OK, I would think this would be easy to find, but after some research I haven't found it. I've found the requirement for 1 forward, 1 back in regards to recall procedures, but nothing nailing down what's required for trace.
My plant has "failed" our last 2 trace exercises. BOTH were due to inadequate inventory controls. First, it was a lack of properly metering in liquid ingredients to give us a baseline to account for. Second, there were qty 48 , 50lb bags missing which according to records never left, but an inventory couldn't account for them. When I was closing out the second one, the statement was made to me that "If it was a real recall, we would know where everything went and just pull up everything that shipped out to recall it. Doesn't the FDA just want us to use these exercises to show we have a system in place?" It was also stated that I'm just "picking the wrong lots to trace" so I take it with a grain of salt.
I am going to call a meeting and want to be prepared with CFR that states what's required for traceability. Can anyone direct me to either CFR, or guidance documents that might touch on this? Has anyone dealt with a similar problem?