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3.0 Regulatory Inspection and Enforcement Actions

Regulatory Inspection                                         Subsequently, the reports on these self-assessments are
                                                              reviewed in AERB along with the sample basis evidences,
       All routine regulatory inspections of the nuclear and  which may include additional records/ documentation,
radiation facilities were deferred temporarily due to the     photographs/ videos and interaction with the personnel of
nation-wide lockdown to contain the spread of COVID-19        the facilities.
pandemic. In the absence of the regular inspections, remote
inspection process was started to ensure continuity in               During this quarter, remote regulatory inspection of
regulatory oversight of AERB on nuclear and radiation         8 nuclear and 9 radiation facilities were carried out. Seven
facilities.                                                   special inspections including type approval (design
                                                              certification) of radiation equipment, pre-commissioning
       Remote inspection involves self-assessment by the      and surprise inspection were also conducted.
licensee based on checklists developed by AERB.

Glipmses of Remote Regulatory Inspection of Nuclera and Radiation Facilities

Enforcement Actions:                                                 show cause notice is under review byAERB.

(i) AERB issued show-cause notice to one of the               (ii) AERB conducted surprise regulatory inspection of
       manufacturer of X-ray based equipment (XRF used to            radiotherapy facility at Ghaziabad, UP. During
       check purity of gold) on September 22, 2020 for               inspection it was noted that RSO of the facility was on
       violating the regulatory requirements specified in             long leave since past several months. A show-cause
       Atomic Energy (Radiation Protection) Rules, 2004.             notice was issued to the institute to explain the non-
       The manufacturer has not obtained Type approval               intimation of long absence of RSO and institute was
       (design certification) of the equipment, and also              directed to stop radiotherapy treatment. Subsequently,
       Licence for commercial production of equipment                RSO resumed the duties in the institute. Based on
       from AERB.                                                    satisfactory response to show-cause by institution,
                                                                     AERB issued permission for resumption of operation
       AERB directed the institution to suspend the                  of radiotherapy treatment along with a warning to
       manufacturing and supply of radiation generating              ensure compliance with regulatory requirements.
       equipment till the issue is resolved. Response to the

Vol. 31, No.3, JULY-SEPTEMBER 2020                                                                                            5
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