Since the inception of the Food Safety Modernization Act (FSMA) in 2011, organizations across the food industry have been challenged to implement Hazard Analysis Risk-based Preventive Controls (HARPC) programs within their operations. The specific regulation related to preventing known risks came into place in 2015 with the implementation of the Preventive Controls rule. This rule created a significant shift from the standard Hazard Analysis Critical Control Points (HACCP) programs, which have been in place within the food industry in some form since the 1960s. Although the industry has greatly benefited from HACCP since its inception, the breakneck speed of technology development and consumer demand required a new way of managing risk.
Preventive controls -- a brief history
When Pillsbury implemented HACCP during the height of the space race in the 1960s, there was a significant need to ensure that the food being served to American astronauts was safe because the threat of illness in space could lead to considerable risk to the mission. It was understood that testing foods for pathogens could ensure that the astronauts were protected. Unfortunately, the limitations of testing demonstrated that they could only ascertain the safety of specific foods and ingredients being tested. Additionally, they could not speak with confidence about the relative safety of the remaining batches, lot or other defined production quantities. This dilemma outlines one of the core challenges pertaining to food safety -- not all products and ingredients can be tested. Thus, programs, policies and standards were needed to ensure consistent safety across the food industry.
Organizations evaluated their programs from top to bottom through the HACCP process to identify hazards—both known and unknown—and implemented effective control points to mitigate food safety risks. For example, businesses learned that foreign metal contamination was a risk likely to occur in a manufacturing environment. In response, the industry implemented control measures, including metal detectors, to identify and mitigate this safety issue to help prevent consumer injury. By identifying hazards and mitigating them through these control points, organizations could vastly improve the food supply chain’s safety.
Taking preventive controls further
With the implementation of FSMA, regulatory agencies posted that the current processes should be reviewed to determine which new and innovative solutions would need to be implemented to move the industry to an even safer place. During this process, HACCP was reviewed thoroughly. Although it has been extremely beneficial in strengthening food safety for many decades, the regulation was limited only to control points (items that are important but not vital) and critical control points (items that are vital).
By implementing HARPC, the critical control point concept would be expanded to encompass the model of preventive controls. This shift allowed companies to move from a reactionary mode of managing risks as they arise to preventing issues from occurring in the first place. This change may seem minor and uncomplicated, but its impact on operational programs and processes have been profound. HARPC requires organizations to revaluate all current programs, not only for known risks that are already managed through critical control points but also for the investigation, testing, and implementation of preventive controls for risks deemed reasonably likely to occur.
An example of a preventive control for an operation may be the requirement to check all dock doors on a predefined routine and to complete the necessary forms to confirm they are kept locked and secure. This is because the ability for doors to be left unlocked may pose a security risk to your facility. Over the last several years, organizations have endeavored to meet the requirements outlined within the Preventive Control Rule within their operation’s four walls. Moving forward, businesses should consider the implications this rule has on inbound and outbound cold supply chains.
One of the most significant hazards posed to the cold supply chain is the risks of loss of temperature control during transit, as well as security as it relates to transportation and economically motivated adulteration. Temperature abuse is a leading cause of foodborne illness in the United States. With the implementation of the Sanitary Transportation of Human and Animal Food Rule, also part of FSMA, regulatory agencies are increasing their focus on this significant and unmanaged risk.
The cold supply chain presents unique challenges to your food safety programs. For example, consider the loss of temperature control for your raw materials and the safety hazards it might pose to them. Understanding these risks is critical when it comes to implementing preventive controls within the supply chain. As a food safety manager, where do you begin this process? An essential first step is maintaining a strong understanding of your supply chain. This presents a good opportunity to partner with your logistics, supply chain and purchasing teams to map out this program.
Once you have a baseline understanding of the supply chain, begin an in-depth risk analysis project as you would when a process change occurs within your facility. During this analysis process, make sure to review previous quality or food safety concerns as an initial step in determining where risks might be. After completing this analysis process and understanding those risks reasonably likely to occur, it is then time to implement preventive controls programs and monitoring procedures to mitigate risks.
There are several common concerns in the supply chain through the analysis of thousands of shipments, including losing power to a reefer truck, refrigeration unit temperatures going outside the approved settings or the units being placed in cycle mode instead of in continuous mode. Transportation security and economically motivated adulteration are also emerging risks that organizations are considering and exploring ways to prevent them. As these risks are reasonably likely to occur, implementing a real-time supply chain monitoring program that identifies light and other events—and provides actionable insights—can be a preventive control measure within your programs.
