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Eurofins Scientific — Technical Presentation (August 2021)
34 slides from Eurofins Scientific's technical presentation, Aug 5, 2021
Slide 1: Root Cause Investigation, Assessment, and Analysis for Fresh Produce
Root Cause Investigation, Assessment, and Analysis for Fresh Produce Eurofins Webinar Series • Root-Cause Analysis (RCA) 5 August 2021 • General with a fresh produce slant • Hazard analysis and risk assessment • RCA/Environmental assessment • Case study examples Trevor Suslow, Ph.D. Emeritus Extensi
Slide 2: Root Cause Investigation, Assessment, and Analysis for Fresh Produce
Root Cause Investigation, Assessment, and Analysis for Fresh Produce • Quality • Condition • Foodborne pathogen • Response to outbreak • Response to recall • Response to stock recovery • Response to preharvest field destruct
Slide 3: Why Engage in a Root Cause Investigation?
Why Engage in a Root Cause Investigation? • Cost of failure to prevent a repeat(s) • Beneficial to systems improvements even if inconclusive • Quality management is often a co-benefit • Business viability protection • Brand • Commodity • Category • Region • Take long-term view of cost … Crop destruc
Slide 4: Is RCA for Fresh Produce Really that Different?
Is RCA for Fresh Produce Really that Different? I would argue YES! • Highly variable environmental conditions • Highly variable inputs • Readily impacted by surrounding, uncontrolled activities • Preharvest conditions cannot always be replicated for RCA • Variable to highly variable product traits •
Slide 5: Produce Root-Cause Analysis (RCA)
Produce Root-Cause Analysis (RCA) • Each site: operation tends to be unique • Hazard(s) may be well known but risk isn’t • Seasonally inconstant or inconsistent • Sources of product • Environments, Climate, Weather • Changes in product traits with storage • Product traits and handling variation • Mu
Slide 6: Systematic Root-Cause Assessment & Analysis
Systematic Root-Cause Assessment & Analysis Probability Prevalence of exposure Risk Hazard Outcome Severity Probability of • Contamination Concentration • Persistence • Amplification
Slide 7: Fresh Produce Root Cause Investigations Are Generally Not Definitive
Fresh Produce Root Cause Investigations Are Generally Not Definitive • Not always a clear and singular factor • Complicated and complex interactions in open environment and variable process controls • Predicating factors no longer present • Incomplete or inadequate records or monitoring • Monitoring
Slide 8: Produce and CAFO contamination pathways diagram
FOOD CROP Water Sources ON-FARM COMPOST Soil WATER GROUND STORAGE & WATER OFF-SITE Amendments LEAFY GREEN DISTRIBUTION CROPS FIELD A CANAL & COMPOST SURFACE RUNOFF ON-SITE Foliar WATER HARVEST AEROSOL PACKAGING Sprays Mortality TYPICAL management ? Sick Pen and CORE-IN-FIELD AEROSOL Location and com
Slide 9: RCA – Where to start?
RCA – Where to start? Define the problem Identify an underlying cause Develop a catalyst hypothesis
Slide 10: After Defining the Problem – Define the Goals
After Defining the Problem – Define the Goals Reassess - Hypothesis Refine generation Are we sure we know the problem? Why did it happen? Analyze-Test- Evaluate Should it have been preventable? What will be done to prevent reoccurrence? What lessons were learned – multi-party What preven
Slide 11: Critical Path Analysis May Take Several Converging Investigative Legs
Critical Path Analysis May Take Several Converging Investigative Legs Testing Forensic Observational Root Cause • WAG Incident • Best guess Interviews • Confirmed Definition Records and Fact and Data Documents Alignment
Slide 12: Critical Path Analysis May Take Several Converging Investigative Legs
Critical Path Analysis May Take Several Converging Investigative Legs Testing Fact and Data Alignment • Acute Incident Forensic • External Data Observational Root Cause • Internal Data Trends • WAG • Locations • Best guess Incident • Timelines Interviews • Confirmed Definition • Activities and Pract
Slide 13: Critical Path Analysis May Take Several Converging Investigative Legs
Critical Path Analysis May Take Several Converging Investigative Legs Testing Testing – retained or investigative • Product • Environment – Pre and Postharvest • Equipment Forensic Observational Root Cause • Process Controls • WAG • Training Incident • Best guess o Compliance Interviews Definition •
Slide 14: The Practical Root Cause Assessment Process: A Real Case Example
THE Problem Identification PRACTICAL Predicating Factors ROOT CAUSE ASSESSMENT Root Cause 1◦Determination PROCESS: A REAL CASE Root Cause Resolution EXAMPLE Verify and Evolve
Slide 15: Case Example: Consecutive Preharvest STEC Detection
Case Example: Consecutive Preharvest STEC Detection Problem Predicating Root Cause Root Cause Verify and ◦ Identification Factors 1 Determination Resolution Evolve Repeat STEC Nearby STEC detected positives on riparian zone in tailwater ditches organic tender greens Preceding crop - carrots
Slide 16: Case Example: Consecutive Preharvest STEC Detection
Case Example: Consecutive Preharvest STEC Detection Problem Predicating Root Cause Root Cause Verify and ◦ Identification Factors 1 Determination Resolution Evolve Evidence of Repeat STEC Nearby animal feeding positives on on remaining riparian zone carrots organic tender greens Preceding cr
Slide 17: Case Example: Consecutive Preharvest STEC Detection
Case Example: Consecutive Preharvest STEC Detection Problem Predicating Root Cause Root Cause Verify and ◦ Identification Factors 1 Determination Resolution Evolve Evidence of animal feeding Anticipate Repeat STEC Nearby on remaining attractant positives on riparian zone potential carrots or
Slide 18: Case Example: Consecutive Preharvest STEC Detection
Case Example: Consecutive Preharvest STEC Detection Problem Predicating Root Cause Root Cause Verify and ◦ Identification Factors 1 Determination Resolution Evolve Evidence of animal feeding Anticipate Confirm non- Repeat STEC Nearby on remaining attractant detect STEC positives on riparia
Slide 19: Five Whys - Cantaloupe shipment rejected for cause
Problem FIVE WHYS - Cantaloupe shipment rejected for cause WHY? Salmonella detected on late season cantaloupe WHY? Unusual but plausible risk of harvest operation cross-contamination Overripe and damaged fruit in furrows (typical) in WHY? contact with probable Salmonella contaminated irrigation sour
Slide 20: EX: Building a Fishbone Diagram
EX: Building a Fishbone Diagram Step 1: Define a problem or issue; develop initial hypothesis Step 2: Construct the skeleton of a fishbone, and name each of the spines coming out of the “backbone” • EX: Measurements, Materials, Personnel, Environment, Methods, Machines • EX: Preharvest – Postharvest
Slide 21: Model Fishbone Diagram for Whole Bulb Dry Onion
Model Fishbone Diagram for Whole Bulb Dry Onion PRODUCTION Pre-plant Production Transport ul Preparation ? Direct Seed? Field Holding Transplant? Lot Definition and Tracking Weather Harvest Soil Traits Amendments Adjacent land risk’ Hand Harvest? purstiade? Labor Availability? Aerosols and Dust Mode
Slide 22: Model Fishbone Diagram PRODUCTION
PRODUCTION Model Fishbone Diagram Site Harvest Pre-plant Production Harvest Transport Selection Preparation Soil Traits Direct Seed Maturity Trigger Mechanized Harvest? Field Holding Prior crops or Transplant Weather Events Machine Assist Harvest? Amendments Lot Definition Adjacent crops Irrigation
Slide 23: Failure to recognize a hazard limited effectiveness of fishbone exercise
Failure to recognize a hazard limited effectiveness of fishbone exercise…one team member missing
Slide 24: Water Conveyances, Linkages, Cross-Connection Potential
Water Conveyances, Linkages, Cross-Connection Potential
Slide 25: Pipe from irrigation well and water linkage diagram
Gate valve in pipe Fresh water between tail water Pipe from reservoir pond and sump pump irrigation well supply gate Pipe connecting irrigation system of Dairy 1 & 2 Supply pipe to fields located on south Gate valve to allow east side of gravity drain from Wildwood Field 213 at Dairy 1 to the lift s
Slide 26: In outbreak RCA, contamination may not be the practical root cause
In outbreak RCA, contamination may not be the “practical root cause” • Zero contamination may be the goal • Not necessarily realistic • Co-factors key in consequence and severity • Root cause in failures to maintain produce handling equipment to prevent injury
Slide 27: RCA led to Seek and Destroy and discovery of established Listeria
RCA led to “Seek and Destroy” which led to discovery of established Listeria within in recirculation system filters - Established an EMP - Daily antimicrobial treatment - Quarterly shock treatment and deep-clean
Slide 28: QA/QC tables
Fans Cold room Cold room Packing and Degreening Packaging rooms Washed O.N. precooler Cold room Bins Drain Drain Drain Emptied bin stacking to washer Stairs Incoming Bin Receiving BIN DUMP UV Dark room Bin Drain Washer HP Shipping Area BIN Hand sort Custom Break Area Wash DUMP bagger Drain from O.N.
Slide 29: QA/QC tables
Fans Cold room Cold room Drain Packing and Degreening Packaging rooms Washed O.N. precooler Cold room Bins Drain Drain Drain Emptied bin stacking to washer Stairs Incoming Bin Receiving BIN DUMP UV Dark room Bin Drain Washer HP Shipping Area Bin Dry Hand sort Custom Break Area Wash DUMP bagger Drain
Slide 30: Have a plan to triage each incident
Have a plan to triage each incident • Every RCA effort is not always “profitable” • What is the likely knowledge gain? • How reliable is the information available? • How much effort (generally testing) is worth the investment? • Have a plan or threshold to pull the plug • Sometime a good-enough deci
Slide 31: A Comprehensive Farm-to-Fork Risk Assessment could prevent the need for RCA
A Comprehensive Farm-to-Fork Risk Assessment could prevent the need for RCA Prevalence Probability of PF PP PR Exposure FARM PROCESS RETAIL HOME RISK CF CP CR Probability of Concentration Infection Lammerding, A. 2000.
Slide 32: RCA Guidance for the Produce Industry
JUST OUT JULY 7, 2021 Link to PDF RCA Guidance for the Produce Industry How to do RCA
Slide 33: Just Informational: freeware tools to help get organized
Just Informational: There are good and adaptable freeware tools to help get organized
Slide 34: Thank you for your attention
Root Cause Investigation, Assessment, and Analysis for Fresh Produce Eurofins Webinar Series 5 August 2021 Thank you for your attention Trevor Suslow, Ph.D. Emeritus Extension Research Specialist UC Davis, Dept. Plant Sciences tvsuslow@ucdavis.edu tvsuslow@gmail.com
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