ML20214Q313

Partially Deleted Notice of Nonconformance from Insp on 860714-18 (Ref 10CFR2.790)

ML20214Q313
Person / Time
Issue date:	11/28/1986
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
To:
Shared Package
ML20214Q300	List: ML20214Q297 ML20214Q313 ML20214Q327
References
REF-QA-99901052 99901052-86-01, 99901052-86-1, NUDOCS 8612050096
Download: ML20214Q313 (5)

Text

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APPENDIX A ,

NOVA Machine Products Corporation Docket No. 99901052/86-01 NOTICE OF NONCONFORf1ANCE

• A. Criterion III, " Quality Assurance Program", of Appendix B to 10 CFR Part 50

. states, in part: "The program should provide for indoctrination and training of personnel performing activities affecting qu'ality as necessary to assure ,,.

that suitable proficiency is achieved and maintained."

Subparagraph NCA-3864.2, " Qualification of Personnel", of Section III of the ASME Boiler and Pressure Vessel Code states, in part: "It shall be -

the responsibility of the Material Manufacturer or Material Supplier to assure that all personnel performing functions within the scope of this Section are qualified as specified in this section...."

Paragraph 3.2 of Nova Procedure NP-RSHS1 states: "The 0.A. Manager is responsible for indoctrinating the warehouseman, production manager, Q.C.

• Inspector (etc.) in the method of this procedure." ~

. Contrary to the above, as of 3/27/86 the warehouseman duties have been performed by an individual who has not received the indoctrination required '

by Nova Procedure NP-RSHSI. (86-01-01)

It should be noted that Nova issued a nonconformance report during the course of the inspection that addressed the above item. Disposition of the Nova Nonconformance Report was to indoctrinate the warehouseman as required and direct the Production Manager to inform Quality Assurance when changing warehouse personnel. The concerned warehouseman works under direct Quality Assurance supervision and had received Level I inspector certification prior to being assigned warehouse duty.

Nonconformance No.' 1 is considered closed and no additional corrective action is required.

B. Criterion V, " Inspections, Procedures, and Drawings," of Appendix B to 10 CFR Part 50 states, in part: " Activities affecting quality shall ,

be prescribed by documented instructions, procedures, or drawings...

Instructions, procedures or drawings shall include appropriate quantitative or qualitative acceptance criteria...."

Subparagraph NCA-3866.1, " Quality Control Procedures," of Section III of the ASME Boiler and Pressure Vessel Code states: "The Material Manufacturer shall maintain a written description of the procedures used by his organization for control of quality and examinations, showing in detail the implementation of the quality system requirements of this section." .

I 10 CFR 2.790 INFORMATION HAS BEEN DELETED

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8612050096 861128 .

PDR GA999 EMVNOVA 99901052 PDR

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i Contrary to the above:

1. Neither NOVA's QAM nor procedure, NP-II, " Receiving Inspection",

Revision 2, dated 5/10/86, provides instructions on how many pieces were to be inspected, what dimensions were required to be checked,'

or what the acceptance or rejection criteria are. (86-01-02) .

2. Neither NOVA's OAM, procedure NP-12. "Fi'nal Inspection," Revision 1, dated 3/14/85, nor the sequence sheet provide instructions on what

'# Y dimensions are required to be inspected, what the acceptance or rejection criteria are or -a reference to the applicable standard (e.g. ANSI B18.2.2, B18.1.1 or B18.1.2). (86-01-03) It was noted that the Quality Control inspecto'r was knowledgeable in what the inspection ,

requirements were, the acceptance and rejection criteria, and the applicable ANSI standards due to his experience and training.

C. Criterion VI, " Document Control", of Appendix B to 10 CFR Part 50 states, .

in part: " Measures shall be established to control the issuance of docu-ments, such as instructions, procedures, and drawings, including changes which prescribe all activities affecting quality. These measures shall assure that documents, including changes, are reviewed for adequacy and  ;

approved for release by authorized personnel..." -

Subparagraph NCA-3866.2, " Document Control", of Section III of the ASME Boiler and Pressure Vessel Code states:

The Program shall include measures to control the issuance and disposition of documents, such as purchase specifications, instructions, procedures, and drawings, including changes 4

which describe the activities affecting quality. These measures shall

assure that documents, including changes, are reviewed for adequacy and i

release by authorized personnel."

Paragraph 8.0 of NOVA's QAM states: "The sales order shall indicate the parts to be manufactured or supplied, as well as all required specifications."

Paragraph 8.2 of NOVA's QAM states: "The sales order shall be reviewed prior to release by the Quality Assurance Manager."

Contrary to the above:

1 1. On sales order 1515 the QA Manager failed to detect that NCA-3800 had been incorrectly listed as a requirement on the sales order. The sequence sheet (traveler), which is prepared from the sales order, did not include the NCA-3800 requirement. (86-01-04)

2. Neither the QAM nor the Ouality' Assurance Procedures (QAPs) required that the sequence sheet be approved prior to issuance to the shop.

Additionally, there was no indication on the sequence sheets that they had been reviewed and approved prior to issuance. However, it was noted that evidence that the sequence sheets were being reviewed and approved by both Production and QA appeared on the sales order.

(86-01-05) 10 CFR 2.790 INFORMATION HAS BEEN DELETED

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3. Neither the QAM nor the QAPs provide controls over changes to the sequence sheet. (86-01-06)

D. Criterion VII, "ContrB1 of Purchased Material, Equipment, and Services,"

of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to assure that purchased material, equipment, inid services...

conform to procurement documents. These measures shall include provisions for source evaluations and selection...."

Criterion XVIII, " Audits", of Appendix B to 10 CFR Part 50 states, in part:

"The audits shall be performed in accordance with the written procedures or checklists...."

Subparagraph NCA-3861(a)(3) of Section III of the ASME Boiler and Pressure Vessel Code requires that the Material Manufacturer survey, qualify, and audit suppliers who do not hold Quality System Certificates.

Paragraph 5.2 of NOVA's QAM states: "The effectiveness and integrity of the control of quality by vendors shall be assessed and reviewed through annual audits and quality history rec ~dt"

.w@my Paragraph 3.0 of NOVA QAP NP-V5, "Ver ~ ~ ~ 0 d... .[ ,i"?i* ~_; w be used to perform and document vendc _

~~ - d Contrary to the above: _-

1. There was no checklist for the v

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The only documentation of the t contained the names of company gg j of the type of work performed. -X

2. The audit checklist used by NO "I'~" w w ... , ' ~

or reporting requirements of 1 -

t contract. (86-01-08) ' '*

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Criterion VIII, " Quality Assurance Progran , -. .."7

E.

Part 50 states, in part: " Measures shall bee 'stablished for un. ...

fication and control of materials, parts and com onents, including partially fabricated assemblies." , ,

Subparagraph NCA-3866.6, " Identification and Marking,of Material Produced,"

of Section III of the ASME Boiler and Pressure Vessel Code states, in part:

" Measures shall be established for controlling and identifying material '

throughout the manufacturing processes and during shipment...."

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Paragraph 6.2 of Nova Procedure NP-03 states, in part: " Markings, each>

piece of bar stock 1" in diameter and over shall be stamped with the heat

. number or a heat code number assigned by the QA department...."

l Contrary to the above, NOVA has not stamped all individual piece of bar stock 1" in diameter or larger. Some pieces Were bundled and identified with a tag. (86-01-09) .

10 CFR 2.790 INFORMATION HAS BEEN DELETED l

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d It should be noted that Nova issued a Nonconformance Report (NCR-6) during the course of the inspection that addressed the above item. Disposition of the Nova Nonconformance Report was to revise procedure'NP-03.

Revision 1 to .NP-03, dated 7/17/86, allows Nova to make a sales order and code review prior to stamping 1" and above material. Nova"had maintained identification of 1" and above material with their tagging system. The revised procedure was reviewed by the inspectors and determined to be acceptable.

This nonconformance is considered closed and no additional corrective action is required.

F. Criterion XV, " Nonconforming Materials, Parts, or Components," of Appendix B to 10 CFR Part 50 states: " Measures shall be established to control materials, parts, or components which do not conform to requirements in-order to prevent their inadvertent use or installation. These measures shall include, as-appropriate, procedures for identification, documentation, segregation, disposition and ilotification to affected organizations.

Nonconforming items shall be reviewed and accepted, rejected, repaired, or reworked in accordance with documented procedures.

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Subparagraph NCA-3867.3, " Nonconforming Material", of Section III to the ASME Boiler and Pressure Vessel Code states, in part: "In order to prevent the inadvertent use of material which does not conform, adequate control measures shall be established to preclude nonconformance with the require- '-

ments of this section."

Paragraph 12.0 of, NOVA's QAM states: "When material is found to be noncon-forming, the material shall be hold tagged by the Quality Inspector and the material removed from production and moved to a designated hold drea. The disposition of the nonconforming material will be made by the Ouality Assurance Manager, and documented on the Nonconforming Material Report."

Paragraph 12.1 of NOVA's QAM states: "Where a nonconformance is discovered i

in material which is the result of a vendor's procedures or operations, or which should have been detected by his normal methods of examination, the Quality Assurance Manager shall forward a Purchase of Nonconforming Material Report."

Contrary to the above:

1. Paragraph 4.1.4.1.1 of QAP NP-II, " Receiving Inspection", and para- .

igraph 3.1.1.1 of QAP NP-V4, " Completing Purchase of Nonconforming Material Report", conflict with the QAM requirements in that minor nonconformances which can be reworked by NOVA are not required to- '

be documented on a Purchase of Nonconforming Material Report (PNMR).

Without a PNMR there is no place to record disposition of the non- i conformance. (86-01-10) 10 CFR 2.790 INFORMATION HAS BEEN DELETED

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2. Neither Cection XII of the Q'AM nor 0AP NP-05,,"Ndnconforming Materials Manufactured" provide controls on the reworking of: nonconforming material. (86-01-11) s' . .

3. Neither the OAM nor the QAPs provide instructions on !ow  ! nonconforming material returned by a customer will be controlled, documented, or disposi tion'ad. (86-01-12)

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G. Criterion XVIll$ "Ricords," of Appendix B to l'O CFR'Part 50 states, in part: "The Records shall include at least the following:...the results of reviews, inspections, tests, audits... Inspection and test records shall, as a minimum, identify the inspector..., the type of observation, the results, the acceptability,. and the action taken in connection with any deficiencies noted." _

Subparagraph NCA-3867.2 " Records of Examination and Tests," of Section III of the ASME Boiler and Pressure Vessel Code states, in part: "All characteristics required to be reported by the material specifications and by this section shall be verified and the results recorded."

Contrary to the above, NOVA's QAM, 0APs, and-sequence sheets do not require recording the number of pieces inspected or the number of pieces accepted /

rejected. (86-01-13)

H. Criterion XVI, " Corrective Action" of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to assure that conditions adverse to quality such as...nonconformances are promptly identified and corrected."

Subparagraph' NCA-3879.2, " Corrective Action," of Section III of the ASME Boiler and Pressure Vessel Code states, in part: " Measures shall be estab-lished to assure that conditions adverse to quality such as...nonconformances as promptly identified...."

Paragraph 12.2 of NOVA's'QAM states in part: "The Quality Assurance Panager shall be responsible for the identification of conditions adverse to quality, determine the cause of the condition...."

Contrary to the above, on Nonconformance/ Corrective Action Report #26 the N0A Manager had closed the report on 6/2/86 indicating that the corrective action had been ' completed when in fact corrective action had not been complsted as of'7/16/86. (86-01-14)

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