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TWS-QAS-QP-03, R7DOCUMENT CONTROL PROCEDUREEffective Date:/6/ '/9r DatePaul GuthalsQA Project LeaderTD. T. 0O-6Technical Projecq303110184 930224PDR WASTEPDRW"-11-,fceffIer,4ý,OV6f.DateDate

TWS-QAS-QP-03, R7Page 1 of 12DOCUMENT CONTROL PROCEDURE1.PURPOSEThis procedure sets forth requirements for the preparation, identification,review, approval, revision, distribution, storage, and control of Quality Level I or IIdocuments generated in the support of the Nevada Waste Storage Investigations(NNWSI) Project.2.SCOPEQuality Assurance (QA) documents are tho),,Quality Level I or II documentsr wprofects that support the Nevadagenerated as a result of experiments, tasNuclear Waste Storage Investigations. (procedures and instructions, dataproject documentsDcu kaccordance with the Ree*3.o iiments include work plans, detailedr s,x9searchcand development documents, andbecome records shall be maintained inonftol Procedure, TWS-MSTQA-QP-09.RESPONSIBILITY3.1The Technical Project Officer (TPO) shall have the overall responsibility fordocument control in accordance with the requirements of this procedure.3.2The QA Support (QAS) shall have the overall responsibility for any documentsthat provide quality assurance controls and evidence of system qualityeffectiveness, such as audit reports, nonconformance reports, and correctiveactions;3.3The QAS is responsible for issuance and distribution control of plans andprocedures comprising the NNWSI QA Program Plans and Procedures Manual.3.4The Project Leaders (PL's), Principal Investigators (PIs), and Quality Assurance Liaison (QAL) for each organization performing work in the NNWSIproject have the responsibility for controlling documents prepared andmaintained within the organization.

TWS-QAS-QP-03, R7Page 2 of 124.GENERAL REQUIREMENTS4.1Document IdentificationDocuments must be properly identified for filing, storage, and retrievalpurposes.An example of an assigned identification that may be used isdescribed below.TWS-INC-11-10/78-10whereTWS-Nevada Nuclear Waste Stf. aTerminal Waste StorINC-l1-44104.2, .Q i).bkS-,NC-7, INC-11, MST-QA, E-8,Originator;WX-i.en10/78'l.pvestigations (formerlyc ates resident file.0ond year originated).assigned to provide a unique identifier.Procedure IdentificationTechnical procedures for the NNWSI Project shall consist of technical WorkPlans (WP's), Detailed (technical) Procedures (DP's), while quality assurance(QA) procedures shall consist of the Quality Assurance Program Plan (QAPP),QA Program Index, and Quality (administrative) Procedures (QP's).AllNNWSI Project procedures (with the exception of the LANL-NNWSI-QAPP)shall be identified as described below.TWS-INC-WP-01, R1whereTWS-Nevada Nuclear Waste Storage Investigations.INC-Procedure originator.Other originators may be ESS,QAS, WX, ES-NP, or E-8.

TWS-QAS-QP-03, R7Page 3 of 12WPDocument identifier. Identifiers shall be as follows:Work PlanWP DP Detailed (technical) Procedure01Quality (administrative) ProcedureDocument number is assigned by QAS (example showsWork Plan number 1).R1Document revision number.QP The identification must be unique and shall not change when revisions arerequired, except that the revision number shall be changed. Each investigaprocedures are being used.ttor shall be responsible for assuring that4.3DistributionDistribution shall be determinogo-the document originator.the QAS will be on distvtg "-ýfor/,documents.4.4Storage and AccessStorage and Ace-V.The TPO andall NNWSI Project Quality-Related'frplontrol shall be in accordance with the NNWSI RecordsControl Procedure, TWS-MSTQA-QP-09.4.5RevisionsRevisions to Project documents shall be controlled in the same manner as theoriginal document. Revisions shall be reviewed and approved by the samepersons who performed the original review and approval or, in their absence,by the organization's assigned alternate or by a person assigned by the TPO.Revised documents shall be distributed promptly to personnel on the originaldistribution list.5.QA PROGRAM PLAN5.1The TPO shall have the responsibility for presentation of the QA ProgramPlan (QAPP) and coordination with line management prior to issuance.

TWS-QAS-QP-03, R7Page 4 of 126.5.2The QAPL,** QAL, and QAS collectively are responsible for assuring thatprocedures meet project requirements.5.3The front page shall include the*document title,*document identification and revision number, and*approval signatures (TPO, QAPL, QAS) and dates.WORK PLANS AND SCIENTIFIC INVESTIGATION PLANS*6.1Work Plans (WPs)6.1.16.1.2Original preparation of a WP shetiesponsib"ity of technicalpersonnel as directed by thetechnical staff.The WPs shall be re 4itfapproved by Project Leader, QAPL, andTPO.6.26.1.3WPs sIeJ'pjBpared and approved before work begins.6.1.4The front page shall Include the-document title,-document Identification and revision number, and-approval signatures (Project Leader, QAPL, TPO) and dates.Scientific Investigation Plans (SIPs)6.2.1A Sclentifie Investigation Plan (SIP) shall be prepared, reviewed, andapproved prior to beginning an investigation.6.2.2The SIP shall include the following Information, as specified inNVO-196-17, Section M: All bold material indicates CR No. 015*The QAPL was previously referred to as the QAIM

TWS-QAS-QP-03, R7Page 5 of 12-overall purpose for the work,-identification of the factors and concerns important for planningand performance of the investigation,description of the work to be performed,brief description of supporting previous work including any-assigned QA levels, anda level of detail that would allow determination of the QA levelfor the work described in the SIP.6.2.3The SIP shall be prepared by the principal investigator (PI) responsiblefor the investigation.6.2.4The SIP shall be technically reviewed by-* competent scientist who hasd.l .W comments and subsequentnot participated In its preparatio .comment resolutions shall bCoIiz 'ed on a standard documentthe document review form showingreview form. The re t- ial become a part of the formal QA record.resolutions of ea e2v.5the SIP shall include:-document title;-document Identification and revision numbers; and**approval signatures and dates of preparer/Pl, technical reviewer,-QAL, TP0, QAPL, WMPO Project Quality Manager, and WMPOBEanch Chief.7.PROCEDURES AND INSTRUCTIONS7.1For operations that have become standardized, Detailed (technical) Procedures (DP's) shall be prepared by technical personnel as directed by the TPOor his technical staff. Operations where techniques are still being developedwill be described in notebooks and reviewed and approved in accordance withSection 11 of this procedure.***All bold material indicates CR No. 015Effective date deleted from cover sheet. WMPO approval needed on each SIP priorto implementation.

TWS-QAS-QP-03, R7Page 6 of 127.2Quality Procedures (QP's) required to supplement the Los Alamos NNWSIQAPP will be prepared as described in the QAPP, NNWSI-QP-01 and asdetermined by the QAIM in coordination with the QAS.7.3Procedures shall be coordinated with the Los Alamos participating organizations for review and concurrence by line management.7.4The front page of Detailed Procedures shall include:*document title,*document identification and revision numbers,uifmture. and*ro. nantoohnial'repviewer'sv.u g.a1project office (QAPL and TPO)7.5The front page of Quality P"s) shall in(!lude:eion and revision numbers, and(QAPL, TPO, and Preparer) and dates.8.CORRESPONDENCECorrespondence that relates to Quality Level I or 11 activities shall bebrought into the document control system at the discretion of the TPO.9.CALIBRATION RECORDS9.1Calibration records shall be prepared in accordance with TWS-QAS-QP- 12.1,Measurement and Test Equipment. Records shall include:Calibration Data and Certificates - On file for each piece of Measurementand Test Equipment (M&TE) included In the program.Calibration Form - To be sent to the QAS as notification that M&TE isbrought into the system; also required for recalibration.*Indicates CR No. 010

TWS-QAS-QP-03, R7Page 7 of 12Calibration Labels - To be affixed on all M&TE. The label may be affixed inthe vicinity of the M&TE when size or functional characteristics of theM&TE preclude direct application.Master Inventory File - To be maintained by the QAS with information sentby the instrument holder; a computer print-out shall be made available to theTPO on a monthly basis.CalibrationProcedures-Calibrationoj M&TEaccording to written procedures that oaRecall Master File - To b./a inedcustodians will be notJWM&TE due (or ove10.be accomplished'i technical and QAS approval.by the QAS.Divisional M&TE puter print-out, on a monthly basis, of allalibration.P, ATIONSPERSONNEL C10.1 For stashallmembers, written certifications shall be reviewed, signed, anddated by the appropriate group leader, or the appropriate supervisor.*10.2 For technicians and other NNWSI participants, certifications shall be signedby the staff member responsible for the task involved, Technicians shall betrained as found necessary by the staff member, depending on the technician's education and prior experience.10.3 Certifications shall be kept on file as evidence of personnel qualifications(See TWS-MSTQA-QP-08).11.LABORATORY NOTEBOOKS AND LOGBOOKS**11.1 Bound laboratory notebooks shall be used to document the performance ofscientific investigations and experiments. Investigations require professionaljudgment and/or trial and error methods and may culminate in***Indicates CR No. 018Indicates CR No. 016

TWS-QAS-QP-03, R7Page 8 of 12the preparation of detailed technical procedures (DPs).Repetitive experiThe work recorded in the notebooksments are performed following DPs.shall be done by the principal investigator (PI) or be done by qualifiedpersonnel following the P1s instructions. Documentation shall distinguishclearly between investigations and work done following a DP. The level ofdocumentation shall be sufficient that another similarly qualified individualcould use the notebook to retrace the investigation and confirm the resultsor, with the DP, could repeat the experiment and achieve similar results,without recourse to the individual who performed the work.***11.2Logbooks shall provide written recod itorepetitivecalibrations,11.3data runs,and d p,! activities such as,,d:-.ior specific instrumentsandwithdrawals from the invenOg;edmaterials in a core library.may alsoLogbooksad bet ooogbooayanalysi&sInformation about samples received forThe frntton-or loose-leaf format.notebook shall contain the following information:number assigned by the group office,-name of the person to whom the book is assigned, and-group Identification and starting date for the notebook's use in theindicated spaces.11.411.5The front of each logbook shall contain the following information:-TWS number if only NlWSI work is to be recorded, otherwise the-unique LANL identification number assigned by the group office;name of the instrument, activity, or samples to be documented; and-group identification and starting date for the logbook's use.When data ase kept In print-out or other loose-leaf form, each page shall beconsecutively numbered. The data sets shall be uniquely identified.*All bold indicates CR No. 016CR No. 016 superceded CR No. 002 in this section