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مهندسی صنایع::
صحه گذاری عملیات
For operational qualification: any discrepancy between the protocol and the actual performed test, test function methodology, testing equipment, and testing material.
Operational qualification (OQ): The process of obtaining and documenting evidence, under controlled conditions, that the premises, equipment and supporting systems operate in accordance with their design specifications.
Depending upon the circumstances, a temperature-mapping study may be carried out in an empty storage area - for example during operational qualification of a new cold room - or in a storage area where TTSPPs are already being kept - for example after alterations have been made to an existing cold room.
Operation qualification process (OQ)- To verify that the operations are carried out as per the recommended procedures of the manufacturers of the critical equipment
Operation qualification process - Pass or Fail
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