The Food Safety Modernization Act isn’t a single document that was fully formed when signed into law in 2011. Instead, the act consists of a series of rules rolled out over the past decade, each covering a specific area of food safety, from rules for importers to others covering third-party auditors and the sanitary transportation of foods. The cornerstone of the new rules, the Preventive Controls Rule, mandates a comprehensive evaluation of the specific processes food companies use to make their products, and the identification of solutions to deal with any reasonably foreseeable hazards. The analysis and application of preventive controls must be completed for every facility registered with the FDA.
This blog from ImEPIK reviews each of the following steps a facility should take to comply with FSMA’s Preventive Controls Rule:
- Train employees
- Analyze hazards and implement preventive controls
- Document and manage preventive controls
- Develop a recall plan
Training’s Role in a Successful Food Safety Plan
FSMA sets training and education standards for facility personnel. Therefore, management must ensure that employees who process, pack or hold food are qualified to perform the duties that fall under their job description.
Employees must have the education, training, and/or experience to manufacture, process, pack or hold food that is clean and safe. Training like ImEPIK’s PCQI Online should cover the principles of food hygiene and food safety and how to use current Good Manufacturing Practices to highlight hazards.
Although there are some exemptions, companies must employ a Preventive Controls Qualified Individual (PCQI) who has been trained to develop and apply risk-based preventive controls, or who already has the job experience required to build a food safety system. This individual must develop the facility’s food safety plan or closely oversee its preparation. PCQIs are also responsible for validating that a facility’s preventive controls adequately address any hazards.
Analyze Hazards and Establish Controls
Food safety plans are designed to tackle “reasonably foreseeable” biological, chemical and physical hazards, both naturally occurring and intentionally introduced.
Preventive controls minimize or prevent hazards from adulterated food. These can include process controls (which outline procedures to ensure product parameters are met, such as heating or cooling products); food allergen controls; and sanitation controls.
Validation of a Control’s Success
Once established, preventive controls must be checked for effectiveness.
Severe or recurring problems, such as positive tests for mold or pathogens warrant corrective actions. These include adding a preventive control for an ongoing issue, so that unsafe food does not reach consumers. These steps must be verified and documented, such as through product testing and environmental monitoring.
Develop a Recall Plan
If there is a need to control a hazard with a preventive control, there is the possibility that tainted or mislabeled food could enter the stream of commerce. Having a recall plan in place and training personnel so they are familiar with the procedures is mandated by the Preventive Controls Rule.
Recall plans should include procedures to contact companies who bought/received the recalled product, how and when to notify the public, and how to dispose of the recalled product.
Preventive Controls and ImEPIK’s Food Safety Training
ImEPIK’s courses guide employees in food production through the FSMA’s regulatory mandates, from building a food safety plan to ensuring that companies are prepared for FDA inspections. The course is also available in Spanish and there is also a version that addresses the Canadians for Safe Food Regulations.
Contact ImEPIK to learn more about our self-paced, multi-module training.