Equipment Qualification

Abstract: This paper describes the development of guidance for the equipment qualification (EQ) of analytical instruments. EQ is a formal process that provides documented evidence that an instrument is fit for its intended purpose and kept in a state of maintenance and calibration consistent with its use.

Abstract: Thirty five three-component ground motions recorded in 18 earthquakes were analyzed and the records were cross-compared based on several parameters. The “best candidate” for the input motion was selected and modified by time-domain spectral matching procedure. The resulting strong motion time history preserves the nonstationary behavior of the real earthquake record while its response spectra envelope the IEEE target response spectra in a broad range of natural frequencies as required by the standard. The resulting strong motion time history is intended for use for equipment qualification testing, and will be considered for inclusion in a future revision to IEEE 693. Additional requirements for the input motion specification and generation procedure in the IEEE 693-1997 are recommended.

Abstract: The sections in this article are Preface Introduction Background and Purpose Overview Types of Near-Infrared Procedures to be Validated Validation Requirements Equipment Equipment Selection Equipment Qualification Design Qualification Installation Qualification Operational Qualification Performance Qualification Change Control Hardware Software Glossary References Books Useful Reference Journals Useful Papers Technical Guidelines for Qualitative Methods Introduction to Qualitative Analysis Feasibility Study Sample Authentication, Collection and Measurement Sample Measurement/Presentation Measurement by Transmission Liquids and Solutions Solids Measurement by Diffuse Reflection Measurement by Transflection Library Development Define the Purpose Selection of Samples/Spectra for Calibration Set Display Data Calibration Set Selection Data Pre-Processing/Transformation Library Construction Determination of Thresholds Library Validation Internal and External Validation Internal External Specificity Repeatability Robustness Routine Use Out-of-Specification Results Library Maintenance Database Material Groupings New Materials Addition Material “Library Group” Modification Technical Guidelines for Quantitative Methods Introduction to Quantitative Analysis Feasibility Study Sample Collection Sample Scanning Displaying and Checking Spectra Reference Data Sample Selection – Calibration and Calibration Test Sets Data Pre-Processing Generation of Calibration Model Validation of Calibration Model Performance Verification Accuracy Monitoring Use of a Check Sample Comparison with Reference Method Maintenance of the Calibration Model Method Transfer Acknowledgments

Abstract: A method for evaluating the quality of data collection in a manufacturing environment is provided. Said data are intended to be analyzed by a process control system. The method comprising the following steps (A) collecting raw data according to a Data Collection plan specifying, and for each data item, a sampling time reference indicating at which time interval it is expected, and associating to each collected data item a timestamp indicating its actual collection time, (B) for at least a part of the raw data included inside a predetermined window, determining a Data Collection Quality Value (DCQV) by: (a) reading the timestamps; (b) computing at least one quality indicator value from the relationship between each timestamp and the corresponding time reference, wherein a shift represents a malfunction of the equipment or of the data collection system; (c) after steps (b) and (c) have been performed for all data items, computing a single data collection quality value (DCQV) indicator for said time window. Application to data qualification for analysis and equipment qualification e.g. in a semiconductor fab.