EA-97-393 - Intergrated Industrial Systems, Inc.
Mr. Robert Herbst, President
Intergrated Industrial Systems, Inc.
475 Main Street
Yalesville, Connecticut 06492-1723
SUBJECT: NOTICE OF VIOLATION (NRC Inspection Report No. 030-20102/97-001)
Dear Mr. Herbst:
This refers to the NRC inspection conducted on July 31 and August 1, 1997, at your facility. The inspection was conducted to review your distribution of nuclear gauging devices to general licensees. During the inspection, violations of NRC requirements were identified, as described in the NRC inspection report transmitted with our letter dated September 8, 1997. Also, a Confirmatory Action Letter (CAL) was issued to you on August 7, 1997 to confirm your commitment to take certain corrective actions. You provided your response to the CAL on August 29, 1997. In addition, in the September 8, 1997 letter, the NRC provided you an opportunity to either respond in writing to the apparent violations addressed in the inspection report or request a predecisional enforcement conference. You responded to the apparent violation in an October 4, 1997 letter to the NRC.
Based on the information developed during the inspection and the information you provided in your August 29, 1997 response to the CAL, as well as your October 4, 1997 response to the inspection report, the NRC has determined that five violations of NRC requirements occurred. The violations are cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding them are described in detail in the subject inspection report. The violations involve (1) manufacturing and distribution of certain nuclear gauges in a manner that was not in accordance with the registration certificate; (2) making modifications to the devices, without the required approval by the Technical Director; (3) failure to maintain records of test results of the devices; (4) approval of a nonconforming part as acceptable for use, without the Production Manager, Technical Director, and the assigned Engineer indicating their approval, as required; and (5) the failure to perform required annual audits.
These violations represent a significant regulatory concern in that the failure to manufacture and distribute the gauges in accordance with the registration certificate could result in the malfunction of the gauge while in the possession of a general licensee, and the resultant potential for unnecessary radiation exposure. The violations demonstrate a significant lack of oversight and control of licensed activities. As such, the violations have been classified in the aggregate as a Severity Level III problem in accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions" (Enforcement Policy), NUREG-1600.
In accordance with the Enforcement Policy, a base civil penalty in the amount of $2,750 is considered for a Severity Level III violation. Because your facility has not been the subject of an escalated enforcement action within the last two years, the NRC considered whether credit was warranted for Corrective Action in accordance with the civil penalty assessment process in Section VI.B.2 of the Enforcement Policy. Credit for corrective actions is warranted because your corrective actions were both prompt and comprehensive. These actions, which were described in your August 29, 1997 and October 4, 1997 letters to the NRC, included, but were not limited to: (1) commitments to manufacture the devices in accordance with the Registration Certificate or to obtain a license amendment; (2) revisions of procedures and records; (3) retraining of staff; and (4) plans to ensure audits of activities.
Therefore, to encourage prompt and comprehensive correction of violations, I have been authorized to not propose a civil penalty in this case. However, similar violations in the future could result in further escalated enforcement action.
The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in your letters to the NRC dated August 29, 1997, and October 4, 1997. Therefore, you are not required to respond to this letter unless the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.
In accordance with 10 CFR 2.790 of the NRC's "Rules of Practice," a copy of this letter, and its enclosure, as well as your response if your choose to provide one, will be placed in the NRC Public Document Room (PDR).
Sincerely, Hubert J. Miller Regional Administrator
Docket No. 030-20102
License No. 06-21253-01
Enclosure: Notice of Violation
State of Connecticut
Intergrated Industrial Systems, Inc. Docket No. 030-20102 Yalesville, Connecticut License No. 06-21253-01 EA 97-393
During an NRC inspection conducted on July 31 and August 1, 1997, for which an exit meeting was conducted on August 1, 1997, violations of NRC requirements were identified. In accordance with the "General Statement of Policy and Procedure for NRC Enforcement Actions," (Enforcement Policy), NUREG-1600, the violations are listed below:
A. 10 CFR 32.210(a) states that manufacturer or initial distributor of a sealed source or device containing a sealed source whose product is intended for use under a specific license may submit a request to NRC for evaluation of radiation safety information about its product and for its registration.
10 CFR 32.210(f)(1) and (2) states that the person submitting the request for evaluation and registration of safety information about the product shall manufacture and distribute the product in accordance with (1) the statements and representations, including quality control program contained in the request and (2) the provisions of the registration certificate.
Contrary to the above, from March 21, 1995 to August 1, 1997, the licensee manufactured and distributed certain nuclear gauges in a manner that was not in accordance with of the registration certificate, as evidenced by the following examples.1. Registration Certificate NR-396-D-101-B specifies that approved shutter thickness for the RSS-06 gauges is 0.125 inch; however, the licensee revised the drawings for the RSS-06 gauges and distributed gauges that had a shutter thickness of 0.120 inch.
2. Registration Certificate NR-396-D-101-B specifies that the approved securing bolt for the RSS-06 gauges is to have a machined end; however, the licensee revised the drawings for the RSS-06 gauges and distributed gauges that incorporated a standard 0.25 inch securing bolt without a machined end.
3. Registration Certificate NR-396-D-101-B specifies that the approved materials of construction for the source plug and mounting plates is to be low carbon steel; however, the licensee revised the drawings for the RSS-06 gauges and distributed gauges that incorporated stainless steel source plugs and mounting plates.
4. Registration Certificate NR-396-D-101-B specifies that the approved tolerances for the source housing dimensions were +/-0.01 inches for the licensee's gauges; however, seven RSS-06 castings were inspected against drawing 300-633, revision A, and did not meet the specifications included on the drawings. At least one device was distributed under this license where at least one dimension was not within tolerance for the casting.
B. Condition 18 of License No. 06-21253-01 requires the licensee to conduct its program in accordance with the statements, representations, and procedures contained in the letter dated December 21, 1993. Appendix D to this letter contains the licensees Quality Assurance (QA) program.1. Section 3 of the QA program requires that design changes to devices be approved by the Technical Director.
Contrary to the above, as of August 1, 1997, a number of design modifications were made to the RSS-06 devices, as described in Violation A herein, and these changes were not approved by the Technical Director as required.
2. Section 10 of the QA program requires that records of results of inspections be maintained.
Contrary to the above, as of August 1, 1997, adequate records of results of inspections for Part 300-63302 (sight glass) were not maintained in that the records reviewed during the inspection included the initials of the persons that performed the inspections and whether the materials passed or failed the inspection, but did not include the results of the inspection. In addition, for numerous parts such as the shutter and the source plug, there were no records of inspections.
3. Section 15 of the QA program requires that when nonconforming parts are deemed acceptable for use, the Production Manager, Technical Director, and the assigned engineer shall indicate their approval.
Contrary to the above, on June 18, 1996, a nonconforming part, namely, the source house castings, was deemed acceptable for use, and the Production Manager, Technical Director, and the assigned Engineer did not indicate their approval. Specifically, there was one example where a nonconformance (i.e., seven housings outside the tolerance of +/- 0.01 inches) was not signed off by all three of these persons.
4. Section 18 of the licensee's quality assurance program requires performance of annual audits by an individual not normally involved in the QA program. It also requires a written report to be prepared and reviewed by management.
Contrary to the above, as of August 1, 1997, annual audits were not performed.
These violations are categorized in the aggregate as a Severity Level III problem (Supplement VI).
The NRC has concluded that information regarding the reason for the violations, the corrective actions taken and planned to correct the violations and prevent recurrence and the date when full compliance was achieved is already adequately addressed on the docket in letters from the Licensee dated August 29, 1997, and October 4, 1997. However, you are required to submit a written statement or explanation pursuant to 10 CFR 2.201 if the description therein does not accurately reflect your corrective actions or your position. In that case, or if you choose to respond, clearly mark your response as a "Reply to a Notice of Violation," and send it to the U.S. Nuclear Regulatory Commission, ATTN: Document Control Desk, Washington, D.C. 20555 with a copy to the Regional Administrator, Region I, within 30 days of the date of the letter transmitting this Notice of Violation (Notice).
Dated at King of Prussia, Pennsylvania
this 7th day of November 1997