ML20028H840
| ML20028H840 | |
| Person / Time | |
|---|---|
| Site: | 07100109 |
| Issue date: | 01/22/1991 |
| From: | Strack R CINTICHEM, INC. |
| To: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| References | |
| NUDOCS 9101300270 | |
| Download: ML20028H840 (5) | |
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. Cl$TICHEM, INC.
P.O. BOX 818 TUXEDO, NEW YOAK 10987
[914)351-2131-January 22, 1991 Charles E.-MacDonald, Chief Transportation Branch
. Division ~of Safeguards and Transportation Branch, NMSS U.
S. Nuclear Regulatory Commission
-Washington, D0.20555
': Dear-Mr..MacDonaldi Regarding our Quality Assurance (QA) Program renewal appilcation,
.(Docket #71-0109)-- dated November.29, 1990, Land in response to your' request for additional :Inf ormation letter of; December 21, 1990,.three revised pages are attached.
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The revisions _onzthese pages are Identified by vertical lines in the ' right margins of each page.
If.-these revisions properly address the~ ltems identifled in the enclosure of your December 21, 1990- letter, as we f eel ;they do,.they should replace _ the
. corresponding pages;of our November 29, 1990 submittel (pages PQ-
. 01-9, PQ-01-21, and PQ-01-24 all dated: November 15, 1990).
Six cop!es of the. revised pages and a
single copy of your
' December 21, 1990 enclosure'are attached.
S.nce.e4 %
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_,A Robert A.
rack Reactor' Project Engineer-1-800-431-1146 RAS /bjc
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Attachments e
BJC/08.918-9101300270 910122 g
ADOCK 0710 9
- hC00(j[f jDR
CintichemInc.(71-0109)
Request for Additional '.nformation Encl. to Lir dtd: DEC 21800 Procurement Document Control A statement committing to the provisions of 10 CFR Part 21.31 with regard to: procurement documents.
Nonconforming Material Parts and Components A statement committing to adoption of appropriate procedures required by 10CFRPart21.21(a).
Audits A statement identifying the requirements for the audit team and the lead auditor, s
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PROCUREMENT DOCUMERT C0KITt0L 4.
in any case where material, equipment, or services whose uso is governed by 10CFR Part 71 oro procured f rom an outside supplier, the applicable requirements of 10CFR Part 71 will be clearly included in the procurement documentation.
Each procurement document for a " basic component", as def!ned in 10CFR 21, shall Particuler that the provisions of 100FR Part 21 apply.
specif y, when applicaole, attention will be devoted to such provisions as are related to safety of sh!pments, and in such Instances the supplier will be required to document his compliance wiih the appropriate sections of 10CFR Part 71.
In addition, the supplier will be required to provido a quellty assurance program in compilance with the pertinent provisions of Part 71 whenever such a program is deemed approprieto.
Preparation of procurement documents and any changos or revisions thereto are under the supervision'of Level 1.
Such documents will either contain or referento the necessary design basis technlcel requirements f or each item or type of ' Item being purchased as to ensure compliance with these requirements, and will clearly identify the documentation required f rom the supplier f or review and approval by the purchaser.
This identif ication will also specify which documents and records are to be prepared end roteined by the suppllor, as wolI as those which are to be colivered to or controlled by the purchaser.
or revisions, will be reviewed by the Health All procurement documents, changes, Physics Supervisor or the Manager, Health Safety end Environmental Affairs prior to approval to ensure egreement with all appropriate design specifications and compliance with applicable regulatory requir ements.
Final approval of procurement documentation including changes and revisions will be provided by the Project Manager only after this review has been accomplished.
Also, no procurement document will be approved unless the purchabor's right of access to the suppilor's facilities and records for source inspection and sudit is clearly specified.
who will Control of procurement documents will be exercised by the Waste Manager, see to it that they are properly maintained end fflod in such a way as to be traceable to the specific item.
Procedure PQ-02 providos the procuremont document preparer with the instructions and checks necessery to moet above requirements.
01/22/91 N-l-9
15.
NONCONFORMING MATERIALS, PARTS, OR COMPONENTS As mentioned under the heading "Inspeerlon, Tos1 and Operating Status" (Section 14), in any case where a questlon exists as to the suitability of a particular packago container, or piece of equipment for use, the item will be segregated by t
location, if possible, and tagged to Indicate its non-operational status, pending inspection by a competent Individual in a position of responsibility.
Such tags wIII spec 1fIcalIy Idontify the non-conforming item and brlefly describe the non-conformanco.
After inspection, the item will either be accepted for use again, removed from service permanently, repaired, or reworked, as is necessary and appropriate.
Such disposition wilI be under the d i rect control of the Weste Manager, who will ensure that the status of the item is correctly stated, that the proper actions are taken in accordance with established procedures, and upon completion of the required action, that all necessary documentation is correct and complete.
The. procedures, mentioned above, shall provide the means for evaluating deviations and specif y the notif ications required by 10CFR Part 21.21(a).
Such documentation will include the tag described above, along with other pertinent information, and will clearly specify the test or inspection requirements which must be met to justlfy restorat ion of the item to operational status.
Upon completion of the necessary tests or inspections, a report will be appended to the documentation describing their results, and delineating the further disposition of the item.
Such disposition will not be accomplished until the report is approved and signed by competent authority, generally the Manager Health Safety and Environmental Affairs.
01/22/91 PQ-01-21
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- 18. AUDITS Tile packaging quality assurance program will be audited on a yearly basis by a representative or designee of the Nuclear Safeguards Cor nittee, and the results of l such audits will be reported to the Plant Manager.
Audits must be performcd in l accordance with written procedures or checklists by appropriately trained personnel not having direct respcnsibilities in the areas being audited.
The primary i
concern in such audits will be the hazard potential involved in all aspects of the packaging operation, and audits will be Intended to improve or maintain a high i'
level of safety, f or employees of the licensee, f or the unilmate recipient of packages containing radioactive material shipped by the licensee, and for members of the general public who may be in proximity to such packages dt ring their transport.
The Plant Manager will evaluate the reports of all audits, with the assistance of such competent authority as he deems necessery, and direct that areas ot-dnficiency be corrected.
The Project Manager, shall direct such corrective activity, and approve its completion.
Audit reports and re,? orts of corrective actions shalI be maintained on f fle as part of the packaging quality control records, and wilI be traceable to such other items in these records as are pertinent.
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i 01/22/91 PQ-01-24
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