ML20199E098

Rev 11 to QA-AD-001, Chem-Nuclear Sys Qap

ML20199E098
Person / Time
Site:	07100231
Issue date:	11/06/1997
From:	Campbell R, Mohundro M, Peay L CHEM-NUCLEAR SYSTEMS, INC.
To:
Shared Package
ML20199E096	List: ML20199E092 ML20199E098
References
QA-AD-001, QA-AD-001-R11, QA-AD-1, QA-AD-1-R11, NUDOCS 9711210099
Download: ML20199E098 (39)

Text

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PRINTED ON 11/4/97 2:15 PM 5

2 CHEM-NUCLEAR SYSTEMS

• lN ADDITION TO ALL APPLICABLE CNS DOCUMENT CONTROL REQUIREMENTS, ANY PROPOSED CHANGE TO QA AO-001 REQUIRES FORMAL US NRC APPROVAL IN ACCORDANCE WITH 10 CFR 71 OR A SIGNED STATEMENT BY THE GENERAL MANAGER, CNS QA WHICH JUSTIFIES THAT SUCH APPROVAL IS UNWARRANTED.

PRINTED OR TYPED SIGNATURE DATE NAME

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11/6/97 PREPARED BY:

Larry G. Peay

,p 3EVIEWED BY:

Michael D. Mohundro g77/gg 11/6/97 iPPROVED BY:

Richard E. Campbell

[ [, g g g 11/6/97 SRB SIGNATURE ON FILE APPROVAL:

DOCUMENT TITLE:

QUALITY ASSURANCE PROGRAM

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DOCUMENT NO.

REV.

PAGE QA AD-00'l 11 1 of 33 g 2g g g yj00231 C

PM

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4 TABLE OF CONIENTS Paae No.

1. 0 Q R G A N I Z ATipE.......................................................................................... 4 2.0 Q U AllTY A S S U RA N C E PR O G RA M................................................................ 6 3.0.D E SI G N C O N T R O L.................................................................

4.0 PROCU RE M E NT DOCUM E NT CONTRO.L...................................................... 10 5.0 INSTRUCTIONS PROCEDURES AND DRAWINGS.........................................11 0.0 DO C U M E NT C O NT R O L..........................................................................

7.0 CONTROL OF PURCHASED MATERIAL EQUIPMENT AND SERVICES.............13 8 O lDENTIFICATION AND CONTROL OF COMEQNENTS AND MATE 8lALS...........17 9.0 CONTRO L O F SPECI A L PROC ESSE S...........................................................

1 0. 0 I N S P E C TI ON........................................................................

1 1. 0 T E ST C O N T R O L............................................................................

12.0 C, ONTROL OF MEASURING AND TEST EQUIPMENT.................................... 21 13.0 H AN DLIN G. STO R AG E AN D SHIPPIN G....................................................... 2 3 14.0 INSPECTION TEST AND OPERATING STATUS........................................... 23 15.0 NONCONFORMING MATERIALS PARTS OR COMPONENTS....................... 25 16.0 C O R R E CTIV E ACTl O N...........................................................................

17.0 QUALITY ASSURANCE RECOPDC...........................................................27 18.0 AUDITS..................................................................................................29 A PP E N D I X A......................,........................................................................... 3 1 A PPE N D I X B...........................................................................................

A PPE N D I X C................ m.......................................................................

QA-AD-001 REV.11 PAGE 2 2.

a.

CHEM NUCLEAR SYSTEMS POLICY STATEMENT ON QUAllTY ASSURANCE LX52:XCEDL::D:2 233T::XXTYL

C T L.

bli:::*,2:'1 Chem-Nuclear Systems (CNS) requires activities governed by regulations, licenses, certificates of compliance, or other quality / safety commitments to be conducted in accordance with the CNS Quality Assurance (QA) Program. CNS's OA program is implemented through procedures, instructions and drawings. Adherence to this policy, the CNS QA Program and the implementing procedures, instructions and drawings is mandatory for all CNS employees and subcontracted organizations.

CNS's Quality Assurance (QA) program complies with the requirements of ASME NOA-1; ASME Boiler and Pressure Vessel Code, Section Vill; ANSI N45.2; 10 CFR 50, Appendix B; 10 CFR 71, Subpart H; 10 CFR 72, Subpart G; NUREG 1293; and Mil-O-9858A. The CNS QA Program alid implementing documents provide the controls and responsibilities that assure compliance with these codes and standards.

The General Manager, Quality Assurance has been delegated the responsibility and l

authority to develop and maintain the CNS OA Program and to verify offective implementation.

Tne objective of the CNS QA program is to achieve reliable quality for activities that affect health and safety and assure full compliance with rcgulatory and customer requirements. This program provides assurance that the performance objectives and technical requirements will be met. The effective implementation of these measures has my full and unconditional support.

Soc d.

Regan E. Voit, President Chem-Nuclear Systems

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1.0 ORGANI/ATION 1.1 The President of Chem-Nuclear Systems (CNS) is responsible for the overall establishment and effectiveness of the QA Program. The President may delegate activities to others, but retains overall responsibility for the QA Program and its implementation. The CNS Organization is shown in Appendix A. The following is a summary of key organizational responsibilities.

1.1.1 Low-Level Waste Disposal Operations - Provide disposal services to generators of Low Level Radioactive Waste in strict accordance with regulatory requirements.

1.1.2 Technical Services and Operations - Provides design, e

development, construction and testing for CNS activities and transportation and waste processing services to generators of Radioactive Waste. Waste processing sen ices includes, but is not limited to, water processing, waste solidification and dewatering, fuel pool cleanup, volume reduction and repackaging services.

1.1.3 Controller - Provides financial and administrative support including procurement of goods and services for operations throughout the company.

1.1.4 Regulatory Affairs - Provides regulatory compliance oversight to assure that CNS's activities comply with regulatory, permit and license requirements. Regulatory Affairs provides interface with regulatory agencies to ensure safe operations that comply fully with federal, state, and local regulations. In addition, the Regulatory Affairs Division works closely with customers to ensure that the waste shipped to disposal facilities meet packaging, transport, and disposal requirements. Regulatory Affairs includes the following functional areas:

Quality Assurance is responsible for the overall direction and management of the corporate QA Program. Within CNS, Quality Assurance is a management tool that evaluates the effectiveness of systems and processes in meeting regulatory requirements and ensures the health and safety of the public and CNS employees.

Licensing is responsible for ensuring compliance with

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applicable federal and state licencing requirements. This department interfaces with licensing agencies and provides them with technical information and requested support information.

QA-AD-001 REV.11 PAGE 4

Health Physics ensures radiation safety, as well as

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compliance with radiation control regulations. Health Physics also has specific responsibilities for the review of radiation control programs and their implementation.

1.2 CNS's organizational structures and responsibility assignments are such that quality is achieved and maintained by those who have been assigned responsibility for performing work, and quality achievemsit is verified by persons or organizations not directly responsible for performing the work.

1.3 The General Manager, Quelity Assurance has the overall responsibility l

for assuring effective establishment and maintenance of the QA program.

The General Manager, Quality Assurance is supported by a staff of l

quality assurance personnel.

1.3.1 The General Manager, Quality Assurance reports to the Vice Presider.t, Regulatory Affa!rs and has unencumbered access to the President of CNS for matters of quality. The Vice President, Regulatory Affairs reports to the President of CNS. QA personnel are provided sufficient authority, responsibility, access to all work areas and records, and the organizational freedom to function effectively without hindrance or reservation to:

Identify quality problems, stop unsatisfactory work, and control further processing, delivery or installation of nonconforming items; initiate, recommend and approve solutions through

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corporate channels; verify implementation of solutions; and assure that measures of control are applied until proper disposition of a nonconformance, deficiency, or unsatisfactory condition has occurred.

1.3.2 Position descriptions for the General Manager, Quality l

Assurance and Quality Assurance personnel include prerequisite experience and/or required training. Qualifications for the General Manager, Quality Assurance include:

l A Bachelor's degree in a technical field or equivalent experience; QA-AD-001 REV.11 PAGE5

At least ten years experience in quality assurance, engineering or manufacturing; A working knowledge of applicable quality-related codes, standards, and regulatory requirements; The ability to prescribe, apply and assess compliance with the applicable requirements.

1.4 Organizations other than CNS may be delegated the tasks of establishment and execution of a OA program, however, the responsibility for CNS activities that are important to Safety is retained by CNS. The General Manager, QA, upon notification of need for further direction or l

resolution of OA problems, has the authority to communicate, or direct communications, with any contractor doing business with CNS.

Where more than one organization is involved in the execution of activities covered by this program, the responsibility and authority of each organization is clearly established. Internal and external interfaces between organizations are documented in project specific plans or implemor. ting procedures.

2.0 QUALITY ASSURANCE PROGRAM The Quality Assurance Program is comprised of those planried and systematic actions necessary to assure adequate confidence that CNS activities that are important to Safety will be conducted in a satisfactory manner and that important to Safety equipment and material will perform satisfactorily in service. Important to Safety items and activities are those necessary to assure that radioactive waste is received, handled, packaged, stored, processed, or disposed, without undue risk to the health and safety of the public or the environment.

Activities within the scope of this program include, but are not limited to, waste and water processing equipment design, fabrication and operation; design, fabrication, maintenance and operation of storage, disposal and transport containers; volume reduction: compaction services; waste transportation services; waste characterization services; and low-level radioactive waste l

disposal site development and operation. The requirements of this program are applied to an extent commensurate with the item's or activity's importance to l

Safety.

CNS uses the graded approach to establish vendor approval requ:rements for threo quality levels. Quality Level 1 includes, as a minimum, all items and services critical to the safe operation of NRC licensed storage and transportation containers. Quality Level ll includes important to Safety items and services that are not critical to safe operation of NRO licensed storage and transportation containers. Quality Level 111 applies to items and services procured as OA-AD-001 REV 11 PAGE6

e commercial grade. The quality level for individual items is established and maintained on a controlled 0 List.

2.1 Manso9 ment The President of CNS has the responsibility to ensure effective implementation, assess the scope and status, and determine the effectiveness of the QA Program. Programmatically these functions are accomplished through the use of audits, field investigations (audits, hispections or surveillances), customer / user service reports, and internal reporting procedures, This program is reviewed annually to assure conformance with current practices and requirements.

The CNS Safety Review Board (SRB) reviews the conduct of CNS business where matters of safety are involved and to assure compliance with applicable regulatory requirements, procedures, policies, licenses, permits and certificates. The SRB is chaired by the Vice President, Regulatory Affairs. SRB membership consists of CNS management personnel providing expertise in engineering, operations, quality assurance, safety, Al. ARA, and other areas as needed. Members are designated by the SRB Chairman.

2.2 Personnel Qualifications Personnel assigned to perform quality functions are indoctrinated in accordance with ANSI N45.2.6, NRC Regulatory Guide 1.58, ASME NOA-1 or other applicable docunients. Indoctrination and training is l

established such that:

2.2.1 CNS personnel responsible for performing important to Safety activities are instructed as to the purpose, scope and implementation of instructions and procedures; 2.2.2 CNS personnel performing important to Safety activities are trained in the principles and techniques of the activity being performed; 2.2.3 The scope, objective and the method of implementing indoctrination and training are documented; 2.2.4 Proficiency of personnel performing important to Safety activities shall be monitored and documented on a periodic basis.

2.3 Quality Assurance Policies. Goals and Ob!ectives 2.3.1 It is the policy of CNS that all activities which are governed by the Code of Federal Regulations, licenses, Certificates of OA-AD-001 RE V.11 PAGE 7

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Compliance, or other regulatory requirements, be conducted in accordance with written, approved procedures or instructions which incorporate the regulatory requirements in a manner i

wnich is easily understood by the user. Important to Safety i

activities shall be performed with specified equipment under suitable environmental conditions and prerequisites shell be satisfied prior to inspection, operation or testing. Adherence to the procedure requirements is mandatory for all CNS activities.

New proceduren affecting health and safety are required to be submitted to the Safety Review Board for approval prior to implementation.

Appendix B provides a typical list of procedures that govern the implementation of this program. Appendix B is current at the time of issuance of this program. Updates to procedures do not require revision of Appendix B. Appendix B will be updated at the next revision of the Quality Assurance Program.

2.3.2 The CNS Quality Assurance Program provides the controls necessary to achieve an effective Quality Assurance Program for activities which are important to Safety.

This is achieved through the use of diawings, procedures and instructions.

2.3.3 Differences of opinion between QA personnel and other CNS departments shall be resolved by the General Manager, Quality l

Assurance.

2,4 Quality Assurance Proaram Distribution Measures to control the distribution of the Quality Assurance Program and revisions thereto are described in Section 6 of this document.

2.5 CNS Implementina Procedures This program incorporates the 18 criteria addressed in 10CFR71, Subpart H; 10CFR72, Subpart G and 10CFR50, Appendix B. Implementation of this program is accomplished through written approved procedures.

3.0 DESIGN CONTROL 3.1 The Design Control Program at CNS ensures that design characteristics are controlled, inspected, and tested; that designs developed by CNS meet applicable regulatory requirements; and that design activities are carried out in a planned, controlled, and orderly manner.

QA-AD-001 REV.11 PAGE 8

3.2 A comprehensive system of established procedures and instructions is used for developing and implementing design projects, as well as controlling design documents (drawings) and design document distribution.

3.3 CNS Technical Services is responsible for the selec(lon and control of design parameters and for the development of design documents. Their responsibilities are summarized below:

3.3.1 The cognizant engineer is responsible for the initial interpretation of design requirements and for confirming that applicable regulatory requirements are correctly translated into specifications, drawings, procedures, and instructions.

3.3.2 The designer produces accurate and precise drawings that conform to the design specifications and that properly list or reference those specifications.

3.3.3 The cognizant engineer is responsible for assuring that the total design package (e.g. calculations, drawings, Engineering Test Instructions, specifications, etc.) is technically accurate, that the design will perform its intended function, that regulatory requirements are met, and that the package is ready for release and fabrication.

3.3.4 Review and approval of design packages is performed by an Individual or group independent of the preparation of the design documents.

3.4 The Design Control Program provides for design review meetings to ensure that design characteristics can be controlled, inspected, and tested, and that inspection and test criteria are identified. Formal design review meetings may include the cognizant engineer, the designer, and any other individuals or groups involved in the development of the design.

Design reviews may be called at any time. Records are kept of these design reviews, and controls are established to ensure that desl n errors 0

are corrected and not repeated. Design controls also extend to other individuals or groups in interfacing design organizations.

3.5 Procurement of items (material, equipment and services) is controlled as outlined in Section 7.0 of this document. The procurement documents specify design base requirements including the applicable regulatory requirements, material and component requirements, drawir gs, specifications, codes and industry standards, test and inspection criteria, c 'd special process instructions. Items are reviewed for suitability prior to i

selection, i-QA-AD-001 REV.11 PAGE 9

3.6 Changes to final designs, field changes and modifications are justified and subject to design control measures commensurate with those applied to the original design. These measures shall include assurance that the design analyses for the items are still valid. Changes are approved by the same groups or organizations responsible for review and approval of original design documents.

3.7 CNS design control procedures ensure that only current copies of deslGn output documents are used.

3.8 Computer programs (whether generated, transferred to, or purchased) used to calculate or develop quality related data shall be subject to documented verifications or validations. Computer programs may be used for design analysis withcut individual verification of the program for each applit,atlcn proviaed:

the computer program has been verified to show that it produces correct solutions for the encoded mathematical model within defined limits for each parameter employed; and the encoded mathematical model has been shown to produce a valid solution to the physical problem associated with the particular application.

3.9 Computer programs are placed under configuration control to assure that changes are documented and approved by authorized personnel prior to their use. Where changes to p eviously verified computer programs are made, verification shall be required for the change.

4.0 PROCUREMENT DOCUMENT CONTROL 4.1 The procurement of items or services for important to Safety applications is accomplished with a procurement document. Personnel authorized to release Purchase Orders are responsible for conforming with established procurement and recor'd keeping procedures. The sequence of events leading to Purchase Order issuance, and the associated record keeping activities om detailed in CNS procedures.

4.2 It is the CNS policy that procurement documents, except for administrative supplies, are reviewed by the cognizant manager / supervisor or their designee. When the manager / supervisor or designee determines that the procurement is for important to Safety items or services, Quality Assurance assures the quality requirements are included in the procurement documents.

4.3 Important to Safety procurement documents include the following items as applicable:

QA-AD-001 REV.11 PAGE 10

4.3.1 The applicable 10CFR Part 50, Appendix B and 10CFR71, Subpart H,10CFR72, Subpar 1 G requirements which must be addressed; 4.3.2 The design basis technical requirements including the applicable reguletory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, tests and inspection requiremonts, and special process instructions; 4.3.3 The documentation to be prepared, maintained, and submitted to the purchaser for review and approval; 4.3.4 The records to be retained, controlled, and maintained by the vendor, and those delivered to the purchaser prior to use or installation of the materials o components; 4.3.5 The procuring agency's right of access to vendor's facilities and records for source inspection and audit; 4.3.6 Inspection, witness and hold points as applicable.

4.4 The individual authorized to control and release purchase orders prepares the Purchase Order, incorporating applicable information referenced in the proceding paragraph. One copy of quailty related Purchase Orders is maintained in a control file.

4.5 Procurement documents for spare or replacement parts shall be subject to the same controls that are applisd to the original equipment. Changes and revisions to procurement documents are subject to the same review process as original documents.

4.G Original and revised procurement documents stiall be clearly annotated to indicate the completion of the aforementioned review and approval sequence.

5.0 INSTRUCTION

S. PROCEDURE

S AND DRAWINGS 5.1 Important to Safety activities are prescribed by documented instructions, 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 drawings.

QA-AD-001 REV.11 PAGE 11 l

5.2 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.

5.3 Management personnel having responsibility for the activity prescribed by tne procedure are designated by the SRB as procedure owners.

Procedure owners are responsible for initial approval, revision approval, and implementation of assigned procedures.

Procedures, instructions and drawings are prepared, reviewed and approved in accordance with established procedures by cognizant department personnel. Personnel responsible for preparation, review and approval of plans, procedures, instructions and drawings used to control important te safety activities are trained to assure incorpcration of appropriate quality and regulatory requirements.

5.4 Descriptions of procedure changes are submitted to the SRB. The CNS Safety Review Board reviews and approves new procedures, assuring safety and health issues are appropriately addressed.

6.0 DOCUMENT CONTROL.

CNS procedures define the controls for drawings, specifications, procedures, instructions and their respective changes.

6.1 Document Types Controlled Controlled Documents include, but are not limited to, procedures, plans, design drawings, specifications, and instructions.

6.2 Document Review 6.2.1 Design drawings and specifications are developed by Technical Services. They are reviewed and approved by trained and qualified personnel for adequacy and compliance with applicable quality standards and/or contractual requirements.

The review assures the availability of all information required to conform with design requirements. The review process is the same for document changes.

6.2.2 Procedures, plans and instructions, including chances, are prepared, reviewed and approved by trained and qualified personnel. New procedures are also approved by the CNS Safety Review Board to assure safety and health issues are appropriately addressed.

QA-AD-001 REV.11 PAGE 12

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6.3 Document Control t

6.3.1 Execution of an effective document control system requires the following:

6.3.1.1 Each document shall have an identifying number and a descriptive title.

l 6.3.1.2 Each document shall have means for identifying the revision status and the effective date of each revision.

6.3.2 Controlled docummns are distributed in accordance with a t

document distribution list.

Obsolete documents are removed from work locations or identified as obsolete to preclude their use in important to Safety activities. History copies of obsolete procedures ara maintained in the document files.

6.3.3 Procedures and their changes are distributed on a formal basis and are of standard format.

l 6.3.4 When distributed, drawings and/or documents are accompanied by a document transmittal letter showing the drawing and/or document number, revision and date of transmittal.

6.3.5 Purchase orders for manufacturing projects are amended to indicate the affect of engineering changes. On completed projects, as-built drawings and documents are maintained in the project file.

6.4 Document Availability Documents shall be available prior to commencement of work at the locations where activities governed by the document are to be performed.

7.0 CONTROL OF PURCHASED MATERIAL. EQUIPMENT AND SERVICES CNS procurement controls establish measures to ensure that procured items -

and services for important to Safety applications are clearly and adequately specified in procurement documents. Important to Safety items and services are supplied by vendors and subcontractors who are capable of producing items and furnishing services which conform to procurement document requirements.

These procurement methods are controlled by procedures for vendor evaluation, review of procurement requirements and surveillance of vendor's facility.

QA-AD@i REV.11 PAGE 13 -

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I Commercial Grade items may be procured and dedicated for Important to Safety application. Technical Services shall identify the critical characteristics and the method (s) (e.g., special tests and inspections, commercial supplier sur/ey, l

source verification, and/or acceptable supplier / item performance record) to be used to dedicate Commercial Grade items. Quality Assurance shall concur with the method of ded: cation.

7.1 Vendor Evaluation 7.1.1 CNS Technical Services, Procurement, and Quality Assurance personnel participate, as appropriate, in evaluation of procurement sources. Recommendations of procurement sources are based on theso evaluations. huults of vendor i

evaluations performed prior to contract award are documented and retained. The evaluations cover review of capabilities and facilities for technical, manufacturing and quality performance, and include any or all of the following as appropriate:

7.1.1.1 Historical performance data, particularly in product quality and de!!very; 7.1.1.2 Review and comment on vendor's quality assurance program; 7.1.1.3 Source audits or surveillances to verify vendor's quality assurance program implementation, as required; 1

7.1.1.4 Source qualification programs or state / national accreditation.

7.1.2 Vendor evaluation considerations include the elements of the Nuclear Regulatory Commission's and other regulatory agency Quality Assurance Criteria to the o' tent these criteria are x

applicable to the items or services being procured.

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Procurement Reauirements Requirements to be met by the vendor are detailed in the procurement documents which may include procurement specifications.' Procurement documents detail the aspects of vendor quality assurance such as inspection reports, provisions for inspection, equipment calibration prior to use, and provisions for inspection after component repair. The procurement documents may also require the successful bidder to submit the following for CNS's review:

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t 7.2.1 Special process procedures for performing ivelding, heat treatment, and nondestructive examination; 7.2.2 Recommended inspection point program; 7.2.3 Appropriate documentation as required by applicable codes, standards and procurement documents; 7.2.4 Notices of nonconformances and their disposition; 7.2.5 Test procedures in accordance with applicable codes and standards.

7.3 Vendor Surveillance 7.3.1 CNS Qual!ty Assurance is responsible for conducting and documenting vendor surveillance activities. Surveillance activities may include:

7.3.1.1 Witnessing tests, inspections, nondestructive examinations and various special process operations; 7.3.1.2 Monitoring heat treatment, welding, cleaning, preserving, and packaging activities; 7.3.1.3 Verifying vendor conformance with established procedures such as:

Use of CNS accepted drawings and procedures; Use of accepted product and process quality planning; Document change control; Material identification and traceability control; Control and calibration of measuring equipment; Control of repair welding.

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7.3.2 The documentation package for purchased items is reviewed by QA or their qualified designee prior to releass of the items for shipment and/or use. This documentation may include material l

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I test reports, inspection and test repods, NDE reports and applicable code data reports.

7.3.3 The frequency and extent of surveillances are consistent with the complexity and quantity of the item or service being furnished.

7.4 Receivina inspection Receipt inspections shall be performed for purchased items that are Important to Safety (including spare or replacement parts) to ensure that' 7.4.1 Items are properly identified and correspond to the receiving documentation; r

7.4.2 Inspection records or certificates of conformance attesting to the acceptance of items are available; 7.4.3 Items accepted and released are identified as to their inspection status prior to forwuing them to a controlled storage area or t

releasing them for mstallation or further work.

7.4.4 Physical attributes comply with specified requirements.

7.5 Vendor Evaluation and Audit A documented evaluation is required anoually for vendors maintained on 1

the Approved Vendors List. Vendor audits, when required, shall be conducted at least once every 36 months in accordance with the audit section of this document.

Triennial vendor audits or surveillances are required for Quality Level I

' Vendors. Quality level ll vendors may be qudlified based on one or more of the following methods:

audit or surveillance of the vendors facilities and implementation

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of an acceptable QA Program.

evaluation of historical performance:

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evaluation of current quality records.

L Quality Level 111 (commercial grade) vendors do not require qualification.

l 7.6 Vendor Performance Trendina The results of vendor audits, evaluations, surveillances, receipt l

-inspections, and shop inspections are tracked and trended to assure any trends adverse to quality are identified and corrected.

QA-AD-001 REV.11 PAGE 16 m

8.0 IDENTIFICATION AND CONTROL OF COMPONENTS AND MATERIALS The identification and control as described herein shall apply to important to Safety 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.

8.1 Components and Materials 8.1.1 The inspection status of items shall be accomplished by marking, tagging or stamping components or materials at the appropriate stages of fabrication or installation. The inspection status is not changed without the concurrence of CNS QA or their qualified designee.

8.1.2 Idontification of items shall be accomplished by a method that will provide legible identification without adverse effect on its lifa and utility.

8.1.3 ltems not suitable for individual marking, shall be individually tagged, placed in an identified container, or otherwise segregated.

8.1.4 The storage area shall contain only items which have been inspected and accepted. Surveillance shall be maintained over the storage areas to assure that materials subject to certification control or age limit requirements are properly segregated, dated and controlled. This surveillance shall also include checking for conformance to proper standards of packaging and storage of all components, materials, parts and assemblies.

8.2 Bulk Raw Material 8.2.1 Following the acceptance of bulk raw materials, a tag showing the purchase order number, the material identification, and lot number shall accompany the material.

8.2.2 If during fabrication all identification has been removed from the part of the material being used, the remnant shall be marked before being returned to stock.

8.2.3 Material marking shall not be affected by contact incident to normal handling, exposure to the elements, shipment or storage.

j All markings shall offer ready readability and prompt I

iderdification of the material. Physical marking of material shall l

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0 be accompDhed in a manner which will not aaversely affect the machining, forming, fabrication or perfonnance of the material.

8.3 Identification Identification requirements shall be determined durirg generstion of specifications and design drawings. Identification of materials ar d parts for important to Safety 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.

9.0 CONTROL OF SPECIAL PROCESSES Fabrication, installation and inspection processes which have an effect upon the i

quality of important to Safety items or services shall be controlled by process procedures.

9.1 Personnel Certification Personnel responsible for performance, inspection and control of spscial processes and opera' ions which require special skills, and have an effect upon quality of important to Safety items, shall be certified. Personnel for these processes or operations shall be trained and qualified in accordance with the codes and/or standards applicable to the process.

The period of effectiveness for all certifications shall be specified and each individual shall be re-certified at the end of such period as required by applicable standards. Inspection results and quality audits shall be used as indicators of the need for additional training and recertification of fabrication, installation and inspection personnel without regard for established re-certification periods. A record of the names of certified personnel, their skills and certification periods shall be maintained on file for review at the facility performing special processes.-

9.2 Subcontractor Control Special processes performed by CNS's subcontractors and vendors shall be specified in procurement documents.

9.3 Procedures Special process procedures and instructions shall be reviewed and approved to ensure their adequacy. Special Process procedures shall include the method, qualification requirements, equipment and associated control parameters.

QA-AD-001 REV.11 PAGE 18 -

10.0 INSPECTION 10.1 The established inspection program at CNS verifies the conformance of important to Safety activities with the applicable requirements. The verification is performed in accordance with written procedures, instructions or drawings. Personnel performing the inspections are independent from the individuals performing the activity being inspected.

Equipment modifir tions, repairs and replacement are inspected in 10.2 s

accordance wi"

'e original design and inspection requirements unless an approver si.1stive exists. Provisions for mandatory inspection hold t

point identifice on requiring witnessing by the inspector are ir.corporated in the appropria documents, such as procurement specifications, test procedures, etc.

10.3 The inspection program also provides for identification and documentation of deficiencies discovered during inspection.

10.4 Inspection Controls 10.4.1 Inspection procedures and instructions are written documents which provide the following information:

10.4.1.1 Identification of characteristics and/or activities to be inspected; 10.4.1.2 Identification of the individual or group responsible for performing the inspection;

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10.4.1.3 Acceptance and rejection criteria; 10.4.1.4 A description of the inspection method; 10.4.1.5 Recorded evidence of completing and verifying a manufacturing, inspection, or test operation; 10.4.1.6 Recording inspector or data recorder, the inspection date, and the results of the inspection operation.

10,4.2 Inspection procedures and/or instructions are used in conjunction with the applicable specifications or drawings when inspection operations are performed.

10.5 Vendor Inspection CNS identifies inspection requirements in procurement documents issued to subcontractors and vendors for Important to Safety items or services.

QA-AD-001 REV.11

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The subcontractors and vendors are responsible for inspection vf their products, and CNS Quality Assurance verifies their controls to assure adequacy cf inspection. Vendor documents (procedures, instructions, drawings, etc.) are required to recognize those CNS notification or hold points specified by procurement documents.

10.6 Indirect Control In the event that direct inspection is not possible, indirect control of the inspection process shall be provided by monitoring processing methods, equipment and personnel where applicable.

11.0 TEST CONTROL A test control program established at CNS for important to Safety items and services assures that required testing is identified and performed in accordance with written test procedures or instructions, which incorporate the requirements and acceptance limits specified by the applicable design documents.

11.1 Test Procedures 11.1.1 Test procedures and instructions prepared by the responsible CNS department are reviewed in accordance with standards, procedures or instructions to ensure inc, * 'n of the following quality assurance requirements, as applicable:

11.1.1.1 Requirements and acceptance limits as contained in the applicable design documents; 11.1.1.2 Detailed instructions for performing the test; 11.1.1.3 Test prerequisites, including, but not limited to the following:

Calibrated instrumentation; Adequate and appropriate equipment; Trained, qualified, and as appropriate, licensed and/or certified personnel; Preparation, condition and completeness of the item to be tested, Suitable and, if required, controlled environmental conditions.

QA-AD-001 REV.11 PAGE 20

t 11.1.1.4 Mandatory inspection hold points for witness by responsible individual; 11.1.1.5 Acceptance and rejection criteria; 11.1.1.6 Method for documenting or recording test data and resulls; 11.1.1.7 Designation of the individual (s) or group (s) responsible for evaluating and making decisions based on test results.

11.1.2 Test procedures shall be subject to document control as outlined in this program. They shall be maintained current by revisions issued upon changes in specifications, documentation, drawings or contracts.

11.2 Test Records 11.2.1 Records of tests performed shall be prepared, showing the applicable drawing or procedure revision, identification of test performed, date, test data and other essential test information.

11.2.2 The test record shall be signed by the individual performing the test and any test witnese, if so required. Test records shall be retained.

11.3 Test Control for Procured items Test control requirements are imposed on vendors by procurement documents. They identify the tests to be performed and stipu ate that vendors' test procedures be submitted for approval. Tests are conducted by groups within the vendor's organization, and test control systems are monitored during Quality Assurance surveillance, evaluation, or audit.

Records of tests are reviewed for acceptability.

11.4 Modifications. Repairs and keplacements Modifications, repairs and replacements shall be tested in accordance with the original design and test requirements or acceptable alternatives l

approved in the same manner as the original.

12.0 CONTROL OF VEASURING AND TEST EQUIPMENT Measuring and test equipment with the necessary range and accuracy shall be provided to qualified personnel for the inspection, test and acceptance of

. material, parts, components and systems. Equipment accuracy shall be ensured QA-AD-001 REV.11 PAGE 21

+.

by calibration traceable to national standards or a documented alternate basis for calibration.

12.1 CNA's Eauipment Calibration and Control 12.1.1 Inspection and test equipment shall be subjected to maintenance and calibration at periodic intervals, prior to use, or immediately after use by qualified personnel or subcontractors.

Frequency of calibration shall be based on the equipment type, historical expe'ence and operational requirements.

12.1.2 Each item of measuring and test equipment (M&TE) shall be serialized for record and identification purposes. A label or tag is attached to the M&TE indicating the due date for the next calibration and the initials or signature of the calibrator. If placing the label or tag on the M&TE is impracilcal, the label or tag may be placed on the M&TE container. The stotus file shall be maintained for all calibrated equipment.

12.1 2 Measuring and test equipment shall be transported, stored, and calibrated in an environment which will not adversely affect its accuracy. M&TE may be i8 sued to and retained between calibrations by those requiring its use. Each user has the responsibility to ascertain, prior to use, that the measuring and test equipment calibration date has not expired and that damage or rework has not taken place since the last calibration.

12.2 Measurino and Test Eauipment at Subcontractors Measuring and test equipment used by subcontractors and vendors engaged in fabricating and fumishing materials, parts and components, that are important to Safety, to CNS shall be controlled commensurate with the requirements of this section.

12 3 Inspection Validity M&TE and reference standards found to be out of calibration or which have not been properly maintained or calibrated, or which have been subjected to possible damage, shall be identified as nonconforming and removed from service until corrective measures have been taken. When M&TE l.s found to be out of tolerance, an evaluation shall be made and documented of the validity of previous inspection or test results and of the acceptability of items previously inspected or tested.

12.4 Records are maintained to demonstrate conformance to M&TE requirements and to identify the calibration status of each device. These records are filed to provide ready retrievability and contain sufficient QA-AD-001 REV.11 PAGE 22 '

Information for traceability to the individual piece of equipment to which it applies. Calibration records shall also contain the identificailon of the persons and company performing the calibration, calibration data inciw'50 th: 6 equipment used, calibration interval, date of the last calibration, when the next calibration is due, and any limitations on equipment use.

13.0 HANDLING. STORAGE ANDfWLPPING 13.1 Measures used to control packaging, shipping, storage and handling of components and material to prevent damage or deterioration shall be documented to reflect contractual and CNS specified requirements.

13.2 Procedures and instructions shall be used for storage, preservation and packaging of shipment to protect the products from damage, loss, deterioration or substitut!on.

13.3 Transpori Casks 13.3.1 Transport cask handling and operation shall conform to the written handling and operating procedure for each licensed cask.

13.3.2 Prior to the shipment of a transport cask, conditions of the NRC's Certificate of Compliance (specifications, tests, inspections) cha!! be satisfied. Required shipping papers shall be prepared and shall accompany the shipment.

13.3.3 Established safety restrictions concerning handling, storage and shipping shall be included in the handling and operating procedures for transport casks.

14.0 INSPECTION. TEST AND OPERATING STATUS 14.1 E.guipment Status 14.1.1 The inspection, test and operating status of important to Safety items shall be known at all times during manufacturing and operation.

14.1.2 Operating procodures shall inciude reporting requirements which establish the equipment status at key events (after unloading, prior to shipment, etc.).

14.1.3 Equipment status will be maintained by operating personnel who are responsible for inspection, test and operating activities.

QA-AD-001 REV.11 PAGE 23

o 14.2 Establishment of Examinations and Tests in-process and final examinations and tests shall be established to ensure conformance with documented instructions, procedures, drawings, rules and regulations.

14.3 Hold Points The procurement documents, drawings, quality plans and transportation and operating procedures shall establish any required mandatory hold points which shall be reflected in the fabrication or operation schedule.

Hold points shall be designated points in the fabrication or operation schedule beyond which the operations shall not proceed without the concurrence of Quality Assurance because of witnessing, examination or testing requirements.

14.4 Check Lists of Examinations. Tests and Inspections Preparod 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 examination, test or inspection and for witness signatures, initials or stamp and date for activities witnessed.

14.5 Examination of Process Status Measures shall be established to indicate during receiving, fabrication and equipment operation the status of examinations and tests performed on items, systems and components that are important to Safety. These measures shall provide identifications of those items which conform to examination and test requirements and those that do not conform.

14.6 Inspection Status 14.6.1 CNS inspection stamps, initials or signatures shall be applied to documentation for importan' fo Safety materials, items, systems and components to indicate the inspection status and to provide traceability to the individual performing the inspection.

14.6.2 A tag indicating the inspection status shull normally be applied directly to the item which has been examined.

14.7 Control of Inspection Stamos inspection stamps shall be serialized for traceability to the individual inspector. Quality Assurance shall control and issue inspection stamps, QA-AD-001 REV.11 PAGE 24

\\

as required, to authorized personnel. Stamps removed from service because of loss, employee termination, etc., shall be retired.

15.0 NONCONFORMING MATERIALS. PARTS OR COMPONENTS Procedures for control of nonconforming materials, parts or components that are Important to Safety ensure that such materials are adequately identified and segregated from acceptable materials, if feasible, to preclude their inadvertent USe.

15.1 Internal Nonconformances CNS Important to Safety materials, parts and components which are determined to be discrepant shall be identified, reported, and, when feasible, physicclly separated from acceptable items. The method of identification shall clearly describe the nature of the defect.

Nonconformance reports shall be forwarded to the designated department (s) for disposition. A holding area with controlled access shall be provided when necessary for material and/or component segregation.

Nonconformance reports shall indicate the nature and extent of the discropancy and the disposition.

15.2 Vendor Nonconformance ContLol Vendors providing important to Safety items shall promptly notify CNS of deviations from the procurement requirements, such as deviations from the required codes or approved drawings. A nonconformance report shall be initiated by the subcontractor in accordance with the vendors quality assurance program. After detection of the deviation, further fabrication shall not be performed until the nonconform*nce has been resolved in accordance with the vendors program and procurement documents. The vendor shall supply records of nonconformance reports dispositioned l

" accept as is" or " repair" as required by the procurement documents.

These reports shall be made part of the inspection records and forwarded with the hardware to CNS for revia and assessment.

15.3 Verification of Rework or Repair Acceptability Acceptability of rework or repair of important to Safety materials, parts, components, systems and structures shall be verified by reinspection and/or rotesting the item to the original criteria, or by a method which is at least equal to the original inspection and testing method. Inspection, testing, rework and repair records shall be documented and filed in CNS quality records files.

QA-AD-001 REV.11 PAGE 25

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15.4 Nonconformance Disposition The individuals or groups identifieo on nonconformance reports shall have the respor.sibility for disposition of nonconforming items. CNS Quality Assurance is responsible for concurring with and verifying implementation of the disposition of nonconformances. Technical justification shall be provided by qualified personnel for the acceptability of nonconforming items dispositioned as repair or use-as-is.

Nonconformances to design requirements dispositioned use-as-is or repelr are subject to design control measures commensurate with those appi;ed to the original design.

15.5

ss,e_ssment of Nonconformances Nonconformance reports shall be analyzed periodically to show quality fronds, and the results reported to CNS management for review and assossment 16.0 CORRECTIVE ACTIQ 11 16.1 Conditions adverse to quality (e.g., nonconformances, failures, malfunctions, deficiencies, deviations, defective materials, etc.) shall be evaluated to determine the need for corrective action iri accordance with established procedures.

16.2 Corrective action shall be promptly initiated when it is determined that a condition adverse to quality exists.

16.3 The corrective action shall include the following for significant conditions adverse to quality:

16.3.1 Investigation of discrepancy; 16.3.2 Determination of cause; 16,3.3 Corrective action to be taken; 16.3 4 Action to preclude recurrence.

16.4 The appropriate departments shall be assigned the responsibility for corrective actions. The results of corrective actions shall be documented.

l Quality Assurance or designee shall verify proper implementation of corrective action. Effectiveness of correctiva actions shall be tracked to identify trends adverse to quality. Significant conditions adverse to quality, the cause of such conditions, and the corrective action taken shall be reported to cognizant levels of CNS management for review and assessment.

OA AD-001 REV.11 PAGE 26 m

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16.5 When corrective action requests affect a CNS vendor, the vendor shall be required to provide the following infortration:

16.5.1 A description of factors contributing to the deficiency; 16.5.2 A description of conective actions taken. Action to prevent recurrence of the discrepancy in future production shall be identified for significant conditions adverse to quality.

17,0,0UALITY ASSURANCE RECORDS 17.1 Maintenance end Atcass to Records The record system maintained by CNS. Includes the retention of thoso design, fabrication, inspection and surveillance recosis essential to demonstrate product quality for important to Safety items and activities. It provides for the identification of materials and their corresponding manufacturing, installation, test and inspection records and cenificates.

Operating records maintained will include inspection, test and audit results. Records are maintained according to established procedures, are identifiable, and are readily retrievable.

17.2 Contents of Record Files 17.2.1 It is the policy of CNS that adequate records be maintained for important to Safety component and material inspections and tests. Inspection and test records shall contain the following, as applicable:

17.2.1.1 A description of the type of observation; 17.2.1.2 Evidence of completing and verifying a manufacturing, inspection or test operation; 17.2.1.3 The date and results of the inspection or test; 17.2.1.4 Information related to conditions adverse to quality; 17.2.1.5 Inspector or data recorder identification; 17.2.1.6 Evidence as to the acceptability of the results; 17.2.1.7 Identification of the procedure (s) and revision (s) used.

1 OA-AD-001 REV.11 PAGE 27

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17.2.2 Records shall also be maintained of vendor and subcontractor quality assurance reviews, surveillances and audits, and documents pertaining to CNS internal quality assurance audits.

The files shall also contain procedures and specifications written for a specific project.

17.3 Lifetime Records Lifetime fue records shall include, as'a minimum: design specifications, stress reports or stress calculations, "as built" and interface control drawings, copies of material test reports, tabulation of materials for "as built" configuration, nondestructive examination reports, including examination resultc, and nonconformance reports. Lifetime record ietention is based on the life of the program, life of the item, life of the facility, or life of the license, as applicable.

17.3.1 OA Records for Packaaina and Transportation of Radioactive Materials OA Records for packaging and transportation of radioactive materials include instructions, procedures, drawings and closely related specifications such as required qualifications, procedures and equipment. These records will be maintained for three years beyond the date CNS last engages in the packaging and transportation of radioactive materials.

Superseded procedures or instructions are retained for a minimurr. of three years after the procedure or instruction is superseded.

17.3.2 OA Recoras for Independent storace of Spent Nuclear Fuel and Hiah Level Waste.

QA Records pertairiing to the design, fabrication, erection, testing, maintenance and use of structures, systems, and components important to Safety are retained for the life of the license or until turned over to the licensee for maintenance.

17.4 Non. Permanent Records All non-permanent records required to verify compliance with the applicable codes and the vendor's or subcontractor's Quality Assurance Prograrn shall be maintaine d until project completion, unless otharwise stipulated.

QA-AD-001 REV.11 PAGE 28

<Y 17.5 Record Storaoe Facilities Record storage facilities shall be constructed, located and/or secured to prevent destruction of records by fire, flood, theft, and deterioration. As an alternative duplicate sets of documentation may be maintained in separate locations.

18.0 AUDITS Planned audi9 shall be performed to provide comprehensive, independent verification and evaluation of the CNS or vendor activity being audited. The audit scope shall encompass evaluation of quality system practices and/or procedures and the effectiveness of their implementation, monitoring of operations and activities, and a review of pertinent documents and their control and maintenance. Checklists or procedures shat! be used when conducting an audit.

18.1 Audit Schedule Internal 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 indicated by the existence of chronic problems. Vendor audits, when required, shall be conducted at least once every 36 months.

18.2 Audit Personnel Audits shall be performed by CNS 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.

Representatives from various CNS departments may be cal!sd upon for technical advice or assistance.

18.3 Audit Reports 18.3.1 A verbal presentation of the findings, conclusions and recommendations of the audit shall be made to management personnel affected by the audit.

18.3.2 A written report containing the findings and recommendations (if any) presented in the verbal report is prepared and distributed to the responsible divisions and appropriate management.

18.3.3 Audits shallinclude an assessment of the effectiveness of the Quality Assurance Program implementation.

QA-AD-001 REV.11 PAGE 29

,y 18.4. ' Audit Follow-Up o

18.4.1 The originator of an audit report or a designated alicmate is required to follow an open finding until action is taken to correct the deficiency.. Follow-up actions _are taken to verify corrective actions are implemented and effective.

g 16.4.2-Responsible management personnel shall evaluate each audit -

report item and correct deficiencies as promptly as possible after they are identified.

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APPENDIX A CNS ORGANIZATION (1 PAGE)

QA-AD401 REV.11 PAGE 31

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Assurance "The General Manager, Quality Assurance has unencumbered access to the President of CNS for matters of quality.

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~ QA IMPLEMENTING PROCEDURES (TYPICAL)

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~ LIST OF QA lUPLEMENTING PROCEDURES (TYPICAL)

Criteria Document No.

Title 1.

Organization QA-AD-001 Quality Assurance Program II.

Qt'ality Assurance Program QA-AD-001 Quality Assurance Program CN-AD-001 Safety Review Board CN-AD-029 Personnel Training Policy and implemen*ation Procedure QA-AD-009 Quality Assurance / Quality Control Department Training

, 111.

Design Control EN-AD-001 Drawing Control Procedure EN-AD-C02 Engineering Design Control EN-AD-007 Preparation and Control of Engineering Specifications IV.

Procurement Document Control CN-AD-007 Purchasing Procedure QA-AD-003 Procurement Document Review V.

Instructions. Procedures and Drawings CN-AD-003 Procedure for document Preparation VI.

Document Control CN-AD-002 Document Storage and Control EN-AD-001 Drawing Control Procedure Vll.

Control of Purchased Material, Equipment and CN-AD-009 Receipt inspection Services QA-AD-007 Vendor Evaluation Procedure Vill. Identification and Control of Materials, Parts and CN-AD-009 Receipt inspection Components QA-AO-008 Equipcent Release Requireme.. s IX.

Control of Special Processes QA-AD-001 Quality Assurance Program (Additional activity specific procedures, instructions and drawings are prepared as appropriate.)

X.

Inspection CN-AD-009 Receipt inspection QA-AD-001 Quality Assurance Program QA-AD-009 Quality Assurance! Quality Control Department Training XI.

Test Control EN-AD-002 Engineering Design Control EN-AD-007 Preparation nd Control of Engineering Specifications QA-AD-001, REVISION 11 APPENDIX B, PAGE 1

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Criteria

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Document No.

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Control of Measuring and Test Equipment CN-AD-011 Control of Measuring and Test Equipment

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XIII. Handling, Shipping and Storage QA-AD-001 Quality Assurance Pro 0 ram (Additional activity specific procedures, instructions and drawings are prepared as appivpiste.)

XIV. Inspection. Test and Operating Status CN-AD-009 Receipt inspet20n QA-AD-001 Quality Assurance Program XV.

Nonconforming Materials, Parts and Components :

CN-AD-015 -

Nonconforming item and Corrective Action Procedure CN-AD-015 XVI. Corrective Action Nonconforming item and Corrective Action Procedure XVil. Quality Assurance Records CN-AD-002 -

Docunent Storage and Control CN-AD-008 Quality Assurance Records XVi!I. Audits QA-AD-011 Quality Assurance Audit Procedure QA-AD-009 QuaHty Assurance / Quality Control Department Training Fw L

QA-AD-OO1, REVISION 11 APPENDIX B, PAGE 2

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.J APPENDIX C GLOSSARY OF TERMS (3 PAGES)

OA-AD-001 REV.11 PAGE 33

< sd Glossary of Terms Acceptance Crfloria Specified limits placed on characteristics of an itein, process or service defined in codes, standards, or other requirement documents.

Audit A planned and documented activity performed to determine by investigation, examination, or evaluation of objective evidence the adequacy of and compliance with established procedures, inttructions, drawings, and other applicable documents, and the effectiveness of implementation. An audit should not be confused with surveillance or inspection activities performed for the sole purpose of process control or product acceptance.

Cerfi/icate of Conformance - A written statement, signed by a qualified party, certifying that items or services comply with specific requirements.

Cerfiticate of Compliance A written statement, signed by a qualified party, attesting that the items or services are in accordance with specified requirements and accompanied by additional Information to substantiate the statement.

Certification The act of determining, verifying, and attesting in writing to the qualifications of personnel, processes, procedures, or items in accordance with specified requirements.

Characterist5 Any property of attribute of an item, process, or service that is distinct, describable, and measurable.

Commercial Grade item - An item satisfying (a), (b) and (c) below; a.

Not subject to design or specification requirements that are unique to nuclear facilities; b.

Used in applications other than nuclear facilities; c.

Is to be oidered from the manufacturer / supplier on the basis of specifications set forth in the manufacturer's published product description (for example, catalog).

Computer Program A sequence of instructicas suitable for processing by computer. Processing may include the use of an assembler, compiler, interpreter, or translator to prepare the program for execution as well as to execute it.

Conditions Adverse to Quality-An all-inclusive term used in reference to any of the following: failures, malfunctions, deficiencies, defective items, and nonconformances. A significant condition adverse to quality is one whict', if uncorrected, could have a serious effect on safety or operability.

Corrective Action - Measures taken to rectify conditions adverse to quality and, where necessary, to preclude recurrence.

Design Change - Any revision or attoration of the technical requiremerits defined by approved and issued design output documents and approved and issued changes thereto.

Design Input-Those criteria, parameters, bases or other design requirements that are the basis for final design.

Design Process - Technical and management processes that commence with identification of design input and that lead to and include issuance of design output documents.

Deviation - A departure from specified requirements.

GA# -001, REVISION 11 APPENDIX C, PAGE 1

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,,e.4 Documentation Any written or pictorial information describing defining, specifying, reporting, or certifying activities, requirements, procedures, or results. A document is not considered a Quality Assurance Record untilIt satisfies the definition of a Quality Assurance Record.

Extema/ Audit-An audit of thos9 portions of another organizations quality assurance program not under the direct control or within the organizational structure of the auditing organization.

Final Design - Approved design output documents and approved changes thereto.

Guideline - A suggested practice that is not mandatory in programs intended to cornply with a standard, important to Safety - ltems and activitics necessary to assure that Radioactive Waste is received, handled, packaged, stored, processed, or dispos 9d, without undue risk to the health and safety of the public or the environment. This includes those I; ems identified as Safety Related, hspector-A person who performs inspection activities to verify conformance to specified requirements.

Inspection - Examination or measurement to verify whether an item or activity conforms to specified requ;rements.

Intemal Audit - An audit of those portions of an organizations quality assurance program retained under its direct control and within its organizational structure, item. An all inclusive term used in place of any of the following: appurtenance, assembly, component, equipment, material, module, part, structure, subassembly, subsystem, system or unit.

May-Denotes an option.

Measuring and Test Equipment - devices or systems used to calibrate, measure, gage, test or inspect in order to control or acquire data to verify conformance to specified requkements.

Nonconformance - A deficiency in characteristic, documentation, or proce< e inat renders the quality of an item or activity unacceptable or indeterminate.

Objective Evidence - Any documented statement of fact or other information or record, either queohtative or qualitative, pertaining to the quality of an item or activity, based on observations, measurements, or tests which can be verified.

Procedure - A document that specifies or describes how an activity is to be performed.

Procurement Document - Purchase requisitions, purchase orders, drawings, contracts, specifications, or instructions used to define requirements for purchases.

Purchaser-The organization responsible for establishment of procurement requirements and for issuance, administration, or both, of procurement documents.

Qualifications (Personnel)- The characteristics or abilities gained through education, training or experience, as measured against established iequirements, such as standards or t. sts, that qualify an Individual to perform a required function.

Qualified Procedures - Approved procedures that have been demonstrated to meet the specified requirements for their intended purpose.

Quality Assurance (QA)- All those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service.

QA-AD-001, REVISION 11 APPENDIX C, PAGE 2

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Documentation - Any written or pictorial information describing defining, specifying, reporting, or certifying activities, requirements, procedures, or results. A document is not considered a Quality Assurance Record untilit satisfies the definition of a Quality Assurance Record.

Extemal Audit. An audit of those portions of another organizations quality assurance program not under the direct control or within the organizational structure of the auditing organization.

FinalDesign Approved design output documents and approved changes thereto.

Guldeline A suggested practice that is not mandatory in programs intended to comply with a standard.

Important to Safety ltems and activities necessary to assure that Radioactive Waste is received, handlod, packaged, stored, processed, or disposed, w nut undue risk to the health and safety of the public or the environment. This includes those items io.,ntified as Safety Related.

Inspector A person who performs inspection activities to verify conformance to specified requirements.

Inspection - Examination or measurement to verify whether an item or activity conforms to specified requirement Intemal Audit - An audit of those portions of an organizations quality assurance program retained under its direct control and within its organizational structure.

t&m-An allinclusive term used in place of any of the following, appurtenance, assembly, component, equipment, material, module, part, structure, subassembly, subsystem, system or unit.

May-Denotes an option.

Measuring and Test Equipment - devices or systems used to calibrate, measuru, gage, test or inspect it; order to control or acquire data to verify conformanos to specified rehulrements.

Nonconformanco - A deficiency in characteristic, documentation, or procedure that renders the quality of an item or activity unacceptable or indeterminate.

Objective Evidence Any documented statement of fact or other information or record, either quantitative or qualitative, pertalning to the quality of an item or activity, based on observations, measurements, or tests which can be verified.

Proc 6duro - A document that specifies or describes how an activity is to be performed.

Procurement Document - Purchase requisitions, purchase orders, drawings, contracts, specifications, or instructions used to define requ!rements for purchases Purchaser The organization responsible for establishment of procurement requirements and for issuance, administration, or both, of procurement documents.

Quahficaflons (Porsonnel) The characteristics or abilities gained through education, training or experience, as measured against established requirements, such as standards or tests, that qualify an individual to perform a required function.

Qualified Procedures - Approved procedures that have been demonstrated to meet the specified requirements for their iniended purpose.

Quality Assurance (QA)- All those planned and systematic actions necessary to provide adequate confidence that a structure, system or component will perform satisfactorily in service.

QA-AD-001 REVISION 11 APPENDIX C, PAGE 2

- Quality Assurance Record. A completed document that fumishes evidence of the quality of items and/or activities affecting quality.

Receiving-Taking delivery of an item.

Repair-The process of restoring a nonconforming characteristic to a condition such that the capability of Jan item to function reliably and safely is unimpaired, even though that item still does net conform to the original requirements.-

Rework-The process by which an item is made to conform to original requirements by completion or correction.

Right of Access The right of a Purchaser or designated representative to enter the premises of a Supplier for the purpose of inspection, surveillance or quality assurance audit.

Service The perfondance of activities such as design, fabrication, inspection, nondestructive examination, repair, remediation or installation.

Shall Denotes a requirement.

Should-Denotes a gu'ideline or recommendation.

Specla/ Process - A process whose resula are highly dependent on the control of the process or skill of the operators,'or both, and for which the specified quality cannot be readily determined by the inspection or test of the product.

Supplier-Any individual or organization or in'lividual who fumishes items or services in accordance with procurement documents. An all-inclusive term used in place of vendor, seller, contractor, subcontractor, fabricator, consultant or their subtler levels.

Surveillance - The act of monitoring, observing or otherwise verifying an item or activity conforms to specified requirements.

Testing-An element of verification for the determination of the capability of an item to meet spec;'ied requirements by subjecting them to a set of physical, chemical environmental or operating conditions.

Traceability-The ability to trace the history, application er location of an item and like items or a:,tivities by means of recordet* Identification.

Use-as-Is - A disposition permitted for a nonconforming item when it can be established that the item is satisfactory for its intended use.

Verification The act of reviewing inspecting, testing, checking, auditing, or otherwise determining and documenting whether items, processes, services or documents conform to specified requirements.

L Walver-Doctimented authorization to depart from soecified requircments.

OA AD-001, REVISION 11 i

APPENDIX C, PAGE 3

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