ML20203H940

Notice of Nonconformance from Insp on 851209-13

ML20203H940
Person / Time
Issue date:	04/28/1986
From:	NRC OFFICE OF INSPECTION & ENFORCEMENT (IE)
To:
Shared Package
ML20203H930	List: ML20203H926 ML20203H933 ML20203H940 ML20203H948
References
REF-QA-99900225 NUDOCS 8604300052
Download: ML20203H940 (3)

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APPENDIX B The Foxboro Company Docket Number 99900225/85-01 NOTICE OF NONCONFORMANCE Based on the results of an NRC inspection conducted on December 9-13, 1985, it appears that certain of your activities were not ' conducted in accordance with NRC requirements. Nonconformances with these requirements are as follows:

A. Criterion II, " Quality Assurance Program," of Appendix B to 10 CFR Part 50 states, in part: "The quality assurance program shall provide control over activities affecting the quality of the ...- systems, and components ... activities affecting quality shall be accomplished under suitably controlled conditions ... the program shall provide for indoctrination and training of personnel-performing activities affecting quality as necessary to assure that suitable proficiency is achieved and maintained."

Section 2.7 of The Foxboro Company's (TFC) Highland-Quality Program Manual (HQPM) states, in part: " ... Indoctrination, informational, and instructive training programs are provided so that personnel ... are aware and competent to assure performance of quality activities. Records of this activity are maintained ...."

Contrary to the above, TFC did not provide the required indoctrination and training programs for engineering, design, testing, corporate quality assurance, customer service, or management personnel (85-01-03).

B. Criterion V, " Instructions, Procedures, and Drawings," 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 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." -

Section 4.1 of TFC's Corporate Quality Assurance (CQA) Procedure 3.18.3, Revision B, dated February 13, 1985, states, in part: " ... Discoveries of conditions adverse to 'the quality of safety-related parts, assemblies -

and products shall be reported to the Nuclear Safety Sub-Committee (NSS)

... Procedures shall be established by all applicable organizations to provide means to notify the NSS ... and a record shall be maintained in the Sub-Committee files ...."

8604300052- 86042 PDR GA999 EMVFOXB 99900225 PDR 3

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Contrary to the above, as of December 13,1985(85-01-04):

1. Procedures were inadequate to provide instructions for personnel to notify the NSS of conditions adverse to quality.

2. Records were not in evidence to assure that the following conditions.

adverse to quality were reported to the NSS for their 10 CFR Part 21 reportability evaluation:

a. Peach Bottom letter to TFC, dated July 22, 1985 " Failed printed circuit cards," utilized on safety related model No.

N 2275 recorders.

b. Report No.1984-CFA-08 "Sangamo Electrolytic Capacitors, Series 139R, Leaking and Corrosion found in Three Lots."

c. Report No. 1985-CFA-019(SI) " Transistor diode and relay failures in the UCM Power supplies," (this was identified as a

"Long-standing problem").

d. Highland No. 1102-1104 "2A0VAI, intermittent output supply -

(Northeast Utilities).

e. Highland No. 4112 " Power supply fuse problem" - (Pilgrim).

f. Highland No. 5169 "62H Electronic Controllers - Erratic Outputs" - (End of life susceptibility).

C. Criterion VII, " Control of Purchased Material, Equipment, and Services,"

of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to assure that... services... conform to the procurement documents...for source evaluation... documentary evidence shall be retained."

Contrary to the above, an outside calibration laboratory (ESSCO) appears on TFC Approved Vendors List, without any documented audit results being inevidence.(85-01-05).

D. Criterion XII, ' Control of Measuring and Test Equipment," of Appendix B to 10 CFR Part 50 states, in part: " Measures shall be established to assure that ... instruments, and other measuring and testing devices used in act'ivities ~ affecting quality are properly . controlled ...."

TFC Highland Plant Quality Procedure Number 56.01, dated May 11, 1983 states, in part: "

... the procedure for the recall of equipment for calibration on a periodic basis will-ensure equipment will be identified as being due for calibration and will not allow equipment to be used on the product after this date is reached ...."

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Contrary to the above, two out of the 18 instruments sampled were past the calibration due date. The two instruments were located in the production areas. The instrument identification numbers were 204700-1 (Calibration due date 8/18/85), and number 20425-1 (Calibration due date 11/16/85)

(85-01-06).

E. Criterion XVIII, " Audits," of Appendix B to 10 CFR Part 50 states, in-part: "... planned and periodic audits shall be carried out to verify.

compliance with all aspects of the quality assurance program ... Audit results shall be documented ... Follow-up action, including reaudit of deficient areas, shall be taken where indicated."

Section 18,'" Audits," of TFC's HQPM states, in part: "A comprehensive system of planned ... audits shall be carried out at all stages of.the; manufacturing cycle to verify compliance with all phases of the Quality ,

Assurance program ... Documentation of auditing results ... is maintained

- by Quality Control Engineering ... Audit results shall_be documented." l Contrary to the above, internal audits were not performed quarterly for all stages of the manufacturing cycles, as required by the Highland Plant quality control audit schedule (85-01-07). Specifically

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a. One out of 37 audits was not performed in the first calendar quarter of 1985.

b. 30 out of 37 audits were not performed in the second calendar cuarter of 1985. ,

c. 37 out of 37 audits were not performed in the third calendar. quarter of 1985.

d. 37 out of 37 audits were not performed in the' fourth calendar. '

quarter of 1985, as of December.13,1985.

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