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If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard. The equipment identification, calibration dates, the individual performing each calibration, and the next calibration date shall be documented.These records shall be displayed on or near each piece of equipment or shall be readily available to the personnel using such equipment and to the individuals responsible for calibrating the equipment.A recurring theme throughout this section is the phrase "shall be documented." I can’t stress enough that if an action is taken or performed but is not documented, as far as any inspector or auditor is concerned, it did not take place.My calibration philosophy for meeting FDA regulations and ISO standards is simple and covers the requirements found in 21 CFR Part 820.72: 1. Write down the process or procedure required to calibrate on all test equipment that makes a quantitative measurement. Use the previously referenced calibration procedures. It’s not enough to go to the trouble of writing, validating, continually updating and improving your calibration procedures if you don’t use them.MEASURE FOR MEASURE by Jay Bucher I’m still amazed by how many experienced, trained, professional calibration personnel do not know what the U. Food and Drug Administration regulations say about calibration requirements.During my workshops and company audits, I’ve found that many professionals might not know there is a requirement, don’t know where to find it, don’t know what it actually says and, in the worst case scenario, don’t know what it means.With that in mind, I’ll clarify what the FDA says about calibration requirements, and I’ll also tell you how to meet those requirements.
Each manufacturer shall ensure that all inspection, measuring, and test equipment, including mechanical, automated, or electronic inspection and test equipment, is suitable for its intended purposes and is capable of producing valid results.
Each manufacturer shall establish and maintain procedures to ensure that equipment is routinely calibrated, inspected, checked, and maintained. Calibration procedures shall include specific directions and limits for accuracy and precision. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards.
The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. When accuracy and precision limits are not met, there shall be provisions for remedial action to reestablish the limits and to evaluate whether there was any adverse effect on the device’s quality. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard.
If the item requires calibration, it also needs to be recalibrated on a regular basis. I understand that in the real world—after performing dozens, hundreds or even thousands of calibrations on a particular type or model of test equipment—calibration practitioners should be able to perform the procedure in their sleep. The FDA requirements and ISO standards call for using written calibration procedures.
You aren’t using a calibration procedure if that procedure is in a binder located in a different room or building and not where the actual calibration is performed.
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Calibration practitioners (as well as any technician, supervisor or manager working in an FDA or ISO-regulated environment) must know where to find the information needed to perform their job and are not required to memorize any of it.