ML22305A627
| ML22305A627 | |
| Person / Time | |
|---|---|
| Site: | 07109337, 07109338, 07100939, 07109398 |
| Issue date: | 11/09/2022 |
| From: | Aida Rivera-Varona NRC/NMSS/DFM/IOB |
| To: | Ralls S Croft Associates Limited |
| References | |
| IR 2022201 | |
| Download: ML22305A627 (1) | |
See also: IR 07100939/2022201
Text
UNITED STATES
NUCLEAR REGULATORY COMMISSION
WASHINGTON, D.C. 20555-0001
November 9, 2022
Stephen Ralls
Quality Manager
Croft Associates Limited
Building F4, Culham Science Center
Culham, Abingdon
Oxfordshire, OX14 3DB, England, UK
SUBJECT: CROFT ASSOCIATES LIMITED - NRC INSPECTION REPORT
NO. 71-0939/2022-201 AND NOTICE OF VIOLATION
Dear Stephen Ralls:
This letter refers to the inspection conducted by the U.S. Nuclear Regulatory Commission
(NRC) on July 18 to 21, 2022, at the Croft Associates Limited (Croft) facility in Oxfordshire,
England in the United Kingdom. The inspection team continued the inspection activities with an
in-office review and held an exit meeting on September 26, 2022, with you and other members
of your staff.
The purpose of the inspection was to verify and assess the adequacy of Crofts activities
associated with the transportation of radioactive material and determine if they were performed
in accordance with the requirements of Title 10 of the Code of Federal Regulations (10 CFR)
Part 71, Packaging and Transportation of Radioactive Material, and Crofts NRC approved
Certificate of Compliances (CoC) and Quality Assurance Program (QAP). The inspection scope
included management, design, fabrication interaction, and maintenance controls. The enclosed
report presents the results of this inspection.
The inspection examined activities conducted under your NRC approved QAP as they relate to
public health and safety, and to confirm compliance with the Commissions rules and regulations
and with the conditions of the applicable CoCs. Within these areas, the inspection consisted of
selected examination of procedures and representative records, observations of activities, and
interviews with personnel.
Based on the results of this inspection, the NRC has determined that two Severity Level IV
violations of NRC requirements occurred. The violations were evaluated in accordance with the
NRC Enforcement Policy. The current Enforcement Policy is included on the NRCs Website at
(http://www.nrc.gov/about-nrc/regulatory/enforcement/enforce-pol.html). One of the violations is
non-cited while the second violation is cited in the enclosed Notice of Violation (Notice) and the
circumstances surrounding both violations are described in detail in the subject inspection
report. The one violation is being cited in the Notice because the violation was repetitive as a
result of inadequate corrective action and was identified by the NRC.
S. Ralls
-2-
You are required to respond to this letter and should follow the instructions specified in the
enclosed Notice when preparing your response. If you have additional information that you
believe the NRC should consider, you may provide it in your response to the Notice. The NRC
review of your response to the Notice will also determine whether further enforcement action is
necessary to ensure compliance with regulatory requirements.
In accordance with 10 CFR 2.390 of the NRCs Rules of Practice, a copy of this letter, its
enclosures, and your response, will be made available electronically for public inspection in the
NRC Public Document Room or from the NRC's Agencywide Documents Access and
Management System (ADAMS), accessible from the NRC Web site at
http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not
include any personal privacy or proprietary information so that it can be made available to the
public without redaction.
Sincerely,
Aida E. Rivera-
Varona
Aida E Rivera-Varona,Chief
Digitally signed by Aida E.
Rivera-Varona
Date: 2022.11.09 10:09:47 -05'00'
Inspection and Oversight Branch
Division of Fuel Management
Office of Nuclear Material Safety
and Safeguards
Docket No. 71-0939
Enclosure:
1. Inspection Report No. 71-0939/2022-201
OFC:
NMSS/DFM
NMSS/DFM
NMSS/DFM
NAME:
JWoodfield
SFigueroa
ARivera-Varona
DATE:
10/31/2022
11/1/2022
11/9/2022
U.S. NUCLEAR REGULATORY COMMISSION
Office of Nuclear Material Safety and Safeguards
Division of Fuel Management
Inspection Report
Docket No.:
Report No.:
71-0939/2022-201
Certificate Holder:
Croft Associates Limited
Building F4, Culham Science Center
Culham, Abingdon
Oxfordshire, OX14 3DB, England, UK
Inspection Dates:
July 18 - September 26, 2022
Inspectors:
Jon Woodfield, Transportation and Storage Safety Inspector, Team
Leader
Jeremy Tapp, Transportation and Storage Safety Inspector
Matthew Learn, Transportation and Storage Safety Inspector
Approved by:
Aida E. Rivera-Varona, Chief
Inspection and Oversight Branch
Division of Fuel Management
Office of Nuclear Material Safety
and Safeguards
Enclosure 1
2
EXECUTIVE SUMMARY
Croft Associates Limited
NRC Inspection Report 71-0939/2022-201
This routine inspection from July 18 to September 26, 2022, evaluated the on-going activities at
Croft Associates Limiteds (Croft) corporate facility in Oxfordshire, England, UK related to the
design of transportation packages for radioactive material. The purpose of the inspection was to
verify and assess the adequacy of Crofts activities associated with the transportation of
radioactive material to determine if they were performed in accordance with the requirements of
Title 10 of the Code of Federal Regulations (10 CFR) Part 71, Packaging and Transportation of
Radioactive Material, and Crofts NRC approved Certificate of Compliances (CoC) and Quality
Assurance Program (QAP). The inspection scope included management, design, fabrication
interface, and maintenance controls. The results of the inspection are as follows:
Management Controls
The team determined that the QA controls at Croft were generally adequate. Regarding the
overall QA policy, the team concluded that Croft conducts its activities associated with QA
organization independence and QA responsibilities in accordance with their NRC approved
QAP. (Section 1.1)
The team concluded that Croft has an adequate nonconformance control program in place to
ensure compliance with the applicable regulations and quality assurance program requirements.
(Section 1.2)
The team identified Crofts corrective action program (CAP) as an area for improvement as
evidenced by the issue identified and described in this report. The team identified one Severity
Level IV violation of 10 CFR 71.133, Corrective action for Crofts failure to take adequate
corrective actions for three issues identified during two previous NRC inspections. Also, a fourth
issue was identified during the current inspection supporting the violation in that Croft failed to
document internal audit nonconformances on corrective action reports per Croft procedures to
officially correct the nonconformances. This was an additional example of Crofts failure to take
adequate corrective action. (Section 1.2)
The team concluded that Croft was effectively implementing its document and records control
program and had adequate procedures in place to ensure compliance with the applicable
regulations and QAP requirements. (Section 1.3)
The team found that for the audits reviewed, Croft conducted the audits with qualified personnel
independent of the areas being audited and adequately evaluated the applicable functional
areas of the QAP. (Section 1.4)
Design Controls
The team identified Crofts design control program as an area for improvement as evidenced by
the issue identified and described in this report. The team identified one Severity Level IV non-
cited violation of 10 CFR 71.111, Instructions, procedures, and drawings for Croft having three
active procedures that did not correctly prescribe activities affecting quality. Specifically, CAP-
02-02, Project Quality Plan; CAP-02-04, Project Specifications; and CAP-02-05, Project Plan;
are no longer current with what Croft is actually doing to fill out Croft form QF376, Project
Quality Plan. (Section 2.)
3
Fabrication Interface
The team determined that the procurement controls were adequate, and Croft was generally
effective in implementing their procurement program to support their transportation packaging
fabricator. (Section 3.1)
Croft's implementation of fabrication controls for fabrication and assembly was assessed to be
adequate based on a sample review of fabrication final documentation packages for Crofts
transportation packages. (Section 3.2)
The team assessed that Croft had adequate controls for testing and inspection of its fabricated
transportation packages as they were being inspected per approved QA procedures and
fabrication specifications by qualified personnel. The team based its assessment on a sample
review of fabrication final documentation packages. (Section 3.3)
Maintenance Controls
The team reviewed maintenance procedures and maintenance records associated with
packaging maintenance controls for activities affecting quality and interviewed Croft personnel
involved with maintenance. The team determined that Crofts implementation in this area was
adequate. (Section 4.1)
The team assessed that overall, the measuring and test equipment (M&TE) quality procedures
being implemented at Croft provided adequate guidance for M&TE calibration and use, and
Croft adequately implemented M&TE calibration, tracking, and use requirements. (Section 4.2)
4
REPORT DETAILS
1.
Management Controls
1.1
Quality Assurance Policy
1.1.1 Scope
The NRC inspection team reviewed Croft's Quality Management System (QMS) and
associated implementing procedures to verify how Croft conducts activities in
accordance with the NRC issued CoCs for the two Safkeg radioactive material
packages, and NRC-approved QAP. The team reviewed Croft's Quality Assurance
Requirements (QAR) 144, "Quality Assurance Program Description Manual (QAPDM)
for 10 CFR Part 71, Subpart H," Issue E, implementing procedures, work instructions
(WI), and quality assurance guidelines (QAG) developed to comply with specific NRC
requirements and guidance. The team reviewed Croft Associates Procedure (CAP) 05-
14, "Graded Approach to Quality," Issue F, to verify that Croft used a graded approach
for identifying Important-to-Safety (ITS) components and applied this graded quality level
to applicable documents and processes. The team also reviewed a sample of personnel
qualifications and indoctrination training records in accordance with implementing
procedure CAP 13-01, "Training and Competence Records," Issue I.
1.1.2 Observations and Findings
The team assessed that Croft's overall program for quality had an adequate QMS and
quality implementing procedures (i.e., CAPs, WIs and QAGs) in place to ensure their
quality activities were conducted in accordance with their CoCs, NRC-approved QAP,
and Part 71 requirements. The team also verified that Croft clearly defined and
documented the quality program authorities and responsibilities and that the quality
assurance organization functioned as an independent group as described in Croft's
QAPDM.
1.1.3 Conclusions
The team determined that the QA controls at Croft were generally adequate. The team
concluded that Croft conducts its activities associated with QA organization
independence, QA responsibilities, and the graded approach in accordance with QAR-
144.
1.2
Nonconformance and Corrective Action Controls
1.2.1 Scope
The team reviewed a sample of Croft's nonconformance reports (NCRs) and interviewed
selected personnel to verify that Croft effectively implemented a nonconformance control
program. The review included an evaluation of how Croft's nonconformance control and
corrective action programs addressed identified quality deficiencies and materials, parts,
and components that do not conform to requirements. The team also reviewed
provisions for reporting defects that could cause a substantial safety hazard.
The team reviewed the following Croft quality procedures and guidelines:
5
- CAP 05-06, Product Nonconformance Control, Issue Q
- CAP 05-17, Conditions Adverse to Quality - NRC, Issue E
- CAP 12-03, QMS Corrective Action, Issue O
- QAG 006, Reporting to US Nuclear Regulatory Commission, Issue D
The team reviewed nonconformances and corrective actions from the previous five
years. The team also reviewed several corrective action notes (CAN) initiated from
NCRs. The team discussed the nonconformances and corrective actions with the Croft
staff to understand the process. The team focused the review on use-as-is and repair
type dispositions to evaluate how Croft technically justified the NCRs reviewed. In
particular, the team reviewed each technical justification provided for the use-as-is and
repair NCRs. In addition, the team requested a list of Part 21 evaluations and
notifications associated with the Croft transportation packagings and interviewed Croft
personnel to verify their familiarity and knowledge of QAG 006 and CAP 05-17. The
team also reviewed postings within the Croft office to determine if Croft complied with
the 10 CFR 21.6, "Posting requirements."
1.2.2 Observations and Findings
Overall, the team assessed that Croft completed NCRs in a technically sound manner.
The team also verified that Croft completed corrective actions for identified deficiencies
and nonconformances in a timely manner for those items identified as needing a CAN or
Corrective Action Report (CAR). The team noted that Croft could initiate a CAN or CAR
for an NCR that needed corrective actions. The team noted that Croft used both to
identify corrective actions needed to resolve issues but mostly used CANs to defer long-
term corrective actions. The long-term corrective actions were for potential CoC and
Safety Analysis Report (SAR) changes. The team noted that Croft would assess the
CAN to determine if the Quality Manager needed to assign a condition adverse to quality
(CAQ) number.
The team assessed and evaluated the implementing procedures for CAQ and corrective
actions, CAP 05-17, and CAP 12-03, respectively.
The team reviewed corrective actions generated as a result of previous inspections at
Croft in 2017 (ML17248A478) and Oxford Engineering Limited, a category A supplier to
Croft, in 2019 (ML19060A092).
The team identified that during the 2017 inspection of Croft, the previous inspection
team identified that CAP 12-01, Issue S, failed to require a periodicity for internal audits
as required by 10 CFR 71.137, Audits, to ensure all applicable quality assurance
criteria are audited on a periodic basis. The team determined this to be a violation of 10
CFR 71.111, Instructions, Procedures, and Drawings. Croft entered this issue into their
corrective action program as CAR 136, dated May 25, 2017; however, the team
determined the actions of the CAR did not directly align with the violation and the
violation was not corrected. Specifically, the team determined that procedure CAP 12-
01, Issue V did not specify a required periodicity for internal audits and that only 14 of 18
quality assurance criteria be audited. Croft subsequently documented this issue again in
CARs 175 and 176 during the 2022 inspection.
6
The team identified that during the 2017 inspection of Croft, the previous inspection
team had identified that CAP 05-17, Issue E and CAP 12-03, Issue M, did not provide
guidance to determine the cause of Significant Conditions Adverse to Quality (SCAQ),
and the corrective action necessary to preclude repetition. The procedures lacked
specific guidance that described a systematic methodology that Croft personnel could
use to 1) identify the causes of SCAQs and how to address the extent of condition and
extent of cause; 2) determine corrective actions taken to address the issue; and 3)
preclude repetition by ensuring that there is a corrective action for each root and
contributing cause. The team determined this to be a violation of 10 CFR 71.133,
Corrective Action. Specifically, the team determined that while the NCR database and
form had been revised to require a causal evaluation, CAP 12-03, Issue M, did not
require a causal evaluation to be performed for SCAQs not associated with a non-
conformance report. Croft entered this issue into their corrective action program as CAR
137; however, the team determined the actions of the CAR did not directly align with the
violation and the violation was not corrected. Croft subsequently documented this issue
again in CAR 174 during the 2022 inspection.
The team identified that during the 2019 inspection of Oxford Engineering Limited (OEL),
the previous inspection team identified that CAP 06-08, Step 2.2.1 stated, in part, that a
Quality Category A supplier shall have a current assessment and approval to an
appropriate quality system standard. Contrary to this, Croft assessed OEL to qualify
them to encompass the additional requirements of 10 CFR Part 71, but OEL's internal
auditor did not meet those requirements nor did OEL have a quality procedure or
process in place for qualifying internal auditors. The team determined that this issue was
a violation of 10 CFR 71.111, "Instructions, procedures, and drawings. Croft entered
this issue into their corrective action program as CAR 147; however, the team
determined the actions of the CAR did not directly align with the violation and the
violation was not corrected. Specifically, the team determined that no action was taken
to ensure that OEL's internal auditors met the requirements of 10 CFR Part 71 and OEL
did not have a quality procedure or process in place for qualifying internal auditors to
ensure compliance with 10 CFR Part 71, Croft subsequently documented this issue
again in CAR 173 during the 2022 inspection.
Additionally, the team sampled a number of internal audits performed by Croft since the
previous inspection (See Section 1.4 of this Inspection Report), and of the audits
sampled, the team noticed that no CARs had been generated as a result of the audits,
even when findings or observations had been identified. Specifically, as an example,
during quality audit 448, Croft identified that no calibration certifications for equipment
items CC0216 and CC0215 existed which was contrary to the requirements of CAP 07-
01, Calibration. CAP 12-01 Section 2.3 identifies that, when carrying out an internal
audit, nonconformances must be recorded in the CAR database. However, the
inspection staff identified that no CAR had been generated for the audit finding. Croft
documented this issue in CAR 180.
The team assessed that these four examples were a violation of NRC requirements.
The team determined a violation of 10 CFR 71.133, Corrective action occurred in that
Croft took inadequate corrective actions during the 2017 and 2019 NRC inspections
after writing CARs to address NRC findings. In addition, Croft failed to document
nonconformances from internal audits on CARs per its procedure so corrective action
could be taken to address the nonconformances.
7
10 CFR 71.133, "Corrective action," states, in part, that the licensee, certificate holder,
and applicant for a CoC shall establish measures to assure that conditions adverse to
quality, such as deficiencies, deviations, defective material and equipment, and
nonconformances, are promptly identified and corrected. In the case of a significant
condition adverse to quality, the measures must assure that the cause of the condition is
determined, and corrective action taken to preclude repetition.
Contrary to this, Croft took inadequate corrective action from the 2017 and 2019
inspections as documented in CARs 136, 137, 147 to preclude repetition of the NRC
findings identified. In addition, Croft has not documented internal audit nonconformances
on CARs so that adequate corrective action could be taken to preclude repetition.
The team dispositioned the violation using the traditional enforcement process in
Section 2.3 of the NRC Enforcement Policy. The team determined the violation was
more-than-minor safety significance in accordance with Inspection Manual Chapter
(IMC) 0617, Vendor and Quality Assurance Implementation Inspection Reports,
Appendix E, Minor Examples of Vendor and QA Implementation Findings. The team
utilized example 16a in its decision to make the violation more than minor since the
adverse conditions were not corrected in the first three examples and recurred and not
documented in the fourth example.
Therefore, the team characterized the violation as a Severity Level IV violation in
accordance with the NRCs Enforcement Policy, Section 6.8. The violation is being cited
since Croft took inadequate corrective action when the first three examples were put into
the Croft corrective action program and must now be readdressed. This violation is being
cited in the enclosed Notice of Violation (Notice) (71-0939/2022-201-01).
1.2.3 Conclusions
The team identified Crofts CAP as an area for improvement as evidenced by the four
examples of corrective action issues identified and described above. The team identified
one violation of NRC requirements concerning the failure by Croft to take adequate
corrective actions from findings identified during the two previous NRC inspections and
the current NRC inspection.
1.3
Documentation Controls
1.3.1 Scope
The team reviewed Crofts documentation and quality records control program and
associated quality procedures to assess the effectiveness of controls established for the
development, review, approval, issuance, use, and revision of quality documents. The
team also reviewed the tracking, verification, and storage of quality records. The team
reviewed the following QAPDM sections and quality procedure documents associated
with document control and records to verify they are being properly implemented:
- QAR 144, Section 71.109, Procurement document control, Issue E
- QAR 144, Section 71.113, Document control, Issue E
- QAR 144, Section 71.135, Quality assurance records, Issue E
8
- CAP 01-11, Control of Records, Issue D
- CAP 01-13, Staff Roles, Document Compilation, Checking and Approval Authorities,
Issue H
- WI 01-01, Document Numbering System, Issue L
- WI 01-02, Drafting Documents, Issue K
- WI 01-03, Change Control of Documents, Issue J
- WI 01-04, Forms, Issue H
- WI 01-05, Document Review, Issue K
- WI 01-06, Issuing Documents, Issue I
- WI 01-09, Reference Document Control, Issue J
- WI 01-10, EMS, CAPs and WIs, Issue K
- WI 04-01, Issue of Drawing/Product Numbers Related, Issue G
- WI 04-02, Preparation of Drawings/Related Documents, Issue M
- WI 04-03, Master Drawing Control, Issue K
- WI 04-04, Modification of Drawings, Issue L
- WI 04-06, Design Job Control, Issue K
- WI 04-07, Illustrations and Sketches, Issue E
- WI 14-06, Creating Project Numbers, Issue J
The team also interviewed Croft personnel regarding documentation and record controls.
1.3.2 Observations and Findings
The team assessed that Croft had adequate and effective controls established by their
implementing procedures for the approval, issuance, use, storage, and revision of quality
documents and records. No issues of significance were identified.
1.3.3 Conclusions
The team concluded that Croft is effectively implementing its document and records
control program and has adequate procedures in place to ensure compliance with the
applicable regulations and QA program requirements.
1.4
Audit Program
1.4.1 Scope
The team reviewed Crofts audit program to determine if Croft scheduled, planned, and
performed internal and external audits in accordance with their approved implementing
CAPs and as described in the Croft QAPDM. The team selected a sample of internal
and external audits since the last Croft corporate inspection in 2017. The team reviewed
the audit results to determine if Croft identified deficiencies and whether Croft addressed
these deficiencies within their corrective action program, as required. The team reviewed
the following QAPDM section and CAPs:
- QAR 144, Section 71.137, Audits, Issue E
- CAP 06-08, Approved Supplier - NRC, Issue G
- CAP 12-01, Audit Procedure, Issue V
- CAP 13-01, Training and Competence Records, Issue I
9
- WI 12-08, Supplier Audit, Issue E
Additionally, the team selected a random sample of audit personnel records, including
lead auditor, to determine if they met the applicable requirements, including those stated
in CAP 13-01 and 13-09.
1.4.2 Observations and Findings
Overall, the team assessed that for the audits sampled Croft generally conducted them
with qualified and certified personnel and identified observations and findings in most of
the audit reports reviewed. The team noted that external audits were performed on the
required 3-year periodicity for ITS Category A suppliers. In addition, the team noted that
some findings identified within the internal audit reports reviewed that were conditions
adverse to quality were not documented as a CAR, as required. The team also noted
that CAP 12-01 did not define an internal audit periodicity. These issues are discussed in
more detail in Section 1.2 above.
1.4.3 Conclusions
The team concluded that Croft had an adequate audit program in place to schedule,
develop an audit plan, evaluate applicable elements of their QAP, and document the
results. The team determined that Croft appropriately identified issues but, in some
cases, did not document conditions adverse to quality in a CAR, as required, when
auditors identified findings or observations during audits. (Reference Section 1.2)
2.
Design Controls
2.1
Design Development
2.1.1 Scope
The team reviewed the design control section of the QAPDM and applicable
implementing quality procedures to verify that Croft was properly implementing their
design control program. The team reviewed the following QAPDM section and quality
procedure documents associated with design control to verify they are being properly
implemented:
- QAR 144, Section 71.107, Package design control, Issue E
- CAP 02-02, Project Quality Plan, Issue L
- CAP 02-03, Project Control, Issue M
- CAP 02-04, Project Specifications, Issue E
- CAP 02-05, Project Plan, Issue D
- CAP 03-02, Design Review, Issue K
- CAP 03-03, Design Control, Issue J
- CAP 10-01, Competent Authority Licensing, Issue J
- CAP 10-02, Review of Certificates and Validations, Issue J
- CAP 10-10, Update of Foreign Competent Authority Approvals, Issue D
- WI 03-04, Deign Calculations, Issue B
10
2.1.2 Observations and Findings
The team assessed that Croft overall had adequate and effective controls established by
their implementing procedures for project planning, development of project quality
requirements, implementing project controls, developing design specifications, design
development and design controls, performing and reviewing design calculations,
performing overall design reviews, and performing competent authority design licensing.
The team reviewed quality form QF 376, Project Quality Plan, for Crofts latest Part 71
model 3977B (Safkeg-HS) packaging which had been recently submitted to the NRC in
an application for NRC review and certification. The form QF 376 had been revised, but
procedures CAP 02-02, Project Quality Plan; CAP 02-04, Project Specifications; and
CAP 02-05, Project Plan; in which procedural guidance was to be provided on how to fill
out QF 376 were no longer current with what Croft was actually doing to fill out form QF
376.
The team assessed that these three examples of inadequate procedures were a
violation of NRC requirements. The team determined a violation of 10 CFR 71.111,
Instructions, procedures, and drawings occurred in that during the NRC inspection
Croft had three active procedures that did not correctly prescribe activities affecting
quality.
10 CFR 71.111, Instructions, procedures, and drawings, states, in part, that the
certificate holder for a CoC shall prescribe activities affecting quality by documented
instructions, procedures, or drawings of a type appropriate to the circumstances and
shall require that these instructions, procedures, and drawings be followed.
Contrary to the above, as of July 21, 2022, CAP 02-02, Project Quality Plan; CAP 02-04,
Project Specifications; and CAP 02-05, Project Plan; are no longer current with what
Croft is actually doing to fill out Croft form QF376. So, during the inspection Croft had
three active procedures that did not correctly prescribe activities affecting quality.
The team dispositioned the violation using the traditional enforcement process in Section
2.3 of the NRC Enforcement Policy. The team determined the violation was more-than-
minor safety significance in accordance with Inspection Manual Chapter 0617, Vendor
and Quality Assurance Implementation Inspection Reports, Appendix E, Minor
Examples of Vendor and QA Implementation Findings. The team utilized examples 6a
and 6b in its decision to make the violation more than minor since three procedures were
not current instead of just one.
Therefore, the team characterized the violation as a Severity Level IV violation in
accordance with the NRCs Enforcement Policy, Section 6.8. In accordance with the
policy, the violation is non-cited since Croft put the issue in its corrective action program
as CAR 177 (71-0939/2022-201-02).
2.1.3 Conclusions
The team concluded that Croft had in place an adequate design control program to meet
the requirements of the transportation regulations. However, the team identified Crofts
11
design control program as an area for improvement as evidenced by the three examples
of design control procedures not being current with Crofts actual practice for filling out
form QF 376 as identified and described above. The team identified the three examples
of inadequate procedures as a violation of 10 CFR 71.111, Instructions, procedures,
and drawings requirements.
3.
Fabrication Interface Controls
3.1
Material Procurement
3.1.1 Scope
The team reviewed Crofts procurement of ITS materials, which included the review of
procurement documents, drawings and procedures, and receipt inspection records. The
team reviewed the following sections of the QAPDM, and CAPs associated with
procurement:
- QAR 144, Section 71.109, Procurement document control, Issue E
- QAR 144, Section 71.115, Control of purchased material, equipment and services,
Issue E
- CAP 05-18, Commercial Grade Dedication, Issue F
- CAP 06-01, Purchasing, Issue Q
The procedures were reviewed to verify if they were being properly implemented. The
team also reviewed Crofts current Approved Suppliers List (ASL), to determine if
materials and services were being procured from qualified suppliers and the suppliers
were being acceptably qualified.
The team selected a sample of ITS Category A materials for review. Croft does not
procure materials from any suppliers designated as ITS Category A so for those
materials required to be ITS Category A, commercial grade dedication is performed.
Therefore, the team selected a sample of stainless steel round bar to review the
adequacy of the commercial grade dedication package and conformance to the
requirements in CAP 05-18. The team focused on the adequacy of the critical
characteristics identified and the traceability of the stainless steel through the
manufacturing, testing, and inspection process.
3.1.2 Observations and Findings
No issues of significance were identified.
3.1.3 Conclusions
The team determined that the procurement controls were adequate, and Croft was
generally effective in implementing their procurement program.
3.2
Fabrication and Assembly
3.2.1 Scope
12
The team reviewed records associated with fabrication and fit-up of SAFKEG-HS
packagings, specifically keg assemblies and a containment vessel for domestic use in
the United States, to verify the fabrication and assembly processes sampled were
properly controlled and implemented. Since Croft contracted the fabrication of the
SAFKEG-HS to the OEL fabrication facility, Crofts responsibility for fabrication and
assembly controls resided in part, in the review and acceptance of the final document
package for the completed SAFKEG-HS packagings. Therefore, the team reviewed
records that were part of the final document package accepted by Croft from OEL. The
records reviewed included routing sheets (shop travelers) and QA Reports to verify that
fabrication and assembly activities were accomplished and appropriately documented
according to the controlled drawings, routing sheets, and manufacturing specification,
MSP 157, Manufacturing Specification HS Safkeg Packaging Assembly Design No
3977A, Issue H.
3.2.2 Observations and Findings
The team noted that for the routing sheets reviewed, Croft signed off on each of the
customer hold points and none had been waived by Croft oversight personnel. No issues
of significance were identified.
3.2.3 Conclusions
Crofts review and acceptance of the final document package records related to
fabrication and assembly, as a part of their implementation of fabrication controls, was
assessed, overall, to be adequate and effective.
3.3
Test and Inspection
3.3.1 Scope
The team reviewed records associated with the test and inspection of the SAFKEG-HS
packaging, specifically a containment vessel for domestic use in the United States, to
verify that the test and inspection processes sampled were properly controlled and
implemented. Like section 3.2 above, the team reviewed records that were part of the
final document package accepted by Croft from OEL. The records reviewed included QA
reports that included weight and dimensional measurements, and a helium leak test
report, to verify that test and inspection activities were accomplished and appropriately
documented according to the controlled drawings, routing sheets, and manufacturing
specification, MSP 157, Issue H.
3.3.2 Observations and Findings
No issues of significance were identified.
3.3.3 Conclusions
Crofts review and acceptance of the final document package records related to
inspection and test, as a part of their implementation of fabrication controls was
assessed, overall, to be adequate.
13
4.
Maintenance Controls
4.1
Maintenance Activities
4.1.1 Scope
Since the last NRC inspection in 2017, Croft has started performing maintenance
activities at their facility in Abingdon, Oxfordshire, England. Both the SAFKEG-LS and
HS models require periodic or annual maintenance to be performed. The team reviewed
Crofts maintenance program to determine if the quality procedures were adequate to
ensure the requirements of the applicable package safety analysis report would be met.
The team reviewed the following quality documents associated with maintenance:
- MIS 049, Periodic Maintenance and Inspection Schedule Packaging Design No.
3977A, HS Safkeg, Issue B
- WI 08-01, Control of Packages at Maintenance, Issue I
The team reviewed a sample of maintenance records for maintenance performed at
Crofts facility for a package user in the United States. In addition, a damage
assessment and repair plan was reviewed regarding four containment vessels and two
tungsten inserts that were returned to Croft from a United States package user to
determine if the proposed repair activities met the requirements of the applicable
licensing drawings and package safety analysis report.
4.1.2 Observations and Findings
No findings of significance were identified
4.1.3 Conclusions
The team determined that, overall, Croft had an adequate maintenance program in place
to ensure proper implementation of the required maintenance activities.
4.2
Tools and Equipment
4.2.1 Scope
The team reviewed selected measuring and test equipment (M&TE) and reviewed
records and procedures to assure that equipment used in activities affecting quality were
properly controlled and calibrated. The team reviewed the following Section of the
QAPDM and CAP:
- QAR 144, Section 71.125, Control of Measuring and Test Equipment, Issue E
- CAP 07-01, Calibration, Issue L
4.2.2 Observations and Findings
No issues of significance were identified.
14
4.2.3 Conclusions
The team concluded that the M&TE quality procedure being implemented at Croft
provided adequate guidance for M&TE calibration and use, and Croft adequately
implemented M&TE calibration, tracking, and use requirements.
5.
Entrance and Exit Meeting
On July 18, 2022, the NRC inspection team discussed the scope of the inspection during
an entrance meeting with Croft Quality Manager Steve Ralls, Managing & Technical
Director Mark Johnson, and other members of the Croft staff. On July 21, 2022, the NRC
inspection team presented the inspection results and observations during an onsite
preliminary exit meeting. On September 26, 2022, the NRC inspection team leader
conducted a final telephone conference exit with Steve Ralls, Mark Johnson, and other
members of the Croft staff. Section 1 of the attachment to this report shows the
attendance for the entrance and exit meetings.
ATTACHMENT
1.
ENTRANCE/EXIT MEETING ATTENDEES AND INDIVIDUALS INTERVIEWED
Name
Title
Affiliation
Entrance
Exit
Inspection Team Leader
NRC/DFM
X
X
Inspector
NRC/DFM
X
Inspector
NRC/DFM
X
Mark Johnson
Managing & Technical
Director
Croft
X
X
Steve Ralls
Quality Manager
Croft
X
X
Alex Ferguson
Licensing Director
Croft
X
X
Ian Dingwall
Head of Manufacture
Croft
X
X
Trevor Tait
Head of Projects &
Engineering
Croft
Greg Tilling
Design
Croft
2.
INSPECTION PROCEDURES AND OTHER NRC DOCUMENTS USED
Design, Fabrication, Testing, and Maintenance of Transportation
Packagings
Classification of Transportation Packaging and Dry Spent Fuel Storage
System Components According to Importance to Safety
Quality Assurance Inspections for Shipping and Storage Containers
3.
LIST OF ACRONYMS USED
Agencywide Documents Access and Management System
ASL
Approved Suppliers List
Corrective Action Notes
Corrective Action Program or Croft Associates Procedure
Corrective Action Report
CFR
Code of Federal Regulations
Certificate of Compliance
DFM
Division of Fuel Management
IMC
Inspection Manual Chapter
IP
Inspection Procedure
Important-to-Safety
Measuring and Test Equipment
Nonconformance Report
NRC
Nuclear Regulatory Commission
Qxford Engineering Limited
Quality Assurance
QAG
Quality Assurance Guidelines
Quality Assurance Program
QAPDM
Quality Assurance Program Description Manual
QAR
Quality Assurance Requirements
QMS
Quality Management System
2
Safety Analysis Report
Significant Condition Adverse to Quality
Safety Evaluation Report
WI
Work Instruction
4.
DOCUMENTS REVIEWED
Certificate holder documents reviewed during the inspection were specifically identified in the
report details above.
5.
LIST OF ITEMS OPENED, CLOSED, AND DISCUSSED
Item Number
Status
Type
Description
71-0939/2022-201-01
Opened
Inadequate corrective action to
address findings from 2017 and
2019 NRC inspections and write
CARs for internal audit
nonconformance findings.
71-0939/2022-201-02
Opened
& Closed
Croft had three active procedures
that were not current with how to fill
out form QF376.
THE FOLLOWING CARs WERE OPENED BY CROFT DURING THE INSPECTION DUE TO
DISCUSSIONS WITH THE INSPECTION TEAM
Item Number
Status
Description
CAR 170
Opened
Possible typographical error in field 36 of MIS049 issue B.
Reference to Section 8.2.3.4.3 of the SARP CTR2008/11
should read 8.2.3.6.3.
CAR 171
Opened
Field 7 of MIS 049 issue B omitted some references to the
drawings that are made in the SARP. The MIS is a record
of maintenance work carried out in accordance with the
SARP and must make the same statements as the
sections referenced.
CAR 172
Opened
Internal audit reports do not show a review of the previous
audit findings as required by CAP 12-01 paragraph 2.4.
Additionally, paragraph 2.2 should contain an instruction to
review the previous audit as part of preparation.
CAR 173
Opened
CAR 147 raised during a previous NRC audit had not been
adequately closed off in that the Oxford Engineering
Limited procedure, CP03, had not been revised to clarify
auditor training and qualification requirements or to clarify
the auditors independence.
3
CAR 174
Opened
CAR 137 raised during a previous NRC audit had not been
adequately closed off due to a misunderstanding of the
required corrective action. The NCR database and form
had been revised to require an assessment of whether a
CAQ had occurred. This requirement had not been applied
to the CAR system.
CAR 175
Opened
The first four clauses of 10CFR71 subpart H were omitted
from the internal audit schedule as they were considered
more to be policy requirements than processes.
CAR 176
Opened
CAR 136 raised during a previous NRC audit required the
internal audit program to specifically address the clauses
of 10CFR71 subpart H. The corrective action added
fourteen of the clauses to the audit schedule which was
considered inadequate by the NRC team - see CAR 175.
Additionally, the revised procedure did not state a specific
period for internal audits.
CAR 177
Opened
During inspection of the 3977B documentation it was noted
that some forms referenced in Croft procedures were not
being used. CAP 02-02 (Quality Plan), CAP 02-04 (Project
Specifications) and CAP 02-055 (Project Plan) and related
forms are no longer used due to the introduction of form
QF376 which incorporated all three activities.
CAR 178
Opened
WI 01-06 Controlled Documents requires revision to reflect
current practice which has undergone some minor
changes due to the move to electronic documentation.
e.g., negating the need to rubber stamp paper documents.
CAR 179
Opened
The 3977B HS package was manufactured ahead of the
design approval and issue of a certificate by the NRC. The
Project Quality Plan has a field in the project closure
section to address manufacture at risk but this needs to be
fully documented as to what was reviewed and confirming
that the as manufactured package complies with the
certificates as issued.
CAR 180
Opened
Internal audit findings as detailed on form QF327 do not
always result in a CAR being raised as required by CAP
12-01 and WI 13-05.
CAR 181
Opened
A document package submitted by Oxford Engineering for
the 3977A had been approved and signed off by Croft but
a number of pages were missing the sign-off by Oxford
Engineering.
CAR 182
Opened
10CFR21.6 Posting Requirements state that Section 206
of the Energy Reorganization Act 1974 and 10CFR71.9
Employee protection state that NRC form 3 shall be posted
4
in a conspicuous position for all staff to see. The
documents had not been posted.
CAR 183
Opened
The SARP CTR2008/11 calls out Hydrostatic testing in
section 8.2.3.1 but this is not called out in MIS049 field 7
which simply states: Pressure Test. The MIS is a record of
maintenance work carried out in accordance with the
SARP and must make the same statements as the
sections referenced.
Croft Associates Limited
Docket No. 07100939
Oxfordshire, England, UK
During an NRC inspection conducted July 18 to September 26, 2022, a violation of NRC
requirements was identified. In accordance with the NRC Enforcement Policy, the violation
is listed below:
Title 10 of the Code of Federal Regulations (10 CFR), Section 71.133, Corrective
action requires, in part, that the certificate holder shall establish measures to
assure that conditions adverse to quality, such as deficiencies, deviations, defective
material and equipment, and nonconformances, are promptly identified and
corrected. In the case of a significant condition adverse to quality, the measures
must assure that the cause of the condition is determined and corrective action
taken to preclude repetition.
Contrary to the above, Croft took inadequate corrective action from the NRC 2017
inspection of Croft and the NRC 2019 inspection of Croft fabricator Oxford
Engineering Limited.
Specifically, in 2017, Croft wrote Corrective Action Report (CAR) 136 to address that
Croft Associates Procedure (CAP) 12-01, Issue S, Audit Procedure, failed to require
a periodicity for internal audits as required by 10 CFR, Section 71.137, Audits to
ensure all applicable quality assurance criteria are audited on a periodic basis.
However, the actions taken by the CAR did not directly align with the issue and the
issue was not corrected.
In 2017, Croft wrote CAR 137 to address that CAP 05-17, Issue E, Conditions
Adverse to Quality, and CAP 12-03, Issue M, QMS Corrective Action, did not provide
guidance to determine the cause of Significant Conditions Adverse to Quality and the
corrective action necessary to preclude repetition. However, the actions taken by the
CAR did not directly align with the issue and the issue was not corrected.
In 2019, Croft wrote CAR 147 to address that CAP 06-08, Approved Supplier, Step
2.2.1 required that a Quality Category A supplier shall have a current assessment
and approval to an appropriate quality system standard. Croft assessed Oxford
Engineering Limited to qualify them to encompass the additional requirements of 10
CFR Part 71, but Oxford Engineerings internal auditor did not meet those
requirements, nor did Oxford Engineering have a quality procedure or process in
place for qualifying internal auditors. However, the actions taken by the CAR did not
directly align with the issue and the issue was not corrected.
In addition, during the 2022 inspection, several Croft internal audits were sampled,
and it was determined that no CARs had been written when findings had been
identified as a result of the audits. CAP 12-01, Audit Procedure, Section 2.3 states
that when carrying out an internal audit, nonconformances must be recorded on the
CAR database.
Enclosure 2
2
This is a Severity Level IV violation (Section 6.8).
Pursuant to the provisions of 10 CFR 2.201, Croft Associates Limited, is hereby required to
submit a written statement or explanation to the U.S. Nuclear Regulatory Commission,
ATTN: Document Control Desk, Washington, DC 20555-0001, with a copy to Aida Rivera-
Varona, Chief, Inspection and Oversight Branch, Division of Fuel Management, Office of
Nuclear Material Safety and Safeguards, within 30 days of the date of the letter transmitting
this Notice of Violation (Notice). This reply should be clearly marked as a Reply to a Notice
of Violation and should include for each violation: (1) the reason for the violation, or, if
contested, the basis for disputing the violation or severity level; (2) the corrective steps that
have been taken and the results achieved; (3) the corrective steps that will be taken; and (4)
the date when full compliance will be achieved. Your response may reference or include
previously docketed correspondence, if the correspondence adequately addresses the
required response. If an adequate reply is not received within the time specified in this
Notice, an order or a Demand for Information may be issued requiring information as to why
the license should not be modified, suspended, or revoked, or why such other action as may
be proper should not be taken. Where good cause is shown, consideration will be given to
extending the response time.
If you contest this enforcement action, you should also provide a copy of your response,
with the basis for your denial, to the Director, Office of Enforcement, United States Nuclear
Regulatory Commission, Washington, DC 20555-0001.
Because your response will be made available electronically for public inspection in the
NRC Public Document Room or in the NRCs Agencywide Documents Access and
Management System (ADAMS), accessible from the NRC Website at
http://www.nrc.gov/reading-rm/adams.html. To the extent possible, your response should not
include any personal privacy, proprietary, or safeguards information so that it can be made
available to the public without redaction. If personal privacy or proprietary information is
necessary to provide an acceptable response, then please provide a bracketed copy of your
response that deletes such information. If you request withholding of such material, you must
specifically identify the portions of your response that you seek to have withheld and provide
in detail the bases for your claim of withholding (e.g., explain why the disclosure of
information will create an unwarranted invasion of personal privacy or provide the information
required by 10 CFR 2.390(b) to support a request for withholding confidential commercial or
financial information). If safeguards information is necessary to provide an acceptable
response, please provide the level of protection described in 10 CFR 73.21.
In accordance with 10 CFR 19.11, you may be required to post this Notice within two
working days of receipt.
Dated this 9th day of November 2022.