ML20024E592
| ML20024E592 | |
| Person / Time | |
|---|---|
| Issue date: | 07/22/1983 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20024E587 | List: |
| References | |
| REF-QA-99900917 NUDOCS 8308150332 | |
| Download: ML20024E592 (3) | |
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APPENDIX B Neutron Products, Inc.
Docket No. 99900917/83-01 NOTICE OF NONCONFORMANCE Based on the results of an NRC inspection conducted on April 4-7, 1983, it appears that certain of your activities were not conducted in accordance with NRC requirements as indicated below:
A.
Crif.erion II of Appendix B to 10 CFR Part 50 states, in part, ".
shall establish.... a quality assurance program which complies with the Aequirements of this appendix....
The quality assurance program shall provide control over activities affecting the quality of the identified structures, systems, and components, to an extent consistent with their importance to safety.
Contrary to the above, Neutron Products, Inc. (NPI) failed to establish a quality assurance program to provide control over activities affecting quality as described below.
1.
Neither the NPI Quality Assurance Program Manual (QAPM) nor existing impicmenting procedures established written quality assurance (QA) program controls over activities affecting quality in accordance with Criterion IV, " Procurement Document Control."
2.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion VI, " Document Control."
3.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion VII, " Control of Purchased Material, Equipment, and Services."
4.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion X, " Inspection."
5.
Neither the QAPM nor existing implementing precedures established written QA program controls over activities affecting quality in accordance with Criterion XI, " Test Control."
6.
Neither the QAPM nor existing implemen' ting procedures established QA program controls over activities affecting quality in accordance with Criterion XIII, " Handling, Storage, and Shipping."
8308150332 830722 PDR GA999 EMVNEUT 99900917 PDR 4
. 7.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion XV, " Nonconforming Materials, Parts, and Components."
8.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion XVII, " Quality Assurance Records."
9.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion XVIII, " Audits."
B.
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 requirements are as follows:
1.
Section II of the QAPM states, in part, "Line management at NPI shall be responsible for establishing an indoctrination and training program.
Contrary to the above, no procedures were established to describe the indoc.trination and training of NPI personnel.
2.
Section V, Subsection 3.4.10 of the QAPM states, in part, " Material, parts and components required for irradiation, except Cobalt 60, shall be stored and identified.
Contrary to the above, no implementing procedures were established to describe how parts would be identified and controlled, and how traceability of items irradiated could be confirmed through records.
3.
Section V, Subsections 3.4.14 of the QAPM and 3.2.14 states, in part,
" Periodic calibrations shall be recorded.
Each calibration record shall show the name of the person who performed the calibration, the date on which it was done, and the next date on which a calibration should be performed."
Contrary to the above, no implementing procedures were established to describe in detail how measuring and test equipment would be identified and controlled, use of outside calibration laboratories, recall system, traceability to national standards, and how calibrations will be recorded.
. 4.
Section V, Subsection 3.4.18 of the QAPM states, in part, "In the event that dosimetry or physical and/or chemical properties testing reveals a product has not received the required dose or other specified environmental conditions....
The responsible section manager shall recommend in writing:
an appropriate disposition for nonconforming products; and, the likely cause of the nonconformance...."
Contrary to the above, no implementing procedures were established to describe how corrective action reports are made and describe the i
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type of failures such as malfunctions, deficiencies, deviations, defective or nonconforming material and equipment that should be identified and corrected relative to the radiation aging of safety-related electrical equipment.
Examples of conditions adverse to quality are, but are not limited to, tests specimen damaged from mishandling, improperly identified test specimens, and out-of-calibration equipment.
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