Volume 2 - Atomic Energy Regulatory Board

APPENDIX-5F
(Refer section 3.4.1.3, 3.4.1.4)
QUALITY ASSURANCE MANUAL (QAM) FOR MEDICAL
CYCLOTRON FACILITIES
A. QUALITY ASSURANCE PROGRAMME DURING CONSTRUCTION
OF MEDICAL CYCLOTRON FACILITIES
The Employer/Licensee shall develop and implement a QA programme which
describes the overall arrangements for the management, performance and
assessment of structures/systems/components related to civil, mechanical,
electrical and instrumentation aspects of medical cyclotron facilities during
construction. This programme should specify the means to ensure that all
work is suitably planned, correctly performed and properly assessed in order
to implement design intent in the construction.
The QA manual (QAM) should be prepared addressing the following aspects:
A.1 INTRODUCTION
This section should include applicability and scope of the QAM.
A.2 MANAGEMENT FUNCTIONS
This section should specify the management’s policy statement and
organisational plan. Organisational plan should be documented addressing
the following aspects:
(a)
(b)
(c)
(d)
Organisational structure
Functional responsibility
Levels of authority
Lines of internal and external communication.
It should also address requirements related to competent manpower for
construction activities of the facility. The functional responsibilities of all
the personnel distinguishing task including their assigned administrative
powers should be identified and documented.
The Licensee should formally identify a person to be responsible for
implementation of QA programme during construction activities.
Responsibilities of key personnel in the organisation should be defined in
writing. The person appointed should have the necessary resources to
discharge the following responsibilities:
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