ML19263B128
| ML19263B128 | |
| Person / Time | |
|---|---|
| Site: | 07100231 |
| Issue date: | 12/21/1978 |
| From: | Reynolds L, Svinis B CHEM-NUCLEAR SYSTEMS, INC. |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 7901050270 | |
| Download: ML19263B128 (55) | |
Text
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.f CHEM-NUCLEAR SYSTEMS INC.
P.O. Box 1866 e Bellevue, Washington 98009 e (206) 827-0711. 2. e E
3 CiG 25 P",12 13 l'h U.1 - G. December 21, 1978 . u-l ,.,'[pg,y Charles E. MacDonald, Chief Transportation Branch Division of Fuel Cycle and Material Safety U.S. Nuclear Regulatory Coc: mission Washington, D.C. 20555
Dear Mr. MacDonald,
Chem-Nuclear Systems, Inc. is pleased to transmit herewith seven copies of our Quality Assurance Program covering shipping packages as required by 10 CFR 71.51. As specified in 10 CFR 71.51 the timely filing of this Quality Assurance Program allows Chem-Nuclear Systems, Inc. to use the existing Quality Assurance Program until its acceptability is finally de-termined by the Commission. If you have any further questions please contact our Quality Asstrance Manager,Mr.BrunoSvinis,at(206)827-0711. Sincerely, CH 1-NUCLEAR SYSTEMS, INC. ,e DCCCD Iou E. Re o is g US:cC Director of Regulatory Affairs 9c'
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[LEYVIDB @F 700AMEDVVA[L 7 CHEM-NUCLEAR SYSTEMS, INC. oATE JO B NO. M' P.O. BOX 1866 12/21/78 BELLEVUE, WASHINGTON 98009 ATTpTION Mr. Charles E. MacDonald, Chief (206) 827-0711 TWX: 910-449-2865 RE: 10 CFR Paragraph 71.51 TO Transportation Branch " 8 C iG 20
- .i p g3 Div. of Fuel Cycle & Material Safety U.S. Nuclear Regulatory Comission U.
'- g Washington, D.C. 20555 .M ~. , _ h,.4 GENTLEMEN: WE ARE SENDING YOU THE FOLLOWING ITEMS: e DESCRIPTION PRINT REPRO S. EC Ouality Assurance Program, CNSI Doc. No. 0A-AD-001. Rev. - 7 t
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THESE ARE TRANSMITTED AS CHECKED BELOW: OFor approval O Approved as submitted CResubmit copies for approval DFor your use O Approved as noted OSubmit copies for distribution O For review and comment a Returned for corrections DReturn corrected prints a Other CFOR BIDS DUE 19 4 REMARKS ~ COPY TO SIGNED: ' " "3 i Bruno Svinis, Manager Quclity Assurance PL F AMF AC(NOWL CDGF RCCFIPT 9 v AFTumNaNO TO US $1dNFO vettgw cgpv ~
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CHEM-NUCLEAR SYSTEMS INC. ~... P.O. Box 1866 e Bellevue, Washington 98009 e (206) 827-0711 QUALITY ASSURANCE PROGRAM 9 \\ e Prepared by: Man er, Quality Assurance Approved b - Director of Rgguhtory Affairs Approved by: bI,3(/(.h' U~^ Pr'esident /CNSI Copy No. b Assigned to: M[b
's r PAGE REVISION STATUS (. Page Rev. Page Rev. I 11-1 II 11-2
- 7. II 12-1 IV 12-2 V
13-1 VI 14-1 1-1 14-2 1-2 14-3 1-3 15-1 1-4 15-2 2-1 16-1 2-2 16-2 3-1 17-1 3-2 17-2 3-3 18-1 ( 3-4 18-2 4-1 4-2 5-1 5-2 6-1 6-2 6-3 7-1 7-2 7-3 8-1 8-2 9-1 9-2 10-1 10-2 ( DOCUME NT REV. SHEET QA-AD-001 I L J CNSO 1002/8 78
F h REVISIONS l Description of Revision i Revised by: Date Approved by: ( Date DOCVMENT REV. SHEET QA-AD-001 II w J CNSQ 1002/8-78
r 3 TABLE OF CONTENTS Page Title Page Page Revision Status I Revicions II Table of Contents III Forevord VI 1.0 Organization 1-1 2.0 Quality Assurance Program 2-1 2.1 Management 2-1 2.2 Quality Assurance Personnel Qualifications ?-l 2.3 Quality Assurance Policies, Goals and Objeccives 2-1 3.0 Design Control 3-1 4.0 Procurement Document Control 4-1 5.0 Instructions, Procedures and Drawings 5-1 6.0 Document Control 6-1 6.1 Document Types Controlled 6-1 6.2 Document Review 6-1 6.3 Document Control 6-1 6.4 Document Change Control 6-2 6.5 Document Control for Subcontractors 6-3 6.6 Document Availability 6-3 7.0 Control of Purchased Material, Fquipment and Services 7-1 7.1 Vendor Evaluation 7-1 7.2 Frocurement Requirements 7-1
- 7. 3 Vendor Surveillance 7-2 8.0 Identification and Control of Components and thterials 8-1 8.1 Components and Materials 8-1 8.2 Bulk Raw Material 8-1
~ 9.0 Control of Special Processes 9-1 9.1 Personnel Certification 9-1 9.2 Subcontractor Control 9-1 9.3 Precedures 9-2 10.0 Inspection 10-1 10.1 Inspection Procedures 10-1 DOCUMENT REV. SHEET QA-AD-001 III L J CNSQ 1002/8 78 =
r 3 Page 10.2 Supplier Inspection 10-2 10.3 Indirect Control 10-2 11.0 Test Control 11-1 11.1 Test Procedures 11-1 11.2 Test Records 11-1 11.3 Test Control for Procured Items 11-2 11.4 Modifications, Repairs and Replacements 11-2 12.0 Control of !kasuring and Test Equip:ent 12-1 12.1 CNSI's Equipment Calibration and Control 12-1 12.2 Measuring and Test Equipment at Subcontractors 12-1 12.3 Inspection Validity 12-2 13.0 llandling, Storage and Shipping 13-1 13.1 Procured Items 13-1 13.? Transport Casks 13-1 14.0 Inspection, Test and Operating Status 14-1 14.1 Equipment Status 14-1 [ 14.2 Establishment of Examinations and Tests 14-1 14.3 Hold Points 14-1 14.4 Check 'ists of Examinations, Tests and Inspections 14-2 14.5 Examination or Process Status 14-2 14.6 Inspection Stacps 14-2 14.7 Control of Inspection Stamps 14-2 15.0 Nonconforming Materials, Parts or Components 15-1 15.1 Identification and Segregation 15-1 15.2 Subcontractor Control 15-1 15.3 Verification of Rework or Repair Acceptability 15-2 15.4 Nonconfo - ..ce Disposition 15-2 16.0 Corrective Action 16-1 16.1 Correction of Nonconformities 16-1 17.0 Quality Assurance Records 17-1 17.1. Maintenance and Access to Records 17-1 17.2 Contents of Record Files 17-1 17.3 Permanent Records 17-1 ( 17.4 Non-permanent Records 17-2 DOCUMEN T REV. SHEET QA-AD-001 IV CNSQ 100L8-79 a
h r Page f 18.0 Atidits 18-1 18.1 Audit Schedule 18-1 18.2 Audit Personnel 18-1 18.3 Audit Reports 18-1 18.4 Audit Follow-Up 18-2 ( ( DOCUMENT REV. SHEET QA-AD-001 V CNSQ 100La-78
3 r. FOC'ORD / This program defines and describes the basic policies and procedures used by Chem-Nuclear Systems. (CNSI) to establish quality assurance re-quirements for all activitle af fecting safety related functions of systems and components, including ttansport casks, o f CNSI. The activities include designing, purchasing, fabricating, handling, shipping, storing, inspecting, testing, operating and using, maintaining, repairing and modifying. Chem-Nuclear Systems, Inc. top management has approved and fully supports ad-herence to the policies and procedures contained in this program. It is intended that policies and procedures described in this program ceet or exceed the appropriate requirements of ASME Boiler and Pressure Vessel Code Section VIII, ANSI N45.2-1977,10CFR30 Appendix B,10CFR71 Appendix E and MIL-Q-9858A. This program, in full or in part, is subject to revieu and comment by customer representatives. Revisions or additions to the program will be made as necessary to con-f form to the current needs of the company. All revisions will be dated and referenced on the revision page in front of the program. Copies of the Quality Assurance Program will be issued to the customer and government representatives, as required. Assigned copies of this pro-gram will be serialized and a record maintained showing the transmittal of each revision. Information copies of the program may be distributed without serialization and they will not be updated with revisions. This program is reviewed in total by CNSI's management at least once a yerr to assure conformance to current practices and requirements. The Quality Assurance (QA) Program for CNSI was established and imple-mented by the President o f CNSI. The Q.A. Program has the full support of CNSI's management and all CNSI's employees shall adhere to its provisions. ( DOCUMENT REV. SHEET QA-AD-001 YI j CNSa 1002/8-78
F 3 1.0 GRCANIZATION ( The Quality Assurance organization within C'ien-Nuclear Systems, Inc., con-sists of a Quality Assurance Ibnager with the overall responsibility for pro-viding quality assurance of design, fabrication and operation. He has a staff of quality assurance personnel reporting to him, who are assigned to the fellowing areas: A. Vendor inspection B. Engineering / Fabrication C. Field Operations D. Barnwell operations The individual assigned to vendor inspection is responsible for audits and surveillance to assure CNSI that all vendor and/or subcontractor activities are conducted in accordance with a written program that addresses the ap-plicable criteria of CNSI's Quality Assurance Program. Quality assm for engineering /fabricasion is responsible for auditing f the CNc' s Engineering group to verify thec all equipment has been designed, fab' .ted and tested in accordance with the established CNSI's procedures. Quality assurance for field operations has the responsibility for audit per-formanced of all CNSI's field operations. The audit includes verification of field unit operation in accordance with prescribed procedures and in-structions. The individual assigned to Barnwell operations is responsible for auditing the operation (use) and maintenance of casks licensed pursuant to 10CFR71 and the performance of applicable quality control checks on the casks. He also has the responsibility for auditing the rolling stock maintenance and health physics activities performed at Barnwell. All quality assurance personnel report directly to the Quality Assurance Manager. The Quality Assurance Manager reports to the Director of Regulatory Af f airs of Chem-Nuclear Sys tems, Inc. (see Figure 1-1). I DOCUMENT l R EV. SHEET QA-AD-001 1-1 k ) CNSQ 100rS 78
I 3 This reporting route has been selected specifically to allow the Quality ( Assurance Manager authority and indenondence required to implement and direct CNSI's Quality Assurance program, effectively assure the conformance to quality requirements, and to provide independence of undue influences and responsibilities for scbcdules and costs (see Figure 1-2). The Quality Assurance Manager shall be free of non-Q. A. duties in order to give full attention to the Quality Assurance Progran. Quality Assurance personnel shall be free to perform the following functions effectively and without hindrance or reservation: Identify quality problems, stop unsatisfactory uork, and to control a. further processing, delivery or installation of nonconforming m Lerial. b. Initiate, recommend and provide solutions through proper channe::, c. Verify implementation of solutions. Position descriptions of the Quality Assurance Manager and all Quality ( Assurance personnel shall include prerequisite experience and/or required training, which assures that they are competent to perform the assigned duties. While other organizations may be delegated the tasks of establishment and execution of a quality assurance program, it must be recognized, that the responsibility for ' equipment owned and operated by CSSI is retained by CUSI. The Quality Assurance Manager, upon notification of need for further direction or resolution of Q. A. problems, has the authority to communicate or direct communications with any contractor doing business with CNSI. Ordinarily, such communications will be through :he branch of CNSI having responsibility for the function provided by the contractor involved. ( DOCUMENT REV. SHEET QA-AD-001 1-2 CNSQ 100W8 78
3 SR P O A. I. gl E M N R A B SR PO A. D. QI S E R I I R F FA l l OF S 1 F SR RA AE l O G TY YA E C 1' Tl R l E0 I. A U RT I M C A. A I I DI U F } UG It C E I R R B AF A. 6 Q RG N E NO I TC E P S A. I N Q ROD N E V a8CiE" $h c f eO i u f ( 8 85$
f o .3 8 g l'ItES I DENT iGz n H ? EX. VICE PRES DIRECTOR Or o REGULATORY AFFAIRS g ENGINEERING p. - --- - t l OUALITY llEALTH f. I ASSUR. SAFETY MANUFACTURING PROCURElfENT i r 3-r- I CONTROLLER PERSONNEL TRECT0lt OF CORPORATE D I RI'.CTOR OF COIii'IllihTV' [ MANAGER SERVICES DEVELOPMENT NORTilEAST OPRS. DIRECTOR OF SITE OPS. i DATA TREASURER CllE!!ICAl, 51RECTolt OF 11A1:NI.'EI l. PROCESSING DIV. MCl?. CORPORATE ffKTG. SITE MCit. l_ _ E E Y^ 9 8 O FIGURE 1-2 I k )
3 ( 2.0 QUALITY ASSURANCE PROGR/0! ( The Quality Assurance Program is comprised of those planned and systematic actions necessary to assure adequate confidence that all Chem-Nuclear activi-ties will be conducted in a satisfactorily in service. It is the intent of this program to insure that all activities are conducted in a manner that has the degree of reliability on which safety and performance of these activities were evaluated. The Quality Assurance Program of CNSI applies to the fol-lowing systems and functions: Solidification Demineralization Decontamination Transportation of radioactive materials. Engineering services provided to the nuclear industry. iadioactive waste burial. llealth Physics services. 2.1 Management In order to assu:e effective implementation, assess the scope and ( status, and determine the effectiveness of the Q.A. Program; the Presi-dent of Chem-Nuclear has appointed a member of Senior Management, with broad authority, to execute these functions. Programmatically, these functions are executed through the use of internal audits, field in-vestigations, customer / user service reports and internal reporting procedure. 2.2 Quality issurance Personnel Oualifications The peis;nnel assigned to perform quality assurance functions with respect to those activities conducted by contractors are trained and qualified to perform those functions in accordance with ANSI /ANS-3.1-1978 and SN-TC-1A. Records of training and qualification of all certified personnel are maintained in company record files. 2.3 Ouality Assurance Policies, Coals and Obiectives It is the policy of Chem-Nuclear that all activities which are governed by the Code of Federal Regulation, license, Certification of Compliance, DOCUMENT REV. SHEET QA-AD-001 2-1 CNSQ 100L'8 78
r 3 Ietter of Approval or other regulatory requirements, be conducted in ( accordance with written, approved procedures which incorporate the regulatory requirements in a manner which is easily understood by the user / operator. Adherence to the procedure requirements is mandatory for all Chem-Nuclear employees. All procedures which are recuired to assure regulatory compliance or health and safety are required to be submitted to the Safety Review Board for approval prior to implementa-tion. It is the stated goal and objective of the Chem-Nuc1 car Quality As-surance Program to provide those mechanisms and enviornments necessary to achieve a reliable Quality Assurance Program for all activities which affect health and safety or are specified by a regulatory re-quirement. This goal and objective is promulgated throughout the company through the use of written procedures, managenent memoranda and management / staff meetings. (' Dif ferences of opinion between QA/QC personnel and other CUSI depart-ments shall be resolved in a meetis of the Safety Review BoarJ. 3 s 4 w-(. DOCUMENT H EV. SHEET QA-AD-001 2-2 CNSQ 10cLS 78
3 r 3.0 DESIGN CONTROL ( Design control at CNS1 consists of a laddered review system (Figure 3-1 and Table 3-1).This independent design review and drafting check is geared towards the following criteria: a. drawing accuracy and precision b. design review in terms of the applicability of the design to standard codes and regulations and the actual mechanics and feasibility of the design itself. i The project engineer is responsible for: a. the initia) interpretation of the design specifications in relation to regulatory codes and standards b. interfacing activi*ies of all associated parties, including the final approval of the quality assurance division. c. insure that all critical environmental, radiological and chemical de-sign considerations are incorporated into the actual engineering design package d. design and implementation of any design testing The drawing control coordinator is responsible for control of th2 engineer-ing drawing system. Doc ument re...se and distribution from the angineering department is supervised by the drawing control coordinator in order to as-sure all approval signatures are on the drawing, the latest revi. .,n level is being distributed, and the file on document distribution is continuc'ly updated. Qoality Assurance reviews the engineering der'.gn packages for inclusion of the applicable quality standards in the design documents. For certain systems and equipment used in nuclear work (transport casks, etc.) an independent verification of design is accomplished by an outside contactor or by other company employees not under the supervision of the original de-signer or his supervisor. The verification includes a determination that valid industry standards and specifications have been selected. k Design changes must follow engineering departmental procedures. Design changes are subject to the review steps listed in Figure 3-1. DOCUMENT REV. SHEET QA-AD-001 3-1 q J CNSQ 100W8-78
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Errces and deficiencies in design, including the design process that could ( adursely affect safety shall be documented and corrective action taken to preclude repetition. Materials, parts and equipmenc which are standard commercial -(of f the shelf) or which have been previously approved for a different application must be reviewed for suitability to any neu application. ( 4 e d DOCUMENT H EV. SHEET QA-AD-001 3-2 L 2 CNSO 1002/8 78
r 3 FICURE 3-1 ( ENGINEERING DESIGN CONTROL LADDER Project Engineer Y Design Lead T Design Draftsman ,i Drafting Checker i Project Engineer e Design Lead v Quality Assurance t Engineering >bnager t Drawing Control Coordinator (' DOCUMENT REV. SHEET QA-AD-001 3-3 j CNSQ 1002/8 78
3 r. TABLE 3-1 ( INDIVIDUAL REVIEU RESPONSIBILITIES FOR ENGINEERING DESIGN CONTROL Project Engineer Confirms overall design package ccets applicable codes and regulations. Confirms accuracy of technical aspects of the design pa cka ge. Design Lead Oversees design drafting. Confirms that all parts and equipment conform to the design specifications. Confirms fit, function, producability of system. Liason between drafting, quality assurance and the pro-ject engineer. Design Draf tsperson Produces design drawings per project engineer's speci-( fication. Responsible for fit and function of unit per design engineer specifications. Drafting Checker Performs a non-technical check of design. Confirms accuracy and precision of drawing in all aspects of drafting techniques. Quality Assurance Reviews specification of quality standards in design documents. Assures design characteristics can be con-trolled, inspected and/or tested. Engineering Manager Confirms total design package is ready for release. Confirms equipment meets customer requirements. ( DOCUMENT REV. SHEET QA-AD-001 3-4 CNSQ 1002/8-78
3 r. 4.0 PROCURDIENT DOCUMENT CONTROL k The procurement of materials, components, services at, or services affecting assemblies, for use of utility customer sites or other licensed activities is accomplished with a written Purchase Order. Purchase Order forms are controlled, and in the possession of a limited number of individuals. Only these individuals are authorized to release Purchase Orders, and are re-sponsible for conforming with established procurement and record keeping procedures. The sequence of events leading to Purchase Order issuance, and the associated record keeping activities, are in compliance with procedures published in ANSI N45.2.13. It is CNSI's policy that Purchase Orders, except for administrative supplies, are written from requisitions that are reviewed by the cognizant department / site manager and, at his direction, an individual certified by the Quality Assurance Manager. Where the department / site manager determines that the procurement action is governed by an applicable standard, specification, code, regulation, license or Certificate of Compliance, the requisition is sub-mitted to the Quality Assurance Manager or his designee for review and ap-k proval. The Quality Assurance reviewer examines the requiettion, amending it as necessary, to ensure that complete information is provided to identify: The applicable 10CFR Part 53, Appendix B and 10CFR71T* Appendix E require-a. ments which must be complied with, b. The design basis technical requirements including the applicable regula-tory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, tests and in-spection requirements, and special process instructions. c. The docamentacion to be prepared, maintained, and submitted to the purchaser for review and approval. d. The records to be retained, controlled, and maintained by the supplier, and those delivered to the purchaser prior to use or installation of the materials or components. The procuring agencies right of access to suppliers facilities and re-e. cords for source inspection and audit. DOCUMENT REV. SHEET QA-AD-001 4-1 CNSQ 100L8-78
T f. That the quality requirements are correctly stated, inspectable and con-( tro11able with adequate acceptance and rejection criteria stated. g. The procurement document has been prepared and reviewed in accordance with QA program requircments. The individual authorized to control and release Purchase Orders, upon re-ceipt of a requisition with all necessary re iews and approvals, writes the Parchase Order Incorporating all informacion contained in the requisition. One copy of all Purchase Orders is maintained in a control file. Procurement documents for spare or replacement parts shall be subject to the same controls that are applied to the original equipment. Changes and revisions to procurement documents are subject to the same review process as original documents. Original and revised procurement documents shall be clearly annotated to indicate the completion of the aforenentioned review and approval sequence. Record copies shall be maintained in accordance with document control pro-( cedures in effect at time of preparation. ( DOCUMENT REV. tHEET QA-AD-001 4-2 ( ) CNSO 1cor3 78
F 3 5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS ( Activities af fecting product quality in design manufacturing, operation, and maintenance are prescribed by documented instructiens, procedures or drawings of a type appropriate to the circumstances. They include quantitative and/or qualitative acceptance criteria for determination that the prescribed activities have been satisfactorily performed. The activities are accomplished in accordance with the instructions, procedures or draw-ings. The purpose of the instructions, procedures and drawings as des cribed here-in, is to provide and communicate standards for the quality determination within the company, to the vendors and to the customers and are directed at maintenance of an overall quality program. These instructions are avail-able for review by customer representatives. Procedures and instructions are prepared by the cognizant department. All instructions and procedures are maintained current with a documented method of revision. Instructions, procedures and drawings are readily available \\ to personnel at locations requiring their use. The drawings, instructions and procedures detail, where applicable, any equipment, environmental conditions and the exact method to be used to determine the condition of the item under examination. Prerequisite calibration of all special test equipment is clearly stated in detail. All acceptance criteria is clearly defined. If visual aids or standards are available and applicable, they are referenced in drawings, instructions and procedures. The CNSI's Quality Assurance organization reviews and concurs with in-spection plans; test, calibration and special process procedures, drawings and specifications and their changes, and verifies that methods for com-plying with regulations, such as Code of Federal Regulations (10CFR50, 10CFR71) are specified in instructions, procedure 5 and drawings requiring such verifications. ( oOCUMENr REV. ItHEET QA-AD-001 5-1 L J CNSO 1002/8-78
F. 3 CNSI's Q. A. organization shall review instructions, procedures and drawings ( to ensure that adequate quantitative and qualitative acceptance criteria are present. The CNSI's Procedure for Document Preparation shall be followed exactly in the course of preparation, review, approval and control of instructions and procedures. Drawings shall be prepared, reviewed, approved and controlled in accordance with engineering department procedures. (. (\\ e DOCUMENT REV. SHEET QA-AD-001 5-2 L CNSO 1 COL'8 78
r. 3 6.0 DOCLNENT CONTROL ( The document control system at CNSI provides controls for drawings, specifi-cations, procedures, instructions and their respective changes to assure ade-quacy, completeness and meeting the intent of such documentation. 6.1 Document Types Controlled The control includes all documents and their changes af fecting the quality program. These documents include, but are not limited to, design drawings and specifications, manufacturing drawings, procure-ment documents, quality assurance manuals, manufacturing, inspection, operating and testing instructions, test procedures and design change requests. The control system provides adequate and timely distribution of all documents to recipients listed on a document distribution list and prompt removal of all obsolete documentation from defined docu-ment control centers. 6.2 Document Review All design drawings, design procedures and specifications are issued ( by Engineering. They are reviewed and approved by Quality Assurance for adequacy and compliance with applicable quality standards and/or contractual requirements. The review assures the availability of all information required to produce an article-in complete conformity with design requirements. The review process is the same for document changes. All procedures and instructions are reviewed by CNSI's Quality Assurance. Non-safety related documents are approved by the cognizant department or site manager. All safety related documents are reviewed and approved by CNSI's Safety Review Board.
- 6. 3 Document Control Execution of an effective document control system requires the following:
a. Each document shall have an identifying number and a complete descriptive title. DOCUMENT REV. SHEET QA-AD-001 6-1 j CNSQ 100L8 78
r 3 b. Each document shall have means for identifying the revision ( status and the effective date of each revision. The number of copies made and issued of a document is controlled by a document distribution list maintained in the document file. This list facilitates retrieval of obsolete or modified copies of the dacument. The removal of obsolete documents, procedures, details, forms, etc., is accomplished immediately when such material is made obsolete by a new or revised docunent. The removal is ef fected promptly af ter release of the new or revised document. Obsolete documents are destroyed except for a history copy maintained in the document file. Procedures and their changes are distributed on a formal basis and are of standard format. In cases of emergency, however, approved handwritten procedures or marked-up changes can be considered satis-factory as long as they are converted to the standard form and be-come official within 30 days. Drawings and/or documents sent to a customer or subcontractor are accompanied by a document transmittal letter showing the drawing and/or document number, revision and date of transmittal. A copy of the transmittal letter is kept in the project file. Purchase orders used on manufacturing type projects are changed to indicate the effect of engineering changes. On completed projects, a list of as-built drawings and documents are maintained in project control file to define the documents to which the item was built. 6.4 Document Change control All changes to documents, specifications and procedures are made utilizing the Change Order form. The form is a one-part reproducible for= used to specifically delineate a proposed change. The form is also used for submission of proposed changes to customers when ( COCUMENr REV. SHEET QA-AD-001 6-2 y CNs0100W9 78
r 3 their approval is required prior to change incorporation. All proposed changes are reviewed by Quality Assurance prior to their approval to determine the effect of the change on the quality of the article and the resultant changes in inspection, procedures or operations. Revisions, changes and modifications of affected documentation is made only after approval of the applicable change order. All approved change documents are attached to the document revised or changed and are incorporated in the document upon con-pletion of the project or sooner. All the aforementioned instru-ments for effecting a change require a definition concerning when the change becomes effective. All drawing changes are reviewed by Engineering at the time of project completion for updating origins! drawings to an "as built" configuration. 6.5 Document Control for Subcontractors Subcontractors and vendors are required to maintain an ef fective drawing change control system when these drawings are provided as part of the contractual requirements. Procurement of articles to CNSI's design requires a document control system that includes assurance of notification of changes to the subcontractor or vendor, verification of change incorporation and appropriate identification of those items on which the change is in-corporated. Procurement of articles of subcontractor's design requires a docu-ment control system that assures notification of CNSI by the sub-contractor of the proposed change, approval of the change by CNSI and appropriate identification of the items on which the change is incorporated. 6.6 Document Availability Documents will be available at the locations where activities in-( volving them are to be performed prior to commencement of work. DOCUMENT REV. SHEET QA-AD-001 6-3 v j CNSO 1002/8 78
3 r. 7.0 CONTROL OF PURCHASED MATERIAL, EOUIPMENT AND SERVICES ( The procurement control methods CNSI uses establish measures to assure that procured items and/or services are clearly and adequately specified in procurement documents and are supplied by vendors and subcontractors who are capable of producing items and furnishing services, which conform to procurement document requirements. These procurement control methods, which consist of procedures or instructions, include provisions for vendor evalua-tion, review of procurement requirements and surve;11ance of vendor's facili-ty. 7.1 Vendor Evaluation Evaluation of procurement sources is performed by CNSI's engineering procure =ent and quality assurance personnel. Recommendation of procurement sources is based on these evaluations. Results of sup-plier evaluations performed prior to contract award are documented and filed. The evaluations cover review of capabilities and facilities for technical, manufacturing and quality performance, and include any or all of the following as appropriate: 1 a. historical performance data, particularly in product quality and delivery b. review and comment on supplier's quality assurance program source audits to verify supplier's implementation of his quality c. quality assurance program, as required d. source qualification programs. The evaluation considerations include the elements of the NRC's Quality Assurance Criteria to the extent these criteria are ap-plicable to the equipment being procured. Actions to correct de-ficiencies in the supplier's organization or quality program are resolved with the supplier's management prio. to fabrication of ordered items. 7.2 Procurement Requirements Requirements to be met by the supplier are detailed in the procure-ment documents which include procurement specification. This DOCUMENT REV. SHEET QA-AD-001 7-1 L J CNSC 100U348
F 3 document details the aspects of supplier quality assurance, for example, inspection reports, provisions for inspection, equipment calibration prior to use, and provisions for inspection after com-ponent repair. The procurement specification also requires the successful bidder to submit the following for CNS1's review: a. special process procedures for performing welding, heat treat-ment, nondestructive exanination b. recommended inspection point program c. appropriate documentation as required by applicable codes, standards and procurement documents d. notices of non-conformances and deviations e. test procedures in accordance with applicable codes and standards.
- 7. 3 Vendor Surveillance CNSI's Quality Assurance has the following typical responsibilities for supplier surveillance:
a. witness test inspections and nondestructive examinations and audit of the various special process operations b. surveillance and audit of heat treatment, welding, cleaning, preserving, packing and packaging activities c. audit supplier conformance with established procedures, such as: 1. use of CNSI accepted drawings and procedures 2. use of accepted product and process quality planning 3. document change control 4. material identification and traceability control 5. control and calibration of measuring equipment 6. control of major repair welding d. review of completed product quality checklists and release tags prior to release of equipment for shipment. DOCUMENT H EV. SHEET QA-AD-001 7-2 CNSO 100LS-78
r. Documentation of not onformances shall be orovided by suppliers as ( prescribed in Section 15 of this program. CiSl's quality assurance personnel perform a review of supplier docu-mentation during in-process, testing and final inspection stages. The entire documentation packa);e is eviewed prior to shipment of manufactured items. This docunentation includes material test re-ports, inspection and test reports, NDE reports and applicable code data reports. The frequency and extent of the surveillance are consistent with the importance to safety, complexity, and quantity of the item or service being furnished. The measures to evaluate the effectiveness of the control of vendor quality are described above. The sur-veillances are in accordance with an inspection point program pre-pared by CNSI. The inspection point program includes manufacturing and testing activities to be witnessed, quality assurance activities to be confirmed by surveillance, and the review of the required docu-( mentation. Receipt inspections shall be performed on all purchased items (in-cluding spare or replacement parts) to assure: a. That material, component or equipment is properly identified and corresponds to the identification on receiving documentation. b. That material, components, equipment and acceptance records are inspected and judged acceptable in accordance with predetermined inspection instructions prior to installation and use. Inspection records or certificates of 'conformance attesting to the c. acceptance of material, components and equipment are available and are filed in the project file prior to use. d. Items accepted and released are identified as to their inspection status prior to forwarding them to a controlled storage area or releasing them for installation or turther work. ( ooCUMENT REV. SHEET QA-AD-001 7-3 J CNSo 100L8 7S
s 3 r. / 8.0 IDENTIFICATION AND CONTROL OF COMPONENfS AND MATERLiLS ( The identification and control as described herein shall apply to components,. production materials, bulk raw materials, parts and assemblies at all stages of fabrication and installation from receipt of components and material to completion of the system or component supplied. These r_quirements shall be imposed on CNSI'a subcontractors and suppliers. 8.1 Components and Materials The inspection status of all components and material shall be evident at all times. This shall be acconplished by marking, tagging or stanping components or material and the stamping of work ordera or reaterial requests accompanying them at the appropriate stages of fabrication or installation. Identification of components and material with an identification num-ber shall be accomplished.with a method that will provide legible identification as permanent as the normal life expectancy of the item marked, without adverse effect on its life and utility. Components or material cot suitable for individual marking, shall be \\. individually tagged or. thall be placed in an identified container. - + \\ N The storeroom shall accept only components or material which have been inspected and accepted. The Inspection shall maintain surveil lance over the storage areas to assure thac mat'erials subject ~ to matching material certification control or age limit requirements are properly segregated, dated ami controlled. This surveillance ( shall also include checking for conforms.ce to proper standards of .r packaging and storage of all stared coep,nents, material parts '\\ and assemblies. i s / \\ 8.2 Bulk Raw Material Following the acceptance of bulk raw materials, a tag showing the r purchase order, the material identification, mill heat number or heat code and the date of receipt shall be fastened to the material. fl r G l >l., DOCUMENT REV. ,HEET g ( , *i QA-AD-001 8-1 , c) ; t I CNSQ 1002/8-73
r. 3 If during fabrication all identification has.been removed from the ( part of the material being used, the remnant shall be marked before returning to stock. Material marking shall be such that it shall not be affected by con-tact incident to normal handling, exposure to the elements, shipment or storage. All markings shall offer ready readability and prompt identification of the material. Physical marking of materials shall be accomplished in a manner which will not adversely affect the machining, forming or fabrication of the material. Impression print-ing shall not be used. Identification requirements shall be determined during generation of specifications and design drawings. Identification of materials and parts for safety related systems or components shall be traceable to the appropriate documentation, such as drawings, specifications, purchase orders, manufacturing and inspection documents, deviation reports and physical and chemical mill test reports. Prior to release for fabrication, assembling, shipping and installa-tion the correct identification of material, parts and components must be verified and documented. (.. DOCUMENT REV. SHEET OA-AD-001 8-2 g J CNSQ 100HS 78 8
(: 3 9.0 CONTROL OF SPECIAL PROCESSES ( All special fabrication, installation and inspection processes which could have an effect upon the quality of the component, system or fabrication operation shall be controlled by process procedures. 9.1 Personnel Certificat ion Personnel responsible for perfo rmance, inspection and control of special processes and operations which require special skills and could have an effect upon quality shall be certified. Certification of personnel for these processes or operations (such as welding, hect treating and nondestructive testing) shall include a formal training program followed by a formal testing procedure to assure the proficiency of each individual. Personnel certification requirements shall conform to the applicable codes and standards, such as, ASME Sec' ion IX for welding and heat treating and SNT-TC-1A for nondestructive testing. The period of effectivity for all certifications shall be specified and each individual shall be re-certified at the end of such period through re-testing. Persons failing the re-test shall be removed from ( operations and shall be provided with additional training as required for re-certificatien. Inspection results and quality audits shall be used as indicators of the need for additional training and recertifi-cation of fabrication, installation and inspection personnel without regard for established re-certification periods. Personnel shall also be re-certified in accordance with the applicable standard. A record of the names of certified personnel their skills and certification periods shall be maintained by Quality Assurance. 9.2 Subcontractor Control Special processes perforced by CNSI's subcontractors and suppliers shall be specified in procurement documents and shall be monitored by Quality Assurance for conformance with CNSI requirements. A certi-ficate of compliance shall be required from all subcontractors and suppliers performing special processes. k DOCUMENT REV. SHEtT QA-AD-001 9-1 CNSO 100UO.73
3 r 9.3 Procedures ( Special process procedures shall be reviewed and approved by Quality Assurance which conducts an audit function to assure that the approved procedures are adequately followed. Process procedures shall include the method required for periodic verification of adequacy of the pro-cessing materials, solutions, equipment and their associated control parameters and the recording of the inspection results and process verifications performed. ( ( DOCUMENT REV. SHEET QA-AD-001 9-2 cNSQ 1CO2/8 78
3 r. 10.0 INSPECTION ( The established inspection program at CNSI verifies the conformancc of quality related activities with the applicable requirements. The verification is per-formed in accordance with written inspection procedures or instructions. Per-sonnel performing the inspection are independent from the individuals per-forming the activity being inspected. The inspectors are qualified in ac-cordcoce with upplicable codes and standards and their qualifications and certifications are kept current. Equipment modifications, rep Irs and replacements are inspected in accordance with the original design and inspection requirements unless an approved al-ternative exists. Provisions for mandatory inspection hold point identifi-cation requiring witnessing by an inspector,are incorporated in e.he appropri-ate documents, such as, procurement specifications, test procedures, etc. The inspection program also provides for identification and documentation of deficiencies discovered during inspection and the required corrective action. ( 10.1 Inspection Procedures Inspection procedures and instructions are written documents which provide the following information: A. Identification of characteristics and/or activities to be inspected. B. Identification of the individual or group responsible for per-forming the inspection. C. Acceptance and rejection criteria. D. A description of the inspection method. E. Recording evidence of completing and verifying a manufacturing, inspection, or test operation. F. Recording inspector or data recorder and the results of the in-spection operation. Inspection procedures and/or instructions are used in conjunction with the specified specifications or drawings when inspection operations are performed. Inspection procedures are maintained current by established document control measures. DOCUMENT REV. SHEET QA-AD-001 10-1 j CNSO 1002/8-78
r 3 10.2 Supolier Inspection ( CNSI identifies inspection requirements in procurement documents is-sued to subcontractors and suppliers. The subcontractors and sup-pliers are responsible for inspection of their products and CNSI's Quality Assurance verify their controls to assure adequacy of in-spection. Supplier's inspection plans are required to recognize those CNSI notification or hold points specified by procurement docu-ments for witnessing by CNSI. 10.3 Indirect Control In the event that direct inspection is not possible, indirect control of the inspection process shall be provided through monitoring pro-cessing methods, equipment and personnel where applicable. s ( ( DOCUMENT REV. SHEET QA-AD-001 10-2 j CNSQ 100W8-70
( 3 11.0 TEST CONTROL ( A test control program established at CNSI assures that all required test-ing is identified and periormed in'accordance with written test procedures, which incorporate the requirements and acceptance limits specified by the applicable design documents, 11.1 Test Procedures Test procedures are prepared by Engineering and reviewed by Quality Assurance in accordance with standards, procedures or instructions that require inclusion of the following quality assurance require-ments, as applicable: A. Requirements and acceptance limits as contained ir the applicable design documents. B. Detailed instructi,ns for perforcing the test. C. Test prerequisites, including, but not linited to the following: a. calibrated instrumentation b. adequate and appropriate equipment trained, qualified, and as appropriate, licensed and/or c. certified personnel d. preparation, condition and completeness of the item to be tested e. suitable and, if required, controlled environmental conditions D. Mandatory inspection hold points for witness by responsible in-dividual. E. Acceptance and rejection criteria. F. Method for documentation or recording of test data and results. Test procedures shall be subject to document control as outlined in Section 6 of this program. They shall be maintained current by I revisions issued upon changes in specifications, documentation, drawings or contracts. 11.2 Test Records Records of tests performed shall be prepared, showing the applicable [ drawing or procedure revision, identification of test performed and date; with test data and other essential test information recorded. DOCUMENT HEV. SHEET QA-AD-001 11-1 ( ) CNSQ 100r8-73
r 3 The test record shall be signed by individual performing the test and ( any test witnesses, if so required. Test records shall be maintained by Quality Assurance. 11.3 Test Control for Procured Items Test control requirements are imposed on suopliers by procurement documents. They identify the tests to be performed and provide for suppliers' test procedure submittal for approval. Tests are con-ducted by groups within the supplier organization considered accept-able during supplier selection, and test control systems are audited during Quality Assurance surveillance. Also, records of tests are reviewed for acceptability during surveillance, and this review in-cludes consideration of the qualifications of the supplier group mak-ing acceptance disposition of test results. 11.4 Modifications, Repairs and Replacements Modifications, repairs and replacements shall be tested in accordance with the original design and test require =ents or acceptable alter-natives approved in the same manner as the original. ( DOCUMENT REV. SHEET 11-2 QA-AD-001 j CNsO 1DOUS-78
(" 3 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT ( Measuring and test equipment with th'e necessary raage and accuracy shall be provided to qualified personnel for the inspection, test and acceptance of material, parts, components and systems. Equipment accuracy shall be assured by calibration traceable to national standards or the alternative basis for calibration shall be documented. Eq uipment calibration shall be based on the requirements of MIL-C-45662. 12.1 CNSI's Equipment Calibration and Control All inspection and test equipment shall be subjected to maintenance and calibration at periodic intervals by qualified personnel or sub-contractors. Frequency of calibration shall be based on the equipment type, historical experience and operational requirements. Each item of measuring and test equipment shall be serialized for re-cord and identification purposes. A sticker shall be attached to the equipment to indicate date of calibration, due date of next cali-bration and the stamp or signature of the person conducting the cali-( bration. A status file shall be maintained for all calibratable equipment. Measuring and test equipment shall be issued to and retained between calibrations by those requiring its use. Each user has the responsi-bility to ascertain, prior to use, that the measuring and test equip-ment calibration date has not expired and that damage or rework has not taken place since the last calibration. Compliance with the above requirements is monitored by Quality Assurance. 12.2 Measuring and Test Equipment at Subcontractors Measuring and test equipment used by subcontractors, vendors and sup-pliers engaged in fabricating and f urnishing materials, parts and components to CNSI shall be under the surveillance of CNSI's Quality Assurance. Surveillance activity include checks to assure that in-spection operations are or have been performed with appropriate mea-suring and test equipment, currently adjusted and calibrated against national standards. Where no national standards for equipment cali- [ DOCUMENT REV. SHEET QA-AD-001 12-1 CNSo 100L'8 78
3 ( bration exist, the documentation for the basis of calibration is ( audited. The surveillance shall cover production tooling, jigs, fixtures and other fabrication equiptent which controls dimensions, contours, etc., and which is used for acceptance. 12.3 Inspection Validity _ t! hen measuring and test equiptent is found to be oct of calibration, measures shall be taken to ensure the validity of 3revious ceasure-cents and tests conducted during the period when the equioment is likely to have been operating in such a condition. F ( (. DOCUM ENT REV. SHEET QA-AD-001 12-2 J CNSO 100LS 78
r 13.0 ILUIDLING, STOP/.GE AND SHIPPING 13.1 Procured Items Measures used to control packaging, shipping, storage and handling of components and material to prevent damage or deterioration shall be documented to reficct contractual or CNSI specified requirements. Procurement documents shall identify the required control measures to suppliers. The supplier must have adequate written work and inspection in-structions for storage, preservation and packaging of shipment to protect the products from damage, loss, deterioration or substitution. As required by the equipment specification and/or procurement docu-ments, these procedures may be subject to approval by CUSI. 13.2 Transport Casks Transport cask handling and operation shall conform to the written handling and operation procedure for each licensed cask. Prior to the shipment of a tra!.. port cask all conditions of the MRC's Certificate of Compliance (specifications, tests, inspections) shall be satisfied. All required shipping papers shall be prepared and shall accompany the shipment. Quality Assurance through the Q A. personnel located at Barnwell, S.C. is responsible for auditing all critical cask handling, storage and shipping operations conducted by Barnwell Site Operations personnel. Established safety restrictions concerning handling, storn e and o shipping shall be included in the handling and operating procedures for t'ransport casks. ( DOCUMENT HEV. SHEET QA-AD-001 13-1 ) g CNSQ 1002/8 78
I T 14.0 INSPECTION, TEST AND OPERATING STATUS ( 14.1 Equipment Status The inspection, test and operating status of systems and components used for processing or transportation of radioactive materials shall be known at all times during manufacturing and use. i insportation and operating procedures shall include reporting re-quirements which establish the equipment status at key events (after unloading, prior to shipment, etc.). Equipment status will be maintained by Barnwell Site operating per-sonnel who are responsible for critical inspection, test and operating activities. Barnwell site quality assurance personnel shall verify equipment status and compliance with procedures. Bypassing of re-quired tests or other critical operations shall be procedurally con-trolled under the cognizance of Barnwell's quality assarance personnel with the concurrence of the Q.A. Manager. 14.2 Establishment of Examinations and Tests In-process and final examinations and tests shall be established to assure conformance with documented instructions, procedures, draw-ings, rules and regulations. 14.3 Hold Points The procurement documents, drawings, quality plans, transportation and operating procedures shall establish any required mandatory hold points in the receiving, fabrication testing and operational sequence which shall be reflected in fabrication or operational schedule. Hold points shall be designated points in the fabrication or operation schedule beyond which the operations shall not proceed without consent of quality assurance because of witnessing, examination or testing requirements. DOCUMENT R E'. SHEET 14-1 QA-AD-001 CNSQ 1 COWS 78
T r 14.4 Check Lists of Examinations, Tests and Inspections ( Prepared check lists shall include the document number and revision to which the examination, inspection or test shall be performed. The check list shall have space provided for recording results of examina-tion, test or inspection and for witness signatures, initials or stamp and date for activities witnessed. 14.5 Examination or Process Status Measures shall be established to indicate during receiving, fabrication and equipment operation the status of examinations and test perforr.ed upon items, systems and components by use of markings that are attached to, remain with, or are traceable to the material, item, systems and components such as stamps, tags, labels, routing cards or other suitable means. These measures shall provide identification of those items which conform to examination and test requirements and those that do not conform. 14.6 Inspection Stamps ( CNSI inspection stamps shall be applied to material, item, system, component or the controlling documentation to indicate the inspection status and to provide traceability to the individual performing the inspection. The appropriate inspection stamp shall be normally applied directly to the item which has been accepted by inspection, material which has been accepted for limited use, and to material which has been rejected and dispositioned as scrap. When size, material or finish, etc., pre-clude stamping the material, a tag shall be attached to the item and appropriately stamped to indicate the status. 14.7 Control of Inspection Stamps Inspection stamps shall be serialized for traceability to the in-dividual inspector. Quality Assurance shall control and issue in-spection stamps, as required, to authorized personnel. Records of in-dividual issue shall be maintained and audits shall be periodically DOCUMENT REV. SHEET QA-AD-001 14-2 cNSQ 100 /8 78
3 r performed to assure legibility and proper ownership. Stamps removed ( from service because of loss, employee termination, etc., shall be retired for a minimum of three months. ( ( DOCUMENT REV. SHEET QA-AD-001 14-3 ) CNSQ 1032/8-78
( 3 15.0 NONCONFORMING MATERIALS, PARTS OR COMPONENTS Procedures for control of nonconforming materials, parts or components assure that such materials are adequately identified and segregated from acceptable materials, if feasible, to preclude their inadvertent use. Corrective action shall be initiated when a nonconformance is determined to be due to an as-signable cause. CNSI's services and operations shall also be subject of nonconformance procedures when applicable. 15.1 Identification and Segregation Materials, parts and components which are determined to be discrepant shall be identified with a tag and a numbered Nonconformance Report and physically separated from acceptable items. The method of identi-fication shall clearly describe the nature and probable cause of the defec* and indicate whether the defective item is to be repaired, re-workt1, scrapped or is to be subject to material review for determina-tion of final disposition. Copies of the Noncon'ormance Report shall be forwarded to the appropriate departments for.isposition. A hold-ing area with controlled access shall be provided hen required for ( material and/or component segregation. The Monconformance Report shall indicate the nature and extent of the discrepancy and the disposition. Minor discrepancies that can be reworked shall be identified by an In-spection Tag until rework has been satisfactorily accomplished. 15.2 Subcontractor Control Subcontractors shall pronptly notify CNSI of all deviations from the procurement requirements, such as, deviations from the required codes or approved drawings. A nonconformance notice shall be initiated by the subcontractor in accordance with subcontractor's quality manual. Further fabrication operations on the material or componeat after detection of the deviation shall not be performed until it has been resolved by the subcontractor and CNSI. The subcontractor shall main-tain records of each rework requirement, including the subcontractor's labor and material costs for each rework. ( DOCUMENT REV. SHEET QA-AD-001 15-1 J CNSQ 1C013 7S
3 ( 15.3 Verification of nework or Repair Acceptability ( Rework or repair of materials, paris, components or systems shall be verified by reinspection and/or retesting the item as originally inspected and/or tested or by a method which is approved by established review procedures as at least equal to original inspections and/or tests. Inspection, testing, rework and repair procedures shall be documented and filed in the appropriate project files of C::SI. 15.4 Nonconformance isposition Final disposition of nonconformance shall be documented by C::SI's Q.A. personnel and shall be filed in the project file associated with the procurement of such material. ( ( DOCUMENT REV. SHEET QA-AD-001 15-2 q J CNSG 1CC2. 3-73
r. 3 16.0 CORRECTIVE ACTION \\ The corrective action program has means for determining the need for cor-rective action, documenting the need and the action taken, follow-up on the action for effectiveness, and reporting the need and action taken to the ap-propriate management personnel. Quality Assurance shall continuously monitor materials, processes and workmanship to assure a timely detection and cor-reution of detrimental trends which could result in nonconforming products. 16.1 Correction of Nonconformities Corrective action shall be initiated when it is determined that an existing nonconformity in a material, a process or a product is due to an assignable cause and is repetitive in nature. The request for corrective action shall be initiated at the earliest possible point; for example, when the request for corrective action is a result of repetitive rejections, the request shall be initiated at the time material disposition is made. The corrective action procedure is divided into five basic steps: (a) Investigate discrepancy (b) Determine cause (c) Define corrective action (d) Implement corrective action (e) Evaluate corrective action Specific individuals from appropriate departments shall be assigned the responsibility of accomplishing each of.the phases. Corrective action is not limited to procurement or manufacturing operations, but includes the areas of design, construction and operation. The results of each phase shall be documented and become part of corrective action records. Quality Assurance shall review corrective action records to determine adequacy as soon as effectiveness can be measured. Ef fectiveness she be continuously monitored as a function of quality surveillance. u.e corrective action shall not be conpleted until re-sults of the corrective action have been evaluated and approved by Quality Assurance. ooCUMENT REV. SHEET -QA-AD-001 16-1 CNSO 1Cor8 78
( 3 When material supplied by a vendor or subcontractor has been rejected, Quality Assurance shall promptly notify the supplier in writing of the reason for rejection and request corrective action. The supplier shall be required to provide the following information: (a) Description of all factors contribut 'g to the deficiency. (b) Description of corrective actions taktn to prevent recurrence of the discrepancy in future productian. (c) Identification of ef fectivity point in production. ( ( DOCUMENT REV. SHEET QA-AD-001 16-2 CNSQ 1002/8-78 s
r 3 17.0 OUALITY ASSURANCE RECORDS k 17.1 }hintenance and Access to Records The records system maintained by Chen-Nuclear Systems, Inc. includes the retention of those fabrication, inspection and surveillance re-cords essential to demonstration of product quality. It provides for the identification of materials and correlation of manufacturing, installation, test and inspection records and certificates. Operat-ing records maintained will include inspection, test and audit results. Maintenance of the record file system is the responsibility of Quality Assurance. All records pertaining to a specific project shall be made available for review by the appropriate inspection agencies, the custo-cer and/or his representative. A list of required records and their storage locations will be maintained by Quality Assurance. All re-cords will be maintained according to established procedures, and will be identifiable and retrievable. 17.2 Cantents of Record Files ( It is the policy of Quality Assurance to provide and maintain adequate records of all component and material inspections and tests, supplier and subcontractor quality assurance implementation audits and reviews, and Chem-Nuclear Systems, Inc. internal quality assurance implementation audits and reviews. Records shall be kept for control and as evidence of inspections, tests, audits, monitoring of work performance, material analysis and certifications, i.e., record files shall contain all docu-cents pertaining to product quality assurance functions. The files shall also contain procedures and specifications written for a specific project. All reports shall reference the procedure and re-vision used, the results, the date, the identification of the inspector or person performing the test, the equipment used and the item examined. Files of personnel qualifications shall also be maintained. 17.3 Permanent Records Permanent records in the record file shall contain: design specifi-cations, stress reports ot stress calculations, "as built" and inter-face control drawings, copies of all certified material test reports, DOCUMENT REV. SHEET QA-AD-001 17-1 j CNSQ 100W8-73
p 3 tabulation of materials for "as built" configuration, nondestructive ( exanination reports, including examination results and disposition reports. 17.4 Non-oermanent Records All non-permanent records required to verify compliance with the applicable codes and the supplier's or subcontractor's Quality As-surance Program shall be maintained for a period of five years after manufacture or installation, unless otherwise stipulated. ( (. DOCUMENT REV. SHEET QA-AD-001 17-2 j CNSQ 100L8-73
3 r ~, 18.0 AUDITS ( Audits to be performed will be dependent on the safety significance of the activity being audited. To verify the ef fectiveness of the Quality Assurance Program, CNSI applies a system of planned and scheduled audits. Audits in-clude evaluation of quality system practices and/or procedures and the ef-fectiveness of their implementation, monitoring of operations and activities, a review of pertinent documents and their control and maintenance. Audit procedures shall be established prior to conducting an audit. 18.1 Audit Schedule Audits shall normally be conducted once every 12 months, however, unscheduled audits may be performed more frequently in specific areas, if deemed necessary by Quality Assurance and/or when the need is in-dicated by the existance of chronic problems. All audits shall be performed on a random, unannounced basis to assure optimum effective-ness and a prompt disclosure of deficiencies. 18.2 Audit Personnel [ Audits shall be performed by CNSI personnel with no direct line responsibility for the function audited. The audit personnel shall have the required level of technical capability to accomplish the audit functions satisfactorily. When required, representatives from various CNS1 departments may be called upon for technical advice or assistance. 18.3 Audit Reports An oral presentation of the findings and conclusions of tbs audit is made to the Department Manager, Quality Assurance Manager, and other personnel affected by the audit findings. The items reco== ended for improvement in the quality assurance program are presented as well as recommendations of approaches for accomplishing these improvements. Following the audit, a written report containing the findings and reconmendations reviewed in the oral report is prepared and distri-buted to the responsible division personnel and the appropriate Head-( quarters personnel. DOCUMENT REV. SHEET QA-AD-001 18-1 CNSQ 1002/8-78
) g Audits shall include an assessment as to how yiell the Quality As-( surance Prograc meets regulatory or other' requirements. 18.4 Audit Foll ow-Ln The originator of an audit report or a designated alternate is re-quired to follow an open item until action is taken to satisfy an audit action item. Records of actions taken to achieve resolution are maintained. Follow-up actions are taken to verify corrective action is effective. Responsible management personnel shall evaluate each audit report item and correct deficiencies as pronptly as possible after they are revealed. ( ( DOCUMENT REV. SHEET QA-AD-001 18-2 CNSQ 100L8-73}}