Now viewing: qualification and validation

Bruce Wold
By Bruce Wold
Wednesday, September 21, 2011 - 21:09

Image previewThis entry is primarily based on the IQ (installation qualification) portion of any process validation. 

One area that we have found to be most important on any process is the validation of the installation of any given process.  All equipment used to manufacture a product needs to be validated and most importantly should have its own procedure and documentation identifying how the equipment should be set-up every time the product is run.  A quick example of this is the hose length of a simple mold heater.  This hose length is an example of how a process can change simply by adding 1 extra foot of hose length to a heater.  All peripheral equipment should always be accounted for when creating a repeatable process.