ML20127N307
| ML20127N307 | |
| Person / Time | |
|---|---|
| Issue date: | 05/21/1985 |
| From: | Alexander S, Potapovs U NRC OFFICE OF INSPECTION & ENFORCEMENT (IE) |
| To: | |
| Shared Package | |
| ML20127N294 | List: |
| References | |
| REF-QA-99900913 NUDOCS 8505230490 | |
| Download: ML20127N307 (13) | |
Text
{{#Wiki_filter:l 1 ORGANIZATION: IS0MEDIX (NEW JERSEY) ZNCORPORATED WHIPPANY, NEW JERSEY REPORT INSPECTION INSPECTION ! NO.: 99900913/85-01 DATE(S): 4/8-11/85 ON-SITE HOURS: 44 I l CORRESPONDENCE ADDRESS: Isomedix (New Jersey) Inc. l ATTN: Mr. G. R. Dietz Executive Vice President and Secretary 11 Apollo Drive i Whippany, New Jersey 07981 ORGANIZATIONAL CONTACT: Mr. Steve Thompson, QA Manager TELEPHONE NUMBER: (201) 887-4700 PRINCIPAL PRODUCT: Gamma irradiation services. NUCLEAR INDUSTRY ACTIVITY: Five percent of Isomedix's business is irradiation of safety-related electrical equipment for environmental qualification testing. ASSIGNED INSPECTOR: S/#d[/5' S. D. Alexander, Equip. Qual. Inspec. Sec. (EQIS) ' Dite OTHER INSPECTOR (S): E. H. Richards, Sandia National Laboratory (SNL) APPROVED BY: U. Potapovs, Chief, EQIS, Vendor Program Branch
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' Date INSPECTION BASES AND SCOPE:
A. BASES: 10 CFR Part 21 and 10 CFR Part 50, Appendix B. B. SCOPE: The purpose'of the inspection was to conduct a technical review and evaluation of irradiation performed on selected safety-related components. PLANT SITE APPLICABILITY: Not identified. 8505230490 850522 PDR GA999 EMVISOM 99900913 PDR
ORGANIZATION:
' ISOMEDIX (NEW JERSEY) INC.
WHIPPANY, NEW JERSEY REPORT INSPECTION NO.- 99900913/85-01 RESULTS: PAGE 2 of 4 A. VIOLATIONS: Non'e. B. NONCONFORMANCES:
- 1. Contrary to the requirements of Criterion V of Appendix B to 10 CFR Part 50 and the requirements of Paragraph 6.4 of the Isomedix Quality Assurance Manual (QAM), Receiving and Product Accountability Record (RPAR) No. 00766 and RPAR No. 00370 did not identify the test items by serial number, part number or other suitable means.
- 2. Contrary to the requirements of Criterion V of Appendix B to 10 CFR Part 50 and the requirements of paragraph 4.3 of Appendix C to the QAM, irradiation test reports dated 3/13/85 for customer 28325, 2/14/85 and 4/1/85 for customer 24200,3/12/85 for customer 44330, and 3/4/85 for customer 45500 did not contain dose rate uniform'ity of the field information.
- 3. Contrary to the requirements of Criterion V of Appendix B to 10 CFR Part 50, the requirements of paragraph 6.10.3 and 6.11 of the QAM, paragraph B.2 of Appendix B to the QAM, paragraph 17.3a-f of Addendum I to the QAM, and the technical specifications of customer 44330 pur-chase order (P0) 54-7-FLC-40416, the dose rate required by the PO was not achieved and there was no documentation in the test file identi-fying, explaining, justifying or authorizing the deviation.
C. UNRESOLVED ITEMS: None. D. STATUS OF PREVIOUS INSPECTION FINDINGS: None. E. OTHER FINDINGS OR COMMENTS:
- 1. A technical review and evaluation of EQ irradiation of Class 1E components was conducted on selected projects from one NSSS supplier, two manufacturers and two test laboratories. The test files were reviewed for technical completeness, accuracy, and consistency and for compliance with referenced specifications and regulatory requirements.
ORGANIZATION: ISOMEDIX (NEW JERSEY) INC. WHIPPANY, NEW JERSEY REPORT INSPECTION NO.- 99900913/85-01 RESULTS: PAGE 3 of 4 The following test files were reviewed: Control No. Component Status
- a. 00084 3 Damper assemblies Completed
- b. 00085 Large pump motor Completed
- c. 00144 Pads, seals Completed (assoc.
with 07142)
- d. 00309 Cables, trays, tape Completed
- e. 00370 Valve seats, pads, discs Completed
- f. 00424 Valve actuator (see 00636) Completed (aging dose)
- g. 00524 Motor controller Completed
- h. 00578 Cable connectors Completed
- i. 00636 Valve actuator (see 00424) Completed (DBEdose)
- j. 00766 Magnetic sensors Completed
- k. 07142 Connector Completed
- 1. 07245 Cables In progress During review of the above test files, the nonconformances of section B were identified.
- 2. With respect to nonconformance B.2, in the cases in which the test items were small enough to see an insignificant flux gradient over the space occupied by the items, the dose rate could appropriately have been described as essentially uniform, but the test report makes no reference to uniformity. In cases where the raw data indicates non-uniform dose rates and their distribution over the field, these data were not included in the test reports cited.
- 3. With respect to nonconformance B.3, Isomedix stated that a customer representative had delivered the samples for irradiation prior to Isomedix's receipt of the P0. The customer representative provided Isomedix a single sheet excerpt from a test plan which he identified verbally as the test specification but which bore no identifying information. The wording of this document was similar to that of the subsequently received P0 with the exception that it provided for dose rates of less than or equal to 1 Mrad per hour. Isomedix further stated that the customer representative was aware of the parameters of the radiation delivered.
. , _ - - , _ - , . - - - . ,,w,,
ORGANIZATION: ISOMEDIX(NEWJERSEY)INC. WHIPPANY, NEW JERSEY REPORT INSPECTION NO
- 44400411/R5-01 RESULTS: ,
PAGE 4 of 4
.y 4. Test report letters reviewed contained the following statement:
" Radiant heat from the source heated the samples somewhat, but the temperature did not exceed 100 degrees Fahrenheit as indicated by previous measurements of an oil solution in the same relative position."
Isomedix stated that this information was intended only as a rough indicator of the radiant heating effect in the irradiator and they do not claim it to be an accurate measure of sample temperature. The NRC inspector recommended clarification of the statement to reflect its intended significance and prevent it from being misconstrued. Isomedix stated that they were considering discontinuing use of the statement and that in practice, when a customer needs actual sample temperature data, Isomedix requires the customer to provide instrumen-tation and support personnel as necessary.
~5. The irradi'ation data forms in use were not the same as described in related documentation and the NRC inspector noted numerous inconsistencies in how they were filled out.. These forms also had no place to record deviations or anomalies as required by procedures.
Isomedix stated that the form was being redesigned, and that related procedural documentation was being revised to refer to the new form and to describe in detail the information required to be recorded.
- 6. Paragraph 7.2 of the QAM describes records relating to irradiation as " permanent." It requires QA records to be retained for 5 years and requires records relating to purchase and calibration [of dosimetry and test equipment] to be retained for 1 year beyond the life of the equipment. This is inconsistent with paragraph 17.4 of Addendum I to the QAM which requires records to be retained for 7 years. Isomedix stated that the QAM was under revision and that this inconsistency would be rectified.
Isomedix's actions regarding concerns addressed in paragraphs E.2 through E.6 above will be reviewed in a future inspection.
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