Performance qualification, plant design

Most basic validation activities within the cGMP pilot plant are identical to those expected in practice in a manufacturing facility. A validation master plan should be developed that addresses the design specifications and qualification, installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ) of all major utility systems, process equipment, and computer control systems. Installation and commissioning data should be retained as part of an engineering documentation package. A workable... 

All processes and equipment should be proven capable of performing the task for which they were designed and so should either be subject to qualification tests or process capability tests. There may be documentation available from the supplier of the equipment which adequately demonstrates its capability, otherwise you may need to carry out qualification and capability tests to your own satisfaction. In the process industries the plant is specially designed and so needs to be commissioned and qualified by the user. Your procedures need to provide for such activities and for records of the tests to be maintained. 

Cold hydro qualification tests, hot functional qualification tests, periodic in-service Inspections, and periodic in-service operation will be performed in situ to verify and assure the functional ability of the valve. These tests will guarantee reliability of the valve for the design life of the plant. The valves will be designed using either stress analyses or the pressure containing minimum wall thickness requirements. On all active valves, an analysis of the extended (e.g., actuator) structure will also be performed for static equivalent SSE loads supplied at the center of gravity of the extended structure. The maximum stress limits allowed in these analyses will assure structural integrity. 

Seismic and environmental qualification of equipment is required in US plants to assure that the equipment will perform its intended functions imder design-basis loading and environmental conditions. For older plants which did not receive adequate qualification when it was designed, the NRC has required that the equipment be reevaluated. 

As specified in both the draft DOE Nuclear Safety Policy and Policy and Expectations for Formal Conduct of Operations in DOE Owned Nuclear Material Production Program Facilities, facilities shall be operated and supported by personnel designated by management as qualified to perform their assigned function. Minimum qualification criteria shall be established and documented consistent with the requirements in DOE Order 5480.6 ANSI/ANS 3.1 draft DOE Order 5480.XX, "Personnel Section, Qualification, and Training Requirements" (Reference 3) and the NRC Policy Statement on Education for Senior Operators and Shift Supervisors at Nuclear Power Plants. Deviations from these requirements will require the approval of the Department of Energy Savannah River Site. Selected positions and their associated requirements are highlighted due to the restart issues that surround them. 

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