Al St. Cyr Joins QA Advisory Board

Departments - From the Advisory Board

Reflections on FSMA Compliance 2018-2019

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February 1, 2019

Al St. Cyr, ASC Consulting

The start of the new year brings a new industry leader to join the experts of QA’s Advisory Board. Please welcome Alfred (Al) St. Cyr, president of ASC Consulting, LLC, Manhattan, Kan.

St. Cyr has been a part of the food and pest management industry for many years beginning as a sanitor in a bakery in 1970. After a stint in the U.S. Navy as a preventive medicine technician, he returned to the commercial baking industry as plant sanitarian and quality assurance manager. In 1985, he partnered with Dr. Austin Frishman, providing assistance to the food and pest management industry. In 1990, St. Cyr joined AIB as an inspector and by 1993 had become the head of food safety education, providing consultation and educational programs for the industry around the world.

St. Cyr continues to provide educational programs for the industry through his own consulting firm.

Following are reflections from St. Cyr on FSMA compliance 2018-2019.

FSMA COMPLIANT? It has been another interesting year of outbreaks and recalls in the food industry. Some would say that with the passage of the Food Safety Modernization Act (FSMA) and all of the Global Food Safety Initiative (GFSI) audits being conducted, food safety compliance is at an all-time high. This argument is made mostly on data that suggests the number of deaths associated with foods has dropped in recent years. Perhaps advances in early detection and treatment strategies has something to do with this.

When we look at the number of failures to stop microbiological and allergen issues, we find a slightly different picture. Our ability to recognize a failure has certainly allowed us to avoid some of the catastrophic failures affecting the consumer. But, the question that begs to be asked is, “Why did they occur in the first place?”

The buzzword throughout the industry has been “FSMA Compliant.” At various seminars we ask the question and then go into a long presentation on documentation requirements for FSMA and GFSI audits. When I visit plants, they are eager to roll out the binders of documentation showing how compliant the facility is while trying to avoid the discussion on their recent recall or product returns and process failures. After all, their documentation is telling everyone they are FSMA compliant.

FSMA is not documentation compliant. Compliance is embracing the philosophy of FSMA. I am talking about a philosophy of “Things that can be foreseen can be prevented.” Under FSMA, every plant has conducted risk assessments for failures, documented them, and designed activities to avoid them — on paper. When the failure reaches the level that we can no longer hide it in the paperwork, the truth comes out that we really did not follow through.

With all we know today and the rules in place, why are we still thinking we can grow ready-to-eat produce downstream from a stockyard and not have a microbiological time bomb waiting to go off?

Where are the adherences to the water quality standards, environmental impact review of the surrounding operations, and every other bit of information pointing to the fact that it should not have happened. Someone had to sign off on all the required documentation. Did that make it safe?

When it comes to recalls due to undeclared allergens because of improper formula control or inadequate post allergen sanitation, how did the program fail?

All of the preventive controls are likely in place on paper but who is actually following them? Where are the checks and balances that are supposed to be in place from supplier approval to the review before introduction into the process, along with correct labeling?

Documentation said that this should not have happened.

FSMA compliant is not simply more documentation with useless data that is not contributing to your ability to manage a process correctly. FSMA requires an honest review of the operations and assessment of what and where your risks are.

It is a very intense vigilance of the failure opportunities and taking continuous action to avoid them. It means that all plant personnel possess the knowledge and skills to do their jobs effectively. It means that all critical controls are monitored and verified before product leaves the facility, not just recorded as such on the documentation.

The cost of failure is often very high. There seems to be too much focus on cost reduction of operations and not enough focus on making sure the resources are available to properly maintain the facility. It appears that less informed people, who are removed from the process environment, are making critical decisions that have a profound impact on true compliance with FSMA.

How many are betting on the money saved by noncompliance vs. the cost of the catastrophic failure? History would tell us it is not a very good bet.