Inspection, Maintenance, and Calibration

This chapter covers general plant safety topics not directly related to specific activities or equipment. Principal subjects are the inspection, maintenance, and calibration of equipment (4.1) spare parts handling (4.2) storage and warehousing (4.3) plant modifications (4.4) hazardous operations (4.5) the use of outside contractors (4.6) and the protection of workers by safety gear and the control of the working environment (4.7,4.8). 

In order to ensure safety of the process plant, a comprehensive maintenance program should be in place to certify, inspect, and, where necessary, calibrate equipment and instruments. This program should include  

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The user of the EBT must maintain records of inspection, maintenance, and calibration. 

Documented inspection, cleaning, maintenance and calibration of apparatus. Calibration to be traceable to national or international standards... 

Written records shall be maintained of all inspection, maintenance, testing, calibration, and/or standardizing operations."... 

Equipment inspection, maintenance, and repair records can be recorded in a logbook especially designed for that purpose. For equipment that is moved from laboratory to laboratory, the logbook should accompany the equipment when it is moved. Documentation of calibrating or standardizing operations, on the other hand, may be more efficiently recorded with the associated records of the data acquisition activities. 

Written records shall be maintained of all inspection, maintenance, testing, calibrating and/or standardizing operations. These records, containing the date of the operation, shall describe whether the maintenance operations were routine and followed the written standard operating procedure. 

Other documentation targeted for storage in archives include the master schedule sheet, copies of protocols, and records of quality assurance inspections, summaries of training and experience, job descriptions, records and reports of the maintenance and calibration and inspection of equipment. In any case, ensure that the protocol or SOPs address the proper archiving of appropriate materials. 

Are records and reports of the maintenance and calibration and inspection of equipment, as required by 58.63 retained for the length of time specified in... 

The elements of a PM plan include periodic inspection, cleaning, and service as warranted, adjustment and calibration of control system components, maintenance equipment and replacement parts that are of good quality and properly selected for the intended function. Critical HVAC system components that require PM in order to maintain comfort and deliver adequate ventilation air include a outdoor air intake opening, damper controls, air filters, drip pans, cooling and heating coils, fan belts, humidification equipment and controls, distribution systems, exhaust fans. 

Procedures are required for the control and maintenance of inspection, measuring, and test equipment and to cover test software, not only for calibration. This section of the standard is often referred to as the calibration requirement but it goes far beyond mere calibration. In assessing compliance with section 4.11, there are at least 30 requirements to check (see the questionnaire at the end of this chapter) and calibration is only one of them. Figure 11.2 shows the processes needed to control, calibrate, and maintain inspection, measuring, and test equipment. The shaded boxes indicate interfaces with other processes. 

To satisfy government agencies, instruments need to be adequately tested, calibrated, and/or standardized according to documented procedures. Current GLP standards state that equipment used in the generation, measurement, or assessment of data and equipment used for facility environmental control must be of appropriate design and capacity to function according to the protocol and shall be suitably located for operation, inspection, cleaning, and maintenance. 

Defined maintenance procedures should include model or manufacturer specifics and a list of parts to be inspected, cleaned, lubricated, replaced, and/or calibrated. The replacement part numbers, cleaning solutions and lubricants, and calibration standards, along with the manufacturer s maintenance procedures to be followed, should be specified. Documentation is easily managed by creating a one-page checklist of instructions or performance parameters that can be checked off as each task is completed. Any issues or comments can be captured directly on the checklist. Provisions for failure or out-of-tolerance notification need to be clearly defined, as the equipment cannot be put back into service until the performance has been verified by conducting a performance qualification. 

As to equipment, the QAU would check to see if it is clean, well maintained, and regularly inspected, as would be evidenced by inspection tags and log books. The unit would want to know if the manuals and log books for equipment use, calibration, and maintenance are readily available and being used properly. The QAU would want to know if calibration is being done correctly and is properly documented, and whether all documentation is recorded in ink. Finally, the unit would check for proper documentation of errors, including initials, dates, and explanations, and whether changes are made so as not to obscure the original entry. 

All aspects of a laboratory s program for the routine inspection, cleaning, maintenance, testing, calibration, and/or standardization of equipment must be in writing (i.e., SOPs, supplemented as necessary by equipment manuals). This would include a description of cleaning materials inspection, cleaning, and maintenance methods and schedules calibra-... 

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