ML20214K306
| ML20214K306 | |
| Person / Time | |
|---|---|
| Site: | 07100261 |
| Issue date: | 07/29/1986 |
| From: | NAVY, DEPT. OF |
| To: | |
| Shared Package | |
| ML20214K291 | List: |
| References | |
| NUDOCS 8608210026 | |
| Download: ML20214K306 (4) | |
Text
Quality Assurance Program 1.
Organization:
(ref.10CFR 71.103) Responsibility for the Quality Assurance (QA) Program rests with SIMON LAKE. The QA Program is implimented using the following organization:
Commanding Officer Repair Officer Quality Assurance Officer Radiographic Safety Officer (RS0)
Radiological Controls Officer (shipping)
Assistant Radiographic Safety Officer (ARS0)
Senior Radiographer Radiographers
-The QA Officer is responsible for scheduling of Audits by personnel not having direct responsibilities in the areas being audited and training of N3T personnel.
-The RSO is responsible for overall administration of the program, certification, and document control.
The Radiological Controls Officer is responsible for shipping.
-Radiographers are responsible for handling, storing, inspecting and record keeping.
2.
Pros ram:
(ref. 10CFR, 71.105)
SIMCN LAKE QA Program will be guided by written instruction contained herein. This instruction will be the basis of Quality Assurance and the guidance provided will be used throughout the period during which packaging is used.
The components to be covered by this Quality Assurance Program include:
(1) Model 660 Gamma Ray Exposure Device.
l (2) Model 820 Source Changer.
(3) Model 650 IR 192 Source Changer.
(4) Model 416 Co 60 Source Changer.
The Quality Assurance Program requirements and procedures are based upon:
(1) The impact of malfunction or failure of the component upon safety.
(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. 10CFR 71.109)
Quality must be insured in documents for procurement of material, 8606210026 860729 PDR ADOCK 07100261 Enci (1)
L
r e_
O, equipment and services. Procureme:1t of IR192 and C060 aboard SIMON LAKE 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 proceedures of; a.
NAVSUPINST 4000.34 Series b.
SPCCINST 4235.108 Series 4.
Control and identification:
(ret 10CFR 71.115 & 71.117)
(a) Assurance must be maintained that material, equipment and services conform to specifications of the procuresent. Examination of the products must be made upon delivery and will be controlled and documented in accordance with enclosure (8) of SIMONLAKEINST 9900.2 Series (NRC Lincense No. 09-21463-01)
(b) Identification and control measures will prevent the uce of incorrect or defective materials, parts, and components. Model number:s will be checked upon receipt and will be.erifief '.o be authorized by NRC License.
Device serial ~ numbers will be legged in SIMON LAKES NDT Lab " Receipt and Transfer Log" for accountability.
Written procedure establisied for ha63TTng(, storage and shipping are in Handlina. Storace, and Shi ppine Control:
refICCFR71.127) 5.
accordance with SIMON LAKE NRC Materials License.
6.
Non-conformins materials parts, components:
(ref 10CFR 71.131)
Written procec ure established for control of materials, parts, and components which dc not conform to license provisions are in accordance
.with SIMON LAKE NRC Materials License.
7.
Corrective Action:
(ref 10C 6 71.133)
All personnel involved in tha oregram 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 10 CFR Part 21 and maintenance of records will be in accordance with 10CFR 21.51 8.
Records:
(ref 10CFR 71.135)
Records will be maintaired tr furnish evidence of Quality. Records must be identifiable and recievable. The Record Retention Program will
[
clearly identify the name of record, responsibility, location and duration required to be maintained.
9.
Inters.a1 Inwections/ Audits:
(ref 10CFR 71.121 and 71.137)
Planned Audits will be co'nEcted Semi Annually to verify compliance with l
all aspects of the Quality Assurance Program. The audits will be conducted by trained personnel not having direct responsibility in the r
area being audited. Audit personnel will be assigned by the Quality r
Assurance Officer. Audit checklists and access to records / personnel will be provided by the RSO/ARSO. Written report of discrepancies noted will be forwarded to the Commanding Officer via the RSO, QA Officer and Repair Officer. ~ Completed audits with annotated corrective action taken will be t
kept as record by the QA Officer (NOT LAB) and copies maintained by RSO.
i 2
O, Packaging "QA" Record Retention Program Name Responsible Location Duration Radiographer Training R-8 Div Off.
R-8 Office 2 years Audit Schedule &
QA off/RSO R-8 Office Indef.
Results Shipping Container RSO/ARSO NDT Office Files Indef.
Certification Copy of License of RSO/ARSO NDT Office Files Indef.
Material Receivers Reports of Defects RSO/ARSO NOT Office Files Retain until Non-Compliance after delivery of component.
Leak Check Records RSO/ARSO/R-5 NDT Office Filer 2 years Package Survey RSO/ARSO NOT Office Files 2 years (Radiation)
Results RADCON Off.
R-5 Files 2 years (Contamination)
Source Accountability RADCON Off.
R-5 Files 2 Years and Inventory Records (sub-custody Card)
Receipt & Transfer Log RADCON Off.
R-5 Files 5 years after (10CFR30.51) transfer Written Procedure for RADCON Off.
R-5 Files Indef.
Shipping RADCON Shipping RADCON Off.
R-5 Files 2 years Personnel Training Shipping Document Radcon Off.
R-5 Files 2 years Files Enci (2)
I "QA" Program Audit Checklist i
Item Attribute Sat Unsat Remark Pre-Req.
Auditor Review SIMONLAKEINST 9893.1 Pre-Req.
Auditor Review 10 CFR Part 70-H Pre-Req.
Auditor review SIMONLAKEINST 9900.2 1.
QA Audit performed by person not having direct responsibility in area being audited.
2.
Current QA Program approval by NRC.
(NRC Form 311) Ref: 10CFR71.101(C) 3.
Current NRC approval (cert of com-pliance) for packages available for all components used.
Ref:
10CFR 71.21 (A) & (B) 4.
NRC materials license available for package receivers.
Ref: 10CFR 71.12 (A) & (B) 5.
. SIMON LAKE NRC materials license current.
(NRC Form 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 enci (8) of NRC License. Ref: 10CFR 71.115 and 117.
8.
Review of proceedures for handling, storage, shipping control.
9.
Non conformance of h terials parts, components identified? Corrective action and reporting adequate?
i Records? Ref: 10CFR 71.131/21.21/
j 21.51 10.
Record Retention Program in affect?
Record identifiable and retrievable?
Responsibility, location and duration established? Ref: 10CFR 71.135 11.
Audits made as per schedule promul-gated by QA Officer? Previous results j
available? Ref: 10CFR 71.121 &.137 l
Note: Provide written report of above audit items to C0 via RSO, QA Officer and R0.
f Enci (3)
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