Adequacy program performance assessment

Design Qualification (DQ) is the first validation element of a new facility system or equipment, where adherence to the user s specifications and to GMP rules is demonstrated. Installation Qualification (IQ) follows with the verification of adequacy of the area, installation of equipment pipelines, utilities, instrumentation, and conformity of the material used to the project specifications. At the Operational Qualification (OQ) phase, carried out after installation of all equipment, it is verified whether the system, when in operation, complies with the acceptance criteria defined in the validation plan. Once the OQ phase is successfully finalized it is possible to proceed with the calibration procedures, operation and cleaning, operator training, and preventive maintenance program. After IQ and OQ are concluded, it is time for the Performance Qualification (PQ), with the aim of verifying that what was designed, built, and operated results in a product that meets the expected specifications. Production and QC personnel are specially trained for these assessments. The tests can be done with the product of interest or a placebo, and are related to all operations, from raw material reception to product release (EC, 2001). 

Moreover, the Advisory Committee on Reactor Safeguards (ACRS, 1999, pg. 2 see also ACRS, 2000) has noted that risk-informed regulation requires a strong research program. In particular, the ACRS (1999, pg. 3) was concerned about the adequacy of current risk assessment methods for dealing with fires software-based digital systems aging of structures, systems and components... human performance safety culture, and low-power and shutdown operations. ... 

An audit is an independent examination of a work product or set of work products to assess compliance with specifications, standards, contractual agreements, or other criteria. There are many different types of audits, such as functional configuration audit (FCA), physical configuration audit (PCA), software audit, and safety audit. The purpose is to conduct an independent review and examination of system records and activities in order to determine the adequacy and effectiveness of the work performed, to ensure compliance with established policy and operational procedures, and to recommend any necessary changes. An audit can be either a formal or informal review of a program, to determine if objectives and requirements have been met. An audit also involves identifying deficiencies, problems, and issues. 

The Railroad Administration could more effectively fulfill its enforcement responsibilities if it would reduce the number of individual, routine inspections performed and shift its emphasis to broad-based system assessments, comprehensive evaluations of railroads entire systems and operations. Through these assessments, the Railroad Administration could determine the overall adequacy of railroads safety programs and bring deficiencies to the attention of railroads top management." (GAO, 1982, cover)... 

A combination of selected, formal design reviews and in-depth limited scope reviews shall be performed to assess the adequacy of the design, installation and testing activities for K-reactor. These reviews should be used in combination with the startup test program to provide reasonable assurance of reactor facility functional and design adequacy for restart. 

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