The Food Safety Modernization Act (FSMA) is transforming the food safety system of the United States. However, companies in the food and beverage industry may still have inspection and compliance questions. While the policy itself is still being tweaked, the new requirements from the U.S. Food & Drug Administration (FDA) will almost certainly mean more citations for food safety violations and an increase in the number of product recalls.

It’s rare that a day passes without at least one media report of a food-related product recall, putting product quality and public health risks under the spotlight. And while the average person is blissfully unaware of how many recalls are in the system, all of that information is available on the U.S. Department of Agriculture recalls website or FDA’s recalls website for any curious consumer to access.

Common wisdom dictates that we can all learn from the mistakes of others. Taking other food and beverage industry challenges into account, here are some ways that industry manufacturers can avoid costly errors, improve product quality, and better protect consumer safety.

Avoid Problems with Your Hazard Analysis and Critical Control Points (HACCP) Plans
Problems with required HACCP plans are rampant among food manufacturers, racking up hundreds of violations in the past few years alone.

In fact, the lack of a written HACCP plan is a major source of citations in this category, as are:

  • Incomplete listing of food safety hazards
  • Incorrectly identifying CCPs
  • Improper identification of critical limits
  • Not validating the HACCP plan annually
  • Avoiding implementation of monitoring, record-keeping, and verification procedures listed in the plan

Identify Maintenance Issues
FDA hands out dozens of violations over building and equipment maintenance every year. Top issues include:

  • Failure to maintain buildings and fixtures in a sufficient manner to prevent adulteration
  • Lack of cleaning and proper maintenance of equipment, containers, and utensils
  • Inadequate plant construction, limiting the proper cleaning of floors, walls, and ceilings
  • Improper plumbing and drainage, including drip and condensate hazards

Review Your Instruments
Frequently, FDA violations are the result of improper function, monitoring, and upkeep of equipment and instruments. Key areas to monitor include calibration and maintenance of analytical instruments and equipment, as well as periodic review of calibration records.

Keep Your House Clean
It will come as no surprise that poor sanitation practices are a huge source of problems in the food manufacturing industry. Common violations here include:

  • Failure to maintain sanitation via regular cleaning of buildings and facilities
  • Improper cleaning of utensils and equipment, including where equipment design prevents effective sanitation
  • Not providing adequate handwashing processes, including sanitizing agents and water of a suitable temperature

Get Rid of Pests
Pests such as mice and other rodents have been behind some of the biggest food safety disasters in recent memory, including the widespread peanut butter contamination in 2009 that sickened hundreds, led to nine deaths and imprisoned the company’s CEO.

Common citations in this category include:

  • Lack of effective pest extermination
  • Improper storage of equipment 
  • Ineffective waste removal processes that may attract and harbor pests
  • Contamination due to pesticide use

Develop an Effective Corrective Action Plan
Many companies received citations last year over problems with corrective action planning and documentation. Having a corrective action plan that doesn’t actually correct problems or prevent unsafe products from entering the market is counterproductive on every level. Fundamentally, many have been cited for inadequately documenting corrective actions.

Establish Specifications
Specification management issues are another frequent source of FDA citations. Top mistakes made by food and beverage companies include not establishing specifications for elements like purity, labeling, packaging, and components. Many companies also fail to even verify that finished products meet federal regulatory or compliance specifications.

Keep Records
?Record-keeping may seem like a minor issue, but it’s something that is sure to come up during on-site inspections. Easy-to-avoid pitfalls include failure to provide complete information on:

  • Batch records
  • Test results
  • Processes that ensure key product specifications are met
  • Packaging and labeling processes
  • Sanitation control records that document monitoring activities and corrective actions
  • Written procedures for complaint management, quality control, and laboratory operations

Monitor Constantly
Effective monitoring practices are vital to the overall food safety and quality process. Typical monitoring issues include:

  • Monitoring frequencies listed in the HACCP plan don’t ensure compliance with critical limits
  • Incomplete records verifying that monitoring keeps values within critical limits
  • Not monitoring sanitation conditions and practices frequently enough

Reduce Improper Storage
Storage violations are rampant in food manufacturing. Routine violations include improper storage of:

  • Sanitized equipment
  • Personal belongings
  • Toxic cleaning compounds
  • Finished foods

The Devil is in the Details
While there are thousands of tiny details to manage throughout the food safety process (including the supply chain), there is a simple way to minimize or avoid problems and the potential for regulatory violations. The answer is quality management software.

With more food and beverage companies now increasing investment in production facilities—an effect of FSMA—automated food safety software integrates the tools you need to manage issues like the HACCP plan, corrective action tracking, risk management, compliance tracking, and audits.

At the end of the day, food safety should be a priority for every producer, regardless of size or resources. Compliance with government regulations is something that food and beverage companies should have in mind from day one because, if you can tie together all of these details, you’re in a better position to reduce risk in your processes overall. And if you don’t make consumers sick, then you are arguably on the right quality journey.

ETQ provides quality and safety software solutions for food and beverage companies. Learn more at