Design qualification , procedures

Brazements included in a piping system that is subjected to a temperature 1,000°F (538°C) and greater shall require tests in addition to those of ASME BPV Code Section IX. These tests shall be considered a part of the qualification procedure for such design temperatures. Two tension tests on production type joints are required, one at the design temperature and one at 1.05T (where T is the design temperature in degrees Fahrenheit). Neither of these production-type joints shall fail in the braze metal. 

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). 

Design qualification should always be performed by the user, whereas installation qualification for large, complex, and high-cost instruments should be performed by the vendor. In some cases, warranty is lost if the user installs the system. Operation qualification can be performed by either the user or the vendor. The decision mainly depends on the available resources at the user s site, and on the vendor s capability to offer such a service with high quality. Performance qualification should always be performed by the user because it is very application-specific and the vendor may not be familiar with the method. As PQ should be performed on a daily basis, this practically limits this task to the user anyway. On completion of equipment qualification, detailed documentation should be available, considering qualification checklist, procedures for testing, qualification test reports with signatures and dates, PQ test procedures, and representative results. 

Examples of engineering actions include design, qualification, and failure analysis. Examples of operations actions include surveillance, carrying out operational procedures within specified limits, and performing environmental measurements. 

The qualification procedure specified for the isolation devices may lead to a definition of a standard and to the use of standardized products for seismic isolation design. 

The employer program must have testing procedures for re-qualification designed to ensure that the operator continues to meet the technical knowledge and skills requirements in paragraphs (j)(1) and (2) of this section. The re-qualification procedures must be audited in accordance with paragraphs (c)(1) and (2) of this section. 

Prior to April 16, 1981, pressure relief devices required approval by the Bureau of Explosives of the Association of American Railroads. Subsequent to April 16, 1981, the U.S. Department of Transportation promulgated new regulations amending 49 CFR 173.34 to eliminate the need for pressure relief device approval by the Bureau of Explosives. It is now the responsibility of the individual manufacturer or shipper to conduct flow and/or fire tests on new pressure relief device combinations to show compliance with CGA S-1.1, Pressure Relief Device Standards-Part 1-Cylinders for Compressed Gases [4] CGA C-12, Qualification Procedure for Acetylene Cylinder Design [5] and CGA C-14, Procedures for Fire Testing of DOT Cylinder Safety Relief Device Systems [6], as applicable, and to retain test records of this compliance. 

F. The number and location of pressure relief devices for cylinders of any particular size shall be proved adequate as a result of the fire test. Any change in style of cylinder, a filler, or quantity of devices can only be approved if found adequate upon reapplication of the fire test. The fire test shall be conducted in accordance with CGA C-12, Qualification Procedure for Acetylene Cylinder Design [5]. 

CGA C-12, Qualification Procedure for Acetylene Cylinder Design, 3 ed.. Compressed Gas Association, Inc., 1725 Jefferson Davis Highway, Arlington, VA 22202. 

C-12 Qualification Procedure for Acetylene Cylinder Design, Describes qualification tests for use by manufacturers of acetylene cylinders as required when a new cylinder design or significant design change occurs. Tests include a proof of the mechanical strength of the filler, a flashback test, an impact stability test, and a fire test. (16 pages)... 

Site protection measures are discussed in Ref. [3] as part of the site qualification procedure and conditions affecting the definitions of the design basis flood itself. 

The methodologies for design and/or assessment of existing facilities, which are developed on the basis of this publication, should be adequately validated. Special validation effort and QA activity should be spent on the qualification procedures based on engineering experience, due to the intrinsic need for trained personnel to follow prescribed procedures. 

As described in Sect. 4.2.1.1, unfueled samples of the graphite foam were irradiated in the HFIR at a neutron flux level on the order of lO neutrons/(cm2-s). From Fig. 5.2, the flux in the SSR is on the order of 2 X I0l2 So a single cycle of 25 d in the HFIR would correspond to a fluence of 12,400 d or 34 years for the SSR—far beyond the design lifetime of 10 years. An examination of fueled specimens would be the next logical step in a fuel qualification procedure, but ihe cost of such an experiment exceeded fimds available for this project. 

Because this initial decomposition is so strongly linked to a specific industrial application and its associated qualification procedure it is not possible to provide an industry independent process. Nevertheless, a description is required of the major controlling parameters which make up the definition of the Real World Problem, such as loads, design critical factors etc. When these factors are examined it is clear that the process is one of finding a taxonomy which adequately defines the terms being addressed. To illustrate the points being made the specific case of deriving a basic definition of the loads is now considered. 

At this time the NICMOS 3 design is complete, the flight qualification focal plane assemblies are in manufacture, and all flight focal planes are on schedule for delivery by the end of 1994. Identical focal plane arrays, not under flight qualification procedures, are in use in many observatories aroimd the world. The read out electronics systems differ and the observational modes differ between users. This has provided important information on the operation of the arrays under different circumstances and has inevitably led to different resrdts which depend on the method of use. The following describes the intended method of use for the NICMOS program. Any information from users utilizing the arrays in a similar way will be most welcome. 

The qualification of brazing procedures, brazers, or brazing operations is required in accordance with the requirements of Part QB, Sec. IX, ASME Code, except that for Category D fluid seiwice at design temperatures not over 93°C (200°F). Such qualification is at the owners option. The clearance between surfaces to be joined by brazing or soldering shall be no larger than is necessary to allow complete capillary distribution of the filler metal. 

Personnel performing examinations other than visual shall be qualified in accordance with applicable portions of SNT TC-IA, Recommended Practice for Nondestructive Testing Personnel Qualification and Ceitification. Procedures shall be qualified as required in Par. T-150, Art. 1, Sec. Vof the ASME Code. Limitations on imperfections shall be in accordance with the engineering design but shall at least meet the requirements of the code (see Tables 10-58 and 10-59) for the specific type of examination. Repairs shall be made as applicable. 

First part qualification. First part qualification is a process performed the first time a new bonded assembly is manufactured or the first time a new tool is used to manufacture a bonded assembly. First part qualification provides assurance that all of the aspects that control bond assembly quality, such as the design dimensions, detail part manufacturing techniques, tool dimensions, layup procedures and autoclave cure cycle parameters are correct and will produce a bond assembly that meets the engineering requirements. 

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. 

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