ML20040A539
| ML20040A539 | |
| Person / Time | |
|---|---|
| Issue date: | 11/13/1981 |
| From: | Oller R, Potapovs U NRC OFFICE OF INSPECTION & ENFORCEMENT (IE REGION IV) |
| To: | |
| Shared Package | |
| ML20040A524 | List: |
| References | |
| REF-QA-99900284 NUDOCS 8201210224 | |
| Download: ML20040A539 (13) | |
Text
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INTERNATIONAL fr4STRUMENTS DIVISI0?l ORGANIZATION: SIGMA INSTRUMENTS, INCORPORATED ORANGE, C0tlNECTICUT REPORT NO.: 99900284/81-01 INSPECTION DATE(S):10/19-23/81 INSPECTION ON-SITE HOURS: 26 CORRESPONDENCE ADDRESS:
International In.Struments Division Sigma Instruments, Inc.
ATTN:
Mr. J. V. LaBlanc Corporate Vice President and General Manager 88 Marsh Hill Road Orange, CT 06477 ORGANIZATION CONTACT:
Mr. M. R. Kalakay, QC Manager TELEPHONE:
(203) 795-4711 PRINCIPAL PRODUCT: Panel Instruments and Electronic Controls NUCLEAR INDUSTRY ACTIVITY:
10 CFR Part 2.790(d) INFORMATION DELETED ASSIGNED INSPECTOR:
hst
- - M 'Y/
R. E. Oiler, Components Section (CS)
Date OTHER INSPECTOR (S):
APPROVED BY:
IhW li - I b 8 I U. Potapovs, Acting Chi pf, CS Date INSPECTION BASES AND SCOPE:
A.
BASES:
10 CFR Part 50 and 10 CFR Part 21 8.
SCOPE:
Status of previous inspection findings; manufacturing process control; l
change control; nonconformances and corrective action, and 10 CFR Part 21.
i pn;IC: ATED CRIGIllAL l
Cert't n M By 1
820121o2.M
INTERNATIONAL INSTRUMENTS DIVISION SIGMA INSTRUMENTS, INCORPORATED ORGANIZATION:
ORANGE, CONNECTICUT REPORT NO.: 99900284/81-01 INSPECTION RESULTS:
PAGE 2 of 5 A.
VIOLATIONS:
1 None B.
NONCONFORMANCES:
None C.
UNRESOLVED ITEMS:
None D.
STATUS OF PREVIOUS INSPECTION FINDINGS:
1.
(Closed) Violation (80-01):
Contrary to paragraph 21.6. of 10 CFR Part 21, I
l and paragraph 3.1. of the internal "Precedure for Reporting of Defects l
and Noncompliance Per 10 CFR Part 21," dated May 5,1978, posting of l
10 CFR Part 21, Section 206 of the Energy Reorganization Act of 1974, and the above internal procedure had not been accomplished.
Prior to the end of the August,1980 inspection, the posting requirements of 10 CFR Part 21 were accomplished.
As a result, this violation did not require a written response.
2.
(Closed) Deviation A (80-01):
Failure by the Manufacturing Engineer to i
approve and date the Operations Routing Order, dated July 18, 1980, for Part No. 92-9487-000, Work Order No. 19807, prior to its issuance to the Manufacturing Department, as required by QA Procedure No.108.
The inspector verified that in accordance with the vendor's corrective action response letter dated September 30, 1980, the corrective action was pro-vided by filling the vacant position of Manufacturing Engineer in July,1980, and issuing him a copy of the QA-108 procedure along with verbal instruc-tions concerning its application to signoffs of OR0s.
A special audit of this area was performed on October 6, 1980, to prevent recurrence of the condi ti on.
3.
(Closed) Deviation B (80-01):
Failure by the QC Manager, or his delegated' representative, to approve five Change Notices for Class 1 Instruments /
Products, as committed to in the vendor's corrective action response letter, dated May 10, 1978.
The inspector verified that in accordance with the vendor's corrective action response letter dated September 30, 1980, the QC Manager was review-ing and approving, by signoff and dating, all Change Notices for Class 1 instruments.
This was verified by examination of several change notices.
A special audit of this area was performed on October 6,1980, to prevent recurrence of the condition.
INTERNATIONAL INSTRUMENTS DIVISION ORG'ANIZATION: SIGMA INSTRUMENTS, INCORPORATED ORANGEc CONNECTICUT REPORT NO.: 99900284/81-01 INSPECTION RESULTS:
PAGE 3 of 5 4.
(Closed) Deviation C (80-01):
Failure by the vendor to perform an audit within 60 days from the date of May 10, 1978, letter to assure corrective action stated in the cited letter and to prevent recurrence of the devia-tions identified in Inspection Report No. 78-01.
The inspector verified that in accordance with the vendor's corrective action letter dated September 30, 1980, that an audit was performed on September 30, 1980, of the deviations identified in the Inspection Report No. 78-01, by the present QC Manager.
This person assumed the position of QC Manager in June, 1980.
The commitment to perform an audit within 60 days of the May,1978 letter was made by the previous QC Manager who subsequently re ti red.
5.
(Closed) Deviation D (80-01):
Failure to use approved Change Notices to change 20 drawings which had been released, as committed to in the vendor's corrective action response letter, dated May 10, 1978, and as required by paragraph 6.2.3.1. of the QC Manual. Revision 3.
The inspector verified that in accordance with the vendor's corrective action response letter dated September 30, 1980, that a Temporary Authori-zation Sheet which provides approvals was being used to expedite drawing changes. A formal Change Notice was initiated from the T.A., and the normal procedure was followed.
Review of a record of audit, dated October 6,1980, verified that the above item was audited to provide pre-ventive action.
6.
(Closed) Deviation E (80-01):
Failure to provide In-Process Inspection Form QC-119 records for in-house fabricated parts and/or assemblies stored in stock, as required by paragraph 8.0.2. of the QC Manual, Revision 3.
The inspector verified that in accordance with the vendor's corrective action response letter dated September 30, 1980, that corrective action was pro-vided by the QC Manager's memorandum dated September 30, 1980, to the Manu-facturing Manager.
This memorandum stated that the forms QC-ll8 and QC-119 for QC accepted vendor supplied items and in-house fabricated items, respectively, should accompany and be retained with the items in stock.
Observation of materials being sent to stock verified that proper forms were with them.
Review of the record of audit dated October 6,1980, veri-fied that this area was audited to provide preventive action.
7.
(Closed) Deviation F (80-01):
Failure by Quality Control to document the internal inspection status on Process Sheets for six instruments on which internal inspection had been completed, as required by paragraph 8.1.3.2.
of the QC Manual, Revision 3.
The inspector verified that in accordance with the vendor's corrective action response letter dated September 30, 1980, that the QC Manager held a
INTERilATIONAL INSTRUMENTS DIVISION ORGANIZATION: ' SIGMA INSTRUMENTS, INCORPORATED ORANGE, CONNECTUICUT REPCF NO.: 99900284/81-01 INSPECTION RESULTS:
PAGE 4 of 5 meeting on August 11, 1980, with all of the QC inspectors.
At this meet-ing the procedure for internal inspection stamping of Class 1 instruments was discussed.
An explanation of each type stamp was also provided.
Review of currently completed process sheets and final test sheets verified that the inspection and tests were being documented by use of the inspection stamps.
8.
(Closed) Deviation G (80-01):
Failure by the first Piece Inspector to sign and date the First Piece Log for conforming items in the Meter Assembly Area, and failure to provide and maintain a First Piece Log in the Control Assembly Area where first piece inspection is performed, as required by paragraph 10.4.1. of the QC Manual, Revision 3.
l l
The inspector verified that in accordance with the vendor's corrective l
action response letter, dated September 30, 1980, that the First Piece Inspection Log in the Meter Assembly Area was being properly signed off by the inspector. The First Piece Log in the Control Assembly Area was also being maintained and signed off as required.
9.
(Closed) Deviation H (80-01):
Failure to stamp internally, on a Model 1251
(
meter, to indicate that internal inspection had been performed and accepted, as required by paragraph 1. of II Standard No. FIS-1000-1151/1251 dated September 14, 1975.
l The inspector verified that in accordance with the vendor's corrective action response letter dated September 30, 1980, that a meeting was held
[
on August 11, 1980, with all of the QC inspectors.
The QC manager dis-cussed the proper stamping procedure for Class 1 instruments.
E.
OTHER FINDINGS OR COMMENTS:
1.
Manufacturing Process Control - The inspector reviewed seven sections of the vendor's QC Manual, Revision 4, which were applicable to material receiving, assembly, inspection, and test for Class IE instruments.
Observations were made in the Meter Assembly and Control Assembly Depart-ments of the in-process assembly and inspection, and final inspection and test of panel meters and electronic control instruments.
To verify that assembly, inspections and tests were controlled and docu-mented in accordance with requirements, review included: two final inspection and test standards for the 1151/1251 Class 1E meters and the 9270 Class 1E indicating alarm instruments, QA procedure No. QAP-108 to control the use of the Operations Routing Order assembly traveler; two customer purchase order specifications; and II Sigma Environmental Test Plan; First Piece Inspection Logs located in the Meter and Control Assem-bly areas; an in-process, inspection and test document package for Class 1E control instruments; final process sheets, test reports and certificates of compliance for four Class 1E instrument orders; final inspection checklists for printed circuit boards for seven Class 1E in-strument orders, and final inspection checklists for six panel meter orders.
INTERNATIONAL INSTRUMENTS DIVISION ORGANIZATION:
SIGMA INSTRUMENTS, INCORPORATED ORANGE, CONNECTICUT REPORT NO.: 99900284/81-01 INSPECTION RESULTS:
PAGE 5 of 5 Within this area, no nonconformances to NRC, customer order, or the QC program requirements were identified and no unresolved items were iden-ti fied.
2.
Change Control - The inspector reviewed two sections of the vendor's QC Manaul, Revision 4, which were applicable to changes to design and manufacturing documents.
To verify that changes in design and manufacturing documents were con-trolled and documented a review was made of: two engineering standards governing drawing changes; a serial number assignment log for the Model 9270 instruments, record documents consisting of change notices, engineer-ing releases and revised drawings related to six design changes; records consisting of two temporary authorizations and the resulting change notice common to a design change; a change notice log, and an engineering release and six revised drawings for a design change in a Model W-1251 1
Class 1 instrument.
Within this area, no nonconformances to NRC, customer order or QC program requirements were identified, and no unresolved items were identified.
3.
Nonconformances and Corrective Action - The inspector reviewed two sections of the vendor's QC Manual, Revision 4, which were applicable to the control and disposition of nonconformances in materials and sub-assemblies received from suppliers and from the assembly departments.
To verify that nonconforming items were reviewed and accepted, rejected, repaired, or reworked, and that conditions adverse to quality, including the cause, are promptly identified and corrected, a review was made of two procedures controlling the use of rejection tags and providing in-structions for correction action; material review reports and vendor inspection records common to orders containing nonconforming items from four vendors; rejection tags common to subassemblies or. five items received from the assembly department.
Within this area, no nonconformances to NRC, customer order, or the QC program were identified, and no unresolved items were identified.
4.
10 CFR Part 21 - The inspector reviewed the vendors document " Procedure for Reporting of Defects and Noncompliance Per 10 CFR Part 21," approved on May 5,1978, to verify that adequate documented measures were available to meet the reporting requirements of 10 CFR Part 21.
Observations were made of the employee's bulletin board on which were posted copies of 10 CFR Part 21, Article 206 of the Energy Reorganization Act of 1974, and the above vendor's procedure.
Within this area, no violations were identified.
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