Post on 19-Jan-2016
AuthorizationAuthorizationAuthorizationAuthorization
Authorization Authorization
Objectives
To provide understanding of the authorization process and the procedures for its implementation
AuthorizationAuthorization
Contents
Part I: Categorization of sourcesRegistration and licensingReview and assessment of
applicationRole of the regulatory staff
Part II: Safety assessment plans
Part III: Content of a licenceDuration of authorizationTermination of authorization
AuthorizationAuthorization
Part IPart I
Categorization of sources Categorization of sources
Why categorization ?
Controls to be applied should be commensurate with radiological risks that the sources and materials present.
Of particular concern are those radiation sources which have the potential for causing significant harm to persons or have the potential for widespread contamination.
Categorization is a tool that can be used in authorization and other relevant decision-making processes.
Categorization of sourcesCategorization of sources
Use of categorization in authorization process
Authorization by registration or licensingSecurity requirements in:
- manufacture- transport- storage- use- transfer and repair- decommissioning and disposal
Emergency preparedness
Categorization of sourcesCategorization of sources
Bases of categorization
Level of activity Construction and properties of radiation
source Probability of accidents causing:
- serious injury to persons- increased exposure to worker- increased exposure to public- contamination
Management of safety and security Type of use (fixed/mobile)
Categorization of sealed sourcesCategorization of sealed sources(IAEA TECDOC 1191)(IAEA TECDOC 1191)
Industrial radiographyTeletherapyIrradiators
BrachyterapyFixed industrial high-activity gaugesWell logging
Fixed industrial low-activity gauges
Category Type of use
1
2
3
Categorization of sealed sourcesCategorization of sealed sourcesCategory 1Category 1
Significant hazard possible
Detailed information to be submitted in application- Conditions of use- Construction and operation of the facility- Training and competence of users- Control mechanisms to assure safety and security- Disposition of disused sources- Patient protection- Preparedness plans for accidents
Notification and authorization Notification and authorization
Practice or source proposed
Excluded? Proceed
Notification only required
Exempted?
Notify
Proceed
Proceed
Yes
Yes
Yes
No
No
Notification and authorization Notification and authorization (cont’d)(cont’d)
Apply for authorization
Notification only required
Suitable for registration
Obtain licence
Proceed
Proceed
Yes
Yes
No
No
Proceed
Authorization by registrationAuthorization by registration
Registration is simple and efficient authorization mechanism.
Suitable if: Safety is ensured by the design of facilities and
equipment Operation procedures are are simple to follow Radiation safety training requirements are minimal Practice is routinely operated Few safety problems are known within operations Number of users is large
Authorization by registrationAuthorization by registration
Examples of practices and devicesadequate for registration:
Dental X-ray diagnostics Low-activity sealed sources X-ray fluorescence Distribution of consumer products Static eliminator * Electron microscope *
*) Notification only ?
Authorization by registrationAuthorization by registration
The Regulatory Authority should:
1. Establish the safety requirements which must be met as a precondition for registration.
and/or
2. Conduct a generic safety assessment of equipment and related operating procedures provided by a supplier or manufacturer.
Depending on the nature of the practice, one or the other or a combination of both may be used.
Authorization by registrationAuthorization by registration
Application for registration should include: Identification of the source and equipment to be utilized
The location of use
The name of a person responsible for radiation safety
Agreement to follow the applicable operating, maintenance and disposal requirements
Authority should record the information in register (database) for regulatory purposes.
Notification / Registration / LicensingNotification / Registration / Licensing
Type of Control Risk level Complexity of practice
Notification Low Simple
Authorization
by registration
Authorization
by licensing High Complex
Authorization by licensingAuthorization by licensing
Application shall include:
Detailed information of the use of sourceRadiation protection provisionsProvisions for source safety and securityAssessment of exposuresArrangements for handling waste
Authorization by licensingAuthorization by licensing
Examples of practices and devicesadequate for licensing:
Medical applications Industrial radiography Industrial irradiatorsHigh-activity gaugesUse of unsealed sourcesManufacturing of sourcesStorage of radioactive material or waste and
disposal
Authorization by licensingAuthorization by licensing
Multi-stage licensing may be suitable for practices involving construction of facilities.
Commercial product irradiators Teletherapy facilities Waste management and disposal facilities
Regulatory Authority should also consider the financial capability of the applicant to comply with regulations.
e.g. decommissioning and waste management
Review and assessment Review and assessment
The applicant is responsible for submitting a detailed information of radiation safety.
The application shall be reviewed and assessed by the Regulatory Authority in accordance with clearly defined procedures.
Review and assessmentReview and assessment
Responsibilities of the Regulatory Authority
Guidance on format and content of the application (application forms, required supplements)
Recording of all documentsAcquiring further information from the
applicant if necessary (time-limits)
Decision on the basis of review and assessment (licence granted / not granted)
The basis for the decision shall be formally recorded
Review and assessmentReview and assessment
Procedures of the Regulatory Authority may be defined in the Standards or in the quality manual.
Review and assessment of the application Responsibilities within the organization(s) Recording and security of documents Procedures to anneal, renew or to suspend an
authorization Filing system of authorization
Authorization processAuthorization process
Application received & recorded
Forms and guidance to applicant
Further info required if necessary
Assessment according to defined procedures
Decision approved by responsible officer
Decision to applicant (granted/not granted)
Recording and filing
Safety assessment of sourcesSafety assessment of sources
Information required in the application:
Location of the operation site- Street address- Place of storage for mobile sources
Identification and safety of sources- Model and serial numbers- Certification of compliance with standards (leak test)
Arrangements to dispose of the sourceDescription about the safety instructions
NOTE: The application must be signed by the legal person
Review and assessmentReview and assessment
By review the Regulatory Authority shall satisfy itself that:
The application demonstrates the safety of the facility or proposed activity.
The information is accurate and in compliance with regulatory requirements.
The technical solutions have been proven or qualified and are capable of achieving the required level of safety.
Authorization fileAuthorization file
Authorization file should include :
The documents submitted by the applicant
The list of those and all other relevant documents
- Also appropriate phone calls and e-mails should be recorded
Memorandum about the facts that the decision is based on, including references to regulations
Archive copy of the final decision (licence)
Role of the regulatory staff Role of the regulatory staff
Requirements for staff members
Professionalism Independence InquisitivenessHelpfulnessAssertiveness
Role of the regulatory staffRole of the regulatory staff
Decision making
Regulatory decisions should have transparency and clarity.
Decisions should be timely, especially when corrective actions are required.
Procedures should be established within the Regulatory Authority organization for prompt decision making.
Authorization Part IAuthorization Part I
References
IAEA, Categorization of Radiation Sources, IAEA-TECDOC-1191, Vienna (2000).
IAEA, Organization and Implementation of a National Regulatory Infrastructure… , IAEA-TECDOC-1067, Vienna (1999).
IAEA, Assessment by Peer Review of… , IAEA-TECDOC-1217, Vienna (2001).
IAEA, Legal and Governmental Infrastructure for … , Safety Standards Series No.GS-R-1 (Draft, version 20.2.2000).
Exercise
Authorization Part I
Choose adequate level of authorization for each practice
N = Notification only required (Yes/No)R = Registration required (Yes/No)L = Licensing required (Yes/No)
Practice N R L
Industrial gammaradiography
Nuclear medicine
Mammography screening
Use of industrial level gauges
Medical ultrasound diagnostics
Dental X-ray diagnostics
Radioisotope tracer techniques
Import of and trade in smoke detectors
Veterinary X-ray diagnostics