There is much talk about HARPC – Hazard analysis and risk-based preventive controls – and how food companies need to either elevate their existing Hazard Analysis at Critical Control Points (HACCP) program, or formulate a new HARPC-based food safety plan, in order to comply with proposed rules under the U.S. Food Safety Modernization Act in the

In a recent FSMA Fridays discussion, Dr. David Acheson and Melanie Neumann of The Acheson Group elaborated along with SafetyChain Software’s Barbara Levin, how HARPC differs from HACCP and what companies can start doing now to be prepared. We present below some excerpts.

How are HACCP and HARPC different?

The key term is that HARPC is risk –based. While HACCCP is more prescriptive, based on the seven-step process, the risk-based analysis requires moving outside of those seven steps to think of how else can I manage risk. Also, under HARPC, it’s no longer deemed sufficient to have a HACCP plan – you need to have a more exhaustive food safety plan.

How should F&B companies approach migrating HACCP to HARPC plans?

In the proposed FSMA rules, FDA has changed the language of defining how and which products should be monitored from ‘reasonably likely to occur,’ which is HACCP type terminology, to ‘significant.’ FDA is doing this in an attempt to differentiate the required HARPC-based food safety plan from traditional HACCP plans. This requires food companies to look at hazards along the whole supply chain – from when we are receiving food to when we are shipping it out (and not just at control points). For instance, environmental controls in a ready-to-eat foods processing area is covered now, which is beyond the traditional HACCP area. So look at those risks in the processing facility and ask if they are significant risks.

Who is the Qualified Individual and how does this impact the HARPC approach?

This is the million dollar question! FDA hasn’t come out with a clear definition yet – only vaguely referring to this person as ‘qualified by training or experience.’ However, this person has a lot of responsibility on their plate – they are responsible for preparing a robust food safety plan that identifies and controls risks, for putting in place corrective actions and validate these, and for doing a reanalysis of the food safety plan as needed. F&B companies need to ask if they have the right person driving this bus. You do need somebody in your business who is capable and qualified to do this, or FDA allows you to use an outside expert as the Qualified Individual.

What will FDA expect to see with HARPC when they come in to see FSMA being enforced?

Once FSMA is implemented (possibly) by August 2016, FDA inspectors can come into F&B facilities and ask to see food safety plans, and details of the HARPC plans. They would want to understand what the process is, what the hazards are, and how and if you are controlling these, and if you are thinking of these hazards from a risk-based preventive controls strategy.

What are top three things that companies should be doing to comply today?

As described often, HARPC is an evolution of HACCP or HACCP on steroids. The first thing you need to do is understand what you are being asked to do with HARPC. Make sure you get the strategy here. Step two, is to get together a team to do this to figure out where your risks are, if they are significant, and build these into food safety plan. Step 3 is look at your current systems and structure. Do you have these now identified significant risks controlled? Have you determined what the controlling steps are, and put in place these preventive controls? Ask yourself if you are controlling these risks, monitoring them, putting in place corrective actions and validating them?

Final point: we often hear people saying, ‘I am going to wait. We are going sit out and watch how the rules evolve.’ But our advice is Do Not Wait! We have a lot of insight on how the final rules are going to pan out and what the compliance requirements will be. So start working now.

For more on this discussion, click here.