I've run QA for a spice plant that kept everything manually for receiving/shipping as far as production was concerned (we had a basic WMS software, but it was only used for accounting). We kept receiving records on paper, recording input lots and output lots in our paper batch records, and could tie them to paper and electronic shipping records rather easily. Our most difficult blends would have 11 ingredients, iirc, which could have multiple lot codes per item, but we never had issues getting the records together for a trace in the 2 hour windows offered by GFSI or customer auditors.
Thanks GM. That's what I thought too.
The auditor gave us a NC for not contacting customer as part of a mock recall. How do I prove that contact info was verified? Does it get documented somewhere?
The mock recall aspects get a little more complicated but depends on how far you want to take it. For the purposes of a mock recall, I usually just write up a memo type document as I work, documenting the time each step being performed as I go:
Example:
12:05pm - Recall event discovered
12:20pm - Recall team assembled in meeting room
12:22pm - Product Trace initiated
12:50pm - Finish product fully traced, contacting customers
1:05pm - Customers contacted, raw material trace completed
So on, so forth, and obviously record more information in the document for each step. I've gotten away with recording the customer's contact information in the record I was keeping ("simulated contacting Mr. So-n-so" and showing the email or phone number). Auditors were more impressed with me actually calling the QA contacts of my customers, telling them that we're running a mock recall and I just wanted to verify we have the best and accurate contact information. You document that as well, taking the chance to show you've updated information if your contact is no longer there or has a different phone number.
The key is that you fully simulate everything you would do in a recall. If your production manager is responsible to verify inventory is gone, send him out to do it. If your receiving staff is responsible for getting the shipping docs to you, make them do it. And write it all up as it is happening minute to minute.
Edited by jfrey123, 16 August 2024 - 05:31 AM.