4090.13,40 Page 1 of 4 FSH 4090.13 - GOOD LABORATORY PRACTICES HANDBOOK WO AMENDMENT 4090.13-93-1 EFFECTIVE 11/10/93 CHAPTER 40 - EQUIPMENT 40.3 - POLICY. All equipment used to conduct Good Laboratory Practices shall: 1. Be properly designed and suited for its purpose. 2. Be calibrated to known standards. 3. Have updated calibration, maintenance, and repair records that are available at study sites and retained in the archives. 4. Have written Standard Operating Procedures (SOPs) (sec. 42.2 and 52) that outline procedures for the use, calibration, and maintenance of the equipment. The SOPs should contain contingency plans in case of equipment malfunction or breakdown during the course of a study. 41 - EQUIPMENT DESIGN. (Sec. 01, ex. 01; 40 CFR 160.61). Use only properly designed equipment that is capable of fulfilling its function, as detailed in the experimental protocol, including the equipment used for the generation, measurement, or assessment of data, as well as that used to regulate the environment of the testing facility. Keep equipment accessible and suitably located for proper operation, inspection, cleaning, and maintenance. Identify all equipment with a unique number, such as an inventory number, for correlation with the calibration, maintenance, and repair records. 42 - CALIBRATION AND MAINTENANCE. (Sec. 01, ex. 01; 40 CFR 160.63). 42.1 - General Considerations. Adequately inspect, clean, and maintain all equipment. Test, calibrate, and/or standardize equipment used for the generation, measurement, or assessment of data. Frequently used equipment, such as balances and pH meters, should be standardized daily or before each use if used periodically. Most modern balances are calibrated by internal electronics and should be recalibrated daily and after a power failure. Periodically verify the calibration of balances with standard laboratory weights. Calibrate pH meters with known buffers before each use. In field studies, calibrate sprayers before the application of test, control, or reference substances to the test system. Recalibrate sprayers between applications, or as often as needed to avoid errors due to calibration changes. Some types of laboratory equipment, such as graduated cylinders and volumetric flasks, are precalibrated and do not need to be recalibrated. Uniform volumes can sometimes be obtained only by repeated use of a particular measuring device. For example, use the same type of syringe to inject reference standards and test samples into a gas chromatograph during chemical characterization studies. 42.2 - Standard Operating Procedures. Have written Standard Operating Procedures (SOPs) in place which adequately describe the procedures, materials, and schedules for routine equipment inspection, cleaning, maintenance, testing, calibration, standardization, or use of equipment. Ensure that these SOPs specify options in event of equipment failure in order that equipment may be fixed and to ensure the timely and adequate completion of the study. Ensure that these SOPs designate the persons and their positions who are responsible for the performance of each operation. This designation may refer to a service department or to the contracting of service personnel in event of equipment failure. See section 52 for further guidance on preparing SOPs. 42.3 - Documentation. Maintain written records of all inspection, maintenance, testing, calibration, and/or standardizing operations in equipment logs. Maintain equipment logs for all laboratory and field equipment, including pH meters, balances, centrifuges, freezers, microscopes, spectrophotometers, autoclaves, hygrothermographs, sprayers, helicopters, generators, insect traps, air samplers, pheromone dispensers, and any other piece of equipment used in a study. Clearly identify the log by equipment name and dates covered. Include the following information in the log: 1. Dates the equipment is in operation. 2. Dates and results of inspections. 3. Maintenance, including cleaning procedures. Describe whether maintenance was routine and followed written Standard Operating Procedures. 4. Testing, calibration, and/or standardization operations. 5. Service and repair events. Record the nature of the failure or malfunction, how and when it was discovered, and any remedial action taken. 6. Changes in configuration and addition of options. Store all written records or equipment logs in the archives when they are no longer kept in the laboratory or field station (sec. 72 and 73). Each log should be adequately identified as to the piece of equipment and dates covered by the log. See exhibit 01 for a sample format for an equipment log. 42 - Exhibit 01 Sample Format for an Equipment Log Equipment: Mettler Balance PE160 Location: Biodeterioration RWU, Building 1, Room 153 Dates Covered by Log:January 1, 1993 - present Identification Number: RWU4502-001 Calibration Records Date Deviation from Balance Written SOPs Standard Weight? Recalibrated? Followed? 1g 10g 100g (Initial) 1/2 no no no no yes JAM 1/3 1.005 10.004 100.708 yes yes JAM 1/5 no no no no yes JAM 1/6 no no no no yes JAM 1/7 0.996 9.997 99.993 yes yes JAM 1/8 0.998 9.994 99.992 yes yes JAM 1/9 no no 100.002 no yes JAM Routine Maintenance Log Date of Next Date & Maintenance Performed Remarks Scheduled Initials Maintenance 1/7 JAM cleaned and 2/17/93 recalibrated 1/8 JAM cleaned due to pan dropped on 2/17/93 chemical spill floor 2/17 JAM cleaned and 3/17/93 recalibrated 2/18 no power; fuse worked OK w/new 3/17/93 JAM replaced fuse 2/19 no power; fuse maintenance called 3/17/92 JAM replaced 2/20 repaired; 3/17/92 JAM recalibrated 42 - Exhibit 01--Continued Equipment: Mettler Balance PE160 Location: Biodeterioration RWU, Building 1, Room 153 Dates Covered by Log: January 1, 1993 - present Identification Number:RWU4502-001 Nonroutine Maintenance Log Date: February 20, 1993 Name (Initial/signature): Jessie A. Micales Description of the problem: Bad integrated circuit caused power surge. How was the problem corrected? Board replaced. Who corrected the problem? Forest Products Laboratory electrical repair shop. What studies could have been affected? (Give experiment numbers and dates.) CLTH 21402 and CLTH 21709; February 17 - 19, 1993 How could the studies have been affected? Data may have been inaccurate due to a bad integrated circuit. Samples were reweighed. Results were not significantly different from the original readings.