ML20151U945
| ML20151U945 | |
| Person / Time | |
|---|---|
| Issue date: | 08/11/1988 |
| From: | Baker E, Conway J Office of Nuclear Reactor Regulation |
| To: | |
| Shared Package | |
| ML20151U923 | List: |
| References | |
| REF-QA-99901105 99901105-88-01, 99901105-88-1, NUDOCS 8808190304 | |
| Download: ML20151U945 (8) | |
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ORGAN 1ZAT10N: AMERSHAM CORPORATION BURLINGTON, MASSACHUSETTS REPORT INSPECTION INSPECTION N0.: 99901105/88-01 DATES: 06/27-29/88 nn RTTr univoc. on CORRESPONDENCE ADDRESS: Victor J. Becker Operations Manager Amersham Corporation
- 40. North Avenue.
Burlington, Massachusetts 01803 ORGANIZATIONAL CCNTACT: C. Roughan, Radiation Safety Officer TELEPHONE NUMBER: (617) 272-2000 NUCLEAR INDUSTRY ACTIVITY: Gamma ray projectors, collimators, and source assemblie:, .
ASSIGNED INSPECTOR: . M, N-/o 68
. T. Conway, Pr$ ram Developnient and Reactive Date spectionSecQin(PDRIS)
OTHER INSPECTORS: L. Gordon, NMSS and J. Davis, RI APPROVED BY: I A/ P/ !
E. T. Baker, Acting Chief PDRIS, Vendor Inspection Branch Da e INSPECTION BASES AND SCOPE:
A. BASES: 10 CFR Part 50, Appendix B and 10 CFR Part 21.
B. SCOPE: The insoection was conducted to perform a programatic evaluation of the implementation of Amersham's QA program as it relates to the fabrication of gamma ray projectors.
I PLANT SITE APPLICABILITY: Not identified.
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ORGAN 12ATION: AMEF. SHAM CORPORATION BURLINGTON, MASSACHUSETTS REPORT INSPECTION NO.- 99901105/88-01 RESULTS: PAGE 2 of 8 l
A. VIOLATIONS:
l Contrary to Section 21.31 of 10 CFR Part 21, a review of purchase orders 1 (PO) to vendors revealed that Amersham did not impose 10 CFR Part 21 requirements on PO Nos. RPD-5261 (October 30,1987) to Computron; 5475 (December 22,1987) to General Latex and Chemical; 4929 (October 28,1987) to Morris and Broms; 2147 (September 18,1985) to Grolex; 1056 (May 22, 1986) and 577 (September 21,1987) to Lindberg Heat Treat; 578 (Septemt,er 22, 1987), 610 (October 13, 1987), 1124 (March 4, 1988), and 1261 (May 19, 1988) to Advanced Heat Treat; 4734 (July 17, 1987), 4914 )
(August 28, 1987), and 5394 (December 10,1987) to M.D. Machine; 4926 1 (September 2,1987) and 4933 (September 3,1987) to Nuclear Metals; 4572 l (May 1,1987) and 5001 (September 8,1987) to Welders Supply, 5995 (March 23, 1988) to Harbor Tool Supply; 4491 (April 16, 1987) to United Service; and 313 (April 3,1987) and 5531 (December 14,1987) to ESSCO Calibration Laboratories. (88-01-01)
B. NONCONFORMANCES:
- 1. Contrary to Section 71.109 of Subpart H to 10 CFR Part 71 and Section IV of the Quality Assurance Program (QAP), the requirement ;
for a vendor to have an approved QA program was not stated on P0 j Nos. RPD-5261 to Computron; 5475 to General Latex and Chemical; 4929 to Morris and Broms; 2147 to Grolex; 1056 and 577 to Lindberg Heat Treat; 578, 610, 1124 and 1261 to Advanced Heat Treat; 4734, 4914 and 5394 to M.D. Machine; 4926 and 4933 to Nuclear Metals; 4572 and !
5001 to Welders Supply; 5995 to Harbor Tool Supply; 4491 to United l Service; and 313 and 5531 to ESSCO Calibration Laboratories.
(88-01-02)
- 2. Contrary to Section V of the QAP, Section 4.6 of QA Procedure 05-01, and Section 4.4.2 of QA Proceaure 03-01, documented evidence was not available to show that the QA organization reviewed and concurred in l Drawing Nos. 66001-15, "Shell" Revision M dated June 7, 1988; 55000-3 i "Connector Sleeve" Revision L dated May 24, 1983; and 66001-917 l "Handle" Revision L oated July!9, 1987. (88-01-03) l
- 3. Contrary to Section 71.111 of Subpart H to 10 CFR Part 71 Section V of the QAP, and Section 4.2 of QA Procedure 09-01, documented evidence was not available to show that procedures or instructions had been written for the following quality affecting activities:
heat treating, forming S-tubes, and mixing of foam and subsequent filling of shell. (88-01-04) 4 i
ORGAN 1ZATION: AMERSHAM CORPORATION BURLINGTON, MASSACHUSETTS REPORT INSPECTION NO.- 99901105/88-01 RESULTS: PAGE 3 of 8
- 4. Contrary to Section X of the QAP, documented evidence was not available to show the qualifications and certifications of the two current inspectors and the QC supervisor. (88-01-05)
- 5. Contrary to Section 7.1. 115 of Subpart H to 10 CFR Part 71 and Section VII of the QAP, external audits were not perfonned on Computron, ;
General Latex & Chemical, Morris & Broms, Grolex, Lindberg Heat Treat, Aovanced Heat Treat, Nuclear Metals, Welders Supply, Harbor .
Tool Supply, United Service and ESSCO Calibration Laboratories; and I an evaluation conducted of M.D. Machine in March 1988 was not documented and filed. (88-01-06)
- 6. Contrary to Section 71.125 of Subpart H to 10 CFR Part 71, Section XII of the QAP, and Section 4.2 of QA Procedure 12-01, a depth micro-meter (S/N RPD) did not have a calibration sticker, ano calibration I records did not exist for the following equipment: (88-01-07) !
l (a) Electrical meters on the Airco TIG welder (No. 1341-0106)
(b) Temperature gages on the Thermolyne Corporation type 1500 l furnace (model FC 1520M-5/N 133527) and Type A 1300 furnace !
(model FA 1315M-S/N 111742) )
(c) Four Centaur 75 Amp TIG Welding Supply units (Model 7001) l 1
(d) 0-18" Mitutoyo height gage (No. 192-656) 1 (e) .0001-2" Mitutoyo digital indicator l
- 7. Contrary to Section 71.105 of Subpart H to 10 CFR Part 71 and '
Section 11 of the QAP, documented evidenca was not available tu show i that personnel performing activities affecting quality were l indoctrinated ano trained in the purpose and scope of the QA i Program. (88-01-08) l
- 8. Contrary to Section 71.137 of Subpart H to 10 CFR Part 71 and Section XVIII of the QAP, internal audits were not performed from l March 1986 to the present. (88-01-09)
C. UNRES0VLED ITEMS:
4 None.
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ORGANIZATION: AMERSHAM CORPORATION BURLINGTON, MASSACHUSETTS REPORT INSPECTION !
NO.: 99901105/88-01 RESULTS: PAGE 4 of 8 !
l D. STATUS OF PREVIOUS INSPECTION FINDINGS:
None. This was the first inspection of this facility. l l
E. OTHER FINDINGS AND COMMENTS:
- 1. Amersham i
In July 1986, kersham Corporation located in Arlington Heights, Illinois purchased the assets of Tech / Ops, Radiation Products l Division located in Burlington, Massachusetts. At the Burlington '
facility, Amersham fabricates source assemblies using Iridium 192 and Cobalt 60, a number of models of gamma ray projectors (i.e.,
"careeras") and collimators.
In January 1988, Amersham acquired the rights to fabricate cameras designed and fabricated previously by Gulf Nuclear (GN) and Gama ;
Industries (GI), respectively. To date, Amersham has not fabricated l any cameras with the GN or GI designs. Amersham also conducts 5-day !
courses in Radiation Safety and Industrial Radiography. I
- 2. Plant Tour The inspector toured the Amersham facility in the presence of the Technical Service Manager (TSM) and the Radiation Safety Officer (RS0). The facility consisted of a storage area which contained l
finished components or raw material (e.g., tubing) for subsequent fabrication into finished cameras. Completed cameras and collimators were also stored in this area. A machine shop area included a welding area and two muffle furnaces for heat treating components, a hot cell area was used for fabrication of sources, and a service area was used for receipt inspection of returned sources and calibration of survey instruments. Receipt inspection of components and calibration of measuring ano test equipment was parformed in a QC area. In addition, the assembly of the camera, testing, ano packaging are accomplished in separate areas.
- 3. Calibration of Measuring and Test Equipment (M&TE)
The inspector reviewed QA Procedure 12-01, "Control of Linear Measuring Equipment," and calibration records to assure M&TE is properly controlled and calibrated. The QC Supervisor is responsi-ble for preparing and maintaining a card which identifies the device, calibrator, calibration date, and due date for the next
ORGANIZATION: AMERSHAM CORPORATION BURLINGTON, MASSACHUSETTS REPORT INSPECTION l NO.: 99901105/88-01 RESULTS: PAGE 5 of 8 l l
calibration. This same information is contained on stickers I attached to each device. The calibration card file was reviewed to ascertain the calibration status for selected test equipment. The ,
equipment included an optical comparator, one height gage, two '
hardness testers, one torque meter, three calipers, one depth gage, I seven mii:rometers, and one set of gage blocks. A depth micrometer ;
(S/N RPD) did not contain a sticker. With the exception of a .001 !
in, caliper and a 0-2 in. digital micrometer, all the instruments had an etched S/N. It was noted that calibration records did not exist for the following equipment: electrical meters on tne Airco TIG welder, temperature gages on the two heat treating furnaces, four welding units in the hot-cell area, one height gage, and one ,
digital indicator. (See Nonconformance 88-01-07) I 1
Three survey meters (model Nos. 571, 726, and 773) are calibrated by a Radiological Technician on a three month frequency in accordance with the Radiation Safety Manual. Certificates of Calibration from United Service Company (hardness tester Nos. 8B-S/N 5737 and AH6-5/N i 127), Van Keuren Company (gage block set No M18), and ESSCO l Laboratory (linear measuring instruments) indicated that reference standards were traceable to the National Bureau of Standards.
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- 4. Control of Purchased Material and Services The inspector reviewed QA Procedure 7-01, "Evaluation of Suppliers" and P0s to assure that material and services conform to the P0s and :
are purchased from approved vendors. P0s to 12 vendors of material l and services were selected to determine if technical and quality requirements were included in P0s. The vendors included Computron l (shell), General Latex & Chemical (ultra-foam), Morris & Broms, Grolex (end plate), Nuclear Metals (uranium shield). Harbor Tool Supply (gage block set), and Welders Supply (weld material), who supplied materials, and five service vendors - Lindberg Heat Treat '
and Advanceo and United ServiceHeat and Treat ESSCO (heat treating),
Calibration M.D. Machine Laboratories (Machining),).
(calibration ,
Twenty-one P0s to these vendors did not reference 10 CFR Part 21 '
requirements or contain a requirement for the vendor to have a QA program which was approved by Amersham. (See Violation 88-01-01 and Nonconformance 88-01-02) kaersham did not have a copy of a QA Program for the 21 vendors noted above. The inspector reviewed a "Vendor Quality Control & Facilities Questionnaire" dated March 25, 1988 for M.D. Machine. The occument contained 47 questions that required a yes or no answer. The l
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ORGANIZATION: AMERSHAM CORPORATION BURLINGTON, PASSACHUSETTS !
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REPORT INSPECTION NO.- 99901105/88-01 RESULTS: pAGE 6 of 8 responses were completed by the vendor which indicates that it was a l "desk audit." There was no documented evidence that Amersham had conducted an audit of any of the 21 vendors. (See Nonconformance 1 88-01-06) I l
- 5. Control of Special Processes i The inspector reviewed QA Procedure 9-01, "Control of Special l Processes." A number of components used in the cameras require heat treating. The heat treat requirement is documented on the individual drawings to the manufacturer. In addition, Amersham heat treats approximately 10 components in one of two Thermolyne Corpora-tion muffle furnaces. However, there was no documentation available I to shcw that the heat treating was conducted in accordance with an l approved procedure or instruction. (SeeNonconformance 88-01-04) '
A review of approximately forty component drawings to assure quality !
requirements were contained therein indicated that two drawings were not reviewed and approved by an individual responsible for quality I assurance. (See Nonconfonnance 88-01-04)
- 6. Design / Fabrication j The inspector examined three cameras in the fabrication area to deter- I mine if the various radiographic exposure devices fabricated or i owned by Amersham were in accordance with the NRC approved design specified in the applicable certificate of compliance.
The cameras ;
examined included Tech / Ops Model Nos. 660, 680, and 920. '
By virtue of visual inspections of the housing, lock mechanisms, source and storage connectors of reversal radiographic devices, the inspector verified that the three devices randomly selected met the i approved NRC drawings. The inspector witnessed the foaming l operation of the cavity of a Tech / Ops Model No. 660 device. The foam is a high density polyurethane made by General Latex and Chemical Company under the trade name "Ultra Foam."
In view of the recent problems with the SPEC 2-T radiographic device.
Amersham was requested to check-out one of their SPEC 2-Ts. A device (S/N 90) was removed from inventory and by analys.s it was noted:
overall length dimension 121 in. (flanges not extended), only one set-screw holding lock assembly housing but no dimple en housing to
ORGANIZATION: AMERSHAM CORPORATION BURLINGTON, MASSACHUSETTS REPORT INSPECTION N0.- 99901105/68-01 RESULTS: PAGE 7 of 8 position and retain set screw thus permitting tho lock housing to move freely. Rivets were drilled out of the name plate, enabling examination of the cavity to determine whether the device contained foan. Foam was not apparent near the surface, but at a depth of about 2 inches, a crusty material unlike plyurethane was detected.
- 7. Audits The inspector reviewed paragraph 71.137 of Subpart H to 10 CFR Part 71 and the audit file to assure that-internal audits are planned and conducted on a periodic basis 1.o verify compliance with all aspects of the QA program. In discussions with the TSM and RSO, it was noted that Amersham has not had an active audit program for the last three years (see Nonconformance 88-01-09). The last audit was conducted by the former TSM in March 1986.
- 8. Indoctrination / Training The inspector reviewed paragraph 71.105 of Subpart H to 10 CFR Part 71 and the training file to assure that individuals performing quality affecting activities are indoctrinated and trained in the applicable portions of the QA program. The TSM indicated that since April 1986, during the transition period covered in the change of ownership from Technfcal Operations to Amersham Corporation, training has been limited to on-the-job lastruction with no formal documentation (see Nonconformance 88 01-08). The TSM reported that i funding has been allocated for formal training which will comence )
in the near future. In addition, there was no documented evidence of the qualifications of the two current inspectors and the QC Supervisor (see Nonconformance 88401-45)e Training is provideo in Radiation Safety by virtue of a formal 40 j hour classroom instruction in subjects covering NRC regulations l including 10 CFR Parts 19, 20, 23 and 34. All nev employees are required to take the course prior to engaging in their assigned activity, including successful completion cf a cmprehensive examin- {
ation.
- 9. Measurement of Surface Radiation Different requirements for measuring surface radiation of radiographic devices are imposed upon Amersham versus other manufacturers (e.g.,
SPEC, Inc., Gama Industries, and Gulf Nuclear) who are located in agreement states. Being in a non-agreement state, Amersham must l
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ORGANIZATION: AMERSHAM CORPORATION BURLINGTON, MASSACHUSETTS l
REPORT INSPECTION NO.: 99901105/88-01 RESULTS: PAGE 8 of 8 adjust the measured value recorded by the survey meter to compensate for the thickness of the survey probe. This small adjustment has caused Amersham to downgrade the gamma-century to a Type A device l because satisfying the 200 mr/hr requirement is marginable by this I method.
F. PERSONNEL CONTACTED:
V. Becker*, Operations Manager l C. Roughan*, Radiation Safety Officer l J. Zlotnicki*, Technical Services Manager l C. White, QC Supervisor l T. Gentile, Machine Shop Supervisor l B. Kelly, Technical Specialist :
K. Gerrard, Manufacturing Manager G. Parsons, Mechanical Designer i
F. Tingley, Draftsman :
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- Attended exit meeting.
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