Design qualification test

See Design Qualification Test for additional related information. 

Regulatory Guide 1.9, "Selection, Design, Qualification, Testing, and Reliability of Diesel Generator Units Used as Class IE Onsite Electric Power Systems at Nuclear Power Plants, Working Draft, November 28, 1989. 

Design validation may take the form of qualification tests which stress the product up to and beyond design limits - beta tests where products are supplied to several typical users on trial in order to gather operational performance data, performance trials, and reliability and maintainability trials where products are put on test for prolonged periods to simulate usage conditions. 

As the cost of testing vast quantities of equipment would be too great and take too long, qualification tests, particularly on hardware, are usually performed on a small sample. The test levels are varied to take account of design assumptions, variations in production processes and the operating environment. 

Test specifications to be produced which define the features and characteristics that are to be verified for design qualification and acceptance... 

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. 

The construction organization has at least one currently employed welder or welding operator who, while in its employ, has satisfactorily passed a performance qualification test using the designated WPS. 

Filler metal is required to conform with the requirements of Sec. IX. Backing rings (of ferrous material), when usecl, shall be of weldable quality with sulfur hmited to 0.05 percent. Backing rings of non-ferrous and nomnetalhc materials may be used provided they are proved satisfactory by procedure-qualification tests and provided their use has been approved by the designer. 

The terms instrument qualification and instrument validation are sometimes used indiscriminately. In this chapter, the term qualification refers to the site preparation and the testing employed to demonstrate that the instrument is properly installed in a suitable environment and the performance meets the predetermined specifications for its intended use. Qualification is a part of the whole validation life cycle. Validation refers to the process to provide assurance that the instrument is suitable for the intended application throughout the lifetime of the instrument. Installation qualification (IQ), operation qualification (OQ), and performance qualification (PQ) are performed to provide evidence that the user requirement specifications (URSs), functional requirement specifications (FRSs), and design qualification (DQs) have been met. The sequence of requirements setting and qualification events as well as the relationships between IQ, OQ, PQ and URS, FRS, and DQ are generally illustrated by the V diagram shown in Figure 2. Installation qualification demonstrates the fulfillment of the DQ. Similarly, OQ demonstrates the fulfillment of the functional requirements and PQ demonstrates the fulfillment of the user requirements. 

For analytical equipment, qualification is broken down into four areas design qualification (DQ), installation qualification (IQ), operational qualification (OQ), and performance verification (PV) [2,3]. In this chapter we focus on the operational qualification of a capillary electrophoresis instrument. The tests used in the operational qualification are often used in the routine performance verification as... 

The installation should be documented. The accuracy of software installation should be verified, and for networked systems, drawings with diagrams should be generated. The instrument should be tested for compliance to user requirements and functional specifications, as defined during the design qualification. Critical parameters should be tested before and during routine analysis. System suitability... 

Process demonstration formerly called process qualification, represents the actual studies or trials conducted to show that all systems, subsystems, or unit operations of a manufacturing process perform as intended that all critical process parameters operate within their assigned control limits and that such studies and trials, which form the basis of process capability design and testing, are verifiable and certifiable through appropriate documentation. 

For each system validation project the validation team must be identified and would typically consist of designated personnel (normally identified by job function at this stage) that will be responsible for the provision, review, and approval of all validation documents and implementation of the qualification testing. 

Quality-related critical parameters, data, and functions are essential for specification and contract considerations, system design and development, qualification testing of the computer system, and PQ for the validation of the process. GMP-related system requirements need to be traceable throughout the specification, design, development, testing, and operation of a system. This can readily be achieved by having a traceability matrix that will identify corresponding sections and data in the key life-cycle documents. 

It is recommended that wherever possible the structure of the URS be used as the basis for the presentation format of the FDS and hardware and software design specifications this helps ensure design decisions are auditable back to the source requirement. Traceability should also be carried forward to the qualification test procedures, where it can link each test and qualification acceptance criterion directly to a specific requirement. 

Design, development, and system build is normally a period of intense activity, in which a supplier will be involved in life-cycle activities and will need to provide a set of auditable design and development documentation to support the validation program. For this, the entire design and development process should be carried out to written and approved procedures, and all design, development, testing, and verification activities should be documented and approved in order to provide a level of computer system documentation that can be used to support the pharmaceutical manufacturer s life-cycle qualification activities. 

It should be recognized that qualification activities need to be undertaken to detailed test procedures that provide comprehensive test records, with all documentation formally reviewed and approved by a designated level of management from the pharmaceutical manufacturer. With this in mind, suitably trained qualification test personnel will be required. 

Design qualification is a formal and systematic verification that the computer system requirements specification is met by succeeding system design specifications and their implementation throughout the development and build (including development testing) activities. 

Computer system decommissioning can also encompass disconnection, disassembly, and storage (or mothballing) for future use. Accurate specification, design, development, qualification testing, and operational documentation is essential to enable controlled redeployment of the system in a GMP environment. 

Requirements Design Implementation Test Qualification and CSV Plan Vendor Qualification Plan/ Certification User Requirements Functional Specifications ... 

Once the protocols have been completed, the test results and data need to be formally evaluated. The written evaluation needs to be presented clearly, in a manner that can be readily understood. The report should also address any nonconformances or deviations to the validation plan encountered during the qualification and their resolutions. The format of the report should be similar to the structure of the associated protocols. The qualification testing should be linked with the acceptance criteria in the relevant specification deliverable, so that the PQ will link with the requirements specification deliverable the OQ will link with the company system specification deliverable and the IQ will link with the technical design specification deliverable. 

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). 

Evaluating composite performance requires test methods for mechanical properties of the constituent materials (fibers, tows, filaments, and matrices) as well as the composite materials themselves. The types and quantities of tests to be performed, and the selection of testing parameters, depends on the information desired. For material development, the tests may be much simpler and less numerous than those that would be chosen for design qualification, but may encompass a greater range of test parameters than would be expected in service. In the case of materials development, it is the trends in the data and the mechanisms by which failures occur which are most important, and it is crucial to examine the extremes of behavior. For component design and qualification, it is more important to know the reliability and reproducibility of the material under conditions which resemble the expected service conditions. 

---