ML20151U940

Notice of Nonconformance from Insp on 880627-29. Nonconformance Noted:Requirement for Vendor to Have Approved QA Program Not Stated on Purchase Orders & Lack of Documentation Re Certification of Two Current Inspectors

ML20151U940
Person / Time
Issue date:	08/12/1988
From:	Office of Nuclear Reactor Regulation
To:
Shared Package
ML20151U923	List: ML20151U920 ML20151U926 ML20151U940 ML20151U945
References
REF-QA-99901105 99901105-88-01, 99901105-88-1, NUDOCS 8808190303
Download: ML20151U940 (3)

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l APPENDIX B l

Amersham Corporation  !

Docket No. 99901105/88-01 '

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NOTICE OF hCNCONFORMANCE  !

l During an inspection conducted June 27-29, 1988, the implementation of the QA I program at the Amersham facility in burlington, Massachusetts was reviewed with l respect to the manufacture of gamma ray projectors. The applicable QA require- l ments are 10 CFR Part 71, Subpart H, and Amersham's Quality Assurance Program  !

(QAP) dated July 9,1979 and Quality Assurance Manual (QAM), dated December 23, 1985. Based on the results of this inspection, it appears that certain activities were not conducted in accordance with these requirements. The following noncon-formances were identified:

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1. Section 71.109 of Subpart H to 10 CFR Part 71 and Section IV of the QAP  !

require that procurement documents impose a QA program upon the vendor. 1 Contrary to the above, the requirement for a vendor to have an approved QA program was not stated on P0 Nos. RPD-5261 to Computron; 5475 to General Latex and Chemical; 4929 to Morris and Broms; 2147 to Grolex; 1056 and 577 to Lindberg Heat Treat; 578, 610, 1124 and 1261 to Advanced Heat Treat; 4734, 4914 and 5394 to M.D. Machine; 4926 and 4933 to Nuclear l Metals; 4572 and 5001 to Welders Supply; 5995 to Harbor Tool Supply; 4491 to United Service; and 313 and 5531 to ESSCO Calibration Laboratories, i (88-01-02)

2. Section V of the QAP states, in part, "The QA organization reviews ano concurs wi th. . . drawings and. . . changes thereto. . . . " ,

l Section 4.6 of QA Procedure 05-01 "Instructions, Procedures anc Drawings" dated April 5, 1985 states, in part, "All original drawings...and all...

revisions...shall be subject to the approval requirements described in Quality Assurance Procedure 03-01." '

Section 4.4.2 of QA Procedure 03-01 "Design Control" dated February 5, 1986 states, in part, "The Technical Director or his designee shall indicate i his approval on the revised drawings." l Contrary to the above, documented evidence was not available to show that l the QA organization reviewed and concurred in Drawing Nos. 66001-15 "Shell" '

Revision M dated June 7, 1988; 55000-3 "Connector Sleeve" Revision L dated May)24, 1983; and 66001-917 "Handle" Revision L dated July 9, 1987.

(80-01-03

3. Section 71.111 of Subpart H to 10 CFR Part 71 and Section V of the QAP require that quality affecting activities be performed in accordance with documented procedures or instructions.

8808190303 880812 PDR OA999 ENVASCP 99901105 PNU

l Section 4.2 of QA Procedure 09-01 "Control of Special Processes" dated April 8,1985 states, in part, "Special processes shall be perfonned in accordance with a written procedure...."

Contrary to the above, documented evidence was not available to show that procedures or instructions had been written for the following quality affecting activities: heat treating, forming S-tubes, and mixing of foam and subsequent filling of shell. (88-01-04)

4.Section X of 'the QAP states, in part, "Inspectors are qualified...and their  !

qualifications ano certifications are kept current." '

Contrary to the above, documented evidence was not available to show the l qualifications and certifications of the two current inspectors and the QC l supervisor. (88-01-05)

5. Section 71.115 of Subpart H to 10 CFR Part 71 requires that a source efaluation be conducted of vendors.

Section VII of the QAP states, in part, "The evaluation of suppliers is based on... survey of the supplier's facilities and QA program.... Results I of supplier evaluations are documented and filed."

Contrary to the above, exterr.al audits were not performed on Computron, ,

General Latex & Chemical, Morris & Broms, Grolex, Lindberg Heat Treat,  !

Advanced Heat Treat, Nuclear Metals, Welders Supply, Harbor Tool Supply, United Service and ESSCO Calibration Laboratories; and an evaluation conducted of M.D. Machie.e in March 1988 was not documented and filed. I (88-01-06)

6. Section 71.125 of Subpart H to 10 CFR Part 71 and Section XII of the QAP 1 require that measuring and test equipment be calibrated. I Section 4.2 of QA Procedure 12-01 "Control of Linear Measuring Equipment" ,

dated April 8,1985 states, in part, "All linear measuring equipment...shall bear a calibration tag.... The calibration tag shall be supported by a  !

i properly completed calibration record." '

Contrary to the above, a depth-micrometer (S/N RPD) did not have a calibration sticker, and calibration records did not exist for the following equipment: (88-01-07)

(a) Electrical meters on the Airco TIG welder (No. 1341-0106)

(b) Temperature gages on the Thermolyne Corporation Type 1500 furnace (Model FC1520M-5/N 133527) and Type A 1300 furnace (Model FA 1315M-S/N 111742)

(c) Four Centaur 75 knp TIG Welding Supply units (Model 7001)

(d) 0-18" Mitutoyo height gage (No. 192-6E6)

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(e) .0001-2" Mitutoyo digital indicator

7. Section 71.105 of Subpart H to 10 CFR Part 71 and Section II of the QAP 1 require that personnel performing activities affecting quality be indoc- '

trinated and trained.

Contrary to the above, documented evidence was not available to show that I personnel performing activities affecting quality were indoctrinated and trained in the purpose and scope of the QA program. (88-01-08)

8. Section 71.137 of Subpart H to 10 CFR Part 71 requires that a comprehensive system of audits be performed.

Section XVIII of the QAP states, in part, "Audits of the QA program are performad at least annually.. . ."

Contrary to the above internal audits were not performed from March 1986 to the present. (88-01-09) l l

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