ML19248D513
| ML19248D513 | |
| Person / Time | |
|---|---|
| Site: | 07100109 |
| Issue date: | 05/18/1979 |
| From: | UNION CARBIDE CORP. |
| To: | |
| Shared Package | |
| ML19248D512 | List: |
| References | |
| NUDOCS 7908160353 | |
| Download: ML19248D513 (37) | |
Text
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PACKAGING QUALITY ASSURANCE PROGRAM Union Carbide Corporation Medical Products Division Sterling Forest Research Center Tuxedo, New York 10987 REVISIONS Dated 5/18/79 mp.;o_G e
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REVISION SHEET Revision Page Subject Of Authorized Number Number Revision Date By 1
1 6/29/7C
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1.
UCC MEDICAL PRODUCTS DIVISION PACKAGING QUALITY ASSURANCE PROGRA'4 INTROCUCTION The licensee is currently engaged in the manufacture of various radiochemical products for sale on a commercial basis.
The majority of shipments of such products consist of discrete packages, each containing only one relatively pure radionuclide, destined for use in the field of nuclear medicine.
Four radioisotopes (Mo-99, I-131, I-125, and P-32) contribute by far the largest portion of the licensee's shipments at this time.
Since most recipients of the licensee's products possess limited facilities for the handling of radioactive material, and most shipments travel by means of commercial transport, the packages are designed to be both simple and sturdy, facilitating maintenance and repeated useage of each container.
Due to the simple nature of the containers used for pack-aging the licensee's products, and the routine nature'of most shipments made by the licensee, it is felt that the Packaging Quality Assurance program should also be of a simple and straightforward nature.
In this manner, it is helieved that the interests of safety and package integrity can best be served within the limited scope of the licensee's activities by the small staff available, while at the same time minimizing confusion and redundant effort.
Other than packages designed for shipments of such products, the only packages utilized for the transport of radioactive material which are under the control of the licensee are those used for the removal of radioactive waste generated during conduct of production operations and processes._and spent reactor fuel elements.
These containers are also of a simple and rugged nature, and may be included under the provisions of the same Quality Assurance program.
Specific items covered by this program include:
1.
Glass and polyethylene bottles of various sizes.
2.
Disposable lead shipping containers ranging in wall thickness from 1/8" to 1 3/4" for shipment of Type A quantities of radioactive materials.
U. w, "w,
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Rev. 5/18/79
2.
INTRODUCTION (cont'd) 3.
Sealed metal cans to enclose lead shielded shipping containers for Type A quantities of radioisotopes.
4.
Corregated paperboard boxes for Type A shipments.
5.
Lead shielded gas cylinders for shipment of Xe-133 at less than atmospheric pressure.
6.
Returnable steel clad lead containers fcr shipment of Type A and Type B quantities of radioactive material.
7.
Returnable stainless steel clad depleted uranium con-tainers for shipment of Type B quantities of radio-isotopes.
8.
Brass and/or stainless steel Type 2R containers fou-Type B shipments.
9.
Steel' clad wooden jackets, Type 20 WC-2, to enclose returnable shipping containers.
10.
Spec 17H steel drums for disposal of radioactive waste.
11.
Stainless steel clad, lead filled Type B-3 transport shields for radioactive warte shipments.
12.
Packagas approved for irradiated MTR fuel elements for which the licensee is a registered user.
Rev. 5/18/79 t go,2 3
sW2 G ts n '
APPENDIX E CRITERIA 3.
1.1 ORGANIZATION Since all of the activities involved in packaging of the licensee's products are conducted within the Radiochemical Production Department, day to day performance of routine packaging quality assurance functions will also be localizcd within this group.
Overall responsibility for the packaging quality assurance program will be in the hands of the Manager of Radiochemical Production.
The Manager of Radiochemical Processing, with the assistance of the Health Physics Supervisor, will be directly responsible for implementation of the program, to include design and procurement criteria; inspection of mamerials, equipment and facilities as necessary, and such testing as is required to meet the standards set our by 10 CFR Part 71, subpart C.
The Supervisor of Radiochemical Processing will oversee the packaging and shipment of radiochemicals, and will see to it that routine, day to day inspection of outgoing parcels and returned shipping containers are performed by the senior technician of the packaging group within the Radiochemical Production Department.
In addition, tne Supervisor of Health Physics will have the authority to call for any repair, modi-fication, or test of such packages that he deems necessary under 10 CFR Part 71, and it will be the responsibility of the Supervisor of Radiochemical Production to ensure that such repairs, modifications or tests are promptly carried out, properly executed, and correctly documented.
The Nuclear Safeguards Committee will also have the responsibility and authority to provide an effective oversight of all functions in-volved under this Q.
A.
program, including the initiation of such actions as may be needed to ensure or improve compliance.
This committee meets periodically (or as needed) at the UCC Stering Forest Laboratory to review those activities which have, or may have, an impact on the safe performance of all operations involving radio-active material.
e,cn.
G J W.,.3. s Rev. 5/18/79
APPENDIX E CRITERIA 4,
1.1 ORANIZATION (cont'd)
Quality Control functions relating to packages of a non-routine or particularly hazardous nature will be directly supervised or performed by individuals possessing specific competence to direct such activities.
In most cases, these individuals will be supervisory personnel from the Poactor Operations, Radiochemical Production, or Facilities Engineering groups, with guidance from the Hsalth Physics Dept.
Through experience and educational background, such people will possess a thorough knowledge and under-standing of regulations pertinent to sh!.pment of packages containing radioactive materials and an awareness of any particular hazards associated with a specific type of package.
(SEE FIGURES 1 & 2)
)
+ d om 6/29/ 78
APPENDIX E CRITERIA FIGURE 1 ORGANIZATION CHART Manager Nuclear Products Manager Manager Radiochemical Health, Safety, &
Production Environmental Affairs Manager Man'ager Supervisor Nuclear Operations Radiochemical Health Physics Processing Supervisor Asst, Supe rvisor Senior Health Facilt i ti t s Radiochemical Physic Technician Engineering Production Reactor Senior Technician Health Physics Supervisor Radiochemical Technician Packaging Radiochemical Packaging Technicians
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1 Dotted lines indicate paths along which responsibility may be shared, or concurrenca achieved on items of conceun.
Rev, S/18/79
APPENDIX E CRI"'ERI A FIGURE 2 RESPONSIBILITY MATRIX Q.A.
MANAGER MANAGER SUPERVISOR SENIOR PACK.
SUPERVISOR FUNCTIONS RC PROD'N RC PROC.
RC PROD' N TECIINICIAN IIEALTII PIIYSICS NSC 1.
Q.A. Program A,C,D B,C, B,E E
B,C, 2.
Training A,D B,D,E E
C,E
- 3. Certification A,D B
C 4.
Testing A
B,D D,E E
A,C,D 5.
Document Change A,C,D B,D,E B,E B,C 6.
Inspection A
B,D,E D,E E
C,D,E 7.
Shipping A
A,D B,D E
8.
Specifications A
B,C C
9.
Audits A
B D,E A:
Approve B:
Accept
- f C :
Concur
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D:
Initi$,te E:
Perfo1m Nu.
5/1R/79
APPENDIX E CRITERIA 5
1.2 OUALITY ASSURANCE PROGRAM 1.
Since the Manager of Radiochemical production will exercise overall authority regarding the Quality Assurance program, the entire program and any revisions to it must be approved by him, with the concurrence of such other com-petent managerial positions as he deems appro-priate for particular items.
The Q.A. program itself will be disseminated and implemented under his approval as an integral part of the regulations cnd operating procedures of the Radiochemical Production Department.
2.
Due to the simple and rout i.ne nature of most shipments of radioactive material from this facility, personnel will be qua12: led to per-form basic visual inspection of standard packages through on-the-job training and instruction re-garding those sections of the applicable regula-tions pertinent to this type of shipment, luality Control functions applicable to non-routine items or activities will be performed by indivi-duals who have demonstrated competence in the area involved, either by virtue of educational back-ground or through acquired experience.
Training required for the acquisition of such competence will be directed by the Manager of Radiochemical Production, with the aid of such other qualified individuals as is appropriate or necessary.
3.
All personnel whose work assignment may occasionally require the performace of any packaging Q.A.
function will be instructed by the Health Physics Department to the extent that they may perform basic inspections of packages sufficient to detect obvious flaws.
Any personnel assigned to work dircctly in the packaging area will be further instructed, under the direction of the Manager of Radiochemical Processing, to the point that they will have a demonstrated working knowledge of applicable regulations and safety criteria sufficient to ensure that no sub-standard package will be released for shipment.
Packages other than routine shipments of radiochemical prodr.sts will be prepared under the direct control of supervisory personnel who have demonstrateri a thorough understanding of the pertinent reella-tions and the parameters which such regulat:ons are meant to control.
v33C18 Rev. 5/18/79
APPENDIX E CRITERIA 6*
1.2 QUALITY ASSURANCE PROGRAM (cont'd) 3.
As previously mentioned, the Q.A. program will be promulgated by management as an integral part of the operation procedures and regula-tions for the Radiochemical Production Dept.
All revisions to the Q.A. program must therefore be reduced to written form and approved by the Manager of Radiochemical Production, with the concuerence of the Supervisor of Health Physicc, before any such revision can take effect.
A record of these revisions will be maintained on file.
4.
Specific Q.C. procedures for each type of package will be provided for the use of those personnel preparing such packages for shipment.
Means for ensuring that these O.C. procedures have been satisfied in each case will be pro-vided, through check-off procedures, tagging, labelling, or logbook entries, as is best applicable to the particular type of package.
Engineering procedures and package design pro-visions will be satisfied by similar means, under the oversight of trained supervisory personnel whare appropriate.
5.
Such package characteristics which have any bearing on the safety of a given shipment will be clearly and specifically delineated through the Q.A. program, and each such item will be subject to particular control through this program.
The Q.A. program will provide that all safety criteria pertinent to each package are satisfied prior to the shipment of that package.
p* *, ~. q 6/?.9/78
APPENDIX E CRITERIA 7.
1.2 QUALITY ASSURANCE PROGRAM (cont'd) 6.
As described in (3) on the previous page, the packaging Q.
A.
program is to be fully integrated into the operating procedures and regulations of the Radiochemical Production Department.
As such, it will be included as a discrete section of the Procedures Manual for this department, along with any and all approved revisions.
Distribution of this manual and revisions are controlled by the issuance of one copy each to the following:
1)
Secretary, Nuclear Safeguards Committee 2)
Manager, Nuclear Operation - in Reactor Control Room 3)
Reactor Supervisor - Training Copy 4)
Manager, Radiochemical Production 5)
Manager, Radiochemical Processing 6)
Site Library 7)
Manager, Nuclear Products 3)
Senior Development Scientist 7.
As a specifically designated portion of the official operating procedures, this Packaging Q. A.
- manual, and all policies and procedures described in it, are mandatory requirements wnich must be followed and implemented by all personnel involved.
Such adherence to all provisions will be enforced in all cases by the Manager of. Radiochemical 'roduction.
8.
Any dispute involving the quality of packaging arising from differences of opinion between persons exercising QA/QC responsibility and any other group shall be resolved first by the Supervisor of Health Physics.
If such a decision is not deemed satis-factory by either party, questions may be escalated to the Manager of Radiochemical Production, acting in concurrence with the Manager of Health, Safety, and Environmental Af f airs.
If further resolution is required, the Nuclear Safeguards Committee will provide a final and binding decision.
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=e 5/18/79
APPENDIX E CRITERIA 8.
1.3 DESIGN CONTROL Although the shipping containers currently used by the licensee are relatively straightforward in design, being meant to provide radiation shielding and accident protection for routine shipments of radiochemicals, it is recognized that appropriate design control measures must be exercised to assure compliance with applicable regulatory provisions and to ensure safety during transport.
For this reasons, all aspects of design of such containers will be approved by the Manager of Radiochemical Production, with the aid and concurrence of the Manager of Health, Safety, and Environrental Affairs.
Such ap-proval will include a review to ensure (1) that all pertinent inspection and test criteria are identifiec and delineated in the appropriate documentation and/or drawings, and (2) that all design characteristics may be adequately controlled, inspected, and tested.
Since the shipping containers under consideration are neither complex nor fragile, it is felt diat such centralized control will be most effective in main-taining high standards of quality and guaranteeing compliance with regulatory requirements.
The job requirements of these two positions are such that a thorough understanding of the pertinent regulatory areas and of engineering requirements fer safety is assured.
Inclusion of the Manager of H,S, and EA in the review and approval process for package design will in all cases provide design verification by an individual of authority in a completely separate line of responsibility from that of the designer.
In most cases where any major changes in package design or application are envisaged, design criteria
- w. ll be verified through testing of srch packages prior to their use.
All such design,4 pplication, or specification changes are subject to'the same design controls and approvals as were applied to the original design of the item.
Such testing will subject the package design under consideration to the most adverse desi gn conditions, and will be directed and approved by the Manager of Radiochemical Production.
Engineer-ing studies or computational methods mcy be substituted for such testing in cases where the use of these means is more appropriate.
s
- u. Mo. a Rev. 5/18/79
APPENDIX E CRITERIA 9.
1.3 DESIGN CONTROL (cont'd)
Package or container designs will not be approved unless design criteria and paramevers necessary to ensure regulatory compliance and safety are cor-rectly and clearly translated into specifications and drawings.
In addition, specific procedures and instructions will be provided in writing where ne-cessary to facilitate such compliance.
Such instruc-tions may include selection of suitable parts, materials, or components, or such other information a' necessary.
Where specific regulatory criteria ure pe -tinent to a package design, such criteria will be inc?uded in package design documents.
All p,ckage design drawings and documentation will be cir ulated to individuals listed on the following checkl.st, a copy of which must accompany such draw-ings rad documentation.
No fabrication of any type will be authorized without written approval on this checklist.
-v d. o.m.,
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.s Rev. 5/18/79
10.
PACKAGE DESIGN AND DOCUMENTATION REVIEW AND APPROVAL CHECKLIST Package Type and
Description:
New Item #:
or Revision #:
to Item #:
Test and Inspection Criteria:
Designed By:
Checked By:
Review:
Manager, Radiochemical Processing:
Comments:
Manager, Nuclear Operations:
Comments:
Supervisor, Health Physics:
Comments:
Verificatio:. and Approval:
Manager, Radiochemical Production Approved:
bd Changes Needed:
Manager, Health, Sa fe ty, & Environmental Affairs:
Approved:
br) chages Needed:
- g.rn O s I *s SJrs; 5/18/79
APPENDIX E CRITERIA 11.
1.4 PROCUREMENT DOCUMENT CONTROL In any case where material, equipment, or services whose use is governed by 10 CFR Part 71 are pro-cured by the licensee from an outside supplier, the applicable requirements of 10 CFR Part 71 will be clearly included in the procurement documentation.
Particular attention will be devoted to such pro-visions as are related to safety of shipments, and in such instances the supplier will be required to document his compliance with the appropriate sections of 10 CFR Part 71.
In addition, the supplier will be required to provide a quality assurance program in compliance with the pertinent provisions of this part whenever such a program is deemed appropriate.
6/29/78 n < r...
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APPENDIX E CRITERIA 12.
1.4 PROCUREMENT DOCUFlNT CONTROL (cont'd)
Preparation of procurement documents and any changes or revisions thereto are under the supervision of the Manager of either Radiochemical Processing or Nuclear Operations.
Such documents will either contain or re-ference the necessary design basis technical requirements for each item or type of item being purchased as to ensure compliance with these requirements, and will clearly identify the documentation required from the supplier for review and approval by the purchaser.
This identification will also specify which documents and records are to be prepared and retained by the supplier, as well as those which are to be delivered to or controlled by the purchaser.
All procurement documents, changes, or revisions, will be reviewed by the Supervisor of Health Physics or the Manager of Health, Safety, and Environmental Affairs prior to approval to ensure agreement with all appropriate design specifications and compliance with applicable regulatory requirements.
Final approval of procurement documentation including changes and re-visions will be provided by the Manager of Radiochemical Production only af ter this review has been accomplished.
Also, no procurement document will be approved unless the purchaser's right of accass to the supplier's facilities and records for source inspection and audit is clearly specified.
Control of procurement documents will be exercised by the Materials Management Group until all items referred to in these documents are received and ap-proved for use by the appropriate and competent authority.
At this time, control of the documents will be transferred to the Manager of Radiochemical Production, who will see to it that they are properly maintained and filed in such a way as to be traceable to the specific item.
v.'.yk' O r. < :
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5/18/79
APPENDIX E CRITERIA 13.
1.5 INSTRUCTIONS, P ROCE DURES, AND DRAWINGS General instructions meant to ensure a high level of quality and safety in the packaging of radioactive materials for transport are included in this program, under the headings of "Handlino, Storage, and Shippin g" (pp.
),
and "Inspeccion, Test, and Operating Status" (pp.
).
Where appropriate or necessary, specific instructions, procedures, and drawings will be provided to maintain or improve s tandards of quality and safety.
Included in such instructions will be any quantitative or qualitative accaptance criteria pertinent to the particular package or shipment under connid iration.
Means will be provided, through check-off oneets, logbook entries, or other applicable records, co document the safisfactory accomplishment of such activities.
Instructions, procedures, and drawings are subject to similar measures of control as are applied to designs (11. 3), and mt'st be accompanied at all times by an identical review and approval checklist.
No such documentation will be accepted as official until this checklist has been completely filled out, indi-cating approval.
All such completed checklists will be filed with the original documentation and all re-visions in a master file for the item maintained by the Radiochemical Production group.
Rev. 5/18/79 v.J.y,,. -
n.
, G.. is a
APPENDIX E CRITERIA 14.
1.6 DOCUMENT CONTROL All documents relative to any particular shipping package will be under the control of the individual responsible for the shipment of such a package.
In most cases, such documents will be controlled by the Supervisor of Radiochemical Production, as most shipments made by the licensee consist of packages containing radiochemical products.
Do-cuments relevant to other types of packages, su:h as shipments of radioactive waste materials for disposal, or service irradiations, or spent reactor fuel will be under the control of supervisory per-sonnel from the particular group directly involved with such packaging.
In addition, documentation regarding non-routine packages or shipments which may pose particular safety or radiation hazards will be available to the Supervisor of Health Physics for approval and confirmation that all applicable Q.C.
and O.A. provisions have been complied with.
No changes will be made to any document regarding the packaging and shipment of radioactive material without the approval of a competent individual in a position of authority regarding the prepara-tion and shipment of such a package.
The specific individual involved will, of course, depend on the particular type of package under discussion.
No changes in such documentation which are pertinent to the safety of a particular shipment will be made without the concurrence of the Health Physics Dept.
?
f}ne ;p>y U =. A / e..s..
- Rev. 5/18/79
APPENDIX E CRITERIA 15.
1.6 DOCUMENT CONTROI; (cont'd)
Since each change in documentation must be accompanied by a checklist ( l.5), an immediate reference is available to determine whether or not the change has received final, official approval.
All documentation will be traceable through such checklis ts to the master file for the item under question, and no changes will be implemented until approval has been verified by signature on such checklists.
A master list, identi-fying each revision, including the current revision will be kept in the master file for each particular item or type of item.
REVISION SHEET Revision Page Subject Of Authorized Number Number Revision Date By i
5/18/79 s 13 "9 " '. e'
- ^i
APPENDIX E CRITERIA 16.
1.7 CONTROL OF PURCHASED MATERIAL, EQUIPMENT, & SERVICES All purchased material, equipment, and services will be examined by the licensee to ensure con-formance with procurement documents.
The supplier of such items will be required to provide documented evidence of the quality of these items and their compliance with all pertinent regulatory requirements.
Such evidence will be provided to the licensee by the supplier before any such purchased material or equip-ment is placed into service.
This documentation, and any objective evidence of quality, shall clearly reference the specific regulatory or quality assurance provisions met by the purchased items.
All such records shall be retained by the licensee in a form traceable to the specific item, or, if more appropriate, group or type of items, whose quality is under consi-deration.
To further control the quality of such purchased products, the licensee will, when appropriate, inspect the supplier's facility, work in progress, and quality assurance program.
In addition, the licensee will, on occasion, perform such tests on purchased items as are necessary to guarantee the maintenance of high standards of quality and safety.
Included in the evaluation of potential suppliers will be their capability to comply with the applicable portions of Appendix E to 10 CFR Part 71 as demonstrated by past perfcrmance in supplying such items to UCC or other purchasers.
If records of previous performance are not available, the supplier's production facilities and Q.A. program will be studied by competent personnel to determine that the capability is available to meet the requirements for compliance.
$n a. c)
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Rev. 5/18/79
APPENDIX E CRITERIA 17.
1.8 IDENTIFICATION AND CONTROL OF MATERIALS, PARTS, AND COMPONENTS As specified under the heading " Design Control" (pp. 6 ),
applicable regulatory requirements and quality assurat. e criteria will be clearly trans-lated into specifications, drawings, procedures, and instructions. Where appropriate, such instruc-tions will call for the positive identification of material, parts, or components throughout fa-brication, installation, or use of the item.
This identification will be made on the basis of heat number, part number, or other such means as is specifically appropriate to the piece under consi-deration.
Such identification will be traceable to a particular completed item, or type of item, either at the item itse]f, or through documenta-tion specific to that item.
Particular care will be taken to ensure that through this procedure no incorrect or defective parts, material, or components are put into use.
The method and location of this identification will be individually determined by each item under con-sideration to ensure th at the fit, function, or quality of the item is in no way compromised by the identifi-cation system.
No item will be accepted for use unless documentation and verification are provided establishing the correct identification of all critical materials, parts, and components.
Rev. 5/18/79 b33230
APPENDIX E CRITERIA 18.
1.9 CONTROL OF SPECIAL PROCESSES Special processes, such as welding, heat treating, or non-destructive testing, will be performed only by qualified personnel.
Prior to the start of such processes, an evaluation will be performed by the Supervisor of Health Physics, or such other ccm-petent authority as may be appropriate, to deter-mine the applicability of the various codes, standards, specifications, criteria, or regulatory provisions which may have a bearing on the process under consi-deration.
A procedure for performance of the pro-cess will then be established to ensure compliance with such requirements and assure that the quality and safety characteristics of the item under process are maintained.
Upon completion of such processing, the item will be inspected by the Supervisor of Health Physics te guarantee that all requirements have been met and the quality of the item has not been compromised.
As such special processes are performed, a record of the procedures developed, the equipment utilized and the qualifications of the personnel involved will be established, filed in such a way as to be traceable to the appropriate ite ns, and Kept current as changes occur.
A copy of these qualification records will be maintained with the Packaging O.A.
manual so as to facilitate assignment and performance of tasks required for such special processes.
L2) n.,,.J. d. -
Rev. 5/13/79
APPENDIX E CRITERIA 19.
1.10 INSPECTIOt]
All activities which could af fect the cuality of packages containing radioactive material for shipment will be subject to inspection under the direction of the Manager of Radiochemical Production.
Such inspections will be conducted to verify con-formance of the activity with documented drawings, instructions, and procedures for its accomplishment, and to maintain high standards of quality and safety.
In general, such inspections will be carried out by individuals having line authority over those who perform the activity.
In addition, such acti-vities may be inspected by other individuals pos-aessing special competence to evaluate the ac-complishment of the activity.
These inspections will be carried out on a regular basis, the timing of which will be dictated by the safety significance of the activity in question and the need to maintain a high level of quality.
Instructions for performance of manufacturing and production processes will include provisions for such inspection, including tests and examination, by mandating specific hold points beyond which work cannot progress without approval by a desi-gnated inspector, or by specifying particular pro-cesses which must be monitored by such an inspector or witness, or both, as necessary.
- 9) m
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6/29/78
APPENDIX E CRITERIA 20.
1.10 INSPECTION (cont'd)
All modifications, repairs, or r3 placements will be subject to the same mode of inspection as required by the original design, where this is practical.
If this is not fe as ib le, inspection methods will be required to establish that the original technical criteria are met through alternate inspection tech-niques.
In the event that speciric codes or standards are applicable to such inspections, specific inspectors will be trained and certified, where necessary, in the appropriate methods and techniques.
In o the r cases, company training programs will be utilized to develop the necessary expertise to perform these inspection functions competencly.
Qualification, certification, and training records of such inspectors will be kept on file with the Packaging Q. A. manual to provide ready reference sc that the appropriate individual may be assigned responsibility for each such inspection.
5/18/79
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Es
APPENDIX E CRITERIA 21.
1.11 TEST CONTROL, Specific written test procedures will be used to verify that all packaging components will perform satisfactorily in service.
Such tests will be written in accordance with the requirements of 10 CFR Part 71 and the requirements and acceptance limits of the specific package approval.
These tests will be conducted under the direction of the Supervisor of Health Physics, with the assistance of such other competent authority as may be ap-propriate in each case.
Test procedures will be written in such a manner that all prerequisites for the est are met, adequate test instrumentation is available and praperly utilized, and the test is performed under suitable environmental condit. ions.
Test results will be clearly documented with parti-cular reference to the specific items under evalua-tion and the type of package or component being tested.
These results will be evaluated by the Supervisor of Health Physics to assure that test requirements have been met and that all applicable criteria have been satisfied.
Such results shall be kept on file and referenced to the particular item or type of item which has been tested.
Where feasible, all modifications, repairs, or re-placements will be tested in the same manner as that required by the original design.
Where this is not practical, alternate methods will be selected on the basis of their ability to satisfy the same criteria as specified in the original design and testing criteria.
,; n o s e Rev. 5/18/79 2
APPENDIX E CRITERIA 22 1.12 CONTROL OF MEASURING AND TEST EQUIPMENT All measurement and testing derices which are used in activities affecting the quality of packages containing radioactive material for transport, or which are used to evaluate the quality of such packages, will be controlled by the Health Physics Department.
Prior to the use of any such device it will be calibrated or adjusted as necessary to ensure its proper performance.
The accuracy of such devices will be verified by periodic calibration, and they will not be released for use unless they are accura te within the necessary limits.
Logbooks documenting such calibration or adjustment will identify the measuring and test equipment and provide traceability to the calibration test data for each item.
Calibration of measuring and test equipment will be performed and documented in such logs prior to its use to ensure that no inspections or tests are performed with equipment which is out of calibration.
Where possible, all standards used will be traceable to nationally recognized standards.
Where this is not practical, the basis for calibration will be selected and evaluated by the Supervisor of Health Physics, who. rill see to it that the needed verification and documentation are recorded along with the appro-priate data.
- v. ),.k ya0 Rev. 5/18/79
APPENDIX E CRITERIA 23.
1.13 HANDLING, ST0 dGE, AND SHIPPING Safety shall be the paramount consideration in the handling, storage, and shipping of packages for radioactive material.
Upon receipt of a returned package for such material, the entire package will be visually inspected by the Senior Technician of the packaging group to determine the extent of any damage which may have occurred during shipment.
Since these packages are relatively simple in nature, specific items to be checked consist of: (1) status of outer 20 WC-2 jacket - secure fit of top and clinch ring; no puncture of outer steel drum or splitting of laminated plywood; no gross damage to threaded fasteners which would hinder subsequent closure of package; (2) condition of stainless steel clad lead or depleted U shipping pig - No significant radioactive contamination; no damage to lifting rings or eyes which could cause a hazard when the pig is lifted; no damage to threaded components which could prevent lid from being securely fastened; (3) condition of inner Type 2R container - Level of radioactive contamination and/or radiation readings below hazardous levels (100 mR/hr.);
lifting bail in satisfactory condition; no damage to threaded closure.
Type B-3 containers for ship-mant of radioactive waste shall be similary in-spected by an authorized member of the Health Physics or Reactor Operations group upon their return, Unless such packages are destined for immediate re-use, they shall be stored in a designated area, safe from possible damage.
They should be stored in a closed condition, with all parts in place, until they are to be used again.
An exception will be made in the case of any part which is not ready for use by virtue of damage or excessive contamination.
Such parts may be removed for repair or decontamination and subsequently stored separately until ready to be re-used.
No shipments wil: be made using any type of package unless all applicable tests, certifications and inspections have been completed.
In general, such tests will include: leak testing under vacuum of primary containers (bottles) containing sufficient radioactive material in liquid form that spillage may be a hazard; testing of Type 2R containers after closure under vacuum to ensure that they are sealed; written certification on the order / invoice
'h,
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6/29/78
APPENDIX E CRITERIA 24.
1.i3 HANDLING, STORAGE, AND SHIPPING (cont'd) from accompanying such shipments that these tests have been performed; certification that the con-tents of the cylinders containing gaseous Xe-133 are packaged at less than 1/2 atm absolute pre-sure; visual inspection of all shipping containers to ensure that all gaskets, packing material, and fasteners are properly located and secure; determination that the level of radiation emitted from any single package or array of such packages does not exceed applicable limits through the use of appropriate monitoring devices; wipe tests to ensure that no significant removable radioactive contamination is present on any package to be ship-ped; and a final visual inspection to ensure that all necessary and appropriate seals, labels, signs, or other identifying devices are properly and securely affixed to each package.
In order to minimize unnecessary handling of radio-active materials and to ensure that all necessary tests, certifications, and inspections have been per fo rmed, responsibility is assigned as follows:
1.
Certification that leak tests on primary containers have been performed vill be done by the technician dispensing the material.
Pressure of Xe-133 cylinders will be similary checked and certified.
Secure, leak tight closures on Type 2R containers will be certified by either a member of the Health Physics Dept. or by supervisory personnel from the Radiochemical Production Department.
3.
The Senior Technician of the Packaging group will check that the above tests and certifications have been performed before accepting any such container for final packaging.
4.
Visual inspection of shipping containers, radia-tion monitoring, and wipe tests will be performed by members of the Packaging group under direction of the Senior Technician of the group.
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,y 6/29/78
APPENDIX E CRITERIA 25.
1.13 HANDLING, STORAGE, AND SHIPPING (con t ' d) 5.
Final visual inspection of each completed package will be performed by individual responsible for delivery of the package to its destination or to any other shipper.
Each package will be so inspected prior to being loaded into a transport vehicle, and will not be accepted unless all identifying tags, labels, seals, or signs are properly affixed and all shipping documentation is completely and correctly filled out.
The above procedures apply to all routine ship-ments of radioactive products, and shall be per-formed under the direct supervision of the Assistant Supervisor of Radiochemical Production.
Shipments of a non-routine nature, or those possessing particular characteristics which pose a potential safety hazard, will be crepared under the supervision of an individual knowledgeable of such particular hazards and competent, through training or experience, to ensure that all safety requirements are properly met.
In such instances, the Supervisor of Health Physics will also take a direct role in certifying that all necessary, appropriate, and applicable actions are taken to ensure that the shipment may be made safely.
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6/29/78
APPENDIX E CRITERIA 26.
1.14 INSPECTION, TEST, ANE OPERATING STATUS As previously stated, upon receipt of returned packages which have contained radioactive material, the Senior Technician of the Packaging group will perform a visual inspection of the entire package and all of its parts.
If this inspection indicates that the package is acceptable for icmediate re-use, the package will be stored in a designated area, and its presence in this area will indicate its availability for shipment.
If, however, any condition exists which indicates that such a package may not be suitable for im-mediate use, it will be segregated in another area and tagged to indicate that it may not be shipped.
In such a case, the Assistant Supervisor of Radiochemical Production, or other individual in a higher position of authority will be notified, and this individual will personally inspect the package, determine its proper disposition, and label it to indicate the action to be taken.
In addition, if any such repairs or modifications could pose a safety or radiological hazard, the Health Physics Dept. will be called upon to indi-cate any special precautions or actions which may have to be taken.
The status of any package, or part thereof, awaiting any such action, or being worked on, will be clearly indicated by tag, label, or marking, as appropriate, and any necessary information will be entered in the pertinent log-book, if such entries are applicable to the type of package under consideration.
In any case where such repairs are necessary, or modification of a package has been performed, the Senior Technician of the Packaging group will not accept the package for use until the repairs or modifications have been inspected and certified by either the Assistant Supervisor of Radiochemical Production, or a competent member of the Health Physics Department, or other responsible authority, if appropriate to the particular type of package.
Similar procedures will be followed in the case of any package which is undergoing test to determine its suitability for any specific packaging appli-cation.
Such containers undergoing test will be clearly marked, and will not be accepted for use until test results have been certified by the pro-per authority.
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6/29/78
APPENDIX E CRITERIA 27.
1.14 INSPECTION, TEST, AND OPERATING STATUS (cont'd)
In the event that any new or substantially changed packaging design is proposed for use, or a new application is proposed for an existing package design, it will be the responsibility of the Health Physics Supervisor to determine what type of tests and inspections are necessary to guarantee that all applicable safety and regulatory criteria have been met.
The Supervisor of Radiochemical Production will oversee the performance of such tests, and with the concurrence of the Health Physics Supervisor and approval of the Manager of Radiochemical Pro-duction, certify that the package design under con-sideration has been adequately tested and is suitable for its proposed use.
u30;.110 6/29/78
APPENDIX E CRITERIA 28.
1.15 NONCONFORMING MATERIALS, PARTS, OR COMPONENTS As mentioned under the heading " Inspection, Test and Operating Status" (pp.
),
in any case where a question exists as to the suitability of a particular package, container, or piece of equip-ment for use, the item will be segregated by location, if possible, and tagged to indicate its non-operational status, pending inspection by a competent individual in a position of authority.
Such tags will specifically identify the non-conforming and briefly describe the non-con formance.
After inspection, the item will either be accepted for use again, removed from service permanently, repaired, or reworked, as is necessary and appropriate.
Such disposition will be under the direct control of the Supervisor of Radiochemical Production, who will ensure that the status of the item is correctly stated, that the proper actions are taken in accordance with esta-blished procedures, and upon completion of the re-quired action, that all necessary documentation is correct and complete.
Such documentation will include the tag described above, along with other pertinent information, and will clearly specify the test or inspection re-quirements which must be met to justify restoration of the item to operational status.
Upon completion of the necessary tests or inspections, a report will be appended to the documentation describing their results, and delineating the further disposition of the item.
Such disposition will not be accom-plished until the report is approved and signed by competent authority, generally the Supervisor of Health Physics.
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1g Rev. 5/18/79
APPENDIX E CRITERIA 29.
1.16 CORRECTIVE ACTION All inspections, tests, and examinations conducted under this program, from those involving new material upon its receipt, to the final inspection of each package before shipment, are aimed at maintaing the highest practical standards of safety and quality, and so are meant to promptly detect any conditions adverse to the maintenance of such standards.
If, through these inspections or through other means, any deficiencies, deviations, defective material and equipment, or noncomformances are dis-covered, immediate action will be taken to identify their source or cause, and to correct the problem.
In the event of any such discovery, the Supervisor of Radiochemical Production will immediately be notified, and he will promptly take such action as necessary to mainta.in or achieve a condition of safety.
In the event that a significant condition adverse to quality, or a serious hazard potential, exists, other authorities having specific competence to deal with the problem will be conculted, and remedial action will be undertaken as soon as possible.
In the case of such a significant condition adverse to quality, the Supervisor of Radiochemical Production will thoroughly investigate the situation, with su~ch assistance as may be useful or necessary, to determine the cause of the condition.
He will then institute corrective action, subject to approval of the Manager of Radiochemical Production, to alleviate the existing situation and prevent recurrence of the condition.
He will also be responsible for the generation of a clear and accurate report, documenting identification of the condition, its cause, and the corrective action which was taken.
This report shall be forwarded to the Manager, Nuclear Products, and to such ather levels of management as may be appropriate.
" y *c o $ '.n tt 6/29/78
^ '
APPENDIX E CRITERIA 30.
1.17 QUALITY ASSURANCE RECORDS Records of the performance of all Packaging Quality Assurance operations will be in a designated lo-cation providing security for such records, while still allowing ready access when necessary.
The form of such records will be appropriate to the type of packaging involved and the nature of the information to be recorded.
Records which are spcci S c to one particular package, container,
- or piece of equipment will be referenced *. that particular item through the use of logboc.s, in which will be entered the results of all inspections and tests, as well as a record of all repairs or modifications which have been performed.
Reco rds referring to particular shipments will be kept in the form of completed check-off sheets or comple-tion notices indicating that all necessary Q.A.
functions have been performed and identifying the responsible individuals.
Those records which are of a general nature, such as audit results or the results of tests applicable to types of packages will be filed in the same location.
Copies of all current and past packaging procedures will also be maintained in this area, along with a copy of this Quality Assurance program.
In addition, all personnel currently involved in the packaging of radioactive materials or engaged in the Q.A. program will have copies of such docu-ments available for their use.
Included will be a clear description of the tasks for which each of the various positions involved in the packaging or shipment of radioactive materials is responsible, as well as a listing of what areas of authority regarding the Q.A. program are to be exercised by personnel at different levels of responsibility or operating groups.
All such records will be maintained on file in such a manner that any specific information required will be readily accessible and traceable to a particular container or shipment.
A listing of the recordc on file and their location will be kept up to date to ensure that these documents are identi-fiable and retrievable.
It will be the responsi-bility of tne individual completing each record to forward it to the proper area for further disposi-tion, and the Supervisor of Radiochemical Production will see to it that this is acccmplished and that all such documents are properly recorded and/or filed.
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,v. N G 1.-
6/29/78
1*
APPENDIX E CRITERIA 1.17 OUALITY ASSURANCE RECORDS (cont'd)
Design related records will be maintained on file throughout the entire period during which a ship-ping package, or type of package, is kept in use.
All other records relating to quality of such pack-ages or shipments will be kept available for in-spection for at least two years.
All inspection and test records will describe the type of observation involved, and will include evidence that all pertinent manufacturing, inspection, and testing operations have been completed and verified.
This evidence will include the date on which such operations were performed, identification of the individuals involved, and the results of the test or inspection.
In addition, where necessary, infor-mation will be included describing any conditions which could adversely af fect the quality of the item or the acceptability of the tests results.
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5/18/79
APPENDIX E CRITERIA 32.
1.18 AUDITS The packaging quality assurance program will be audited on a yearly basis by a representative of the Nuclear Safeguards Committee, and the results of such audits will be reported to the Manager, Nuclear Products.
The primary concern in such audits will be the hazard potential involved in all aspects of the packaging operation, and audits will be intended to improve or maintain a high level of safety, for employees of the licensee, for the ultimate recipient of packages containing radio-active material shipped by the licensee, and for members of the general public who may be in proxi-mity to such packages during their transport.
The Manager, Nuclear Products will evaluate the reports of all audits, with the assistance of such competent authority as he leems necessary, and direct that areas of deficiency be corrected.
The Manager of Radiochemical Production shall direct such corrective activity, and approve its completion.
Audi*t reports and reports of corrective actions shall be maintained on file as part of the packaging quality control records, and will be traceable to such other items in these records as are pertinent.
6/29/78 g, ' },' ),] 'j,
DRAWINGS (sent)
XENON SHIPPING CONTAINER No. 101256 10 ML XENON SHIPPING CONTAINER No. 101270 2
STEEL CLAD SHIPPING CONTAINER 150 lbs. No. 100880 2"
STAINLESS CLAD SHIPPING CONTAINER No. HL-09 2R CONTnINER No. 100959B SK712 2RM 200 Seconday Container STAINLESS CLAD SHIPPING CONTAINCR 240 lbs. P-3 No. 100710 GRP URANIUM CASK No. 101259 (General Electric) 8400 J1cket 8590 Model (Standard Lid) Isotopes Mo-99 No. 289E796 (General Electric) 8400 Isotope Shipping Cask 8500 Model (Isotope - LSA Mo-99) No. 195F169 20 WC-2 PROTECTIVE JACKET No. 100964 D G.' }."h3 'i i v