ML20024E595
| ML20024E595 | |
| Person / Time | |
|---|---|
| Issue date: | 07/15/1983 |
| From: | Agee J, Benson J, Phillips H NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV), SANDIA NATIONAL LABORATORIES |
| To: | |
| Shared Package | |
| ML20024E587 | List: |
| References | |
| REF-QA-99900917 NUDOCS 8308150335 | |
| Download: ML20024E595 (10) | |
Text
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ORGANIZATION:
NEUTRON PRODUCTS, INC.
DICKERSON, MARYLAND RtF0ki INSPECTION INSPECTION NO.:
99900917/83-01 DATE(S) 4/4-7/83 ON-SITE HOURS:
6a CORRESPONDENCE ADDRESS:
heutron Products, Inc.
ATTN:
Mr. C. Smedira, Vice President anc Quality Assurance Manager P. O. Box 68, Mt. Ephrain Road Dickerson, Maryland 90753 ORGANIZATIONAL CONTACT: Mr. C. Smedira, Vice President and (uality Assurance Manager TELEPHONE NbMBER:
(301) 349-5001 PRINCIPAL PRODUCT:
Radiation sources and irradiation services.
NUCLEAR INDUSTRY ACTIVITY:
Neutron Products, Inc. (hPI) produces and sells radioactive sources and irradiates products and components for various customers.
hPI has approximately 87 employees. Approximately 1% of NPI work capacity is used for the irradiation aging of nuclear safety-related electric equipment as a part of the environmental qualification testing per IEEE 323.
ASSIGNED INSPECTOR:
W k 7- / 5 - 3'J J. R. Agee, Equipment Quaiification Section (EQS)
Date OTHER INSPECTOR (S):
J. J. Benson, Sandia National Laboratories APPROVED BY:
./
b 7 y3 H.~S.
Phillips, Chidf, EQS Date INSPECTION BASES AND SCOPE:
A.
BASES:
10 CFR Part 50, Appendix B, and 10 CFR Part 21.
B.
SCOPE: This inspection consisted of (1) an in-office review of the NPI QA manual; (2) a review of implementing procedures at NPI offices; and (3) an onsite inspection to evaluate ccmpliance with 10 CFR Part 21 requirements.
PLANT SITE APPLICABILITY:
73D ORIGlHAI' gM Not identified.
B308150335 830722 PDR GA999 ENVNEUT i
99900917 PDR
ORGANIZATION: NEUTRON PRODUCTS, IhC.
DICKERSON, MARYLAND REPORT INSPECTION N0.:
99900917/83-01 RESULTS:
PAGE 2 of 8 A.
VIOLATIONS:
Contrary to Section 21.6 of 10 CFR Part'21 posting requirements, NPI had neither posted current copies of the 10 CFR Part 21 regulation nor Section 206 of the Energy Reorganization Act of 1974.
B.
HONCONFORMANCES:
1.
Contrary to the requirements of Criterion II of Appendix B to 10 CFR Part 50, NPI failed to establish a quality assurance program (QA) cocumented by written policies, procedures, or instructions to control activities affecting quality and to assure that activities affecting quality were accomplishea uncer suitably controlled conditions.
This failure to establish a QA program is supported by the following:
a.
Neither the NPI Quality Assurance Program Manual (QAPN) nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion IV, " Procurement Document Control."
b.
Neither the QAPN nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion VI,
" Document Control."
c.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion VII, "Ccntrol of Purchased Material, Equipment and Services."
d.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion X, " Inspection."
e.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Critericn XI, " Test Control."
f.
Neither the QAPM nor existing implementing procedures
)
established QA program controls over activities affecting quality in accordance with Criterion XIII, " Handling, Storage, and Shipping."
ORGANIZATION:
t;EUTRON PRODUCTS, INC.
DICKERSON, MARYLAf;D REFCRT INSPECTION NO.:
999C0917/83-01 RESULTS:
3 AGE 3 of a g.
Neither the QAPM nor existing implementing proceaures established wr.itten QA program controls over activities affecting qual'1ty in accordance with Criterion XV,
" Nonconforming 9aterials, Parts, and Components."
h.
lieither the QAFh nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criterion XVII, "Ouality Assurance Records."
i.
Neither the QAPM nor existing implementing procedures established written QA program controls over activities affecting quality in accordance with Criteria XVIII, "Aucits."
2.
Contrary to the requirements of Criterion V of Appendix B to 10 CFR Part 50 and QAPM,Section II, NPI failed tc establish implementing procedures which would describe the indoctrination and training of NPI personnel.
3.
Contrary to the requirements of Criterion V of Appendix B to 10 CFR Part 50 and QAPM,Section V, NPI failed to establish implementing procedures to describe how materials, parts or components would be identified and centrolled during irradiation and how identification numbers would be recorded to be able to maintain traceability of items irradiated, or show that the prerequisites of environmental testing were in accordance with IEEE Standarc 323 and QAPM, Subsection 3.4.10.
4.
Contrary to the requirements of Criterion V of Appendix B to 10 CFR Part 50 and QAPM, Subsections 3.4.14 and 3.2.14, fiPI failed to establish implementing procedures to cescribe the control of measuring and test equipment.
5.
Contrary to the requirements of Criterion X of Appendix B to 10 CFR Part 50 and QAPM, Subsection 3.4.18,f;PI failed to establish implementing procedures to describe how the flPI corrective action system work',.
C.
Uf4 RESOLVED ITEMS:
None
ORGANIZATION:
NEUTRON PRCDUCTS, IfiC.
DICKERSON, MARYLAND REPORT INSPECTION NO.:
99900917/83-01 RESULTS:
> AGE 4 of 8 D.
OTHER FINDINGS OR COMMENTS:
1.
0A Manual and Implementing Procedures Review:
The NRC inspector reviewed QAPM, Revision 4, (catea October 16,1980) in the NRC office prior to the onsite inspection.
The manual was written to satisfy the requirements of the NRC, Food and Drug Administration, the Department of Transportation, and the State at Maryland.
Section IV of the manual states that their QA program was written to meet the QA requirements of 10 CFR Part 50, Appendix B and specifically,Section V.3, " Radiation Processing," Subsection 3.4, "Other Irradiations," of the QAFM was written to establish this QA program.
The QAPM referenced NPI supplemental or implementing procedures R 2013, "Special Irradiations"; R 6001, " General Procedure for Dickerson I Irradiator Operations"; and " Procedure for Dickerson II Irradiator Operations."
The NRC inspector determinec that 16 of the 18 criterla of 10 CFR Part 50 Appendix B were applicable. Cnly Criterion III
" Design Control," and Criterion IX, " Control of Special Processes,"
were not applicable to the irradiation aging of safety-related electrical components to be tested by their customers.
The QAFit contained general statements about the specific criterion but failea ',a address each point of each criterion.
The existing impleme ting procedures did not describe how each criterion or applicable part of a criterion would be implemented.
Sixteen applicable criteria which should have been fully described in the QAPM and/or procedures were evaluated and nonconformances were identified relative to each of the 16 applicable criteria.
Therefore, this apparent failure to develop and establish a QA program in writing is a nonconformance to 10 CFR Part 50 Appendix B, Criterion II, "QA Program," which requires that a QA program be established at the earliest practicable time to provice control over activities affecting quality.
The following findings are concerned with the failure to establish a QA program fcr the 16 applicable criteria of 10 CFR Part 50, Appendix B:
a.
Organization: The authority and duties of persons and responsibilities of organizations were described in writing and in organizational charts.
Persons and organizations performing quality assurance functions had sufficient authority and organizational freedom to identify quality problems, recommend solutions and verify implementation of solutions.
ho rionconformances were icentified.
l l
ORGANIZATION: NEUTRON PRODUCTS, INC.
DICKERSOfi, MARYLAfl0 REPORT INSPECTION NO.:
99500917/83-01 RESULTS:
> AGE 5 of 8 b.
QA Program:
The NRC inspector (hereafter referred to as the inspector) determined that a QA program had r.ot been established in writing as required by 10 CFR Part 50, Appendix C.
See Nonconformances B.1-B.S.
The QAPM,Section II, required that indoctrination and training of personnel be accomplished; however, no implerrenting proceaure had been established to describe how this would be accomplished. See Nonconformance B.2.
c.
Design Control:
Not applicable.
d.
Procurement Document Control:
The inspector reviewed the QAPM, Subsection 3.4.o anc hPI procedure R 2013 and determined that these documents neither described the requirements of the criterion nor how the criterien was to be implemented.
See Nonconformance B.l.a.
e.
Instructions, Procedures, and Drawings:
The inspector reviewed the QAPM anc implementing procedures and cetermined that procedures hac not been established for most of the criteria.
See the other sections of this part of the report relative to the failure to establish procedures as required by Criterion V.
f.
Document Control: The inspector reviewed the QAPM and implementing procedures and determined that neither addressed the requirement to review comments nor describe how the review would be accomplished. Likewise there was nothing in writirg relative to requiring review of changes by the same organization and distributing instructions, procedures, and drawings to the prescribed work location.
See Nonconformance B.1.b.
g.
Centrol of Purchased Material, Equipment, and Services:
The inspector reviewea the QAPM ana implementing procedures and detennined that these procedures failed to describe vendor / supplier evaluation and selection; objective evicence of quality (certificate of conformance, etc.) to be furnished to NPI; inspection and audit at the source (as necessary) to assure quality; and receipt inspection.
See Nonconformance B.1.c.
h.
Icentification and Control of Materials, Parts, and Components:
The inspector reviewed the QAPN anc no nonconformances were l
identified relative to this document; however, there were no l
1 ORGANIZATIOf.:
fiEUTRON PRODUCTS, INC.
DICKERSON, MARYLANC REPORT If4SPECTIOh NO.:
99900917/83-01 RESULTS:
3 AGE 6 of 8 implementing procedures which described how the identification of equipment, parts, and ccmponents would be identified prior to, during, and after testing.
There was no descriptien of the recording of the icentification of such items in order for test specimen to be traceable during the testing process.
This is especially 1mportant if testing takes place at one or more other locations.
See Nonconformance B.1.c.
i.
Control of Special Processes:
Not applicable.
j.
Inspection:
The inspector reviewed the QAPM and implementing procedures and determined that the involvement of the quality organization relative to monitoring the process of irradiating test specimen and inspection activities, such as, receipt and inspection of incoming specimen, ano handling and storage of specimens were not addre'ssed.
See Nonconfornance B.1.d.
k.
Test Control:
The inspector reviewed the QAPM, Subsection 3.4.15 and tnat subsection stated that this criterion is not applicable.
It is granted that providing an irradiation dose to a component is not a test; however, the specimen is to be tested in accordance with IEEE Std. 323 and daughter stanoards, and this testing required irradiation aging as a part of the testing process.
Therefore, this preconditioning is prerequisite to testing and this part of the criterion must be addressea.
See Nonconformance B.1. e.
1.
Control of Measuring and Test Equipment:
The inspector reviewed QAPM, Subsection 3.4.14 wnich referenced Subsection 3.2.14.
The QAPM discussed the general requirements of this criterion; however, neither the QAFM nor the implementing procedure specifically discusseo how the calibration system works, that is, use of outside calibration organizations, identification of instruments and measuring equipment, recall system, traceability to national standards, and record of calibrations and status.
See Monconformance B.4.
m.
Handling, Storace and Shipping:
The inspector reviewed the QAPM and implementing procedures and determined that measures had not been established to describe the handling, and storage of components to be tested; however, in this case the customer delivers and picks up the ccmponents so shipping is not a function performed by NPI. Additionally, the procedures cid address the protection and preservation of critically sensitive or high value articles ana, when necessary, special envircomental protection.
See lionconformance B.1.f.
i
ORGANIZATION: NEUTRON PRODUCTS, IhC.
DICKERSON, MARYLAND REPORT INSPECTION NO.:
99900917/83-01 RESULTS:
JAGE 7 of 6 n.
Inspection Test and Operating Status:
The i,spector reviewed the QAFM ano implementing procecures R 6001 and R 7003 which provide instructions for operating the system for raciation aging materials used in safety-related electrical equipment.
No nonconformances were identified.
o.
Nonconforming Material;, Parts, or Comconents:
The inspector reviewed QAPM, Subsection 3.4.17, "Nonconformance," ano this section stated that this criterion was not applicable under the QA program; however, Subsection 3.4.12, " Inspection" contradicted this statement and described the tagging and segregation of nonconforming products.
NPI procedure R 2013, Revision 0 (March 5, 1980), Section 5.6, has a general comment relative to this criterion but does not describe a system for centrolling nonconforming materials, parts or components.
This criterion is applicable 'because test specimen may be mishanoled and damaged, improperly stored, or irradiateo.
f'easuring and test or irradiation equipment may be damaged cr be improperly calibrated.
For these types of conditions adverse to quality, no procedures were established to describe a requirement for such a nonconformance system or how the system would work.
Credit cannot be given for the general comments described under QAPM, Subsection 3.4.12 because Subsection 3.4.17 states that Criterion XV is not applicable.
See Nonconformance B.1.g.
p.
Corrective Action: The inspector reviewed the QAPt' and determineo that corrective action was generally addresseo; however, no implementing procedures were established to describe the NPI corrective action process.
See Nonconformance B.5.
q.
Records: The hRC inspector determined that neither the QA manual nor implementing procedures contained a subsection to describe a system to control QA records.
See Nonconformance B.1.h.
r.
Audits:
The NRC inspector determined that neither the QA i
manual nor implementing procedures contair.ed a subsection to describe an audit system.
See Nonconformance B.1.i.
2.
Evaluation of 0A Program Implementation:
The QA manual and l
procedures were reviewed ano documented in paragraph D.1 above.
The inspector determined that a QA program had not been establishec.
Since implementing procedures were not established, the inspector did not evaluate the implementation of the QA program.
See all the l
nonconformances in paragraphs B.1-B.5.
The inspector will evaluate l
implementation during a future inspection after procecures have been establishec.
ORGANIZATION:
NEUTRON PRODUCTS, IhC.
DICKERSON, MARYLAND l
REPORT INSPECTION NO.:
99900917/83-01 RESULTS:
4GE 8 cf b 4
3.
Implementation of 10 CFR Part 21 Reporting System: The inspector reviewed the hPI 10 CFR Fart 21 reporting procedure which was maintained in a set of rule books.
No ncnconformances or violations were identified relative to the procedure.
The inspector visually inspected bulletin boards to determine if 10 CFR Part 21 posting requirements had been met.
Current copies of the 10 CFR Part 21, Section 206 of the Reorganization Act of 1974 and procedures adopted pursuant to the regulation had not been posteo; however, NPI did maintain a set of notebooks concerning NRC requirements and these documents were incluced in the notebook.
See Violation A above.
During the inspection, NPI took corrective action by posting both documents. The inspector verified that these documents had been posted.
NPI will prevent recurrence by placing this on an audit check list. Because corrective action was completed, the inspector considers this matter closed and no response to this violation will be required.
4.
Exit Meeting:
The inspection team met with NPI management to summarize inspection findings. The violation and each nonconformance were discussed.
The inspector stated that there was an apparant failure to establish in writing a QA program as required by 10 CFR Part 50, Appendix B.
NPI management acknowledged the findings; however, they stated that they did not think that Critericn IV, " Procurement Document Controi";
Criterion VI, " Document Control"; Criterion VII, "Centrol of Purchased Material, Equipment, and Services"; Criterion VIII,
" Identification and Ccntrol of Materials, Parts, and Components":
Criterion XII, " Control of Measuring and Test Equipment"; ano Criterion XIV, " Inspection, Test and Operating Status," were applicable to the irradiation of safety-related electrical equipment, parts, or l
components.
l NPI management committed to extensively review their QA program and establish procedures for all applicable criteria.
Inspector j' F AJ U*Ck H* OfS Report No. 2n$JY 9ee di Scep2/ Module DOCUMENTS EXAMINED i
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