ML22069A333
| ML22069A333 | |
| Person / Time | |
|---|---|
| Site: | Zion File:ZionSolutions icon.png |
| Issue date: | 11/11/2020 |
| From: | ZionSolutions |
| To: | Office of Nuclear Material Safety and Safeguards |
| Shared Package | |
| ML22069A328 | List: |
| References | |
| ZS-2022-005 AD-8, Rev 12 | |
| Download: ML22069A333 (31) | |
Text
AD-8 Revision 12 Information Use
AD-8
Corrective Action Program
ZionSolutions Project
NOTE
The classification determination information must be completed for all procedures classified as SGI, SGI-M, or SUNSI (2.390) in accordance with SP-18. Procedures that do not qualify as SGI, SGI-M, or SUNSI do not require a classification to be made.
Effective Date:
Page 1 of 31 AD -8 Revis ion 12 Jnfo1mation Use
Corrective Action Program P rocedur e No. AD-8 Revision No. 12
Pre parer (Print name! sign):.Matthew S iebert /w p,, ' ~ Dace: JO/ 'L'l. ( i.-_1> _ __
Seco ndary Reviewer (Print name 1 ~i!,ln):.Sh a nn911 Ouillin° d-~,,.,,/ ~ -,... ~,,.,/~ Date: ~1~,d}
1s*FsI Routiae Activity Item Dnrnbnse Assessrfient Affected TB C Tracking I N i A
NA if no acti\\ ities are affected by rbi~ procedure revision. Attach revi~ed or marked up list for review.
VP Re!!nlat)1y. \\f' fam, or D.:~ign*::-.* ha,; r<!' tt'.. d and det~nnme<l icqmr t d p1ogrnm & r~gt1fa1ol) re~ie,1s ("'new 1 procedure<. 0/U) ' ) : <:IGN,\\TUJlEJi.A... --- *- DATt. - --*-.. --- --- -~---- ------**-- -~*~----
RPgubitory Required Reviews - - -
Part 50 License: JO CFR.s'0. 59 and 50,9ll, DYES IXl NO
Fire Protcc1ion: l 0 CFR 50,48(1) 0 YES IXl NO
CoI?diti r,n~ oflice11<(.': PSP : 10 CFR.50.54(p) vr:s [g)* NO
Cond itions of License: E-Plan: l 0 CFR 50.54(q) 0 YES IZ!NO
Termination of License: 10 CFR 50,82(a)(6) and 50.S2(a)(7J 0 YI:S f8J NO
Part T2 Lic-nse; IO CFR 72.48 0 YES IXl NO Pro1m1m Requ ired Reviews
RP : 0 Y E S I&] NO S £GN A TURF._,EA DATE:. NI A T: -D k - rr.i..-.::..= - --
QA: !ZJ YES ONO SIGNATURE __,m u es f,.,..::=:--- DA TE:_j.1L1_QLiQ~
TR: 0 YES [81 NO TR SIGNATURE...b..b.. -*- -- DATE:_l:t6_ ____
TR SIGNATURE J~ A DA TE:_Nt A Anorovsl Section
JSFS! MAN AGER: SIGNATURE~ DATE: -11}_19) ct,t?,a.U
DECOMMISSIONING _))AfE: N/A __ _ _ _
PLANT MANAGER~; SIUNATlHU* N' A - -*---- --*
- Required fo r Technical R-:.-icws only
Vecifioa<io,,fR<<wire<l R"*iew, '"/;,°' C"",p'rd ' o/, :Jil 6, // ZQl?
DOCUivlENT CONTRO L:. _/(i-r_e,,_ Ia !!I..!, '/-.._.. _ - - --....-0-ATI::
Print Name I Si<mnt e.
Page 2 of31 AD-8 Revision 12 Information Use
- 1. PURPOSE...............................................................................................................................4
- 2. SCOPE....................................................................................................................................4
- 3. DEFINITIONS.......................................................................................................................4
- 4. NOTES, PRECAUTIONS, LIMITATIONS.......................................................................6
- 5. REFERENCES.......................................................................................................................6
- 6. RESPONSIBILITIES............................................................................................................6
- 7. PROCEDURE........................................................................................................................9
- 8. REVISION CHANGES.......................................................................................................21
- 9. ATTACHMENTS................................................................................................................21
Page 3 of 31 AD-8 Revision 12 Information Use
- 1. PURPOSE
The purpose of this procedure is to establish the program and key controls for the prompt identification, screening, evaluation tracking, resolution and documentation of adverse conditions and conditions adverse to quality. This procedure also provides a mechanism to be used to improve the efficiency and effectiveness for management controls that could impact project cost and schedule and/or customer satisfaction. This is done by means of a Condition Report (CR).
- 2. SCOPE
This procedure applies to adverse conditions for processes, programs, work activities, materials, parts, and components at the Zion Station Restoration Project, including the ISFSI.
- 3. DEFINITIONS
Adverse Condition - A general term used in reference to a condition that is contrary to established direction, conflicting, detrimental, undesired or harmful. A significant adverse condition is one that, if uncorrected, could have a serious effect on nuclear, personnel or radiological safety, regulatory compliance or cost.
Cause Code - Codes that are applied to a CR that correspond to the causal factors determined through investigation and analysis of the issues identified in a CR.
Cognitive Trending - a way of trending that requires an individual involved in day-to-day activities at the site to maintain a mental awareness of current and past department and station issues, and to connect the dots to identify similar or repetitive trends.
Condition Adverse to Quality (CAQ) - An all -inclusive term used in reference to any of the following: failures, malfunctions, deficiencies, defective items, unexpected or undesired results of work performed, and nonconformances. A significant condition adverse to quality (SCAQ) is one that, if uncorrected, could have a serious effect on safety or operability.
Condition Report Module (CRM) - The web application for initiating, tracking and completing CRs. The CRM is available from the Web Applications page on the ES Intraweb. User guide information is also available on the ES Intraweb.
Corrective Action (CA) - An action taken or planned that restores an adverse condition to an acceptable condition or capability by correcting a condition, or creating or reinforcing a barrier to prevent a similar condition in the future.
Page 4 of 31 AD-8 Revision 12 Information Use Corrective Action to Prevent Recurrence (CAPR) - Action taken to prevent recurrence of the root cause(s) or apparent cause identified in a CR. CAPR attributes include being specific, measurable, accountable, reasonable, timely, effective, and reviewable. In addition, CAPRs are actionable (e.g., revise, implement, install - not review, develop, or consider), long lasting (i.e., not temporary), process-oriented (unless the root cause is truly an isolated individual or equipment problem), linked to a root /apparent cause, and limited in number (typically one or two per root /apparent cause).
Deficiency, Deviation or Discrepancy - A departure from specified requirements, standards or expectations.
Event Code - Similar to a Cause Code, except the Event Codes are based on types of events, and organized by work group, instead of by causal factors. Event Codes are applied to CRs to flag them for reporting purposes so by sorting and analyzing CRs, clusters of similar events can be identified to identify problem areas that warrant heightened management attention.
Extent of Cause - Extent to which the actual cause of the condition has led to identified issues with processes, equipment, or human performance. The extent of cause investigation should be limited to a reasonable scope, based on risk /
consequence assessment.
Extent of Condition - Extent to which the actual condition exists with processes, equipment, or human performance. While IRs should include a discussion of extent of condition, it is expected the level of effort in determining and documenting the extent of condition is commensurate with the level of investigation and significance of the event.
First Notification - An EnergySolutions corporate-wide notification used to disseminate significant incidents and operating experience issues.
Issue Review (IR) - A cause evaluation performed using Attachment 3 of this procedure.
Latent Organizational Weakness (LOW) - An undetected deficiency in management control processes (e.g., strategy, policies, work control, training, and resource allocation) or values (shared beliefs, attitudes, norms, and assumptions),
which creates workplace conditions that provoke human error (precursors) or degrades the integrity of defenses (flawed defenses).
Management Review Committee (MRC) - A group of Functional Area Managers who meet to review all condition reports; make Sig Level determinations; assign cause evaluation, corrective action assignments, and ownership assignments, review and approve CAP products, and consider trending data.
Nonconformance A deficiency in characteristic, documentation, or procedure that renders the quality of an item or activity unacceptable or indetermi nate.
Page 5 of 31 AD-8 Revision 12 Information Use Significance Level (of a CR) - CRs are graded by order of significance, with Significance Level 1 (Sig 1) being the most significance, and Sig 4 being the least significant. Attachment 2 provides the guidance on grading CRs.
- 4. NOTES, PRECAUTIONS, LIMITATIONS
Information documented in the Corrective Action Program shall not be written in a manner that constitutes Safeguards Information or include Personally Identifiable Information (PII).
First Notifications per Reference 5.7 must be kept internal to EnergySolutions /
ZionSolutions
In cases where ZionSolutions receives notification that NAC has initiated their 10 CFR 21 process for an issue related to the MAGNASTOR dry fuel systems in use at Zion, ZionSolutions shall issue a Condition Report (CR) to track the issue to closure and document the issue in the ZionSolutions records system.
- 5. REFERENCES
ZS-QA-10, Quality Assurance Project Plan (QAPP)
AD-9, Equipment Operability and Functionality Assessment
AD-15, Evaluation of Component or Equipment Failure or Deviation for 10 CFR 21 Reportability
AD-20, Records Management Program
AD-21, Control of Nonconforming Items
SP-19, ISFSI Fitness For Duty Program
ES-AD-PR-005, First Notifications (EnergySolutions corporate procedure)
ES-SH-PR-403, Incident Investigation (EnergySolutions corporate procedure)
- 6. RESPONSIBILITIES
General Manager (GM) - is responsible for:
Ensuring Functional Area M anagement at the site is supportive of the Corrective Action Program (CAP) mission and promotes consistent application of the CAP process.
Acting as final arbiter in cases of differing professional opinions between Functional Area Managers over CAP issues.
Page 6 of 31 AD-8 Revision 12 Information Use Functional Area Managers - are responsible for:
Ensuring personnel in their functional areas are trained in the corrective action program.
Ensuring designated members / alternates attend Management Review Committee (MRC) meetings.
Assigning appropriate staff in their organization to perform cause evaluations, and complete corrective actions (CAs).
Ensuring Corrective Actions are taken in a timely manner and an appropriate level of supervision reviews CAs before the CA is Completed in the CRM.
ISFSI Manager - is responsible for:
Serving as Chairperson for the MRC, including dete rmination of meeting frequency.
Ensuring the adequate staffing of the CAP process.
Quality Assurance Manager (QAM) - is responsible for:
The QAM should attend MRC meetings, but is not a required attendee, and is not a voting member of MRC.
Review and approve closure of CRs where a QA audit finding is addressed.
Corrective Action Program Lead (CAPL) - is responsible for:
The responsible person authorized by software controlled administrative privileges to perform the actions in the CRM described in this procedure.
Validating the CR and / or canceling a CR that is not valid.
Accepting ownership of CRs for CR processing purposes within the CRM.
CAPL ensures CR report is generated and distributed for the daily/weekly MRC meeting.
Monitoring the paper CR lock box and inputting any CRs placed in the lock box into the CRM.
Facilitating the MRC meetings, ensuring the MRC is conducted in accordance with this procedure, and ensuring MRC directives are implemented.
Issuing Weekly MRC packages, as required and ensuring the packages are maintained for reference. The packages are used as an aid to record notes so the CRM can be updated and processed, as necessary, for each CR.
Page 7 of 31 AD-8 Revision 12 Information Use Monitoring the progress of CRs through the various stages of processing, and processing requests for extensions.
Reviewing and accepting completed CAs and CRs for closure.
Ensuring the CRs are entered into the record system.
Assisting the ISFSI Manager in reporting on CAP KPIs.
Assisting the departments with completing evaluations and CAs.
Maintaining a list of Cause Codes and Event Codes that is aligned with the CRM, and making them available for project use.
CAP Product Evaluators - are responsible for:
Conducting the evaluation for and developing the CAP product (IR, CA, or any other assigned by MRC).
Obtaining concurrence from the appropriate Functional Area Manager on the completed CAP products prior to submitting it to the MRC for approval
Supporting, as necessary, the review and approval of the CAP product.
ISFSI Shift Supervisors (ISS) - are responsible for:
The Operations Review described in this procedure, including the following:
Promptly reviewing CRs for adequacy of immediate corrective actions taken, reportability and operability, 10 CFR 50.75g / 10 CFR 72.30d applicability, and ensuring any follow-up actions are initiated as warranted.
Verifying Supervisors have initiated Fitness For Duty (FFD) assessments as warranted, and if they have not done so, ensuring FFD assessments are promptly conducted, and ensuring any follow-up actions are initiated as warranted.
Initiating an ISFSI W ork Order to address ISFSI facility / equipment repairs or actions that are clearly warranted.
Management Review Committee (MRC) Members - are responsible for:
The Screening Review described in this procedure, including the following:
Review all new CRs and perform the following:
Assign Significance Level
Assign CAQ/NCAQ designation
Page 8 of 31 AD-8 Revision 12 Information Use Determine cause evaluation, CR Owner, and action assignments.
Review and approval / disapproval of cause evaluations for Sig 1, Sig 2 and Sig 3 CRs, and other CA items referred to the MRC by the ISFSI Manager.
Applying Cognitive Trending to CR data and identifying potential negative trends.
CR / CA Owners - are responsible for:
Providing timely written response to CR assigned to them which includes establishing CAs that address identified causes, identifying causes through analysis, and establishing CAs to prevent recurrence (CAPRs), when required.
Ensuring CAs and CAPRs, when required, are implemented in accordance with the scheduled completion dates, and requesting extensions through the CRM BEFORE the assignments go overdue.
Ensuring that for any issues with ITS hardware, a nonconformance report is issued per procedure AD-21, as applicable.
All workers at the Zion Site - are responsible for:
Identifying and documenting adverse conditions or barriers to improvement in accordance with this procedure.
- 7. PROCEDURE
Initiation
A CR should be initiated for issues such as the following:
To report non-compliances of procedure and program requirements.
To report unsafe conditions, injuries, accidents, and near misses.
To report undesirable conditions and problems.
To report procedure and process weaknesses or issues.
To report damage to site, property, or to the environment.
To report regulatory compliance issues.
To report the spill or detection of radiological contamination around the facility, equipment or site.
To report if unexpected subsurface debris, systems or buried components are encountered while, digging, probing or excavating.
Page 9 of 31 AD-8 Revision 12 Information Use To report security related deficiencies.
A CR should not normally be initiated for the following types of issues:
To identify normal or routine level of effort activities SharePoint Action Tracking or other methods may be used instead.
To identify issues with site and equipment for routine repairs (e.g. problems with a door latching, or a leaking toilet). Use D&D or ISFSI work control processes.
To state a personal opinion on a matter.
To address a personal issue you may have with other site personnel.
General actions for all situations for which a CR is being initiated:
If the condition is unsafe, and represents immediate danger to the health and safety of workers, put the work in a safe condition, stop the work and notify your supervisor.
CAUTION
Only take any immediate actions yourself that you are qualified to perform, and that are safe to perform.
If the condition is a minor safety issue, but does not warrant stopping work, initiate appropriate actions to ensure worker safety (e.g., secure or otherwise cordon off the potential issue) before initiating the CR, and notify your supervisor.
If there may be an immediate operability or reportability concern, immediately notify the ISS.
Promptly (within 6 hours6.944444e-5 days <br />0.00167 hours <br />9.920635e-6 weeks <br />2.283e-6 months <br /> for active issues, up to 24 hours2.777778e-4 days <br />0.00667 hours <br />3.968254e-5 weeks <br />9.132e-6 months <br /> for administrative or legacy issues) initiate a CR using a computer or paper form.
If you have access to the computer network, then use the CRM to initiate the CR as follows:
Using the electronic Condition Report (CR) Initiator Form (appears similar to Attachment 1), follow the guidance on the form to input the required information.
Condition
Title:
Enter a brief description ( CR t itle) that concisely captures the issue. The Condition Title should directly relate to the Description of Adverse Condition field.
Page 10 of 31 AD-8 Revision 12 Information Use Description of Adverse Condition: Enter details as follows:
Write a problem statement (i.e., contrary to statement) that elaborates upon the Condition Title to completely describe the adverse condition.
Include requirement violated, items/services involved, specification, drawing, code or standards to which items/services do not comply, submit sketch if applicable.
Write the description such that the average person somewhat knowledgeable of the program, process, or system, but not the problem, can understand the issue and its implications.
Explain the issue with enough detail to enable the ISS to conduct an initial review without contacting the author.
Define acronyms and abbreviations the first time they are used unless they are commonly known.
Provide information to the extent known. Avoid speculation. Clearly indicate what the facts are, versus what are interpretations, and what are opinions.
Immediate Action: Ensure immediate actions taken to secure the condition in a safe condition are fully recorded.
Recommended Action: Enter any recommended actions you think would be warranted to address the adverse condition identified.
Other details: Enter event date, discovery date and the remaining details when prompted by the CRM.
When satisfied the CR is complete, select the Save box, and the CR will automatically be routed to the ISS for ini tial review.
If you DO NOT have access to the computer network, then use the paper option to initiate the CR as follows:
Using the paper Attachment 1, Condition Report (CR) Initiator Form, follow the guidance on page 2 of 2 of the form and as provided above to add the required information. Paper forms may be printed and used from any current revision of this procedure, or taken from the paper CR station provided at the ISFSI for use.
When completed, give the form to your supervisor for input into the CRM.
Page 11 of 31 AD-8 Revision 12 Information Use You may also choose to submit the CR anonymously. In this case, write anonymous in the NAME field, and leave the paper CR in the lock-box provided at designated locations. The CAP L (or designee) will monitor the box and will input paper CRs into the CRM.
If you do not have network computer access, but would like feedback on how the CR you wrote was dispositioned, check the box provided on the form for that purpose.
Operations Review
The CRM will route CRs to the ISS immediately upon submittal by the Initiator after the Initiator selects Save. The on -duty ISS will promptly (within current shift) perform the operations review of the CR as follows:
If the information of the CR is not adequate to understand and assess the condition, contact the initiator or their supervisor to obtain the necessary additional detail.
Assess the adequacy of any immediate actions performed, and if necessary, initiate any additional immediate actions to make the condition safe.
If a Work Order (WO) is clearly warranted to initiate work on affected equipment or facilities, initiate a WO using the appropriate Work Control procedure, and list this as an immediate action taken on the CR.
Assess the potential impact to the operability of required ISFSI structures, systems or components (SSCs), and ensure any required operability assessments are initiated in accordance with procedure AD-9.
Screen the CR for reportability, including 10 CFR 21 reportability, in accordance with the Reportability Manual. Note the reportability manual section in the CR, as applicable. For any conditions that warrant formal evaluation for 10 CFR 21 reportability, ensure the actions required by procedure AD-15 are initiated. Contact Regulatory Affairs representative if assistance is needed. If required, INITIATE an immediate investigation.
If the event is an operational event caused by human error, contact the employees immediate supervisor to ensure a Fitness for Duty (FFD) assessment is initiated in accordance with the FFD program per procedure SP-19.
If not already done, notify the General Manager of issues that could result in a violation within 12 hours1.388889e-4 days <br />0.00333 hours <br />1.984127e-5 weeks <br />4.566e-6 months <br /> of occurrence or identification.
Page 12 of 31 AD-8 Revision 12 Information Use If the event involves the spill or detection of radiological contamination around the facility, equipment or site, or involves encountering unexpected buried plant systems or components, notify the FSS manager of the potential for 10 CFR 50.75(g) considerations. Code the CR as 10 CFR 50.75g (for all areas outside the ISFSI boundary) or 10 CFR 72.30d (for all areas inside the ISFSI boundary).
Document all the above actions in the CRM as indicated on the electronic form, and close the Operations Review section when completed (select the Save box). This will route the CR to the CAPL (or designee) for Screening.
Screening
The CAPL will monitor the CRM on a daily basis and will perform the following, as applicable:
If the CR is invalid, cancel the CR, by closing the CR with annotation on the CR as to why it was canceled. The following are examples of situations where CRs may be judged as invalid:
A CR that is a duplicate of a CR already initiated.
A CR that was mistakenly submitted prior to being completed by the initiator, and another CR will be initiated to properly document the issue.
A CR that only documents something that should be addressed by the Work Control processes (e.g., identifying the need for physical work to be done at the site). In this case, ensure action is initiated per the appropriate Work Control procedure.
A CR documenting something that is routine level of effort in the business (e.g., submittal due dates, conduct of routine evaluations, etc.).
In this case, notify the responsible group manager of the CR content when canceling the CR.
Prepare a CR Daily Report, if required (i.e., N/A if there no new CRs). This will consist of CRs since the last MRC meeting.
Ensure CRM auto generated CR Daily Report is distributed on a daily basis to MRC members.
An MRC meeting should be held weekly at a minimum (if CRs have been initiated) to review and screen new CRs, and to review and approve cause evaluations. MRC is conducted in accordance with Attachment 4. For each MRC meeting, the CAPL (or designee) shall ensure MRC members receive material to be covered in advance of the meeting.
Page 13 of 31 AD-8 Revision 12 Information Use At the Daily/Weekly MRC meeting, the MRC shall screen new CRs per the following guidance:
Sig Level: Use Attachment 2 for significance level guidance. Any issue that is graded a Sig 1 is considered a significant adverse condition, or an SCAQ, as applicable.
CAQ / NCAQ designation: The following are CAQ issues (all others are Non-CAQ):
Issues with activities associated with structures, systems, and components (SSCs) which are important to safety (10 CFR 72) as listed in Appendix A of the QAPP.
Issues with activities associated with Important-to-Safety components of transportation packages licensed by the NRC under 10 CFR 71 (not expected for the remainder of the project).
Issues with activities included in QAPP sections 3.1 (Organization), 3.2 (QA Program), 3.16 (Corrective Actions), 3.17 (QA Records) and 3.18 (Audits).
Issues with activities included in QAPP Appendix B, including:
Facility Staff Qualifications
Procedures and processes implementing the following:
Offsite Dose Calculation Manual (ODCM)
Radioactive Effluent Controls Program
Outdoor Storage Tank Radioactivity Monitoring Program
License Termination Plan (LTP)
Annual Radiological Environmental Operating Report
Radioactive Effluent Release Report
Qualified Technical Review
Page 14 of 31 AD-8 Revision 12 Information Use Cause Evaluation assignments:
A. For Sig 4 CRs, no specific cause evaluation is required. The action owner should provide explanatory notes and information on the CRM sufficient for others to understand the issue and concur that the actions taken were adequate.
For Sig 3 CRs that were initiated to respond to an identified negative trend, a Common Cause Evaluation should be assigned.
For Sig 3 CRs for which the cause and corrective actions are readily apparent, and for which there is minimal risk of a recurrence that would have significant consequences, no specific cause evaluation is required.
The action owner should provide explanatory notes and information on the CRM sufficient for others to understand the issue and concur that the actions taken were adequate.
For Sig 3 CRs where the cause(s) may be more complicated (e.g.
process or procedure issues, training issues, etc.), and where the risk of recurrence with deleterious consequences is present, an IR should be assigned. The scope and complexity of the IR should be subject to MRC discretion, to be commensurate with the significance and complexity of the issue.
For Sig 2 CRs, an IR is mandatory, as a minimum. An Apparent Cause Evaluation should be considered in cases where the causal factors are complex and include management or organizational aspects.
For Sig 1 CRs, an ACE is mandatory, as a minimum along with an Effectiveness Review. A Root Cause Evaluation should be considered in cases where the issue is an SCAQ.
For Common Cause Evaluation, Apparent Cause Evaluation, Root Cause Evaluation, and Effectiveness Reviews, previous site procedures may be used as Job Aids administered under the direction of the CAPL on a case-by-case basis. Other approaches and other guidance (e.g.
EnergySolutions corporate processes) may be used in addition at the option of the MRC.
The Incident Cause Analysis method (ICAM) process (see Ref. 5.8) may be used in lieu of, or in conjunction with, the site cause evaluation processes. In these cases, a site IR should be used in addition to the ICAM report, to ensure all site-specific CAP elements are included (e.g.
cause codes and action assignments), and the ICAM report should be attached to the CR.
Page 15 of 31 AD-8 Revision 12 Information Use CA assignments: MRC acceptance of CA assignments and due dates should be based on MRC judgment of the importance of the issues and risk to the project. CAs should be spe cific, measurable, accountable, reasonable, timely, effective, and reviewable. The following guidelines should also be adhered to unless there are good reasons not to do so:
Add CAs to track the completion of any assessments that may be ongoing for Reportability or Operability.
Add CAs to document notifications for any 10 CFR 50.75(g) or 10 CFR 72.30 (d) considerations.
An action shall be assigned to QA to review and concur with CR completion in cases where the CR issue involves a QA Audit Finding.
An Effectiveness Review (EFR) is mandatory for SIG 1 CRs, and should be should be considered for Sig 2 CRs, based on the likelihood and risk to the project of recurrence. Timing of EFRs is at the discretion of the MRC.
Due dates for cause evaluations should be based on the following:
Sig 1 cause evaluations: 30 working days.
Sig 2 cause evaluations: 20 working days.
Sig 3 cause evaluations 10 working days.
At MRC meetings, the CAPL (or designee) shall attend and perform the following actions:
Monitor the discussion, and provide input as a subject matter expert.
Update the CRM with the CR Owner, Significance Level, evaluation assignment, and due dates as decided at the MRC meeting. Recording this documents actions taken and the results of discussions. No other form of minutes or notes is required to be taken.
If no cause evaluation is assigned;
Make the MRC-approved CA assignments using the CRM.
Apply any applicable cause codes and event codes (except for Sig Level 4 CRs) to the CR in accordance with the lists maintained by the CAPL.
Page 16 of 31 AD-8 Revision 12 Information Use Processing
NOTE
The CR/CA Owner is not necessarily bound by suggested actions or recommendations identified on the CR. However, changes to actions committed to in an MRC-approved cause evaluation are binding, and any deviations must be returned to MRC for concurrence. The CR Owner, as directed by the MRC, may judge that actions already taken are completed, or that no actions are required.
Any of these decisions should be annotated on the CR by either the CR Owner or the CAPL when closing the CR.
The CAPL (or designee) shall monitor status of all CRs, and include updated status in weekly MRC tracking list, highlighting those that are overdue.
CR and CA Owners should manage the CA and / or cause evaluation that is assigned in order to complete the m in the time allotted.
It is the responsibility of the CA Owner to manage the due date in conjunction with the MRC schedule. In addition, due dates for cause evaluations need to be managed with consideration to the time needed for the CAPL review and possible changes prior to s ubmitting for MRC approval. Once a cause evaluation is accepted by the CAPL, the report is sent to the MRC members on Tuesday afternoon to allow time for review prior to the Thursday meeting. CA Owners should consider this timing when managing due dates.
If an IR is assigned, complete the IR in accordance with the Attachment 3 form. Any special instructions from the MRC with respect to IR scope and complexity should be considered and adhered to.
Complete any other types of cause evaluation assigned by MRC in consultation with the CAPL (or designee), as applicable.
Communicate any potential delays to the CR owner, and request a due date extension, if required, BEFORE the CA becomes overdue.
CAP assignments should be completed on a timely basis and extensions should only be authorized when necessary.
A. The ISFSI Manager may approve extensions for any cause evaluations and corrective actions for CRs.
B. Granting of extensions should be documented on the CR system by the CAPL.
C. Consideration may be given to using supplemental / contract support for CAP assignments.
Page 17 of 31 AD-8 Revision 12 Information Use Provide a complete description of action(s) taken and justification for CA task completion and closure.
List all documents created or revised as a result of this CA task.
List supporting documentation that provides objective evidence of the actions taken to correct the condition.
Attach any documentation used to support closure that was uniquely generated, or that is otherwise not retrievable in the records system from a reference.
When cause evaluations are completed, the responsible organization shall notify the CAPL (or designee) and forward a copy of the completed evaluation to the CAPL (or designee) to obtain CAP L (or designee) concurrence that the evaluation is ready for the MRC, based on the following:
The cause evaluation is in the format specified by the MRC, with all fields completed as applicable, and is approved by the designated Owner;
The cause evaluation appears to adequately consider the required elements per the guidance specified by the MRC;
When CAPL (or designee) concurrence is obtained, the CAPL (or designee) will schedule the cause evaluation for review and approval at the earliest practical Weekly MRC meeting. The Owner (or responsible manager in Owner organization) should perform the following actions:
Attend the MRC meeting to present and discuss the cause evaluation.
Address any issues identified at the meeting, which may include preparing a revision to the cause evaluation and presenting it again at a subsequent meeting.
If the cause evaluation is a result of a QA initiated CR:
QA should attend the MRC meeting to concur with the MRC review and approval of the cause evaluation, or alternatively:
QA should review the MRC-approved cause evaluation and address any issues through the MRC.
After the cause evaluation has been accepted by the MRC, the CAPL (or designee) will add the accepted corrective actions into the CRM, and will apply applicable cause codes and event codes to the CR in accordance with the lists maintained by the CAPL.
Page 18 of 31 AD-8 Revision 12 Information Use When all CAs are completed, the CR Owner shall review the entire CR, and ensure all CAs have been adequately documented on the CR, and supporting documentation has been attached in the CRM as appropriate. The review should include the following attributes:
Ensure all completed actions, including immediate actions, and First Notifications, are documented.
Ensure all actions have been completed in full compliance with the MRC approved assignments;
Ensure the closure does not include any promises or reliance upon yet to be completed actions.
Ensure the closure includes objective evidence to substantiate completion.
This may be by reference in cases where the reference is an item that is known to be included in the records system by process (e.g. the case of a procedure). Alternatively, the item should be attached to the CR and referenced in the action / CR completion comments.
The CR Owner shall close the CR in the CRM. This forwards the CR to the CAPL (or designee), who will conduct a final review of the CR before it is archived as a record.
The CAPL (or designee) shall review completed CAs as follows:
Review for attributes 7.4.5 (1 to 4).
Ensure the narrative that was input to describe the actions taken is comprehensible, and provides a complete description of the action taken.
Ensure there is no inappropriate language or materials input or attached to the CRM.
Ensure the completed actions meet the intent of the assignment.
If the CA is associated with a QA initiated CR, QA should be consulted, as necessary, if there are questions with regard to the CAs completeness, documentation, and meeting the intent of the CA description.
The CAPL (or designee) shall review completed CRs as follows:
Ensure the CR has been processed in accordance with the requirements of this procedure.
Ensure references to MRC meetings have been provided, and any MRC designated actions / revisions have been completed, as applicable.
Page 19 of 31 AD-8 Revision 12 Information Use Ensure the cause evaluation / IR is attached, and is the final approved version.
Ensure all the CAs are completed.
Ensure any applicable Cause Codes and Event Codes have been applied.
Remove any codes that are not applicable.
Ensure names of any affected equipment or related documents have been added to the CR.
In cases where issues identified by the CAPL (or designee) in the review of CRs, cause evaluations, or CAs cannot be resolved with the CR owner, the CAPL (or designee) should discuss the issues with the group manager, and the ISFSI Manager, if necessary. In cases where resolution cannot be agreed to at this level, the issue will be referred to the GM for resolution.
Verify in cases where the originator selected Feedback on the paper CR, an action has been added to the CR to provide feedback.
When the CR is closed, the CAPL (or designee) shall ensure an electronic copy is available to be entered into the records system in accordance with procedure AD-20. This includes the CR, all completed CAs, and attached supporting documents.
Reporting
The CRM contains a pre-determined array of CAP Key Performance Indicator (KPI) reports.
KPI reports should include metrics that track CR and CA tracking and closure, in a manner that facilitates identification of lack of management attention to the CAP process.
At any time, a manager may use the CRM to see a report of any of the CAP KPIs.
Quarterly, the CAPL should print reports of CAP KPIs and include them in an MRC Meeting agenda.
The MRC should monitor the KPIs for trends, and issue CRs to address any adverse trends that are identified.
QA Records
Sig 1, Sig 2 and Sig 3 CR files are QA records and are processed in accordance with Procedure AD-20.
Sig 4 CR files and MRC records are not QA records and may be maintained for information only.
Page 20 of 31 AD-8 Revision 12 Information Use
- 8. REVISION CHANGES
Added note 4.3.
- 9. ATTACHMENTS
NOTE All of the forms within this procedure are samples and all of the information needs to be consistent with that provided within the forms. The forms can be electronic and need not contain page numbers or similar information.
Attachment 1 - Condition Report (CR) Initiator Form
Attachment 2 - Significance Level Guidance
Attachment 3 - Issue Review (IR) Template
Attachment 4 - Conduct of MRC
Page 21 of 31 AD-8 Revision 12 Information Use ATTACHMENT 1 Condition Report (CR) Initiator Form Page 1 of 3
Immediately notify your Supervisor or the ISS (x4242) if you believe this condition could have an adverse effect on site, personnel or public safety. Provide enough information so others reviewing this report can understand the condition. Use titles instead of names. Do not use inappropriate language. See Page 2 of 3 for Instructions.
(These fields are auto-assigned: Input name/date/time by hand if using the paper CR option)
CR No : Initiated By: Initiation Date: Initiation Time:
Will be assigned _______________________ _____/_____/_____ ____:____
Condition
Title:
Description of Adverse Condition:
What immediate corrective actions were taken? { } N/A
What further corrective actions do you recommend? { } N/A
Event Date and Date Discovered (Enter dates if either date is different from CR Initiation Date, otherwise select { }
N/A):
Event Date: __/__/____ Date Discovered: __/__/____
Who identified the issue, if other than CR Initiator: { } N/A
[ ] QA [ ] NRC [ ] Other: (Must have a Name Identified): _________________________
Affected Equipment: { } N/A
ISFSI: _______________________Dry Fuel Storage Components: ___________________
Related Documents: { } N/A MFO: _______ QA Audit / Surveillance: _________ NCR No: _________
FASA: _____________ Other CR No.: ________ WO: __________ Other: ________________
[ ] Send a copy of the CR closeout documentation to _______________________. NOTE: Initiator will automatically get feedback. Complete this line ONLY IF the issue was identified by someone other than the Initiator of the CR, and that individual wants feedback upon CR closure. Otherwise select { } N/A.
Page 22 of 31 AD-8 Revision 12 Information Use ATTACHMENT 1 Condition Report (CR) Initiator Form Page 2 of 3
The CR initiator performs the following steps:
- 1. Condition
Title:
Enter a brief description (CR title) that concisely captures the issue. The Condition Title should directly relate to the Description of Adverse Condition field.
- 2. Description of Adverse Condition: Enter details as follows:
Write a problem statement (i.e., contrary to statement) that elaborates upon the Condition Title to completely describe the adverse condition.
Include requirement violated, items/services involved, specification, drawing, code or standards to which items/services do not comply, submit sketch if applicable.
Write the description such that the average person somewhat knowledgeable of the program, process, or system, but not the problem, can understand the issue and its implications.
Explain the issue with enough detail to enable the ISS to conduct an initial review without contacting the author.
Define acronyms and abbreviations the first time they are used unless they are commonly known.
Provide information to the extent known. Avoid speculation. Clearly indicate what the facts are, versus what are interpretations, and what are opinions.
- 3. Immediate Action: Ensure immediate actions taken to secure the condition in a safe condition are fully recorded.
- 4. Recommended Action: Enter any recommended actions you think would be warranted to address the adverse condition identified.
- 5. Other details: Enter event date, discovery date and other important details.
- 6. Check box if initiator wants a copy of closeout documentation.
- 7. Print, sign, date and time the Initiator form.
- 8. The initiator may submit the CR to anyone who has access to the site network computer system for processing and entry using the computer network.
- 9. The CR may also be submitted anonymously. In this case, write anonymous on the CR or leave it unsigned. If submitted anonymously, the CR may be left in the CR lock-box provided. The CAPL shall ensure the CR is entered into the CRM on the computer network.
Page 23 of 31 AD-8 Revision 12 Information Use ATTACHMENT 1 Condition Report (CR) Initiator Form Page 3 of 3
- 10. The individual that enters the paper CR in the CRM performs the following steps:
The individual assisting the CR Initiator shall ensure the CR is entered in the CRM on the computer network as written by the Initiator.
All paper CR forms should be forwarded to the CAPL (or designee) for filing after they are entered in the CRM.
Page 24 of 31 AD-8 Revision 12 Information Use ATTACHMENT 2 Significance Level Guidance Page 1 of 4
Attachment 2 provides guidance in an attempt to have a consistent approach at classifying significance. It is recognized the guidance provided will probably not capture each issue exactly and the classification is therefore dependent on the judgment of the MRC members.
1.0 Sig 1 Examples:
1.1 Nuclear Safety - Any event which results in:
1.1.1 Undesired effect (high-impact or consequential event) on ITS equipment 1.1.2 OOS/clearance error discovered after work commences that results in personnel injury, equipment damage, unplanned Tech Spec action requirement entry, unplanned personnel exposure or contamination, or other consequence of similar magnitude 1.1.3 Fire requiring action by the Zion Fire Department and that results in significant damage (>$200,000) to plant structures and/or equipment 1.2 Regulatory - Any event which results in:
1.2.1 LER per 10CFR50.73 1.2.2 Security report per 10CFR73.71 or inadvertent weapon discharge 1.2.3 Non-compliance with federal or state permits 1.2.4 OSHA violation (serious injury, or unsafe condition, not administrative issues) 1.2.5 Hazmat emergency event as classified by response team leader 1.3 Personnel Safety - Any event which results in:
1.3.1 Fatality 1.3.2 Lost Time Accident 1.3.3 Injury requiring offsite medical attention and individual is medically unable to return to work 1.4 Radiological Safety - Any event which results in:
1.4.1 Overexposure above administrative limit 1.4.2 Uncontrolled radioactive material identified outside the RCA 1.4.3 Cited violation of NRC or DOT radioactive material shipment regulations 1.4.4 Unintended exposure > 10 mrem 1.4.5 Public exposure due to RAM outside the RCA > 5 mrem 1.5 Any event which in the opinion of the ISFSI Manager is commensurate with any of the above criteria.
1.6 QA identified significant issue of a generalized failure of a Regulatory Required Program.
Page 25 of 31 AD-8 Revision 12 Information Use ATTACHMENT 2 Significance Level Guidance Page 2 of 4 Sig 2 Examples:
2.1 OSHA Recordable personnel injury caused by failure to adhere to personnel safety requirements.
2.2 Any high impact or consequential configuration control occurrence.
2.3 Any missed Tech Spec / ODCM surveillance.
2.4 Any of the following HAZMAT events:
2.5.1 Any chemical or hazardous waste spillage reportable to an outside agency or any spillage that exceeds thresholds established in site procedures 2.5 Inadequate control of safeguards material.
2.6 QA identified programmatic failure or deviation from a regulatory commitment or requirement.
2.7 NRC notice of violation (not including non-cited violations) 2.8 Radiological Safety - Any event which results in:
2.8.1 Violation of Radiation Protection procedures, RWPs, signs, or postings with the potential to cause significant radiological consequences.
2.8.2 Improper work practices or operation of equipment which have the potential to result in significant increase in worker radiation dose.
2.10 Fire requiring action by the Zion Fire Department and that results in significant damage (>$50,000 &
<$200,000) to plant structures and/or equipment.
Page 26 of 31 AD-8 Revision 12 Information Use ATTACHMENT 2 Significance Level Guidance Page 3 of 4 3.0 Sig 3 Examples:
3.1 Failure to use required human performance tools such as peer check, first check, self-check, procedure place keeping, pre-job brief, etc.
3.2 Inadequate documentation of records such as logs, work orders, surveillances, safety evaluations, and design basis documents.
3.3 Configuration control occurrence (those not mentioned in Sig 1 or Sig 2 examples).
3.4 Failure to adhere to personal safety requirements (such as failure to use proper PPE) identified before accident or injury occurred.
3.5 Failure to comply with procedure or direction.
3.6 Work performed without proper certification or qualification.
3.7 Event of similar significance as determined by the ISFSI manager.
3.8 Equipment failure due to inadequate program monitoring or implementation.
3.9 QA audit or Surveillance Deficiency.
3.10 Security Reportable events.
3.10.1 Security door left unsecured 3.10.2 Lost security badge inside the ISFSI security area unless self-identified.
3.10.3 Tailgating 3.11 Radiation Safety 3.11.1 Eating, drinking, or smoking in the RCA.
3.11.2 RP personnel exercise Stop Work authority and the work group does not adhere to it 3.12 Failure to meet CAP process requirements:
3.12.1 Untimely CA/CAPR that results in undesirable consequences.
3.12.2 Inadequate causal analysis resulting in: Repeat Level 1 or 2 Event or inappropriate CA/CAPR.
4.0 Sig 4 Examples:
4.1 A condition not adverse to quality or public safety, or a concern, suggestion, or a question that does not represent a condition adverse to quality or public safety, nonconformance, or program deficiency as defined by Sig Level 1, 2, or 3.
4.2 A condition that would not render equipment, material, documents or procedures unacceptable from a standpoint of quality or public safety.
4.3 Recommendations and Observations resulting from QA Audits and surveillances.
4.4 Other recommendations suggested by internal or external organizations leading to opportunities for improvement.
4.5 Procedure enhancements and typographical errors found in documentation.
Page 27 of 31 AD-8 Revision 12 Information Use ATTACHMENT 2 Significance Level Guidance Page 4 of 4
For cases where the subject of the CR cannot be found, an analogy may be made using the examples provided.
However, if Significance Level cannot be determined, THEN the significance of the deficiency is determined using the table below, by separately estimating the probability and the potential consequences.
Instructions:
- 1. Select the appropriate potential consequences of recurrence of the deficiency, if not corrected, from the table below.
POTENTIAL CONSEQUENCES HIGH Program: Generalized failure of regulatory required program, significant regulatory attention and concern; significant economic and/or schedule impacts.
Facility/Staff: Permanent disability or health damage; significant onsite environmental damage; significant breach of security; loss of use of important system or facility for >3 months; regulatory fines or punitive action within a program or operation.
MEDIUM Program: Program requirement failure, internal Functional Area Management attention/concern; potential economic and/or schedule impact Facility/Staff: Injury requiring treatment beyond first aid, or results in restricted duty, or lost time; partial loss of use of system or facility; immediately detected and recoverable onsite environmental damage; regulatory attention heightened.
LOW Program: Program requirement noncompliance; internal department attention/concern; low potential for economic and/or schedule impact Facility/Staff: Minor injury, minor system or process damage, environmental threat or minimal damage, noncompliance with low potential of regulatory impact, security infractions.
- 2. Select the appropriate probability of the deficiency recurring.
PROBABILITY DEFINITION HIGH Same or similar failure likely to occur often during the remaining life of the facility, operation, or activity.
MEDIUM Similar failure could occur - likely to occur at least once in the remaining life of the facility, operation, or activity.
LOW Similar failure could occur, but remote - not likely to occur in the remaining life of the facility, operation or activity.
- 3. Using the consequences and probability selected from the guidance provided above, determine the significance of the condition.
SIGNIFICANCE POTENTIAL CONSEQUENCES PROBABILITY HIGH MEDIUM LOW HIGH Sig 1 Sig 1 Sig 2 MEDIUM Sig 1 Sig 2 Sig 3 LOW Sig 3 Sig 3 Sig 3
ALL OTHERS = Sig 4: CAs as deemed appropriate by group manager.
Page 28 of 31 AD-8 Revision 12 Information Use ATTACHMENT 3 Issue Review (IR) Template Issue Review for CR-20XX-00XXXX
CR
Title:
(Title of the Condition Report)
CR Significance Level:
Evaluator: (Name of person conducting the IR.) Date: (Date of the IR.)
I. Problem (Provide a clear statement that describes the problem(s) / issue(s) identified by the CR.
Statement: Also, provide a clear statement of what the consequences/impact was resulting from the problem statement. Develop this statement AFTER conducting the IR analysis, so that it accurately reflects the issues / problems, which may vary from what was documented by the author of the CR. Typically the problem and consequences/impact statement can be reduced to one sentence each.)
II. Background / (Include the relevant background information to enable reviewers to understand exactly Analysis: what happened, what the requirements were, and any relevant mitigating circumstances.
Describe how the problem happened and the cause of the problem. Include sufficient analysis to allow the reviewer to link the problem to the cause. Once cause(s) is/are determined identify applicable cause code(s) and event code from Job Aids CAP-JA-01 and CAP-JA-02. Use titles instead of names and use appropriate language. Address Extent of Condition, and Extent of Cause, as applicable. Discuss the research conducted to identify any other cases of the condition identified in the CR. List any other previous conditions that were identified for lessons learned, along with any actions taken or initiated to address them; identify actions below.)
III. Immediate Actions Taken: (List all immediate actions taken to arrest the condition. These are corrective actions that have been taken to correct the deficient or degraded condition. Immediate actions are considered to be those actions completed within two days after the discovery date of the event. Identify any Cause Codes associated with any Immediate Actions.)
1 (Action):
COMPLETED BY:
DATE COMPLETED:
- 2. (Action):
COMPLETED BY:
DATE COMPLETED:
IV. Planned Actions: (List all planned CAs to correct the condition, and to take reasonable measures to ensure it does not happen again. Ensure some action is logically tied to address the cause of the problem. Ensure sufficient actions are included to correct the condition identified in the CR, and any to correct any additional issues identified by the extent of condition review. Include the Owner to whom the action is to be assigned, and include due date for completion of the action. Planned Actions are those actions to be completed greater than two days after the events discovery date. Planned Actions may be complete by the time the IR is reviewed and approved by the MRC, if so; note the completion date. Identify any Cause Codes associated with any Planned Actions.)
1 (Action):
OWNER:
DUE DATE:
- 2. (Action):
OWNER:
DUE DATE:
- 3. (Action):
OWNER:
DUE DATE:
Page 29 of 31 AD-8 Revision 12 Information Use ATTACHMENT 4 Conduct of MRC Page 1 of 2 I. MRC MANDATE A. Review and approve or disapprove of all Sig level, cause evaluation and CA assignments, to ensure:
Primary responsibility to correct the probable causes of the condition is within the Owner organization.
Sig level, cause evaluation and CA assignment are in accordance with the guidance in this procedure.
Timely measures are taken to ensure potential consequences are appropriately addressed in parallel with the cause evaluation or CA.
B. Review and approve or disapprove cause evaluations / IRs for Sig 1, Sig 2 and Sig 3 CRs, and other CA items referred to the MRC by the ISFSI Manager. Ensure the CAP products listed above:
Have been produced in accordance with the procedural guidance.
Present a clear issue description and analysis commensurate with significance Establish appropriate actions Consider extent of condition and extent of cause as appropriate.
Establish a complete record of the issues, and leave no important questions unanswered.
In cases where no actions are necessary, or all required actions have been completed, the CR may be closed to actions taken (CTAT).
C. MRC membership should individually apply Cognitive Trending to the issues identified in CRs, and as a group (i.e., at an MRC meeting) should periodically review KPI / Trend reports, and take actions as follows:
In cases where an MRC member has identified a potential negative trend through Cognitive Trending, an individual should be assigned to investigate the CAP system and report back to the MRC as to the results. If a negative trend is confirmed, a CR should be initiated, and a Common Cause Evaluation assigned.
In cases where an MRC meeting has identified a negative trend through review of KPI / Trend reports, a CR should be initiated, and a Common Cause Evaluation assigned.
Page 30 of 31 AD-8 Revision 12 Information Use ATTACHMENT 4 Conduct of MRC Page 2 of 2 II. MRC COMPOSITION A. The members constituting the minimum Quorum for conduct of the MRC should be:
A Chairperson (ISFSI Manager)
RP/ LTP Management representative CAP Lead Should be individuals involved in day-to-day activities at the site to facilitate Cognitive Trending The Chairperson may authorize deviations from this list B. The following MRC members should attend when possible, but are not required for the quorum:
Quality Assurance representative Regulatory Affairs representative Safety Management representative C. The MRC representatives shall be designated by management. New MRC Members should complete an Orientation/Read & Sign of AD-8 and associated CAP Program Job Aids before becoming voting Members of the MRC.
III. MRC RULES
NOTE:
There may be differences of opinion at times regarding Significance Level, actions to be taken, persons to be assigned action, etc. This is natural, expected, and to an extent beneficial. The MRC should attempt to reach a consensus, but in the interest of effectiveness and efficiency decisions will be based on the opinion of the majority when a consensus cannot be reached.
A. The MRC package shall be distributed to the designated MRC membership sufficiently in advance of the meeting to permit study of the materials prior to the meeting.
B. The MRC attendees shall have read the package before the meeting, and shall be prepared to engage meaningful discussion of the contents at the meeting.
C. A copy of this procedure (latest revision) should be present at the meeting for reference.
In particular, the guidance for significance level and evaluation criteria should be referred to when needed during the discussion, to foster consistency.
D. A Sign-in Sheet shall be distributed to identify those MRC members and others in attendance. A Quorum shall be verified before proceeding. If a Quorum cannot be met, the meeting will be rescheduled, and a CR shall be issued.
E. In general, the MRC should attempt to reach a consensus on all matters dealt with.
However, the majority opinion should be adopted as the decision of the MRC when a consensus cannot be obtained.
F. For IRs and all other MRC issues, a formal vote is not necessary, the Chairperson will state the MRC decision on the topic, and if there are no dissenters, the position will be final.
Page 31 of 31