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2013:29 Regulatory Approaches in Nuclear Power Supervision

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Research

Report number: 2013:29 ISSN: 2000-0456 Available at www.stralsakerhetsmyndigheten.se

Regulatory Approaches in

Nuclear Power Supervision

2013:29

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SSM perspective Background

Between 2003 and 2005 the Swedish Nuclear Power Inspectorate (SKI) sponsored a study to better understand the benefits and difficulties of using various regulatory approaches for supervision of commercial nuclear power safety. At the time of the study little research had been published on the use and impact of different regulatory strategies. This is still the situation today.

The main purpose of this exploratory study was to contribute to a more systematic understanding of the experiences of nuclear regulatory staff when using different regulatory approaches. This type of information can facilitate the building of a better knowledge base on the conditions under which experts have found certain strategies to be more or less effective. In the first study, a number of regulatory approaches were identified and defined by consulting with nuclear regulatory staff. Since the previous study was completed major changes have taken place in the nuclear in-dustry worldwide. Long term operation (LTO), beyond the initial licenses, is planned in many countries. As a result of these plans, more attention needs to be given to aging management. In some countries, moderni-sations are also needed to allow longer periods of operating. Actions to further increase the terminal output in nuclear power reactors are underway in several countries. New reactors are being built and licensing processes are underway. Taken together, these conditions lead to signi-ficant new challenges for regulatory bodies. Although many regulatory organizations are being strengthened with additional resources in this situation, they need to continue developing and refining their strategies for their regulatory supervision in different functional supervision areas in order to conduct their regulatory activities as efficiently as possible. Objectives

The objective of this follow-up study was to support SSM in further understanding regulatory approaches and how they can be combined as part of effective strategies. The survey was intended to assist SSM in identifying current standards, experiences, and practices in the regula-tion of nuclear power plants. The results will also be valuable for the participating authorities as well as other parties interested in nuclear regulatory supervision activities.

Results

In the more in-depth study, it was stressed that regulatory supervision is a dynamic process and that the approaches being examined in this survey were important tools, used iteratively and in combination to add-ress complex cases. The effectiveness of any approach was linked to how appropriate it was to the specific characteristics of the case.

Many of the findings from the previous study were confirmed by the findings from the extended new study, including most of the benefits

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and difficulties of different approaches. As found in the previous study, combinations of approaches were used across all the areas of regulatory supervision studied. The findings from the study show that the combi-nations of approaches depend on the nature of regulatory supervision. There is also a tendency to combine additional approaches as a functio-nal area of regulatory supervision becomes more complex.

SSM will use the findings in order to achieve a regulatory supervision that is more effective and even more appropriate for purpose. In SSM’s further development of its regulatory activities, approaches and strate-gies will be developed for various areas of regulatory supervision and be adapted to the nature of the areas and matters of regulatory supervision as well as their importance for safety.

The starting point of this work will be the discussion on the findings of the present study at the CNRA workshop on Regulatory Approaches and the Characteristics of an Effective Regulator, which will be held 28-30 October 2013 in Stockholm. The results from the workshop will be docu-mented in a CNRA Green Booklet.

Need for further research

The two studies have contributed to a more systematic understanding of experience with different regulatory approaches and practices—their selection, their use, and their outcomes. However, there is a need for further research in the area. This includes the need to study how the re-sults from the area of nuclear safety can be transferred to other related regulatory areas, such as radiation protection and security.

Project information

Contact person at SSM: Anna Franzén Reference: 7030021-01

Dnr: SSM 2011-58 Project no: 7030021-01

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2013:29

Author:

Date: September 2013

Report number: 2013:29 ISSN: 2000-0456 Available at www.stralsakerhetsmyndigheten.se

Nancy E. Durbin

Nancy E. Durbin Consulting, San Luis Obispo, California USA

Regulatory Approaches in

Nuclear Power Supervision

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This report concerns a study which has been conducted for the Swedish Radiation Safety Authority, SSM. The conclusions and view-points presented in the report are those of the author/authors and do not necessarily coincide with those of the SSM.

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Content

Sammanfattning av rapporten ... 6

Report Summary ... 12

1. Introduction ... 17

1.1. Background and study goals ... 18

1.1.1. Method and findings from 2003-2004 study and 2004 workshop . 20 Findings from the 2003/04 interviews ... 22

Workshop on findings from the 2003/04 study ... 22

1.2. Overview of the 2011/12 study and organization of this report ... 23

2. Research plan and implementation ... 26

2.1. Defining terms ... 26

2.1.1. Regulatory supervision ... 26

2.1.2. Approaches ... 27

2.1.3. Areas of supervision ... 27

2.2. Developing the questionnaire ... 29

2.2.1. Section I: Case study examples ... 30

2.2.2. Section II: Usual approach or combination of approaches ... 32

2.2.3. Section III: Approach definitions and usefulness ... 33

2.2.4. Response categories and requests for comments ... 33

2.3. Administering the questionnaire ... 33

2.4. Completing initial analysis ... 35

2.5. Meeting with participating agencies ... 35

2.6. Analysing written comments and discussion ... 36

3. General findings regarding the role of approaches in regulatory supervision ... 37

3.1. Regulatory supervision is a dynamic process ... 37

3.2. Approaches used in combination and described as tools ... 38

3.3. Approaches are complementary tools, not competing options ... 38

3.4. Approaches differed in emphasis but used/useful across all areas . 39 3.5. Increase in the use of approaches ... 39

3.6. Circumstances often determine the approach(es) used, and effectiveness of outcomes ... 39

3.7. Resources, expertise requirements can be high regardless of approach ... 40

3.8. Prescriptive and education/influence approaches represent multiple tools ... 41

4. Follow up of 2003/04 findings ... 42

4.1. Benefits and difficulties of regulatory approaches ... 42

4.1.1. Prescriptive ... 43

4.1.2. Case-based and Facility-based ... 43

4.1.3. Outcome-based ... 43

4.1.4. Risk-based and Risk/hazard-based ... 44

4.1.5. Process-based ... 44

4.1.6. Self-assessment based ... 44

4.1.7. Education/influence approach ... 44

4.2. Use of approaches in regulatory supervision ... 45

4.2.1. Combinations of approaches used in all areas of supervision ... 45

4.2.2. Less reliance on a prescriptive recently, moving toward process-based with prescriptive for action/closure when necessary ... 46

4.2.3. Risk-based to prioritize for quality systems and plant design/modifications ... 46

4.2.4. Risk-based for plant design/modification: tension and balance .... 46

4.3. Consequences of regulatory approaches ... 47

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4.3.1. Primary responsibility for safety on licensee or regulator? ... 47

4.3.2. Clear requirements and expectations of licensee? ... 48

4.3.3. Important safety issues identified and addressed? ... 49

4.3.4. Level of expertise required of licensee? Of regulator? ... 49

4.3.5. Level of resources required of licensee? Of regulator? ... 50

4.3.6. Flexibility given licensee with usual approach(es)? ... 51

4.3.7. Do approach(es) affect public credibility regarding safety of licensee facility? Regarding regulator? ... 52

4.3.8. Do approach(es) affect safety culture of licensee? Of regulator?. 53 4.4. 2003/04 report issues that emerged from examples regarding regulatory approaches ... 54

4.4.1. Resistance to changing regulatory approaches ... 54

4.4.2. Tension concerning use of risk analysis for regulatory decisions . 54 4.4.3. Differences in interpretations of regulatory approach definitions .. 55

4.4.4. Importance of combinations of approaches for regulatory effectiveness ... 55

5. Circumstances that affect regulatory supervision ... 56

5.1. Experience ... 56

5.2. Characteristics of the industry ... 57

5.3. The use of contractors ... 57

5.4. Cooperation/agreement between regulator and licensee ... 58

5.5. Characteristics of the case: scope and early intervention ... 59

5.6. Performance by licensee and regulator... 60

6. Usefulness, use, emphasis, and change of regulatory approaches: overall and within areas of supervision ... 61

6.1. Results across all areas of supervision ... 61

6.1.1. Overall usefulness of approaches ... 62

6.1.2. Overall use and emphasis of different approaches ... 63

6.1.3. Overall change in the use of approaches ... 64

New regulation ... 65

Increased use of self-assessment ... 65

Increased use of risk/hazard approach ... 66

Experience/learning by the agency ... 66

Increased use of outcome approach ... 66

An event led to the change ... 66

6.2. Evaluation of approaches in each area of supervision ... 66

6.2.1. Management Systems ... 67

6.2.2. Maintenance ... 69

6.2.3. Operations ... 71

6.2.4. Safety Culture ... 73

6.2.5. Plant Life Extension ... 75

6.2.6. Major Plant Modifications ... 77

6.2.7. Power Up Rates ... 79

6.2.8. Construction ... 81

7. Discussion of specific approaches ... 83

7.1. Prescriptive ... 83

7.1.1. Usefulness of approach ... 86

Clear and detailed requirements ... 86

Rigid, inefficient, and places responsibility for safety on the regulator ... 87

Exertion of regulatory authority ... 87

7.1.2. Use, emphasis, and change in use of prescriptive approach ... 88

7.2. Facility ... 88

7.2.1. Usefulness of approach ... 89

Overarching regulations... 89

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Both general and site specific approaches needed ... 90

Reasons for using a facility approach ... 90

7.2.2. Use, emphasis, and change in use of facility approach ... 91

7.3. Outcome ... 91

7.3.1. Usefulness of approach ... 91

Improving plant performance ... 92

Responsibility for performance placed with licensee ... 93

Difficulties of finding good outcome measures ... 93

7.3.2. Use, emphasis, and change in use of outcome approach ... 93

7.4. Risk/Hazard ... 94

7.4.1. Usefulness of approach ... 94

Using a risk/hazard approach to focus regulatory attention ... 94

Using a risk/hazard approach to improve safety performance ... 94

Difficulties with method used for risk/hazard based ... 95

7.4.2. Use, emphasis, and change in use of risk/hazard approach ... 96

7.5. Process ... 96

7.5.1. Usefulness of approach ... 96

Critical approach for safety management ... 97

Requires a high level of expertise ... 98

7.5.2. Use, emphasis, and change in use of process approach ... 98

7.6. Self-Assessment ... 98

7.6.1. Usefulness of approach ... 99

Promoting continuous improvement ... 100

Placing responsibility on the licensee ... 100

Should be used with other approaches and monitored by the regulator ... 100

7.6.2. Use, emphasis, and change in use of self-assessment approach ... 101

7.7. Education/Influence ... 101

7.7.1. Usefulness of approach ... 101

Key tool for regulators ... 104

Providing information ... 104

Requires a great deal of experience ... 104

Depends upon licensee acceptance ... 104

7.7.2. Use, emphasis, and change in use of education/influence approach ... 105

7.8. Responses to “Additional comments” and “Should other approaches to regulatory supervision be added?” ... 105

8. Summary and concluding remarks ... 107

8.1. Summary... 107 8.2. Concluding Remarks ... 110 Appendix 1...... 113 Appendix 2 ...... 127 Appendix 3 ...... 129 Appendix 4 ...... 135 Appendix 5 ...... 137  SSM 2013:29

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Acknowledgments

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Sammanfattning av rapporten

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Huvudsakliga resultat

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Report Summary

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1 See report for full definitions of these approaches.

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Key findings

Regulatory supervision is an iterative and dynamic process that uses combinations of approaches as tools to address the complexity of regulatory supervi-sion 7KHH[SHUWVVXUYH\HGE\WKHTXHVWLRQQDLUHDQGLQFOXGHGLQGLVFXVVLRQV DWPHHWLQJVVWUHVVHGWKDWUHJXODWRU\VXSHUYLVLRQLVDG\QDPLFSURFHVV DQGWKDWWKHDSSURDFKHVEHLQJH[DPLQHGLQWKLVVXUYH\ZHUHLPSRUWDQW WRROVXVHGLWHUDWLYHO\DQGLQFRPELQDWLRQWRDGGUHVVWKHFRPSOH[LW\RI UHJXODWRU\VXSHUYLVLRQ7KHVHDSSURDFKHVZHUHSUHVHQWHGDVFRPSOH PHQWDU\²QRWFRPSHWLQJ²ZD\VRIPDQDJLQJUHJXODWRU\SUDFWLFH

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The effectiveness and efficiency of any approach was tied to how appropriate it was to the specific charac-teristics of the case

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Many of the findings from the 2003/04 study were sup-ported by the findings in the 2011/12 study

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1. Introduction

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2: Regulatory supervision is defined in section 2.1.1 and includes all areas of regulatory

over-sight.

3: Available at http:// www.stralsakerhetsmyndigheten.se

4: These questionnaires did not include the identities, experience, or agencies of the

respond-ents. The data available from these questionnaires was examined to see if there were any significant differences in the approaches used. In addition, the case studies from these ques-tionnaires were used in the qualitative analysis.

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1.1. Background and study goals

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5: In the 2003/04 study, the specific ways in which regulators approached supervision were

referred to as “strategies”. Based on feedback from that study, in the 2011/12 study, and throughout this report, the term “approach” is used to refer to the specific approaches to super-vision and the term “strategy” is not used.

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1.1.1.

Method and findings from 2003-2004 study and 2004 workshop ,QH[SHUWVIURPQXFOHDUSRZHUUHJXODWRUVLQ&DQDGD)LQODQG 6SDLQ6ZHGHQWKH8QLWHG.LQJGRPDQGWKH8QLWHG6WDWHVZHUHLQWHU YLHZHGDERXWWKHLUH[SHULHQFHVZLWKUHJXODWRU\DSSURDFKHV6L[UHJX ODWRU\DSSURDFKHVZHUHLGHQWLILHGDQGGHILQHGE\FRQVXOWLQJZLWKQX FOHDUUHJXODWRU\VWDII   3UHVFULSWLYH &DVHEDVHG  2XWFRPHEDVHG  5LVNEDVHG  3URFHVVV\VWHPEDVHG  6HOIDVVHVVPHQWEDVHG  6\VWHPDWLFVWUXFWXUHGRSHQHQGHGLQWHUYLHZVZLWKH[SHUWUHJXODWRUV ZKRKDGH[WHQVLYHH[SHULHQFHLQQXFOHDUSRZHUUHJXODWLRQZHUHXVHG WREHWWHUXQGHUVWDQGKRZUHJXODWRU\DSSURDFKHVDUHDSSOLHGLQSUDF WLFH7KHLQWHUYLHZEHJDQZLWKDUHYLHZDQGEULHIGLVFXVVLRQRIVL[ DSSURDFKHVIROORZHGE\TXHVWLRQVUHJDUGLQJZKHWKHU 

6: See Appendix 2 for a comparison of the definitions of the strategies/approaches from the two

studies.

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Findings from the 2003/04 interviews

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Workshop on findings from the 2003/04 study

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7: It was noted that these findings do not necessarily apply to other areas of regulation, such as

waste management.

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1.2. Overview of the 2011/12 study and organization of this report ,Q660FRPPLVVLRQHGDVWXG\WRGHYHORSDQGXVHDZULWWHQ TXHVWLRQQDLUHVXUYH\RIH[SHUWVIURP6ZHGHQDQGRWKHUFRXQWULHVWR DVVHVVFXUUHQWUHJXODWRU\VXSHUYLVLRQDQGWRIROORZXSRQWKHILQGLQJV IURPWKHVWXG\  6SHFLILFDOO\660DVNHGWKDWWKHVWXG\ORRNDWUHJXODWRU\DS SURDFKHVWR 

8: In the 2011/12 report the term “practice” rather than the suggested term “strategy” is used to

describe the use of a combination of approaches to achieve regulatory goals.

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2. Research plan and implementation

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9: Summary statistics of responses, including percentages, means, and standard deviations

were obtained. No inferential statistics, such as correlations, were derived as the data are not appropriate for that type of statistical analysis.

(33)

 2.1.2. Approaches 6HYHQDSSURDFKHVZHUHWKHIRFLRIWKHVWXG\7KHDSSURDFKHV ZHUHEDVHGRQWKHVL[DSSURDFKHVIURPWKHVWXG\7KHWHUPV XVHGDQGWKHGHILQLWLRQVZHUHUHYLVHGWRUHVSRQGWRFRPPHQWVDQG VXJJHVWLRQVIURPLQWHUYLHZHHVDQGZRUNVKRSSDUWLFLSDQWV,QDGGLWLRQ education and influenceZDVDGGHGDVDQDSSURDFKEDVHGRQVXJJHV WLRQVPDGHIROORZLQJWKHVWXG\7KHVHYHQDSSURDFKHVLQ FOXGHGZHUHprescriptive, facility based, outcome based, risk or haz-ard based, process based, self-assessment, and education and/or in-fluence based. 'HILQLWLRQVRIWKHVHDSSURDFKHVDUHSURYLGHGLQ7DEOH EHORZ([DPSOHVRIWKHXVHRIHDFKDSSURDFKLQWKHDUHDRI SHUVRQQHOFRPSHWHQF\ZHUHSURYLGHGLQWKHGHILQLWLRQV2QHUHFXUULQJ FRPPHQWRQWKHGHILQLWLRQVZDVWKDWLWZRXOGEHXVHIXOWRKDYHH[DP SOHVRIHDFKDSSURDFKIURPHDFKDUHDRIVXSHUYLVLRQ:KLOHWKLVZDV QRWSRVVLEOHIRUWKLVSURMHFWLWLVDXVHIXOVXJJHVWLRQIRUIXUWKHUZRUN LQWKLVDUHD 2.1.3. Areas of supervision 660ZDVLQWHUHVWHGLQORRNLQJDWUHJXODWRU\SUDFWLFHVLQHLJKWDUHDVRI VXSHUYLVLRQ7KHVWXG\KDGDGGUHVVHGWKUHHDUHDVIDFLOLW\ GHVLJQDQGPRGLILFDWLRQVTXDOLW\V\VWHPVDQGWUDLQLQJDQGTXDOLILFD WLRQV7KHVWXG\UHYLVLWVPDMRUSODQWPRGLILFDWLRQV SDUWRI ³GHVLJQDQGPRGLILFDWLRQV´IURPWKHVWXG\ DQGORRNVDWVHY HQDGGLWLRQDODUHDVPDQDJHPHQWV\VWHPVPDLQWHQDQFHRSHUDWLRQV VDIHW\FXOWXUHORQJWHUPRSHUDWLRQ LQFOXGHVSODQWOLIHH[WHQVLRQDQG OLFHQVHUHQHZDO DQGSRZHUXSUDWHVDQGFRQVWUXFWLRQ VHH7DEOH IRUGHILQLWLRQVRIWKHVHDUHDV    

10: A comparison of the definitions of these approaches with the “strategies” used in the

2003/04 study is provided in Appendix 2.

11: Some functional areas, such as power up rates and construction of new nuclear power

plants, are not relevant for some agencies. In this case only those agencies engaging in the activity filled out the questionnaire.

(34)

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area of personnel competency, requirements for specific education-al degrees or experience for a position would be prescriptive

)DFLOLW\ $IDFLOLW\EDVHGDSSURDFKGHWHUPLQHVWKHVDIHW\UHTXLUHPHQWVIRU HDFKOLFHQVHHWKURXJKLQGLYLGXDODVVHVVPHQWRILWVGHVLJQDQGRSHUD WLRQFRQVLGHULQJWKHXQLTXHKLVWRU\RIHDFKIDFLOLW\. Example: In the

area of personnel competency, requirements for different positions based on the characteristics of the facility would be a facility based approach

2XWFRPH $QRXWFRPHDSSURDFKHVWDEOLVKHVVSHFLILFSHUIRUPDQFHJRDOVRU RXWFRPHVIRUOLFHQVHHVWRDWWDLQEXWGRHVQRWVSHFLI\KRZWKH\VKDOO EHDWWDLQHG/LFHQVHHVGHWHUPLQHKRZWKH\ZLOOFRQGXFWWKHLUZRUN DFWLYLWLHVExample: In the area of personnel competency,

perfor-mance on a simulator would be outcome based.

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com-petency, a requirement that licensees use a systematic approach to training to determine requirements would be process based.

6HOI $VVHVVPHQW /LFHQVHHVGHYHORSDQGLPSOHPHQWVHOIDVVHVVPHQWSURJUDPVLQFOXGLQJWKHLGHQWLILFDWLRQRIERWKJRRGSUDFWLFHVDQGSUREOHPDUHDV QHHGLQJLPSURYHPHQWLQWHUQDOUHYLHZVDQGIROORZXS7KHUHJXOD WRUHYDOXDWHVWKHOLFHQVHHVHOIDVVHVVPHQWSURJUDPUHYLHZVWKH UHVXOWVRIWKHOLFHQVHHDVVHVVPHQWVDQGVHOHFWLYHO\LQVSHFWVWKH OLFHQVHHV¶IROORZXSRQVHOIDVVHVVPHQWUHVXOWVExample: In the

area of personnel competency, a requirement that licensees do an evaluation of how effective and complete their training program is would be an example of self-assessment.

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Ex-ample: In the area of personnel competency, the regulator sponsor-ing a seminar on trainsponsor-ing for licensees or presentsponsor-ing at a regulatory information conference regarding training activities would be edu-cation or influence based.





 

(35)

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2.2. Developing the questionnaire

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2.2.1. Section I: Case study examples

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12: Respondents were asked whether they found the definitions clear, with options for response

of 1 (very clear) to 5 (very unclear). The ratings for the clarity of the definitions were similar across all of the approaches. The proportion of those responding that the definition was be-tween somewhat to very clear (a rating of 3, 2, or 1) ranged from 85% to 93% (see Tables 7.1 through 7.7). Because the definitions of approaches were reported as relatively clear by the majority of the respondents, lack of understanding of the approaches should not substantially impact the validity of the results.

Figure

Table 1: Prescriptive Approach by Area:  Usefulness, Use and Emphasis, Change in Use
Table 2:  Facility Approach by Area:  Usefulness, Use and Emphasis, Change in Use
Table 3:  Outcome Approach by Area:  Usefulness, Use and Emphasis, Change in Use
Table 4:  Risk/Hazard Approach by Area:  Usefulness, Use and Emphasis, Change in Use
+4

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