I am testing all incoming raw materials before releasing it to be used in finished product as part of a new supplier qualification program I am trying to establish. This has not been done prior to my Direction as head of QC, so I have no trending history to base my decisions on for any anomoly I might encounter in testing.
Some of our raw materials are failing specification for pH and Particle Size (as an example), whereas within formulation would typically pass; however, I want to be wary of "order of addition" issues and know that sometimes the raw material result can count as much or more than the final pH.
I do not know how to proceed for these raw materials that are not passing spec and whether or not I should "release" them? Based on histroy, our finished product has never been rejected or had failures to do pH or Particle size... and obviously I cannot change the specification for particle size as that is set by federal guidelines (recommendations).