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HR T D Human Resources Training & Development HR T D Human Resources Training & Development U.S.NRC UNITED STATES NUCLEAR REGULATORY COMMISSION Protecting People and the Environment March 2011- Slide 1 of 114 G-108 – Inspection Procedures INSPECTION OVERVIEW

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Page 1: 0457 - G108 - Inspection Procedures - 02 - Inspection ...G-108 – Inspection Procedures March 2011- Slide 32 of 114 y(for an incinerator, human research, no permanent storage location,

HRTDHuman ResourcesTraining & Development

HRTDHuman ResourcesTraining & Development

U.S.NRCUNITED STATES NUCLEAR REGULATORY COMMISSION

Protecting People and the Environment

March 2011- Slide 1 of 114G-108 – Inspection Procedures

INSPECTION OVERVIEW

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The NRC's mission is to regulate the Nation's civilian use of byproduct, source, and special nuclear materials including NORM (Natural-Occurring Radioactive Material) and NARM (Natural-Occurring and

Regulatory Mission

March 2011- Slide 2 of 114G-108 – Inspection Procedures

Material) and NARM (Natural-Occurring and Accelerator-Produced Radioactive Material), to ensure adequate protection of public health and safety, to promote the common defense and security, and to protect the environment.

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Authority(Atomic Energy Act of 1954 and Energy Reorganization Act of 1974)

Regulatory Program

March 2011- Slide 3 of 114G-108 – Inspection Procedures

Implementing Regulations(Title 10, Code of Federal Regulations, Parts 1 to 199)

Licensing/Permitting/Registration(10 CFR 30.3)

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Inspection ProgramManual Chapter 2800 Inspection Procedures (IP 87100 series)

Regulatory Program

March 2011- Slide 4 of 114G-108 – Inspection Procedures

TrainingThis course - adequate startMentor – getting thereInspection accompaniments - betterOn-going - continually learning - best

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NRC’s Training ProcessHow to Become an Inspector…

MC 1246 “Formal Qualification Programs in the Nuclear Material Safety and Safeguards Program Area”

Core training

March 2011- Slide 5 of 114G-108 – Inspection Procedures

g

Specialized training

Self study

Qualification journal

Oral Board

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Examples of “Core” Training

This course

Root Cause/Incident Investigation Workshop (G-205)

H lth Ph i T h l C (H 201)

March 2011- Slide 6 of 114G-108 – Inspection Procedures

Health Physics Technology Course (H-201)

Diagnostic and Therapeutic Nuclear Medicine Course (H-304)

Safety Aspects of Industrial Radiography Course (H-305)

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“Specialized Training”

Internal Dosimetry & Whole Body Counting Course (H-312)

Safety Aspects of Well Logging Course (H-314)

I di t T h l C (H 315)

March 2011- Slide 7 of 114G-108 – Inspection Procedures

Irradiator Technology Course (H-315)

Environmental Monitoring for Radioactivity Course (H-111)

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Will I Learn Everything Here?

Will I learn everything I need to know about conducting inspections in this course? NO!

But… it’s an adequate start…

March 2011- Slide 8 of 114G-108 – Inspection Procedures

As a general rule, training courses speed up the knowledge acquisition process.

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Purpose

To determine if licensed activities are being conducted in a manner that will protect the health and safety of workers and the general public

Inspection

March 2011- Slide 9 of 114G-108 – Inspection Procedures

and safety of workers and the general public

To determine if licensed programs are being conducted in accordance with U.S. Nuclear Regulatory Commission requirements

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COMPLIANCE VS. PERFORMANCE

(OLD SCHOOL VS. NEW SCHOOL)

Two Approaches to Inspection

March 2011- Slide 10 of 114G-108 – Inspection Procedures

m2

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Slide 10

m2 New School is Oslo, Norway Law School

Old School is Ying Qui Township School (China)mml, 9/3/2008

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Inspector secluded in an office or conference room

Review lots of records

Id tif i l ti dl f th f t

Compliance-BasedInspection

March 2011- Slide 11 of 114G-108 – Inspection Procedures

Identify violations regardless of the safety significance

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What is the requirement?

How did the licensee comply with the requirement?

Two Basic Questions fora Compliance Inspection

March 2011- Slide 12 of 114G-108 – Inspection Procedures

requirement?

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Focus on radiation safety problems (potential and actual) and evaluate outcomes (licensee performance)

Observe activities in progress

Risk-Informed, Performance-Based Inspection

March 2011- Slide 13 of 114G-108 – Inspection Procedures

Demonstrations of activities

Independent surveys

Interviews

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What are the potential radiological problem areas?

What could lead to significant exposures of workers or the public?

Basic Questions for thePerformance Inspector

March 2011- Slide 14 of 114G-108 – Inspection Procedures

What could lead to significant releases of licensed materials to the environment?

What could lead to the loss of control/security of significant quantities of licensed material?

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General policy for the materials inspection programs.

Manual Chapter 2800 Highlights

March 2011- Slide 15 of 114G-108 – Inspection Procedures

Describes performance-based inspection approach

Identify specific conditions of poor performance which require more frequent inspections.

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Major emphasis on event response

Inspectors can issue clear inspection records (Form 591M) to licensees during the onsite inspection

MC 2800 Highlights

March 2011- Slide 16 of 114G-108 – Inspection Procedures

Requires less intensive preparation for routine inspections

Inspection priorities are based on risks associated with program types

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MC 2800 Highlights(Inspection Priorities)

Example: industrial radiography programs

High quantity of material

Poor inspection history for the industry as a whole

March 2011- Slide 17 of 114G-108 – Inspection Procedures

History of significant overexposures resulting in serious injuries

Inspected every year (Priority 1)

High risk use = higher inspection priority = more frequent inspections

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MC 2800 Highlights(Inspection Priorities)

Example: cardiology clinic

Low quantities of short-lived material

Very good inspection history for the industry as a whole

March 2011- Slide 18 of 114G-108 – Inspection Procedures

No history of overexposures resulting in serious injuries and

Inspected every 5 years (Priority 5)

Low risk use = lower priority = less frequent inspections

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7 Focus Areas at a Glance

Common Elements for All Licensee Programs

1 - Security & control of licensed material

2 - Shielding of licensed material

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g

3 - Comprehensive safety measures

4 - Radiation dosimetry program

5 - Radiation instrumentation & surveys

6 - Radiation safety training & practices

7 - Management oversight

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Focus Area 1 - Security & Control of Licensed Material

The licensee should control access to and prevent loss of licensed material so as to limit radiation exposure to workers and members of the public to values below 10 CFR Part 20 limits

March 2011- Slide 20 of 114G-108 – Inspection Procedures

LocksKeys to devices/unit are controlledConstant surveillanceAdministrative controls

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Focus Area 2 - Shielding of RAM

The licensee should maintain shielding of licensed materials in a manner consistent with operating procedures and design and performance criteria for devices and equipment

March 2011- Slide 21 of 114G-108 – Inspection Procedures

Shielding material should be appropriate for the nuclide (beta vs. gamma)

Integrity of the shielding

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Focus Area 3 - ComprehensiveSafety Measures

The licensee should implement comprehensive safety measures to limit other hazards from compromising the safe use and storage of licensed material

March 2011- Slide 22 of 114G-108 – Inspection Procedures

Fire/explosives/hazardous chemicals, etc

Protection of materials from the elements

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Focus Area 4 - RadiationDosimetry Program

The licensee should implement a radiation dosimetry program to accurately measure and record radiation doses received by workers or members of the public as a result of licensed operations

March 2011- Slide 23 of 114G-108 – Inspection Procedures

Personnel dosimetry (WB, extremity, direct-read)Bioassay programEvaluation that no personnel monitoring is required (low levels of H-3, C-14, gauges)Workers informed of their exposures

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Focus Area 5 - Radiation Instrumentation & Surveys

The licensee should provide radiation instrumentation in sufficient number, condition, and location to accurately monitor radiation levels in areas where licensed material is used and stored

March 2011- Slide 24 of 114G-108 – Inspection Procedures

Exposure rate surveys, wipes, leak tests

Instrumentation appropriate for use

In-house calibrations

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Focus Area 6 - Radiation Safety Training & Practices

The licensee should ensure that workers are:

Knowledgeable of radiation uses and safety practices

March 2011- Slide 25 of 114G-108 – Inspection Procedures

Knowledgeable of operating and emergency procedures

Empowered to implement the radiation safety program (will vary depending on industry/position within the organization)

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Focus Area 7 - Management Oversight

The licensee’s management should support radiation protection program (financially and by granting authority to the RSO)

March 2011- Slide 26 of 114G-108 – Inspection Procedures

Direct reporting path from RSO to senior management

RSO’s Authority (can he stop unsafe activities)

Program Audits

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Reactive Inspections (medical events, incidents,overexposures, allegations)

Perform within guidelines of MC2800 or by di ti f t

Inspection Frequency/Priority

March 2011- Slide 27 of 114G-108 – Inspection Procedures

direction of management

Initial Inspections of New Licensees or upgrades to an Existing Licensee Code 02240 (Medical Therapy -Other Emerging Technology)

within one year of license issuance and every year after until program is active

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Routine Inspections

Routine Inspections are to be completed within ± 25% of Priority

Inspection Frequency/Priority

March 2011- Slide 28 of 114G-108 – Inspection Procedures

Priority I Licensees (Temporary Job Site Radiography) inspected every year ± 3 months of the due date

Priority II Licenses (broad scope medical, HDR, Permanent Radiographic Installation radiography) inspected every 2 years ± 6 months of the due date

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Priority III Licenses (Medical institution with written directive required, mobile medical with no written directive required) can be inspected every 3 years ± 9 months

Inspection Frequency/Priority

March 2011- Slide 29 of 114G-108 – Inspection Procedures

of the due date

Priority V Licensees (gauges, medical institution with no written directive required) can be inspected every 5 years± 12 months of the due date

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Preparing for Inspections

Inspections take more than just paper to get ready…

March 2011- Slide 30 of 114G-108 – Inspection Procedures

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The inspector should be familiar with the types of uses and the generic requirements applicable to the licensed program

Inspection preparation should be based upon the

Preparing for Inspections

March 2011- Slide 31 of 114G-108 – Inspection Procedures

Inspection preparation should be based upon the complexity and scope of licensed activities and on the experience level of the individual inspector

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Before hitting the road . . . do your homework

Review the license

Note any unusual license conditions (authorization

Preparing for Inspections

March 2011- Slide 32 of 114G-108 – Inspection Procedures

y (for an incinerator, human research, no permanent storage location, restrictions on time of day usage)

Review the licensee’s recent inspection & enforcement history (results of the last inspection, any open items, any events reported by the licensee since the previous inspection

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Review any commitments made by the licensee or restrictions imposed by NRC as a result of a Confirmatory Action Letter or Order issued since the last inspection

Preparing for Inspections

March 2011- Slide 33 of 114G-108 – Inspection Procedures

Review any notes in the license file regarding special amendments

Note new medical therapy modality under 10 CFR 35.1000 shall be inspected within 12 months of the date of the amendment

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Identify the location(s) of the licensee and make travel arrangements

Itinerary approved by and discuss with supervisor

Preparing for Inspections

March 2011- Slide 34 of 114G-108 – Inspection Procedures

One week in advance of the inspection trip, the inspector sends the itinerary to the State agency to give their personnel an option to accompany the inspector

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Survey meter (appropriate and calibrated)

Inspection forms (NRC Form 591M’s, Form 3s)

R f d t (R l ti I f ti

What to pack for an inspection trip ….

March 2011- Slide 35 of 114G-108 – Inspection Procedures

Reference documents (Regulations, Information Notices, Standards, Reg Guides, NUREGs, etc.)

License and backup material

Maps, driving directions

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More stuff to pack for an inspection trip ….

Notebook

Pens, highlighters, post-it notes

Camera - (get permission

Small flashlight

Mechanical pencils (ink freezes!)

Calculator

March 2011- Slide 36 of 114G-108 – Inspection Procedures

from licensee)

Personnel dosimetry

ID badge

Business cards

Safety shoes/glasses

Survey instrument

Tape measure

Stop watch/timer

GPS unit

Maps

Hard hat

Filter paper (for wipes)

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Most airlines prohibit hazardous materials (including exempt radioactive check sources)

NRC Region III inspectors do not carry check sources when traveling by air

Please be advised…

March 2011- Slide 37 of 114G-108 – Inspection Procedures

So how do I make sure my survey meter is working?

Battery/constancy/calibration check before leaving the office Battery check daily before use

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Main Office

Permanent Field Offices

The goal for each inspection cycle is based on the number of facilities approved on the license

Locations

March 2011- Slide 38 of 114G-108 – Inspection Procedures

the number of facilities approved on the license (one location if 2 or 3 are approved, two locations for 4 to 10 approved sites, and 20 percent for more than 10 approved sites)

Temporary job sites

Off-Shore Waters

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How long to budget

For scheduling purposes & flexibility, check the last inspection. Note - cardiac clinic: 2 - 3 hours, gauge program: 3-4 hours, large medical, academic, industrial facilities: 1+ days depending on

Length of Inspections

March 2011- Slide 39 of 114G-108 – Inspection Procedures

industrial facilities: 1+ days, depending on

1. scope of program; and 2. multiple locations of use

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Length of Inspections

Travel Time

Be prepared & be flexible! Weather, road conditions/construction, and availability of licensee personnel can significantly impact the best planned inspection trip

March 2011- Slide 40 of 114G-108 – Inspection Procedures

impact the best-planned inspection trip

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Schedule inspections during time periods when work with licensed materials is most likely to be performed

If licensed activities are only done between midnight

Timing of Inspections

March 2011- Slide 41 of 114G-108 – Inspection Procedures

and 5 AM – set the alarm and get enough rest

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Program Scope

Authorized Uses, Users, Materials and Locations

Significant Amendments Since Last Inspection

License File Review

March 2011- Slide 42 of 114G-108 – Inspection Procedures

Significant Amendments Since Last Inspection

License Conditions

Locations of Use (Same as Mailing Address? Different Part of the City? Different Part of the State? Different State? Different Region?)

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Authorized users

Special Standard Conditions (e.g., leak tests and inventory of sealed sources)

License File Review

March 2011- Slide 43 of 114G-108 – Inspection Procedures

y )

Special Unique Conditions (e.g., The licensee shall continuously monitor the exhaust air from the waste compactor at the point of release to unrestricted areas. Samples shall be collected and analyzed on a weekly basis.)

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Inspection History

Last two inspection reports (previous violations)

License File Review

March 2011- Slide 44 of 114G-108 – Inspection Procedures

Scope and Status of Licensed Program at time of last inspection

Identification of Key Licensee Personnel and Management (RSO & RSC Chairman)

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Amendments Since Last Inspection

Search the NMED for Reported Events Since Last Inspection

License File Review

March 2011- Slide 45 of 114G-108 – Inspection Procedures

Search NSTS for sources possessed – If applicable

Research SSDR for sealed sources and devices – if applicable

Bulletin Responses, Notifications (non-Event), etc.

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General

Authorization

Unannounced vs. Announced

Conducting a Routine Inspection

March 2011- Slide 46 of 114G-108 – Inspection Procedures

Objective

Attitude/conduct

Dress appropriately for the environment

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Elements of Any Inspection (MC2800 - Basic Inspection Process)

Entrance and Exit Management MeetingsFollow up on Previous Items

Conducting a Routine Inspection

March 2011- Slide 47 of 114G-108 – Inspection Procedures

o o up o e ous te sGeneral Overview

OrganizationScope of Program

Observation of Actual Facilities and Licensed ActivitiesConfirmatory/Independent MeasurementsSpecial License Conditions

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10 CFR 30.52 Inspections

Each licensee shall afford to the Commission at all reasonable times opportunity to inspect byproduct material and the premises and facilities wherein byproduct material is used or

Authorization

March 2011- Slide 48 of 114G-108 – Inspection Procedures

facilities wherein byproduct material is used or stored

Each licensee shall make available to the Commission for inspection, upon reasonable notice, records kept by him pursuant to the regulations in this chapter

What is your State’s equivalent regulation?

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Manual Chapter 2800 - all routine materials inspections should be performed on an unannounced basis

Unannounced vs. Announced

March 2011- Slide 49 of 114G-108 – Inspection Procedures

Announce initial inspections

Inspectors may announce inspections of licensees located in remote areas to verify that a routine inspection can be performed before undertaking such travel

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Identify radiological health and safety problems

Evaluate licensee’s corrective actions to resolve and prevent radiological health and safety problems

Purpose of an inspection

March 2011- Slide 50 of 114G-108 – Inspection Procedures

p g y p

What, when, where, who, how, AND WHY?

Who is responsible for radiation safety?

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Be professional

You are a visitor/guest at the licensee’s facility

Obey the licensee’s safety rules and procedures

Rules of Conduct

March 2011- Slide 51 of 114G-108 – Inspection Procedures

Obey the licensee s safety rules and procedures

Try to maintain your composure in difficult situations

Be knowledgeable about the nuclear field and regulatory requirements – OK to admit you don’t know something

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Dress for the occasion

What you wear at a hospital/clinic/university may not be the most appropriate for a radiography or fixed gauge inspection

What to wear or what NOT to wear

March 2011- Slide 52 of 114G-108 – Inspection Procedures

gauge inspection

Especially observe rules at industrial and field sites (e.g., safety shoes, hard hats, eye protection, hearing protection, etc.)

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Industrial sites/field inspections(Dress for the Environment)

Denim, cotton or corduroy pants

Casual closed-toe shoes

Knit or cotton polo shirts, casual shirts

A oid loose clothing hich ma catch on machiner

March 2011- Slide 53 of 114G-108 – Inspection Procedures

Avoid loose clothing which may catch on machinery

Consider tucking in ties or not wearing ties all together

Consider pulling back long hair

Don’t wear your best clothes to these sites

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Medical/Office/Academic(Dress for the Environment)

Business, business-casual attire

No open-toed shoes, flip-flops

No t-shirts

March 2011- Slide 54 of 114G-108 – Inspection Procedures

Again, careful wearing loose clothing which may get caught on equipment, experimental set-ups, etc.

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On site Inspection

After all the preparation, the time has come to interact with the licensee

Entrance Meeting

March 2011- Slide 55 of 114G-108 – Inspection Procedures

Entrance Meeting

Inspection

Exit Meeting

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Main Purposes of Meeting

Let licensee management know:that you are therewhy you are there

Entrance Meeting

March 2011- Slide 56 of 114G-108 – Inspection Procedures

what you will be doingapproximately how long the inspection will take

Discussions should includePrevious violationsUnresolved itemsBulletins or orders issuedSignificant changes to the program

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surveyssurveys

interviewsinterviews

records reviewHierarchy

of Inspection

Toolsdemonstrate demonstrate

activitiesactivities

observe observe activitiesactivities

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Facility tour soon after entrance meeting

Security measures and control of materialsIs facility as described in licenseEngineering controls in use

Observations

March 2011- Slide 58 of 114G-108 – Inspection Procedures

Protective equipment usedUsers wearing dosimetryAdequate procedures followedPosting and labelingSurvey instrument availableEvidence of food & drink (In fridge w/ nuclides?) Spill kit available

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10 CFR 19.15(a) - Commission inspectors may consult privately with workers concerning matters of occupational radiation protection and other matters

Interviews

March 2011- Slide 59 of 114G-108 – Inspection Procedures

related to applicable provisions of Commission regulations and licenses to the extent the inspectors deem necessary for the conduct of an effective and thorough inspection.

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Help inspectors identify health and safety problems that may not be immediately evident from other sources such as records review

Help confirm the existence of health and safety bl id tifi d th h th

Interviews

March 2011- Slide 60 of 114G-108 – Inspection Procedures

problems identified through other sources

Interviews with management at entrance and exit meetings reveal the management awareness of the radiation protection program; identify who is involved in audits and meetings; and provide insights to organizational changes, responsibilities and staffing

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The RSO is the primary contact and usually responsible for implementation of the radiation protection program

Other interviews as necessary

Interviews

March 2011- Slide 61 of 114G-108 – Inspection Procedures

Other interviews as necessary

Authorized and Supervised usersTechniciansMaintenance/engineersSecurity personnelHousekeeping personnel

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Seek privacy whenever possible

Ask open ended questions and avoid “yes/no” questions

SuccessfulInterviews of Workers

March 2011- Slide 62 of 114G-108 – Inspection Procedures

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Successful Interviews of Workers

Put the individual at ease and let the individual talk

Control your voice and non-verbal language-interviewees will respond to your reactions

March 2011- Slide 63 of 114G-108 – Inspection Procedures

Take notes (as appropriate)

Get the details if violations are identified

Less Talking – MORE LISTENING

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Don’t center your interviews on the RSO and management. The RSO and management will tell you know how things SHOULD be. The worker will tell you how work is ACTUALLY performed.

Some Don’ts for RoutineInterviews of Workers

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Don’t do all the talking or you won’t get information

Don’t use jargon or overly technical terms because you’re not out to impress the interviewee with your credentials or knowledge, and the interviewee may “clam up” due to intimidation

Don’t ask leading questions

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Don’t interrupt responses unless they are becoming lengthy and heading way off track

Don’t let interviews interfere with safety

Some Don’ts for RoutineInterviews of Workers

March 2011- Slide 65 of 114G-108 – Inspection Procedures

Don’t sandbag a worker. If the responses indicate a violation or an unsafe practice, let the worker know

Don’t be non responsive

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SURVEY METER USAGE

The purposes include:

Confirmatory/IndependentMeasurements

March 2011- Slide 66 of 114G-108 – Inspection Procedures

confirmation of the licensee’s measurements

identification of facility contamination

identification of ambient exposure rates

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Confirmatory/IndependentMeasurements

Ensure that the proper survey instrument is used for the type of radiation to be detected

March 2011- Slide 67 of 114G-108 – Inspection Procedures

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Confirmatory/IndependentMeasurements

Waste cans Conduits Clothing Telephones

Look for radiation and contamination where it is expected and also where it is not expected:

March 2011- Slide 68 of 114G-108 – Inspection Procedures

Hands/feet Desk Sink traps Door knobs

AC filters Floors Hood filters Incinerators

Effluent Storage Sumps

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FOR ROUTINE INSPECTIONS

A record review should supplement and confirm information obtained through direct observation and interviews

Records Review

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Records may be used to identify trends or weaknesses in the licensee’s radiation safety program (e.g., dosimetry records)

Records may be used to find events not identified during interviews

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FOR REACTIVE INSPECTIONS

Records can be used to reconstruct events following an incident such as:

Records Review

March 2011- Slide 70 of 114G-108 – Inspection Procedures

Medical EventsOverexposures

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NRC recommends that inspectors use a sampling method to determine adequacy of licensee’s record system

Types of Records that could be reviewed are:

Records Sampling

March 2011- Slide 71 of 114G-108 – Inspection Procedures

ypDosimetryWritten DirectivesInternal/External AuditsLeak TestsTrainingInventory

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Beware of Distractions/Diversions

Some licensee’s may attempt to side track you from your inspection… (delay tactics, change your focus away from the inspection, etc.)

March 2011- Slide 72 of 114G-108 – Inspection Procedures

p , )

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Ways to get an inspector off track:

Asking questions about your job/travel/family

Offer to take out to lunch

Long tours

Beware of Distractions/Diversions

March 2011- Slide 73 of 114G-108 – Inspection Procedures

g

Showing pictures of kids, vacation, etc.

Stalling - leaving for long periods of time to retrieve records

Interrupting observations/tours

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Witnessing Violations (never allow an unsafe work practice or a violation to continue in your presence in order to provide a basis for enforcement action.)

Common Pitfalls and Traps

March 2011- Slide 74 of 114G-108 – Inspection Procedures

Interference with Licensed Activities

Recommendations/Perceived Consulting

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Keep the licensee informed of the inspection findings throughout the course of the inspection (i.e., don’t wait until the exit meeting to inform licensee/RSO of violations)

Common Pitfalls and Traps

March 2011- Slide 75 of 114G-108 – Inspection Procedures

Keep your management informed of significant findings (e.g., safety hazards, willful violations, and potential escalated enforcement issues)

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Purpose is to present the preliminary or finalinspection findings and provide the licensee an opportunity to provide additional information that could change findings

Exit Management Meeting

March 2011- Slide 76 of 114G-108 – Inspection Procedures

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Exit Meeting

Prior to the Exit Meeting:

For large programs, brief RSO prior to exit meeting

March 2011- Slide 77 of 114G-108 – Inspection Procedures

Arrange with highest management representative availablePrepare notes for the exit meetingPrioritize FindingsIf significant or odd finding identified, contact your NRC manager in private

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Exit Meeting

During Exit Meeting:

Purpose is two-way communication

Be courteous, clear and concise – do

March 2011- Slide 78 of 114G-108 – Inspection Procedures

Be courteous, clear and concise do not use technical/professional jargon

Listen to licensee’s responses and answer their questions

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Objectives/Purposes:

Record of Assessment of Licensee’s Performance (generally, no news is good news)

Documentation of Inspections

March 2011- Slide 79 of 114G-108 – Inspection Procedures

Document Status of Licensee’s Program at Time of Inspection

Basis for Enforcement Actions and Licensee Corrective Actions

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Types of Reports

Form 591M, “Safety Inspection Report and Compliance Inspection” (simple)

Documentation of Inspections

March 2011- Slide 80 of 114G-108 – Inspection Procedures

p p ( p )

Enclosure 6 of MC2800, “Inspection Record” (more labor intensive; but manageable)

Narrative report using MC0610 (don’t bother going anywhere soon)

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For clear inspections (no violations) Non-willful, non-repetitive Severity Level IV violations Non-cited violationsDocument cited and non-cited violations, and the

NRC Form 591M -When and How to Use

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ocu e t c ted a d o c ted o at o s, a d t elicensee’s proposed corrective actions in plain language Form signed by inspector and licensee management representative

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Used to document administrative data (licensee contact information, date of next inspection, and scope of licensed activities (Page 3)

Only Page 1 (& 2, if necessary) provided to the

NRC Form 591M

March 2011- Slide 82 of 114G-108 – Inspection Procedures

y g ( , y) plicensee

The 591M is the official agency record of the inspection

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If an NRC Form 591M is not issued and a Narrative Report is not appropriate, then the inspection results shall be documented on Enclosure 6

The Region will communicate the inspection

Enclosure 6

March 2011- Slide 83 of 114G-108 – Inspection Procedures

g pfindings to the licensee in a formal letter with a Notice of Violation, if appropriate - the inspection record should contain:

the procedure(s) usedthe focus areas examined

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the status of follow-up items involving prior enforcement or reported licensee events

sufficient information to support cited violations, non-cited violations and closed violations identified

Enclosure 6

March 2011- Slide 84 of 114G-108 – Inspection Procedures

non cited violations, and closed violations identified during a previous inspection

description of completed and anticipated corrective actions to any identified violations

a description of the scope of the licensee’s program

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Used for documentation of:

escalated enforcement cases

medical events

Narrative Reports (MC0610)

March 2011- Slide 85 of 114G-108 – Inspection Procedures

medical events

special inspections

team inspections

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Details

Follow 5 W’s rule

Format must show direct line from “Inspection Scope” through “Observations and Findings” in order to reach

Narrative Reports (MC0610)

March 2011- Slide 86 of 114G-108 – Inspection Procedures

“Conclusions”

Conclusions must also appear in Executive Summary

Avoid names and do not include personal privacy information

Avoid excessive use of acronyms, especially those that only appear in your report

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Used to Transmit NOVs, Narrative Reports

Examples: repetitive violations

Letters Signed byRegional Management

March 2011- Slide 87 of 114G-108 – Inspection Procedures

willful violations

Severity Level I, II, or III violations or problems

when an enforcement conference or a management meeting is to be held

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where the corrective action includes a request for an amendment to the license

when a specific message should be provided to

Letters Signed byRegional Management

March 2011- Slide 88 of 114G-108 – Inspection Procedures

when a specific message should be provided to the licensee

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DEFINITION - A regulatory requirement is a direction or prohibition imposed upon a licensee or person that is legally binding, i.e., it is enforceable in the courts

These include:

Documenting Violations

March 2011- Slide 89 of 114G-108 – Inspection Procedures

These include:

Rules and RegulationsOrders

Modify LicenseSuspend LicenseRevoke License

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Licenses

General - requirements, and exceptions described in the regulation conferring the General License (10 CFR 31 5)

Documenting Violations

March 2011- Slide 90 of 114G-108 – Inspection Procedures

CFR 31.5)

Specific - beyond specific regulations, requirements and exceptions are described in License Conditions and in licensee documents “tied down” to the license

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Non-Enforceable Standards

Licensee Commitments not tied to license

I f ti N ti Ci l B ll ti t

Documenting Violations

March 2011- Slide 91 of 114G-108 – Inspection Procedures

Information Notices, Circulars, Bulletins, etc.

Regulatory Guides

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Interpretations

Official - only the NRC Office of General Counsel (the lawyers) may give official/binding interpretations of the regulations (See 10 CFR 20.1006 – Interpretations)

Documenting Violations

March 2011- Slide 92 of 114G-108 – Inspection Procedures

NRC staff (inspectors and license reviewers) cannot give interpretations of regulations

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Terminology

Must, Shall - enforceable requirement

Should May - suggestion permissive not

Documenting Violations

March 2011- Slide 93 of 114G-108 – Inspection Procedures

Should, May suggestion, permissive, not enforceable

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Documenting the Citation

REMEMBER: Any citation of an item of non-compliance is a potential candidate for contesting in a hearing or in a court of law

Documenting Violations

March 2011- Slide 94 of 114G-108 – Inspection Procedures

Newspaper Reporters Creed

WhoWhatWhenWhereWhy (cause)

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Also:

Were there previous violations of a similar nature (repeats)?

Are there multiple examples of the violation?

W th l di d f i t i di ti

Documenting Violations

March 2011- Slide 95 of 114G-108 – Inspection Procedures

Was there careless disregard of requirements or indications of knowingly violating requirements?

Was management aware of the violation?

Should management have been aware of the violation?

Was there opportunity for management to discover the violation?

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Rules of evidence

Inspector’s personal observations and measurements

Documenting Violations

March 2011- Slide 96 of 114G-108 – Inspection Procedures

Inspector’s interviews

Observing operations and/or demonstrations

Inspector’s review of records

Obtain copies of supporting documentation

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Summary

Is there a requirement?

Is it enforceable?

Documenting Violations

March 2011- Slide 97 of 114G-108 – Inspection Procedures

Is it enforceable?

Is it applicable?

Confirm that there are no exemptions

Document your findings

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Enforcement

A mechanism to encourage licensee’s to

March 2011- Slide 98 of 114G-108 – Inspection Procedures

licensee’s to comply with regulations and safety standards.

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Enforcement should be sufficient to deter licensee non-compliance with regulatory requirements

NRC Enforcement Policy (www.nrc.gov)

Enforcement

March 2011- Slide 99 of 114G-108 – Inspection Procedures

Deter non-compliance by emphasizing the importance of compliance

Encourage prompt identification and prompt correction of violations

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Drafting the inspection report and enforcement correspondence

30 day clock for report and transmittal letter

Enforcement

March 2011- Slide 100 of 114G-108 – Inspection Procedures

y p

All violations tied to specific regulations or license conditions

30 day licensee response clock

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Escalated Enforcement

Predecisional Enforcement Conferences

Enforcement

March 2011- Slide 101 of 114G-108 – Inspection Procedures

Civil Penalties (CPs)

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Categories of Violations - based on significance, including actual and potential safety impact, and regulatory significance

NRC Level I and II normally require CP

Enforcement

March 2011- Slide 102 of 114G-108 – Inspection Procedures

NRC Level III - CP is possible

NRC Level IV - CP possible, but very unlikely

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Enforcement

CPs are not intended to put licensees out of business

Credit for self-identification and prompt

March 2011- Slide 103 of 114G-108 – Inspection Procedures

correction of non-compliances

Escalation for ineffective programs

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Orders

Issued to address specific health and safety concerns, where prompt attention may be needed and where a high degree of assurance of

Enforcement

March 2011- Slide 104 of 114G-108 – Inspection Procedures

and where a high degree of assurance of compliance is needed

Examples:

Orders for Increased ControlsOrder for Payment of Fees

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Be familiar with your agency’s procedures

Documentation

Forms and formats

Enforcement

March 2011- Slide 105 of 114G-108 – Inspection Procedures

Forms and formats

Regulations

Signature Authority

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Trust is the cornerstone of NRC and Agreement State regulatory programs

In the nuclear materials program:

Enforcement

March 2011- Slide 106 of 114G-108 – Inspection Procedures

there is no resident inspector

inspections are relatively infrequent

some program areas and licensed activities are not routinely inspected

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In the nuclear materials program, safety is heavily dependent on the licensees’ honesty and veracity regarding:

the license application

Enforcement

March 2011- Slide 107 of 114G-108 – Inspection Procedures

the license application

compliance with procedures

compliance with regulations

event reporting

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Therefore, NRC enforcement weighs heavily in cases involving distrust, such as:

falsification of records

Enforcement

March 2011- Slide 108 of 114G-108 – Inspection Procedures

willful/deliberate violations

material false statements

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NRC can refer/offer cases to the Department of Justice (DOJ) for criminal prosecution

The DOJ occasionally acceptswillful violations for

Enforcement

March 2011- Slide 109 of 114G-108 – Inspection Procedures

criminal prosecution

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Real World Experiences

Typical Security infraction at a Medical

or Research facility:

Attempt to open door

March 2011- Slide 110 of 114G-108 – Inspection Procedures

Attempt to open door

Door opens and no one inside

Radioactive material inside and unsecured

Licensee staff later explains they were only gone for a few minutes

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Real World Experiences

Licensee uses survey meter to monitor radioactive material

March 2011- Slide 111 of 114G-108 – Inspection Procedures

Licensee uses improper survey technique, doesn’t know how to interpret survey results, doesn’t know the action level, doesn’t know how to respond to results in excess of the action level

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Real World Experiences

Finding of Medical Event:

Reviewing Radiation Safety Committee Meeting minutes and noticed an issue with

March 2011- Slide 112 of 114G-108 – Inspection Procedures

Meeting minutes and noticed an issue with administration of Patient

Further review identified that a medical event occurred without licensee identification

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Lessons Learned

Be cautious when entering a licensee’s facility in questionable conditions w/o assistance

Don’t hesitate to call for help

Always be aware of surroundings in urban areas

March 2011- Slide 113 of 114G-108 – Inspection Procedures

Look out for your own personal safety

Expect the unexpected (think about escape options)

Don’t look, “easy prey” (e.g., project confidence in the way you carry yourself, look people in the eye)

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March 2011- Slide 114 of 114G-108 – Inspection Procedures

THE END