Give Attention to Equipment Calibration Certificates
April 30th, 2013 // 4:40 pm @ jmpickett
Updated Daily – Read our latest FDA, cGMP Compliance News
FDA has noted recently that many medical device companies are not checking the quality of finished devices after learning that equipment was not calibrated properly.
Many manufacturers contract out activities such as calibration. So, what can happen is that companies just accept calibration certificates from a test house. A test house is a 3rd party that is used by device companies to make sure that equipment used for inspection and testing is calibrated and maintained right.
Calibration certificates are delivered to companies that describe the equipment condition after the test house received it, and also the condition after it was sent back to the manufacturer.
There have been situations where the test house returned equipment to the manufacturer and the certificate just said, yes this item was not in proper calibration and it has been recalculated.
The question to the company is, what was done with this data? Now you know that there was finished product sold during a time when the instrument was not calibrated right.
The device company should check to make sure that equipment did not have any adverse events involved.
Also, certificates from test houses specify the type of calibration method that was utilized. Such methods usually will tie into standards from ISO, ANSI and A2LA.
Note that FDA mandates testing and calibration of equipment under QSR Section 820.72, and Section 820.70(g).
Equipment for manufacturing and instruments used for testing and inspection can be just a ruler, a voltage meter, complex test equipment that has software. But all of them require a high degree of accuracy and need to be calibrated.
All of the equipment you use in processes must be appropriate for the job you are doing and you must be sure that it is maintained, cleaned and adjusted regularly.
You also can opt to have representatives from test houses come to your facility to calibrate the equipment if it is too large to be moved.
Having your equipment properly calibrated is essential to maintain quality and to minimize the chances of FDA 483s and cGMP violations.
