ML20212J856

Draft NRC Insp Manual,Insp Procedure 95001, Supplemental Insp for One or Two White Inputs in Strategic Performance

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Issue date:	09/13/1999
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95001, NUDOCS 9910060012
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NRC INSPECTION MANUAL AAAA I

Inspection Procedure 95001 SUPPLEMENTAL INSPECTION FOR ONE OR TWO WHITE INPUTS IN A STRATEGIC PERFORMAN AREA PROGRAM APPLICABILITY: 2515 FUNCTIONAL AREA: Initiating Events Mitigating Systems Barrier Integrity l Emergency Prepare ~dness '

Occupational Radiation Safety Public Radiation Safety Physical Protection INSPECTION BASIS:

The NRC's revised inspection program includes three parts: baseline inspections:

generic safety issues and special inspections: and supplemental inspections performed as a result of risk significant performance issues. The inspection  ;

program is designed to apply NRC inspection assets in an increasing manner when l risk significant performnce issues are identified. either by inspection findings  !

evaluated using the significance determination process (SDP) or when performance indicator thresholds are exceeded. Accordingly, following the identification of an inspection finding categorized as risk significant (i.e., white, yellow, or red) via the SDP, or when a performance indicator exceeds the " licensee response band" threshold, the NRC regional office will perform supplemental inspection (s).

The scope and breadth of these inspections will be based upon the guidance provided in the NRC's assessment " Action Matrix" and the Supplemental Inspection Table (included in 2515 Appendix B). The supplemental inspection program is designed to support the NRC's goals of maintaining safety, enhancing public confidence, improving the effectiveness and efficiency of the regulatory process, and reducing unnecessary regulatory burden.

This procedure provides the supplemental response for one or two White inputs in a strategic performance area. The guidance provided in this procedure was developed with consideration of the following boundary conditions:

e supplemental inspection will not be done for single or multiple green issues:

• the baseline inspection procedure for identification and resolution of problems is independent of the supplemental response:

Issue Date: 09/13/99 Draft 95001 9910060012 990928 PDR REVQP ERONUMRC PDR i

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e the inspection requirements contained in this procedure will be completed for each White issue and are the same regardless of whether the issue emanated from a performance indicator or from an inspection finding:

. new examples of performance issues resulting from supplemental inspections will be evaluated and categorized in a similar manner to that of the baseline inspection program using the significance determination process. I 95001-01 INSPECTION OBJECTIVE (S) 01.01 To provide assurance that the root causes and contributing causes of risk significant performance issues are understood.

i 01.02 To provide assurance that the extent of condition of risk significant performance issues is identified.

01.03 To provide assurance that licensee corrective actions to risk significant performance issues are sufficient to address the root causes and contributing causes, and to prevert recurrence.

95002-02 INSPECTION REQUIREMENTS 4

In order to provide for adequate protection of public health and safety, once a risk significant performance issue is identified, the NRC needs to ensure that licensees take actions to identify the causes of the performance issue and j preclude repetition. The most effective and efficient way for the NRC to '

accomplish this objective is allow the licensee the opportunity to perform their own evaluation of the performance issue, and then perform a review of the licensee *s evaluation. The following inspection requirements represent a  ;

comprehensive set of attributes related to problem identification, root cause '

analysis, and establishment of corrective actions.

In order to ensure that the causes of the performance issue are identified and that effective corrective actions are taken to prevent recurrence. it is expected that the licensee's evaluation will generally need to address each of the inspection requirements: however, the depth of the licensee's analysis may vary depending on the significance and complexity of the issue (s). In some cases, the answers to specific inspection requirements will be self-evident with little additional review or analysis required.

In completing this inspection procedure, it is not intended that NRC inspectors perform an independent evaluation of the performance issue, nor is the intent to merely verify that an evaluation has been performed without assessing its adequacy. Rather, inspectors should sufficiently challenge aspects of the

. licensee's evaluation, as necessary to ensure that the cause(s) of the performance issues have been identified and that appropriate corrective actions have been taken to prevent recurrence. Inspectors may utilize information previously obtained as part of the baseline inspection program to fulfill the inspection requirements: however, the inspection report associated with this 95001 Issue Date: 09/13/99 Draft

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1 inspection should contain the NRC's assessment of the licensee's evaluation for

, each inspection requirement.

Significant weaknesses in the licensee's evaluation of the performance issue may be subject to additional agency actions, including an expansion of this procedure '

as necessary to independently acquire the information necessary to satisfy the inspection requirements. . Also, the original performance issue will remain open and will not be removed from the action matrix until the weaknesses in the evaluation are addressed and corrected. Programmatic weaknesses associated with the licensee's evaluation of the performance issue will also be documented in the inspection report and additional focus will be given to those areas during the next annual problem identification and resolution baseline inspection.

Should new or additional examples of performance issues (non-programmatic) be identified by this inspection or by the licensee during their evaluation, the new issues will be categorized using the SDP and the corresponding supplemental inspection procedure will be performed. Supplemental inspections will also be performed if additional examples of performance issues are reported via PIs that result in crossing a new PI threshold. Additional supplemental inspections will  !

generally not be performed if the new or additional examples of performance issues reported via PIs do not result in crossing a new PI threshold.

The following inspection requirements are generally applicable for both single inspection findings and for performance issues reported by PIs that might '

represent more than one independent event (e.g. four scrams). In the case where the white performance issue is due to multiple events or occurrences, it is expected that the licensee *s evaluation would address each of the events or occurrences. This could be accomplished either by doing independent evaluations i for each occurrence or by doing one collective evaluation.

02.01 Problem Identification

a. Determine that the evaluation identifies who (i.e. licensee, self revealing, or NRC), and under what conditions the issue was identified.

b. Determine that the evaluation documents how long the issue existed, and prior opportunities for identification.

c. Determine that the evaluation documents the plant specific risk consequences (as applicable) and compliance concerns associated with the ,

issue.

02.02 Root Cause and Extent of Condition Evaluation  ;

a. Determine that the problem was evaluated using a systematic method (s) to identify root cause(s) and contributing cause(s).

b. Determine that the root cause evaluation was conducted to a level of detail commensurate with the significance of the problem.

Issue Date: 09/13/99 Draft 95001

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c. Determine that the root cause evaluation included a consideration of prior occurrences of the problem and knowledge of prior operating experience,

d. Determine that the root cause evaluation included consideration of potential common cause(s) and extent of condition of the problem.

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02.03 Corrective Actions

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a. Determine that appropriate corrective action (s) are specified for each root / contributing cause or that there is an evaluation that no actions l -

are necessary.

b. Determine that the corrective actions have been prioritized with consideration of the risk significance and regulatory compliance.

c. Determine that a schedule has been established for implementing and completing the corrective actions.

d. Determine that quantitative or qualitative measures of success have been developed for determining the effectiveness of the corrective actions to prevent recurrence.

95001-03 INSPECTION GUIDANCE General Guidance *

' This inspection procedure is designed to be used to assess the adequacy of the licensee *s evaluation of White issues. As such, a reasonable time (generally within 30-60 days) should be allowed for the licensee to complete their l evaluation: however all corrective actions may not be fully completed upon l l

commencement of this procedure. Implementation of these corrective actions  !

should be verified during subsequent follow-up inspections which should be charged to this procedure.  ;

The following sections of the procedure are provided as guidance to help the inspector fulfill the specific inspection requirements contained in paragraph

02. It is not intended that the inspector verify that the licensee's evaluation of the White issue contains every attribute contained in the inspection guidance section. The intent is that the inspector use the guidance sections of the procedure to look for weaknesses in the licensee's evaluation that might indicate an issue associated with-one of the inspection requirements.

Definitions

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Root Cause(s) are defined as the basic reason (s) (i.e., hardware, process, human performance). for a problem. which if corrected, will prevent recurrence of that problem.

Contributing Cause(s) are defined as causes that by themselves would not create the problem. but are important enough to be recognized as needing corrective action. Contributing causes are sometimes referred to as causal 95001 Issue Date: 09/13/99 Draft

factors. Causal factors are those actions, conditions, or events which  !

directly or indirectly influence the outcome of a situation or problem.

i Repeat occurrences are defined as two or more independent conditions which are '

the result of the same basic causes. I Common Cause is defined as multiple failures (i.e., two or more) of plant equipment or processes attributable to a shared cause. I Extent of Condition is defined as the extent to which an identified problem has the potential to impact other plant equipment or processes in the same manner identified in the root cause analysis. l

~ Consequences are defined as the actual or potential outcome of an identified )

problem or condition. . >

Soecific Guidance l

03.01 Problem Identification

a. The evaluation should state how and by whom the issue was identified.

When appropriate, failure of the licensee to identify the problem at a precursor level should be evaluated. Specifically, the failure of the licensee to identify a problem at an early stage may be indicative of a more substantial problem. Examples would include a failure of the licensee's staff to enter a recognized non-compliance into the corrective action program, or raise safety concerns to management. or the failure to complete corrective actions for a previous problem resulting in further degradation. If the NRC identified the White issue, the evaluation should address why licensee processes such as peer review, supervisory oversight inspection, testing, self assessments, or quality activities did not identify the problem.

b. The evaluation should state when the problem was identified, how long the condition (s) existed, and whether there were prior opportunities for '

correction. For example, if a maintenance activity resulte'd in an inoperable system that was not detected by post-maintenance testing or by quality assurance oversight, the reasons that the testing and quality

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oversight did not detect the error should be included in the problem identification statement and addressed in the root cause evaluation.

c. The evaluation should address the plant specific risk consequences of the issue. A plant specific assessment may better characterize the r.isk associated with the White issue due to the generic nature of the performance indicators. For conditions that are not easily assessed quantitatively, such as the unavailable of security equipment, a qualitative assessment should be completed. The evaluation should also include an assessment of compliance. As applicable some events may be more appropriately assessed as hazards to plant personnel or the environment. The inspector's review of the risk assessment should be coordinated with the Senior Reactor Analyst.

03.02 Root Cause Evaluation Issue Date: 09/13/99 Draft 95001 L

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a. The licensee's evaluation should generally make use of a systematic method (s) to identify root cause(s) and contributing cause(s)

The root cause evaluation methods that are commonly used in nuclear facilities are:

. Events and causal factors analysis -- to identify the events and conditions that led up to an event:

. Fault tree analysis -- to identify relationships among events and the probability of event occurrence:

• Barrier analysis -- to identify the barriers that, if present or strengthened, would have prevented the event from occurring:

. Change analysis -- to identify changes in the work environment since the activity was last performed successfully that may have caused or contributed to the event:

. Management Oversight and Risk Tree (MORT) analysis --

to systematically check that all possible causes of problems have been ,

considered; and l l

. Critical incident techniques -- to identify critical actions that, if performed correctly, would have prevented the event from occurring or would have significantly reduced its consequences.

t The licensee may use other methods to conduct the root cause evaluations.

A systematic evaluation of a problem using one of the above methods should normally include: j

. A clear identification of the problem and the assumptions made as a part of the root cause evaluation.

For example, the evaluation should describe the initial operating l conditions of the system / component identified, staffing levels, and i training requirements as applicable. j

. A timely collection of data, verification of data, and preservation of evidence to ensure that the information and circumstances ,

surrounding the problem are fully understood. The analysis should l be documented such that the progression of the problem is clearly understood, any missing information or inconsistencies are identified, and the problem can be easily explained / understood by j others.

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. A determination of cause and effect relationships resulting in an identification of root and contributory causes which consider potential hardware, process, and human performance issues. For example:

95001 Issue Date: 09/13/99 Draft L

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- hardware issues could include design, materials, systems aging. and environmental conditions:

- process issues could include procedures, work practices, operational policies, supervision and oversight, preventive and corrective maintenance programs, and quality control methods: and human performance issues could include training, communications, human system interface, and fitness for duty.

b. The root cause evaluation should be conducted to an adequate level of detail, considering the significance of the problem.

. Different root cause evaluation methods provide different perspectives on the problem. In some instances. using a combination of methods helps to ensure the analysis is thorough. Therefore. the root cause evaluation should consider evaluating complex problems which could result in significant consequences using multi-disciplinary teams and/or different and complimentary methods appropriate to the circumstances. For example, problems that involve hardware issues may be evaluated using barrier analysis, change analysis, or fault trees.

The depth of a root cause evaluation is normally achieved by repeatedly asking the question "Why?" about the occurrences and circumstances that caused or contributed to the problem. Once the analysis has developed all of the causes for the problem (i.e.. root, contributory, programmatic),

the evaluation should also look for any relationships among the different causes. l j

The depth of the root cause evaluation may be assessed by:

• Determining that the questioning process appeared to have been conducted until the causes were beyond the licensee's control.

For example, problems.that were initiated by an act of nature, such as a lightning strike or tornado could have the act of nature as one of the causes of the problem. However, the act of nature would not be a candidate root cause, in part, because the licensee could I not prevent it from happening again. However, a licensee's failure to plan for or respond properly to acts of nature would be under management control and could be root causes for the problem.

• Determining that the problem was evaluated to ensure that other root l and contributing causes were not inappropriately ruled out due to l assumptions made as a part of the analysis.

For example, a root cause evaluation may not consider the adequacy i of the design or process controls for a system if the problem appears to be primarily human performance focused. Consideration of the technical appropriateness of the evaluation assumptions and

, their impact on the root causes would also be appropriate.

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! l o Determining that the evaluation collectively reviewed all root and l contributory causes, for indications of higher level problems with

>> a process or system.

For example, a problem that involved a number of procedural inadequacies or errors may indicate a more fundamental or higher level problem in the processes for procedural development, control, review, and approval. Issues associated with personnel failing to follow procedures may also be indicative of a problem with  !

supervisory oversight and communication of standards.

• Determining that the root cause evaluation properly ensures that correcting the causes would prevent the same and similar problems from happening again or sufficiently minimizes the chances of re-occurrence. Complex problems may have more than one root cause as  :

well as several contributory causes. The evaluation should include l checks to ensure that corrections for the identified root causes do not rely on unstated assumptions or conditions which are not controlled or ensured.

For example, root causes based upon normal modes of operation may not be valid for accident modes or other "off normal" modes of operation.

• Determining that the evaluation appropriately considered other possible root causes. Providing a rationale for ruling out alternative possible root cause(s) helps to ensure the validity of the specific root cause(s) that are identified.

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c. The root cause evaluation should include a proper consideration of repeat occurrences of the same or similar problems at the facility and knowledge of prior operating experience. This review is necessary to help in developing the specific root and contributing causes and also to provide indication as to whether the White issue is due to a more fundamental concern involving weaknesses in the licensee's corrective action program.

The evaluation should:

e Broadly question the applicability of other similar events or issues with related root or contributory causes.

For example, root cause evaluations associated with outage activities and safety related systems could include a review of prior operating experience involving off-normal operation of systems, unusual system alignments, and infrequently performed l

evolutions, e Assess whether previous root cause evaluations and/or corrective actions missed or inappropriately characterized the issues and what aspects of the prior corrective actions did not preclude reoccurrence of the problem.

95001 Issue Date: 09/13/99 Draft l

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For example, the evaluation should review the implementation of the previously specified corrective actions and a reassessment of the identified root causes to determine process or performance errors which may have contributed to the repeat occurrence.

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Determine if the root cause evaluation for the current problem specifically addresses those aspects of the prior root cause l 1

evaluation or corrective actions that were not successfully l addressed. '

For example, if during the review of a tagging error that resulted i in a mis-positioned valve the licensee determines that a previous similar problem occurred and the corrective actions only focused on ,

individual training then the root cause for the repeat occurrence )

should evaluate why the previous corrective actions were inadequate.  !

l e Include a review of prior documentation of problems and their  :

associated corrective actions to determine if similar incidents have {

occurred in the past. j For example, the licensee should consider in its review of prior operating experience internal self-assessments, maintenance history, t adverse problem reports, and external data bases developed to identify and track operating experience issues. Examples of external data bases may include Information Notices. Generic Letters, and vendor / industry generic communications.

l The inspectors should discuss the problem and associated root causes with other resident, regional, or headquarters personnel associated l with the facility to assess whether other similar problems or root '

causes for dissimilar problems have occurred at the facility that should have been considered. l t

d. The root cause evaluation should include a proper consideration of the extent of condition of the problem including whether other systems, equipment, programs or conditions could be effected. The evaluation should:  !

e Assess the applicability of the root causes across disciplines or l departments, for different programmatic activities, for human .

performance, or for different types of equipment. I For example, the Fire-Protection Organization considered that the root causes identified for the mis-alignment associated with the i safety injection system could potentially affect their systems since they shared a common tagging and alignment method with operations.

As a result, feedback was provided to the incident review committee to include modification of the Fire-Protection control procedure, and provide formal training to all Fire-Protection personnel.

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03.03 Corrective Action The proposed corrective actions to the root and contributing causes should:

Issue Date: 09/13/99 Draft 95001

a. Address each of the root and contributing causes to the White issue and i o the extent of condition of the issue. The corrective actions should be l clearly defined. Examples of corrective actions may include, but are not l limited to. modifications, inspections, testing. process or procedure changes. and training. i 1

The proposed corrective actions should not create new or different t

problems as a result of the corrective action. If the licensee determines that no corrective actions are necessary. the basis for this decision j

should be documented in the evaluation.

b. Include consideration of the results of the licensee's risk assessment of the issue in prioritizing the type of corrective action chosen. Attention should be given to solutions that involve only changing procedures or providing training as they are sometimes over-utilized. In such cases, consideration should be given to more comprehensive corrective actions such as design modifications. The corrective action plan should also include a review of the regulations to ensure that if compliance issues exist, the plan achieves compliance.

Also, the licensee should ensure that:

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c. The corrective actions are assigned to individuals or organizations that l are appropriate to ensure that the actions are taken in a timely manner. I Also, the licensee should ensure that there is a formal tracking mechanism established for each of the specific corrective actions. l

d. A method exists to validate the effectiveness of the overall corrective action plan. Specifically, a method should be established to measure.  !

either quantitatively or qualitatively, the effectiveness of the corrective actions. Effective methods would include, but are not limited to. assessments, audits. inspections. tests. and trending of plant data, or follow-up discussions with plant staff.

95001-04 RESOURCE ESTIMATE It is estimated that this procedure will take between 16 and 40 man-hours to complete for each White issue. The inspector or inspectors assigned should be familiar with the discipline associated with the subject of the licensee's evaluation. For planning purposes a resource estimate near the lower end of the scale should be used for licensees with corrective actions programs that have been determined to be thorough during the annual inspection for the identification and resolution of problems. For licensees with corrective action programs that have been previously determined to be ineffective, a resource estimate near the higher end of the scale should be used.

95001-05 REFERENCES None f

END 95001 Issue Date: 09/13/99 Draft

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September 20,1999 EGM 99-006 MEMORANDUM TO: Hubert J. Miller, Regional Administrator Region I Luis A. Reyes, Regional Administrator Region ll

{ James Dyer, Regional Administrator Region 111 Ellis W. Merschoff, Regional Administrator Region IV William Kane, Associate Director for inspection and Programs, NRR Brian W. Sheron, Associate Director for Project Licensing and Technical Analysis, NRR Elizabeth O. Ten Eyck, Director, Division of Fuel Cycle and Safeguards, NMSS Donald A. Cool, Director, Division of Industrial and Medical Nuclear Safety, NMSS E. William Brach, Director Spent Fuel Project Office, NMSS John T. Greeves, Director, Division of Waste Management, NMSS FROM: R.W. Borchardt, Director Office of Enforcement

SUBJECT:

ENFORCEMENT GUIDANCE MEMORANDUM -

IMPLEMENTATION OF THE INTERIM ENFORCEMENT POLICY FOR USE DURING THE REACTOR OVERSIGHT PILOT PROGRAM The purpose of this EGM is to provide enforcement guidance for implementation of Enbrcement Policy Appendix F," Interim Enforcement Policy for Use During the NRC Reactor i Oversight Process P9ot Plant Study." Feedback and lessons learned during the pilot program will be incorporated into future revisions to this EGM and to the enforcement policy for full implementation of the new reactor oversight program. The Interim Policy will be in effect for power reactors during the reactor oversight process pilot program, which began June 1,1999.

The policy revises the treatment of violations of the requirements of 10 CFR Part 50 and associated license conditions during the pilot program. Following the pilot program, the NRC will evaluate the results and will incorporate ar.y changes into the Enforcement Policy for full implementation at all reactor plant sites regulated in accordance with 10 CFR Part 50.

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BACKGROUND As described in NUREG-1600, Revision 1," General Statement of Policy and Procedures for NRC Enforcement Actions," the purpose of the Commission's enforcement program is to support the NRC's overall safety mission in protecting the public and the environment.

Consistent with that purpose, the Commission has historically used enforcement actions as a deterrent to emphasize the importance of compliance with requirements and to encourage prompt identification and prompt, comprehensive correction of violations.

The current Enforcement Policy has been successful in focusing attention on compliance issues to improve safety. The process uses enforcement to (1) assess the safety significance of individual inspection findings and events, (2) formulate the appropriate agency response to these findings and events, (3) emphasize good performance and compliance, (4) provide incentives for performance improvement, and (5) provide public notification of the Commission's i views on licensees' performance and actions. Escalated enforcement actions have provided regulatory messages to encourage licensees to improve their performance. However, the Commission has not always integrated the decision making in the performance assessment program with the enforcement program. This separation of processes has resulted in mixed regulatory messages regarding performance and approaches to improve it. Also, the i enforcement process has been criticized as not being sufficiently risk - informed, sometimes leading licensees to focus on issues of low risk significance at the expense of more risk-significant items. The Enforcement Policy was also criticized as difficult to understand, subjective, inconsistent, and unpredictable.

The staff has developed a new reactor oversight process and is applying it to nine reactor sites l as part of a pilot program that began in June 1999. Given the new reactor oversight process, a greater agency focus on risk, and improved overall industry performance, the Enforcement Policy has been revised to better integrate into the reactor oversight process.

IMPLEMENTATION The enforcemer; e roach for the pilot program divides violations into two groups. The first group is those t J ens that the Significance Determination Process (SDP) can evaluate, where the Agency Ation Matrix will determine eppropriate action. The assessment process will use the SDP to characterize most inspection findings based on their risk significance. The SDP will assign a color of green, white, yellow, or red to each finding to reflect its significance. The ;

Enforcement Policy will use the results of the SDP categorization of the significance of findings involving violations.

The second group is violations that result in actual consequences, violations that th' e SDP does not evaluate such as willful violations, and those violations that may impact the regulatory process for oversight of reactors. Actual consequences are those violations that result in, (1) occupational and public doses greater than regulatoly limits, (2) releases of radioactive material greater than regulatory limits and, (3) failure to make required notifications during an actual general or site area emergency and during a transportation event. Violations in this category will be processed in accordance with the conventional Enforcement Policy using both severity levels and civil penalties.

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Figure I illustrates the different enforcement paths described in more detail below.

NEW ENFORCEMENT PROCESS  !

White Assessed yongow  !

by SDP Red Actual YES Current NOV !

Violation SDP Conseq Enf r ent --* L&C As seed NO by SDP Exception YES NOV 1,2,3 NO l

NCV i

Current SL 1. II. lit Enforcement Policy SLIV Exce t on NOV NO NCV FIGURE 1 l

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l. Violations Evaluated by the Significance Determination Process j inspection findings that the SDP can evaluate and are violations will be disp?sitioned as either a cited or non cited violation. Because the Action Matrix will determine the agency response, severity levels and civil penalties will not normally be used.

A. Violations that the SDP evaluates as of low significance (i.e., green).

Violations that the SDP evaluates as of low significance from a risk perspective (i.e., green) will normally be documented in inspection reports as non cited violations (NCVs). However, a notice of violation (NOV) will be issued for three exceptions.

1. Did the licensee fail to restore compliance within a reasonable time after identification of a violation?

Note: This criterion applies only to violations that are continuing at the time of discovery l (See discussion below).

This criterion emphasizes the need to take action to restore compliance in a reasonable time once a violation is identified. If the licensee cannot restore compliance, they must take compensatory measures until they restore compliance. Action must be taken to restore compliance absent an exemption, license amendment, or Notice of Enforcement Discretion (NOED).

For purposes of this criterion, restoring compliance includes those actions needed to stop an ongoing violation from continuing. It does not include actions necessary to address root causes and prevent recurrence. The NRC recognizes that some violations ,

require prompt action to restore compliance and some do not depending on whether the underlying requirement is continuous or conditional. Thus, "within a reasonable time" refers to the time needed to stop or take compensatory measures for an ongoing violation (which should be as soon as possible). The time needed to place the plant in an operational mode where the requirement no longer applies is considered reasonable.

For example, if a valve is found in the wrong position, the NRC expects a licensee to take prompt action to either place the valve in the required position, take action to be in a mode where the requirement no longer applies, take appropriate compensatory actions or request relief from the NRC. On the other hand, the requirement may not be applicable for the mode or circumstances the licensee is in when the violation is identified. Reasonableness allows the licensee to delay corrective actions until the requirement is next applicable. For example, if the violation involved an inadequate .

refueling procedure, corrective action would not be needed until the next refueling outage when the procedure would be used.

2. Did the licensee fall to place the violation into a corrective action program?

The purpose of this criterion is to emphasize the need to consider actions beyond those necessary to restore compliance, including actions necessary to address root causes.

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E Placing a violation into a corrective action program is fundamental to the NRC's ability to close a violation in an inspection report without detailed information regarding the l licensee's corrective actions. Documenting the corrective action system reference i number in an inspection report will help the NRC in subsequent reviews of the effectiveness of the corrective action program.

3. Is the violation willful? (However, even if willful, an NCV may still be appropriate if it meets all of the criteria for discretion in Section Vil.B.1 of the Enforcement Policy.)

l The purpose of this criterion is to emphasize the importance of integrity and candor in l

' carrying out licensed activities, as expressed in Section IV.C. of the Enforcement Policy.

Nonetheless, certain licensee identified willful violations would remain eligible for I

treatment as NCVs, as they are under the current policy in Section Vll.B.1. Specifically, an NCV may be appropriate provided it was licensee identified and:

a. The information concerning the violation, if not previc usly reported to the .

Commission, was promptly provided to appropriate NRC personnel, such as a resident  !

inspector or regional branch chief who, in turn, is responsible for getting the information to the appropriate regional staff;

b. The violation involved the acts of a low-level individual (and not a licensee official as defined in Section IV.C of the Enforcement Policy); l

c. The violation appears to be the isolated action of the employee without management involvement and the lack of management oversight did not cause the violation; -

d. The licensee took significant remedial action commensurate with the circumstances such that it demonstrated the seriousness of the violation to other employees and contractors, thereby creating a deterrent effect within the licensee's organization.

In addition, willfulness may result in treating the violation ir) accordance with the Enforcement Policy as described in Section ll below which may result in a notice of l

violation with a severity level and civil penalty.

B. Violations evaluated by the SDP as risk significant Violations that the SDP evaluates as risk significant (i.e., white, yellow, or red) will be subject to action as determined by the Action Matrix. Such violations will result in the issuance of a NOV  !

requiring a written response, unless sufficient information describing the reasons for the violation and corrective action being taken is already on the docket. The Action Matrix will be  ;

used to formulate the agency response and to emphasize the need to improve performance for l safety significant violations. Assessment panels as described in draft inspection Manual i Chapter 06XX and regulatory conferences will be held if merited by the specific violations or overall licensee performance. No severity levels or civil penalties will normally be used.  ;

Despite the process described above, for violations addressed by the Agency Action Matrix, the Commission reserves the discretion for particularly significant violations to assess civil penalties in accordance with Section 234 of the Atomic Energy Act of 1954, as amended. Based on l

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current performance of licensees, this discretion is expected to be rarely exercised. An example where such discretion may be considered would be for Severity Level I violations

. under the existing Enforcement Policy, e.g., an accidental criticality categorized in Appendix B,

Supplement I, Reactor Operations.

II. Violations Not Evaluated by the SDP and those Having Actual Consequences .l l

In the second group of violations, the conventional Enforcement Policy will be applied, including the use of severity levels to characterize the significance of violations and the use of civil penalties or other appropriate enforcement action. The three categories of violations are within this group are:

A. violations that involve willfulness, including discrimination; j

. B. violations that may impact the NRC's ability to oversee licensee activities ! Examples include violations associated with reporting requirements; failure to obtain NRC approvals, such as for changes to the facility as required by 10 CFR 50.59,10 CFR 50.54(a),10 CFR 50.54 (p); and failure to provide the NRC with complete and accurate information or to maintain complete and accurate records.];

(1) Provisions for Performance Indicator (PI) Data (O CFR 50.9 requires that information provided to the Commission by a licensee shall

.be complete and accurate in all material respects. This includes the voluntary

. submitting of Pi information. This information may be considered material because the NRC uses it to assess licensee performance and to make decisions on regulatory action. As a result, submitting inaccurate Pi information that is material is a violation of 10 CFR 50.9.

Because this area is outside the SDP and Action Matrix, the conventional enforcement approach applies to these cases, if the inaccuracy was not willful, the assessment of significance of the inaccurate information is determined by the effect it had on the NRC's

~ processes.

Clearly, some inaccuracies are of so low significance that do not warrant identification as a 10 CFR 50.9 violation. Specifically, if the error in Pl information provided by a licensee would not have caused a PI to change color, and therefore would not change the NRC actions in response to the information, the error is not considered significant.

The violation would be characterized as a minor violation and no violation of NRC requirements should be cited. Errors that would cause a color change, such as from green to white, would be considered significant since a change in the NRC response, i such as some type of increased inspection or other regulatory activity, may result.

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However, for the pilot plants, because of the time constraints to gather and submit i historical data, a best effort by licensees on the collection of this data was considered  ;

adequate for the start of the program. As a result, some errors in this data are  !

expected. Also, because the pilot program is a voluntary program and both the NRC  ;

and licensees are in a learning process for the submission and review of this data, 6

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errors in current data submitted are expected. OE has determined that during the pilot program, if non willful significant errors in data are identified, Enforcement Discretion in accordance with section Vll.B.6 of the enforcement policy is appropriate. Refer to Attachment I for an example of cover letter language. Use of this discretion during full implementation of the new oversight process will be addressed in future Enforcement Policy changes.

Each case where this discretion is used will require assignment of an EA number in order for OE to track the extent of its use. The following should be included in the text of the report discussing the inspection finding:

"During the inspection, errors were identified in the performance indicator (PI) data l submitted to the NRC. (include a brief description of the errors identified and any effect i

(i.e., change in color bands) these errors had on the assessment process.) However, l because these errors were not willful and are associated with data submitted during the l . voluntary pilot plant program, we are exercising Discretion pursuant to Section Vil.B.6 of I

the Enforcement Policy not to issue a Notice of Violation." .

C. violations that involve actual consequences (such as an overexposure to the public or l plant personnel, failure to make the required notifications that affect the ability of

!; federal, state and local agencies to respond to an actual emergency preparedness or l

. transportation event, or a substantial release of radioactive material).

Ill. Documentation and Tracking of Violations

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l This section provides guidance for documenting and tracking violations that the SDP evaluates l and are dispositioned as (1) NCVs and (2) NOVs. Violations not assessed by the SDP should j be documented in accordance with the Enforcement Policy.

The staff should follow the general guidanct for inspection report cover letters in draft

, inspection Manual Chapter 0610* and use the appropriate paragraphs for Attachment 1 of this EGM for discussing violations in the cover letter. Usually, cited violations should be discussed before non cited violations.

A. NCVs Violations determined to be " green" and are dispositioned as an NCV should be documented in inspection reports in accordance with the guidance below. An exception to this is minor violations, which are those violations of requirements of minor safety significance and should not normally be documented in inspection reports. l l The documentation of NCVs should briefly describe the applicable requirement and how the i

requirement was violated. The discussion should be detailed enough to provide the basis for  ;

the determination that a requirement was violated. Documentation should also include the licensee's corrective action program file reference. Often, the licensee will not have yet developed the corrective actions at the time the inspection report is issued. If the inspector is l

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l aware of the licensee's corrective actions, then he or she may choose to document them in the inspection report. However, documentation of the licensee's corrective actions is not required.

NCVs should be discussed in the report details and summary of findings sections of the report. I A conclusion that no formal enforcement action will be taken should be documented as follows:

"We are treating this violation as a non cited violation, consistent with the Interim Enforcement Policy for pilot plants. This violation is in the licensee's corrective action program as (include file reference)."

NCVs should be addressed in the inspection report transmittal letter (cover letter) after any cited violations. The discussion should simply note how many NCVs were identified. The

. details of specific NCVs should not normally be discussed in inspection report cover letters.

Cover letters should not be used as a substitute for a NOV. In particular, cover letters should not normally seek' additional information about an NCV. The applicable inspection report section should include NCV appeal process language (see Section Vi for guidance on the NCV appeal process).

In accordance with the existing guidance in the Enforcement Manual, the region should

continue the practice of requesting an EA number for a willful violation that will be dispositioned I

as an NCV.

The Reactor Program System (RPS) and the PIM will list NCVs .

B. NOVs i

Violations assessed as " green" that meet an exception in Section I of this Interim Policy for consideration as a NOV should be documented in inspection reports in accordance with i inspection Manual Chapter 0610*.. The NOV cover letter must clearly state why a citation is I

being issued in terms of which exception in Section I the violation met and how/why it was met.

The staff should use the cover letter examples in Attachment 1.

NOVs will be issued for all risk significant (white, yellow, or red) violations and violations outside  !

- the SDP process as described in Section,ll. For risk significant violations, the NOV cover letter j should briefly describe why the violation is risk significant and the color resulting from the SDP l evaluation. A response will be requeisted unless adequate information is already on the docket. 1 The format of Attachment 1 should be used. ,

if by the end of the inspection or the close of the inspection period, the risk significance of a ,

violation was not determined, the violation should be classified as an apparent violation in the  !

cover letter until a final determination of the significance can be made.

As described above, violat' ions determined to be potentially significant violations (white, yellow, i or red) by the SDP process will be discussed at an assessment panel. If the phase 2 SDP analysis suggests that a significant (white, yellow, or red) violation exists, a regulatory i conference with the licensee may be held to discuss the licensee's views on safety significance.

In these cases a Phase 3 analysis may have been performed and the licensee's and NRC's analysis may be discussed. Attachment I provides language for reports with apparent )

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l violations, and when a regulatory conference is being requested (choice letter) or confirmed

- (conference letter).

Consistent with existing practice, the staff may waive a licensee's written response to an NOV, if sufficient information is already on the docket in an inspection report, licensee event report (LER), or other correspondence. NOVs should be discussed in the report detail? observation and findings, and summary of findings sections of the report.

To track the use of NOVs, an enforcement action (EA) number will be assigned to each NOV.

The Enforcement Action Tracking System (EATS) will be used to record the disposition of these NOVs and which exception was met if applicable.

NOVs will be tracked in the Reactor Program System (RPS) and the PIM.

IV. Violation Coordination and Review This section provides guidance for coordination and review of violations for which the SDP can determine a risk significance and that result in NCVs or NOVs. Coordination and review of violations not assessed by the SDP will be in accordance with the Enforcement Manual.

All violations that are screened into the Phase 2 evaluation of the SDP process will be subject to a review by an assessment / enforcement oversight panel to ensure consistency between the regions. The purpose of the panelis to come to agreement on the risk significance of the issue. Any enforcement action taken will be based on the risk significance determined for the issue.

A. NCVs .

NCVs for power reactors screened out of the SDP as green during the phase I analyus will continue to be issued by the region normally without prior OE approval. Enforcement Coordinators are available and should be consulted on NCVs, as warranted. The regional ,

i Division Director should concur on an NCV before issuance if: (1) the Branch Chief and l Enforcement Coordinator disagree on the disposition of the issue, (2) the violation meets the l criteria for disposition as an NCV but the licensee informs the staff that it disagrees that ?he issue is a violation or that the violation is more than a minor violation.

4 Violations determined to be of green significance are to be issued as an NCV by the region without OE review. Consistent with existing guidance in Section 6.3.1.c of the Enforcement Manual, the approval of the Director, OE, with consultation with the Deputy Executive Director for Reactor Programs (DEDR) as warranted, is required for issuing an NCV where. a willful violation is involved.

l B. NOVs Division Directors, the regional Enforcement Coordinators and OE will concur on all NOVs before being issued.

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V. Violation Signature Authority This section provides guidance for the signature authority of NCVs and NOVs for issues that the SDP has assessed. Violations not assessed by the SDP will be handled in accordance with the Enforcement Manual.

A. NCVs The Regional Administrator may delegate to Branch Chiefs and above the authority to sign and issue inspection reports that include NCVs.

B. Green Significance NOVs The FIegiorial Administrator may delegate to Branch Chiefs and abova the authority to sign and issue green significance NOVs.

C. Risk Significant NOVs The Regional Administrator may delegate to Division Directors the authority to sign and issue white, yellow and red significance NOVs.

VI. NCV Appeal Process Licensees will be provided an opportunity to dispute NCVs if they disagree that the issue is a violation or that the issue warrants a Severity Level IV categorization. The inspection report should include the following appeal process language:

"If you contest the violation or the severity level of the NCV, you should provide a response within 30 days of the date of this inspection report, with the basis for your denial, to the Nuclear Regulatory Commission, ATTN.: Document Control Desk, Washington DC 20555-0001, with a copy to the Regional Administrator, Region Resident inspector and the Director, Office of Enforcement, United States Nuclear Regulatory Commission, Washington, DC 20555-0001.

The region should normally respond to the licensee within 60 days. The response, which should be sent to the same person and address as the inspection report, should address the licensee's points of contention, if the licensee denies the violation based on additional information not previously disclosed, the region should prepare a more detailed response as necessary to explain the decision. Licensee denials include disputes involving NRC requirements, facts of the case, application of the Enforcement Policy, and severity levels. The l region's response must address any errors identified in the inspection report. .

l As described in the NRC Enforcement Manual, within 21 days of the date of the licensee's j denial, the region should submit its prepared response to the licensee. OE will decide whether

! thers is any interest in the dispute, or whether to conduct a review of the regional response).

l The region's submittal to OE should include all documents necessary to support the region's position and sufficient information to initiate an EA number.

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Within three days of the date of the region's submittal, OE will inform the region of its

involvement and provide the region an EA number for the case. For all disputed violations in

l. which it is decided that a second, revised NOV should be issued, the region should ensure that I

the response to the licensee clearly reflects, in both the subject line of the cover letter and the revised NOV, that a violation is being revised (i.e., REVISED NOTICE OF VIOLATION).

, cc: SECY

! The Chairman The Commissioners F.' Miraglia, DEDR CPaperiello, DEDMRS l D. Dambly, OGC G. Caputo,01 I

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TAttachment 1 i l

Cover Letter Transmitting Inspection Report (includes optional paragraphs for NOVs, NCVs, and " apparent" violations)

'EA (if applicable) 1-(Name of Licensee)

(Address)

SUBJECT:

NRC [ include type of inspection, e.g.,," INTEGRATED, SPECIAL"]

INSPECTION REPORT NO(S). XX XXX/YY-NN [if applicable, add "AND (INVESTIGATION REPORT NO(S). X XX-XXX)"][if applicable, add, " AND

. NOTICE OF VIOLATION", or " EXERCISE OF ENFORCEMENT DISCRETlON"]

Dear  :

(Refer to IMC 0610* for guidance related to the overall structure of the cover letter and content ~

of introductory paragraphs).

[For inspection reports with NOVs include the next paragraph and include either the " response required" or the "no response required" paragraph.]

Based on the results of this inspection, the NRC has determined that a low risk significant (risk

. significant) violation (s) of NRC requirements occurred. The(se) violation (s) is (are) cited in the enclosed Notice of Violation (Notice) and the circumstances surrounding it (them) are described in detall in the subject inspection report. The violation (s) is (are) of concern because [an explanation MUST be included that clearly articulates why a NOV is being issued in terms of the Interim Policy NCV criteria they failed. This explanation may be expanded, where warranted, to convey the appropriate message to the licensee in terms of those actions that require additional attention.] This violation does not meet the criteria for being dispositioned as a non cited violation, (e.g., the violation is being cited because compliance with regulatory requirements

~ has not been restored, and, based on our understanding of your disposition of this issue in your corrective action system, there are no efforts underway to restore compliance. Accordingly, a response to this violation is necessary.)

You are required to respond to this letter and should follow the instructions specified in the enclosed Notice when preparing your response. [Other specific responses required should be L ' a.ddressed as appropriate.] The NRC will use your response, in part, to determine whether L further enforcement action is necessary to ensure compliance with regulatory requirements.

! . [For NOVs where the region has determined that no response is required, the

following paragraph may be substituted. In addition, the last paragraph of the letter referencing the responses directed by the letter and Notice should also be deleted.]

The cause of the violation and the corrective actions taken and planned to correct the violation and prevent recurrence are already adequately addressed on the docket in [ indicate 12 r

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k n 3 correspondence, e.g., inspection Report No. XX-XXX/YY-NN, LER YY-NNN, or letter from

Licensee) dated . Therefore, you are not required to respond to this letter unless the description L ~ therein does not accurately reflect your corrective actions or your position. in that case, or if you choose to provide additional information, you should follow the instructions specified in the enclosed Notice.

[For inspection reports where Discretion for inaccurate performance indicator data is being

. exercised include the following paragraph)

We have determined during this inspection that performance indicator (PI) data with significant

(

errors were submitted to the NRC. However, discretion is being exercised pursuant to Section

- Vll.B.6 not to cite the violation because the errors were not willful and all aspects of the process

for the submission Pi data have not been finalized, l

' [ Include the next three paragraphs if " apparent" violations'are being addressed and a pre decisional regulatory conference is being confirmed (" conference letter").]

in addition, during this inspection (number) potential risk significant issues that appear to be l . , , violation (s) of NRC requirements was (were) identified. [The narrative that follows should briefly

- discuss the nature and significance of the apparent violation (s).)

l An open (A closed) pre decisional regulatory conference to discuss this (these) issue (s) has l been scheduled for (date) . The decision to hold a pre decisional regulatory conference does

! not mean that the NRC has determined that a violation has occurred, the risk significance of the l Lviolations or that enforcement action will be taken. This conference is being held to obtain l information to enable the NRC to make a risk significance decision, such as a common understanding of the facts, the plant design, equipment affected, and available mitigating equipment. (if appropriate add: "In particular, we expect you to address .") In addition, this is an opportunity for you to point out any errors in our inspection report and for you to provide any information concerning your perspectives on the significance of the apparent violation (s).

- Accordingly, no Notice of Violation is presently being issued for these inspection findings.

Please be advised that the number and characterization of apparent violations described in the l enclosed inspection report may c.hange as a result of further NRC review.

L You will be advised by separate correspondence of the results of our deliberations on this matter. No response regarding the(se) apparent violation (s) is required at this time.

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l [ Include the next five paragraphs if " apparent" violations are being addressed and a response is being requested (" choice letter").)

In addition, (number) risk significant apparent violation (s) was (were) identified [The narrative that follows should briefly discuss the nature of the apparent violation (s) with references to the applicable section(s) of the inspection report, the risk significance of the issues and applicable assumptions used.)

l 1 Although we believe that we have sufficient information to make our final significance L determination, we are giving you the opportunity to send us the following information within 14 13

days of this letter. (include requested information) Accordingly, no Notice of Violation is presently being issued for these inspection findings.

Your response should be clearly marked as a " Response to An Apparent Violation (s) in inspection Report No(s). XX XXX\YY-NN". If a response is not received within the time specified or we have not granted an extension of time, we will continue with our significance determination and enforcement decision.

Also please inform us if you would like to schedule a regulatory conference to discuss your evaluation and any differences with the NRC evaluation. The NRC will also issue a press release to announce the meeting. Please contact (name) at (phone number) within 7 days of the date of this letter to notify the NRC of your intended response.

In addition, please be advised that the number and characterization of apparent violations described in the enclosed inspection report may change as a result of further NRC review. You will be advised by separate correspondence of the results of our deliberations on this matter.

in accordance with 10 CFR 2.790 of the NRC's " Rules of Practice," a copy of this letter, its enclosure (s), and your response will be placed in the NRC Public Document Room .

Sincerely, Regional Administrator

. or Designee Docket No.

License No.

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Distribution RWBorchardt OE Staff Enforcement Coordinators RI, Ril, Rill, RIV, NMSS, NRR (Also by E-Mail)

EGM File Day File -

WEB (2 weeks after issuance)-

PUBLIC (2-weeks after issuance) 1 1

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1 OE NRR OE:D BWestreich BBorchardt 9/13 199 9/ 14 /99 9/14/99 I

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