ML20058G542
| ML20058G542 | |
| Person / Time | |
|---|---|
| Site: | 07100354 |
| Issue date: | 12/06/1993 |
| From: | Jankovich J NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Stein S ADVANCED MEDICAL SYSTEMS, INC. |
| References | |
| NUDOCS 9312090271 | |
| Download: ML20058G542 (4) | |
Text
,
DEC 0 61993 t
4 e
SCDB:D'GR 71-0354 i
Advanced Medical Systems, Inc.
ATTN: Ms. Sherry Stein Director, Regulatory Affairs 121 North Eagle Street Geneva, Ohio 44041
Dear Ms. Stein:
This refers to your application dated September 23, 1993 requesting an amendment to your Quality Assurance (QA) Program Approval No. 0354.
In connection with our review of your Procedure No. QA 2000 1.0, please provide additional information that is identified in the enclosure to this letter. This information should be provided within 45 days from the date of this letter. Your Procedure No. 2000 2.0, 10 CFR Reporting of Defects and Non-compliance and Procedures for Compliance with 10 CFR Part 21, submitted along with your QA Program, is not required for a QA program approval. This procedure was not reviewed. If you have any questions regarding this matter, you may contact Dennis Reid of my staff at (301) 504-2482.
Sincerely, OdginalSigned try John P. Jankovich, Section Leader Quality Assurance Section Source Containment and Devices Branch Division of Industrial and Medical Nuclear Safety, NMSS
Enclosure:
As stated IllSTRIBUTION:
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Request for Additional Information Advanced Medical Systems, Inc.
Docket No. 07100354 Enclosure to letter dated December 0 6 1993 1.0 ORGANIZATION A.
Procedure QA 2000 1.0, Quality Assurance Policy. for Compliance with I'0 CFR Part 71, shows an issue date of November 7, 1979, however, it was not approved until July 8, 1993. In addition, your procedure does'not have a revision number, nor is the " Prepared By" block filled out as required.
Please clarify the discrepancy between the issue date and the approval date and the reason for the not completing the " Prepared By" block.
B.
Paragraph 3 states that the Quality Assurance (QA) Department being an independent reporting group, is responsible to the Engineering Manager.
The Engineering Manager is also responsible for the Sales, Service, Purchasing, Quality Control and Production functions.
Please change your Organizational Chart to show that QA reports to'a level of management that provides the required independence from influences of cost and schedule, as required by 10 CFR 5 71.103, Quality Assurance Organization. We recognize that in some organizations it may be necessary for an individual to perform other functions in addition to QA (eg. QA Manager / Director of-Regulatory Affairs), however, in such a case, your QA Program should specify when the individual is acting in each capacity, and that the individual has the required authority and organizational freedom to perform the QA functions, in addition, the organizational chart should show the independence of the QA function.
C.
Paragraph 5 states that the Director of Regulatory Affairs is responsible for the overall administration of the program, training, and certification, document control and auditing. Since many of these functions are QA related, this makes it unclear as to what the specific activities of QA is.
Please clarify the responsibilities of QA and the Director of Regulatory Affairs.
The Organizational Chart shows a box with the title " Management Team,"
however its meaning is unclear. Please clarify the term if it has a function related to QA activities.
2 2.0 QUALITY ASSURANCE PROGRAM A.
Paragraph 3 of Section 1.0 states that the QA Department is an independent reporting group, however, they are not on the distribution lists in paragraphs 2.3 and 2.4.5 of your QA Program, to receive copies of your QA manual and approved procedures respectively.
Please add the QA Department to the distribution list for information affecting quality.
B.
In Paragraph 2.4.4, a typographical error was apparently made regarding the word " approval". We assume you intended to refer to the word
" approval". Please let us know if our assumption is incorrect.
C.
Paragraph 2.6 states that all items purchased, manufactured, or used by AMS in the manufacture or service of its package, are subject to QA control. However, Paragraph 2.1 states that the QA Program will emphasize control of the characteristics of the package which are critical to safety.
Please clarify these terms in terms of 0A's definitive role. It is unclear if your QA Program uses a graded approach or if it uses one set of quality controls for all items related to the packaging.
D.
Paragraph 2.7 states that any disputes involving quality between QA personnel and other department personnel, will be resolved by the Engineering Manager.
As indicated in Section 1.0, paragraph B above, the Engineering Manager does not maintain sufficient freedom from influences of cost and schedule. Please identify how QA will report through a management hierarchy to maintain sufficient freedom from cost and schedule.
4.0 PROCUREMENT DOCUMENT CONTROL Paragraph 4.8 states that procurement documents will be reviewed by the Engineering Manager and signed prior to being issued to suppliers of package components. However,it is not clear if procurement documents are reviewed by your QA Department personnel as required by 10 CFR Part 71.
Please state in your procedure that procurement documents are reviewed and approved by your QA Department personnel.
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3 6.0 DOCUMENT CONTROL Paragraph 6.2 states that changes to documents are reviewed and approved either by the same organizations that performed the original review and approval or by other qualified responsible organizations delegated by the applicant.
Please state that changes to documents are reviewed and approved by the same organization that performed the original review and approval.
7.0 CONTROL OF PURCHASED MATERIALS, PARTS AND COMPONENTS A.
Paragraph 7.1.1 states that the Directory of Regulatory Affairs, assisted by the Engineering Manager, will evaluate suppliers.
Regarding the word " Directory", a typographical error was apparently made. We assume you intended to refer to the word " Director" instead.
Please let us know if our interpretation is inaccurate.
As stated in Section 1.0 above, this does not comply with 10'CFR 71 requirements, due to the various responsibilities of the Engineering Manager that conflicts with the necessary independence from influences of cost and schedule.
Please specify the role of your QA Department in supplier evaluations.
Please note that the comments made earlier in Section 1.0, Paragraph B, also apply here relative to AMS' staff size and multiple assignment responsibilities.
10.0 INSPECTIONS Paragraph 10.4 states that modifications, repairs and replacements are inspected in accordance with the original design and inspection requirements, or acceptable alternative. Please clarify the term or
" acceptable alternative," or eliminate it.
14.0 INSPECTION TEST AND OPERATING STATUS Paragraph 14.1 states that identification of the inspection, test and operating status of packages and components is known by the affected organizations. Please state how this is accomplished.
15.0 NON-CONFORMING MATERIAL, PARTS OR COMPONENTS Paragraph 15.2 states that documentation identifies the nonconforming item, describes the non-conformity, and includes signature approval of the disposition.
Please specify, in terms of QA requirements, which activities are included in the review and approval of nonconforming items.
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