ML22340A020
| ML22340A020 | |
| Person / Time | |
|---|---|
| Site: | 07100939 |
| Issue date: | 11/25/2022 |
| From: | Ralls S Croft Associates Limited |
| To: | Document Control Desk, Office of Nuclear Material Safety and Safeguards |
| References | |
| Download: ML22340A020 (1) | |
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USNRC Attn: Document Contro l Desk Washington DC 20555-000 l USA 25 th November 2022 Reply to Notice of Vio lation 7 l-0939 US NRC 9th November 2022 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 .
Item 1 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 .
Response
The initial observation advised to Croft by the NRC team was that the internal audit schedule related to internal procedures and processes and not the specific clauses of 10CFR71 Subpart H.
This was always the case since before Croft gained 10CFR71 certification . 14 of the 18 clauses were added to the audit schedule accordingly in 2017 at the request of the Inspection Team . With respect to the periodicity of audits, 10CFR71 does not specify what that period should be . Croft has audited these 14 clauses on an annual basis since then . The procedure, CAP 12-01 revision W , did not specifically state the periodicity of audits since our OMS is dual certified and neither standard ( 10CFR71 or ISO 9001 ) specify a 12 month period . The NRC team initially stated that a 12 month periodicity was a mandatory requirement under other NRC guidelines but later conceded r\
that this could not be enforced. Croft acknowledged that some periodicity should be defined and _ fl \
CAP 12-01 has been revised to state: "Audits shall normally be conducted annually but the audit \ C,. V period may be extended up to a maximum of two years in areas where there is evidence of V CS consistent compliance and conversely may be reduced in areas where there is evidence of \ ~~
repeated non compliance." This was accepted by the NRC team at the time of the inspection in ~
IWI I Croft Associates Ltd T: +44 (0)1 865 407740 F4 Culham Science Centre E: info@croftltd .com The Nationa~
Abingdon , Oxfordshire, W: www.croftltd .com Skills Academy United Kingdom NUCLEAR OX14 30B Manuf-acturing FM 28718 - 1509001 EMS 720456 - 15014001 Registered in England No: 1698337 Page 1 of 9 L
2022 . CAR 176 refers to this and is now closed with the action completed .
'W CROFT 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 .
Response
CAR 137 was raised to address if a Condition Adverse to Quality had occurred when closing out an NCR. CAR's were not discussed at the 2017 inspection . The corrective action was to include an assessment and to decide if a CAQ had occurred and if it was reportable under 10CFR21 requirements. The guidance for this is provided in procedure QAG006 and not in CAP 05-17 or CAP 12-03. QAG006 has been reviewed by the NRC in the past and found to be acceptable.
At the time of the 2017 inspection no reference was made to CAR's by the Inspection Team . It should be noted that both the NCR and CAR processes also address actions that do not result from a failure of any kind but also planned deviations such as concessions or document review and updates. In such cases Croft would not approve anything which would cause a CAQ . The CAR database has been revised to include a root cause analysis requirement to determine if a CAQ has occurred and if it is reportable when a CAR is closed out and CAP12-03 and WI 12-05 have both been revised and the database user instructions have been amended . QAG006 issue D remains valid . CAR 174 refers to this and is now closed with the actions completed .
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 Engineering's 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 .
Response
When Croft performed the Supplier Approval audit against the requirements of NQA-1, records for the previous two years were sampled with respect to internal audits with no adverse findings . The NRC Inspection Team took this back a further year and discovered one instance where the auditor in question, A Lakhani , had, amongst a number of samples, sampled one audit he had himself carried out.
It was acknowledged that the OEL procedure lacked clarity and this was discussed with OEL's Quality Manager. He reviewed 10CFR71 requirements which do not appear to specifically address supplier approval requirements.
WI Croft Associates Ltd T: +44 (0)1865 407740 F4 Culham Science Centre E: info@croftltd .com The Nationa~
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Clauses 71 .109 Procurement Document Control and 71 .115 Control of Purchased Material, Equipment and Services do not state that the suppliers Quality Management System must meet all of the requirements of 10CFR71 and and 71 .109 ambiguously states "to the extent necessary".
OEL initially declined to amend their audit procedure but following intervention at Director level their procedures were reviewed and revised . OEL had disagreed with the NRC findings and initially declined to make the changes to their OMS as requested by CAR 147. There was also the question of how far back do you go when auditing .
After intervention at Director level OEL have provided evidence of training and certification by a recognised body for their two auditors and have revised the procedure CP03 to add the following:
- 4. 1 Formally trained staff, with an appropriate certificate issued by a recognised certification body, who are objective and impartial will carry out audits.
4.2 To ensure independence and impartiality the Auditors shall not sample any previous activities or records for which they are (or were) responsible .
Procedure CP03 was released at issue K on the 2nd August 2022.
CAR 173 refers to this and is now closed with the actions completed .
Item 4 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.
Response
CAP12-01 has been revised to reflect that CAR's arising from internal audits will be raised by the Croft Quality Manager as part of the Management Review of audit reports It was previously the responsibility of the individual auditor and this was not always being done.
CAR 180 refers to this and is now closed with the actions completed .
Conclusion Croft have now addressed the requirements of the notice of violation . All corrective actions have been implemented and verified and the corresponding CAR's closed .
S P Ralls COP MCQI Quality Manager IWI I Croft Associates Ltd T: +44 (0)1865 407740 F4 Culham Science Centre E: info@croflltd .com The Nationa~
Abingdon , Oxfordshire, W: www.croftltd.com Skills Academy United Kingdom NUCLEAR OX 14 30B Manufacturing FM 28718 - 150900 1 EMS 720456 - 15014001 Reg istered in England No: 1698337 Page 3 of 9
w CROFT CC : Aida Rivera-Varona , Chief Inspection and Oversight Branch , Division of Fuel Management, Office of Nuclear Material Safety and Safeguards.
1~11 Croft Associates Ltd T: +44 (0)1865 407740 F4 Culham Science Centre E: info@croftltd .com The Nationa~
Abingdon , Oxfordshire, W: www.croftltd .com Skills Academy United Kingdom NUCLEAR OX14 30B Manufacturing FM 28718
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CROFT Appendix CAR' s raised by Croft during the inspection:
CAR Details Cause / Actions Status No 170 Possible typographical error in field This was found to be a 36 of M[S049 issue B. Reference to typographical error when Section 8.2.3.4.3 of the SARP compiling the original Closed CTR2008/ l l should read 8.2.3.6.3. document. MIS049 has been revised to correct the error and released at issue C on 3 rd August 2022.
171 Field 7 of M[S 049 issue B omitted Drawing references were some references to the drawings that omitted for brevity of the MIS as are made in the SARP. The M[S is a the drawings were referenced record of maintenance work carried three times in the same section.
out in accordance with the SARP Drawing references have been and must make the same statements reinstated at the request of the Closed as the sections referenced. NRC inspectors. MIS049 has been revised and released at issue C. The MIS now reads the same as the SARP wrt the cited drawing references.
172 Internal audit reports do not show a Caused by a Slow deviation in review of the previous audit findings applying the requirements of the as required by CAP 12-01 para 2.4. procedures. All auditors have Closed Additionally, para 2.2 should contain been reminded of the an instruction to review the previous requirements and the procedure audit as part of the preparation. CAP 12-0 l has been revised and released at issue W with more explicit instructions on documenting the review.
173 CAR 147 raised during a previous OEL disagreed with the NRC NRC audit had not been adequately findings and initially declined to closed off in that the Oxford make the changes to their QMS Engineering procedure, CP03 , had as requested by CAR 14 7.
not been revised to clarify auditor After consultation at Director Closed training and qualification level OEL have revised the requirements or to clarify the procedure CP03 to add the auditor's independence. following:
- 4. 1 Formally trained staff, with an appropriate certificate issued by a recognised IWI I Croft Associates Ltd T: +44 (0)1865 407740 F4 Culham Science Centre E: info@croftltd .com The Nationa~
Abingdon . Oxfordshire, W: www.croftltd .com Skills Academy United Kingdom NUCLEAR OX14 308 Manufacturing FM 28718 - 1509001 EMS 720456 - 15014001 Registered in England No: 1698337 Page 5 of 9
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'W certification body, who are objective and impartial will carry out audits.
4.2 To ensure independence and impartiality the Auditors shall not sample any previous activities or records for which they are (or were) responsible.
174 CAR 137 raised during a previous The CAR system did not have a NRC audit had not been adequately cause analysis as it was intended closed off due to a to be for management systems.
misunderstanding. The NCR However, it was not fully database and form had been revised realised that significant to require an assessment of whether breakdowns in the management or not a CAQ had occurred. This systems could be a SCAQ in requirement had not been applied to itself. Closed the CAR system. The CAR database has been revised to include a root cause analysis requirement and CAP12-03 and Wll2-05 have both been revised and the database user instructions have been amended. QAG006 issue D remains valid.
175 The first four clauses of I 0CFR 71 The original audit sc hedules had subpart H were omitted from the been based on [SO9001 and internal audit schedule as they were internal procedures for many considered more to be policy years and this had been accepted requirements than processes. The by NRC inspectors. ln 2017 it first four clauses of 10CFR 71 was requested that we add subpart H were omitted from the clauses of 10CFR 71 to the audit internal audit schedule as they were schedule. The clauses 71.10 I, Closed considered more to be policy 7l.103 , 71.105 & 71.106 were requirements than processes. not included in the schedule for the reasons already stated.
These four clauses have now been added to the audit schedule such that all eighteen clauses are audited annually.
176 CAR 136 raised during a previous I0CFR7I does not state a RC audit required the internal audit specific period, RC guidelines program to specifically address the state audits 'should' be carried clauses of I0CFR7l subpart H. The out annually but this is guidance corrective action added fourteen of only.
the clauses to the audit schedule Clause 2 of the procedure, IWI I Croft Associates Ltd T: +44 (0) 1865 407740 F4 Culham Science Centre E: info@croftltd .com The Nationa~
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which was considered inadequate by CAP 12-0 l , has been amended to the NRC team - see CAR 175. state that: " Audits shall Additionally, the revised procedure normally be conducted annually did not state a specific period for but the audit period may be Closed internal audits. extended up to a maximum of two years in areas where there is evidence of consistent compliance and conversely may be reduced in areas where there is evidence of repeated non compliance."
177 During inspection of the 3977B The form QF376 has been documentation it was noted that developed to include project some forms referenced in Croft specifications and project plans, procedures were not being used. it was not realised that the forms CAP02-02 ( quality plan) , 02-04 from the other two procedures
( project specifications) & 02-05 were no longer used . Closed
( project plan ) and related forms are CAP02-02,CAP 02-04 &
no longer used due to the CAP02-05 have been revised to introduction of form QF3 76 which reflect current practice and use incorporates all three activities. of forms . Obsolete forms have been withdrawn.
178 WIO 1-06 Controlled Documents WIO 1-06 revised and issued as requires revision to reflect current issue J. This refers to electronic practice which has undergone some stamping etc as opposed to minor changes due to the move to ' rubber stamps ' and ' red ink'. Closed electronic documentation e.g.
negating the need to ' rubber stamp '
paper documents.
179 The 3977B HS package was This is already covered in the manufactured ahead of the design Project Quality Plan form approval and issue of a certificate by QF376 . Section 5 ( Project the NRC. The Project Quality Plan Closure) states:-
has a field in the project closure If manufacture at risk has taken section to address manufacture at place ( e.g. manufacture to risk but this needs to be fully drawings ahead of approval by documented as to what was reviewed regulatory bodies NRC/ONR) and confirming that the ' as verify that the as built product manufactured ' package complies complies with the approved Closed with the certificate as issued. drawings/licence requirements.
A full review of the as built package against the licence requirements will take place and be documented. With the exception of the label, the package is the same as the IWI ]
Croft Associates Ltd T: +44 (0)1865 407740 F4 Culham Science Centre E: info@croftltd .com The Nationa~
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3977 A, only the inserts ( internal hardware ) are different due to different customer requirements.
As previously explained, this is already addressed in the Project Quality Plan. The change to the package is only the label on the keg. The reason for the design number change is to cover different internal hardware at the customer's request. Therefore, the as built package will be to the approved design requirements.
180 [nternal audit finding do not always Deviation from procedure, result in a CAR being raised as Corrective actions were carried required by CAP12-0l and Wll3 -05 . out but not documented as CAR' s. Awareness of the requirements of the procedure Closed was raised with the Croft QM to have responsibility to raise CAR's when the audit report is reviewed .
181 A document package submitted by Pressure of work led to errors Oxford Engineering for the 3977 A when reviewing the documents had been approved and signed off by specifically for accuracy of Croft but a number of pages were content and final signature missing the signoff by Oxford requirements had been missed.
Engineering. A review of OEL ro ute cards related to the HS / LS documentation was carried out, Closed and signed by OEL where required and resubmitted to Croft. The route cards have now all been signed . Documents were reviewed by I Dingwall ref: PRF 714 182 l 0CR2 l - 21.6 Posting Croft had previously only Requirements states that Section 206 addressed the reporting of the Energy Reorganisation Act requirements of the l 0CFR2 l 1974 and NCR regulation. Croft were unaware form 3 shall be posted in a of the requirement to post these conspicuous position for all staff to documents and this was Closed see. The documents had not been addressed at the time of the 111 Croft Associates Ltd T: +44 (0)1865 407740 F4 Culham Science Centre E: info@croftltd .com The Nationo~
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posted. inspection.
Both documents are now displayed in a prominent position adjacent to the main office noticeboard and attention raised to all staff via email.
183 The SARP CTR2008/ l l calls up The SARP calls up Hydrostatic Hydrostatic testing in section 8.2.3 .1 testing when there has been but this is not called up in M[S049 pitting corrosion which has been field 7 which simply states 'Pressure dressed out. However, for initial Test'. The MIS is a record of manufacture Section 8.1 .3 maintenance work carried out in simply states 'Pressure test' Closed accordance with the SARP and must referencing ASME NB-make the same statements as the 6000[8.2].
sections referenced . MIS049 field 7 has been revised to correlate with SARP CTR2008/ I I section 7.
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