There continue to be many questions around Hazard Analysis and Risk-based Preventive Controls (HARPC) and how a company’s food safety program will need to change to meet the new Food Safety Modernization Act (FSMA) requirements. Through FSMA, the FDA has basically stated that Prerequisite Program (PRPs) are now considered of equal importance as Critical Control Points (CCPs), clumping them all together and calling them preventive controls. PRPs can further be broken down to include Operational Prerequisite Programs (OPRPs). OPRPs are defined as a PRP that has a control measure that controls a significant hazard—ISO 22000 introduced the concept of OPRP. This is an important distinction as we’ve seen that most incidents today are a result of poor management of PRPs, rather than CCP failures.
So how does this tie into FSMA?
Well, our current Hazard Analysis and Critical Control Points (HACCP) programs only take us part of the way toward fulfilling FSMA requirements. It is still very relevant and can be used as a foundational tool for building your HARPC plan. We’ve mentioned before that you won’t need to reinvent the wheel here. You can continue to use your HACCP and CCPs but will need to add more structure around your risk-based preventive controls program by further defining your PRPs and OPRPs. This can simply be a similar analysis tool to what you already use for your HACCP program.
Here are some distinctions between these three types of programs and their related control measures (remember, HACCP and HARPC are both risk assessments but differ on how significant hazards are addressed).
Listen to my podcast for information on the FSMA cGMP and preventive controls for human food rule:(Or listen to the podcast here)
Critical Control Points
The traditional definition is “a point, step or procedure at which controls can be applied and a food safety hazard (biological, chemical, physical or radiological) can be prevented, eliminated or reduced to acceptable levels.” They are focused on process flow and processing parameters within a facility. It is considered an absolute control and is tied to a specific hazard and step in the process. This is the only one that requires you to designate a critical limit.
- pH level
- Moisture activity
These are food safety programs and practices put in place to address the role that the production environment plays in producing safe food products. They are general control measures that may or may not be measurable and therefore are often not monitored and documented at the same level as CCPs. They are not specific to one step in the process and do not control a specific hazard like CCPs do. They ensure that the environment is maintained in a hygienic manner to reduce food safety risk. You will need to document how these programs are managed.
- Pest control
- Allergen control
Operational Prerequisite Programs
An OPRP is a prerequisite program that controls a significant hazard. It is a control measure that has been deemed crucial, but not considered a CCP (not an absolute control or can be managed upstream from the CCP). OPRPs are identified through risk assessments. You will need to determine what can be measured and then determine how. They should be treated just like a CCP (identify, monitor, verification, corrective actions, recordkeeping, etc) but you won’t need to define a critical limit. And they may not target a specific source of the hazard but should reduce the likelihood of exposure to the hazard or other contamination sources.
- Temperature control
- Sanitation effectiveness (pathogen or allergen)
- Hand washing and sanitizing
- Glass/metal control (not designated as CCP)
Some newer methods for monitoring OPRPs include:
- Pest e-monitoring: device installed on top of the bait station that instantly sends a signal to a facility device to alert that pest activity is occurring
- Hand washing and sanitizing monitoring systems
- Smart ID badges: zone movement monitoring, hand sanitizing monitoring by location or interval, and bathroom/hand wash monitoring
- Remote video monitoring (could improve food safety, quality and production efficiency)
- ATP bioluminescence cleanliness monitoring
Risk assessment tools, like decision trees and risk matrices, will support your efforts to determine how a hazard will be managed by one or more of these preventive control processes. If you have a comprehensive HACCP program that has already identified all your PRPs and various control measures, both processing and environmental, then it should only be a matter of documenting your PRP and OPRP control measures and ensuring that any monitoring, verification, corrective actions and recordkeeping are being completed in the same manner that you have used with your CCPs. You can then add these to your existing food safety programs to eliminate any gaps between your current HACCP and new HARPC plans.
For more information on this topic, please listen to the podcast where we will talk more about the FSMA cGMP and preventive controls for human food rule.