ML19257A479
| ML19257A479 | |
| Person / Time | |
|---|---|
| Issue date: | 10/29/1979 |
| From: | Kelley W, Whitesell D NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML19257A476 | List: |
| References | |
| REF-QA-99900391 99900391-79-1, NUDOCS 8001040410 | |
| Download: ML19257A479 (12) | |
Text
,
U. S. NUCLEAR REGULATORY COMMISSION OFFICE OF INSPECTION AND ENFORCEMENT REGION IV Report No.
99900391/79-01 Program No. 51300 Company:
Marotta Scientific Controls, Inc.
Boonton Avenue Boonton, New Jersey 07005 Inspection Conducted: October 1-5, 1979 Inspector:
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/C 7.7 /f Wm.D. Kell 6y',ContradtorTaspftor
/ Date' ComponentsSection I
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Vendor Inspection Branch Approved by:
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/4/d.9/19 D. E. Whitesell, Chief Date ComponentsSection I Vendor Inspection Branch Summary Inspection on October 1-5, 1979 (99900391/79-01)
Areas Inspected:
Implementation of 10 CFR 50, Appendix B and applicable codes and standards including, quality assurance program review, audits (internal and management), training, manufacturing process control, and procurement control (procedure, document and drawing control); also, conducted initial management neeting and exit interview and performed a general review of the vendor's activities. The inspection involved thirty-two (32) inspector-hour on site by one (1) NRC inspector.
Results:
In the five (5) areas inspected, no deviations or unresolved items were identified in four (4) areas. The following were identified in the re-maining one (1) area.
Deviation:
Procurement Control - Procedure, Document, and Drawing Control.
(Details paragraph G.3.a.)
Production changed tolerances on drawing without an Engineering Change Notice.
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DETAILS SECTION A.
Persons Contacted Marotta Scientific Controls, Inc. (MSC)
W. T. Brown - Vice President Marketing & Sales
- D. L. Denise - Quality Assurance Manager K. Hancock - Welding Engineer & NDE Level IV
- J. G. Kenann - President & Chief E::ecutive Officer Lumbermens Mutual Casualty Co.
J. Cash - Authorized Nuclear Inspector #5894
- Denotes those persons who attended the Exit Interview.
B.
General Review of Vendor's Activities 1.
The ASME issued the following Certificates of Authorization to MSC to use their symbol:
Certification No.
Symbol Product N-1369 N
Class 1, 2, and 3 valves N-1370 NPT Class 1. 2, and 3 valve parts and appurtenances These certificates expire on April 27, 1982.
2.
The authorized inspection agency i: Lumbermens Mutual Casualty Co.
The authorized nuclear inspector is an itinerant inspector.
3.
MSC's contribution to the nuclear industry represents approximately ten percent (10%) of its total workload.
4.
MSC has the design and manufacturing capabilities to produce 1/4 inch to 12 inch - 1509 to 2500# ANSI ratings - check, excess flow, 2, 3 and 4 way solenoid and pressure regulator valves for the nuclear industry.
5.
MSC is presently reevaluating their position in the nuclear valve market and are not submitting bids for new order until their evalu-ation of the nuclear cost-overhead and profit study is completed.
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C.
Initial Management Meeting 1.
Objectives The objectives of this meeting were to accomplish the following:
a.
To meet with the Marotta Scientific Controls, Inc. management and those persons responsible for the administration of the ASME accepted Quality Assurance program, and to establish channels of communication.
I b.
To determine the axtent of the company's involvement in the commercial nuclear business.
c.
To explain NRC direc inspection program including the LCVIP l
organization, VIB ist action method and documentation.
d.
To describe the NRC evaluation of the ASME inspection system.
2.
Method of Accomplishment i
The preceding objectives were accomplished by a meeting on October 3, 1979. The following is a summary of the meeting:
j L
a.
Attendees were:
Marotta Scientific Controls, Inc.
J. G. Kenann - President & Chief Executive Officer D. L. Denise - Quality Assurance Manager b.
The VIB organization was describcd and its relationshop to NRC Region IV and the NRC Headquarters component of the Office of Inspection and Enforcement.
c.
The LCVIP function was described including the reasons for its establishment, its objectives, its implementation structure, and the more significant program changes.
d.
The conduct of VIB inspections was described, how the inspections results are documented and reported, what the responses to reports, should include, how proprietary information is handled, the Public Document Room, and the White Book were explained.
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3 e.
The purpose, scope, and status of the NRC's two year program to evaluate the ASME inspection system as an acceptable independent third party was discussed.
f.
The company's contribution to the nuclear industry was discussed including current and projected activities, the status of the ASME certification of authorization, and the third party inspec-tion services.
3.
Results Management acknowledged the NRC presentation as being understood by them, and provided the information concerning the company's activities, products and nuclear involvement, as stated in paragraph B.
D.
Quality Assurance Program Review 1.
Objectives The objectives of this inspection were te ascertain whether the QA program has been documented in writing, and if properly implemented, will ensure that the specified quality of completed components has been achieved in compliance with NRC rules and regulations, code and contract requirements and the commitments in the Quality Assurance Manual. Also, ascertain whether the program provides for the following:
a.
Management's policy statements concerning QA.
b.
Delineates how the QA organization is structured, to achieve appropriate independence from scheduling and costs, the free-dom and independence to identify quality problems, initiate appropriate resolutions, and verify corrective action.
c.
Whether the duties and authority of the QA staff is clearly delineated in writing, and that they have access to a level of management that can ensure effective implementation of the QA program elements, and to enforce positive and timely cor-rective action.
d.
Detailed written procedures are properly reviewed, approved, released, and issued to control quality activities, as appro-priate.
e.
A training and indoctrination program to improve or maintain the proficiency of personnel performing quality activities, and per-sonnel verifying that quality activities have been correctly performed.
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4 2.
Method of Accomplishment The preceding objectives were accomplished by:
a.
Review of the ASME accepted Quality Assurance Manual.
b.
Review of appropriate organization charts.
c.
Review of the documents concerning the authority duties, independence and freedom of the Quality Assurance staff.
d.
Review of Statement of Authority, Revision 1, dated May II, 1979, signed by the President & Chief Executive Officer.
Review of documents to verify that they had been reviewed e.
and approved by authorized personnel, f.
Review of the training and indoctrination program require-ments and documentation.
g.
Interviews with cognizant personnel.
i h.
Observation of work and test in progress.
3.
Findings The evidence demonstrates that the QA program has been documented in writing and clearly defines the duties, authority, and organi-zational independence and freedom of the QA staff. Detailed written implementing documents are appropriately reviewed, approved, released, and issued by authorized personnel. The QA staff has access to a level of management to ensure effective implementation of the program and timely and positive corrective action of enforcement items. A viable training and indoctrination program has been provided for upgrading, and maintaining, the proficiencies of personnel involved in quality activities.
Within this area of the inspection no deviations or unresolved items were identified.
E.
Audits (Internal and Management) 1.
Objectives The objectives of this area of the inspection were to verify that:
Procedures had been prepared and approved by the vendor to prescribe a.
a system for auditing (Internal and Management) which is consistent i
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5 with NRC rules and regulation, and the vendor's commitments in the ASME accepted Quality Assurance Program.
b.
The audit procedures are being properly and effectively imple-mented by the vendor.
2.
Method of Accomplishment The objectives of this area of the inspection were accomplished by:
a.
Review of the ASME accepted Quality Assurance Manual, Revision 3, (1) Section 5.
Procurement a'nd Material Controi, and (2) Section 13, Audit to verify that the vendor had established procedures which prescribe a system for periodic internal management audits.
b.
Review of the following documents.
(1) Quality Assurance Procedure QAP40 Revision 1 Indoctrination and Training and (2) Quality Assurance Procedure QAP41 Revision 1 Audits to verify that they had been prepared by the designated authority, approved by responsible management, and reviewed by the quality assurance staff.
c.
Review of the documents referenced in paragraphs a. and b. to verify that they identify the organization responsible for auditing, establishes the audit personnel qualifications, pro-vides for training and indoctrination of audit personnel, estab-lishes the essential elements of the audit system, provides for audit schedules to assure coverage of all elements of the quality assurance program, requires reporting, and follow-up audits to verify that corrective action has been implemented.
d.
Review of Internal Audit Schedule.
Review of six (6) internal audit reports to verify whether the e.
procedures and the necessary audit system documents, are availabla to the auditing personnel; and whether the procedures are being properly and effectively implemented.
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6 f.
Review of the Management Audit Committee's audit of the Quality Assurance Department.
3.
Findings I
The inspector verified that:
a.
l (1) Procedures had been prepared and approved by the vendor which j
prescribes a system for auditing which is consistent with NRC rules and regulations, ASME Code and contract require-ments, and the vendor's commitments.
(2) The audit procedures are being properly and effectively implemented by the vendor.
b.
The inspector identified that the findings of the 1978 management audit of the quality assurance department had not been closed out i
I using the prescribed internal Quality Audit report form. The j
Quality Assurance Manager stated this was a finding of the ASME survey team in their survey for the reissue of the Certificates of Authorization and that they had completed all corrective action and presented an internal memo to the inspector verifying com-pletion of corrective action.
I c.
The inspector also identified that Quality Assurance Procedure QAP41 did not specifically provide for management audits. The l
Quality Assurance Manager presented to the inspector, prior to l
the exit interview, QAP41 Revision 2, which had been revised to
}
include a new paragraph C, " Management Audit".
The revised pro-cedure had been approved in accordance with the requirements of the ASME accepted Quality Assurance Program, d.
Within this arca of the inspection no deviations or unresolved items were identified.
F.
Training 1.
Objectives The objectives of this area of the inspection were to ascertain:
Whether procedures had been developed and approved by the vendor a.
prescribing a system for training personnel performing quality activities in a manner which is consistent with the NRC rules and regulations, and the vendor's QA Program commitments, b.
That the training procedures are being properly and effectively implemented by the vendor.
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7 2.
Method of Accomplishment The objectives of this area of the inspection were accomplished by:
a.
Review of the ASME accepted Quality Assurance Manual, Revision 3, (1) Section 13 Audit and (2) Section 14 Indoctrination & Training, to verify the vendor had established procedures to prescribe a system for training personnel whose activities affect the quality of their products.
b.
Review of the following documents:
(1) Quality Assurance Procedure QAP40, Revision 1, Indoctrination and Training and (2) Quality Assurance Procedure QAP41, Revision 1, Audits to verify that they had been prepared by the designated authority, approved by management, and reviewed by QA. Also that provisions are made for formal training and retraining of new employees, inspection and testing personnel, personnel performing special processes, audit personnel, and personnel involved in quality related design and procurement activities.
c.
Review of the documents referenced in paragraph a. and b. to verify that they provided fo.- the indoctrination with the technical objectives of the product, Codes and standards to be used, and the quality assurance / control elements that are to be employed. Also, to verify that they provided for testing the capability and proficiency of nondestructive testing personnel, and retraining and recertification, if evaluation of perfor-mance indicates that the individual's capabilities are not within the specified acceptance limits.
d.
Review of the training records of inspectors, nondestructive testing personnel, auditors, designers and quality assurance and procurement personnel, to verify that the procedures and necessary training documents are available to the personnel performing the training, and that the training procedures are being properly and effectively implemented and appropriately documented.
e.
Interviewed personnel to verify whether the training performed was commensurate with the persons assigned quality related activities.
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8 3.
Findings The inspector verified that the vendor had developed and approved a.
procedures that prescribed a system for the training of personnel performing quality related activities, to ensure their qualifi-cations and maintenance of their proficiency, in a manner which is consistent with NRC rules and regulations, and commitments in the ASME accepted Quality Assurance Program, c.
The inspector verified that the training procedures were being properly and effectively implemented by the vendor at the time of this inspection.
c.
Within this area of the inspection, no deviations or unresolved items were identified.
G.
Manufacturing Process Control 1.
Objectives The objectives of this area of the inspection were to verify that the vendor's manufacturing processes are:
a.
Performed under a controlled system which is consistent with the NRC rules and regulations, ASME Code requirements, the vendor's commitments, and contract requirements.
b.
Effective in assuring the product quality.
2.
Method of Accomplishment The objectives of this area of the inspection were accomplished by:
a.
Review of the ASKE accepted Quality Assurance Manual, Revision 3, (1) Section 6 Machining, Assembly and Test Control, (2)Section II Control of Nonconformities, and 1
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9 (3) Section 15 Handling, Storage, Shipping and Preservation.
to verify that procedures had been established which prescribes a system for the control of the manufacturing processes.
b.
Review of the following documents (1) Quality Assurance Procedure QAP30, Revision 1, Assembly and Test Control, and (2) Quality Assurance Procedure QAP31, Revision 1, Assembly and Completed Product Inspection to verify that the control system requires shop travelers or process control check lists, to be prepared which identifies the document numbers and revisions to which the process must conform. Also to verify that all processes and tests are to be performed by qualified personnel using qualified procedures, c.
Review of the shop traveler, or process control check lists, to verify that spaces are provided for reporting the results of specific operations, or reference to other documents where the results are maintained. Also that it includes space for the signoff by the vendor, indicating the date on which the operation or test was performed, and space for signoff and date, by the authorized nuclear inspector, to document his acceptance of the activities that he has selected as mandatory hold points.
d.
Review of selected shop travelers (Quality Control Plan) for the following valve parts:
(1) M69234 - Poppet (2) M68402 - Body (3) M68396 - Body (4) M68411 - Core to verify that they comply with the above referenced procedures, and the QA program documentation requirements, including the establishment of mandatory hold points by the authorized nuclear inspector.
e.
Interviews with personnel to verify they are knowledgeable in the procedures applicable to manufacturing process control.
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10 3.
Findings a.
The inspector verified that the vendor's manufacturing processes are performed under a controlled system which is consistent with the NRC rules and regulations, the Code requirements, the Quality Assurance Program commitments, and that the system is effective in achieving the specified product quality with the exception of the one isolated drawing change note in paragraph b.
b.
Deviation - See Letter of transmittal, attachment - Notice of Deviation c.
Within this area of the inspection, no unresolved items were identified.
H.
Procurement Control - Procedure, Document, and Drawing Control 1.
Objectives The objectives of this area of the inspection were to ascertain.
a.
Whether procurement control procedures had been developed to control the review, approval, release and issuance, of procedures, documents and drawings in a manner consistent with NRC rules and regulations, and the vendors ASME accepted Quality Assurance Program.
b.
That the procurement control procedures were being properly and effectively implemented by the vendor.
2.
Method of Accomplishment The objectives of this area of the inspection were accomplished by:
The review of the ASME accepted Quality Assurance Manual, Revision 3.
a.
(1) Section 4 Document Control, (2) Section 5 Procurement and Material Control and (3) Section 12 Documentation to verify that the vendor had established procedures to prescribe a system for controlling procedures, documents and drawings.
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11 b.
Review of the following procedures:
(1) Quality Assurance Procedure QAP 23, Revision 2, Design Control (2) Quality Assurance Procedure QAP 25, Revision 1, Procurement Control (3) Quality Assurance Procedure QAP 35, Revision 1, Procutement, Control Pressure Boundary, and (4) Quality Assurance Procedure QAP 39, Revision 1, Quality Assurance Records to verify that they had been prepared by the designated authority, approved by management and reviewed by quality assurance.
c.
Review of the documents referenced in paragraphs a. and b.
to verify that they provide for the identification of personnel responsible for preparing, reviewing, approving, and issuing procedures, documents, and drawings; and that the review and approval of significant changes are performed by the same personnel, also to ascertain whether minor changes to design drawings, that do not require design approval, are identified.
d.
Review of the following documents (1) Operating Procedures B155 Add.2 & B180A (2) Welding Procedure Specification SP196-0031(WPS)
(3) Drawing 188903-9901 to verify that the distribution lists are current and that the proper documents are identified, accessible, and are being used.
Interviewed personnel to verify whether they are knowledgeable e.
in the procedures applicable to procedure, document, and drawing control.
3.
Findings a.
The inspector verified that (1) Procurement control procedures had been developed to control the review, approval, release and issuance of procedures, 1687 0 9 me o
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12 documents and drawing in a manner consistent with NRC rules and regulations and the vendor's ASME accepted Quality Assurance Program.
(2) The procurement control procedures are being properly and effectively implemented by the vendor.
h.
Within the area of the inspection no deviations or unresolved items were identified.
I.
Exit Interview At the conclusion of the inspection October 5, 1979, the inspector met with the company's management identified in paragraph A, for the purpose of informing them as to the results of the inspection.
During this meeting the one deviation was discussed and the evidence which supported the finding was identified.
The company's management acknowledged the find and supporting evidence as being understood, but had no additional comments.
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