ML20057C378
| ML20057C378 | |
| Person / Time | |
|---|---|
| Site: | 07100354 |
| Issue date: | 07/07/1993 |
| From: | Stein S, Svigel E ADVANCED MEDICAL SYSTEMS, INC. |
| To: | |
| Shared Package | |
| ML20057C376 | List: |
| References | |
| QA-2000-2.0, NUDOCS 9309280286 | |
| Download: ML20057C378 (6) | |
Text
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Provision No.
QA 2000 2.0 10 CFR Reporting of Defects and Non-Compliance and Procedures Revision:
A for Compliance with 10 CFR Part 21 Date Issued:
9/29/89 Page 1 of 5 f
NOTE: This Procedure should be followed in conjunction with QA 1000 8.1 Procedure For Handling of Customer Complaints and QA 1000 8.2 Procedure for Handling of Incident Reports.
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1.0 SCOPE
1.
This procedure has been established to indicate the practice which will be used by any individual director or responsible officer of AMS who obtains information reasonably indicating that a teletherapy unit's operations, functions, parts, maintenance or repairs thereto present a i
substantial safety hazard.
The individual director or responsible officer is to immediately notify the NRC of such failure to comply or such defect, unless he has actual knowledge that the NRC has been adequately informed of such defect or failure to comply.
2.
The AMS Engineering and Quality Control ("QC") Departments will evaluate suspected defects or failures to comply within 60 days of discovery in order to identify a reportable defect or failure to comply that could create a substantial safety hazard were it to remain uncorrected.
The suspected defects or failures to comply will have been brought to their attention by the Safety Committee through review of Service Reports, by customer input or in-house observations.
The evaluation will include, but not be limited to, past QC history checks, past customer problems, part specification checks, and if necessary, in-house testing to isolate and define the defect.
If the problem is beyond the technical expertise of the AMS staff, outside consultants / experts will be used.
Within five
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days after completion of the evaluation, a written report of the deviation will be submitted to the isotope and AMS Safety Committees l
for their review and action.
3.
Results of the evaluation and recommendations will be reviewed by the Safety Committee.
The Director of Regulatory Affairs, as a responsible officer, or a delegate will notify the appropriate Regulatory Agency in writing within 30 days following receipt of this information, as set forth in sections 5.2 and 5.3 of this procedure, if a reportable defect or failure to comply is determined to exist.
The report will be made in accordance with 10 CFR Part 21 and this procedure.
i Advanced Medical Systems, Inc.
Quality Assurance Department Prepsred by Approval Revisions E. Svigel gf f f y y j f]
9309280286 930923 e
Provision No.
QA 2000 2.0 10 CFR Reporting of Defects and Non-Compliance and Procedures Revision:
A for Compliance with 10 CFR Part 21 Date Issued:
9/29/89 Page 2 of 5 2.0 DEFINITIONS (A) " Defect" means:
1.
A deviation (see 10 CFR S21.3(e)) in a basic component delivered to AMS for use in an AMS teletherapy unit is subject to the regulations in this part if, on the basis of an evaluation (see 10 CFR S21.3(g)), the deviation could create a substantial safety hazard; or 2.
the installation, use or operation of a basic component of a teletherapy
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unit containing a defcet as defined in paragraph (a)(1) of this section.
(B) " Deviation" means a departure from the technical requirements for teletherapy unit components included in a procurement document (see 10 CFR S21.3(i)).
(C) " Director" means an individual authorized to manage and direct the affairs of AMS.
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(D) " Substantial safety hazard" means a loss of safety function in a teletherapy unit to the extent that there is a major reduction in the degree of protection
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l provided to public heal'.h and safety for any facility or activity licensed, other than for export, parenant to Parts 30, 40 or 71 of 10 CFR Chapter 1.
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(E) " Supplying" or " supplies" means contractually responsible for a basic com-ponent used or to be used in the manufacture or repair of teletherapy units.
3.0 WHOM TO NOTIFY All communications and reports concerning the regulations in this part should be addressed to the Director, Office of Nuclear Material Safety and Safeguards, l
U.S. Nuclear Regulatory Commission, Washington, DC 20555, FAX No. (301)492-8187, or Telephone No. (301) 951-0550, or to the Administrator of a Regional Office at the' address specified in Appendix D of Part 20 of Chapter 1.
Communications and reports may be delivered in person at the Commissioner's offices at l
2120 L Street, N.W., Washington, DC or at 11555 Rockville Pike, Rockville, l
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l Advanced Medical Systems, Inc.
Quality Assurance Department Prepared by Approval Revisions E. Svigel
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Provision No.
QA 2000 2.0 10 CFR Reporting of Defects and Non-Compliance and Procedures Revision:
A for Compliance with 10 CFR Part 21 Date Issued:
9/29/89 Page 4 of 5-4.
The written report shall include, but need not be limited to, the following information, to the extent known:
r (i)
Name and address of the individual informing the NRC.
(ii)
Identification of the basic teletherapy unit component supplied by or for AMS within the United States which fails to comply or contains a defect.
(iii) Identification of the firm srpplying the basic teletherapy unit component which fails to comply or contains a defect.
(iv)
Nature of the defect or failure to comply and the safety hazard which is created or could be created by such defect or failure to comply.
(v)
The date on which the information..f such defect or failure to comply was obtained.
(vi)
In the case of a basic teletherapy unit component which contains a defect or f ails to comply, the number and location of all such components in l
use at, supplied for, or being supplied for one or more facilities or activities subject to the regulations in 10 CFR Part 21.
(vii) The corrective action which has been, is being, or will be taken; the name of the individual or organization responsible for the action; and the length of time that has been or will be taken to complete the action.
(viii) Any advice related to the defect or failure to comply about the activity or basic component that has been, is being, or will be given to purchasers or licensees.
5.
The director or responsible officer may authorize an individual to provide tha notification required by 10 CFR Part 21.21, provided that this shall not relieve the director or responsible officer of his or her responsibility under 10 CFR Part 21.21.
Advanced Medical Systems, Inc.
Quality Assurance Department Prepared by Approval Revisions E. Svigel
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Provision No.
QA 2000 2.0 10 CFR Reporting of Defects and Non-Compliance and Procedures Revision:
A i
for Compliance with 10 CFR Part 21 Date Issued:
9/29/89 g
Page 5 of 5 i
l 6.0 PROCUREMENT DOCUMENTS AMS shall assure that each procurement document for a basic teletherapy unit component issued by him, her, or it on or af ter January 6,1978, specifies, when applicable, that the provisions of 10 CFR Part 21 apply.
6.1 Procurement documents for basic components utilized in the following assemblies shall specify that the provisions of 10 CFR Part 21 apply:
sourcchead; rotor: C-Arm; Yoke and source capsule.
7.0 1NSPECTIONS AMS shall permit duly-authorized representatives of the NRC to inspect its records, premises, activities and basic components as necessary to effectuate l
the purposes of 10 CFR Part 21.
8.0 MAINTENANCE OF RECORDS l
1.
AMS shall maintain such records in connection with teletherapy unit operations, functions, parts, maintenance or repairs as may be required to assure compliance with the regulations in 10 CFR Part 21.
(i)
Retain evaluations of all deviations and failures to comply for a minimum of five years after the date of the evaluation; (ii)
Retain any notifications sent to purchasers of basic components and affected licensees for a minimum of five years after the date of the notification.
(iii) Retain a record of the purchasers of basic components for 10 years after delivery of the basic component or service associated with a basic component.
2.
Records that are prepared only for the purpose of assuring compliance with the regulations in 10 CFR Part 21 and are not related to evaluations or notifications to the Commission may be destroyed after delivery of the teletherapy unit component.
Advanced Medical Systems, Inc.
Quality Assurance Department Prepared by Approval Revisions 7 fd E. Svigel 6
l PROPOSED TRAINING DOCUMENTATION RECORD AMS,
ity Assurance Policy for Compliance with 10 CFR Part 21 Procedure 2000 2.0 Training Acknowledgement I have reviewed ooth 10 CFR Part 21 and QA 2000 2.0 and am familiar with their contents.
I have been instructed in the principles and techniques of AMS' quality assurance procedures as they affect my job.
Date Name I
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