Hazard Analysis and Critical Control Point (HACCP) systems have been recognized as a successful means of controlling food safety hazards for over 50 years. As we approach implementation of the Food Safety Modernization Act (FSMA), it appears the Food and Drug Administration intends to require something other than HACCP. The FSMA requires registered facilities to conduct a hazard analysis, identify and implement preventive controls, monitor the performance of those controls, and maintain records. The FSMA requirement, a Hazard Analysis and Risk-Based Process Control (HAPC) system, seems to differ from HACCP in that it does not require identification of critical control points with critical limits.
Both HACCP and HAPC require a hazard analysis. Facilities have approached the hazard analysis in various ways. The purpose has always been to identify hazards and the significance of their risk and then identify controls and their related significance within each portion or process in the food chain. Methods to guide and document the hazard analysis include the use of decision trees, matrices with numerical values for hazards’ risk and severity, and questions in table format to assist in the decision process. Under a HACCP system, the result of the hazard analysis answers the questions: “Are there any critical control points?” and if so, “How are they controlled?”. In theory, this clarifies the absolute bottom line to ensure process safety. It focuses the food safety plan and those developing it on the critical steps and their control.
Over time, the number of critical control points (CCPs) identified in a single HACCP plan has gone down dramatically compared to what it was when HACCP was first implemented. In the early years, plans had 12 or more CCPs. It was later thought that this many critical steps diluted the focus. How could so many things actually be critical? Some of those CCPs, if data supported the stability of the process, were changed to control points and no longer considered quite so critical. The intent was appropriate and industry has continued to demonstrate strong control over essential food safety steps.
The number of CCPs in a plan has also been influenced by factors outside of science and food safety. If a specific step is not readily measurable, the company may have decided it isn’t critical. If a step is not fully under company control (such as receiving), the company may have decided it just doesn’t work well as a CCP. Companies under HACCP systems worked to simplify and retain focus on what is truly critical.
Now, there is a concern that companies may lose sight of the pre-requisite programs because there is too great an emphasis on CCPs and not enough on each step or control in the process.
Although the exact requirements have not been identified, the FSMA mandates a hazard analysis without necessarily asking for identification of CCPs. One factor for this may be the complexity of the process and the challenges in regulating CCP or HACCP requirements. One could assume that the FDA version of a mandatory food safety plan might be easier than what has been required for those with regulated HACCP Plans. On the other hand, the HAPC systems could turn out to be equally or even more demanding as HACCP. HAPC may require a greater focus on prevention through a step-by-careful (regulated)-step approach rather such as strong emphasis on (only) the critical steps.
Over the past 10-12 years, companies under the inspection of the Food Safety Inspection Service (FSIS) have experienced increasing HACCP related requirements. First there was a need for more supporting documentation for CCPs and their limits, then for more support of decisions documented in the hazard analysis, then for more verification and validation data for CCPs, and very recently, there is a push for validation of pre-requisite programs. These changes aren’t just to create jobs—they are to ensure food safety is being accomplished and can be proven. This recent push toward validation of the pre-requisite programs is very much in line with what the FSMA may propose through HAPC. The emphasis is on process control.
The bottom line of any strong food safety program isn’t only the CCPs. It is the total process with multiple hurdles managing and reducing risk. If any one hurdle is inadequate, the variation may increase ultimately causing failure at a critical junction. What is most important is creating a system that uses science and controls that can be examined through collecting accurate data and using that data to ensure and maintain control.
Identification of CCPs and implementation of a HACCP Plan is still the best method to ensure food safety but this plan is only as strong as the pre-requisites that support it. So perhaps it is time for another look at HACCP. If foundational pre-requisite programs are not verified and validated with the same vigor as a CCP, perhaps that foundation is not as strong as needed. Perhaps it is time to reassess the HACCP Plan with increased emphasis on process control in light of all of results of a Hazard Analysis and the risk-based Process Controls, HAPC.
About the Author
Cathy Crawford, Vice President, HACCP Consulting Group, L.L.C.
Cathy@foodsafety1.com | 757.371.5832 | www.haccpcg.com
Ms. Crawford has a broad range of experience in consulting, food manufacturing and food chemistry / microbiology laboratories. She is an enthusiastic trainer who has provided HACCP and other food safety training to a wide variety of businesses, including meat and poultry processors, bakeries, fruit and vegetable processors/packers, and food service establishments. She is a registered auditor for Safe Quality Foods (SQF). Ms. Crawford holds a master’s degree in food safety from Michigan State and a bachelor’s degree in biology from Arizona State University.