Written By: Chandler Conley, Business Development Manager
Accuracy of equipment for testing and measurement is necessary for developing and manufacturing critical products, pharmaceuticals, medical devices and more. If you have a well-organized calibration program, you minimize your risk of using out of tolerance equipment. Oh yes, your calibration program prevents FDA 483 citations. Failure to perform calibration, inspection, and checking ranked at number 9 of the top 15 deficiencies in 2014. Related citations include absence of written protocols, failure to follow written procedures, and the absence of scientifically sound laboratory controls.
You need to decide which pieces of equipment need to be calibrated and how often they need calibration. The obvious list includes critical equipment used for product approval, sensors used for qualifications, and equipment that is used to assure processes are performing as needed. You also need to consider equipment in your indirect and utility systems. A comprehensive asset list with calibration due dates, calibration parameters, and processes makes calibration program management easier. PSC Software™’s (ACE™) electronic Quality Management System provides an integrated quality solution that can manage you calibration program and seamlessly integrate it into your quality system.
Your “smart” equipment may be able to alert you that calibration is due, such as the Lives International XpertLog thermal validation systems and wireless data loggers, where you can restrict sensor operation if calibration is overdue, or the CLiMET Instruments lines of particle counters, which can be set to not operate if the current calibration has expired. These “smart” instruments add ways to prevent use when calibration has expired. Calibration stickers with due dates on equipment may eventually fall off or wear down on equipment that is cleaned frequently. They also may be in areas that are not obviously visible to users, so built in lock-outs or restrictions are a great backup plan.