3.9.4 Traceability & 3.12.8 Withdrawal/Recall

Good Morning All,

I have a query in regards to Traceability (Clause 3.9.4) & Withdraw / Recall (Clause 3.12.8)

I am in-charge of testing our withdrawal procedure as well as our product traceability. 

3.9.4 - Must be completed from raw material to finished product and vice versa, at least on an annual basis. 

3.12.8 - The withdrawal procedure shall be tested, at least annually, in a way that ensures it's effective operation.

We have controlled procedures relating to both of these but when it comes to testing the systems, I'm struggling on how many tests need to be conducted.

In recent years the Traceability has been tested (mock) to a couple of product groups (Raw > Finished, Finished > Raw), and the same with Withdrawal/Recall.

Do we need to be completing these mock tests on all product groups? i.e.

Traceability

Raw > Finished = Greaseproof // Greaseproof // Sheeter // Paper Sack

Finished > Raw = Greaseproof // Greaseproof // Sheeter // Paper Sack // Merchant

Recall / Withdraw

Raw > Finished = Greaseproof // Greaseproof // Sheeter // Paper Sack

Finished > Raw = Greaseproof // Greaseproof // Sheeter // Paper Sack // Merchant

if the above is correct, that would mean 18 tests need to be completed annually. Or is the test more to check the system (not as intense as every product group) and we'd get away with choosing a couple of products per year? (raw > finished, finished > raw Traceability & Recall/Withdrawal = 8 mock tests per year max)?

We haven't had a BRC NC on this in the past, but for some reason I'm reading the standard that ALL raw materials have to be traceable (3.9), so that means all finished product groups need to be tested?

Any knowledge on this topic would be greatly appreciated.

Dear Sim,

We need to conduct traceability from RM to FP and vice versa atleast annually for all the product type and pack type, mock withdrawal/recall can be conducted on any one major product, and Where appropriate, the verification of the effectiveness of the system is expected to include the reconciliation of quantities of end products with the quantity of ingredients/raw materials as evidence of effectiveness.

Regards

Mahantesh

Your Recall/Withdrawal procedure depends on your Traceability procedure.

A mock Recall/Withdrawal test will check your entire system:  raw materials --> finished product --> customer.  So it is not necessarily doing 8 different tests - it is one test of various system elements.

It is more a matter of finding out where things were used or sentt:

Bad Product - all in inventory, any at the customer, customer sent any to the public market, or any other customers impacted?

Main focus is communicating with the customer(s) - one step forward.

Bad Raw Material - any on order, any in inventory, or any in other finished products (go back to Bad Product step)

Main focus is communicating with suppliers - one step back.

Verifying the problem - may need to inspect finished product and/or raw materials to confirm the extent of the problem.

Notify the proper authorities (FDA, etc.) depending on the severity of the problem.