ML20041G227
| ML20041G227 | |
| Person / Time | |
|---|---|
| Issue date: | 02/26/1982 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20041G221 | List: |
| References | |
| REF-QA-99900512 NUDOCS 8203190418 | |
| Download: ML20041G227 (2) | |
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APPENDIX A Quadrex Corporation Docket No. 99900512/82-01 NOTICE OF NONCONFORMANCE Based on the results of an NRC inspection conducted on February 1-5, 1982, it appears that certain of your activities were not conducted in accordance with NRC requirements.
Criterion V of Appendix B to 10 CFR Part 50 states:
" Activities affecting quality shall be prescribed by documented instructions, procedures, or drawings, of a type appropriate to the circumstances and shall be accom-plished in accordance with these instructions, procedures, or drawings.
Instructions, procedures, or drawings shall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished."
Nonconformances with this criterion are as follows:
A.
The Quadrex Corporation Quality Assurance Program commits to applying the requirements of ANSI N45.2-1977 and its applicable daughter stan-dards.
Section 9 (Corrective Action) of ANSI N45.2.11 states in part that in addition to correcting a deficiency (or error), corrective action also includes determining the cause and instituting appropriate changes in the design process and quality assurance program.
Where a significant design change is necessary because of an incorrect design, the design process and verification procedure shall be reviewed and modified as necessary.
A procedure shall be employed for providing such corrective action.
Contrary to the above, the Qaadrex Corporation Quality Assurance Program and its implementing procedures do not provide for such corrective action.
B.
Section 3.1 of QAP-201 (Quality Assurance and Project Indoctrination) states that each responsible Manager shall ensure that personnel assigned to his group receives QA indoctrination and, as appropriate, project indoctrination.
Attendance at QA indoctrination sessions shall be recorded.
8203190418 820226 PDR GA999 EMVGUAD 99900512 PDR
Quadrex Corporation Contrary to the above, the records of attendance at QA indoctrination sessions did not provide evidence that two members of the Procurement Department and one member of Engineering had received QA indoctrination.
C.
The Quadrex Corporation Quality Assurance Program commits to applying the requirements of ANSI N45.2-1977 and its applicable daughter stan-dards.
It further commits (Section 2.2.3) to the requirements in appli-cable Regulatory Guides (RG).
Section 3.a(2) of RG 1.144 states tilat applicable elements of an organization's quality assurance program should be audited at least annually or at least once within the life of the activity, whichever is shorter.
Contrary to the above, annual audits of QA Engineering and Computer Program Verification activities were not conducted during 1981.
D.
Section 4.1.5 of QAP-1003 (Audit Reporting, Follow up and Closecut) requires that the response to the audit report be submitted to the Audit Team Leader within 30 days or the time mutually agreed upon at the audit exit meeting.
Contrary to the above, the response to a Quality Audit Finding of audit 81-12 was not submitted to the Audit Team Leader within 30 days, nor was an extension agreed upon.
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