The concept of equipment calibration is an important one throughout FDA and ISO requirements. ISO 9001, section 7.6 discusses it in a broad sense, while ISO 17025, “General Requirements for the Competence of Testing and Calibration Laboratories”, is specifically about calibration. In 21 CFR 820.72, it’s stated that “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.”
When creating a calibration program, there are 5 steps to consider:
- Say what you do. This entails writing down the process(es) as a procedure a calibration on all necessary equipment. If a piece of equipment requires calibration, it will require recalibration on a scheduled basis.
- Do what you say. What this translates to is to actually use the above mentioned procedures to perform the calibration(s).
- Record what you did. It is imperative that you write down the calibration information: as-found, as-left, and a standard reading from the calibration. Without capturing these details, there is no proof that calibration was performed nor would you have the historical information for comparisons.
- Check the results. Use this step to verify the tolerances were met, the standards used were not overdue for calibration, and that the correct calibration intervals were adhered to. This is the point where you would identify when the next calibration is due.
- Act on the difference. If the precision limits were not met, remedial action must be taken to reestablish the limits and evaluate if there were any adverse effects on the quality of the device.
The integrity of the test results, and the process of performing these tests through the use of calibrated equipment is a fundamental requirement enforced by FDA and other regulatory bodies. This will be strictly enforced during any regulatory inspections.
The equipment that is utilized for inspection, measuring and testing must be protected from damage. This is to ensure that it functions correctly and accurately. All equipment must be calibrated to a recognized standard, such as NIST. The calibration stickers on your equipment should contain basic information: date calibrated, calibration due date, the signature of person performing the calibration, and the equipment identification number.
Should your company decide to outsource your calibration activities, make sure the supplier meets these requirements:
- An accredited facility to ISO 17025
- Audited by your company as part of your supplier management program
- Listed on your Approved Supplier List
- Trained to your procedures and/or requirements
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