ML19296B661
| ML19296B661 | |
| Person / Time | |
|---|---|
| Issue date: | 09/19/1979 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19296B650 | List: |
| References | |
| REF-QA-99900376 99900376-79-1, NUDOCS 8002210211 | |
| Download: ML19296B661 (5) | |
Text
.
Haveg Industries, Incorporated Wire and Cable Division Docket No. 99900376/79-01 NOTICE OF DEVIATION Based on the results of an NRC inspection conducted on August 21-23, 1979, it appears that certain of your activities were not conducted in accordance with NRC requirements.
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 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." Deviations from these requirements are as follows:
A.
Paragraph 3.6.3.1 of the Quality Control Manual, Revision XVI, dated August 14, 1978, states in part, "All incoming shipments scheduled for inspection will be recorded on the Receiving Inspection Log, noting all pertinent information, including lot size and sample size."
Contrary to the above, lot size and sample size had not been included on the Receiving Inspection Log for Kapton Polyimide Film received and subjected to sample inspection during the period of January 12, 1979 to August 3, 1979.
B.
Paragraphs 3.9.7.1 and 3.9.7.2 of the Quality Control Manual, Revision XVI, dated August 14, 1978 states, respectively:
"A record card file of calibrated inspection measuring equipment will be mainta,ined and each verification of calibration will be entered and dated together with the standard used during calibration.
"The card files and actual units, where practical, will visibly display tF# next due date for recalibration."
Contrary to the above, each verification of calibration of calibrated inspection measuring equipment, had not been entered in the record card files, nor did the card files visibly display the next due date for recalibration as shown by later dates on the calibration labels, for the following calibrated measuring equipment:
Equipment /
Record Card Calibration LabeI~-
Serial Number Information Information Portable Potentiometer /
Cal: April 19, 1978 Cal: April 27, 1979 1829978 Due: January 19, 1979 Due: April 27, 1980 8002210
- 2. I \\
2 AC Voltmeter /
Cal: February 9, 1979 Cal: May 30, 1979 442 Due: May 9, 1979 Due: August 30, 1979 VHF Oscillator /
Cal: April 16, 1979 Cal: August 20, 1979
. Inventory No. 2476 Due: July 16, 1979 Due: November 20, 1979 C.
Pa: agrap'2 3.9.6.4 of the Quality Control Manual,' Revision XVI, dated Auguct li,1978 states, " Equipment which is out of date, discrepant or damaged will be red-tagged with notation of status and placed in separate locations from acceptable equipment pending rework, recalibration, destruc-tion, etc."
Contrary to the above, the following equipment which was out of date for recalibration had not been red-tagged and placed in a location separate from acceptable equipment:
Equipment /
Calibration Label Located Serial Number Information In Pressure Micro-Cal: December 31, 1978 Film Coat meter /20851 Due: June 30, 1979 Department Digital Multimeter/
Cal: January 9, 1979 Quality Control B 032860 Due: July 9, 1979 Laboratory Note: The record cards for this equipment displayed identical calibration performed and recalibration due information as that recorded on the calibration label.
D.
Paragraph 2.4.4.3.2 of the Quality Control Manual, Revision XVI, dated August 14, 1978, states in part, "All changes will be noted by an entry in the revision block. This entry will include the numerical symbol of the revision, the date effective, the signature of the person who initiated the change and the signature of the Manager of Engf.neering, or a designated alternate, signifying approval."
Contrary to the above, a signature indicating approval, had not beea entered in the revision block for Revision 2, dated July 20, 19 3 of Drawing No. 30-02906. The drawing 1.ad been released and distributed.
E.
Paragraphs 2.4.4.4.1 and 2.4.4.5.1 of the Quality Control Manual, Revision XVI, dated August 14, 1978 states, respectively:
"TwocopiesofeachnewandrevisedManufacturingSpecificationshallb7 issued to the Accounting Department. A signature, indicating receipt
3 of the same, will be recorded on the distribution record, which is part of the revision record form.
" Copies of each new and revised Engineering Instruction will be 2ssued to all departments having a need for the particrilar document concerned.
Receipt will be acknowledged by signing the revision / distribution record."
Contrary to the above:
1.
A signature indicating receipt had not been recorded on the dis-tribution records for the following revised Manufacturing Specifica-tions which had been issued to the Accounting Department.
(a) Number 30-02906, Revision 2, dated July 20, 1979.
(b) Number 30-02108, Revision 9, dated July 24, 1979.
2.
Revision / distribution records had not been signed to acknowledge receipt of the following revised Engineering Instructions which had been issued to affected departments:
(a) Number 701328, Revision 6, dated August 14, 1979.
(b) Number 701587, Revision 1, dated August 7, 1979.
F.
Paragraphs 3.8.5 and 3.8.4.4 of the Quality Control Manual, Revision XVI, dated August 14, 1978, states in part, respectively:
" Records of MRB action will be maintained on the Production Rejection report form. The MRB stamp will be used in the appropriate location on the MRB form to determine the disposition of the material.
" Material designated as ' Rework' will be reinspected after rework has been completed and, if acceptable, will be handled as normal giaterial The Prcduction Rejection form contains the following information:
'QC Acceptance of Rework: Yes O No Contrary to the above, reinspection after rework, had not been accomplished for material designated for Rework; as evidenced by the following Production Rejection (PR) forms that exhibited no information regarding Quality Control acceptance of rework: PR No. 23491, dated February 16, 1979; PR No. 20210, dated March 23, 1979; PR No. 20604, dated April 26, 1979; PR No. 29116, dated July 5, 1979; PR No. 26090, dated July 13, 1979; and 23100, dated August 1, 1979.
4 G.
Paragraph 3.9.5.1 of the Quality Control Manual, Revision XVI, dated August 14, 1978 states in part, "All gaging equipment used in production work will be.
subjected to these procedures."
The referenced procedures are encompassed in the control of measuring and test equipment.
Contrary to the above, gaging equipment used in production work had not been subjected to procedures of measuring and test equipment, as evi-denced by the following:
1.
The Strobotac used to measure speed of the tape heads on August 22, 1979, exhibited a calibration label which indicated the instrument was due for recalibration on May 7, 1979. The Tachometer used to measure speed of the wire on August 22, 1979, had not been placed under the calibration program. Wire was being processed in the Tape Wrapping Department for Order No. 30715 on Machine No. 11.
2.
The Spark Tester used to identify insulation problems on August 23, 1979, exhibited a calibration label which indicated the instrument was due for recalibration on August 21, 1979. Wire was being processed in the Irradiated Products Department for Order No. 33164 on Machine No. El.
H.
Paragraphs 3.6.5.2 and 3.6.5.3 of the Quality Control Manual, Revision XVI, dated August 14, 1978 states (the latter in part),
"The process control inspector will obtain a current sample of wire from all operations and check it anninst the appropriate order and specification, at least twice per shift.
"The results of each sampling will be posted on a Process Control Record.
The in-process inspector will identify himself by stamping the appropriate column with his inspection stamp."
Contrary.to the above, regarding the tape wrapping operation for Order No. 30715 on Machine No. 11:
1.
A sample of wire had not been taken from the tape wrapping operation and checked against the appropriate order and specification.
2.
A Process Control Record had not been initiated for posting results of sampling inspection.
These conditions were noted for August 22, 1979.
In addition to the above, the following deviation on Quality Assurance Program content was identified:
5 I.
Criterion XVIII of Appendix B to 10 CFR 50 states in part, "A comprehensive system of planned and periodic audits shall be carried out to verify compli-ance with all aspects of the quality assurance program and to determine the effectiveness of the program. The audits shall be performed in accordance with the written procedures or check lists by appropriately trained personnel not having direct responsioilities in the areas teing audited."
The Quality Assurance Policy of the Quality Control Manual, Revision XVI, dated August 14, 1978, states in part, "This Manual has been prepared to meet the basic requirements of... AEC's 10 CFR 50 - Appendix B as appli-cable to the manufacture and inspection of Haveg Products."
Contrary to the above, a comprehensive system of planned and periodic audits had not been carried out in accordance with written procedures or check lists to verify compliance with all aspects of the quality assurance program to determine the effectiveness of the program. Specifically, Incoming Inspec-tion, In-Process Inspection, Final Inspection, and Packaging were the only areas that had been audited ta prepared check lists.
v O
?