ML20246N206
| ML20246N206 | |
| Person / Time | |
|---|---|
| Site: | 07100087 |
| Issue date: | 01/18/1989 |
| From: | Colavito T NAVY, DEPT. OF |
| To: | NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20246N171 | List: |
| References | |
| 25312, NUDOCS 8903270323 | |
| Download: ML20246N206 (11) | |
Text
_
A DEPARTMENT OF THE NAVY 4
I USS PUGET SOUND (AD-38) j FPO NEW YORK, N.Y. 09544 9090 Ser AD38 58/049 18 January 1989 From:
Commanding Officer, USS PUGET SOUND (AD-38)
To:
- Director, Office of Nuclear
- Material, Safety and Safeguards, NMSS, U.S.
Nuclear Regulatory Commision, Washington, DC Via:
(1) Commander, Naval Surface Force, U.S.
Atlantic' Fleet (ATTN:
LCDR James'P. Grub er, ' Assistant Chief of Staff l
Engineering, Code N421N)
(2) Officer.in Charge, Naval Sea Systems Command Detachment, Radiological Affairs Support Office l
APPLICATION' FOR APPROVAL OF QUALITY ASSURANCE PROGRAM FOR i
R ADIO ACTIVE.M ATERI AL PACKAGES ASSOCIATED WITH RADIOGRAPHY AND HADIAC CALIBRATION Enc 1:
(1) Quality Assurance Program for Radioactive Material Shipping Packages Associated with Radiography and Radiac Calib ration, 'Instruc tions (5100.21 Series) 1.
Enclosure (1) is s ub mi t te d for review and approval and supersedes previously approved programs under Docket Numb er 71-0087 2.
The scope of the change includes procedures to better clarify i
re s ponsib ilitie s and procedures in accordance with 10CFR 71 and I
includes improved audit plan, QA Program attributes, and record retention.
3.-
Present terms and conditions under Docket Numb er 71-0087 will be complied with until approval is granted and received on NRC Form 311, Quality Assurance Program approval.
C J.
COLAVITO j
Copy to:
COMLOGGRU TWO (w/o enc 1) i 4
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p DEPARTMENT OF THE NAVY l
USS PUGET SOUND (AD-38)
FPO NEW YORK, N.Y. 09544 AD38 INST 5100.21 05:alc.
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USS PUGET SOUND-(AD-38) INSTRUCTION 5100.21
~
Subj:
QUALITY ASSURANCE PROGRAM FOR RADIOACTIVE MATERIAL SHIPPING PACKAGES ASSOCIATED WITH RADIOGRAPHY AND RADIAC l
CALIBRATION J
I Ref:
(a) Title.10, Code of ~ Federal Regulations, Partj71 Subpart' l
H-QA
~
(b ) OPMAVINST. 6470.3 Navy Rad la t i on Sa f e ty Conmi t't ee
- I
.i Encl:
(1) Quality' Assurance Program (2) Packaging QA Record Retention Program
~
(3) QA Program Audit Checklist 1.
Purpose. To establish and. ma i n t a i n an auditable QA' Pr og r am for
- s. hipping packages for radioactive material associated.with radiography.
2.
Backgrou'nd.
Reference' (a) established the requirement 'for PUGET SOUND to execute the subject QA Program and states the required attributes of the program.
3.
Scope.
This instruction' applies only to shipping. packages intended for-use with radioactive material associated with-radiography and. radiac - calibrat ion.
It specifically does not apply to shipping of. radioactive materials associated the Naval Nuclear Propulsion Plants.
4.
, Procedures.
Enclosure (1) is hereby established as the basic QA Program for PUGET SOUND for purchasing,
- handling, shipping, storing, inspecting, operating, a n d. ma i n t a i n i n g, packages for use in shipping radioact ive mater ials associated with radiography and radiac calibration.
"QA" comprises all planned and systematic.
1 actions necessary to provide adequate.. confidence that a system or component will perform satisfactorily in service.
The.QA program contained
.herein is approved by the Nuclear Regulatory Conmi s s i o n.
5.
Action.
The Radlation Safety Officer (RSO),
unde.r the supervision of the Repair Officer, shall implement, execute and ma i n t a i n ~ t h i s QA Program as outlined in enclosures (1), (2) and (3)..
The Radiation, Safety Officer shall insure that transportation and receiving activities meet the requirements of 10CFR 71.101.
This requirement is satisfied by obtaining certifications from package suppliers (ie, certificates of compliance, NRC Form 618 and materials license NRC Form 374).
6.
Annual Review.
This instruction shall be reviewed by the Radiation Safety Officer and updated as required prior to expiration date. indicated in block 3 of the Quality Assurance Program approval'(NRC Form 311).
Updates to program will be
s AD381NST 5100.2!
submitted for approval to the
- Director, Office of Nuclear Material Safety and Safeguards, U.S.
Nuclear Regulatory Conmi s s i on in advance of program expiration to insure continuity.
Any change to this instruction or its procedures shall require prior approval by t he Nu c l ea r Re g u l a t o r y Conmi s s i on.
l T.
- 3. COLAVITO 1
2
AD381NST 5100.21-Quality Assurance Program 1.
Organization (Ref.
Responsibility for the Quali ty Assurance (QA) Program rests with PUGET SOUND.
The QA Program is implemented using the following organization:
Corrma nd i n g Of f i ce r Repair Officer Quality Assurance Officer Radiation Safety Officer (RSO)
Radiological Controls Officer (shipping)
Assistant Radiation Safety Officer (ARSO)
Senior Radiographer j
Radiographer l
- The QA Officer is responsible for scheduling of Audits by personnel not having direct responsibilities in the areas being audited and training of NDT personnel.
- The RSO is responsible for overall administration of the program, certification, and document control.
- The Radiological Controls Officer is responsible for shipping.
- Radiographer are responsible for handling, storing, inspecting and record keeping.
2.
Program:
(Ref. 10CFR 71.105) PUGET SOUND QA Program will be guided by written instruction contained herein.
This instruction will be the basis of Qje li ty Assurance and the guidance provided l
will be used throughout the period during which packaging is used.
The compoi.ents to be covered by this Quality Assurance Program include:
(1) Mode 1 660 Ganma-r ay Exp o s u r e Dev ice.
(2) Model 650 Source Changer.
(3) Model 520 Gamna ~-ray Exposure Device.
3 (4) Model 500 SU Source Changer, j
(5) Model TS-1216 Calibrator.
(6) Model AN-UDM-10 Calibrator.
l Enclosure (1) i 3
____-__-____ _-_ a
1 AD38 INST 5100.21 i
The Quality Assurance Program requirements and procedures are based upon:-
)
(1) The impact of malfunction or failure of the component
{
upon safety, i
(2)
The need for special controls and surveillance over processes and equipment.
(3)
The requirement for indoctrination and training of personnel.
3.
Procurement Documents:
(Ref.
0CFR 71.109)
Quality must. e 4
insured in documents for procurement of material, equipment and services.
Procurement of IR-192, CS-137 and AM-241 aboard PUGET SOUND will be guided by current directives outlined in SPCC Instruction 4235.108 Series, and safety precautions according to 10CFR Part 20.
Documents for procurement will be controlled through use of written procedures of:
(a)
NAVSUPINST 4000.34 Series (b)
SPCCINST 4235.108 Series 4.
Control and identification:
(Ref 10CFR 71.115 and 71.117)
(a) Assurance must be maintained that material, equipment and services conform to specifications of the procurement.
l Examination of the products must be made upon delivery and will be controlled and documented in accordance with enclosure (8) of AD38 INST 5100.19 and 5100.20 Series (Navy Radioactive Material Permits).
(b) Identification and control measures will prevent the use of
. incorrect or defective materials,
- parts, and components.
Model numbers will be checked upon receipt and will be verified to be authorized by Navy Radioactive Material Permits.
Device serial numbers will be logged in PUGET SOUND's NDT Lab " Receipt and Transfer Log" for accountability.
5.
Handling, Storage, and Shi g nq Control:
(Ref 10CFR 71.127)
Written procedure established for handling, storage and shipping are in accordance with PUGET SOUND NRMP Materials Permits.
6.
Non-conforming materials
- parts, components:
(Ref 10CFR 71.131) Written procedure established for control of materials, parts, and components which do not conform to license provisions are in accordance with PUGET SOUND NRMP Materials Permits.
7.
Corrective Action:
(Ref 10CFR 71.133) All personnel involved in the program are responsible for prompt reporting of conditions adverse to quality.
Once identified, corrective action must be pursued as appropriate.
Reporting will be in accordance with 10CFR Part 21 and maintenance of records will be in accordance Enclosure (1) 4
l 1
i l
1 1
(
l AD381NST 5100.21 i
)
with 10CFR 21.51.
l 1
8.
Records:
(Ref 10CFR 71.135) Records will be naintained to i
furnish evidence of quality.
Records must be identifiable and J
retrievable.
The Record Retent ion Program will clearly identify the nane of
- record, responsibility, location and duration required to be maintained.
9 Internal Inspections /Andits:
(Ref 10CFR 71.121 and 71.137)
Planned Audits will be conducted semi-annually to verify compliance with all aspects of the Quality Assurance Program.
The audits wil be conducted by trained personnel not having direct responsibility in the area being audited.
Audit personnel will be assigned by the Qualit Assurance Officer.
Audit records /y checklists a r. '
access to personnel will be provided by the RSO/ ARF.'.
Written report of discrepancies noted will be forwarded to the Conmand i n g Officer via the RSO, QA Officer and Repair Officer.
Completed audits with annotated corrective action taken will be kept as record by the QA Officer (NDT Lab) and copies maintained by the RSO.
Enclesure (1) 5
f u
i i
AD38 INST 5100.21 Packaging "QA" Record Retention Program 1
Name Responsible Location Duration Radiographer QAO/RSO RSO Files 5 years Training Audit Schedule QAO/RSO QA Office Indef.
I and Results Shipping RSO/ARSO RSO Office Files Indef.
Container 1
Certification Copy of License RSO/ARSO NDT Office Files Indef.
of Nb ter ial Receivers i
Reports of RSO/ARSO RSO Office Files Retain Defects Non-until Compliance after delivery of com-ponent Leak Check RSO/ARSO/R-6 R-6 Files 3 Years Records Package Survey RSO/ARSO/R-6 R-6 Files 3 years (Radiation)
Results RADCON off.
R-6 Files 3 years (Contamination) i Source RADOON Off.
R-6 Files 5 years Accountability and inventory Records (sub-custody card)
Receipt and RADCON Off.
R-6 Files 5 years Transfer Log after (10CFR 30.51) transfer Written Procedure RADCON Off.
R-6 Files
- Indef, for Shipping RADCON Shipping RADCON Off.
R-6 Files 3 years Personnel Training.
Enclosure (?)
6
t.,
e AD381NST 5100.21 Name Responsible Location Duration Shipping RADCON Off.
R-6 Files 5 years Document Files RSO NDT Office Files 1
L l
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1 I
I Enclosure (2)
[
7 l
f.
c AD381NST.5100.21 "QA" Program Audit Checklist item Attribute.
Sat.
Unsat Remark Pre-Reg Auditor Review AD38 INST 5100.21 Pre-Req Auditor Review AD381NST 5100.20 Pre-Reg Auditor Review AD381NST 5100.19 Pre-Req Auditor Review 10CFR Part 70-d 1.
QA Audit per f orned by per son not having direct responsibility in area being audited.
2.
Current QA Program approval by NRC.
(NRC Form 311) Ref:
Current NRC approval (cert of com-pliance) for packages available for all components used.
Ref:
10CFR 71.21 (a) and (b) 4.
NRC materials license available for package receivers.
Ref:
10CFR 71.21 (a) and (b) 5.
PUGET SOUND NRC Materials License current.
'(MK: "orm 374) Ref:
10CFR 30.3 6.
Procurement documents available and of good quality.
Ref:
10CFR 71.109/21.31 7.
Control and identification of packages IAW encl. (8) of NRC License.
Ref:
10CFR 71.115 and 117.
8.
Review of procedures for handling, storage, shipping control.
l 9.
Non con f ormance of na te r ial s par t s,
components identified?
Corrective action and reporting adequate?
Records?
Ref:
10CFR 71.131/21 ?1/
21.51 10.
Record Retention Program in affect?
Record identifiable and retrievable?
Enclosure (3) 8 w___-__-_-____
a.
~
o, s.
i AD381NST 5100.21 1
Item Attribute Sat Unsat Remark Responsibility, location.and duration established?
Ref:
')
11.
Audits made.as per schedu le prornu l0-gated by QA Officer?
Previous results 1
available?
Ref:
10CFR 71.121 and.137 Note:
Provide written report of above audit items to
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Enclosure (3)
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