Volume 2 - Atomic Energy Regulatory Board
Volume 2 - Atomic Energy Regulatory Board
Volume 2 - Atomic Energy Regulatory Board
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B.3.2<br />
(b)<br />
(c)<br />
(d)<br />
Document release and distribution system shall be established<br />
utilising up-to-date distribution lists. Individuals responsible for issue<br />
of documents shall be identified.<br />
Documents important for commissioning and operation include<br />
among others, final safety analysis report (FSAR), acceptance test<br />
report (ATR), and radiation protection manual (RPM), commissioning<br />
reports and technical specifications for operation.<br />
Procedures for making interface with various components and<br />
systems should be prepared. Verification and validation of software<br />
used for operational control should be done by the independent<br />
agencies.<br />
Process Control<br />
B.3.2.1 Commissioning Control<br />
Procedures should be established to ensure that appropriate tests are performed<br />
during commissioning to demonstrate that design intent and, regulatory and<br />
other statutory requirements are met. Satisfactory demonstration of functional<br />
capability of safety systems is a prerequisite for considering the medical<br />
cyclotron facilites to be suitable for the operating phase.<br />
Measures shall be established to ensure that all commissioning activities<br />
including beam extraction, transport and dumping are planned, controlled<br />
and implemented in accordance with approved documents such as procedures,<br />
instructions and checklists, and results documented.<br />
Commissioning activities shall commence only after due completion of<br />
respective construction activities supported by certified documents. Inspection<br />
and surveillance shall be performed by the facility and documented to verify<br />
compliance with specification requirements.<br />
Measures shall be established to identify, review, resolve and document all<br />
non-conformances and design changes.<br />
A system for audit of commissioning, follow-up and record of corrective<br />
actions shall be established.<br />
B.3.2.2 Operation Control<br />
Documented procedure shall be established for safe operation of the medical<br />
cyclotron facilites in accordance with the design intent and specified<br />
operational limits.<br />
Provisions should be included to ensure interface among agencies for<br />
operation, maintenance, technical services, plant management, design,<br />
inspection, testing, verification and audit.<br />
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