTE

REGULATORY ANALYSES


Proc.

Revision - Chg -

Page of -

aUWEA r- OP

Sample

F:iollre 2rNKnWrD A arm f A DlweF' TV ro wuU ill r

0CENTER FOR NUCLEAR WASTE Proc. OAP-008


Page 9 of 16QUALITY ASSURANCE PROCEDURE

Proc.

CENTER FOR NUCLEAR WASTEREGULATORY ANALYSES Revision

Page 1j od 3TECHNICAL OPERATING PROCEDURE Page ___Of __

Title

EFFECTIVITYRevision of this procedure became effective onThis procedure consists of the pages and changes listed below.

Page No. Chance No. Date Effective


Approvals

Written by Date Technical Review Date

Ouality Assurance Date Cognizant Director Date

CNWRA Vofn TOP-1 (Lil3)

Sample

Fioure 3CNWRA Form QAP-2

0


REGULATORY ANALYSES Revision 3 Chg.


CENTER FOR NUCLEAR WASTE Proc. OAP-REGULATORY ANALYSES Revislon

OUALTY ASSURANCE PROCEDURE Page or

TitleGAP-


Revision of this procedure became effective on This procedure consistsot the pages and changes listed below.

Pace No. Chanoe Date Effective


Approvals

Written By Date Concurrence Review Dots

Ouality Assurance Daft Cognizant Director Date

CNtWRA Form OAP I (M12001)

Sample

Figure 4CNWRA Form QAP-2

* 0


REGULATORY ANALYSES Revision 3 Chg. 0


CENTER FOR NUCLEAR WASTE Proc. AP-Oxx

REGULATORY ANALYSES Revision Change_

ADMINISTRATIVE PROCEDURE Page _ °o

Title:

EFFECTIVITYRevision of this procedure became effective on .This procedure consists of the pages and changeslisted below.

Page No. Chanoe No. Dale Effective


Approvals

Written by Date Concurrence Review Date

Ouality Assurance Date Cognizant Director Date

CNWRA Fom AP-1

Sample

Figure 5INW KA POM QAP-2

Ad 0

CENTER FOR NUCLEAR WASTE Proc. OAP-008REGULATORY ANALYSES Revision 3 ChgO


Proc.

CENTER FOR NUCLEAR WASTEREGULATORY ANALYSES Reviion_Change

Page _ ofTECHNICAL OPERATING PROCEDURE

CNWRA Form TOP-2

Sample

Finurp A�."- . -- - - I - -

AN VY W A rorrM VAY-;Z

_ _

CENTER FOR NUCLEAR WASTE Proc. QAP-008REGULATORY ANALYSES Revision 3 ChgO

QUALITY ASSURANCE PROCEDURE _Page 1 of 16

CENTER FOR NUCLEAR WASTE Proc.REGULATORY ANALYSES Revision _ Chg -

QUALITY ASSURANCE PROCEDURE Page - of -

cNWwR Form OAP-2

Sample

Finiera 7

CNWRA Form QAP-2

*.

CENTER FOR NUCLEAR WASTE Proc. OAP-008REGULATORY ANALYSES Revision 3 ChgQ

QUALITYASSURANCE PROCEDURE Page 14 of 16

CENTER FOR -NUCLEAR WASTE PaorREGULATORY ANALYSES Revision _Chg _

ADMINISTRATIVE PROCEDURE Page _ af_

CWPFotn A"

Sample

c1_...^ ae. cur ICNWRA Form QAP-2

0 SCENTER FOR NUCLEAR WASTE Proc. QAP-008

REGULATORY ANALYSES Revision 3 ChgQ


CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESCONTROLLED DOCUMENT DISTRIBUTION LIST i

PAGE _ OF _

Document

Name Address

i

i

i

i

I9

I

.9.

i

i

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*1*

.9.

I

CN"WA FORM AP-3 11W2001)

SampleFigure 9

CNWRA Form QAP-2


REGULATORY ANALYSES Revislon 3 ChgO


CENTER FOR NUCLEAR WASTE REGULATORY ANALYSESDOCUMENT TRANSMITTAL. TRAINING AND ACKNOWl FDGMENT RoiApnn

TO: FROM:Document ControlCNWRA/Division 20Southwest Research Institute6220 Culebra Rd.San Antonio, Texas 78238

Date Sent:

Attached are the following CNWRA controlled or uncontrolled documents:

Document Revision/ TitleNumber Change

Number


1 . Review and become familiar with the subject documents. Contact CNWRAQA at 210.522.5149 for additional training.

2. For revisions and changes, mark or discard the superseded documents ordocument pages and insert the current document or pages.

3. Sign and date the acknowledgment below attesting that the attached controlledor uncontrolled documents, revisions, or changes have been reviewed andunderstood, and that obsolete documents or pages have been removed.

4. The objective of this training is to ensure that you have reviewed, understood,and are able to implement the attached procedure(s), which are the content ofthis training.

5. Upon completion, return this form to CNWRA OA/Document Control at theaddress indicated above within 30 days.

Acknowledged by Datew-- --II --- .. f...._,,._.,,, ,,,....-,-., ss^ul}

Sample

Finlr'n in.c a A. W

t'XTUMn A tV... f A 1n WVF.~FJJIyi-

we1' VT Is ron n Bet- z

CENTER FOR NUCLEAR WASTE Proc. QAP-008REGULATORY ANALYSES Revision4 Chg 0




Revision 4 of this procedure became effective on 9/12/2003. This procedure consists of thepages and changes listed below.


All 0 9/12/2003

Supersedes Procedure No. QAP-008, Rev. 3, Chg 0 dated 11/07/2001

AnnrnvsdlS

Written By Date Concurrence Rev'pv Date

R Brient M. Padilla

Quality Assurance Date ognizant Director Date

______________________________ ________ B. Sagar _ _9l__L__

CNWRA Form QAP-1 (12/92)

0

CENTER FOR NUCLEAR WASTE Proc. QAP-008REGULATORY ANALYSES Revision 4 Chgo 0

QUALITY ASSURANCE PROCEDURE Page 2_Z of 6

DOCUMENT CONTROL

1. PURPOSE

The purpose of this procedure is to describe the methods of preparing, approving,and distributing, Center for Nuclear Waste Regulatory Analyses (CNWRA) controlleddocuments such as plans, manuals, procedures, and instructions. This procedurealso provides controls for documents other than those prepared by the CNWRA butnecessary to effectively perform work activities. This procedure implements therequirements of CNWRA Quality Assurance Manual (CQAM), Section 6.

2. RESPONSIBILITIES

2.1 The Director of Quality Assurance (QA) is responsible for the overall implementationof this procedure.

2.2 Element Managers (EMs) are responsible for identifying recipients ofcontrolled documents.

2.3 Individuals performing CNWRA activities affecting quality are responsible for using theappropriate document and revision.

2.4 Controlled document recipients are responsible for acknowledging receipt andunderstanding documents and incorporating revisions and changes.

3. PROCEDURE


3.1.1 The CQAM, Operations Plans, Project Plans, Work Plans, Test Plans, proceduresand including those of External Origin shall be identified by unique titles reflectingtheir content and subject matter. Revisions and changes to these documents shall beidentified by sequential numbers. Issuance of a revision shall reset the changenumber to zero.

3.1.2 Operating Procedures {Quality Assurance Procedures (QAPs), Technical OperatingProcedures (TOPs), and Administrative Procedures (APs)) shall be identified byunique numbers assigned by Document Control, and sequential revision and changenumbers. The change number shall reset to zero upon revision of the document. Theauthor shall contact Document Control during the preparation of new OperatingProcedures to obtain the document and revision/change number. In general, the nextsequential three digit number shall be assigned to new Operating Procedures, suchas TOP-O0n. Operating Procedures of similar application may be assigned the samethree digit base number with a subnumber or revision date.

CNWRA Form OAP-2

0

CENTER FOR NUCLEAR WASTE Proc. QAP-008REGULATORY ANALYSES Revision 4 Chg 0


3.1.3 Scientific notebooks shall be assigned a unique number upon issuance. A log ofscientific notebook issuance shall be maintained by Document Control containing itsnumber, date of issuance, the notebook subject, and the individual to whom thenotebook was issued.

3.2 Document Format: CQAM, QAPs, and TOPs

3.2.1 The CQAM shall consist of an Introduction and sufficient sections to describe thecorresponding quality requirements of the CNWRA sponsor and clients. In general,individual CQAM Sections should include a Purpose, Responsibilities, andDescription of Requirements.

3.2.2 The CQAM shall include a policy statement signed by the President of the CNWRA,and an Effectivity and Approval page. The Effectivity and Approval page shallindicate the change status and date of the document. In addition, it shall contain therequired approval signatures.

3.2.3 Each page of the CQAM shall identify in headings the section number, revision andchange number, and page number (page 1 of n).

3.2.4 Operating Procedures shall include, as a minimum, sections describing the Purpose,Responsibilities, Procedure, and Records requirements. Operating Procedures arethe principal media of instructions for conducting CNWRA activities and shall providesufficient details and step-by-step descriptions of the methods to be used that may beeasily understood by the intended user of the procedure.

3.2.5 Operating Procedures shall include an Effectivity and Approval page, indicating therevision and change status of the procedure and each of its pages, and shall containthe required approval signatures.

3.2.6 Each page of Operating Procedures shall identify in headings the Procedure number,revision and change number, and page number (page 1 of n).


3.3.1 Original documents, changes, and revisions shall receive approvals as specified inQAP-002.

CNWRA Form OAP-2

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CENTER FOR NUCLEAR WASTE Proc. QAP-008REGULATORY ANALYSES

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3.3.2 Documents may be changed on a page-by-page basis or revised in total. For achanged document, an effectivity page with signatures approving the change and thechanged pages (only) shall be prepared. Changes in such documents shall beidentified in the right margin with a vertical bar. A "revised" document shall include aneffectivity page approving the entire document, but no vertical bars will be shown.

3.3.3 TOPs may be changed in the laboratory or field without the required approvalsprovided that the change is authorized by the Principal Investigator and that thechange is documented in the appropriate Scientific Notebook. The approvals (requiredby QAP-002) shall be obtained by the Pi within a 30-day period, and may bedocumented by signatures in the Scientific Notebook. Field or laboratory changes arenot permanent unless officially incorporated as changes, and apply only to theimmediately affected activities. Permanent changes to TOPs require the usual(QAP-002) review and approval process.

3.3.4 Document Control shall maintain a document list of the procedures contained on theCNWRA webpage (htto://tuti/qa). The Master Document List shall include the followinginformation:


3.4 Distribution

3.4.1 Controlled documents may also be distributed by means of electronic media(e.g., read-only information on computer networks) or by distribution of hard copies.

3.4.2 Documents shall be distributed so that the procedures are available at the point of use.Individuals requiring documents shall be identified by EMs in accordance withQAP-005, and shall be documented on the Controlled Document Distribution List,CNWRA Form AP-3. In addition to the affected technical staff, document distributionshall include:

CQAM-CNWRA President, Directors, EMs, Pls, and SwRI QA Manager.

Operations Plans-President, Directors, EMs, and affected Pls.

CNWRA Form QAP-2


Revision 4LAUN P E Chg.9. 0oQUALITY ASSURANCE PROCEDURE Page 5 of 6

APs QAPs, and TOPs-CNWRA President, Directors, EMs, Pls, Consultants, and SwRI staffmembers.

3.4.3 Additions to the Controlled Document Distribution Lists shall be made as necessaryas new staff are added or as assignments to different activities are made asdocumented in QAP-005.

3.4.4 Whenever possible document distribution will be accomplished electronically.

(a) For CNWRA staff, procedures shall be displayed on the CNWRA website(http://tuti/ga). Acknowledgment for training purposes (QAP-005) shall beaccomplished by using the "Verification notice for QA" feature.

(b) For CNWRA staff, consultants, and subcontractors distribution shall beaccomplished by e-mail attachment to affected individuals in the ControlledDocument Distribution List. Acknowledgment for training purposes (QAP-005)shall be accomplished by return e-mail.

3.4.5 Distribution of hard copies of documents shall be by the use of the ControlledDocument Transmittal, Training and Acknowledgement Record, CNWRA FormDC-1-2. Recipients shall incorporate the changes or revisions and destroy or markas obsolete superseded documents, as applicable, and acknowledge receipt oftransmittal by signing and returning the Form DC-1-2 to Document Control.

3.4.6 As appropriate, uncontrolled copies may be distributed to clients and others listed inthe Controlled Document Distribution Lists, however, receipt acknowledgment is notrequired.

3.4.7 The Director of QA shall notify EMs of those individuals not acknowledging receipt.The Director of QA and EM shall take action as necessary to obtain theacknowledgments.

3.4.8 The effectivity page of uncontrolled copies of documents shall be clearly identifiedas uncontrolled.

3.4.9 EMs and Pls shall take action as necessary to provide current and correct proceduresto the point of use and to prevent obsolete copies (controlled or uncontrolled) frombeing available for use in quality affecting activities.

CNWRA Form QAP-2

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3.5 Documents of External Origin

3.5.1 The CNWRA Library shall be the central location for the collection, issuance, andstorage for documents of external origin. Documents are entered into the ElectronicLibrary Function (ELF) database and the physical document shall belabeled accordingly.

3.5.2 The CNWRA staff members can request a document from the CNWRA Library byidentifying the document's title, author, identifying number, or published date.

3.5.3 The CNWRA staff member is responsible for determining if the external document inthe library is acceptable for use on project work. The CNWRA staff member also hasthe responsibility for assuring that distribution is made of the appropriate revision ofthe document. The CNWRA library staff should be consulted to identify thecurrent revision.

3.5.4 If the CNWRA staff member obtains an external document that should be maintainedin the CNWRA library, the staff member shall interface with CNWRA DocumentControl. The external document shall be entered in the CNWRA library database,given a control number, and placed in the CNWRA library.

3.5.5 Classified, proprietary, company sensitive, and other information not releaseable shallbe controlled in accordance with the security level of the document. Appropriateprotection shall be provided where necessary.

3.5.6 Electronic media, databases, codes, maps, drawings, photos and other nonprintedexternal origin text shall be maintained as shelved library documents and are enteredinto the ELF database. Such documents of external origin shall be protected so themedia/data are not compromised and shall be available for review to CNWRA staffmember for their use in project work.

4. RECORDS

4.1 Controlled Document Transmittal, Training and Acknowledgement Record forms shallbe maintained as QA Records in accordance with QAP-012.

4.2 Archive copies of the CQAM and Operating Procedures, including supercededversions shall be maintained as QA Records in accordance with QAP-012.

CNWRA Form QAP-2