Operational definitions and there proper use

GOOD VALIDATION PRACTICE (cGVP) GENERAL VALIDATION AND cGMP DEFINITIONS
1

Describing a device or operation can be a bit confusing for both the writer and the reader. An activity contained within the confines of time and space must be clearly defined especially when the desired or expected result is the object of the input or action. When following an instruction that directs you to toggle a switch to the “On” position; what do you do if the switch is already toggled to the “On” position? Some might say…“toggle it Off then on”.

Well, if it’s not written down, it didn’t happen…right!

Let’s do a better job with our “Operational Definitions”!

2

Agreed. We try to be very meticulous in setup to ensure that these situations don’t occur. If we have a case where we tell the operator to move the switch to the on position, we make sure that the setup confirms the switch is in the off position. Either that or a caveat in the procedure when it’s not critical; e.g., switch it to the on position if it’s not already there.