There has been an excellent dialog going on the LinkedIn Pharmaceutical Calibration Group on where the calibration group works best – Quality, Operations or Engineering.
The group’s real world practitioners were quick to point out various advantages/disadvantages of it being in any of these reporting chains. Since we are all striving for using the best practices, this discussion is very helpful in understanding the current thinking in the GMP environment. It’s clear from your comments that the calibration group or function can work well in any environment as long as there is:
- High level of management support
- Well trained and conscientious technicians
- Solid metrology and engineering practices
- Quality Assurance oversight
- Positive Collaboration with the other constituent groups
- Continuous education to employees and management of the role of calibration
In our ever demanding industry, it’s good to get a quick read on what others are thinking. The FDA certainly has been benchmarking the effectiveness of the position within organizations as witnessed by various 483 and Warning Letters. If you haven’t read the dialog or participated in the discussion, I encourage you to as there is much to be gained.