ML19296B077
| ML19296B077 | |
| Person / Time | |
|---|---|
| Site: | 07100173 |
| Issue date: | 02/07/1980 |
| From: | Mcdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | Richmond W Battelle Memorial Institute, PACIFIC NORTHWEST NATION |
| References | |
| NUDOCS 8002200011 | |
| Download: ML19296B077 (4) | |
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UNITED STATES 8 y',.n g.}g
' g NUCLEAR REGULATORY COMMISSION WASHING TO N, D. C. 20555
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% s.- f FEB 0 71980 FCTC: RHO 71-0173 Pacific Northwest Laboratories ATTN: Mr. W. P. Richmond P.O. Box 999 Richland, WA 99352 Gentlemen:
We have evaluated your Quality Assurance Program Description for Shipping Packages of Radioactive Material submitted with your December 22, 1978 letter to satisfy the requirements of 10 CFR 571.51.
Our review indicates that additional information is required to satisfy the applicable requirements of Appendix E to 10 CFR Part 71.
Please address the enclosed request for additional information and submit seven copies of the revised program within 60 days following receipt of this letter.
If you have any questions regarding this request, please feel free to contact Mr. Jim Conway at (301) 492-7741.
Sincerely, CY
"^
Y Charles E. MacDonald, Chief Transportation Certification dranch Division of Fuel Cycle and Material Safety, NMSS
Enclosure:
Request for Additional Information e
80022o0o\\\\
PACIFIC NORTHWEST LABORATORIES (71-0173)
Request for Additional Information 1.
Describe the QA/QC functions performed by PNL's QA organization or delegated to other organizations.
2.
Describe the QA responsibilities of each organizational element identified in Figure 1.
3.
Identify the level of management responsible for establishing PNL's QA policies, goals, and objectives.
4.
Describe how the Transportation Safety Officer, who appears to be responsible for the implementation of the major part of the QA program, is independent from undue influence and responsibilities for schedules and cost.
5.
Describe the qualification requirements for the position of Manager, Quality Assurance Office.
6.
Provide a statement that verification of conformance to established requirements is accomplished by individuals or groups who do not have direct responsibility for performing the work being verified.
7.
Provide a statement that designated QA individuals have the responsibility and authority, delineated in writing, to stop unsatisfactory work and contro].further processing, delivery, or installation of nonconforming material.
8.
Provide a statement that management (i.e., above or outside the QA organization) regularly assesses the scope, status, implementation, and effectiveness of the QA program to assure that the program is adequate and complies with 10 CFR Part 71, Appendix E criteria, 9.
Provide a statement that provisions are established to control the distribution of the QA manuals and guides and revisions thereto.
10.
Describe how disputes involving quality, arising from a difference of opinion between QA/QC personnel and other department (engineering, procurement, manu-facturing, etc.) personnel are resolved, 11.
Provide a statement that an indoctrination and training program is established such that:
a.
Personnel responsible for performing quality-affecting activities are instructed as to the purpose, scope, and implementation of the quality-related manuals, instructions, and procedures.
b.
Personnel performing quality-affecting activities are trained and qualified in the principles and techniques of the activity being performed.
4
c.
The scope, the objective, and the method of implementing the ~indoctrina-tion and training program are documented.
d.
Proficiency of personnel performing quality-affecting activities is main-tained by retraining, reexamining, and /or recertifying.
12.
Provide a statement that a review and concurrence of the adequacy of quality requirements stated in procurement documents is performed by qualified personnel.
This review should determine that quality require;nents are correctly stated, inspectable, and controllable; there are adequate acceptance and rejection criteria; and the procurement document has been prepared, reviewed, and approved in accordance with QA program requirements.
13.
Provide a statement that the review and approval of procurement documents are documented prior to release and available for verification.
14.
Provide a statement that procurement documents identify the applicable 10 CFR Part 71, Appendix E requirements which must be complied with and described in the supplier's QA program.
This QA program or portions thereof shall be reviewed and concurred with by qualified personnel in QA prior to initiation of activities affected by the program.
15.
Provide a statement that procurement documents contain or reference the design basis technical requirements including the applicable regulatory requirements, material and component identification requirements, drawings, specifications, codes and industrial standards, test and inspection requirements, and special process instructions.
16.
Provide a statement that procurement documents identify the documentation (e.g.,
drawings, specifications, procedures, inspection and fabrication plans, inspection and test records, personnel and procedure qualifications, add chemical and physical test results of material) to be prepared, maintained, and submitted to the purchaser for review and approval.
17.
Provide a statement that procurement documents identify those records to be retained, controlled, and maintained by the supplier, and those delivered to PNL prior _to use or installation of the hardware.
18.
Provide a statement that procurement documents contain the procuring agency's right of access to supplier's facilities and records for source inspection and audit.
19.
Provide a statement that changes and revisions to procurement documents are subject to at least the same review and approval as the original document.
20.
Provide a statement that activities affecting quality are r
' bed and accomplished in accordance with documented instructions, proc aees, or drawings.
21.
Provide a statement that provisions are established which clearly delineate the sequence of actions to be accomplished in the preparation, review, approval and co'ntrol of instructions, procedures, and drawings.
22.
Provide a statement that the QA organization reviews and concurs with inspection plans; test, calibration, and special process procedures; drawings and speciff-cations; and changes thereto or acceptable alternatives are described.
23.
Provide a statement that approved changes are included in instructions, pro-cedures, drawings, and other documents prior to implementation of the change.
24.
Provide a statement that a master list or equivalent is established to identify the current revision number of instructions, procedures, specifications, drawings, and procurement documents.
This list is updated and distributed to predetermined, responsible personnel to preclude use of superseded documents.
25.
Provide a statement that special processes such as welding, heat treating, nondestructive testing, and cleaning are procedurally controlled.
26.
Provide a statement that an inspection program which verifies conformance of quality-affecting activities with requirements is established, documented, and accomplished in accordance with written controlled procedures.
27.
Provide. a statement that inspection personnel are independent from the individuals performing the activity being inspected.
28.
Provide a statement that measuring and test equipment is identified and trace-able to the calibration test data.
29.
Provide a statement that measuring and test instruments are calibrated at specified intervals based on the required accuracy, purpose, degree of usage, stability characteristics, and other conditions affecting the measurement.
30.
Provide a statement that measures are taken and documented to determine the validity of previous inspections performed when measuring and test equipment is found to be out of calibration.
31.
Provide a statement that reference and transfer standards are traceable to nationally recognized standards; or, where national standards to not exist, provisions are established to document the basis for calibration.
32.
Provide a statement that departure, arrival time, and destination of a package will be establ_ished and monitored to a degree consistent with the safe trans-portation of the package.
33.
Provide a statement that bypassing of required inspections, tests, and other critical operations is procedurally controlled under the connizance of the QA organization.
34.
Provide a statement that the identification, documentation, segregation, review, disposition, and notification to affected organizations of nonconforming materials, parts, components, or services are procedurally controlled.
.