Environmental Monitoring Programs and The Cost of Failure
Effective Environmental Monitoring, Sampling and Testing (EMS) Programs are absolutely necessary to protect our consumers, and make safe food, and are also required from a regulatory and food safety point of view, and to verify that our food safety programs are working.
In a recent webinar, Prof. Ann Draughon offered some insights on what happens when such an EMS program is not set in place – the cost of failure is much greater, and the repercussions can be severe, she warns.
What is on the horizon with EMS given the new regulatory landscape under the Food Safety Modernization Act and the proposed rules? Prof. Draughon talked about the Mandatory Preventive Controls described in Section 103 of the Act that lists the following controls that FDA will require:
- Environmental monitoring programs;
- Sanitation and cleaning requirements;
- Allergen control;
- Mitigation of hazards; and
- Supplier verification.
How will FSMA affect FDA’s regulatory sampling of food facilities and products? The volume of environmental samples will increase at a much higher rate than sampling for allergens or ingredients, she adds. And in order to meet such a high demand for environmental inspection and sampling, it will be important to have in place effective EMS programs. Prevention will be cost-effective and give companies the ability to detect and destroy the microorganism before they cause any issues. Prof. Draughon provided the following numbers as cost of reinspection: $224 per hour for domestic inspections, $325 per hour for foreign inspections, and cost of FDA reinspection in FY 2012 estimated to be around $21,000.
She described two case studies of companies that suffered bankruptcy, and business losses due to massive food safety related recalls, caused by inadequate or lack of environmental monitoring programs.
“This company is currently bankrupt due to a massive recall. While they had a great food safety plan, they did not back it up with a strong EMS program,” Prof. Draughon explained.
Speaking about the second company, she explained that the strong and capable leadership had done everything right for the company, but what went wrong? “There was a:
- Lack of communication within company about any positives Listeria results;
- Sporadic Listeria positives occurred – while the problem was fixed, they continue to reoccur and the source was never detected or fixed;
- The company had a reactive EMS, but not proactive,” she explained.
What are some of the recurring problems due to ineffective EMS programs? Prof. Draughon listed these as:
- Increased risk of recall;
- Increase loss of product;
- Increased liability exposure;
- Build-up of pathogens and spoilage agents or chemicals in environment;
- Lack of regulatory compliance; and
- Reaction to problems, not prevention.
Based on this high cost of compliance, Prof. Draughon strongly recommended establishing an effective EMS program, which has the following attributes:
- Focus on having the appropriate indicators and hazards;
- Ensure the best procedures selected and validated;
- Strong sampling plan, which is well-designed and dynamic;
- Data analysis and data management; and
- Education and training.
Learn more by listening to the series of webinars on Environmental Monitoring, presented by 3M Food Safety. Click here for more details.