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.
You know that 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 probably think it’s difficult and time consuming.
Does the following sound like a scary but familiar process?
Dig through receiving records to locate the date of when the recalled lot was received.
Dig again through production records starting with the date receipt and by pulling all the batch records impacted by that lot.
Scrambling to figure out what was the last batch created using that lot, and whether there is still any on hand. Run out to the warehouse and search for it.
Dig yet again through your shipping records to figure out which customers you shipped to. 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, filled with uncertainty that your lists are complete and accurate.
All of the above assumes that you actually 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.
You will know, if you have tried this, that 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 recalls in mind can make this process completely painless, and can take under 60 seconds (if you don’t believe it fill out this form and we will be happy to show you). The best part? This is a seamless side-effect of keeping your regular receiving, manufacturing, and shipping records.