Effective Implementation of PEM Pathogen Environment Monitoring - PowerPoint PPT Presentation

Effective Implementation of PEM Pathogen Environment Monitoring Ganesh Kamath 3 rd Dec 2014, Master Classes CII, New Delhi

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

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 Number of cases of culture-confirmed bacterial and sampling, probability, extent of laboratory-confirmed parasitic infection, hospitalizations, and deaths, by pathogen — Foodborne Diseases Active Surveillance Network, United States, 2013* contamination, recovery etc  So the Intent is ◦ Protect our Consumers ◦ Protect our Business

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 nt and Elim limin inate

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

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

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 e Dry ry during production  Cleaning of cleaning tools?

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 RTE area Tools ◦ Is separate maintenance tools used for RTE zones Raw area Tools ◦ What about cleaning after maintenance activities?

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

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?

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

Mistakes in data analysis Cross contamination Improper  Trends… Why? cleaning  Do we know the hot spots?  Can we trace the exact root cause of cross contamination Major Maintenance

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

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

Thank You Qu Ques estions tions?