ML18149A047
| ML18149A047 | |
| Person / Time | |
|---|---|
| Site: | 07109342, 07109291, 07100249, 07109315 |
| Issue date: | 05/25/2018 |
| From: | Meraj Rahimi NRC/NMSS/DSFM/IOB |
| To: | Freudenberger R Nuclear Fuel Services |
| Woodfield J | |
| References | |
| IR 2017201 | |
| Download: ML18149A047 (22) | |
See also: IR 07100249/2017201
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
WASHINGTON, D.C. 20555-0001
May 25, 2018
Mr. Richard J. Freudenberger
Quality, Safety, & Safeguards Director
Nuclear Fuel Services, Inc.
1205 Banner Hill Road
Erwin, Tennessee 37650
SUBJECT:
NRC INSPECTION REPORT 71-0249/2017-201
Dear Mr. Freudenberger:
From July 24 through 27, 2017, the U.S. Nuclear Regulatory Commission (NRC) performed an
announced inspection of Nuclear Fuel Services, Inc. (NFS) at its facility in Erwin, Tennessee.
The inspection continued in NRC headquarters with further review of documents supplied by
NFS until a final exit meeting was conducted with NFS by teleconference on April 26, 2018.
The team inspected NFS activities associated with transportation of radioactive material to
determine if they were executed in accordance with the requirements of 10 CFR Parts 21 and
71, Certificates of Compliances (CoCs), Safety Analysis Reports, and NFS NRC-approved
Quality Assurance Program (QAP). The team inspected NFS management and maintenance
controls. Inspection results are detailed in Enclosure 1 to this letter.
With respect to the inspection results, the NRC inspection team assessed that, overall, as
presently developed and implemented, NFS QAP and procedures are adequate in meeting the
QA requirements of 10 CFR Part 71 and 10 CFR Part 21 with the exception of one unresolved
item. The unresolved item is discussed in detail in the inspection report. The team also
identified examples where records were not properly maintained and measuring and testing
equipment used in activities affecting quality were not properly calibrated.
Based on the results of this inspection, the NRC has determined that one non-cited Severity
Level IV violation and one minor violation of NRC requirements occurred, in addition to the
unresolved item. The violation and minor violation are non-cited because NFS placed the items
in their corrective action program, the issues were of low safety significance, not willful on NFS
part, and actions were taken to address the immediate issue.
R. Freudenberger -2-
In accordance with 10 CFR 2.390, Public inspections, exemptions, requests for withholding, a
copy of this letter, and its enclosure will be made available electronically for public inspection in
the NRC Public Document Room or from the Publicly Available Records System (PARS)
component of NRCs Agencywide Documents Access and Management System (ADAMS).
ADAMS is accessible from the NRC Web site at https://www.nrc.gov/reading-rm/adams.html.
Sincerely,
/RA/
Meraj Rahimi, Acting Branch Chief
Inspections and Operations Branch
Division of Spent Fuel Management
Office of Nuclear Material Safety
and Safeguards
Docket No. 71-0249
Enclosures:
1. NRC Inspection Report No. 71-0249/2017-201
R. Freudenberger -2-
SUBJECT:
NRC INSPECTION REPORT 71-0249/2017-201 DOCUMENT
DATE: MAY 25, 2018
Distribution:
NRC f/c
Public
NMSS r/f
DSFM r/f
MLayton, DSFM
AHsia, DSFM
NHilton, OE
MBurgess, NMSS EC
ADAMS: ML18149A047
OFC:
NMSS/DSFM/IOB
E
NMSS/DSFM/IOB
E
NMSS/DSFM/IOB
E
NAME:
JWoodfield
CRoque-Cruz
via E-mail
MRahimi
DATE:
5/22/2018
5/15/18
5/25/2018
OFFICIAL RECORD COPY
Enclosure 1
U.S. NUCLEAR REGULATORY COMMISSION
Office of Nuclear Material Safety and Safeguards
Division of Spent Fuel Management
Inspection Report
Docket No.
Report No.
71-0249/2017-201
User of Certificates: Nuclear Fuel Services, Inc.
1205 Banner Hill Road
Erwin, Tennessee 37650
Inspection Location: Nuclear Fuel Services, Inc.
1205 Banner Hill Road
Erwin, Tennessee 37650
Inspection Dates:
July 24-27, 2017 at NFS Facility and in NRC Headquarters until Exit
Meeting by Teleconference on April 26, 2018
Inspection Team:
Jon Woodfield, Team Leader, Safety Inspector, DSFM, IOB
Carla Roque-Cruz, Safety Inspector Engineer, DSFM, IOB
Approved by:
Meraj Rahimi, Acting Branch Chief
Inspections and Operations Branch
Division of Spent Fuel Management
Office of Nuclear Material Safety and Safeguards
2
U.S. NUCLEAR REGULATORY COMMISSION
Office of Nuclear Material Safety and Safeguards
Division of Spent Fuel Management
EXECUTIVE SUMMARY
Nuclear Fuel Services, Inc.
NRC Inspection Report 71-0249/2017-201
From July 24 through July 27, 2018, the U.S. Nuclear Regulatory Commission (NRC) performed
an announced inspection of Nuclear Fuel Services, Inc. (NFS), at its facility in Erwin,
Tennessee. The inspection continued in the NRCs Headquarters Office until the final exit
meeting on April 26, 2018, which was held by teleconference. The team inspected NFS
activities associated with transportation of radioactive material to determine if they were
executed in accordance with the requirements of 10 CFR Parts 21 and 71, Certificates of
Compliances (CoCs), Safety Analysis Reports (SARs), and NFS NRC-approved quality
assurance program (QAP). The team inspected NFS management and maintenance controls.
The results of the inspection are as follows:
Management Controls
The team interviewed NFS personnel and reviewed and verified documented aspects of quality
assurance, nonconformance controls, documentation controls, as well as various audit
activities. The team determined that NFS implementation in this area was adequate with one
finding and one unresolved item.
The finding was against 10 CFR 71.135, Quality assurance records. The team requested NFS
to provide the original qualification records for Rainier Rubber, a commercial supplier of O-rings
that were used in an important-to-safety (ITS) Category A application on the ES-3100
packaging. NFS was unable to locate the original qualification records and initiated Problem
Identification, Resolution and Correction System (PIRCS) report 61250 to place the issue in its
corrective action program. The team determined this violation to be of minor safety significance
and not subject to formal enforcement action because other audits had been performed since
the original audit and it appeared to be an isolated incident.
The unresolved item is associated with 10 CFR 71.115, Control of purchased material,
equipment, and services. The following instance was identified by the team where NFS vendor
qualification records did not provide adequate evaluations and at intervals consistent with the
importance of the material being procured. NFS Vendor Qualification Procedure NFS-Q-224,
Revision 1, Method I, (to evaluate a vendors history of providing a product/service that has
performed satisfactorily in actual use) was used in 2017 and 2014 to qualify a commercial grade
vendor to supply ITS Category A O-rings for use in the ES-3100 packaging. This level of quality
assessment of the commercial grade O-ring vendor performed at three year intervals is not
consistent with the significance of an ITS Category A component. However, it should be noted
that NFS Procedure NFS-Q-224 was developed from an NRC-approved QAP. NFS also took
immediate corrective action to procure the ITS Category A O-rings directly from the ES-3100
packaging CoC holder. The inspection team evaluated the violation in accordance with Section
3
2.3 of the NRC Enforcement Policy and dispositioned it as a potential non-cited Severity Level
IV violation since it was of low safety significance due to NFS leak testing the O-rings once
installed and NFS decision to procure the O-rings directly from the ES-3100 CoC holder going
forward. However, this item is unresolved.
As a generic implication of the unresolved O-ring item, the team has determined that Section
7.0, Control of Purchased Material, Equipment, and Services, of NFS QAP is inadequate as
currently written to evaluate a suppliers capability to comply with the elements of 10 CFR
71.115, Control of purchased material, equipment, and services. NFS has stated that it plans
to revise and correct Section 7.0 of its QAP and submit it to the NRC for re-approval as part of
the resolution of the unresolved item.
Maintenance
The team reviewed maintenance documents associated with maintenance controls for activities
affecting quality and interviewed NFS personnel involved with maintenance. The team
determined that NFS implementation in this area was adequate with one finding against 10
CFR 71.125, Control of measuring and test equipment.
NFS Procedure NFS-WST-026 Revision 12 for handling/shipping ES-3100 packagings requires
the ES-3100 containment vessel (CV) closure nut to be tightened to 120 ft-lbs +/- 5 ft-lbs torque
using a calibrated torque wrench.
Contrary to this requirement, the calibrated torque wrench dedicated to the task of tightening the
CV closure nut had been set/calibrated at a value of 125 ft-lbs +/- 5 ft-lbs and used in the field at
this setting for at least four years.
Overall
The team assessed that NFS overall implementation of its NRC-approved QAP was adequate,
with the one unresolved item associated with NFS QAP as noted above. A summary of
inspection findings is presented in Table 1 below.
Table 1
Summary of Inspection Findings
Regulatory
Requirement
10 CFR Section
Subject of Violation or
Noncompliance
No. of
Findings
Type of Finding
Report
Section
71.115
Control of purchased material,
equipment, and services
1
Potential Non-cited Level
IV Violation - Unresolved
Item (URI)
2.5.2
71.125
Control of measuring and test
equipment
1
Non-cited Level IV
Violation
5.3.2
71.135
Quality assurance records
1
Minor Violation
2.4.2
4
REPORT DETAILS
1.0
Inspection Scope
The team inspected NFS management and maintenance controls to determine whether they
were executed in accordance with the requirements of 10 CFR Parts 21 and 71, applicable
CoCs, related SARs, and NFS NRC-approved QAP. The team reviewed documentation,
interviewed personnel, and observed activities in various facility areas. The team focused its
review on the following transportation packagings for which NFS is a user only.
Model
Package ID#
Certificate
Revision
Expiration Date
Liqui-Rad (LR-
230)
USA/9291/B(U)F-96
9291
9
7/31/2019
USA/9315/B(U)F-96
9315
15
4/30/2021
Versa-Pac, VP-
110
USA/9342/AF-96
9342
12
8/31/2020
1.1
Inspection Procedures/Guidance Documents Used
IP 86001, Design, Fabrication, Testing, and Maintenance of Transportation Packagings
NUREG/CR-6314, Quality Assurance Inspections for Shipping and Storage Containers
NUREG/CR-6407, Classification of Transportation Packaging and Dry Spent Fuel Storage
System Components According to Importance to Safety
Regulatory Guide 7.10, Establishing Quality Assurance Programs for Packaging Used in the
Transport of Radioactive Material
1.2 List of Acronyms Used
Corrective Action Program
Corrective Actions Report
CFR Code of Federal Regulations
CoC Certificate of Compliance
CV
Containment Vessel
ITS Important-to-Safety
Measuring and Test Equipment
NCR Nonconformance Report
Nuclear Fuel Services
NRC U.S. Nuclear Regulatory Commission
PIRCS
Problem Identification, Resolution and Correction System
QA Quality Assurance
Quality Assurance Program
Quality Control
Records Administrator
Safety Analysis Report
TWM
Transportation Waste Management
5
Unresolved Item
Waste Management Specialist
1.3
Persons Contacted
The team held an entrance meeting with NFS on the afternoon of July 24, 2017, to present the
scope and objectives of the NRC inspection. On the afternoon of July 27, 2017, the team held a
preliminary exit meeting with NFS to present the preliminary results of the inspection. On
April 26, 2018 the team held the final exit meeting by teleconference with NFS. Individuals
present at the entrance, preliminary exit meeting, and final exit meeting are listed in Table 2.
Table 2
Entrance and Exit Meeting Attendees
Name
Affiliation
Entrance
Preliminary
Exit
Final Exit
NRC
X
X
X
NRC
X
X
NRC (Region II)
X
X
Larry Harris
NRC (Resident)
X
X
X
Joel Duling
X
Rich Freudenberger
X
X
X
Marie Moore
X
X
Amaryl Morie
X
X
X
Dave Deming
X
X
Robert Dotson
X
X
X
Rebecca Lind
X
X
X
Carol Anderson
X
X
Brad McKeehan
X
Natalie Willis
X
Jim Hutton
X
Jerry May
X
X
Tim Knowles
X
Randy Shackelford
X
X
Jon Hagemann
X
Jeffery Eidens
X
Tom Holly
X
Danielle Rogers
X
Ron Rice
X
6
2.0
Management Controls
2.1
General
The team assessed the adequacy of management controls in the areas of NFS QAP
implementation, nonconformance controls, documentation controls, and audit program.
The team reviewed NFS practices and procedures, and their implementation, to
determine the effectiveness of management controls.
2.2
Quality Assurance Program
2.2.1 Scope
The team reviewed NFS QAP to determine the effectiveness of instructions and
procedures that implement its program. The team inspected NFS QAP goals, objectives
and practices, personnel responsibilities, QA organizational independence, management
involvement, and staffing levels.
2.2.2 Observations and Findings
The team reviewed NFS' Quality Assurance Program for Shipping Packages for
Radioactive Material, Revision 16, dated 8/11/2016; and NFS procedures NFS-M-48,
Quality Assurance Program, Revision 5, dated 3/18/2013; and NFS-GH-49,
Implementing Procedure for the Transportation Quality Assurance Program, Revision 7,
dated 9/22/2015.
The team verified that the Quality Assurance Program as written, (with the exception of
vendor audits, reference section 2.5 and URI) adequately addresses the applicable
Quality Assurance criteria of 10 CFR Part 71 used for the activities performed at NFS. As
stated in the NFS QAP Quality Assurance Policy and Authority section, the company
President has the responsibility for the overall NFS QAP. All NFS employees are
responsible for the execution of the QAP in their specific activities, jobs, and work
assignments. Each employee is responsible for Quality Assurance as it applies to his or
her work assignments. However, the responsibility for evaluating the effectiveness of the
QAP is delegated to the Deputy Quality Assurance Director. The team noted that the
Quality Assurance function is independent and does not have direct responsibility for
performing work and is independent from groups having production responsibilities in the
Transportation Program. The team also noted that the NFS Transportation QA Program
as outlined is an adequate framework of controls for the ITS activities (with the exception
of vendor audits associated with the procurement URI) associated with the use,
maintenance, and minor repair of packages used under NRCs approval for the shipment
of radioactive materials.
2.2.3 Conclusion
7
Overall, the team determined that responsibilities were identified in quality procedures
and controls for quality activities. Other than the URI for vendor audits associated with
procurement, no concerns were identified with NFS QAP.
2.3 Nonconformance and Corrective Action Controls
2.3.1 Scope
The team reviewed NFS nonconformance control program to assess the effectiveness of
measures established to control materials, parts, or components that did not conform to
requirements. The team evaluated how NFS identified, segregated, tracked, and
controlled, any nonconforming items and any program deficiencies. The team inspected
nonconformance reports (NCR), nonconforming items, and measures used to keep track
of the status of nonconforming items. In addition, the team reviewed NFS corrective
action program.
The team also reviewed training and implementing procedures, internal postings, supplier
notifications, reporting processes, and program controls in accordance with the provisions
of 10 CFR Part 21, "Reporting of Defects and Noncompliance."
2.3.2 Observations and Findings
The team reviewed NFS nonconformance program to assess the effectiveness of
controls established for the processing of nonconforming materials, parts, or components.
The requirements for NFS nonconformance program are contained in NFS procedure
NFS-Q-185, Control of Nonconforming Items, Revision 9, dated 11/14/2016. This
procedure describes the control system for nonconforming and suspected nonconforming
items at NFS. This control system provides the requirements for identifying, segregating,
controlling, and dispositioning of suspected nonconforming items.
NFS-Q-185 requires that nonconforming items be tagged, segregated and classified.
The Quality Department maintains a log of nonconformance reports. This log is located
on the NFS intranet and allows access to NCR status information. Once the quality staff
is notified of the nonconformance, an entry in the PIRCS is generated. PIRCS is the
software program used to document plant wide corrective action activities. The
Respondent, the individual to whom the NCR was written, will evaluate the
nonconformance and determine the appropriate disposition, document the factors
supporting the proposed disposition, and obtain approval from the responsible manager.
Dispositions of Use-As-Is, Rework, or Repair, and Reject can be assigned to the
nonconforming item. Once the disposition has been proposed, approved, and
corresponding activities completed, Quality will verify each nonconforming item was
processed in accordance with the approved disposition and record the verification of the
disposition in the NCR log.
The team interviewed NFS Quality Control (QC) and QA personnel on the NCR process
and found them all knowledgeable with an understanding of the process as described in
the procedures. The team also reviewed a sample of NCRs from the last year that
involved ITS items. The team confirmed that the NCRs received the required review,
evaluation, and approvals by NFS personnel as evidenced by the entries into the PIRCS
8
system. The team assessed that the NCRs reviewed had been appropriately
dispositioned and closed in a timely manner. No concerns were identified by the team in
the processing of NCRs by NFS.
The team reviewed NFS' corrective action program (CAP) to assess the effectiveness of
controls established for the processing of programmatic issues or hardware non-
conformances. The objective of NFS corrective action program is to provide and
administer a program which enables NFS to report, investigate, correct, and track events
and conditions adverse to safety. The requirements for NFS corrective action program
are contained in NFS procedure NFS-CAP-009, The NFS Corrective Action Program,
Revision 7, dated 12/12/2016. As stated in Section 2.0, Scope, the Corrective Action
Program at NFS is to provide for accurate and timely notification, ensure rapid and risk-
graded investigations, tracking of the investigative process to closure, as well as the
resultant corrective actions; and provide for trending analysis of problems through a
database of problems information and causes.
All NFS employees and contractor employees are required to identify and report events
and conditions adverse to safety through their management and/or the PIRCS. NFS
procedure NFS-GH-65, Problem Identification, Revision 9, dated 3/20/2015, defines the
types of problems/adverse conditions that should be identified (or reported) through the
CAP. This procedure also provides guidance on how to document items into PIRCS.
The team interviewed NFS QC and QA personnel on the Corrective Action process and
Corrective Action software used by NFS. The team determined the NFS personnel were
all knowledgeable and understood the process as described in the applicable procedures.
The team reviewed a sample of Corrective Actions Reports (CARs) generated in the prior
year before the inspection on issues identified at NFS. The corresponding CAR response
and evaluation documented by NFS was also reviewed. For the majority of the CARs
and corresponding response, the team found that the corrective actions proposed and
taken by NFS were adequate and closed out in a timeframe commensurate with the
safety significance of the issue. The team found a few instances where complete
documentation or evidence of completion of activities were missing from the Problem
Reports generated by PIRCS. The staff discussed these instances with NFS staff and in
all cases the activities had been completed but the information not entered in PIRCS.
The team also assessed how the requirements of 10 CFR Part 21 were being
implemented for activities being performed at NFS. NFS procedure NFS-MGT-058,
Nuclear Fuel Services 10 CFR Part 21.21 Program, Revision 0, dated 9/30/2015
provides the process for notifying management of any condition potentially reportable to a
regulatory authority and for tracking the condition to ensure that reportability
determinations, and reports, if necessary; are filed within a timely fashion. The team
verified that for each NCR and CAR reviewed, the assessment for reportability was
performed. The team noted that this is one of the entries required in PIRCS. The team
also reviewed Part 21 evaluations from the last five years and verified that the required
Part 21 postings were posted and accessible in the NFS main entrance building.
2.3.3 Conclusion
9
Overall, the team assessed that NFS implementation of its nonconformance, corrective
action, and Part 21 programs was adequate with no concerns identified.
2.4
Documentation Controls
2.4.1 Scope
The team reviewed NFS documentation control program to determine the effectiveness
of the QAP in controlling quality-related documentation and records. The team reviewed
instructions, procedures, and drawings for adequacy, approval signatures, document
releases by authorized personnel, and document availability to personnel. The team
reviewed the control of such documents as inspection work orders, QA procedures, and
packaging drawings. The team reviewed quality records to assure that they were
properly identified, retrievable, controlled, and maintained.
2.4.2 Observations and Findings
The team reviewed the section of the NFS QAP, Revision 16 and the NFS procedures
specifically related to documentation controls. The team also had discussions with the
NFS staff responsible for document control and quality records.
The team specifically reviewed the following procedures associated with document
controls and records:
NFS-GH-49, Implementing Procedure for the Transportation Quality Assurance (QA)
Program, Revision 7
NFS-DOC-001, Procedure Implementation Process, Revision 8
NFS-DOC-002, Procedure Development Standards, Revision 8
NFS-RM-002, Vital Records Protection Procedure, Revision 12
The team focused its review of document controls on procedures that were written for
addressing purchase orders, operations, maintenance, repair, inspection, testing,
transportation, loading, and unloading of the transportation packagings for which NFS is a
user.
Obsolete or superseded hard copies of procedures are removed from work areas to
prevent inadvertent use. The initiator of new revisions is responsible for removal of the
superseded document.
Procedure NFS-DOC-001 goes into great detail describing the approval, distribution,
revision, and deletion process that establishes NFS formal document control process.
The team had extensive discussions with the NFS personnel responsible for the NFS
electronic document control system. NFS personnel demonstrated to the team how the
NFS electronic document control system worked at their computer stations.
The team requested to see NFS copies of all the Certificate of Compliances (CoC) and
Safety Analysis Reports (SAR) for the transportation packages for which NFS is an NRC
10
registered user. An NFS transportation and waste management specialist was able to
demonstrate that the documents could be quickly found and retrieved through NFS
computer/electronic controlled document system.
The team reviewed two examples of form FM-DOC-005, Unclassified Document
Distribution Sheets, Revision 3, which is a return receipt for controlled document holders
to acknowledge their receipt of a revised document. These two forms were used to
distribute hard copies of NFS procedures NFS-WST-036, Handling and Packaging of the
Versa-Pac, Revision 2 and NFS-WST-026, Handling/Shipping Instructions for the ES-
3100 Drum, Revision 12.A. Each form listed several areas of the facility, or persons,
which were to receive a numbered controlled copy of the revised procedure. The team
gained access to secured areas where loading of the ES-3100 and Versa-Pac packaging
occurred to verify the correct/current revision of procedure NFS-WST-036 and NFS-WST-
026 were being used in the secured loading areas. The team verified that the controlled
documents in the ES-3100 and Versa-Pac secured loading areas were current.
The quality records retained for the transportation packagings used by NFS are records
verifying replacement of parts, supplier evaluations, maintenance work orders,
procurement and receipt inspection records for both new packagings and repair parts if
needed; and records of personnel qualification and personnel training/retraining. It
should be noted that the scope of this inspection did not include the review of records for
the contents of the transportation packagings when used.
NFS personnel demonstrated how all the records associated with an individual
transportation package during its use and maintenance were collected and reviewed by a
Waste Management Specialist (WMS) in the Transportation and Waste Management
Technical Services Organization. The WMS logs all the documents/records on form FM-
DOC-017, Document Management Log, with the records attached, for delivery to the
quality records department and administrator for retention. Each individual transportation
packaging is uniquely labeled with a sticker containing a number and bar code prior to
each use to trace it back to packaging document records at NFS. The identifying number
provides traceability back to the packaging contents, fabrication records, and
maintenance records.
The team interviewed the records administrator (RA) in a standalone building dedicated
to records storage that had a controlled environment. The RA stated that documents
included in NFS Vital Records Program are routinely microfilmed or scanned to provide a
second set of the records in a different location. The RA demonstrated to the team how
quality records for a particular transportation packaging could be easily retrieved. The
RA also discussed how NFS procedure NFS-RM-006, Uniform Classification System
Outline, Revision 23 was used to classify quality records and their retention period.
As part of an unresolved item involving external audits of commercial grade vendors
supplying ITS Category A components, (Reference Section 2.5 below, Audit Program)
the team requested NFS to provide the original qualification records for Rainier Rubber, a
commercial supplier of O-rings that were used in an ITS Category A application on the
ES-3100 packaging. This request to NFS was made by the team after the inspection
continued back in NRC headquarters. NFS was unable to locate the original qualification
records and initialed PIRCS 61250 to place the issue in its corrective action program.
11
The team determined the missing original qualification records to be a violation of 10 CFR
71.135, Quality assurance records, which states, in part, that the licensee shall maintain
sufficient written records to describe the activities affecting quality. The licensee shall
retain these records for 3 years beyond the date when the licensee last engage in the
activity for which the QAP was developed. The team determined this to be a minor
violation with minor safety significance and not subject to formal enforcement action
because other audits had been performed since the original audit and it appeared to be
an isolated incident.
2.4.3 Conclusion
The team assessed that document controls and records management at NFS were
adequate and effective for the transportation packagings for which NFS is an NRC
registered user. However, there was one minor violation of minor safety significance
identified for missing records.
2.5
Audit Program
2.5.1 Scope
The team reviewed NFS audit program to determine whether audit plans, procedures,
and records were developed and maintained. The team evaluated whether NFS
scheduled and performed internal QA audits and vendor audits in accordance with
approved procedures or checklists; whether qualified and independent personnel
performed the audits; whether NFS management reviewed audit results; and whether
NFS took appropriate follow up actions in those areas found to be deficient.
2.5.2 Observations and Findings
Internal Audits
The team reviewed NFS-Q-178, Quality Assurance Audit Process, Revision 8, dated
7/7/2014. This procedure describes the methods for planning, scheduling, conducting,
documenting, and follow up of Internal Audits. In addition, the team reviewed the results
of two audits performed at NFS by the U.S. Department of Energy on June 2016 and by
BWXT Fluor - BWXT Portsmouth on April 2017. The team noted that the audit reports
contained findings and observations with adequate supporting details. The audits were
also conducted and documented using a checklist tailored specifically to NFS' quality
program. The team determined that the audits were adequate in there scope. The team
noted that CARs were initiated for the findings documented in the audit reports. The
team reviewed these CARs and determined that for the findings reviewed, all were
adequately evaluated and corrective actions implemented in a timely manner. No
concerns were identified by the team regarding NFS internal audit process.
External Audits
Additionally, the team reviewed NFS-Q-224, Quality Assurance Shipping Vendor
Qualification Procedure, Revision 001, dated 4/1/13, attachment A: Quality Assurance
Shipping Vendor Evaluation Form and the training records for NFS auditors and lead
12
auditors. The team reviewed NFS vendor evaluations for three suppliers, Accurate
Machine Products performed on 2/1/2017, Duncan Machine Inc. performed on 10/19/15
and Rainier Rubber in 2014 and 2017. The team determined the Accurate Machine
Products and Duncan Machine vendor evaluations to be adequate.
The team noted that Rainier Rubber was a commercial vendor of O-rings. NFS stated
that they procured the inner and outer CV O-rings from Rainier for the ES-3100
packaging. The team asked NFS if the inner O-ring was an ITS Category A component
and after consulting with the ES-3100 CoC holder, NFS confirmed the inner O-ring was
an ITS Category A component.
The team assessed that the method used by NFS to evaluate Rainier to supply an ITS
Category A component was not adequate and a violation of 10 CFR 71.115, Control of
purchased materials, equipment and services.
Title 10 CFR 71.115, Control of purchased material, equipment, and services, states in
part, that the licensee shall establish measures to assure that purchased material,
equipment, and services, whether purchased directly or through contractors and
subcontractors, conform to the procurement documents. These measures must include
provisions, as appropriate, for source evaluation and selection, objective evidence of
quality furnished by the contractor or subcontractor, inspection at the contractor or
subcontractor source, and examination of products on delivery. The licensee shall
assess the effectiveness of the control of quality by contractors and subcontractors at
intervals consistent with the importance, complexity, and quantity of the product or
services.
Contrary to the requirements of 10 CFR 71.115, the following instance was identified by
the NRC where NFS vendor qualification records did not provide adequate evaluations
and at intervals consistent with the importance of the material being procured. NFS
Vendor Qualification Procedure NFS-Q-224, revision 1, Method I, (to evaluate a vendors
history of providing a product/service that has performed satisfactorily in actual use) was
used in 2017 and 2014 to qualify a commercial grade vendor to supply ITS Category A O-
rings for use in the ES-3100 packaging. This level of quality assessment of the
commercial grade O-ring vendor performed at three year intervals is not consistent with
the importance of an ITS Category A component.
This violation was entered into NFS' corrective action program as PIRCS 61300. The
team determined that there was no immediate safety issue because the CV is leak tested
before each shipment, which verifies that the O-rings are adequately performing their
containment function. As part of the corrective action, NFS stated that it was no longer
going to procure the ITS Category A O-rings directly from Rainier but procure them from
the ES-3100 CoC holder. Therefore, the inadequate NFS evaluation of Rainier as an ITS
Category A supplier concern was eliminated.
Although the issue of procurement of O-rings for the ES-3100 CV has been addressed,
there is a generic procurement issue not addressed by PIRCS 61300. The team has
determined that Section 7.0, Control of Purchased Material, Equipment, and Services, of
NFS QAP is inadequate as currently written to evaluate a suppliers capability to comply
with the elements of 10 CFR 71.115, Control of purchased material, equipment, and
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services. However, it should be noted that NFS submitted its QAP with section 7.0 as
currently written for NRC approval and the NRC approved it. This QAP programmatic
failure and prior procurement of ITS Category A O-rings from commercial grade vendor
Rainier is an URI. NFS has stated that it plans to revise and correct Section 7.0 of its
QAP and submit it to the NRC for re-approval as part of the resolution of the unresolved
item. In resolution of the URI, this is one factor which will be considered in making the
issue a potential non-cited Level IV violation.
2.5.3 Conclusion
Overall, the team assessed that NFS was marginally adequate in implementing its audit
program, with the team identifying this as an area needing improvement with a URI. A
potential non-cited Severity Level IV violation was identified by the team and a generic
issue with Section 7.0 of the NFS QAP was also identified which are part of a URI.
3.0
Design Controls
3.1
General
NFS NRC approved QAP is for a transportation packaging user only and not for a
packaging CoC holder. As a user only, NFS is not responsible for the design of any
packagings it uses. Therefore, this section was not inspected by the team.
4.0
Fabrication Controls
4.1
General
NFS NRC approved QAP is for a transportation packaging user only and not for a
packaging CoC holder. As a user only, NFS is not responsible for the fabrication of any
packagings it uses. Therefore, this section was not inspected by the team.
5.0
Maintenance Controls
5.1
General
The team assessed the adequacy of maintenance controls in the areas of maintenance
activities and maintenance tools and equipment to ensure: 1) that each packaging will
meet its design task throughout its useful life; 2) suitable spare parts are used and; 3) that
adequate tool and equipment controls are established. The team reviewed NFS
practices and procedures, and their implementation to determine the effectiveness of
maintenance controls.
5.2
Maintenance Activities
5.2.1 Scope
The team evaluated the maintenance process to ensure that it was controlled and
verifiable from the onset of placing packagings into service. The team verified that the
maintenance procedures required the performance of packaging inspections to identify
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the need for maintenance and also the performance of routine package maintenance.
Documents reviewed included maintenance procedures, SAR Chapter 8 requirements,
maintenance checklists, and completed maintenance records.
5.2.2 Observations and Findings
The team reviewed NFS transportation packaging maintenance program which involves
routine inspections prior to packaging use and annual packaging inspections.
The team specifically reviewed NFS procedure NFS-WST-026, Handling/Shipping
Instructions for the ES-3100 Drum, Revision 12.A. The ES-3100 is a reusable
transportation packaging and procedure NFS-WST-026 addresses the operations of
opening, loading or unloading, closing, leak testing, inspection, routine maintenance, and
annual maintenance for the ES-3100.
Each ES-3100 is required to be inspected prior to every loading. Form FM-WST-011,
ES-3100 Inspection Checklist, is a checklist associated with NFS-WST-026 for
performing the inspection and documenting the results. Any deficiencies discovered
during the inspection are to be corrected before that particular ES-3100 can be used.
The form is a quality record associated with each ES-3100 packaging identification
number and retained.
The team toured the NFS warehouse of empty ES-3100 packagings and randomly
selected two ES-3100s to review their maintenance records and verify compliance with
procedure NFS-WST-026. The team reviewed the maintenance records for ES-3100
packaging serial numbers 2007-11-059 and 2007-33-121. Being a procedure, NFS-
WST-026 provides detailed instructions on how to inspect ES-3100s. The team reviewed
the latest FM-WST-011 form for each of the ES-3100s sampled and compared the
checklists to all the detailed written instructions in the procedure and found the correlation
adequate. The team found both FM-WST-011 checklists to be completely filled out and
each itemized step checked off and initialed by the inspector. It should be noted that the
form FW-WST-011 is used as a material loading checklist also. The loader verification
section of the forms were also found to be properly filled out and each step checked and
initialed by the loader. Both forms reviewed also had a transportation waste
management (TWM) supervisor review signature. For the ES-3100 to ship material, a
leak test is required to be performed on the containment vessel. The team also reviewed
the leak test record of performance for each of the sampled ES-3100s. The team found
that the CVs passed the leak testing and the documentation of the testing acceptable.
Procedure NFS-WST-026 requires that a Runsheet 33D (Form FM-WST-013) be
completed for each ES-3100 containing product material for shipment. The procedure
states that the material handlers are to initial all the checklist line items on the Runsheet
form and when completed, sign and date it. The TWM supervisor also signs as reviewer
of the form and dates it. The team reviewed the latest Runsheet for each of the two ES-
3100s sampled and found them to be completely filled out, checklist items initialed,
Measuring & Test Equipment calibration due dates provided, and having all three
required signatures and dates.
As stated above, procedure NFS-WST-026 also addresses ES-3100 annual
maintenance. Each ES-3100 shall be inspected once per year during its time of service.
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Form FM-WST-012, ES-3100 Annual Inspection/Maintenance Checklist, is used to
document the annual maintenance and any deficiencies are to be corrected before an
ES-3100 is placed back into service. The FM-WST-012 is to be completed by two
material handlers and reviewed by a TWM supervisor. A package certifier is to be
present during the inspection process; concur with the handlers inspections; and sign the
inspection checklist. Annually both of the O-rings of the CV are replaced by an approved
vendor and the packaging leak tested by the same vendor. Inspection stickers on the
side of the ES-3100 drum assembly and the lid of the CV are applied by the approved
vendor. The annual NFS inspections and checklist are completed after the O-rings are
replaced and Helium leak testing completed by the approved vendor.
The team reviewed the 2016 annual inspection documentation for the two sample ES-
3100s. The outside vendor provided recertification documentation for each of the two
sample ES-3100s with leak test performance records for the ES-3100 lid, nut assembly,
and vessel body. The team then reviewed the NFS annual inspection/maintenance
checklists for the two ES-3100s which were completed after the leak testing was
performed. The checklists followed the described inspection criteria in the NFS-WST-026
procedure. The team found the inspection forms to be completely filled out with
checkoffs and the inspectors initials; and also with the TWM supervisors signature,
package certifier concurrence signature, and dates. One of the inspector checks is to
verify that the drum and CV have an annual leak test certification sticker with the correct
expiration date applied by the approved vendor.
The team reviewed the requirements for ES-3100 packaging operations and maintenance
in NFS procedure NFS-WST-026 against the requirements in Section 7, Package
Operations, and Section 8, Acceptance Tests and Maintenance Program, of revision 5
of the ES-3100 SAR listed as a reference on ES-3100 CoC 9315, Revision 15. The team
determined the requirements in Sections 7 and 8 of the SAR were adequately transferred
as requirements in the NFS NFS-WST-026 procedure.
It should be noted that in NFS-WST-026, as users only, it is stated that NFS personnel
are not authorized to perform welding and structural repairs to the ES-3100 drum body or
CV assembly. At the time of the inspection, all spare parts for the ES-3100 were supplied
by the ES-3100 CoC holder to NFS except for the CV inner and outer O-rings.
The team reviewed the NFS training department lesson plan for ES-3100 Shipping
Container Training which required an objective test and on the job training. The training
covered NFS-WST-026 and the ES-3100 SAR sections 7 and 8. The team assessed the
training plan to be thorough and adequate.
The team also toured the NFS warehouse for new and empty Versa-Pac packagings and
randomly selected four Versa-Pacs to review their documentation. Two of the Versa-
Pacs were fabricated by one vendor and two fabricated by another. The Versa-Pac is a
one-time use transportation packaging and therefore does not have any maintenance.
The team therefore focused on the NFS receipt inspection of the four Versa-Pacs. The
team reviewed the manufacturers (fabricators) certification documentation provided with
the four Versa-Pacs. The team also reviewed NFS form FM-WST-019, Versa-Pac
Inspection Checklist, for each of the four packagings and the associated form NFS-SCM-
003, Category 2 and Category 3 Inspection Documentation Form. The team
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determined the receipt inspection forms to be thorough and properly filled out for each of
the four packagings.
The team reviewed NFS procedure NFS-WST-036, Handling and Packaging of the
Versa-Pac, Revision 2. The procedure provides instructions for opening, closing, pre-
load inspection, and packaging (loading) of Versa-Pacs. NFS forms NFS-WST-017
(Load Sheet for the Versa-Pac) and NFS-WST-050 (Pre-Load Inspection Checklist for the
Versa-Pac) are used with the procedure. Although receipt inspected for initial placement
in the NFS warehouse, each Versa-Pac is again pre-loaded inspected using form FM-
WST-050. The checklist is completed by two material handlers and reviewed by a TWM
supervisor. The team reviewed blank FM-WST-050 and NFS-WST-017 forms and
determined the checklist and load sheet to be appropriate, thorough, and adequate. Due
to time constraints, the team was not able to review completed forms NFS-WST-017 and
FM-WST-050 for loaded and shipped Versa-Pacs. However, the team was able to
review the training records for several individuals qualified on handling and packaging of
the Versa-Pac. The team determined the training was in-depth, thorough, and well
documented for the material handlers using and loading the Versa-Pacs.
5.2.3 Conclusion
Although only a small sampling was performed by the team; overall, the team found the
packaging periodic and annual maintenance program for re-usable packagings at NFS to
be comprehensive with detailed guidance on inspection acceptance criteria. The team
identified no concerns with the general operations, pre-loading inspections, periodic
maintenance, and annual maintenance of either one time use or re-usable transportation
packagings.
5.3 Measuring and Test Equipment
5.3.1 Scope
The team reviewed the controls for the calibration of measuring, testing, and inspection
tools/equipment and verified the procedural controls for tool traceability, as well as out of
calibration controls.
5.3.2 Observations and Findings
The team reviewed NFS procedure NFS-M-17, Calibration System Manual, Revision 27
for the QA requirements for maintenance of measuring and test equipment (M&TE) and
to verify that it was being properly implemented. M&TE that are in service are to be
labeled to indicate the calibration status. For calibrated instruments in service the label
shall include:
Instrument identification
Date of calibration
Calibration due date
Technicians or Suppliers initials
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The team focused on the loading operations for the ES-3100 and Versa-Pac packagings.
Since these packagings utilize bolted/nut closure devices, the M&TE used on these
packagings are torque wrenches. NFS-M-17 in Attachment B shows torque wrenches to
be calibrated annually using calibration procedure NFS-EC-33, Calibration of Torque
Wrenches Using an Electronic Torque Tester.
From NFS procedures NFS-WST-036 (Versa-Pac) and NFS-WST-026 (ES-3100), a
torque wrench set at 60 ft-lbs is used to tighten closure devices on the Versa-Pac and
two torque wrenches set at 30 ft-lbs and 120 ft-lbs +/- 5 ft-lbs are used on the ES-3100 to
tighten its closure devices.
NFS stated that it uses dedicated torque wrenches to specifically use on the two
packagings at specific locations in the NFS facility. The team requested to see the listing
of the three torque wrenches in the NFS master calibration M&TE database. The
database identified the 30 ft-lb torque wrench as TW-156, the 60 ft-lb torque wrench as
TW-173, and the 120 ft-lb torque wrench as TW-152 (although the database showed it as
a 125 ft-lb torque wrench). The database also showed the location of use in the NFS
facility and calibration due date for each wrench.
Since an Electronic Torque Tester is used to calibrate the torque wrenches, the team
requested the last calibration record for the tester. The tester calibration is performed by
an outside calibration laboratory at an interval of 12 months. The team reviewed the
latest calibration certificate from the vendor and found it adequate.
The team requested and reviewed the calibration records for the three torque wrenches.
A review of the records showed that the three wrenches have been calibrated at three
month intervals instead of annually. However, the calibration records for the torque
wrench which by procedure NFS-WST-026 required a 120 ft-lb +/- 5 ft-lbs torque wrench,
had actually been historically calibrated to 125 ft-lbs +/- 5 ft-lbs.
The team walked down the three torque wrenches in the secured areas of the facility to
check the calibration label sticker information on the actual torque wrenches in service.
The calibration labels for all three torque wrenches had information that agreed with the
database, calibration logs, and M&TE procedures. The torque wrench that was
supposed to be set at 120 ft-lbs +/- 5 ft-lbs per procedure NFS-WST-026 was found to be
currently and historically calibrated to 125 ft-lbs +/- 5 ft-lbs.
The team determined that based on the calibration records provided, torque wrench TW-
152 had been used on all ES-3100 packagings for tightening closure devices with an
incorrect torque value of 125 ft-lbs +/- 5 ft-lbs since 10/29/2012, instead of the required
120 ft-lbs +/- 5 ft-lbs torque value. NFS Procedure NFS-WST-026 Revision 12.A for
handling/shipping ES-3100 packagings requires the ES-3100 containment vessel closure
nut to be tightened to 120 ft-lbs +/- 5 ft-lbs torque using a calibrated torque wrench.
The team determined this failure to be a violation of 10 CFR 71.125, "Control of
measuring and test equipment," which states, in part, that the licensee shall establish
measures to assure that tools, gauges, instruments, and other measuring and testing
devices used in activities affecting quality are properly controlled, calibrated, and adjusted
at specified times to maintain accuracy within necessary limits. Contrary to the
18
requirements of 10 CFR 71.125, the calibrated torque wrench dedicated to the task of
tightening the CV closure nut had been set/calibrated at a value of 125 ft-lbs +/- 5 ft-lbs
and used in the field at that setting for at least four years.
This violation was entered into NFS' corrective action program PIRCS as Problem Report
59151, dated July 27, 2017. The inspection team evaluated the violation in accordance
with Section 2.3 of the NRC Enforcement Policy and dispositioned it as a non-cited
Severity Level IV violation.
The team determined that there was no immediate safety issue because the CV is leak
tested before each shipment, which verifies that the O-rings are adequately performing
their containment function.
5.3.3 Conclusion
Overall, the team found that the control of measuring and test equipment was adequate,
with the one non-cited violation described above.
6.0
Other Issues Reviewed By The Inspection Team
6.1
Corrective Action Follow-up to 2006 NFS Inspection Notice of Violation
6.1.1 Notice of Violation
The team reviewed NFS corrective actions associated with the violation identified during
the September 11-13, 2006 inspection (Inspection Report 71-0249/2006-201, NRC
ADAMS ML062710015) to verify the corrective actions had been completed as described
in NFS response to the violation on October 12, 2006 (ADAMS ML062960383). In 2006
NFS procedure NFS-RM-008, Document Control Procedure, Revision 6, Section 6.b
stated, in part, that a distribution sheet is prepared and maintained identifying the
document being distributed, number of copies made, to whom issued, and date of
issuance. Section 6.c stated, in part, that the copy number is written in red ink on the
front of each copy. Section 6.e stated, in part, that a master file of the current original
document and the distribution sheet is maintained for each controlled document in the
controlling department, and that these documents may be entered into the vital records
systems for microfilming as instructed by the area manager/director. 10 CFR 71.111
states, in part, that a licensee or certificate holder shall prescribe activities affecting
quality by documented procedures and shall require that these procedures be followed.
Contrary to this requirement, the requirements from NFS-RM-008 were not implemented
by NFS when Revision 4 to NFS-GH-49, Implementing Procedure for Transportation QA
Program, was issued and thus being in violation of 71.111.
The team tried to verify the following actions described in the NFS response letter were
taken: 1) a document distribution sheet for Revision 4 of NFS-GH-49, was prepared and
maintained with the original copy; and 2) the employee responsible for issuance of
procedures by the controlling department involved in the violation was informed of the
non-conformance and read procedure NFS-RM-008, Document Control Procedure,
again.
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Due to the age of this violation, the document distribution sheet for Revision 4 of NFS-
GH-49 and the original procedure had been discarded. NFS provided to the team their
procedure NFS-RM-006 Revision 24, Uniform File Classification Outline, which shows
how long records are to be retained. Records such as the document distribution sheet for
revision 4 and the original procedure were discarded after two years in compliance with
the procedure and therefore could not be verified by the team.
NFS was able to provide the training records for the employee that did not follow the
procedure NFS-RM-008 requirements and caused the violation. The team verified that
the training records recorded that the individual had read NFS-RM-008, Revision 6 and
later revisions also. It should be noted that NFS-RM-008 was superseded by NFS-DOC-
001, Document Standards and Control, Revision 0 in 2012 and is currently at revision 8
and now titled, Procedure Implementation Process.
6.1.2 Conclusion
The team determined the corrective actions in response to the violation were adequate
and the violation is closed.
7.0
Exit Meeting
On July 27, 2017, the NRC inspection team presented the preliminary inspection results
and observations during an on-site preliminary exit meeting. On April 26, 2018, the NRC
inspection team conducted the final exit meeting with NFS by teleconference. The team
exited with one Non-cited Level IV Violation, one Minor Violation, and one Unresolved
Item. Table 2 of this report shows the attendance for the entrance, preliminary exit, and
final exit meetings.