Many companies have been faced with developing and implementing an environmental monitoring program (EMP) in the last few years. The implementation of the Food and Drug Administration's (FDA’s) Preventive Control Rule has necessitated the need to evaluate the potential for cross-contamination (microbial) and cross-contact (allergen/chemical). Creating an EMP can be daunting, with numerous inquiries to address while developing and implementing a thorough EMP.
Important Factors to Consider:
- When, where, and how to sample
- What to test
- Who performs the test
- Establishment of corrective actions
- Budget constraints
- Data review and analysis
An Effective EMP Includes:
- A basic understanding of microorganisms
- The purpose of the sampling
- Understanding how the data will be used
- It fits the individual needs of the company
- Utilizes good judgment
At Mérieux NutriSciences (MXNS), we are frequently asked, “How do I make all these decisions?” A comprehensive environmental assessment can guide facilities to those activities, process points, and facility/equipment conditions that can ultimately lead to EM program failure and threaten product safety.
Importance of Food Safety Risk Mitigation Based on a Well-Designed Risk Assessment Can:
- Identify growth niches
- Assess sanitary design of facility and equipment
- Assess Adequacy of Sanitation Procedures
- Identify cross-contamination sites
- Hygenic zoning evaluation
- Ensure raw/cooked separation
- Prove lot/line separation
- Evaluate traffic and people flow
- Verify personnel practices
- Equipment maintenance and repair
- Routine practices
- Special requirements
- Alert mechanism for out-of-control processes (EM program)
- Routine practices
No two facilities are identical, even if the layout or footprint is identical. Something seemingly insignificant as the facility's location is essential in food safety challenges. A facility located in a city has a very different set of conditions that influence contamination compared to a facility located next to agricultural activities. These different challenges influence the nature of microbial sampling and testing. The facility's age is a huge factor in determining the frequency of swabbing activities, the target microorganisms, and the location of sampling activities.
Many facilities fail to understand the significance or relationship of the target microorganism to product safety or quality. The levels established for quantitative microorganisms should be based on a baseline study of product shelf-life. The relationship of indicator or index microorganism to the presence of pathogens must be understood.
Understanding how data will be used is an essential factor to consider. If out-of-specification results are received, how will any affected product be handled? Root cause analysis, corrective action, expanded sampling, and testing will be required. Staff should be trained appropriately to perform practical root cause analysis. Merieux Nutrisciences is strategically positioned to assist you with environmental assessments and for training on program execution and corrective action.
Ready to elevate your EMP? Contact us for expert guidance and consulting services. Let's ensure your food safety standards are second to none.
