ML19330A992
| ML19330A992 | |
| Person / Time | |
|---|---|
| Site: | 07100370 |
| Issue date: | 07/14/1980 |
| From: | Belgrair D AMERSHAM CORP. |
| To: | |
| Shared Package | |
| ML19330A991 | List: |
| References | |
| 16872, NUDOCS 8007290934 | |
| Download: ML19330A992 (11) | |
Text
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e QUALITY ASSURANCE PROCEDURES FOR PACKAGING FOR RADIOACTIVE MATERIALS Ref. No. : 001 4
i Amersham Corporation Author:
D. P. Belgrair 2636 S. Clearbrook Dr.
Date Issued:
14 July 1980 Arlington Hts., IL 60005 Approved by:
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Date: I4 d 8007290 MN
-f-10 CFR 71 APPENDIX E I.
Organizction 1.
The Q.A. program will be retained and exercised by:
Amersham Corporation 2.
Prior to shipment to the U.S. each transportation package will be
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checked by Q.A. personnel at TRC, using the attached audit check-list.
Prior to use within the U.S., Amersham Corporation personnel will inspect those items applicable to trans-shipment of the package to insure compliance with Appendix E of 10 CFR 71.
In the case of a shipment originating in the U.S., Amersham Corporation will be responsible for all Q. A. performed on each type B container it uses.
3.
Please refer to attachments 8 and C for complete organi:ation charts for TRC and Amersham Corporation.
4.
The Responsibilities of Each Job Function.
A.
Radiation Safety Officer will regularly audit the Q. A. Plan and report to Regulatory Affairs Manager his findings.
B.
Director, Q. A., shall retain responsibility for Q. A. plan to be executed by Q. A. personnel.
C.
Supervisor, Q.A. is to insure that line personnel (Q. A. inspec-tors) shall carry out the plan.
Q.A. Supervisor reports to Q.A. Manager.
D.
Q. A. Inspectors are to report inspection findir.gs to Q.A. Super-visor.
E.
Q.A. Supervisor will release to the Shipping Supervisor each type 3 container that has been approved by Q.A. line personnel.
F.
Shipping Supervisor will be responsible for proper labeling and surveying of each type 3 container being transported.
ME G+b 5.
Q.A. program responsibility rests in Q.A. Director. This individual has overall responsibility for Q. A. and is appropri-ately trained and experienced.
6.
Packages that do not meet the requirements set forth in 10 CFR 71 shall not be released by the Q.A. Department to Shipping.
Any of the following individuals have the authority to withhold release:
Q. A. Director
).
Q.A. Manager Q.A. Supervisor Radiat;o., Safety Officer Manager, Regulatory Affairs Safety Officer Non-conforming material may be stopped by any one of the afore-mentioned individuals, with or without the presence or consultation of any of the others.
II. Quality Assurance Program 1.
Regulatory Affairs Department, consisting of Manager of Regulatory Affairs, Radiation Safety Officer and Safety Officer, shall rou-tinely assess the Q.A. program for compliance with 10 CFR 71.
These individuals report to Q.A. Director, and will inspect and issue formal reports to him.
2.
Q.A. manuals and revisions shall be controlled and distributed by Q. A. Supervisor, following review by a member of the Regulatory Affairs staff, who may also request revisions to the plan.
3.
Each of the individuals listed in the organizational chart shall be made aware that the Q. A. program.is mandatory and will be enforced; and compliance audited regularly by a member of the Regulatory Affairs staff.
4.
The Following components shall be controlled by the Q.A. program:
A.
For Type B quantities of radioactive materials that will not be repackaged, the following components shall be inspected:
a) Outer packaging
I b) Material and integrity c)
Lifting attachments d)
Pt.rmanent labels e)
Sealing gaskets f)
Bolts, closures, fasteners, both inside and outside B)
For Type B quantities, shipments originating within the United States:
a)
Inner packaging b)
Intermediate packaging, including shield #ng material and integrity c) Outer packaging d)
Lifting attachments e)
Permanent labels f) Sealing gaskets g)
Bolts, closures and fasteners, both inside and out 5.
In the event of a dispute involving quality, a meeting shall be arranged in order to present opposing viewpoints and reach a resolution of the conflict consistent with the ir. tent of 10 CFR 71.
An indoctrination and training program for Q. A. personnel, as well as examination of proficiency will be estaolished and adminis-tered by the RSO, or the Safety Officer.
7.
All quality-related activities will be performed under normal conditions of use incident to transport and handling of each package covered by 10 CFR 71.
III. Design Control All package designs originate in, and design specifications are set by the Engineering Group of the parent company, The Radiochemical
's 4
Centre (TRC).
Cesigns must be approved by United Xingdom Competent Authority prior to transport and re-use within the U.S.
All aspects of design control are executed by TRC personnel. Those design aspects that may be inspectable without unpacking the container (i.e., those features listed in 4A of Part II of this document) will be re-inspected by Amersham Corporation personnel.
For those shipments of Type B quantities originating in the U.S.,
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each container will be completely inspected at Amersham Corporation before use, in a manner consistent with the in%nt c ' 10 CFR 71.
IV.
Procurement Document Control All necessary requirements are carried out by properly trained individuals at TRC.
Procurement documents are maintained at TRC and are available for inspection. As an integral part of Amersham Corporation's Q.A. program, these documents will be regularly reviewed by a designated member of the Regulatory Affairs staff.
Each supplier of components for use in TRC packages is to be notified that his facilities must be open for inspection and audit by TRC personnel. All revisions to procurement documents are to be subject to the same review and approval as original documents.
V.
Instructions, Procedures and Crawings All activities affecting quality shall be specified formally in wri ting.
This includes package design information and engineering drawings.
Q.A. will be in accordance with Amersham Corporation and TRC official Q.A. Procedures.
VI. All documents relating to components and designs, including Q. A.
inspection findings and design changes shall be available for inspec-tion at TRC. Additionally, copies of Q. A. reports for inspections perfonned at Amersham Corporation will be on file there as well.
VII. Control of Purchased Materials, Parts and Components This will be carried out by prtoerly trained individuals in the Engineering staff of TRC. Wheneverdeemed necessary, staff memcers are to inspect and audit suppliers of package components, as indicated in Section IV of this document.
Y VIII. Identification and Control of Materials, Parts and Components All package designs must be clearly and permanently labeled with appropriate identifying information.
Components will be identified, with information accompanying each container that is used by Amersham Corporation within the U.S.
IX.
Control of Special Processes f_,
These will be carried out according to formal written procedures at TRC.
Records will be available for inspection at TRC.
X.
Inspection The inspection program is carried out in accordance with formal written procedures,. including checklists accompanied by formal instruction. The individuals carrying out the inspection shall be separate from those involved with design of the package.
XI.
Test Control All testing will be perfonned at TRC or at locations in the U.K.
designated by TRC. Written records of test results will be maintained at TRC.
XII. Control of Measuring and Test Equipment Whenever necessary, calibrations of test equipment will be performed using appropriate methods, by personnel designated responsible at TRC.
XIII. Handling, Storage and Shipping All conditions of NRC and U.S. DOT shall be met prior to re-use of TRC packages within the U.S.
The appropriate certifications and instructions to carriers and consignees will accompany each package shipped.
o ME El+D XIV.
Inspection, Test and Operating Status All test results, including inspections of markings, labels and tags will be comunicated formally to the appropriate individuals at her-sham Corporation, TRC, carriers and consignees. Whenever a package fails inspection, its status shall be clearly indicated on the package and it is to be stored in such manner to prevent its unauthori::ed use.
XV.
Non-conforming Materials, Parts or Components As specified in Section XIV, these are to be segregated to prevent their use and await formal proceedings to scrap or return to TRC for further inspection and repair. The ultimate disposition of non-conforming components will be formally recorded and available for inspection at TRC, or harsham Corporation whenever warranted.
XVI.
Corrective Action Corrective action w111 be initiated whenever deemed necessary by TRC, with comolete reports furnished to TRC and Amersham Corporation.
XVII. Quality Assurance Records All recorcs relating to safety characteristics of pe ages, including design criteria, engineering drawings and specificar-,ns and pmtotypes testing will be documented by TRC personnel.
Records will be main-tained at TRC and available for inspection there. All TRC inspections prior to use of packages will be filed at TRC, and appropriate docu-ments provided with each package shipped to Amersham Corporation.
Marsham Corporation will maintain these on file in addition to:
1.
U.S. COT revalidations 2.
NRC appmvals 3.
Q.A. inspections performed at Amersham Corporation 4
Inspections of TRC procedures performed by hersham Corporation personnel.
,1+B All records will be dated, signed and approved by a level of manage-ment consistent with its significance to health and safety, as required by 10 CFR 71, Appendix E.
X'/III. Audits Audits will be conducted annually:
Results of all audits will be maintained wherever the work was performed.
Corrective action will
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be documented. This will be reviewed by a level of management respon-sible for corporate compliance with U.S. NRC and DOT regulations.
. Attachment A Tir lusDICCHmICAL CDCHE ouALITY Cornnob Dr.PAlmmfc CUALITY CURROL PROCEDUIE 1.
Title:
Turn-around inspection and maintenance of transport container:
R A vatt,DP."C)VED:
. 24.10. 7a...
...... date:
1 2.-
Procedure prepared by:
.i fil N f.
l 3.
Procedure approved by:
N.lLPa.
M........ date:
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4.
Turn-around inspection is to be carried out by the user in accordance vi th the following check-list before use at every turn-around:
4.1 Monitor the container to ensure that it is empty.
4.2 Test for external and internal contamination. Maximum pemissible 2
levels for non-fixed contamination are 10-4 pC1/cm for beta /gama, 2
2 cnd 10-SpCi/cm for alpha, when averaged over any area of 300 cn,
4.3 Checi
the assembly visually for damage or defects:
(a) Check the condition and fit of plug and other shielding emponent
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(b) Check that sealing gaskets are undamaged and seating correctly.
- (c) Check the condition of bolts, all closures, and fasteners, DJ internal and external.
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(d) Check the soundness of lifting attachnents.
- 4 a.
(e) Check the conditi... of paintwork and the general standard of
$ Us appearance.
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(f) Check the security and legibility of permanent labelling. This
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should include a metal trefoil label and an orange-coloured oval Dk
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identity label' ed9.}... Check that a"11 temporary' labels have been removed.
4.4 h'here practicable rectify any defect. Where further work is required attach a 'Haintenance please' label, arrange for Health Physics clearance, and request the maintenance required using attached Maintenance Request form.
4.5 Maintain a record of each inspection and the result.
4.G 3 f the cinte shown on the 'tiaintenance due" label (for Scheduled Maintenance) is close to expiry, inform the Owner Sectien.
Attachment B ORG41IZATICN CHART: TRC GROUP PW4AGIBG DIRECTCR 9
4 QUALITY RADICLCGICAL CCNTRCLLER SAFETY CmTm'9 TRANSPCRT DISPATCH CCNTAINER CFFICER CFFICER i
CESIGN ENGINt=ns
. I i
Attachment C i
CR%NIZATIOfJ CHART: AlfRS*rWi CORPORATICt1 PRESIDENT DIR.
Q.A.
DIRECTCR Am TECH.
CFERATICNS SERVICES MANAGER MANAGER MANAGER I
REGLLATCRY &
PLANT CUALITY CPERATICNAL CLIN. Ar7 AIRS ASSURANCE SERVICES RADIATICN StPERVISCR SAFETY QUALITY CF ICER ASSURANCE SUPERVISCR SHIPCING SAFETY CSCL.P CFFICER LEACER SHIPPING CLERKS C-RCUP LEACER ten ~n s-(N I