ML20235L798

Notice of Nonconformance from Insp on 870803-06. Nonconformances Noted:Activities Affecting Quality Not Documented,Source Audit Not Performed & Requirements for Acceptable QA Program Omitted from Purchase Orders

ML20235L798
Person / Time
Issue date:	10/02/1987
From:	NRC
To:
Shared Package
ML20235L758	List: ML20235L757 ML20235L784 ML20235L798 ML20235L835
References
REF-QA-99901097 99901097-87-01, 99901097-87-1, NUDOCS 8710050603
Download: ML20235L798 (4)

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l* . 1 j APPENDIX B j I Southwestern Laboratories Docket No. 99901097/87-01 i NOTICE OF NONCONFORMANCE I During an inspection conducted August 3-6, 1987, the implementation of the QA program at the SWL facility in Houston, Texas was reviewed with respect to the analytical services, metals testing, and nondestructive examination (NDE) performed j for nuclear customers. The applicable QA requirements are 10 CFR Part 50, l Appendix B, and SWL's Quality Assurance Manual (QAM), Revision 4, dated July 15, 1983. Based on the results of this inspection, it appears that certain activi- j ties were not conducted in accordance with these requirements. The following nonconformaares were identified. i l

1. Criterion V of Appendix B to 10 CFR Part 50 and Section 6 of ANSI N45.2  !

stata, in part, " Activities affecting quality shall be prescribed by i documented instructions, procedures.. .."  ; Section 5.3 of the QAM, Revision No. 4, states, in part, "All activities performd by SWL departments...shall be governed by documented instructions, proced xes...." Contrary to the above, instructions and/or procedures did not exist for the following activities: (87-01-04) a) Establishment of criteria for the qualification of auditors, b) Control (e.g., origination, review, approval) of procurement documents, c) Overall individual / group responsibilities from the receipt of an item to the origination, review, and approval of the final report. I d) Generation and use of the Approved Vendors List. l 2. Criterion VII of Appendix B to 10 CFR Part 50 and Section 8 of ANSI N45.2 require that a source inspection or audit be performed on vendors supplying services. Section 7.3 of the QAM states, in part, " Selection of outside vendors shall be made on basis of survey or audit...." 1 l Contrary to the above, there was no documented evidence that a survey or audit had been undertalen on three vendors who performed services for SWL. The vendors include Coffer Laboratories (December 1986 and July 1987), Page-Wilson (March 1987), 6nd Technology & Calibration (March 1986). l (87-01-05) l

3. Criterion IV of Appendix G to 10 CFR Part 50 states, in part, "...other requirements...necessary to assure adequate quality are... included or.

referenced in the documents for. procurement of... services...." B710050603 B71002 PDR GA999 EECSOUTW 99901097 PDR

Section 5 of ANSI N45.2 states, in part, "... procurement documents shall require contractors to provide a Quality Assurance Program....' Section 7.4 of the QAM states, in part, "... subcontractors shall be imposed on to satisfy any or all of the SWL quality system requirements." Contrary to the above, the requirement to have an acceptable QA program was not included or referred in P0s to Coffer Laboratories (Nos. 5150, 1308, and 1810) Page Wilson (No. 5542), and Gulf States Balance (Nos. 6183 and j 440). (87-01-06)

4. Criterion XVIII of Appendix B to 10 CFR Part 50 and Section 19 of ANSI N45.2 state, in part, "The audits shall be performed in accordance with the written procedures or check lists.... Audit results shall be documented...."

Section 16.11 of the QAM requires that an External Auditing Program follow tne same procedures as used for an internal audit. Section 18.3.6 of the QAM states, in part, "The Quality Assurance or the audit team leader shall write up...the audit report...." Contrary to the above, there was no documented evidence of written procedures, checklists, or a report for an audit performed of Grady Cook Sales in May 1985. (87-01-07)

5. Criterion II of Appendix B to 10 CFR Part 50 and Section II of ANSI N45.2 )

state, in part, "The program shall provide for indoctrination and training l cf personnel performing activities affecting quality...." ) i Section 1.4.1 of the QAM states, in part, " Personnel performing testing, examining, and inspecting activities...are subject to qualification under ANSI N45.2.6...." Section 3.2 of Procedure No. 9700-105-82 " Indoctrination of Personnel in  ; Company Policies and Quality Assurance Procedures, Revision 0, states in part, "All personnel engaged in the inspection and testing activities... shall participate in Quality Assurance policy and procedure review , sessions." Section 6.0 of Procedure No. 9700-105-82 states, in part, "A permanent record of indoctrination and orientation shall be maintained on each . participating employee using form SWL-105-2...." Contrary to the above, a review of training records revealed the following: (87-01-08) a) Tests and certifications to ANSI N45.2.6 were missing for F. Plummer and A. Norwood both from the Metals Testing and Metallurgy (MTM) department.

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i I 1 b) Documented evidence did not exist to show that J. O'Neal from the Analytical Services (AS) department and M. Peterson and C. Albritton from the HTM department had been trained / indoctrinated in the QA l program, c) Indoctrination and QA orientation were not documented on form SWL-105-2 for approximately 31 individuals (11-NDE, 4-AS, and 9-MTM).

6. Criterion V of Appendix B to 10 CFR Part 50 requires that activities J affecting quality be accomplished in accordance with documented instructions '

or procedures. Section 5.4.4 of the QAM states, "Any instruction, procedure, or form which is generated by any SWL department, which pertains to quality assurance, requires the review and approval of the Quality Assurance Manager." Contrary to the above, the QA Manager failed to sign: (a)Reportof Analysis and Tests No. 42711-9 ( April 18,1986) to Bechtel and Nos. 947 (June 18,1986),830-842and744-842(June 11,1986),6938-6939 (December 3,1985),5958-5962(October 22, 1985) and 3671-3683 (June 28, 1985) to, Texas Utilities Generating Company; and (b) approximately 55 NDE reports (7 to Gulfalloy in 1982 and 1983, 7 to WFI in 1986, 41 to Ladish  ! in1984and1985). (87-01-09)

7. Criterion I of Appendix B to 10 CFR Part 50 and Section 3 of ANSI NAS.2 requires that the authority and responsibility of persons and organiza-  !

tions performing activities affecting quality be clearly established. ' l l Contrary to the above, there was no documented evidence of the authority I and responsibility of all the persons and organizations which are a part i of the QA department. (87-01-10) l 8. Criterion IV of Appendix B to 10 CFR Part 50 and Section 5 of ANSI N45.2 require that measures be established and documented to assure a satisfactory control of procurement documents. Contrary to the above, there was no documented evidence that adequate i measures were established for the issuance, review, and approval of P0s l including changes to the P0. (87-01-11)

9. Criterion V of Appendix B to 10 CFR Part 50, requires that activities affecting quality be accomplished in accordance with documented instructions or procedures.

l Section 11.4.4 of the QAM states, in part, " Inspection, examination, and test results shall be documented on the applicable SWL forms. Each report shall identify...as a minimum...the following: .. 3) Identity of inspector or tester...." Contrary to the above, the identity of the person conducting testing was not documented on some test documentation. (87-01-12) l l

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10. Criterion XII of Appendix.B to 10 CFR Part 50 requires that measuring and- l test equipment (M&TR) be calibrated at specified periods. -l

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Section 5.2.1 of the QAM states, in part, " Calibration,' or inspection, . .. ; shall be performed at regular scheduled intervals. Equipment requiring  ; calibration, or inspection, within each Division of SWL and the calibra- l tion, or inspection frequency shall be as specified in the Measuring and j Test. Equipment Master List...." , Contrary to the above,~ some M&TE were not calibrated at the specified -} frequency. (87-01-13)  !

11. Criterion V of Appendix B to 10 CFR Part 50 requires that activities affecting quality be accomplished in accordance.with documented instruc-  ;

tions or procedures. Section 5.7 of Procedure No. 9700-102-75, Control of Measuring and , Test Equipment," Revision 5, states, in part, " Calibration of Class 1 MTE- j by a independent external source shall include documentary evidence of. j traceability to National Bureau of Standards or other acceptable' industry 1 standards and the certification of calibration for the equipment must include a statement that this traceability exists, such as:

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The following standards were used as referenced for calibration. Their calibration is directly traceable to the National Reference Standards maintained by the National Bureau of. Standards...." Contrary to the above, calibration vendors have not always supplied '! the proper traceability on certification documentation. (87-01-14) l l

12. Critericn XVIII of Appendix B to 10 CFR Part 50 requires that periodic  ;

audits be performed in accordance with checklists. 1 Section 18.4 of the QAM states, in part, " Applicable elements of the SWL Quality Assurance Program shall be audited at least every twelve months...." Section 4.3.2 of Procedure No. 9700-104-82, " Auditing of 0A Program,"' Revision 0, states, "A checklist shall be'used to ensure' depth and , continuity of audits." Contrary to the above, it was noted that internal audits of some departments were not conducted at least once every 12 months, and a checklist was , missing for one internal audit. (87-01-31 i i L_________-_-___-____________}}