Clarification to UUSA response for the use of Non-Cited ... · UUSA Facility dated July 10, 2013. 2. IN-13-00079-NRC, NRC Request for Additional Information, Louisiana Energy Services,

OCT 16 2013

LES-13-00144-NRC

Mike G. Raddatz, Project ManagerU.S. Nuclear Regulatory CommissionThree White Flint NorthMailstop: 13A12MWashington, DC 20555-0001

Louisiana Energy Services, LLCNRC Docket No. 70-3103

Subject: Clarification to UUSA response for the use of Non-Cited Violations at theUrenco USA facility.

References:1. LES-1 3-0083-NRC, Request for use of Non-cited Violations for the

UUSA Facility dated July 10, 2013.2. IN-13-00079-NRC, NRC Request for Additional Information,

Louisiana Energy Services, LLC Requesting the use of Non-CitedViolations at the URENCO USA Enrichment Facility dated August 7,2013

3. LES-1 3-0131-NRC, Response to NRC Request for AdditionalInformation on Louisiana Energy Services, LLC Requesting the Use ofNon-cited Violations at the URENCO USA Enrichment Facility datedSeptember 10, 2013

4. Electronic communication from M. Raddatz, NRC, to T. Knowles,UUSA, regarding reference 3.

5. Telephone communication between S. Atack and M. Franovich, NRC,and T. Knowles, UUSA -regarding reference 4 on September 20, 2013.

Louisiana Energy Services, LLC (dba "UUSA") is eager to participate in the NRC pilotProgram to utilize NUREG-2154 as a basis for allowing Non-Cited Violation (NCV) in lieuof Severity Level 4 violations.

Pursuant to reference 4 and reference 5 UUSA submits changes to the QAPD,Enclosure 2 and Corrective Action Program, Enclosure 3 for the NRC's furtherconsideration for inclusion in the NCV program.

Should there be any questions regarding this submittal, please contact TimothyKnowles, UUSA Licensing and Performance Assessment Manager, at 575-394-6212.

Respecfull,

Du 4henodforJay LaughlinChief Nuclear Officer and Head of Operations

Rq Fiinir-p New Mpxirn RR2:•I.USA T'+I1 S7S q94 4646 F-:+I S75 394 4S45 W~wwwiurenroncom/LFE5I FS P0 Rrw 171LES PO Box 1789 Eunice New Mexico 88231 USA T.+1 575 394 4646 F:+1 575 394 4545 :www urenco.corn/LES

Enclosures:1. Response to Electronic Communication from M. Raddatz, NRC, to T.

Knowles, UUSA2. UUSA QAPD Section 16 Mark-ups3. CA-3-1000-01, Corrective Action Program, Revision 27

CC: (with enclosures)

James HickeyBranch Chief, Fuel Facility Branch 2USNRC, Region II245 Peachtree Center Ave, NESuite 1200Atlanta, GA 30303-1257

Brian W. SmithChief, Enrichment and Conversion BranchU.S. Nuclear Regulatory CommissionThree White Flint NorthMailstop: 13A12MWashington, DC 20555-0001

ENCLOSURE1

Response to Electronic Communication fromM. Raddatz, NRC, to T. Knowles, UUSA

UUSA received the aforementioned e-mail communication which references two previous UUSA

responses. The email contents are restated below.

I would also like some clarification of the response to RAI 3, which discusses theinvolvement of the independent review organization (QA) in the review of corrective actiondevelopment, implementation, and verification for significant conditions adverse to quality.Specifically, Some (sic) discussion on what the procedure excerpts mean may be useful.

In response to RAI 4, which asked about the trending of conditions adverse to quality, LESreferenced the QAPD, which identifies that significant conditions will be trended at aminimum. LES also identified that it is their practice to trend all conditions (significant ornot). In order to satisfy the review criteria, the license commitment (QAPD) needs toidentify that all conditions will be trended.

RAI 3 and UUSA's original response are restated below.

RAI 3:

Section 16 of the QAPD states that "The procedure(s) establishing the CAP shall include arequirement for management to take follow-up action to verify implementation of correctiveaction taken to address significant conditions adverse to quality. The quality assurance (QA)organization shall be responsible for conducting periodic audits of these follow-up actions inaccordance with Section 18 of the QAPD."

The acceptance criteria of Draft NUREG-2154 identify that the licensee should implement agraded approach to verify proper implementation and close out the corrective actions in atimeframe consistent with the safety or security significance of the issue, with theindependent organization reviewing the corrective actions for significant conditions adverseto safety or security.

Please describe in the QAPD the involvement of the independent organization (QA) in thereview of corrective actions for significant conditions adverse to quality (i.e., is QA involvedin the review/approval of planned actions, assessment of adequacy of designated orcompleted actions, or only the verification of completed actions).

Original UUSA Response

UUSA is committed to a 10 CFR 50, Appendix B Quality Assurance program asdescribed UUSA's QAPD, which has been approved by the NRC. This includes therequirements detailed in Criterion 16, Corrective Action. These requirements areimplemented in UUSA procedures and programs.

The UUSA QAPD states in section 16:

"The procedure(s) establishing the CAP shall include a requirement for managementto take follow-up action to verify implementation of corrective action taken to addresssignificant conditions adverse to quality. The QA organization shall be responsible forconducting periodic audits of these follow-up actions in accordance with Section 18of the QAPD."

UUSA Procedure CA-3-1000-01, Rev 26 Performance Improvement Program Section5.11.1 states:

"For all SCAQ and CAQ Event Reports that are the result of a QA inspection orsurveillance finding shall be reviewed and approved by QA."

Section 5.13.2.d, CAPRs, CAMRs, CAs, LTCAs, EFRs or other actions1 created duringIdentified SCAQ Root Cause Evaluation states:

"For actions within ERs that QA identified as the Source, obtain approval from QAand document this approval in the action taken section."

UUSA Response to Email Regarding RAI 3

UUSA Procedure CA-3-1000-01, Corrective Action Program, Revision 27, was issued to ensurethat QA has independent review of items classified as Significant Conditions Adverse to Quality;Enclosure 3 of this submittal. Section 4.4.2 remains the same in that the QA organization isnotified when event reports are screened as Condition Adverse to Quality or SignificantConditions Adverse to Quality. Section 5.11 was modified to ensure that QA has both reviewsduring the evaluation phase and the final approval of closure. Please review Enclosure 3 of thissubmittal.

RAI 4 and UUSA's original response are restated below.

RAI 4:

Section 16, "Corrective Action," of the QAPD states that "Significant conditions adverse toquality shall be tracked and evaluated so that adverse trends can be identified andappropriate corrective action can be taken." and [sic] "Procedures shall include requirementsand organizational responsibility for trending which will include significant conditions adverseto quality at a minimum." Further, Section 15, "Nonconforming Items," of the QAPD statesthat "Non-conformance documentation shall be periodically analyzed by the UUSA QAorganization to identify adverse quality trends."

Please identify in the QAPD how UUSA will identify trends in conditions adverse to qualitywhen those conditions do not rise to the level of significant conditions adverse to quality.

Original UUSA Response

UUSA is committed to a 10 CFR 50, Appendix B Quality Assurance program asdescribed UUSA's QAPD, which has been approved by the NRC. This includes therequirements detailed in Criterion 16, Corrective Action. These requirements areimplemented in UUSA procedures and programs.

The UUSA QAPD states in Section 16:

"Procedures shall include requirements and organizational responsibility fortrending which will include significant conditions adverse to quality at a

CAPR - Corrective Action to Prevent RecurrenceCAMR - Corrective Action to Minimize RecurrenceCA - Corrective ActionLTCA - Long Term Corrective Action (Actions that cannot be completed within 120 days)EFR - Effectiveness Review

minimum. Trend evaluation shall be performed in a manner and at afrequency that provides for prompt identification of adverse quality trends.Identified adverse trends shall be handled in accordance with the CAP andreported to the appropriate management."

The UUSA Trending Program reviews all Event Reports, including nonconforming itemsregardless of the significance levels, to determine trends. This process is formallydescribed with procedures CA-3-1000-01, Performance Improvement Program and CA-4-1000-04, Performance Improvement Trend Code Manual. Among other things, theseprocedures provide that 1) ERs are initiated to address adverse trends; 2) the QA FAMwill make a determination after reviewing the Cognitive Trending results on the need toincrease surveillances or audits; and 3) the QA FAM will make a determination, after anadverse trend has been identified, if the condition is such that the Chief Nuclear Officer(CNO) requires prompt notification exclusive of the normal routing or reporting methods.This correspondence will be retained with applicable Event Report Records.

The Event Report Screening Committee and the Performance Assessment Departmentidentify related and/or similar Event Reports for monitoring and identification of trendsduring the screening of each Event Report. This screening is attended by FunctionalArea Managers to ensure the appropriate level of management is involved in theidentification of trends both through trend reports and cognitively through the screeningcommittee.

UUSA Response to Email Regarding RAI 4

Pursuant to reference 5 of this submittal, Telephone communications with S. Atack and MFranovich, UUSA made changes to the UUSA QAPD to reflect observations on behalf of theNRC. These changes, illustrated in Enclosure 2 of this submittal, are consistent with otherlicensed facilities that are incorporated with the NCV program and include trending to includeitems adverse to safety and security. Please review Enclosure 2 of this submittal.

ENCLOSURE 2

UUSA QAPD Section 16 Mark-ups

SECTION 16 Corrective Action

Significant conditions adverse to quality are defined as:

* A deficiency that would seriously impact a QL-1 (inclusive) item, activity or service frommeeting or performing its intended function or output of assuring public health and safety;

apprved or abriatio orLBDCR-" A deficiency in QL-1 (inclusive) design that has been approved for fabrication or 13-0033

construction where the design deviates extensively from design criteria and bases;" A deficiency in the fabrication or construction of, or significant damage to, QL-1 (inclusive)

structures, systems or components that require extensive evaluation, re-design or repair inorder to establish the adequacy of the structure, system or component to perform itsintended function of assuring public health and safety;

* A deviation from QL-1 (inclusive) performance specifications that shall require extensiveevaluation, re-design, or repair to establish the adequacy of the structure, system orcomponent to perform its intended function;

" A significant error in a QL-1 (inclusive) computer program used to support activities affecting 3LBDCR-13-0033quality after it has been released for use;

" A deficiency, repetitive in nature, related to a QL-1 or QL-2 (inclusive), activity, service oritem subject to the LES QAPD; and

* A condition that, if left uncorrected, has the potential to have a serious negative impact onQL-1 or QL-2 (inclusive) activities, services or items subject to the LES QAPD controls.

If a supplier or subtier supplier discovers a defect or noncompliance which the supplierevaluates as a substantial safety hazard, then the supplier shall be required to report the itemunder 10 CFR 21, Reporting of Defects and Noncompliance, and notify LES in writing. If thesupplier or subtier supplier is unable to determine if the defect/non compliance is a substantialsafety hazard then the supplier or subtier supplier is required to report the item to LES fordetermination of reportability. In accordance with the CAP, significant conditions adverse toquality shall be evaluated for a stop work condition to determine if stopping work is warranted. Ifa stop work condition is identified, management shall issue stop work in accordance with theapplicable procedure. Upon completion of action(s) to return the related significant conditionadverse to quality to compliance, management shall take appropriate action to lift and close (inpart or total) the stop work order.

FOLLOW-UP ACTION

The procedure(s) establishing the CAP shall include a requirement for management to takefollow-up action to verify implementation of corrective action taken to address significantconditions adverse to quality. The QA organization shall be responsible for conducting periodicaudits of these follow-up actions in accordance with Section 18 of the QAPD.

Significant Conditions adverse to quality shall be reported to the QA organization for tracking.Responsible management shall then determine the root cause, and corrective action (includingremedial action and actions to prevent recurrence) based on investigation results. Concurrence LBDCR-

from QA organization shall be obtained to ensure that QA requirements are satisfied. The QA 13-0033

organization will verify implementation of corrective actions.

Quality Assurance Program Description Page -1 LES-13-00144-NRC

SECTION 16 Corrective Action

TRENDING

Procedures shall include requirements and organizational responsibility for trending which willinclude conditions adverse to quality, significant conditions adverse to quality, as well asadverse conditions to safety and security. Trend evaluation shall be performed in a manner andat a frequency that provides for prompt identification of adverse quality trends. Identifiedadverse trends shall be handled in accordance with the CAP and reported to the appropriatemanagement.

Pro.edure, shall iRnclde requirements and ergganizational responsibility for trending Which Willinc~lude significant conditionS adverco to quality at a minimum. TrFend evaluation shall beperformed in a manner aRnd at a frequency that prevides for prompt identification of adversequality tr•nds. ldentified advese trends•6hall be handled i•na•ccodance with the CAP andreported to the appro~prfiate mnanagement.

LBDCR-13-0033

Quality Assurance Program Description Page -2 LES-13-00144-NRC

ENCLOSURE 3

CA-3-1000-01, Corrective Action Program, Revision 27

Performance Improvement Program

CA-3-1 000-01

Revision 27

Level 3 - Information Use

Licensing & Performance Assessment Manager

I Effective Date 10/09/2013

URENCO USA

CA-3-1 000-01Rev. 27

Performance Improvement Program Level 3 - Information UseI_ Page 2 of 34

Revision Summary

Change Reason for Change

Inserted Section 4.11 - Security Manager Clarification of responsibilities

Section 5.1, Event Identification - Inserted Clarification of responsibilitiesitems g and h.

Section 5.1.8.c - Inserted item 7. Clarification of responsibilities

Section 5.1.8.i - Inserted item 2. Clarification of responsibilities

Section 5.2.4 - Inserted item b. Clarification of responsibilities

To accommodate CC-LS-2013-005, organizationalSection 5.7.1 .b - add Licensing, Security, change eliminating the Vice President ofand Performance Assessment. Human Regulatory Affairs and General Counsel andPerformance was eliminated, moving Licensing and Performance Assessment

into the Compliance Group.

Section 5.7.1 .c - Replace with Technical To accommodate CC-LS-2013-005, organizational

Services - Plant Engineering, change eliminating the Vice President of

Maintenance, Recycling, Information Regulatory Affairs and General Counsel andServices or Facilities, (Previously 5.7.1.d) moving Licensing and Performance Assessment

into the Compliance Group.

Section 5.7.1 .d - Replace with To accommodate CC-LS-2013-005, organizational

Operations-Shift Operations, Operations change eliminating the Vice President of

Support, Training, Chemistry or Logistics. Regulatory Affairs and General Counsel and(Previously 5.7.1.e) moving Licensing and Performance Assessmentinto the Compliance Group.

Section 5.7.1 .e - Replace with Site To accommodate CC-LS-2013-005, organizational

Projects - Project Engineering, change eliminating the Vice President of

Construction or Construction Support Regulatory Affairs and General Counsel and

(previously 5.7.1.f) moving Licensing and Performance Assessmentinto the Compliance Group.To accommodate CC-LS-2013-005, organizationalchange eliminating the Vice President of

Section 5.7.1 .f - delete Regulatory Affairs and General Counsel andmoving Licensing and Performance Assessmentinto the Compliance Group.

Section 5.7.7.b.1 bullets 1,3, 4, 6, and 7- added "(all inclusive)" to QL-1 and QL-2 LBDCR 2013-0025 - QAPD Clarification andreferences.Section 5.7.8 c added "and BR consistency. Assessment 2013 -0018with an assigned evaluation"


CA-3-1 000-01Rev. 27

Level 3 - Information UsePage 3 of 34

Attachment 1 Event Report Decision Tree- Moved the "Is the description a QL-1G, LBDCR 2013-0025 - QAPD Correction to the Flow1 F, 2 or 2AC item..." "yes" line to the "Is I Chart Assessment 2013 -0018the description a QL-1 item..." box.Section5.7.13 Added step for clarification

Section 5.7.14 Added step for clarification Assessment 2013 -0018

Section 5.7.13 is now 5.7.15 Renumbered



Section 5.11.1 - deleted "Such review and Clarification of the Quality Assuranceapproval is not required for Level BR Department's oversight and involvement in theEvent Reports or SCAQ or CAQ events Corrective Action Program.not identified by QA as findings."

CA-3-1 000-01Rev. 27

Performance Improvement Program Level 3 - Information UseI Page 4 of 34

TABLE OF CONTENTS

1. PURPOSE .............................................................................................................................. 5

2. SCOPE ................................................................................................................................... 5

3. TERMS, DEFINITIONS, ABBREVIATIONS, AND ACRONYMS ....................................... 5

4. RESPONSIBILITIES ..................................................................................................... 6

5. MAIN BODY ........................................................................................................................... 8

5.1 Event Identification .................................................................................................. 8

5.2 Supervisor Review ............................................................................................... 11

5.3 Operability Determ ination ................................................................................... 13

5.4 Licensing Review ................................................................................................. 13

5.5 Temporary Screening Review ............................................................................. 14

5.6 Event Prescreening ............................................................................................. 14

5.7 Event Report Screening Com mittee (ERSC) Screening ...................................... 15

5.8 Event Evaluation ................................................................................................. 20

5.9 SCAQ and CAQ Evaluation Completion ............................................................... 23

5.10 Event Review Board (ERB) Review/Approval ...................................................... 23

5.11 Quality Assurance Department (QAD) Review/Approval ...................................... 24

5.12 SCAQ and CAQ Prescribed Actions ................................................................... 24

5.13 Com pletion of Actions .......................................................................................... 26

5.14 SCAQ and CAQ Extensions ................................................................................. 27

5.15 FAM ER Closure ................................................................................................. 28

5.16 Performance Assessment (PA) ER Closure ........................................................ 29

5.17 Records Action .................................................................................................... 29

6. DOCUMENTATION AND RECORDS ............................................................................. 30

7. LICENSE COMMITMENTS AND REQUIREMENTS ...................................................... 30

8. REFERENCES ..................................................................................................................... 30

ATTACHMENTSAttachment 1, Event Report Decision Tree ............................................................................. 32

FORMSCA-3-1000-01-F-1, Event Report ............................................................................................ 33

CA-3-1000-01-F-2, Evaluation/Corrective Action Extension Request ..................................... 34

CA-3-1 000-01Rev. 27

Performance Improvement Program Level 3 - Information UsePage 5 of 34

1. PURPOSE

1.1 This procedure establishes the URENCO-USA program for the prompt identification,screening, evaluation and resolution of events (Significant Conditions Adverse to Quality,Conditions Adverse to Quality and Business Risk). (7.3, 7.4)

1.2 This procedure satisfies 10CFR50 Appendix B, Section 16 Corrective Action and theSafety Analysis Report, Appendix A, Quality Assurance Program Description, Section 16,Corrective Actions.

1.3 This procedure implements the Performance Improvement Program to identify, evaluateand take action for events and improvement initiatives at URENCO USA.

2. SCOPE

2.1 This procedure applies to all processes, programs, materials, parts, and components atURENCO USA.

2.2 This procedure is applicable to all personnel at URENCO USA.

3. TERMS, DEFINITIONS, ABBREVIATIONS, AND ACRONYMS

3.1 Apparent Cause Evaluation (ACE) - An analysis to determine the most probable cause ofan event based on readily available information.

3.2 Conditions Adverse to Quality (CAQ) - Failures, malfunctions, deficiencies, deviations,defective material and equipment and nonconformances directly associated with a QL-1or QL-2 (all inclusive) item, activity or service.

3.3 Detailed Apparent Cause Evaluation (DACE) - A detailed analysis to determine the mostprobable cause of an event based on readily available information and includes a reviewfor extent of condition.

3.4 Improvement Initiatives - An enhancement, opportunity, recommendation, orimprovement to current processes or procedures.

3.5 Management Measures - Functions applied to Item(s) Relied on for Safety (IROFS) andany items which are essential to the function of IROFS to provide reasonable assurancethat the IROFS are available and able to perform their functions when needed.

3.6 Root Cause Evaluation (RCE) - An analysis technique that identifies the underlyingcause(s) (Root Causes) of a problem or condition and associated corrective actions topreclude recurrence.

3.7 Business Risk Event - An event of sufficient business impact that warrants identification,documentation, evaluation and correction at the discretion of the Functional AreaManager through the Performance Improvement Program. This does not include eventsthat impact QL-1 or QL-2 items or activities.

3.8 Significant Condition Adverse to Quality (SCAQ) - Significant Conditions Adverse toQuality are defined as;

CA-3-1 000-01Rev. 27

Performance Improvement Program Level 3 - Information UseI Page 6 of 34

A deficiency that would seriously impact a QL-1 item (inclusive), activity orservice from meeting or performing its intended function or output of assuringpublic health and safety

A deficiency in QL-1 design that has been approved for fabrication orconstruction where the design deviates extensively from design criteria andbases

A deficiency in the fabrication or construction of, or significant damage to QL-1(inclusive) structures, systems or components that require extensive evaluation,re-design or repair in order to establish the adequacy of the structure, system orcomponent to perform its intended function of assuring public health and safety

A deviation from QL-1 (inclusive) performance specifications that shall requireextensive evaluation, redesign, or repair to establish the adequacy of thestructure, system or component to perform its intended function

A significant error in a QL-1 computer program used to support activitiesaffecting quality after it has been released for use

A deficiency, repetitive in nature, related to a QL-1 or QL-2 (inclusive) activity,service or item subject to the URENCO-USA QAPD

A condition that, if left uncorrected, has the potential to have a serious negativeimpact on QL-1 or QL-2 (inclusive) activities, services or items.

3.9 Suspected Cause - A cause statement based upon a direct observation orknowledgeable/experienced appraisal of the condition.

4. RESPONSIBILITIES

4.1 All personnel

4.1.1 Promptly (should be within one working day of discovery) initiate an EventReport (ER) when an event is identified.

4.1.2 Identify improvement initiatives (which may be entered into the PerformanceImprovement Program through the submission of an Event Report) when apotential improvement opportunity is identified.

4.1.3 Complete basic ZIA user training in order to initiate ERs electronically.

4.1.4 Participate in evaluation and resolution of events as necessary.

4.2 Health Safety & Environmental Mananer

4.2.1 Identify Safety Near Miss Reports that warrant identification of an Event Report.

4.3 Event Report Evaluator

4.3.1 Perform evaluations with the intent of correcting the factor(s) that allowed theevent to occur (when appropriate) as well as correcting the identified event.

CA-3-1 000-01Rev. 27


4.4 Event Report Screening Committee (ERSC)

4.4.1 Meet on a frequency adequate to support the timely screening of EventReports.

4.4.2 Notify the Quality Assurance Manager when a Significant Condition Adverse toQuality is identified.

4.4.3 Review/Approve requests to change the Significance Level or evaluationmethod for CAQs or SCAQs..

4.4.4 Review/Approve Root Cause charters (CA-3-1000-03-F-1) within two workingdays of Event Report Screening.

4.4.5 Review Event Reports for any apparent adverse trends as part of initialscreening.

4.4.6 Perform a screen of each Event Report to determine if the event is a CAQ,SCAQ or Business Risk.

4.4.7 Identify and document in ERSC screening comments, if aware of the fact, thatthe new ER is related to a previous or pending NRC Notice of Violation. (7.1)

4.5 Functional Area Manager

4.5.1 Ensure timely and adequate evaluation of the Event Report.

4.5.2 Ensure timely completion of actions.

4.5.3 Approve Evaluations and Actions within their functional area.

4.5.4 Provide a summary of actions taken for Business Risk items in the EventReport Closing Comments.

4.6 Managers and Supervisors

4.6.1 Foster a work environment that encourages prompt identification of events inthe Performance Improvement Program.

4.6.2 Support timely evaluation and resolution of events.

4.7 Operations Shift Managers

4.7.1 Perform timely and accurate Operability Determinations of conditions anddocument in Event Reports.

4.8 Licensing & Performance Assessment Manager

4.8.1 Designate the Chairperson of the Event Report Screening Committee.

4.8.2 Ensure the Performance Improvement Program meets all regulatoryrequirements.

4.8.3 Ensure Event Reports submitted are reviewed for priority and temporary review.

4.8.4 Foster a culture in which the Performance Improvement program is valued asthe means to improve performance at URENCO-USA.

CA-3-1 000-01Rev. 27


4.8.5 Initiate an Event Report for the Potential Notice of Violations (identified duringthe NRC Exit Meeting).

4.8.6 Confirm Event Report issued for Notice of Violations identified in an NRCInspection Report.

4.8.7 Review and approve actions coded as commitments. (8.2.5)

4.9 Quality Assurance Mananer

4.9.1 Review and approve evaluations and closure for Event Reports initiated as aresult of QA audit or surveillance findings.

4.10 Senior Management

4.10.1 Maintain the resources to ensure timely identification, reporting and resolutionof issues.

4.10.2 Maintain a culture in which the Performance Improvement Program is viewedas the foundation of strong safety culture.

4.11 Security Manager

4.11.1 Ensure security related events are reported in a timely manner whilemaintaining the classification of issues.

5. MAIN BODY

NOTE:

Names may only be used in an ER when providing contact information. Use titles whendescribing the actions of individuals.

NOTE:

The term Event Report and Condition Report are interchangeable throughout thisProcedure.

5.1 Event Identification

5.1.1 An Event Report shall be written if:

a. A nonconformance is identified in accordance with EG-3-2100-09.

b. A failure or degradation of an IROFS occurs.

c. A failure or degradation of a management measure occurs.

d. Personnel dose monitoring results exceed the administrative personnellimits.

e. An incident results in airborne occupational exposures exceeding theadministrative limits.

CA-3-1 000-01Rev. 27


f. The dose limits in 10 CFR 20 Appendix B or 10 CFR 70.61 are exceeded.

g. A failure or degradation of security equipment.

h. A non-compliance with security processes or procedures.

5.1.2 If an action is coded as a commitment, then assign the Licensing/PerformanceAssessment Manager as the FAM for approval of the action. (8.2.5)

5.1.3 An Event Report may be written when an improvement initiative is identified.

5.1.4 Event Reports should be initiated within one working day of identification of theevent using the ZIA software (preferred) or CA-3-1 000-01-F-1, Event Report.

5.1.5 Initiate anonymous Event Reports using CA-3-1 000-01-F-1, Event Report.

5.1.6 When multiple events have been identified, initiate a separate Event Report foreach event unless the events are related to each other.

5.1.7 Immediately notify the Shift Manager if a condition is identified that involves asafety hazard, equipment that may be inoperable or may be reportable.

5.1.8 Complete the Problem Identification section of the Event Report as follows:

a. Source-Identify the source that identified the condition:

1) External - Events identified by an organization outside of URENCO-USA, including the Nuclear Regulatory Commission, OSHA, TheState of New Mexico, Department of Transportation, businesscustomers. This does not include contractors performing work forURENCO-USA.

2) QA - Quality Assurance - Events identified by company QualityAssurance functions.

3) SI - Self Identified - Events identified by personnel within theURENCO-USA organization and contractors performing work forURENCO-USA.

4) SR - Self Revealing - Events that are identified when an equipmentabnormality signals that a problem has occurred and the individualimmediately discovers the problem as a result of the signal.

b. Title - A short one-line summary of the event.

c. Description of Condition - A detailed description of the event.

1) Write the description such that the average person somewhatknowledgeable of the program, process or system but not theproblem, can understand the event and its implications.

2) Describe the condition fully. Include all known information. Identifyand document, if aware of the fact, that the new ER is related to aprevious or pending NRC Notice of Violation. (7.1)

CA-3-1 000-01Rev. 27


3) Define acronyms and abbreviations the first time they are usedunless they are commonly known.

NOTE:Purchase Order information can be found on the Material Requisition sheet contained inthe identified work plan or on the receipt inspection documents for the material.

4) Include specifics such as document numbers, piece numbers,component numbers, Purchase Order Numbers and name of Vendorinvolved.

5) Clearly indicate what are facts, what are interpretations and what areopinions.

6) Identify the workgroup(s) involved if known.

7) Security related events shall state the problem in generic terms tomaintain the appropriate classification.

d. Immediate Actions Taken - The actions taken to correct the event ormitigate the consequences.

e. Procedure/Criteria Violated - A list of the procedures, specifications,requirements, etc. that have not been complied with.

f. Suggested Corrective Action - The actions, suggested to the evaluator, toresolve the event if actions beyond immediate actions taken arewarranted.

g. Originated/Identified By - The identified date and name of personidentifying the condition.

1) Enter the date the issue was identified. The identified date willdefault to the date the ER was created.

2) The Event Report Identifier will default to the person creating the ER.If the issue was identified by a different ZIA user, enter that person.

3) If the Event Report is anonymous, select the Anonymous user.

4) If the Event Report Identifier cannot be chosen, leave the name thesame as the ER creator and indicate the Event Report identifier bytitle in the Description of Condition.

h. Building/System - This is the building and system where the event hasoccurred.

1) Indicate the building where the issue occurred

2) Indicate the System associated with the issue

3) Select the identifiers supervisor (supervisor must be a ZIA user)

CA-3-1 000-01Rev. 27


4) Type in the supervisors phone number

i. Attach any supporting documents or reference material that may not beavailable to the supervisor or evaluator.

1) For Event Reports (ER) that identify non-conformances as defined inQuality Assurance Program Description (QAPD) Section 15"NONCONFORMING ITEMS", attach a copy of the approved NCRinitiation form (EG-3-2100-09 F-I). Ensure that the original NCR isforwarded to the NCR Coordinator in accordance with EG-3-2100-09, "Identification, Disposition, and Resolution of Nonconformingitems" for processing.

2) For ERs that identify security related events, ensure attachments donot contain classified information. Reference of location of relateddocuments should be noted.

NOTE:

Once initiated, only the ER Originator may authorize deletion of the Event Report. TheER will be labeled as deleted, but retained in the ZIA database.

j. Initiate the ER as follows:

1) If the ER is being created in ZIA, initiate the ER by clicking theSubmit button.

2) If a Near Miss Report is submitted, HS&E representative orPerformance Assessment will initiate an ER.

3) If the ER is being initiated anonymously, send the ER toPerformance Assessment.

4) If the ER is being created on the paper form, deliver it to thereviewing supervisor.

5) Immediately notify the supervisor verbally that the ER is ready for theSupervisor Review.

5.2 Supervisor Review

5.2.1 The supervisory review should be completed within one working day of EventReport submittal.

5.2.2 Review the ER and determine if the originator has adequately described theissue per section 5.1.

a. Return the ER to the originator as follows to have information added orcorrections made.

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1) Click the Return to Originator button.

2) Describe in the Signature Comment screen the changes theOriginator is to make.

3) Click the Save button to return the ER to the Originator.

4) Discuss the changes verbally with the Originator to ensureunderstanding.

5) Follow up to ensure timely response to comments and re-submittalfor Supervisory Review.

b. Provide additional or clarifying information in the supervisory comments asneeded.

c. Contact the Control Room for any event which involves equipment issues.

5.2.3 Complete the Building/System section of the event report as follows

a. Management Measures Affected - Select the management measure,associated with the affected IROFS that is described in the Description ofCondition.

1) Audits and Assessments

2) Configuration Management

3) Incident Investigations and Corrective Action Process

4) Maintenance

5) N/A

6) Other Quality Assurance Elements

7) Procedures Development and Implementation

8) Records Management

9) Training and Qualifications

b. Items Relied On For Safety Affected - Indicate the IROFS affected by theDescription of Condition. If none, state None.

c. Adverse To Quality - Indicate whether the Description of Event is Adverseto Quality.

d. Stop Work lAW AD-3-1000-08 - Indicate whether a Stop Work wasinitiated or is needed per AD-3-1000-08.

e. Interim Action - Indicate yes if additional interim actions are required toprotect plant equipment or comply with license requirements. Documentthe needed actions in the supervisor comments. This information will beused by the evaluator.

f. NCR lAW EG-3-2100-09 - Indicate whether an NCR is required.

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g. Promptly Reportable lAW LS-3-1000-05 - Indicate Yes if the conditionrequires a prompt (24 hours or less) report to the NRC or other regulatorybody using the guidance in LS-3-1000-05, Notifications and EventReporting. Get assistance from Licensing personnel as needed.

5.2.4 Attach any supporting documents or reference material that may not beavailable to the evaluator. Identify and document, if aware of the fact, that thenew ER is related to a previous or pending NRC Notice of Violation. (7.1)

a. For Event Reports (ER) that identify non-conformances as defined inQuality Assurance Program Description (QAPD) Section 15"NONCONFORMING ITEMS", attach a copy of the approved NCRinitiation form (EG-3-2100-09 F-i). Ensure that the original NCR isforwarded to the NCR Coordinator in accordance with EG-3-2100-09,"Identification, Disposition, and Resolution of Nonconforming items" forprocessing.

b. Security related ERs should identify the location of documentationassociated with the problem identification description.

5.2.5 If the Event Report was initiated on paper, scan and attach it to the ZIA record.

5.2.6 Complete the Supervisor Review in ZIA by clicking the Review Completebutton.

5.3 Operability Determination

5.3.1 If the Operability review has been previously saved, click the Revise OD buttonto allow editing.

5.3.2 In the determination section, select N/A, Inoperable, Operable, Operable butDegraded or Operable but Nonconforming.

5.3.3 Fill in the Operability Comments as required by OP-3-1000-09.

5.3.4 Save the Operability Determination by clicking the Save OD button.

5.3.5 If the Operability Determination is to be closed, click the Close OD button.

5.4 Licensing Review

5.4.1 Perform a reportability determination lAW LS-3-1000-05, Notifications andEvent Reporting.

5.4.2 Document the reportability determination in the Basis for Determination-Comments.

a. If the ER identifies a deficiency related to a basic component (IROFS) or aQL-1 service, then initiate an UUSA Part 21 Screen in accordance withLS-3-1000-01, Implementation of 10CFR21.

5.4.3 If the event is determined to be reportable, then attach the Event NotificationWorksheet or a summary of the information provided to the regulatory agencies,to the Event Report.

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5.4.4 If the supervisor has determined the condition to be promptly reportable,document the following:

a. The date and time the report was made to the regulatory agency.

b. How the report was delivered to the regulatory agency.

c. The title of the person the report was delivered to.

5.4.5 Click the Ready to Complete Licensing button to accept the assignment.

5.4.6 If the event is promptly reportable, click the Submit button to indicate that theprompt notification was completed.

5.4.7 Click the Submit button to complete the evaluation.

5.5 Temporary Screening Review

NOTE:

When business conditions warrant, Event Reports may be processed prior to ERSCreview

5.5.1 Contact the prospective Assignee for concurrence.

5.5.2 Document in the screening comments the temporary review.

5.5.3 The Licensing & Performance Assessment Manager or designated alternate willauthorize the temporary screening review.

5.5.4 Event Reports undergoing temporary review will be presented at the nextscheduled ERSC meeting.

5.6 Event Prescreeninq

5.6.1 Review each Problem Identification and Supervisor comment to ensure theevent is clearly stated with appropriate supporting documentation.

5.6.2 IF insufficient information is documented limiting completion of prescreening,THEN return Event Reports to the Reviewing Supervisor/originator forappropriate information. The Supervisor/originator shall be contacted verballyto ensure understanding of the comments.

5.6.3 Perform the following to prepare each SCAQ/CAQ Event Report for the EventReport Screening Committee (ERSC) review.

a. Recommend a SCAQ or CAQ significance level

b. Recommend an Evaluation method

c. Recommend a FAM to own the ER

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d. Provide a list of similar previous events for use during the evaluation.Identify and document, if aware of the fact, that the new ER is related to aprevious or pending NRC Notice of Violation. (7.1)

e. Assign Event Codes based upon the Description of Event.

f. Verify names in the ER text are only used to provide contact information.

g. Correct typographical and grammar errors.

5.6.4 Perform the following to prepare each Business Risk Event Report for the EventReport Screening Committee (ERSC) review.

a. Recommend a FAM to own the ER.

b. Provide a list of similar previous events for use during FAM assessment.

c. If the new ER is related to previous or pending NRC Notice of Violationensure the ER is assigned a CAQ significance level per Section 5.6.3.

d. Assign Event Codes based upon the Description of Event.

e. Verify names in the ER text are only used to provide contact information.

f. Correct typographical and grammar errors.

5.7 Event Report Screening Committee (ERSC) Screeninq

5.7.1 ERSC membership includes Functional Area Managers (or designees) thatrepresent the following work groups.

a. Chief Financial Officer and other CEO groups - Information TechnologyCommunications, Total Rewards, Procurement or Finance.

b. Compliance - HS&E, Safeguards, Radiation Protection, Licensing,Performance Assessment, Security, or Emergency Preparedness..

c. Technical Services - Plant Engineering, Maintenance, Recycling,Information Services or Facilities.

d. Operations-Shift Operations, Operations Support, Training, Chemistry orLogistics.

e. Site Projects - Project Engineering, Construction or Construction Support

5.7.2 A quorum of members consists of the Chairperson and representatives of twoof the other membership groups.

5.7.3 The ERSC chairperson will make decisions when the quorum members cannotreach a consensus.

5.7.4 Identify Significant Conditions Adverse to Quality and document in the ERSCcomments.

a. Significant Conditions Adverse to Quality shall review the description ofthe event for potential stop work.

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5.7.5 Identify and document in ERSC comments, if aware of the fact, that the new ERis related to a previous or pending NRC Notice of Violation. (7.1)

5.7.6 Review the Problem Description prior to the ERSC meeting to ensure the issueis clearly understood, supported with facts and applicable documentation isattached.

a. If ERSC rejects an ER for insufficient documentation, comments shall bedocumented in the Screening comments by Performance Assessment.

1) ERSC shall assign the respective member to discuss the commentsverbally with the Supervisor/originator.

b. Performance Assessment shall:

1) Return the ERSC rejected Event Report to the Reviewing Supervisorfor action.

2) Track on the ERSC Screening Report all Event Reports returned byERSC.

5.7.7 Determine the Event Report significance level. Refer to Attachment 1, EventReport Decision Tree

a. If the description directly involves a QL-1, QL-1G, or QL-1F item, service,function or is essential to the function of an IROFS, then the significancelevel is a Condition Adverse to Quality (CAQ). Examples

" IROFS is degraded or inoperable

* Essential function to support an IROFS is degraded orinoperable

" Violation of a QL-1, 1 G or 1 F work package work steps thatcreates a non-conformance or impacts the function of theequipment.

* QL-1 nonconformance

* Work Notification associated with an IROFS

" Failed surveillance for an IROFS

* Service provided by a QL-1 vendor for QL-1 services or items

" Failure to construct within the requirements of a QL-1, I G or 1Fdesign.

b. If the description directly involves a QL-2 or QL-2AC item, service,function or affects an IROFS but not essential to it's function, then thesignificance level is a CAQ. Examples:

Support function not essential to the functionality or operabilityof an IROFS

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* Functionality of an Administrative IROFS

* QL-2 nonconformance

Violation of a QL-2 Work Package that creates a non-conformance or impacts the function of the equipment.

* Service provided by a QL-1 vendor for a QL-2 service or item

* Commercial Grade Dedication of an item or service

* Failure to construct within the requirements of a QL-2 design.

1) If the CAQ meets any of the criteria below, the significance level is aSignificant Condition Adverse to Quality (SCAQ).

" A deficiency that would seriously impact a QL-1 (inclusive)item, activity or service from meeting or performing its intendedfunction or output of assuring public health and safety.

* A deficiency in QL-1 design that has been approved forfabrication or construction where the design deviatesextensively from design criteria and bases.

" A deficiency in the fabrication or construction of, or significantdamage to QL-1 (inclusive) structures, systems or componentsthat require extensive evaluation, re-design or repair in order toestablish the adequacy of the structure, system or componentto perform its intended function of assuring public health andsafety.

* A deviation from QL-1 (inclusive) performance specificationsthat shall require extensive evaluation, redesign, or repair toestablish the adequacy of the structure, system or componentto perform its intended function.

* A significant error in a QL-1 computer program used to supportactivities affecting quality after it has been released for use.

* A deficiency, repetitive in nature, related to a QL-1 or QL-2(inclusive) activity, service or item subject to the URENCO-USAQAPD.

* A condition that, if left uncorrected, has the potential to have aserious negative impact on QL-1 or QL-2 (inclusive) activities,services or items subject to the URENCO-USA QAPD controls.

c. If the description directly involves a failure or deficiency of the ISA processthen the significance level is a CAQ.

d. If the description directly involves a potential for regulatory impact on the18 criterion of the QAPD, then the significance level is a CAQ.

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e. Level CAQ Condition Reports - describe Condition Adverse to Quality.

Examples include but are not limited to:

1) An event indicating a programmatic breakdown of a QL-1 or QL-2 (allinclusive) program.

2) An adverse trend of a QL-1 or QL-2 (all inclusive) items or servicesfor which past corrective actions have not proven adequate toresolve.

3) Effectiveness Review failed to meet acceptance criteria.

4) A QL-1 or QL-2 (all inclusive) equipment condition that reduces themargin of safety.

5) Cited violations or equivalent identified in an inspection report fromNRC.

6) Failure to follow QL-1 or QL-2 (all inclusive) work plan or procedure.

f. If the description is not QL-1 or QL-2 but involves a significant risk to theorganization or an identified trend, then the significance level is aBusiness Risk (BR) with an assigned evaluation. Examples:

* Excavation involving the damage to electrical equipment.

" Electrical arc flash

* Lost time accident

* Violation of the environmental discharge permit

* Rework causing an unplanned loss of production

" Adverse trends

" A human performance event which results in a site clock reset.

g. If the description involves a QL-3 item, service or activity and does notpose a significant risk to the organization, then the significance level is a(BR) with no an assigned evaluation.

5.7.8 Determine the SCAQ/CAQ Event Evaluation Method

a. A Significant Conditions Adverse to Quality (SCAQ) is to be assigned aRoot Cause Evaluation.

b. Consider assigning a Common Cause Evaluation (CCE) when an EventReport identifies multiple similar or related SCAQ or CAQ events.

c. Utilize the Risk Confidence matrix to assist in determining the evaluationmethod for all CAQ and BR Event Reports with an assigned evaluation.Functional Area Managers may utilize this matrix for any Business Risk(BR) item.


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Level 3 - Information UsePage 19 of 34

1) The evaluation method is chosen based on both risk and confidence.For example, an event with a high risk of future undesirableconsequences and a low confidence that the cause is understoodwill warrant a Root Cause Evaluation. Similarly, a low risk ofrecurrence with a high confidence that the correct cause is knownwill warrant a Fix and, if applicable, a determination that the ER canbe closed to actions taken/trending.

* Confidence - is the amount of confidence that the cause isunderstood sufficiently to correct conditions without furtherinvestigation.

* Risk - Means the risk that undesirable consequences(recurrence) will occur again if the cause is not corrected. Thenumber of previous similar Event Reports may indicate that thecause has not been identified/corrected and will be factoredinto the screening determination of the evaluation method.

Confidence

Risk Low Medium High

High Root Cause Detailed ApparentEvaluation Apparent Cause

Cause EvaluationEvaluation

Medium Detailed Apparent SuspectedApparent Cause Cause

Cause EvaluationEvaluation

Low ApparentCause

Evaluation

SuspectedCause

Fix

5.7.9 Consider directing Event Review Board (ERB) review of Apparent CauseEvaluations by considering the following factors:

a. Issues/events that have the potential for regulatory implications.

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b. QL-1 or QL-2 (all inclusive) issues/events that have occurred repeatedly.

c. Issues/events that were investigated using an ACE/DACE/RCE that havenot been successful in minimizing/precluding recurrence of the event.

5.7.10 Assign the FAM to own the ER.

a. The FAM is to be in the group that can best correct the condition and itscauses.

5.7.11 Establish the evaluation due date (normally 30 days) for all SCAQ and CAQEvent Reports.

5.7.12 Business Risk Event Reports will not be assigned a due date and the EventReport will be stepped through to FAM closure by Performance Assessmentfollowing approval by ERSC.

5.7.13 If a BR Event Report is requested to remain open at the evaluation stage, thenestablish a due date (normally 30 days) for completion of the evaluation.

5.7.14 If a BR Event Report identifies a significant risk to the organization or isrequested by the assigned FAM (or ERSC representative) the evaluation maybe designated as requiring a specific evaluation method.

5.7.15 Identify Significant Conditions Adverse to Quality and document in the ERSCcomments.

5.7.16 Direct, by using the ERSC Comments:

a. Additional items to be addressed in the evaluation (such as extent ofcondition) for SCAQ or CAQ level items.

b. Identify in the ERSC Comments known risks to UUSA for Business RiskEvent Reports.

c. Address in the evaluation why previous corrective actions were noteffective in resolving the prior/pending NRC Notice of Violation. (7.1)

5.7.17 Review for approval FAM requests to downgrade previous ER or CR screeningdeterminations for significance level and evaluation method.

5.8 Event Evaluation

5.8.1 Perform the following for all SCAQ and CAQ evaluation methods.

a. Review all ER text and attachments to ensure a good understanding of thecondition.

b. Review the Immediate and Suggested corrective actions.

1) Document completion of the immediate actions.

2) If the suggested actions are appropriate, document completion of theactions or create corrective actions lAW step 5.9.

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3) If suggested corrective actions will not be completed, document thereason.

c. Review previous ERs and CRs identified in the PAF comments to gaininsight into the effectiveness of previous actions. Document the results ofthis review in the evaluation.

d. If the previous events indicate a potential adverse trend, initiate a new ERto evaluate the potential trend.

e. If, during the evaluation, a new or similar Condition Adverse to Quality isidentified, then initiate a new Event Report. (7.2)

f. Address any ERSC comments and document in the evaluation.

g. For Event Reports, if known, related to prior/pending NRC Notice ofViolation, address why previous corrective actions were not effective inresolving the prior/pending NRC Notice of Violation. (7.1)

h. During the course of an evaluation, if the FAM determines the issue doesnot warrant the significance level or method of evaluation, the FAM mayreturn (with justification) to ERSC and request a downgrade per section5.7.

i. During the course of an evaluation, if the FAM determines the issueshould warrant an upgrade in the significance level or method ofevaluation, notify Performance Assessment to initiate the changes in ZIA.

5.8.2 The evaluation involving a QL-1 or QL-2 (all inclusive) receipt inspection, fieldinspection or other material deficiency with an NCR should address thefollowing:

a. Explain how this material degradation occurred (cause) in order to assignresponsibility for the occurrence (UUSA: material was dropped; vendor:material received damaged),

b. Identify if the vendor has been notified and what was the vendor response(i.e., return material, they will come and repair, etc).

c. If the vendor was not notified include an action for Procurement to notifythe vendor of the material deficiency if determined it was caused by thevendor.

d. Include an action for Procurement to recover costs related to resolving thisNCR from the identified vendor (LES to repair/rework the material andback charge the vendor depending on the result of the NCR dispositionand scheduled need date) or request the vendor to perform the identifiedrepairs, rework, or replacement of the material if rejected..

e. If an NCR was identified / initiated, ensure the closed NCR is attached tothe Event Report or an action assigned to track the NCR for closure.

5.8.3 For the CAQ Fix evaluation method:

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a. Determine the prescribed actions needed to correct the condition. Forexample, if a procedure is in error, the prescribed action should be torevise and issue the procedure.

5.8.4 For the CAQ Suspected Cause evaluation method:

a. Perform the actions in step 5.8.3 for a CAQ Fix evaluation.

b. Determine the suspected cause(s) of the condition. For example, if aprocedure is in error, the suspected cause(s) answers the question 'Whyis the procedure in error?'

c. State the suspected cause in the evaluation beginning with 'Thesuspected cause is .....

d. Ensure that all causes have prescribed or completed actions.

5.8.5 For Common Cause Evaluations, complete the evaluation lAW CA-3-1000-07,Common Cause Evaluation Guidelines.

5.8.6 For the Detailed Apparent Cause Evaluation or Apparent Cause Evaluationmethods, complete the evaluation lAW CA-3-1000-02, Apparent CauseEvaluation Guidelines.

5.8.7 For the Root Cause Evaluation method, complete the evaluation lAW CA-3-1000-03, Root Cause Evaluation Guidelines.

5.8.8 For all Business Risk Event Reports the responsible FAM will:

a. Determine the investigation process and actions to be taken based on theassociated risks.

b. Determine the completion time of any investigation and actions basedupon the identified risk.

c. May request the Event Report to be reset by Performance Assessment toallow use of the evaluation and/or actions section of the ZIA program.

1) If the responsible FAM elects to use the evaluation and/or actionsections within ZIA all the associated requirements will be adhered tofor completion of the Event Report.

d. Provide a summary of the investigation and actions taken in the closurecomments in ZIA

5.8.9 Previously ERSC assigned Event Reports are reassigned based upon the FAMdetermination:

a. Such Event Reports do not have to return for re-screening by ERSC.

b. The FAM will secure the concurrence of the new FAM to accept the EventReport, and make the reassignment in ZIA with documentation for thetransfer acceptance in the comment field.

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5.9 SCAQ and CAQ Evaluation Completion

5.9.1 If the evaluation was documented in a separate document, perform thefollowing.

a. Attach the report to the ZIA Evaluation Tab as a single pdf file (if possible).

b. Provide an executive summary for each required section of the evaluationTab.

5.9.2 If the evaluation is to be recorded in the Results of Investigation and Evaluationsection, type the evaluation into this section.

5.9.3 Attach any documentation that substantiates the evaluation.

5.9.4 Complete the evaluation in ZIA by clicking the Submit button. [Evaluator]

NOTE:

The person approving the evaluation is an independent review and should not be thesame person who performed the evaluation.

5.9.5 Approve or Reject the evaluation within five business days of the evaluationcompletion as follows: [FAM]

a. If the evaluation is acceptable, approve the evaluation in ZIA by clickingthe Approve button.

b. If the evaluation needs to be corrected, return the evaluation to theevaluator.

1) Verbally discuss with the evaluator the reasons for the rejection.

2) Prior to rejecting the item, the FAM will evaluate all Event Reportevaluation and actions to determine if an extension is needed.

3) Click the Reject button in ZIA.

c. Follow up with the evaluator to ensure timely completion for theevaluation.

d. Initiate an extension request if needed, should the rejection occur after theestablished due date, and will not be resubmitted on the same workingday.

5.10 Event Review Board (ERB) Review/Approval

5.10.1 Evaluations requiring ERB review/approval will be processed in accordancewith CA-3-1000-06, Event Review Board.

5.10.2 Performance Assessment will document the ERB approval in ZIA withappropriate ERB meeting documentation.

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5.11 Quality Assurance Department (QAD) Review/Approval

5.11.1 All SCAQ and any CAQ Event Reports resulting from a QA audit or surveillancefinding shall be reviewed and approved by QA.

a. QAD will review Event Reports and document in ZIA.

1 ) QAD approval/disapproval of the Event Report evaluation.

2) QAD approval/disapproval of the Event Report Closure.

b. If QAD disapproves any of the above steps (i.e., Event Report evaluationand Event Report Closure)

1) QAD will verbally discuss all rejections with the appropriate FAMprior to pushing the reject button.

2) The reason for a QAD rejection will be documented in the commentfield in ZIA.

3) Recommend extension if due date is past due.

5.12 SCAQ and CAQ Prescribed Actions

5.12.1 Develop prescribed actions for each condition requiring correction and for eachcause identified during the evaluation unless the action is documentedcomplete in the evaluation.

5.12.2 If an action is coded as a commitment, then assign the Licensing andPerformance Assessment Manager as the FAM for approval of the action. (8.2.5)

5.12.3 Additional NRC commitments shall be entered as corrective actions. Theaction(s) may be created after the evaluation has been approved.

5.12.4 Click the Add Corrective Action button to add a new action.

5.12.5 Select the Actions Impact Level:

a. CAPR (Corrective Action to Prevent Recurrence) - The action is intendedto correct a root cause.

b. CAMR (Corrective Action to Minimize Recurrence) - The action is intendedto reduce the chance that the condition will occur again.

c. CA (Corrective Action) - The action is intended to correct the condition orthe cause.

d. Other - Other actions that do not meet the intent of CAPRs, CAMRs andCAs.

e. LTCAs (Long Term Corrective Actions) - Actions that cannot be completedwithin 120 days of initiation of the action.

f. EFR (Effectiveness Review) - The action is intended to evaluate theeffectiveness of other actions.

5.12.6 Regulatory Issue - Check Yes if the CR describes one or more of the following:

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a. Regulatory Commitment

b. Notice of Violation

c. 10CFR21.21 Reporting of Defects and Noncompliance.

d. Reportability Issue

5.12.7 Special Code - Select the appropriate code if the action is to be associated withone of the special tracking codes.

5.12.8 Develop prescribed actions using the SMART philosophy explained below:

a. The S in SMART stands for Specific. The prescribed action should bespecific enough so the person performing the action can perform theaction as intended without researching other documents or contacting theauthor.

b. The M in SMART stands for Measurable. The prescribed action shouldclearly indicate the desired condition when the action is completed so thata reviewer can easily determine the completion of the action.

c. The A in SMART stands for Accountable. The prescribed action is writtenso that it is clear who is to implement the action.

d. The R in SMART stands for Reasonable. The prescribed action should bewithin the control of the person/organization assigned to implement theaction.

e. The T in SMART stands for Timely. The action due date should allowsufficient time to complete the action but be performed expeditiously toprevent repeat events before the action is implemented.

5.12.9 Action Due Date - Establish the action due date to ensure the action iscompleted in a timely manner.

5.12.10 Obtain concurrence for the prescribed action and due date from both theassignee and the assignee's manager before submitting to the assignee.

5.12.11 Click the Assignment/Reassignment button and assign 'Accept Action',Submit Action' and 'Approve Action' to individuals.

5.12.12 Click OK to return to the new action screen.

5.12.13 Click Save to save the changes to the assignments.

5.12.14 Click Submit to Assignee and then close the new action screen.

5.12.15 After all of the actions have been created in ZIA, click the Click Here When AllActions Have Been Created button in the evaluation section.

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5.13 Completion of Actions

5.13.1 Click Accept to make the Action Taken section available for editing.

NOTE:

It is a change of intent to use another process or another Event Report to complete aprescribed action.

5.13.2 Perform Actions as intended in the prescribed action section. If the intentcannot be satisfied, then obtain approval for the change of intent as follows:

a. The ERB will review any changes to the corrective actions for RCEspreviously approved by the ERB.

b. For CA and Other Actions impact levels, obtain approval from the FAMthat is assigned to approve the closure of the ER and document thisapproval in the action taken section.

c. For actions that have Yes in the Regulatory Commitment field, obtainapproval from Licensing and document this approval in the action takensection.

d. For actions within ERs that have QA Identified as the Source, obtainapproval from QA and document this approval in the action taken section.

5.13.3 Document, in the Action Taken section, what was performed to complete theprescribed action using the following guidelines:

a. Use past tense instead of present or future tense (ie 'has been' rather than'is being' or 'will be'.

b. Reference any documents that provide supporting evidence of actioncompletion.

c. For documents that will not be attached, include sufficient informationsuch that the documents can be retrieved from Intellidox (documentnumber, revision, date, etc).

d. Use direct wording such that an independent reader will have confidencethat the prescribed action was performed as intended.

5.13.4 Attach any referenced documents that are not available in Intellidox.

5.13.5 Complete the action in ZIA by clicking the Submit button. [Assignee]

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NOTE:

The person approving the corrective action is an independent review and should not bethe same person who performed the corrective action.

5.13.6 Approve or Reject the action as follows: [FAM]

a. Conditions Adverse to Quality have documentation to substantiatecompleted actions taken.

b. If the action taken is acceptable, approve the action in ZIA by clicking theApprove button.

c. If the action taken needs to be corrected:

1) Return the action taken to the assignee by clicking the Reject buttonin ZIA.

2) Verbally discuss with the assignee the reasons for rejection.

3) Initiate an extension request if needed, should the rejection occurafter the established due date.

4) Verify the due date provides sufficient time to complete the action.

5.14 SCAQ and CAQ Extensions

5.14.1 Submit extensions for final approval in advance of the due date to allowsufficient time to either complete the evaluation/action or to extend theevaluation/action prior to the due date.

5.14.2 For RCE, CCE, DACE and ACE evaluations and the actions associated withthese evaluations, complete CA-3-1000-01-F-2, Evaluation/Corrective ActionExtension Request.

a. Obtain the approvals specified on the form.

b. Attach the form to the ZIA record as a pdf file.

c. Complete the ZIA extension lAW step 5.14.3.

5.14.3 Perform an Extension in ZIA as follows:

a. Prepare the request. [Requester]

1 ) Enter the requested due date.

2) Provide the reason(s) that the evaluation/action cannot be completedby the current due date.

3) Document an analysis of the risk due to not expeditiously performingthe evaluation/action and list any mitigating actions that are alreadyin place to reduce the probability of repeat conditions.

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4) Submit the extension request for approval in ZIA by clicking the OKbutton.

5) Verbally notify the FAM for approval.

b. Approve or Reject the extension request in ZIA as follows: [FAM]

1) If the extension is acceptable:

* Initiate approval by clicking the Approve button.

0 Edit the Reason and Impact fields as necessary.

* Click the OK button to approve the request.

a Notify the requestor that the extension was approved.

2) If the request is not acceptable:

* Click the Not Approve button in ZIA.

* Edit the Reason and Impact fields as necessary.

" Verbally discuss the reasons for not approving the extensionwith the requestor.

" Click the OK button to disapprove the request.

5.15 FAM ER Closure

5.15.1 Event Reports with a higher significance level will not be closed to or actionstracked by Event Reports of a lower significance level (e.g., can not close aLevel CAQ ER to a Level BR ER)

NOTE:

Related ER actions may be tracked in one ER as long as the related ERs are clearlyidentified prior to closure.

If a condition or action is expected to be addressed in a different ER, then step 5.15.2shall verify the condition description is resolved and the related ER is clearly identified.

5.15.2 Review the SCAQ or CAQ ER and attached documentation and verify thefollowing:

a. Satisfactory resolution of the issue/condition.

b. Congruent alignment between the Description of Condition, evaluation,prescribed actions and completed actions.

c. Sufficient documentation is included to substantiate that CAPRS, CAMRs,CA and EFR actions have been completed as specified.

d. The identified cause(s) have been corrected.

CA-3-1 000-01Rev. 27


5.15.3 Approve or Reject the ER as follows: [FAM]

a. If the ER is acceptable, approve the ER in ZIA by clicking the Approvebutton.

b. If the ER needs to be corrected, notify the FAM responsible for correctionand notify Performance Assessment of the section(s) that need to bereopened.

5.15.4 Closure of Business Risk Event Reports:

a. Document in the closing comments a summary of what was completed toaddress the issue or a summary of why no action will be taken.

b. Approve the ER by clicking the Approve button.

5.16 Performance Assessment (PA) ER Closure

NOTE:

PA Closure Review is not required for Level BR ERs.

5.16.1 Review the SCAQ or CAQ ER for compliance with Performance ImprovementProgram procedures.

NOTE:

If a condition or action is expected to be addressed in a different ER, then step 5.13.2shall verify the condition description is resolved and the related ER is clearly identified.

5.16.2 Review the ER for adequate documentation.

5.16.3 Review the ER for adequate compliance with Performance ImprovementProgram expectations.

5.16.4 Verify adequate Event codes are assigned.

5.16.5 Assign cause codes based on the information in the evaluation.

5.16.6 Approve or Reject the ER as follows:

a. If the ER is acceptable, approve the CR in ZIA by clicking the Approvebutton.

b. If the ER needs to be corrected, click the Reject button and notify the ERClosure FAM of the needed corrections.

5.17 Records Action

5.17.1 Print the SCAQ or CAQ ZIA Record and assemble into a transmittal package.

CA-3-1 000-01Rev. 27


5.17.2 Transmit to Records Management in accordance with RM-3-2000-01, RecordsManagement Program.

6. DOCUMENTATION AND RECORDS

6.1 The following forms may be generated by use of this procedure and will be retained inaccordance with RM-3-2000-01:

6.1.1 CA-3-1000-01-F-1, Event Report, including associated documentation

6.1.2 CA-3-1000-01-F-2, Evaluation/Corrective Action Extension Request

7. LICENSE COMMITMENTS AND REQUIREMENTS

7.1 Commitment CT-2011-60, LSE-1 1-00002-NRC Notice of Violation 70-3103/2010-015,Violation A, item 3.D

7.2 LES-10-00228-NRC, Reply to NOV 70-3103/2010-002 Part 1. NRC Commitment torequire a ER when a CAQ is identified during evaluation (CR 2010-2382 Action 2)

7.3 Safety Analyses Report, Section 11.6, Incident Investigations and Corrective ActionsProcess

7.4 Safety Analysis Report, Appendix A, Quality Assurance Program Description

8. REFERENCES

8.1 Use References

8.1.1 AD-3-1000-08, Stop Work

8.1.2 CA-3-1000-02, Apparent Cause Evaluation Guidelines

8.1.3 CA-3-1000-03, Root Cause Evaluation Guidelines

8.1.4 CA-3-1000-06, Event Review Board

8.1.5 CA-3-1000-07, Common Cause Evaluation Guidelines

8.1.6 EG-3-2100-09, Identification, Disposition and Resolution of NonconformingItems

8.1.7 LS-3-1000-05, Notifications and Event Reporting

8.1.8 LS-3-1000-01, Implementation of 10CFR21.

8.1.9 OP-3-1000-09, Operability Determination

8.1.10 RM-3-2000-01, Records Management Program

8.2 Source References

8.2.1 Safety Analyses Report, Section 4.1. Commitment to Radiation ProtectionProgram Implementation

8.2.2 ER 2009-373, Potential Notice Of Violation, Corrective Actions 10 CFR 50Appendix B, Criterion XVI

CA-3-1 000-01Rev. 27


Page 31 of 34

8.2.3 ER 2009-858, Lack of procedure guidance for Effectiveness Reviews whichidentify recurring issues/events.

8.2.4 ER 2009-1167, The "Measure of Success" defined in action #6 for theCorrective Action Effectiveness Review for RCE 2008-1463 has NOT beensatisfied.

8.2.5 ER 2012-3016, action 2 requires the Licensing and Performance AssessmentManager to review and approve actions coded as commitments.

Procedure Title: Performance Improvement Program

Attachment I CA-3-1 000-01

Event Report Decision Tree Rev. 27Level 3 - Information

(Page 32 to 32) Use

No


CA-3-1000-01-F-I CA-3-1000-01

Event Report Rev. 27Level 3 - Information Use

(Pages 33 to 33) Page 33 of 34

Event Report Number.

Originator

[Title: Source:

Description of the Event:

Immediate Actions Taken:

Procedure/Criteria Violated:

Suggested Corrective Actions:

Location (Building, Room): Equipment Tag Number:

Identifier's Supervisor (Print Name): Supervisor's Phone:

Event Report Identifier (if other than Originator) (Print Name): Date/Time: Identifier Organization:

Originator (Print Name And Sign): Date/Time: Originator Organization:

Event Report Reviewing SupervisorComments:

Management Measure Affected: Items Relied On For Safety Affected:

Adverse to quality? 0 Yes El NoStop Work lAW AD-3-1000-08 E]Yes F1 NoInterim Action? E] Yes E] No (If yes, document in comment section.)NCR lAW EG-3-2100-09 E] Yes F1 NoPromptly Reportable in accordance with LS-3-1000-05? El Yes E NoEvent Report Reviewing Supervisor (Print Name And Sign): Organization: Date:


CA-3-1 000-01 -F-2 CA-3-1 000-01Rev. 27

Evaluation/Corrective Action Extension Request Level 3 - Information Use

(Pages 34 to 34) Page 34 of 34

ER Number: Significance Level: # of Previous Extensions

Extension is For: 17 Evaluation R_ ActionMethod Action # Impact level

Original Due Date Current Due Date Requested Due Date

Reason for Extension:

Risk Determination and Mitigating Actions:

Requested By (Print Name And Sign): Date

Is the Source QA Identified? C] Yes No QA Approval (Print Name and Sign): DateIf Yes, QA approval is required.

Does the ER describe a; Licensing Approval (Print Name and Sign): DateRegulatory commitment? Yes NoNotice of Violation? El Yes 0] No

Reportable Issue? El Yes F1 No

IIfan Yes, Lieadseaimebe approval is required. _______________________________

• Evaluation Approver FAM (Print Name And Sign): Date

Is this extension for a RCE, DACE, CCE or ACE ERSC (Print Chairman Name and Sign): Dateevaluations?

C0 Yes [I NoIf Yes, ERSC approval is required.

Is this extension for an RCE, DACE or action Evaluation Approver Dept Lead Team Member (Print Name and Datefrom an RCE or DACE? Sign):El Yes [I NoIf Yes, Lead Teammembr aprval is required.

Is this extension for an RCE or action from an ERB Approval (Print Name and Sign): DateRCE? 0] Yes El NoIs this extension for a DACE that requiresLicensing Approval above? [] Yes [] No Chief Nuclear Officer (Print Name and Sign): DateIf any Yes, ERB and CNO approval is required.

Documents

Clarification to UUSA response for the use of Non-Cited ... · UUSA Facility dated July 10, 2013. 2. IN-13-00079-NRC, NRC Request for Additional Information, Louisiana Energy Services,