ML20210J775
| ML20210J775 | |
| Person / Time | |
|---|---|
| Site: | 07100231 |
| Issue date: | 07/26/1999 |
| From: | Campbell R, Kozlowsky D, Mohundro M CHEM-NUCLEAR SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20210J774 | List: |
| References | |
| QA-AD-001, NUDOCS 9908050092 | |
| Download: ML20210J775 (38) | |
Text
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i CHEM-NUCLEAR SYSTEMS IN ADDITION TO ALL APPLICABLE CNS DOCUMENT CONTROL REQUIREMENTS, ANY PROPOSED CHANGE TO QA-AD-001 REQUIRES FORMAL US NRC APPROVAL IN ACCORDANCE WITH 10 CFR 71 OR A SIGNED STATEMENT BY THE SENIOR MANAGER, QUALITY / LICENSING WHICH JUSTIFIES THAT SUCH APPROVAL IS UNWARRANTED.
Revisions to this procedure must be evaluated per the requirements of SC DHEC License No. 097, Condition 12.
PRINTED OR TYPED SIGNATURE DATE NAME PREPARED BY:
/
f David S. Kozlowsky dw 7/26/99 REVIEWED BY:
Michael D. Mohundro 7/26/99 APPROVED BY:
Richard E. Campbell
[bM 7/26/99 SRB
' SIGNATURE ON FILE
~
APPROVAL:
DOCUMENT TITLE:
4 QUALITY ASSURANCE PROGRAM DOCUMENT NO.
REV.
PAGE QA-AD-001 12 1 of 32 l
HRS 288 M U??8 eat C
TABLE OF CONTENTS Paaa.N1 1.0 '
O R G A N I ZATI O N...........................................................................
'2.0 Q UALITY AS S U RANC E PROG RAM........................................................... 6
' 3.0 D E S I G N CO N TR O L........................................................................
4.0 PROCURE ME NT DOCUME NT CONTROL................................................ 10 5.0 INSTRUCTION
S. PROCEDURE
S AND DRAWINGS...................................11 1
6.G DOC U M E NT C O NTR O L.....................................................................
7.0 CONTROL OF PURCHASED MATERIAL. EQUIPMENT AND SERVICES.......13 8.0 IDENTIFICATION AND CONTROL OF COMPONENTS AND MATERIALS......16 9.0 CONTROL OF SPECI AL PROCESSES..................................................... 17 1
1 1
10.0 I N S P E CTI O N.................................................................................... )
I 11.0 TE ST C O NTR O L..................................................................................
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT................................ 21 13.0 H AN DLI NG. STORAG E AN D SHI PPI NG................................................. 2 2
-14.0 INSPECTION. TEST AND OPERATING STATUS....................................... 23 15.0 NONCONFORMING MATERIALS. PARTS OR COMPONENTS.................... 24 16.0 CO R R E CTIVE ACTI O N.......................................................................... 2 5 17.0 QU ALITY AS S U RAN C E R E COR DS.......................................................... 2 6 l
18.0 AUDITS..............................................................................................28 AP P E N D I X A...........................................................................................
AP P E N D I X B.................................................................................................. 3 l
AP P E N D IX C................................................................................................. 3 2j I
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QA-AD-001 REV.12 PAGE 2 1
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CHEM-NUCLEAR SYSTEMS POLICY STATEMENT ON QUALITY ASSURANCE
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lammersammmawmMgrarsumurramsnman Chem-Nuclear Systems, LLC (CNS) requires activities governed by regulations, licenses, certificates of compilance, or other quality / safety commitments to be conducted in accordance with the CNS Quality Assurance (QA) Program. CNS's QA Program is implemented through procedures, instructions and drawings. Adherence to this policy, the CNS QA Program and the implemerting 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, Aopendix B; 10 CFR 71, Subpart H; 10 CFR 72, Subpart G; NUREG 1293; and
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Mil-Q-9858A. The CNS QA Program and implementing documents provide the controls and responsibilities that assure compliance with these codes and standards.
The Senior Manager, Quality / Licensing has been delegated the responsibility and l
authority to develop and maintain the CNS QA Program and to verify effective implementation.
The objective of the CNS QA Program is to achieve reliable quality for activities that l
affect health and safety and assure full compliance with regulatory and customer j
requirements. This program provides assurance that the performance objectives and i
technical requirements will be met. The effective implementation of these measures has my full and unconditional support.
Regan E. Voit, President Chem-Nuclear Systems, LLC l
QA-AD-001 REV.12 PAGE 3
1.0 ORGANIZATION 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 overali 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 Barnwell Operations - Provides disposal services to generators l
of Low-Level Radioactive Waste in strict accordance with regulatory requirements. Provides waste processing services at Chem-Nuclear Consolidation Facility.
1.1.2 Service Operations - Provides engineering for CNS activities.
Manages large component projects and special projects.
Service operations provides the licensing expertise for CFR Part 71 transportation casks.
1.1.3 Commercial Operations - Provides transportation and waste processing services to generators of radioactive waste.
1.1.4 Regulatory Affairs - Provides regulatory compliance oversight to assure that CNS's activities comply with regulatory, permit and j
license requirements. Regulatory Affairs provides interface with j
regulatory agencies to ensure safe operations that comply fully with federal, state, and loca! regulations. In addition, the Regulatory Affairs department works closely with customers to l
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 applicable federal and state licensing requirements. This department interfaces with licensing agencies and provides them with technical information and requested support information.
Health Physics ensures radiation safety, as well as compliance with radiation control regulations. Health OA-AD-001 REV.12 PAGE 4
I Physics also has specific responsibilities for the review of t
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 achievement is verified by persons or organizations not directly responsible for performing the work.
1.3 The Senior Manager, Quality / Licensing has the overall responsibility for l
assuring effective establishment and maintenance of the QA program.
The Senior Manager, Quality / Licensing is supported by a staff of Quakty Assurance / Quality Control (OA/QC) personnel.
1.3.1 The Senior Manager, Quality / Licensing reports to the Vice l
President, Regulatory Affairs and has unencumbered accets to the President of CNS for matters of quality. The Vice President, Regulatory Affairs reports to the President of CNS. QA/OC l
1 personnel are provided sufficient autnority, responsibility, access to all work arecs and records, and the organizational freedom to function effectively without hindrance or reservation to:
identify quality problems, stop unsatisfactory work, and l
control further processing, delivery or installation of nonconforming items:
initiate, recommend, and approve solutions through corporate channels; verify implementation of solutions; and 1
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 Senior Manager, Quality / Licensing, and QA!OC personnelinclude prerequisite experience and/or required training Qualifications for the Senior Manager, Quality / Licensing include:
l A Bachelor's degree in a technical field or equivalent experience; At least ten years experience in quality assurance, engineering or mariufacturing; A working knowledge of applicable quality-related codes, standards, and regula*c,y requirements; QA-AD-001 REV.12 PAGE5
l The ability to prescribe, apply arid assess compliance with the applicable requirements.
1.4 Organizations other than CNS may be delegated tha 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 Senior Manager - Quality / Licensing, upon notification of need for further l
direction or resolution of QA 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 p;agram, the responsibility and authority of each organization is clearly established. Iriternal and external interfaces between organizations are documented in project specific plans or
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implementing procedures.
t 2.0 QUALITY ASSURANCE PROGRAM j
The Quality A.ssurance Program is comprised of those planned and systematic l
actions necessary to assure adequate confidence that CNS activities that are important to Safety w;Il be conducted in a satisfactory manner and that important j
to Safety equipment and material will penorm satisfactorily in service, important to Safety items and actWities 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 progrxn include, but are not limited to, weste and water processing equipment design, fabrication and operation; design, fabrication, maintenance and cperation of storage, disposal and transport j
containers; nozzio dam services; volume reduction (compaction cad processing j
services); waste transportation services; waste characterizauon.earvices; end low-level radioactive waste disposal site development and opermion. The requirements of this program are applied to an extent commensurate with the item's or activity's importance to Safety.
CNS uses the graded approach to establish vendor approval requkements for three quality levels. Quality Level I includes, as a minimum, all items and services critical to the safe operation of NRC licensed storage and transportation containers. Quality Level 11 includes important to Safety iterns and services that are not critical to safe operation of NRC licensed storage and transportation containers. Quality Level til applies to items and services procured as commercial grade. The quality level for individual items is established and maintained on a controlled Q-List.
QA-AD-001 REV.12 PAGE 6
F 2.1 Manaaement The President of CNS has the responsibility to ensure effective imp!ementation, assess the ccope and status, and determine the effectiveness of the QA Program. Programmatically these functions are accomplished through the use of audiis, field investigations (audits, inspections or survoillances), customer / user service reports, and intemal j
reporting procedures. This program is revie ved 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 appEcable regulatory requirements, procedures, policies, licenses, permits and certificates. The SRB is chaired by the Vice President, P.egulatory Affairs. SRB membership consists of CNS managament personnel providing expertise in engineering, operations, quality assurance, safety, ALARA, and other areas as needed. Members are designated by the SRB Chairrnan.
2.2 Personnel Qualification 3 j
Personnel assigned to perform quality functions are indoctrinated in accordance with SNT-TC-1 A, ANSI N45.2.6, NRC Regulatory Guide 1.58, l ASME NOA-1 or other applicable documents. Indoctrination and training is 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; j
2.2.2 CNS personnel performing !mportant to Safety activities are trained in the principles and techniques of the activity being performed; 2.2.3 Tha scope, objective and the method of implementing indoctrination and training ere documented; i
2.2.4 Proficiency of personnel perform.'ng important to Safety activities l
shall be monitored and documented on a periodic basis.
2.3 Quality Assurance Policies. Goals and Objectivec 2.3.1 It is the poficy of CNS that all activities which are govemed by the Code of Federal Regulations, licenses, Certificates of Compliance, or other regulatory requirements, be conducted in accordance with written, approved procedurcs or instructions I
which incorporate the regulatory requirements in a manner QA-AD-001 REV.12 PAGE 7
which is easily understood by the user. Important to Safety activities shall be performed with cpecified equipment under suitable environmental conditions and prerequisites shall be satisfied prior to inspection, operation or testing. Adherence to the procedure requirements is mandatory for all CNS activities.
New procedures affecting health and safety are required to be submitted to the Safety Review Board for approval prior to implementation.
Appendix B provides a typicallist of procedures that govern the implementation of this program. Appendix B is current at the
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time ofissuance 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 drawings, procedures and instructions.
2.3.3 Differences of opinion between QA personnel and other CNS departments shall be resolved by the Senior Manager, Quality / Licensing.
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 10 CFR 71, Subpart H: 10 CFR 72, Subpart G; 10 CFR 50, Appendix B; and NOA-1.
l 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.
l 3.2 A comprehensive system of established procedures and instructions is used for developing and implementing design projects, as weii as controlling design documents (drawings) and design document distribution.
QA-AD-001 REV.12 PAGE 8
3.3 CNS Service Operations is responsible for the selection and control of l
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 perforrn its intended function, that regulatory f
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 contro!ied, 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 design errors 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 procurernent documents specify design base requirements including the applicable regulatory requirements, material and component requirements, drawings, specifications, codes and industry standards, test and inspection criteria, and special process instructions, items are reviewed for suitability prior to selection.
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 QA-AD-001 REV.12 PAGE 9
i same groups or organizations responsible for review and approval of
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original design documents.
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3.7 CNS design control procedures ensure that only current copies of design output documents are used.
l 3.8 Computer programs (whether generated, transferred to, or purchased)
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used to calculate or develop quality related data shall be subject to I
accumented verifications or validations. Computer programs (mc ! e used for design analysis without individual verification of the pro; gam for each application provided:
i 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 previously 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 record keeping procedures. The sequence of events leading to Purchase Order issuance, and the associated record keeping activities are 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:
4.3 1 The applicable NOA-1: 10 CFR Part 50, Appendix B; 10 CFR 71, Subpart H; and 10 CFR 72, Subpart G requirements which must be addressed; QA-AD-001 REV.12 PAGE 10
4.3.2 The design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, tests and inspection requirements, and special j
process instructions;
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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 or 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 preceding paragraph. One copy of quality 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 applied to the original equipment. Changes and revisions to procurement documents are subject to the same review process as original documents.
4.6 Original and revised procurement documents shall be clearly annotated to indicate the completion of the aforementioned review and approval i
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 criterie for determination that the prescribed activities have been satisfactorily performed. The activities are accomplished in accordance with the instructions, procedures or drawings.
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.
QA-AD-001 REV.12 PAGE 11
5.3 Procedures, instructions and drawings are prepared, reviewed and l
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 to safety activities are trained to assure incorporation 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 Tvoes Controlled Controlled Documents include, but are not limited to, procedures, plans, design drawings, specifications, and instructions.
6.2 Document Control l
6.2.1 Execution of an effective document control system requires the l
following:
6.2.1.1 Each document shall have an identifying number and l a descriptive title.
6.2.1.2 Each document shall have means for identifying the l
revision status and the effective date of each revision.
6.2.2 Controlled documents are distributed in accordance with a j
document distribution list.
Obsolete documents are removed from work locations or l
identified as obsolete to preclude their use in important to Safety activities. History copies of obsolete procedures are maintained in the document files.
6.2.3 Procedures and their changes are distributed on a formal basis l
and are of standard format.
6.2.4 When distributed, drawings and/or documents are accompanied l by a document transmittal letter showing the drawing and/or document number, revision and date of transmittal.
QA-AD-001 REV.12 PAGE 12 -
6.2.5 Purchase orders for manufacturing projects are amended to l
indicate the affect of engineering changes. On completed i
projects, as-built drawings and documents are maintained in the project file.
6.3 Document Availability l
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.
Commercial Grade items may be procured and dedicated for important to Safety application. Service Operations shall identify the critical characteristics and the l
method (s) (e.g., special tests and inspections, commercial supplier survey, 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 dedication.
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i 7.1 Vendor Evaluation j
7.1.1 CNS Service Operations, Procurement, and Quality Assurance l
personnel participate, as appropriate, in evaluation of procurement sources. Recommendations of procurement sources are based on these evaluations. Results of vendor 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 of the following as appropriate:
l 7.1.1.1 Historical performance data, particularly in product quality and delivery; 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; QA-AD-001 REV.12 PAGE 13
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7.1.1.4 Source qualification programs or state / national / international accreditation.
l 7.1.2 Vendor evaluation considerations include the elements of the Nuclear Regulatory Commission's and other regulatory agency Quality Assurance Criteria to the extent these criteria are applicable to the items or services being procured.
7.2 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 j
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:
7.2.1 Special process procedures for performing welding, heat j
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 nonconformance and associated disposition; l
1 7.2.5 Test procedures in accordance with applicable codes and j
standards.
7.3 Vendor Surveillance I
7.3.1 CNS QA/QC is responsible for conducting and documenting l
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:
QA-AD-001 REV.12 PAGE 14
i 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.
7.3.2 The documentation package for purchased items is reviewed by QA/QC or their qualified designee prior to release of the items l
for shipment and/or use. This documentation may inc!ude material test reports, inspection and test reports, NDE reports and applicable code data reports.
7.3.3 The frequency and extent of surveil ances 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 identif;ed and correspond to the receiving documentation; 7.4.2 Inspection records or certificates of conformance/ compliance l
attesting to the acceptance of items are available; 7.4.3 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 further work.
7.4.4 Physical attributes comply with specified requirements.
7.5 Vendor Evaluation and Audit A documented evaluation is required annually for vendors maintained on the Approved Vendors List. Vendor audits, when required, shall be OA-AD-001 REV.12 PAGE 15
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 11 vendors may be qualified based on one or more of the following methods:
audit or surveillance of the vendor's facilities and implementation of an l acceptable QA Program.
evaluation of historical performance.
evaluation of current quality records.
Quality Level 111 (commercial grade) vendors do not require qualification.
7.6 Vendor Performance Trendina The results of vendor audits, evaluations, surveillances and inspections l
are tracked and trended to assure any trends adverse to quality are identified and corrected.
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
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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 i
status is not changed without the concurrence of CNS OA or their qualiiled designee.
8.1.2 Identification ofitems shall be accomplished by a method that will provide legible identification without adverse effect on its life I
and utility.
8.1.3 Items not suitable for individual markir.g shall be individually tagged, placed in an identified container, or otherwise segregated.
8.1.4 Surveillance shall be maintained over the storage areas to l
assure that materials subject to certification control or age limit QA-AD-001 REV.12 PAGE 16 L
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 impodant to safety bulk raw l
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 pad 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.
All markings shall effer ready readability and prompt identification of the material. Physical marking of material shall be accomplished in a manner which will not adversely affect the machining, forming, fabrication or performance of the material.
8.3 Identificatior.
Identification requirements shall be determined during generation of specifications and design drawings. Identification of materials and 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 physicai and chemical mill test reports.
9.0 CONTROL OF SPECIAL PROCESSES Fabrication, installation and inspection processes which have an effect upon the 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 special processes and operations 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 QA-AD-001 REV.12 PAGE 17
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.
1 9.2 Subcontractor Control Special processes performed by CNS's subcontractors and vendors shall be specified in procurement documents.
l 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.
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.
10.2 Equipment modifications, repairs and replacement are inspected in accordance with the original design and inspection requirements unless
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an approved alternative exists. Provisions for mandatory inspection hold point identification requiring witnessing by the inspector are incorporated in the appropriate 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; QA-AD-001 REV.12 PAGE 18
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 insnection CNS identifies inspection requirements in procurement documents issued to subcontractors and vendors for important to Safety items or services.
The subcontractors and vendors are responsible for inspection of their products, and CNS Quality Assurance verifies their controls to assure adequacy of inspection. Vendor documents (procedures, instructions, drawings, etc.) are required to recognize those CNS notification or hold points specified by procurement documents.
10.6 Indirect Contr_oj 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.
i 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 j
with written test procedures or instructions, which incorporate the requirements and acceptance limits specified by the applicable design dccuments.
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 inclusion of the following quality assurance requirements, as applicable:
11.1.1.1 Requirements and acceptance limits as contained in the applicable design documents; QA-AD-001 REV.12 PAGE 19
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11.1.1.2 Detailed instructions for performing the test;
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11.1.1.3 Test prerequisites, including, but nut limited to the following:
Calibrated instrumentation; Adequate and appropriate equipment; l
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Trained, qualified, and as appropriate, licensed and/or certified personnel; Preparation, condition and completeness of the item to be tested; l
Suitable and, if required, controlled environmental conditions.
1 11.1.1.4 Mandatory inspection hold points for witness by i
responsible individus!;
11.1.1.5 Acceptance and rejection criteria; 11.1.1.6 Method for documenting or recording test data and results; I
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 witness, if so required. Test records shall be retained.
QA-AD-001 REV.12 PAGE 20
i 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 stipulate 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 QA/QC surveillance, evaluation, or audit. Records of l
tests are reviewed for acceptability.
11.4 Modifications. Repairs and Replacernents I
Modifications, repairs and replacements shall be tested in accordance with the original design and test requirements or acceptable alternatives approved in the same manner as the original.
12.0 CONTROL OF MEASURING AND TEST EQUIPMENT Measuring and test equipment (M&TE) with the necessary range and accuracy l
shall oe provided to qualified personnel for the inspection, test and acceptance of material, parts, components and systems. Equipment accuracy shall be ensured by calibration traceable to national standards or a documented alternate basis for calibration.
12.1 CNS'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 experience and operational requirements.
12.1.2 Each item of M&TE shall be serialized for record and l
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 impractical, the label or tag may be placed on the M&TE container. A status file shall be maintained for all l
calibrated equipment.
12.1.3 M&TE shall be transported, stored, and calibrated in an l
environment which will not adversely affect its accuracy. M&TE may be issued to and retained between calibrations by those requiring its use. Each user has the responsibility to ascertain, prior to use, that the M&TE calibration date has not expired and l
that damage or rework has not taken place since the last calibration.
QA-AD-001 REV.12 PAGE 21
12.2 Measurina and Test Eauipment at Subcontractors M&TE used by subcontractors and vendors engaged in fabricating and l
furnishing 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 is found to be out of tolerance, an evaluation shall be made and l
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 l
records are filed to provide ready retrievability and contain sufficient information for traceability to the individual piece of equipment to which it applies. Calibration records shall also contain the identification of the persons and company performing the calibration, calibration data including the test equipment used, calibration interval, date of the last j
calibration, when the next calibration is due, and any limitations on equipment use.
13.0 HANDLING. STORAGE AND SHIPPING 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 substitution.
13.3 Transport 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) shall be satisfied. Required shipping papers shall be prepared and shall accompany the shipment.
OA-AD-001 REV.12 PAGE 22
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 1
14.1 Eauioment Status i
14.1.1 The inspection, test and operating status of important to Safety
{
items shall be known at all times during manufacturing and operation.
j 14.1.2 Operating procedures shall include 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 personnel who are l
responsible for inspection, test and operating activities.
14.2 Establishment of Examinntions 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, qua'ity 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 OA/QC because of witnessing, examination or testing l
requirements.
l 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 examination, test or
)
inspection and for witness signatures, initials or stamp and date for J
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 OA-AD-001 REV.12 PAGE 23
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 Important to 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 shall normally be applied directly to the item which has been examined.
j j
14.7 Control of Inspection Stamos inspection stamps shall be serialized for traceability to the individual 1
inspector. QA/QC shall control and issue inspection stamps, as required, l
to authorized personnel. Stamps removed from service because ofloss, 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, physically 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 i
be provided when necessary for material and/or component segregation.
Nonconformance reports shall indicate the nature and extent of the discrepancy and the disposition.
15.2 Vendor Nonconformance Control Vendors providing important to Safety items shall promptly notify CNS of deviations from the procurement requirements, such as deviations from the required coaes or approved drawings. A nonconformance report shall be initiated by the subcontractor in accordance with the vendor's quality assurance program. After detection of the deviation, further fabrication QA-AD-001 REV.12 PAGE 24
i shall not be performed until the nonconformance has been resolved in accordance with the vendor's program and procurement documents. The vendor shall supply records of nonconformance reports dispositioned
" accept as is" or " repair" as required by the procurement documents.
These reports shall be made part of the inspection records and forwarded i
with the hardware to CNS for review and assessment.
I 15.3 Verification of Rework or Repair Acceptability j
Acceptability of rework or repair of important to Safety materials, parts, components, systems and structures shall be verified by reinspection and/or retesting 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 accumented and filed in CNS quality records files.
15.4 Nonconformance Disposition The individuals or groups identified on nonconformance reports shall have the responsibility for disposition of nonconforming items. CNS QA/QC is l
responsible for concurring with and verifying implementation of the disposition of nonconformances. Technicaljustification shall be orovided by qualified personnel for the acceptability of nonconforming ite dispositioned as repair or use-as-is. Nonconformances to der requirements dispositioned use-as-is or repair are subject to A. jn control measures commensurate with those applied to the original design.
15.5 Assessment of Nonconformances Nonconformance reports shall be anal'/ zed periodically to show quality trends, and the results reported to CNS management for review and assessment.
16.0 CORRECTIVE ACTION 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 in 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; OA-AD-001 REV.12 PAGE 25
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.
QA/QC or designee shall verify proper implementation of corrective l
action. Effectiveness of corrective 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.
16.5 When corrective action requests affect a CNS vendor, the vendor should l
be required to provide the following information:
16.5.1 A description of factors contributing to the deficiency; 16.5.2 A description of corrective actions taken. Action to prevent recurrence of the discrepancy in future production shall be identified for significant conditions adverse to quality.
17.0 QUALITY ASSURANCE RECORDS 17.1 Maintenance and Access to Records The record system maintained by CNS includes the retention of those design, fabrication, inspection and surveillance records 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 certificates.
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; QA-AD-001 REV.12 PAGE 26
17.2.1.2 Evidenco 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.
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.
j The files shall also contain procedures and specifications written for a specific project.
17.3 Lifetime Records Lifetime file 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 results, and nonconformance reports. Lifetime record retention is based on the life of the program, life o"he item, life of the facility, or life of the license, as applicable.
17.3.1 QA Records for Packaaina and Transportation of Radioactive Materials QA Records for packaging and transportation of radioactive materials include instructions, procedures, drawings and closely related specifications such as required qualifications, procedure.
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 minimum of three years after the procedure or instruction is superseded.
)
i 17.3.2 OA Records for Independent storace of Spent Nuclear Fuel and Hiah Level Waste.
QA Records pertaining to the design, fabr: cation, erection, testing, maintenance and use of structures, systems, and QA-AD-001 REV.12 PAGE 27
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 Program shall be maintained until project completion, unless otherwise stipulated.
17.5 Record Storaae 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 dncumentation may be maintained in separate locations.
18.0 AUDITS Planned audits 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 shall 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 auditad. The audit personnel shall have the required level of technical capability to accomplish the audit functions.
Representatives from various CNS departments may be called upon for technical advice or assistance.
QA-AD-001 REV.12 PAGE 28
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 resnonsible divisions and appropriate management.
18.3.3 Audits shallinclude an assessment of the effectiveness of the Quality Assurance Program implementation.
18.4 Audit Follow-Up 18.4.1 The originator of an audit report or a designated alternate 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.
18.4.2 Responsible management personnel shall evaluate each audit report item and correct deficiencies as promptly as possible after they are identified.
I QA-AD-001 REV.12 PAGE 29 1
I i
i APPENDIX A CNS ORGANIZATION (1 PAGE) i QA AD-001 REV.12 PAGE 30
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APPENDlX C GLOSSARY OF TERMS (3 PAGES) i QA-AD-001 REV.1?
PAGE 32
i i
Glossary of Terms Acceptance Criterla - Specified limits placed on characteristics of an item, process or ser/ce 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, instructions, 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, i
Certificate of Conformance - A written statement, signed by a qualified party, certifying that items or services comply with specific requirements.
Certificate of Compliance - A written statement, signed by a qualified party, stiesting that the items or services are in accordance with specified requirements and accompanied by additionot information to substantiate the statement.
Certification - The act of determining, verifying, and attesting in writing to the quakfications of personnel, processes, procedures, or items in accordance with specified requirements.
Characteristic 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 ordered from the manufacturer /supp!ier on the basis of specifications set forth in the manufacturer's published product description (for example, catalog).
Computer Program - A sequence of instructions 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.
I
' Conditions Adverse to Quality-An all-inclusive term used in reference to any of the fobowing: failures, malfunctions, deficiencies, defective items, and nonconformances. A significant condition adversa to quality is one which, 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 alteration of tne technical requirements 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 end include issuance of design output documents.
i i
OA-AD-001, REVISlON 12 APPENDIX C, PAGE 1 i
Deviation - A departure from specified requirements.
. 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 those portions of another organizations quality assurance program not under the direct control or within the organizational structure of the auditing organization.
FinaIDocign - Approved design output documents and approved changes thereto.
Guldeilne A suggested practice that is not mandatory in programs intended to comply with a standard.
important to Safety - items and activities necessary to assure that Radioactive Waste is received, handled, packaged, stored, procesced, or disposed, without undue risk to the health and safety of the public or the environment. This includes those items identified as Safety Related.
inspector-A person who performs inspection activities to verify conformance to specified requirements.
Inspecilon - Examinat;on or measurement to verify whether an item or activity conforma to specified i
requirements.
1 Intemat Audit - An audit of those portions of an organizations quality assurance program retained under its direct control and within its organizationa! structure.
j
. tem - An all inclusive term t. sed in place of' any of the following: appurtenance, assembly, component, I
equipment, material, module, part, structure, subassembly, subsystem, system or unit.
May-Denotes an option.
Measuring and Test Equip.nent devices or systems used to calibrate, measure, gage, test or inspect in order to control or acquire data to verify conformance to specified requirements.
Nonconformrnce - A deficiency in characteristic, documentation, or procedure that renders the quality of an item or cctivity unacceptable or indeterminate.
Objective Evidence - /my documented f.tatement of fact or other information or record, either quantitative or qualitative, pertaining to the quaey uf an item or act,vity. sesed on observetions, measurements, or tests which can be verified.
Procedure - A document that specifies or describes how an activity is to be performed.
Procuremonf Documonf - 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 procurernent documents.
Qualifications (Personnel) - The characteristics or abilities gained through education, training or experierice, as measured against establish.d requirements, such as standards or tests, that quahfy an individual to perform a required function.
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Qualified Procedures - Approved procedures that have been demonstrated to meet the specified requirements for tlicir intended purpose.
Quality Assurance (OA)- All those planned and systematic actions necessary in provide adequate confidence that a structure, system or component will perform satisfactorily in service.
Quality Assurance Record-A completed document that furnishes 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 an item to function reliably and safely is unimpaired, even though that item still does not 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, survellance or quality assurance audit.
Service - The performance of activities such as design, fabrication, inspoction, nondestructive examination, repair, remediation or installation.
Shall-Dono!es a requirement.
Should-Denotes a guideline or recommendation.
Specia/ Process - A process whose results are highly dependent on the contro! raf 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.
Supp/!er-Any individual or organization or individual who furnishes items or services in accordance with procurement documents. An all-inclusive term used in place of vendor, seller, contractor, subcontractor, fabricator, consultant or (neir subtier levels.
Suiveillance - The act of monitoring, observing or otherwise verifying an item or activity conforms to specified requirements.
Testing-An eWnent of verification for the determination of the capability of an item to meet specified requirements t*y subjecting them to a set of physical, chemical environmental or operating conditions.
Traceability-The ability to trace the history, application or location of an item and like items or activities by means of recorded identification.
f)se-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.
Waiver Documented authorization to depart from specified requirements.
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