Effective implementation of pem
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Pathogen monitoring in Environment is a challenge in Food industry and is extremely important control mechanism to manage pathogens. have tried to highlight important aspects to be considered while implementing this program
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Effective implementation of pem
- 1. Effective Implementation of PEM Pathogen Environment Monitoring Ganesh Kamath 3rd Dec 2014, Master Classes CII, New Delhi
- 2. To conclude, the take home message is.. 5 messages on PEM Program Understand the Intent Pre-requisites are backbone, know your mistakes Be sure of your target and sampling Listen to the data Manage Adverse events carefully
- 3. Understand the Program Is Finished food analysis good enough? ◦ What criteria absent/g, /10g, /25g. / 5x25g??? If so then why this statistics? Microbiology results are based on sampling, probability, extent of contamination, recovery etc So the Intent is ◦ Protect our Consumers ◦ Protect our Business Number of cases of culture-confirmed bacterial and laboratory-confirmed parasitic infection, hospitalizations, and deaths, by pathogen — Foodborne Diseases Active Surveillance Network, United States, 2013*
- 4. Understand the Intent What is the intention of this program? ◦ To have a clean data? ◦ To have a clean manufacturing line? ◦ To pass the audits? The intent is ◦ To verify the effectiveness of certain prerequisite programs implemented in the site to assure Microbiological Food Safety ◦ To understand the cause of cross contamination ◦ To establish an early warning system ◦ To Hunt and Eliminate
- 5. Pre-requisites are backbone When to implement the PEM program? Start with Pre-requisite programs First ◦ Zoning ◦ Pest Management ◦ Cleaning and Sanitation ◦ Maintenance practices ◦ Training and people practices
- 6. Mistakes in Zoning Do we know our Raw and RTE Areas? ◦ Do we have controlled access from exteriors Is our traffic under control? ◦ Do we move pallets between Areas ◦ Do we move trolleys between Areas ◦ Do we have transition zones How is the air flowing between Areas? Are our buildings and roofs ensure integrity to natural forces? Is our Zoning in RTE correct? ◦ Zone 1 / Zone 2 / Zone 3 / Zone 4
- 7. Mistakes in Cleaning and Sanitation Dedicated cleaning tools in Raw and RTE area ◦ Are they colour coded Dedicated tools for different Zones in RTE area ◦ Are they colour coded ◦ Are these tools handled, cleaned and sanitised separately? Dedicated Vacuum cleaners Do we have dedicated cleaning tools for drains Are our RTE areas maintained Bone Dry during production Cleaning of cleaning tools?
- 8. Mistakes in maintenance practices Breakdowns ◦ All rules are thrown out of window! Sunday Maintenance ◦ GMP does not apply ◦ Microbiologist / Hygienist on leave ◦ OEM, Contractors have no idea about zoning and PEM Practices ◦ Is separate maintenance tools used for RTE zones ◦ What about cleaning after maintenance activities? RTE area Tools Raw area Tools
- 9. Mistakes in People practices Transition zone bypass ◦ Rules are not for me! Cleaning practices ◦ Do it fast, we need to start production ◦ Dry cleaning, what is that? ◦ Untrained contract labour does the cleaning job ◦ Tool control, how does that matter? ◦ Drains the most neglected part of a factory Training and monitoring program
- 10. Mistakes in Target Organism What is our Target Pathogen ◦ Salmonella, Listeria, E Coli? ◦ Not TPC, Coliforms and Y&M ◦ Sole dependence of Target Pathogen? Do we use Indicator organism ◦ Enterobacteriaceae (EB) ◦ Do we have action limits? Root cause analysis and Corrective actions? Where do we sample ◦ Line>Zone 1>Zone2>Zone3>Zone4? ◦ Raw Area?
- 11. Mistakes in sampling Are we using the right tools and techniques? Targeting conformance! ◦ Sample after cleaning ◦ Sample the same spot over and again Mostly missed hot spots ◦ Focus on items that cross transitions zones (Pallets, forklift wheels, shoes) ◦ Dust bins, Vacuum cleaners ◦ Hunting for dirty, hidden, moist, hard to reach
- 12. Mistakes in data analysis Trends… Why? Do we know the hot spots? Can we trace the exact root cause of cross contamination Major Maintenance Cross contamination Improper cleaning
- 13. Adverse Event Management What is an adverse event? ◦ Roof leakage ◦ Un controlled water in RTE area ◦ Drain back off etc What should you do? ◦ Isolate the area ◦ Take control of incriminated products ◦ Clean and Disinfect ◦ Verify with extensive sampling (Line, Environment & Products) ◦ Start production ◦ Monitor at an escalated level
- 14. To conclude, the take home message is.. 5 messages on PEM Program Understand the Intent Pre-requisites are backbone, Know your mistakes Be sure of your target and sampling Listen to the data Manage Adverse events carefully