Preventive Controls Guidance

What are Preventive Controls ?

Preventive controls are part of a robust food safety management program that allows for a properly trained team to protect the food supply and the consumer. Some of the tools may include process preventive controls, allergen preventive controls, sanitation preventive controls, supply chain preventive controls. The concepts of preventive controls can be used on almost any food manufacturing, packaging, storage or distribution system.

Products that fall under preventive controls are:

  • Ready to eat meals,
  • Peanut butter,
  • Power bars,
  • Produce,
  • Most regulated FDA food products .
    (Please contact us for the complete list).

 

If a product is produced and distributed only in a single State they can choose between a HACCP plan and a PC Plan but since the product is not crossing State lines it is regulated by the State government. Certain products have their own regulations – just to name a few: seafood, juice, USDA regulated products, and low acid canned foods.

 

Why set up Preventive Controls ?

The beginning of the Preventive Controls Manual states:

“The Current Good Manufacturing Practice, Hazard Analysis, and Risk based Preventive Controls for Human Food regulation (hereafter referred to as the Preventive Controls for Human Food regulation) was published on September 17, 2015 and is intended to ensure safe manufacturing/processing, packing and holding of food products for human consumption in the United States. The regulation requires that certain activities must be completed by a “preventive controls qualified individual” who has “successfully completed training in the development and application of risk‐based preventive controls at least equivalent to that received under a standardized curriculum recognized as adequate by FDA or be otherwise qualified through job experience to develop and apply a food safety system.”

The ultimate goal is to have a set of repeatable guidelines that keep our food supply safe. There are exemptions to the rule, but the overall methodology is to have a checklist to make sure we are looking at every potential hazard that is reasonably likely to occur. So you will see similar terms as we are building preventive controls:

  • Hazard
  • Controls
  • Monitoring
  • Training
Every food safety plan starts with a foundation of Good Manufacturing Practices (GMPs), Standard Sanitation Operating Procedures (SSOPs), management commitment, education and best practices. We can also include good agricultural practices and good distribution practices, along with other programs that help keep a clean environment for the processing and logistics of food manufacturing.
 
Preventive Controls provide a system intended to be more flexible but, as always, making sure products are produced safely.

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PC Process

Instead of just developing a Food Safety Plan, including determining where the controls are food safety plans are facility specific and projects and can be grouped based on hazards and similar control points.

As the curriculum states: Preventive Controls are needed, this involves a systematic process based on science to help ensure the safety of the product.

  • It starts with hazard analysis which is intended to identify the hazards mentioned above and prevent foodborne illness. When we are looking at the hazards requiring a preventive control, we are looking at the ones that matter most for food safety.
  • When these hazards are known and identified, preventive controls that are essential to prevent the hazard from causing illness or injury are put into place.

What is DIFFERENT about Preventive Controls than a normal HACCP plan is that Preventive Controls may include process preventive controls, allergen preventive controls, sanitation preventive controls, and supply chain preventive controls.

When HACCP was first introduced it was a way to ensure that products leaving a facility were safe and “reasonably likely NOT to cause injury or illness.” HACCP works and is still utilized by regulatory organizations locally and globally. When The Food Safety Modernization Act was published, the decision was to have a focus on the same things that HACCP did – preventing food borne illness – but has a broader base to it with more tools and a slightly different way of looking at a food safety plan and implementation.

Once Preventive Controls are identified, you need to determine relevant parameters that define the conditions that must be met to effectively manage the hazard. Monitoring provides documentation that demonstrates these conditions are met. Corrective actions or corrections are predefined to enable swift action when things go wrong, thus preventing expansion of a potential food safety issue. When things go wrong, you also have to ask if it was because a hazard was overlooked (in which case you must adjust the hazard analysis), or if a preventive control was not properly identified or implemented. All of the above is recorded and verified to ensure the system is operating as intended and to provide a record for others (e.g., inspectors, auditors, management) to show that this is the case.

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