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Labeling audit template

Labeling audit template

A systematic tool for evaluating product labeling compliance with regulatory requirements and internal standards to prevent costly errors and recalls.

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Labeling audit template

A systematic tool for evaluating product labeling compliance with regulatory requirements and internal standards to prevent costly errors and recalls.

Use this template with Lumiform

  • Customize this template or build your own
  • Fill out templates via mobile app
  • Get reports and analyse your data
Prices start from ░░░ per month
Book a demo
Learn more
or Download template as PDF

A labeling audit template is a structured inspection tool that helps you systematically evaluate product labels for compliance with regulatory requirements and company standards. This digital checklist guides you through a comprehensive assessment of your labeling practices, from verifying required information and formatting to examining approval processes and documentation systems.

According to the FDA, proper labeling compliance is crucial for ensuring that product information is “truthful, not misleading, and compliant with federal regulations”. With increasing regulatory scrutiny, this template helps you catch costly labeling errors before products reach the market, preventing recalls, penalties, and damage to your brand reputation. We designed this template to transform tedious paper-based audits into a streamlined digital process where you can document findings, capture photo evidence, and assign corrective actions directly from your mobile device.

Related categories

  • Operational excellence templates
  • General templates
  • Manufacturing templates
  • Templates for manufacturing processes

Created by

Author Name Inioluwa Ademuwagun
Preview of the template
Entity
Labeling Processes
Are labeling procedures documented and followed consistently?
Is the labeling process validated and reviewed periodically?
Are labeling responsibilities and approvals clearly defined?
Labeling Accuracy
Are labels checked for accuracy against approved artwork/specifications?
Are there checks to ensure accurate translation of multi-lingual labels?
Are label change controls effective to prevent mix-ups?
Regulatory Compliance
Do labels comply with all applicable regulations?
Are there processes to stay up to date with labeling regulations?
Are there controls to ensure regulatory labeling statements are current?
Corrective Actions
Are there processes to investigate and address labeling issues?
Are corrective and preventive actions documented and tracked to closure?
Are labeling lessons learned communicated and implemented?

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Tailored audit template for label accuracy, completeness, regulatory compliance, and traceability
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Label Checks Template
Tailored to the person searching and their labeling process. Includes items for verifying label content, placement, legibility, and regulatory compliance.
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Related resources

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Topic guides

Read in-depth guides covering key topics related to this article.

Final inspection: Your complete guide to flawless productsAdvanced Product Quality Planning (APQP): A detailed guideLayered process audit (LPA): A complete guide to mastering product qualityA beginner’s guide to product development 
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Frequently asked questions

Who should be responsible for conducting labeling audits?

Ideally, labeling audits should be conducted by quality assurance personnel or compliance officers who understand regulatory requirements but aren’t directly involved in the labeling process. This ensures objectivity and fresh perspectives. For smaller organizations, consider rotating responsibility among trained staff or occasionally bringing in external consultants to provide unbiased assessments.

How can I use the labeling audit template to improve our compliance program?

Use the template to establish baseline compliance metrics by conducting initial comprehensive audits. Then implement regular scheduled audits, track findings over time, and analyze trends to identify systemic issues. The template’s structured approach helps create consistency across multiple auditors and facilities while providing documentation for continuous improvement initiatives.

How can digital tools enhance the labeling audit process?

Digital tools transform labeling audits by enabling real-time data collection, photo documentation of issues, automatic report generation, and easier tracking of corrective actions. With Lumiform’s mobile app, you can conduct audits on-site, instantly share findings with stakeholders, set automatic reminders for follow-up tasks, and also analyze trends across multiple audits to drive continuous improvement.

Author
Inioluwa Ademuwagun
Inioluwa is a freelance content writer with a passion for words and everything marketing. She has worked closely with B2B SaaS and e-commerce brands creating product-led content. She loves to read fiction and would describe herself as an introverted nerd who desires to travel around the world. She currently doing that with her words till she can with her eyes
This template, developed by Lumiform employees, serves as a starting point for businesses using the Lumiform platform and is intended as a hypothetical example only. It does not replace professional advice. Companies should consult qualified professionals to assess the suitability and legality of using this template in their specific workplace or jurisdiction. Lumiform is not liable for any errors or omissions in this template or for any actions taken based on its content.
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