ML19289D950
| ML19289D950 | |
| Person / Time | |
|---|---|
| Site: | Beaver Valley, 07100275 |
| Issue date: | 02/23/1979 |
| From: | DUQUESNE LIGHT CO. |
| To: | |
| Shared Package | |
| ML19289D949 | List: |
| References | |
| NUDOCS 7903210004 | |
| Download: ML19289D950 (36) | |
Text
'
l DUQUESNE LIGHT COMPANY Beaver Valley Power Station, Unit No. 1 Operating License DPR-66 Solid Radioactive Waste Packaging Quality Assurance Progran 7 9 0 3 210C'k
PREFACE This Solid Radioactive Waste Packaging Quality Assurance Program has been established by Duquesne Light Company for the packaging and shipment of solid radioactive waste at its nuclear facilities. Duquesne Light Company, as operator and owner, recognizes its responsibility to ship solid radioactive waste with due regard for the health and safety of its employees and the general public. The handling and shipment of solid radioactive waste may involve large quantities of radioactive materials and high levels of radiation. In response to the need for safety in shipping radioactive materials, numerous standards and regulations for the packaging and shipment of solid radioactive waste have been developed by national standards groups and regulatory agencies. The Solid Radioactive Waste Packaging Quality Assurance Program is a specific application of the general provisions of the Duquesne Light Company Quality Assurance Program and is responsive to the applicable standards and regulations. The program is specifically designed to ensure compliance with the provisions of Appendix E to 10 CFR Part 71, " Quality Assurance Criteria for Shipping Packages for Radioactive Mater-ial", Regulatory Guide 1.33, " Quality Assurance Program Requirements (Opcr-ations)", (( and Regulatory Guide 7.XX, " Establishment of a Quality Assurance Program for Shipping Packages for Wast e")).
The Solid Radioactive Waste Packaging Quality Assurance Program has been instituted as an independent program within the Health Physics group. Personnel within this group have the level of technical expertise necessary to adequately evaluate the quality of the Solid Radioactive Waste Management Program. This Solid Radioactive Waste Packaging Quality Assurance Program document defines the requirements and specific responsibilities for implementing and administering the program.
This Solid Radioactive Waste Packaging Quality Assurance Program shall be applied to all safety related operations involving the packaging and shipment of solid radioactive waste of Type B quantities. As used in this quality assurance program, a Type B package is defined as any package licensed and used for the shipment of Type B or greater quantities of solid radioactive waste.
Type B packages used for the shipment of Type A or lesser quantities are exempt from the provisions of this quality assurance program. The provisions of this program shall
be applied with a graded approach. The application to specific items and activities 5
shall be consistent with their importance to the safety for the operation being performed, or in the case of a subtask, to the task as a whole. Significant tasks for which the Solid Radioactive Waste Packaging Quality Assurance Program applies are the handling, design, shipping, storage, cleaning, inspecting, modifying, and maintenance of shipping packages.
This quality assurance program is not generally applicable to the design, construct-ion, repair, modification, inspection, testing, or operation of installed radioactive waste systems, unless those functions have an adverse effect on the quality of the packaged radioactive waste.
Duquesne Light Company personnel act in accordance with the applicable require-ments of the Solid Radioactive Waste Packaging Quality Assurance Program, as contained in the Radiological Controls Manual and the DLC QA/QC Manual.
Management shall give full support to maintaining an effective quality program.
Contracts between Duquesne Light Company and vendors who supply Type B packaging, materials, and services designated as important to safety shall specify requirements of applicable provisions of the Solid Radioactive Was'2 Packaging Quality Assurance Program.
1.0 QUALITY ASSURANCE ORG ANIZATION 1.1 INTRODUCTIO N Duquesne Light Company has a Quality Assurance organization which is charged with the responsibility for implementation and administration of the overall Quality Assurance Program at its nuclear facilities. This program is applicable to all safety related structures, systems, components and operations performed at the nuclear facilities operated by Duquesne Light Company.
The handling and shipment of solid radioactive waste, in Type B containers, are specific operations important to safety within the scope of the Duquesne Light Company Quality Assurance Program.
In order to ensure that quality assurance functions, especially audit and review, will be performed by individuals with an adequate level of technical expertise in the handling and shipment of Type B quantities of radioactive waste, an indepen-dent Solid Radioactive Waste Packaging Quality Assurance Program has been instituted through applicable procedures in the Beaver Valley Power Station Radiological Controls Manual and the DLC QA/QC Manual.
1.2 POLICY 1.2.1 The quality assurance functions performed by the Solid Radioactive Waste Packaging Quality Assurance organization or delegated to outside organizations shall be identified and described in written procedures. The lines of communications between the Solid Radio-active Waste Packaging Quality Assurance organization and principal vendors and/or operating groups within Duquesne Light Company, shall be identified and described in written procedures.
1.2.2 The overall authority and responsibility for the Solid Radioactive Waste Packaging Quality Assurance Program is vested in the Beaver Valley Power Station Superintendent, who has the authority and independence necessary to direct and control the program and to assure the conformance to quality standards.
1
1,.3 IMPLEM ENTATION 1.3.1 The Radiation Protection Manager, or an alternate designated by the Station Superintendent, shall have the authority and responsibility to direct and control the Solid IMdioactive Waste Packaging Quality Assurance Program. Ir, the exercise of his responsibility and author-ity, the Radiation Protection Manager shall assure conformance to accepted packaging and shipping standards, applicable provisions of various regulatory agencies having jurisdiction over the packaging of radioactive materials from nuclear facilities, and the policies and procedures of Duquesne Light Company. The Radiation Protection Manager, may delegate tasks in the Solid Radioactive Waste Pack-aging Quality Assurance Program to other individuals or organiz-ations, however, the Radiation Protection Manager shall retain responsibility for such delegated tasks. The Radiation Protection Manager, his designated alternate, individuals or organizations delegated tasks, shall not have direct responsibility for the work being verified.
1.3.2 The Radiation Protection Manager, for the purpose of quality assur-ance, reports to the Station Superintendent. The Solid Radioactive Waste Packaging Quality Assurance Program is subject to audit and review in accordance with the Duquesne Light Company Quality Assurance Program.
2
4 2.0 SOLID RADIOACTIVE WASTE PACKAGING QUALITY ASSURANCE PROGRAM
2.1 INTRODUCTION
The Solid Radioactive Waste Packaging Quality Assurance Program applies to all planned and systematic actions necessary to assure that a Type B shipping package, and the use of this Type B package, have the reliability on which the designed and safe performance of the package were based.
The Solid Radioactive Waste Packaging Quality Assurance Program also provides assurance that the shipment of radioactive waste, from the Beaver Valley Power Station, is performed in compli-ance with all applicable standards and regulations.
All significant activities performed within the scope of the Solid Radioactive Waste Packaging Quality Assurance Program shall be documented in written procedures.
2.2 POLICY 2.2.1 The scope, status, implementation, and effectiveness of the Solid Radioactive Waste Packaging Quality Assurance Program shall be periodically assessed to ensure that the program is adequate and continues to comply with the criteria of 10 CFR Part 71, Appendix E.
2.2.2 Operations and components important to safety within the scope of the Solid Radioactive Waste Packaging Quality Assurance Program shall be identified and described in written documents.
2.2.3 Authorized representatives of Duquesne Light Company, who request services of an outside organization for activities involving Type B packaging important to safety shall assure that the Duquesne Light Company Quality Assurance Department has ascertained that the quality assurance program of the outside organization meets all applicable provisions of the Solid Radioactive Waste Packaging Quality Assurance Program, in accordance with the policy of section 8.0 of the Solid Radioactive Waste Packaging Quality Assurance Program.
3
2.2.4 Responsibilities for the performance of the major activities specified in the Solid Radioactive Waste Packaging Quality Assurance Program shall be specified in written procedures. Individuals or organizations so designated shall have the authority and responsibility to stop unsatisfactory work.
Personnel designated to perform activities specified within this quality assurance program shall have the exper-ience, knowledge, aptitude, and other qualifications deemed neces-sary to adequately perform his designated activities. Provisions shall be made in this quality assurance program for the resolution of differences in opinion between quality assurance personnel and per-sonnel from other departments.
2.2.5 Provisions are made in applicable employee training programs for the instruction of personnel performing quality-affecting activities re-lated to the packaging and shipment of solid radioactive waste. Such training shall include:
2.2.5.1.
Instructions as to the purpose, scope, and implementation of the Solid Radioactive Waste Packaging Quality Assur-ance Program.
2.2.5.2 Principles and techniques of the activity to which they may be assigned.
2.2.5.3 Periodic retraining shall be documented.
2.2.6 Activities affecting quality shall be performed under suitably con-trolled conditions which include, as applicable, appropriate equip-ment, environmental conditions, and documented evidence that all prerequisites and requirements for performing the activity have been met.
Procedures, for the performance of these activities shall identify, as necessary, the requirements for special controls, pro-cesses, equipment, skills, and verification of quality by tests and/or inspections.
4
2.3 IMPLEMENTATION 2.3.1 The scope, implementation, and effectiveness of the Solid Radioac-tive Waste Packaging Quality Assurance Program shall be periodic--
ally assessed by the Radiation Protection Manager.
The scope, implementation, and effectiveness of the Solid Radioactive Waste Packaging Quality Assurance Program will also be assessed periodic-ally by quality assurance personnel.
2.3.2 Items and activities identified in this section shall be within the scope of the Solid Radioactive Waste Packaging Quality Assurance Program. These items and activities shall be subject to provisions which are applicable to quality affecting systems and/or components in the Solid Radioactive Waste Packaging Quality Assurance Program. These provisions shall be applied in a graded approach, ie.,
to the extent which is consistent to the radiological safety and performance of the Type B packaged waste. Designated items and activities are:
2.3.2.1 The procurement of packages, ancilliary materials, and/or services relevent to the packaging of solid radioactive waste.
2.3.2.2 The design, fabrication, assembly, testing, use, repair, storing, cleaning, inspecting, modifying, and maintenance of packages for the shipment of solid radioactive waste.
2.3.2.3 The processing of liquid waste streams prior to solidifica-tion, if the processing has an effect un the quality of the solidified waste.
2.3.2.4 The preparation of the waste for packaging, including, as necessary, solidification, encapsulation, or immobilization.
2.3.2.5 The determination or estimation of radionuclide composi--
tion and curie content.
5
1
\\
\\
2.3.2.6 The filling or loading of packages and containers with I
processed and/or prepared waste, including the sealing of
\\
containers.
2.3.2.7 The labeling of packaged radioactive waste for shipment.
2.3.2.8 The storage of packaged radioactive waste awaiting ship-m ent.
2.3.2.9 The loading and securing of packaged radioactive waste on transport vehicles, including loading liners into shipping casks, and sealing the package.
2.3.2.10 Radiological surveys and physical inspections performed on packages and transport vehicles.
2.3.2.11 All shipping packages, including, but not limited to, drums, liners, shipping casks, and/or overpacks.
2.3.2.12 Media used for solidification of waste.
2.3.2.13 Fabrication and/or leasing of shipping packages.
2.3.2.14 On site solidification and/or packaging services (apart from installed solidification / packaging systems).
2.3.3 The Radiation Protection Manager, or his designated alternate, has the responsibility and authority to perform Solid Radioactive Waste Packaging Quality Assurance Program functions.
The Radiation Protection Manager may delegate responsibility for performance of such functions to other qualified individuals or organizations. The Radiation Protection Manager, his designated alternate, individuals or orgainizations delegated activities, shall not be directly respons-ible for the activity affecting quality being monitored.
6
$.3.4 If differences of opinion arise between personnel performing quality assurance functions and personnel performing, or responsible for the
\\
performance of, quality affecting activities, ethose differences shall be resolved as follows:
2.3.4.1 If the difference of opinion is between organizations within the nuclear facility, it shall be resolved by the Station Superintendent.
2.3.4.2 If the difference of opinion is between Duquesne Light Company organizations within and outside the station, it shall be resolved at the level of management having administrative responsiblity for both organizations.
2.3.5 Written procedures covering activities tabulated in paragraph 2.3.2 shall be established, implemented, and maintained, as necessary.
Procedures and revisions shall be reviewed and approved in accord-ance with the station administrative manual. In addition to the general content specified in the station administrative manual, those procedures shall include as applicable:
2.3.5.1 Identification and description of environmental conditions required.
2.3.5.2 Identification and description of required tests and inspec-tions, and the acceptance criteria therefor.
2.3.5.3 Idantification and description of documentation require-ments.
7
3.0 DESIGN CONTROL
)
3.1 INTRODUCTION
Appropriate regulatory provisions and design features for Type B shipping packages shall be correctly translated into specifications, fabrication drawings and proce-dures.
3.2 POLICY 3.2.1 To the extent possible, packages and containers used to ship radicac-tive materials from the Beaver Valley Power Station shall be relected from standard designs which have been approved and/or Itcensed by the Nuclear Regulatory Commission and/or the Department of Trans-portation. The use of standard approved and/or licersed packages shall preclude the need for design control measures to be identified and described in the Solid Radioactive Waste Packaging Quality Assurance Program, except as follows:
3.2.1.1 This exemption shall be applicable only if the use of the package meets all usage provisions specified in the Nuclear Regulatory Commisssion package license and/or the De-partment of Transportation package specifications.
3.2.1.2 Prior to the first use of a vendor-supplied licensed package for the shipment of Type a quantity radioactive materials, the quality assurance program of the vendor shall be reviewed to assure that the design controls of the vendor meet the provisions of Criterion 3 of Appendix E to 10 CFR Part 71.
Certification by the vendor that the quality assurance program of the vendor has been accepted by the Nuclear Regulatory Commission may be considered to satisfy that review.
8
332.2 Appropriate design controls shall be implemented if it becomes i
necessary to perform design activities relevent to the fabrication or modification of a shipping package or cor$tainer.
Those design controls shall meet the requirements of Criterion 3 of Appendix E to 10 CFR Part 71, and shall be documented by appropriate revision to section 3.0 of the Solid Radioactive Waste Packaging Quality Assur-ance Program.
3.2.3 The provisions of paragraph 3.2.2 of this program shall not be applicable to design activities relevent to the fabrication or modifi-cation of packages for the shipment of radioactive materials exempr-ted in 10 CFR Part 71.6 or 10 CFR Part 71.7.
3.2.3.1 For the purposes of this program, shipping cask liners to be utili?.ed with Type B licensed casks are considered to be exempt, unless the liner constitutes a specified component of the licensed package design. Liners so specified shall be subject to the provisions of paragraph 3.2.1 and 3.2.2.
3.3 IMPLEMENTATION 3.3.1 Suitable provisions shall be made in procedures covering the pack-aging of radioactive waste to ensure that only packages licensed by the Nuclear Regulatory Commission, or approved by the Department of Transportation are utilized. Suitable provisions shall be made in those procedures for the required review of package licenses and specifications to ensure that the use requirements and limitations are met.
9
4.0 PROCUREMENT DOCUMENT CONTROL
4.1 INTRODUCTION
Procurement documents, such as purchase contracts and supporting documents, shall include appropriate quality assurance requirements, basic technical require-ments, and documentation requirements.
4.2 POLICY 4.2.1 All procurement documents generated pursuant to the packaging and shipment of Type B quantities of solid radioactive waste shall be prepared in accordance with the applicable provisions of the Duquesne Light Company Quality Assurance Program.
4.3 IMPLEMENTATION 4.3.1 Personnel preparing requisitions for components, materials, or ser-vices identified in paragraph 2.3.2 of the Solid Radioactive Waste Packaging Quality Assurance Program shall follow the appropriate procedures or instructions of the Duquesne Light Company Quality Assurance Program, as implemented in the station administrative manual.
4.3.2 The Radiation Protection Manager shall review all procurement documents for quality affecting materials or services related to the packaging and shipment of Type B quantities of solid radioactive waste, to ensure that all required quality, technical, and document-ation information is incorporated.
4.3.3 The Nuclear Services Quality Control (NSQC) Department of Duquesne Light Company shall ensure that the reviews required by paragraph 4.2.2 have been performed.
10
5.0 INSTRUCTIONS, PROCEDURES. AND DRAWINGS
5.1 INTRODUCTION
-Instructions, procedures, and drawings, which prescribe quality affecting items and activities, related to the packaging and shipment of Type B quantities of radioactive waste chall be properly prepared, reviewed, approved and issued.
5.2 POLICY 5.2.1 Activities affecting quality shall be prescribed and performed in accordance with documented instructions, procedures, and as applica-ble, drawings. Those procedures and instructions shall include, as applicable, quantitative and/or qualitative acceptance criteria.
5.2.2 Procedures shall be prepared and implemented to prescribe methods for complying with the applicable criteria of Appendix E to 10 CFR Part 71.
5.3 IMPLEMENTATION 5.3.1 Suitable written procedures shall be established, implemented, and maintained covering activities delineated in paragraph 2.3.2 of the Solid Radioactive Waste Packaging Quality Assurance Program. In addition to the general content specified in the Duquesne Light Company Quality Assurance Program, those procedures shall include as applicable:
5.3.1.1 Identification of environmental conditions.
5.3.1.2 Identification of required tests and inspections, including acceptance criteria.
5.3.1.3 Identification of documentation requirements.
11
i 6.0 DOCUMENT CONTROL
6.1 INTRODUCTION
Controls shall be applied to the release, distribution, receipt, use, storage and revision of documents which affect the quality of Type B packaging. Included in such documents are; procedures, drawings, operating logs, and records.
6.2 POLICY 6.2.1 Document control measures shall be implemented for documents which prescribe quality affecting activities. Those cocument control measures shall include provisions for the review, approval, issue, revision, and use of controlled documents. Procedures which identify and describe those document control measures and assignment of responsibility for accomplishment shall be prepared and implemented.
Those procedures shall clearly delineate the sequence of actions to be accomplished in the review, approval, issue, revision, and use of controlled documents.
6.3 IMPLEMENTATION 6.3.1 The document control measures of the Duquesne Light Company Quality Assurance Program are applicable to documents relating to the packaging and shipment of Type B quantitics of solid radioactive waste. The following documents, shall be considered as controlled documents within the purview of the Solid Radioactive Waste Pack-aging Quality Assurance Program.
6.3.1.1 Operating, maintenance, test, inspection, and modification procedures.
6.3.1.2 Procurement Documents.
6.3.1.3 Package Design Specifications and Drawin!,s.
12
6.3.1.4 Quality Assurance Manuals, Procedures, and Instructions.
6.3.1.5 Radioactive Shipment Records.
6.3.1.6 Radiological Survey Records.
6.3.1.7 Radionuclide Composition and Concentration Sample Results and/or Estimate Analyses.
6.3.1.8 Non-Conformance Reports.
13
7.0 CONTROL OF PURCIIASED MATERIALS, PARTS, AND COMPONENTS
7.1 INTRODUCTION
Appropriate controls shall be applied to the receipt of purchased materials, parts, and components related to Type B packaging to ensure that those items conform to procurement documents, certifications, and specifications.
7.2 POLICY 7.2.1 Vendors / contractors shall be selected on the basis of demonstrated ability to provide the material, part or component required by 1;ie procurement document.
7.2.2 Vendors / contractors supplying quality affecting materials, parts and components shall have an appropriate quality assurance program which shall include measures for ensuring conformance with the requirements of the procurement documents. Those programs shall also provide documented evidence that the quality requirements imposed by the procurement documents have been satisfied.
7.2.3 Source inspections and/or audits to assure the specified quality of the item shall be performed as necessary.
7.2.4 Materials, parts or components procured from vendors shall be inspected or. tested, as appropriate, upon delivery. The characteris-ties which shall be assessed during receipt inspections include, damage during shipment, correctness of material or equipment, traceability, and conformance to the requirements of procurement documents. Provisions for receipt inspections, including acceptance criteria, shall be provided in procedures.
7.2.5 Applicable requirements of this policy shall be similarly imposed by the vendors / contractors on any of their subvendors/ subcontractors.
14
f?.2.6 Documents generated pursuent to this section, including certifica-tions and audit reports shall be considered to be controlled documents and handled appropriately.
7.3 IMPLEMENTATION 7.3.1 All Type B shipping packages shall be inspacted in accordance with paragraph 7.2.4 upon receipt and prior to use. Packages failing to meet the acceptance criteria of that inspection shall not be used for the shipment of solid radioactive waste, and shall be handled as specified in section 15 of this program. In addition to the general provisions of paragraph 7.2.4, procedures for receipt inspections shall specify that for Nuclear Regulatory Commission licensed packages, (Type B, Isrge quantity, fissile), the serial number of the supplied package shall be as specified in the license document.
Packages which do not meet these criteria shall not be used until the proper license document has been obtained and reviewed.
7.3.2 Authorized representatives of Duquesne Light Company, who request services of an outside organization for activities involving Type B packaging important to safety shall assure that the Du desne Light y
Company Quality Assurance Department has ascertained that the quality assurance program of the outside organization meets all applicable provisions of the Solid Radioactive Wasta Packaging Quality Assurance Program, in accordance with paragraph 7.2.3. An exception to the applicability of this provision is that if the package to be procured is a standard design, licensed by the Nuclear Regula-tory Commission, certification by the vendor that their quality assurance program has been accepted by the Nuclear Regulatory Commission may be considered to satisfy the review provision.
15
8.0 IDENTIFICATION AND CONTItOL OF 51 ATERI ALS, PAllTS, AND coa 1PONENTS
8.1 INTRODUCTION
The identification and control of materials, parts, and components used in the shipping of Type B quantities of radioactive waste, including the fabrication of Type B shipping packages, shall be established to prevent the use of incorrect or defective material. Traceability shall be maintained on Type B packages at all stnges from initial receipt to the final use by Duquesne Light Company.
8.2 POLICY 8.2.1 Traceability shall be maintained on all materials and components used in the fabrication of shipping packages which are to be licensed for shipping Type B quantities of radioactive materials. Vendors who supply licensed packages as a service must provide evidence that the materials, processes and tests used in the fabrication of those packages are traceable. As a minimum, all shipping packages shall be permanently identified with the vendor's serial number, and/or the Nuclear Regulatory Commission license number.
8.2.2 Packages which do not meet the provisions of 8.2.1 shall not be used for the shipment of radioactive waste, except for limited quantity or low specific activity (LSA) radioactive materials.
Non-traceable packages shall be marked and handled as non-conforming items.
8.3 IMPLEMENTATION 8.3.1 Provisions shall be made in procedures for the packaging and ship-ment of solid radioactive waste to ensure for verification of package identification prior to filling or af ter filling as applicable, and to prevent the use of packages which are not traceable.
8.3.2 Vendors who supply licensed packages shall provide certification that the materials, processes, and tests used in the fabrication of the package are traceable.
16
9.0 CONTROL OF SPECI AL PROCESSES
9.1 INTRODUCTION
Special processes, including welding, heat treating, and non-destructive testing for Type 13 packaging shall be controlled in accordance with applicable standards by qualified personnel.
9.2 POLICY 9.2.1 Special processes used in the fabriention or modification of shipping packages shall be performed in accordance with controlled proce-dures, and drawings, as applicable. The documents shall identify equipment, preparation, processing details, and applicable tests and inspections.
9.2.2 Personnel responsible for the performance of special processes shall be trained and qualified in accordance with applicable standards.
9.2.3 Controlled records shall be maintained current on personnel qualifi--
cations, procedures used, test results, and traceable materials.
9.3 IMPLEMENTATION 9.3.1 Vendors who supply licensed packages shall provide certification that the provisions of 9.2 have been satisfied in the fabrication and modification of the shipping package.
17
10.0 INSPECTION
10.1 INTRODUCTION
Inspection of quality affecting activities shall be performed to ensure conformance with documented procedures, specifications, regulations, and procurement require-ments. Inspections shall be performed for receipt of quality related materials, during quality related work, and at the completion of quality related work.
10.2 POLICY 10.2.1 Personnel responsible for inspections shall be independent of those personnel performing the activity being inspected, or persons respon-sible for completion of the activity being inspected.
Personnel assigned inspection tasks shall be qualified in accordance with applicable standards and/or Duquesne Light Company training pro-grams, or in the case of vendors / contractors, appropriate training programs of the vendor / contractor.
10.2.2 Provisions for inspections shall be incorporated into work procedures, consistent with the importance of the inspection to the safety or quality of the package or the material involved. IIold points shall be incorporat d into procedures, as applicable, if continuance of the work beyond such point results in the condition in which inspection is impossible or disadvantageous. Inspection procedures shall be devel-oped and implemented consistent with the compicxity or importance of the inspection to quality. Inspection procedures shall include as applicable:
10.2.2.1 Identification and description of characteristics and activ-ities to be inspected.
10.2.2.2 Identification of the individuals or groups responsible for performing the inspection.
18
10.2.2.3 Acceptance criteria.
10.2.2.4 Description of the method, and techniques for performing the inspection.
10.2.2.5 Requirements for documentation of inspection data and results.
10.2.2.6 Approval of completed inspection by supervision.
10.2.3 Provisions shall be made in inspection procedures for in-process inspections and/or other indirect inspections if necessary.
10.3 IMPLEMENTATION 10.3.1 Vendors who supply licensed packages shall provide certification that the provisions of 10.2 have been satisfied in the fabrication and/or modification of the shipping package.
10.3.2 Provisions shall be made in procedures for packaging and shipping of solid radioactive waste for the performance of inspections, as appli-cable. The need and scope of required inspections shall be consistent with the complexity and importance to quality of the item or activity.
19
4 f
11.0 TEST CONTROL s
8
11.1 INTRODUCTION
Tests performed on Type B shipping packages shall be identified and performed in accordance with written test procedures which implement requirements and acceptance limits.
11.2 POLICY 11.2.1 Test programs for 'lype B shipping packages shall be established to demonstrate that the package will perform satisfactorily in service.
Required tests shall be acomplished in accordance with written procedures and the test results documented. The test procedures shall include or reference:
11.2.1.1 Design requirements and acceptance limits.
11.2.1.2 Test prerequisites such as:
o Calibrated instrum entation.
e Adequate and appropriate equipment.
Qualified, licensed or certified personnel.
e o
Completeness of item to be tested, e
Environmental conditions.
e Provisions for data collection and storage.
11.2.1.3 Instructions for performing the test.
11.2.1.4 Applicable inspection hold points 11.2.1.5 Acceptance and rejection criteria.
11.2.1.6 Test data and results.
20
I 11.2.2 Test results shall be documented, evaluated, and their acceptability determined by qualified, responsible individuhls, and/or by super-vision.
11.3 IMPLEMENTATION 11.3.1 Vendors who supply licensed packages shall provide certification that the provisions of 11.2 have been satisfied in the fabrication and modification of the shipping package.
21
l 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT
)
12.1 INTRODUCTION
Tools, gauges, instruments, and other measuring and testing devices used in activities affecting Type B packaging quality shall be celibrated and properly adjusted at specified periods to maintain accuracy within necessary limits.
12.2 POLICY 12.2.1 Measurement and test equipment used in activities related to the quality of shipping packages and the shipment of radioactive waste shall be adjusted and calibrated at established intervals against known standards. When possible, the known standard shall have a valid relationship to National Standards, and shall have an uncertain-ty of no more than 4th of the tolerance of the equipment being calibrated unless limited by the state-of-the-art.
12.2.2 Activities requiring the use of calibrated measurement and/or test equipments shall be performed using only measurement and/or test equipments which have been calibrated in accordance with the provisions of the Duquesne Light Company Quality Assurance Pro-gram.
12.3 IMPLEMENTATION 12.3.1 Procedures for the packaging and shipment of radioactive waste shall specify the applicability of calibrated equipment where appropriate.
12.3.2 Vendors who supply licensed packages shall provide certification that the provisions of Criteria 12 of Appendix E to 10 CFR Part 71 have been satisfied in the fabrication and modification of the shipping package.
22
13.0 IIANDLING, STORAGE AND SHIPi>ING
\\
13.1 INTRODUCTION
The handling, storage and shipment of materials and components used in the fabrication of Type B packaging shall be performed in such a manner that the quality of these materials and components is not adversely affected.
13.2 POLICY 13.2.1 All applicable provisions of the Nuclear Regulatory Commission package license and the Department of Transportation shipping requirements shall be satisfied prior to releasing packaged radioae--
tive waste to the carrier for transport.
13.2.2 All necessary documentation such as shipping papers, and the Radio-active Shipping Record shall be prepared, reviewed, approved, and issued in accordance with established procedures.
13.2.3 To the extent consistent with safe transportation of the packaged waste and requirements for accountability, the departure time, arrival time, destination and receipt of the package by '.he consignee shall be documented.
13.2.4 Provisions for the handling, cleaning, and storage, packaging and shipping of empty shipping packages, or material for the fabrication of shipping packages shall be established in written procedures.
These provisions shall ensure that the quality of the shipping package is not adversely affected in handling, storage and shipping.
13.3 IMPLEMENTATION 13.3.1 Provisions shall be made in procedures for the packaging and ship-ment of solid radioactive waste for methods of handling, storage and shipment of packages for shipping radioactive materials 23
13.3.2 Provisions shall be made in procedures for the packaging and ship-ment of solid radioactive waste for inspections to assure that all provisions of the package license or approval have been met and that the shipment meets all applicable requirements of the Department of Transportation.
13.3.3 Vendors who supply licensed packages shall provide certification that the provisions of 13.2 are met in the fabrication, modification and use of the shipping package.
24
14.0 INSPECTION TEST AND OPERATING' STATUS
14.1 INTRODUCTION
Identification of the test and operating status of materials and components used in the fabrication of Type B packaging shall indicate the status of the inspections and tests performed on materials and packages. Items which do not conform to the test or inspection requirements shall be clearly marked for subsequent identific-ation.
14.2 POLICY 14.2.1 The status of material, packages, and packaged radioactive waste shall be indicated by appropriate stickers, tags, labels, routing cards, marking, or traceable records. Status indicators which are attached to the item, such as tags or labels shall be securely fastened.
Marking shall be done in such a manner as not to adversely affect the quality of the package, or material.
14.2.2 The application and control of status indicators shall be specified in written procedures.
14.2.3 Non-conforming, inoperative, or malfunctioning packages or compon-ents shall be identified to prevent inadvertent use.
14.3 IMPLEMENTATION 14.3.1 Appropriate checklists shall be provided in procedures relevent to the packaging and shipping of solid radioactive waste to ensure that all required tests and inspections are performed on packages of radioae-tive waste and transport vehicles.
14.3.2 To facilitate the use of those checklists, traceability shall be maintained on packaged radioactive waste through the use of suitable identification labels.
25
14.3.3 Packages which do not conform to inspection and test requirements I
shall be appropriately labeled to prevent inadvertent use. Similarly, filed packages which exceed shipping limitat{ons shall be marked to prevent inadvertent release to a carrier.
14.3.4 Vendors who supply licensed packages shall provide certification that the provisions of 14.2 are met in the fabrication, modification and use of the shipping package.
26
I 15.0 NON-CONFORMING M ATERIAL, PARTS, OR COMPONENTS
'\\
15.1 INTRODUCTION
Material, parts, components, or Type B packages of solid radioactive waste which do not conform to requirements shall be controlled to prevent their inadvertent use or installation; or in the case of packaged waste, release to the carrier for shipment.
15.2 POLICY 15.2.1 Non-conforming items shall be reviewed in order to determine their disposition. The disposition of a non-conforming item shall be one of the following: accept as is, rework, repair, or reject. Repaired or reworked items shall be reinspected or retested in accordance with the original inspection / test procedure or by methods which are at least equal to the original inspection / test.
15.2.2 Non-conforming items shall be clearly identified by the use of tags, labels, stickers, markings or by other appropriate means.
Non-conforming items shall be physically segregated from conforming items, or controlled in other manner which prevent inadvertent use.
15.2.3 Non-conformance reports shall be prepared for all items of non-conformance. Non-conformance reports shall include: identification of the non-conforming item, description of the non-conformance, disposition of the non-conformance, inspection requirements, and approval signatures. Non-conformance reports shall be periodically analyzed to show quality trends.
15.3 IMPLEMENTATION 15.3.1 Provisions for the identification, documentation, segregation review, disposition, retest, and rework of non-conforming items pertaining to the packaging and shipment of radioactive waste, and delegation of 27
responsibility and authority for performing those activities shall be I
incorporated into procedures, relevent to the packaging and shipment of radioactive waste.
\\
15.3.2 All activities related to the fabrication or modification of shipping packages shall be subject to the provisions of this section. Items of non-conformance identified in the packaging and handling of solid radioactive waste need not be handled in accordance with this section, provided that the non-conformance is identified during in-process inspections and tests, and is rectified immediately by person-nel performing the activity.
Retest or reinspection shall be per-formed as appropriate.
15.3.3 Vendors who supply licensed packages shall provide certification that the provisions of 15.2 are met during the fabrication, modification and maintenance of the licensed package.
28
l 16.0 CORRECTIVE ACTION
(
\\
16.1 INTRODUCTION
Conditions adverse to the quality of Type B packages shall be promptly identified and corrected.
16.2 POLICY 16.2.1 Conditions adverse to quality are identified in inspections, tests and audits.
An evaluation of those conditions, such as, non-confor-mances, failures, malfunctions, deficiencies, deviations, and defee-tive material shall be performed to identify the cause, and to ascertain the need for corrective action.
The results of that evaluation, including recommendations for corrective action shall be reported to appropriate levels of management.
16.2.2 The effectiveness of a corrective action shall be evaluated by follow-up audits and inspections, and the acceptability of the corrective action assessed and documented.
16.2.3 Results of the above evaluations, and subsequent reports shall be considered as controlled documents and handled accordingly.
16.3 IMPLEMENTATION 16.3.1 Provisions for corrective actions pertaining to the packaging and shipment of solid radioactive waste shall be incorporated into proce-dures.
16.3.2 Corrective actions performed to correct items of non-conformance which were identified in activities related to the packaging and shipment of radioactive waste need not be controlled in accordance with this section, provided that the need for the corrective action is identified during in-process inspections and tests, and if the corree-29
tive action is performed immediately by personnel performing the activity. The acceptability of corrective ackion performed shall be assessed by retest or reinspection as appropriate.
16.3.3 Vendors who supply licensed packages shall provide certification that the provisions of paragraph 16.2 are met during the fabrication, modification and maintenance of the licensed package.
30
17.0 QUALITY ASSURANCE RECORbS
'\\'
17.1 INTRODUCTION
Records shall be maintained to furnish documentary evidence that required activities affecting quality have been performed in accordance with specifications, regulations and standards.
17.2 POLICY 17.2.1 Document control measures which are established in the Duquesne Light Company Quality Assurarce Program are applicable to records generated during the performance of quality activities specified in the Solid Radioactive Waste Packaging Quality Assurance Program, and during the performance of quality affecting activities relevent to the packaging and shipment of solid radioactive waste. All records thus generated shall be prepared, reviewed, filed, handled, and retained in accordance with applicable provisions of the Duquesne Light Company Quality Assurance Program.
17.3 IMPLEMENTATION 17.3.1 Provisions for document requirements shall be incorporated into procedures for the packaging and shipment of solid radioactive waste.
17.3.2 Vendors who supply licensed packages for the shipment of radioactive waste shall provide certification that the appropriate provisions of Criteria 17 of Appendix E to 10 CFR Part 71 have been met during the fabrication, modification, and maintenance of the licensed pack-age.
31
f 18.0 AUDITS
,I N
18.1 INTRODUCTION
A comprehensive system of planned and documented audits shall be implemented.
Audits shall be carried out to verify that all aspects of the Solid Radioactive Waste Packaging Quality Assurance Program are properly implemented, and to monitor the effectiveness of the program.
18.2 POLICY 18.2.1 Audits shall be preformed in accordance with written procedures or checklists by appropriately trained personnel who do not have direct responsibility for the activities and areas being audited.
Written procedures or checklists shall identify the characteristics to be audited and provide a minimum basis for performing the audit.
18.2.2 Audits shall be conducted periodically, at frequencies which are consistent with the complexity of the activity, the importance of the activity to safety, the results of previous audits, and the severity of previous non-conformances.
18.2.3 Audits shall be performed in areas or activities where the criteria of Appendix E to 10 CFR Part 71 are applicable. Those audits shall include of an objective evaluation of quality related practices, procedures, instructions, documents and records, work areas, activi-ties, and processes for safety related activities associated with:
18.2.3.1 Use, maintenance and repair of packages.
18.2.3.2 The preparation, review, approval, and control of designs, specifications, procurement documents, procedures, and drawings.
18.2.3.3 Receipt inspections.
32
18.2.3.4 Training programs.
The implementation and use of test hrocedures.
18.2.3.5 18.2.3.6 The calibration of measuring and testing equipment.
18.2.4 The results of audits shall be documented and reviewed with manage-ment having responsibility in the area audited. Responsible manage-ment shall undertake necessary action to correct deficiencies identi-fled by the audit.
Deficient areas shall be reaudited to verify implementation of corrective action.
18.3 IMPLEMENTATION 18.3.1 The scope, implementation, and effectiveness of the Solid Radioae-tive Waste Packaging Quality Assurance Program shall be regularly assessed through the use of appropriate audits. The scope, scheduling and performance of those audits shall be in compliance with the provisions of 18.2, and shall be described in written procedures.
18.3.2 The scope, implementation, and effectiveness of the Solid Radione-tive Waste Packaging Quality Assurance Program shall be assessed at least annually by an individual or crganization designated by the Station Superintendent.
18.3.3 Audits performed on outside organizations shall be performed in accordance with applicable provisions of the Duquesne Light Company Quality Assurance Program.
18.3.4 Vendors who supply licensed packages for the shipment of redioactive waste shall provide certification that the provisions of 10.
me been met in the fabrication, modification, and maintenance of the licensed package.
33