ML20033A932
| ML20033A932 | |
| Person / Time | |
|---|---|
| Issue date: | 11/16/1981 |
| From: | NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20033A928 | List: |
| References | |
| REF-QA-99900754 NUDOCS 8111300178 | |
| Download: ML20033A932 (3) | |
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APPENDIX B NOTICE OF NONCONFORMANCE Acimet Manufacturing Docket No. 99900754/81-01 Based on the results of an NRC inspection conducted on September 14-18, 1981, it appears that certain of your activities were not conducted in accordance with NRC ~ 'rements as indicated below:
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 accom-plished in accordance with these instructions, procedures, or drawings.
Instructions, procedures, or drawings shall include appropriate quanti-tative er qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished."
Nonconformances with these requirements are as follows:
A.
QA Manual Section VII, paragraph 7.2.2 states in part, "... vendor 4
audits are performed annually to insure the effectiveness of the program. Vendors who hold ASME Quality System Certificate (Material) need not be surveyed or audited...."
Paragraph NCA-3867.4(e) in Section III of the A",ME Code pemits a 4
material manufacturer, who certifies stock from a manufacturer whose quality system program has not been qualificd under NCA-3800, to accept the manufacturer's certification of heat analysis and the requirements of the materia' specification which must be performed i
during the melting, provided:
1.
The material manufacturer ?erforms or subcontract; all other material specification requirements en each piece of stock i
material, or, on each heat and lot of material if traceability j
has been established by his program or the program of the certificate holder who uses the material.
2.
The material manufacturer performs or subcontracts a product r
analysis to verify the chemical composition of each piece of j
stock material furnished by the stock material utanufacturer.
Contrary to the above:
1.
Acimet Manufacturing (AM) purchased finished bolting products for use in ASME Code Section III applications from an AM approved bolting material manufacturer. The material used came from a stock raterial manufacturer, through a material supplier; neither of which hea been audited by AM nor were they holders of ASME Quality System Certificates.
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Verification of compliance of these.naterials with the material specification requirements had not been accomplished in accordance with the provisions of NCA-3867.4(e) in Section III of the ASME Code.
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i B.
QA Manual S u tion IX, paragraph 9.5 states in part, "... Heat treating h rerformed in accordance with written procedures that have been approved by the Quality Assurance Manager...."
l Heat Treat Procedure No. 4.1, paragraph 2.1 states, " Heat treatment of these fasteners must be accomplished in a controlled atmosphere, l
batch type furnace, with temperature controls and a quench media j
that can obtain the proper metallurgical structure. Time in and time out must be recordol for hardening as well as draw.
Charts and certifications shall be supplied with each lot of material.
3 Care must also be taken that parts are not permitted to come to room temperature prior to tempering."
Contrary to the above, time in and time out was not recorded for j
hardening (austenitizing) and draw (tempering) phases of heat treatment, nor could it be verified that parts were not permitted to come to room temperature prior to tempering.
C.
QA Manual Section XII states in part, "A calibration program is in effect and documented, assuring calibrated measuring and testing equipment used to verify material conformance is adequate and accurate.... Irspection equipment is calibrated... at scheduled intervals against standards traceable to the Natienal Bureau of Standards, where such standards exist.
Inspection and measuring devices worn, damaged or not to accuracy standards are reworked, repaired and calibrated or replaced.... The Quality Assurance Managar shall maintain a card file for all measuring and test equipment.... Actual calibration dimension shall be recorded.... In the event that the measuring or test equipment is found to be out of calibration, a nonconformance report shall be initiated...."
j Contrary to the above:
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1.
Inspection equipment had not been calibrated at scheduled intervals; e.g., at least 12 working plug gages, scheduled for calioration in July 1981, had not been calibrated as of September 16, 1981, and were still in service.
2.
Mi. ster Jill Block Set No.17 was scheduled for annual cali-bration during February 1981; however, it was not calibrated until June 8, 1981. The records showed that this set was 4
removed from service on Februery 20, 1981, and not returned 4
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the use of Set No.17 during April ar.u May 1981.
3.
Master Jill Block Set No. 89 was scheduled for annual calibration on May 1, 1981. The record showed that Set No. 89 was removed from the system on May 19, 1931, and calibrated on June 1, 1981.
i However, review of records for.16 working plug gages show that these gages were calibrated by the use of Set No. 89 aftm-May 19, 1981, and before Jur.e 1,1981.
1 4.
Calibration of certain settina plugs could not be traced to National Bureau of Standards because AM failed to record the master set numbers used in calibrating these plugs.
5.
Calibration record ca.rds showed that actual recorded calibration dimensions of at least six plug gages were out of tolerance, yet they were noted as being "0.K.," were not removed from service, and nonconformance reports were not gererated.
D.
QA Manual Section XVIII, paragraph 18.1 states in part, "... Internal audits are performed such that the entire program is audited annually by trained, qualified personnel.... Personnel selected to perform audits are teamed with an experienced iditor as an observer for a minimum of one (1) complete audit.
Aftar training as an observer, the individual receives instructions from the Quality Assurance Manager
.... Only after completion of the above training and instructions will personnel be assigned internal audit functions at Acimet."
i Contrary to the above, the seven internal audits conducted during August 1981 were performed by the Ger,eral Manager who had not been trained as an observer on previous audits, nor had he received any i
other documented instructions or training by the Qualtiy Assurance Manager.
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