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.

Interpretation:

Measurements are taken for product evaluation and process improvement decisions.  Depending on your medical device production process this could end up being a very complicated undertaking.  Many organization find it useful to use a third party software to keep track of calibrations and related status.  Some have also combined the calibration process with the preventive maintenance activities.  Again the level of organization depends on the complexity of the process and the degree to which measurement plays an active role.

One often overlooked requirement (which can easily be automated using 3^rd party software) is trending.  Trending helps you recognize instances where equipment accuracy is beginning to drift and using this information to predict when it will fail.  Doing this allows you to safely replace defected parts prior to actual failure.  In return this will help prevent releasing nonconforming products to the market (and hence prevent recalls).   It is common practice to evaluate the ‘life’ of a particular measuring system and incorporate this calculation into your preventive maintenance system. Knowing the interval will allow you to schedule equipment downtime in advance at regularly planned times.

If ever a piece of equipment is verified (during calibration time) and found to be out of specification it is important that your firm evaluate the safety and effectiveness of the products produced with the inaccurate measurements.  It is natural for some equipment to drift out of specification, your technician will have to recalibrate using a standard.  This out of spec reading does not automatically mean that the efficacy of the process is questionable.  For this reason some organization like to have two limits.  The first is the specification limit.  Readings inside this range are left as is.  Readings outside of this range are calibrated and brought back to read within the specification limit.  Another range often called the “Action Limit” is used to flag measurement drift passed predefined safety boundaries.  In such Action Limit occurrences an investigation with corrective action is required and a decision must be made with regards to affected product.

  *** for more extensive look ---- Download our 328 page guide to Interpretation of FDA's QSR with QSIT Reference!

Reference: www.FDA.gov

The information provided here is for "public consumption" and is open to interpretation. MedicalDeviceSchool.com is not responsible for the content or the accuracy of the information. For all official interpretation and accuracy we ask that you consult the FDA's website directly and that you consult with your legal and regulatory experts on all matters of interpretation.