ML20198H004
| ML20198H004 | |
| Person / Time | |
|---|---|
| Site: | 07100557 |
| Issue date: | 12/02/1985 |
| From: | Thomas Taylor NDE SERVICES, INC. |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| 26143, NUDOCS 8601300038 | |
| Download: ML20198H004 (1) | |
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7/-s&1 83 af a P3 -_o December 2, 1985 M -Jg M 4, United States Nuclear Regulatory Commission Washington, D.C. 20555 y
Attn: Charles E. MacDonald, Chief si g
Transportation Certification Branch
%Q d%7 Division of Fuel Cycle and Material Safety, NMSS
'8 NDE Services, Inc.
8775 E. Orchard Rd.
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Englewood, CO 80111 3
3 License: 05-19821-01 cs g
Subject:
QA Program 3
Gentleman:
N, As a result of your audit on July 15, 1982, Mr. R.C. Brown of your office noted that a written Quality Assurance Program was not available (Item Sa). In response to your Notice of Violation, NDE Services, Inc. submitted a written QA Program for your review on August 25, 1982. On September 28, 1982 a letter of acceptance was received and no action was necessary. If this is not adequate or you have any further questions, please do not hesitate to contact me.
Sincerely,
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UNITED STATES
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NUCLEAR REGULATORY COMMISSION REGION IV
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ATTN: Mr. Edward Briggs President 8775 E. Orchard Road Suite 809 Englewood, CO 80111 Gentlemen:
This refers to the routine safety inspection conducted by Mr. R. C. Brown of this office on July 15, 1982, of the activities authorized by the NRC Byproduct Material License 05-19821-01 and to the discussion of our findings held by the inspector with members of your staff at the conclusion of the inspection.
The inspection was an examination of the activities conducted under the license as they relate to radiation safety and to compliance with the Commission's rules and regulations, and the conditions of the license. The inspection consisted of selective examinations of procedures and representative records, interviews of personnel, independent measurements, and observations by the inspector.
During this inspection certain of your activities were found not to t>e conducted in full compliance with NRC requirements.
Consequently, you are required to respond to this matter, in writing, in accordance with the provisions of Section 2.201 of the NRC " Rules of Practice," Part 2, Title 10, Code of Ft fural Regulations. Your response should be based on the specifics contained in the Notice of Violation attached to this letter.
The responses directed by this letter and accompanying Notice are not subject to the clearance procedures of the Office of Management and Budget as required by the Paperwork Reduction Act of 1980, PL 96-511.
Should you have any questions concerning this letter, we will be pleased to discuss them with you.
Sincerely,
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Glen D. Brown,, Chief
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Technical Program Branch
Enclosure:
Appendix - Notice of Violation
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APPENDIX NOTICE OF VIOLATION NDE Services, Inc.
Docket: 30-19284 License:
05-19821-01 As a result of the inspection conducted on July 15, 1982, and in accordance with the NRC Enforcement Policy (10 CFR Part 2, Appendix C), 47 FR 9987 (March 9, 1982), the following violations were identified:
1.
10 CFR 20.102(a) requires that the licensee require each individual, prior to first entry into the licensee's restricted area under such circumstances that the individual is likely to receive in any period of
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one calendar quarter an occupational dose in excess of 25% of the standards specified in 20.101(a), to disclose in a written signed statement, either (1) that the individual had no prior occupational dose during the current calendar quarter, or (2) the nature and amount of any occupational dose which the individual may have received during the specifically identified current calendar quarter from sources of radiation possessed or controlled by other-persons.
Contrary to this requirement, signed statements indicating either the individual had no prior occupational dose or the nature and amount of the occupational dose which may have been received were not obtained upon hire for two employees assigned duties associated with radiography on July 6,1981, and February 15, 1982.
This is a Severity Level IV violation (Supplement IV).
2.
10 CFR 20.407(a) requires, in part, that personnel monitoring reports be submitted to the NRC within the first quarter following the calendar year d for the total number of individuals for whom personnel monitoring was required or provided.
Contrary to this requirement, no such reports were submitted by the licensee for the 1981 calendar year.
This is a Severity Level V violation (Supplement IV).
3.
10 CFR 20.407(b) requires, in part, that a statistical summary report of personnel monitoring information recorded by the licensee for individuals
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for whom personnel monitorin was either required or provided as described in 10 CFR 20.407(a.
Contrary to this requirement, no such reports were submitted by the licensee for the 1981 calendar year.
This is a Severity Level V violation (Supplement IV).
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4.
10 CFR 20.205(c)(1) requires that each licensee, upon receipt of a package containing quantities of radioactive material in excess of the Type A quantities specified in 10 CFR 20.205(b)(2) other than those
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transported by exclusive use vehicle, shall monitor the radiation levels external to the package.
- Contrary to this requirement, such monitoring was not performed upon receipt of radiographic devices in excess of Type A quantities received during the period January 1982 to July 1982.
This is a Severity Level IV violation (Supplement IV).
5.
10 CFR 71.5(a) requires, in part, that no licensee shall transport any licensed material outside of the confines of his plant or other place of use, or deliver any licensed material to a carrier for transport unless the licensee complies with the applicable requirements of the regulations appropriate to the mode of transport of the Department of Transportation in 49 CFR Parts 170-189.
a.
O CFR 71.12 requires, in part, that a-licensee who delivers for transport a Type B quantity of radioactive material as specified in 49 CFR 173.394(b) shall have a quality assurance program for shipping packages for which a description has been submitted to and approved by the Commission.
Contrary to this requirement, a quality assurance program was not established for shipments of licensed material during the period January 1982 to July 1982.
b.
49 CFR 173.393a(1) requires, in part, that before the first shipment in a package approved by the U. S. Nuclear Regulatory Commission for use by another person, each shipper shall register, in writing, with the U. S. Nuclear Regulatory Commission, Division of Materials Licensing, his name and address, the name of the person to whom the U. S. Nuclear Regulatory Commission approval was issued, and approval number assigned to the package.
Contrary to this requirement, the licensee did not register prior to using Technical Operations Model 660 exposure device and Technical Operations Model 650 source changer during the period January 1982 to July 1982.
This is a Severity Level V violation (Supplement V).
i NDE Services, Inc. -
Pursuant to the provisions of 10 CFR 2.201, NDE Services, Inc., is hereby required to submit to this office, within 30 days of the date of this Notice, a written statement or explanation in reply, including:
(1) the corrective steps which have been taken and the results achieved; (2) the corrective steps which will be taken to avoid further violations; and (3) the date when full compliance will be achieved.
Consideration may be given to extending your response time for good cause shown.
Dated 5
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SSVICES,INC.
August 25, 1982 U.S. Nuclear Regulatory Comission Division of Materials Licensing Washington, D.C.
20555 Per 49 CFR 173.393a (1) is registering the use of Technical Operations Model 660 Exporure devices and Model 650 shipping containers.
Shipper: NDE Services, Inc.
8775 E. Orchard Rd.
Suite 809 Englewood, CO 80111 U.S.N.R.C. Approval Designation:
Technical Operations, Inc.
Nothwest Industrial Park Burlington, Mass. 01803 U.S.N.R.C. Approval Numbers:
T/0 660 USA /9033/B()
T/0 650 USA /9032/B ( )
Sincerely, v
Edward. Briggs Radiation Protection Officer 4
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10CFR71 QA PROGRA FOR INDUSTRIAL RADIOGRAPHY LICENSEES 1.
Organization The final responsibility for the Quality Assurance Program for Part 71 Requirements rests with NDE Services, Incorporated. Design and fab-rication of radioactive material shipping pachages shall not be conducted under this Quality Assurance Program. The Quality Assurance Program is imp'emented using the following orgnization:
Note:
The Organizational Chart as used in the license application should be presented. It may be ad-visable to designate the Radiation Safety Officer as the responsible individual for the Part 71 Quality Assurance Requirements.
The Radiation Safety Officer is responsible for overall administration of the program, training and certification, document control, and auditing.
The Radiographers are responsible for handling, storing, shipping, inspection, test, operating status and record keeping.
2.
Quality Assurance Program The management of NDE Services, Inc. establishes and implements the Quality Assurance Program. Training for all QA functions, prior to engagement in these functions, is required according to written procedures. QA Program revisions will be made according to written procedures with management apporal. The QA Pragram will ensure that all defined QC procedures, engineering procedures and specific provisions of the package design approval are satisfied. The QA Program will emphasize control of the characteristics of the package which are critical to safety.
The Radiation Safety Officer shall assure that all radioactive material shipping packages are designed and manufactured under a Quality Assurance Program apporved by the Nucl 2ar Regulatory Commission for all packages designed or fabricated after 1 January 1979. This requirement can be satisfied by receiving a certification to this effect from the manufacturer.
.Af 7sa SERVICES, INC.
8775 East Orchard Road. Suite 809. Englewood, Colorado 80111. (303) 741-0518
N SERVICES, INC.
3.
Document Control All documents related to a specific shipping package will be controlled through the use of written procedures. All document changes will be performed according to written procdures approved by management.
The Radiation Safety Officer shall insure that all QA functions are conducted in accordance v. th the latest applicable changes to these documents.
4.
Handling Storage and Shipping Written safety proedures concerning the handling, storage and shipping of packages for certain special form radioactive material will be followed. Shipments will not be made unless all tests, certifications, acceptances, and final inspections have been completed. Work instructions will be provided for handling, storage and shipping operations.
Radiography personnel shall perform the critical handling, storage and shipping operations.
5.
Inspection, Test and Operating Status Inspection, test and operating status of packages for certain special form radioactive material will be indicated and controlled by v.ritten procedures. Status will be indicated by tag, label, marking or log entry. Status of nonconfrming parts or packages will be positively maintained by written porcudures.
Radiography personnel shall perfonn the regulatory required inspections and tests in accordance with written procedures. The Radiation Safety Officer shall ensure that these functions are perfonned.
6.
Quality Assurance Records Records of package approvals (including refereneces and drawings),
inspections, tests, operating logs, audit results, personnel training and qualifications and records of shipments will be maintained. Descrip-tions of equipment and written procedures will also be maintained.
These record; will be maintained in accordance with written procedures.
Tne records will be identifiable and retrievable. A list of these records, with their storage locations, will be maintained by the Radiation Safety Officer.
l neb SERVICES, INC.
8775 East Orchard Road. Suite 809. Englewood, Colorado 80111. (303) 7410518
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7 Audits Established schedules of audits of the Quality Assurance Program will be performed using written checklists. Results of audits will be maintained and reported to management. Audit reports will be evaluated and deficient areas corrected. The audits will be dependent of the safety significance of the activity being audited, but each activity will be audited at least once per year. Audit reports will be maintained as part of the quality assurance records. Members of the audit team shall have no responsibility in the activity being audited.
. M SERVICES, INC.
8775 East Orchard Road. Suite 809. Englewood, Colorado 80111. (303) 741-0518
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s11 RY AN PLAZA DRIVE. SUITE 1000 ARLINGTON. TEXAS 78011 SEP 2 81982 License:
05-19821-01 NDE Services, Inc.
ATTN: Mr. Edward Briggs President 8775 E. Orchard Road Suite 809 Englewood, CO 80111 Gentlemen:
Thank you for your letter of September 7,1982, in response to our letter and the attached Notice of Violation dated August 13, 1982.
We have no further questions at this time, and we will review your corrective action during a future inspection.
Sincerely, ha en D. Brown, Chief Technical Program Branch W
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