0457 - G108 - Inspection Procedures - 02 - Inspection ...G-108 – Inspection Procedures March 2011-...
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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
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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
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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
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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
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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)
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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)
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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…
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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
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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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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
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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
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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
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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
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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
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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
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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)
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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
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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
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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
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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…
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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
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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
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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
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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
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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 ….
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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
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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…
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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
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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
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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
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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
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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
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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
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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
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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
March 2011- Slide 64 of 114G-108 – Inspection Procedures
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
March 2011- Slide 69 of 114G-108 – Inspection Procedures
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
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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
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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
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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
March 2011- Slide 81 of 114G-108 – Inspection Procedures
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
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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
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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
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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
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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
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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
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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
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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