ML20247G911
| ML20247G911 | |
| Person / Time | |
|---|---|
| Issue date: | 03/29/1990 |
| From: | Deschamps F NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Glenn J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| Shared Package | |
| ML20247G916 | List: |
| References | |
| SSD, NUDOCS 9805210009 | |
| Download: ML20247G911 (8) | |
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NUCLEAR REGULATORY COMMISSION n
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WASHINGTON, D. C. 20555
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i MAR 2 91990 1
MEMORANDUM FOR: John E. Glenn, Chief Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, i: MSS THRU:
Michael A. Lamastra, Section Leader g/
Commercial Section fiedical, Academic, and Corr,ercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS FROM:
Floyd Deschamps Commercial Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, HMSS
SUBJECT:
NOTIFICATION OF POTENTIAL QUALITY ASSURANCE PROBLEMS AT AMERSHAM CORPORATION
.The _ State of Washington reported in November 1989 that one of their industrial radiography licenser 1, PM Testing, had received Ir-192 sources with duplicate serial numbers from Amersham Corporation.
It was also reported that Amersham has previously shipped wrong connectors or defective connectors to the lict.nsee. The State of Washington has expressed concerns that such a large company as Amersham is having quality assurance problems of this nature.
It was noted that since PM Testing which has found these errors in a short time, it may be indicative of a larger problem.
The cause of these problems appears to be a lack on implementation of good quality control practices and procedures by the OA Department at Amersham.
A review of the proposed Amersham Corporation's Quality Assurance Panual was made.
In Section 4.4.2 of Amersham OA Procedure Number 10-01, it is stated that all accepted final assemblies shall be accompanied by the inspection i
record and shall be labeled with an " Accept" tag indicating the model number, t
i serial number, date of final inspection and test and the identification of the i
inspector making the acceptance.
Section 4.0 of Amersham OA Procedure 08-01 addresses the identification of items by a unique part number. The part l
number relates to the appropriate engineering drawing for the part. This section also indicates that the final assemblies shall bear a properly completed acceptance tag, b
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MAR 2 91990 Mr.. John E. Glenn
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On May 15 and 16, 1989, several members of the NRC staff conducted an inspection of the Amersham Corporation's Quality Assurance Program.
Reviews of the inspection report revealed that no problems were discovered in the final assembly inspection area during the inspection.
However, a recommendation was made to Amersham that all similar parts should be clearly separated and labeled while in the assembly area.
Based on the above information, the Auershan's proposu; Cuality Assurance fianual, once implemented, shouli ensure that the problems identified by PM Testirig does not occur again.
It is risted that no QA plan can be successful unless those responsible ensures that the procedures and practices of that plan are implemented.
Floyd Deschamps Commercial Section Medical, Academic, and Commercial Use Safety Branch Division of Industrial and Medical Nuclear Safety, NMSS i
Am:rsham Corporation y
40 North Avsnue Burhngton, Massachusetts 01803 g/4cM l*
Telephone (617) 272-2000 f[
f5 January 12, 1988 Mr. Joseph Klinger Bureau of Radiation Control Texas Dept. o 1100 West 49gHealth
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t Street chTROL Austin, TX 78756-3187
Dear Mr. Klinger:
Amersham Corporation purchased the business assets of Gamma Industries and Gulf Nuclear on January 8, 1988.
We have received approval from U S Muclear Regulatory Commission to manufacture Gamma Industries and Gulf Nuclear industrial
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radiography equipment.
A copy of this approval is enclosed for your information.
Amersham Corporation had previously complied with all applicable Texas regulations on any source assembly sold in Texas after October 1, 1987.
With the acquisition of Gamma and Gulf we had to commit to support current equipment in the field.
This means that we must provide the Gamma slotted connector if it is listed on the customers license.
Due 'to this acquisition and subsequent commitments we request that Amersham Corporation be granted an extension to comply with state of Texas regulations in Part 31 paragraph 31.15 (a)(2).
Gamma Industries had been working on a connector that would meet this Texas requirement.
We intend to continue with this research or possibly modify one of our current connectors to produce an acceptable connector.
Upon v
further design and successful completion of endurance testing of the new connector we will submit to NRC for approval.
We feel that we can produce an acceptable connector by March 31, 1988 and we ask that we be granted an extension until this date.
As we cannot ship to Texas until this extension is granted, we ask for an expeditious review and approval for our request.
I trust this contains the information necessary to support our request.
If I can provide any additional information please contact me.
Sincerely, f
Ohh 8#\\./
l Cathleen M. Roughan Radiation Safety Officer
1 5
NOTE TO ALL USERS OF THE SEALED SOURCE AND DEVICE REGISTRY-
SUBJECT:
Amersham Corporation has purchased the assets of Gulf Nuclear (GNI)
. located in Webster. TW. The GNI business includes products produced at Gamma Industries located in Baton Rouge, LA.
NRC will recognition the use of the existing registry sheets for GNI and Gama Ind. radiography products until Amersham has detemined which products they will continue to manufacture. Amersham will work with NRC during the next three to six months to develop a cross reference list of source assembly models which they will continue to manufacture. At that time NRC will amend the registry sheets as necessary.
Amersham will initally manufacture the radiography products at the
(,O '3 Burlington Massachusetts facility under their present NRC license, 1
Quality Control program and to the manufacturing drawings provided by GNI.
This acquisition allows Amersham to ship compatable source designs in any of the source changers (Amersham models 650, 500 SU, 820, 855; Gamma Industries model' C-10 or Gulf Nuclear Model U-110).
Amersham will continue the maintainance and service of the Gama Industries and Gulf Nuclear radiography equipment in the field.
If you have any questions please call me. M NEW hone number is 301-492-0613.
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Texas Department of Health Robert Bernstein, M.D., F.A.C.P.
1100 West 49th Street Robert A. MacLean, M.'D.
Commissioner i
Austin, Texas 7875fr3189 Deputy Commissioner j
(512)458-7111 Professional Services Hermas L. Miller Radiation Control Deputy Commissioner (512)835 7000 Management and Administration l
l January 14, 1988 l
Amersham Corporation Attn:
Cathleen M. Roughan 40 North Avenue Burlington, Massachusetts 01803
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Dear Ms. Roughan:
l, In accordance with your letter dated January 12,.1988, you are hereby i
' granted an extension until March 31, 1988, for compliance with Texas
. Regulations for Control of Radiation 31.15(a)(2).
Please keep us informed as to the progress being made as we will.,be rece,1ving, many inquiries concerning your products.
If w'e, may-be of any fur.ther asssistance to you, do not hesitate to fr9.ca11)or write..
l Sincerely, g+ J s ph C Klinger, Adm strator
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..g Branch 1
iv sion of Licensing, registration d Standards ureau of Radiation Co' trol n
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Richard Ratliff
' Division of Compliance and Inspection l
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Amersham Corporation 40 North Avsnus
- BurHngton, Massachusetts 01803 Telephone (617) 272 2000 March 23, 1988 gj tj f
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Mr. Joe Klinge W 3 6. [ {,
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5 Bureau of' Radiation Contrdi k
Texas Department of Health
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Dear Mr. Klinger:
As' discussed in our telephone conversation of 21 March 1988, this letter sets out our current position on the radiography connector problem.
A brief history is important to understanding the current situation:
Tech / Ops, prior to the Amersham acquisition, developed a connector for the tight "S" bend projectors such as the Gamma Century or Gulf 20V.
This connector, known as the 861, meets the new Texas regulation and works relatively well in a well maintained, reasonable condition machine.
As you know, some radiography companies are using worn out equipment.
This usually means that a "V" groove is worn in the "S"
tube.
Unfortunately, our 861 style connector fails to perform well in a worn out tube and has a tendency to hang-up.
If we were to go with this connector I feel there would be several problems:
1.
We would use the connector as an interim solution only.
Thus customers would have no choice but to re-terminate their drive cables twice.
Additionally, licenses would have to be changed twice.
.2.
Some customers would experience hang-ups.
We might be creating as many problems as we are solving.
3.
We are not geared up to manufacture the number of connectors that would be required.
On top of this, it is a particularly difficult component to produce in the small volumes used in our industry.
We would prefer to go with one of the alternatives outlined below:
a.
Gamma Industries J connector Although this connector looks promising, there is further work to be done before we could introduce it.
Firstly, the casting tcoling requires modification to allow the parts to be safely connected to the wires.
Secondly, a full 20,000 cycle test is needed in order to comply with ANSI N432.
page 2 i
This connector does look promising.
It does have one design drawback, nanely hookup is at 90* which puts unnecessary strain on the drive cable connection.
However this option looks best at this time.
It will take us about 3 months to l
complete testing and modification.
b.
Shortened Tech / ops style 660 female (model 550 connector) with shortened male connector.
I To date we have not been able to devise such a system that can pass the 20,000 cycle test in the tight "S"
tube.
Further development is in progress and a result that meets l
our needs using this option would be best for everyone.
About 2 months is needed to complete this program.
l Tech / Ops style 660 connector system connected to the wire c.
using a novel process such as laser welding.
This is a new development program.
Our first samples have come back and further work is needed before we know if this is a viable or cost effective solution.
This program is likely to take about 6 months and is the most uncertain.
In conclusion, we feel that although we have a connector that works well in good equipment, it is not in anyones interest for us to put it on the market in place of the Gamma Slotted connector currently in use.
We request a further extension to continue to pursue a connector design that both fully meets the regulatory requirements and is indeed a safer connector in the field.
Sincerely, Q
J.M. Zlotnicki Technical Services Manager CC:
V. Becker L. Hendrickson J. McClellan C. Roughan jaj/JMZ
Texas Department of Health Robert Bernstein, M.D., F.A.C.P.
1100 West 49th Street Robert A. MacLean, M.D.
Commissioner Austin, Texas 78756-3189 Deputy Commissioner l
(512)458-7111 Professional Services i
Hermas L. Miller Radiation Control Deputy Commissioner (512)835-7000 Management and Administration April 4, 1988 Amersham Corporation l
Attn:
J. M. Zlotnicki i
40 North Avenue Burlington, Massachusetts 01803 l
Dear Mr. Zlotnicki:
In reference to your letter dated March 23, 1988, we agree that there are many problems associated with the designing, testing and production of a new connector which meets the Texas regulatory requirements.
However, we feel that sufficient time has been allocated for full compliance with the regulations.
In order to avoid placing an undue burden on the industry you serve and in response to your request for an extension from compliance with the connector requirements, Amersham Corporation is hereby granted an extension until May 15, 1988, for full compliance with the Texas Regulations for Control of Radiation.
If you have any questions, please contact us.
Sincerely, Joseph G.
Klinger, Administrator Licensing Branch Division of Licensing, Registration and Standards Bureau of Radiation Control I
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