Traceability and Recalls

Keeping lot and traceability records, and maintaining the ability to perform recalls is really hard on paper – it’s time to consider a system designed for this purpose that will make the task simple and easy.

In today’s regulatory environment, you need to be able to perform recalls quickly and accurately. If you have tried keeping lot and traceability records on a paper and by using an excel system, you know that this is a painstaking and error-prone process.

Does the following sound familiar (and painful)?

• Look through paper inventory receipt records to find the date a recalled lot was received from your supplier.
• Look through paper production records starting with the date receipt and by pulling all the batch records impacted by that lot.
• Scramble to identify the last batch created using a lot, and whether there is still any on hand. Run out to the warehouse to physically confirm.
• Look yet again through your paper shipping records to figure out which customers you shipped each contaminated lot/batch. If you are a pick-and-pack operation with thousands of shipping records this becomes a nightmare.
• Sort and organize all the customer shipping records by customer. Make a list for each of them of the potentially impacted batches.
• You are finally ready to start calling/emailing your customer, filled with uncertainty that your lists are complete and accurate :(

All of this, of course, assumes that you accurately recorded lot numbers on your batches and shipments. If not, you are left to make assumptions based on the range of dates the product was used, and when you produced the product you shipped to your customers.

For an organization of any size and complexity it is impossible to do this in the limited time required by the FDA and other auditors.

The good news is that a bit of timely record keeping and a system designed with traceability and recall capability in mind can make this process completely painless, and can take under 60 seconds. The best part? This is a seamless side-effect of keeping your regular receiving, manufacturing, and shipping records.