Hi All,
If a piece of equipment is calibrated and at the next interval it is found to be out of calibration, does that affect the equipment validation? What about the entire validated manufacturing process?
Much Thanks,
Steve
Depends. If you have shown that the system operates correctly when the equipment is validated, then you may be able to make the risk-based case that re-validation isn’t required.
The bigger issue is, of course, what sounds like a case of product being made with equipment out of calibration. Your calibration controls procedure should kick in and you should do a risk analysis of the product made since the last known (good) calibration date. It might also be an indication that more frequent calibration is required or periodic tests to confirm the equipment is in calibration.
And then, of course, part of maintaining the system in a validated state is ensuring that calibrated equipment used in the system is always producing correct results so you probably need to do some kind of analysis on the failure to determine why the situation wasn’t identified immediately (presuming it wasn’t) and take appropriate corrective actions.
As Yodon stated, it depends.
One of the items you review during periodic review (which is what is required, not necessarily re-validation), is that you access the equipment, to ensure that it is still in a controlled/validated state.
So, if you see a trend of calibration being off or too many (that’s interpretive) deviations from calibration, this current instance is of concern. If this is the first time, then you can take the wonderful stroll of risk management and conclude that it does not.
Of course, you would need to open a deviation/NCR to address the current OOS.