IR 07100192/1989001
| ML19325F020 | |
| Person / Time | |
|---|---|
| Site: | 07100192 |
| Issue date: | 11/03/1989 |
| From: | Jackie Cook, Gordon L, Jankovich J, Macdonald C NRC OFFICE OF NUCLEAR MATERIAL SAFETY & SAFEGUARDS (NMSS) |
| To: | |
| Shared Package | |
| ML19325F019 | List: |
| References | |
| 71-0192-89-01, NUDOCS 8911130228 | |
| Download: ML19325F020 (15) | |
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UNITED $TATEs i
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NUCLEAR REGULATORY COMMISSION
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W ASHING TOh, D. C. 2055$
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CONTAINER SUPPLIER INSPECTION PROGRAM i
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Inspection Report
i ORGANIZATION: Pacific Nuclear Systems, Inc.
ADDRESS:
1010 South 336th Street Federal Way, WA 98003
CONTACT:
Dr. C. J. Temus TELEPHONE: 206-874-2235 TITLE:
Technical Director
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ACTIVITY:
Design, fabricate and supply radioactive material packages
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QUALITY ASSURANCE PROGRAM APPROVAL NO.: 0192
Report Number:
Inspection Dates:
Inspection On-Site
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710192/89-01 4/25-27/89 Person-Hrs: 96
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r INSPECTION BASES AND SCOPE:
A.
BASES:
Title 10 CFR Parts 21 and 71, and Certificate of Compliance Nos. 5806, 6244, 6601, 9070, 9079, 9080, t
9081, 9108, 9111, 9151 9159, 9168, 9216.
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B.
SCOPE:
To determine whether the organization has established, documented and executed procedures which fulfill the commitments made in the organization's NRC-approved t
quality assurance program.
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To determine whether fabricated packages were manu-
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l factured in accordance with the ilesign approved by
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the Commission.
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i 8911130228 891106 PDR ADOCK 07100192 C
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Page 2 CONTAINER SUPPLIER INSPECTION PROGRAM
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Inspection Report
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FINDINGS:
Noncoformances with the requirements of 10 CFR Sections
71.37(b);71.103;71.115(b)71.135wereidentified.
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INSPECTION TEAM LEADER:
DATE:
l'/3/#7 JoMn P. Jafftovich,19155
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OTHER NRC INSPECTORS:
,f/4 [h DATE: il/1/F$
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l L. Len 50rdon, MPD5
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DATE:
l John R. Cook, nri35
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NRC CONTRACTOR:
H. M. Stromberg i
INEL/EG8G Idaho, Inc.
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ad[/t DATE: eIr//1 REPORT APPROVED BY:
cnarles E. Mac)onald, chief Transportation Branch, NMSS
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1.
SupMARY
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l An announced team inspection of Pacific Nuclear Systems, Inc. (NUPAC) was
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conducted on April 25-27, 1989. The U.S. Nuclear Regulatory Comission (NRC) conducted the inspection using the Temporary Instruction, "Trans-
portation Package Suppliers Inspection", the Draft Technical Report,
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" Container Supplier Inspection Guide", and the attached Container Supplier Inspection Tree (Fig.1).
Inspection findings are based on data collected
through observation of selected activities, review of implementation pro-
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cedures and controls, review of selected documents and records, and inter-views with personnel. The inspection included an assessment of the
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QualityAssurance(QA)activitiesoftwoprincipalvendorsattheir facilities. The inspection team concluded that the implementation of the
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QA program was satisfactory. However, it identified specific items of nonconformanceonsomeaspectsofQAmanagement(10CFRSection71.103),'
the fabrication process (10 CFR Subsection 71.37(b)), materials control
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(10 CFR Subsection 71.115(b)) and design modification (10 CFR Section f
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71.135). The team discussed tentative findings with the organization's representatives, at the exit meeting.
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2.
CONTAINER SUPPLIER INSPECTION The inspection was an announced team inspection of container design, fabrication, maintenance and facility management activities. The objec-
tives of the inspection were to determine how well NUPAC's QA program com-i plied with comitments made to NRC, to review the implementation of the QA
program, and to verify whether the products were fabricated and maintained in compliance with NRC requirements.
The team evaluated NUPAC's QA acti-vities, during the inspection, in the framework of seven functional sle-
ments:
(1)QAmanagement;(2)FabricationProcess;(3) Materials;
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(4) Testing / Inspection;(5)DesignModification/ Verification;(6)Mainte-
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nanceControl;and(7)HandlingandStorageControl. The inspection team
' visited the facilities of two principal vendors, Leo Fabricators and Ideal Machine and Manufacturing Cos., to evaluate the QA activities related to
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the certificates of compliance for the NUPAC containers. The vendor in-l spections were also conducted in the framework of the seven aforementioned
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functional elements.
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2.1. Persons Contacted
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The NRC inspection team interviewed the following persons.
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i Pacific Nuclear Systems, Inc.
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- L. E. Kapinos, Vice President / General Manager
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- C. J. Temus, Technical Director
- R. H. Smith, Director, Corporate Quality Assurance
- F. L. Bamford, Quality Assurance Manager l
- D. E. Rodgers, Senior QA Inspector
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- N. K. Hanna, Inspection Supervisor
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- J. D. Kent, Engineer III
'D. L. Swannack Section Manager
- W. L. Henkel, Director of Engineering
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- S. A. Porter, Analysis Manager
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N. Swannack, Document Control Manager J. Frith, Engineer
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Pacific Nuclear S.ystems. Inc. Subcontractors l
Lee Fabricators P.O. Box 4307 j
Bremerton, WA 98312 j
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D. D. Lee, Owner R. Segeman, Certified delding Inspector Ideal Machine & Manufacturing 3611 South Warner Avenue
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Tacona, WA 98409 J. Anderson, QA/ Quality Control (QC) Manager f
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2.2 QA Management
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The QA management element was reviewed to determine the effectiveness of
the QA program and the proficiency and independence of the assigned QA
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personnel responsible for fulfilling the QA comitment. The inspectors l
interviewed the Vice/l' resident General Manager Quality Assurance Manager;
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Corporate Quality Assurance Director; Technical Director; Director of Engineering; a Section Manager; the Analysis Manager; and staff personnel
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performing safety-related activities.
In addition, the team inspected
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contractor facilities and interviewed contractor personnel. The inspec-tors also examined QA documents, administrative procedures, organization
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charts, completed container manufacturing documents, modification controls,
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contractor inspection reports, and contractor QA programs.
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The inspection of this element included a review in two primary areas:
Program and Personnel.
It was found that the facility management had in-
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plemented an effective and detailed QA program. The program addressed t
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- Attended exit meeting.
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i personnel and control for most aspects of the design, certift:ation, I
manufacturing, testing / inspection, and hancling and storage processes, j
The emphasis NUPAC places on ensuring a quality product is a major
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sf.rength of its operation.
It was evident, in most areas of the process, that management had been a driving force.
Its involvement was clear and
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documented.
A nonconformance was identified with regard to 10 CFR Section 71.103, i
which requires that the authority and duties of persons performing acti-vities affecting safety-related ~.dnctions be clearly established and
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delineated in writing.
In nonconformance with this Section, the Technical l
Director's job description did not completely describe his responsibi-
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lities.
It did not list his responsibility to review any deficiencies or
nonconformances and manufacturing changes to determine if there are any i
implications for the Safety Analyses Report (SAR) evaluation analysis.
The inspection team was concerned that if Technical Director was replaced,
this critical portion of their process would not be performed adequately.
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2.3 Fabrication Process
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The team inspected this elenent to verify that all phases of the fabrica-tion process are properly controlled. The fabrication processes are to be l
controlled, verifiable, and traceable, from the onset of design through completion of the assembly process.
The team reviewed documents to verify l
the completeness of processes, hold points, acceptar.ce s.riteria, and the
controls provided for the fabrication process. The team performed contractor facility walk-through inspections to determine the adequacy of i
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l contractor controls and programs.
The inspection of this element considered three major areas:
Program,
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Process, and QA.
The inspection determined that the fabrication process program was exemplary. Hold points were identified during the fabrication l
process. When they were reached, fabrication stopped until the inspection or testing was witnessed by NUPAC inspectors.
The hold points were estab-lished at strategic points in the process, helping to ensure a quality c
product.
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i The team reviewed implementing procedures concerning defect and j
noncompliance reporting requirements which are applicable to purchases of
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goods / services. The procedures were adequate and met the requirements of l
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A nonconformance with regard to 10 CFR Subsection 71.37(b) which requires that established codes and standards proposed for use in package design,
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fabrication, assembly, testing, maintenance and use be identified.
l NUPAC's contractor was not aware of any restrictions on the cleaning of
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stainless steel.
NUPAC, as required by 10 CFR 71.37(b), had not identified
the requirement to clean stainless steel with a fluid that is low in I
chlor!de concentration.
2.4 Materials l
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The materials inspection element was reviewed to determine the effective-l ness of the controls used to ensure compliance with requirements placed on l
materials. Materials should be controlled, verifiable, and traceable fror.
the time of purchass through the life of the container.
The inspection of l
this element considered three major areas:
Program, Process, and QA.
l Documents were reviewed to ensure completeness of material identification l
and certification, to verify that the specified material was used, and to
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evaluate material controls and QA program controls. The contractor facility f
controls were inspected to verify that they also met material control
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requirements.
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It was determined that material control was adequate ar.d met the regula-t tory requirements and QA application commitments.
I Anonconformancewasidentifiedwithregardto10CFRSubsection71.115(b)
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which requires that documentation showing conformation to the procurement specifications be available for the life of the packages.
Suppliers provide to NUPAC a certificate of conformance which states that materials conform to the procurement specifications.
The certificate is based on the information provided to them by their suppliers. Typically, NUPAC
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is not provided with the name of the original supplier.
When asked if the original supplier could be identified, NUPAC's response was that it was possible but may be difficult. Because this infermation may not be available, material may not be traceable to its original supplier and documentation, as required by 10 CFR Subsection 71.11MS Loy not be available.
2.5 Testing / Inspection The various areas involving tests and inspections were reviewed to deter-mine the offectiveness of the controls used to ensure compliance with re-c;uirements placed on the testing and inspection program. Tests and inspections should be controlled, verifieble, and traceable, from the design-basis events through the entire testing and inspection program, up
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to and including the review of closed-out procedures and inspection reports.
Documents were reviewed fot:
completeness of testing and inspection requirements; verification that the testing and inspection controls and QA program controls were met. The contractor facility controls were inspected to verify that they also met measurement, testing, inspection, and calibration control requirements.
The inspection of this element considered three major areas: Program, Implementation, and QA.
It was determined that testing and inspection
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controls were adequate and met the regulatory requirements and QA applica-l tion commitments. There was one area of major strength identified during l
the inspection of this element. The inspectors found the testing and in.
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spection personnel training and qualification to be exemplary.
It was sufficiently detailed and exceeded the regulatory requirements.
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l 2.6 Design Modification Verification Process
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A review of the design modification process was made to verify that adequate controls had been developed and implemented ensuring compliance
with the SAR and QA requirements. The design modification process should j
be controlled and traceable from the onset of design through completion of l
testing and delivery to owners or users.
Documents were reviewed for
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i completeness, adequacy and verification that design modification requirements l
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were met. The review also evaluated design-modification controls and QA program controls.
The inspection of this element considered three major areas:
Program, Process, and QA.
It was determined that design modification controls appeared adequate however, one nonconformance was identified.
A nonconformance was identified with regard to 10 CTR Section 71.135 which requires that written records describing the activities affecting quality be maintained for three years beyond the date when the licensee last engages in the activity for which the QA progam was developed. The team found occasions where changes had been made to containers.
The Technical Director reviewed the changes to determine if the SAR requirements were f
satisfied or if further review by NUPAC personnel was required. The results of the review, as required by 10 CFR Section 71.135, were not i
Jocumented or referenced in any documentation, i
r 2.7 Maintenance Control
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The performance of maintenance ensures that the container will remain in a
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l safe and usable condition. The goals of maintenance inspection are to l
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identify the maintenance that should be performed on the container to ensure it will meet its design objectives, and then inform the owner / user l
of the required maintenance. Documents were reviewed for:
completeness
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of maintenance controls; follow-up of maintenance after container salet and QA program controls. The inspection of this element considered three i
major areas: Program, Process, and QA.
It was determined that l
maintenance controls appeared to be adequate and that controls provide sufficient control to satisfy the SAR and QA application commitments.
2.8 Handling and Storage Control The inspection of handling and storage control verifies that adequate measures are established to prevent damage or deterioration of materials I
and equipment during handling, storage, shipping, cleaning and preserva-l tion. Documents were reviewed for handling and storage requirements and l
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QA program controls. The adequacy of handling and storage operations were j
reviewed.
The need for handling and storage control is limited since con-tainers are usually manufactured only af ter a purchase order is received,
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not as shelf items.
It was found that procedures for storage gave consi-i deration to required maintenance.
Handling controls were adequate and the procedures for storage were exemplary.
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3.
DOCUMENTS REVIEWED Document ID Rev. No.
Title l
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WO No. Z41 Fabrication documents for a 10-142
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container
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WO No. 2019 Fabrication documents for a 10-142
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container i
WO No. GN Fabrication documents for a 14-210
f container
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WO No. Z70 Fabrication documents for a 14-210 container
WO No. 3522 Fabrication documents for a 14 210 container
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WO No. XX2 Fabrication documents for a N-55 container NPI.F-0018-NP N-55 Polyurthane foam Specification i
OM-08, Rev. 0 Operation and Maintenance Manual for
the NUPAC PAS-2 Sampling Cask and Trans-portaticn Packaging
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OM-12, Rev. 3 Operation and Maintenance Manual for NUPAC OH-142 Shipping Cask Typical Trailers and Standard Liners
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l FS-01, Rev. 7 Specification for Machining and Fabricating Equipment
Q1-5, Rev. 0 QA Planning
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QP-5, Rev. 07 QA Planning l
h OM-10 Rev. 4 Installation and Torquing of NUPAC Binders i
LT-04, Rev. 3 General Procedure for Soap Bubble i
(LowPressure)LeakTest
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L-01, Rev. 7 Specification for Pouring Molten Lead for Radiation Shielding
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GS-001, Rev. 4 General Procedure for Gmma Scan of
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Shielded Container
QANPI.0305.LF8901 Lee Fabrir,ators Audit File from 1/19/1989 l
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QANPI.0305.LF8605 Lee Fabricators Audit File from 5/29/1986
QANPI.0305.IM&M8610 Ideal Machine and Mfg. Audit File from 10/22/1966 QANPI.0305.IM&M8609 Ideal Machine and Mfg. Audit File from i
l 9/29/1986 i
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QP-6 Rev. 5 Inspection and Verification QP-7 Rev. O Discrepancy Reporting IM-6, 15, 16, 23 Welding Procedures, WDE QP-4 10 CFR 21 Reporting Requirements Package QANPI.0305.MPL8610 Metalex Products, LTD Audit File from 10/09/1986 QANP!.0305.MPL8504 Metalex Products, LTD Audit File from
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04/29/1985
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Purchase Order No. 7363-3566 to Lee Fabricators, file from 11/21/88 to present.
~4.
NONCONFORMANCES The following nonconformances were identified:
Nonconformance 1 10 CFR Section 71.103, requires, in part, that the authority and duties of persons and organizations performing activities affecting safety-related functions must be clearly established and delineated in writing.
In nonconformance with 10 CFR Section 71.103, the Technical Director's job description did not list the responsibility for reviewing deficiencies and nonconformances and manufacturing changes to determine implications for the SAR evaluations or analyses.
(Reference Section 2.2 Page 6)
Nonconformance 2 l
l 10CFRSubsection71.37(b),requiresthatestablishedcodesandstandards proposed for use in package design, fabrication, assembly, testing, neintenance and use be identified.
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Innonconformancewith10CFRSubsection71.37(b),proceduresdonot specify applicable codes, standards and regulations concerning cleaning
fluids used in the fabrication process.
(Reference Section 2.3, Page 7)
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Nonconformance 3 j
l 10CFRSection71.115(b)requiresdocumentationwhichshowsthatmaterial i
and equipment conforms to procurement specifications to be retained or to
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be available for the life of the package.
In nonconformance with 10 CFR Section 71.115(b), documentation of material and equips. ant suppliers was not available.
(ReferenceSection2.4,Page l'
7)
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Nonconformance 4
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10 CFR Section 71.135, specifies that written records describing the activities Affecting quality be maintained for three years beyond the date j
when the licensee last engages in the activity for which the QA Program
was developed.
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In nonconformance with 10 CFR Section 71.135, the results of the review of l
design modification changed against the SAR were not documented.
(Reference i
Section2.4,Page9)
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5.
EX1T MEETING
l On April 27, 1989, an exit meeting was conducted with facility management, l
supervisors, and engineers.
The following personnel attendeo the exit I
meeting:
L. E. Kapinos, Vice President / General Manager C. J. Temus Technical Director l
R. H. Smith, Director, Corporate Quality Assurance l
F. L Bamford, Quality Assurance Manager l
D. E. Rodgers, Senior Quality Assurance Inspector N. K. Hanna, Inspection Supervisor l.
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J. D. Kent Engineer III D. L. Swannack, Section Manager W. L. Henkel. Director of Engineering
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S. A. Porter, Analysis Manager In the meeting, the team members summarized the preliminary results of the inspection and discussed a draft of the inspection tree with the meeting participants, s
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