ML19296B663
| ML19296B663 | |
| Person / Time | |
|---|---|
| Issue date: | 09/19/1979 |
| From: | Foster W, Hunnicutt D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19296B650 | List: |
| References | |
| REF-QA-99900376 99900376-79-1, NUDOCS 8002210215 | |
| Download: ML19296B663 (9) | |
Text
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U. S. NUCLEAR REGUI.ATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT PIGION IV Report No. 99900376/79-01 Program No. 51400 C<mpany:
Haveg Industries, Incorporated Wire and Cable Division P. O. Box 7 Winooski, Vermont 05404 Inspection at:
Hercules Drive Colchester, Vermont 05446 Inspection Conducted: August 21-23, 1979 l
Inspector:
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b ~ lT--7 T W. E. Foster, Contrac tor Inspector Date Components Section Il' Vendor Inspection Branch fl Approved by:
OLs 2.41 /2 _
(b i - (i ~19 D. M. Hunnicutt, Chief
)
Date ComponentsSection II Vendor Inspection Branch Summary:
Inspection on August 21-23, 1979 (99900376/79-01)
Areas Inspected:
Implementation of 10 CFR 50, Appendix B criteria, and applicable codes and ;tandards, including organization; quality assurance program; change control; and manufacturing process control. The initial management meeting was also conducted. The inspection involved twenty-four (24) inspector-hours on site.
Results:
In the four (4) areas inspected, no deviatiots or unresolved items s
were identified in one (1) area. The following deviations and unresolved items were identified in the remaining three (3) areas:
Deviations: Quality Assurance Program practices were not consietent with _
Criteria V and XVIII of Appendix B to 10 CFR 50; the QA Policy statement, and paragraphs 3.6.3.1, 3.9.5.4, 3.9.7.1 and 3.9.7.2 of the Quality Control Manual, Revision XVI, dated August 14, 1978 (Notice of Deviation, Items A, B, C, and I).
3002s10 2_l I
2 Change Control practices were not consistent with Criterion V of Appendix B to 10 CFR 50; and paragraphs 2.4.4.3.2, 2.4.4.4.1, 2.4.4.5.1, 3.8.5 and 3.8.4.4 of the Quality Control Manual, Revision XVI, dated August 14, 1978 (Notice of Deviation, Items D, E, and F).
Manufacturing Process Control practices were not consistent with Criterion V of Appendix B to 10 CFR 50; and paragraphs 3.9.5.1, 3.6.5.2 and 3.6.5.3 of the Quality Control Manual, Revision XVI, dated August 14, 1978 (Notice of Deviation, Items G and H).
Unresolved Items: Quality Assurance Program - the NRC inspector was unable to determine that follow-up records had been issued within five (5) working days for non-receipt of corrective action responses (Details Section, para-graph D.3.b).
Change Control - the NRC inspector was unable to determine whether or not changes to engineering documents require approval of the QC Manager (Details Section, paragraph E.3.b).
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3 Details Section A.
Persons Contacted
- D. Binch, General Manager
- R. Curren, Manager, Engineering
- R. Currier, Manager, Manufacturing J. Gardner, Foreman, Tape Wrapping Department R. O. Gibeault, Supervisor, Technical Services J. Giles, Technician, Electronic L. Holden, Supervisor, Inside Sales D. M. Holmes, Specialist, Technical
- C. Martin, Manager, Quality Control R. G. Palmer, Inspector, Quality Control R. M. Reed, Supervisor, Employee Relations M. J. Wirsing, Senior Personnel Assistant
- Attended initial management meeting.
- Attended initial management meeting and exit interview.
B.
Initial Management Meeting 1.
Objectives An initial management meeting was conducted to acquaint the vendor's management with the NRC responsibility to protect the health and safety of the public and to inform them of certain responsibilities imposed on vendors by the " Energy Reorganization Act of 1974" (Public Law 93-438). Those in attendance are denoted in paragraph A.
2.
Method of Accomplishment The preceding objectives were accomplished by:
a.
Describing the historical events that indicated the need for the Vendor Inspection Program (VIP).
b.
Explaining the inspection base and how the inspections are conducted.
c.
Describing how inspection results are documented and how proprietary items are handled, including the vendor's oppor __
tunity to review the report for the purpose of identifying items considered to be proprietary.
d.
Describing the vendor's responsibility in responding to identified enforcement items relating to:
4 (1) Correction of the identified deviation.
(2) Action to be implemented to prevent recurrence.
(3) The dates when (1) and (2) above will be implemented or completed.
Explaining that all reports and communications are placed in e.
the Public Document Room (PDR).
f.
Explaining the publication and function of the " White Book."
3.
Findings Conax Corporation is the only purchaser recognized by Haveg, as purchasing products to be supplied to nuclear generating stations.
This recognition is due to the purchase orders of Conax imposing 10 CFR 21 and 10 CFR 50, Appendix B.
Products supplied to Conax are Kapton Insulated Bare Copper, Solid Wire and Rods. There are eighteen (18) active purchase orders of Conax which represent approximately one and one-half (1.5) percent of production activity devoted to nuclear generating station use.
Some major suppliers are Du Pont Company; Wirewynd Incorporated; Hudson Wire Company; and International Wire Incorporated.
During the course of the inspection, the NRC inspector observed numerous active purchase orders for the Foxboro Company. These orders are for Irradiated Cross-Linked Polyethylene Lead Wire and Cable.
A referenced Foxboro Specification, in turn, references a Bechtel Specification. These products are required to pass the flame test of the Institute of Electrical and Electronics Engineers, Incorporated (LEEE) 383. Further, the NRC inspector recognized the Bechtel Specification as one applicable to nuclear generating stations.
C.
Organization 1.
Objectives The objectives of this area of the inspection were to verify that authority and duties of pcrsons and organizations performing activities affecting safety-related functions (achievers and verifiers) had been clearly established and delineated in writing. Also, to verify that performers of the quality assurance functions had sufficient authority and freedom to identify quality pro'21 ems; to initiate, recommend or provide solutions; and to verify implementation of solutions. Further, the individuals responsible for assuring effective execution of any portion of the quality assurance program had direct access to such levels of management necessary to perform this function.
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2.
Methods of Accomplishment The preceding objectives were accomplished by:
Review of the following documents to verify the quality organization was independent, and authority and duties of persons and organizations performing activities affecting safety-related functions had been clearly established and delineated in writing:
(1) Quality Control Manual, Revision XVI, dated August 14, 1978, paragraph 2.2.3 and the referenced organization charts (incorporated in the QC Manual).
(2) Position Descriptions for: Product Development Engineer, dated August 26, 1977; Production Manager, dated October 27, 1975; Impregnating and Curing Operator, dated December 8, 1978; and Production Machine Operator, undated.
3.
Findings Within this area of the inspection, no deviations or unresolved items were identified.
D.
Quality Assurance Program 1.
Objectives The objectives of this area of the inspection were to verify that the program had been documented, controls had been established and the program had been implemented.
2.
Methods of Accomplishment The preceding objectives were accomplished by:
a.
Review of the following documents to verify the program had been documented by written policies, procedures, or instructions:
(1) Quality Control Manual, Revision XVI, dated August 14, 1978; paragraphs 2.2.4, 3.6.3.1, 3.6.3.8, 3.9.6.4, 3.9.7.1, 3.9.7.2, and 3.14.3.1.1.
(2) Quality Control Procedure No. 0054, Revision 1, dated February 28, 1972, List of Raw Materials Scheduled for Incoming Inspection.
b.
Review of hardware covered by the program to verify indentifica-tion had been established.
6 c.
Review of the following activities to verify the program had been implemented: Control of Purchased Material, Equipment, and Services; Control of Measuring and Test Equipment; Corrective Action; and Audits.
3.
Findings a.
Deviations From Commitment (1) See Notice of Deviation, Item A.
(2) See Notice of Deviation, Item B.
(3) See Notice of Deviation, Item C.
(4) See Notice of Deviation, Item I.
b.
Unresolved Item Paragraph 3.14.3.1.1 of the QC Manual requires that follow-up records be issued if corrective action responses had not been received within five (5) working days. The paragraph also requires that a file be maintained of all corrective action records.
The NRC inspector was informed that follow-up records were destroyed when their purpose had been served; consequently, the NRC inspector was unable to determine that follow-up_ records had been issued within five (5) working days for non-receipt of corrective action responses.
E.
Change Control 1.
Objectives The objectives of this area of the inspection were to verify that measures had been established to control changes to software and hardware. Also, to verify the measures for software changes included provisions for review, approval, and distribution to and usage at the location where the prescribed activity is performed. An additional phase was to verify the measures had been implemented.
2.
Methods of Accomplishment The preceding objectives ware accomplished by:
a.
Review of the following document to verify measures had been established to control changes to software and hardware:
7 Quality Control Manual, Revision XVI, dated August 14, 1978; paragraphs 2.4.4, 3.5.7, 3.6.3.4, 3.6.3.6, 3.6.5.8, and 3.8.
b.
Review of the following to verify the procedures had been implemented:
(1) Manufacturing Specifications, Drawing Numbers: 30-02906, Revision 2, dated July 20, 1979; and 30-02108, Revision 9, dated July 24, 1979.
(2) Engineering Instructions, Drawing Numbers: EI 701328, Revision 6, dated August 14, 1979; EI 701587, Revision 1, dated August 7, 1979; EI 701173, Revision 9, dated March 12, 1979; and EI 700623, Revision 14, dated August 10, 1979.
(3) Raw Material Rejection Reports, Numbers:
12084, dated August 16, 1979; 12069, dated July 2, 1979; 12063, dated May 15, 1979; and 12060, dated May 3, 1979.
(4) Production Rejections, Numbers: 23491, dated February 16, 1979; 23254, dated March 29, 1979; 20210, dated March 23, 1979; 20556, dated April 20, 1979; 20604, dated April 26, 1979; 29116, dated July 5, 1979; and 26090, dated July 13, 6
1979.
3.
Findings a.
Deviations From Commitment (1) See Notice of Deviation, Item D.
(2) See Notice of Deviation, Item E.
(3) See Notice of Deviation, Item F.
b.
Unresolved Items (1) Paragraph 2.4.4.1.1 of the QC Manual requires that no f
drawings, specifications, test outlines or other documents l
be changed without the approval of the Manager of' Engineering i
and the Manager of Quality Control. Paragraph 2.4.4.3 i
discusses the method of making changes but it does not l
address participation by the QC Manager. As a result, th3 NRC inspector was unable to determine whether or not changes i
to engineering documents require approval of the QC Manager.
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8 F.
Manufacturing Process Control 1.
Objectives The objectives of this area of the inspection were to verify that measures had been established and documented to control manufacturing, inspection and test activities. Also, to verify these activities had been accomplished in accordance with the established and documented measures. Additionally, verification of indication of mandatory hold points in appropriate documents.
2.
Method of Accomplishment The preceding objectives were accomplished by:
a.
Review of the following documents to verify measures had been established and documented to control manufacturing, inspection and test activities:
(1) Quality Control Manual, Revision XVI, dated August 14, 1978; paragraphs 2.4.1, 3.6.4, 3.6.5, 3.6.6, 3.6.7, 3.7, 3.9.5.1, and 3.10.
(2) Manufacturing Specification Drawing Numbers: 30-02491, Revision 8, dated September 23, 1977; 30-03833, Revision 5, dated June 14, 1979; EI 700949, Revision 19, dated June 5, 1979; EI 701127, Revision 27, dated June 12, 1979; 30-02108, Revision 9, dated July 24, 1979; and 30-03895,. dated June 22, 1979.
(3) Quality Control Procedures, Numbers: 0080, dated September 10, 1971; 0082, dated December 23, 1971, and l
0133, Revision 1, dated March 9, 1976.
(4) Process Control Records: Tape Wrapping Department Machine Numbers:
29, dated August 17-20, 1979; 22, dated August 20, 1979.
t b.
Observed: Tape Wrapping operation on Order No. 30715 at Machine No. 11 in the Tape Wrapping Department; Extrusion o eration on Order No. 33164 in the Irradiated Products Department; Spooling operation on Order No. 33164 at Machine No. El in the Irradiated Products Department.
9 3.
Findings a.
Deviations From Commitment (1) See Notice of Deviation, Item G.
(2) See Notice of Deviation, Item H.
b.
Unresolved Item None.
G.
Exit Interview 1.
The inspector met with management representatives denoted in para-graph A. at the conclusion of the inspection on August 23, 1979.
2.
The following subjects were discussed:
a.
Areas inspected.
b.
Deviations identified.
c.
Unresolved Items identified.
d.
Contractor response to the report.
The contractor was requested to structure his response under headings of corrective action, preventive measures, and dates for each deviation.
Additionally, management representatives were requested to notify the Commission in writing if dates require adjustment, commitments require modification, etc.
3.
Management comments were generally related to clarification of the findings.