US FSMA PCP -Tips and Tricks for Compliance

The Food Safety Modernization Act (FSMA) Preventive Controls for Human Food rule requires food facilities to develop and implement a written food safety plan known as the US FSMA Preventive Control Plan (FSMA PCP). This plan identifies and prevents hazards that could cause foodborne illness. In this blog post, we will provide an overview of the US FSMA PCP Plan, discuss key requirements for compliance, offer tips for developing and implementing an effective plan, address common challenges, and explore best practices for maintaining compliance. This blog post aims to help businesses understand the importance of the FSMA PCP Plan and provide guidance on how to meet its requirements.

Understanding the FSMA PCP Plan: An Overview

The FSMA PCP Plan is a written document that outlines the steps a food facility will take to prevent or minimize the risk of foodborne illness. It is a proactive approach to food safety that focuses on preventing hazards rather than reacting to them after they occur. The plan must be overseen and implemented by a “preventive controls qualified individual” (PCQI) who has completed training or has experience in developing and applying risk-based preventive controls.

The FSMA PCP Plan is important because it helps ensure the safety of the food supply by identifying and addressing potential hazards before they can cause harm. By implementing preventive controls, monitoring procedures, corrective actions, and verification activities, food facilities can reduce the risk of contamination and protect consumers from foodborne illnesses.

Key components of the FSMA PCP Plan include a hazard analysis, preventive controls, monitoring procedures, corrective actions, verification activities, and recordkeeping. These components work together to create a comprehensive food safety plan that addresses potential hazards and ensures compliance with FSMA regulations.

Key Requirements for Compliance with the FSMA PCP Plan

To comply with the FSMA PCP Plan requirements, food facilities must adhere to several key requirements:

1. Hazard analysis: Food facilities must conduct a thorough hazard analysis to identify potential hazards that could affect the safety of their products. This analysis should consider biological, chemical, and physical hazards that could occur at each step of the manufacturing process.

2. Preventive controls: Once hazards have been identified, food facilities must develop and implement preventive controls to minimize or prevent those hazards. Preventive controls may include process controls, allergen controls, sanitation controls, and supplier controls.

3. Monitoring: Food facilities must establish procedures to monitor the effectiveness of their preventive controls. This may involve monitoring critical control points, such as temperature, time, pH levels, or other critical parameters to control hazards.

4. Corrective actions: If preventive control is not properly implemented or is ineffective, food facilities must take corrective actions to address the issue and prevent the recurrence of the problem. Corrective actions may include adjusting processes, retraining employees, or implementing additional controls.

5. Verification: Food facilities must verify that preventive controls are consistently implemented and effectively control hazards. This may involve reviewing records, testing or sampling, or other activities to ensure compliance.

6. Recordkeeping: Food facilities must maintain records documenting the implementation and effectiveness of their preventive controls. These records must be kept for a specified period of time and made available to regulatory authorities upon request.

Challenges for US FSMA PCP Plan Requirements

Meeting the requirements of the FSMA PCP Plan can be challenging for many food facilities. Some common challenges include:

Lack of resources: 

Developing and implementing an effective FSMA PCP Plan requires time, money, and personnel. Many small businesses may struggle to allocate the necessary resources to meet these requirements. FSMA Preventive Control Plan is an ongoing program that requires resources for maintenance. 


Limited knowledge and expertise:

Some food facilities may have limited knowledge or understanding of the FSMA PCP Plan and its requirements. Losing a PCQI staff may also contribute to discontinuing a PCP plan at a facility. 

Developing preventive controls that are effective in controlling hazards and feasible to implement can be challenging. Finding the right controls for your facility may require trial and error, testing, and continuous improvement. 

Without a credible PCQI individual, it is challenging to maintain and implement an effective PCP plan. 
 

Best Practices for Maintaining FSMA PCP Plan Compliance

To maintain compliance with the FSMA PCP Plan, consider the following best practices:

Employee Competency and Training

Hire a competent PCQI individual to manage and run the FSMA PCP plan. The PCQI personnel must understand the food safety requirements and how to manage the PCP requirements. The PCQI personnel must also know how to follow through with routine and daily tasks to ensure Preventive Control Plans are being followed and act upon any deviations.

I recommend assigning a PCQI back-up person, just as you would, for the SQF code. While the FSMA doesn’t require the designation of a backup PCQI person, you will benefit from having a PCQI backup, especially during the main personnel’s vacation and if the main person decides to leave the position. 

See our blog on who is SQF Practitioner and what are the criteria for an SQF Practitioner.

Remember, hiring an unqualified and incompetent staff to manage your food safety program can often do more harm to your operations in the long run. The incompetent staff makes it hard for you to detect mistakes in your food safety programs and allows bad habits to develop in your food operations. 

If you are seeking qualified PCQI personnel, take time to find and train the right personnel. Consider our services to help review your food safety records and guide your team on your day-to-day Preventive Control requirements. 

Find a Time with me here

See the differences we can make in your business operations and food safety. I specialize in guiding non-food professionals to understand food safety program requirements and implement them. 

We teach our clients how to fish instead of giving them the fish. When you know how to “fish, ” you can confidently maintain your food safety program. 

 Using technologies to maintain your FSMA Preventive Control Plan.

Technologies are becoming more important when meeting regulatory and audit requirements. 

We work with our food safety software partners to integrate your food safety program so that we leverage technological advancement to alert us on non-compliance and food safety tasks as well as to collect documents from suppliers.

These can be very helpful, especially when you have limited resources for your food safety programs. 

Technology application in meeting FSMA 204 requirements for food traceability is also important as it allows for smooth trace and tracking at your fingertips. Generate the report you need in a few clicks. 

Tell me about your ideal software applications, and we can connect you with our partners or customize the software for you.  Find a Time with me here

While the FSMA PCP plan compliance can seem tedious, ensuring that our US consumers are safe is an important element. Your staff can make or break your FSMA compliance. Be compliant with your FSMA PCP plan with qualified and competent staff. 

Take time to hire the right food safety personnel. Many consultants know how to do the work but aren’t willing to share how to implement the program. Consider keeping a credible FSMA consultant who can guide you and your team with food safety compliance while you search for the right person. 

Continuous US FSMA PCP implementation allows for both regulatory compliance and consumer safety.