FDA Requirements for traceability

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?

You don't need to reference the FDA to show or illustrate you have a problem.  There are systemic inventory control issues highlighted by the two traces and mass balances you conducted.

Try to show it in sum of dollars or time involved.  If you cannot account for all of the specific item in question you have to broaden your recall if it were a real recall based on that item.  In the second example, 48 bags (50 lbs) are missing where did they go?  If you can't answer that, guess what?  You have to recall all the products you use that ingredient in of all the batches you have made with that ingredient since the date you received that lot (that is if you can account for the date you received it).  How much does that cost versus a specific batch of product?  Do the math and show the group of those involved.  It will open their eyes quickly....people don't think about this until it is too late when they have an issue.

Thanks Ryan, that's a good point. I'm trying to work it for my audience though (plant manager) and the only thing that works for him is black and white CFR. The money issue with a recall costing more isn't going to work as an argument because we run continuous batch and realistically if there was a recall of our product there is a HIGH probability that everything produced in the 10 day run would need to be recalled, we even state that in our recall policy.

I have decided however to take your approach with focusing on the money lost to incorrect inventory. I am going to push a digital system our sister company uses (who claim they can track every input down to the pallet of final product). That would kill two birds with one stone for me. No matter how I look at it, without a semi accurate inventory, there will be no way to perform a passing trace exercise.

I agree with Ryan. You don't need to reference the FDA for a black and white CFR statement. Clearly, there is evidence that you cannot fully trace your ingredients/products. It doesn't matter if the FDA has an explicit statement or not; if you can't find things, then your recall scope widens. 

I might suggest just as a side exercise, to have your plant manager basically do a trace of material, and show you that they can "just pull up everything that shipped out and recall it". You should also ask them what the right lot to trace would be if you have a recall. That line of thinking just doesn't cut it. 

I think to some degree a lot of us feel a similar crunch. Places I've worked have always had ERP systems, but never used them to their fullest functionality. This often lends itself to manually calculating, and physically walking inventories. We always knew our deficits though; and in cases where we knew we wouldn't be able to account for everything (fully enclosed systems with shared piping or mixed receipt loads), we knew we'd be recalling quite a lot of material and wrote our plan as such.

Referring back to the OP, is the conclusion then that FDA do not offer any specific traceability requirements ? Seems improbable.

Charles,

I also felt that was an improbability, but I have yet to find any information to the contrary. The bio law is the last law that had some black and white info on recalling one forward one back, and the FSMA laws 'touch' on what's required, but I was hoping for something with requirements in regards to traceability.

I have yet to find it.

I did however take a different tack to prove we needed to improve. It would have been a stronger foundation with some black and white Current Federal Regulation backing it.

3rd party systems like SQF 2.6 have their own traceability requirements as well. Not conforming to those can lose your certification.

If you want, below is a direct link to the draft guidance that FDA released on this past October 4th concerning guidance on developing a recall plan.  It might be of use.

Download Draft guidance: https://www.fda.gov/...100002/download

21 CFR 1117.139(b)(2) is the actual requirement that requires recall effectiveness checks.

Good luck.  As long as food safety is seen as a cost and not a core principle of a business, we will all have (sometimes frustrating) jobs.

Todd