FSSC Environment Monitoring for Oleochemicals products for food application
Based on new Fssc EMP guidance doc dated Oct22 it stated list down all potential microbiological hazards and then conduct risk assessment based on the zones. My question as following:
1. What is the typical/common biological hazard expected to be present in above Oleochemicals products? Any example to share?
2. The zoning need to be done for entire facility eg warehouse, store, big plant etc or only for area involve inside packing/ gmp room? Eg in entire facility there are production plant which has vessel, warehouse, store, lab, office etc, so zoning need to be done for each area identified from facility layout? Eg inside packing room, zone1-3 exist, inside warehouse zone 3 exist etc. So risk assessment is for individual area within facility?
3. Once zoning is determined, need to conduct risk assessment for all the individual area identified in the zone? Example inside packing room there are oil filling nozzle ( direct contact), conveyors that convey the packed fatty acid in bag etc. So risk assessment as in severity and likelihood need to conduct for filling nozzle, conveyor one by one for each identified possible biological hazard ?
4. Is there any guidance how to describe the severity for EMP?. Eg in food safety high severity can be described can cause fatality. Does this description is sufficient and able to replicate the same when describing the severity for EMP? How should one able to describe the severity related to emp?
5. What is the different between risk assessment of biological hazards conducted for EMP vs risk assessment on biological hazards conducted for food safety hazard analysis?
6. The severity of EMP based on risk matrix is described as impact of the biological hazard to the product or human or how we decribe the different severity level on EMP?
7. The biological hazard assessment normally conducted for HACCP hazard analysis does it require to be align with EMP biological hazard assessment to avoid discrepancy? Or?
Interesting. I have about 2 months of intern experience with oleochemicals 30 years ago. But...just thinking about it, it all depends on the product makeup, the facility, the process and the personnel. Such as, is it high or low moisture, is there a lot of personnel handling of equipment and/or ingredients/products. What is the sanitation frequency and what does it involve.
1. What is the typical/common biological hazard expected to be present in above Oleochemicals products? Any example to share? I would think pathogens that grow or stay alive in low moisture environments at moderate temperatures. Maybe salmonella and staph. aureus are two off the top of my head. Listeria tends to favor higher moisture environments and can survive freezing temperatures. E.coli more temperature sensitive. Consider moisture, pH, environment temperature / humidity.
2. The zoning need to be done for entire facility eg warehouse, store, big plant etc or only for area involve inside packing/ gmp room? Eg in entire facility there are production plant which has vessel, warehouse, store, lab, office etc, so zoning need to be done for each area identified from facility layout? Eg inside packing room, zone1-3 exist, inside warehouse zone 3 exist etc. So risk assessment is for individual area within facility? Typically, in areas where there is ingredients, primary packaging, or products that are in process will be Zones 1, 2, and 3. Zone 4 would be for outlying areas such as warehouse (depending on location and materials), maintenance shop, QA lab, office, etc. You can make a map which is great, but you can also list and define what is a zone 1, 2, 3, and 4. We don't have a zone map, but we have listed and defined all zone areas. We have a huge list of all potential swab sites with the zone numbers and then randomly select X amount from each zone.
3. Once zoning is determined, need to conduct risk assessment for all the individual area identified in the zone? Example inside packing room there are oil filling nozzle ( direct contact), conveyors that convey the packed fatty acid in bag etc. So risk assessment as in severity and likelihood need to conduct for filling nozzle, conveyor one by one for each identified possible biological hazard ? Part of the risk assessment will involve a hierarchy of your zones. So Zone 1 & 2 would typically have more sampling than Zone 3 & 4. But again, depends on your process and sanitation and what other measures you have in place. Because our facility does a full wet CIP cleaning daily of all equipment and we include ATP swabs and pre-op of equipment after sanitation Zone 1 is low-risk, but Zone 2 and 3 are higher risk for us. And yes, also dependent on your pathogens of risk. Where could they harbor and grow best?
4. Is there any guidance how to describe the severity for EMP?. Eg in food safety high severity can be described can cause fatality. Does this description is sufficient and able to replicate the same when describing the severity for EMP? How should one able to describe the severity related to emp?
5. What is the different between risk assessment of biological hazards conducted for EMP vs risk assessment on biological hazards conducted for food safety hazard analysis? B. Hazards in EMP focuses strictly on the environmental and the risk of introduction, or having B. Hazards, in the environment. B. Hazards in your food safety (HACCP or HARPC) plans focuses on the totality of the potential of B. Hazards throughout the process from ingredient sourcing to the customer / consumer. You may have B. Hazards in your ingredients which fall under the food safety plan and not the EMP, or B. Hazards in shipping and transport if dependent on temperature for control.
6. The severity of EMP based on risk matrix is described as impact of the biological hazard to the product or human or how we decribe the different severity level on EMP? It includes hazards and risk of the EMP. The EMP risk is based on the potential impact on the food coming from the environmental pathogens of risk, or concern with your process, facility and product.
7. The biological hazard assessment normally conducted for HACCP hazard analysis does it require to be align with EMP biological hazard assessment to avoid discrepancy? Or? Yes, there should be alignment. For example, your food safety plan hazard analysis should include all B. Hazards associated with your environment. In your FS Plan you can put as one of your controls for B. Hazards your EMP to control environmental B. Hazards (but not always control all the B. Hazards in the FS Plan, see response to question 5). But in the EMP you need to identify the B. Hazards associated with the environment. You would likely have more B. Hazards listed in your FS Plan hazard assessment versus your EMP.
Hope this helps.