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Transforming the Cold Chain


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Module One of six modules on cold chain supply

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Transforming the Cold Chain

  1. 1. Module One
  2. 2. Standards and Technology for Maintaining Food Safety in Food Transportation Cold Chain Processes Transportation Food Safety Training, GAP Analysis and Certification Services (
  3. 3. Workshop Schedule 08:30 Registration 09:00 Workshop commences 10:30 Morning refreshments and coffee break 11:00 Workshop re-commences 12:30 Luncheon 13:45 Workshop re-commences 16:00 End of Workshop
  4. 4. Instructor Dr. John M. Ryan Retired Administrator Hawaii State Department of Agriculture Quality Assurance Division
  5. 5. Dr. John Ryan is the retired quality assurance administrator for the Hawaii State Department of Agriculture and the owner of Ryan Systems, Inc. He has spent 30 years designing and implementing quality and operational control systems for international companies throughout Asia and the U.S. Ryan Systems specializes in helping select monitoring technology and designing the systems required for establishing food safety systems for the transportation sector. The company provides certification, gap analysis, training, planning and consulting services for companies in need of controlling food sanitation, traceability and monitoring during transportation processes. The company owns and operates three websites: http://www.SanitaryColdChain provides training and certification audit functions for food carriers, maintenance stations and companies that transport food. is focused on consulting to help select food transportation traceability systems. provides training and planning services for food supply companies to use their current quality systems to establish and maintain systems that combine quality and food safety into a single system.
  6. 6. • Technology and Costs • Impact of the U.S. Food Safety Modernization Act (FSMA) • Current and emerging International Transportation • Food Safety Guidance and Laws • Hard Data: What happens during cold chain food transportation • processes: Farms, air, ship, truck, trays, bins • Management, HACCP implementation, sanitation, traceability standards and record keeping requirements • Implementing an auditable system • Return on investment and marketing advantages • The future of cold chain transportation food safety We will cover
  7. 7. Transportation Delivery Controls Sanitation and Traceability Dr. John M. Ryan (808) 469-0046 Module 1
  8. 8. Welcome to class!
  9. 9. Ask questions any time.
  10. 10. What is your job title: What is our company’s primary function? Why are you in this training? Your name: Your email address: Data
  11. 11. Agenda • Some Definitions • Food Safety Modernization Act (food handling, transportation) - import, local and export • International food safety and temperature controls • The Cold Chain • Transporter, carrier and maintenance station standards • Sanitation and traceability technologies • Temperature tracking sensors that communicate via RFID • GPS tracking to provide the "ANYWHERE" data and GSM to communicate ANYTIME • Real-Time cold chain traceability approaches • Return on investment (ROI) issues • Plastic pallets: costs, weight, recycling, cleaning, food safety • Continuous improvement controls • Capturing data from the grower pallet loop • Intelligent routing configuration from cooling, at the distribution center and during transit • How the system can be designed to provide anytime/anywhere transportation control data Food on the move
  12. 12. Cold Chain Market is Poised to Grow at a CAGR of 13.2% & to Reach $157,142.2 Million by 2017 New Report by MarketsandMarkets
  13. 13.
  14. 14. CONTAINER: Any device used to transport food or food products between or among distant operations. Containers include bins, trays, pallets, trucks, truck trailers, shipping containers and other similar devices and are used to move or hold food on the move. The term “device” excludes what is commonly referred to as packaging. CARRIER: Any company or individual responsible for the transportation of food and food products MAINTENANCE STATION: Any company involved in the sanitation or traceability implementation for carriers or containers. FOOD SAFETY: Freedom from adulterants including chemical, bacteriological, radiological, or metal, glass, wood, etc. FOOD QUALITY: Appearance (commodity standards), taste and nutrition A Few Definitions
  15. 15. System Goal Homeostasis A process in which the body's internal environment is kept stable. View transportation as a process – Farm to Fork
  16. 16. The idea of limited responsibility for food safety and quality as food moves through the supply chain is dying out. “One Up and One Down” One up and one down is dead!
  17. 17. Harvest to Bins Truck (Reefer) Distributor (Wholesale) Truck (Shipping Container) Pallet Packing House (Cold) Ship Chiller Dock LoadTruck Dock Unload Re-Pallet Distributor (Wholesaler) Truck ChillerStore Shelf (Remaining Shelf Life) Car PurchasePrep- Cook RefrigeratorYum! The Cold Chain
  18. 18. Prevention Versus Corrective Action Prevention requires causal analysis and removal of causes. Corrective action means to get a quick fix in place to stop and control escaped products. Generally considered a material review board (MRB) activity. (More later)
  19. 19. Quality Control and Food Safety Quality Control to provide stability and control over transportation processes Food Safety to prevent adulteration of food in short and long transportation processes Current food safety certification activities are moving towards applying both food safety and quality control principles and practices into “food safety” certification.
  20. 20. Exercise 1. Draw a quick flow of your transportation process 2. On your drawing, make notes showing how you control the process. You may show inspections, temperature measurements, food safety certification points at farms, distributors, etc. or other details that you know about.
  21. 21. What’s wrong with this picture?
  22. 22. What’s wrong with this picture?
  23. 23. Water Soil Produce FARM USHI9Y4 Pesticides and Chemical Fertilizers Microbial Unknowns Samples Lab Analysis Primary Risk Assessment (1) Site Visit Risk Assessment Food Safety Certification (3) Certification Auditor Central Hosted System (5) System Reports Distribution Center Restaurant Retailer Public ID # Access USHI9Y4 Food Supply Chain Traceability System (2) Real-Time Biosensors & Temp/Hum Sensors (4) VBA Marketing Capabilities 23 Think “System”
  24. 24. The Warm Chain Countries with no or limited refrigeration: Duration = 1 Day Distance = Less than 50 miles Distribution = Simple 1. Harvest 2. Market 3. Preparation 4. Eat The Cold Chain Duration = Shelf Live Distance = Thousands of Miles (international) Distribution = Complex Evolution of Food Transportation Models
  25. 25. Three primary factors cause food suppliers to adopt food safety measures: Market Forces – Risk of recall forces buyers to purchase from safety certified sources (Customers can’t afford to pay for your problems) (Standards like ISO 22000 cascade downward) Product Liability – You are liable for what you buy and sell. Insurance costs go up as suppliers are forced to pay for recall and food safety coverage – lawyers get rich. Food Safety Laws and Regulations - Government involvement and oversight increases (HR 2749, SB 510 = FSMA)
  26. 26. The U.S. Food Safety Modernization Act Impact to the Entire Food Chain A. From Farm-to-Retail B. Local and Imported (Same Requirements) C. Heavy Fines ($244/Hour for Inspection) D. Stoppage of shipments “Suspected” of adulteration E. Vicarious Liability (is Shared - Top to Bottom) F. New Documentation Requirements to prove all handlers control their suppliers and all trucks, bins touching food are sanitized, tracked and controlled. Enhanced Tracking and Tracing and Recordkeeping of Food and Containers Provisions for secure electronic data sharing Pallet level Temperature Control Monitoring for produce food safety, frozen foods, etc. (HACCP)
  27. 27. Establishment of Plans Focused on Hazards and Prevention Hazard Analysis Preventive Controls (Causal Analysis) Monitoring Corrective Action Verification Record Keeping FSMA: Importing to the U.S. Critical Control Points (CCP) Debate Goal: Reduce risks to human health and prevent deaths
  28. 28. Appropriate temperature control during transport; Sanitation, including: Monitoring and ensuring the sanitation and condition of transportation vehicles as appropriate; Pest control; and Sanitation associated with loading/unloading procedures; Appropriate packaging/packing of food products and transportation units (e.g., good quality pallets, correct use of packing materials); Good communications between shipper, transporter and receiver; Employee awareness and training FDA Guidance for Industry: Sanitary Transportation of Food
  29. 29. Vicarious liability is a form of strict, secondary liability that arises under the common law doctrine of agency – respondeat superior – the responsibility of the superior for the acts of their subordinate, or, in a broader sense, the responsibility of any third party that had the "right, ability or duty to control" the activities of a violator. It can be distinguished from contributory liability, another form of secondary liability, which is rooted in the tort theory of enterprise liability. Product Liability is the area of law in which manufacturers, distributors, suppliers, retailers, and others who make (or grow) products available to the public are held responsible for the injuries those products cause From Wikipedia, the free encyclopedia Vicarious and Product Liabilities
  30. 30.
  31. 31.
  32. 32. Establishing Standards for Food Transporters
  33. 33. 33 Four Primary Container Standards Management HACCP Sanitation Traceability
  34. 34. Container Standards Container Maintenance Maintenance Capabilities Maintenance Stations • Independent Sanitation (Wash) • Company Owned Sanitation • Independent Traceability/Monitoring • Company Owned Traceability/Monitoring
  35. 35. 1. Is there a documented container sanitation and traceability policy detailing the company's commitment to safe food transportation? 2. Is there a container sanitation and traceability component to the company's food safety manual? 3. Is there a detailed organizational structure chart of all employees whose activities affect container sanitation and traceability? 4. Is there a specific individual named with primary responsible for container sanitation and traceability? 5. Is there evidence of an annual container sanitation and traceability system review by management level personnel? 6. A container sanitation and traceability HACCP Plan exists and is reviewed annually: Auto Fail if no HACCP Plan 7. Does a system for maintaining HACCP records exist? 8. Is there a numbering and filing system that makes container sanitation and traceability procedures easy to find? System Management Standards (1)
  36. 36. 9. Filing system is organized to include HACCP, management, sanitation and traceability. 10. Container records are inspected to determine records maintenance and accuracy. 11. Preventive planning and implementation activities include causal analysis, cost analysis, action plans, measurement and implementation results. 12. Preventive action program activities are recorded. 13. The preventive action component establish elimination of causes as a primary goal. 14. A system for corrective action records is maintained. 15. Data for proof of prevention is available. 16. Container records merge container ID, sanitation and traceability and corrective action information electronically for fast recall. 17. Container sanitation and traceability records are maintained for at least two years? System Management Standards (2)
  37. 37. HACCP • • Analyze hazards (contaminants, adulterants) • • Identify critical control points • • Establish preventive measures with critical limits for each control point • • Establish procedures to monitor the critical control points • • Establish corrective actions to be taken when monitoring • • Establish procedures to verify that the system is working • • Establish effective recordkeeping
  38. 38. Container HACCP Standards (1 – Planning) •A HACCP Plan exists •The plan is supported by procedures •A support team is in place •HACCP training is ongoing •There is location specific information in all records •HAZARDS are identified •CCPs are identified •CRITICAL Limits are identified •Monitoring procedures assure critical limits are met •CORRECTIVE ACTIONS keep adulterated food out of commerce •RECORD KEEPING documents CCP monitoring •VERIFICATION ACTIVITIES are listed •VERIFICATION ACTIVITIES are implemented •HACCP plan is signed and dated
  39. 39. Container HACCP Standards (2 – Implementation) 1. MONITORING and RECORDKEEPING procedures are implemented. 2. RECORDS contain actual values obtained. 3. Data is recorded when collected. 4. RECORDS and timeframes are reviewed 5. RECORD formats meet general requirements are performed and documented. 6. CORRECTIVE ACTIONS are documented, taken, recorded reviewed, and prevent food from entering commerce. 7. PREVENTIVE ACTIONS are taken, documented and reviewed within timeframes. Instruments are CALIBRATED according to established procedures. 8. CALIBRATION RECORDS REVIEW are performed and assure procedural conformance. 9. VERIFICATION activities are performed include complaints, calibration, monitoring and records review and are documented. 10. CORRECTIVE ACTION is completed when required by VERIFICATION. 11. HACCP records are maintained for 2 years and available to copy.
  40. 40. Container Sanitation • Container Adulteration Prevention Planning • Container Sanitation Procedures • Containers have unique ID numbers • Records are maintained for each Unique Container ID Number • Container sanitation • Container Inspection • Inspection Data Sheets are available • If Fail, containers are sanitized • Containers are tested for sanitation • If Fail, Containers are retested • Container ATP test data is required • Pre and Post Inspection Reports are Maintained • The water source is recorded • Wash water is tested against city standards on an annual basis • Water quality must meet city standards • Wash water temperatures are verified annually • Temperature measurement devices are calibrated • The container is pest free • Container is dedicated to food transportation
  41. 41. Transportation Controls
  42. 42. Truck Washout
  43. 43. Mobile Truck Washout
  44. 44. Harvest Bin Sanitizers
  45. 45.
  46. 46. Container Traceability • A container traceability system has been defined and is in place • Traceability plan • Responsibilities • Training plan • Competency • Monitoring • Records • Performance • Internal Audits • Management Review • Corrective Action • Recall procedures exist • Recall system has been tested • Pallet Level Traceability is functional • Container Tampering • Container accident control procedures exist • Container accident control records exist
  47. 47. 47
  48. 48. Farm to Retail Stream
  49. 49. 49 Load Pallet Tag Cases With Bar Code Tags RFID Temp-Tag Pallet Pallet Ship Read Data Parent-Child RFID/BarCode Data Relationship Established Farm Level Handheld Local Know-The-Flow Database At the Farm
  50. 50. 50 RFID Pallet Tag Temp Reads Pallet Tag Reads at Dist Center Incoming Pallet Tag Reads at Dist Center Cooler-In Transit Parent-Child RFID/BarCode Data Relationship Established Portal Portal Handheld RFID Temp-Tag Pallet Outgoing Pallet Build Local Know-the-Flow Database TaggedCases With HarvestMark Bar Code Tags ReadData Cooler/ShipOut Distribution Center Distribution
  51. 51. Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Chain Know-the-Flow Database Retail Tracking
  52. 52. 52 Load APP Pallet Tag Cases With HarvestMark Bar Code Tags Intelleflex RFID Temp-Tag Pallet APP Pallet Ship Read Data Intelleflex RFID APP Pallet Tag Temp Reads Intelleflex Pallet Tag Reads at Dist Center Incoming Intelleflex Pallet Tag Reads at Dist Center Cooler-In ezTRACK or Internet Primary Tracking Database Parent-Child RFID/BarCode Data Relationship Established Farm Level Transit Parent-Child RFID/BarCode Data Relationship Established Handheld Portal Portal Handheld Intelleflex RFID Temp-Tag APP Pallet Outgoing Pallet Build Local IFSS Database Local IFSS Database TaggedCases With HarvestMark Bar Code Tags ReadData Cooler/ShipOut Distribution Center Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Outlet Incoming Handheld Retail Outlet Handheld Retail Chain IFSS Database Cold Chain Traceability
  53. 53. Pallet versus Container Tracking (Intermodal Monitoring) Pallet: Track from Farm into distribution using Pallet tags (and maybe case Level barcode tags) Container: ILC or RFID GPS Real-time satellite or RF
  54. 54.
  55. 55. What’s wrong with this picture?
  56. 56. Pallet (Plastic) Traceability
  57. 57. Container Level Traceability Technology
  58. 58.
  59. 59.
  60. 60.
  61. 61. Container Tracker with eSeal and Mapping
  62. 62. Financial Losses to the Industry: Waste Inspection Yield Culls Recalls Rejected Disposal Returned Loads Lost Customers The Supply Chain Ignores Losses Throughout
  63. 63. Supply Chain Loss Analysis
  64. 64. Summary
  65. 65. Why the waste?
  66. 66. Lack of or Improper Pre-cool Contributes to the Losses
  67. 67. Mexico to California – Truck 1031 Ambient Air INSIDE of FLAT (the real temperature to consider)
  68. 68. 1. Lots of temp variation during that early handling - and even on the ship - these warmer temps mean shorter shelf life - easily shorter by a few days. 2. Relative stability during sea transport – But lines trend upwards indicating that the pallet was warming during ship transportation for some reason. 3. Top of pallets are warmer than bottom - by up to 5 degrees F. Lack of Shipment Controls Add to Pre-cool Problems
  69. 69. Pallet Temperatures
  70. 70. Pallet Temperatures
  71. 71. Some Solutions
  72. 72. Intelligent Delivery Control Systems Real-Time GPS & Sensor Enabled Tracking & Detection Temperature Explosives Bacterial Contamination Shipper S/O Invoice 10 + 2
  73. 73. Receiving Docks Shipping Docks CoolerCoolerCooler Cooler Cooler P o r t a l P o r t a l P o r t a l P o r t a l CONFIG PO/SO Invoice 10 + 2 Tag Read StopTag Start Read Truck To Air Cargo At the Distribution Center RFID Fixed Readers RFID Fixed Readers GPS/GMS Read/Transmit En-route SAT/Cell Inbound Pallets Intelligent Routing Configuration PO/SO Invoice 10 + 2
  74. 74. RFID Temperature Sensor Waypoint Reads Train Ship Truck SAT British Telecom Cell GPS GMS Shipping Container (ID) Plastic Pallet RFID Tags GS1 HK GTS ARKNAV Module Explosive Sensor Contamination Sensor Tamper Detection Sensor (eSeal) DHS CBP IFS PO/SO Invoice 10 + 2 PO/SO Invoice 10 + 2
  75. 75. • Identity – What is it? • Location – Time/LAT/LON (Track) • Condition – Quality Control Requirements Temperature Cleanliness (Sanitation) • History – Records – Source/Handlers • Cost - ROI ILC
  76. 76. Real-Time Visibility
  77. 77. All Supplier, Reefer, Distributor, Store Data housed in Corporate Server Supplier Supplier Supplier Distribution Center Store Store Store Store Store Store Supplier Supplier Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer All Tag Temp/Time Data Available via BlueTooth ZigBee Systems
  78. 78. Supplier Supplier Supplier Distribution Center Store Store Store Store Store Store Supplier Supplier Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer All Tag Temp/Time Data Available via BlueTooth All Supplier, Reefer, Distributor, Store Data housed in Corporate Server Supplier Supplier Supplier Distribution Center Store Store Store Store Store Store Supplier Supplier Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer All Tag Temp/Time Data Available via BlueTooth Supplier Supplier Supplier Distribution Center Store Store Store Store Store Store Supplier Supplier Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer All Tag Temp/Time Data Available via BlueTooth Supplier Supplier Supplier Distribution Center Store Store Store Store Store Store Supplier Supplier Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer Reefer All Tag Temp/Time Data Available via BlueTooth ZigBee Systems
  79. 79. Receiver Repeater (Optional) Mobile Modules Facility Modules Facility Modules Receiver - USB Cable to PC or Laptop Network PCs ZigBee Systems
  80. 80. Reader Computer Facility Layout Supplier Distributor Store Floor Tag Cooler Tag Cooler Tag ReeferTag Tag ZigBee Systems
  81. 81. Maintenance: Container Sanitation and Test
  82. 82. Maintenance: Container Sanitation and Test
  83. 83. InterModal
  84. 84. ROI Issues Old Process (A) Define the process steps (flowchart or using the process SOP) Add up man hour and other costs for each process step Add up all costs for a single event (or sample and take the average). Proposed Process (B) Define the process steps for the “NEW” process Add up man hour and other costs for each process step Add up all costs for a single event If the new process is cheaper, try to figure out how many times per year that particular process is actually done (Estimate it!). Multiply that number by the new process cost for years 1, 2 and 3 (for both A and B). Subtract the cost of the Proposed Process from the cost of the Old Process (B-A) If B minus A is negative, the old process is cheaper (keep it). If B minus A is positive, the new process is cheaper – show your analysis to your boss. ROI Depends on Process Comparison Run ROI Calculations for Losses Due to Waste
  85. 85. Shipment & Tracking Results
  86. 86. GPS/Temp Tracking From So. Cal Farm to Port
  87. 87.
  88. 88. Capturing product event data (traceability information and temperature status) in real-time
  89. 89. 2nd GPS/Temp Trans-Pacific Tracking (7 Days) Consolidation Center (LA) Truck Pier On Board Receipt in HNL
  90. 90. Make container sanitation and traceability an installed part of the basic business strategy. It will help you sell more product. The Bottom Line
  91. 91. Exercise 2 1. Look at the drawing you made in Exercise 1. 2. On your drawing, show any changes you might make to your original drawings.
  92. 92. AFRIS. AsianFoodRegulationInformationService. We have the largest database of Asian food regulations in the world and it’s FREE to use. We publish a range of communication services, list a very large number of food events and online educational webinars and continue to grow our Digital Library. We look forward to hearing from you soon!