ML20129G825
| ML20129G825 | |
| Person / Time | |
|---|---|
| Issue date: | 07/09/1985 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| Shared Package | |
| ML20129G820 | List: |
| References | |
| REF-QA-99900905 NUDOCS 8507180290 | |
| Download: ML20129G825 (4) | |
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APPENDIX A Wyle Laboratories Norco 99900905.85-01 NOTICE OF NONCONFORMANCE Based on the results of an NRC inspection conducted on May 13-17, 1985, it appears that certain of your activities were not conducted in accor-dance with NRC requirements as indicated below:
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 instructioni procedures, or drawings.
Instructions, procedures, or drawings shall include appropriate quantita-tive or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished."
Nonconformances with these requirements are as follows:
A.
Paragraph 6.1 of Standing Practice Procedure 518-3-B dated March 15, 1982, states, " changes to documents, other than those defined as minor changes in 6.2 below, are considered as major changes and shall be reviewed and approved by the same organizations that performed the
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original review and approval unless other organizations are speci-fically designated."
Contrary to the above, Test Plans 566-1674 Revision A dated May 1, 1984 and 566-1674-1 Revision A dated May 1, 1984, had no documented objective evidence of approval by the same organization that performed the ori-ginal review and approval.
B.
Section 11, Paragraph 11.10 of Wyle Laboratories Quality Assurance Manual Revision E dated March 1,1985, states, in part, " Form WL-109A, Notice of Deviation will be used when test results deviate from the prescribed requirements as outlined in a specification such as, when a test measure-ment or observed parameter does not meet specification requirements and when test parameters have deviated from the test specification require-ment."
Contrary to the above, Test reports 58063-1 dated November 20, 1984 and 58883 dated August 24, 1984 documented instances where deviations to the prescribed requirements occurred during testing but Notices of Deviation were not written.
8507180290 850709 PDR GA999 EXIWYLE 99900905 PDR
APPENDIX A (con't)
C.
Section 5, paragraph 5.0 of Wyle Laboratories Quality Assurance Manual Revision E dated March 1, 1985, states, " Activities affecting quality will be implemented in accordance with documented instructions, proce-dures of drawings."
Ccqtrary to the above, Wyle Laboratories did not have a documented procedure for the control of mixing the chemical spray solution used during design basis event testing and monitoring the solution's PH.
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APPENDIX A Wyle Laboratories 99900905/85-01 NOTICE OF NONCONFORMANCE Based on the results of an NRC inspection conducted on May 13-17, 1985, it appears that certain of your activities were not conducted in accordance with NRC requirements as indicated below:
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 accomplished 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 these requireme.nts are as follows:
A.
Paragraph 6.1 of Standing Practice Procedure 518-3-B dated March 15, 1982, states, " changes to documents, other than those defined as minor changes in 6.2 below, are considered as major changes and shall be reviewed and approved by the same organizations that performed the original review and approval unless other organizations are speci-fically designated."
Contrary to the above, Test Plans 566-1674 Revision A dated May 1,1984 and 566-1674-1 Revision A dated May 1, 1984, had no documented objective evidence of approval by the same organization that performed the original review and approval.
B.
Section 11, Paragraph 11.10 of Wyle Laboratories Quality Assurance Manual Revision E dated March 1, 1985, states, in part, " Form WL-109A, Notice of Deviation will be used when test results deviate from the prescribed requirements as outlined in a specification such as, when a test measure-ment or observed parameter does not meet specification requirements and when test parameters have deviated from the test specification require-ment."
Contrary to the above, Test reports 58883-1 dated November 20,1984 and 58883 dated August 24, 1984 documented instances where deviations to the prescribed requirements occurred during testing but Notices of Deviation were not written.
. C.
Section 5, paragraph 5.0 of Wyle Laboratories Quality Assurance Manual Revision E dated March 1,1985, states, " Activities affecting quality will be implemented in accordance with documented instructions, proce-dures of drawings."
Contrary to the above, Wyle Laboratories did not have a documented procedure for the control of mixing the chemical spray solution used during design basis event testing and monitoring the solution's pH.
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