What is a Label Audit Trail? Everything You Need to Know

What is a Label Audit Trail? Everything You Need to Know

BY: CASEY SCIANO / DATE: 20/10/2022 / TOPICS: HEALTHCARE, MEDICAL DEVICE, PHARMACEUTICAL, ENTERPRISE LABEL MANAGEMENT, LABEL TRACEABILITY, REGULATORY COMPLIANCE

If you encountered a labeling error today, would you be able to confidently pinpoint how and why it took place? Unfortunately, for many companies, the answer is “no.” 

Help Me Solve Labeling Errors

Many companies have a label design and approval process that is informal, manual, and prone to mistakes. Labeling mistakes are no small issue: at least 40% of recalls published by the United States Food and Drug Administration (FDA) are due to labeling errors. For example, Van Law Food Products Inc. recently recalled Whole Foods Market 365 Organic Creamy Caesar Dressing because it contained undeclared soy and wheat allergens. Product recalls can be extremely costly, from wasted products to additional labor costs; not to mention the damage to the brand from negative press.  

So, how can you reduce the risk of labeling errors to near zero? You can set your company up for success by implementing an automated label audit trail. A label audit trail is a reliable, consistent way of documenting changes made to label designs. Maintaining an accurate label audit trail reduces the risk of labeling errors and helps pinpoint the cause if they happen. 

What is a label audit trail and why is it important? 

Audits are most associated with the accounting and tax world, but did you know audits are used by a variety of industries for a wide range of purposes? An audit trail is simply a record of changes made to an entity. When it comes to labeling, a label audit trail is an accurate and detailed record of changes made to labels and actions taken with those labels. A detailed label audit trail contains data such as: 

• Details of label design requests:  
  • When a new label design was requested 
  • Who requested a new label design 
  • Why a new label design was requested 
• Who designed the label 
• Who requested edits and why 
• Who edited the label  
• Who approved the label 
• Details of label print jobs:
  • When labels were printed 
  • Who printed the labels 
  • To which printer labels were printed 
  • The quantity of labels printed 
  • Variable data printed on the labels 

Because the label audit trail includes records of any changes made to the label design, it also supports a label version history. Using label version history, you can review the changes made over time and even revert to a previous version if necessary. 

For example, a label audit trail could tell you that Darryl requested a new label template for a new line of pre-made salads. You could then see that Judith created the first draft of the label and sent it to Sam for review. Sam sent back edit requests to include proper allergen labeling for the wheat in the croutons and almonds in the crunchy topping. Judith made the edits and Sam approved the label. You could see that Kelly printed a batch of 50 labels with an expiration date of November 1, 2022, on your Zebra ZT400 label printer. One day, the allergen statement goes missing from your salad labels! Luckily, Kelly notices before the salads are labeled. By looking at your label audit trail, you see that your new employee, Brent, made changes to the label, and Sam approved it without any edit requests. Now you can provide further training for Brent and Sam to prevent the mistake from happening again.

The benefits of a label audit trail 

Having a detailed label audit trail has numerous benefits, from improving internal processes to minimizing damage in the event of a labeling-related recall. Here are three of the most important benefits: 

• Enforced label change and approval process: A prerequisite to implementing a label audit trail is to define an electronic label approval process. This typically involves three steps: design, approval, and print, but it can be customized for your company’s needs. A defined and enforced label approval process ensures that the right people are involved in the process at the right time. It also ensures that unapproved labels cannot be printed and enter the production environment.
• Automatic label traceability: A label audit trail is an unbiased system that tracks exactly what happens with your labels automatically. You should never have to rely on memory, subjective interpretation of notes, or scribbled handwriting. With a label audit trail, the system is responsible for reporting rather than humans.
• Label error detection and tracing: If a labeling error occurs, a label audit trail makes it extremely easy to access the entire history of the affected label. Once the error is identified, it can be remedied. You’ll know exactly how many labels were affected and need to be pulled out of production for relabeling. You’ll know who made the mistake and can retrain employees in the correct procedures. Or, better yet, you can improve your label templates to remove the ability to make this mistake.

Reducing labeling errors has a ripple effect across the business, all the way to the bottom line. When fewer labeling errors are made, fewer products, labels, and boxes are wasted. Employees spend less time correcting and reprinting labels, allowing them to focus on value-added activities. Overall productivity and efficiency increase while waste and rework decrease. The result? A better bottom line.  

Is a label audit trail required for my company? 

Maintaining a label audit trail is required in certain industries. The FDA 21 Code of Federal Regulations (CFR) Part 11 labeling regulation requires medical device manufacturers and pharmaceutical companies to maintain records of their labeling process. Electronic signatures, a feature of labeling audit trail software, are required for accountability and security. 

For the food and beverage industry, while label audit trails are not required by any federal regulation, labeling accuracy is crucial. Other regulations and initiatives such as the Food Safety Modernization Act (FSMA), Food Allergen Labeling and Consumer Protection Act (FALCPA), and Produce Traceability Initiative (PTI) are in place to promote the safety of the food supply chain. Food and beverage companies can maximize their protection against labeling errors by taking advantage of a label audit trail. 

Other industries, such as chemical, aerospace & defense, and cannabis, have similar safety labeling requirements. While a label audit trail is not strictly required, the benefits of having one in place are highly valued by companies in these industries.  

Whether your company operates in a highly regulated industry or not, ask yourself: Would a labeling error ruin my day? If the answer is yes, consider implementing a label audit trail to quickly identify and fix labeling errors before they have a big impact on production.  

How do I set up a label audit trail? 

To set up a label audit trail and protect your company from labeling errors, follow these recommendations: 

• Leverage label audit trail software: Label audit trail software is specifically designed to create an automated, searchable, accurate label history. Specialized software, such as LABEL ARCHIVE label security and traceability software from TEKLYNX, meets these goals out-of-the-box.  
• Use off-the-shelf software: A useful label audit trail is electronic, searchable, and accurate. To achieve these goals, select specialized off-the-shelf software. Using specialized software is much more cost-effective and future-proof than developing new custom software or trying to retrofit another type of software to meet your label audit goals. 
• Make an investment that will pay off: Consider the potential cost of a labeling-related product recall. When you weigh the cost of software against this, the investment is an easy decision. Plus, LABEL ARCHIVE label security and traceability software is available at a low upfront cost with a subscription license. Request a price quote.  

Want to see how LABEL ARCHIVE automatically creates a label audit trail?  

Request a demo

Implementing a label audit trail just might save your company from a recall 

Now that you know what a label audit trail is and why it’s so important, ask yourself this question: Can my company afford not to have a label audit trail in place?  

TEKLYNX has years of experience implementing label traceability systems for thousands of customers. Get in touch with our labeling experts to find out how we can help you achieve your labeling goals. 

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