Volume 2 - Atomic Energy Regulatory Board

A.7.
for review and disposition of non-conformances should be identified. The
programme should provide that appropriate action be taken to ensure that
conditions adverse to quality, such as failures, malfunctions, deficiencies,
deviations, defective or incorrect material, equipment and any other nonconformances
are identified, corrected and recurrences are prevented.
RECORDS
Records should be prepared and maintained to provide objective evidence
of quality to meet the requirements of applicable codes, standards and
specifications to include details such as:
(a)
(b)
(c)
(d)
(e)
(f)
Certificates of each component from the supplier/manufacturer; and
the test and inspection records
Non-conformance reports, corrective/preventive actions carried out
Certificates about raw material such as cement, sand, iron, steel used
during constructions
Records of the test results, acceptance criteria and as-built condition
of structures.
Design reports and drawings
Safety analysis reports
The record system shall be established which includes the arrangements and
responsibilities for the categorisation, receipt, indexing, preservation/storage,
retrieval, inspection and disposal of records after expiry of the specified
retention period of non-permanent records.
B. QUALITY ASSURANCE DURING COMMISSIONING AND
OPERATION OF MEDICAL CYCLOTRON
B.1.
Employer/Licensee shall develop and implement a QA programme which
describes the overall arrangements for the management, performance and
assessment of the medical cyclotron facilites. This programme shall also
provide means to ensure that all work is suitably planned, correctly performed
and properly assessed. Procedures shall be defined by the Employer to ensure
that the commissioning and operation of medical cyclotron facilites fulfils
specified requirements.
The QAM should be prepared in following format addressing the different
aspects of the facility.
INTRODUCTION
This section should include Applicability and Scope of the QAM.
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