ML20055A842
| ML20055A842 | |
| Person / Time | |
|---|---|
| Site: | 07100454 |
| Issue date: | 07/12/1982 |
| From: | Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Ridout E ATOMIC ENERGY OF CANADA, LTD. |
| References | |
| NUDOCS 8207200035 | |
| Download: ML20055A842 (4) | |
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JUL 121982 wvvt f}t4 C[A O FCTC:LLG 71-0454 3 46-SI Atomic Energy of Canada, Ltd.
Connercial Products ATTN: Mr. E. F. Ridout P.O. Box 6300 Ottawa, Canada K2A3W3 Gentlemen:
This refers to your application of June 3,1982 requesting review and approval of QAP Number 2, " Design, Testing and Fabrication of Radioactive Material Transport Packages," dated October 1981.
We reviewed your QA program description painst our requirements and find that your QA program should be reviseo '.o include the additional infomation identified ia the enclosure to tnis letter.
If you have questions regardir.g this request, please contact Mr. Leonard Gordon of my staff at 331/427-4122.
Sincerely.
Original signed by canes E. MACDOUM Charles E. MacDonald, Chief Transportation Certification Branch Division of Fuel Cycle and Material Safety, HMSS
Enclosure:
As stated Distribution: w/ encl LLGordon Docket File NMSS R/F FCTC R/F NRC PDR IE HQ Region @
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NRC FORM 318 (10-80) NRCM O240 Q Q __ Q @ @ @
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Request for Additional Information Atomic Energy of Canada Limited Docket No. 71-0474 Encl to ltr dtd:
The following questions are arranged so as to facilitate cross referencing with the applicable section of the QA program description:
Orgaaization (Section2.)
1.
Paragraph 2.4 states that the general manager, industrial products, is responsible for preparation of the design and also for ensuring compliance with the QA program for design activities. Expand paragraph 2.4 by providing a description of how the Appendix E to Part 71 requirement that personnel performing the work are independent from individuals or groups not directly responsible for verification of the work.
2.
Expand paragraph 2.3 to delineate qualification requirements AECL imposes for the principal QA and QC management positions.
3.
Revise Figure 1 (Organization Chart) to show the lines of communication and direction between AECL-Canada and the U.S. Branch Office subsidiaries.
QA Program (Section3.)
1.
Expand paragraph 3.3 by identifying components and structures to be controlled by the QA program.
2.
Expandparagraph3.2(orattachasanAppendix)amatrixofthose QA procedures that implement each criterion of Appendix E.
With respect to those activities not yet initiated, but anticipated, the implementing procedures should be identified by title and procedure number. Also include a brief description of the content of the procedures with an estimated date of completion.
Design Control
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(Section3.5) 1.
Expand paragraph 3.5.2 by adding statement that verification of the design will be performed by individuals other than those performing the design.
2.
Expand paragraph 3.5.3 by adding a statement that maintenance, repair, in-service inspections, storage, and cleaning requirements are specified in design documents.
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. Procurement Docueant Control (Notaddressed) i 1.
Criterion 4 of Appendix E, " Procurement Document Control" apparently was inadvertantly omitted in your desciption and needs to be addressed as a separate item.
Instructions, Procedures, and Drawings (Section5) 1.
Expand paragraph 5.2 by adding statement that instructions and checklists include acceptance criteria to verify activities important to safety have been accomplished. satisfactorily.
Corrective Action (Section 15) 1.
Add a paragraph 15.2 to identify individuals or organizations responsible for closing out corrective actions and documenting their resolution.
Records (Section 16) 1.
Expand paragraph 16.2 (or add an appendix) to provide a list of specific records in each category (e.g., QA, design, procurement, etc.). Also add that records documenting the condition of packages will be retained for the time that items remained installed or are stored for further use.
2.
Add paragraph 16.5 by describing means for ensuring that certain l
records (e.g., identified on certificate of compliance) are readily available and kept current at designated U.S. Branch offices subsidiaries.
l 3.
Describe means for ensuring records are stored to minimize risk l
from damage or destruction from severe natural conditions such as l
flood, fire, temperature, or humidity.
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OFFICIAL RECORD COPY
. Audits (Section17) 1.
Describe the extent that U.S. Branch office subsidiaries will audit design / fabrication activities of AECL-Canada to ensure themselves of compliance with the NRC approved QA program.
2.
Provide a statement that the overall effectiveness of implementation of the described in-house QA program will be audited by top management, and identify the frequency of audit.
3.
Identify the qualification requirements for auditors including lead auditor.
4.
Specify the time constraints imposed for issuing audit reports and corrective action response from audited organizations.
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