Calibration program

The assessor should also find out whether an effective testing program is in place to help ensure the serviceability of process measurement equipment. The successful toller should have an established calibration program to address the accuracy of critical measurement equipment. Safety critical process parameters should be monitored and critical process equipment should automatically interlock when monitoring instrumentation detects safety critical deviations. Interlocks should either facilitate a remedy to the critical deviation or bring the process to the zero energy state. These instruments and interlocking devices should be routinely tested to ensure operational reliability. 

The assessor should find out that a testing program is in place, which ensures the serviceability of the existing measurement equipment. They should have an established calibration program, which addresses the accuracy of all measurement equipment. 

A benefit of the use of accelerometers is that they do not require a calibration program to ensure accuracy. However, they are susceptible to thermal damage. If sufficient heat radiates into the piezoelectric crystal, it can be damaged or destroyed. However, thermal damage is rare since data acquisition time is relatively short (i.e. less than thirty seconds) using temporary mounting techniques. 

The major limitation of velocity transducers is their sensitivity to mechanical and thermal damage. Normal plant use can cause a loss of calibration and therefore a strict re-calibration program must be used to prevent distortion of data. As a minimum, velocity transducers should be re-calibrated at least every six months. Even with periodic re-calibration, programs using velocity transducers are prone to bad or distorted data that results from loss of calibration. 

In this case, instead of normal OLS calibration, the weighted calibration has to be chosen. For WLS the dependence of the variance of the measurement values, s2, on the analytical values x(and therefore on the measured values y, too) has to be determined in preliminary studies. Then the resulting variance function, s2 = f(y), can be entered for weighting directly in corresponding calibration programs, e.g. in the form w = 1/s2 = 1 = 1 /y see Sect. 6.2.3. 

C. Bronk Ramsey, Development of the radiocarbon calibration program, Radiocarbon 43,... 

This solid state detector is therefore capable of detecting information from all elements simultaneously. Software allows peaks to be identified and quantified, and usually includes calibration programs which perform... 

This is usually as far as most analysts (or automatic calibration programs) go in terms of processing the data, but it gives no indication of the error associated with the measurement arising from uncertainties in the calibration... 

Since calibration is time consuming and is often viewed as nonproductive work, the decisions in developing a calibration program often... 

Fundamental Parameters (FP) are universal standardless, factory built-in calibration programs that describe the physics of the detector s response to pure elements, correction factors for overlapping peaks, and a number of other parameters to estimate element concentration while theoretically correcting for matrix discrepancies (e.g., Figure 1987). FP should be used for accurately measuring samples of unknown chemical composition in which concentrations of light and heavy elements may vary from ppm to high percent levels. 

Required Protocols and Procedures for Parenterals Production Calibration Program Summary Preventive Maintenance Program Summary Key SOPs... 

The calibration manager is responsible for establishing an adequate and organized calibration program. Supervision of the whole program should be done by the quality assurance manager. 

Upon receipt, all equipment should be reviewed by the calibration lab manager and the user department to establish if the equipment has to be kept on calibration program. 

The last GMP included in this listing is the original document that identified calibration program requirements but was never formally issued.]... 

The manufacturer should verify the operation of these critical components during the installation according to their standard procedures for evaluating the proper operation of these components. Additional IQ checks will verify that the necessary documentation is available for proper operation of the chamber. These checks should confirm that standard operating procedures and equipment manuals are available. In addition, all calibrated instruments associated with the chamber should be documented in current calibration and placed on a calibration program. 

The coating process (equipment design, process parameters employed, maintenance and calibration programs, etc.)... 

The protocol must include directions on selecting or developing the maintenance program, including preventive and corrective action. The maintenance program includes the calibration program of measurement equipment and the replacement of equipment parts. 

Equipment calibration. This quality function for production consists of a viable calibration program for equipment that provides in-process test data or a measurable indication of the controlled process used. This activity is needed so that the manufacturing unit will know whether the equipment is operating consistendy during the time period covered by the calibration activity. This effort is also a continuing commitment of production to maintain its equipment as it was documented to perform during its installation qualification (IQ) and operational qualification (OQ) activities. 

Design, operation and maintenance of buildings and equipment, with attention to housekeeping, sanitation, pest control, prevention of contamination of product, cleaning of equipment, a calibration program for all instruments and gauges, and environmentally satisfactory methods of waste disposal. 

Operating devices may become miscalibrated after a while (e.g., the temperature accuracy of a gas chromatography [GC] column oven or the wavelength accuracy of a UV/visible detector s optical unit). This can have an impact on the performance of an instrument. Therefore, a calibration program should be in place to recalibrate critical items of an instrument. 

A wavelength calibration program allows readout of signal information in terms of nanometers rather than diode numbers. 

After initial qualification, the system is placed in service and is kept in a qualified state using a periodic calibration program. In addition, its performance for the specific application is also verified at the time of use using system suitability testing. This section describes the procedures and documentation used for HPLC hardware qualification. Detailed discussions of this subject can be found in books and articles elsewhere.3,4 The regulations and qualification of computerized data systems and networks with their associated software can be quite elaborate and is described elsewhere.5 7... 

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