Develop test/calibration/maintenance

Parts/Supplies Purchase and/or Inventory Management Develop Test/Calibration/ Maintenance Procedures Technical Library/Service Manuals Management... 

Outside of the occasional system calibration and model verification tests, the routine maintenance burden of a Raman system is quite low. Optical windows may need to be cleaned, though automatic window cleaning systems can be implemented if it is a known issue. The most likely maintenance activity is laser replacement. Some systems have a backup laser that turns on automatically if the primary laser fails. This lessens the impact of a failure if the unit is being used for closed-loop process control. With a quality instrument and well-developed models, process Raman installations need less maintenance than many competing techniques. 

GMP regulations encompass every phase of product development (manufacturing, testing, acceptance, etc.), from the purity of the raw materials to the quality of the finished product. Established procedures include staffing and training, quality control, facilities and maintenance, selection, calibration and maintenance of equipment, procurement, testing and storage of raw materials,... 

The performance of a diagnostic X-ray machine should be checked at least annually with appropriate instruments by a qualified person. If the capability to do this is not available in-house, a qualified consultant should be hired to do the task. If any maintenance is done or if the machine is relocated, a survey should be undertaken for leakage radiation fromthe source. If the unit is moved to another facility, the exposure levels in the adjacent areas should be tested to ensure that the exposure levels are within the permissible limits forcontrolled and uncontrolled areas. Records of all maintenance, surveys, leakage checks, calibration, personnel monitoring, etc. should be maintained at the facility and at the radiation safety office. Because of the long latency period for cancer developing from radiation exposures, it would not be unreasonable to maintain personnel exposure records for up to 40 years. 

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