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The role sampling plays in meeting U.S. FSMA guidelines

Posted by AJ Naber on 3/17/16 10:46 AM
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FSMA Current Good Manufacturing Practices CGMP

In the U.S. regulatory world, the big news in 2016 is the implementation of the hazard analysis and risk-based preventive control (HARPC) provisions under Section 103 of the U.S. FDA Food Safety Modernization Act (FSMA). Food and beverage producers and processors have known this was coming, as FSMA was signed into U.S. law in January 2011. Now, the regulations implementing HARPC have been issued.

Prevention instead of reaction is key

FSMA represents a significant amendment to the longstanding Current Good Manufacturing Practices (CGMP) framework. It moves from a reactive approach to food safety that involved responding to issues to a preventative framework that puts great responsibility on the food industry to proactively identify potential food safety risks and counter those risks before harm occurs.

The core obligations of HARPC require covered food facilities to conduct hazard analyses and, when necessary, implement risk-based preventive controls. More specifically, this requires a covered facility to:

  • Identify known or reasonably foreseeable hazards that may be present in the food handled at that facility (including biological, chemical, and physical hazards).

  • Implement risk-based preventive controls at the critical points within the process for hazards that require such a control to significantly minimize or prevent them to ensure safety of the food.

  • Develop and implement effective monitoring procedures for the controls.

  • Establish written corrective action plans if preventive controls are found to be ineffective.

  • Create and implement verification steps to ensure that the preventive controls, monitoring and corrective action plans are all functioning properly.

  • Record, document and maintain food hazards and process control systems for no less than two years.

  • Re-analyze the food safety plan at least once every three years and sooner if made necessary by production changes.

Most companies, except for those defined in the HARPC rule as “small” or “very small,” must comply by Sept. 19 of this year. Given the complexities of the rule, companies are, or should be, immediately working on their food safety plans in order to meet the compliance deadline.

For food processors, some key requirements include:

  • Covered facilities must establish and implement a food safety system that includes an analysis of hazards and risk-based preventive controls. A rule regarding oversight and management of preventive controls provides flexibility in ensuring that preventive controls are effective and correcting problems that may arise. Preventive controls include monitoring, corrective actions, and verification.

  • Manufacturing/processing facilities must have a risk-based supply chain program for those raw material and other ingredients for which it has identified a hazard requiring a supply-chain applied control. Covered food facilities are responsible for ensuring that these foods are received only from approved suppliers, or on a temporary basis from unapproved suppliers whose materials are subject to verification activities before being accepted for use.

  • CGMPs are updated and clarified, with some of the previously nonbinding provisions, such as education and training, now binding. Management is required to ensure that all employees who manufacture, process, pack or hold food are qualified to perform their assigned duties. Such employees must have the necessary combination of education, training, and/or experience necessary to manufacture, process, pack, or hold clean and safe food. Individuals must receive training in the principles of food hygiene and food safety, including the importance of employee health and hygiene.
  • The FDA’s longstanding position that CGMPs address allergen cross-contact is now explicit in the regulatory text.

Learn more about the guidelines at

These guidelines make specific several systems and procedures that many food and beverage processors already have put into practice.

Automatic sampling within a process line can automate preventive verification of critical process controls.

Automatic sampling ensures a composite sample can be easily and safely obtained with no direct involvement from an operator. This ensures the integrity of the sample and increases efficiency over manual sampling, since the production line can continue on without downtime.

Rather than a hand scoop or shovel, an automatic sampler provides a truly representative sample for analysis. Because analysis data then are based on reality and accurate, plant management can make important decisions about the process with confidence.

Sample automation within a process assures that food and beverage processors can better meet the stringent requirements of the HARPC provisions and ensure product quality and safety.

Learn more about our food and beverage sampling solutions here.

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Topics: Food & Beverage

Written by AJ Naber

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AJ likes all kinds of foods and beverages. Not only interested in consuming them, he also offers expertise in engineering and installation of process systems for the dairy, food, beverage and brewing industries.