Quality Assurance Plan QAP

Adequacy of the Quality Systems supported through Quality Assurance Plans (QAPs). in design, process, installation and servicing. 

Erroneous values have a way of creeping into results despite the control measures in the Quality Assurance Plan (QAP). The data review process must be designed to remove such mistakes. Data review should accompany each step of the analytical process from sample receipt to calculation of activity. Thereafter, weeding out erroneous values becomes a management responsibility during data compilation for presentation andretention. Especially for the reality checks described below, the data compiler must be knowledgeable about radioanalytical chemistry processes as well as the pattern of analytical results related to sources of radionuclides, or must be assisted by specialists in these topics. 

As these QA measures became more pervasive and intricate, their formal organization as a quality assurance plan (QAP) was deemed necessary. Every laboratory should prepare a QAP that meets all the requirements stated by its operating license, its nuclear materials license (see Section 13.8.2), and all local, state, and federal regulations. In addition, the laboratory must prepare a QAP suitable for each customer who may have different format preferences or requirements. 

A radioanalytical chemistry laboratory requires a Radiation Safety Manual (RSM) or Radiation Protection Plan (RPP) in addition to a Quality Assurance Plan (QAP). The format is controlled by the licensing agency for the facility the Nuclear Regulatory Commission (NRC) requires the RSM, while the Department of Energy (DOE) requires the RPP. These plans are stand-alone documents that deal specifically with radiation safety issues and practices to set safe operating parameters in the laboratory. 

The system validation documentation includes but is not limited to Quality Assurance Plan (QAP), Operation and Maintenance Manual (O M), and Factory Acceptance Test (FAT) reports. A properly developed QAP and its supporting documentation help to reduce cost, boost product quality, ensure regulatory compliance and increase profitability. The FAT validation is the first verification step of the customer s validation process, which may include design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance qualification (PQ). 

Chapter 18 or RTR-2600 provides the following direction "Before the completion of the Technical Baseline Program, the Program Director will request a surveillance of the entire program in accordance with the Savannah River Plan Quality Assurance Manual QAP 18.3"... 

The QAP for the TA-V facilities and experiments Is documented in the Sandia Research Reactor and Experimental Programs Quality Assurance Program Plan (RREP-QAPP) (SNL 1998). 

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