ML19320D056
| ML19320D056 | |
| Person / Time | |
|---|---|
| Site: | 07100249 |
| Issue date: | 06/13/1980 |
| From: | NUCLEAR FUEL SERVICES, INC. |
| To: | |
| Shared Package | |
| ML19320D051 | List: |
| References | |
| NUDOCS 8007180483 | |
| Download: ML19320D056 (21) | |
Text
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-IDIN11fIrAfION Cri tiic'sTi~tF-Jg
,_ and_Licensin_g_
Nuclear Fuct Servicott, Inc. ERWIN, TENNESSEE 37050 S
01 (60cedu' c l'a !
%)
A Subsidiary of Getty Oil Company N/A (sect E )
3-(kevision)
__ Jane _13g180 Nsk bbiT Page 1 of 21 QUALITY ASSURANCE PROGRAM FOR SHIPPING PACKAGES FOR RADIO?CT!"E MATERIAL E
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0 800718098 j
NFS-CL-001, Rev. 3 Page 2 of 21 June 13, 1980 RECORD OF 9.EVISIONS Revision Page Number Date Number Description, (0) 12/29/78 All Initial. Submittal (1) 11/29/79 All Complete Revision (2) 3/17/80 All Complete Revision (3) 6/13/80 6
Revised last paragraph of Section 1.0 7-Added reference to Appendix B to Section 2.0 7&8.
Added Design Criteria to Section 3.0 9
Added last two paragraphs to Section 4.0 19 Updated Figure 1 21 Added Appendix B f'
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NFS-CL-001, Rev.3 Page_ 3 of 21 June 13, 1980
' TABLE OF CONTENTS INTRODUCTION
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l.0 ORGANIZATION 2.0 QUALITY ASSURANCE PROGRAM 3.0 DESIGN AND FABRICATION CONTROL l
4.0 PROCUREMENT DOCUMENT CONTROL k
5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS 6.0 DOCUMENT CONTROL 7.0 CONTROL 0F PURCHASED !!ATERIAL, EQUIPMENT AND SERVICES 8.0 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS AND COMPONENTS 9.0 CONTROL ~0F SPECIAL PROCESSES i-10.0 INSPECTIONS' 11.0 TEST CONTROL-
-12.0 CONTROL 0F MEASURING AND TEST EQUIPMENT 13.0 HANDLING, STORAGE AND SHIPPING 14.0 INSPECTION, TEST AND OPERATING STATUS 15.0 - NON-CONFOR;11NG MATERI ALS, PARTS OR COMPONENTS fI6.0 CORRECTIVE ACTION 17.0 QUALA'Y ASSURANCE RECORDS
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18.0 AUDITS
.19.0. SPECIFIC PROVISIONS Figure 1 Appendix A
. Appendix'8 l
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NFS-CL-001,.Rev. 3 Page 4 of 21 June 13, 1980 INTRODUCTION The purpose of this document is to describe the NFS Quality Assurance policies and procedures which are applicable to the safety aspect of the fabrication, testing, use and maintenance of each shipping package of radio-active material as defined in 10 CFR 71.4(1) and to show how these comply with the Quality Assurance requirements defined in Title 10, Code of Federal Regu-lations, Part 71, Paragraph 71.24 and Appendix E, thereof.
The. Quality Assurance Program is designed to provide the appropriate control of quality for safety-related activities associated with tLe pur-chasing, fabricating, handling, shipping, storing, cleaning, inspecting, testing, operating, maintaining, repairing, and modifying of packaging used for the shipment of radioactive materials.
The Quality Assurance program applies to Nuclear Fuel Services, Inc., at Erwin, Tennessee only and is applicable in some degree to all packages used by NFS at Erwin.
These packages are authorized for the shipment of special nuclear material, primarily enriched uranium.
NFS at Erwin is not authorized to ship spent fuel, high level waste and certain fanns of plutonium in large quantities.
This program includes then, only the pertinent requirements of Appendix E that are applicable to packages used by NFS at Erwin.
Appendix A lists the packages for which NFS at Erwin holds the NRC Certificate of Compli-ance or is listed as a user.
This description serves as the authorizing document for the Quality Assurance Program.
It is approved by and distributed to the responsible organizations who must be aware of the Quality Assurance requirements.
1.0 ORGANIZATION The NFS Quality Assurance organization for shipping packages is retained and exercised within the Administrative Department.
The Admin-
- istrative Department enforces the policies set forth in this document and reports at a level that will permit the freedom of action to do so.
Figure 1 shows the organization structure.
The Administrative Manegar's qualifications are a Baccalaureate Degree in science or engineering with eight years nuclear experience in the quality and safety fields - three of which have been in a super-visory position.
The Administrative Manager is responsible for:
. Insuring that the Quality Assurance. Program is carried out in accordance with this document.
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NFS-CL-001, Revo 3 Page 5 of. 21 June 13, 1980 1
Reviewing annually the status and adequacy of this Quality Assurance Program by checking, auditing and inspecting.
The Administrative Manager may appoint a representative with a minimum of 2' years experience in the quality field to conduct the annual review described above.
The Q. A. function as referenced co in this document means the Criticality and Licensing Department and/or the Health & Safety Depart-ment. 'The Q. A. function reports to the Administrative Manager as iden-
_tified in Figure 1.
The organization is structured so that the Q. A.
functica does not have direct responsibility for perfonning the work being verified.
The Criticality and. Licensing Supervisor's qualifications are a Baccalaureate Degree in Nuclear Science or Nuclear Engineering and three years of nuclear experience relating to nuclear criticality safety, and be a qualified nuclear safety specialist.
The Nuclear Safety Specialist qualifications are a Baccaiaureate Degree in Nuclear Science or Nuclear Engineering with at least one year o.f experience in Nuclear Criticality Safety.
The Health and Safety Manager's qualifications are a Baccalauraate Degree with specialized training in Health Physics with three years of nuclear experience in health and safety and one year in a supervisory position.
The Health Physics Specialist's qualifications are a Baccalaureate Degree with specialized training in Health Physics and at least one year of experience in' professionally responsible health physics.
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Equivalent experience may be used in place of a Baccalaureate Degrea in accordance with the requirement of Special Nuclear Material License SNM-124 that is held by NFS.
The Q. A. function is responsible for:
Insuring the documentation of the Quality Assurance Program by written procedures. or instructions.
Insuring that the Qality Assurance Program is carried out in accordance with these procedures.
Implementing the Quality Assurance Program approved for each licensed package.
Identifying the material and components to be covered by the Qua'lity Assurance Program.
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NFS-CL-001, Reva 3 Page 6 of 21 June 13, 1980 Insuring that proper indoctrination and training of personnel perfonning activities affecting quality is proficiently a-j chieved and maintained.
Approving requirements for contractor's and subcontractor's Q.
' A.' Program.
Insuring proper identification of containers.
Approving requisitions for procurement of shipping containers.
Reviewing and approving shipping documents, procedures, and letters of authorization.
Insure that applicable regulatory requirements are correctly translated into written procedures and instructions.
9 The Q. A. function has the responsibility and authority to stop unsatis-factory work and control further processing, delivery, or installation of non-conforming material, and to reject non-conforming material.
2.0 QUALITY ASSURANCE PROGRAM The purpose of the Quality Assurance Program is to provide the appropriate control of qua'lty for' safety-related activities associated with the purchasing, fabricating, handling, shipping, storing, cleaning, inspecting, testing, operating, maintaining, repairing, and modifying of packaging used for the shipment of radioactive materials.
It is the responsibility of the Q. A. Function to verify that there
'is strict compliance to the requirements of this program and its imple-menting documentation.
The Quality Assu.ance Program is reviewed annually to assess the C
scope, status, implementation 01d effectiveness of the program to assure that the program is adequate and complies with 10 CFR Part 71, Appendix E l
criteria.
This assessment is performed by personnel not within the 0. A.
Function.
Personnel performing the review must have at least two years of experience in the quality field.
Q. A. responsibilities may be delegated to principal contractors.
The NFS Q. A. Function will determine that functions delegated te princi-pal contractors are being properly accomplished.
This is accomplished by audits and inspections of contractor activities to insure compliance with the NFS Q.' A. Plan or the contractor's approved Q. A. Plan.
In addition the Q." A. Function reviews and documents agreement with the Q. A. Program of the contractor to assure that Appendix E can be implemented.
DisEribution of the Q. A. Plan, manuals and procedures, are con-trolled under.the NFS Document Control Procedure.
Any revisions are I-
1 NFS-CL-001, Rev. 3 Page 7 of 21 June 13, 1980 similarly controlled-Distribution is made to all departments whose operations affect the quality of shipping packages.
The packagings covered by this Plan are listed in Appendix A.
In addition to these packages, the Q. A. Plan is applicable to the handling, shipping, inspecting, testing, maintaining and repairing of D0T specifi-cation containers.
Disputes involving quality arising from a difference of opinion between the Q. A. Function and other departments are submitted to the NFS Quality Control Manager for resolution.
Personnel responsible for performing quality - affecting activities are trained in accordance with established training procedures.
The training procedures require instruction of personnel in accordance with Standard Operating Procedure (50P).
All quality related activities are included in the SOPS.
Personnel must be qualified in order to perform the activities.
Procedures that implement the Quality Assurance Program are con-tained in the Quality Assurance manuai for shipping packages for radio-active material.
Each criterion of Appendix E to 10 CFR Part 71 is addressed as a separate section in the manual.
Appendix B lists the Quality Assurance Procedures and contains a matrix of these procedures cross referenced to each criterion of Appendix E or 10 CFR Part 71.
3.0 DESIGN AND FABRICATION CONTROL l
Shipping packagings will be fabricated only in accordance with designs previously certified by the NRC or as specified by D0T regula-tions.
The Q. A. function is responsible for maintaining current files on packagings certified by the NRC and maintaining an up to date copy of the 00T regulations that contain the specifications of packagings uti-lized by f1FS Erwin. Modifications to packagings will be performed only in accordance with changes issued by the NRC cr DOT.
Newly constructed packages are inspected by the Q. A. Function to insure that they have been constructed in accordance with approved draw-ings and/or specifications.
Contractors and sub-contractors employed to fabricate a shipping package are required, if applicable, to submit a copy of their quality assurance program to NFS.
NFS will determine if their program meets the requirements of the NRC or D0T, whichever is applicable.
The following design control requirements must be met for modification and repair activities associated with existing shipping containers:
a.
Quality standards are spacified in the design documents, and devir. cions and changer from these quality standards are con-trolled.
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NFS-CL-001, Rev. 3 Page 8 of 21 June 13, 1980 b.
Designs are reviewed to assure that (1) design characteristics can be controlled, inspected, and tested and (2) inspection and test i:riteria' arc identified.
Proper selection and accomplishment of design verification
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or' checking processes such as by design reviews, alternate calculations, or qualification testing are performed. When a test program is used.to verify the adequacy of a design, a qualification test of a prototype unit under design conditions should be used.
d.
Individuals or groups responsible for design verification are other than the original designer and the designer's immediate supervisor.
e.
Design and specification changes are subject to the same design controls and approvals that were applicable to the original design unless NFS designates another qualified re-sponsible organization.
f.
The positions or groups responsible for design reviews and other design verification activities and their authority and responsibility are identified and controlled by written pro-cedures.
4.0 PROCUREMENT DOCUMENT CONTROL All purchase requisitions for shipping packagings or material, equipment, services, etc. related to shipping packagings must be approved' by the Q. A. Function to insure that specifications for safety-related items are included. The requisitions initiated for shipping containers require Q. A. Function approval which attests to the adequacy of the quality requirements required for the procurement document.
The preparatica, review, approval, and control of procurement docu-ments are performed in accordance with established procedures that clearly delineate the sequence of actions to be accomplished.
The Q. A.
Function review of purchase requisitions determines that quality require-ments are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with Q. A. pro-gram requirements. The review and approval of purchase requisitions must be documented prior to release and available for verification.
The Q. A.. Function will insure that procurement documents identify the applicable 10 CFR J1, Appendix E requirements which must be complied with. and described -in the supplier's Q. A. program. This Q. A. program or portions thereof shall be reviewed and concurred with by the Q. A.
Function prior to. initiation of activities affected by the program.
As
. determined by the Q. A.. function purchase requisitions will:
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NFS-CL-001, Rev. 3 Page 9 of 21 June 13, 1980 Identify those records to be retained, controlled and main-tained by the supplier, and those delivered to NFS prior to use or installation of the hardware.
Contain NFS's right of access to supplier's facilities and records for source inspection and audit.
Provide that changes and revisions are subject to at least the same review and approval as the original requisition.
Provide that spare or replacement parts of safety-related structures, systems, and components are acceptable in accor-dance with DOT specifications or NRC Certificates of Compli-ance.
Contain or reference the design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifi-cations, codes and industrial standards, test and inspection requirements, and special process instructions.
Identify the documentation (e.g., drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, and chemical and physical test results of material) to be prepared, maintained, and submitted to NFS for review and approval.
5.0 INSTRUCTIONS, PROCEDURES AND DRAWINGS Activities affecting quality of shipping packages are included in documented instructions, procedures or drawings.
All such documents are approved by the Q. A. Function, and distributed to implement @g personnel in accordance with Document Control Program described herein.
Provisions are established which clearly delineate the sequence of actions to be accomplished in the preparation, review, approval, and control of instructions, procedures and drawings.
Methods for complying with the applicable 18 criteria of 10 CFR Part 71, Appendix E are specified in instructions, procedures, and drawings.
Instructions, procedures, and drawiogs include quantitative (such as dimensions, tolerances, and operating limits) and qualitative (such as workmanship samples) acceptance criteria to veiify that important activ-ities have been satisfactorily accomplished.
The review, approval, and issue of documents and changes thereto, prior to release, are procedurally controlled to assure they are adequate and the quality requirements are stated.
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NFS-CL-001,.Rev. 3 Page 10 of 21 June 13, 1980
~The following deparbnents are responsible for reviewing and ap-
. proving internal NFS documents and revisions thereto:
Production Engineering Technical Services Criticality and Licensing Health and Safety Materials Approved documents are-issued and controlled by the originating depart-ment.
Changes to documents are reviewed and approved by the same organi-zations that perform the original review and approval ~.
Changes in instructions, procedures, drawings, and other documents are not imple-mented until the change is approved and revised documents are issued.
Supplier's instructions, procedures and drawings are prepared, reviewed, approved and controlled in accordance with the supplier's Lapproved Q. A.~ Program.
6.0 DOCUMENT' CONTROL The Q. A. Plan along with associated' manuals and procedures are subject to the NFS Document Control Procedure.
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Obsolete or superseded documents are controlled to prevent inad-vertent use. -The originating department is responsible for distributing revised documents and disposing of obsolete documents.
Disposal of documents is recorded and a list of current documents is maintained.
r This list-is updated and distributed with revised documents to preclude
^ use of superseded documents.
Documents controlled include.as a minimum:
Purchase requisitions.
Manufacturing, inspection and testing instructions.
Nonconformance' reports.
Packaging, shipping and receiving procedures.
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NFS-CL-001, Revo 3
.Page 11 of 21 June 13, 1980 7.0. CONTROL:0F PURCHASED MATERIAL, EQUIPMENT AND SERVICES Prior tc.the use' of purchased material, equipment or services, the NFS Q. A.. Function will insure conformance with purchase requisitions.
Qualified personnel evaluate the supplier's capability to provide acceptable quality services and products before the award of the purchase order or contract. The Q. A. Function performs the evaluation of those suppliers providing equipment and services. The evaluation of suppliers is based on the following:
a.
The supplier's capability to comply with the elements of 10 CFR Part 71, Appendix E that are applicable to the type of material, equip-ment, or service being procured.
b.
A review of previous records and performance of suppliers who have provided similar articles of the type being procured.
c.
A survey of the supplier's facilities and QA program to determine his capability to supply a product which meets the design, manu-facturing, and quality requirements.
Results of supplier evaluations are documented and retained.
i Surveillance of suppliers during fabrication, inspection, testing, and shipment of materials, equipment, and components is planned and performed in accordance with written procedures to assure conformance to the purchase order requirements. These procedures provide for:
a.
Instructions that specify the characteristics or processes to be witnessed, inspected or verified, and accepted; the method of sur-veillance and the extent of documentation required; and those re-sponsible for implementing these instructions.
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Audits and surveillance which assure that the supplier complies with the quality requirements.
Surveillance is performed on those items where verification of procurement requirements'cannot be determined
'upon receipt.
The supplier furnishes the following records as a minimum to NFS:
a.
Documentation that identifies the purchased material or equipment and the specific procurement requirements (e.g., codes, standards, and specifications) met by the items.
b._
Documentation that identifies any procurement requirements which
_have not; been met together with a description of those noncomfor-
~mances dispositioned " accept as is" or " repair."
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- NFS-CL-001, Rev. 3 Page 12 of 21 June 13,-1980 The review and acceptance of these documents shall be performed as de-scribed'in NFS's QA program and as a minimum'shall be undertaken by a l
responsible.QA-individual. The supplier's certificates of conformance
.are periodically evaluated by audits, incependent inspections, or tests D
to assure.they are valid.
The receiving inspection of the supplier-furnished material, equip-ment, and services-is performed to assure:
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a.
The material, component, or equipment is properly -identified and corresponds with the identification on receiving documentation.
4 b.
. Material, components, equipments, and acceptance records are inspec-ted and judged acceptable in accordance with predetermined inspec-
-tion instructions, prior to installation or use.
Inspection records or certificates of confonnance attesting to the c.-
acceptance of material, components, and equipment are available at NFS prior to installation or use.
d.
Items accepted and released are identified as to their inspection status. prior to forwarding them to a controlled storage area or releasing them for installation or further work.
The effectiseness of the control of quality by suppliers is assessed by:NFS at~ intervals consistent with the importance, complexity, and quantity of the item.
8.01 IDENTIFICATION AND CONTROL OF MATERIALS,' PARTS AND COMPONENTS ThelNFS'Q. A. function will review the suppliers' Q. A. Program to insure that:
-Materials, parts and components affecting quality of shipping pack-a.
ages are identified by part number 'or other means approved by the suppliers' Q. A. Function.
Such identity appears on drawings and
- other' appropr,iate documents. Materials, parts and components which are standard, commercial.(off the shelf)- or which have been previ-ously approved for. a different application will be -reviewed for suitability by ~ the suppliers' Q. A. Function prior to selection.
b.
Procedures are established to identify 'and control materials, parts, and components including partially fabricated subassemblies.
The
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identification and control procedures assure that identification is maintained'either'on the item or on records traceable to the item to preclude use of incorrect-or_ defective items.
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Idmitification.of materials-and' parts important to the function of
~safety-related-structures, systems, and components can be traced to the appropriate documentation such as ' drawings, specifications, L
. purchase-orders, manufacturing and inspection documents, deviation reports, and physical and. chemical? mill = test reports.
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NFS-CL-001, Rev. 3 Page 13 of 21 June 13, 1980 d.
The location and the method of identification do not affect the fit, function, or quality of the item being identified.
Correct identi-fication of material, parts, and components is verified and documented prior to release for fabrication, assembling, shipping, and installation.
9.0 CONTROL OF SPECIAl. PROCESSES The NFS Q. A. function will review the suppliers' Q. A. Program to insure that:
a.
Applicable codes, standards or specifications are utilized for Welding, heat treating and nondestructive testing that affect quality. The qualifications of personnel performing the activities are documented.
b.
Special processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
Procedures, equipment, and personnel connected with special processes are quali-fied in accordance with applicable codes, standards, and specifi-cations.
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Special processes are performed by qualified personnel and accom-plished in accordance with written procedures or instructions with recorded evidence of verification.
Qualification records of proce-dures, equipment, and personnel associated with special processes are established, filed, and kept current.
10.0 INSPECTIONS The inspection program which verifies conformance of quality-affec-ting activities with requirments is established, documented, and accom-plished in accordance with written controlled procedures.
Inspection procedures, instructions, and check lists provide for the followii g-C a.
Identification of characteristics and activities to be inspeu; u.
b.
Identification of the, individuals or groups responsible for per-forming the inspection operation.
c.
Acceptance and rejection criteria.
d.
A description of the method of inspection.
e.
Recording evidence of completing and verifying a manufacturing, inspection, or test operation, f.
Recording inspector or data recorder and the results of the inspec-tion operation.
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NFS-CL-001,.Rev. 3 Page 14 of 21 June 13,1980 Inspection procedures or inst.uctions are used with necessary drawings and specifications when performing inspection operations.
Inspection personnel are independent from the individuals performing the acti ity being inspected.
Inspectors are qualified in accordance with app.icable codes, standards, and company training programs; and their qualifications and certifications are kept current.
Modifications, repairs, and replacements are inspected in accordance with the original design and inspection requirements or acceptable alter-natives.
Provisions are established that identify mandatery inspection hold points for witness by an inspector and for indirect control by monitoring processing methods, equipment, and personnel if direct inspec-tion is not possible, 11.0 TEST CONTROL All testing of packagings must be done in accordar;ce with written procedures approved by the Q. A. Function. The procedures shall specify equipment to be used, prerequisites to be met prior to testing and envir-onmental conditions. All test results must be documented.
A copy of such documentation must be sent to the Q. A. Function.
The Q. A. Func-tion evaluates the test results to assure that the testing requirements are satisfied.
Written test procedures incorporate or reference:
1 a.
The requirements and acceptance limits contained in applicable design and procurement documents.
b.
Instructions for performing the test.
c.
Test prerequisites such as:
Calibrated instrumentation Adequate and appropriate equipment Trained, qualified, and licensed or certified personnel.
Completeness of item to be tested.
Suitable and controlled environmental conditions.
Provisions for data collection and storage.
d.
Mandatory inspection hold points for witness by owner, contrac-tor, or inspector.
e.
Acceptance and rejection criteria.
f.
Methods of documenting or recording test data and results.
Modifications, repairs, and replacements are tested in accordance with the original design and testing requirements or acceptable alter-natives.
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NFS-CL-001, Rev. 3 Page 15 of 21 June 13, 1980 12.0 CONTROL OF MEASURING AND TEST EQUIPMENT Tools, gauges, instruments, and other measuring and testing devices used in activities affecting quality must be controlled, calibrated and adjusted to maintain accuracy. The method and frequency of control or calibration 'must be specified in written procedures approved by the Q. A.
Function.
Measuring and test equipment is identified and traceable to.the calibration test data and is labeled or tagged to indicate date of the next calibration.
Calibration is performed at specified intervals based on the required accuracy, purpose, degree of usage, stability character-istics, and other conditions affecting the measurement.
The ccmplete status of all items under the calibration system is recorded and main-tained.
Reference and transfer standards are traceable to natio'mily recog-nized standards; or, where national standards do not exist, provisions are established to document the basis for calibration.
Calibrating standards have an uncertainty (error) requirement of no more than 1/4th of the tolerance of the equipment being calibrated.
A greater uncer-tainty may be acceptable when limited by the " state-of-the-art."
Measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
13.0 HANDLING, STORAGE AND SHIPPING Any special handling and storage requirements must be contained in written procedures that have been approved by the Q. A. Function.
In addition, all shipments of radioactive material must be approved by the Q. A. Function.
These procedures control the cleaning, handling, storage, packaging, shipping, and preservation of materials, components, and systems in accordance with design and specification requirements to preclude damage, loss, or deterioration by environmental conditions such as temperature or humidity.
14.0 INSPECTION, TEST AND OPERATING STATUS Inspections of new containers are performed by the shipping super-visor and the Q. A. Function.
The shipping supervisor perfonns packaging inspection prior to shipment and upon receipt of the empty packages.
The operational groups who use the package are responsible for insuring that required tests are performed.
Testing procedures must be approved by the Q. A. Function, who must also insure that the qualifications of licensed or certified individuals performing certain inspections or tests are adequate. Any required labeling or tagging of the package to document 2
1 NFS-CL-001, Rev. 3 Page 16 of 21 June 13, 1980 inspections or. tests must be included in the appropriate procedures or instructions.
Identification.of the inspection, test, and operating status of components is known throughout fabrication.
Bypassing of required in-spections, tests, and other critical operations is procedurally con-trolled under the coor:zance of the NFS Q. A. Function or the suppliers' Q.:A. organization.
15.0 NONCONFORMING MATERIALS, PARTS OR COMP 0NENTS The status of nonconforming, inoperative, or malfunctioning compo-nents is identified to prevent inadvertent use.
Documentation identifies the nonconforming item, describes the nonconformance, the disposition of the nonconformance, and the inspection requirements; and includes signa-ture approval of the disposition.
Nonconforming items are segregated from. acceptable items and identified as discrepant until properly dispo-sitioned. The'NFS Q. A. Function has the responsibility and authority for the disposition and approval of nonccnforming items identified at NFS.
Acceptability of rework or :epair of materials, parts, components, systems, and structures is verified by reinspecting and retesting the item as originally inspected and tested or by a method which is at lerst equal to the original inspection and testing method.
Inspection, test-ing, rework, and repair procedures are documented.
Nonconformance re-ports dispositioned 'faccept as is" or " repair" are made part of the inspection records and forwarded with the hardware to NFS for review and assessment.
Noncontormance reports are periodically analyzed to show quality trends, and the results are reported to management for review and assessment.
Evaluation of conditions adverse to quality (such as nonconform-
-ances, failures, malfunctions, deficiencies, deviations, and defective r
material and equipment) is conducted to determine the need for corrective action.in accordance with established procedures.
16.0 CORRECTIVE ACTION All deviations observed by the Q. A. Function duri.'q required audits are documented along with corrective actions taken and reported to the General Manager.
Corrective action.is initiated following the determination of a condition adverse to quality _to preclude recurrence.
Follow-up reviews are'_ conducted to verify proper implementation of corrective actions and
'to'close out the corrective action documentation.
Significant conditions' adverse to quality, the cause of the condi-
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. tions, and the corrective action takan are reported to cognizant levels of management for review and assess ent.
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NFS-CL-001, Rev. 3 Page 17 of 21 June 13, 1980 17.0. QUALITY ASSURANCE RECORDS
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= Records of-activities described'in this document are maintained in
.accordance with federal regulation, current license conditions and estab-lished NFS procedures. The Q. A. Function insures that all records of required container inspections and testing be maintained in accordance with established procedures and regulatory requirements.
Q. A. records include operating logs; results of reviews, audits, and material analyses; monitoring of work performance; qualification of personnel procedures, and equipment and other documentation such as drawings, specifications, procurement documents, calibration procedures and reports; nonconformance reports; and corrective action reports.
Q.~ A. records are identifiable and retrievable.
-Requirements and responsibilities for record transmittals, retention (such as: duration, location, fire protection, and assigned responsi-bilities)', and maintenance subsequent to completion of work are con-sistent with pplicable codes, standards, and procurement documents.
Inspection and test records contain the following where applicable:
a.
A description of the type of observation.
b.
Evidence of completing and verifyir:g a manufacturing, inspec-tion, or test operation.
-c.
The date and results of the inspection or test.
d.
Information related to conditions adverse to quality.
e.
Inspector or data recorder identification, f.
Evidence as to the acceptability of the results.
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Record storage facilities are constructed, located, and secured to prevent destruction of the records by fire, flooding, thef t, and deteri-
-oration by environmental conditions such as temperature or humidity.
18.0 AUDITS Audits are performed in accordance with preestablished written procedures or check lists and _ conducted by trained personnel not having direct responsibilities"in the areas being audited.
Audit results are
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documented _ and then reviewed with management inving responsibility in the area audited. -Responsible management takes the necessary action to correct. the deficiencies revealed by the audit.
Deficient areas are reaudited on a timely basis to verify implementation of corrective ac-
-tions which minimize recurrence of deficiencies.
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NFS-CL-001, Rev. 3 Page 18 of 21 June 13, 1980 Audits include an objective evaluation of quality-related practices, procedures, and. instructions and the effectiveness of implementation; as 1well as objective evaluation of work areas, activities, processes, and itenis, and the review of documents and records.
Audits to assure'that procedures and activities are meaningful and comply with the overall Q. A. program are performed by:
a.
The Q. A. Function, to provide a comprehensive independent verification and evaluation of the quality-related procedures and activities.
b.
NFS and its principal contractors, to verify and evaluate their suppliers' Q. A. programs, procedures, and activities.
Audits are regularly scheduled on the basis of the status and safety importance of the activities being performed and are initiated early enough to assure effective quality assurance during the procurement and contracting activities.
Audit data are analyzed and the reports, which indicate quality
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trends and the effectiveness of the Q. A. program are reported to manage-ment for review and. assessment.
19.0 SPECIFIC PROVISIONS
'The General Provisions of the NFS Quality Assurance Program provide the controls to assure compliance with any specific provisions introduced,
in and specified by applicable D0T regulations, package approvals by the NRC, and package approvals that have been revalidated by the DOT and Subpart D of _10 CFR Part 71. The NFS Radioactive Materials Packaging Manual is a summary of these specific provisions. The manual is approved by and distributed to the responsible plant organizations who must be aware.of the' specific provisions.
The Q. A. Function is responsible for i
timely updating of the manual. The Q. A. Function is also responsible for maintaining current files for the packages listed in Appendix A.
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FIGURE 1 General
.Dnager i
~
Sales Administrative Materials Operations Finance f!anager
-Manager Manager
-Manager Manager j
l Industrial Data Systems Quality Control Seccrity l
Criticality &
Safety & Decem-l Licensing Mgr.
missioning Mgr.
Relatiens'Mgr'J Manager Manager Officer I
l I
I Q. A. Function i
i I
I i
fiuclear Safety Health Physics
& 2' M Scecialist
-Scecialist i
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NFS-CL-001, Rev. 3 Page 20 of 21 June 13, 1980 APPENDIX A Listed below are the packages.for which NFS at Erwin holds the NRC Certificate,of Compliance or is listed as a user.
Certificate Certificate Number
,Model No.
4915 1(EDL-55 4949 UNC-1484
.5059 NFS Tanker 5442 LA-36 5468 NFS-lX-A
~
5492 RMG-181-I 5517 BB-250-1 5687 RMG-184 5754
~
RMG-172 5768 BB-250-2
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5908 6M (Type B) 6273 48A, F, X&Y j
q 6387 ilEDL-60 6400 Super Tiger 6458 BU-5 6581 51032-1 9078~
GENS i
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9 I4FS-CL-001, Rev. 3 Page_21.of 21~
June 13, 1980
^
APPENDIX B Matrix of NFS Procedures Cross Referenced to s
Criterion of Appendix E of 10CFR71 Criterion P
- v
.1 :2' 3:'4.5 6 7. 8 9 10 11 12 13 14 15 16 17 18 R
A
-x x x x x xx x x x x
x x
x x
x x
x 0-N C.
B x
x x
x F.E
-C x
x x
3 U
D x
f-E x
S F.
x x
x x
x Index of NFS Procedures:
A.
Quality Assurance Manual for Shipping Packages for Radioactive.
materials..
B.
Radioactive Materials Packaging Manual C.
Procedure for Shipping Radioactive Materials D.
Training Procedures y
E.
Document Control Procedures
~F.
Procedures for Packing, Testing and Inspecting Packagings (contained in various Standard Operating Procedures) g I
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