Need help creating a Label Control SOP

Hi everyone,

I was hoping to get some help in creating a Label Control SOP. Any templates are welcomed. I work for a company that mainly does ready-to-eat products like creamers, lattes, coffee, etc. I'm fairly new to QC and was hoping to get some insight on what a Label Control SOP would consist of. Would it be more towards checking labels being used during production are accurate towards the product being produced or checking labels to ensure compliance with FDA. Any help is welcome, thanks in advance. :)

Two main parts needed.

1. Labels compliant with regulatory (FDA, USDA, etc).  This depends on the products, pack type, and destination or region of distributing / sales.
   1. Requires involvement with different departments, such as quality and R&D to review and approve labels.  Some labels require regulatory approval (typically USDA labeling).  However, if you deal with dairy / milk products this can apply as well depending on the state (location) you operate.
2. Verify the correct labels and versions of the labels used in production.
   1. Can be a visual check and verification of the label against the "approved label".  Usually, this is done at label receipt and prior to use on the packaging line.

In your SOP you would need to identify who is responsible for what, the steps for each part, scope, frequency, records / docs, and what to do in the event you are out of compliance (corrective action).

Hi Lynette,

Welcome to the wacky world of QC. 

I recommend starting with two checkpoints, which I will explain next. Meanwhile, collect as much data (incident history), and observe the process for vulnerabilities. 

First checkpoint upon receiving because:

1. the labels are all in one spot
2. it allows the greatest amount of time to replenish if you need to return any unacceptable labels
3. decreases risk of unapproved labels being used 

Priorities: legal requirements are met and traceability. Allergen recalls are quite common simply due to mislabeling. If you think a label mock recall would be a disaster, add quantity and lot number to the label receiving sheet. 

Second checkpoint during production because:  

1. opportunity to confirm what product is inside and rework if mislabeled
2. easy to scan for product uniformity, quality issues
3. verify your adding correct lot code/expiration date

There might be opportunities to add something to production related documentation here. 

Happy to help if you have additional questions!