CFR 21 Part 820.72--Have you heard of "Once Only Calibration”?
Has anyone every come across the concept of “Once Only Calibration”? My calibration department currently takes this approach with certain gages and custom fixtures that are deemed to be inherently stable. For example, steel rulers are calibration before they are commissioned into production, it is the equipment owners responsibility to ensure that the rule is fit for use thereafter. No periodic calibration or no exit calibration is performed if and when the steel rule is made inactive. Another example would be, a glass reticle for the eye piece of a microscope – the parameters on the reticle are calibrated, reticle is installed in the microscope and the magnification set-up for the microscope is calibrated periodically, however the reticle is never checked again.
I’m concerned that this practice would not stand up to the full rigors of an audit particularly when one reads CFR 820.72(a) “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 it accuracy and fitness for use are maintained."
Any comments / feedback would be much appreciated.
Has anyone every come across the concept of “Once Only Calibration”? My calibration department currently takes this approach with certain gages and custom fixtures that are deemed to be inherently stable. For example, steel rulers are calibration before they are commissioned into production, it is the equipment owners responsibility to ensure that the rule is fit for use thereafter. No periodic calibration or no exit calibration is performed if and when the steel rule is made inactive. Another example would be, a glass reticle for the eye piece of a microscope – the parameters on the reticle are calibrated, reticle is installed in the microscope and the magnification set-up for the microscope is calibrated periodically, however the reticle is never checked again.
I’m concerned that this practice would not stand up to the full rigors of an audit particularly when one reads CFR 820.72(a) “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 it accuracy and fitness for use are maintained."
Any comments / feedback would be much appreciated.