12. Equipment and Maintenance
Effective Date: 07/2008
Point of Contact: Quality Engineer for Regulatory Programs
Routine maintenance is performed to reduce instrument downtime and promote acceptable instrument performance. Preventative maintenance is based on manufacturers' recommendations, instrument characteristics, and performance history. It consists of the important tasks that need to be done to minimize downtime of measurement systems.
An analyst conducts routine inspections (e.g., daily, weekly, or as needed) based on the manufacturers' recommendations (see the Suggested Preventive Maintenance Frequencies for Specific Instruments exhibit for examples), historical performance, or applicable technical procedures.
The analyst documents anomalies in a logbook, which will be kept next to the instrument, maintained in a project file, or in an electronic record system. Additionally, the name of the instrument, serial number or unique identifier, date received and placed in service, condition at receipt, date of calibration or date of next calibration, and the location are documented.
The analyst assigns action(s) for the instrument and makes a notation in a logbook, maintained in a project file, or electronic record system. The notation should include a description of the action, the date performed, and the initials of the person who performed the action. Additionally, the name of the instrument, serial number or unique identifier, and the location are documented.
Instrument maintenance should be performed by individuals knowledgeable with the instrument. This may be through an external maintenance contract.
The analyst documents instrument maintenance and repairs, including the date and signatures of personnel who performed the maintenance. This documentation may be in a logbook, service report, or electronic record system. Additionally, the name of the instrument, serial number or unique identifier, and the location is documented.
All equipment subject to maintenance or repair shall be re-calibrated as necessary prior to use.
The analyst maintains critical spare parts in accordance with manufacturer specifications and work load needs. When spare parts are used, and no other spares remain, the analyst procures another.