Volume 2 - Atomic Energy Regulatory Board

Provision shall exist for regular verification of operation activities related to
safety. Preventive and maintenance schedule should be prepared for all safety
systems as per the applicable codes.
Inspection and testing/surveillance during operation of safety equipment as
well as subsequent to maintenance, modification or procedural changes should
be performed to specified requirements and documented.
B.4 VERIFICATION FUNCTIONS
B.4.1
B.4.2
B.4.3
Verification Programme
A comprehensive documented verification programme should be prepared
and verification conducted accordingly to assure conformance of
commissioning and operation of the medical cyclotron facilites as per the
relevant specified codes and procedures. Verification programme should
comprise external as well as internal verification
Inspection and Test Controls
Measures should be established to ensure that testing and measuring devices
(e.g. radiation survey meters, area monitors, tools, gauges and other devices)
used in determining conformance to acceptance criteria are of proper range,
type, accuracy and precision.
Testing and measuring devices should be controlled, calibrated and adjusted
at specified intervals, or before use, to maintain accuracy within necessary
limits.
Controls shall be established to ensure proper handling, storage and use of
calibrated instruments.
Audit
Provisions need to be prescribed detailing the establishment and
implementation of a comprehensive system of planned and documented audits
to verify the implementation and effectiveness of the various elements of the
quality assurance programme. It should address the audit performance, audit
personnel, audit plan and audit timing etc. The requirement for QA audit and
extent of its application should be based on the safety significance of the
system.
B.5 CORRECTIVE FUNCTIONS
B.5.1
Non-conformity Control and Corrective Actions
A system for the control of non-conformances and their corrective actions
should be established. Non-conformances, deviations or inadequacies
affecting quality should be identified and controlled. The persons responsible
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