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{{#Wiki_filter:NOTICE OF VIOLATION RESPONSES Docket No. 07100062 EA-2021-091 INC has reviewed the three violations cited by the NRC as a result of the inspection conducted on May 25 to June 25, 2021 and offers the following responses: | {{#Wiki_filter:NOTICE OF VIOLATION RESPONSES Docket No. 07100062 EA-2021-091 | ||
INC has reviewed the three violations cited by the NRC as a result of the inspection conducted on May 25 to June 25, 2021 and offers the following responses: | |||
VIOLATION: | VIOLATION: | ||
A. | |||
Contrary to the above, as of 2016, INC failed to establish measures to assure that a condition adverse to quality was promptly corrected when required QA program areas not reviewed during the 2015 internal audit and documented in CAR 2016-001 were | A. 10 CFR 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. | ||
Contrary to the above, as of 2016, INC failed to establish measures to assure that a condition adverse to quality was promptly corrected when required QA program areas not reviewed during the 2015 internal audit and documented in CAR 2016-001 were not corrected during the planned 2016 internal audit or thereafter. | |||
RESPONSE: CAR 16-001 was closed on May 26, 2021 by reference to new CAR 21-001. | RESPONSE: CAR 16-001 was closed on May 26, 2021 by reference to new CAR 21-001. | ||
CAR 21-001 identified that objective evidence of the 2017, 2018 and 2019 internal audits could not be produced. These records were lost during a hard drive failure by INC's Lead Auditor. The 2020 internal audit was not performed due to workplace and travel restrictions imposed by the State of California because of the global pandemic; however, the 2021 full scope internal audit was completed as required after the restrictions were lifted. As the Lead Auditor was determined to be the cause of these conditions, as well as the CAR 16-001 issue, the CAR required retraining of the Lead Auditor in records storage requirements and internal audit scheduling and performance requirements. Record storage training was to the newly revised QP 17.1, Quality Assurance Records. Rev. 4, June 11, 2021. INC added specific record types to be maintained and the storage requirements for hardcopy and electronic types of documents. As no additional corrective actions were deemed necessary, CAR 21-001 was closed on July 2, 2021. See Attachment A. | CAR 21-001 identified that objective evidence of the 2017, 2018 and 2019 internal audits could not be produced. These records were lost during a hard drive failure by INC's Lead Auditor. The 2020 internal audit was not performed due to workplace and travel restrictions imposed by the State of California because of the global pandemic; however, the 2021 full scope internal audit was completed as required after the restrictions were lifted. As the Lead Auditor was determined to be the cause of these conditions, as well as the CAR 16-001 issue, the CAR required retraining of the Lead Auditor in records storage requirements and internal audit scheduling and performance requirements. Record storage training was to the newly revised QP 17.1, Quality Assurance Records. Rev. 4, June 11, 2021. INC added specific record types to be maintained and the storage requirements for hardcopy and electronic types of documents. As no additional corrective actions were deemed necessary, CAR 21-001 was closed on July 2, 2021. See Attachment A. | ||
VIOLATION: | VIOLATION: | ||
B. | |||
Contrary to the above, as of 2016, INC failed to follow quality related procedures | B. 10 CFR 71.111, Instructions, procedures, and drawings states, in part, that the certificate holder 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. | ||
: 1. QP 16.1, Corrective Action, Revision 3, Step 6.2 states, in part, in cases | |||
Contrary to the above, as of 2016, INC failed to follow quality related procedures as evidenced by the following examples: | |||
: 1. QP 16.1, Corrective Action, Revision 3, Step 6.2 states, in part, in cases where the adverse condition is not identified and being corrected by some other form of documentation, the Quality Assurance Manager shall identify the adverse condition on a CAR. Specifically, INC failed to document a condition adverse to quality on a CAR to enter it into their CAP, in which the issue was identified by the NRC during the previous 2017 follow-up inspection for failure to receive prior NRC approval for an IR-100 CoC change. | |||
RESPONSE: INCs failure to generate a CAR for this issue was a simple misunderstanding of the requirement being cited by NRC following correction of a material defect via NCR. In light of the clarification of this violation, INC issued CAR 21-004 to identify that INC failed to receive advanced NRC approval of an IR100 CoC drawing revision related to the completed disposition of the NCR. CAR 21-004 required retraining of the responsible individual in both NRC approval of CoC drawing revisions and issuance of CARs to address NRC violations. Retraining has been completed and the CAR closed on October 12, 2021. See Attachments A and B. | RESPONSE: INCs failure to generate a CAR for this issue was a simple misunderstanding of the requirement being cited by NRC following correction of a material defect via NCR. In light of the clarification of this violation, INC issued CAR 21-004 to identify that INC failed to receive advanced NRC approval of an IR100 CoC drawing revision related to the completed disposition of the NCR. CAR 21-004 required retraining of the responsible individual in both NRC approval of CoC drawing revisions and issuance of CARs to address NRC violations. Retraining has been completed and the CAR closed on October 12, 2021. See Attachments A and B. | ||
: 2. QP 18.1, "Audits and Commercial Grade Surveys,'' Revision 3, Step 6.1.1, states, in part, that all elements of the QA program shall be audited within a 12-month period. Specifically, INC failed to perform an audit within a 12-month period by not performing an internal audit of the QA program in 2016. | : 2. QP 18.1, "Audits and Commercial Grade Surveys,'' Revision 3, Step 6.1.1, states, in part, that all elements of the QA program shall be audited within a 12-month period. Specifically, INC failed to perform an audit within a 12-month period by not performing an internal audit of the QA program in 2016. | ||
RESPONSE: As noted above, CAR 21-001 was issued and closed to address this violation. CAR 21-003 was also issued to identify the lack of performance of the 2020 internal audit due to the global pandemic. CAR 21-003 was closed on July 20, 2021. | RESPONSE: As noted above, CAR 21-001 was issued and closed to address this violation. CAR 21-003 was also issued to identify the lack of performance of the 2020 internal audit due to the global pandemic. CAR 21-003 was closed on July 20, 2021. | ||
See Attachment D. | See Attachment D. | ||
C. | |||
C. 10 CFR 71.111, Instructions, procedures, and drawings states, in part, that the certificate holder (INC) 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. | |||
The instructions, procedures, and drawings must include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished. | The instructions, procedures, and drawings must include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished. | ||
Contrary to the above, as of 2011, INC failed to prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances and include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished as | |||
: 1. QP 6.1, Document Control, Revision 5 and QP 17.1, Quality Assurance Records, Revision 3 establish the methods for the control of documents and requirements for the classification, filing, storage, retention, and disposition of quality records generated by INC. Specifically, INC failed to maintain control of quality documentation such as audits and receipt inspections and describe how to control electronic quality records and other generated quality documentation | Contrary to the above, as of 2011, INC failed to prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances and include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished as evidenced by the following examples: | ||
: 2. INC failed to adequately prescribe material testing performed by an alloy analyzer device by a documented instruction or procedure when the device | : 1. QP 6.1, Document Control, Revision 5 and QP 17.1, Quality Assurance Records, Revision 3 establish the methods for the control of documents and requirements for the classification, filing, storage, retention, and disposition of quality records generated by INC. Specifically, INC failed to maintain control of quality documentation such as audits and receipt inspections and describe how to control electronic quality records and other generated quality documentation in QP 6.1 and QP 17.1, respectively, such that the documents were readily retrievable. | ||
: 2. INC failed to adequately prescribe material testing performed by an alloy analyzer device by a documented instruction or procedure when the device was used as a method to verify and dedicate the material property conformance to the approved requirements. | |||
RESPONSE: CAR 21-002 was issued to address this violation. The responsible personnel were retrained on the requirements, and a new work instruction, WI 28, Rev, 0, Alloy Analysis Process dated June 3, 2021 was issued to assure corrective measures will preclude recurrence. CAR 21-002 was closed on June 4, 2021. See Attachments E and F. | RESPONSE: CAR 21-002 was issued to address this violation. The responsible personnel were retrained on the requirements, and a new work instruction, WI 28, Rev, 0, Alloy Analysis Process dated June 3, 2021 was issued to assure corrective measures will preclude recurrence. CAR 21-002 was closed on June 4, 2021. See Attachments E and F. | ||
: 3. INC failed to adequately prescribe the appropriate supplier qualification | : 3. INC failed to adequately prescribe the appropriate supplier qualification methods by including an allowance in QP 7.1, Control of Purchased Items and Services, Revision 5, Step 6.4, for qualification of a supplier based solely on having an NRC approved QAP, which is not an adequate supplier qualification method that meets the requirements of 10 CFR 71.115 for control of purchased material, equipment, and services. | ||
RESPONSE: INC issued CAR 21-005 to review, evaluate and correct this condition. | RESPONSE: INC issued CAR 21-005 to review, evaluate and correct this condition. | ||
Currently, recommended corrective actions have been provided; however, due to the complexities of the cause of the condition and possible corrective measures, INC has chosen a review period of 90 days. This issue remains under review. See Attachment G. | Currently, recommended corrective actions have been provided; however, due to the complexities of the cause of the condition and possible corrective measures, INC has chosen a review period of 90 days. This issue remains under review. See Attachment G.}} | ||
Latest revision as of 11:53, 19 November 2024
| ML21320A198 | |
| Person / Time | |
|---|---|
| Site: | 07100062 |
| Issue date: | 10/27/2021 |
| From: | Maret Rose Industrial Nuclear Co |
| To: | Francis Peduzzi NRC/NMSS/DFM/IOB |
| J TAPP NRC/NMSS/DFM/IOB 3014158047 | |
| References | |
| EA-2021-091, IR 2021201 | |
| Download: ML21320A198 (12) | |
Text
NOTICE OF VIOLATION RESPONSES Docket No. 07100062 EA-2021-091
INC has reviewed the three violations cited by the NRC as a result of the inspection conducted on May 25 to June 25, 2021 and offers the following responses:
VIOLATION:
A. 10 CFR 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.
Contrary to the above, as of 2016, INC failed to establish measures to assure that a condition adverse to quality was promptly corrected when required QA program areas not reviewed during the 2015 internal audit and documented in CAR 2016-001 were not corrected during the planned 2016 internal audit or thereafter.
RESPONSE: CAR 16-001 was closed on May 26, 2021 by reference to new CAR 21-001.
CAR 21-001 identified that objective evidence of the 2017, 2018 and 2019 internal audits could not be produced. These records were lost during a hard drive failure by INC's Lead Auditor. The 2020 internal audit was not performed due to workplace and travel restrictions imposed by the State of California because of the global pandemic; however, the 2021 full scope internal audit was completed as required after the restrictions were lifted. As the Lead Auditor was determined to be the cause of these conditions, as well as the CAR 16-001 issue, the CAR required retraining of the Lead Auditor in records storage requirements and internal audit scheduling and performance requirements. Record storage training was to the newly revised QP 17.1, Quality Assurance Records. Rev. 4, June 11, 2021. INC added specific record types to be maintained and the storage requirements for hardcopy and electronic types of documents. As no additional corrective actions were deemed necessary, CAR 21-001 was closed on July 2, 2021. See Attachment A.
VIOLATION:
B. 10 CFR 71.111, Instructions, procedures, and drawings states, in part, that the certificate holder 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 2016, INC failed to follow quality related procedures as evidenced by the following examples:
- 1. QP 16.1, Corrective Action, Revision 3, Step 6.2 states, in part, in cases where the adverse condition is not identified and being corrected by some other form of documentation, the Quality Assurance Manager shall identify the adverse condition on a CAR. Specifically, INC failed to document a condition adverse to quality on a CAR to enter it into their CAP, in which the issue was identified by the NRC during the previous 2017 follow-up inspection for failure to receive prior NRC approval for an IR-100 CoC change.
RESPONSE: INCs failure to generate a CAR for this issue was a simple misunderstanding of the requirement being cited by NRC following correction of a material defect via NCR. In light of the clarification of this violation, INC issued CAR 21-004 to identify that INC failed to receive advanced NRC approval of an IR100 CoC drawing revision related to the completed disposition of the NCR. CAR 21-004 required retraining of the responsible individual in both NRC approval of CoC drawing revisions and issuance of CARs to address NRC violations. Retraining has been completed and the CAR closed on October 12, 2021. See Attachments A and B.
- 2. QP 18.1, "Audits and Commercial Grade Surveys, Revision 3, Step 6.1.1, states, in part, that all elements of the QA program shall be audited within a 12-month period. Specifically, INC failed to perform an audit within a 12-month period by not performing an internal audit of the QA program in 2016.
RESPONSE: As noted above, CAR 21-001 was issued and closed to address this violation. CAR 21-003 was also issued to identify the lack of performance of the 2020 internal audit due to the global pandemic. CAR 21-003 was closed on July 20, 2021.
See Attachment D.
C. 10 CFR 71.111, Instructions, procedures, and drawings states, in part, that the certificate holder (INC) 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.
The instructions, procedures, and drawings must include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished.
Contrary to the above, as of 2011, INC failed to prescribe activities affecting quality by documented instructions, procedures, or drawings of a type appropriate to the circumstances and include appropriate quantitative or qualitative acceptance criteria for determining that important activities have been satisfactorily accomplished as evidenced by the following examples:
- 1. QP 6.1, Document Control, Revision 5 and QP 17.1, Quality Assurance Records, Revision 3 establish the methods for the control of documents and requirements for the classification, filing, storage, retention, and disposition of quality records generated by INC. Specifically, INC failed to maintain control of quality documentation such as audits and receipt inspections and describe how to control electronic quality records and other generated quality documentation in QP 6.1 and QP 17.1, respectively, such that the documents were readily retrievable.
- 2. INC failed to adequately prescribe material testing performed by an alloy analyzer device by a documented instruction or procedure when the device was used as a method to verify and dedicate the material property conformance to the approved requirements.
RESPONSE: CAR 21-002 was issued to address this violation. The responsible personnel were retrained on the requirements, and a new work instruction, WI 28, Rev, 0, Alloy Analysis Process dated June 3, 2021 was issued to assure corrective measures will preclude recurrence. CAR 21-002 was closed on June 4, 2021. See Attachments E and F.
- 3. INC failed to adequately prescribe the appropriate supplier qualification methods by including an allowance in QP 7.1, Control of Purchased Items and Services, Revision 5, Step 6.4, for qualification of a supplier based solely on having an NRC approved QAP, which is not an adequate supplier qualification method that meets the requirements of 10 CFR 71.115 for control of purchased material, equipment, and services.
RESPONSE: INC issued CAR 21-005 to review, evaluate and correct this condition.
Currently, recommended corrective actions have been provided; however, due to the complexities of the cause of the condition and possible corrective measures, INC has chosen a review period of 90 days. This issue remains under review. See Attachment G.