Microbiological Process Control SEEK & DESTROY PROCESS John Butts Ph.D United Fresh - PMA Listeria Workshop July 2017
Learning Objectives Seek & Destroy Process - Tools of our Trade Operational Definitions - We need a common language Sampling Programs can have Differing Purposes - For Cause vs Not For Cause Effects of Sampling Programs Can Help Create or Hurt Development of the Desired Food Safety Culture - The Purpose of Food Safety Management is not to Create Programs, but to Create The Desired Food Safety Culture Maturity Models
Today with many, yesterday with a few LET S LOOK AT THE TYPICAL ENVIRONMENTAL CONTROL PROGRAM
Typical Environmental Monitoring Program List of sites in Zone 2 & 3 Sites are selected randomly Some sites sampled weekly, some monthly - Positive results initiate intensified sanitation followed by For Cause Investigation Verification by 3 Ls- in a row Infrequent periodic investigation sampling outside of above program - Positive results initiate intensified sanitation followed by For Cause Investigation Verification by 3 Ls- in a row Zone 1 and Product sampling done with extreme caution
Deploys Investigative Sampling, Indicator sites as well as Verification Sampling SEEK & DESTROY PROCESS
Production Dry clean Break Disassemble Rinse Production Foam Verify Control Break Production Break Production Break When to Sample? Sampling Objective Effectiveness of Sanitation Production Setup Sanitize Inspect Looking for LS Rinse Growth Niches Sanitize Break Assemble 7
Verification Monitoring Program Find the organism in motion as it is being transferred from a harborage site to the product Routine program to verify the effectiveness of the sanitation process control program; includes sampling of: - Product - Zone 1, 2, and 3 environmental sites during operation in the RTE area. This program is used for regulatory compliance Part of the USDA establishment s HACCP or SSOP program For FDA plants, measures the effectiveness of the Preventive Controls deployed
Pillars of Microbiological Process Control Technology 1. Eliminate the organism from Exposed Product Area 2. Control Transfer of the Organism 3. Deploy Process Management Techniques These work whether you have a kill stop or not to eliminate any persistent resident strain
Eliminate the Organism From the Exposed Product Area
Operational Definition Corrective and Preventive Action Harborage site(s) located [Seek] Organisms in Harborage sites eliminated with an intervention [Destroy] Site(s) either redesigned to eliminate growth niche or managed with Preventive or Predictive Intervention [Process]
Prevent Movement of the Organism
Plot Pathways of Movement Common Vectors - People - Equipment - Materials - Product Mark on a plant blueprint with equipment in place each of these vectors. The marked pathways define the primary Verification site locations. Drains - Next plot water flow from sources to drains
Plot Pathways of Movement The marked pathways define the primary Verification site locations. Flow from source to drains defines pathway of movement to drain. The top surface and floor juncture of drains are included as Verification Sites
Control of Transfer Vectors Sanitary Design 101 Distinct Hygienic Zones are established in the facility Physical separation (raw from RTE) or from one hygienic zone to another o Personnel, equipment & material flows are controlled to reduce hazards: Water accumulation is controlled inside the facility Sanitation GMP s Operational GMP s are designed and executed to establish control and to prevent cross contamination from hygienic zone to hygienic zone and to control the movement of the organism within a hygienic zone.
Adequate hurdles (e.g., doorway foamers, boot washers) are provided at locations as required to maintain zones of control
Barrier Wall Concept with Zones of Risk Control Receiving Initial Prep Zones with no wood or cardboard Secondary Prep Filling Pkging Gow ning room with sole scru bber Gow ning room with sole scru bber Gow ning room with sole scru bber Secondary Veg Prep Dump er Conv eyor to flume First flume 2nd flume Filling and Packaging Product Prep Dice, Comitrol etc. Receiving - Storage Barrier wall Initial Veg Prep Barrier wall Filling and Packaging Mix Product Transfer Filling and Packaging Product Prep Dice, Comitrol etc. Dump er Conv eyor to flume First flume 2nd flume Filling and Packaging Barrier wall Packoff Barrier wall Transfer Packoff casing and Conveyor palletizing Transfer Packoff casing and Conveyor palletizing Transfer Packoff casing and Conveyor palletizing Secondary Packaging Cartoning, Casing and Palletizing
Process Management
We ve all heard: You are not sampling hard enough, if you are not finding positives
Operational Definitions For Cause Investigation The purpose of a For Cause Investigation is to find the root cause of a Verification Site positive - A For Cause Investigation is triggered by a Verification Program positive (Product, Z1, Z2 or Z3) Verification program by definition measures the effectiveness of the plant s Sanitation Process Control System or the Environmental Control Program - Example: Food Safety has been compromised by a product positive Food Safety may be potentially compromised by a Z1 Ls positive Investigation following a Z2 or Z3 Ls Verification Site positive For Cause Investigation is conducted in response to a positive finding that calls into question the effectiveness of the control system
The Effect of Verification Driven Control Product Positive Contact Surface Positive Verification Site Positive Food Safety System Failure - Reassess
Define Indicator Sites that are Early Warning Predictors of the Loss of Control POSITIVES CAN BE A SUCCESS! We want a reason to buy pizza!
Sampling Methods to Control Environmental Pathogens Indicator Sites Verification Monitoring Pathogen Control
Operational Definitions Preventive Control (Not For Cause) Investigation Food Safety has not been compromised - Examples: Samples taken to find a new growth niche Samples taken to find a new transfer vector / pathway Samples taken to establish or qualify a hurdle or barrier system Samples taken to establish a monitoring procedure or process Samples taken to assess or characterize risk of a control procedure, part of facility or process change
Operational Definitions Preventive Control (Not For Cause) Investigation Food Safety has not been compromised - Examples: Can be triggered by a Z2, Z3 or Z4 indicator site positive. These indicator sites are strategically located in close proximity to a known growth niche, barrier or hurdle. Movement of the organism from the indicator site through a verification site or area would be required before violation of food safety. These indicator sites over time measure the strength of the barrier or hurdle or the effectiveness of the management of growth niches
Operational Definitions Preventive Control (Not For Cause) Investigation Food Safety has not been compromised - Examples: Seek and Destroy Investigation on a new piece of equipment to develop sanitation methods and identify potential areas of risk Seek and Destroy Investigation on a piece of equipment that has been in operation without any linked Verification positives. The purpose of this investigation is to measure effectiveness of sanitation methods below the normal level of disassembly. Investigative sampling to identify optimal locations for placement of indicator sites in either Z3 or Z4 Measurement of risk in Z4 area
Cause & Effect 1. The punitive effect of Verification Only monitoring programs a) Creates excessive firefighting b) Fails to promote a Preventive Mindset and a strong Food Safety Culture 2. Sampling Programs can be designed to create success when positives are found. 3. Aggressive sampling techniques can aid in discovering problems before contact surfaces or product are engaged. 4. Data from Sampling Programs is used to measure the application of Preventive controls Nothing succeeds like success Alexandre Dumas
Sources of Ls in High-Risk RTE Area Transferred from Zone 4 area outside of the High-Risk RTE area - Homeless, but looking for a harborage location - Typically found with a transfer point monitoring positive - On incoming product Growth niches within High-Risk RTE area 1. This means they are established, and have found a protective home in equipment or facility. 2. They may exist in a transient home such as rework pans, trash containers or other difficult to clean mobile container / environment.
Seek and Destroy Systematic approach to finding sites of persistent growth ("niches") in food processing plants Environmental sampling with follow up on every positive sample Goal is to either eradicate or mitigate effects of niches Seek and Destroy can be applied to specific equipment (e.g., new equipment qualification) or the facility as a whole
Tools in your toolbox INVESTIGATION METHODS
Complete Disassembly
Doubtful to Internalized THE EVOLUTION OF THE S&D PROCESS
The Food Safety Culture Journey Preventive Predictive Enlightenment Awareness Internalized Credit to Dr. Lone Jespersen Formerly Maple Leaf Foods now Cultivate Food Safety Firefighting Intensity
Seek & Destroy Maturity Model Listeria Control in Processed Meats Stage 1 Doubt Stage 2 Awareness Stage 3 Enlightenment Stage 4 Preventive Stage 5 Predictive No testing or only testing as required to meet regulatory requirements Think Blue Bell, Bars and Stripes.. Initially sampled finished product, then some contact surfaces and environmental sites Environmental sampling and corrective action resulted in giving the drains to Listeria. Growth niches recognized in both equipment and facilities Interventions developed and applied to manage growth niches. Sanitary design applied to eliminate. Comprehensive indicator site process controlling facility and equipment growth niches combined with hurdles and barriers to control transfer pathways. Indicator sites used to measure risk and signal when to apply intervention or
Listeria Control in Processed Meats There has been no linked illness or death from a US federally inspected plant since 2003 Stage 1 Doubt Stage 2 React to Stage 3 Know of Stage 4 Predict Stage 5 Internalize No testing or only testing as required to meet regulatory requirements Mid 80 s to early 90 s Sampled finished product And contact surfaces Environmental sampling and corrective action resulted in giving the drains to Listeria. Growth niches recognized and harborage sites either redesigned or managed with interventions Timeframe 90 s Late 90 s to early 2000 AMI Lm workshop started in 2000 AMI Board declared Food Safety noncompetitive in 2001 Interventions applied when needed based on indicator sites Comprehensive indicator site process controlling facility and equipment growth niches combined with hurdles and barriers to control transfer pathways Mid 2000 s 2010
Stage 1 Doubt Listeria Control in FDA Regulated Production Stage 2 Awareness Stage 3 Enlightenment Stage 4 Preventive Stage 5 Predictive No testing or only testing as required to meet regulatory requirements Think Blue Bell, Bars and Stripes.. Zone 2 & 3 sites randomly sampled. Positive results trigger intensified cleaning of affected area followed by investigative vector sampling. Most of sampling done at preop or early in production run Growth niches recognized in both equipment an. Some minor amt sampling towards end of production d facilities Interventions developed and applied to manage growth niches. Sanitary design applied to eliminate. Comprehensive indicator site process controlling facility and equipment growth niches combined with hurdles and barriers to control transfer pathways. Indicator sites used to measure risk and signal when to apply intervention or strengthen hurdle
Hygienic Zoning Maturity Model Listeria Control in FDA Regulated Production Stage 2 Awareness Product stream only. Perimeter hurdles applied equally Stage 3 Enlightenment Recognition of more positives in less processed areas. Product streams of varying risks comingled Stage 4 Preventive Products of varying risk separated. Physical barriers with hurdles separate processes as microbial reduction occurs Stage 5 Predictive Comprehensive indicator sites measure effectiveness of hurdles and barriers to control transfer pathways. Indicator sites used to measure risk and signal when to apply intervention or strengthen hurdle
Maturity Model Listeria Control in FDA Regulated Production Hygienic Zoning Hygienic Zoning of Transient Equipment Utensils, tools, product containers & material handling equipment Stage 2 Awareness Product stream only. Perimeter hurdles applied equally No separation Stage 3 Enlightenment Recognition of more positives in less processed areas. Product streams of varying risks comingled Receiving equipment separated from packaging equipment. Product containers mostly comingled among all zones Stage 4 Preventive Products of varying risk separated. Physical barriers with hurdles separate processes as microbial reduction occurs Interventions developed for high risk items. High risk items separated from other processing areas Stage 5 Predictive Comprehensive indicator sites measure effectiveness of hurdles and barriers to control transfer pathways. Indicator sites used to measure risk and signal when to apply intervention or strengthen hurdle Hygienic zones established with strict separation. Interventions applied based indicator sampling results for large items. Scheduled interventions for product containers. Tools and utensils have daily or more frequent interventions applied.
My Perception of Activities Listeria Control Current Products without a Kill Step Stage Doubtful React to Know of Preventive Internalize Behavior: QA Samples not to find organism. Behavior: Retesting of positive sites after enhanced sanitation at positive site Effects driven Behavior: Lots of firefighting. Problems do not go away. Looking for root cause Behavior: Investigative facility based positives dominate RTE. S&D team actively seeks out growth niches and applies interventions. Z4 positives Cascading hurdles Behavior: S&D Team conducts Not For Cause Investigations and constantly monitors Indicator Sites for trends. Interventions applied when and where data indicates need. Intervention Hurdles and Interventions: Some minor reduction Hurdles and Interventions: Whole genome sequencing moves research to farm and packing houses. Preventive controls evolve. Hurdles and Interventions: Most significant issues are addressed by preventive measures
Visual Evidence of the Maturity Level of Organizational Process Thinking & Environmental Monitoring Awareness Doubt Enlightenment Firefighting Preventive Firefighting. Ls+ repeatedly found but not eliminated Predictive Interventions & Preventive measures and designs exist. Root causes are identified. Preventive practices are understood by the workforce as such Process design is simplified. Error rate is low Variation is measured and managed
If employee line of sight is not created to the Company Mission and Corporate Strategy then buy-in and a commitment to Food Safety is not generated Culture eats Strategy for Breakfast FOOD SAFETY CULTURE MATURITY DRIVES MICROBIOLOGICAL PROCESS CONTROL -- or -- MICROBIOLOGICAL PROCESS CONTROL DRIVES FOOD SAFETY CULTURE MATURITY
Summary of Lessons Learned 1. Growth niches can be identified and eliminated or managed. 2. Transfer points & pathways can be identified and their effect minimized with GMP practices 3. Sampling techniques such as post rinse sampling can aid in discovering problems before contact surfaces or product are engaged. 4. Sanitation Process Control Critical Factors can provide the basis for attaining and maintaining control of microbial contaminates in High-Risk RTE areas.
Summary of Lessons Learned 5. The regulatory environment is going to be very challenging due to DNA linkage and new requirements 6. We must continually build our consumers confidence in our Food Safety system a) Food Safety incidents, Recalls, Bad Press in our Food Supply System is bad for all in the System i. None of us benefit by another s loss of control 7. We must share Best Practices and Preventive Designs
Questions? Thank you Food Safety Consulting Focused to Prevent "John Butts" foodsafetybydesign@gmail.com 219-718-5640 United Fresh PMA Listeria Workshop July 2017