Records design review

Do the design controls ensure that design reviews and design verification and validation are recorded and demonstrate the product meets the design input and user requirements ... 

The standard requires records of design reviews to be maintained. 

You may only need one procedure that covers all the requirements but this is not always practical. The provisions you make for specific quality records should be included in the procedures for controlling the activity being recorded. For example, provisions for inspection records should be included in the inspection procedures, provisions for design review records should be included in the design review procedure. Within such procedures you should provide the forms (or content requirements for the records), the identification, collection/submission provisions, the indexing and filing provisions. It may be more practical to cover the storage, disposal, and retention provisions in separate procedures because they may not be type-dependent. Where each department retains its own records, these provisions may vary and therefore warrant separate procedures. 

Validation deviations during the project must be managed. Details of deviations must be recorded with a description of the circumstances under which the deviation was noted (e.g., reference to design review or test case) and the name of the person noting the deviation. A record is also required... 

All GxP functions, processes, components, and devices identified within the GxP assessment should be challenged as part of the Design Review. Consideration may also be given to occupational health matters such as the potential effects of the computer system and associated equipment on the personnel who may use or contact the system. GxP functionality includes the use of electronic records and signatures. Hybrid systems must be dehned and subject to a verification process to determine whether or not they are robust. It is often nsefnl for processes to be mapped, showing critical points in the process and how varions compnter systems support these critical process points. 

Design Reviews should be revisited as appropriate to consider errors diseovered during Qualification. All errors identified in a COTS product should be reported to the supplier and a response sought. If no satisfactory response is forthcoming, the seriousness of the failure should be assessed and the ensuing decision, with any mitigating further actions, recorded. 

GE EER and GE s Global Research Center (GRC) will analyze the design for reliability (DFR) of the fuel processor. The components that require a design review to reduce capital costs have been identified. DFR templates that have been developed by GRC to record all failures will be used. This data will be analyzed and all identified reliability issues will be addressed during the design of the next system. The DFR plan also includes component testing that will help identify failures of subsystems and components. Information from DFR analysis will be combined with the economic analysis to determine the economic benefits of the advanced fuel processor system. 

A properly controlled system of calibration is necessary. Calibration is defined [15] as the comparison of a measurement system or device of unknown accuracy to another measurement system or device of known accuracy. The purpose of calibration is to correlate the two devices, or eliminate by adjustment any variation from the required performance limits of the unverified measurement system or device. In other words, it determines the accuracy of an item of measuring equipment. Any adjustment made to a measuring device since last calibrated should be recorded and reviewed measuring devices that lose their calibration easily should be calibrated at a frequency designed to avoid significant consequences arising from loss of accuracy. 

Verlinden J, Horvath I, Nam T-J (2009) Recording augmented reality experiences to capture design reviews. Int J Interact Des Manuf 3 189-200... 

Risk assessment techniques such as HAZOP, design reviews and fault and event trees are systematic methods to guide and record the process of creative thinking. They are also often used to quantify the chance of failure. That step is only legitimate if we are certain that all models of failure have... 

It is objective and maximizes traceability in the estimation of BETA. In other words the choice of checklist scores, when assessing the design, can be recorded and reviewed. 

Problems elicited during design review will be recorded on form xxxx. Failures during test will be recorded as indicated in STD/xxx (factory) and PROC/xxx (Site). 

Architectural Index. 1950-. Boulder, CO. Electronic database http //www.archindex. com/free/copyright.htm. Free area for years 1982-1988. Also in paper format. Jerry T. Moore, AlA, editor and publisher Ervin J. Bell, AlA, editor and publisher, emeritus. Indexes the following major architectural journals Architecture, Architectural Record, Architectural Review, Builder, Building Design Construction, Interior Design, Journal of Architectural Education, Landscape Architecture, Residential Architect, and The Construction Specifier. Emphasis is on aesthetics rather than engineering. Last updated December 2007. 

The safety review report is distributed to the committee which meets to work its way through the report, section by section, discussing safety concerns and potential improvements to the process or procedure. An individual must be designated to take minutes at the meeting and record suggested modifications. If the review concerns an existing process, the committee should perform a site visit to examine the actual equipment. 

Nuclear power has achieved an excellent safety record. Exceptions are the accidents at Three Mile Island in 1979 and at Chernobyl in 1986. In the United States, safety can be attributed in part to the strict regulation provided by the Nuclear Regulatory Commission, which reviews proposed reactor designs, processes appHcations forUcenses to constmct and operate plants, and provides surveillance of all safety-related activities of a utiUty. The utiUties seek continued improvement in capabiUty, use procedures extensively, and analy2e any plant incidents for their root causes. Similar programs intended to ensure reactor safety are in place in other countries. 

At present, according to the review of Tsotsis et al. (in Becker and Pereira, eds., Computer-Aided Design of Catalysts, Dekker, 1993, pp. 471-551), there is no record of industrial implementation of reac-tors with catalytic membranes. 

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