In highly regulated industries such as food and beverage, pharmaceuticals, and medical devices, coding compliance is critical. During regulatory inspections, companies frequently encounter coding compliance failures, which can lead to product recalls, fines, and reputational damage. While coding errors are often attributed to operators or printers, most compliance failures arise from systemic issues in printing technology, workflow, and data management.

Understanding these common failures allows manufacturers to prevent non-compliance and ensure traceable, accurate product coding.

What Coding Compliance Means

Coding compliance involves ensuring that every product unit meets legal, regulatory, and customer requirements for marking and labeling. Common coding elements include:

1、Batch numbers

2、Expiration or “use-by” dates

3、Lot identifiers

4、Barcodes and QR codes

Regulators inspect not only accuracy and legibility, but also traceability, documentation, and process controls.

Common Coding Compliance Failures

1. Incorrect or Missing Batch Information

One of the most frequent failures is inaccurate or missing batch/lot numbers. Causes include:

1）Manual entry errors

2）Misaligned ERP or MES data

3）Printer misconfiguration

This failure can compromise traceability and recall effectiveness, exposing manufacturers to legal and financial risk.

2. Illegible or Faded Prints

Even when the correct data is printed, legibility issues can lead to non-compliance:

1）Inks not suitable for the substrate

2）Environmental factors like humidity or heat

3）Wear on print heads or improper maintenance

Ensuring high-resolution printing and proper ink selection is essential for compliance.

3. Barcode and QR Code Errors

Barcode compliance failures are common and critical:

1）Incorrect encoding standards (e.g., GS1 vs proprietary formats)

2）Damaged or misaligned codes

3）Inconsistent placement on packaging

Errors here can break traceability links in supply chain management systems.

4. Missing Audit Trails and Documentation

Regulators often review electronic or physical records of coding operations. Failures include:

1）Lack of printed or digital logs

2）Incomplete records of batch runs

3）Missing operator verification steps

Without proper documentation, even perfectly coded products can fail inspections.

5. Inconsistent Coding Across Multiple Lines

Large facilities with multiple production lines may experience variability in coding:

1）Different printer models or settings

2）Non-standardized workflows

3）Uncoordinated data management

Consistency is essential for uniform compliance across all products.

Strategies to Prevent Coding Compliance Failures

Standardize Workflows and Procedures

1、Implement clear setup, printing, and verification procedures
2、Train operators regularly
3、Use checklists and digital guides for accuracy

Choose the Right Printing Technology

1、TIJ, CIJ, and laser printers each have strengths depending on substrate, speed, and code type
2、Ensure printers support regulatory standards and traceability requirements

Integrate Data and Traceability Systems

1、Connect printers with ERP, MES, and traceability platforms
2、Automate data transfer to reduce manual errors
3、Maintain centralized audit logs for every batch

Regular Maintenance and Monitoring

1、Schedule routine maintenance of printers
2、Monitor print quality in real-time
3、Replace worn components to prevent fading or smudging

Conduct Internal Audits

1、Simulate regulatory inspections
2、Identify potential coding failures before official audits
3、Continuously improve processes based on audit findings

Benefits of Proactive Compliance Management

By addressing the root causes of coding compliance failures, manufacturers can achieve:

1、Regulatory confidence with reduced risk of fines

2、Improved traceability and recall readiness

3、Reduced operational downtime

4、Higher product quality and customer trust

Proactive compliance management transforms coding from a regulatory burden into a competitive advantage.

Coding Compliance Requires a System Approach

Most coding compliance failures are preventable when systems, processes, and technology are aligned. Standardized workflows, integrated data management, and the correct choice of printers (TIJ, CIJ, or laser) are crucial. Manufacturers that focus on system-level solutions reduce errors, improve traceability, and ensure inspection-ready operations.

Ensure Your Coding Compliance Today

Don’t wait for a regulatory inspection to reveal coding failures. Contact our company to:

1、Audit your coding systems for compliance gaps

2、Integrate printers with ERP, MES, and traceability software

3、Standardize workflows and operator procedures

4、Monitor print quality in real-time to prevent errors

We help companies maintain inspection-ready coding and traceability with minimal operational risk.