ML19275A547
| ML19275A547 | |
| Person / Time | |
|---|---|
| Issue date: | 06/27/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19275A539 | List: |
| References | |
| REF-QA-99900360 99900360-79-1, NUDOCS 7910040623 | |
| Download: ML19275A547 (3) | |
Text
ESB Int.rporated Exide Industrial Battery Division Sumter, South Carolina Docket No. 99900360/79-01 NOTICE OF DEVIATION Based on the results of an hTC inspection conducted on ?!ay 30 - June 1,1979, it appeared that certain of your activities were not conducted in full accordance with hTC requirements as indicated below:
A.
Criterion VIII of Appendix B to 10 CFR 50, states in part, "fleasures shall be established for the identification and control of materials, parts, and components, including partially fabricated assemblies.
These measures shall assure that identification of the item is maintained by heat number, part number, serial number, or other appropriate means, either on the item or on records traceable to the item, as required throughout fabrication, erection, installation, and use of the item.
These identification and control measures shall be designed to prevent the use of incorrect or defective material, parts, and components."
Criterion VIII is implemented in part by paragraph 8.3.2 of the Quality Assurance t!anual (QAt!), Revision 8, dated January 27, 1979, that states,
" Purchased parts and components shall be identified by part number, lot number or other means as defined in drawings, specifications or purchase orders. These items must show evidence of inspection and acceptability.
These items must retain identification through storerooms and movement until the parts or components become a part of an assembly."
Criterion VIII is further implemented by paragraph 3.7 of Quality Control Procedure (QCP) 58.0, dated Flay 19, 1975, that states in part, "The inspect-ion status of materials, parts, and components is accomplished through the use of stamps, tags, punches, and color coding."
Contrary to paragraphs 8.3.2 of the QAFI and 3.7 of the QCP, purchased parts such as, separators, spacers, spacer plates, and covers, at the E cell assembly line, did not show evidence of inspection and acceptability.
B.
Criterion V of Appendix B to 10 CFR 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 accord-ance with these instructions, procedures, or drawings.
Instructions, pro-cedures or drawings chall include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished."
1.
Paragraph 3.1.1.2 of Quality Control Procedure (QCP) No. 50.0(S), dated t!ay 14, 1979, states; "The samples shall be analyzed for Red Lead 1101 138 7910040 g
2 percentage, Acid Absorption, Apparent Density and Tap Density. Test results shall then be compared to those of the vendor; and shall be recorded on a log sheet which is maintained on file in the lab."
Paragraph 3.3 of Purchase Requirements (PR) No. 2, Section 2, dated September 29, 1977, requires an Apparent Density of 20-25
- gms/cu. in.
(* = 25 preferred).
Contrary to the above, the log sheets of red lead analysis revealed twenty-three (23) readings that exceeded twenty-five (25) grams per cubic inch; e.g.,
Lot No. R-75-9 read 25.110; Lot No. R-75-21 read 26.31; Lot No. R-75-2 read 28.79; and Lot No. R-75-7 read 30.0.
See Details Section, paragraph D.3.a.
2.
Paragraph 3.1.1 of QCP No. 86.1.1(S), dated December 30, 1977, states, "Twice weekly select a lot of complete parts and sample inspect per QCL 86.1.1."
Contrary to the above, completed parts had not been selected twice weekly and sample inspected; as evidence by the Small Parts Inspection Record for the week ending May 11, 1979.
The record reflected entries of April 23, 27; May 2, 8, 8, and 30 3.
Paragraph 3.3 of QCP No. 86.1.1(S) dated December 30, 1977, states "On a daily basis, take samples from E and CC casting pots and titrate per MTP-15. Post results on charts at titration station."
Contrary to the above, daily samples had not been taken and results posted on charts at the titration station for casting pot No. 3.
The Control Charts dated January 8 - May 30, 1979, displayed thirty-one (31) missed days, discounting weekends.
4.
Paragraph 3.1 of QCP No. 102.3(S), dated February 13, 1978, states, "All assembly lines will be monitored on a daily basis and inspection results will be recorded on the attached checklists" (Stationary Inspection and Process Verification Record).
Contrary to the above, assembly lines had not been monitored daily with inspection results recorded on the Stationary Inspection and Process Verification Record.
Inspection records for the C and E lines revealed the following:
Week Ending Days Missing February 17, IF8 Thursday 1101 159
3 March 3, 1978 Mon?ay, Tuesday, Wednesday, also Thursday and Friday on the E line March 10, 17, Friday 24, 1978 October 6, 1978 Wedneaday on E line March 2, 1979 Wednesday; also, Friday on C line March 9, 1979 Monday, Tuesday, Thursday, Friday March 23, 1979 Friday on E Line C.
Criterion IV of Appendix B to 10 CFR 50, states in part, " Measures shall be established to assure that applicable regulatory requirements, design bases, and other requirements which are necessary to assure adequate quality are suitably included or referenced in the documents for procurement of material, equipment, and services, whether purchased by the applicant or by its contractors or subcontractors."
Criterion IV.is implemented, in part, by QCP No. 30.7, dated November 1, 1978, as follows:
Subparagraph C.3. states, "Any discrepancies found during the Qual hy Assurance / Quality Control review shall be brought to the attention of Purchasing who will take appropriate action to correct."
Contrary to the above, discrepancies found during Quality Assurance review had not been brought to the attention of the Purchasing Department nor had corrective action been taken. Examples of QA observed discrepancies:
Purchase Order (PO) No. 42400 dated March 26, 1979, fails to show the revision for Part Number (PN) 82862; PO No. 42381 dated March 23, 1979, fails to show the revision for PNs 78388, 77348, 77349, and 77478 with incorrect revision for PNs 79498 and 79499; PO No. 42387 dated March 23, 1979, shows the incorrect revision for PN 79612; and P0 No. 42386 dated March 23, 1979, shows the incorrect revision for PN 79615.
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