1. Regulatory Inspection and Enforcement
Prepared by: Jay Hopkins
Presented by: Luis Lederman
Regulatory Activities Section | Division of Nuclear Installation Safety
Department of Nuclear Safety and Security
YOU HAVE 1 HOUR.

2. Outline
Governmental, Legal, and Regulatory Framework for Safety, General Safety Requirement (GSR) Part 1 (Rev. 1).
Regulatory Inspection of Nuclear Facilities and Enforcement by the
Regulatory Body, General Safety Guide GS-G-1.3.
Overview of the Inspection and Enforcement Process (GS-G-1.3).

3. GSR Part 1 (Rev. 1): Governmental, Legal and Regulatory Framework for Safety
Requirements 2 – 4 and specifically address authority and requirements for inspection and enforcement.
Requirement 2: Establishment of a Framework for Safety.
Item 2.5 (10) requires “provision for the inspection of facilities and activities and for the enforcement of regulations, in accordance with a graded approach.”
Requirement 3: Establishment of a Regulatory Body.
Requirement 4: Independence of the Regulatory Body.
Item 2.13 requires that the Regulatory Body (RB) be conferred with the legal authority to require authorized parties or applicants to provide access for making inspections (unfettered access).
36 Safety Requirements - General Safety Requirement (GSR)
graded approach
1. For a system of control, such as a regulatory system or a safety system, a process or method in which the stringency of the control measures and conditions to be applied is commensurate, to the extent practicable, with the likelihood and possible consequences of, and the level of risk associated with, a loss of control.
􀁌 An example of a graded approach in general would be a structured method by means of which the stringency of application of requirements is varied in accordance with the circumstances, the regulatory systems used, the management systems used, etc.
For example, a method in which:
(1) The significance and complexity of a product or service are determined;
(2) The potential impacts of the product or service on health, safety, security, the environment, and the achieving of quality and the organization’s objectives are determined;
(3) The consequences if a product fails or if a service is carried out incorrectly are taken into account.
2. An application of safety requirements that is commensurate with the characteristics of the practice or source and with the magnitude and likelihood of the exposures.
See also exclusion, exemption and clearance and optimization.

4. Requirement 27: Inspection of facilities and activities.
GSR Part 1 (Rev. 1): Governmental, Legal and Regulatory Framework for Safety
Requirement 27: Inspection of facilities and activities.
The RB shall carry out inspections of facilities and activities to verify that the authorized party is in compliance with the regulatory requirements and with the conditions specified in the authorization.
Requirement 28: Types of inspection of facilities and activities.
Inspections of facilities and activities shall include programmed inspections and reactive inspections; both announced and unannounced.
graded approach
2. An application of safety requirements that is commensurate with the characteristics of the practice or source and with the magnitude and likelihood of the exposures.
􀁌 See also exclusion, exemption and clearance and optimization.
Types of Inspections

5. Requirement 30: Establishment of an Enforcement Policy.
GSR Part 1 (Rev. 1): Governmental, Legal and Regulatory Framework for Safety
Requirement 29: Graded approach to inspections of facilities and activities.
Inspections of facilities and activities shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach.
Requirement 30: Establishment of an Enforcement Policy.
The RB shall establish and implement an enforcement policy with the legal framework for responding to non-compliance by authorized parties with the regulatory requirements or with any conditions specified in the authorization.
graded approach
2. An application of safety requirements that is commensurate with the characteristics of the practice or source and with the magnitude and likelihood of the exposures.
􀁌 See also exclusion, exemption and clearance and optimization.

6. GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Safety Fundamentals
Set out principles for protecting people and the environment.
Safety Requirements
Establish requirements to ensure the protection of people and the environment.
What has to be done to meet the objectives. (Shall)
Safety Guides
Provides recommended ways of meeting the requirements. (Should)
Safety Guides provide recommendations and guidance on how to comply with the safety requirements
GS-G-1.3 Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.

7. Objectives of Regulatory Inspections:
GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Objectives of Regulatory Inspections:
To provide a high level of confidence that all activities performed by the operator at all stages during the lifetime of a nuclear facility have been executed safely and meet the safety objectives, license conditions, and legal requirements.
Regulatory Body shall have the legal authority for conducting and coordinating inspection and enforcement actions during the lifetime of a facility.
Safety Guide
GS-G-1.3 Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Part 2. Objectives of Regulatory Inspection and Enforcement. (pg 2)

8. Objectives of Regulatory Inspections (con’t)
GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Objectives of Regulatory Inspections (con’t)
Inspections should independently confirm:
… the required quality … of safety related activities and structures, systems and components (SSCs) of the facility are maintained.
… strong and effective management, good safety culture and self-assessment systems ….
… sufficient personnel and trained and available to efficiently and safely performance of their duties …
… deficiencies and abnormal conditions are identified, promptly evaluated, and remedied by the operator …
… duly reported to Regulatory Body ...
Safety Guide
GS-G-1.3 Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Part 2. Objectives of Regulatory Inspection and Enforcement. (pg 2)

9. GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body. Section 4 – Performance of Regulatory Inspections
INSPECTION PROCESS
2. Preparation of Inspection
1. Inspection Programme
3. Conducting the Inspection
5. Program Evaluation
4. Findings Evaluation
Inspection areas, types, frequency
Resources
Inspection team
Inspection plan
Methods
Inspection
report
Safety significance
Regulatory actions
Regulatory control improvements?
Relevant information
Safety Guide
GS-G-1.3 Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Section 4. ‘Performance of Regulatory Inspections’

10. GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Inspection Programme
Shall be planned, systematic, comprehensive, and consistent.
Provide a high level of confidence that the operators (i.e., licensee, contractors, vendors) are:
Complying with procedures, standards, legal & regulatory requirements.
Identifying & solving problems to ensure safety.
FROM NRC WEB PAGE – DETAILED ROP DESCRIPTION:
The Inspection Programs:
The baseline inspection program, based on the "cornerstone" areas, focuses on activities and systems that are "risk significant," that is, those activities and systems that have a potential to trigger an accident, can mitigate the effects of an accident, or increase the consequences of a possible accident. The inspection program will also review the "cross-cutting issues" of human performance, the "safety-conscious work environment," and how the utilities find and fix problems. Inspections beyond the baseline will be performed at plants with performance below established thresholds, as assessed through information gained from performance indicators and NRC inspections. Additional inspections may also be performed in response to a specific event or problem which may arise at a plant.
The baseline inspection program has three parts -- inspection of areas not covered by performance indicators or where a performance indicator does not fully cover the inspection area; inspections to verify the accuracy of a licensee's reports on performance indicators; and a thorough review of the utility's effectiveness in finding and resolving problems on its own.).

11. Inspection Programme (con’t) Developed by considering:
GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Inspection Programme (con’t)
Developed by considering:
Legal and regulatory requirements, standards.
International practices & inspection programmes in other States.
Results of safety analysis (Operator: Deterministic, Probabilistic), and Regulatory Review and assessment.
Performance indicator programmes or other systematic method for assessing the operator’s performance.
Operational experience and lessons learned.
Human and Organizational Factors (HOF): safety culture, leadership, and management for safety…
Deterministic vs. probabilistic approach
Deterministic (postulating)
 Events completely determined by cause-effect-chains (causality).
 Analyse of the effects of assumed causes.
Statistically (retrospective)
 Rules can be derived from a large number of similar events (based on
experience).
 Directly applicable observations can be transferred to the system or to
the event level.
Probabilistic (prognostic)
 Events can be identified by the probability of occurrence.
 Use of observations on the level of components (Axiom system of Kolmogoroff).

12. Preparation for an Inspection
GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Preparation for an Inspection
Inspection personnel should be thoroughly prepared.
Preparation may include a review of:
Regulatory Requirements
Past Operating Experience
Findings of previous inspections and Enforcement actions
Past correspondence
The Safety Documentation and Operational Limits and Conditions.
Documentation on Operation and Design for the facility.
The operator’s management system, including the quality assurance programme.
Preparation may include a review of …….. relating to the area of inspection.
Preparation will depend on the type and method of inspection

13. Types of Inspections (1)
Planned and Reactive
Team Inspections
Announced and Unannounced

14. Types of Inspections (2)
Planned Inspections
Scheduled in advance. Are part of the prearranged or ‘baseline’ inspection programme.
Planned inspections, both announced and unannounced, should be conducted at all stages of the lifetime of a nuclear facility.
Provide an opportunity to assess the operator’s performance and to identify potential problems at an early stage.
Usually focus on observation and assessment of safety activities to determine the effectiveness of the operator’s performance.

15. Types of Inspections (3)
Reactive Inspections
Usually initiated in response to:
an unexpected situation or incident to assess its significance and implications and the adequacy of corrective actions;
a generic problem encountered at another plant or identified by the review and assessment of the Regulatory Body.
Situations with potential hazards to workers, the public and the environment;
Events which may be of concern to the public or misinterpreted by the public.
graded approach: Taken, in part, from IAEA glossary of safety terms.
For a system such as a regulatory system or a safety system, a graded approach is a process or method in which the amount and type of measures and conditions applied
is commensurate, to the extent practicable, with the likelihood and possible consequences of, and the level of risk associated with, a loss of control.

16. Types of Inspections (4)
Reactive Inspections (cont.)
May disrupt regulatory programmes and schedules.
Graded approach should be used in responding to unforeseen circumstances:
For a serious event, all available resources should be used.
For a less serious or simple case, only one inspector may be needed.

17. Types of Inspections (5)
Team Inspections (Planned)
Provide an in-depth, independent and balanced assessment of the operator’s performance.
Team composition should reflect the scope, depth, technicalities and expertise needed for the inspection activity.
e.g.: civil, mechanical, electrical, I&C, materials, management system and human factors.
Different approaches in planning team inspections:
horizontal slice team inspections: broad in focus and cover a wide subject area in the programme area of interest;
vertical slice team inspections: narrow in focus and cover a smaller subject area.
Provide an in-depth, independent and balanced assessment of the operator’s performance.
Normal inspections cover only small samples of the operator’s activities in any particular area.

18. Types of Inspections (6)
Announced and Unannounced Inspections
Announced: the operator is notified in advance.
to observe a specific test or activity, or to review a specific self-assessment by the operator while it is in progress.
Announcement may enhance effectiveness of the inspection:
documentation and personnel will be available for inspection;
activities can be inspected as scheduled.
Advantage of Unannounced inspections:
actual condition of the facility and actual operation can be observed;
inspections may be carried out at any time of the day or night to provide a more complete picture of the situation at the facility.

19. Conducting the Inspection
GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Conducting the Inspection
Monitoring and Direct Observation (such as of working practices and equipment).
Discussions and Interviews (both with the Operator and Contractors).
Review of Procedures, Records and Documentation.
Independent Tests and Measurements and Evaluation of Operator’s Tests and Results.
One or more of these methods should be employed in a balanced way, depending on the specific issues being considered.

20. Inspection Reports and Findings
GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Inspection Reports and Findings
Purposes of Inspection Report:
Record the findings and conclusions.
Document and record the Regulatory Body’s (RB) assessment of the operator’s activities in relation to safety.
Record Enforcement Action.
The inspection report should be:
Prepared by the inspectors who performed the inspection.
Reviewed and approved according to RB internal procedures.
NRC Manual 0612:
03.03 Finding. A performance deficiency determined to be More-than-Minor in accordance with Manual Chapter 0612, Appendix B.
03.04 Issue of Concern. A well-defined Observation or collection of observations potentially impacting safety or security which may warrant further inspection, screening, evaluation, or regulatory action.
03.10 Observation. A factual detail noted during an inspection.
03.11 Pending Significance. A significance characterization assigned to a Finding which requires further safety or security significance evaluation to determine a preliminary significance.
03.12 Performance Deficiency. The licensee’s failure to satisfy one or more regulatory requirements or self-imposed standards where such failure was reasonably foreseeable and preventable. Additional information is provided in Block 2 of Appendix B of this Manual Chapter.

21. Inspection Program Evaluation
GS-G-1.3, Regulatory Inspection of Nuclear Facilities and Enforcement by the Regulatory Body.
Inspection Program Evaluation
The Regulatory Body should modify and re-organize its inspection activities as a facility passes from one stage to another.
To improve efficiency and effective use of resources.

22. Summary Inspection Process
Must have Authority from State and be Independent.
Provides a High Level of confidence that Operators comply with procedures, standards, and regulatory requirements.
Uses a Graded Approach commensurate with safety significance.
Planned, systematic, comprehensive, and consistent.
Document results of inspections.
Continually evaluate and modify inspection program.
Inspect during all stages of the nuclear facility.

23. Enforcement 23

24. Outline Definitions. Purpose of Enforcement.
Factors in determining Enforcement Actions.
Types of Enforcement Actions.
Implementing Enforcement Actions using a Graded Approach.
Openness and Transparency.
IAEA Safety Glossary
enforcement
The application by a regulatory body of sanctions against an operator,
intended to correct and, as appropriate, penalize, non-compliance with
conditions of an authorization

25. Enforcement The IAEA Safety Glossary defines enforcement:
The application by the Regulatory Body of sanctions against the operator intended to correct and, as appropriate, penalize, non-compliance with the conditions of an authorization (i.e., requirement or license condition).
IAEA Safety Glossary - enforcement
The application by a regulatory body of sanctions against an operator,
intended to correct and, as appropriate, penalize, non-compliance with
conditions of an authorization
The primary purpose is enforcement action is to stop non-compliance with the health, safety, security and environmental requirement. (BPTC Module 20)
US NRC Public Website: Enforcement Program Overview
two goals of the enforcement program remain unchanged:
1) to emphasize the importance of compliance with regulatory requirements, and
2) to encourage prompt identification, and prompt, comprehensive correction of violations.
NRC Enforcement Policy 12 July 2011 (?White Paper?)
the Enforcement Policy endeavours to do the following:
a. Deter noncompliance by emphasizing the importance of compliance with NRC requirements.
b. Encourage prompt identification and prompt comprehensive correction of violations of NRC requirements.

26. Enforcement
General Safety Requirement (GSR) Part 1 (Rev.1), Governmental, Legal and Regulatory Framework for Safety;
Requirement 30: Establishment of an Enforcement Policy.
The Regulatory Body shall establish and implement an enforcement policy … for responding to non-compliance … with regulatory requirements ….
GSR Part 1 (Rev.1)
Requirement 30: Establishment of an enforcement policy
The regulatory body shall establish and implement an enforcement policy within the legal framework for responding to non-compliance by authorized parties with regulatory requirements or with any conditions specified in the authorization.
The primary purpose is enforcement action is to stop non-compliance with the health, safety, security and environmental requirement. (BPTC Module 20)
US NRC Public Website: Enforcement Program Overview
two goals of the enforcement program remain unchanged:
1) to emphasize the importance of compliance with regulatory requirements, and
2) to encourage prompt identification, and prompt, comprehensive correction of violations.
NRC Enforcement Policy 12 July 2011 (?White Paper?)
the Enforcement Policy endeavours to do the following:
a. Deter noncompliance by emphasizing the importance of compliance with NRC requirements.
b. Encourage prompt identification and prompt comprehensive correction of violations of NRC requirements.

27. Purpose of Enforcement
The primary purpose of Enforcement is to restore compliance.
Enforcement:
Holds Licensee Accountable For Violations And Performance Deficiencies of Requirements.
Encourages Prompt Identification and Prompt, Comprehensive Corrective Actions.
Emphasizes the importance of compliance.
Deters non-compliance.
GSR Part 1 (Rev.1)
Requirement 30: Establishment of an enforcement policy
The regulatory body shall establish and implement an enforcement policy within the legal framework for responding to non-compliance by authorized parties with regulatory requirements or with any conditions specified in the authorization.
The primary purpose is enforcement action is to stop non-compliance with the health, safety, security and environmental requirement. (BPTC Module 20)
US NRC Public Website: Enforcement Program Overview
two goals of the enforcement program remain unchanged:
1) to emphasize the importance of compliance with regulatory requirements, and
2) to encourage prompt identification, and prompt, comprehensive correction of violations.
NRC Enforcement Policy 12 July 2011 (?White Paper?)
the Enforcement Policy endeavours to do the following:
a. Deter noncompliance by emphasizing the importance of compliance with NRC requirements.
b. Encourage prompt identification and prompt comprehensive correction of violations of NRC requirements.

28. Enforcement Policy (1)
The Regulatory Body must have the authority to compel a licensee to comply with regulatory requirements.
This authority will depend on the regulatory framework of the State, but should include a graduated or graded series of actions.
Enforcement actions are not intended to be punitive, but are designed to protect the health and safety of persons and the environment.
GSR Part 1 (Rev.1)
Requirement 30: Establishment of an enforcement policy
The regulatory body shall establish and implement an enforcement policy within the legal framework for responding to non-compliance by authorized parties with regulatory
The primary purpose is enforcement action is to stop non-compliance with the health, safety, security and environmental requirement. (BPTC Module 20)
US NRC Public Website: Enforcement Program Overview
two goals of the enforcement program remain unchanged:
1) to emphasize the importance of compliance with regulatory requirements, and
2) to encourage prompt identification, and prompt, comprehensive correction of violations.
NRC Enforcement Policy 12 July 2011 (?White Paper?)
the Enforcement Policy endeavours to do the following:
a. Deter noncompliance by emphasizing the importance of compliance with NRC requirements.
b. Encourage prompt identification and prompt comprehensive correction of violations of NRC requirements.

29. Enforcement Policy (2)
The Regulatory Body should confirm all enforcement actions in writing.
Records should be kept for both audit purposes and for knowledge management.
The Regulatory Body should review its enforcement process as part of its self-assessment programme.

30. Enforcement Policy (3)
The Regulatory Body needs to establish a clear enforcement policy that details how it will enforce its regulatory requirements.
Processes, procedures, and work instructions should support the policy.
The policy should include a graded approach commensurate with the seriousness of the non-compliance.

31. In all cases, the licensee must:
Enforcement Policy (4)
In all cases, the licensee must:
return to compliance,
determine the root causes, and
prevent recurrence.

32. Types of Enforcement Actions (1)
The Regulatory Body must have clear administrative procedures and guidelines governing the use and implementation of enforcement actions and All inspectors must be trained in and knowledgeable about these procedures and guidelines.

33. Types of Enforcement Actions (2)
The Regulatory Body should implement enforcement actions using a graded approach. Typical enforcement actions include:
Verbal warnings;
Written warnings;
Written directives;
Orders;
Modification, suspension or revocation of the license;
Monetary or other civil penalties;
Prosecution.

34. Factors in Determining Enforcement Actions
The Regulatory Body must take into account a number of factors, including:
Safety significance of the non-compliance;
Complexity of the correction action required;
Seriousness of the non-compliance;
Whether the same non-compliance has occurred before;
Whether the non-compliance was deliberate or willful;
Who identified and reported the non-compliance;
If reported by the licensee, the timeliness of the reporting;
Past performance of the licensee;
Need for consistency and transparency in the treatment of licensees.

35. Graded Approach (1)
In the case of a minor non-compliance, in the first instance a verbal warning may be all that is necessary.
In the case of a serious non-compliance, an order, licence modification or prosecution may be appropriate.
In some States experience has shown that, imposing penalties on the licensee, rather than on individuals, is more likely to improve safety performance.
A structured method which determines the areas of inspection and amount of inspection effort that is applied. The effort is commensurate with the level of risk.
graded approach
1. For a system of control, such as a regulatory system or a safety system, a process or method in which the stringency of the control measures and conditions to be applied is commensurate, to the extent practicable, with the likelihood and possible consequences of, and the level of risk associated with, a loss of control.
􀁌 An example of a graded approach in general would be a structured method by means of which the stringency of application of requirements is varied in accordance with the circumstances, the regulatory systems used, the management systems used, etc.
For example, a method in which:
(1) The significance and complexity of a product or service are determined;
(2) The potential impacts of the product or service on health, safety, security, the environment, and the achieving of quality and the organization’s objectives are determined;
(3) The consequences if a product fails or if a service is carried out incorrectly are taken into account.

36. Graded Approach (2)
Depending on the safety risk, the seriousness of the issue and the complexity of the corrective action, the Regulatory Body must allow the licensee a reasonable period of time to complete corrective actions.
An integrated approach to safety will consider the contribution to the total risk to the installation of each individual non-compliance.

37. Openness and Transparency
The Regulatory Body must be open and transparent regarding:
its enforcement policy and procedures,
the conduct of inspections,
and how enforcement actions are determined
The Regulatory Body should:
inform the public of the types and frequencies of the inspections and
provide a summary of the licensee’s compliance with regulatory requirements .
The extent to which such information is made publicly available depends on the legal provisions of the State.

38. Summary Enforcement Process Restores Compliance
Must have Authority from State
Requires Effective Corrective Actions
Commensurate with Safety Significance
Uses a Graded Approach
Clear Requirements, Procedures, and Processes
Open and Transparent

39. Thank You