Devine Guidance

Calibration

By Dr. Christopher Joseph Devine

This is the 21 st  Century and if a device manufacturer has not figured out that gauges need to be calibrated and traceable to a national standard, e.g. NIST, then the device manufacturer is probably in the wrong business. 

Dr. D hopes that all of the readers had a safe and enjoyable 4th of July. While perusing through the FDA’s warning letter database, I was astounded to find a manufacturer that was not calibrating their monitoring and measuring devices. People, this is the 21st Century and if a device manufacturer has not figured out that gauges need to be calibrated and traceable to a national standard, e.g. NIST, then the device manufacturer is probably in the wrong business. Just maybe the manufacturing of flyswatters might be a viable option.

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).

FDA Warning Letter Issued on June 20, 2013
Failure to 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, as required by 21 CFR 820.72(a). For example, your firm did not calibrate gauges, thermometers, and other devices used to monitor the (b)(4) manufacturing process for the (b)(4).
The doctor has taken the opportunity to cut-and-paste the requirement from the QSR so the readers can focus on this week’s blog. Basically, FDA, through the QSR, conveys one very clear message; “Device manufacturers must calibrate equipment (as appropriate) and collect records to support claims of compliance.”
21 CFR, Part 820.72 – Inspection, Measuring, and Test Equipment

(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.

  1. 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.
  2. 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
Let Dr. D begin by saying, the metrology house selected for calibration should be ISO/IEC 17025:2005 accredited. This requirement should not be negotiable. Obviously, device manufacturers can place the calibration requirement squarely on the backs of employees and calibrate equipment in-house. However, Dr. D has a better idea, find a good metrology lab and outsource the fun. Regardless of where the calibration is performed, device manufacturers still need an SOP to document their approach to managing calibration. As a minimum, the scripted procedure should contain:
  • 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.
If a device manufacturer decides to calibrate their equipment, calibration procedures will need to be scripted delineating the calibration process, including accuracy and tolerances for each type of gauge or equipment. As the doctor previously stated, it may be more practical to just outsource the calibration. If outsourcing is selected as the preferred process, make sure you review the calibration report for accuracy and trends versus previous calibration cycles. 
Takeaways
For this week’s guidance, Dr. D will leave the readers with two takeaways. One – it is much easier to outsource calibration to a competent and ISO/IEC 17025:2005 accredited lab. However, if your organization decides to tackle calibration (in-house) then equipment and gage-specific calibration procedures will be required. Two – Regardless of the approach pursued for calibration (in-house versus outsourced) device manufacturers are still required to script a procedure defining the approach to calibration.

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. 

References: 
  1. Code of Federal Regulation. (2012, April). Title 21 Part 820: Quality system regulation. Washington, D.C.: U. S. Government Printing Office.
  2. Devine, C. (2011). Devine guidance for complying with the FDA’s quality system regulation – 21 CFR, Part 820. Charleston, SC: Amazon.
  3. FDA – U.S. Food and Drug Administration Website. (2013, June). Warning letters. Retrieved July 5, 2013, from http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/

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About The Author

Dr. Christopher Joseph Devine, President, Devine Guidance International