Are You Justified?

Editor’s Note: This article focuses on justifying the plant’s HACCP plan to the USDA. However, with FSMA preventive controls just around the corner, plants that are inspected by FDA can essentially replace “HACCP” with a “Food Safety Plan” to ensure they are prepared.

There is a great show on the FX network called “Justified.” It is about a U.S. Marshall in the Kentucky backwoods who shoots first and asks questions later. I suggest you watch it; it has some of the best writing and character development on TV. The reason I bring up this excellent TV drama is the title — “Justified.”

The dictionary defines the word justification as: “the action of showing something to be right or reasonable.”

One of the things I have noticed in recent conversations with other food safety employees is the disconnect between the HACCP plan on paper and the HACCP plan in reality. As we all know, the USDA does not write our HACCP plans, we do. And as we write them, every decision that we make must be “Justified.” From selecting CCPs, to selecting critical limits, to monitoring frequencies, to conducting verification activities, to determining corrective actions — it all must be “Justified.”

You must be extremely comfortable with and understand what your justification is and why you made that decision. During USDA and third-party audits, this is where I see plants getting into problems. They make decisions in their HACCP plan but they can’t back up the “why” of that decision. Telling a USDA inspector or an auditor that you check the temperature once an hour because that’s what most people do or because that’s what you were told to do will not cut it. I cannot tell you how many times I have heard an employee monitoring a CCP say, “That’s what I was told to do.”

Here is a good example: A fed-cattle slaughter plant that receives cattle from approximately 30 feedyards in the surrounding area has determined that residues as a chemical hazard are “not likely to occur” in their receiving step of their HACCP plan. The USDA auditor asks, “How can you justify that decision?” The plant responds, “The USDA has never informed us that they have ever received a positive residue test, therefore it must be not likely to occur.”

Did this plant justify its decision? The answer is no. Just using the USDA test results is not enough justification.

What should a plant have as justification? Never be afraid to explain what you are really thinking; what your thought process was in making a decision. This is the whole idea of a HACCP team. Use people from multiple disciplines to answer the questions when you are making a decision on how to justify. In this example, the plant should answer that it only slaughters fed cattle, no cows, thus the likelihood is less for residues; that they have ongoing communication with the feedyards; that these feedyards are audited at least yearly; and that all have animal health and welfare programs which must be submitted before they can be approved as a supplier.

Take the time to look at your HACCP plan. Remember, this is a living document. Review all your decisions: Are they justified? If you are checking your metal detector once per hour—how do you justify that frequency? Can you control one hour of product? What is your history of finding it? You might say something like: “Our low occurrence of finding metal, and the ability to control one hour of product, justifies the frequency of our monitoring.”

Do you have supporting documentation? Wait — you are not done yet. Do you have the supporting documentation for that justification? If you are using past history, do you have proof? If you are using supplier documents (which a lot of people do), do you have those documents? Are they current and up to date? Letters of Guarantee from your suppliers can work well, if they contain the right information, and you are able to present them to your inspector/auditor with a current date and, preferably, for each load/PO. Don’t wait until you are asked to call your supplier and “get a letter.” This doesn’t end well for you or the supplier.

Take some time today to go back through your HACCP plan, and take a look at your decisions. Try to put yourself on the outside looking in, or better yet have someone else look at it with you. For every decision that you made, ask: Can I justify this?

Start at the beginning. If you said there was a hazard, but it was not reasonably likely to occur, why did you say that? Conversely, if you said there was a hazard reasonably likely to occur, why did you say that?

As a character in a famous movie once said “Show me the justification!” Okay, the actual quote was “the money,” but you get the point.

I cannot stress enough: the HACCP plan is YOUR plan. Know it, learn it, and, most importantly, be able to justify all of your decisions.

The more confident you are in explaining your justification, the more comfortable the USDA and auditors will be with you and your plan.