ML20198Q635
| ML20198Q635 | |
| Person / Time | |
|---|---|
| Issue date: | 01/21/1998 |
| From: | Cool D NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Camper L NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| SSD, NUDOCS 9801230103 | |
| Download: ML20198Q635 (7) | |
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NUCLEAR RE^Ul.ATORY C MMISSIEN e
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January 21, 1998 MEMORANDUM TO:
Larry W. Camper, Chief Medical, Academic, and Commercial Use Safety Branch Division of Industrial and i
Medical Nucleat Safety, NMSS FROM:
Donald A. Cool, Director Medical Nuclear Safety, NMSS ' / '[
Diviulon of Industrial and
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SUBJECT:
SPECIAL INSPECTION TEAM CHARTER (AMERSHAM RADIOGRAPHY DRIVE CABLE FAILURES)
This memorandum confirms the establishment of a Speciallnspection Team to conduct inspection follow up of the Amersham radiography drive cable failures, involving MQS, Calumet Testing Services, Inc, and possibly other licensees and/or facilities. The inspection will review not only these failures, but reports of drive cable failures over the past several years to determine l': 1eneric problem exists and the root cause(s) of the failures. You are hereby designated ine team leader and should report status directly to me. Your team members are:
John Pelchat (Region 11 Senior inspector), Debbie Piskura (Region lll Senior inspector),
Douglas Broaddus (NMSS Mechanical Engineer). Portions of the inspection follow up that occur in Agreement States (e.0.. Louisiana, Texas, and the Commonwealth of Massachusetts) willinclude representatives from their respective regulatory bodies. For inspections conducted in an Agreement State, the applicable regulatory body will retain the lead for these activities and follow up. The specialinspection team shallintegrate theses findings with the results of its own inspections to complete the assigned task.
A SpecialInspection Charter has been prepared in accordance with NRC Management Directive MD 8.3 and Inspection Manual Chapters 0325 and 93800. A copy of the Charter, MD, and Chapters are attached for your use. The objective of the team is to gather information and make appropriate findings and conclusions in the areas listed in the Charter. These will then be used as a basis for any necessary follow up actions. The inspection will be conducted in two phases. The initial phase commenced on December 22,1997, focusing on inspection of the NRC licensees reporting cable failures The second phase of the inspection will take place during January and February 1998 and will focus on site visits to Amersham manufacturing a customer service facilities, interface with Agreement State licensees and/or regulators who
, l have CONTACT:
Douglas Broaddus, NMSS/IMNS (301) 415-5847 e-mail DAB @NRC. GOV 9801230103 900121 PDR RC n j[fff f
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L. Camper 2-reviewed similar drive cable failures, review of the Nuclear Materials Event database and 10 CFR Part 21 reports, and review of the failure nnalyses performed for Amersham.
While assigned to this inspection, all team members are relieved of their normal duties. The team's report should be issued within about 30 days of the time the team completes all inspection and review activities.
You should serve as the on site NRC spokesperson.
Attachments: 1. SpecialInspection Team Charter
- 2. Proposed Inspe ction Schedule
- 3. MD B.3
- 4. IMC 0325
- 5. IMC 03800 cc w/atts:
H. Thompson, EDO C. Paperiello, NMSS D. Cool, NMSS T. Martin, AEOD D. Bangart, OSP Distribution; IMNS r/f U NE02-SSD-7 '
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i L. Camper reviewed similar drive cable failure, review of the Nuclear Materials Event database and 10 CFR Part 21 reports, and review of the failure analyses performed for Amersham.
While assigned to this inspection, all team members are rc!ieved of their normal duties. The team's report should be issued within about 30 days of the time the team completes all inspection and review activities.
You should serve as the on site NRC spokesperson.
Attachments: 1. SpecialInspection Team Charter
- 2. Proposed inspection Schedule
- 3. MD 8.3
- 4. IMC 0325
- 5. IMC 93800 cc w/atts:
J. Thompson, EDO C. Paperiello, NMSS D. Cool, NMSS T. Martin, AEOD D. Bangart, OSP Distribution:
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i Amersham Soecial Inspection Team Charter A.
Basis MQS Inspection, Inc. (MQS), an NRC radiography licensee, reported that on November 16,1997, the drive cable on one of their Amersham Model 660 exposure devices had broken, separating the source assembly from the cable. On December 8,1997, MQS reported an additionalinstance where the source became separated from the drive cable. A record search of the Nuclear Materials Event Database (NMED) indicated that l
as of December 11,1997, MOS had reported a total of four drive cable failures. The two additional failures occurred in 1995 (broke off in the camera during retraction) and in I
1996 (identified during periodic maintenance). Calumet Testing Services Inc. (CTSI),
also a radi,,.,1y licensee, reported an additional cable break that occurred cn November 21,1997. All cable failures have occurred 0.125" to 0.5" (0.64 cm to 1.27 cm) behind the male connector. All these events / failures involved an Amersham Mode! 660 radiography system. All cables were subsequently sent to Amersham, either in Massachusetts or Louisiana, for analysis.
A review of the NMED data and Part 21 reports indicate that as many as 15 additional reports of cable breaks have occurred in the past. The majority of these failures have occurred in the States of Texas and Louisiana. These cable breaks have occurred with Amersham Model 660 equipment as well as with SPEC Model 150 and INC Model IR-100 radiographic exposure devices. This data may indicato that the scope of the problem is broader than originally suspected and support the possibility of a generic issue.
Amersham, the manufacturer of the Model 660 radiography system, is located in Massachusetts, an Agreement State, and operates a customer service facility in Louisiana. The Commonwealth of Massachusetts has authority over materiallicensees and sealed source and device certificate holders within its borders, including those certificates issued for Amersham equipment. The State of Louisiana has equivalent authority within its borders, but has no registration certificates issued to Amersham.
Massachusetts has been followit'; up with the analysis of the broken cables and has been providing NRC with their results. NRC has volunteered assistance for inspections and other functions to assist them with their review of the failures.
A contractor has performed metallurgical analyses on all five of the recent failed cables.
Amersham has received reports from the contractor for all of these analyses and has shared the findings with NRC. Amersham expects to complete its analysis of the reports by the end of January,1998.
Triumph Controls, the manu'acturer of the drive cable, is located in Pennsylvania.
Triumph is not an NRC licensee, but is a supplier of basic component equipment intended for use in devices used by NRC licensees. Triumph supplies its cable to all three radiography equipment manufacturers in 500-1000 foot lengths that are cut to the desired length by the manufacturers. Use of this "off the-shelf" component by all three major rat,raphy camera manufacturers increases the likelihood that the cable failures are of generic consequence.
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The oasis of the Specialinspection is that this may be indicative of generic product problems that may present significant health and safety concems. Further investigation is necessary to evaluate this issue, determine 6)e root cause(s) for the failures and recommend an appropriate course of regulatory action.
B.
Scope in order to evaluate whether there is a generic product problem, develop the safety significance of the failures, and recommend an appropriate course of action, the team should address the following:
1.
Evaluate the root cause(s) of the failures and associated problems with manufacturing processes and user procedures. This should include:
(a) inspection of licensees reporting cable failures and the circumstances surrounding the failures. This would include MQS, Calumet, and a sample of Loulslana and Texas licensees (b) adequacy of user maintenance of the cables, including visualinspections, cleansing, and lubrication (c) review of the licensee's (user's) radiographic operations to evaluate if the use conditions and/or environment contributed to the cause(s) of the failures and any similar use conditions (trends) associated with each of the failures (d) inspection of the Amersham's customer service records located in MA and LA to help bound the scope of the failure and determine if similar problems have occurred resulting in the same or similar failures (e) an interface with Louisiana and Texas regulators responsible for reviewing previous reports of drive cable failures (f) the design and actual condition of the cables (including an appropriate independent evaluation of the cable condition) to determine the failure mode (g)
Amersham's and Triumph's production process for the cables to determine if any significant changes have occurred with the cable construction and evaluate if any of the processes could cause stress concentrations that could lead to the failures 2.
Evaluate the failure analysis report performed by Amersham's contr;tetor for the five recent cable icilures.
3.
Evaluate whether early warning of these types of failures could be detected during maintenance or periodic user inspection.
4.
Evaluate the adequacy of the Amersham's investigation of the event and corrective actions.
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5.
Determine the cause of the failures of the (approximately 15) other cable failures
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that were identified in NMED and the Part 21 reports and if they occurred in the i
same manner and under similar conditions as the MQS and CTSI failures.
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6.
Determine, through inspection, if the other manufacturers (SPEC and/or INC) of radiographic equipment are experiencing similar failures and evaluate the design and use conditions of the other manufacturer's equipment to identify any similarities.
- i 7.
Determine if Triumph Controls has had reports of similar failures with other users of their cable when subjected to similar conditions in other industries.
L 8.
Evaluate the adequacy of MQS's and CTSI's dose evalus' ions.
3 9.
Determine /ovaluate the generic'espects of the above.
10.
Thoroughly evaluate any other technical or regulatory issues associated with the cable failures which may arise during the inspection, but are currently unknown.
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11.
Provide recommendations for technical and regulatory adjustments based upon
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the inspection findings.
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i Proposed Schedule forinspections:
r January 22 23,1998 (firm)
Meeting with Massachusetts Radiological Staff e
Inspection of Amersham Manufacturing facility in Burlington Massachusetts January 29,1998 (tentative)
Inspection Team meeting at NRC HQ to review Amersham inspection findings and plan umoming inspection activities I
January 30,1998 (firm)
_ inspection of Triumph Controls in North Wales, Pennsylvania February 4 6 (firm)
Review of Loulslana licensee event data with the State of Louisiana radiological staff in Baton Rouge, LA, and site visits to sample Loulslana licensees who have experienced failures.
Inspection of Amersham Service facility in Baton Rouge, LA, to review earlier cable failures Review of event data at Source Production and Equipment Company (SPEC) in
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St. Rose, LA February 9-11 (firm)
Review of Texas licensee event data with the State of Texas radiological staff in Austin,
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TX, and site visits to sample Texas licensees who have experienced failures February 17 27
- Complete review and analysis of all NMED data on drive cable failures Complete review of all Part 21 reports of drive cable failures
. Review and evaluate Amersham contractor analyses of cable failures
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March 9-20 Compile inspection findings and prepare report i
1 Attachment '2
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