regional workshop on legislation and regulation

Stephen Evans

Project Officer, Regulatory Infrastructure and Transport Safety Section, IAEA

Effective Compliance Monitoring: Strategies for Inspection

REGIONAL WORKSHOP ON LEGISLATION AND REGULATION (REGULATORY FUNDAMENTALS FOR NUCLEAR AND RADIATION

INSTALLATIONS AND ACTIVITIES) Amman, Jordan 01 – 05 September 2013

28 March 2017

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REGIONAL WORKSHOP ON LEGISLATION AND REGULATION (REGULATORY FUNDAMENTALS FOR NUCLEAR AND RADIATION INSTALLATIONS AND ACTIVITIES) Amman, Jordan

SEPT 01 to 05 2013

Objective

The purpose of this presentation is to propose strategies for a graded approach to planning, performing and following-up inspections and for establishing a systematic, graded inspection programme.

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SEPT 01 to 05 2013

Inspect What’s Important

Question: Is it necessary to inspect

every practice in an identical manner to be reasonably assured that most licensees are in compliance with most regulatory requirements?

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GSR Part 1 Requirements for inspections

• Requirement 27 “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 “Inspections of facilities and activities include programmed inspections and reactive inspections; both announced and unannounced”

• Requirement 29 “Inspections of facilities and activities shall be commensurate with the radiation risks associated with the facility or activity, in accordance with a graded approach”

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Priority and Frequency of Inspections

Inspections and the inspection programme should be informed by:

– the risk associated with the radiation source (source

categorization) – the complexity of the practice – the possible consequences of an accident and – the type and frequency of any violations found by

inspections.

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SEPT 01 to 05 2013

Choice of Compliance Monitoring Tools

DIRECT MEANS OF VERIFYING COMPIANCE

INDIRECT MEANS OF VERIFYING COMPLIANCE

Inspector observes work practices RB staff review annual compliance reports

Inspector interviews workers RB staff review licensee’s self-assessment reports

Inspector conducts tests and measurements

RB staff review licensee’s independent assessment reports

Inspector reviews on site records RB staff review licensee’s policies, procedures and programmes

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Strategy: Plan Team and Individual Inspections on a Graded Basis

• Inspections may be either single checklist-type inspection or a team inspection that follows processes similar to those used in audits.

• Employ a graded approach to planning inspections based upon the risk of the sources and practices and the complexity associated with the facility or activity.

• A team inspection at a large facility may require a preliminary visit by the team leader to gather relevant information and plan the scope and depth of the later work of the team.

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Strategy: Foster Self-Assessment

• Require that the authorized party perform their own monitoring and auditing of radiation protection programme. They should conduct their own self assessment and report the results to the RB.

• Such self-assessment is part of safety culture and part of a sound management system

• Advantage of self assessment: Routine internal monitoring contributes to better safety performance and enables inspectors to focus on problem areas

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Strategy: Implement a Sampling Approach to Inspections

• A “complete” inspection is not always feasible because:

Some sources may be used in field locations Sources may be in inaccessible locations Some key staff may be absent

• It is pragmatic and sensible to plan to perform partial inspections or sampling inspections where the most important items are given priority.

• The challenge for the inspector is to start with the high risk items and to stop when he/she has a representative sample of compliance results sufficient to build confidence.

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SEPT 01 to 05 2013

Records Inspection versus Field Inspection

Records inspections versus field inspections • The RB needs both types, but not necessarily both types of

inspection every time.

• Records may be inadequate (a finding) or “doctored” to look good

• Field inspections usually find workers on their best behaviour.

• Field locations may be remote, time-consuming and difficult or expensive to reach.

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Strategies for the Management of the Inspection Programme

• Establish criteria to determine the type of inspection; i.e. team or single inspector

• Establish criteria for field and records inspections

• Inspection programme managers must be realistic: i.e. familiar with practical and administrative matters such as availability and locations of experienced inspection staff, availability of equipment, scale of licensee operations and licensee locations …. as well as budget constraints.

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• Use assessment/authorization specialists in some inspections, particularly team inspections.

• Use contract staff to conduct inspections under supervision

• Locate some inspectors in the regions – in closer proximity to the facilities that they inspect.

• Emphasize the importance to inspectors of informing each planned inspection with the results of the last inspection

Strategies for the Management of the Inspection Programme

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SEPT 01 to 05 2013

The Challenge of Inspection Consistency

• Some degree of interpretation will always be required of inspectors. – For example, records are often in different formats and what is

acceptable to one inspector may not be acceptable for another.

• There may be good reasons why one inspector may cite what a previous inspector did not:

– The sequential inspections may show differing results because they have a different focus. For example, one inspection may focus on records rather than the field operations that were the focus of the previous inspection

– Or, perhaps more significantly, performance may have deteriorated to the point that what the previous inspector accepted as passable is now clearly a non-compliance

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• The focus of inspections may vary, but, in accordance with a graded approach, the same core high risk items should be inspected every time.

• The regulatory body should strive to reduce the latitude for interpretation through the use of standard forms and clear descriptions of regulatory requirements whilst at the same time allowing inspectors to use their judgment.

The Challenge of Inspection Consistency

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Strategy: Improve Inspection Consistency

• Draft inspection procedures. • Develop a formal training programme for inspectors in

inspection procedures and methods. • Employ some inspectors having experience in the field

they are asked to inspect and use them to train less practically experienced inspectors.

• Cross-train inspectors with authorization, review and assessment staff

• Vary the facilities that inspectors visit. • Develop and publish compliance expectations. • Routinely analyze reported inconsistencies

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Strategy: Inspection Grading System

Examples of compliance performance grades: – Compliant/Not Compliant and comments

– Best Practices/Suggestions/Recommendations

– Report Card Grades: A, B, C, D, F

– Narrative description of inspection findings with list of

non-compliances

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Grade Definition Risk to Health, Safety, Security and the Environment

A Exceeds requirements No unreasonable risk

B Meets requirements No unreasonable risk

C Below requirements No unreasonable risk but potential

D Significantly below requirements

High potential for unreasonable risk if not corrected

E Unacceptable Very high potential for unreasonable risk

Strategy: Inspection Grading System

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Strategy: Graded Process for Verifying Completion of Corrective Actions

How each corrective action should be closed should be based on the severity of the non-compliance.

• Low risk items – accept the facility’s assurance that corrective action is complete

• High risk items – inspectors verify the completion of corrective action at the next available opportunity

• Moderate risk items – it depends… • Accept a photo? • Accept a promise?

Generally, the regulatory body needs evidence (not necessarily legal evidence) that a corrective action is complete

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• Inspection reports should indicate what has to be corrected, but not state how the non-compliance should be corrected.

• When an item of non-compliance has to be corrected is often a negotiated matter.

• However, the severity of the non-compliance will dictate the time frame for the corrective action. – High risk – immediately – Low risk – reasonable time frame – Moderate risk – it depends

Strategy: Graded Process for Verifying Completion of Corrective Actions

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Strategy: Graded Approach to Inspection Follow-up

• In a database such as RAIS, the regulatory body should capture all inspection findings for each facility together with the non-compliances and the dates that they were closed and the means of closure.

• The same database can be used to capture all outstanding open compliance actions together with the time taken to close the item.

• The rationale for closing an item should be documented

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• The regulatory body needs to show when all of the inspection findings have been addressed and the inspection itself may be considered closed.

• The regulatory body should have a “bring forward” (BF) or reminder system for open items and inspections.

• The reality is that the regulatory body needs to periodically remind the authorized parties about unfinished business

Strategy: Graded Approach to Inspection Follow-up

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Strategy: Inspection Database to Optimize Inspections

• Use information from the inspection database (such as RAIS) to optimize inspections

• Develop inspection workload measures such as: • Number of inspections, • location of inspections, • type of licensed activity, • Identifying inspection cost factors (not in RAIS capacity) • number of sources/devices at each inspected location,

• time required to conduct each type of inspection

• Then …..

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• Decide an inspection frequency, based upon: • radiological risk associated with the type of facility/activity • Use the IAEA categorization of radioactive sources • and the compliance history of the authorized party

• Use three or five categories (grades) of compliance performance

• Assign scores in such a way that priorities may be established for inspections

• Establish a risk-based, performance-driven inspection programme by combining the general inspection data and the previous inspection information for specific authorized parties

Strategy: Inspection Database to Optimize Inspections

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SEPT 01 to 05 2013

More Information

• GSR Part 1: Governmental, Legal and Regulatory Framework for Safety

• The IAEA Code of Conduct on the Safety and Security of Radioactive Sources

• GS-G-1.5 Regulatory Control of Radiation Sources (Safety Guide)

• IAEA-TECDOC-1526, Inspection of Radiation Sources and Regulatory Enforcement

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SEPT 01 to 05 2013

THANK YOU FOR YOUR ATTENTION

This activity is conducted by the IAEA, with funding by the European Union, among others. The views expressed in this presentation do not necessarily reflect th i f th E U i

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