Effective Implementation of PEM Pathogen Environment Monitoring - - PowerPoint PPT Presentation

Effective Implementation of PEM

Pathogen Environment Monitoring

Ganesh Kamath 3rd 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

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*

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
• n 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

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
• f 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
• ver 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

 Trends… Why?  Do we know the hot

spots?

 Can we trace the exact

root cause of cross contamination

Major Maintenance Cross contamination Improper cleaning

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

Qu Ques estions tions?

Thank You