Seriously, Inspection, Measuring, and Test Equipment (§820.72) or its ISO cousin Control of Monitoring and Measuring Devices (ISO 13485:2003, Clause 7.6) have been industry mainstays for years. The Quality System Regulation (QSR) and ISO 13485 are quite similar in that device manufacturers shall establish a written procedure or procedures; and equipment is expected to be calibrated and records associated with the calibration shall be retained. Sorry folks, a regulation or standard just does not get any easier to understand then the requirements surrounding calibration. That being said, the doctor hopes that you find this week’s guidance “utile” (look-it-up).
(a) Control of inspection, measuring, and test equipment. 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. The procedures shall include provisions for handling, preservation, and storage of equipment, so that its accuracy and fitness for use are maintained. These activities shall be documented.(b) Calibration. Calibration procedures shall include specific directions and limits for accuracy and precision. 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. These activities shall be documented.
- Calibration standards. Calibration standards used for inspection, measuring, and test equipment shall be traceable to national or international standards. If national or international standards are not practical or available, the manufacturer shall use an independent reproducible standard. If no applicable standard exists, the manufacturer shall establish and maintain an in-house standard.
- Calibration records. 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.
- Calibration cycles;
- A process for labeling of pieces of equipment with a calibration sticker that contains: (a) date calibrated; (b) date due; and (c) calibrated by;
- Provisions for managing calibration records;
- Provisions for labeling equipment that is not calibrated (i.e., calibration not required or for reference only);
- Provisions for identification and removal from service of measuring and monitoring equipment when calibration has expired or the equipment is damaged;
- Handling, preservation and storage of equipment;
- A provision for reviewing the calibration report if an independent metrology facility is employed for calibration;
- A traceability requirement to a national standard, e.g. NIST; and
- Provisions for pursing corrective action if a piece of equipment is found to be out-of-tolerance during the calibration process, including a notification process.
In closing, thank you again for joining Dr. D and I hope you find value in the guidance provided. Until the next installment of DG – cheers from Dr. D. and best wishes for continued professional success.
- Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
- Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
- FDA – U.S. Food and Drug Administration Website. (2013, June). Warning letters. Retrieved July 5, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/